IHU LIRYC, CHU de Bordeaux, University of Bordeaux, Bordeaux-Pessac, France.
J Cardiovasc Electrophysiol. 2019 Sep;30(9):1644-1651. doi: 10.1111/jce.14089. Epub 2019 Aug 1.
Radiofrequency (RF) ablation is an established treatment for ventricular tachycardia (VT). However, the inability of current RF catheters to address deep or large substrate may explain most of the clinical failures.
The aim of this study is to assess the efficacy and safety of ablation in the left ventricle (LV) in sheep using a novel 8-Fr deflectable ablation catheter (Sphere-9; Affera, Inc) with a 9-mm expandable spherical monopolar irrigated RF tip vs a standard RF irrigated catheter (Biosense Webster, Diamond Bar, CA). The impact on tissue was assessed on local bipolar electrograms (from nine uniformly distributed mini surface electrodes and an internal central reference electrode), as well as on direct lesion measurement post mortem.
Eleven sheep underwent LV endocardial ablation in healthy tissue using the Sphere-9 catheter (n = 6), or a conventional irrigated RF catheter (n = 5). Twenty lesions were created with the Sphere-9 (current limit: 2.7 A; temp. limit: 60°C; irrigation: 30 mL/min; and duration: 60-120 seconds). Local bipolar electrograms at the surface of the catheter disappeared during RF delivery in 17 of 20 (85%) lesions. The mean lesion volume was 1707 ± 771 mm (length: 15.8 ± 3.3 mm; width: 11.6 ± 4.2 mm; and depth: 10.3 ± 2.9 mm). Twenty-five lesions were created with a standard RF irrigated catheter (power control 35 W; irrigation: 30 mL/min; duration: 60 seconds; volume 537 ± 398 mm ; length: 8.2 ± 2.3 mm; width: 5.2 ± 1.8 mm; and depth: 5.5 ± 2.4 mm). The novel spherical RF catheter created significantly larger lesions ( P < .001 for measurements in all dimensions). There were no steam pops with the novel ablation catheter vs one with the conventional catheter.
This novel spherical monopolar irrigated RF catheter creates lesions that are twice as large and deep as a standard irrigated RF catheter.
射频（RF）消融是治疗室性心动过速（VT）的一种既定方法。然而，目前的 RF 导管无法解决深层或大面积的基质问题，这可能解释了大多数临床失败的原因。
本研究旨在评估使用新型 8Fr 可弯曲消融导管（Sphere-9；Affera，Inc）与标准 RF 灌注导管（Biosense Webster，Diamond Bar，CA）进行左心室（LV）消融的有效性和安全性。通过测量九个均匀分布的微型表面电极和一个内部中央参考电极的局部双极电图，以及死后直接测量的直接损伤，评估对组织的影响。
11 只绵羊在健康组织中接受 LV 心内膜消融，使用 Sphere-9 导管（n=6）或标准灌注 RF 导管（n=5）。使用 Sphere-9 导管创建 20 个病灶（电流限制：2.7A；温度限制：60°C；灌注：30mL/min；持续时间：60-120 秒）。在 RF 输送过程中，导管表面的局部双极电图在 20 个病灶中的 17 个（85%）中消失。平均病灶体积为 1707±771mm （长度：15.8±3.3mm；宽度：11.6±4.2mm；深度：10.3±2.9mm）。使用标准 RF 灌注导管创建 25 个病灶（功率控制 35W；灌注：30mL/min；持续时间：60 秒；体积 537±398mm ；长度：8.2±2.3mm；宽度：5.2±1.8mm；深度：5.5±2.4mm）。新型球形 RF 导管创建的病灶明显更大（所有尺寸的测量值均<.001）。与传统消融导管相比，新型消融导管无蒸汽弹出。
与标准灌注 RF 导管相比，新型球形单极灌注 RF 导管创建的病灶大两倍，深度更深。
