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1. Anticoagulatory treatment and clinical outcomes after transcatheter aortic valve implantation: results from 45,598 patients of the German Aortic Valve Registry (GARY)

Author

Hohmann, C, primary, Pfister, R, additional, Frerker, C, additional, Beckmann, A, additional, Walther, T, additional, Bleiziffer, S, additional, Ensminger, S, additional, Bekeredjian, R, additional, Seiffert, M, additional, Sinning, J M, additional, Moellmann, H, additional, Beyersdorf, F, additional, Herrmann, E, additional, Balaban, Ü, additional, and Kuhn, E W, additional

Published
2023
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4. Beyond 10 Years—The Impact of Patient-Prosthesis Mismatch on Long-Term Survival and Reoperation Rates.

Author

Graser, M., Bleiziffer, S., Zittermann, A., Mayr, B., Puluca, N., Krane, M., and Prinzing, A.

Subjects
*SURVIVAL rate, *AORTIC valve transplantation
Abstract

This article, published in the journal Thoracic & Cardiovascular Surgeon, examines the impact of patient-prosthesis mismatch (PPM) on long-term survival and reoperation rates after valve replacement surgery. The study included 645 patients who underwent biological aortic valve replacement between 2000 and 2007. The incidence of PPM was determined based on echocardiographic examinations, and patient survival and reoperation status were analyzed during a mean follow-up of 12.5 years. The results showed that severe PPM was associated with impaired survival beyond 10 years, while higher age, arterial hypertension, and diabetes were significantly associated with overall mortality. However, there was no significant link between PPM and the rate of reintervention. [Extracted from the article]

Published
2024
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5. Early Versus Delayed Revascularization in Myocardial Infarction Patients: A Propensity-Matched Analysis Stratified by Ventricular Function.

Author

Opacic, D., Schröer, S., Hachem, G. El, Radakovic, D., Ibishi, A., Cheaban, R., Velasquez-Silva, C., Sharaf, M., Deutsch, M.A., Bleiziffer, S., Schramm, R., Renner, A., Gummert, J., and Rojas, S.V.

Subjects
MYOCARDIAL revascularization, MYOCARDIAL infarction
Abstract

This article compares the outcomes of early (¿24 hours) versus late (>24 hours) surgical revascularization in patients with acute myocardial infarction (AMI) and normal or diminished left ventricular ejection fraction (LVEF). The study analyzed data from 1227 AMI patients and used propensity score matching to create balanced subgroups. The results showed that early revascularization did not improve mortality or long-term survival in either group, but it did significantly enhance LVEF in patients with reduced baseline levels. The authors suggest that further randomized trials are needed to determine if early surgical intervention can benefit AMI patients beyond the initial hours postinfarction. [Extracted from the article]

Published
2024
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6. 2-Year Outcomes after Transcatheter Mitral Valve Replacement: Results from the CHOICE-MI Registry

Author

Ludwig, S., additional, Ben, A. W., additional, Coisne, A., additional, Ruge, H., additional, Bleiziffer, S., additional, Weimann, J., additional, Duncan, A., additional, Nickenig, G., additional, Hausleiter, J., additional, Adam, M., additional, Dumonteil, N., additional, Sondergaard, L., additional, Garatti, A., additional, Schmidt, T., additional, Gry, D., additional, Maurizio, T., additional, Walther, T., additional, Kempfert, J., additional, Obadia, J. F., additional, Reardon, M., additional, Andreas, M., additional, Denti, P., additional, Praz, F., additional, Von, B. R.S., additional, Blankenberg, S., additional, Reichenspurner, H., additional, Modine, T., additional, and Conradi, L., additional

Published
2023
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7. Periprocedural Outcomes of Transcatheter Mitral Valve Implantation Using a Tethered Device in a Post-market Follow-up Study

Author

Conradi, L., additional, Petronio, A. S., additional, Ruge, H., additional, Labrousse, L., additional, Walther, T., additional, Reuthebuch, O., additional, Praz, F., additional, Zierer, A., additional, Kempfert, J., additional, Nia, P. Sardari, additional, Bleiziffer, S., additional, Dahle, G., additional, Lutter, G., additional, and Dumonteil, N., additional

