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.

[1]  Vivek Y. Reddy,et al.  Visually-Guided Balloon Catheter Ablation of Atrial Fibrillation: Experimental Feasibility and First-in-Human Multicenter Clinical Outcome , 2009, Circulation.

[2]  W. Saliba,et al.  Catheter ablation for atrial fibrillation. , 2011, The New England journal of medicine.

[3]  R. Cappato,et al.  Prospective Assessment of Late Conduction Recurrence Across Radiofrequency Lesions Producing Electrical Disconnection at the Pulmonary Vein Ostium in Patients With Atrial Fibrillation , 2003, Circulation.

[4]  C. Tai,et al.  Initiation of atrial fibrillation by ectopic beats originating from the pulmonary veins: electrophysiological characteristics, pharmacological responses, and effects of radiofrequency ablation. , 1999, Circulation.

[5]  J. Ruskin,et al.  HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. , 2007, Heart rhythm.

[6]  Hakan Oral,et al.  Pulmonary Vein Isolation for Paroxysmal and Persistent Atrial Fibrillation , 2002, Circulation.

[7]  Sabine Ernst,et al.  Complete Isolation of Left Atrium Surrounding the Pulmonary Veins: New Insights From the Double-Lasso Technique in Paroxysmal Atrial Fibrillation , 2004, Circulation.

[8]  Michel Haïssaguerre,et al.  Ablation therapy for atrial fibrillation (AF): past, present and future. , 2002, Cardiovascular research.

[9]  Atul Verma,et al.  Response of Atrial Fibrillation to Pulmonary Vein Antrum Isolation Is Directly Related to Resumption and Delay of Pulmonary Vein Conduction , 2005, Circulation.

[10]  H. Ueno,et al.  Feasibility of the Radiofrequency Hot Balloon Catheter for Isolation of the Posterior Left Atrium and Pulmonary Veins for the Treatment of Atrial Fibrillation , 2009, Circulation. Arrhythmia and electrophysiology.

[11]  David O. Martin,et al.  Pulmonary vein antral isolation using an open irrigation ablation catheter for the treatment of atrial fibrillation: a randomized pilot study. , 2007, Journal of the American College of Cardiology.

[12]  E. Aliot,et al.  Catheter Ablation of Atrial Fibrillation , 2011 .

[13]  L. Lickfett,et al.  Comparison of Cryoballoon and Radiofrequency Ablation of Pulmonary Veins in 40 Patients with Paroxysmal Atrial Fibrillation: A Case‐Control Study , 2009, Journal of cardiovascular electrophysiology.

[14]  J Clémenty,et al.  Electrophysiological end point for catheter ablation of atrial fibrillation initiated from multiple pulmonary venous foci. , 2000, Circulation.

[15]  L. Jordaens,et al.  One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation , 2008, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[16]  J Clémenty,et al.  Catheter ablation for atrial fibrillation. , 2007, Circulation.

[17]  Sabine Ernst,et al.  Pulmonary vein isolation by high-intensity focused ultrasound: first-in-man study with a steerable balloon catheter. , 2007, Heart rhythm.

[18]  K. Kuck,et al.  Pulmonary vein isolation with high-intensity focused ultrasound: results from the HIFU 12F study. , 2009, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[19]  G. Hindricks,et al.  Venice Chart International Consensus Document on Atrial Fibrillation Ablation , 2007, Journal of cardiovascular electrophysiology.

[20]  Ottavio Alfieri,et al.  Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. , 2003, Journal of the American College of Cardiology.

[21]  M. Lesh,et al.  Clinical Outcome after Radiofrequency Catheter Ablation of Focal Atrial Fibrillation Triggers , 2001, Journal of cardiovascular electrophysiology.

[22]  Kumaraswamy Nanthakumar,et al.  Resumption of Electrical Conduction in Previously Isolated Pulmonary Veins: Rationale for a Different Strategy? , 2004, Circulation.