139 results on '"Landes, Uri"'
Search Results
102. TRANSCATHETER AORTIC VALVE REPLACEMENT IN ONCOLOGY PATIENTS WITH AORTIC STENOSIS
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Landes, Uri, primary, Jubran, Ayman, additional, Yoon, Sung-Han, additional, Taramasso, Maurizio, additional, Russo, Marco, additional, Sinning, Jan-Malte, additional, Luigi, Biasco, additional, Pedrazzini, Giovanni, additional, Latib, Azeem, additional, Pagnesi, Matteo, additional, Tamburino, Corrado, additional, Arrigo, Paolo D’, additional, Pilgrim, Thomas, additional, Tchetche, Didier, additional, Iftikhar, Omer, additional, Bosmans, Johan, additional, Bedzra, Edo, additional, Dvir, Danny, additional, Mylotte, Darren, additional, De Bruijn, Sabine, additional, Watanabe, Yusuke, additional, Dagnegård, Hanna, additional, Kodali, Susheel K., additional, Leon, Martin B., additional, and Kornowski, Ran, additional
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- 2018
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103. Usefulness of the CHA 2 DS 2 -VASc Score to Predict Outcome in Patients Who Underwent Transcatheter Aortic Valve Implantation
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Orvin, Katia, primary, Levi, Amos, additional, Landes, Uri, additional, Bental, Tamir, additional, Sagie, Alexander, additional, Shapira, Yaron, additional, Vaknin-Assa, Hana, additional, Assali, Abid, additional, and Kornowski, Ran, additional
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- 2018
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104. Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period
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Landes, Uri, primary, Bental, Tamir, additional, Levi, Amos, additional, Assali, Abid, additional, Vaknin-Assa, Hana, additional, Lev, Eli I., additional, Rechavia, Eldad, additional, Greenberg, Gabriel, additional, Orvin, Katia, additional, and Kornowski, Ran, additional
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- 2017
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105. TCT-516 Trans-catheter aortic valve replacement in the presence of mitral prosthesis or ring
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Biton, David, primary, Grossman, Yoni, additional, Finkelstein, Ariel, additional, Brodov, Yafim, additional, Fefer, Paul, additional, Barbash, Israel, additional, Landes, Uri, additional, Arbel, Yaron, additional, Guetta, Victor, additional, and Segev, Amit, additional
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- 2017
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106. TCT-160 Valve-in-Valve Transcatheter Aortic Implantation in Degenerative Sutureless Bioprostheses
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Landes, Uri, primary, Dvir, Danny, additional, Schoels, Wolfgang, additional, Tron, Christophe, additional, Ensminger, Stephan, additional, Simonato dos Santos, Matheus, additional, Schäfer, Ulrich, additional, Bunc, Matjaz, additional, Aldea, Gabriel, additional, Cerillo, Alfredo, additional, Windecker, Stephan, additional, Andreas, Martin, additional, Webb, John, additional, and Kornowski, Ran, additional
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- 2017
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107. Temporal trends in transcatheter aortic valve implantation, 2008-2014: patient characteristics, procedural issues, and clinical outcome
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Landes, Uri, primary, Barsheshet, Alon, additional, Finkelstein, Ariel, additional, Guetta, Victor, additional, Assali, Abid, additional, Halkin, Amir, additional, Vaknin-Assa, Hanna, additional, Segev, Amit, additional, Bental, Tamir, additional, Ben-Shoshan, Jeremy, additional, Barbash, Israel M., additional, and Kornowski, Ran, additional
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- 2016
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108. Transcatheter aortic valve implantation in degenerative sutureless perceval aortic bioprosthesis
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Landes, Uri, primary, Sagie, Alexander, additional, and Kornowski, Ran, additional
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- 2016
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109. Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12‐year period.
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Landes, Uri, Bental, Tamir, Levi, Amos, Assali, Abid, Vaknin‐Assa, Hana, Lev, Eli I., Rechavia, Eldad, Greenberg, Gabriel, Orvin, Katia, and Kornowski, Ran
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- 2018
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110. In vitro evaluation of implantation depth in valve-in-valve using different transcatheter heart valves
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Simonato, Matheus, primary, Azadani, Ali N., additional, Webb, John, additional, Leipsic, Jonathon, additional, Kornowski, Ran, additional, Vahanian, Alec, additional, Wood, David, additional, Piazza, Nicolo, additional, Kodali, Susheel, additional, Ye, Jian, additional, Whisenant, Brian, additional, Gaia, Diego, additional, Aziz, Mina, additional, Pasala, Tilak, additional, Mehilli, Julinda, additional, Wijeysundera, Harindra C., additional, Tchetche, Didier, additional, Moat, Neil, additional, Teles, Rui, additional, Petronio, Anna Sonia, additional, Hildick-Smith, David, additional, Landes, Uri, additional, Windecker, Stephan, additional, Arbel, Yaron, additional, Mendiz, Oscar, additional, Makkar, Raj, additional, Tseng, Elaine, additional, and Dvir, Danny, additional
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- 2016
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111. Type 2 myocardial infarction: A descriptive analysis and comparison with type 1 myocardial infarction
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Landes, Uri, primary, Bental, Tamir, additional, Orvin, Katia, additional, Vaknin-Assa, Hana, additional, Rechavia, Eldad, additional, Iakobishvili, Zaza, additional, Lev, Eli, additional, Assali, Abid, additional, and Kornowski, Ran, additional
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- 2016
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112. Transcatheter aortic valve implantation in degenerative sutureless perceval aortic bioprosthesis.
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Landes, Uri, Sagie, Alexander, and Kornowski, Ran
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- 2018
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113. Transcatheter Tricuspid Valve-In-Valve Implantation in Patients with Tricuspid Bioprosthetic Valve Degeneration at High Surgical Risk: A Multicenter Case Series.
