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1. Catheter-induced postextrasystolic potentiation in the assessment of severity of low-gradient aortic valve stenosis

Author: Dehghani, Payam, Singh, Jyotpal, Singer, Zachary, Booker, Jeffrey, Lavoie, Andrea J., Zimmermann, Rodney H., Shavadia, Jay S., Webb, John G., Clavel, Marie-Annick, Pibarot, Philippe, Dehghani, Payam, Singh, Jyotpal, Singer, Zachary, Booker, Jeffrey, Lavoie, Andrea J., Zimmermann, Rodney H., Shavadia, Jay S., Webb, John G., Clavel, Marie-Annick, and Pibarot, Philippe
Abstract: Background: Deciphering which patients with low-gradient aortic valve disease have severe stenosis can be difficult. We aimed to correlate the postextrasystolic potentiation (PESP) with dobutamine stress echocardiography and multidetector computed tomography in patients with low-gradient aortic valve stenosis. Methods: Patients with an aortic valve area ≤1 cm2 and a mean gradient <40 mm Hg were included. Aortic valve stenosis severity was assessed by a core lab with dobutamine stress echocardiography, followed by a multidetector computed tomography aortic valve score if indeterminate. A premature ventricular contraction was induced by intentional catheter contact with the myocardium within the left ventricle. PESP was calculated as a percent change of pre-to-post mean gradient. Multidetector computed tomography was used to measure the aortic valve calcification score, and subsequently, aortic valve calcification density. Results: Twenty-eight patients (age, 77±10 years; 19 female) were included. Dobutamine stress echocardiography increased mean gradient from baseline of 25±7 mm Hg to 36±11 mm Hg; pre-premature ventricular contraction mean gradient was 25±7 mm Hg and increased to post-premature ventricular contraction mean gradient of 32±10 mm Hg, representing a PESP of 24±11%. A ≥20% in PESP resulted in 100% sensitivity, 77% specificity, 83% positive predictive value, and 100% negative predictive value for diagnosing severe aortic valve stenosis. There was a significant correlation between PESP and projected aortic valve area and aortic valve calcification density (R=−0.64, P=0.0003; R=0.057, P=0.014, respectively). Conclusions: In patients with low-gradient aortic valve stenosis, catheter-induced premature ventricular contractions during cardiac catheterization causing ≥20% PESP has a 100% sensitivity for severe aortic valve stenosis. Validation of this 20% cutoff in larger groups with correlation to clinical end points is required.
Published: 2023

2. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation:A Propensity Score-Matched Comparison

Author: Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Scott Lim, D., Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean François, Von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, Joann, Modine, Thomas, Stone, Gregg W., Granada, Juan F., Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Scott Lim, D., Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean François, Von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, Joann, Modine, Thomas, Stone, Gregg W., and Granada, Juan F.
Abstract: Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35–0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62–1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondar, Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant red
Published: 2023

3. Timing of bioprosthetic valve fracture in transcatheter valve-in-valve intervention:impact on valve durability and leaflet integrity

Author: Meier, David, Payne, Geoffrey W., Mostaço-Guidolin, Leila B., Bouchareb, Rihab, Rich, Courtney, Lai, Althea, Chatfield, Andrew G., Akodad, Mariama, Salcudean, Hannah, Lutter, Georg, Puehler, Thomas, Pibarot, Philippe, Allen, Keith B., Chhatriwalla, Adnan K., Sondergaard, Lars, Wood, David A., Webb, John G., Leipsic, Jonathon A., Sathananthan, Janarthanan, Sellers, Stephanie L., Meier, David, Payne, Geoffrey W., Mostaço-Guidolin, Leila B., Bouchareb, Rihab, Rich, Courtney, Lai, Althea, Chatfield, Andrew G., Akodad, Mariama, Salcudean, Hannah, Lutter, Georg, Puehler, Thomas, Pibarot, Philippe, Allen, Keith B., Chhatriwalla, Adnan K., Sondergaard, Lars, Wood, David A., Webb, John G., Leipsic, Jonathon A., Sathananthan, Janarthanan, and Sellers, Stephanie L.
Abstract: BACKGROUND: Bioprosthetic valve fracture (BVF) can be used to improve transcatheter heart valve (THV) haemodynamics following a valve-in-valve (ViV) intervention. However, whether BVF should be performed before or after THV deployment and the implications on durability are unknown. Aims: We sought to assess the impact of BVF timing on long-term THV durability. METHODS: The impact of BVF timing was assessed using small ACURATE neo (ACn) or 23 mm SAPIEN 3 (S3) THV deployed in 21 mm Mitroflow valves compared to no-BVF controls. Valves underwent accelerated wear testing up to 200 million (M) cycles (equivalent to 5 years). At 200M cycles, THV were evaluated by hydrodynamic testing, second-harmonic generation (SHG) microscopy, scanning electron microscopy (SEM) and histology. RESULTS: At 200M cycles, the regurgitant fraction (RF) and effective orifice area (EOA) for the ACn were 8.03±0.30%/1.74±0.01 cm2 (no BVF), 12.48±0.70%/1.97±0.02 cm2 (BVF before ViV) and 9.29±0.38%/2.21±0.0 cm2 (BVF after ViV), respectively. For the S3 these values were 2.63±0.51%/1.26±0.01 cm2, 2.03±0.42%/1.65±0.01 cm2, and 1.62±0.38%/2.22±0.01 cm2, respectively. Further, SHG and SEM revealed a higher degree of superficial leaflet damage when BVF was performed after ViV for the ACn and S3. However, the histological analysis revealed significantly less damage, as determined by matrix density analysis, through the entire leaflet thickness when BVF was performed after ViV with the S3 and a similar but non-significant trend with the ACn. Conclusions: BVF performed after ViV appears to offer superior long-term EOA without increased RF. Ultrastructure leaflet analysis reveals that the timing of BVF can differentially impact leaflets, with more superficial damage but greater preservation of overall leaflet structure when BVF is performed after ViV.
Published: 2023

4. Explant vs Redo-TAVR After Transcatheter Valve Failure:Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

Author: Tang, Gilbert H.L., Zaid, Syed, Kleiman, Neal S., Goel, Sachin S., Fukuhara, Shinichi, Marin-Cuartas, Mateo, Kiefer, Philipp, Abdel-Wahab, Mohamed, De Backer, Ole, Søndergaard, Lars, Saha, Shekhar, Hagl, Christian, Wyler von Ballmoos, Moritz, Bhadra, Oliver, Conradi, Lenard, Grubb, Kendra J., Shih, Emily, DiMaio, J. Michael, Szerlip, Molly, Vitanova, Keti, Ruge, Hendrik, Unbehaun, Axel, Kempfert, Jorg, Pirelli, Luigi, Kliger, Chad A., Van Mieghem, Nicholas, Hokken, Thijmen W., Adrichem, Rik, Modine, Thomas, Corona, Silvia, Wang, Lin, Petrossian, George, Robinson, Newell, Meier, David, Webb, John G., Cheung, Anson, Ramlawi, Basel, Herrmann, Howard C., Desai, Nimesh D., Andreas, Martin, Mach, Markus, Waksman, Ron, Schults, Christian C., Ahmad, Hasan, Goldberg, Joshua B., Geirsson, Arnar, Forrest, John K., Denti, Paolo, Belluschi, Igor, Ben-Ali, Walid, Asgar, Anita W., Taramasso, Maurizio, Rovin, Joshua D., Di Eusanio, Marco, Colli, Andrea, Kaneko, Tsuyoshi, Nazif, Tamim N., Leon, Martin B., Bapat, Vinayak N., Mack, Michael J., Reardon, Michael J., Sathananthan, Janarthanan, Tang, Gilbert H.L., Zaid, Syed, Kleiman, Neal S., Goel, Sachin S., Fukuhara, Shinichi, Marin-Cuartas, Mateo, Kiefer, Philipp, Abdel-Wahab, Mohamed, De Backer, Ole, Søndergaard, Lars, Saha, Shekhar, Hagl, Christian, Wyler von Ballmoos, Moritz, Bhadra, Oliver, Conradi, Lenard, Grubb, Kendra J., Shih, Emily, DiMaio, J. Michael, Szerlip, Molly, Vitanova, Keti, Ruge, Hendrik, Unbehaun, Axel, Kempfert, Jorg, Pirelli, Luigi, Kliger, Chad A., Van Mieghem, Nicholas, Hokken, Thijmen W., Adrichem, Rik, Modine, Thomas, Corona, Silvia, Wang, Lin, Petrossian, George, Robinson, Newell, Meier, David, Webb, John G., Cheung, Anson, Ramlawi, Basel, Herrmann, Howard C., Desai, Nimesh D., Andreas, Martin, Mach, Markus, Waksman, Ron, Schults, Christian C., Ahmad, Hasan, Goldberg, Joshua B., Geirsson, Arnar, Forrest, John K., Denti, Paolo, Belluschi, Igor, Ben-Ali, Walid, Asgar, Anita W., Taramasso, Maurizio, Rovin, Joshua D., Di Eusanio, Marco, Colli, Andrea, Kaneko, Tsuyoshi, Nazif, Tamim N., Leon, Martin B., Bapat, Vinayak N., Mack, Michael J., Reardon, Michael J., and Sathananthan, Janarthanan
Abstract: Background: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. Objectives: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. Methods: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. Results: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis–patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). Conclusions: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis–patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar r
Published: 2023

5. TAVR in Bicuspid Aortic Stenosis:Current Evidence and Proposal for a Randomized Controlled Trial Design

Author: Nuyens, Philippe, De Backer, Ole, Sathananthan, Janarthanan, Højsgaard Jørgensen, Troels, Treede, Hendrik, Leipsic, Jonathon A., Bax, Jeroen J., Webb, John G., Mehran, Roxana, Chen, Mao, Reardon, Michael, Leon, Martin B., Søndergaard, Lars, Nuyens, Philippe, De Backer, Ole, Sathananthan, Janarthanan, Højsgaard Jørgensen, Troels, Treede, Hendrik, Leipsic, Jonathon A., Bax, Jeroen J., Webb, John G., Mehran, Roxana, Chen, Mao, Reardon, Michael, Leon, Martin B., and Søndergaard, Lars
Published: 2023

