A suture not always the ideal solution: Problems encountered in developing a suture‐based PFO closure technique

OBJECTIVES: To summarize our experiences with the first-in-man suture-based patent foramen ovale (PFO) closure technique. BACKGROUND: PFO is often present with the occurrence of cryptogenic stroke and migraine with aura. Successful PFO closure can be performed percutaneously using catheter techniques with many different closure devices. The described novel closure system is intended to deliver, via endovascular access, a suture into the atrial septal wall tissue for closure of PFO. METHODS: Eleven patients, between 22 and 58 years of age (mean 46.6 +/- 9.6), who had a cryptogenic ischemic stroke, TIA, or a peripheral embolism and a PFO were considered for percutaneous closure with this technique. RESULTS: The mean stretched diameter of the defect evaluated during balloon sizing was 8.8 +/- 0.4 mm (range 7-12.5). Delivery of the suture was successful in all patients. No intraprocedural complications occurred. During the follow up, complete closure could be achieved in one patient. Six patients with significant residual shunting during follow-up had successful closure using a conventional device. One patient was lost for follow-up after the 3-month visit. The residual shunt in the remaining three patients was very small and they declined to be treated with a conventional device. No complications occurred during the follow up. CONCLUSIONS: Transcatheter application of a suture for closure of PFO is technically feasible and safe. However, despite successful suturing of the septum primum to the septum secundum, the PFO did not close in most of the patients.