6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study.

BACKGROUND

The AltaValve transcatheter mitral valve replacement (TMVR) system is an atrial fixation TMVR device that is designed to overcome the limitations of transcatheter edge-to-edge repair and current TMVR devices.

OBJECTIVES

The aim of this study was to evaluate the procedural feasibility, safety, and performance of the AltaValve system in treating patients with symptomatic mitral regurgitation (MR) and unsuitable for surgery.

METHODS

The primary endpoint of the AltaValve Early Feasibility Study was technical success, defined as: 1) absence of procedural mortality; 2) successful delivery and deployment of the implant; 3) successful retrieval of the delivery system; and 4) no emergency surgery or re-intervention related to the implant. Echocardiographic data were assessed by an independent core laboratory, while all reported events were adjudicated by an independent clinical events committee.

RESULTS

A total of 30 patients with a median age of 77 years were enrolled. Median follow-up duration was 182 days (Q1-Q3: 171-191 days). Procedural success was achieved in 29 of the 30 cases (96.7%; 95% CI: 82.8%-99.9%). Reduction to mild or less MR was achieved in all surviving patients at 30 days and maintained in all but 1 patient at 6 months. There were no strokes, new pacemaker implantations, or mitral valve reinterventions within 6 months postprocedure. Significant improvements were observed in functional class and quality-of-life assessments.

CONCLUSIONS

Among patients with significant MR, the AltaValve TMVR system was feasible, safe, and associated with good valve function at 6 months. (AltaValve Early Feasibility Study Protocol; NCT03997305).