AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification.

Background

Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.

Methods

Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.

Results

Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.

Conclusions

In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.

Informations de copyright

© 2024 The Author(s).

Déclaration de conflit d'intérêts

P. Généreux has been a consultant for 4C Medical, Abbott Vascular, Abiomed, Boston Scientific, CARANX Medical, Cardiovascular System Inc, Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Soundbite Medical Inc, and Teleflex; has been an advisor to Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Medtronic, Shockwave, and Siemens; has been a principal investigator of 4C Medical for a feasibility study, Cardiovascular System Inc for Eclipse Trial, and Edwards Lifesciences for EARLY-TAVR and PROGRESS trials; holds equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; and has been a proctor for and received institutional grants from Edwards Lifesciences. Krzysztof Wróbel is a consultant and proctor for 4C Medical. M. J. Rinaldi is a consultant for Abbott Vascular, a consultant for Edwards Lifesciences, a consultant for Bostin Scientific, a consultant for Johnson and Johnson, a consultant for Abiomed, and a consultant for Shockwave Medical. T. Modine served on the advisory board of Medtronic, Valfix, and Valcare, is a consultant for Abbott, Edwards Lifesciences, Microport, GE, and Boston Scientific, received research grants from Edwards Lifesciences, Medtronic, and Abbott, and is the principal investigator of Apollo trial, Trinity study, and Neocord study. V. Bapat is a consultant for Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Anteris. V. Ninios is a proctor for 4C Medical, Abbott, and Boston Scientific. P. Sorajja served on the advisory boards of 4C Medical, Abbott Structural (Cephea, Global Valve Masters, Global Complexity Score, Tricuspid Advisory Board), Boston Scientific SHV Strategic Advisory Board, Boston Scientific Advisory Board, Medtronic Structural Advisory Board, and VDyne Advisory Board. Serves as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, xDot. Serves as National or Global Principal Investigator of TRILUMINATE Pivotal US Trial, SUMMIT MAC Pivotal Trial, EXPAND 2 Pivotal US Trial, HighLife (USA) EFS, and VDyne EFS.