Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.
embolism
nanoparticle
patent foramen ovale (PFO)
platinum
translational
Journal
Frontiers in cardiovascular medicine
ISSN: 2297-055X
Titre abrégé: Front Cardiovasc Med
Pays: Switzerland
ID NLM: 101653388
Informations de publication
Date de publication:
2022
2022
Historique:
received:
07
10
2022
accepted:
20
12
2022
entrez:
30
1
2023
pubmed:
31
1
2023
medline:
31
1
2023
Statut:
epublish
Résumé
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.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry.
Methods
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.
Identifiants
pubmed: 36712245
doi: 10.3389/fcvm.2022.1064026
pmc: PMC9875285
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1064026Informations de copyright
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.
Déclaration de conflit d'intérêts
GC was employed by GVM Care and Research. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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