Transcatheter Mitral Valve Implantation Compared to Surgery: One-Year Clinical Outcome

Abstract

Background

Transcatheter mitral valve implantation (TMVI) is an evolving technology, expanding therapeutic options for patients at higher operative risk. Data comparing TMVI to surgical mitral valve replacement (SMVR) are lacking.

Methods

Clinical outcomes after TMVI with the Tendyne mitral valve and SMVR were compared utilizing propensity score matching, including seven variables. The current study reports 1-year clinical outcomes after TMVI and 1-year mortality in both cohorts.

Results

Forty TMVI patients were compared to 80 SMVR patients. Baseline characteristics included in the matching protocol were well balanced: Age (78 years [interquartile range, IQR 75; 80] vs. 78 years [IQR 73; 80], p = 0.797), female sex (60% vs. 60% [p = 1.0]), atrial fibrillation (68% vs. 64% [p = 0.839]), previous coronary artery bypass grafting (CABG) or surgical aortic valve replacement (25% vs. 25% [p = 1.0]), body mass index (kg/m²; 26 ± 4 vs. 25 ± 4 [p = 0.723]), mitral valve pathology (regurgitation 70% vs. 74%, stenosis 7.5% vs. 4%, and mixed disease 22.5% vs. 23% [p = 0.649]), and concomitant tricuspid regurgitation (35% vs. 30% [p = 0.678]). Thirty-day mortality was similar in both groups (TMVI, n = 1, 2.5%; SMVR, n = 3, 3.75%, p = 0.47). Kaplan–Meier estimated survival at 1 year was comparable after TMVI (80 ± 6% [95% CI 69–93%]) and SMVR (86 ± 4% [95% CI 79–94%], p = 0.18) with seven additional deaths beyond 30 days in the TMVI group and eight in the SMVR group. In the TMVI group, two were non-cardiovascular deaths for encephalitis and sepsis after hip replacement, and five were cardiovascular deaths. In the SMVR group, one patient died due to intestinal ischemia, and in seven patients, the cause of death is unknown. At 1 year, in all TMVI patients, echocardiography showed ≤mild paravalvular regurgitation. Within 1 year after TMVI, 21 patients (52.5%) required rehospitalization for heart failure symptoms.

Conclusion

TMVI and SMVR in a propensity score-matched cohort displaying an intermediate surgical risk resulted in similar 1-year survival. TMVI achieved a sustained MR elimination at 1 year, and 80% of patients presented in the New York Heart Association (NYHA) class I or II.

Keywords

heart valve - transapical - percutaneous (TAVI) - mitral valve surgery

Ethical Approval Statement

The study was approved by the local ethical committee (2023-359-S-KH). For retrospective studies, written informed consent is not required by the regulatory authorities and is in accordance with the local ethical committee requirements.

Data Availability Statement

Data are available on request.

