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新型灌流控温网格消融导管用于心室消融的临床前多模态生物物理特性评估

Novel Irrigated Temperature-Controlled Lattice Ablation Catheter for Ventricular Ablation: A Preclinical Multimodality Biophysical Characterization.

机构信息

Harvard-Thorndike Electrophysiology Institute, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (A.S.-D., M.B., H.Y., J.S., E.A.).

Helmsley Center for Electrophysiology, Department of Cardiology, Icahn School of Medicine at Mount Sinai, NY (V.Y.R.).

出版信息

Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007661. doi: 10.1161/CIRCEP.119.007661. Epub 2019 Nov 11.

Abstract

BACKGROUND

Ventricular tachycardia ablation is often limited by insufficient lesion creation. A novel radiofrequency catheter with an expandable lattice electrode has a larger surface area capable of delivering higher currents at a lower density to potentially increase lesion dimensions without overheating.

METHODS

This 8F bidirectional irrigated catheter (Sphere-9, Affera Inc) has a 9 mm spherical lattice tip ("lattice") with an effective surface area 10-fold larger than standard linear catheters. Nine surface thermocouples provide temperature feedback to a proprietary high-current generator operating in a temperature-controlled mode. Ex vivo phase: in 11 bovine hearts, unipolar ablation at 30, 60, and 120 seconds was compared between the lattice (Tmax60°C) and a standard linear irrigated-tip catheter (40 W) at contact force of 10 g. In 5 porcine hearts, bipolar ablation was compared between the catheters (Tmax60°C versus 40 W; 60 seconds). In vivo phase: in 9 swine, ventricular ablation at Tmax60°C versus 40 W was performed for 60 seconds. In addition, direct tissue temperature at 3- and 7-mm tissue depth was measured in a thigh muscle preparation.

RESULTS

Ex vivo: lattice produced deeper lesions at 30, 60, and 120 seconds application duration (6.7±1.3 versus 4.8±1.2 mm; 8.3±1.4 versus 5.4±0.8 mm; 10.0±1.6 versus 6.1±1.6 mm, respectively, ≤0.001 for all). Bipolar lesions were deeper (15.8±4.1 versus 10.5±1.4 mm, <0.001) and more likely to be transmural (80% versus 0%, =0.002). In vivo: lattice produced deeper lesions (10.5±1.4 versus 6.5±0.8 mm, ≤0.001). Tissue temperature at 7 mm was higher with the lattice (+15.1±2.4°C; <0.001). The steam-pop occurrence was lower with the lattice (total: 4% versus 18%, =0.02; in vivo 0% versus 14.2%, =0.13).

CONCLUSIONS

This novel radiofrequency system produces larger ventricular lesions compared with standard irrigated catheters and at a lower risk of tissue overheating. This may improve the efficacy of ventricular tachycardia ablation procedures while reducing the number of applications and procedural duration.

摘要

背景

室性心动过速消融术常因病灶形成不足而受限。一种新型的具有可扩张网格电极的射频导管具有更大的表面积,能够以更低的密度输送更高的电流,从而有可能在不使导管过热的情况下增加病灶的尺寸。

方法

这种 8F 双向灌流导管(Sphere-9,Affera Inc)具有一个 9 毫米的球形网格尖端(“网格”),其有效表面积是标准线性导管的 10 倍。九个表面热电偶为专有的高电流发生器提供温度反馈,该发生器以温度控制模式运行。

离体阶段

在 11 只牛心,在接触力为 10 g 时,分别比较了网格(Tmax60°C)和标准线性灌流尖端导管(40 W)在 30、60 和 120 秒的单相消融。在 5 只猪心,比较了两种导管之间的双相消融(Tmax60°C 与 40 W;60 秒)。

体内阶段

在 9 只猪中,Tmax60°C 与 40 W 进行 60 秒的心室消融。此外,还在大腿肌肉准备中测量了 3-7 毫米组织深度的直接组织温度。

结果

离体:网格在 30、60 和 120 秒的应用时间内产生更深的病灶(分别为 6.7±1.3、8.3±1.4 和 10.0±1.6 毫米,均<0.001)。双相病灶更深(15.8±4.1 毫米与 10.5±1.4 毫米,<0.001)且更有可能透壁(80%与 0%,=0.002)。在体内:网格产生的病灶更深(10.5±1.4 毫米与 6.5±0.8 毫米,均<0.001)。网格的组织温度更高(7 毫米时+15.1±2.4°C,<0.001)。网格的蒸汽弹出发生率更低(总发生率为 4%与 18%,=0.02;体内为 0%与 14.2%,=0.13)。

结论

与标准灌流导管相比,这种新型的射频系统产生的心室病灶更大,组织过热的风险更低。这可能提高室性心动过速消融术的疗效,同时减少应用次数和手术时间。

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