Published
2023
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9. Female patients with coronary artery disease and aortic stenosis undergoing a surgical or interventional treatment in terms of revascularization and valve replacement

Author

Fortmeier, V, primary, Hoeflsauer, K, additional, Mueller, P, additional, Potratz, M, additional, Friedrichs, K P, additional, Scholtz, S, additional, Gummert, J, additional, Rudolph, V, additional, Gilis-Januszewski, T, additional, Bleiziffer, S, additional, and Rudolph, T, additional

Published
2022
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10. TAVI versus SAVR in intermediate-risk patients with severe aortic stenosis and chronic kidney disease: a matched comparison in a subcohort from the GARY registry

Author

Mas-Peiro, S, primary, Faerber, G, additional, Herrmann, E, additional, Bauer, T, additional, Bleiziffer, S, additional, Bekeredjian, R, additional, Boening, A, additional, Frerker, C, additional, Beckmann, A, additional, Moellmann, H, additional, Ensminger, S, additional, Hamm, C, additional, Beyersdorf, F, additional, Fichtlscherer, S, additional, and Walther, T, additional

Published
2022
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14. Surgical Aortic Valve Replacement in Patients Aged 50 to 69 Years: Insights from the German Aortic Valve Registry (GARY)

Author

Vogt, F., additional, Santarpino, G., additional, Fujita, B., additional, Frerker, C., additional, Bauer, T., additional, Bekeredjian, R., additional, Bleiziffer, S., additional, Beckmann, A., additional, Möllmann, H., additional, Walther, T., additional, Beyersdorf, F., additional, Hamm, C., additional, Böning, A., additional, Baldus, S., additional, Ensminger, S., additional, Fischlein, T., additional, and Eckner, D., additional

Published
2022
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15. Characteristics and Outcomes of Patients Undergoing Screening for Transcatheter Mitral Valve Implantation: Results from the CHOICE-MI Registry

Author

Ludwig, S., additional, Ben, A. W., additional, Duncan, A., additional, Weimann, J., additional, Nickenig, G., additional, Hausleiter, J., additional, Baldus, S., additional, Ruge, H., additional, Von Bardeleben, R. S., additional, Walther, T., additional, Bleiziffer, S., additional, Kempfert, J., additional, Granada, J., additional, Tang, G., additional, Blankenberg, S., additional, Reichenspurner, H., additional, Modine, T., additional, and Conradi, L., additional

Published
2022
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16. 1-Year Outcomes after Transcatheter Mitral Valve Implantation: Results from the Global CHOICE-MI Registry

Author

Ludwig, S., additional, Ben, A. W., additional, Duncan, A., additional, Weimann, J., additional, Nickenig, G., additional, Hausleiter, J., additional, Baldus, S., additional, Ruge, H., additional, Von Bardeleben, R. S., additional, Walther, T., additional, Bleiziffer, S., additional, Kempfert, J., additional, Granada, J., additional, Tang, G., additional, Blankenberg, S., additional, Reichenspurner, H., additional, Modine, T., additional, and Conradi, L., additional

Published
2022
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17. Refined prediction and validation of individual risk using machine learning in transcatheter aortic valve implantation: TAVI Risk Machine (TRIM) scores

Author

Leha, A, primary, Huber, C, additional, Friede, T, additional, Bauer, T, additional, Beckmann, A, additional, Bekeredjian, R, additional, Bleiziffer, S, additional, Herrmann, E, additional, Moellmann, H, additional, Walther, T, additional, Kutschka, I, additional, Hasenfuss, G, additional, Ensminger, S, additional, Frerker, C, additional, and Seidler, T, additional

Published
2021
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18. Glycoprotein IIb/IIIa receptor targeted PET/CT imaging: a novel diagnostic tool for detecting bioprosthetic valve thrombosis

Author

Deutsch, M A, primary, Zabel, R, additional, Preuss, R, additional, Lindner, O, additional, Friedrichs, K, additional, Rudolph, T K, additional, Rudolph, V, additional, Bleiziffer, S, additional, Milting, H, additional, Stephens, A, additional, Koglin, N, additional, Gummert, J F, additional, Burchert, W, additional, and Hugenberg, V, additional

