Acute and Long‐Term Outcomes of Catheter Ablation of Atrial Fibrillation Using the Second‐Generation Cryoballoon versus Open‐Irrigated Radiofrequency: A Multicenter Experience

Abstract

Second-Generation Cryoballoon versus RF. Introduction:There are limited comparative data on catheter ablation of atrial fibrillation (CAAF) using the second-generation cryoballoon (CB-2) versus point-by-point radiofrequency (RF). This study examines the acute/long-term CAAF outcomes using these 2 strategies.Methods and Results: In this multicenter, retrospective, nonrandomized analysis, procedural and clinical outcomes of 1,196 patients (76% with paroxysmal AF) undergoing CAAF using CB-2 (n = 773) and openirrigated, non-force sensing RF (n = 423) were evaluated. Pulmonary vein isolation was achieved in 98% with CB-2 and 99% with RF (P = 0.168). CB-2 was associated with shorter ablation time (40 ± 14 min vs. 66 ± 26 min; P < 0.001) and procedure time (145 ± 49 minutes vs. 188 ± 42 minutes; P < 0.001), but greater fluoroscopic utilization (29 ± 13 minutes vs. 23 ± 14 minutes; P < 0.001). While transient (7.6% vs. 0%; P < 0.001) and persistent (1.2% vs. 0%; P = 0.026) phrenic nerve palsy occurred exclusively with CB-2, other adverse event rates were similar between CB-2 (1.6%) and RF (2.6%); P = 0.207. However, freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 (76.6%) versus RF (60.4%); P < 0.001. While this difference was evident in patients with paroxysmal AF (P < 0.001), it did not reach significance in those with persistent AF (P = 0.089). Additionally, CB-2 was associated with reduced long-term need for antiarrhythmic therapy (16.7% vs. 22.0%; P = 0.024) and repeat ablations (14.6% vs. 24.1%; P < 0.001).Conclusion: In this multicenter, retrospective, nonrandomized study, CAAF using CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated, non-force sensing RF, alone. (J Cardiovasc Electrophysiol, Vol. 26, pp. 832-839, August 2015) atrial fibrillation, catheter ablation, cryoablation, cryoballoon, phrenic nerve palsy Drs. Aryana, Kowalski, Banker, and O'Neill have received consulting fees and speaker honoraria, and Drs. Aryana and O'Neill have received a research grant from Medtronic, Inc., the manufacturer of the second-generation cryoballoon used in this study. Additionally, Drs. Cohen, Banker, Fuenzalida, and d'Avila have received consulting fees and speaker honoraria, and Drs. Aryana and O'Neill have received research grants from Biosense Webster, Inc., the manufacturer of the radiofrequency ablation catheter used in this study. Other authors: No disclosures.

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes

“…In fact, the majority of patients in the RF group received treatment with the first generation device, while for the CB procedure, there were significantly more second generation devices used. Notably, there are early indications that the non-inferiority of CB compared to RF could be maintained for the later generations of catheter ablation systems [13, 15, 30]. However, at present, there are no long-term data available concerning the efficacy of the newer systems.…”

Recent Advances in Lesion Formation for Catheter Ablation of Atrial Fibrillation

“…During the off period, tissue temperature remains close to target. 49 The cryoballoon and radiofrequency ablation will be compared in the prospective randomized FIRE AND ICE trial, 50 with results expected in 2016. Cryoballoon ablation is also being investigated as first-line therapy in patients with paroxysmal AF in the Cryo-FIRST Trial (NCT01803438).…”

Hope or Hype – Does Cryoballoon Simplify Atrial Fibrillation Ablation Technique or Just Another Costly Toy? –

“…These study results are consistent with the outcomes reported in other global trials of the effectiveness of cryoballoon. [8][9][10][11][12] Although this study was a PMS, the safety outcome seems not a significant problem with new cryoballoon users.…”

“…Most of the studies demonstrated a similar efficacy between cryoablation and irrigated-tip RF ablation for paroxysmal AF. [8][9][10][11][12] In most studies, procedural duration was shorter and fluoroscopic exposure a little longer than with conventional RF ablation with 3D mapping system. Nevertheless, efficacy is not the only issue we need to consider; safety is also paramount before making this ablation technique available to most operators, including less experienced doctors.…”

“…For example, phrenic nerve paralysis, which occurred in 5-10% of patients after cryoablation, although most cases were transient and asymptomatic. [8][9][10][11][12] There are also concerns of collateral damage to neighboring soft tissues, including the esophagus or bronchus. How to adjust for adequate energy and freezing duration in order to avoid these complications or collateral damage is still unclear and whether a bonus lesion is required after acute PV adiofrequency (RF) energy for catheter ablation of atrial fibrillation (AF) has been a therapeutic option since the reports from Haïssaguerre et al 1 and Chen et al 2 Electrical isolation of the pulmonary veins (PVs) is the cornerstone and established endpoint of AF ablation.…”