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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

1
Sussex Cardiac Centre, Royal Sussex County Hospital, Brighton BN2 5BE, UK. Electronic address: david.hildick-smith@bsuh.nhs.uk.
2
Sussex Cardiac Centre, Royal Sussex County Hospital, Brighton BN2 5BE, UK.
3
Department of Cardiology, Kings College Hospital, Denmark Hill, London SE5 9RS, UK.
4
Belfast City Hospital, Lisburn Road, Belfast BT9 7AB, UK.
5
East Midlands Congenital Heart Centre/NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester LE3 9QP, UK.
6
Barts Heart Centre, London EC1A 7BE, UK.
7
Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.

Abstract

INTRODUCTION:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

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

PMID:
28778466
DOI:
10.1016/j.ijcard.2017.07.058
[Indexed for MEDLINE]

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