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Multicenter Study
. 2020 Nov 1;5(11):1245-1252.
doi: 10.1001/jamacardio.2020.2974.

One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve

Brian Whisenant  1 , Samir R Kapadia  2 , Mackram F Eleid  3 , Susheel K Kodali  4 , James M McCabe  5 , Amar Krishnaswamy  2 , Michael Morse  6 , Richard W Smalling  7 , Mark Reisman  5 , Michael Mack  8 , William W O'Neill  9 , Vinayak N Bapat  4 , Martin B Leon  4 , Charanjit S Rihal  3 , Raj R Makkar  10 , Mayra Guerrero  3
Affiliations
Multicenter Study

One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve

Brian Whisenant et al. JAMA Cardiol. .

Abstract

Importance: Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients.

Objective: To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.

Design, setting, and participants: In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.

Exposures: Mitral valve-in-valve for degenerated bioprosthetic mitral valves.

Main outcomes and measures: The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance.

Results: A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.

Conclusions and relevance: Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Whisenant reported personal fees from Edwards Lifesciences outside the submitted work. Dr Kodali reported grants from Edwards Lifesciences, Medtronic, and Boston Scientific; grants and personal fees from Abbott Vascular and JenaValve; personal fees from Merrill Lifesciences and Admedus; personal fees and nonfinancial support from Dura Biotech; and nonfinancial support from Supira, Microinterventional Devices, and Thubrikar Aortic Valve Inc outside the submitted work. Dr McCabe reported personal fees from Edwards Lifesciences, Boston Scientific, and Teleflex outside the submitted work. Dr Morse reported consulting fees from Edwards Lifesciences. Dr Mack reported nonfinancial support from Edwards Lifesciences, Medtronic, and Abbott outside the submitted work. Dr Bapat reported personal fees from Merrill outside the submitted work. Dr Leon reported grants from Edwards Lifesciences during the conduct of the study. Dr Makkar reported grants from Abbott and Edwards Lifesciences and personal fees from Cordis, Medtronic, and Cedars-Sinai Medical Center. Dr Guerrero reported grants from Edwards Lifesciences outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. SAPIEN 3 Transcatheter Heart Valve, Transseptal, and Transapical Access Approaches
A, SAPIEN 3 (Edwards Lifesciences) within the stented bioprosthetic valve. B, Transseptal mitral valve-in-valve. C, Transapical mitral valve-in-valve.
Figure 2.
Figure 2.. Time-to-Event Curves for All-Cause Mortality
Kaplan-Meier estimates of the rate of all-cause mortality to 1 year in patients who underwent mitral valve-in-valve via a transseptal or transapical approach. HR indicates hazard ratio.
See this image and copyright information in PMC

Comment in

  • doi: 10.1001/jamacardio.2020.2993

References

    1. Vemulapalli S, Grau-Sepulveda M, Habib R, Thourani V, Bavaria J, Badhwar V. Patient and hospital characteristics of mitral valve surgery in the United States. JAMA Cardiol. 2019;4(11):1149-1155. doi:10.1001/jamacardio.2019.3659 - DOI - PMC - PubMed
    1. Thourani VH, Weintraub WS, Guyton RA, et al. . Outcomes and long-term survival for patients undergoing mitral valve repair versus replacement: effect of age and concomitant coronary artery bypass grafting. Circulation. 2003;108(3):298-304. doi:10.1161/01.CIR.0000079169.15862.13 - DOI - PubMed
    1. Mehaffey HJ, Hawkins RB, Schubert S, et al. . Contemporary outcomes in reoperative mitral valve surgery. Heart. 2018;104(8):652-656. doi:10.1136/heartjnl-2017-312047 - DOI - PubMed
    1. Kilic A, Acker MA, Gleason TG, et al. . Clinical outcomes of mitral valve reoperations in the United States: an analysis of the Society of Thoracic Surgeons National Database. Ann Thorac Surg. 2019;107(3):754-759. doi:10.1016/j.athoracsur.2018.08.083 - DOI - PubMed
    1. Jamieson WR, Burr LH, Miyagishima RT, et al. . Reoperation for bioprosthetic mitral structural failure: risk assessment. Circulation. 2003;108(suppl 1):II98-II102. doi:10.1161/01.cir.0000089184.46999.f4 - DOI - PubMed

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