6. A bench study of balloon-expandable valves for the treatment of self-expanding valve failure

Author: Akodad, Mariama, Meier, David, Sellers, Stephanie, de Backer, Ole, Mylotte, Darren, Landes, Uri, Frawley, Chris, Lynch, Lisa, Tang, Gilbert H.L., Sondergaard, Lars, Wood, David A., Webb, John G., Sathananthan, Janarthanan, Akodad, Mariama, Meier, David, Sellers, Stephanie, de Backer, Ole, Mylotte, Darren, Landes, Uri, Frawley, Chris, Lynch, Lisa, Tang, Gilbert H.L., Sondergaard, Lars, Wood, David A., Webb, John G., and Sathananthan, Janarthanan
Abstract: Background: Coronary obstruction and access are concerns in patients undergoing redo transcatheter aortic valve implantation (TAVI). Aims: We sought to assess the neoskirt height, leaflet overhang, leaflet deflection,and transcatheter heart valve (THV) expansion and performance, at 2 different implant depths, of the SAPIEN 3 Ultra (S3U) within the ACURATE neo2 (ACn2) THV. Methods: An in vitro study was performed with a 23 mm S3U deployed within a small (S) ACn2 and a 26 mm S3U deployed within a medium (M) and a large (L) ACn2. The S3U outflow was positioned at the top of the ACn2 crown (low implant) and at the base of the commissural post of the ACn2 (high implant). Testing was performed under physiological conditions as per ISO-5840-3 standard. Results: The neoskirt height was shorter when the S3U outflow was positioned at a low implantation depth (S: 9.6 mm, M: 12.2 mm, L: 13.8 mm vs S: 15.2 mm, M: 15.1 mm, L: 17.8 mm ACn2 for high implants). Hydrodynamic performance was acceptable for all configurations. Leaflet overhang was <50% for all configurations except the low implant of the 26 mm S3U in the L ACn2 (77.6%). There was a gap from the side of the neoskirt to the outer border of the THV frame which was >2 mm for all configurations. The S3U was underexpanded for all configurations, and the achieved area was 77.9%-92.9% of the expected nominal area. Conclusions: Redo TAVI with an S3U within an ACn2 has favourable hydrodynamics and moderate leaflet overhang. Importantly, the design of the ACn2 results in a neoskirt that is not deflected all the way to the outer dimensions of the THV, hence creating a space that facilitates coronary flow and access., BACKGROUND: Coronary obstruction and access are concerns in patients undergoing redo transcatheter aortic valve implantation (TAVI). AIMS: We sought to assess the neoskirt height, leaflet overhang, leaflet deflection,and transcatheter heart valve (THV) expansion and performance, at 2 different implant depths, of the SAPIEN 3 Ultra (S3U) within the ACURATE neo2 (ACn2) THV. METHODS: An in vitro study was performed with a 23 mm S3U deployed within a small (S) ACn2 and a 26 mm S3U deployed within a medium (M) and a large (L) ACn2. The S3U outflow was positioned at the top of the ACn2 crown (low implant) and at the base of the commissural post of the ACn2 (high implant). Testing was performed under physiological conditions as per ISO-5840-3 standard. RESULTS: The neoskirt height was shorter when the S3U outflow was positioned at a low implantation depth (S: 9.6 mm, M: 12.2 mm, L: 13.8 mm vs S: 15.2 mm, M: 15.1 mm, L: 17.8 mm ACn2 for high implants). Hydrodynamic performance was acceptable for all configurations. Leaflet overhang was <50% for all configurations except the low implant of the 26 mm S3U in the L ACn2 (77.6%). There was a gap from the side of the neoskirt to the outer border of the THV frame which was >2 mm for all configurations. The S3U was underexpanded for all configurations, and the achieved area was 77.9%-92.9% of the expected nominal area. CONCLUSIONS: Redo TAVI with an S3U within an ACn2 has favourable hydrodynamics and moderate leaflet overhang. Importantly, the design of the ACn2 results in a neoskirt that is not deflected all the way to the outer dimensions of the THV, hence creating a space that facilitates coronary flow and access.
Published: 2023

7. Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation:prognostic implications

Author: Landes, Uri, Hochstadt, Aviram, Manevich, Lisa, Webb, John G., Sathananthan, Janarthanan, Sievert, Horst, Piayda, Kerstin, Leon, Martin B., Nazif, Tamim M., Blusztein, David, Hildick-Smith, David, Pavitt, Chris, Thiele, Holger, Abdel-Wahab, Mohamed, Van Mieghem, Nicolas M., Adrichem, Rik, Sondergaard, Lars, De Backer, Ole, Makkar, Raj R., Koren, Ofir, Pilgrim, Thomas, Okuno, Taishi, Kornowski, Ran, Codner, Pablo, Finkelstein, Ariel, Loewenstein, Itamar, Barbash, Israel, Sharon, Amir, De Marco, Federico, Montorfano, Matteo, Buzzatti, Nicola, Latib, Azeem, Scotti, Andrea, Kim, Won Keun, Hamm, Christian, Franco, Luis Nombela, Mangieri, Antonio, Schoels, Wolfgang H., Barbanti, Marco, Bunc, Matjaz, Akodad, Myriama, Rubinshtein, Ronen, Danenberg, Haim, Landes, Uri, Hochstadt, Aviram, Manevich, Lisa, Webb, John G., Sathananthan, Janarthanan, Sievert, Horst, Piayda, Kerstin, Leon, Martin B., Nazif, Tamim M., Blusztein, David, Hildick-Smith, David, Pavitt, Chris, Thiele, Holger, Abdel-Wahab, Mohamed, Van Mieghem, Nicolas M., Adrichem, Rik, Sondergaard, Lars, De Backer, Ole, Makkar, Raj R., Koren, Ofir, Pilgrim, Thomas, Okuno, Taishi, Kornowski, Ran, Codner, Pablo, Finkelstein, Ariel, Loewenstein, Itamar, Barbash, Israel, Sharon, Amir, De Marco, Federico, Montorfano, Matteo, Buzzatti, Nicola, Latib, Azeem, Scotti, Andrea, Kim, Won Keun, Hamm, Christian, Franco, Luis Nombela, Mangieri, Antonio, Schoels, Wolfgang H., Barbanti, Marco, Bunc, Matjaz, Akodad, Myriama, Rubinshtein, Ronen, and Danenberg, Haim
Abstract: Aims Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. Methods and results A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. Conclusion This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation., Aims Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. Methods A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 and results centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. Conclusion This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.
Published: 2023

8. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation:A Propensity Score-Matched Comparison

Author: Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Scott Lim, D., Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean François, Von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, Joann, Modine, Thomas, Stone, Gregg W., Granada, Juan F., Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Scott Lim, D., Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean François, Von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, Joann, Modine, Thomas, Stone, Gregg W., and Granada, Juan F.
Abstract: Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35–0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62–1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondar, Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant red
Published: 2023

9. Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.

Author: UCL - (SLuc) Département cardiovasculaire, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, UCL - (SLuc) Département cardiovasculaire, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.
Published: 2022

10. Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation.

Author: UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Scislo, Piotr, Huczek, Zenon, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Brito, Fabio Sandoli de, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Breton, Hervé Le, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Scislo, Piotr, Huczek, Zenon, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Brito, Fabio Sandoli de, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Breton, Hervé Le, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up.
Published: 2022

11. Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

Author: UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Mangner, Norman, del Val, David, Abdel-Wahab, Mohamed, Crusius, Lisa, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Côté, Mélanie, Holzhey, David, Linke, Axel, Rodés-Cabau, Josep, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Mangner, Norman, del Val, David, Abdel-Wahab, Mohamed, Crusius, Lisa, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Gervais, Philippe, Côté, Mélanie, Holzhey, David, Linke, Axel, and Rodés-Cabau, Josep
Abstract: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HR: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HR: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HR: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HR: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications.
Published: 2022

12. Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry

Author: Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W. M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Joerg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rudiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean-Francois, Walther, Thomas, Taramasso, Maurizio, Sondergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H. L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W. M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Joerg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rudiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean-Francois, Walther, Thomas, Taramasso, Maurizio, Sondergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H. L., von Bardeleben, Ralph Stephan, Conradi, Lenard, and Modine, Thomas
Abstract: Aims Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. Methods and results From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR <= 1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR <= 1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. Conclusion This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
Published: 2022

13. Coronary Access Following Redo TAVR:Impact of THV Design, Implant Technique, and Cell Misalignment

Author: Meier, David, Akodad, Mariama, Landes, Uri, Barlow, Aaron M., Chatfield, Andrew G., Lai, Althea, Tzimas, Georgios, Tang, Gilbert H.L., Puehler, Thomas, Lutter, Georg, Leipsic, Jonathon A., Søndergaard, Lars, Wood, David A., Webb, John G., Sellers, Stephanie L., Sathananthan, Janarthanan, Meier, David, Akodad, Mariama, Landes, Uri, Barlow, Aaron M., Chatfield, Andrew G., Lai, Althea, Tzimas, Georgios, Tang, Gilbert H.L., Puehler, Thomas, Lutter, Georg, Leipsic, Jonathon A., Søndergaard, Lars, Wood, David A., Webb, John G., Sellers, Stephanie L., and Sathananthan, Janarthanan
Abstract: Background: The implications and potential challenges of coronary access after redo transcatheter aortic valve replacement (TAVR) are unknown. Objectives: The authors sought to evaluate the impact of different transcatheter heart valve (THV) designs, neoskirt height, implant technique, and cell misalignment on coronary access after redo TAVR. Methods: Different THV designs (Sapien 3 [Edwards Lifesciences LLC], Evolut Pro [Medtronic], ACURATE neo [Boston Scientific Corporation], and Portico [Abbott Structural Heart]) and sizes were implanted inside Sapien XT (Edwards Lifesciences LLC) and Evolut R (Medtronic) THVs, which were modeled as the “failed” THVs, at different implant depths. Valve combinations underwent micro–computed tomography to determine the neoskirt height and dimensions of the lowest accessible cell for potential coronary access. This was compared with dimensions of 6-F/7-F/8-F coronary guiding catheters. Results: Redo TAVR combinations resulted in a wide range of neoskirt heights (15.4-31.6 mm) and a variable diameter of the lowest accessible cell (1.9-21.8 mm). An ACURATE neo implanted in a Sapien XT resulted in the largest accessible cells, whereas a Portico implanted in a Sapien XT resulted in the lowest neoskirt heights. The smallest accessible cell was observed in the Evolut Pro–in–Evolut R configuration with higher neoskirt heights. Redo TAVR in a tall frame valve with supra-annular leaflets caused a taller neoskirt height. In Evolut-in-Evolut combinations, misalignment of the cells of the 2 THVs reduced the cell area by 30% to 50% compared with an aligned configuration. Conclusions: This study demonstrates that different redo TAVR combinations are not equivalent in terms of future coronary access. Redo TAVR using a tall frame valve in a failed tall frame valve and misaligned cells may lead to potentially challenging coronary access.
Published: 2022

