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Background: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited., Objectives: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned., Methods: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm)., Results: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size., Conclusions: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Cheung has received speaker honoraria from Edwards Lifesciences, Abbott Vascular, and Medtronic; and has served as an eligibility committee member for the TRINITY trial. Dr Boone has served as a consultant for Edwards Lifesciences and Abbott. Dr Fam has served as a consultant for Edwards Lifesciences, Abbott, and Cardiovalve. Dr Villablanca has served as a consultant for Edwards Lifesciences, Medtronic, Angiodynamic, Telflex, and Abiomed. Dr De Backer has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. Dr Tchétché has served as consultant for Abbott, Edwards Lifesciences, Boston Scientific, and Medtronic. Dr So has served as a proctor for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Latib has served on the Advisory Board for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. Dr Scotti has served as a consultant for NeoChord and Edwards Lifesciences. Dr Estévez-Loureiro has served as a consultant to Abbott Vascular, Edwards Lifesciences, Boston Scientific, Venus Medtech, and Jenscare. Dr Leurent has received speaker and proctoring honoraria from Edwards Lifesciences and Abbott Medical. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

An increasing number of patients experience late valvular disease after heart transplantation (HTx). While mostly being primarily addressed through surgical interventions, transcatheter valve procedures to treat these conditions are rising, particularly for unsuitable surgical candidates. This review aims at analyzing the outcomes of transcatheter valvular procedures in this subset of patients. A systematic review was conducted including studies reporting on adult patients requiring any form of transcatheter valvular intervention after a previous HTx. Studies involving a surgical approach, heterotopic heart transplants, or concomitant procedures performed during the transplant itself were excluded. Twenty-five articles with a total of 33 patients met the inclusion criteria, 10 regarding the aortic valve (14 patients), 5 the mitral valve (6 patients), and 6 the tricuspid valve (13 patients). In two cases, the procedure was recommended to stabilize the valvular lesion before re-transplantation, as both were very young patients. Overall, the mean time from heart transplantation to reintervention was 14.7 ± 9.5 years. The mean follow-up was 15.5 ± 13.5 months, and only one patient died 22.3 months after the intervention. There is a growing emergence of transcatheter interventions for valvular disease after heart transplantation, especially in cases where surgery is deemed high-risk or prohibitive. A different strategy may also be considered in young patients to permit longer allograft life before later re-transplantation. Although encouraging outcomes have been documented, additional research is required to establish the most appropriate approach within this specific subset of patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background and Aims: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE., Methods: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD)., Results: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16)., Conclusions: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR., Aims: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR., Methods: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed., Results: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047)., Conclusions: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm 2 for TAVR and 1.6 ± 0.5 cm 2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group., Competing Interests: Declaration of competing interest Thomas Modine reports administrative support, article publishing charges, statistical analysis, and writing assistance were provided by Medtronic. Thomas Modine reports a relationship with Abbott that includes: consulting or advisory. Thomas Modine reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Thomas Modine reports a relationship with Microport that includes: consulting or advisory. Thomas Modine reports a relationship with Edwards Lifesciences that includes: consulting or advisory and funding grants. Thomas Modine reports a relationship with Jenscare Scientific Co that includes: consulting or advisory. John K. Forrest reports a relationship with Edwards Lifesciences that includes: consulting or advisory and funding grants. John K. Forrest reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Abbott that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Edwards Lifesciences that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with Boston Scientific that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Abiomed that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with PulseCath BV that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with Daiichi Sankyo that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with JenaValve that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Anteris Technologies that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Siemens that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Pie Medical Imaging BV that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Amgen that includes: consulting or advisory. Michael Deeb reports a relationship with Medtronic that includes: funding grants. Steven J. Yakubov reports a relationship with Boston Scientific that includes: funding grants. Steven J. Yakubov reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Walid Ben Ali reports a relationship with Medtronic that includes: funding grants. Walid Ben Ali reports a relationship with Edwards Lifesciences that includes: funding grants. Didier Tchetche reports a relationship with Abbott that includes: consulting or advisory. Didier Tchetche reports a relationship with Boston Scientific that includes: consulting or advisory. Didier Tchetche reports a relationship with Edwards Lifesciences that includes: consulting or advisory. Didier Tchetche reports a relationship with Medtronic that includes: consulting or advisory. Jae K. Oh reports a relationship with Echocardiography Core Laboratory that includes: employment. Jae K. Oh reports a relationship with Medtronic that includes: consulting or advisory. Jae K. Oh reports a relationship with REDNVIA that includes: funding grants. Jian Huang reports a relationship with Medtronic that includes: employment and equity or stocks. Michael J. Reardon reports a relationship with Medtronic that includes: funding grants. Michael J. Reardon reports a relationship with Abbott that includes: consulting or advisory. Michael J. Reardon reports a relationship with Boston Scientific that includes: consulting or advisory. Michael J. Reardon reports a relationship with Gore Medical that includes: consulting or advisory. Roxana Mehran reports a relationship with Abbott that includes: funding grants. Roxana Mehran reports a relationship with Abiomed that includes: funding grants. Roxana Mehran reports a relationship with Affluent Medical that includes: consulting or advisory and funding grants. Roxana Mehran reports a relationship with Alleviant Medical that includes: funding grants. Roxana Mehran reports a relationship with Amgen that includes: funding grants. Roxana Mehran reports a relationship with AM-Pharma that includes: funding grants. Roxana Mehran reports a relationship with Arena that includes: funding grants. Roxana Mehran reports a relationship with AstraZeneca that includes: funding grants. Roxana Mehran reports a relationship with AtriCure Inc that includes: funding grants. Roxana Mehran reports a relationship with Biosensors that includes: funding grants. Roxana Mehran reports a relationship with Biotronik that includes: funding grants. Roxana Mehran reports a relationship with Boston Scientific that includes: funding grants. Roxana Mehran reports a relationship with Bristol-Myers Squibb that includes: funding grants. Roxana Mehran reports a relationship with CardiaWave that includes: funding grants. Roxana Mehran reports a relationship with CeloNova that includes: funding grants. Roxana Mehran reports a relationship with CERC that includes: funding grants. Roxana Mehran reports a relationship with Chiesi that includes: funding grants. Roxana Mehran reports a relationship with Concept Medical that includes: funding grants. Roxana Mehran reports a relationship with Cytosorbents that includes: funding grants. Roxana Mehran reports a relationship with Daiichi Sankyo that includes: consulting or advisory and funding grants. Roxana Mehran reports a relationship with Duke that includes: funding grants. Roxana Mehran reports a relationship with Element Science that includes: funding grants. Roxana Mehran reports a relationship with Essential Medical that includes: funding grants. Roxana Mehran reports a relationship with Faraday that includes: funding grants. Roxana Mehran reports a relationship with Idorsia Pharmaceuticals that includes: funding grants. Roxana Mehran reports a relationship with Janssen that includes: funding grants. Roxana Mehran reports a relationship with MedAlliance that includes: funding grants. Roxana Mehran reports a relationship with Mediasphere that includes: funding grants. Roxana Mehran reports a relationship with Medtelligence that includes: funding grants. Roxana Mehran reports a relationship with Medtronic that includes: funding grants. Roxana Mehran reports a relationship with MJH Healthcare that includes: funding grants. Roxana Mehran reports a relationship with OrbusNeich that includes: funding grants. Roxana Mehran reports a relationship with Penumbra that includes: funding grants. Roxana Mehran reports a relationship with PhaseBio that includes: funding grants. Roxana Mehran reports a relationship with Philips that includes: funding grants. Roxana Mehran reports a relationship with Pi-Cardia that includes: funding grants. Roxana Mehran reports a relationship with PLx Pharma that includes: funding grants. Roxana Mehran reports a relationship with Population Health Research Institute that includes: funding grants. Roxana Mehran reports a relationship with Protembis that includes: funding grants. Roxana Mehran reports a relationship with RecCor Medical Inc that includes: funding grants. Roxana Mehran reports a relationship with RenalPro that includes: funding grants. Roxana Mehran reports a relationship with RM Global that includes: funding grants. Roxana Mehran reports a relationship with Sanofi that includes: funding grants. Roxana Mehran reports a relationship with Shockwave that includes: funding grants. Roxana Mehran reports a relationship with Vivasure that includes: funding grants. Roxana Mehran reports a relationship with Zoll that includes: funding grants. Roxana Mehran reports a relationship with Cardiovascular Research Foundation that includes: consulting or advisory. Roxana Mehran reports a relationship with Cordis that includes: consulting or advisory. Roxana Mehran reports a relationship with E.R. Squibb & Sons that includes: consulting or advisory. Roxana Mehran reports a relationship with Esperion Science Innovative Biopharma that includes: consulting or advisory. Roxana Mehran reports a relationship with Europa Group Boston Scientific that includes: consulting or advisory. Roxana Mehran reports a relationship with Gaffney Events that includes: consulting or advisory. Roxana Mehran reports a relationship with Educational Trust that includes: consulting or advisory. Roxana Mehran reports a relationship with Ionis Pharmaceuticals that includes: consulting or advisory. Roxana Mehran reports a relationship with MedCon International that includes: consulting or advisory. Roxana Mehran reports a relationship with NovoNordisk that includes: consulting or advisory. Roxana Mehran reports a relationship with PeerView Institute for Medical Education that includes: consulting or advisory. Roxana Mehran reports a relationship with Terumo Europe NV that includes: consulting or advisory. Roxana Mehran reports a relationship with Vectura that includes: consulting or advisory. Roxana Mehran reports a relationship with VoxMedia that includes: consulting or advisory. Roxana Mehran reports a relationship with WebMD that includes: consulting or advisory. Roxana Mehran reports a relationship with IQVIA that includes: consulting or advisory. Roxana Mehran reports a relationship with Radcliffe that includes: consulting or advisory. Roxana Mehran reports a relationship with TARSUS Cardiology that includes: consulting or advisory. Roxana Mehran reports a relationship with Applied Therapeutics that includes: equity or stocks. Roxana Mehran reports a relationship with Elixir Medical that includes: equity or stocks. Roxana Mehran reports a relationship with Stel that includes: equity or stocks. Co-author serves on scientific advisory board for AMA, Women in Innovations Committee Member for SCAI, Associate Editor for JAMA Cardiology, BOT Member, SC Member CTR Program for ACC - RM If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial., Objectives: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER., Methods: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization., Results: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35)., Conclusions: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients., Competing Interests: Funding Support and Author Disclosures Dr Ludwig has received travel compensation from Edwards Lifesciences; has received speaker honoraria from Abbott; has received advisory fees from Bayer; and is a consultant for New Valve Technology. Dr Koell has received personal fees from Edwards Lifesciences. Dr Donal has received research facilities from GE Healthcare and Abbott. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Scotti has served as a consultant for Edwards Lifesciences and NeoChord Inc. Dr Melica has served as a proctor for Abbott. Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Dreyfus has received consulting or speaker fees from Abbott. Dr Karam has received consultant fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kessler has received speaker honoraria for Edwards Lifesciences and Abbott. Dr Lavie Badie has served as a consultant and proctor for Abbott; and has served as a proctor for Abbott. Dr Metra has received consulting honoraria of minimal amounts from Abbott Structural, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences Roche diagnostics Novo Nordisk, in the last 3 years. Dr Iliadis has received personal fees from Abbott and Edwards Lifesciences. Dr Gerçek has received funding from the Ruhr University Bochum (Advanced Clinician Scientist); and has served as a consultant for Edwards Lifesciences. Dr Latib has served on the Advisory Board for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. Dr Kalbacher has received personal fees from Abbott Medical, Edwards Lifesciences, Medtronic, and Pi-Cardia Ltd. Dr Coisne has served as a consultant for Abbott, Edwards Lifesciences, and GE Healthcare; and has received speaker fees from Abbott, AstraZeneca, GE Healthcare, Merck Sharp & Dohme, and Pfizer. 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.)

