Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project
| Autor: | Luca Testa, Antonio Popolo Rubbio, Mattia Squillace, Flavio Albano, Vincenzo Cesario, Matteo Casenghi, Giuseppe Tarantini, Paolo Pagnotta, Alfonso Ielasi, Grigore Popusoi, Leonardo Paloscia, Alessandro Durante, Diego Maffeo, Francesco Meucci, Giuliano Valentini, Gian Paolo Ussia, Paolo Cioffi, Bernardo Cortese, Giuseppe Sangiorgi, Gaetano Contegiacomo, Francesco Bedogni |
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| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Frontiers in Cardiovascular Medicine, Vol 9 (2023) |
| Druh dokumentu: | article |
| ISSN: | 2297-055X 06361420 |
| DOI: | 10.3389/fcvm.2022.1064026 |
| Popis: | BackgroundThe Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing.AimsTo assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry.MethodsThis is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years.ResultsClosure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day.ConclusionsPercutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry. |
| Databáze: | Directory of Open Access Journals |
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