Published
2021
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22. Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement

Author

Yoon SH, Bleiziffer S, Latib A, Eschenbach L, Ancona M, Vincent F, Kim WK, Unbehaum A, Asami M, Dhoble A, Silaschi M, Frangieh AH, Veulemans V, Tang GHL, Kuwata S, Rampat R, Schmidt T, Patel AJ, Nicz PFG, Nombela-Franco L, Kini A, Kitamura M, Sharma R, Chakravarty T, Hildick-Smith D, Arnold M, de Brito FS, Jr., Jensen C, Jung C, Jilaihawi H, Smalling RW, Maisano F, Kasel AM, Treede H, Kempfert J, Pilgrim T, Kar S, Bapat V, Whisenant BK, Van Belle E, Delgado V, Modine T, Bax JJ, Makkar RR, Yoon, Sh, Bleiziffer, S, Latib, A, Eschenbach, L, Ancona, M, Vincent, F, Kim, Wk, Unbehaum, A, Asami, M, Dhoble, A, Silaschi, M, Frangieh, Ah, Veulemans, V, Tang, Ghl, Kuwata, S, Rampat, R, Schmidt, T, Patel, Aj, Nicz, Pfg, Nombela-Franco, L, Kini, A, Kitamura, M, Sharma, R, Chakravarty, T, Hildick-Smith, D, Arnold, M, de Brito, F, J, R., Jensen, C, Jung, C, Jilaihawi, H, Smalling, Rw, Maisano, F, Kasel, Am, Treede, H, Kempfert, J, Pilgrim, T, Kar, S, Bapat, V, Whisenant, Bk, Van Belle, E, Delgado, V, Modine, T, Bax, Jj, and Makkar, Rr

Published
2019

23. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification

Author

Yoon SH, Whisenant BK, Bleiziffer S, Delgado V, Dhoble A, Schofer N, Eschenbach L, Bansal E, Murdoch DJ, Ancona M, Schmidt T, Yzeiraj E, Vincent F, Niikura H, Kim WK, Asami M, Unbehaun A, Hirji S, Fujita B, Silaschi M, Tang GHL, Kuwata S, Wong SC, Frangieh AH, Barker CM, Davies JE, Lauten A, Deuschl F, Nombela-Franco L, Rampat R, Nicz PFG, Masson JB, Wijeysundera HC, Sievert H, Blackman DJ, Gutierrez-Ibanes E, Sugiyama D, Chakravarty T, Hildick-Smith D, de Brito FS, Jr., Jensen C, Jung C, Smalling RW, Arnold M, Redwood S, Kasel AM, Maisano F, Treede H, Ensminger SM, Kar S, Kaneko T, Pilgrim T, Sorajja P, Van Belle E, Prendergast BD, Bapat V, Modine T, Schofer J, Frerker C, Kempfert J, Attizzani GF, Latib A, Schaefer U, Webb JG, Bax JJ, Makkar RR, Yoon, Sh, Whisenant, Bk, Bleiziffer, S, Delgado, V, Dhoble, A, Schofer, N, Eschenbach, L, Bansal, E, Murdoch, Dj, Ancona, M, Schmidt, T, Yzeiraj, E, Vincent, F, Niikura, H, Kim, Wk, Asami, M, Unbehaun, A, Hirji, S, Fujita, B, Silaschi, M, Tang, Ghl, Kuwata, S, Wong, Sc, Frangieh, Ah, Barker, Cm, Davies, Je, Lauten, A, Deuschl, F, Nombela-Franco, L, Rampat, R, Nicz, Pfg, Masson, Jb, Wijeysundera, Hc, Sievert, H, Blackman, Dj, Gutierrez-Ibanes, E, Sugiyama, D, Chakravarty, T, Hildick-Smith, D, de Brito, F, J, R., Jensen, C, Jung, C, Smalling, Rw, Arnold, M, Redwood, S, Kasel, Am, Maisano, F, Treede, H, Ensminger, Sm, Kar, S, Kaneko, T, Pilgrim, T, Sorajja, P, Van Belle, E, Prendergast, Bd, Bapat, V, Modine, T, Schofer, J, Frerker, C, Kempfert, J, Attizzani, Gf, Latib, A, Schaefer, U, Webb, Jg, Bax, Jj, and Makkar, Rr

