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 Yaariv Khaykin, MD; Allan Skanes, MD; Jean Champagne, MD; Sakis Themistoclakis, MD; Lorne Gula, MD; Antonio Rossillo, MD; Aldo Bonso, MD; Antonio Raviele, MD; Carlos A. Morillo, MD; Atul Verma, MD; Zaev Wulffhart, MD; David O. Martin, MD; Andrea Natale, MD 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°C of baseline or under 39°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. (Circ Arrhythmia Electrophysiol. 2009;2:481-487.) Key Words: atrial fibrillation  catheter ablation  echocardiography  mapping A trial fibrillation (AF) is the most common sustained cardiac arrhythmia. 1 It increases mortality rates, causes considerable disability, impairs quality of life, and is difficult to treat. 2–4 It is common in clinical practice to prefer sinus rhythm to AF in many patients largely for symptom relief. Clinical Perspective on p 487 There is accumulating evidence implicating triggered ac- tivity in the pulmonary veins (PV) in initiating AF. 5,6 Abla- tion of such foci of ectopic electric activity has been shown to prevent atrial fibrillation recurrences and in some cases terminate chronic AF. 7–11 Early ablation strategies included direct focal mapping and elimination of PV triggers. This was time consuming and resulted in low efficacy at a significant risk of PV stenosis. Two of the mainstream approaches to ablation targeting triggered activity in the PVs in patients with AF include electroanatomically guided circumferential PV ablation using a 3D mapping system (CPVA) 9,11 and PV Received January 6, 2009; accepted August 5, 2009. From the Southlake Regional Health Center (Y.K., A.V., Z.W.), Newmarket, Ontario, Canada; London Health Sciences Center (A.S., L.G.), London, Ontario, Canada; Laval Hospital (J.C.), Quebec City, Quebec, Canada; Umberto I Hospital (S.T., A.Rossillo, A.B., A.Raviele), Venice, Italy; Hamilton Health Sciences Corporation (C.A.M.), Hamilton, Ontario, Canada; Cleveland Clinic Foundation (D.M.), Cleveland, Ohio; and St David’s Medical Center (A.N.), Austin, Tex. Correspondence to Yaariv Khaykin, MD, 105-712 Davis Drive, Newmarket, Ontario, Canada L3Y 8C3. E-mail y.khaykin@utoronto.ca © 2009 American Heart Association, Inc. Circ Arrhythmia Electrophysiol is available at http://circep.ahajournals.org DOI: 10.1161/CIRCEP.109.848978 481 by guest on June 7, 2016 http://circep.ahajournals.org/ Downloaded from