| Title |
The AF-FICIENT magnetic resonance imaging and endoscopy safety substudy: A visually guided radiofrequency balloon ablation catheter for pulmonary vein isolation / |
| Authors |
Daly, Matthew ; Hurrell, Michael ; Melton, Iain ; Lim, Gary ; Aidietis, Audrius ; Račkauskas, Gediminas ; Al-Ahmad, Amin ; Crozier, Ian |
| DOI |
10.1016/j.hroo.2021.12.001 |
| Full Text |
|
| Is Part of |
Heart rhythm O2.. Washington : Elsevier Inc.. 2022, vol. 3, no. 1, p. 15-22.. ISSN 2666-5018 |
| Keywords [eng] |
atrial fibrillation ; catheter ablation ; radiofrequency balloon ; pulmonary vein isolation ; silent cerebral events ; esophageal thermal lesions |
| Abstract [eng] |
Background Early experience with a novel multi-electrode saline-irrigated radiofrequency balloon (RFB) catheter with an integrated camera system found that it was safe and effective at performing single-shot pulmonary vein isolation (PVI) for atrial fibrillation. Objective This study aims to further assess potential treatment risks by looking for subclinical events. Methods The study was performed at 2 sites. Patients underwent PVI by RFB. A control group underwent conventional point-by-point radiofrequency ablation. Stroke scale questionnaire and brain magnetic resonance imaging (MRI) were performed before and after the ablation procedure, and esophageal endoscopy was performed after the procedure in the RFB patients only. Results We enrolled 27 patients in the RFB group and 15 patients in the control group. The patient groups were well matched, predominantly male; 62 and 53%, CHA2DS2-VASc; 1.9±1.3 and 1.5±1.6 (RFB and control respectively) and mean age 60 years in both groups. All patients underwent successful ablation and completed study assessments. We observed clinically silent new MRI diffusion weighted imaging (DWI) cerebral lesions in 8 patients (30%) in the RFB group and 1 (7%) in controls, and 11 susceptibility weighted lesions (SWI) in the RFB group and 1 in controls. Endoscopy showed 1 patient had a minor thermal injury in the RFB group. Conclusion There was an increased rate of clinically silent cerebral events in RFB group. There was a low rate of thermal injury. |
| Published |
Washington : Elsevier Inc |
| Type |
Journal article |
| Language |
English |
| Publication date |
2022 |
| CC license |
|
