Sergeant Paul, Wouters Patrick, Meyns Bart, Bert Christophe, Van Hemelrijck Jan, Bogaerts Chris, Sergeant Gregory, Slabbaert Koen
Department of Cardiac Surgery, Gasthuisberg University Hospital, Herestreet, 3000 Leuven, Belgium.
Eur J Cardiothorac Surg. 2004 May;25(5):779-85. doi: 10.1016/j.ejcts.2004.02.013.
To evaluate the impact of OPCAB on major postoperative events in a large consecutive cohort of patients, covering the complete spectrum of risk.
A consecutive series of 3333 CABG patients operated in a single institution (Jan/97-Jan/03) is analyzed after a complete (98%) midterm reengineering towards off-pump surgery (Oct/99). Patients in cardiogenic shock are excluded. The on- (N=1593) or off-pump (N=1740) datasets are comparable for most demographic and non-cardiac variability. The studied events are early mortality, early stroke, early infarct, early dialysis and hospital stay. Three methods adjust for possible patient selection: similar datasets, forced inclusion of a saturated OPCAB propensity score and finally multivariate correction.
Non-risk adjusted. The 3-month survival was 96.7+/-0.4% (OPCAB) and 95.9+/-0.5% (ECC) (P=0.2). The 8-day freedom from stroke was 99.4+/-0.2% (OPCAB) and 98.5+/-0.3% (ECC) (P=0.004). The prevalence of dialysis was 1.67% in OPCAB and 2.27% in ECC (P=0.2). The 8-day freedom from infarct was 98.4+/-0.2% (OPCAB) and 98.3+/-0.2% (ECC) (P=0.7). The freedom from hospital discharge day 15 was 17.6+/-0.9% (OPCAB) and 18.4+/-0.8% (ECC) (P=0.001). Propensity score corrected and adjusted for event-related variability. The survival effect remained non-significant (P=0.3), also for patients with a EuroSCORE>8 (P=0.9). The stroke effect became non-significant (P=0.2), but stayed significant for patients with severe internal carotid artery stenosis (P=0.02). The dialysis-effect remained non-significant (P=0.6), also for patients with an elevated creatinine (P=0.7). The early infarct-effect remained non-significant (P=0.8), also for the female patients (P=0.8). The hospital discharge was significantly influenced by the OPCAB approach for the total group (P=0.02) as well as for the patients with EuroSCORE>8 (P=0.01).
The observed 20% reduction of mortality, 60% reduction of stroke and 20% reduction of dialysis were partly neutralized by the adjusting methods and demand, at least, larger datasets to obtain statistical significance. Subdatasets with fewer patients but higher risk identified risk-reducing effects for stroke. Hospital stay was shortened by the OPCAB approach. The interactions between risk, number of patients and the risk-reducing effect are the cornerstones of evidence generation for the OPCAB approach. These results were obtained through a very strict reengineering and cannot be extended to all OPCAB programs.
在涵盖全部风险范围的大型连续队列患者中评估非体外循环冠状动脉搭桥术（OPCAB）对术后主要事件的影响。
对在单一机构（1997年1月至2003年1月）接受手术的3333例冠状动脉搭桥术（CABG）患者进行连续系列分析，该机构在向非体外循环手术进行全面（98%）的中期改造后（1999年10月）。排除心源性休克患者。体外循环（N = 1593）或非体外循环（N = 1740）数据集在大多数人口统计学和非心脏变异性方面具有可比性。所研究的事件包括早期死亡率、早期卒中、早期梗死、早期透析和住院时间。三种方法对可能的患者选择进行校正：相似数据集、强制纳入饱和的OPCAB倾向评分以及最终的多变量校正。
未进行风险调整。3个月生存率在OPCAB组为96.7±0.4%，在体外循环组（ECC）为95.9±0.5%（P = 0.2）。8天无卒中率在OPCAB组为99.4±0.2%，在ECC组为98.5±0.3%（P = 0.004）。透析发生率在OPCAB组为1.67%，在ECC组为2.27%（P = 0.2）。8天无梗死率在OPCAB组为98.4±0.2%，在ECC组为98.3±0.2%（P = 0.7）。15天内出院率在OPCAB组为17.6±0.9%，在ECC组为18.4±0.8%（P = 0.001）。倾向评分校正并针对事件相关变异性进行调整。生存效应仍无统计学意义（P = 0.3），对于欧洲心脏手术风险评估系统（EuroSCORE）>8的患者也是如此（P = 0.9）。卒中效应变得无统计学意义（P = 0.2），但对于严重颈内动脉狭窄的患者仍具有统计学意义（P = 0.02）。透析效应仍无统计学意义（P = 0.6），对于肌酐升高的患者也是如此（P = 0.7）。早期梗死效应仍无统计学意义（P = 0.8），对于女性患者也是如此（P = 0.8）。OPCAB方法对总体组的出院情况有显著影响（P = 0.02），对于EuroSCORE>8的患者也有显著影响（P = 0.01）。
观察到的死亡率降低20%、卒中降低60%和透析降低20%在一定程度上被调整方法抵消，并且至少需要更大的数据集才能获得统计学意义。患者数量较少但风险较高的亚数据集显示出对卒中的风险降低作用。OPCAB方法缩短了住院时间。风险、患者数量和风险降低效应之间的相互作用是OPCAB方法证据生成的基石。这些结果是通过非常严格的改造获得的，不能推广到所有OPCAB项目。
