Dubner Sergio, Dubner Yael, Rubio Horacio, Goldin Eran
Clinica Suizo Argentina, Argentina.
Pacing Clin Electrophysiol. 2007 Apr;30(4):472-5. doi: 10.1111/j.1540-8159.2007.00695.x.
The purpose of this study was to evaluate potential interference between the Pill-cam video-capsule and implanted cardio-defibrillators (ICD) in both in vitro and in vivo test environments.
Phase I consisted of in vitro testing utilized 6 ICD models. Each was placed in a saline gel bath in conjunction with a tool designed to emit the same wave length as the Pill-Cam (the Test Cap). Tests were performed at both the manufacturer's nominal and most sensitive settings with the test probe placed at 1, 5, 10, and 15 cm from three different points. There were emissions of 10-, 30-, and 60- second duration at each location. Phase II was the in vivo study utilizing patients with implanted ICDs for standard clinical reasons who were undergoing evaluation with the Test Cap.
In Phase I, 864 tests were performed involving the 6 ICDs. There was totally normal behavior in 5 of the devices. The Biotronik Belos (Berlin, Germany) demonstrated oversensing and delivery of inappropriate therapy. In phase II, 6 patients underwent a total number of 288 tests (48 in each patient). There were 4 men and 2 women, mean age 61 (33-77) and none demonstrated any adverse interactions.
In patients with devices identical to those evaluated that showed no interference, the use of the Pill-Cam is safe. However, in patients with a Biotronik Belos ICD (or any other nontested ICD) the use of the Pill-Cam should be done only in-hospital, after suspended ICD therapy and in conjunction with close monitoring.
本研究旨在评估在体外和体内测试环境中, Pill-cam视频胶囊与植入式心脏除颤器(ICD)之间的潜在干扰。
第一阶段包括体外测试,使用了6种ICD模型。每个模型都放置在盐凝胶浴中,并与一个设计为发射与Pill-Cam相同波长的工具(测试帽)一起使用。在制造商的标称和最敏感设置下进行测试,测试探头分别从三个不同点放置在1、5、10和15厘米处。在每个位置进行10秒、30秒和60秒的发射。第二阶段是体内研究,利用因标准临床原因植入ICD且正在接受测试帽评估的患者。
在第一阶段,对6种ICD进行了864次测试。其中5台设备的行为完全正常。百多力公司(德国柏林)的设备表现出过度感知和不适当的治疗。在第二阶段,6名患者总共进行了288次测试(每位患者48次)。其中有4名男性和2名女性,平均年龄61岁(33 - 77岁),均未显示任何不良相互作用。
对于使用与所评估的无干扰设备相同的患者,使用Pill-Cam是安全的。然而,对于植入百多力公司Belos ICD(或任何其他未经测试的ICD)的患者,仅应在医院内,在暂停ICD治疗并密切监测的情况下使用Pill-Cam。