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

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.

SUBMITTER: Dukkipati SR

PROVIDER: S-EPMC4679695 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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

Dukkipati Srinivas R SR Woollett Ian I McELDERRY H Thomas HT Böhmer Marie-Christine MC Doshi Shephal K SK Gerstenfeld Edward P EP Horton Rodney R D'Avila Andre A Haines David E DE Valderrabano Miguel M Mangrum J Michael JM Ruskin Jeremy N JN Natale Andrea A Reddy Vivek Y VY

Journal of cardiovascular electrophysiology 20150810 9

<h4>Introduction</h4>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.<h4>Methods</h4>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 c ...[more]

PMID: 26080067

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Project description:A 73-year-old woman underwent radiofrequency hot balloon ablation (RHBA) for paroxysmal atrial fibrillation. After delivery into the left inferior pulmonary vein (LIPV), the guidewire perforated the venous wall. We injected contrast medium while the inflated balloon occluded the PV. Subsequently, bronchial-pulmonary venous fistula (BPVF) occurred and the severe hypoxia caused pulseless electrical activity (PEA). Cardiopulmonary resuscitation and intubation quickly recovered spontaneous circulation. She was initially treated by a multidisciplinary team in the intensive care unit and subsequently discharged without sequelae. Although relatively rare, there are some reports of wire perforation during RHBA and cryoballoon ablation. Some cases resolved after discontinuing anticoagulant therapy, while others required invasive procedures. This is the first case in which hypoxia, shock, and PEA were caused by wire perforation. As such complications can occur in all balloon ablation procedures, operators need to take care when using the guidewire and guide catheter. Anticoagulant therapy should be discontinued following PV perforation, if possible. Hemostasis with ventilator management is desirable. If hemostasis cannot be achieved, lung resection must be considered. Although wire perforation causing BPVF is rare, establishment of preventive measures and treatment protocols is needed. <Learning objective: The safety of radiofrequency hot balloon (RHB) ablation for paroxysmal atrial fibrillation has been established. This case report presents the rare complication of a soft J-tipped guidewire perforating the pulmonary vein (PV) without any resistance. Pulmonary venography was performed with the RHB blocking the PV, eventually causing pulseless electrical activity from hypoxia due to a bronchial-pulmonary venous fistula. Artificial ventilation management by positive end expiratory pressure after discontinuing anticoagulant therapy was effective for hemostasis and improvement of respiratory condition.>.

Dataset Information

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

Publications

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

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