Citations 2
Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study
Muller, David W. , Duncan, AM, Sorajja, Paul, Dahle, Gry , Babaliaros, Vasilis, Lubos, Edith, Badhwar, Vinay , Denti, Paolo, Eng, Marvin H. , Grayburn, Paul, Bethea, Brian, Walters, Darren, Nickenig, Georg, As, Petronio, Thourani, Vinod H, Mumtaz, Mubashir, Dumonteil, Nicolas, Jf, Obadia, Kapadia, S R, Guerrero, Mayra E, Medeiros, Ricardo de, McNutt, Robert, Nie, Hong , Chuang, Michael, Blanke, Philipp, Conradi, Lenard, Duncan, Alison , Muller, David W M , Donal, Erwan , Modine, Thomas , Sorajja, Paul , Babaliaros, Vasilis , Denti, Paolo , Grayburn, Paul , Bethea, Brian, Walters, Darren, Donal, Erwan , Thourani, Vinod H. , Mumtaz, Mubashir , Modine, Thomas , Dumonteil, Nicolas, Guerrero, Mayra , Blanke, Philipp , Conradi, Lenard
ESC Heart Failure | June 25, 2026 | Volume: 13 | Issue: 4 | Pages: No page available
Abstract Aims Transcatheter mitral valve replacement (TMVR) with the Tendyne Mitral Valve System is a treatment option for patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). This study sought to evaluate the safety and effectiveness of TMVR through 5-year follow-up. Methods and Results The Tendyne Expanded Clinical Study is a prospective, single-arm, multicentre study that enrolled patients between November 2014 and June 2020. The study enrolled 191 patients (mean age 74.1 ± 8.0 years, 62.8% male, 70.2% New York Heart Association Class (NYHA) class III/IV, 88.5% secondary MR), of whom 186 (97.4%) underwent TMVR with Tendyne. MR grade decreased from ≥3+ in 99.5% patients at baseline to grade ≤1+ in 95.3% at 5 years. In those patients surviving to 5 years (n = 49), durable symptomatic improvement was evidenced by 73.5% patients being in NYHA class I/II at 5 years. The Kansas City Cardiomyopathy Questionnaire overall summary score increased from 48.5 ± 22.5 points at baseline to 67.6 ± 21.5 points at 5 years. Serious adverse events that occurred through 5 years included life-threatening bleeding (11.5%), fatal bleeding (2.6%), renal insufficiency/failure (28.8%), endocarditis (7.3%), device thrombosis (5.8%), and new onset atrial fibrillation (13.1%). No structural device degeneration or device embolism occurred through 5 years. Conclusions The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.
TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation
Dreyfus, Julien , Galloo, Xavier , Heitzinger, Gregor , Benfari, Giovanni , Kresoja, Karl-Patrick, Juarez-Casso, Fernando M. , Omran, Hazem , Russo, Giulio , Topilsky, Yan , Weber, Marcel, Sala, Alessandra , Eixerés‐Esteve, Andrea , Riant, Elisabeth , Donal, Erwan , Hausleiter, Jörg , Badano, Luigi P. , Coisne, Augustin , Windecker, Stephan , Zamorano, José Luis , Tang, Gilbert H L, Webb, John G. , Muraru, Denisa , Nejjari, Mohammed , Bonis, Michele De , Carnero, Manuel , Nickenig, Georg, Pfister, Roman , Tribouilloy, Christophe , Rudolph, Volker , Lurz, Philipp , Bartko, Philipp E. , Messika–Zeitoun, David , investigators, TRIGISTRY, Heitzinger, Gregor, Bohbot, Yohan, Topilsky, Yan , Weber, Marcel, Lim, Pascal , Bazire, Baptiste , Donal, Erwan, Tourneau, Thierry Le, Modine, Thomas, Doguet, Fabien , Ajmone-Marsan, N, Stolz, Lukas, Praz, Fabien, Zamorano, José Luís , Bardeleben, Ralph Stephan von, Tang, Gilbert H L, Lubos, Edith, Webb, John A., Schöfer, Joachim, Fam, Neil , Lauten, Alexander , Pedrazzini, Giovanni , Rodés‐Cabau, Josep , Gavazzoni, Mara , Flagiello, Michele, Radu, Costin , Mbaki, Yannick, Tomasi, Jacques , Sénage, Thomas , Chan, Vincent, Alessandrini, Hannes , Eyharts, Damien , Viau, F , Himbert, Dominique , Sievert, Horst, Eggenspieler, Florian , Nicol, Martin , Nickenig, Georg , Pfister, Romain, Crestanello, Juan, Maisano, Francesco, Messika-Zeitoun, David, Kresoja, Karl-Patrik , Heitzinger, Gregor , Juarez-Casso, Fernando, Omran, Hazem , Russo, Giulio , Topilsky, Yan , Nombela-Franco, Luis , Riant, Elisabeth , Donal, Erwan , Hausleiter, Jörg , Coisne, Augustin , Praz, Fabien , Windecker, Stephan , Nejjari, Mohammed , Chan, Vincent , De Bonis, Michele , Carnero-Alcazar, Manuel , Pfister, Roman , Tribouilloy, Christophe , Rudolph, Volker , Lurz, Philipp , Maisano, Francesco , Messika-Zeitoun, David , Enriquez-Sarano, Maurice , Benfari, Giovanni , Kresoja, Karl-Patrik , Taramasso, Maurizio , Bohbot, Yohann , Iliadis, Christos , Weber, Marcel , Nombela‐Franco, Luis , Iung, Bernard , Obadia, Jean‐François , Estévez‐Loureiro, Rodrigo , Tourneau, Thierry Le , Modine, Thomas , Latib, Azeem , Praz, Fabien , von Bardeleben, Ralph Stephan , Tang, Gilbert H L, Hahn, Rebecca T , Chan, Vincent , Crestanello, Juan A. , Maisano, Francesco , Bax, Jeroen J. , Enriquez‐Sarano, Maurice , investigators, TRIGISTRY, Heitzinger, Gregor, Weber, Marcel, Donal, Erwan, Tourneau, Thierry Le, Modine, Thomas, Lavie-Badie, Yoan , Habib, Gilbert , Selton‐Suty, Christine , Stolz, Lukas , Praz, Fabien, Bardeleben, Ralph Stephan von, Ruf, Tobias Friedrich , Tang, Gilbert H L, Webb, John, Michelena, Héctor I. , Solı́s, Jorge , Flagiello, Michele, Chan, Vincent, Rahmouni, Kenza , Viau, Florence, Pfister, R, Crestanello, Juan, Maisano, Francesco, Messika-Zeitoun, David
European Heart Journal | August 24, 2023 | Volume: 45 | Issue: 8 | Pages: 586-597
Abstract 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.