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
Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
Front Cardiovasc Med. 2023 Jan 11;9:1064026. doi: 10.3389/fcvm.2022.1064026. eCollection 2022.
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.
To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry.
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.
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.
Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.
“茧”型卵圆孔未闭（PFO）封堵器是新一代涂有纳米铂的镍钛诺合金双盘装置，可能适用于对镍过敏的患者。该装置在经皮PFO封堵中的早期结果和中期结局尚不清楚。
在意大利多中心注册研究中评估使用“茧”型装置封堵PFO的初步疗效和安全性。
这是一项前瞻性注册研究，纳入了2017年5月至2020年5月期间在意大利15个中心接受“茧”型PFO封堵器治疗的189例连续成年患者。对患者进行了2年的随访。
所有患者均成功使用“茧”型封堵器封堵PFO，94.7%的患者实现完全封堵且无残余分流，5.3%的患者有微量分流。除1例阵发性室上性心动过速和1例严重血管出血外，未发生与手术和住院期间装置相关的并发症。随访期间，无患者发生心脏侵蚀、对镍的过敏反应或任何其他严重并发症。在随访期内，30天内发生了2例新发房颤。
在真实世界注册研究中，使用“茧”型封堵器经皮封堵PFO在手术过程和中期临床随访中均取得了令人满意的结果。
