Title

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

Affiliations

Aurora St. Luke's Medical Center

Abstract

Objectives: To evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.

Background: Prohibitive surgical risk may preclude MVR surgery in some patients. The investigational Intrepid TMVR system (Medtronic, Minneapolis, MN) has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.

Methods: This prospective, multi-center, non-randomized early feasibility study (EFS) evaluated safety and performance of the Intrepid valve using transfemoral/transseptal access in patients with moderate-severe/severe, symptomatic mitral regurgitation (MR) at high surgical risk. Candidacy was determined by heart teams with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.

Results: Fifteen patients were enrolled at 6 sites from Feb 2020-May 2021. Median age was 80 years and STS-PROM was 4.7%; 87% were male and 53% had prior sternotomy. Fourteen implants were successful. One patient converted to surgery during the index procedure. Patients stayed a median 5 days post-procedure. There were 6 (40%) access site bleeds and 11 (73%) iatrogenic ASD closures. At 30 days, there were no deaths, strokes, or reinterventions. All implanted patients had trace/no valvar or paravalvar MR and mean gradient was 4.7±1.8 mmHg.

Conclusions: Thirty-day results from the Intrepid transfemoral TMVR EFS demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings.

Document Type

Article

PubMed ID

34747699

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