Kleman J M, Castle L W, Kidwell G A, Maloney J D, Morant V A, Trohman R G, Wilkoff B L, McCarthy P M, Pinski S L
Department of Cardiology, Cleveland Clinic Foundation, OH 44195.
Circulation. 1994 Dec;90(6):2833-42. doi: 10.1161/01.cir.90.6.2833.
Nonthoracotomy-implantable cardioverter/defibrillator (ICD) systems may represent a significant advance in the treatment of patients with life-threatening ventricular arrhythmias, but their merits relative to those of the well-established thoracotomy systems remain largely unknown. The objective of this study was to compare the short- and long-term clinical outcomes after attempted ICD implantation via a nonthoracotomy versus thoracotomy approach in similar groups of patients.
Between September 1990 and December 1992, 212 consecutive patients underwent attempted ICD system implantation without concomitant cardiac surgery at a single institution. Approach selection was not randomized but rather was based primarily on hardware availability. Primary comparisons of short- and long-term outcome were performed according to the "intention-to-treat" principle. Implantation was attempted via a nonthoracotomy approach in 120 patients (57%) and via a thoracotomy approach in 92 patients (43%). Prior cardiac surgery was more prevalent in the nonthoracotomy patients; otherwise, groups did not differ significantly in terms of prognostically relevant clinical characteristics. Nonthoracotomy implantation was successful in 101 patients (84%). After crossover to thoracotomy implantation (14 patients), the eventual success rate for ICD system implantation was 96% in the nonthoracotomy group. Thoracotomy implantation was successful in 89 patients (97%). Operative mortality was 3.3% in the nonthoracotomy and 4.3% in the thoracotomy groups (P = .73). Nonthoracotomy group patients were less likely to experience postoperative congestive heart failure (6% versus 16%; P = .02) or supraventricular arrhythmia (6% versus 18%; P = .004) and had significantly shorter postoperative intensive care and total hospitalization. Total hospital costs were significantly lower in the nonthoracotomy group ($32,205 versus $37,265; P = .001). After a follow-up of 16 +/- 9 months, there were 17 deaths in the nonthoracotomy group (none sudden) and 12 deaths in the thoracotomy group (1 sudden). One- and 2-year Kaplan-Meier survival probabilities were .87 (95% CI, .78 to .91) and .80 (95% CI, .68 to .88) in the nonthoracotomy group and .90 (95% CI, .82 to .95) and .87 (95% CI, .77 to .93) in the thoracotomy group (P = .56; log-rank test).
Nonthoracotomy ICD implantation is associated with reduced surgical morbidity, postoperative hospital care requirement, and hospital costs and has similar efficacy in preventing sudden death relative to the thoracotomy approach. From these nonrandomized data, it appears that a nonthoracotomy approach should be considered preferable in most patients requiring ICD therapy.
非开胸植入式心脏复律除颤器（ICD）系统可能是治疗危及生命的室性心律失常患者的一项重大进展，但其相对于成熟的开胸系统的优点在很大程度上仍不为人知。本研究的目的是比较在相似患者群体中，通过非开胸与开胸途径尝试植入ICD后的短期和长期临床结果。
1990年9月至1992年12月期间，212例连续患者在单一机构接受了不伴有心脏手术的ICD系统植入尝试。手术途径的选择并非随机，而是主要基于硬件可用性。根据“意向性治疗”原则对短期和长期结果进行了初步比较。120例患者（57%）尝试通过非开胸途径植入，92例患者（43%）尝试通过开胸途径植入。非开胸患者先前进行心脏手术的情况更为普遍；除此之外，两组在预后相关的临床特征方面无显著差异。101例患者（84%）非开胸植入成功。在转为开胸植入（14例患者）后，非开胸组ICD系统植入的最终成功率为96%。89例患者（97%）开胸植入成功。非开胸组手术死亡率为3.3%，开胸组为4.3%（P = 0.73）。非开胸组患者术后发生充血性心力衰竭（6%对16%；P = 0.02）或室上性心律失常（6%对18%；P = 0.004）的可能性较小，术后重症监护和总住院时间显著缩短。非开胸组的总住院费用显著更低（32,205美元对37,265美元；P = 0.001）。在16±9个月的随访后，非开胸组有17例死亡（均非猝死），开胸组有12例死亡（1例猝死）。非开胸组1年和2年的Kaplan-Meier生存概率分别为0.87（95%CI，0.78至0.91）和0.80（95%CI，0.68至0.88），开胸组分别为0.90（95%CI，0.82至0.95）和0.87（95%CI，0.77至0.93）（P = 0.56；对数秩检验）。
非开胸ICD植入与手术并发症减少、术后住院护理需求降低以及住院费用降低相关，并且在预防猝死方面与开胸途径具有相似的疗效。从这些非随机数据来看，对于大多数需要ICD治疗的患者，似乎应优先考虑非开胸途径。
