Efficacy and Safety of Pulmonary Vein Isolation with Irrigated Radiofrequency Balloon with a Zero-Fluoroscopy Protocol

Funding Acknowledgements Type of funding sources: None. Introduction From the beginning, the use of X-ray (XR) has been a critical component in both the guidance and development of arrhythmia ablation procedures. Despite the development of non-fluoroscopic navigators, the single-shot techniques for atrial fibrillation ablation procedures still rely almost exclusively on the use of XR. Recently, the Heliostar® irrigated radiofrequency balloon has been developed, which can be completely visualized on the Carto 3® navigation system. This special feature makes it possible to minimise the use of XR in this type of procedure or even suppress it. We present our first experience after the implementation of a "zero-XR" protocol for this procedure. Objectives The aim of this study was to demonstrate that "zero-XR" ablation of atrial fibrillation with Heliostar® radiofrequency balloon is possible and safe. Methods This is a single-centre study. Consecutively 22 patients with paroxysmal (63.6%) or persistent (36.4%) atrial fibrillation underwent pulmonary vein isolation by irrigated radiofrequency balloon (Heliostar®). Eight of the cases were performed without fluoroscopy, supported by the navigation system and intracardiac ultrasound, and the remaining 14 were performed without limitation of the use of XR. Clinical, echocardiographic and technical data were collected from all 22 patients. All cases were performed under general anaesthesia, with the Carto 3® navigation system. Mapping was performed in sinus rhythm whenever possible. Results 100% isolation of the veins was achieved, with 62.1% first pass isolation in the non-XR group versus 56.4% in the XR group (non-significant difference). The vein with the highest percentage of first pass isolations was the left inferior vein in both groups. There were no complications in either group. Procedure times were similar (left atrial dwell time of 32 minutes in the non-XR group and 40 minutes in the XR group, non-significant difference), although the mapping time was slightly shorter in the non-XR group (9,9±5 non-XR vs 16±6.9, p=0.04). There was also no difference in the mean time to isolation from the start of radiofrequency application in each vein (10.6 seconds in the non-XR group and 11 seconds in the XR group, p=0.75). The non-XR group had a higher number of patients with left main trunk, but the XR group had a higher percentage of patients with persistent forms of atrial fibrillation. Left atrial size was normal in most patients, and ventricular function was preserved, with no differences between the two groups. Conclusion Pulmonary vein isolation with the Heliostar® radiofrequency balloon without XR is possible and safe, with similar efficacy and first pass isolation rate, similar procedure time and no relevant complications in our series.