LAUSR

Silent cerebral lesions (SCL) often occur after invasive cardiac procedures. Reported SCL incidence with AF ablation varies (incidence, up to 50%), depending on technology used, procedural workflow, and detection method. To evaluate the impact of ablation workflow modifications on SCL incidence following pulmonary vein isolation radiofrequency (RF) ablation with a novel multi-electrode RF balloon catheter in patients with symptomatic paroxysmal AF (PAF). In the RADIANCE feasibility study of the balloon catheter, all enrolled patients who underwent ablation were screened for SCL using pre- and post-procedural diffusion-weighted MRI. Several modifications were made to the ablation workflow in a subsequent European registration study (SHINE) of the same catheter: eliminating dual transseptal access, using an over-the-wire mini lasso, continuously irrigating all side ports, bolus dosing with heparin before transseptal puncture, maintaining activated clotting time (ACT) at 350–400 sec, and setting a maximum temperature limit of 55°C (previously, 60–65°C). Interim data are presented for SHINE (data cutoff, 22 Oct 2018). In the neurological assessment evaluable (NAE) populations of RADIANCE (n=38) and SHINE (n=30), respectively, mean ages were 60.8±10.04 and 59.7±7.83 years, and 57.9% and 70.0% were male. One patient in each study had a history of TIAs. SCL incidences were 23.7% (10 lesions in 9 patients) in RADIANCE and 7.1% (2 lesions in 2 patients) in SHINE (excluding 1 SCL that occurred in a patient who failed to meet inclusion criteria [age>75] and 1 SCL that occurred after data cut-off). SHINE NAE enrollment has since completed with no further SCL occurrences. Overall, mean ACTs were 344.3±24.55 sec in RADIANCE and 381.6±73.31 sec in SHINE (p=0.01); in patients with SCL, mean ACTs were 349.3±25.65 and 417.8±87.33 sec, respectively. Modifications to the workflow led to a decrease in the SCL incidence for PAF ablation using the novel RF balloon catheter. These studies were sponsored by Biosense Webster, Inc.