Published
2019

24. Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement

Author

Yoon, S.H., Kim, W.K., Dhoble, A., Pio, S.M., Babaliaros, V., Jilaihawi, H., Pilgrim, T., Backer, O. de, Bleiziffer, S., Vincent, F., Schmidit, T., Butter, C., Kamioka, N., Eschenbach, L., Renker, M., Asami, M., Lazkani, M., Fujita, B., Birs, A., Barbanti, M., Pershad, A., Landes, U., Oldemeyer, B., Kitamura, M., Oakley, L., Ochiai, T., Chakravarty, T., Nakamura, M., Ruile, P., Deuschl, F., Berman, D., Modine, T., Ensminger, S., Kornowski, R., Lange, R., McCabe, J.M., Williams, M.R., Whisenant, B., Delgado, V., Windecker, S., Belle, E. van, Sondergaard, L., Chevalier, B., Mack, M., Bax, J.J., Leon, M.B., Makkar, R.R., and Bicuspid Aortic Valve Stenosis

Subjects
Male, medicine.medical_specialty, Internationality, bicuspid aortic valve, Transcatheter aortic, medicine.medical_treatment, 030204 cardiovascular system & hematology, Transcatheter Aortic Valve Replacement, 03 medical and health sciences, 0302 clinical medicine, Bicuspid aortic valve, Aortic valve replacement, Valve replacement, Bicuspid Aortic Valve Disease, Internal medicine, medicine, Humans, 030212 general & internal medicine, Prospective Studies, Registries, Mortality, 610 Medicine & health, transcatheter aortic valve implantation, Aged, Aged, 80 and over, Raphe, business.industry, aortic stenosis, medicine.disease, Clinical trial, Stenosis, Treatment Outcome, cardiovascular system, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Tomography, X-Ray Computed, Calcification, Follow-Up Studies
Abstract

Background: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. Objectives: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. Methods: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. Results: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). Conclusions: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521)

Published
2020

25. Insights on Embolic Protection, Repositioning, and Stroke: A Subanalysis of the RESPOND Study

Author

Seeger, J. (Julia), Falk, V. (Volkmar), Hildick-Smith, D. (David), Bleiziffer, S. (Sabine), Blackman, D.J. (Daniel J.), Abdel-Wahab, M. (Mohamed), Allocco, D., Meredith, I.T. (Ian T.), Wöhrle, J. (Jochen), Mieghem, N.M. (Nicolas) van, Seeger, J. (Julia), Falk, V. (Volkmar), Hildick-Smith, D. (David), Bleiziffer, S. (Sabine), Blackman, D.J. (Daniel J.), Abdel-Wahab, M. (Mohamed), Allocco, D., Meredith, I.T. (Ian T.), Wöhrle, J. (Jochen), and Mieghem, N.M. (Nicolas) van

Abstract

RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valv

Published
2020
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28. Clinical outcomes after surgical or transcatheter aortic valve replacement in patients with chronic kidney disease: an analysis in 29 893 patients from the German Aortic Valve Registry

Author

Mas-Peiro, S, primary, Faerber, G, additional, Bauer, T, additional, Bleiziffer, S, additional, Bekeredjian, R, additional, Boening, A, additional, Frerker, C, additional, Beckmann, A, additional, Moellmann, H, additional, Vasa-Nicotera, M, additional, Ensminger, S, additional, Hamm, C.W, additional, Beyersdorf, F, additional, Walther, T, additional, and Fichtlscherer, S, additional

Published
2020
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33. Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation

