Department of HPB Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Eur Radiol. 2019 Aug;29(8):4026-4035. doi: 10.1007/s00330-018-5842-z. Epub 2018 Nov 30.
The aim of the present study is to analyze preclinical and clinical data on the performance of the currently US Food and Drug Administration (FDA)-approved microwave ablation (MWA) systems.
A review of the literature, published between January 1, 2005, and December 31, 2016, on seven FDA-approved MWA systems, was conducted. Ratio of ablation zone volume to applied energy R(AZ:E) and sphericity indices were calculated for ex vivo and in vivo experiments.
Thirty-four studies with ex vivo, in vivo, and clinical data were summarized. In total, 14 studies reporting data on ablation zone volume and applied energy were included for comparison R(AZ:E). A significant correlation between volume and energy was found for the ex vivo experiments (r = 0.85, p < 0.001) in contrast to the in vivo experiments (r = 0.54, p = 0.27).
Manufacturers' algorithms on microwave ablation zone sizes are based on preclinical animal experiments with normal liver parenchyma. Clinical data reporting on ablation zone volume in relation to applied energy and sphericity index during MWA are scarce and require more adequate reporting of MWA data.
• Clinical data reporting on the ablation zone volume in relation to applied energy during microwave ablation are scarce. • Manufacturers' algorithms on microwave ablation zone sizes are based on preclinical animal experiments with normal liver parenchyma. • Preclinical data do not predict actual clinical ablation zone volumes in patients with liver tumors.
本研究旨在分析目前获得美国食品和药物管理局(FDA)批准的微波消融(MWA)系统的临床前和临床数据。
对 2005 年 1 月 1 日至 2016 年 12 月 31 日期间发表的 7 种 FDA 批准的 MWA 系统的文献进行了回顾。对离体和体内实验计算了消融区体积与应用能量的比值(AZ:E)和球形指数。
总结了 34 项具有离体、体内和临床数据的研究。共有 14 项研究报告了消融区体积和应用能量的数据,用于比较 AZ:E。离体实验中体积与能量之间存在显著相关性(r=0.85,p<0.001),而在体内实验中相关性较弱(r=0.54,p=0.27)。
制造商的微波消融区大小算法是基于正常肝组织的临床前动物实验。关于 MWA 过程中应用能量和球形指数与消融区体积的临床数据报告很少,需要更充分地报告 MWA 数据。
• 关于微波消融过程中消融区体积与应用能量的临床数据报告很少。
• 制造商的微波消融区大小算法是基于正常肝组织的临床前动物实验。
• 临床前数据并不能预测肿瘤患者的实际临床消融区体积。