14. Multimodality Imaging to Assess Leaflet Height in Mitral Bioprosthetic Valves:Implications for Mitral Valve-in-Valve Procedure

Author: Akodad, Mariama, Sathananthan, Janarthanan, Tzimas, Georgios, Salcudean, Hannah, Hensey, Mark, Gulsin, Gaurav S., Meier, David, (Anthony) Chuang, Ming yu, Chatfield, Andrew G., Landes, Uri, Blanke, Philipp, Sondergaard, Lars, Payne, Geoffrey W., Lutter, Georg, Puehler, Thomas, Wood, David A., Webb, John G., Leipsic, Jonathon A., Sellers, Stephanie L., Akodad, Mariama, Sathananthan, Janarthanan, Tzimas, Georgios, Salcudean, Hannah, Hensey, Mark, Gulsin, Gaurav S., Meier, David, (Anthony) Chuang, Ming yu, Chatfield, Andrew G., Landes, Uri, Blanke, Philipp, Sondergaard, Lars, Payne, Geoffrey W., Lutter, Georg, Puehler, Thomas, Wood, David A., Webb, John G., Leipsic, Jonathon A., and Sellers, Stephanie L.
Published: 2022

15. Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves:The Multicenter OPERA-TAVI Registry

Author: Costa, Giuliano, Saia, Francesco, Pilgrim, Thomas, Abdel-Wahab, Mohamed, Garot, Philippe, Valvo, Roberto, Gandolfo, Caterina, Branca, Luca, Latib, Azeem, Santos, Ignacio Amat, Mylotte, Darren, De Marco, Federico, De Backer, Ole, Franco, Luis Nombela, Akodad, Mariama, Mazzapicchi, Alessandro, Tomii, Daijiro, Laforgia, Pietro, Cannata, Stefano, Fiorina, Claudia, Scotti, Andrea, Lunardi, Mattia, Poletti, Enrico, Mazzucca, Mattia, Quagliana, Angelo, Hennessey, Breda, Meier, David, Adamo, Marianna, Sgroi, Carmelo, Reddavid, Claudia Maria, Strazzieri, Orazio, Motta, Silvia Crescenzia, Frittitta, Valentina, Dipietro, Elena, Comis, Alessandro, Melfa, Chiara, Thiele, Holger, Webb, John G., Søndergaard, Lars, Tamburino, Corrado, Barbanti, Marco, Costa, Giuliano, Saia, Francesco, Pilgrim, Thomas, Abdel-Wahab, Mohamed, Garot, Philippe, Valvo, Roberto, Gandolfo, Caterina, Branca, Luca, Latib, Azeem, Santos, Ignacio Amat, Mylotte, Darren, De Marco, Federico, De Backer, Ole, Franco, Luis Nombela, Akodad, Mariama, Mazzapicchi, Alessandro, Tomii, Daijiro, Laforgia, Pietro, Cannata, Stefano, Fiorina, Claudia, Scotti, Andrea, Lunardi, Mattia, Poletti, Enrico, Mazzucca, Mattia, Quagliana, Angelo, Hennessey, Breda, Meier, David, Adamo, Marianna, Sgroi, Carmelo, Reddavid, Claudia Maria, Strazzieri, Orazio, Motta, Silvia Crescenzia, Frittitta, Valentina, Dipietro, Elena, Comis, Alessandro, Melfa, Chiara, Thiele, Holger, Webb, John G., Søndergaard, Lars, Tamburino, Corrado, and Barbanti, Marco
Abstract: Background: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. Objectives: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. Methods: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium 3 device success and early safety, respectively. Results: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). Conclusions: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium 3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE devi
Published: 2022

16. Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type

Author: Landes, Uri, Richter, Ilan, Danenberg, Haim, Kornowski, Ran, Sathananthan, Janarthanan, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Yoon, Sung Han, Makkar, Raj R., Thiele, Holger, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Schofer, Niklas, Voigtlaender, Lisa, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Mesnier, Jules, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Barbanti, Marco, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Witberg, Guy, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Finkelstein, Ariel, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Bruoha, Sharon, Godfrey, Rebecca, Hildick-Smith, David, Barbash, Israel, Segev, Amit, Maurovich-Horvat, Pál, Szilveszter, Balint, Spargias, Konstantinos, Aravadinos, Dionisis, Nazif, Tamim M., Leon, Martin B., Webb, John G., Landes, Uri, Richter, Ilan, Danenberg, Haim, Kornowski, Ran, Sathananthan, Janarthanan, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Yoon, Sung Han, Makkar, Raj R., Thiele, Holger, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Schofer, Niklas, Voigtlaender, Lisa, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Mesnier, Jules, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Barbanti, Marco, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Witberg, Guy, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Finkelstein, Ariel, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Bruoha, Sharon, Godfrey, Rebecca, Hildick-Smith, David, Barbash, Israel, Segev, Amit, Maurovich-Horvat, Pál, Szilveszter, Balint, Spargias, Konstantinos, Aravadinos, Dionisis, Nazif, Tamim M., Leon, Martin B., and Webb, John G.
Abstract: Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]). Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176). Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.
Published: 2022

17. Impact of Commissural Misalignment on Hydrodynamic Function Following Valve-in-Valve Intervention With the ACURATE neo

Author: Meier, David, Akodad, Mariama, Chatfield, Andrew G., Lutter, Georg, Puehler, Thomas, Søndergaard, Lars, Wood, David A., Webb, John G., Sellers, Stephanie L., Sathananthan, Janarthanan, Meier, David, Akodad, Mariama, Chatfield, Andrew G., Lutter, Georg, Puehler, Thomas, Søndergaard, Lars, Wood, David A., Webb, John G., Sellers, Stephanie L., and Sathananthan, Janarthanan
Abstract: Background: Limited evidence is available regarding valve-in-valve (VIV) intervention with the ACURATE neo transcatheter heart valve (THV). Low implantation has demonstrated leaflet interaction between the surgical bioprosthesis and the THV, leading to impaired hydrodynamic performance. It is unknown if commissural alignment (CA) can affect this phenomenon. Novel techniques have now been developed to achieve CA with the ACURATE neo THV. Objectives: The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model. Methods: VIV intervention was performed with the ACURATE neo (a self-expanding THV with supra-annular leaflet position) implanted deep in the surgical bioprosthetic aortic valve (Mitroflow). Hydrodynamic function at CA (0°) and 3 different degrees of CMA (30°, 60°, and 90°) was tested. As per the International Organization for Standardization, a regurgitant fraction <20% is considered optimal. Results: Following VIV, the central THV regurgitant fraction at 0°, 30°, 60°, and 90° of CMA was 8.6% ± 2.0%, 30.3% ± 12.0%, 42.6% ± 11.9%, and 66.7% ± 25.4% (P < 0.0001), respectively. On high-speed video there was no evidence of leaflet interaction at CA, whereas at 30°, 60°, and 90° of CMA there was clear evidence of THV leaflet interaction with those of the surgical valve, leading to impaired leaflet closure and to severe central THV regurgitation. Conclusions: In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.
Published: 2022

18. Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement

Author: Levi, Amos, Linder, Matthias, Seiffert, Moritz, Witberg, Guy, Pilgrim, Thomas, Tomii, Daijiro, Talmor-Barkan, Yeela, Van Mieghem, Nicolas M., Adrichem, Rik, Codner, Pablo, Smith, David Hildick, Arunothayaraj, Sandeep, Perl, Leor, Finkelstein, Ariel, Loewenstein, Itamar, Findler, Michael, Søndergaard, Lars, De Backer, Ole, Wang, Christina, Barnea, Rani, Tarantini, Giuseppe, Fovino, Luca Nai, Vaknin-Assa, Hana, Mylotte, Darren, Lunardi, Mattia, Raphaeli, Guy, Webb, John G., Akodad, Mariama, Colombo, Antonio, Mangieri, Antonio, Latib, Azeem, Kargoli, Faraj, Giannini, Francesco, Ielasi, Alfonso, Cockburn, James, Higgen, Focko L., Aviram, Itay, Gitto, Mauro, Hokken, Thijmen W., Auriel, Eitan, Kornowski, Ran, Levi, Amos, Linder, Matthias, Seiffert, Moritz, Witberg, Guy, Pilgrim, Thomas, Tomii, Daijiro, Talmor-Barkan, Yeela, Van Mieghem, Nicolas M., Adrichem, Rik, Codner, Pablo, Smith, David Hildick, Arunothayaraj, Sandeep, Perl, Leor, Finkelstein, Ariel, Loewenstein, Itamar, Findler, Michael, Søndergaard, Lars, De Backer, Ole, Wang, Christina, Barnea, Rani, Tarantini, Giuseppe, Fovino, Luca Nai, Vaknin-Assa, Hana, Mylotte, Darren, Lunardi, Mattia, Raphaeli, Guy, Webb, John G., Akodad, Mariama, Colombo, Antonio, Mangieri, Antonio, Latib, Azeem, Kargoli, Faraj, Giannini, Francesco, Ielasi, Alfonso, Cockburn, James, Higgen, Focko L., Aviram, Itay, Gitto, Mauro, Hokken, Thijmen W., Auriel, Eitan, and Kornowski, Ran
Abstract: Background: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern. Objectives: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT. Methods: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score. Results: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days. Conclusions: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.
Published: 2022

