Dataset from Bedogni F, Testa L, Rubbio AP, Bianchi G, Grasso C, Scandura S, De Marco F, Tusa M, Denti P, Alfieri O, Giordano A, Ferraro P, Bartorelli AL, Mongiardo A, Petronio AS, Giannini C, De Felice F, Baldi C, Castriota F, Adamo M, Masiero G, Godino C, Montorfano M, Tarantini G, Tamburino C. 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). Cardiovasc Revasc Med. 2020 Sep;21(9):1057-1062. doi: 10.1016/j.carrev.2020.01.002. Epub 2020 Jan 7. PMID: 32001165.
- Francesco Bedogni1
- Luca Testa2
- Antonio Popolo Rubbio3
- Giovanni Bianchi1
- Carmelo Grasso3
- Salvatore Scandura3
- Federico De Marco1
- Maurizio Tusa1
- Paolo Denti4
- Ottavio Alfieri4
- Arturo Giordano5
- Paolo Ferraro5
- Antonio L Bartorelli6
- Annalisa Mongiardo7
- Anna Sonia Petronio8
- Cristina Giannini8
- Francesco De Felice9
- Cesare Baldi10
- Fausto Castriota11
- Marianna Adamo12
- Giulia Masiero13
- Cosmo Godino14
- Matteo Montorfano14
- Giuseppe Tarantini13
- Corrado Tamburino3
- 1. Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
- 2. Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. Electronic address: luctes@gmail.com.
- 3. Division of Cardiology, Centro Alte Specialità e Trapianti (CAST), Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele, University of Catania, Catania, Italy.
- 4. Cardiac Surgery Department, San Raffaele University Hospital, Milan, Italy.
- 5. Invasive Cardiology Unit, Pineta Grande Hospital, Castelvolturno, Italy.
- 6. Centro Cardiologico Monzino, University of Milan, Milan, Italy.
- 7. Division of Cardiology, University Magna Graecia, Catanzaro, Italy.
- 8. Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
- 9. Division of Interventional Cardiology, Azienda Ospedaliera S. Camillo Forlanini, Rome, Italy.
- 10. Heart Department, University Hospital 'Scuola Medica Salernitana', Salerno, Italy.
- 11. Cardiovascular Department of Humanitas Gavazzeni Hospital, Bergamo, Italy.
- 12. Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy.
- 13. Department of Cardiac, Thoracic and Vascular Science, Interventional Cardiology Unit, University of Padua, Padua, Italy.
- 14. Cardio-Thoracic-Vascular Department, San Raffaele University Hospital, Milan, Italy.
Description
Dataset from the article Bedogni F, Testa L, Rubbio AP, Bianchi G, Grasso C, Scandura S, De Marco F, Tusa M, Denti P, Alfieri O, Giordano A, Ferraro P, Bartorelli AL, Mongiardo A, Petronio AS, Giannini C, De Felice F, Baldi C, Castriota F, Adamo M, Masiero G, Godino C, Montorfano M, Tarantini G, Tamburino C. 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). Cardiovasc Revasc Med. 2020 Sep;21(9):1057-1062. doi: 10.1016/j.carrev.2020.01.002. Epub 2020 Jan 7. PMID: 32001165.
This is the 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.
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