1. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation
- Author
-
Maria Brinkmeier-Theofanopoulou, Meinhard Kieser, Marlene Walter, Claus Schmitt, Nicolas Horn, Andrea Radzewitz, Peter Bramlage, Armin Luik, Kevin Kunzmann, Gerhard Schymik, Matthias Merkel, Kerstin N. Schmidt, Patrick Hörmann, and Tobias Riexinger
- Subjects
Male ,Radiofrequency ablation ,medicine.medical_treatment ,Comorbidity ,Cryosurgery ,law.invention ,law ,Atrial Fibrillation ,catheter ablation ,Clinical endpoint ,Thrombophilia ,Prospective Studies ,Intraoperative Complications ,Prospective cohort study ,education.field_of_study ,Arrhythmia/Electrophysiology ,Atrial fibrillation ,Middle Aged ,Ablation ,Combined Modality Therapy ,Phrenic Nerve ,Treatment Outcome ,Cardiovascular Diseases ,Pulmonary Veins ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Adrenergic beta-Antagonists ,Population ,Catheter ablation ,Postoperative Hemorrhage ,Risk Assessment ,Pericardial Effusion ,Imaging, Three-Dimensional ,Physiology (medical) ,Diabetes Mellitus ,medicine ,Humans ,education ,Aged ,business.industry ,Anticoagulants ,Original Articles ,arrhythmias, cardiac ,medicine.disease ,Confidence interval ,Surgery ,Sample Size ,Electrocardiography, Ambulatory ,business - Abstract
Supplemental Digital Content is available in the text., Background— 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. Methods and Results— 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; P=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; P=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; P
- Published
- 2015
- Full Text
- View/download PDF