Publication History

Received: 17 April 2025

Accepted: 07 July 2025

Article published online:
18 July 2025

• References

• 1 Stone GW, Lindenfeld J, Abraham WT. et al.; COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med 2018; 379 (24) 2307-2318
• 2 Feldman T, Foster E, Glower DD. et al.; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011; 364 (15) 1395-1406
• 3 Baldus S, Doenst T, Pfister R. et al.; MATTERHORN Investigators. Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. N Engl J Med 2024; 391 (19) 1787-1798
• 4 Zahr F, Song HK, Chadderdon SM. et al. 30-Day outcomes following transfemoral transseptal transcatheter mitral valve replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv 2022; 15 (01) 80-89
• 5 Webb J, Hensey M, Fam N. et al. Transcatheter mitral valve replacement with the transseptal EVOQUE system. JACC Cardiovasc Interv 2020; 13 (20) 2418-2426
• 6 Alperi A, Dagenais F, Del Val D. et al. Early experience with a novel transfemoral mitral valve implantation system in complex degenerative mitral regurgitation. JACC Cardiovasc Interv 2020; 13 (20) 2427-2437
• 7 Hell MM, Wild MG, Baldus S. et al.; TENDER Investigators. Transapical mitral valve replacement: 1-Year results of the real-world Tendyne European Experience Registry. JACC Cardiovasc Interv 2024; 17 (05) 648-661
• 8 Muller DWM, Sorajja P, Duncan A. et al. 2-Year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation. J Am Coll Cardiol 2021; 78 (19) 1847-1859
• 9 Conradi L, Ludwig S, Sorajja P. et al. Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: The Tendyne Expanded Clinical Study. EuroIntervention 2024; 20 (14) e887-e897
• 10 Hungerford S, Bart N, Song N. et al. Thirty-day and one-year outcomes following transcatheter mitral valve edge-to-edge repair versus transapical mitral valve replacement in patients with left ventricular dysfunction. AsiaIntervention 2023; 9 (01) 78-86
• 11 Wilde N, Tanaka T, Vij V. et al. Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. Clin Res Cardiol 2024; 113 (01) 1-10
• 12 Ziegelmueller JA, Burri M, Stein A. et al. Early outcomes of transapical mitral valve implantation versus surgical replacement in matched elderly patients at intermediate surgical risk. EuroIntervention 2024; 20 (05) e281-e288
• 13 Laschinger JC, Ibrahim NG, Zuckerman BD. Mitral Valve Academic Research Consortium Consensus Report: The U.S. Food and Drug Administration perspective. J Am Coll Cardiol 2015; 66 (03) 322-323
• 14 Chivasso P, Bruno VD, Farid S. et al. Predictors of survival in octogenarians after mitral valve surgery for degenerative disease: The Mitral Surgery in Octogenarians study. J Thorac Cardiovasc Surg 2018; 155 (04) 1474-1482.e2
• 15 Seese LM, Sultan I, Gleason TG. et al. Outcomes of mitral valve repair versus replacement in the elderly. Ann Thorac Surg 2020; 109 (04) 1202-1209
• 16 Sorajja P, Moat N, Badhwar V. et al. Initial feasibility study of a new transcatheter mitral prosthesis: The first 100 patients. J Am Coll Cardiol 2019; 73 (11) 1250-1260
• 17 Schneider LM, Worthley S, Nickenig G. et al. 1-Year outcomes following transfemoral transseptal transcatheter mitral valve replacement: The HighLife TSMVR Feasibility Study. JACC Cardiovasc Interv 2023; 16 (23) 2854-2865
• 18 Goldstein D, Moskowitz AJ, Gelijns AC. et al.; CTSN. Two-Year outcomes of surgical treatment of severe ischemic mitral regurgitation. N Engl J Med 2016; 374 (04) 344-353
• 19 Vahanian A, Beyersdorf F, Praz F. et al.; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2022; 43 (07) 561-632
• 20 Goel K, Lindenfeld J, Makkar R. et al. Transcatheter edge-to-edge repair in 5,000 patients with secondary mitral regurgitation: COAPT Post-Approval Study. J Am Coll Cardiol 2023; 82 (13) 1281-1297
• 21 von Bardeleben RS, Mahoney P, Morse MA. et al. 1-Year outcomes with fourth-generation mitral valve transcatheter edge-to-edge repair from the EXPAND G4 study. JACC Cardiovasc Interv 2023; 16 (21) 2600-2610
• 22 Hausleiter J, Stocker TJ, Adamo M, Karam N, Swaans MJ, Praz F. Mitral valve transcatheter edge-to-edge repair. EuroIntervention 2023; 18 (12) 957-976
• 23 Makkar RR, Chikwe J, Chakravarty T. et al. Transcatheter mitral valve repair for degenerative mitral regurgitation. JAMA 2023; 329 (20) 1778-1788
• 24 Reichart D, Kalbacher D, Rübsamen N. et al. The impact of residual mitral regurgitation after MitraClip therapy in functional mitral regurgitation. Eur J Heart Fail 2020; 22 (10) 1840-1848
• 25 Higuchi S, Orban M, Stolz L. et al. Impact of residual mitral regurgitation on survival after transcatheter edge-to-edge repair for secondary mitral regurgitation. JACC Cardiovasc Interv 2021; 14 (11) 1243-1253
• 26 Abramowitz Y, Jilaihawi H, Chakravarty T, Mack MJ, Makkar RR. Mitral annulus calcification. J Am Coll Cardiol 2015 66.
• 27 Coisne A, Ludwig S, Scotti A. et al.; CHOICE-MI Investigators. Outcomes following transcatheter mitral valve replacement using dedicated devices in patients with mitral annular calcification. JACC Cardiovasc Interv 2024; 17 (18) 2141-2153
• 28 Gössl M, Thourani V, Babaliaros V. et al. Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification. EuroIntervention 2022; 17 (18) 1523-1531
• 29 Kellermair J, Damian I, Grund M. et al. Transapical electrosurgical laceration and stabilization of mitral clips followed by transcatheter mitral valve replacement-A one-stop shop. JTCVS Tech 2023; 22: 189-196
• 30 Guerrero ME, Eleid MF, Wang DD. et al. 5-Year prospective evaluation of mitral valve-in-valve, valve-in-ring, and valve-in-MAC outcomes: MITRAL Trial Final Results. JACC Cardiovasc Interv 2023; 16 (18) 2211-2227