Short and long term complications of device closure of atrial septal defect and patent foramen ovale: meta-analysis of 28,142 patients from 203 studies.

ABSTRACT

BACKGROUND: Device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) are both associated with short- and long-term complications. Our knowledge of the complication rates of ASD and PFO closure is limited. Our objective was to review the peri-procedural and long-term complications of ASD and PFO closure. METHODS: Medline, EMBASE, and Scopus databases were searched between 1973 and 2012. A total of 28,142 patients from 203 case series were included. Of these 203 articles, 111 were reporting ASD closure, 61 were reporting PFO closure, and 31 were reporting both. Pooled incidence rates of cardiac complications were calculated separately for peri-procedural and at follow-up. RESULTS: Peri-procedural major complications were reported from 0% to 9.4%, with a pooled estimate rate of 1.4% (95% CI 1.3-1.6%). It was 1.6% (95% CI 1.4-1.8%) in ASD group, 1.1% (95% CI 0.9-1.3%) in PFO group, and 1.3% (95% CI 0.9-1.9%) in ASD/PFO group. The most common major complication was the device embolization requiring surgery. Peri-procedural minor complications were reported with a pooled estimate rate of 1.4% (95% CI 1.2-1.7%). It was 1.6% (95% CI 1.2-2.1%) in ASD group, 1.3% (95% CI 1.0-1.7%) in PFO group, and 1.5% (95% CI 1.1-1.2.1%) in ASD/PFO group. The most frequent major complications at follow-up were cerebrovascular events [1.3% (95% CI 1.1-1.6%)] and device thrombosis [1.2% (95% CI 1.0-1.4%)]. Both were more frequent in PFO group. CONCLUSION: Device closure of ASD and PFO are associated with non-negligible serious complications, both in early and long-term.