Stambler B S, Wood M A, Damiano R J, Greenway P S, Smutka M L, Ellenbogen K A
Division of Cardiology and Cardiothoracic Surgery, Medical College of Virginia, Richmond 23249.
J Am Coll Cardiol. 1994 Jan;23(1):123-32. doi: 10.1016/0735-1097(94)90510-x.
This report describes the sensing/pacing lead complications that developed during a worldwide clinical trial of a new implantable cardioverter-defibrillator.
The reliability of the leads used for sensing and pacing with the implantable cardioverter-defibrillator has not been adequately studied.
The Guardian ATP 4210 was implanted in 302 patients. The sensing/pacing leads consisted of either two unipolar epicardial electrodes or a bipolar endocardial electrode from a variety of manufacturers.
During a mean follow-up period of 380 days, 39 patients (12.9%) required reoperation because their device developed sensing/pacing lead system complications. The most common clinical presentation was device oversensing (multiple tachycardia or noise detections or inappropriate shocks), which was observed in 27 patients, whereas elevated pacing thresholds were seen in 10 patients. Forty-one (11.8%) of 347 implanted lead systems required revision. The mean time to revision was 156 +/- 145 days. Actuarial lead survival rate at 1 and 3 years was 89% and 79%, respectively. Epicardial lead systems required significantly (p < 0.05) more revision than did endocardial systems, but when adapter problems were excluded, the revision rates of epicardial and endocardial leads were similar. Causes of lead system failures included adapter connection problems, lead dislodgement and insulation disruption. Predictors of lead revision were use of an epicardial lead system or an adapter.
A high rate of sensing/pacing lead complications was found with this newer generation implantable cardioverter-defibrillator. The enhanced diagnostic and data storage capabilities of this implantable cardioverter-defibrillator facilitated the recognition and troubleshooting of these complications. These findings emphasize the need for careful surveillance and testing of implantable cardioverter-defibrillator sensing/pacing leads during follow-up.
本报告描述了在一项新型植入式心脏复律除颤器的全球临床试验期间出现的感知/起搏导线并发症。
用于植入式心脏复律除颤器感知和起搏的导线的可靠性尚未得到充分研究。
将Guardian ATP 4210植入302例患者体内。感知/起搏导线由来自不同制造商的两个单极心外膜电极或一个双极心内膜电极组成。
在平均380天的随访期内，39例患者（12.9%）因设备出现感知/起搏导线系统并发症而需要再次手术。最常见的临床表现是设备过度感知（多次心动过速或噪声检测或不适当电击），27例患者出现这种情况，而10例患者出现起搏阈值升高。347个植入导线系统中有41个（11.8%）需要修订。修订的平均时间为156±145天。1年和3年的导线精算生存率分别为89%和79%。心外膜导线系统比心内膜系统需要显著更多的修订（p<0.05），但排除适配器问题后，心外膜和心内膜导线的修订率相似。导线系统故障的原因包括适配器连接问题、导线移位和绝缘破坏。导线修订的预测因素是使用心外膜导线系统或适配器。
发现这种新一代植入式心脏复律除颤器的感知/起搏导线并发症发生率很高。这种植入式心脏复律除颤器增强的诊断和数据存储功能有助于识别和解决这些并发症。这些发现强调了在随访期间对植入式心脏复律除颤器感知/起搏导线进行仔细监测和测试的必要性。
Zotero 插件