Competing Interests: Conflict of interest: A.L. is a consultant for VDyne and Shifamed. T.M. received consulting fees from JensCare Scientific. The other authors have no relationships relevant to the contents of this paper to disclose.

Background: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern., Objectives: The authors sought to assess the impact of residual TR severity post-TTV repair on survival., Methods: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe)., Results: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96)., Conclusions: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention., Competing Interests: Funding Support and Author Disclosures Dr Dreyfus has received speaker or proctoring fees from Abbott. Dr Kresoja has received consulting fees from Edwards Lifesciences. Dr Taramasso has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, PiCardia, CoreMedic, VentriMend, MEDIRA, CoreQuest, and HiD Imaging. Dr Iliadis has received consulting fees from Abbott Vascular and Edwards Lifesciences. Dr Nombela-Franco has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Products and Features. Dr Estevez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Hausleiter has received grants and consulting fees from Edwards Lifesciences. Dr Stolz has received consulting or speaker fees from Edwards Lifesciences. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an Advisory Board member and/or member of the Steering/Executive Group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has served as a member of the Steering/Executive Committee Group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Zamorano has received consulting or speaker fees from Novartis, Bayer, and Pfizer. Dr von Bardeleben has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, and Siemens. 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; has served as a consultant and Physician Screening Committee Member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Boston Scientific, Edwards Lifesciences, and Philips Healthcare. Dr Webb has received consulting fees from Edwards Lifesciences; and has received research funding from Medtronic, Abbott, Boston Scientific, and Edwards Lifesciences. Dr Lauten has received speaker fees from Boehringer Ingelheim, Medtronic, Amgen, Bayer, Novartis, Sanofi, Chiesi, and AstraZeneca; and is a shareholder of the Devie Medical Drug Eluting Valve for Endocarditis Treatment. Dr Rodés-Cabau has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Nejjari has received consulting or speaker fees from Abbott Vascular, Medtronic, Edwards Lifesciences, Boston Scientific, and Robocath. Dr Badano has received consulting or speaker fees from Edwards Lifesciences, GE Healthcare, and Philips Medical Systems. Dr Himbert has received proctoring fees from Edwards Lifesciences and Abbott Vascular. Dr Modine has received speaker or consulting fees from Abbott, Edwards Lifesciences, Medtronic, Microport, and GE. Dr Rudolph has received consulting or speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences. Dr Lurz has received consulting fees from Abbott Medical, Innoventric, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Venus, and 3mensio; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, and Squadra; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) in Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, and 4Tech. Dr Messika-Zeitoun has received research grants from Edwards Lifesciences. 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.)

