使用可视化引导激光球囊进行肺静脉隔离：与标准射频消融的前瞻性、多中心、随机比较。
Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.
机构信息
Icahn School of Medicine at Mount Sinai, New York, New York.
Medical University of South Carolina, Charleston, South Carolina.
出版信息
J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.
BACKGROUND
Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance.
OBJECTIVES
This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF.
METHODS
Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority.
RESULTS
A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB.
CONCLUSIONS
Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).
背景
球囊导管的设计旨在促进阵发性心房颤动（AF）患者的肺静脉（PV）隔离。可视引导激光球囊（VGLB）采用激光能量在直接可视引导下消融组织。
目的
本研究比较了 VGLB 消融与标准灌流射频消融（RFA）在 AF 导管消融中的疗效和安全性。
方法
招募了药物难治性阵发性 AF 患者，进行了一项多中心、随机对照研究，使用 VGLB 或 RFA（对照）进行 PV 隔离。主要疗效终点是 12 个月时无方案定义的治疗失败，包括 90 天空白期后出现有症状的 AF。主要疗效和安全性终点的效能为非劣效性。
结果
共 353 例患者（VGLB 组 178 例，对照组 175 例）在 19 个临床中心随机分组。与对照组相比，VGLB 组的手术、消融和透视时间较长。VGLB 组的主要疗效终点为 61.1%，对照组为 61.7%（绝对差值-0.6%；95%置信区间下限：-9.3%；p=0.003 表示非劣效性）。VGLB 组的主要不良事件发生率为 11.8%，对照组为 14.5%（绝对差值-2.8%；95%置信区间上限：3.5%；p=0.002 表示非劣效性），主要由电复律引起。膈神经麻痹发生率较高（3.5%比 0.6%；p=0.05），但 VGLB 组的 PV 狭窄发生率较低（0.0%比 2.9%；p=0.03）。
结论
尽管 VGLB 消融的经验有限，但对于阵发性 AF 的治疗，VGLB 消融的安全性和疗效与 RFA 相当。（关键临床试验：CardioFocus 内镜消融系统-自适应接触[EAS-AC]（HeartLight）在阵发性心房颤动（PAF）患者中的应用[HeartLight]；NCT01456000）。
Zotero 插件