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.
Age and Procedural Timing for Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial
Goel, Kashish , Lindman, Brian R. , Schwartz, Allan, Cohen, DE, Giustino, Gennaro, Oldemeyer, J. Bradley , Strote, Justin, Babaliaros, Vasilis, Devireddy, Chandan , Fischbein, Michael P. , Fearon, W F, Daniels, David, Spies, Christian, Shah, Pinak , Dahle, Thom, Apostolou, Dimitrios , Makkar, R, Davidson, Charles J. , Sheth, Tej, Sorajja, Paul , DeVries, James T. , Southard, J.H., Depta, Jeremiah P. , Pop, Andrei, Rinaldi, Michael J., Badr, Salem , Russo, Mark J., Wang, Yizhuo , Leon, Martin B. , Généreux, Philippe , Cohen, David J. , Schwartz, Allan , Cohen, David Jonathan , Babaliaros, Vasilis , Devireddy, Chandan M , Fearon, William F , Chhatriwalla, Adnan K , Suradi, Hussam , Shah, Pinak , Szerlip, Molly , Dahle, Thom , Apostolou, Dimitrios , Makkar, Raj , Davidson, Charles J. , Sorajja, Paul , DeVries, James T , Southard, Jeffrey , Depta, Jeremiah P , Badr, Salem , Guerrero, Mayra E , McCabe, James M , Pibarot, Phillippe , Wang, Yizhuo , Leon, Martin B. , Généreux, Philippe , Lindman, Brian R , Giustino, Gennaro , Babaliaros, Vasilis , Fearon, William F. , Makkar, Raj , Sheth, Tej , Rinaldi, Michael , Williams, Mathew , Russo, Mark J., Guerrero, Mayra
Circulation: Cardiovascular Interventions | June 3, 2026 | Volume: 19 | Issue: 8 | Pages: No page available
10.1161/circinterventions.125.016370
BACKGROUND: The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.