Acute Safety and Efficacy of Fluoroless Cryoballoon Ablation for Atrial Fibrillation

Abstract

Pulmonary vein isolation (PVI) is widely used for the ablation of atrial fibrillation, with prior reports suggesting good efficacy. Due to the widespread use of three-dimensional electroanatomic mapping systems and advances in intracardiac echocardiography, fluoroless ablation has been made possible. Fluoroless ablation with a cryoballoon (CB), however, has not been widely performed because of the need to prove occlusion of the vein with contrast dye and fluoroscopy. The objective of this study is to show that CB ablation can be performed safely and effectively without fluoroscopy. A dual-center, case–control study was performed of patients undergoing CB PVI with a fluoroless approach and a control group with traditional fluoroscopic techniques. The absence of color-flow Doppler signals around the periphery of the CB on intracardiac echocardiography and an increase in mean pressure by 5 mmHg, loss of the A-wave, and an increase in the V-wave as measured with continuous-wave pressure monitoring were adopted as indicators of vein occlusion in the absence of fluoroscopy. Temperature at 30 seconds, minimum temperature, time to isolation, procedure length, and complications were evaluated. During the study period of November 15, 2018 to November 15, 2019, a total of 100 patients underwent CB PVI at the participating centers. A total of 50 patients were enrolled in the fluoroless arm [35 men (70%), mean age: 64.9 ± 12 years, mean left atrium size: 44.2 ± 16 mL/m 2 , left ventricular ejection fraction: 61% ± 5%], while 50 patients were enrolled in the control arm with similar characteristics. Four hundred forty-one 441 PVs were evaluated in the study cohort compared to 339 PVs in the control arm. When comparing fluoroless and traditional techniques, the mean temperature at 30 seconds was −31.7°C ± 6°C versus −32.8°C ± 5°C (p = 0.037), the minimum temperature was −47.4°C ± 6°C versus −47.7°C ± 9°C (p = 0.677), the time to isolation was 56.8 ± 28 seconds versus 74.8 ± 45 seconds (p = 0.212), and the procedure time was 102.2 ± 27.3 seconds versus 104.5 ± 16.9 seconds (p = 0.6436). Ultimately, t his proof-of-concept study revealed that fluoroless ablation can be performed with success and efficiency outcomes similar to those of a traditional ablation approach. This suggests that the ablation of atrial fibrillation with CB can be performed safely and effectively without the use of fluoroscopy by experienced operators.

Safety and efficacy of intracardiac echocardiography–guided zero-fluoroscopic cryoballoon ablation for atrial fibrillation: a prospective randomized controlled trial

“…Alyesh et al . 12 conducted a first-of-its-kind, proof-of-concept case–control study comparing fluoroless CBA with the traditional fluoroscopic technique. The procedure was exclusively performed under ICE guidance and employed ICE imaging combined with haemodynamic measures with continuous-wave pressure monitoring (CWPM).…”

Step by step: How to perform a fluoroless cryoballoon ablation for atrial fibrillation

“…Alyesh et al, 14 reported on the use of non‐fluoroscopic methods for patients undergoing CB PVI with a fluoroless approach and compared to a control group with traditional fluoroscopic techniques. Temperature at 30 s, minimum temperature, time to isolation, and procedural length and complications were evaluated.…”

“…This last method may be more difficult to visualize but can provide useful information about the location of a potential leak (Supporting Information: Video 10). Alyesh et al, 14 reported on the use of non-fluoroscopic methods for patients undergoing CB PVI with a fluoroless approach and compared to a control group with traditional fluoroscopic techniques. Temperature at 30 s, minimum temperature, time to isolation, and procedural length and complications were evaluated.…”

“…A reduction in fluoroscopy has also been achieved with the use of continuous wave pressure monitoring (CWPM) as a hemodynamic measure of vein occlusion 10–13 . Additionally, recent studies have demonstrated that a completely fluoroless CB can be performed with similar acute results to CB with fluoroscopy 14 . In this step‐by‐step guide, the authors will show how CB ablation for atrial fibrillation can be performed without the use of fluoroscopy.…”

“…[10][11][12][13] Additionally, recent studies have demonstrated that a completely fluoroless CB can be performed with similar acute results to CB with fluoroscopy. 14 In this step-by-step guide, the authors will show how CB ablation for atrial fibrillation can be performed without the use of fluoroscopy.…”