Author

De Backer O, Pilgrim T, Simonato M, Mackensen GB, Fiorina C, Veulemanns V, Cerillo A, Schofer J, Amabile N, Achkouty G, Schafer U, Deutsch MA, Sinning JM, Rahman MS, Sawaya FJ, Hildick-Smith D, Hernandez JM, Kim WK, Lefevre T, Seiffert M, Bleiziffer S, Petronio AS, Van Mieghem N, Taramasso M, Sondergaard L, Windecker S, Latib A, Dvir D, Maisano F, De Backer, O, Pilgrim, T, Simonato, M, Mackensen, Gb, Fiorina, C, Veulemanns, V, Cerillo, A, Schofer, J, Amabile, N, Achkouty, G, Schafer, U, Deutsch, Ma, Sinning, Jm, Rahman, M, Sawaya, Fj, Hildick-Smith, D, Hernandez, Jm, Kim, Wk, Lefevre, T, Seiffert, M, Bleiziffer, S, Petronio, A, Van Mieghem, N, Taramasso, M, Sondergaard, L, Windecker, S, Latib, A, Dvir, D, and Maisano, F

Published
2018

34. Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights fromthe European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI) vol 39, pg 676, 2018

Author

Eggebrecht H, Vaquerizo B, Moris C, Bossone E, Lammer J, Czerny M, Zierer A, Schrofel H, Kim WK, Walther T, Scholtz S, Rudolph T, Hengstenberg C, Kempfert J, Spaziano M, Lefevre T, Bleiziffer S, Schofer J, Mehilli J, Seiffert M, Naber C, Biancari F, Eckner D, Cornet C, Lhermusier T, Philippart R, Siljander A, Cerillo AG, Blackman D, Chieffo A, Kahlert P, Czerwinska-Jelonkiewicz K, Szymanski P, Landes U, Kornowski R, D'Onofrio A, Kaulfersch C, Sondergaard L, Mylotte D, Mehta RH, De Backe O, Agrifoglio M, Akin I, Attisano T, Banning A, Barbanti M, Alonso JAB, Benit E, Bianchi ABG, Bosmans J, Calle G, Capretti G, Cruz-Gonzalez I, Cuellas C, Dabrowski M, D'Andrea A, De Marco F, Fernandez RD, Diarte-De Miquel JA, Eskola MJ, Ferdinande B, Ferrer-Garcia MC, Fraccaro C, Hwang DHL, Gutierrez E, Haude M, Antolin RA, Garcia JM, Iacovelli F, Iadanza A, Jacobshagen C, Jeger R, Jessl J, Diaz VAJ, Jimenez-Quevedo P, Kefer J, Lambert T, Lassnig E, Legrand V, Lippe B, Otero DL, Makikallio T, Moreno R, del Amo FN, Niemela M, Nofrerias EF, Rassaf T, Rys M, Savontaus M, Schachinger V, Sievert H, Staudt A, Stewart J, Tarantini G, Tchetche D, Tesorio T, Thielmann M, Toggweiler S, Vorpahl M, Witkowski A, Wolf A, Yzeiraj E, Gil JZ, Eggebrecht, H, Vaquerizo, B, Moris, C, Bossone, E, Lammer, J, Czerny, M, Zierer, A, Schrofel, H, Kim, Wk, Walther, T, Scholtz, S, Rudolph, T, Hengstenberg, C, Kempfert, J, Spaziano, M, Lefevre, T, Bleiziffer, S, Schofer, J, Mehilli, J, Seiffert, M, Naber, C, Biancari, F, Eckner, D, Cornet, C, Lhermusier, T, Philippart, R, Siljander, A, Cerillo, Ag, Blackman, D, Chieffo, A, Kahlert, P, Czerwinska-Jelonkiewicz, K, Szymanski, P, Landes, U, Kornowski, R, D'Onofrio, A, Kaulfersch, C, Sondergaard, L, Mylotte, D, Mehta, Rh, De Backe, O, Agrifoglio, M, Akin, I, Attisano, T, Banning, A, Barbanti, M, Alonso, Jab, Benit, E, Bianchi, Abg, Bosmans, J, Calle, G, Capretti, G, Cruz-Gonzalez, I, Cuellas, C, Dabrowski, M, D'Andrea, A, De Marco, F, Fernandez, Rd, Diarte-De Miquel, Ja, Eskola, Mj, Ferdinande, B, Ferrer-Garcia, Mc, Fraccaro, C, Hwang, Dhl, Gutierrez, E, Haude, M, Antolin, Ra, Garcia, Jm, Iacovelli, F, Iadanza, A, Jacobshagen, C, Jeger, R, Jessl, J, Diaz, Vaj, Jimenez-Quevedo, P, Kefer, J, Lambert, T, Lassnig, E, Legrand, V, Lippe, B, Otero, Dl, Makikallio, T, Moreno, R, del Amo, Fn, Niemela, M, Nofrerias, Ef, Rassaf, T, Rys, M, Savontaus, M, Schachinger, V, Sievert, H, Staudt, A, Stewart, J, Tarantini, G, Tchetche, D, Tesorio, T, Thielmann, M, Toggweiler, S, Vorpahl, M, Witkowski, A, Wolf, A, Yzeiraj, E, and Gil, Jz

