Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification

BACKGROUND: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak.

AIMS: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC.

METHODS: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days.

RESULTS: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients.

CONCLUSIONS: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.