JACC. Cardiovascular interventions · 2025
Transapical Transcatheter Mitral Valve Replacement After Failed Transcatheter Edge-to-Edge Repair: A Multicenter Experience.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Samim Daryoush, Sorajja Paul, Lanz Jonas, Stolz Lukas, Angellotti Domenico, Hausleiter Jörg, Ruge Hendrik, Kuhn Elmar W, Baldus Stephan, Ochs Laurin, Ueyama Hiroki A, Babaliaros Vasilis, Greenbaum Adam B, Gössl Mario, Januska Jaroslav, Alreshidan Mohammad, Reineke David, Windecker Stephan, Adam Matti, Praz Fabien
Аннотация
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.
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.
Предметные рубрики MeSH
HumansFemaleAgedMaleMitral Valve InsufficiencyRetrospective StudiesHeart Valve Prosthesis ImplantationCardiac CatheterizationMitral ValveAged, 80 and overTime FactorsHeart Valve ProsthesisRecurrenceMitral Valve StenosisRisk FactorsCompassionate Use TrialsTreatment OutcomeIatrogenic DiseaseTreatment FailureRecovery of FunctionProsthesis DesignEurope