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Landes, Uri, Kerner, Arthur, Segev, Amit, Danenberg, Haim, Shapira, Yaron, Finkelstein, Ariel, and Kornowski, Ran
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- 2017
114. Temporal trends in transcatheter aortic valve implantation, 2008-2014: patient characteristics, procedural issues, and clinical outcome.
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Landes, Uri, Barsheshet, Alon, Finkelstein, Ariel, Guetta, Victor, Assali, Abid, Halkin, Amir, Vaknin-Assa, Hanna, Segev, Amit, Bental, Tamir, Ben-Shoshan, Jeremy, Barbash, Israel M., and Kornowski, Ran
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- 2017
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115. Reply: Redo-TAVR May Not Always Be an Option.
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Landes, Uri, Sathananthan, Janarthanan, Wood, David, and Webb, John G.
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HEART valve prosthesis implantation , *AORTIC valve transplantation , *PROSTHETIC heart valves , *COMPLICATIONS of prosthesis ,AORTIC valve surgery - Published
- 2020
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116. Abstract 12885: Mid-Term Outcomes After Percutaneous Coronary Intervention in Cancer Patients
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Quintana Quezada, Raymundo A, Monlezun, Dominique, Davogustto, Giovanni E, Saenz, Humberto R, Lozano-Ruiz, Francisco, Sueta, Daisuke, Tsujita, Kenichi, Landes, Uri, Denktas, Ali E, Alam, Mahboob, Addison, Daniel, Paniagua, David, and Jneid, Hani
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Introduction:Randomized clinical trials demonstrated the benefits of percutaneous coronary interventions (PCI) in diverse clinical settings. Patients with cancer were not included in these studies.Methods:Literature search of PubMed, Cochrane, Medline, SCOPUS, EMBASE and ClinicalTrials was conducted to identify studies that assessed one-year all-cause, cardiovascular and non-cardiovascular mortality in patients with historical or active cancer. Using the random effects model, we computed risk ratios (RR) and standardized mean differences and their 95% confidence intervals for the dichotomous and continuous measures and outcomes, respectively.Results:Overall, 171 articles were evaluated and 5 studies were included in this meta-analysis. In total, 33, 175 patients receiving PCI were analyzed, of whom 3, 323 patients had cancer and 29, 852 with no cancer history. Patients in the cancer group had greater all-cause mortality [RR 2.22 (1.51-3.26; p <0.001)] (Figure 1A), including cardiovascular mortality [RR 1.34 (1.1-1.65; p=0.005)] (Figure 1B) and non-cardiovascular mortality [RR 2.93 (1.32-6.49; p=<0.008)] (Figure 1C), at one-year compared to non-cancer patients. Patients in the cancer group had greater one-month all-cause mortality [RR 2.01 (1.24-3.27; p=0.005)] and greater non-cardiovascular mortality [RR 5.77 (3.07-10.86; p=<0.001)]butno difference in one-month cardiovascular mortality between the two groups.Meta-regression analysis showed the difference in all-cause and cardiovascular one-year mortality between both groups of patients were not attributable to differences in baseline characteristics, index PCI characteristics, or medications prescribed at discharge.Conclusions:Patients with cancer undergoing PCI have worse mid-term outcomes compared to non-cancer patients. Cancer patients should be managed by a multi-specialist team, in an effort to close the mortality gap.
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- 2019
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117. Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry.
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Moscarella, Elisabetta, Mangieri, Antonio, Giannini, Francesco, Tchetchè, Didier, Kim, Won-Keun, Sinning, Jan-Malte, Landes, Uri, Kornowski, Ran, De Backer, Ole, Nickenig, Georg, De Biase, Chiara, Søndergaard, Lars, De Marco, Federico, Bedogni, Francesco, Ancona, Marco, Montorfano, Matteo, Regazzoli, Damiano, Stefanini, Giulio, Toggweiler, Stefan, and Tamburino, Corrado
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HEART valve prosthesis implantation , *AORTIC stenosis , *MITRAL valve , *AORTIC valve , *HEART valves , *VENTRICULAR ejection fraction - Abstract
Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs. • TAVR can be successfully performed in severe bicuspid aortic stenosis. • However, interaction between annular size and THV type is still unclear. • We compared BEV and SEV hemodynamics by aortic annulus size in BAV patients. • In large annuli a higher rate of PVLs was observed SEVs compared to BEVs. • No differences in clinical outcomes were observed according to annular size nor THV. [ABSTRACT FROM AUTHOR]
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- 2022
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118. Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry
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Stefan Toggweiler, Jan-Malte Sinning, Paolo Calabrò, Horst Sievert, Chiara De Biase, Azeem Latib, Georg Nickenig, Won-Keun Kim, Giulio G. Stefanini, Marco Ancona, Sebastiano Immè, Uri Landes, Antonio Colombo, Francesco Giannini, Ulrich Schäfer, Lars Søndergaard, Corrado Tamburino, Ran Kornowski, Elisabetta Moscarella, Ole De Backer, Giuseppe Tarantini, Antonio Mangieri, Matteo Montorfano, Didier Tchetche, Federico De Marco, Damiano Regazzoli, Francesco Bedogni, Jörg Kempfert, Alfonso Ielasi, Jochen Woehrle, Maurizio Tespili, Massimo Medda, Moscarella, Elisabetta, Mangieri, Antonio, Giannini, Francesco, Tchetchè, Didier, Kim, Won-Keun, Sinning, Jan-Malte, Landes, Uri, Kornowski, Ran, De Backer, Ole, Nickenig, Georg, De Biase, Chiara, Søndergaard, Lar, De Marco, Federico, Bedogni, Francesco, Ancona, Marco, Montorfano, Matteo, Regazzoli, Damiano, Stefanini, Giulio, Toggweiler, Stefan, Tamburino, Corrado, Immè, Sebastiano, Tarantini, Giuseppe, Sievert, Horst, Schäfer, Ulrich, Kempfert, Jörg, Wöehrle, Jochen, Latib, Azeem, Calabrò, Paolo, Medda, Massimo, Tespili, Maurizio, Colombo, Antonio, and Ielasi, Alfonso
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Male ,Annulus dimensions ,medicine.medical_specialty ,Catheters ,Bicuspid aortic valve ,medicine.medical_treatment ,Severe aortic stenosi ,Constriction, Pathologic ,Balloon expandable valves ,Self-expanding valve ,Severe aortic stenosis ,Trans-catheter valve replacement ,Prosthesis Design ,Ventricular Function, Left ,Transcatheter Aortic Valve Replacement ,Annulus dimension ,Bicuspid Aortic Valve Disease ,Valve replacement ,Internal medicine ,medicine ,Humans ,Registries ,Heart valve ,Cardiac skeleton ,Balloon expandable valve ,Ejection fraction ,business.industry ,Stroke Volume ,Aortic Valve Stenosis ,medicine.disease ,Catheter ,Stenosis ,Treatment Outcome ,medicine.anatomical_structure ,Aortic Valve ,Heart Valve Prosthesis ,cardiovascular system ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Calcification - Abstract
Background: Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). Methods: BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area 
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- 2021
119. Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry.
