The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI Occluders.

Autor: Pioch N; Cardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, France., Trabattoni D; Centro Cardiologico Monzino, Istituto di Ricerca e Cura a Carattere Scientifico, 20122 Milan, Italy., Bouvaist H; Cardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, France., Vautrin E; Cardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, France., Teruzzi G; Centro Cardiologico Monzino, Istituto di Ricerca e Cura a Carattere Scientifico, 20122 Milan, Italy., Dollinger C; Fondation Force, 2 rue André Fruchard, 54320 Maxéville, France., Rioufol G; Hospices Civils de Lyon, 69002 Lyon, France., Godart F; Centre Hospitalier Universitaire, 59000 Lille, France., Fraisse A; Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2024 Mar 14; Vol. 13 (6). Date of Electronic Publication: 2024 Mar 14.
DOI: 10.3390/jcm13061681
Abstrakt: Background: Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. Methods: We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. Results : 527 patients were included. Mean age was 48.9 (±13.8) years. The procedure was under transthoracic, transesophageal or intracardiac echocardiography in 185 (35.1%), 193 (36.6%) and 149 (28.3%) cases, respectively, and under general anesthesia in 191 patients (36.2%). The FFP and FFU were used in 408 (77.4%) and 119 (22.6%) cases, respectively. The success rate was 99.1%. Median follow-up was 1.1 (0.5-2.5) years. A new atrial fibrillation/flutter within six months occurred in 14 (2.7%) cases, with no difference between devices. One device embolization in the pulmonary artery was identified two years post-procedure. Residual shunts occurred in 18 (6.9%) cases at 1 year, with TIA in three (16.6%) patients. Out of 437 patients with stroke/TIA, 260 (59%) were followed more than one year after closure. Median follow-up was 2.1 (1.17-3.1) years, with four recurrent strokes/TIA. Conclusions: The FFP and FFU devices are safe and effective for PFO closure, with very few atrial fibrillation/flutter and neurologic events, except in cases with a residual shunt.
Competing Interests: Alain Fraisse and Francois Godart are both consultants and proctors for Occlutech Inc and Abbott Inc. Other authors have no conflicts of interest.
Databáze: MEDLINE
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