Comparison of the First and Second Cryoballoon

Abstract

There were 2 main objectives:1. To compare the procedural efficacy of CBG1 and CBG2 by analyzing rates of acute PVI, time to isolation (TTI), balloon © 2014 American Heart Association, Inc. Original ArticleBackground-Cryoballoon (CB) ablation results in >70% freedom from atrial fibrillation at 1 year. Single-center data of the first (CBG1) and second (CBG2) cryoballoon, recently introduced, were analyzed to compare safety and efficacy. Methods and Results-From March 2011 to December 2012, CB ablation with spiral mapping was performed consecutively in 484 patients with symptomatic atrial fibrillation. CBG1 was used in 364 of 484 (75%) and CBG2 in 120 of 484 (25%) patients. Periprocedural data were analyzed. Acute pulmonary vein (PV) isolation with CB only was achieved in 99.86% and 100% of veins with CBG1 and CBG2, respectively (P=0.43). Number of applications until PV isolation decreased significantly with CBG2 (1.45±0.81 versus 1.28±0.64; P=0.001). Procedural, left atrial, and fluoroscopy time were reduced by −5%, −11%, and −15% (P<0.05), respectively. Two balloons were used less frequently. Time to isolation decreased significantly with 23-mm (48 versus 33 seconds; P<0.0001) and 28-mm CBG2 (76 versus 52 seconds; P<0.0001). Early PV reconduction rarely occurred with CBG2 (2.6% versus 0.42%; P=0.0023). In-hospital atrial fibrillation recurrence rates were similar. Balloon temperatures were significantly warmer with 23-mm CBG2 and a trend for colder balloon temperature with 28-mm CBG2 were observed compared with their predecessors. Comparable low rates of phrenic nerve palsy were recorded (1.1% versus 1.7%; P=0.64). Esophageal temperatures were similar. Major complication rates were low (3.3% versus 3.33%; P=1.0). Conclusions-CBG2 attains high rates of acute PV isolation within a significant faster and less complex procedure. Time to isolation is shorter, and PV isolation is achieved with fewer applications using CBG2. These enhancements were not at the cost of complications. Study PopulationFrom 2007 to November 2012, all patients undergoing CB ablation for catheter ablation of symptomatic AF at our center were prospectively enrolled in a consecutive fashion. Informed consent was obtained from all patients for the observational registry study which was approved by the local ethical committee. Baseline characteristics, periprocedural data, and follow-up during blanking period for procedure-associated complications were assessed prospectively. For this interim analysis, we included only patients undergoing a CB procedure in combination with the Achieve spiral mapping catheter (Medtronic Inc., Minneapolis, MN) introduced in March 2011 as the standard catheter to our laboratory for positioning of the balloon and real-time PV potential recordings. Until May 2012, all patients were treated with the Arctic Front, and afterward, all patients were treated with the Arctic Front Advance. Ablation Procedure and Verification of PVICB procedure was performed with an anatomy-based individualized approach as described before u...

Electromyographic Monitoring for Prevention of Phrenic Nerve Palsy in Second-Generation Cryoballoon Procedures

“…3 In studies using CB2, the PNP rate has ranged from 3.5% to 27.5% and the vast majority of cases regressed completely. [12][13][14][15][16][17] The rate of threatened PNP in our previous series using CB1 1 was identical to the 1 observed in this series with CB2: 12% versus 13.6%, respectively. This similarity occurred despite more frequent use of 28-mm CB2 (90% versus 32%).…”

Practical Techniques in Cryoballoon Ablation: How to Isolate Inferior Pulmonary Veins

“…2-10 It has a single procedure one-year success rate in paroxysmal AF of >80 % in patients no longer taking antiarrhythmic drugs. [2][3][4][5][6][7][8][9][10] A large multicentre ablation registry study from Germany showed that the overall rates of major complications were similar in cryoablation and RF. 11 We compared the results of 3,000 RF and balloon PVI procedures for AF and found a significantly reduced risk of cardiac tamponade in balloon ablation; no cardiac tamponade was observed in the cryoablation group.…”

Quantitative Analysis of the Isolation Area During the Chronic Phase After a 28-mm Second-Generation Cryoballoon Ablation Demarcated by High-Resolution Electroanatomic Mapping

“…7 The more recently introduced second-generation CB has exhibited a significantly higher performance than the first-generation CB because of the improved cooling effect. 8,9 However, CB ablation cannot specifically control the left atrial (LA) lesion size, which means that the isolation area is basically defined by the LA and PV anatomy. Although a previous study showed that the isolation area was wide and antral during the acute phase post 28-mm secondgeneration CB ablation, [10][11][12] the data during the chronic phase (after disappearance of tissue edema) has not been reported.…”