Secondary retensioning of a tether-based device for transapical transcatheter mitral valve implantation

Abstract

Objectives Relevant paravalvular leakage (PVL) due to prothesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI-system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre-study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning-maneuvers.
Methods From 2017 to 2021, N = 18 patients who underwent secondary tether-retensioning were identified. Baseline, procedural and follow-up data were available from N = 11 patients and analyzed according to the Mitral Valve Research Consortium (MVARC) definitions. Continuous variables are shown as median with interquartile range.
Results All Patients [age 75 years (73.5, 85.0), 64% male (N = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N = 7) with PVL ≥ 3+]. Of these, 54% (N = 6) showed signs of hemolysis. The majority were severely symptomatic [NYHA≥III (91%, N = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N = 10) of patients with one case of remaining moderate PVL. At 30 days, MVARC device success was achieved in 82% (N = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N = 8) of patients with successful retensioning procedure NYHA-class was I/II. There was no 30-day mortality.
Conclusion This multicentre-study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning-procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk.

Keywords: TMVI, TMVR, paravalvular leakage, mitral valve, retensioning, Tendyne