Visual balloon-guided point-by-point ablation: reliable, reproducible, and persistent pulmonary vein isolation.

BACKGROUND: While conceptually straightforward, placing point-to-point contiguous radiofrequency lesions to achieve pulmonary vein isolation (PVI) is technically challenging in patients with paroxysmal atrial fibrillation. Furthermore, chronic efficacy is limited by late PV reconnections. A novel compliant balloon ablation catheter able to deliver visually guided short arcs/spots of laser energy was tested in initial preclinical and clinical cases to determine if visual guidance could predict reliable and persistent PVI. METHODS AND
RESULTS: This study consisted of (1) an experimental porcine phase with both acute (n=15 pigs) and 4-week chronic (n=10) data and (2) a single-center clinical feasibility phase (n=27 patients with paroxysmal atrial fibrillation), again with acute and 3-month chronic data. Under endoscopic guidance, point-by-point perivenous ablation was performed in a contiguous and overlapping manner. Each porcine PV was longitudinally sectioned for detailed histological analysis. At 3 months after ablation, patients underwent a prespecified remapping procedure regardless of symptomotology. In the acute and chronic animals, 29 of 30 (97%) PVs were electrically isolated after placing the initial circumferential lesion set. For the 4-week chronic animals, 80% of PVs remained isolated; lesions were histologically circumferential in 120 of 120 (100%) PV sections and transmural in 116 of 120 (96.7%) PV sections (average transmurality=99.0+/-5.5%). In patients, 100% of the PVs were isolated after 1.3 attempts per PV-84% of them (85 of 101) isolated after the initial visually guided lesion set. At 3 months, 61 of 68 (90%) PVs continued to be electrically isolated.
CONCLUSIONS: Using a visually guided, compliant balloon ablation catheter with point-by-point ablative capability, PV isolation can be achieved in a reliable, reproducible, and persistent manner.