Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project

Author:

Testa Luca,Popolo Rubbio Antonio,Squillace Mattia,Albano Flavio,Cesario Vincenzo,Casenghi Matteo,Tarantini Giuseppe,Pagnotta Paolo,Ielasi Alfonso,Popusoi Grigore,Paloscia Leonardo,Durante Alessandro,Maffeo Diego,Meucci Francesco,Valentini Giuliano,Ussia Gian Paolo,Cioffi Paolo,Cortese Bernardo,Sangiorgi Giuseppe,Contegiacomo Gaetano,Bedogni Francesco

Abstract

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.

Publisher

Frontiers Media SA

Subject

Cardiology and Cardiovascular Medicine

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