Percutaneous closure of the patent foramen ovale using the HELEX® Septal Occluder: acute and long-term results in 405 patients.

AIMS: Although routinely used, limited data are available regarding the long-term outcome after patent foramen ovale (PFO) closure using the HELEX® Occluder system. The aim of this study was therefore the examination of the acute and long-term outcome after transcatheter PFO closure using this system. METHODS AND RESULTS: All (n=407) patients included had undergone PFO closure with the HELEX® Occluder system for secondary prevention of stroke, transient ischaemic attack (TIA) or peripheral embolism at a single centre. Primary endpoints were residual shunts at six or 12 months (assessed by transoesophageal echocardiography) and the number of neurological and other adverse events during follow-up. Device implantation was successful in 99% of patients. Complete closure at six months was achieved in 81%. During follow-up of 1,695 patient-years, 10 neurologic events occurred (four TIA, six strokes). The annual incidence of stroke was 1.2%. Other adverse events were wire frame fractures requiring no further intervention in five (1%), device-associated thrombus formation in one (0.25%), and paroxysmal atrial fibrillation in nine patients (2%). CONCLUSIONS: PFO closure using the HELEX® Occluder system is feasible and safe. Complications and adverse events during long-term follow-up are rare. The safety profile and efficacy in prevention of recurrent events compare well to that reported with other closure devices.

Patent foramen ovale closure with the SeptRx device initial experience with the first "In-Tunnel" device.

OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of the SeptRx patent foramen ovale (PFO) closure device (SeptRx, Inc., Fremont, California). BACKGROUND: A PFO is a relatively common remnant of the fetal circulation that can be associated with cryptogenic stroke, transient ischemic attack, migraine, or decompression sickness. Percutaneous PFO closure with different devices has been performed for many years. However, most of the common devices leave a relatively large amount of material in the left and right atria. The SeptRx PFO device (SeptRx, Inc.) is the first PFO closure device designed to fit directly into the pocket of the PFO. METHODS: From July 2006 to May 2007, 13 patients between 18 and 65 years of age with a history of cryptogenic stroke or transient ischemic attack were included into this first-in-man trial. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Follow-up was done at 1 and 6 months after procedure with transesophageal echocardiography and transcranial Doppler. RESULTS: In 11 of 13 patients, PFO closure with the SeptRx device was successfully performed. In 2 patients, PFO closure with this device was not possible due to the anatomy of the PFO; 1 device was retrieved before release, and the other was recaptured with a snare. After 30 days, 6 of the 11 PFOs were closed; after 6 months, all were closed. No adverse events occurred. CONCLUSIONS: The SeptRx PFO closure device appears to be safe and effective. The advantage of this occluder is that there is only minimal foreign material on the left and right sides of the interatrial septum. This is the first such "in-tunnel" PFO closure device.

New onset atrial fibrillation after patent foramen ovale closure.

OBJECTIVES: In this study, we evaluated the incidence of new onset atrial fibrillation (symptomatic or detected by routine ECG) after patent foramen ovale (PFO-) closure. BACKGROUND: Although atrial fibrillation is known to occur in some patients following patent foramen ovale closure, the incidence and the risk associated with each device is not well known. METHODS: We evaluated 1,349 consecutive patients who underwent PFO closure with an approved device and examined the incidence and risk factors associated with the development of atrial fibrillation. The patients had a mean age of 50 years and underwent PFO closure for cerebrovascular accident in 696 (51.6%), transient ischemic attack in 610 (45.2%), paradoxical embolism in 22 (1.6%), decompression sickness in 13 (0.9%), and other reasons including migraine headaches in 6 (0.4%) of cases. RESULTS: Over a mean follow-up period of 38.1 +/- 28 months, 53 (3.9%) patients developed new onset atrial fibrillation, which is higher compared with an age-matched population. Of these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6 months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty (56.6%) patients developed chronic atrial fibrillation. On multivariate analysis, advanced age and use of the STARFlex device predicted atrial fibrillation. CONCLUSIONS: The number of patients in whom atrial fibrillation was detected was relatively low. It is often a self-limited complication of PFO closure that may occur more frequently in elderly patients and those treated with the STARFlex device.

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.