19. Transcatheter aortic valve-in-valve implantation to treat aortic para-valvular regurgitation after TAVI

Author: Landes, Uri, Morelli, Olga, Danenberg, Haim, Sathananthan, Janarthanan, Backer, Ole De, Sondergaard, Lars, Abdel-Wahab, Mohamed, Yoon, Sung Han, Makkar, Raj R., Thiele, Holger, Kim, Won Keun, Hamm, Christian, Guerrero, Mayra, Rodés-Cabau, Josep, Okuno, Taishi, Pilgrim, Thomas, Mangieri, Antonio, Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Barbanti, Marco, Sinning, Jan Malte, Ielasi, Alfonso, Tarantini, Giuseppe, De Marco, Federico, Finkelstein, Ariel, Sievert, Horst, Andreas, Martin, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Manevich, Lisa, Kornowski, Ran, Nazif, Tamim M., Leon, Martin B., Webb, John G., Landes, Uri, Morelli, Olga, Danenberg, Haim, Sathananthan, Janarthanan, Backer, Ole De, Sondergaard, Lars, Abdel-Wahab, Mohamed, Yoon, Sung Han, Makkar, Raj R., Thiele, Holger, Kim, Won Keun, Hamm, Christian, Guerrero, Mayra, Rodés-Cabau, Josep, Okuno, Taishi, Pilgrim, Thomas, Mangieri, Antonio, Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Barbanti, Marco, Sinning, Jan Malte, Ielasi, Alfonso, Tarantini, Giuseppe, De Marco, Federico, Finkelstein, Ariel, Sievert, Horst, Andreas, Martin, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Manevich, Lisa, Kornowski, Ran, Nazif, Tamim M., Leon, Martin B., and Webb, John G.
Abstract: Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation.
Published: 2022

20. Redo Transcatheter Aortic Valve Implantation with the ALLEGRA Transcatheter Heart Valve:Insights from Bench Testing

Author: Akodad, Mariama, Kütting, Maximilian, Sellers, Stephanie, Kirsten, Alina, Marx, Philipp, Kim, Isabel, Cheung, Anson, Leipsic, Jonathon, Søndergaard, Lars, Toggweiler, Stefan, Wood, David A., Webb, John G., Sathananthan, Janarthanan, Akodad, Mariama, Kütting, Maximilian, Sellers, Stephanie, Kirsten, Alina, Marx, Philipp, Kim, Isabel, Cheung, Anson, Leipsic, Jonathon, Søndergaard, Lars, Toggweiler, Stefan, Wood, David A., Webb, John G., and Sathananthan, Janarthanan
Abstract: Purpose: Failure of transcatheter heart valves (THV) may potentially be treated with repeat transcatheter aortic valve implantation (redo TAVI). We assessed hydrodynamic performance, stability and pinwheeling utilizing the ALLEGRA (New Valve Technology, Hechingen, Germany) THV, a CE approved and marketed THV in Europe, inside different THVs. Methods: Redo TAVI was simulated with the 27 mm ALLEGRA THV at three implantation depths (−4 mm, 0 mm and +4 mm) in seven different ‘failed’ THVs: 26 mm Evolut Pro, 25 mm Lotus, 25 mm JenaValve, 25 mm Portico, 23 mm Sapien 3, 27 mm ALLEGRA and M ACURATE neo. Hydrodynamic evaluation was performed according to International Standards Organization 5840-3:2021. Results: The ALLEGRA THV was stable with acceptable performance (gradient <20 mmHg, effective orifice area >2 cm2, and regurgitant fraction <20%) in all ‘failed’ THVs except the Evolut Pro at −4 mm implantation depth. In this configuration, the outflow of the ALLEGRA frame was constrained by the Evolut Pro THV and the ALLEGRA leaflets were unable to fully close. Pinwheeling was severe for the ALLEGRA in Evolut Pro. The neo-skirt was higher with taller frame THVs. Conclusion: The ALLEGRA THV had favorable hydrodynamic performance, stability and pinwheeling in all redo TAVI samples except the Evolut Pro at low implantation depth with compromised function. The choice of initial THV may have late implications on new THV choice and function.
Published: 2022

21. Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement

Author: Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.
Published: 2022

22. Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement

Author: Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, Panagides, Vassili, Del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.
Published: 2022

23. Balloon-Expandable Valve for Treatment of Evolut Valve Failure:Implications on Neoskirt Height and Leaflet Overhang

Author: Akodad, Mariama, Sellers, Stephanie, Landes, Uri, Meier, David, Tang, Gilbert H.L., Gada, Hemal, Rogers, Toby, Caskey, Michael, Rutkin, Bruce, Puri, Rishi, Rovin, Joshua, Leipsic, Jonathon, Sondergaard, Lars, Grubb, Kendra J., Gleason, Patrick, Garde, Kshitija, Tadros, Hatem, Teodoru, Sebastian, Wood, David A., Webb, John G., Sathananthan, Janarthanan, Akodad, Mariama, Sellers, Stephanie, Landes, Uri, Meier, David, Tang, Gilbert H.L., Gada, Hemal, Rogers, Toby, Caskey, Michael, Rutkin, Bruce, Puri, Rishi, Rovin, Joshua, Leipsic, Jonathon, Sondergaard, Lars, Grubb, Kendra J., Gleason, Patrick, Garde, Kshitija, Tadros, Hatem, Teodoru, Sebastian, Wood, David A., Webb, John G., and Sathananthan, Janarthanan
Abstract: Objectives: This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV. Background: Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs. Methods: An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard. Results: The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm. Conclusions: Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement.
Published: 2022

24. Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement

Author: del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Background: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Methods: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. Results: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). Conclusions: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.
Published: 2022

25. Characteristics and outcomes of patients screened for transcatheter mitral valve implantation:1-year results from the CHOICE-MI registry

Author: Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W.M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Jörg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean Francois, Walther, Thomas, Taramasso, Maurizio, Søndergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H.L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Kalbacher, Daniel, Blankenberg, Stefan, Koell, Benedikt, Schofer, Niklas, Westermann, Dirk, Weber, Marcel, Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W.M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Jörg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean Francois, Walther, Thomas, Taramasso, Maurizio, Søndergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H.L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Kalbacher, Daniel, Blankenberg, Stefan, Koell, Benedikt, Schofer, Niklas, Westermann, Dirk, and Weber, Marcel
Abstract: Aims: Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. Methods and results: From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0–83.0, EuroSCORE II 4.7% [IQR 2.7–9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. Conclusion: This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
Published: 2022

26. Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation

Author: Mangner, Norman, del Val, David, Abdel-Wahab, Mohamed, Crusius, Lisa, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutierrez-Ibanes, Enrique, Serra, Vicenc, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frederic, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, de Brito, Fabio Sandoli, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Sondergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Herve, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Cote, Melanie, Holzhey, David, Linke, Axel, Rodes-Cabau, Josep, Mangner, Norman, del Val, David, Abdel-Wahab, Mohamed, Crusius, Lisa, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutierrez-Ibanes, Enrique, Serra, Vicenc, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frederic, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, de Brito, Fabio Sandoli, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Sondergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Herve, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Cote, Melanie, Holzhey, David, Linke, Axel, and Rodes-Cabau, Josep
Abstract: BACKGROUND The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain.OBJECTIVES The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB).METHODS Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry.RESULTS Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock.CONCLUSIONS In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications. (C) 2022 by the American College of Cardiology Foundation.
Published: 2022

27. Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation

Author: Panagides, Vassili, del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Scislo, Piotr, Huczek, Zenon, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, de Brito, Fabio Sandoli, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Breton, Hervé Le, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, Panagides, Vassili, del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Scislo, Piotr, Huczek, Zenon, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Kim, Won-Keun, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, de Brito, Fabio Sandoli, Dato, Guglielmo Mario Actis, Rosato, Francesco, Ferreira, Maria-Cristina, de Lima, Valter Correia, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Breton, Hervé Le, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up.
Published: 2022

28. Characteristics and outcomes of patients screened for transcatheter mitral valve implantation:1-year results from the CHOICE-MI registry

Author: Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W.M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Jörg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean Francois, Walther, Thomas, Taramasso, Maurizio, Søndergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H.L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Kalbacher, Daniel, Blankenberg, Stefan, Koell, Benedikt, Schofer, Niklas, Westermann, Dirk, Weber, Marcel, Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W.M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Jörg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean Francois, Walther, Thomas, Taramasso, Maurizio, Søndergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H.L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Kalbacher, Daniel, Blankenberg, Stefan, Koell, Benedikt, Schofer, Niklas, Westermann, Dirk, and Weber, Marcel
Abstract: Aims: Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. Methods and results: From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0–83.0, EuroSCORE II 4.7% [IQR 2.7–9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. Conclusion: This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
Published: 2022

29. Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement

Author: del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Vendramin, Igor, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Corriea de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Background: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Methods: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. Results: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). Conclusions: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.
Published: 2022

30. Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry

Author: Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Sondergaard, Lars, De Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jorg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, Jose Honorio, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan-Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodes-Cabau, Josep, Kim, Won-Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., Dvir, Danny, Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Sondergaard, Lars, De Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jorg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, Jose Honorio, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan-Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodes-Cabau, Josep, Kim, Won-Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., and Dvir, Danny
Abstract: Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient >= 10 mm Hg and significant residual mitral regurgitation (MR) as >= moderate. Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5 +/- 12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7 +/- 2.8 mm Hg (>= 5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient >= 5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual
Published: 2021

31. Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement

Author: Alperi, Alberto, Rodes-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Bjorn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Joerg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won-Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Sondergaard, Lars, Webb, John G., Dvir, Danny, Alperi, Alberto, Rodes-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Bjorn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Joerg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won-Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Sondergaard, Lars, Webb, John G., and Dvir, Danny
Abstract: BACKGROUND Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon-and self expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS In a contemporary
Published: 2021

32. Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

Author: UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Del Val, David, Abdel-Wahab, Mohamed, Linke, Axel, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Antonio, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, de Brito, Fabio Sandoli, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Lima, Valter Correa, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Mangner, Norman, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Del Val, David, Abdel-Wahab, Mohamed, Linke, Axel, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Antonio, Herrmann, Howard C, Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C, Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Barbanti, Marco, Masson, Jean-Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B, Mangione, Jose Armando, de Brito, Fabio Sandoli, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria-Cristina, Lima, Valter Correa, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G, Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S, Boukhris, Marouane, Mangner, Norman, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
Published: 2021

33. Transcatheter mitral valve replacement after surgical repair or replacement:comprehensive midterm evaluation of valve-in-valve and valve-in-ring implantation from the VIVID registry

Author: Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Søndergaard, Lars, de Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jörg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, José Honório, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodés-Cabau, Josep, Kim, Won Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., Dvir, Danny, Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Søndergaard, Lars, de Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jörg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, José Honório, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodés-Cabau, Josep, Kim, Won Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., and Dvir, Danny
Abstract: BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mmHg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mmHg (≥5 mmHg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mmHg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subha
Published: 2021

34. Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement

Author: Alperi, Alberto, Rodes-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Bjorn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Joerg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won-Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Sondergaard, Lars, Webb, John G., Dvir, Danny, Alperi, Alberto, Rodes-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Bjorn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Joerg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won-Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Sondergaard, Lars, Webb, John G., and Dvir, Danny
Abstract: BACKGROUND Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon-and self expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS In a contemporary
Published: 2021

35. Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry

Author: Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Sondergaard, Lars, De Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jorg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, Jose Honorio, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan-Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodes-Cabau, Josep, Kim, Won-Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., Dvir, Danny, Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Sondergaard, Lars, De Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jorg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, Jose Honorio, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan-Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodes-Cabau, Josep, Kim, Won-Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., and Dvir, Danny
Abstract: Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient >= 10 mm Hg and significant residual mitral regurgitation (MR) as >= moderate. Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5 +/- 12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7 +/- 2.8 mm Hg (>= 5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient >= 5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual
Published: 2021

36. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses

Author: Landes, Uri, Sathananthan, Janarthanan, Witberg, Guy, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Holzhey, David, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Conradi, Lenard, Seiffert, Moritz, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Guimaraes, Leonardo, Codner, Pablo, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Danenberg, Haim, Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Castriota, Fausto, Finkelstein, Ariel, Loewenstein, Itamar, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Alosaimi, Hind, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Chuang, Ming Yu A., Blanke, Philipp, Leipsic, Jonathon, Wood, David A., Nazif, Tamim M., Kodali, Susheel, Barbanti, Marco, Kornowski, Ran, Leon, Martin B., Webb, John G., Landes, Uri, Sathananthan, Janarthanan, Witberg, Guy, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Holzhey, David, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Conradi, Lenard, Seiffert, Moritz, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Guimaraes, Leonardo, Codner, Pablo, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Danenberg, Haim, Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Castriota, Fausto, Finkelstein, Ariel, Loewenstein, Itamar, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Alosaimi, Hind, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Chuang, Ming Yu A., Blanke, Philipp, Leipsic, Jonathon, Wood, David A., Nazif, Tamim M., Kodali, Susheel, Barbanti, Marco, Kornowski, Ran, Leon, Martin B., and Webb, John G.
Abstract: Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year. Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003). Conclusions: In propensity score–matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
Published: 2021

37. ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement

Author: Faroux, Laurent, Lhermusier, Thibault, Vincent, Flavien, Nombela-Franco, Luis, Tchetche, Didier, Barbanti, Marco, Abdel-Wahab, Mohamed, Windecker, Stephan, Auffret, Vincent, Campanha-Borges, Diego Carter, Fischer, Quentin, Munoz-Garcia, Erika, Trillo-Nouche, Ramiro, Jorgensen, Troels, Serra, Vicens, Toggweiler, Stefan, Tarantini, Giuseppe, Saia, Francesco, Durand, Eric, Donaint, Pierre, Gutierrez-Ibanes, Enrique, Wijeysundera, Harindra C., Veiga, Gabriela, Patti, Giuseppe, D'Ascenzo, Fabrizio, Moreno, Raul, Hengstenberg, Christian, Chamandi, Chekrallah, Asmarats, Lluis, Hernandez-Antolin, Rosana, Antoni Gomez-Hospital, Joan, Gabriel Cordoba-Soriano, Juan, Landes, Uri, Alfonso Jimenez-Diaz, Victor, Cruz-Gonzalez, Ignacio, Nejjari, Mohammed, Roubille, Francois, Van Belle, Eric, Armijo, German, Siddiqui, Saifullah, Costa, Giuliano, Elsaify, Sameh, Pilgrim, Thomas, le Breton, Herve, Urena, Marina, Jesus Munoz-Garcia, Antonio, Sondergaard, Lars, Bach-Oller, Montserrat, Fraccaro, Chiara, Eltchaninoff, Helene, Metz, Damien, Tamargo, Maria, Fradejas-Sastre, Victor, Rognoni, Andrea, Bruno, Francesco, Goliasch, Georg, Santalo-Corcoy, Marcelo, Jimenez-Mazuecos, Jesus, Webb, John G., Muntane-Carol, Guillem, Paradis, Jean-Michal, Mangieri, Antonio, Barbosa Ribeiro, Henrique, Campelo-Parada, Francisco, Rodes-Cabau, Josep, Faroux, Laurent, Lhermusier, Thibault, Vincent, Flavien, Nombela-Franco, Luis, Tchetche, Didier, Barbanti, Marco, Abdel-Wahab, Mohamed, Windecker, Stephan, Auffret, Vincent, Campanha-Borges, Diego Carter, Fischer, Quentin, Munoz-Garcia, Erika, Trillo-Nouche, Ramiro, Jorgensen, Troels, Serra, Vicens, Toggweiler, Stefan, Tarantini, Giuseppe, Saia, Francesco, Durand, Eric, Donaint, Pierre, Gutierrez-Ibanes, Enrique, Wijeysundera, Harindra C., Veiga, Gabriela, Patti, Giuseppe, D'Ascenzo, Fabrizio, Moreno, Raul, Hengstenberg, Christian, Chamandi, Chekrallah, Asmarats, Lluis, Hernandez-Antolin, Rosana, Antoni Gomez-Hospital, Joan, Gabriel Cordoba-Soriano, Juan, Landes, Uri, Alfonso Jimenez-Diaz, Victor, Cruz-Gonzalez, Ignacio, Nejjari, Mohammed, Roubille, Francois, Van Belle, Eric, Armijo, German, Siddiqui, Saifullah, Costa, Giuliano, Elsaify, Sameh, Pilgrim, Thomas, le Breton, Herve, Urena, Marina, Jesus Munoz-Garcia, Antonio, Sondergaard, Lars, Bach-Oller, Montserrat, Fraccaro, Chiara, Eltchaninoff, Helene, Metz, Damien, Tamargo, Maria, Fradejas-Sastre, Victor, Rognoni, Andrea, Bruno, Francesco, Goliasch, Georg, Santalo-Corcoy, Marcelo, Jimenez-Mazuecos, Jesus, Webb, John G., Muntane-Carol, Guillem, Paradis, Jean-Michal, Mangieri, Antonio, Barbosa Ribeiro, Henrique, Campelo-Parada, Francisco, and Rodes-Cabau, Josep
Abstract: BACKGROUND Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.METHODS This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (inter quartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.RESULTS Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate < 60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class $2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.CONCLUSIONS STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary acces
Published: 2021

38. Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement

Author: Del Val, David, Abdel-Wahab, Mohamed, Linke, Axel, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Antonio, Herrmann, Howard C., Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, de Brito, Fabio Sandoli, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Lima, Valter Correa, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Mangner, Norman, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, Del Val, David, Abdel-Wahab, Mohamed, Linke, Axel, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim, Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Antonio, Herrmann, Howard C., Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio, Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, de Brito, Fabio Sandoli, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Lima, Valter Correa, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Mangner, Norman, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
Published: 2021

39. Transcatheter mitral valve replacement after surgical repair or replacement:comprehensive midterm evaluation of valve-in-valve and valve-in-ring implantation from the VIVID registry

Author: Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Søndergaard, Lars, de Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jörg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, José Honório, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodés-Cabau, Josep, Kim, Won Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., Dvir, Danny, Simonato, Matheus, Whisenant, Brian, Ribeiro, Henrique Barbosa, Webb, John G., Kornowski, Ran, Guerrero, Mayra, Wijeysundera, Harindra, Søndergaard, Lars, de Backer, Ole, Villablanca, Pedro, Rihal, Charanjit, Eleid, Mackram, Kempfert, Jörg, Unbehaun, Axel, Erlebach, Magdalena, Casselman, Filip, Adam, Matti, Montorfano, Matteo, Ancona, Marco, Saia, Francesco, Ubben, Timm, Meincke, Felix, Napodano, Massimo, Codner, Pablo, Schofer, Joachim, Pelletier, Marc, Cheung, Anson, Shuvy, Mony, Palma, José Honório, Gaia, Diego Felipe, Duncan, Alison, Hildick-Smith, David, Veulemans, Verena, Sinning, Jan Malte, Arbel, Yaron, Testa, Luca, de Weger, Arend, Eltchaninoff, Helene, Hemery, Thibault, Landes, Uri, Tchetche, Didier, Dumonteil, Nicolas, Rodés-Cabau, Josep, Kim, Won Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben-Yehuda, Ori, Teles, Rui Campante, Barbanti, Marco, Fiorina, Claudia, Thukkani, Arun, Mackensen, G. Burkhard, Jones, Noah, Presbitero, Patrizia, Petronio, Anna Sonia, Allali, Abdelhakim, Champagnac, Didier, Bleiziffer, Sabine, Rudolph, Tanja, Iadanza, Alessandro, Salizzoni, Stefano, Agrifoglio, Marco, Nombela-Franco, Luis, Bonaros, Nikolaos, Kass, Malek, Bruschi, Giuseppe, Amabile, Nicolas, Chhatriwalla, Adnan, Messina, Antonio, Hirji, Sameer A., Andreas, Martin, Welsh, Robert, Schoels, Wolfgang, Hellig, Farrel, Windecker, Stephan, Stortecky, Stefan, Maisano, Francesco, Stone, Gregg W., and Dvir, Danny
Abstract: BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mmHg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mmHg (≥5 mmHg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mmHg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subha
Published: 2021