Published
2018

38. Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study

Author

Blackman, D.J., Gils, L. (Lennart) van, Bleiziffer, S. (Sabine), Gerckens, U. (Ulrich), Petronio, AS, Abdel-Wahab, M. (Mohamed), Werner, N. (Nikos), Khogali, S.S., Wenaweser, P. (Peter), Wohrle, J., Soliman, O.I.I. (Osama Ibrahim Ibrahim), Laborde, J.C., Allocco, D.J., Meredith, IT, Falk, V. (Volkmar), Mieghem, N.M. (Nicolas) van, Blackman, D.J., Gils, L. (Lennart) van, Bleiziffer, S. (Sabine), Gerckens, U. (Ulrich), Petronio, AS, Abdel-Wahab, M. (Mohamed), Werner, N. (Nikos), Khogali, S.S., Wenaweser, P. (Peter), Wohrle, J., Soliman, O.I.I. (Osama Ibrahim Ibrahim), Laborde, J.C., Allocco, D.J., Meredith, IT, Falk, V. (Volkmar), and Mieghem, N.M. (Nicolas) van

Abstract

Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. Methods and Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA)

Published
2019
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39. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort

Author

Mieghem, N.M. (Nicolas) van, Wöhrle, J. (Jochen), Hildick-Smith, D. (David), Bleiziffer, S. (Sabine), Blackman, D.J. (Daniel J.), Abdel-Wahab, M. (Mohamed), Gerckens, U. (Ulrich), Linke, A. (Axel), Ince, H. (Hüseyin), Wenaweser, P. (Peter), Allocco, D., Meredith, I. (Ian), Falk, V. (Volkmar), Mieghem, N.M. (Nicolas) van, Wöhrle, J. (Jochen), Hildick-Smith, D. (David), Bleiziffer, S. (Sabine), Blackman, D.J. (Daniel J.), Abdel-Wahab, M. (Mohamed), Gerckens, U. (Ulrich), Linke, A. (Axel), Ince, H. (Hüseyin), Wenaweser, P. (Peter), Allocco, D., Meredith, I. (Ian), and Falk, V. (Volkmar)

Abstract

Objectives: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. Background: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. Methods: The RESPOND (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. Results: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). Conclusions: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical

Published
2019
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40. Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study

Author

Blackman, DJ, van Gils, Lennart, Bleiziffer, S, Gerckens, U, Petronio, AS, Abdel-Wahab, M, Werner, N, Khogali, SS, Wenaweser, P, Wohrle, J, Soliman, Osama, Laborde, JC, Allocco, DJ, Meredith, IT, Falk, V, van Mieghem, Nicolas, Blackman, DJ, van Gils, Lennart, Bleiziffer, S, Gerckens, U, Petronio, AS, Abdel-Wahab, M, Werner, N, Khogali, SS, Wenaweser, P, Wohrle, J, Soliman, Osama, Laborde, JC, Allocco, DJ, Meredith, IT, Falk, V, and van Mieghem, Nicolas

Published
2019

44. Incidence of new Permanent Pacemaker Implantation after Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Implantation and Its Impact on 1-Year Mortality—Insights from the German Aortic Valve Registry

