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
<b>Background:</b> Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. <b>Methods:</b> We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-03-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/13/6/1681 |
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| author | Nicolas Pioch Daniela Trabattoni Helene Bouvaist Estelle Vautrin Giovanni Teruzzi Cecile Dollinger Gilles Rioufol François Godart Alain Fraisse |
| author_facet | Nicolas Pioch Daniela Trabattoni Helene Bouvaist Estelle Vautrin Giovanni Teruzzi Cecile Dollinger Gilles Rioufol François Godart Alain Fraisse |
| author_sort | Nicolas Pioch |
| collection | DOAJ |
| description | <b>Background:</b> Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. <b>Methods:</b> We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. <b>Results</b>: 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. <b>Conclusions:</b> 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. |
| first_indexed | 2024-04-24T18:09:17Z |
| format | Article |
| id | doaj.art-7dd33271b42c45458fa9b62a5f8164ed |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-04-24T18:09:17Z |
| publishDate | 2024-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-7dd33271b42c45458fa9b62a5f8164ed2024-03-27T13:48:01ZengMDPI AGJournal of Clinical Medicine2077-03832024-03-01136168110.3390/jcm13061681The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI OccludersNicolas Pioch0Daniela Trabattoni1Helene Bouvaist2Estelle Vautrin3Giovanni Teruzzi4Cecile Dollinger5Gilles Rioufol6François Godart7Alain Fraisse8Cardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, FranceCentro Cardiologico Monzino, Istituto di Ricerca e Cura a Carattere Scientifico, 20122 Milan, ItalyCardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, FranceCardiology Department, University Hospital of Grenoble Alpes, 38700 La Tronche, FranceCentro Cardiologico Monzino, Istituto di Ricerca e Cura a Carattere Scientifico, 20122 Milan, ItalyFondation Force, 2 rue André Fruchard, 54320 Maxéville, FranceHospices Civils de Lyon, 69002 Lyon, FranceCentre Hospitalier Universitaire, 59000 Lille, FranceRoyal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK<b>Background:</b> Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. <b>Methods:</b> We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. <b>Results</b>: 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. <b>Conclusions:</b> 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.https://www.mdpi.com/2077-0383/13/6/1681patent foramen ovaleinterventional catheterizationcryptogenic stroke |
| spellingShingle | Nicolas Pioch Daniela Trabattoni Helene Bouvaist Estelle Vautrin Giovanni Teruzzi Cecile Dollinger Gilles Rioufol François Godart Alain Fraisse 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 Journal of Clinical Medicine patent foramen ovale interventional catheterization cryptogenic stroke |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | rise study retrospective registry for the international safety and efficacy results of patent foramen ovale closure with figulla flex il pfo and uni occluders |
| topic | patent foramen ovale interventional catheterization cryptogenic stroke |
| url | https://www.mdpi.com/2077-0383/13/6/1681 |
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