Faculty Collaboration Database

Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol 2017 Jan 31;69(4):381-391

Date

01/04/2017

Pubmed ID

28040318

DOI

10.1016/j.jacc.2016.10.068

Scopus ID

2-s2.0-85009343073 (requires institutional sign-in at Scopus site)   239 Citations

Abstract

BACKGROUND: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR.

OBJECTIVES: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery.

METHODS: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes.

RESULTS: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m² at baseline vs. 72.1 ± 19.3 ml/m² at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m² vs. 43.1 ± 16.2 ml/m²; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.

CONCLUSIONS: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).

Author List

Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P, Tendyne Global Feasibility Trial Investigators

Author

Paul Joseph Pearson MD, PhD Chief, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Catheterization
Echocardiography
Feasibility Studies
Female
Heart Valve Prosthesis Implantation
Humans
Male
Middle Aged
Mitral Valve Insufficiency
Tomography, X-Ray Computed
Treatment Outcome