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Parma R, Joner M, Saia F, Cuisset T, Delgado V, Rodes-Cabau J, Modine T, Van Belle E, Fovino LN, Landes U, Alvarez-Covarrubias HA, Abdel-Wahab M, Zamorano JL, Eden M, Cademartiri F, Skipirzepa JN, Kurucova J, Greinert D, Bramlage P, and Tarantini G
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- Humans, Prospective Studies, Treatment Outcome, Heart Valve Prosthesis, Prosthesis Failure, Male, Aged, Transcatheter Aortic Valve Replacement methods, Registries, Aortic Valve Stenosis surgery
- Abstract
Background: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI., Methods: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025., Conclusions: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)
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- 2024
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120. A Guide to Transcatheter Aortic Valve Design and Systematic Planning for a Redo-TAV (TAV-in-TAV) Procedure.
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Bapat VN, Fukui M, Zaid S, Okada A, Jilaihawi H, Rogers T, Khalique O, Cavalcante JL, Landes U, Sathananthan J, Tarantini G, Tang GHL, Blackman DJ, De Backer O, Mack MJ, and Leon MB
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- Humans, Treatment Outcome, Risk Factors, Clinical Decision-Making, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Terminology as Topic, Predictive Value of Tests, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis, Prosthesis Design, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Reoperation
- Abstract
Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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121. Incidence, Predictors, and Outcomes of Paravalvular Regurgitation After TAVR in Sievers Type 1 Bicuspid Aortic Valves.
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Zito A, Buono A, Scotti A, Kim WK, Fabris T, de Biase C, Bellamoli M, Montarello N, Costa G, Alfadhel M, Koren O, Fezzi S, Bellini B, Massussi M, Bai L, Costa G, Mazzapicchi A, Giacomin E, Gorla R, Hug K, Briguori C, Bettari L, Messina A, Villa E, Boiago M, Romagnoli E, Orbach A, Laterra G, Aurigemma C, De Carlo M, Renker M, Garcia Gomez M, Trani C, Ielasi A, Landes U, Rheude T, Testa L, Amat Santos I, Mangieri A, Saia F, Favero L, Chen M, Adamo M, Sonia Petronio A, Montorfano M, Makkar RR, Mylotte D, Blackman DJ, Barbanti M, De Backer O, Tchètchè D, Tarantini G, Latib A, Maffeo D, and Burzotta F
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- Humans, Male, Female, Risk Factors, Aged, Treatment Outcome, Aged, 80 and over, Incidence, Time Factors, Heart Valve Diseases diagnostic imaging, Heart Valve Diseases surgery, Heart Valve Diseases physiopathology, Europe, Risk Assessment, Prosthesis Design, Odds Ratio, Stroke etiology, Stroke diagnosis, Heart Failure physiopathology, Heart Failure etiology, Heart Failure diagnosis, Retrospective Studies, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement mortality, Aortic Valve Insufficiency physiopathology, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency etiology, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis mortality, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve abnormalities, Bicuspid Aortic Valve Disease surgery, Bicuspid Aortic Valve Disease diagnostic imaging, Heart Valve Prosthesis, Severity of Illness Index
- Abstract
Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR)., Objectives: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis., Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up., Results: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09)., Conclusions: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up., Competing Interests: Funding Support and Author Disclosures Dr Aurigemma has reported speaker fees from Abbott, Medtronic, Abiomed, and Terumo. Dr Trani has been involved in advisory board meetings or received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Dr Adamo has reported speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Burzotta has been involved in advisory board meetings or has received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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122. Redo-TAVI with the ACURATE neo2 and Prime XL for balloon-expandable transcatheter heart valve failure.
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Meier D, Grant D, Frawley C, Akodad M, Landes U, Khokhar A, Dudek D, George I, Rinaldi MJ, Kim WK, Yakubov SJ, Sorajja P, Tarantini G, Wood DA, Webb JG, Sellers SL, and Sathananthan J
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- Humans, X-Ray Microtomography, Catheters, Heart Valves, Transcatheter Aortic Valve Replacement, Heart Failure
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Background: There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI)., Aims: We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3., Methods: Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV. Hydrodynamic testing was performed to assess THV function. Multimodality assessment was performed using photography, X-ray, microcomputed tomography (micro-CT), and high-speed videos., Results: The ACURATE in S3 combinations had favourable hydrodynamic performance compared to the S3 in S3 for all size combinations. In the 20 mm S3, redo-TAVI with the ACn2 had lower gradients compared to the S3 (mean gradient 16.3 mmHg for the ACn2 vs 24.7 mmHg for the 20 mm S3 in 20 mm S3). Pinwheeling was less marked for the ACURATE THVs than for the S3s. On micro-CT, the S3s used for redo-TAVI were underexpanded across all sizes. This was also observed for the ACURATE platform, but to a lesser extent., Conclusions: Redo-TAVI with an ACn2/AC XL within an S3 has favourable hydrodynamic performance and less pinwheeling compared to an S3 in S3. This comes at the price of a taller neoskirt.
