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. 2015 Sep;26(9):944-949.
doi: 10.1111/jce.12727. Epub 2015 Aug 10.

Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: Results of the U.S. Feasibility Study

Srinivas R Dukkipati  1 , Ian Woollett  2 , H Thomas McELDERRY  3 , Marie-Christine Böhmer  1 , Shephal K Doshi  4 , Edward P Gerstenfeld  5 , Rodney Horton  6 , Andre D'Avila  1 , David E Haines  7 , Miguel Valderrabano  8 , J Michael Mangrum  9 , Jeremy N Ruskin  10 , Andrea Natale  6 , Vivek Y Reddy  1
Affiliations

Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: Results of the U.S. Feasibility Study

Srinivas R Dukkipati et al. J Cardiovasc Electrophysiol. 2015 Sep.

Abstract

Introduction: Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB.

Methods: Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up.

Results: A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis.

Conclusions: This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.

Keywords: atrial fibrillation; catheter ablation; laser; pulmonary veins; visual guidance.

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Figures

Figure 1
Figure 1
The Kaplan-Meier curve for the primary effectiveness endpoint is shown for the follow-up period of one year.
Figure 2
Figure 2
The graph shows the proportion of patients that had failure of the primary effectiveness endpoint based on cause.
Figure 3
Figure 3
The three secondary effectiveness endpoints are shown. Technical success was defined as the percentage of targeted PVs that were successfully isolated acutely. Freedom from any AF represents the percentage of patients that were free of symptomatic or asymptomatic atrial arrhythmias off drugs at the conclusion of the 12 months of follow-up. There were no patients that had clinical success on previously failed AADs.
See this image and copyright information in PMC

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