Management and long-term outcomes associated with recalled implantable cardioverter-defibrillator leads: A multicenter experience

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植入型心律转复除颤器导线故障分析

目的总结分析我院植入型心律转复除颤器（ICD）起搏除颤导线故障病例特点。方法对2005年10月至2009年12月62例在我院新植入ICD导线患者进行随访分析,所有导线植入均以锁骨下静脉作为入路。随访中出现以下1项或多项异常考虑导线故障：（1）起搏阻抗永久性或间歇性〉2000n或〈250Q;（2）除颤高压阻抗〉200n;（3）心内电图证实除颤导线感知非生理性高频噪声导致误放电。结果中位数随访时间28（10～46）个月,4例患者（6．5％）诊断ICD导线故障,导线寿命18～38个月;临床均以ICD误放电至医院就诊,同时程控发现ICD导线起搏阻抗异常。其中1例患者放电前闻及ICD导线阻抗报警,4例患者均重新植入新的起搏感知导线。结论ICD导线故障是一个值得重视的临床问题。ICD导线阻抗报警功能可能有助于早期发现导线故障。如程控发现仅仅除颤导线起搏阻抗异常,植入新的起搏感知导线可以作为首选的故障处理方法。     

Inadvertent transarterial insertion of atrial and ventricular defibrillator leads

Inadvertent placement of pacemaker and implantable cardioverter-defibrillator (ICD) leads in the left ventricle (LV) is a rare but well-recognized complication of device implantation [1]. We report a case of inadvertent transarterial implantation of dual-chamber ICD leads; the ventricular lead positioned in the LV and the atrial lead positioned in the aortic root. The tip of the atrial lead migrated across the aortic wall and captured the epicardial surface of the left atrium. The diagnosis was made 5 years after the implantation procedure with no apparent adverse events directly related to left heart lead placement.     

Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead

BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice. OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads. METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models. RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor. CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified.     

Longevity of model 3501 subcutaneous implantable cardioverter-defibrillator leads in clinical practice

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Recurrence of ventricular tachycardia degeneration by low-energy implantable cardioverter-defibrillator shocks: a case report

Despite their proven efficacy at reducing mortality in selected patients, implantable cardioverter-defibrillators have some proarrhythmic effects. In this report, we present a case of a patient with recurrent ventricular tachycardia degeneration to ventricular fibrillation by appropriate low-energy implantable cardioverter-defibrillator shocks.     

Development and testing of an algorithm to detect implantable cardioverter-defibrillator lead failure

BACKGROUND: Implantable cardioverter-defibrillator (ICD) lead failures often present as inappropriate shock therapy. An algorithm that can reliably discriminate between ventricular tachyarrhythmias and noise due to lead failure may prevent patient discomfort and anxiety and avoid device-induced proarrhythmia by preventing inappropriate ICD shocks. OBJECTIVES: The goal of this analysis was to test an ICD tachycardia detection algorithm that differentiates noise due to lead failure from ventricular tachyarrhythmias. METHODS: We tested an algorithm that uses a measure of the ventricular intracardiac electrogram baseline to discriminate the sinus rhythm isoelectric line from the right ventricular coil-can (i.e., far-field) electrogram during oversensing of noise caused by a lead failure. The baseline measure was defined as the product of the sum (mV) and standard deviation (mV) of the voltage samples for a 188-ms window centered on each sensed electrogram. If the minimum baseline measure of the last 12 beats was <0.35 mV-mV, then the detected rhythm was considered noise due to a lead failure. The first ICD-detected episode of lead failure and inappropriate detection from 24 ICD patients with a pace/sense lead failure and all ventricular arrhythmias from 56 ICD patients without a lead failure were selected. The stored data were analyzed to determine the sensitivity and specificity of the algorithm to detect lead failures. RESULTS: The minimum baseline measure for the 24 lead failure episodes (0.28 +/- 0.34 mV-mV) was smaller than the 135 ventricular tachycardia (40.8 +/- 43.0 mV-mV, P <.0001) and 55 ventricular fibrillation episodes (19.1 +/- 22.8 mV-mV, P <.05). A minimum baseline <0.35 mV-mV threshold had a sensitivity of 83% (20/24) with a 100% (190/190) specificity. CONCLUSION: A baseline measure of the far-field electrogram had a high sensitivity and specificity to detect lead failure noise compared with ventricular tachycardia or fibrillation.     

Outcomes of subcutaneous implantable cardioverter-defibrillator in dialysis patients: Results from the S-ICD post-approval study

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心脏性猝死的预防及我国埋藏式心律转复除颤器应用状况

目的通过对全国部分医院的回顾性调查研究,了解我国埋藏式心律转复除颤器(ICD)使用状况.方法回顾性分析了1996年1月18日到2003年1月31日,来自82家医院的173例ICD患者的临床情况,了解其基础病因、心律失常类型、ICD对心律失常的治疗情况以及ICD的并发症.结果 173例植入ICD患者,其中115例(66.5%)有各种器质性心脏病,以冠心病为最常见.植入患者中室性心动过速(VT) 106例(61.3%),心室颤动(VF) 34例(19.6%),VT合并VF 33例(19.1%).在平均随访27.8个月(1～86个月)中,82例 (47.4%)发生VT和/或VF,并接受ICD成功治疗;73.04%的VT通过抗心动过速起搏(ATP)终止;VF除颤成功率为100%;误放电率为2.0%.术后并发症发生率为2.3%,随访期间共有11例患者死亡,占6.4%.结论本研究的有限数据表明ICD治疗对我国患者带来的好处,但其应用尚处于起步阶段.     

Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study

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