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- 2024
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123. What should we expect when we explant?
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Landes U and Harari E
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- 2024
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124. First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.
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Danenberg H, Vaknin-Assa H, Makkar R, Virmani R, Manevich L, Codner P, Patel V, Finn AV, Landes U, Rubinshtein R, Bar A, Barnea R, Mezape Y, Teichman E, Eli S, Weisz G, and Kornowski R
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- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Treatment Outcome, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Intracranial Embolism etiology, Intracranial Embolism prevention & control, Embolic Protection Devices, Stroke etiology, Embolism etiology, Embolism prevention & control
- Abstract
Background: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation., Aims: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR., Methods: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours., Results: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients., Conclusions: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.
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- 2023
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125. Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion.
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Meier D, Landes U, Sondergaard L, De Backer O, Lutter G, Puehler T, Akodad M, Tzimas G, Blanke P, Payne GW, Lai A, Gill H, Wood DA, Webb JG, Sellers SL, and Sathananthan J
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- Humans, X-Ray Microtomography, Dilatation, Treatment Outcome, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Transcatheter Aortic Valve Replacement methods, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis
- Abstract
Background: When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance., Aims: We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI)., Methods: Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted., Results: Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling., Conclusions: When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.
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- 2023
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126. Challenges and Future Directions in Redo Aortic Valve Reintervention After Transcatheter Aortic Valve Replacement Failure.
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Zaid S, Bapat VN, Sathananthan J, Landes U, De Backer O, Tarantini G, Grubb KJ, Kaneko T, Khalique OK, Jilaihawi H, Fukui M, Madhavan M, Cangut B, Harrington K, Thourani VH, Makkar RR, Leon MB, Mack MJ, and Tang GHL
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- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Risk Factors, Treatment Outcome, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis etiology, Bioprosthesis, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Reintervention for failed transcatheter heart valves will likely increase in the future as younger patients are expected to outlive the initial bioprosthesis. While redo-TAVR has emerged as an attractive and less invasive alternative to surgical explantation (TAVR-explant) to treat transcatheter heart valve failure, it may not be feasible in all patients due to the risk of coronary obstruction and impaired coronary access. Conversely, TAVR-explant can be offered to most patients who are surgical candidates, but the reported outcomes have shown high mortality and morbidity. This review provides the latest evidence, current challenges, and future directions on redo-TAVR and TAVR-explant for transcatheter heart valve failure, to guide aortic valve reintervention and facilitate patients' lifetime management of aortic stenosis., Competing Interests: Disclosures V.N. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. J. Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific and is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris. Dr Landes has received consulting fees from Edwards Lifesciences. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Tarantini has received lecture fees from Edwards Lifesciences, Medtronic, Abbott, Boston Scientifics, and Abiomed. Dr Grubb is a physician proctor for Medtronic and Boston Scientific and has severed as a consultant for Medtronic, Edwards Lifesciences, Boston Scientific, Ancora, Abbott, and 4C Medical. Dr Kaneko is a speaker for Edwards Life Sciences, Medtronic, Abbott, and Baylis Medical and is a consultant for 4C Medical. Dr Khalique is a consultant for Edwards, Abbott Structural, Triflo, Cardiac Implants, Restore Medical, and Croivalve and is a member of a corelab (he receives no direct industry compensation) with contracts with Ancora, Jenavalve, Atricure, and Abbott Structural and holds equity in Triflo and Cardiac Implants. Dr Jilaihawi has received consulting fees from Edwards Lifesciences, St. Jude Medical, and Venous MedTech. Dr Thourani has received grants or is an advisor for Abbott Vascular, Artivion, Atricure, Boston Scientific, Croi Valve, Edwards Lifesciences, Jenavalve, Shockwave, and Trisol and holds equity in Dasi Simulations. Dr Makkar received grant support from Edwards and is a consultant for Abbott, Cordis, and Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards, JenaValve, and Medtronic; has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. Dr Mack served as coprimary investigator for the PARTNER trial (The Placement of Aortic Transcatheter Valves) for Edwards Lifesciences and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) for Abbott and served as study chair for the APOLLO trial (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) for Medtronic. Dr Tang is a physician proctor, consultant, and advisory board member for Medtronic; a consultant and physician advisory board member for Abbott Structural Heart; and a physician advisory board member for Boston Scientific and JenaValve. Dr Madhavan has received an institutional educational grant to Columbia University from Boston Scientific Corporation. The other authors report no conflicts.
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- 2023
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127. Coronary Embolism After Transcatheter Aortic Valve Replacement-Case Series and Review of Literature.
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Akuka A, Landes U, Manevich L, Rubinshtein R, and Danenberg HD
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- Humans, Transcatheter Aortic Valve Replacement adverse effects, Embolism epidemiology, Embolism etiology, Coronary Artery Disease, Vascular Diseases, Intracranial Embolism
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Periprocedural systemic embolism is a well-documented complication of transcatheter aortic valve replacement (TAVR). Although the most focus was given to cerebral embolism (which remains unpredictable, difficult to prevent, and a source of increased morbidity and mortality after TAVR), coronary embolism remains less investigated and potentially overlooked. This study provides a case series of 3 patients diagnosed with coronary embolism after TAVR in our institution over a 2-year period (3 of 297 cases, 1%) and a systematic literature review (4 studies; 19 case reports). Overall, coronary embolism associated with TAVR is frequently characterized by proximal vessel occlusion causing ST-elevation myocardial infarction and hemodynamic instability with lower mortality in the acute phase as compared with late coronary embolism. However, it often presents with distal vessel occlusion and minor symptoms that may be overlooked in the periprocedural period. In conclusion, we suggest that TAVR-associated coronary embolism has a much higher prevalence than previously documented. Further studies are warranted to properly assess the prevalence and impact of this phenomenon., Competing Interests: Declaration of Competing Interest Dr. Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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128. Thoracic Aorta Perforation Treated Conservatively After TAVR in a Patient With Extremely Tortuous Aorta.