Background: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated., Objectives: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk., Methods: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory., Results: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR., Conclusions: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and has served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Thourani has been an advisor to or received research grants from Artivion, Atricure, Abbott Vascular, Boston Scientific, Dasi Simulations, Edwards Lifesciences, Medtronic, and JenaValve. Dr Yadav is a proctor and speaker for Edwards Lifesciences; and a consultant for and holds stock in Shockwave Medical. Dr Thaden has received institutional consulting fees from Medtronic; and speaker fees from Edwards Lifesciences. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, NXT, V Wave, and WL Gore; and has received consulting fees from Philips, Valgen Medtech, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Pinney has received consulting fees from Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech. Dr Adams is national coprincipal investigator for Medtronic APOLLO FDA Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial; and his institution, the Icahn School of Medicine at Mount Sinai, receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr Yakubov has received research grants from Medtronic and Boston Scientific; serves on advisory boards for Medtronic and Boston Scientific; and is a principal investigator, steering committee member, and screening committee member for the CoreValve clinical trials. Dr Modine is a consultant for Abbott, Boston Scientific, Cephea, Edwards Lifesciences, GE Healthcare, Medtronic, and MicroPort; and is a proctor for and receives speaker fees from Medtronic. Dr Redwood has received speaker fees from Edwards Lifesciences. Dr Walton has served as a proctor and received advisory board fees and grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr Spargias has received grant support and proctor fees from Medtronic, Abbott Vascular, and Edwards Lifesciences. Ms Zhang is an employee of Medtronic. Dr Mack is on the executive board for the APOLLO trial sponsored by Medtronic; and is coprincipal investigator for the PARTNER 3 and COAPT trials sponsored by Edwards Lifesciences and Abbott Vascular. Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Structural valve deterioration after aortic root replacement (ARR) surgery may be treated by transcatheter valve-in-valve (ViV-TAVI) intervention. However, several technical challenges and outcomes are not well described. The aim of the present review was to analyze the outcomes of ViV-TAVI in deteriorated ARR. This review included studies reporting any form of transcatheter valvular intervention in patients with a previous ARR. All forms of ARR were considered, as long as the entire root was replaced. Pubmed, ScienceDirect, SciELO, DOAJ, and Cochrane library databases were searched until September 2023. Overall, 86 patients were included from 31 articles that met our inclusion criteria out of 741 potentially eligible studies. In the entire population, the mean time from ARR to reintervention was 11.0 years (range: 0.33-22). The most frequently performed techniques/grafts for ARR was homograft (67.4%) and the main indication for intervention was aortic regurgitation (69.7%). Twenty-three articles reported no postoperative complications. Six (7.0%) patients required permanent pacemaker implantation (PPI) after the ViV-TAVI procedure, and 4 (4.7%) patients had a second ViV-TAVI implant. There were three device migrations (3.5%) and 1 stroke (1.2%). Patients with previous ARR present a high surgical risk. ViV-TAVI can be considered in selected patients, despite unique technical challenges that need to be carefully addressed according to the characteristics of the previous surgery and on computed tomography analysis., (© 2024 Wiley Periodicals LLC.)

Background: The permanent pacemaker (PPM) implantation and pacemaker dependency rates after transcatheter aortic valve replacement (TAVR) are highly variable as some of the conduction disturbances are reversible. It remains poorly investigated how to optimise temporary pacing in these patients. This study aimed to explore the potential reduction in the PPM implantation rate using temporary-permanent pacemaker (TPPM) as a 1-month bridge., Methods: This is a prospective, multicentre, single-arm, observational study. Consecutive patients undergoing TAVR from March 1, 2022 to March 1, 2023 in 13 tertiary hospitals in China were screened. Patients who developed high-degree atrioventricular block, complete heart block, or first-degree atrioventricular block plus new onset left bundle branch block during the TAVR procedure or within 1 month after TAVR were included to receive TPPM. Patients with pre-existing PPM implantation or indications for PPM implantation before the TAVR procedure were excluded. Patients with TPPM were monitored to determine whether the conduction disturbances persisted or recovered. The primary endpoint was the rate of freedom from indications for PPM implantation 1 month after TAVR. This study is registered with ChiCTR, ChiCTR2200057931., Findings: Of 688 patients who have undergone TAVR, 71 developed conduction disturbance and met the inclusion criteria, 1 patient withdrew due to noncompliance, 70 patients received TPPM and completed follow-up. There were 41 (58.6%) men and 29 (41.4%) women in the study, with a mean age of 74.3 ± 7.3 years. At 1 month follow-up, 75.7% (53/70) of the patients with TPPM did not require PPM implantation. For 688 patients who have undergone TAVR, the rate of PPM implantation at 1 month was 2.47% (17/688, 95% CI 1.55%-3.92%), representing a significant reduction in self-comparison with the rate at 48 h after TPPM (2.47% vs. 8.28% [95% CI 6.45%-10.58%], P < 0.0001). Similar results were obtained in the subgroup analysis of patients with HAVB/CHB. Multivariate analysis revealed the baseline PR interval, difference between the membranous septum length and implantation depth, and timing of postprocedural conduction disturbance occurrence were independent predictors of freedom from indications for PPM implantation at 1 month after TAVR., Interpretation: Using TPPM as a 1-month bridge allows for a buffer period to distinguish whether conduction disturbances are reversible or persistent, resulting in a significant reduction in the PPM implantation rate after TAVR when compared with the current strategy. However, this is an observational study, the results need to be confirmed in a randomized trial., Funding: Beijing Science and Technology Plan 2022 from Beijing Municipal Science & Technology Commission., Competing Interests: HJ received grants from Pi-Cardia for his institution, and received consulting fees from Edwards Lifesciences and Medtronic Inc. All other authors declare no competing interests., (© 2024 The Author(s).)

