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

Abstract

Aims The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance. Methods and results Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 ± 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence. Conclusion Intracardiac echocardiography–guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates.

Intracardiac echo: The secret sauce or simply ICE'ing on the (ablation) cake?

“…7,8 A recent randomized trial examining the feasibility of ICE-guided CBA without fluoroscopy demonstrated significantly decreased radiation with similar success rates and no difference in complications. 9 In the current study, Pongratz et…”

“…Two large observational studies suggest ICE use in RF ablation is associated with a significant decrease in procedural complications, lower in‐hospital mortality, and shorter hospital length of stay but higher procedural cost 7,8 . A recent randomized trial examining the feasibility of ICE‐guided CBA without fluoroscopy demonstrated significantly decreased radiation with similar success rates and no difference in complications 9 . In the current study, Pongratz et al elegantly describe similar findings of decreased complications and higher acute success rate with decreased radiation exposure associated with ICE use.…”

Zero‐fluoroscopy ablation with multielectrode pulse field ablation system: Case series

“…Recently Ahn, et al 9 . have shown that zero‐fluoroscopy cryoballoon ablation for AF is feasible without compromising acute and long‐term success or complication rates.…”

O Ecocardiograma Intracardíaco Deve Ser Utilizado em Todo Paciente Submetido a Ablação de FA?

“…Além dos benefícios da redução da exposição ao RX o método “zero fluoro” permite reduzir o risco de problemas ortopédicos pela não necessidade dos aventais de chumbo. 8 , 9 Além destas, uma aplicação validada recentemente é a utilização do EIC para a investigação da presença de trombos, principalmente no apêndice atrial esquerdo, antes da realização de ablação de FA, prescindindo do eco tranesofágico. A técnica foi validada recentemente com o posicionamento do cateter do EIC na artéria pulmonar com demonstração de equivalência quando comparada com o eco transesofágico.…”

“…In addition to the benefits of reducing exposure to X-rays, the “zero fluoro” method allows for reducing the risk of orthopedic problems by not requiring lead aprons. 8 , 9 In addition to these, a recently validated application is the use of ICE to investigate the presence of thrombi, mainly in the left atrial appendage, before performing AF ablation, dispensing with transesophageal echo. The technique was recently validated with the positioning of the ICE catheter in the pulmonary artery, demonstrating equivalence when compared with the transesophageal echo.…”