1-year outcomes following transfemoral transseptal transcatheter mitral valve replacement: Intrepid TMVR early feasibility study results

Authors

Firas Zahr, Oregon Health and Science University, Portland, OR. Electronic address: zahr@ohsu.edu.
Howard K. Song, Oregon Health and Science University, Portland, OR.
Scott Chadderdon, Oregon Health and Science University, Portland, OR.
Hemal Gada, UPMC Pinnacle Harrisburg Campus, Harrisburg, PA.
Mubashir Mumtaz, UPMC Pinnacle Harrisburg Campus, Harrisburg, PA.
Timothy Byrne, Abrazo Arizona Heart Hospital, Phoenix, AZ.
Merick Kirshner, Abrazo Arizona Heart Hospital, Phoenix, AZ.
Samin Sharma, Mount Sinai Medical Center, New York, NY.
Susheel Kodali, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.
Isaac George, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.
William Merhi, Spectrum Health Hospitals, Grand Rapids, MI.
Leora Yarboro, University of Virginia Health System Hospital, Charlottesville, VA.
Paul Sorajja, Abbott Northwestern Hospital, Minneapolis, MN.
Vinayak Bapat, Abbott Northwestern Hospital, Minneapolis, MN.
Tanvir Bajwa, Advocate Aurora HealthFollow
Eric Weiss, Advocate Aurora HealthFollow
Jeremy J. Thaden, Mayo Clinic, Rochester, MN.
Elizabeth Gearhart, Medtronic PLC, Minneapolis, MN.
Scott Lim, University of Virginia Health System Hospital, Charlottesville, VA.
Michael Reardon, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
David Adams, Mount Sinai Medical Center, New York, NY.
Michael Mack, Baylor Scott and White Heart Hospital, Plano, TX.
Martin B. Leon, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.

Recommended Citation

Zahr F, Song HK, Chadderdon S, et al. 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2023;16(23):2868-2879. doi:10.1016/j.jcin.2023.10.001

Affiliations

Aurora Saint Luke's Medical Center

Abstract

Background:High surgical risk may preclude mitral valve replacement in many patients. Transcatheter Mitral Valve Replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.

Objective:This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study (EFS) in patients with ≥ moderate-severe MR.

Methods:The EFS is a multi-center, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to MVARC criteria.

Results:Thirty-three patients, enrolled at 9 U.S. sites between February 2020-August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean STS-PROM for MV replacement was 5.3%. Thirty-one patients were successfully implanted (93.9%). Median post-procedural hospitalization length of stay was 5 days and 87.9% of patients were discharged to home. At 30 days there were no deaths or strokes; 8 patients had major vascular complications (24.2%) none required surgical intervention; there were 4 cases of venous thromboembolism all successfully treated without sequelae; and 1 patient had MV re-intervention for severe LVOT obstruction. At 1-year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, no/trace paravalvular leak in all patients, median (Q1, Q3) mitral valve mean gradient was 4.6 (3.9, 5.3) mmHg, and 91.7% of survivors were in NYHA Class I/II with a median 11.4-point improvement in KCCQ overall summary scores.

Conclusion:The early benefits of the Intrepid Transfemoral Transseptal TMVR System were maintained up to 1 year with low mortality, low re-intervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Type

Article

PubMed ID

37902145