Background: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry., Methods: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year., Results: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07)., Conclusions: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR., Methods: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis., Results: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up., Conclusions: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Competing Interests: Disclosures Drs Modine and Leroux: Proctor for Abbott Laboratories and Medtronic Inc, and consultant for Edwards Lifesciences. The other authors report no conflicts.

Background: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD., Aims: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD., Methods: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis., Summary: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR)., Competing Interests: Conflict of interest E.K. reports institutional research grants support from Abbott Vascular Laboratories and Medtronic as well as proctor/lecture fees from Abbott Vascular. R.H. reports lecture fees from Abbott Vascular, Amgen, Novartis. M.H. reports proctor for Meril Life. I.A.S. reports proctor for Boston Scientific, Medtronic and Meril Life. M.A. reports proctor/speaker/consultant fees from Edwards, Abbott, Medtronic, Boston, Zoll, Abbvie and received institutional research grants Edwards, Abbott, Medtronic, LSI. L.C: Advisory Board member for Abbott, Medtronic and JenaValve, consultant for Edwards Lifesciences, Boston Scientific, PiCardia, MicroPort, MicroInterventions. W. Wojakowski: Medtronic advisory board, lecture fees from Edwards Lifesciences, Abbott, Medtronic; E.L.Institutional Research from Abbott Medical Netherlands. All other authors don't report any conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC., Methods: Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available., Results: Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline., Conclusions: In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC., Competing Interests: P. Généreux has been a consultant for 4C Medical, Abbott Vascular, Abiomed, Boston Scientific, CARANX Medical, Cardiovascular System Inc, Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Soundbite Medical Inc, and Teleflex; has been an advisor to Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Medtronic, Shockwave, and Siemens; has been a principal investigator of 4C Medical for a feasibility study, Cardiovascular System Inc for Eclipse Trial, and Edwards Lifesciences for EARLY-TAVR and PROGRESS trials; holds equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; and has been a proctor for and received institutional grants from Edwards Lifesciences. Krzysztof Wróbel is a consultant and proctor for 4C Medical. M. J. Rinaldi is a consultant for Abbott Vascular, a consultant for Edwards Lifesciences, a consultant for Bostin Scientific, a consultant for Johnson and Johnson, a consultant for Abiomed, and a consultant for Shockwave Medical. T. Modine served on the advisory board of Medtronic, Valfix, and Valcare, is a consultant for Abbott, Edwards Lifesciences, Microport, GE, and Boston Scientific, received research grants from Edwards Lifesciences, Medtronic, and Abbott, and is the principal investigator of Apollo trial, Trinity study, and Neocord study. V. Bapat is a consultant for Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Anteris. V. Ninios is a proctor for 4C Medical, Abbott, and Boston Scientific. P. Sorajja served on the advisory boards of 4C Medical, Abbott Structural (Cephea, Global Valve Masters, Global Complexity Score, Tricuspid Advisory Board), Boston Scientific SHV Strategic Advisory Board, Boston Scientific Advisory Board, Medtronic Structural Advisory Board, and VDyne Advisory Board. Serves as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, xDot. Serves as National or Global Principal Investigator of TRILUMINATE Pivotal US Trial, SUMMIT MAC Pivotal Trial, EXPAND 2 Pivotal US Trial, HighLife (USA) EFS, and VDyne EFS., (© 2024 The Author(s).)

Background and Aims: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France., Methods: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes., Results: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction., Conclusions: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort., Objectives: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry., Methods: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year., Results: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year., Conclusions: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335)., Competing Interests: Funding Support and Author Disclosures The TENDER study was carried out without financial support from industry. It was initiated as an academic investigator trial by LMU University Hospital and Universitätsmedizin Mainz. Dr Baldus has received research grants and honoraria from Abbott and Edwards Lifesciences. Dr Rudolph has received speaker honoraria from Abbott. Dr Andreas has received proctoring, consulting, and speaker fees from Edwards Lifesciences, Abbott, Medtronic, Boston, Zoll, and AbbVie; and institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Duncan has received consulting fees and honoraria from Abbott, Edwards Lifesciences, Medtronic, NeoChord. Dr Nombela serves as a physician proctor for and has received advisory fees from Abbott Cardiovascular, Edwards Lifesciences, and Products + Features. Dr Ruge serves as a physician proctor for and has received advisory fees from Abbott Medical. Dr Conradi serves as an advisory board member for Abbott, Medtronic, and JenaValve; and is a consultant for Edwards Lifesciences, Boston Scientific, MicroPort, Pi-Cardia. Dr Dumonteil has received consulting and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Barth has received speaker and advisory fees from Abbott Cardiovascular and Edwards Lifesciences. Dr Adamo has received speaker honoraria from Abbott, Medtronic, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, New Valve Technology, Terumo, and Venus; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, MTEX Cardio, Venus, and Squadra; has received royalty income from and holds intellectual property rights with Edwards Lifesciences; is a shareholder (including share options) in CardioGard, Cardiovalve, Magenta, SwissVortex, Transseptal Solutions, 4Tech, and Perifect. Dr Lurz has received honoraria from ReCor Medical and Innoventric; and has received institutional grants from Edwards Lifesciences and ReCor. Dr Hausleiter has received speaker fees, research support, and advisory fees from Edwards Lifesciences. Dr von Bardeleben has received speaker or advisory fees from Abbott Cardiovascular, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens; and has conducted unpaid trial activity for Abbott Cardiovascular, Edwards Lifesciences, Jenscare Scientific, Medtronic, and NeoChord. 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.)

