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Int J Cardiol. 2017 Oct 15;245:99-104. doi: 10.1016/j.ijcard.2017.07.058. Epub 2017 Jul 21.

Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE).

Author information

Sussex Cardiac Centre, Royal Sussex County Hospital, Brighton BN2 5BE, UK. Electronic address:
Sussex Cardiac Centre, Royal Sussex County Hospital, Brighton BN2 5BE, UK.
Department of Cardiology, Kings College Hospital, Denmark Hill, London SE5 9RS, UK.
Belfast City Hospital, Lisburn Road, Belfast BT9 7AB, UK.
East Midlands Congenital Heart Centre/NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester LE3 9QP, UK.
Barts Heart Centre, London EC1A 7BE, UK.
Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.



Safety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device.


100 patients undergoing PFO closure were enrolled into the OPPOSE Registry at 6 UK centres. The primary endpoint was PFO closure (grade 0 or 1 shunt) at 6-month BCTTE assessed by Corelab. Secondary endpoints included implantation success, complications, and atrial fibrillation during follow-up.


100 patients aged 43.8±11.5years, 53% male, were recruited. Indications for PFO closure included stroke (56%), TIA (29%) systemic embolism (4%) and MI (3%). Closure was undertaken under GA (44%) or LA (56%), with TOE (45%), ICE (31%), no imaging (20%) or TTE (3%). Balloon sizing was used in 98% of cases and showed a tunnel length of 7.3±3.6mm, primum-secundum separation of 7.0±2.9mm and basal inlet width of 8.5±3.5mm. Implantation was successful in all cases using 18mm (9%), 25mm (80%), 30mm (10%) and 35mm (1%) devices. 5 patients were lost to follow-up. 92 patients underwent six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was 79.3%. One patient developed major bleeding (BARC 3b), one patient required vascular surgery, and in one patient device embolization was noted at six months and a larger device implanted. There was one case of new atrial fibrillation.


This first prospective monitored data for the Occlutech Figulla Flex II device demonstrates good safety and efficacy data at implant and six-month follow-up.


Occlutech; PFO (patent foramen ovale); Stroke prevention; Structural intervention

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