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Transapical Transcatheter Mitral Valve Replacement After Failed Transcatheter Edge-to-Edge Repair: A Multicenter Experience

D. Samim, P. Sorajja, J. Lanz, L. Stolz, D. Angellotti, J. Hausleiter, H. Ruge, EW. Kuhn, S. Baldus, L. Ochs, HA. Ueyama, V. Babaliaros, AB. Greenbaum, M. Gössl, J. Januska, M. Alreshidan, D. Reineke, S. Windecker, M. Adam, F. Praz

. 2025 ; 18 (3) : 311-321. [pub] 20250210

Jazyk angličtina Země Spojené státy americké

Typ dokumentu multicentrická studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc25009902

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.

Citace poskytuje Crossref.org

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$a 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.
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$a Sorajja, Paul $u Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
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$a Lanz, Jonas $u Department of Cardiology, Bern University Hospital, Bern, Switzerland
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$a Stolz, Lukas $u Medizinische Klinik und Poliklinik I, LMU University Hospital, Munich, Germany
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$a Angellotti, Domenico $u Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
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$a Hausleiter, Jörg $u Medizinische Klinik und Poliklinik I, LMU University Hospital, Munich, Germany
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$a Ruge, Hendrik $u Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine & Health, Technical University of Munich, Germany
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$a Kuhn, Elmar W $u Department of Cardiothoracic Surgery, Heart Center of the University of Cologne, Cologne, Germany
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$a Baldus, Stephan $u Department of Cardiology, Heart Center of the University of Cologne, Cologne, Germany
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$a Ochs, Laurin $u Department of Cardiology, Heart Center of the University of Cologne, Cologne, Germany
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$a Ueyama, Hiroki A $u Division of Cardiology, Emory University School of Medicine, Atlanta, USA
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$a Babaliaros, Vasilis $u Division of Cardiology, Emory University School of Medicine, Atlanta, USA
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$a Greenbaum, Adam B $u Division of Cardiology, Emory University School of Medicine, Atlanta, USA
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$a Gössl, Mario $u Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
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$a Januska, Jaroslav $u Department of Cardiology, Cardiocentre Podlesí, Třinec, Czech Republic
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$a Alreshidan, Mohammad $u Cardiovascular & Thoracic Surgery Department, King Salman Heart Center, King Fahad Medical City, Riyadh, Saudi Arabia
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