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Manevich L, Landes U, Gluzman Y, Welt M, Rubinshtein R, and Danenberg HD
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Aortic perforation is a rare complication of transcatheter aortic valve replacement associated with grim outcomes. Tortuous and calcified aortas increase the risk of aortic trauma and perforation. We report a case in which, despite massive thoracic bleeding, avoidance of thoracic aortic surgery resulted in clinical recovery. ( Level of Difficulty: Intermediate. )., Competing Interests: Dr Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 Published by Elsevier on behalf of the American College of Cardiology Foundation.)
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- 2022
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129. Standardized Definitions for Bioprosthetic Valve Dysfunction Following Aortic or Mitral Valve Replacement: JACC State-of-the-Art Review.
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Pibarot P, Herrmann HC, Wu C, Hahn RT, Otto CM, Abbas AE, Chambers J, Dweck MR, Leipsic JA, Simonato M, Rogers T, Sathananthan J, Guerrero M, Ternacle J, Wijeysundera HC, Sondergaard L, Barbanti M, Salaun E, Généreux P, Kaneko T, Landes U, Wood DA, Deeb GM, Sellers SL, Lewis J, Madhavan M, Gillam L, Reardon M, Bleiziffer S, O'Gara PT, Rodés-Cabau J, Grayburn PA, Lancellotti P, Thourani VH, Bax JJ, Mack MJ, and Leon MB
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Prosthesis Design, Prosthesis Failure, Treatment Outcome, Aortic Valve Stenosis surgery, Bioprosthesis adverse effects, Heart Valve Diseases surgery, Heart Valve Prosthesis adverse effects, Transcatheter Aortic Valve Replacement methods
- Abstract
Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up., Competing Interests: Funding Support and Author Disclosures Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Holistick Medical and Microinterventional Devices. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic and Novartis; and has equity in Navigate. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Dweck has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Leipsic has served as a consultant for Circle CVI and MVRX; and has received institutional funding for CT core laboratory analyses from Edwards Lifesciences, Neovasc, Abbott, Medtronic, Boston Scientific, PI Cardia, and Conformal. Dr Rogers has served as a consultant and physician proctor for Edwards Lifesciences and Medtronic; has served as an advisory board member for Medtronic; and holds equity interest in Transmural Systems. Dr Sathananthan has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Ternacle has served as a consultant for Philips Healthcare and Abbott Medical. Dr Barbanti has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr Généreux has served as a consultant and advisor for and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, GE Healthcare, iRhythm Technologies, Opsens, Siemens, and Teleflex; has served as a consultant, PI Eclipse Trial, for Cardiovascular System Inc; has served as a consultant, advisor, and proctor for and received speaker fees and research grant from Edwards LifeSciences for the PI EARLY-TAVR and PI PROGRESS trials; has served as a consultant for and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as a consultant for the PI Feasibility study for 4C Medical. Dr Kaneko has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Structural. Dr Wood has served as a consultant to and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Gillam has served as a consultant to Philips and Bracco; is an advisory board member for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences, Medtronic, and Abbott for which she receives no direct compensation. Dr Reardon has served as a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical; all fees for such are to his department. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Thourani has performed consulting/research for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, Medtronic, and Shockwave. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Mack has served as a co-principal investigator for clinical trials for Abbott and Edwards Lifesciences; and has served as study chair for a trial for Medtronic; all roles were uncompensated. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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130. Mechanical vs Bioprosthetic Aortic Valve Replacement in Patients Younger Than 70 Years of Age: A Hazard Ratio Meta-analysis.
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Leviner DB, Witberg G, Levi A, Landes U, Schwartz N, Shiran A, Kornowski R, and Sharoni E
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- Aortic Valve Disease surgery, Humans, Middle Aged, Mortality, Aortic Valve surgery, Bioprosthesis adverse effects, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation methods, Long Term Adverse Effects etiology, Long Term Adverse Effects mortality, Postoperative Complications classification, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Reoperation statistics & numerical data
- Abstract
Background: The choice between mechanical valves (MVs) and bioprosthetic valves (BVs) in patients undergoing aortic valve surgery is complex, requiring a balance between the inferior durability of BV and the indicated long-term anticoagulation therapy with MV. This is especially challenging in the middle age group (< 70 years), which has seen an increased use of BV over recent years., Methods: A meta-analysis of randomised controlled trials (RCTs), observational studies using propensity score matching (PSM) and inverse probability weighting (IPW) was conducted to examine the clinical outcomes of patients < 70 years of age undergoing aortic valve replacement. The primary outcome was overall long-term mortality. Secondary outcomes included bleeding events, reoperation, systemic thromboembolism, and cerebrovascular accident., Results: Fifteen studies (1 RCT, 12 PSM studies, and 2 IPW studies; aggregated sample size 16,876 patients) were included. Median follow-up was 7.8 years. Mortality was higher with BVs vs MVs (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.00-1.49), as was reoperation (HR 3.05, 95% CI 2.22-4.19). Bleeding risk was lower with BVs (HR 0.58, 95% CI 0.48-0.69), and the risk of stroke was similar in both valve types (HR 0.96, 95% CI 0.83-1.11) CONCLUSIONS: This broadest meta-analysis comparing BV and MV suggests a survival benefit for MVs in patients < 70 years of age. This should lead to reassessment of current patterns used in the choice of valves for patients < 70 among the cardiothoracic surgery community., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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131. Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR.
