A randomized controlled trial of the efficacy and safety of electroanatomic circumferential pulmonary vein ablation supplemented by ablation of complex fractionated atrial electrograms versus potential-guided pulmonary vein antrum isolation guided by intracardiac ultrasound.

BACKGROUND The study was conducted to compare relative safety and efficacy of pulmonary vein antrum isolation (PVAI) using intracardiac echocardiographic guidance and circumferential pulmonary vein ablation (CPVA) for atrial fibrillation (AF) using radiofrequency energy. METHODS AND RESULTS Sixty patients (81% men; 81% paroxysmal; age, 56+/-8 years) failing 2+/-1 antiarrhythmic drugs were randomly assigned to undergo CPVA (n=30) or PVAI (n=30) at 5 centers between December 2004 and October 2007. CPVA patients had circular lesions placed at least 1 cm outside of the veins. Ipsilateral veins were ablated en block with the end point of disappearance of potentials within the circular lesion. Left atrial roof line and mitral isthmus line were ablated without verification of block. For patients in AF postablation or with AF induced with programmed stimulation, complex fractionated electrograms were mapped and ablated to the end point of AF termination or disappearance of complex fractionated electrograms. PVAI did not include complex fractionated electrogram ablation. Esophageal temperature was monitored and kept within 2 degrees C of baseline or under 39 degrees C. Success was defined as absence of atrial tachyarrhythmias (AF/AT) off antiarrhythmic drugs. There was no difference between CPVA and PVAI regarding to baseline variables, catheter used, duration of the procedure, or RF delivery. Fluoroscopy time was longer with PVAI (54+/-17 minutes versus 77+/-18 minutes, P=0.0001). No significant complications occurred in either arm. PVAI was more likely to achieve control of AF/AT off antiarrhythmic drugs (57% versus 27%, P=0.02) at 2+/-1 years of follow-up. CONCLUSIONS A single PVAI procedure is more likely to result in freedom from AF/AT off antiarrhythmic drugs than CPVA supplemented by complex fractionated electrogram ablation in select patients.