The first-in-human experience with the transseptal EVOQUE transcatheter mitral valve replacement (TMVR) system demonstrated feasibility in a high surgical-risk population, including functional and degenerative mitral regurgitation (MR), according to research presented during EuroPCR's e-Course 2020 and simultaneously published in JACC: Cardiovascular Interventions.

TMVR offers an additional option in the treatment of patients with MR, especially for those at high or prohibitive surgical risk. Most of the initial experience with TMVR has centered around the transapical approach. John G. Webb, MD, FACC, et al., evaluated the novel EVOQUE mitral valve replacement system which uses the transseptal approach.

The EVOQUE valve consists of a self-expanding nitinol frame, bovine pericardial leaflets and fabric skirt to minimize paravalvular leak. The valve has a unique anchoring mechanism that uses the annulus, leaflets and chords for secure placement in the anatomy. The delivery system offers extensive maneuverability and stability resulting in a controlled deployment without hemodynamic compromise.

Fourteen patients with significant symptomatic MR were treated with the EVOQUE TMVR system from September 2018 to October 2019. Their median age was 84 years and median STS score was 4.6%.

Results showed that technical success was achieved in thirteen patients and one patient was converted to surgery. At 30 days, there was one noncardiovascular death, two strokes, no myocardial infarctions and no rehospitalizations.

Furthermore, two patients required paravalvular leak closure and one underwent alcohol septal ablation for left ventricular outflow tract obstruction. MR was mild or better in all implanted patients at 30 days, including the two who had paravalvular leak closure, with no MR in ten patients. At 30 days, the mean mitral gradient was 5.8 mm Hg and nine patients had improvement in functional class to NYHA II or better.

"TMVR is a welcome addition to the range of options available in the contemporary management of mitral valve disease," the authors conclude. "This transseptal approach to TMVR potentially offers advantages over a transapical approach. Continued clinical studies will continue to clarify its role within the armory of mitral interventions."

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Mitral Valve Insufficiency, Mitral Valve, Feasibility Studies, Heart Valve Diseases, Alloys, Myocardial Infarction, Heart Valve Prosthesis Implantation, Hemodynamics

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