Spotnitz H M, Herre J M, Baker L D, Fitzgerald D M, Kron I L, Bigger J T
Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Circulation. 1996 Nov 1;94(9 Suppl):II248-53.
Whether prophylactic insertion of an implantable cardioverter defibrillator (ICD) improves the survival of high-risk patients undergoing coronary artery bypass graft surgery (CABG) is being assessed in the CABG Patch Trial. This report describes the surgical aspects of the study.
As of February 28, 1995, 847 patients (1.6% of 54102 screened) were enrolled and eligible for randomization to CABG or CABG plus ICD. Intraoperatively, 56 were eliminated by postenrollment exclusions, 67 were judged too unstable for randomization, and 724 were randomized (80% of the goal of 900). The average preoperative ejection fraction was 0.27 +/- 0.06 (n = 724); left ventricular (LV) end-diastolic pressure averaged 22 +/- 12 mm Hg (n = 548) Cardiopulmonary bypass (CPB) time averaged 108 minutes in control subjects, 126 minutes in the ICD group. After CPB, mechanical support was employed in 23% of patients and inotropic support in 73%; shock occurred in 8% and deep sternal wound infection in 1.3%. The surgical mortality was 6%; median length of stay was 8 days. Compared with randomized patients, patients whom surgeons judged too unstable to randomize were distinguished by statistically significant increases in mechanical support after CPB (51% versus 23%, P < .05) and postoperative shock (19% versus 8%, P < .05). Also, surgical mortality was greater (9% versus 6%) but was not statistically significant.
The initial phases of the CABG Patch Trial have been conducted with acceptable surgical mortality, morbidity, and length of stay. Surgical exclusion of some patients from randomization has been corroborated by data indicating hemodynamic instability. This trial will provide information about the risks and outcome of CABG surgery in patients with impaired LV function.
冠状动脉搭桥术（CABG）补片试验正在评估预防性植入植入式心脏复律除颤器（ICD）是否能提高接受冠状动脉搭桥术的高危患者的生存率。本报告描述了该研究的手术方面情况。
截至1995年2月28日，847例患者（占54102例筛查患者的1.6%）被纳入研究且符合随机分组至CABG组或CABG加ICD组的条件。术中，56例因入组后排除标准被剔除，67例被判定病情过于不稳定而无法随机分组，724例被随机分组（占900例目标的80%）。术前平均射血分数为0.27±0.06（n = 724）；左心室（LV）舒张末期压力平均为22±12 mmHg（n = 548）。对照组体外循环（CPB）时间平均为108分钟，ICD组为126分钟。CPB后，23%的患者使用了机械支持，73%的患者使用了强心支持；8%的患者发生休克，1.3%的患者发生深部胸骨伤口感染。手术死亡率为6%；中位住院时间为8天。与随机分组的患者相比，外科医生判定过于不稳定而无法随机分组的患者在CPB后机械支持（51%对23%，P <.05）和术后休克（19%对8%，P <.05）方面有统计学显著增加。此外，手术死亡率更高（9%对6%），但无统计学显著性差异。
CABG补片试验的初始阶段手术死亡率、发病率和住院时间均可接受。一些患者因手术原因被排除在随机分组之外，数据表明存在血流动力学不稳定证实了这一点。该试验将提供有关左心室功能受损患者CABG手术风险和结果的信息。
