Author + information
- David Hildick-Smith1,
- Philip Maccarthy2,
- Michael Mullen3,
- Lindsay Morrison4,
- Christopher Duke5 and
- Mark Spence6
- 1Sussex Cardiac Centre, Brighton, United Kingdom
- 2King's College Hospital, London, United Kingdom
- 3University College Hospital London, London, United Kingdom
- 4Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
- 5sheikh khalifa medical city, abu dhabi, United Arab Emirates
- 6NHS, Belfast, United Kingdom
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 prospectively enrolled into the OPPOSE Registry at 6 centres in the UK. The primary endpoint was PFO closure (grade 0 or 1 shunt) at 6-month bubble contrast transthoracic echocardiography. Secondary endpoints included device implantation success, complications and atrial fibrillation during follow-up.
100 patients aged 43.8±11.5 yrs, 53% male, were recruited. Indications for PFO closure included stroke (56%), TIA (23%) systemic embolism (4%) and myocardial infarction (3%). Closure was undertaken under GA or LA (44% vs 56% respectively), 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, separation of 7.0±2.9mm and basal inlet width of 8.5±3.5mm. Three patients had a florid hypermobile septum. Device implantation was successful in all 100 cases using 18mm (9%), 25mm (80%), 30mm (10%) and 35mm (1%) devices. 5 patients were lost to follow-up. 93 patients underwent the six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was met in 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 were no cases of atrial fibrillation requiring treatment.
This first prospective monitored data for the Occlutech Figulla Flex II device demonstrates good safety and efficacy data at implant and at six-month follow-up.
STRUCTURAL: Congenital and Other Structural Heart Disease