Tricuspid regurgitation (TR) severity after mitral transcatheter edge-to-edge repair (TEER) has been shown to impact outcomes but unknown in patients requiring mitral valve (MV) surgery after TEER. We sought to determine the impact of preoperative TR severity and right ventricular (RV) dysfunction on MV surgery after TEER. From 7/2009 to 7/2020, 260/332 patients in the CUTTING-EDGE registry who underwent MV surgery after TEER had paired echocardiographic evaluation on TR severity, and ≥moderate (2+) vs <2+ TR at the time of index TEER were compared. Median follow-up post-MV surgery was 9.1 months, 96.5% complete at 30 days and 81.9% complete at 1 year. Mean age was 73.8 ± 10.3; with primary/mixed and secondary MR present in 65.6% and 32.0%, respectively. Proportion of ≥2+ TR increased from TEER to MV surgery (40% vs 57%, P < 0.001). Compared to <2+ TR group, ≥2+ pre-TEER TR patients were older, had higher STS risk score at TEER, higher RVSP, more RV dysfunction, more MR post-TEER, and a shorter median interval from TEER to MV surgery (1.9 vs 4.9 months, P = 0.023). Mortality was higher in the ≥2+ pre-TEER TR group at 30 days(24.2% vs 13.8%, P = 0.043) and 1 year (45.3% vs 22.3%, P = 0.003). On Kaplan-Meier analysis, cumulative mortality was 23.8% at 1 year and 31.6% at 3 years after MV surgery overall, and was associated with preoperative RV dysfunction (P = 0.023), ≥2+ TR at pre-TEER (P = 0.001) and presurgery (P = 0.004), but not concomitant tricuspid surgery. Moderate or greater pre-TEER TR was associated with worse outcomes, and pre-TEER TR worsened significantly at MV surgery. Concomitant tricuspid surgery did not increase overall mortality., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Transcatheter tricuspid valve replacement (TTVR) abolishes tricuspid regurgitation (TR) and has emerged as a definitive treatment for TR., Objectives: The purpose of this multicenter, observational study was to determine the clinical characteristics and short-term outcomes of patients with TR screened for TTVR., Methods: Patients underwent TTVR screening at 7 centers on a compassionate-use basis. The primary endpoints were NYHA functional class and TR grade at 30-day follow-up. Secondary endpoints included all-cause mortality, heart failure hospitalization, technical success, and reasons for TTVR screening failure., Results: A total of 149 patients (median age 79 years [Q1-Q3: 72-84 years], 54% women) underwent TTVR screening. The TTVR screening failure rate was 74%, mainly related to large tricuspid annular diameter. Patients undergoing TTVR (n = 38) had significant functional improvements (NYHA functional class I or II from 21% to 68%; P < 0.001), with TR ≤1+ in 97% at 30-day follow-up (P < 0.001 from baseline). Technical success was achieved in 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalization 5%, major bleeding 18%, and reintervention 9%. Patients who failed screening for TTVR and subsequently underwent "bailout" transcatheter edge-to-edge repair (n = 26) had favorable outcomes (NYHA functional class I or II from 27% to 58%; P < 0.001), with TR ≤1+ in 43% at 30-day follow-up (P < 0.001 from baseline)., Conclusions: This first real-world report of TTVR screening demonstrated a high screening failure rate, mainly related to large tricuspid annular diameter. Patients undergoing TTVR had superior TR reduction and symptom alleviation compared with bailout tricuspid transcatheter edge-to-edge repair, at the cost of greater procedural complications., Competing Interests: Funding Support and Author Disclosures Dr Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Ancora Heart, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has been a consultant for Boston Scientific, Medtronic, Edwards Lifesciences, MicroPort, GE, and Abbott. Dr Latib has served on advisory boards for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord, VDyne, and Philips. Dr Praz has received travel expense reimbursement from Edwards Lifesciences, Abbott Vascular, and Polares Medical. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences; and is a consultant to Abbott Vascular and Edwards Lifesciences. Dr Fam is a consultant to Edwards Lifesciences, Abbott, and Cardiovalve. 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.)

Background and Aims: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE., Methods: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years., Results: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively)., Conclusions: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Transcatheter aortic valve replacement (TAVR) has emerged as a viable treatment for aortic valve disease, including low-risk patients. However, as TAVR usage increases, concerns about long-term durability and the potential for addition interventions have arisen. Transcatheter aortic valve (TAV)-in-TAV procedures have shown promise in selected patients in numerous registries, offering a less morbid alternative to TAVR explantation. In this review, the authors aimed to comprehensively review the experience surrounding TAV-in-TAV, summarize available data, discuss pre-procedural planning, highlight associated challenges, emphasize the importance of coronary obstruction assessment and provide insights into the future of this technique., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Hayek, Prieur, Dürrleman, Chatelain, Ibrahim, Asgar, Modine and Ben Ali.)

Background: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays., Objectives: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity., Methods: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses., Results: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity., Conclusions: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises., Competing Interests: Funding Support and Author Disclosures Dr Lefèvre has served as a proctor for Edwards Lifesciences; and received minor fees from Boston Scientific, Terumo, and Abbott. Dr Pilgrim has received research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi Sankyo, AstraZeneca, Teleflex; and advisory board fees from Abbott Vascular, Boston Scientific, Inari, JenaValve, Medtronic, Daiichi Sankyo, AstraZeneca, Siemens, Pie Medical, and Teleflex. Dr Swaans has served as a proctor/lecturer for Abbott Vascular, Boston Scientific, Bioventrix Inc, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, and Philips Healthcare. Dr Prendergast has received speaker/consultancy fees from Medtronic, MicroPort, Anteris, and Edwards Lifesciences. Dr Resar has received institutional research funding from Medtronic, Edwards Lifesciences, and Abbott; and served as a TAVR proctor for Medtronic. Dr Chen has served as a consultant for Venus MedTech. Dr Hildick-Smith has received research funds and speaker fees from Medtronic. Dr Spence has received TAVR proctoring and consultancy fees from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Bunc has served as a proctor for Abbott, Meril, Edwards Lifesciences, and Medtronic. Dr Molnár has served as a consultant for Medtronic and Abbott. Dr Toggweiler has served as a consultant and proctor for Medtronic, Boston Scientific, and Biosensors; has served as a proctor for Edwards Lifesciences and Abbott Vascular; has served as a consultant for Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, and Polares Medical; has received institutional research grants from Boston Scientific, Fumedica, and Novartis; has received speaker honoraria from Sanofi, AstraZeneca, ReCor Medical, and Daiichi Sankyo; and holds equity in Hi-D Imaging. Dr Ojeda has received consulting fees from Medtronic and Edwards Lifesciences; and speaker fees from Philips and Word Medica. Dr Toutouzas has served as a proctor for Medtronic, Abbott, Myval, and Boston Scientific. Dr AlMerri has served as a TAVR proctor for Medtronic. Dr Noble has served as a proctor for Medtronic; and received institutional grant support from Edwards Lifesciences, Boston Scientific, Abbott Vascular, and Medtronic. Dr Kala has served as a consultant for Boston Scientific; served on the Speakers Bureau for Edwards Lifesciences, Servier, and AstraZeneca; and received research support from Novartis. Dr Kurt has served as a TAVR proctor for Abbott. Dr Yin has served as a TAVR proctor for Medtronic, Edwards Lifesciences, and Abbott. Dr Sztejfman has served as a proctor for Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and MicroPort. Dr Mendiz has served as a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Gunasekaran has received fees from Medtronic, Meril Life Sciences, Abbott, and Boston Scientific. Dr Kao has served as a proctor for Medtronic and Edwards Lifesciences. Dr Dager has served as a consultant for Medtronic. Dr Ferrero-Guadagnoli has served as a proctor for Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a consultant for and received honorarium from Abbott, Medtronic, and Edwards Lifesciences. Dr Hayashida has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. Dr Makkar has received research grants from Abbott, Edwards Lifesciences, and Boston Scientific, and served as a consultant for Cordis and Medtronic. Dr Mylotte has received institutional grant funding from Boston Scientific and Medtronic; and personal fees from Boston Scientific, Medtronic, and MicroPort. 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.)

