Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation. Issue 14 (6th October 2015)

• Record Type: Journal Article
• Authors: Luik, Armin; Radzewitz, Andrea; Kieser, Meinhard; Walter, Marlene; Bramlage, Peter; Hörmann, Patrick; Schmidt, Kerstin; Horn, Nicolas; Brinkmeier-Theofanopoulou, Maria; Kunzmann, Kevin; Riexinger, Tobias; Schymik, Gerhard; Merkel, Matthias; Schmitt, Claus
• Is Part Of: Circulation. Volume 132:Issue 14(2015)
• Publication Date: 2015-10-06
• Subjects: Blood -- Circulation -- Periodicals; Cardiovascular system -- Periodicals; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; Blood Circulation; Cardiovascular System; Vascular Diseases; 616.1
• DOI: 10.1161/CIRCULATIONAHA.115.016871
• Languages: English
• ISSNs: 0009-7322

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Background—</title> <p>There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.</p> </sec> <sec> <title>Methods and Results—</title> <p>In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; <italic>P</italic>=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; <italic>P</italic>=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, −0.074 to 0.132; <italic>P</italic><0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, −0.097 to 0.116; <italic>P</italic>=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; <italic>P</italic>=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; <italic>P</italic>=0.002).</p> </sec> <sec> <title>Conclusion—</title> <p>This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation.</p> </sec> <sec> <title>Clinical Trial Registration—</title> <p>URL: <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.clinicaltrials.gov</ext-link>. Unique identifier: NCT00774566.</p> </sec> </abstract>