Kim S G, Pathapati R, Fisher J D, Rameneni A, Nagabhairu R, Ferrick K J, Roth J A, Ben-Zur U, Gross J, Brodman R, Furman S
Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Am J Cardiol. 1996 Nov 15;78(10):1109-12. doi: 10.1016/s0002-9149(96)90061-2.
In 193 consecutive patients treated with implantable defibrillators at our institution, thoracotomy approaches were used in 87 patients and nonthoracotomy approaches in 106 patients. Long-term outcomes of the 2 groups were compared by the intention-to-treat analysis. Surgical mortality (30-day mortality) rates were 5.7% in the thoracotomy group and 0% in the nonthoracotomy group. Six of 106 patients who underwent nonthoracotomy implantation had a high defibrillation threshold and did not receive nonthoracotomy defibrillators. The duration of follow-up was 52 +/- 31 months in the thoracotomy group, and 23 +/- 15 months in nonthoracotomy group. Actuarial survival rates at 6 and 24 months were, respectively, 90% and 81% in nonthoracotomy patients and 89% and 80% in thoracotomy patients (p = NS). In patients with left ventricular ejection fraction <30%, surgical mortality was 0% by the nonthoracotomy and 10% by the thoracotomy approach. Despite the 10% difference in 30-day mortality, survival rates at 6 months were 85% in nonthoracotomy patients and 81% in thoracotomy patients. At 24 months they were 73% in nonthoracotomy patients and 74% in thoracotomy patients. Thus, this nonrandomized study suggests that while short-term survival is better in nonthoracotomy patients than thoracotomy patients, the difference in survival diminishes quickly during the first few months and disappears by 6 months. The results were similar in patients with severe ventricular dysfunction. Several important implantable-cardioverter defibrillator (ICD) trials initially utilized thoracotomy ICDs. Although questions may be raised with regard to applicability of such a trial in the era of nonthoracotomy ICDs, this study suggests that the results of such ICD trials will be largely applicable to patients treated with nonthoracotomy ICDs.
在我们机构接受植入式除颤器治疗的193例连续患者中,87例采用开胸手术方法,106例采用非开胸手术方法。通过意向性分析比较两组的长期结局。开胸手术组的手术死亡率(30天死亡率)为5.7%,非开胸手术组为0%。106例行非开胸植入术的患者中有6例除颤阈值高,未接受非开胸除颤器。开胸手术组的随访时间为52±31个月,非开胸手术组为23±15个月。非开胸手术患者6个月和24个月的精算生存率分别为90%和81%,开胸手术患者分别为89%和80%(p=无统计学意义)。左心室射血分数<30%的患者,非开胸手术的手术死亡率为0%,开胸手术为10%。尽管30天死亡率相差10%,但非开胸手术患者6个月时的生存率为85%,开胸手术患者为81%。24个月时,非开胸手术患者为73%,开胸手术患者为74%。因此,这项非随机研究表明,虽然非开胸手术患者的短期生存率优于开胸手术患者,但生存率差异在最初几个月迅速减小,并在6个月时消失。重度心室功能障碍患者的结果相似。几项重要的植入式心脏复律除颤器(ICD)试验最初使用的是开胸ICD。尽管对于此类试验在非开胸ICD时代的适用性可能存在疑问,但这项研究表明,此类ICD试验的结果在很大程度上适用于接受非开胸ICD治疗的患者。