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Kim WK, Pellegrini C, Ludwig S, Möllmann H, Leuschner F, Makkar R, Leick J, Amat-Santos IJ, Dörr O, Breitbart P, Jimenez Diaz VA, Dabrowski M, Rudolph T, Avanzas P, Kaur J, Toggweiler S, Kerber S, Ranosch P, Regazzoli D, Frank D, Landes U, Webb J, Barbanti M, Purita P, Pilgrim T, Liska B, Tabata N, Rheude T, Seiffert M, Eckel C, Allali A, Valvo R, Yoon SH, Werner N, Nef H, Choi YH, Hamm CW, and Sinning JM
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Feasibility Studies, Humans, Retrospective Studies, Treatment Outcome, Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome therapy, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Coronary Artery Disease surgery, Coronary Artery Disease therapy, Percutaneous Coronary Intervention adverse effects, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Objectives: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR)., Background: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences., Methods: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included., Results: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement., Conclusions: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality., Competing Interests: Funding Support and Author Disclosures Dr Kim has received proctor and speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Möllmann has received proctor fees and/or speaker honoraria from Abbott, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Amat-Santos is a proctor for Boston Scientific; Dr Dabrowski has received proctor fees from Boston Scientific; and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Rudolph has received proctor fees and/or lecture honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott. Dr Toggweiler is a consultant and/or proctor for New Valve Technology/Biosensors, Boston Scientific, Abbott, Medtronic, Carag, and Medira; has received institutional research grants from Boston Scientific and Fumedica; and holds equity in Hi-D Imaging. Dr Frank is a consultant for Edwards Lifesciences and Medtronic; and has received an institutional research grant from Edwards Lifesciences. Dr Webb is a consultant to Edwards Lifesciences; and has received research grants from Abbott, Boston Scientific, and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and an advisory board member for Medtronic. Dr Pilgrim has received research grants to the institution from Biotronik and Boston Scientific; has received speaker fees from Biotronik and Boston Scientific; is a consultant for HighLife SAS; and is a proctor for Medtronic and Boston Scientific. Dr Seiffert is a consultant for JenaValve and Boston Scientific; has received travel compensation from Abbott Vascular, Edwards Lifesciences, JenaValve, Boston Scientific, and Biotronik; and has received speaker honoraria from Medtronic. Dr Werner is a proctor for Medtronic; and has received speaker honoraria from Edwards Lifesciences, Boston Scientific, Medtronic. Dr Allali has received proctor and speaker fees from Boston Scientific. Dr Makkar has received consultant fees from Abbott; and has received research grants and consulting and speaker fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Nef has received proctor or speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received research grants from Boston Scientific, Edwards, and Medtronic; and has received speaker honoraria from Abbott, Abiomed, Boston Scientific, Edwards, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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132. Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.
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Witberg G, Codner P, Landes U, Schwartzenberg S, Barbanti M, Valvo R, De Backer O, Ooms JF, Islas F, Marroquin L, Sedaghat A, Sugiura A, Masiero G, Werner P, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Fernández-Vázquez F, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Grasso C, Branca L, Estévez-Loureiro R, Benito-González T, Amat-Santos IJ, Mylotte D, Andreas M, Bunc M, Tarantini G, Sinning JM, Nombela-Franco L, Søndergaard L, Van Mieghem NM, Finkelstein A, and Kornowski R
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited., Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared., Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097)., Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr. Barbanti has received consultant fees from Edwards Lifesciences. Dr. Grasso has served as a proctor for Abbott Vascular. Dr. De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr. Andreas has served as a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr. Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific. Dr. Amat-Santos has served as a proctor for Boston Scientific. Dr. Nombela-Franco has received consultant fees from Edwards Lifesciences; and has served as a proctor for Abbott. Dr. Søndergaard has received consultant fees and institutional research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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133. ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.
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Faroux L, Lhermusier T, Vincent F, Nombela-Franco L, Tchétché D, Barbanti M, Abdel-Wahab M, Windecker S, Auffret V, Campanha-Borges DC, Fischer Q, Muñoz-Garcia E, Trillo-Nouche R, Jorgensen T, Serra V, Toggweiler S, Tarantini G, Saia F, Durand E, Donaint P, Gutierrez-Ibanes E, Wijeysundera HC, Veiga G, Patti G, D'Ascenzo F, Moreno R, Hengstenberg C, Chamandi C, Asmarats L, Hernandez-Antolin R, Gomez-Hospital JA, Cordoba-Soriano JG, Landes U, Jimenez-Diaz VA, Cruz-Gonzalez I, Nejjari M, Roubille F, Van Belle É, Armijo G, Siddiqui S, Costa G, Elsaify S, Pilgrim T, le Breton H, Urena M, Muñoz-Garcia AJ, Sondergaard L, Bach-Oller M, Fraccaro C, Eltchaninoff H, Metz D, Tamargo M, Fradejas-Sastre V, Rognoni A, Bruno F, Goliasch G, Santaló-Corcoy M, Jimenez-Mazuecos J, Webb JG, Muntané-Carol G, Paradis JM, Mangieri A, Ribeiro HB, Campelo-Parada F, and Rodés-Cabau J
- Subjects
- Aged, 80 and over, Coronary Angiography, Female, Follow-Up Studies, Global Health, Hospital Mortality trends, Humans, Incidence, Male, Percutaneous Coronary Intervention, Postoperative Complications epidemiology, Risk Factors, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction epidemiology, Time Factors, Aortic Valve Stenosis surgery, Postoperative Complications etiology, Risk Assessment methods, ST Elevation Myocardial Infarction etiology, Transcatheter Aortic Valve Replacement adverse effects
- 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 (interquartile 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 access issues specific to the TAVR population, and this was associated with poorer outcomes., Competing Interests: Funding Support and Author Disclosures Dr. Faroux has received fellowship support from Institut Servier and the Association Régionale de Cardiologie de Champagne-Ardenne (ARCCA); and has received research grants from Biotronik, Edwards Lifesciences, and Medtronic. Dr. Abdel-Wahab has served as a consultant for Boston Scientific and Medtronic. Dr. Windecker has received research and educational grants from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. Dr. Auffret has received lecture fees from Edwards Lifesciences and Medtronic. Dr. Trillo-Nouche has served as a proctor for Boston Scientific and Medtronic. Dr. Toggweiler has served as a consultant and proctor for Abbott, Boston Scientific, Biosensors, and Medtronic. Dr. Tarantini has received lecture fees from Boston Scientific, Edwards Lifesciences, Gada, and Medtronic. Dr. Saia has served as a member of advisory boards for Abbott, Edwards Lifesciences, and Medtronic. Dr. Durand has served as a consultant for Edwards Lifesciences. Dr. Asmarats has served as a proctor for Abbott. Dr. Nejjari has served as a proctor for Abbott and Boston Scientific. Dr. Muntané-Carol was supported by a grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr. Mangieri has received an institutional grant from Boston Scientific. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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134. Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis.
