Seven-year follow-up of percutaneous closure of patent foramen ovale

Abstract

BackgroundObservational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure.MethodsBetween 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012.ResultsPercutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3 years (5 to 12.4 years). Mean age at PFO closure was 49 years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed.ConclusionsPercutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term.

Long‐Term Contrast Echocardiography and Clinical Follow‐Up after Percutaneous Closure of Patent Foramen Ovale Using Two Different Atrial Septal Occluder Devices

“…In our long‐term follow‐up study, PFO closure was associated with a remarkably low recurrence of neurological events. This remarkably low recurrence is similar to that reported in the long‐term study by Mirzada et al who recorded a particularly low recurrent event rate of 0.3% per year and a success rate of 99% over a follow‐up of up to 12.4 years. The 0.3% per year rate of recurrent neurological events in their study is lower than that reported in a published meta‐analysis of 48 studies, which showed a recurrence rate of 0.8% per year for PFO closure and 5% per year for pharmacologically treated PFO patients .…”

“…In a study by Mirzada, minimal shunting was observed in 7% of treated PFO patients after 18 months of follow‐up; it was not considered to be of any clinical relevance and was not associated with recurrent events. Neither of the 2 patients in that study who had recurrent stroke or TIA (2%) had any detectable residual shunting.…”

“…Some studies have reported the long‐term clinical outcomes of PFO device closure. In the above‐mentioned study by Mirzada et al, the mean follow‐up after PFO closure was 53 months, with a follow‐up rate of 100%; the majority of patients seen at outpatient clinic visits underwent clinical examination, including echocardiography . Two other studies involved comparable follow‐up periods, but both had a lower follow‐up rate.…”

“…Three randomized trials showed that transcatheter PFO closure was not inferior to medical treatment alone in preventing recurrent stroke or TIA in patients with cryptogenic cerebral events and PFO . Moreover, percutaneous PFO closure by means of a variety of devices has proved to be safe and feasible, though marked differences have been observed among the devices used . The initial device‐related complications associated with large delivery systems, device dislodgment and embolization, structural failure, thrombus formation, and the inability to reposition or remove the device have been reduced by improvements in device projecting.…”

Recurrent stroke in patients with patent foramen ovale: An observational prospective study of percutaneous closure of PFO versus non-closure

“…A meta-analysis of observational studies comparing two treatment modalities indicates that PFO closure lowers the rate of recurrent neurologic events to 0.8 events per person-year compared to five events per person-year in medically treated patients [6]. In a previous study, we showed that percutaneous closure of PFO was associated with as low as three neurological events per 1000 person-years [7]. However, the results of three randomized trials failed to show superiority of PFO closure over medical therapy and their primary outcome was not significantly affected by which treatment was given [8][9][10].…”