Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: Results of the U.S. Feasibility Study.
Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: Results of the U.S. Feasibility Study.
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DOI：
10.1111/jce.12727
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发表时间：
2015-09
影响因子：
2.7
通讯作者：
Reddy VY
中科院分区：
文献类型：
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作者：
Dukkipati SR;Woollett I;McELDERRY HT;Böhmer MC;Doshi SK;Gerstenfeld EP;Horton R;D'Avila A;Haines DE;Valderrabano M;Mangrum JM;Ruskin JN;Natale A;Reddy VY
视觉引导激光气球消融术的独特之处在于操作者在直接视觉引导下提供消融能量。在这项多中心研究中，我们试图确定使用这种VGLB进行肺静脉隔离(PVI)的可行性、有效性和安全性。有症状、药物难治性阵发性房颤(AF)的患者接受了使用VGLB的PVI，大多数操作员进行了他们的第一次临床VGLB病例。主要疗效终点被定义为免于治疗失败，包括：90天空白后1min出现症状性房颤发作≥，不能分离一个上位和两个全肺静脉，出现左房扑动或房性心动过速，或在随访期间进行左房消融/手术。共有86名患者(平均年龄56±10岁，其中67%为男性)在10个US中心接受了VGLB治疗。平均透视时间39.8±24.3min，平均消融时间205.2±61.7min，平均手术时间253.5±71.3min。314/323(97.2%)的靶静脉达到急性PVI。在完成随访的84名患者中，有50名(60%)患者达到了主要疗效终点。无症状或无症状的房颤发生率为61%。主要不良事件发生率为16.3%，其中心包炎8.1%，膈神经损伤5.8%，心包填塞3.5%。没有发生脑血管事件、房性食管瘘或明显的门静脉狭窄。这项对学习曲线早期阶段的操作员进行的多中心研究表明，VGLB可以实现PVI，具有合理的安全性和类似于射频消融的疗效。
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. 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 which included: occurrence of symptomatic AF episodes ≥1 min beyond the 90-day blanking, the inability to isolate one superior and two total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. 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 min, 205.2±61.7 min, and 253.5±71.3 min, 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. 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.