40. Stroke Complicating Infective Endocarditis After Transcatheter Aortic Valve Replacement

Author: del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, Rodés-Cabau, Josep, del Val, David, Abdel-Wahab, Mohamed, Mangner, Norman, Durand, Eric, Ihlemann, Nikolaj, Urena, Marina, Pellegrini, Costanza, Giannini, Francesco, Gasior, Tomasz, Wojakowski, Wojtek, Landt, Martin, Auffret, Vincent, Sinning, Jan Malte, Cheema, Asim N., Nombela-Franco, Luis, Chamandi, Chekrallah, Campelo-Parada, Francisco, Munoz-Garcia, Erika, Herrmann, Howard C., Testa, Luca, Won-Keun, Kim, Castillo, Juan Carlos, Alperi, Alberto, Tchetche, Didier, Bartorelli, Antonio L., Kapadia, Samir, Stortecky, Stefan, Amat-Santos, Ignacio, Wijeysundera, Harindra C., Lisko, John, Gutiérrez-Ibanes, Enrique, Serra, Vicenç, Salido, Luisa, Alkhodair, Abdullah, Livi, Ugolino, Chakravarty, Tarun, Lerakis, Stamatios, Vilalta, Victoria, Regueiro, Ander, Romaguera, Rafael, Kappert, Utz, Barbanti, Marco, Masson, Jean Bernard, Maes, Frédéric, Fiorina, Claudia, Miceli, Antonio, Kodali, Susheel, Ribeiro, Henrique B., Mangione, Jose Armando, Sandoli de Brito, Fabio, Actis Dato, Guglielmo Mario, Rosato, Francesco, Ferreira, Maria Cristina, Correia de Lima, Valter, Colafranceschi, Alexandre Siciliano, Abizaid, Alexandre, Marino, Marcos Antonio, Esteves, Vinicius, Andrea, Julio, Godinho, Roger R., Alfonso, Fernando, Eltchaninoff, Helene, Søndergaard, Lars, Himbert, Dominique, Husser, Oliver, Latib, Azeem, Le Breton, Hervé, Servoz, Clement, Pascual, Isaac, Siddiqui, Saif, Olivares, Paolo, Hernandez-Antolin, Rosana, Webb, John G., Sponga, Sandro, Makkar, Raj, Kini, Annapoorna S., Boukhris, Marouane, Gervais, Philippe, Linke, Axel, Crusius, Lisa, Holzhey, David, and Rodés-Cabau, Josep
Abstract: Background: Stroke is one of the most common and potentially disabling complications of infective endocarditis (IE). However, scarce data exist about stroke complicating IE after transcatheter aortic valve replacement (TAVR). Objectives: The purpose of this study was to determine the incidence, risk factors, clinical characteristics, management, and outcomes of patients with definite IE after TAVR complicated by stroke during index IE hospitalization. Methods: Data from the Infectious Endocarditis after TAVR International Registry (including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries) was analyzed. Patients were divided into two groups according to stroke occurrence during IE admission (stroke [S-IE] vs. no stroke [NS-IE]). Results: A total of 57 (10%) patients had a stroke during IE hospitalization, with no differences in causative microorganism between groups. S-IE patients exhibited higher rates of acute renal failure, systemic embolization, and persistent bacteremia (p < 0.05 for all). Previous stroke before IE, residual aortic regurgitation ≥moderate after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size >8 mm were associated with a higher risk of stroke during the index IE hospitalization (p < 0.05 for all). Stroke rate in patients with no risk factors was 3.1% and increased up to 60% in the presence of >3 risk factors. S-IE patients had higher rates of in-hospital mortality (54.4% vs. 28.7%; p < 0.001) and overall mortality at 1 year (66.3% vs. 45.6%; p < 0.001). Surgical treatment was not associated with improved outcomes in S-IE patients (in-hospital mortality: 46.2% in surgical vs. 58.1% in no surgical treatment; p = 0.47). Conclusions: Stroke occurred in 1 of 10 patients with IE post-TAVR. A history of stroke, short time between TAVR and IE, vegetation size, valve prosthesis type, and residual aortic regurgitation determined an increased risk. The occurrence
Published: 2021

41. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses

Author: Landes, Uri, Sathananthan, Janarthanan, Witberg, Guy, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Holzhey, David, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Conradi, Lenard, Seiffert, Moritz, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Guimaraes, Leonardo, Codner, Pablo, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Danenberg, Haim, Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Castriota, Fausto, Finkelstein, Ariel, Loewenstein, Itamar, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Alosaimi, Hind, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Chuang, Ming Yu A., Blanke, Philipp, Leipsic, Jonathon, Wood, David A., Nazif, Tamim M., Kodali, Susheel, Barbanti, Marco, Kornowski, Ran, Leon, Martin B., Webb, John G., Landes, Uri, Sathananthan, Janarthanan, Witberg, Guy, De Backer, Ole, Søndergaard, Lars, Abdel-Wahab, Mohamed, Holzhey, David, Kim, Won Keun, Hamm, Christian, Buzzatti, Nicola, Montorfano, Matteo, Ludwig, Sebastian, Conradi, Lenard, Seiffert, Moritz, Guerrero, Mayra, El Sabbagh, Abdallah, Rodés-Cabau, Josep, Guimaraes, Leonardo, Codner, Pablo, Okuno, Taishi, Pilgrim, Thomas, Fiorina, Claudia, Colombo, Antonio, Mangieri, Antonio, Eltchaninoff, Helene, Nombela-Franco, Luis, Van Wiechen, Maarten P.H., Van Mieghem, Nicolas M., Tchétché, Didier, Schoels, Wolfgang H., Kullmer, Matthias, Tamburino, Corrado, Sinning, Jan Malte, Al-Kassou, Baravan, Perlman, Gidon Y., Danenberg, Haim, Ielasi, Alfonso, Fraccaro, Chiara, Tarantini, Giuseppe, De Marco, Federico, Redwood, Simon R., Lisko, John C., Babaliaros, Vasilis C., Laine, Mika, Nerla, Roberto, Castriota, Fausto, Finkelstein, Ariel, Loewenstein, Itamar, Eitan, Amnon, Jaffe, Ronen, Ruile, Philipp, Neumann, Franz J., Piazza, Nicolo, Alosaimi, Hind, Sievert, Horst, Sievert, Kolja, Russo, Marco, Andreas, Martin, Bunc, Matjaz, Latib, Azeem, Godfrey, Rebecca, Hildick-Smith, David, Chuang, Ming Yu A., Blanke, Philipp, Leipsic, Jonathon, Wood, David A., Nazif, Tamim M., Kodali, Susheel, Barbanti, Marco, Kornowski, Ran, Leon, Martin B., and Webb, John G.
Abstract: Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year. Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003). Conclusions: In propensity score–matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
Published: 2021

42. Long-Term Durability of the Next-Generation Acurate neo 2 Transcatheter Heart Valve:Insights From Bench Testing to 25 Years

Author: Sathananthan, Janarthanan, Landes, Uri, Flaction, Lionel, Humair, Arnaud, Delaloye, Stéphane, Toggweiler, Stefan, Søndergaard, Lars, Wood, David A., Webb, John G., Sathananthan, Janarthanan, Landes, Uri, Flaction, Lionel, Humair, Arnaud, Delaloye, Stéphane, Toggweiler, Stefan, Søndergaard, Lars, Wood, David A., and Webb, John G.
Published: 2021

43. Incidence, Causes, and Outcomes Associated with Urgent Implantation of a Supplementary Valve during Transcatheter Aortic Valve Replacement

Author: Landes, Uri, Witberg, Guy, Sathananthan, Janarthanan, Kim, Won Keun, Codner, Pablo, Buzzatti, Nicola, Montorfano, Matteo, Godfrey, Rebecca, Hildick-Smith, David, Fraccaro, Chiara, Tarantini, Giuseppe, De Backer, Ole, Sondergaard, Lars, Okuno, Taishi, Pilgrim, Thomas, Rodés-Cabau, Josep, Jaffe, Ronen, Eitan, Amnon, Sinning, Jan Malte, Ielasi, Alfonso, Eltchaninoff, Helene, Maurovich-Horvat, Pál, Merkely, Bela, Guerrero, Mayra, El Sabbagh, Abdallah, Ruile, Philipp, Barbanti, Marco, Redwood, Simon R., Van Mieghem, Nicolas M., Van Wiechen, Maarten P.H., Finkelstein, Ariel, Bunc, Matjaz, Leon, Martin B., Kornowski, Ran, Webb, John G., Landes, Uri, Witberg, Guy, Sathananthan, Janarthanan, Kim, Won Keun, Codner, Pablo, Buzzatti, Nicola, Montorfano, Matteo, Godfrey, Rebecca, Hildick-Smith, David, Fraccaro, Chiara, Tarantini, Giuseppe, De Backer, Ole, Sondergaard, Lars, Okuno, Taishi, Pilgrim, Thomas, Rodés-Cabau, Josep, Jaffe, Ronen, Eitan, Amnon, Sinning, Jan Malte, Ielasi, Alfonso, Eltchaninoff, Helene, Maurovich-Horvat, Pál, Merkely, Bela, Guerrero, Mayra, El Sabbagh, Abdallah, Ruile, Philipp, Barbanti, Marco, Redwood, Simon R., Van Mieghem, Nicolas M., Van Wiechen, Maarten P.H., Finkelstein, Ariel, Bunc, Matjaz, Leon, Martin B., Kornowski, Ran, and Webb, John G.
Abstract: Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective: To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures: Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures: Mortality at 30 days and 1 year. Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P =.02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P <.001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P =.02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P <.001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P <.001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P =.004) were associate
Published: 2021

