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Panminerva Medica 2021 Jul 26

DOI: 10.23736/S0031-0808.21.04497-9

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Implantation of one, two or multiple MitraClips for transcatheter mitral valve repair: insights from a 1824-patient multicenter study

Arturo GIORDANO 1, Paolo FERRARO 2, Filippo FINIZIO 1, Giuseppe BIONDI-ZOCCAI 3, 4 , Paolo DENTI 5, Francesco BEDOGNI 6, Antonio P. RUBBIO 6, Anna S. PETRONIO 7, Antonio L. BARTORELLI 8, 9, Annalisa MONGIARDO 10, Salvatore GIORDANO 10, Francesco DE FELICE 11, Marianna ADAMO 12, Matteo MONTORFANO 13, Cesare BALDI 14, Giuseppe TARANTINI 15, Francesco GIANNINI 16, Federico RONCO 17, Ida MONTEFORTE 18, Emmanuel VILLA 19, Maurizio FERRARIO 20, Luigi FIOCCA 21, Fausto CASTRIOTA 22, Corrado TAMBURINO 23

1 Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Caserta, Italy; 2 Unità Operativa di Emodinamica, Santa Lucia Hospital, San Giuseppe Vesuviano, Napoli, Italy; 3 Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; 4 Mediterranea Cardiocentro, Naples, Italy; 5 Department of Cardiac Surgery, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy; 6 Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; 7 Cardiothoracic and Vascular Department, University Hospital Pisa, Pisa, Italy; 8 Centro Cardiologico Monzino, IRCCS, Milan, Italy; 9 Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy; 10 Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy; 11 Division of Interventional Cardiology, Azienda Ospedaliera S. Camillo Forlanini, Rome, Italy; 12 Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy; 13 Cardio-Thoracic-Vascular Department, San Raffaele University Hospital, Milan, Italy; 14 Heart Department, University Hospital Scuola Medica Salernitana, Salerno, Italy; 15 Department of Cardiac, Thoracic and Vascular Science, Interventional Cardiology Unit, University of Padua, Padua, Italy; 16 Interventional Cardiology Unit, GVM Care & Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy; 17 Interventional Cardiology, Department of Cardio-Thoracic and Vascular Sciences, Ospedale dell'Angelo, AULSS3 Serenissima, Mestre, Venezia, Italy; 18 Divisione di Cardiologia, A.O. dei Colli, Ospedale Monaldi, Napoli, Italy; 19 Department of Cardiac Surgery, Poliambulanza Foundation Hospital, Brescia, Italy; 20 Division of Cardiology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; 21 Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy; 22 Cardiovascular Department of Humanitas Gavazzeni Hospital, Bergamo, Italy; 23 Division of Cardiology, Centro Alte Specialità e Trapianti (CAST), Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele, University of Catania, Catania, Italy



BACKGROUND: Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR.
METHODS: Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes.
RESULTS: As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p<0.05). Several imaging features were also different, including left ventricular dimensions, MR severity and proportionality, mitral valve area, flail leaflet, and pulmonary vein flow (all p<0.05). Among procedural features, significant differences were found for anesthesia type, MitraClip type, fluoroscopy, device, and operating room times, postprocedural mitral gradient, residual MR, smoke-like effect, device success partial detachment and surgical conversion (all p<0.05). In-hospital death occurred more frequently in patients receiving multiple MitraClips, and the same applied severe residual MR (all p<0.05). Mid-term follow-up (15±13 months) showed significant difference in the risk of death, cardiac death, rehospitalization for heart failure, and their composites, mainly, but not solely, associated with multiple MitraClips (all p<0.05). Adjusted analysis confirmed the significantly increased risk of composite adverse events when comparing the multiple vs single MitraClip groups (p=0.014 for death and rehospitalization, p=0.013 for cardiac death or rehospitalization).
CONCLUSIONS: Implantation of one or two MitraClips is associated with favorable clinical outcomes. Conversely, bail-out implantation of three or more MitraClips may portend a worse long-term prognosis.


KEY WORDS: MitraClip; Mitral regurgitation; Structural heart disease; Transcatheter mitral valve repair

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