One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients

Author:

Malaisrie S. Chris1ORCID,Guerrero Mayra2ORCID,Davidson Charles1ORCID,Williams Mathew3,de Brito Fábio Sândoli4,Abizaid Alexandre4ORCID,Shah Pinak5ORCID,Kaneko Tsuyoshi6ORCID,Poon Karl7,Levisay Justin8ORCID,Yu Xiao9ORCID,Pibarot Philippe10ORCID,Hahn Rebecca T.1112ORCID,Blanke Philipp13,Leon Martin B.1112,Mack Michael J.14ORCID,Zajarias Alan6,

Affiliation:

1. Northwestern University, Chicago, IL (S.C.M., C.D.).

2. Mayo Clinic, Rochester, MN (M.G.).

3. NYU Langone Medical Center, New York, NY (M.W.).

4. Instituto do Coração da Universidade de São Paulo, São Paulo, Brazil (F.S.d.B., A.A.).

5. Brigham and Women’s Hospital, Boston, MA (P.S.).

6. Washington University, Barnes-Jewish Hospital, St. Louis, MO (T.K., A.Z.).

7. Prince Charles Hospital, Brisbane, Australia (K.P.).

8. NorthShore University Health System, Evanston, IL (J.L.).

9. Edwards Lifesciences, Irvine, CA (X.Y.).

10. Université Laval, Québec City, Canada (P.P.).

11. Columbia University, New York (R.T.H., M.B.L.).

12. Cardiovascular Research Foundation, New York (R.T.H., M.B.L.).

13. St. Paul’s Hospital, Vancouver, BC, Canada (P.B.).

14. Baylor Scott & White Health, Plano, TX (M.J.M.).

Abstract

BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03193801.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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