Background and Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI)., Methods: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs., Results: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry., Conclusion: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure., Aims: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV)., Methods: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV., Results: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69)., Conclusions: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Objectives: Relevant paravalvular leakage (PVL) due to prosthesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning manoeuvres., Methods: From 2017 to 2021, N = 18 patients who underwent secondary tether retensioning were identified. Baseline, procedural and follow-up data were available from N = 11 patients and analysed according to the Mitral Valve Research Consortium definitions. Continuous variables are shown as median with interquartile range., Results: All patients [age 75 years (73.5, 85.0), 64% male (N = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N = 7) with PVL ≥3+]. Of these, 54% (N = 6) showed signs of haemolysis. The majority were severely symptomatic [New York Heart Association ≥III (91%, N = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N = 10) of patients with 1 case of remaining moderate PVL. At 30 days, Mitral Valve Research Consortium device success was achieved in 82% (N = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N = 8) of patients with successful retensioning procedure, New York Heart Association class was I/II. There was no 30-day mortality., Conclusions: This multicentre study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Tricuspid regurgitation (TR) is the most common valvular pathology after heart transplantation (HTx) and endomyocardial biopsy (EMB) remains responsible for the majority of cases due to the high probability of structural valve damage. The aim of the present review was to describe the results of surgical management of severe tricuspid regurgitation through tricuspid valve replacement (TVR) after a previous HTx. A systematic review was conducted by searching Pubmed, ScienceDirect, SciELO, DOAJ, and Cochrane databases until June 2023 for publications reporting patients undergoing TVR surgery after a previous HTx. If no right heart valve surgery was undertaken, or a heterotopic heart transplant was performed, or if the concomitant procedure was performed during the transplant itself, the paper was excluded. Twenty articles met our inclusion criteria out of 1532 potentially eligible studies, with a total of 300 patients. Mean age was 55.1 ± 9.6 years, and 85.1% were male. The mean number of EMB per patient was 31.1 ± 5.5 with a mean time between HTx and TVR of 7.64 ± 3.31 years. Bioprostheses were used in 83.3% of cases and 75.0% of patients with a bioprosthesis were reported as alive at last follow-up. Tricuspid valve repair is a valuable option, but these patients will be susceptible to recurrent TR after EMB. TVR with a bioprosthesis may provide the optimal solution for this subset of patients, as EMB is not feasible with a mechanical valve., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

As the survival after heart transplantation (HTx) is steadily improving, an increasing number of patients with late cardiac pathologies such as valvular disease is expected to rise. Nevertheless, no guidelines for indication of redo cardiac surgery after HTx exists. The aim of the present systematic review is to describe the results reported in the literature of surgical management of severe aortic and/or mitral valve disease. A systematic review was conducted including studies reporting on adult patients with severe mitral or aortic valve pathology needing surgery after their previous HTx. Exclusion criteria consisted in surgery with no left heart valve surgery, concomitant valve surgery during heart transplant, transcatheter interventions, and heterotopic HTx. A total of 35 papers met our inclusion criteria out of 2755 potentially eligible studies with 44 mitral valve surgery patients and 20 aortic valve surgery patients. In the entire population, the mean time from HTx to reintervention was 6.19 ± 5.22 years. After a mean follow-up of 2.78 ± 3.54 years and 1.53 ± 2.26 years from reintervention, 65.6% mitral and 86.7% aortic patients were reported as alive, respectively. As guidelines on cardiac surgery after HTx are currently lacking, left-sided valvular cardiac reinterventions can be considered a possible therapeutic approach in carefully selected patients. These interventions may not only improve the patient's functional status and survival, but may ultimately reduce the need for re-transplantation due to the chronic shortage of donor hearts. However, the support of more robust data is warranted., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aims: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes., Methods: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year., Results: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure., Conclusions: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Aortic arch surgery still represents a challenge, and the frozen elephant trunk (FET) allows a one-step surgery for complex aortic diseases. The aim of the study was to analyze the results of patients undergoing FET procedure for aortic arch surgery at Bordeaux University Hospital., Methods: Patients undergoing FET procedure for multisegmented aortic arch pathologies were analyzed in this single-center retrospective study. Further subgroup analyses were performed according to the degree of urgency of the operation (elective versus emergent surgery) and cerebral protection technique: bilateral selective antegrade cerebral perfusion (B-SACP) versus the unilateral one (U-SACP), regardless of the degree of urgency., Results: From August 2018 to August 2022, 77 consecutive patients (64.1±9.9 years, 54 males) were enrolled: 43 (55.8%) for elective surgery and 34 (44.2%) in emergency. Technical success was 100%. 30-day mortality was 15.6% (N.=12, 7% elective vs. 26.5% emergent, P=0.043). Six (7.8%) non-disabling strokes occurred (1.9% B-SACP vs. 20% U-SACP, P=0.021). Median follow-up was 1.11 years (interquartile range, 0.62-2.07). The 1-year overall survival was 81.6±4.45%. The elective group showed a survival trend when compared to the emergency one (P=0.054). However, further examination at landmark analysis elective surgery showed a better survival trend compared to emergency surgery up to 1.78 years (P=0.034), after which significance was lost (P=0.521)., Conclusions: Thoraflex hybrid prosthesis for FET technique demonstrated feasibility and satisfactory short-term clinical outcomes, even in emergent settings. In our practice B-SACP seems to offer better protection and less neurological complications compared to U-SACP, nevertheless further analyses are warranted.