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Bugani G, Pagnesi M, Tchetchè D, Kim WK, Khokhar A, Sinning JM, Landes U, Kornowski R, Codner P, De Backer O, Nickenig G, Ielasi A, De Biase C, Søndergaard L, De Marco F, Ancona M, Montorfano M, Regazzoli D, Stefanini G, Toggweiler S, Tamburino C, Immè S, Tarantini G, Sievert H, Schäfer U, Kempfert J, Wöehrle J, Tespili M, Laricchia A, Latib A, Giannini F, Colombo A, and Mangieri A
- Subjects
- Aged, Aged, 80 and over, Aortic Valve Stenosis pathology, Bicuspid Aortic Valve Disease pathology, Female, Follow-Up Studies, Humans, Incidence, Male, Mortality, Registries, Treatment Outcome, Aortic Valve Stenosis surgery, Bicuspid Aortic Valve Disease surgery, Transcatheter Aortic Valve Replacement methods
- Abstract
Objectives: To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality., Background: Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking., Methods: The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure., Results: Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05-1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45-37.06, p < 0.0001) were confirmed as independent predictors of high gradient., Conclusion: HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy.
- Published
- 2021
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135. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.
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Landes U, Sathananthan J, Witberg G, De Backer O, Sondergaard L, Abdel-Wahab M, Holzhey D, Kim WK, Hamm C, Buzzatti N, Montorfano M, Ludwig S, Conradi L, Seiffert M, Guerrero M, El Sabbagh A, Rodés-Cabau J, Guimaraes L, Codner P, Okuno T, Pilgrim T, Fiorina C, Colombo A, Mangieri A, Eltchaninoff H, Nombela-Franco L, Van Wiechen MPH, Van Mieghem NM, Tchétché D, Schoels WH, Kullmer M, Tamburino C, Sinning JM, Al-Kassou B, Perlman GY, Danenberg H, Ielasi A, Fraccaro C, Tarantini G, De Marco F, Redwood SR, Lisko JC, Babaliaros VC, Laine M, Nerla R, Castriota F, Finkelstein A, Loewenstein I, Eitan A, Jaffe R, Ruile P, Neumann FJ, Piazza N, Alosaimi H, Sievert H, Sievert K, Russo M, Andreas M, Bunc M, Latib A, Godfrey R, Hildick-Smith D, Chuang MA, Blanke P, Leipsic J, Wood DA, Nazif TM, Kodali S, Barbanti M, Kornowski R, Leon MB, and Webb JG
- Subjects
- Acute Kidney Injury epidemiology, Aged, Aged, 80 and over, Aortic Valve Insufficiency epidemiology, Aortic Valve Stenosis mortality, Conversion to Open Surgery statistics & numerical data, Coronary Occlusion epidemiology, Female, Hemorrhage epidemiology, Humans, Male, Pacemaker, Artificial statistics & numerical data, Patient Safety, Propensity Score, Registries, Aortic Valve Stenosis surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
- 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 cm
2 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., Competing Interests: Author Disclosures Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Kim has received proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr. Barbanti is a consultant for Edwards; and is an Advisory Board member for Biotronik. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Redwood is a proctor for and has received lecture fees from Edwards. Dr. Hamm is an Advisory Board member for Medtronic. Dr. Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Wood is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Sathananthan is a consultant to Edwards Lifesciences. Dr. Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr. Leipsic is a consultant to Circle CVI and Edwards Lifesciences; and provides institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Andreas is a proctor for Edwards and Abbott; and is an Advisory Board member for Medtronic. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Castriota is a proctor for Medtronic and Boston Scientific. Dr. Kodali has received research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences; has received personal fees from and holds equity in Admedus; and holds equity in Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve. Dr. Conradi is a consultant to Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Neovasc, and JenaValve. Dr. Nazif has received consulting fees or honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and has received consulting fees from and holds equity in Venus Medtech. Dr. Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr. Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi-Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr. Latib has received institutional research or grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr. Hildick-Smith is a proctor and adviser to Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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136. Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry.
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Witberg G, Codner P, Landes U, Barbanti M, Valvo R, De Backer O, Ooms JF, Sievert K, El Sabbagh A, Jimenez-Quevedo P, Brennan PF, Sedaghat A, Masiero G, Werner P, Overtchouk P, Watanabe Y, Montorfano M, Bijjam VR, Hein M, Fiorina C, Arzamendi D, Rodriguez-Gabella T, Fernández-Vázquez F, Baz JA, Laperche C, Grasso C, Branca L, Estévez-Loureiro R, Benito-González T, Amat Santos IJ, Ruile P, Mylotte D, Buzzatti N, Piazza N, Andreas M, Tarantini G, Sinning JM, Spence MS, Nombela-Franco L, Guerrero M, Sievert H, Sondergaard L, Van Mieghem NM, Tchetche D, Webb JG, and Kornowski R
- Subjects
- Aged, Aged, 80 and over, Aortic Valve surgery, Aortic Valve Stenosis surgery, Humans, Registries, Severity of Illness Index, Treatment Outcome, Mitral Valve Insufficiency surgery, Transcatheter Aortic Valve Replacement
- Abstract
Objectives: The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit., Background: The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging., Methods: This was an international registry of 23 TAVR centers., Results: In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05)., Conclusions: For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274)., Competing Interests: Author Disclosures Dr. Barbanti has received consultant fees from Edwards Lifesciences. Dr. De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr. Sievert has received institutional honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, CardiacDimensions, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, RenalGuard, Terumo, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Grasso has been a proctor for Abbott Vascular. Dr. Andreas has been a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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137. Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis.
