Why is this study important?

This is the first public release of feasibility data following transfemoral transseptal transcatheter mitral valve replacement (TMVR) in a small cohort of patients using Intrepid TMVR system® (Medtronic, Minneapolis, MN) Findings were published simultaneously in JACC: Interventions.

Should I change my practice because of these findings?  

The Intrepid Transcatheter Mitral Valve Replacement System is investigational at this time.

What question was this study supposed to answer? 

There is an unmet need for percutaneous valve therapies among patients with severe native mitral valve regurgitation who are at high surgical risk and not suitable for transcatheter-edge-to-edge-repair (TEER) due to mitral valve anatomy or elevated baseline transmitral gradients. Intrepid is a dual stent valve consisting of an outer stent that provides fixation and seal with an inner bioprosthesis that is a 27 mm trileaflet Bovine pericardial valve. The current study reported the early results using the Intrepid TMVR 35-Fr transfemoral delivery system.

What did the study show?

15 patients with moderately severe/severe symptomatic mitral regurgitation who were at high surgical risk were enrolled between February 2020 and May 2021 at 6 sites. Median age was 80 years and STS-PROM was 4.7%; 53% had prior sternotomy. Fourteen implants were successful. One patient converted to surgery due to atrial valve migration. Median length of hospitalization was 5 days post-procedure. 40% of patients had major access site bleeds and 73% had iatrogenic ASD closures. At 30 days, there were no deaths, strokes, or reinterventions. All patients had trace/no valvar or paravalvular MR and mean transmitral gradient was 4.7±1.8 mmHg.

How good was the approach/methodology?

Very well-designed and run feasibility study. In this tiny patient sample, technical success was good and reduction in MR was great. Safety issues were identified and will need to improve. Based on the results of this early feasibility study the transfemoral delivery system will be used in the APOLLO pivotal trial. Medtronic is developing a smaller 29-Fr delivery system to reduce rates of vascular/bleeding events related to delivery sheath size. 

All editors: Kalkidan Bishu, MD, MS, FSCAI; Andrew M. Goldsweig, MD, MSc, RPVI, FSCAI; Kirk N. Garratt, MD, MSCAI; and David A. Cox, MD, MSCAI

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