Real-World Safety and Efficacy of Transcatheter Mitral Valve Repair With MitraClip: Thirty-Day Results From the Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO)

Francesco Bedogni, Luca Testa, Antonio Popolo Rubbio, Giovanni Bianchi, Carmelo Grasso, Salvatore Scandura, Federico De Marco, Maurizio Tusa, Paolo Denti, Ottavio Alfieri, Arturo Giordano, Paolo Ferraro, Antonio L Bartorelli, Annalisa Mongiardo, Anna Sonia Petronio, Cristina Giannini, Francesco De Felice, Cesare Baldi, Fausto Castriota, Marianna AdamoGiulia Masiero, Cosmo Godino, Matteo Montorfano, Giuseppe Tarantini, Corrado Tamburino

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Available scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size.

AIM: To collect real-world data in a multicenter, prospective, country-level registry.

METHODS AND RESULT: The Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up (n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02-0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95-0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93-0.99), LVEDV-I (OR 0.99, 95% CI 0.98-0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97-0.99) were negative independent factors of MVARC procedural success at 30-day.

CONCLUSIONS: The GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy.

Original languageEnglish
Pages (from-to)1057-1062
Number of pages6
JournalCardiovascular Revascularization Medicine
Volume21
Issue number9
DOIs
Publication statusPublished - Sep 2020

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