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Circulation: Arrhythmia and Electrophysiology
This prospective, randomized multicenter study compares the efficacy and safety of laser balloon with wide-area circumferential pulmonary vein isolation with radiofrequency ablation. The results demonstrated that laser balloon ablation is similarly effective as radiofrequency ablation in patients with persistent atrial fibrillation.
Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation
A Multicenter Prospective Randomized Study
Boris Schmidt, MD
Petr Neuzil, MD
Armin Luik, MD
Joaquin Osca Asensi, MD
Jan Wilko Schrickel, MD
Thomas Deneke, MD
Stefano Bordignon, MD
Jan Petru, MD
Matthias Merkel, MD
Lucie Sediva, PhD
Annemarie Klostermann, BS
Laura Perrotta, MD
Oscar Cano, MD
K.R. Julian Chun, MD
Correspondence to: Boris Schmidt, MD, Cardioangiologisches Centrum Bethanien, Wilhelm-Epstein-Straße 4, 60431 Frankfurt am Main, Germany. E-mail email@example.com
BACKGROUND: Pulmonary vein isolation is the cornerstone of ablation for persistent atrial fibrillation (AF). The role of balloon catheters in this patient population remains ill defined. We sought to compare efficacy and safety of the laser balloon (LB) with wide-area circumferential pulmonary vein isolation using irrigated radiofrequency current (RF) ablation and 3-dimensional mapping.
METHODS AND RESULTS: In 6 European centers, patients with persistent AF were prospectively randomized. Follow-up included 3-day Holter ECG recordings and office visits at 3, 6, and 12 months. The primary efficacy end point was freedom from AF between 90 and 365 days after a single ablation. The primary safety end point was the incidence of any periprocedural complications. Of 152 enrolled patients, 134 (n=68 LB and 66 RF; 63% men; mean age, 66+10 years) with persistent AF (median AF history, 14 months; Q1–Q3, 7–36 months) underwent pulmonary vein isolation and completed the entire follow-up. Baseline parameters were similar in both groups. Procedure and fluoroscopy times were similar in both groups (135±38 and 14±9 minutes (LB) versus 128±51 and 11±9 minutes). The primary efficacy end point was met by 71.2% versus 69.3%, in the LB and RF groups, respectively (P=0.40). In the LB …