Safety verification of a novel irrigation catheter with flexible tip of laser‐cut kerfs and contact force sensor

医学 导管 接触力 生物医学工程 激光器 病变 垂直的 核医学 生理盐水 下降(电信) 长轴 外科 麻醉 光学 电气工程 工程类 物理 量子力学 数学 几何学
作者
Junji Yamaguchi,Masateru Takigawa,Masahiko Goya,Tasuku Yamamoto,Takashi Ikenouchi,Hidehiro Iwakawa,Miho Negishi,Kentaro Goto,Takatoshi Shigeta,Takuro Nishimura,Tomomasa Takamiya,Susumu Tao,Shinsuke Miyazaki,Tetsuo Sasano
出处
期刊:Pacing and Clinical Electrophysiology [Wiley]
卷期号:46 (12): 1536-1545 被引量:5
标识
DOI:10.1111/pace.14868
摘要

Abstract Background and aims The safety evaluation of TactiFlex, a novel contact‐force sensing catheter with a flexible 4‐mm tip irrigated through laser‐cut kerfs, has been ongoing. This study aimed to verify the safety of this type of catheter. Methods Study 1: Radiofrequency (RF) applications at a range of powers (30–50 W), contact forces (10–20 g), and durations (10–60 s) using perpendicular/parallel catheter orientation with half‐normal (HNS) or normal saline irrigation were compared between TactiFlex (4‐mm tip) and TactiCath (3.5‐mm tip) with temperature‐controlled mode in excised porcine hearts. Study 2: The relation between RF applications using TactiFlex and the incidence of steam‐pops in the real clinical cases were examined. Results Study‐1: 576 RF lesions were examined. TactiFlex demonstrated a significantly lower risk of steam‐pops (5[1.7%] vs. 59[20.5%], p < .0001). Compared to 3.5‐mm‐tip catheter (TactiCath), 4‐mm‐tip catheter (TactiFlex) produced smaller lesion volume at perpendicular (193[98–554]mm 3 vs. 263[139–436]mm 3 , p < .0001), but relatively similar lesion volume at parallel contact (243[105–443]mm 3 vs. 278[180–440]mm 3 , p = .06). HNS‐irrigation tended to increase the lesion volume in both catheters and to increase the incidence of steam‐pops with TactiCath, but not with TactiFlex. The cut‐off value of %impedance‐drop ( = absolute impedance‐drop/initial impedance) of 20% predicted steam‐pops with a sensitivity = 100% and specificity = 89.6% in TactiFlex. Study‐2: 5496 RF applications in 84 patients (51AFs/8ATs/3AVNRTs/4AVRTs/17PVCs/4VTs) using TactiFlex were analyzed. Four steam‐pops (0.07%) in three patients with pericardial effusion were observed (%impedance‐drop = 24%/26%/29%/35%, respectively). The cut‐off value of %impedance‐drop = 20%, derived from ex‐vivo study, showed sensitivity = 100% and specificity = 90.1% in detecting steam‐pops. Conclusion TactiFlex reduced the risk of steam‐pops than TactiCath. %impedance‐drop ≤ 20% may be reasonable for safely use with a sufficient safety margin. For 4‐mm‐tip catheter, parallel‐contact may be recommended for larger lesion creation.
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