812 Complications From Catheter Ablation of AF: Insights From the Contemporary Multicenter International ADVICE Trial

Abstract

Available data regarding major complications associated with catheter ablation of AF are limited to surveys, single-center studies, and small trials. We prospectively assessed acute and longer-term complications after pulmonary vein (PV) isolation (PVI) in the context of a randomized multicenter study (ADVICE). Patients undergoing a first PVI procedure for paroxysmal AF were enrolled from 15 centers. PVI was performed using irrigated RF ablation guided by a circular mapping catheter. After PVI, dormant PV conduction was assessed using IV adenosine. Patients with dormant conduction were randomized to no further ablation or additional adenosine-guided ablation. All patients with dormant conduction and randomly selected patients without dormant conduction were followed for 12 months. Adverse events occurring during the study were classified according to their severity. An adverse event was considered “major” if it resulted in death, was life-threatening, caused functional disability, or required or prolonged hospitalization. Adverse events qualified as possibly, probably, or definitely related to the procedure were analyzed. A total of 355 patients (mean age 60±10 yrs, 32% female) were included, 148 (42%) of whom had hypertension and 32 (10%) structural heart disease. In accordance with the randomization scheme, data on acute complications (prior to hospital discharge) were available for all and longer-term follow-up data for 248 patients. Acute complications occurred in 3.1% [95% confidence interval (1.3%-4.9%)] of patients and included 5 tamponades (1.4%; 3 requiring percutaneous drainage, 2 surgery), 3 access complications (0.8%; 2 groin hematomas, 1 pneumothorax), 2 pericarditis, 1 air embolism and 1 migraine. Additional complications after hospital discharge (median follow-up 353 days) occurred in 1.6% [95% confidence interval (0.04%-3.2%)] of patients and included 1 late pericarditis/pericardial effusion (40 days post ablation), 1 stroke (4 days post ablation, complete recovery), 1 PV stenosis and 1 acute pyelonephritis. Our ongoing prospective multinational trial confirms previously reported low rates of major complications associated with AF ablation. The most frequent complication was pericardial effusion (with or without tamponade), which may present late after ablation.