Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Severe mitral regurgitation (MR) is associated with significant morbidity and mortality.
• Surgical intervention for severe MR may not be suitable for all patients, necessitating alternative treatment options.

Purpose of the Study:

• To evaluate the feasibility and safety of a novel percutaneous transseptal transcatheter mitral valve replacement (TMVR) system.
• To assess the efficacy of the TMVR system in reducing mitral regurgitation and improving patient outcomes.

Main Methods:

• A first-in-human study involving ten patients with severe symptomatic MR and high surgical risk.
• Utilized a system comprising a nitinol dock and a balloon-expandable transcatheter heart valve, implanted via a percutaneous transvenous transseptal approach.
• Primary endpoint: technical success per MVARC criteria; Secondary endpoint: freedom from mortality, stroke, and device dysfunction at 30 days.

Main Results:

• Technical success was achieved in 90% of patients (9 out of 10).
• All implanted patients demonstrated reduction of MR to trivial levels with a mean transmitral gradient of 2.3 ± 1.4 mm Hg.
• No mortality, stroke, or device-related major adverse events were observed at 30 days; one patient required a closure device for a paravalvular leak.

Conclusions:

• Percutaneous transvenous transseptal TMVR is a feasible and safe treatment option for severe MR in high-risk surgical patients.
• The novel TMVR system effectively reduces mitral regurgitation and shows promising early safety outcomes.
• Further investigation and evaluation of this transcatheter mitral valve replacement technology are warranted.