Percutaneous Foramen Ovale Closure (PFOC)
The Structural Heart Intervention Registries are within the National Cardiac Audit Programme (NCAP). There are four structural heart intervention registries including Percutaneous Foramen Ovale Closure (PFOC).
The structure of the embryonic heart is very different from the developed heart. In the fetal heart, oxygenated blood can enter the left atrium from the right atrium through the foramen ovale.
In the majority of people, the foramen ovale closes at birth when the lungs begin to function. However, in approximately 15-25% of adults this channel does not close, leaving a patent (open) foramen ovale.
There is evidence suggesting individuals with PFO have a higher incidence of stroke than those who don’t. Substances, gas bubbles for example, are thought to cross from the right hand side of the heart to the left hand side of the heart through this opening, which then cause blockages in arterial circulation, thereby increasing the risk of stroke.
Percutaneous patent foramen closure (PFOC) is performed in hospitals under anaesthetic using x-ray guidance and usually takes less than one hour.
The closure device is delivered to the heart by a catheter delivery system. The usual access point is the femoral artery in the leg, the device is then guided to the right atrium over a wire. Once the device is in the right position, the device is deployed and the catheter is removed.
The aim of the audit is to collect clinical and outcome data on structural heart intervention services carried out in the UK. This is a significant development and will enable identification of key metrics for benchmarking, improving care of patients undergoing these procedures and for the safe introduction of new technologies in this country. The audit is managed by NICOR, with clinical direction and strategy provided by national professional societies.
- Current evidence suggests that there are no major safety concerns and that percutaneous closure of patent foramen ovale for the prevention of cerebral embolic stroke is efficacious in achieving closure of the foramen. However, its efficacy in preventing future strokes has not been clearly shown.
The clinical expert view is PFOC is likely to be beneficial in carefully selected individuals.
2026 Interim Summary Report Key findings:
Patent Foramen Ovale Closure (PFOC) Registry: 750 new cases thus far in 2025/26 with very few complications but there are notable variations in how the procedures are performed. 90% of PFOC procedures are now being submitted to the PFOC Registry, whilst 10% are still preferentially being submitted to the NCHDA. The PFOC Registry most reliably captures data for those patients in whom PFOC has been selected as a treatment in adults for the prevention of stroke. Nearly 750 cases were reported for Q1/Q2 2025/26. Data quality is good in most hospitals, but some need to provide complete and more timely data.
Three devices are used most commonly for these procedures. There are differences in the adjunctive imaging used for procedures, which probably impact on quite significant variations in fluoroscopy times for procedures and overall X-ray doses needed. Complication rates are very low.
Clinical lead: Dr Mark Turner