Background: Severe TR is associated with impaired prognosis while limited interventional options available. The purpose of this observational first-in-human experience with the K-Clip™ transcatheter tricuspid annular reconstruction system is to investigate its feasibility, safety as well as short-term clinical impact on patients with severe functional tricuspid regurgitation (TR)., Methods: In this compassionate-use, prospective, multi-center, single-arm study, 15 patients with severe symptomatic functional TR were treated with the K-Clip™ system and followed up at 30 days after discharge. Feasibility endpoints consisted of safety (major clinical cardiovascular events (MACEs), echocardiographic, clinical and functional endpoints., Results: All the 15 patients (9 males, 72.67 ± 9.42 years of age) successfully received implants and no MACEs were reported throughout the study at 30 days. Between baseline and 30 days, echocardiography showed remarkable reduction of tricuspid annular circumference and area by 14.30% and 25.96%. Improvement of ≥ + 2 grade and ≥ +3 grade TR was presented in 9/15(60.00%) and 4/15(26.67%) respectively while 10/15(66.67%) of patients had ≤ moderate TR. Clinical evaluation indicated that 86.67% of patients were finally in NYHA functional class I or II (p<0.001) and overall Kansas City Cardiomyopathy Questionnaire score improved from 62.28 ± 18.97 to 77.90 ± 11.70 (p = 0.016)., Conclusion: Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, acceptable safety and remarkable TR reduction in consistent with significant clinical improvement. Larger-scaled prospective trials with longer follow-up duration are warranted to further determine whether these promising findings could be promoted to a broader population in the long term., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Recent reports have demonstrated worse than expected outcomes of surgical explantation after transcatheter aortic valve replacement (TAVR). However in-depth analysis of the short- and mid-term risk of concomitant cardiac surgery at the time of TAVR explant is lacking., Methods: Data from the multicenter EXPLANT-TAVR registry of patients undergoing TAVR-explant between November 2009 and September 2020 were retrospectively analyzed. Patients undergoing concomitant procedures were included, but explants performed during the same admission as the initial TAVR or concomitant procedures performed on the aortic root, ascending aorta, or arch were excluded. Outcomes were evaluated between the isolated surgical aortic valve replacement (SAVR) and concomitant SAVR groups. Median follow-up was 6.6 months., Results: Among 199 patients, concomitant SAVR was performed in 94 patients (47.2%), primarily with mitral valve surgery (n = 45) followed by coronary artery bypass grafting (n = 23). Despite similar mean ages between groups (72.8 vs 73.4 years), concomitant SAVR had a higher median Society of Thoracic Surgeons Predicted Risk of Mortality score at the index TAVR (5.9% vs 3.7%, P = .001). There were no differences in median time-to-explant between groups (12.9 vs 8.7 months, P = .78). However concomitant SAVR had longer mean cardiopulmonary bypass (166 vs 114 minutes, P = .001) and cross-clamp times (123 vs 81 minutes, P = .001). Both 30-day (16.7% vs 9.9%) and 1-year mortality (36.1% vs 22.1%) were higher with concomitant SAVR but did not reach statistical significance (both P > .05). On Kaplan-Meier analysis, actuarial estimates of cumulative survival were significantly lower with concomitant SAVR at 3 years (56.8% vs 81.1%, P = .020)., Conclusions: For surgical explantation after TAVR failure, concomitant SAVR is associated with increased mortality. Further studies with longer follow-up are warranted to examine the benefit from earlier intervention before concomitant disease develops., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown., Methods: From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year., Results: Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P < .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups., Conclusions: In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery for treating severe aortic stenosis. Despite its benefits, the risk of procedural complications necessitates careful preoperative planning., Methods: This study proposes a fully automated deep learning-based method, TAVI-PREP, for pre-TAVI planning, focusing on measurements extracted from computed tomography (CT) scans. The algorithm was trained on the public MM-WHS dataset and a small subset of private data. It uses MeshDeformNet for 3D surface mesh generation and a 3D Residual U-Net for landmark detection. TAVI-PREP is designed to extract 22 different measurements from the aortic valvular complex. A total of 200 CT-scans were analyzed, and automatic measurements were compared to the ones made manually by an expert cardiologist. A second cardiologist analyzed 115 scans to evaluate inter-operator variability., Results: High Pearson correlation coefficients between the expert and the algorithm were obtained for most parameters (0.90-0.97), except for left and right coronary height (0.8 and 0.72, respectively). Similarly, the mean absolute relative error was within 5% for most measurements, except for left and right coronary height (11.6% and 16.5%, respectively). A greater consensus was observed among experts than when compared to the automatic approach, with TAVI-PREP showing no discernable bias towards either the lower or higher ends of the measurement spectrum., Conclusions: TAVI-PREP provides reliable and time-efficient measurements of the aortic valvular complex that could aid clinicians in the preprocedural planning of TAVI procedures.

Background: The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown., Objectives: This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices., Methods: This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves., Results: After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR., Conclusions: Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD., Competing Interests: Funding Support and Author Disclosures Dr Mesnier was supported by a research grant from Fédération Française de Cardiologie. Dr Belahnech was supported by a research grant from Aula Vall d’Hebron. Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions; and has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. Dr Ternacle has served as a consultant for Abbott. Dr Modine has served as a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Nombela-Franco has served as a proctor for Abbott and Edwards Lifesciences. Dr Reguiero has served as a proctor for Abbott. Dr Himbert has served as a proctor for Abbott and Edwards Lifesciences. Dr Asmarats has received speaker fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited., Aims: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry., Methods: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria., Results: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm 2 , and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies., Conclusions: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Background: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR)., Aims: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry., Methods: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality., Results: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality., Conclusions: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.

