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.


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.
Dukkipati
Srinivas R
SR
Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, NY, USA.
Neuzil
Petr
P
Skoda
Jan
J
Petru
Jan
J
d'Avila
Andre
A
Doshi
Shephal K
SK
Reddy
Vivek Y
VY
D000328:Adult; D000368:Aged; D000818:Animals; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography / Q000379:methods; D022062:Electrophysiologic Techniques, Cardiac; D019723:Endoscopes; D004724:Endoscopy / Q000009:adverse effects; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000503:physiopathology / Q000601:surgery*; D012008:Recurrence; D013552:Swine; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome