1. Transapical Transcatheter Mitral Valve Replacement After Failed Transcatheter Edge-to-Edge Repair: A Multicenter Experience.
- Author
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Samim D, Sorajja P, Lanz J, Stolz L, Angellotti D, Hausleiter J, Ruge H, Kuhn EW, Baldus S, Ochs L, Ueyama HA, Babaliaros V, Greenbaum AB, Gössl M, Januska J, Alreshidan M, Reineke D, Windecker S, Adam M, and Praz F
- Subjects
- Humans, Female, Aged, Male, Retrospective Studies, Aged, 80 and over, Time Factors, Risk Factors, Treatment Failure, Electrosurgery adverse effects, Iatrogenic Disease, Recovery of Function, Europe, Compassionate Use Trials, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency etiology, Mitral Valve surgery, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Stenosis surgery, Mitral Valve Stenosis diagnostic imaging, Mitral Valve Stenosis physiopathology, Mitral Valve Stenosis etiology, Recurrence, Heart Valve Prosthesis
- Abstract
Background: Management of recurrent mitral regurgitation (MR) or relevant iatrogenic mitral valve (MV) stenosis after mitral transcatheter edge-to-edge repair (M-TEER) emerges as an increasingly relevant clinical issue. Surgery after M-TEER is associated with higher morbidity and mortality. Electrosurgical leaflet laceration and stabilization of the implant (ELASTA-Clip) followed by transcatheter mitral valve replacement (TMVR) is an innovative, less-invasive treatment option for patients with TEER failure., Objectives: The authors sought to evaluate the early results of ELASTA-Clip followed by transapical TMVR in patients with symptomatic failed M-TEER (defined as persistent or recurrent MR, or iatrogenic MV stenosis)., Methods: Data from symptomatic patients with failed M-TEER who underwent ELASTA-Clip followed by compassionate use or commercial transapical TMVR using the Abbott Tendyne system were retrospectively collected from 8 tertiary care centers in 4 countries. Safety and efficacy of the procedure were assessed up to 1 year according to Mitral Valve Academic Research Consortium (MVARC) criteria., Results: A total of 22 patients (mean age 77.8 ± 9.2 years, 40.9% [9/22] female) at high surgical risk (EuroSCORE II 8.0 ± 0.4, STS score 7.2% ± 1.1%) with symptomatic residual MR ≥3+ (n = 21) or iatrogenic MV stenosis (n = 1) after failed M-TEER were followed for a median period of 8.5 [Q1-Q3: 2.6-11.6] months. The ELASTA-Clip procedure (90.9% [20/22] transseptal, 9.1% [2/22] transapical) followed by TMVR were successful in all patients (22/22). Technical success according to MVARC was achieved in 21 patients (21/22, 95.4%) without left ventricular outflow tract obstruction or conversion to sternotomy. At 30 days, 3 patients had paravalvular leak progression, ischemic stroke occurred in 3 patients (3/20, 15.0%). Baseline MR (≥3+ in 95.5% [21/22]) was reduced to grade 1+ or less in all patients with durable results in 89.5% (17/19) (P < 0.001). NYHA functional class significantly improved to ≤II in 81.3% (13/16) at discharge (P < 0.001) and 72.2% (13/18) at last follow-up (P < 0.001). At 30 days, all patients (20/20) were alive. Three patients (3/20, 15.0%) were rehospitalized for heart failure (uncontrolled atrial fibrillation in 2 cases) and 1 of them (1/22, 4.5%) underwent a reintervention (valve retensioning)., Conclusions: Transapical TMVR after ELASTA-Clip is a feasible and less invasive option for the management of failed M-TEER that can be performed with acceptable results in a carefully selected patient population. Particular attention is required to avoid paravalvular leakage and measures to minimize the risk of periprocedural cerebrovascular events need to be implemented in future larger-scale prospective studies with longer-term follow-up., Competing Interests: Funding Support and Author Disclosures Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Sorajja has served as consultant for 4C Medical, Abbott Structural, Adona Shifamed, Boston Scientific, Foldax, GE Medical, Haemonetics, Laza, Medtronic, Philipps, xDot, and VDyne. Dr Lanz has received institutional speaker fees from Abbott and Edwards Lifesciences. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Angellotti is funded by a research grant provided by the Cardiopath PhD program. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences. Dr Ruge has served as a physician proctor for Abbott and Edwards Lifesciences; is consultant for Medtronic, Abbott, and Edwards Lifesciences; and is member of the Abbott advisory board. Dr Babaliaros holds equity in Transmural Systems; and is a consultant for Edwards Lifesciences. Drs Babaliaros and Greenbaum have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. Dr Gössl is a consultant for Abbott Vascular; and has reported research grants from Edwards Lifesciences and Medtronic. Dr Reineke has reported travel expenses from Abbott, Edwards Lifesciences, and Medtronic; and has proctor and consulting contracts with Abbott and Medtronic. Dr Baldus has received lecture fees from JenaValve and Edwards Lifesciences; and speaker fees from Edwards Lifesciences. Dr Windecker has received institutional research and educational grants from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave. Dr Windecker has served as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, Med Alliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration; is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee; is a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the Advisory Board of the Australian Victorian Heart Institute; and is a chairperson of the ESC Congress Program Committee and Deputy Editor of JACC: Cardiovascular Interventions. Dr Adam has received personal fees/speaker honoraria from Abbott, JenaValve, Meril, and Medtronic. Dr Praz was compensated for travel expenses by Abbott Vascular, Edwards Lifesciences, Medira, inQB8 Medical Technologies, and Siemens Healthineers. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2025
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