44. Repeat transcatheter aortic valve implantation and implications for transcatheter heart valve performance:Insights from bench testing

Author: Sathananthan, Janarthanan, Fraser, Rob, Landes, Uri, Rich, Courtney, Sellers, Stephanie, Leipsic, Jonathan, Blanke, Philipp, Lutter, Georg, Frank, Derk, Puehler, Thomas, Wood, David A., Søndergaard, Lars, Webb, John G, Sathananthan, Janarthanan, Fraser, Rob, Landes, Uri, Rich, Courtney, Sellers, Stephanie, Leipsic, Jonathan, Blanke, Philipp, Lutter, Georg, Frank, Derk, Puehler, Thomas, Wood, David A., Søndergaard, Lars, and Webb, John G
Abstract: Background: THV implantation within failed surgical valves is well established. However, the implications of THV implantation within failed THVs are poorly understood. Aims: This study aimed to assess the impact of different transcatheter heart valve (THV) designs and implant positioning strategies on hydrodynamic performance after redo transcatheter aortic valve implantation (TAVI). Methods: THVs of varying design (SAPIEN 3, Evolut PRO, ACURATE neo, ALLEGRA, and Portico) and size were implanted inside SAPIEN XT and Evolut R THVs. Hydrodynamic function as per International Organization for Standardization (ISO) specifications was evaluated using a pulse duplicator, and multimodality imaging was performed. Results: The majority of tested THV-in-THV combinations resulted in stable anchoring of the new implant. However, some combinations resulted in unstable anchoring with the potential for dislodgement or embolisation. Hydrodynamic function was favourable for all tested THV designs implanted in the intraannular SAPIEN XT THV. SAPIEN 3 implantation within an Evolut THV with supra-annular leaflets must be appropriately sized to ensure adequate anchoring. Avoidance of an intra-annular deployment mitigated leaflet overhang of the Evolut leaflets and optimised hydrodynamic performance. Conclusions: This study demonstrates that most THV designs and implantation strategies can result in favourable hydrodynamic performance following redo TAVI. Whether the leaflets of a failed THV are intraor supra-annular may have important implications for the positioning of a redo-THV implant. Certain THV designs or implantation positions may be more desirable when performing redo TAVI.
Published: 2021

45. Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement:VIVID Registry

Author: Alperi, Alberto, Rodés-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Björn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Jörg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Søndergaard, Lars, Webb, John G., Dvir, Danny, Alperi, Alberto, Rodés-Cabau, Josep, Simonato, Matheus, Tchetche, Didier, Charbonnier, Gaetan, Ribeiro, Henrique B., Latib, Azeem, Montorfano, Matteo, Barbanti, Marco, Bleiziffer, Sabine, Redfors, Björn, Abdel-Wahab, Mohamed, Allali, Abdelhakim, Bruschi, Giuseppe, Napodano, Massimo, Agrifoglio, Marco, Petronio, Anna Sonia, Giannini, Cristina, Chan, Albert, Kornowski, Ran, Pravda, Nili Schamroth, Adam, Matti, Iadanza, Alessandro, Noble, Stephane, Chatfield, Andrew, Erlebach, Magdalena, Kempfert, Jörg, Ubben, Timm, Wijeysundera, Harindra, Seiffert, Moritz, Pilgrim, Thomas, Kim, Won Keun, Testa, Luca, Hildick-Smith, David, Nerla, Roberto, Fiorina, Claudia, Brinkmann, Christina, Conzelmann, Lars, Champagnac, Didier, Saia, Francesco, Nissen, Henrik, Amrane, Hafid, Whisenant, Brian, Shamekhi, Jasmin, Søndergaard, Lars, Webb, John G., and Dvir, Danny
Abstract: Background: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions: In a cont
Published: 2021

46. ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement

Author: Faroux, Laurent, Lhermusier, Thibault, Vincent, Flavien, Nombela-Franco, Luis, Tchetche, Didier, Barbanti, Marco, Abdel-Wahab, Mohamed, Windecker, Stephan, Auffret, Vincent, Campanha-Borges, Diego Carter, Fischer, Quentin, Munoz-Garcia, Erika, Trillo-Nouche, Ramiro, Jorgensen, Troels, Serra, Vicens, Toggweiler, Stefan, Tarantini, Giuseppe, Saia, Francesco, Durand, Eric, Donaint, Pierre, Gutierrez-Ibanes, Enrique, Wijeysundera, Harindra C., Veiga, Gabriela, Patti, Giuseppe, D'Ascenzo, Fabrizio, Moreno, Raul, Hengstenberg, Christian, Chamandi, Chekrallah, Asmarats, Lluis, Hernandez-Antolin, Rosana, Antoni Gomez-Hospital, Joan, Gabriel Cordoba-Soriano, Juan, Landes, Uri, Alfonso Jimenez-Diaz, Victor, Cruz-Gonzalez, Ignacio, Nejjari, Mohammed, Roubille, Francois, Van Belle, Eric, Armijo, German, Siddiqui, Saifullah, Costa, Giuliano, Elsaify, Sameh, Pilgrim, Thomas, le Breton, Herve, Urena, Marina, Jesus Munoz-Garcia, Antonio, Sondergaard, Lars, Bach-Oller, Montserrat, Fraccaro, Chiara, Eltchaninoff, Helene, Metz, Damien, Tamargo, Maria, Fradejas-Sastre, Victor, Rognoni, Andrea, Bruno, Francesco, Goliasch, Georg, Santalo-Corcoy, Marcelo, Jimenez-Mazuecos, Jesus, Webb, John G., Muntane-Carol, Guillem, Paradis, Jean-Michal, Mangieri, Antonio, Barbosa Ribeiro, Henrique, Campelo-Parada, Francisco, Rodes-Cabau, Josep, Faroux, Laurent, Lhermusier, Thibault, Vincent, Flavien, Nombela-Franco, Luis, Tchetche, Didier, Barbanti, Marco, Abdel-Wahab, Mohamed, Windecker, Stephan, Auffret, Vincent, Campanha-Borges, Diego Carter, Fischer, Quentin, Munoz-Garcia, Erika, Trillo-Nouche, Ramiro, Jorgensen, Troels, Serra, Vicens, Toggweiler, Stefan, Tarantini, Giuseppe, Saia, Francesco, Durand, Eric, Donaint, Pierre, Gutierrez-Ibanes, Enrique, Wijeysundera, Harindra C., Veiga, Gabriela, Patti, Giuseppe, D'Ascenzo, Fabrizio, Moreno, Raul, Hengstenberg, Christian, Chamandi, Chekrallah, Asmarats, Lluis, Hernandez-Antolin, Rosana, Antoni Gomez-Hospital, Joan, Gabriel Cordoba-Soriano, Juan, Landes, Uri, Alfonso Jimenez-Diaz, Victor, Cruz-Gonzalez, Ignacio, Nejjari, Mohammed, Roubille, Francois, Van Belle, Eric, Armijo, German, Siddiqui, Saifullah, Costa, Giuliano, Elsaify, Sameh, Pilgrim, Thomas, le Breton, Herve, Urena, Marina, Jesus Munoz-Garcia, Antonio, Sondergaard, Lars, Bach-Oller, Montserrat, Fraccaro, Chiara, Eltchaninoff, Helene, Metz, Damien, Tamargo, Maria, Fradejas-Sastre, Victor, Rognoni, Andrea, Bruno, Francesco, Goliasch, Georg, Santalo-Corcoy, Marcelo, Jimenez-Mazuecos, Jesus, Webb, John G., Muntane-Carol, Guillem, Paradis, Jean-Michal, Mangieri, Antonio, Barbosa Ribeiro, Henrique, Campelo-Parada, Francisco, and Rodes-Cabau, Josep
Abstract: BACKGROUND Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.METHODS This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (inter quartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.RESULTS Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate < 60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class $2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.CONCLUSIONS STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary acces
Published: 2021

47. Valve Academic Research Consortium 3:Updated endpoint definitions for aortic valve clinical research

Author: Généreux, Philippe, Piazza, Nicolo, Alu, Maria C., Nazif, Tamim, Hahn, Rebecca T., Pibarot, Philippe, Bax, Jeroen J., Leipsic, Jonathon A., Blanke, Philipp, Blackstone, Eugene H., Finn, Matthew T., Kapadia, Samir, Linke, Axel, Mack, Michael J., Makkar, Raj, Mehran, Roxana, Popma, Jeffrey J., Reardon, Michael, Rodes-Cabau, Josep, Van Mieghem, Nicolas M., Webb, John G., Cohen, David J., Leon, Martin B., Généreux, Philippe, Piazza, Nicolo, Alu, Maria C., Nazif, Tamim, Hahn, Rebecca T., Pibarot, Philippe, Bax, Jeroen J., Leipsic, Jonathon A., Blanke, Philipp, Blackstone, Eugene H., Finn, Matthew T., Kapadia, Samir, Linke, Axel, Mack, Michael J., Makkar, Raj, Mehran, Roxana, Popma, Jeffrey J., Reardon, Michael, Rodes-Cabau, Josep, Van Mieghem, Nicolas M., Webb, John G., Cohen, David J., and Leon, Martin B.
Abstract: Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Methods and results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class
Published: 2021

