Early Feasibility Study with the SATURN Transapical Mitral Valve Replacement Device

Kestutis Ručinskas; Lauren S Ranard; Stefano Stella; David Hildick-Smith; Matthew J Price; Vinayak Bapat; Paolo Denti

doi:10.1016/j.atssr.2024.06.011

Early Feasibility Study with the SATURN Transapical Mitral Valve Replacement Device

Ann Thorac Surg Short Rep. 2024 Jun 28;2(4):765-771. doi: 10.1016/j.atssr.2024.06.011. eCollection 2024 Dec.

Authors

Kestutis Ručinskas¹, Lauren S Ranard², Stefano Stella³, David Hildick-Smith⁴, Matthew J Price⁵, Vinayak Bapat⁶, Paolo Denti³

Affiliations

¹ Department of Medicine, Clinic of Cardiac and Vascular Diseases, Vilnius University, Vilnius, Lithuania.
² Department of Medicine, Columbia University Irving Medical Center, New York, New York.
³ Department of Cardiac Surgery, San Raffaele University Hospital, Milano, Italy.
⁴ Department of Medicine, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK.
⁵ Department of Medicine, Scripps Clinic, La Jolla, California.
⁶ Department of Surgery, Abbott Northwestern Hospital, Allina Health, Minneapolis, Minnesota.

Abstract

Purpose: To report the outcomes of the early feasibility study of transapical transcatheter mitral valve replacement (TMVR) with the SATURN System (InnovHeart, Milano, Italy) to treat patients with severe functional mitral regurgitation.

Description: Five high surgical risk patients underwent transapical transcatheter mitral valve replacement with the SATURN System at a single center. One-year follow-up is complete for all patients.

Evaluation: The valve was implanted successfully in all patients without any major adverse events. All patients were alive at the last follow-up. Kansas City Cardiomyopathy Questionnaire improved from a median of 63.5 (interquartile range, 19.6) at baseline to 99.0 (interquartile range, 21.6) at 1 year. Echocardiographic follow-up demonstrates stable valve function, no transvalvular or paravalvular mitral regurgitation, and absence of left ventricular outflow tract obstruction.

Conclusions: At 1 year after transapical SATURN transcatheter mitral valve replacement, all patients are alive with quality of life improvement and favorable device hemodynamics. These initial results are promising and larger scale studies with continued follow-up are required to further elucidate the efficacy and safety of this novel technology.