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Gozdek M, Ratajczak J, Arndt A, Zieliński K, Pasierski M, Matteucci M, Fina D, Jiritano F, Meani P, Raffa GM, Malvindi PG, Pilato M, Paparella D, Słomka A, Landes U, Kornowski R, Kubica J, Lorusso R, Suwalski P, and Kowalewski M
- Abstract
Background: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3., Methods: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3. In a random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed., Results: Eleven observational studies including 2,836 patients (Lotus N=862 vs. Sapien 3 N=1,974) met inclusion criteria. No differences were observed regarding composite endpoints-device success and early safety. Similarly, 30-day mortality, major vascular complications, acute kidney injury and serious bleeding events were similar with both devices. Lotus valve demonstrated 35% reduction of the risk for mild PVL: risk ratio (RR) 0.65, 95% confidence interval (CI): 0.49-0.85, P=0.002; but there were no statistical differences with regard to moderate/severe PVL (RR 0.56, 95% CI: 0.18-1.77, P=0.320). Lotus valves produced significantly higher mean transaortic gradients: mean difference (MD) 0.88 mmHg, 95% CI, 0.24-1.53 mmHg, P=0.007; however, without translation into higher rate of prosthesis-patient mismatch (RR 1.10, 95% CI: 0.82-1.47, P=0.540). As compared to Sapien 3, Lotus device placement was associated with significantly higher rate of permanent pacemaker implantation (RR 2.30, 95% CI: 1.95-2.71, P<0.00001) and cerebrovascular events (RR 1.76, 95% CI: 1.03-2.99, P=0.040)., Conclusions: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events., Competing Interests: Conflicts of Interest: MK serves as the unpaid editorial board member of Journal of Thoracic Disease from Sep 2018 to Aug 2020. The other authors have no conflicts of interest to declare., (2020 Journal of Thoracic Disease. All rights reserved.)
- Published
- 2020
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138. 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).
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Eggebrecht H, Vaquerizo B, Moris C, Bossone E, Lämmer J, Czerny M, Zierer A, Schröfel 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, Giuseppe Cerillo A, Blackman D, Chieffo A, Kahlert P, Czerwinska-Jelonkiewicz K, Szymanski P, Landes U, Kornowski R, D'Onofrio A, Kaulfersch C, Søndergaard L, Mylotte D, Mehta RH, and De Backer O
- Subjects
- Aged, Aged, 80 and over, Aortic Valve Stenosis mortality, Cardiac Surgical Procedures trends, Emergency Treatment trends, Europe epidemiology, Female, Humans, Incidence, Male, Registries, Risk Assessment, Aortic Valve Stenosis surgery, Cardiac Surgical Procedures statistics & numerical data, Hospital Mortality trends, Transcatheter Aortic Valve Replacement adverse effects
- 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 on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2018
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139. Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation.
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Landes U, Bental T, Barsheshet A, Assali A, Vaknin Assa H, Levi A, Orvin K, and Kornowski R
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- Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve Stenosis diagnosis, Echocardiography, Transesophageal, Female, Follow-Up Studies, Humans, Incidence, Israel epidemiology, Male, Prosthesis Design, Retrospective Studies, Risk Factors, Severity of Illness Index, Survival Rate trends, Time Factors, Treatment Outcome, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Postoperative Complications epidemiology, Propensity Score, Transcatheter Aortic Valve Replacement methods
- Abstract
Objectives: The Evolut-R (Medtronic, Inc) is a transcatheter aortic valve implantation (TAVI) system that was built on the well-established foundation of Medtronic's CoreValve device platform. Although already in extensive clinical utilization, it is unknown if the Evolut-R improves TAVI outcomes. Herein, we compared TAVI outcomes of the Evolut-R and CoreValve devices., Methods: A propensity score 1:1 matching was conducted on 358 Evolut-R patients (n = 75) and CoreValve patients (n = 283). Thirty-day outcomes were compared using Valve Academic Research Consortium (VARC)-2 criteria. A combined 30-day endpoint including all-cause death, stroke, major vascular complication, major bleeding, implantation failure, paravalvular leak (PVL) ≥ moderate, and new pacemaker implantation was also tested., Results: The final study group included 146 patients (73 Evolut-R; 73 CoreValve). Post matching, baseline characteristics were similar between the two groups. Mean patient age was 82 ± 6 years, mean STS score was 5.2 ± 3.8, 72% were female, and 17% were deemed frail. Implantation success reached 99% with Evolut-R and 94% with CoreValve (P=.10). Both groups had low periprocedural stroke/myocardial infarction/mortality rates and there was also no difference in 30-day vascular complications (P=.18), bleeding (P=.37), PVL (P=.24), and new pacemaker (P=.14). The combined outcome rate was 24% with Evolut-R and 37% with CoreValve (P=.10)., Conclusion: This study indicates that the efficacy and safety of the self-expandable second-generation Evolut-R transcatheter valve is at least comparable with the first-generation CoreValve. The observed improved performance in correct positioning of a single valve and the numerically lower chance to suffer a combined TAVI endpoint needs further investigation.
- Published
- 2017
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