@article{2c758fac71d94b09a75c4491f3818486,
title = "Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: First results of the North American arctic front (STOP AF) pivotal trial",
abstract = "Objectives: This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology designed to achieve single-delivery pulmonary vein (PV) isolation. Background: Standard radiofrequency ablation is effective in eliminating atrial fibrillation (AF) but requires multiple lesion delivery at the risk of significant complications. Methods: Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥1 membrane active antiarrhythmic drug underwent 2:1 randomization to either cryoballoon ablation (n = 163) or drug therapy (n = 82). A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary. Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months. Results: Patients had highly symptomatic AF (78% paroxysmal, 22% early persistent) and experienced failure of at least one antiarrhythmic drug. Cryoablation produced acute isolation of three or more PVs in 98.2% and all four PVs in 97.6% of patients. PVs isolation was achieved with the balloon catheter alone in 83%. At 12 months, treatment success was 69.9% (114 of 163) of cryoblation patients compared with 7.3% of antiarrhythmic drug patients (absolute difference, 62.6% [p < 0.001]). Sixty-five (79%) drug-treated patients crossed over to cryoablation during 12 months of study follow-up due to recurrent, symptomatic AF, constituting drug treatment failure. There were 7 of the resulting 228 cryoablated patients (3.1%) with a >75% reduction in PV area during 12 months of follow-up. Twenty-nine of 259 procedures (11.2%) were associated with phrenic nerve palsy as determined by radiographic screening; 25 of these had resolved by 12 months. Cryoablation patients had significantly improved symptoms at 12 months. Conclusions: The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF, for whom at least one antiarrhythmic drug has failed, with risks within accepted standards for ablation therapy. (A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Stop AF]; NCT00523978)",
keywords = "atrial fibrillation, catheter ablation, cryoballoon ablation",
author = "Packer, {Douglas L.} and Kowal, {Robert C.} and Wheelan, {Kevin R.} and Irwin, {James M.} and Jean Champagne and Guerra, {Peter G.} and Marc Dubuc and Vivek Reddy and Linda Nelson and Holcomb, {Richard G.} and Lehmann, {John W.} and Ruskin, {Jeremy N.}",
note = "Funding Information: The STOP AF study was funded by Medtronic, Inc. (which purchased Cryocath over the course of the study). Dr. Packer receives research funding from Biosense Webster, Boston Scientific/EPT, Endosense, EpiEP, EP Advocate, Medtronic CryoCath LP, Minnesota Partnership for Biotechnology and Medical Genomics/University of Minnesota, National Institutes of Health, St. Jude Medical, Siemens AcuNav, and Thermedical (EP Ltd.); is a consultant without personal compensation for Abiomed, Biosense Webster, Inc., CardioFocus, Cardiomedics, Cyberheart, Endosense, Johnson & Johnson Healthcare Systems, Medtronic/CryoCath, OrthoMcNeill, Sanofi-Aventis, St. Jude Medical, Siemens AG, and Valencia Technologies; and receives royalties from St. Jude Medical and Blackwell Publishing. Dr. Kowal is a Medtronic advisor; and teaches at Arctic Front Programs. Dr. Wheelan receives honoraria as a Medtronic consultant and has stock ownership. Dr. Irwin contracts with Medtronic to train other EPs in the use of Arctic Front. Dr. Guerra is a Sanofi-Aventis board member and receives payment for lectures, including service on speakers bureaus at St. Jude Medical and Medtronic. Dr. Dubuc received a research grant, consulting fees and/or honoraria, and payment for lectures, including service on speakers' bureau, from Medtronic/CryoCath . Dr. Reddy is a consultant for Medtronic. Dr. Lehmann is an hourly consultant with Medtronic for STOP AF clinical trial design and implementation and holds patents assigned to Medtronics, although no royalties or benefits are received. Dr. Ruskin receives research grants from Medtronic/CryoCath , Biosense Webster , Boston Scientific , and St. Jude Medical ; is an advisory board member for Medtronic/CryoCath and CardioFocus (no personal compensation) and a board member for Pfizer, Biosense Webster, CardioInsight Scientific, and Sequel (no personal compensation); a compensated consultant with Astellas/Cardiome, GE Healthcare, Sanofi-Aventis, Medtronic, Portola, MedIQ, and Third Rock Ventures; and receives honoraria for lectures from Med-IQ and holds stock/options with Portola. Dr. Nelson is an employee of Medtronic, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ",
year = "2013",
month = apr,
day = "23",
doi = "10.1016/j.jacc.2012.11.064",
language = "English (US)",
volume = "61",
pages = "1713--1723",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "16",
}