48. Characteristics and usefulness of unintended premature ventricular contraction during invasive assessment of aortic stenosis

Author: Dehghani, Payam, Singer, Zachary, Morrison, Jamie, Booker, Jeffery, Lavoie, Andrea, Zimmermann, Rodney, Basran, Paul, Webb, John G. (John Graydon), Cheema, Asim, Pibarot, Philippe, Clavel, Marie-Annick, Dehghani, Payam, Singer, Zachary, Morrison, Jamie, Booker, Jeffery, Lavoie, Andrea, Zimmermann, Rodney, Basran, Paul, Webb, John G. (John Graydon), Cheema, Asim, Pibarot, Philippe, and Clavel, Marie-Annick
Abstract: Background Postextrasystolic potentiation (PESP)-associated augmentation in left ventricular-aorta pressure gradient (LVAoG) observed after incidental premature ventricular contraction (PVC) during resting echocardiography is similar to dobutamine stress echocardiography (DSE)-associated augmentation in LVAoG in patients with low-flow, low-gradient (LF-LG) aortic stenosis (AS). What is not known is whether a similar relationship exists when unintended PVC causes PESP during cardiac catheterization in patients with AS. Methods We retrospectively reviewed all catheterizations performed for patients with at least moderate AS who had LVAoG assessment. Univariate and multivariate analyses were conducted to determine the predictors of pre- and post-PVC mean LVAoG ≥ 40 mmHg. Results Between September 2015 to September 2017, of 140 individuals undergoing cardiac catheterization, 34 met study criteria. Mean pre-PVC gradient was 38.9 ± 22.8 mmHg. All patients exhibited PESP-associated augmentation of LVAoG by an average of 28 ± 12%. In multivariate analysis, the only significant predictor of post-PVC mean LVAoG ≥ 40 mmHg was preserved LV function (OR 6.81; 95% CI 1.41–32.82, p = 0.02). Inability to generate ≥ 40 mmHg of mean LVAoG post-PVC had 100% specificity for nonsevere AS in our observational cohort. Conclusions Unintended but interpretable PVCs occurred in one in four patients with AS undergoing cardiac catheterization with measurable hemodynamics. All of our patients with PVCs, regardless of underlying LVEF, exhibited PESP-associated augmentation of LVAoG. Our exploratory analysis suggests that inability to generate ≥40 mmHg of mean LVAoG post-PVC is highly specific for nonsevere AS.
Published: 2020

49. Outcome of flow-gradient patterns of aortic stenosis after aortic valve replacement : an analysis of the PARTNER 2 trial and registry

Author: Salaun, Erwan, Clavel, Marie-Annick, Hahn, Rebecca T., Jaber, Wael A., Asch, Federico M., Rodriguez, L. Leonardo, Weissman, Neil J., Gertz, Zachary M., Herrmann, Howard C., Dahou, Abdellaziz, Annabi, Mohamed Salah, Toubal, Oumhani, Bernier, Mathieu, Beaudoin, Jonathan, Leipsic, Jonathon, Blanke, Philipp, Ridard, Carine, Ong, Géraldine, Rodés-Cabau, Josep, Webb, John G. (John Graydon), Zhang, Yiran, Alu, Maria C., Douglas, Pamela S., Makkar, Rajendra, Miller, D. Craig, Lindman, Brian R., Thourani, Vinod H., Leon, Martin B., Pibarot, Philippe, Salaun, Erwan, Clavel, Marie-Annick, Hahn, Rebecca T., Jaber, Wael A., Asch, Federico M., Rodriguez, L. Leonardo, Weissman, Neil J., Gertz, Zachary M., Herrmann, Howard C., Dahou, Abdellaziz, Annabi, Mohamed Salah, Toubal, Oumhani, Bernier, Mathieu, Beaudoin, Jonathan, Leipsic, Jonathon, Blanke, Philipp, Ridard, Carine, Ong, Géraldine, Rodés-Cabau, Josep, Webb, John G. (John Graydon), Zhang, Yiran, Alu, Maria C., Douglas, Pamela S., Makkar, Rajendra, Miller, D. Craig, Lindman, Brian R., Thourani, Vinod H., Leon, Martin B., and Pibarot, Philippe
Abstract: Background : Although aortic valve replacement is associated with a major benefit in high-gradient (HG) severe aortic stenosis (AS), the results in low-gradient (LG, mean gradient <40 mm Hg) AS are conflicting. LG severe AS may be subdivided in classical low-flow (left ventricular ejection fraction <50%) and LG (CLF-LG); paradoxical low-flow (left ventricular ejection fraction ≥50% but stroke volume index <35 mL/m2) and LG; and normal-flow (left ventricular ejection fraction ≥50% and stroke volume index ≥35 mL/m2) and LG. The primary objective is to determine in the PARTNER 2 trial (The Placement of Aortic Transcatheter Valves) and registry the outcomes after aortic valve replacement of the 4 flow-gradient groups. Methods : A total of 3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included. The flow-gradient pattern was determined at baseline transthoracic echocardiography and classified as follows: (1) HG; (2) CLF-LG; (3) paradoxical low-flow-LG; and (4) normal-flow-LG. The primary end point for this analysis was the composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke. Results : The distribution was HG, 2229 patients (63.5%); CLF-LG, 689 patients (19.6%); paradoxical low-flow-LG, 247 patients (7.0%); and normal-flow-LG, 346 patients (9.9%). The 2-year rate of primary end point was higher in CLF-LG (38.8%) versus HG: 31.8% (P=0.002) and normal-flow-LG: 32.1% (P=0.05) but was not statistically different from paradoxical low-flow-LG: 33.6% (P=0.18). There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group. Conclusions : The LG AS pattern was highly prevalent (36.5%) in the PARTNER 2 trial and registry. CLF-LG was the most common pattern of LG AS and was associated with higher rates of
Published: 2020

50. Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves

Author: Bleiziffer, Sabine, Simonato, Matheus, Webb, John G., Rodes-Cabau, Josep, Pibarot, Philippe, Kornowski, Ran, Windecker, Stephan, Erlebach, Magdalena, Duncan, Alison, Seiffert, Moritz, Unbehaun, Axel, Frerker, Christian, Conzelmann, Lars, Wijeysundera, Harindra, Kim, Won-Keun, Montorfano, Matteo, Latib, Azeem, Tchetche, Didier, Allali, Abdelhakim, Abdel-Wahab, Mohamed, Orvin, Katia, Stortecky, Stefan, Nissen, Henrik, Holzamer, Andreas, Urena, Marina, Testa, Luca, Agrifoglio, Marco, Whisenant, Brian, Sathananthan, Janarthanan, Napodano, Massimo, Landi, Antonio, Fiorina, Claudia, Zittermann, Armin, Veulemans, Verena, Sinning, Jan-Malte, Saia, Francesco, Brecker, Stephen, Presbitero, Patrizia, De Backer, Ole, Sondergaard, Lars, Bruschi, Giuseppe, Franco, Luis Nombela, Petronio, Anna Sonia, Barbanti, Marco, Cerillo, Alfredo, Spargias, Konstantinos, Schofer, Joachim, Cohen, Mauricio, Munoz-Garcia, Antonio, Finkelstein, Ariel, Adam, Matti, Serra, Vicenc, Teles, Rui Campante, Champagnac, Didier, Iadanza, Alessandro, Chodor, Piotr, Eggebrecht, Holger, Welsh, Robert, Caixeta, Adriano, Salizzoni, Stefano, Dager, Antonio, Auffret, Vincent, Cheema, Asim, Ubben, Timm, Ancona, Marco, Rudolph, Tanja, Gummert, Jan, Tseng, Elaine, Noble, Stephane, Bunc, Matjaz, Roberts, David, Kass, Malek, Gupta, Anuj, Leon, Martin B., Dvir, Danny, Bleiziffer, Sabine, Simonato, Matheus, Webb, John G., Rodes-Cabau, Josep, Pibarot, Philippe, Kornowski, Ran, Windecker, Stephan, Erlebach, Magdalena, Duncan, Alison, Seiffert, Moritz, Unbehaun, Axel, Frerker, Christian, Conzelmann, Lars, Wijeysundera, Harindra, Kim, Won-Keun, Montorfano, Matteo, Latib, Azeem, Tchetche, Didier, Allali, Abdelhakim, Abdel-Wahab, Mohamed, Orvin, Katia, Stortecky, Stefan, Nissen, Henrik, Holzamer, Andreas, Urena, Marina, Testa, Luca, Agrifoglio, Marco, Whisenant, Brian, Sathananthan, Janarthanan, Napodano, Massimo, Landi, Antonio, Fiorina, Claudia, Zittermann, Armin, Veulemans, Verena, Sinning, Jan-Malte, Saia, Francesco, Brecker, Stephen, Presbitero, Patrizia, De Backer, Ole, Sondergaard, Lars, Bruschi, Giuseppe, Franco, Luis Nombela, Petronio, Anna Sonia, Barbanti, Marco, Cerillo, Alfredo, Spargias, Konstantinos, Schofer, Joachim, Cohen, Mauricio, Munoz-Garcia, Antonio, Finkelstein, Ariel, Adam, Matti, Serra, Vicenc, Teles, Rui Campante, Champagnac, Didier, Iadanza, Alessandro, Chodor, Piotr, Eggebrecht, Holger, Welsh, Robert, Caixeta, Adriano, Salizzoni, Stefano, Dager, Antonio, Auffret, Vincent, Cheema, Asim, Ubben, Timm, Ancona, Marco, Rudolph, Tanja, Gummert, Jan, Tseng, Elaine, Noble, Stephane, Bunc, Matjaz, Roberts, David, Kass, Malek, Gupta, Anuj, Leon, Martin B., and Dvir, Danny
Abstract: Aims Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Methods and results A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 +/- 9.7 years; 58.8% mate; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreVatve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloo-nexpandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n=435, 43.2%), and other devices (n =48, 4.8%). Survival was tower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) < 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P= 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]. Conclusions: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV. [GRAPHICS] .
Published: 2020

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