Abstract 9464: International Incidence of Complications After Catheter Ablation of Persistent Atrial Fibrillation (AF): Insights From the Multicenter, Prospective, Randomized STAR AF II Trial
Background: Complication rates after AF ablation are mostly reported in single center experiences or surveys. Little international, multicenter, prospective data on the contemporary incidence of complications is available. We report the incidence of complications from the large STAR AF II randomized trial.
Methods: The STAR AF II trial is an international, randomized trial comparing 3 different strategies for ablation of persistent AF: pulmonary vein isolation (PVI) alone, PVI + linear ablation, and PVI + ablation of complex fractionated electrograms. 48 centers were involved across Canada, Australia, Korea, China, & 8 countries in Europe. Post-ablation, patients were all followed for 18 months. All adverse events were reported by protocol and were classified as “serious” if it was fatal, life-threatening, disabling, or required/prolonged hospitalization. Adverse events were also reviewed by an independent data safety monitoring board and classified as either being related or unrelated to the ablation procedure. Adverse events related to the ablation procedure were included in this analysis.
Results: Patients (n=589) were enrolled in the STAR AF II trial (age 60±10 years, 79% male, EF 56±10%, LA diameter 44±9 mm). The most common post-procedural complications were access site hematoma (n=16, 2.7%), fluid overload/pulmonary edema (n=16, 2.7%), and transient pericarditis (n=15, 2.5%). Access site arterio-venous fistulas or pseudoaneurysms occurred in 7 patients (1.2%). Complications related to sedation occurred in 5 patients (0.8%). Cardiac tamponade (n=3, 0.5%), stroke or transient ischemic attack (n=3, 0.5%), and symptomatic PV stenosis (n=1, 0.2%) were uncommon. None of the neurological events resulted in permanent deficit. There was one atrio-esophageal fistula complicated by stroke which was successfully stented, but the patient died of aspiration pneumonia three months later.
Conclusions: The most common complications were access site hematoma, fluid overload, and transient pericarditis. The rates of serious adverse events such as tamponade, stroke and symptomatic PV stenosis were quite low. There was one atrio-esophageal fistula that caused late death despite successful repair.
- © 2013 by American Heart Association, Inc.