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.
Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement
Simonato, Matheus , Ribeiro, Henrique Barbosa , Webb, John G. , Backer, Ole De , Villablanca, Pedro, Rihal, Charanjit S. , Eleid, Mackram F. , Kempfert, Jörg , Unbehaun, Axel , Erlebach, Magdalena , Casselman, Filip , Saia, Francesco , Ubben, Timm , Meincke, Felix , Napodano, Massimo, Codner, Pablo , Schöfer, Joachim, Pelletier, Marc , Cheung, Anson , Shuvy, Mony , Palma, José Honório , Duncan, Alison , Sinning, Jan-Malte, Arbel, Yaron , Weger, Arend de , Eltchaninoff, Hélène, Hemery, Thibault, Tchétché, Didier , Dumonteil, Nicolas, Rodés‐Cabau, Josep , Kim, Won-Keun, Spargias, Konstantinos, Kourkoveli, Panagiota, Ben‐Yehuda, Ori , Barbanti, Marco , Fiorina, Claudia , Thukkani, Arun K., Jones, Noah, Presbitero, Patrizia , Petronio, Anna Sonia , Champagnac, Didier , Rudolph, Tanja K. , Iadanza, Alessandro , Nombela‐Franco, Luis , Bonaros, Nikolaos , Kass, Malek , Amabile, Nicolas , Messina, Antonio , Andreas, Martin , Welsh, Robert C. , Schoels, Wolfgang , Hellig, Farrel, Windecker, Stephan , Stortecky, Stefan , Maisano, Francesco , Stone, Gregg W. , Dvir, Danny , Rihal, Charanjit, Eleid, Mackram, Nombela-Franco, Luis , Windecker, Stephan , Maisano, Francesco , De Backer, Ole , Whisenant, Brian K. , Kornowski, Ran , Guerrero, Mayra , Wijeysundera, Harindra C. , Søndergaard, Lars , Rihal, Charanjit S. , Adam, Matti , Montorfano, Matteo , Ancona, Marco , Gaia, Diego Felipe , Hildick-Smith, David , Veulemans, Verena , Sinning, Jan‐Malte, Testa, Luca , Landes, Uri , Kim, Won-Keun, Teles, Rui Campante , Mackensen, G. Burkhard , Allali, Abdelhakim , Bleiziffer, Sabine , Salizzoni, Stefano , Agrifoglio, Marco , Bruschi, Giuseppe , Chhatriwalla, Adnan K , Hirji, Sameer
Circulation | September 25, 2020 | Volume: 143 | Issue: 2 | Pages: 104-116
10.1161/circulationaha.120.049088
Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76–996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510–1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR ( P <0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients ( P =0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P =0.02). The rates of Mitral Valve Academic Research Consortium–defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74–12.56; P =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88–21.53; P <0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.