Wever E F, Hauer R N, van Capelle F L, Tijssen J G, Crijns H J, Algra A, Wiesfeld A C, Bakker P F, Robles de Medina E O
Heart-Lung Institute, University Hospital, Utrecht, The Netherlands.
Circulation. 1995 Apr 15;91(8):2195-203. doi: 10.1161/01.cir.91.8.2195.
In retrospective studies of sudden cardiac death survivors, the implantable cardioverter-defibrillator (ICD) compares favorably with medical and surgical therapy. Thus, use of the conventional strategy of starting treatment with antiarrhythmic drugs (AD), at least in certain patient categories, may be questionable. The goal of this study was to analyze the effectiveness of ICD implantation as first-choice therapy versus the conventional therapeutic strategy of starting with AD.
Sixty consecutive survivors of cardiac arrest caused by old myocardial infarction were randomly assigned early ICD implantation (n = 29) or conventional therapy (n = 31). Baseline characteristics were similar in the two groups. Therapy in each patient was always guided by ECG monitoring, exercise testing, and programmed electrical stimulation (PES). Primary end points (main outcome events, including death, recurrent cardiac arrest, and cardiac transplantation), number of invasive procedures and antiarrhythmic therapy changes, and duration of hospitalization were compared. Median follow-up was 24 months (mean, 27 months). In the early ICD group, 4 patients (14%) died, all of cardiac causes. In the conventional group, 20 patients failed AD and subsequently underwent map-guided ventricular tachycardia (VT) surgery (6 patients) or ICD implantation (14 patients). Of the 6 VT surgery patients, 1 died, 1 had cardiac transplantation, and 1 had an ICD implantation because of persistent inducibility despite the addition of AD. Of the 11 patients who remained on AD as sole therapy, 2 died in the hospital before they could be retested by PES, leaving 9, judged adequately protected by AD alone. Of those, 5 died, and 1 survived recurrent cardiac arrest followed by ICD implantation. In total, 16 conventionally treated patients ended up with late ICD implantation, 3 of whom died. Thus, total mortality in the conventional group was 11 patients (35%): 4 died suddenly, 5 died of heart failure, and 2 died of noncardiac causes. Comparison of the main outcome events in both strategies showed a significant difference in favor of early ICD implantation (hazard ratio, 0.27; 95% CI, 0.09 to 0.85; P = .02). In addition, the early ICD group underwent fewer invasive procedures (median, 1 versus 3; P < .0001), had less therapy changes (P < .0001), and spent fewer days in hospital (median, 34 versus 49; P = .02).
These data suggest that ICD implantation as first choice is preferable to the conventional approach in survivors of cardiac arrest caused by old myocardial infarction. Conventionally treated patients are likely to end up with an ICD, and those who remain on AD as sole therapy have a high risk of death regardless of efficacy assessment, including PES.
在对心脏性猝死幸存者的回顾性研究中，植入式心脏复律除颤器（ICD）与药物及手术治疗相比具有优势。因此，至少在某些患者类别中，采用抗心律失常药物（AD）开始治疗的传统策略可能存在疑问。本研究的目的是分析ICD植入作为首选治疗与以AD开始的传统治疗策略的有效性。
连续60例因陈旧性心肌梗死导致心脏骤停的幸存者被随机分配接受早期ICD植入（n = 29）或传统治疗（n = 31）。两组的基线特征相似。每位患者的治疗始终由心电图监测、运动试验和程控电刺激（PES）指导。比较主要终点（主要结局事件，包括死亡、复发性心脏骤停和心脏移植）、侵入性操作次数和抗心律失常治疗的变化以及住院时间。中位随访时间为24个月（平均27个月）。在早期ICD组中，4例患者（14%）死亡，均为心脏原因。在传统治疗组中，20例患者AD治疗失败，随后接受了标测引导的室性心动过速（VT）手术（6例）或ICD植入（14例）。在6例VT手术患者中，1例死亡，1例接受心脏移植，1例因尽管加用了AD仍持续可诱发而接受ICD植入。在11例仅接受AD作为唯一治疗的患者中，2例在接受PES重新检测前死于医院，剩下9例，被判定仅AD治疗即可充分保护。其中，5例死亡，1例在复发性心脏骤停后接受ICD植入而存活。总体而言，16例接受传统治疗的患者最终接受了晚期ICD植入，其中3例死亡。因此，传统治疗组的总死亡率为11例患者（35%）：4例猝死，5例死于心力衰竭，2例死于非心脏原因。两种策略的主要结局事件比较显示，早期ICD植入具有显著优势（风险比，0.27；95%可信区间，0.09至0.85；P = 0.02）。此外，早期ICD组的侵入性操作更少（中位数，1次对3次；P < 0.0001），治疗变化更少（P < 0.0001），住院天数更少（中位数，34天对49天；P = 0.02）。
这些数据表明，对于因陈旧性心肌梗死导致心脏骤停的幸存者，ICD植入作为首选优于传统方法。接受传统治疗的患者最终可能会接受ICD，而那些仅接受AD作为唯一治疗的患者，无论包括PES在内的疗效评估如何，都有很高的死亡风险。
