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

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

doi:10.3389/fcvm.2022.1064026

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

Front Cardiovasc Med. 2023 Jan 11:9:1064026. doi: 10.3389/fcvm.2022.1064026. eCollection 2022.

Authors

Luca Testa¹, Antonio Popolo Rubbio¹, Mattia Squillace¹, Flavio Albano¹, Vincenzo Cesario¹, Matteo Casenghi¹, Giuseppe Tarantini², Paolo Pagnotta³, Alfonso Ielasi⁴, Grigore Popusoi⁵, Leonardo Paloscia⁶, Alessandro Durante⁷, Diego Maffeo⁸, Francesco Meucci⁹, Giuliano Valentini¹⁰, Gian Paolo Ussia¹¹, Paolo Cioffi¹², Bernardo Cortese¹³, Giuseppe Sangiorgi¹⁴, Gaetano Contegiacomo¹⁵, Francesco Bedogni¹

Affiliations

¹ Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
² Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
³ Cardio Center, Humanitas Research Hospital, Milan, Italy.
⁴ Clinical and Interventional Cardiology Unit, Istituto Clinico Sant'Ambrogio, Milan, Italy.
⁵ Interventional Cardiology Service, Montevergine Clinic, Mercogliano, Italy.
⁶ U.O.C. Cardiologia-UTIC, Ospedale Santo Spirito, Pescara, Italy.
⁷ Cardiology Unit, Policlinico San Marco, Bergamo, Italy.
⁸ Fondazione Poliambulanza, Brescia, Italy.
⁹ Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy.
¹⁰ Cardiology Intensive Care Unit and Cath Lab, Ospedale Civile SS. Filippo e Nicola, L'Aquila, Italy.
¹¹ Unit of Cardiovascular Science, Department of Medicine, Campus Bio-Medico University, Rome, Italy.
¹² Department of Cardiology, Cardiac Cath Lab, Città di Alessandria Institute, Alessandria, Italy.
¹³ Department of Cardiology, San Carlo Clinic, Milan, Italy.
¹⁴ Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy.
¹⁵ Department of Interventional Cardiology, Anthea Hospital, GVM Care and Research, Bari, Italy.

Abstract

Background: The 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.

Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry.

Methods: This 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.

Results: Closure 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.

Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Keywords: embolism; nanoparticle; patent foramen ovale (PFO); platinum; translational.

Copyright © 2023 Testa, Popolo Rubbio, Squillace, Albano, Cesario, Casenghi, Tarantini, Pagnotta, Ielasi, Popusoi, Paloscia, Durante, Maffeo, Meucci, Valentini, Ussia, Cioffi, Cortese, Sangiorgi, Contegiacomo and Bedogni.