Percutaneous Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism: A Network Meta-Analysis

Study Questions:

How effective is device closure of patent foramen ovale (PFO) after cryptogenic stroke?

Methods:

A network meta-analysis was performed of four randomized trials comparing device closure with medical management for patients with PFO and cryptogenic stroke. A network meta-analysis allows for comparison of multiple potentially effective interventions.

Results:

The four randomized trials included a total of 2,963 patients with 9,309 patient-years, and studied the Amplatzer, STARFlex, and Helex devices. Patients randomized to the Amplatzer were less likely to experience a stroke than those randomized to medical therapy (rate ratio [RR], 0.39; 95% confidence interval [CI], 0.17-0.84). No reduction in stroke was seen with the STARFlex or Helex device as compared with medical therapy. The probability of the Amplatzer being the best device in preventing stroke was 77.1%, as compared with 20.9% for the Helex and 1.7% for the STARFlex. No benefit in reducing transient ischemic attack (TIA) or death was seen with any of the devices. The risk of new-onset atrial fibrillation was highest for the STARFlex device (RR, 7.67; 95% CI, 3.25-19.63), as compared with the Amplatzer (RR, 2.14; 95% CI, 1.00-4.62) and the Helex (RR, 1.33; 95% CI, 0.33-4.50).

Conclusions:

The authors concluded that the effectiveness of PFO depends on the device used, and that PFO closure with the Amplatzer device appears superior to medical therapy in preventing strokes in patients with cryptogenic embolism.

Perspective:

Several recent randomized trials have failed to demonstrate superiority of PFO closure over medical therapy for patients with cryptogenic stroke. The results of these studies have been questioned because of concerns for adequacy of sample size, varying inclusion criteria, heterogeneity of medical management, and possible differences between devices. This study uses the method of network meta-analysis, which allows for comparison of differing treatment approaches across multiple studies. A limitation of the study is heterogeneity in the medical management group. The study suggests superiority of the Amplatzer device over the other devices as well as medical therapy. The number needed to treat for the Amplatzer was 29, with an accompanying cost analysis placing the cost-effectiveness ratio just at the ‘willingness to pay’ threshold for countries with national health care programs. An interesting accompanying editorial by Benkhadra, et al. discusses the methodology of network meta-analysis, and questions the authors’ conclusions of this study over concerns for the relatively high rate of lost-to-follow-up leading to possible bias and the low event rate leading to imprecision.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD & Pediatrics and Arrhythmias, CHD & Pediatrics and Quality Improvement

Keywords: Stroke, Follow-Up Studies, Ischemic Attack, Transient, Atrial Fibrillation, Foramen Ovale, Patent, Confidence Intervals, Embolism


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