Objectives: Multidisciplinary approach is well established in various disciplines, with evidence highlighting improved patient outcomes. The objective of this survey was to determine the real-world practice of heart teams across Europe., Methods: The survey was drafted after a consensus opinion from the authors. The survey was sent to cardiac surgeons and cardiologists identified through electronic search. The survey link and the information sheet were sent through email followed by survey completion reminders. The survey responses were cumulated and analysed., Results: Among 2188 invited clinicians, 220 clinicians from 26 countries took part in the survey (response rate 10%). The completion rate for the survey questions was 85%. A total of 140 (64%) were cardiac surgeons and 80 (36%) were cardiologists. The heart team meeting frequency was weekly according to 104 (55%) respondents. This was conducted face to face according to 139 (73%) of the responses. Eighty-seven (56%) of the respondents reported 10-20% of patients undergoing percutaneous coronary intervention were discussed at the heart team meeting. Seventy-nine (47%) respondents had ad hoc percutaneous coronary intervention institutional guidelines. Fifty-four (32%) respondents reported an audit process for the heart team decisions., Conclusions: This survey suggests that there is marked variability in the infra-structure and execution of heart teams in different institutions. The results of the survey suggest a need to formulate guidelines on the composition and execution of heart teams which may result in an increase in transparency of decision-making within different institutions in reporting and comparing outcomes., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models., Aims: This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI., Methods: Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process., Results: Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%., Conclusions: MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: The aim of this study was to investigate the impact of Valve Academic Research Consortium 3 minor access site vascular complications (VCs) in patients who underwent percutaneous transfemoral (TF) transcatheter aortic valve implantation (TAVI)., Methods: This single-centre retrospective study included consecutive patients who underwent percutaneous TF-TAVI from 2009 to 2021. A propensity score-matched analysis was performed to compare early and long-term clinical results between patients with VC and without VC (nVC)., Results: A total of 2161 patients were included, of whom 284 (13.1%) experienced access site VC. Propensity score analysis allowed to match 270 patients from the VC group with 727 patients from the nVC group. In the matched cohorts, the VC group showed longer operative times (63.5 vs 50.0 min, P < 0.001), higher operative and in-hospital mortality (2.6% vs 0.7%, P = 0.022; and 6.3% vs 3.2%, P = 0.040, respectively), longer hospital length of stay (8 vs 7 days, P = 0.001) and higher rates of blood transfusion (20.4% vs 4.3%, P < 0.001) and infectious complications (8.9% vs 3.8%, P = 0.003). Overall survival during follow-up was significantly lower in the VC group (hazard ratio 1.37, 95% CI 1.03-1.82, P = 0.031) with 5-year survival rates being 58.0% (95% CI 49.5-68.0%) and 70.7% (95% CI 66.2-75.5%) for the VC and nVC groups, respectively., Conclusions: This retrospective study observed that minor access site VCs during percutaneous TF-TAVI can be serious events affecting early and long-term outcomes., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this study was to investigate the long-term outcomes of concomitant suture bicuspidization to treat mild or moderate tricuspid regurgitation at the time of mitral valve (MV) surgery., Methods: Data from patients who underwent MV surgery for degenerative MV regurgitation with mild or moderate tricuspid regurgitation and annular dilatation between January 2009 and December 2017 were analysed. The cohort was divided into 2 groups: mitral valve surgery alone (MVA) and MV surgery with concomitant tricuspid valve (TV) repair., Results: A total of 196 patients were included in the study. MVA and MV surgery with concomitant TV repair were performed in 91 (46.4%) and 105 (53.6%) patients, respectively. Propensity score matching analysis identified 54 pairs. In the matched cohort, 30-day mortality (0.0% vs 1.9%, P = 1.0) and new permanent pacemaker implantation (11.1% vs 7.4%, P = 0.740) did not differ significantly between groups. After a mean follow-up of 6.0 (2.8) years, MV surgery with concomitant TV repair was not associated with increased mortality risk compared to MVA (hazard ratio 1.04, 95% confidence interval 0.47-2.28, P = 0.927) with 10-year overall survival rates of 69.9% and 77.2%, respectively. Furthermore, MV surgery with concomitant TV repair was associated with a significantly reduced progression of TV regurgitation (P < 0.001)., Conclusions: Patients undergoing MV surgery with concomitant TV repair had similar 30-day and long-term survival, similar permanent pacemaker implantation rate and reduced progression of TV regurgitation compared to those undergoing MVA., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone., Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences., Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P <0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P =0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P =0.03) and at 2 years (77.8% versus 53.2%; P =0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P =0.98)., Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT., Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT)., Competing Interests: Disclosures Dr Ludwig reports travel compensation from Edwards; speaker honoraria from Abbott; and advisory fees from Bayer. Dr Conradi reports being on the advisory board at Abbott, Medtronic, and Boston Scientific and personal fees from Edwards. Dr Cohen reports research grant and consulting fees from Abbott, Edwards Lifesciences, Boston Scientific, and Medtronic AC; is a proctor at Abbott; and is a speaker at Abbott and General Electric Healthcare. Dr Scotti is a consultant for NeoChord. Dr Abraham reports research grant from the National Institutes of Health–National Heart, Lung, and Blood Institute (National Institutes of Health 1 UG3/UH3 HL140144-01, 08/01/18-07/31/22, LOFT-HF [Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Readmission/Mortality in Patients With Heart Failure and Central Sleep Apnea]); consulting at Abbott, Boehringer Ingelheim, and Zoll; honoraria from Impulse Dynamics; and salary from V-Wave Medical. Dr Ben Ali reports grants from Medtronic and Edwards. Dr Kar reports grants and consulting from Abbott, Boston Scientific, Edwards, and 4TECH and stock at 4TECH. Dr Scott Lim reports grants from Abbott, Boston Scientific, Corvia, Edwards, Medtronic, Trisol, and V-Wave and is a consultant at Ancora, Philips, Valgen, and Venus. Dr Duncan is a consultant at Abbott, Edwards, and Medtronic. Dr Adamo reports personal fees from Edwards and Boston Scientific and grants and honoraria from Medtronic. Dr Muller is on the advisory board at Abbott, Medtronic, and Edwards. Dr Petronio is a consultant at Medtronic, Boston Scientific, and Abbott. Dr Ruge is on the advisory board at Abbott and is a proctor at Abbott and Edwards. Dr Sondergaard reports grants and consulting at Edwards and Medtronic. Dr Adam reports grants and honoraria from Medtronic and personal fees from Boston Scientific and Edwards. Dr Dahle is a proctor/speaker at Abbott and Edwards. Dr Kempfert reports honoraria from Edwards, Medtronic, Abbott, and CryoLife. Dr Garatti is a proctor at Abbott. Dr Schmidt reports honoraria and travel support from Abbott and Cardiovalve. Dr Tang is a proctor/consultant at Medtronic; consultant/advisory board at Abbott; consultant at NeoChord; advisory board at JenaValve; and honoraria from Siemens and EastEnd Medical. Dr Redwood is a proctor at and reports personal fees from Edwards and is on the advisory board at Medtronic. Dr Taramasso is a consultant at Abbott, Edwards, Boston Scientific, Shenqi Medical, Simulands, Occlufit, MTEx, Medira, 4tech, and CoreMedic and reports personal fees from Cardiovalve. Dr Praz is a consultant at Edwards. Dr Fam is a consultant at Edwards, Abbott, and Cardiovalve. Dr Dumonteil is a consultant/proctor at Abbott, Boston Scientific, Edwards, and Medtronic. Dr von Bardeleben reports consulting/honoraria from Abbott, Edwards, and Medtronic and research grants to the university from Abbott and Edwards. Dr Rudolph reports honoraria from Abbott. Dr Reardon is a consultant at Medtronic, Boston, Abbott, and Gore (all funds to the department). Dr Metra reports personal fees from Actelion, Amgen, Livanova, Servier, Vifor Pharma as member of the Executive or Data Monitoring Committees of sponsored clinical trials, AstraZeneca, Abbott, Bayer, Boheringer Ingelhelm, and Edwards Therapeutics for participation to advisory boards and speeches at sponsored meetings. Dr Denti reports personal fees from Abbott and Edwards. Dr Mack reports being a co-Principal Investigator for the PARTNER trial (Placement of Aortic Transcatheter Valve Trial; Edwards) and COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation; Abbott) and is a study chair for the APOLLO trial (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation; Medtronic). Dr Hausleiter reports consulting fees, speaker honoraria, and research support to the institution from Abbott and Edwards. Dr Asch reports institutional contracts from Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr Latib is on the advisory board at Medtronic, Boston Scientific, Philips, Edwards, and Abbott. Dr Lindenfeld reports grant support from AstraZeneca and consulting at Abbott, Alleviant, AstraZeneca, Cordio, CVRx, Edwards, Boehringer Ingelheim, Merck, Medtronic, Vascular Dynamics, and V-Wave. Dr Modine is a consultant at Abbott, Edwards, and Medtronic. Dr Stone reports honoraria from Medtronic, Pulnovo, and Infraredx; is a consultant at Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and reports equity/options at Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s daughter is an employee at Medtronic. Dr Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Granada is the President and Chief Executive Officer of Cardiovascular Research Foundation. The other authors report no conflicts.