1. Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
- Author
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Ferrero-de-Loma-Osorio Á, García-Fernández A, Castillo-Castillo J, Izquierdo-de-Francisco M, Ibáñez-Críado A, Moreno-Arribas J, Martínez A, Bertomeu-González V, López-Mases P, Ajo-Ferrer M, Núñez C, Bondanza-Saavedra L, Sánchez-Gómez JM, Martínez-Martínez JG, Chorro-Gascó FJ, and Ruiz-Granell R
- Subjects
atrial fibrillation, cryosurgery, cryotherapy, heart atria, humans ,heart atria ,cryosurgery ,cardiovascular system ,atrial fibrillation ,humans ,cryotherapy - Abstract
Background: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. Methods and Results: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Delta=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.62 versus 9.92.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3 +/- 7 versus 19.4 +/- 4.3 minutes; P
- Published
- 2017