Author

Fujita, B., additional, Schmidt, T., additional, Bleiziffer, S., additional, Bauer, T., additional, Beckmann, A., additional, Bekeredjian, R., additional, Möllmann, H., additional, Walther, T., additional, Landwehr, S., additional, Hamm, C., additional, Beyersdorf, F., additional, Katus, H., additional, Harringer, W., additional, Ensminger, S., additional, and Frerker, C., additional

Published
2019
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47. Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI)

Author

Eggebrecht, H. (Holger), Vaquerizo, B. (Beatriz), Moris, C. (Cesar), Bossone, E. (Eduardo), Lämmer, J. (Johannes), Czerny, M. (Martin), Zierer, A. (Andreas), Schröfel, H. (Holger), Kim, W.-K. (Won-Keun), Walther, T. (Thomas), Scholtz, S. (Smita), Rudolph, T. (Tanja), Hengstenberg, C. (Christian), Kempfert, J. (Jörg), Spaziano, M. (Marco), Lefevre, T. (Thierry), Bleiziffer, S. (Sabine), Schofer, J. (Joachim), Mehilli, J. (Julinda), Seiffert, M. (Moritz), Naber, C. (Christoph), Biancari, F. (Fausto), Eckner, D. (Dennis), Cornet, C. (Charles), Lhermusier, T. (Thibault), Philippart, R. (Raphael), Siljander, A. (Antti), Cerillo, A. G. (Alfredo Giuseppe), Blackman, D. (Daniel), Chieffo, A. (Alaide), Kahlert, P. (Philipp), Czerwinska-Jelonkiewicz, K. (Katarzyna), Szymanski, P. (Piotr), Landes, U. (Uri), Kornowski, R. (Ran), D’Onofrio, A. (Augusto), Kaulfersch, C. (Carl), Søndergaard, L. (Lars), Mylotte, D. (Darren), Mehta, R. H. (Rajendra H.), De Backer, O. (Ole), Eggebrecht, H. (Holger), Vaquerizo, B. (Beatriz), Moris, C. (Cesar), Bossone, E. (Eduardo), Lämmer, J. (Johannes), Czerny, M. (Martin), Zierer, A. (Andreas), Schröfel, H. (Holger), Kim, W.-K. (Won-Keun), Walther, T. (Thomas), Scholtz, S. (Smita), Rudolph, T. (Tanja), Hengstenberg, C. (Christian), Kempfert, J. (Jörg), Spaziano, M. (Marco), Lefevre, T. (Thierry), Bleiziffer, S. (Sabine), Schofer, J. (Joachim), Mehilli, J. (Julinda), Seiffert, M. (Moritz), Naber, C. (Christoph), Biancari, F. (Fausto), Eckner, D. (Dennis), Cornet, C. (Charles), Lhermusier, T. (Thibault), Philippart, R. (Raphael), Siljander, A. (Antti), Cerillo, A. G. (Alfredo Giuseppe), Blackman, D. (Daniel), Chieffo, A. (Alaide), Kahlert, P. (Philipp), Czerwinska-Jelonkiewicz, K. (Katarzyna), Szymanski, P. (Piotr), Landes, U. (Uri), Kornowski, R. (Ran), D’Onofrio, A. (Augusto), Kaulfersch, C. (Carl), Søndergaard, L. (Lars), Mylotte, D. (Darren), Mehta, R. H. (Rajendra H.), and De Backer, O. (Ole)

Abstract

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02–3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94–4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07–9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS—nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Published
2018

49. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Author

Grube, E, van Mieghem, Nicolas, Bleiziffer, S, Modine, T, Bosmans, J, Manoharan, G, Linke, A, Scholtz, W, Tchetche, D, Finkelstein, A, Trillo, R, Fiorina, C, Walton, A, Malkin, CJ, Oh, JK, Qiao, HY, Windecker, S, FORWARD Study Investigators, and Cardiology

Subjects
Human medicine, 610 Medicine & health
Abstract

BACKGROUND Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. OBJECTIVES This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. METHODS The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multi-center, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocar-diograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. RESULTS Mean age was 81.8 +/- 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 +/- 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 +/- 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. CONCLUSIONS TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (C) 2017 by the American College of Cardiology Foundation.

Published
2017
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