Kenney Kimberly M, Marzo Mitchell C, Ondrasik Nicholas R, Wisenbaugh Thomas
Tripler Army Medical Center, Tripler AMC, Hawaii 96859-5000, USA.
Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):671-7. doi: 10.1161/CIRCOUTCOMES.109.867077.
American College of Cardiology (ACC) guidelines state that percutaneous coronary interventions (PCI) be performed at centers and by operators with high-volume (>400 yearly/center) whose historical and current risk-adjusted outcomes statistics are comparable to those reported in large registries. Tripler Army Medical Center is a low-volume treatment facility but has a geographic need and special mission requirement for providing this service.
We computed 30-day incidence of stent thrombosis, need for repeat revascularization, and all-cause mortality for all PCIs performed at Tripler from January 2002 through June 2008. The New York State Registry regression model was selected among 3 risk-adjustment models that we assessed in our patients. This model was used to compute expected mortality rate based on patient risk factors. The 30-day incidence of stent thrombosis and repeat revascularization was also determined, and the long-term incidence of these events was estimated with the Kaplan-Meier method as was survival. For all 546 PCI procedures, 30-day mortality was 1.47%, the incidence of stent thrombosis 2.1%, the incidence of any repeat revascularization 5.1%, and the combined event rate 5.9%. Based on risk factors used in the New York State Registry, our expected mortality was 1.93% and not significantly different from the observed rate. Although survival at 1 and 3 years appeared comparable with benchmarks at 94.6% and 89.3%, as did repeat revascularization rates at 13.0% and 21.4%, the incidence of stent thrombosis was regarded as high whether the definition included possible cases (3.2% and 3.9%) or only those regarded as definite or probable (2.7% and 3.1%). We did not identify any remediable risk factors for stent thrombosis, nor were we able to identify significant differences by year or by operator. However, visual inspection of a plot of deciles of New York State risk of death demonstrated 2 outlier cases among the 8 who died, who could have been considered candidates for thorough peer review.
We recommend other low-volume interventional programs enter all patients undergoing PCI into a database, their own local registry even if not a national one such as the American College of Cardiology National Cardiovascular Data Registry, obtain information about survival and cardiac events during follow-up, compute and risk-adjust in-hospital or 30-day mortality, and use the objective assessment of risk in individual patients to identify outliers when outcome is adverse, and possibly as a means of triaging patients to appropriate therapy before choosing PCI.
美国心脏病学会（ACC）指南指出，经皮冠状动脉介入治疗（PCI）应在每年手术量较大（>400例/中心）的中心由术者进行，这些中心历史和当前的风险调整后结果统计数据应与大型注册研究报告的数据相当。特里普勒陆军医疗中心是一个手术量较低的治疗机构，但出于地理位置需求和特殊任务要求而提供这项服务。
我们计算了2002年1月至2008年6月在特里普勒进行的所有PCI手术的30天支架血栓形成发生率、再次血管重建需求和全因死亡率。在我们评估的3种风险调整模型中，选择了纽约州注册研究回归模型用于我们的患者。该模型用于根据患者风险因素计算预期死亡率。还确定了30天支架血栓形成和再次血管重建的发生率，并采用Kaplan-Meier方法估计这些事件的长期发生率以及生存率。对于所有546例PCI手术，30天死亡率为1.47%，支架血栓形成发生率为2.1%，任何再次血管重建发生率为5.1%，联合事件发生率为5.9%。根据纽约州注册研究中使用的风险因素，我们的预期死亡率为1.93%，与观察到的死亡率无显著差异。尽管1年和3年生存率分别为94.6%和89.3%，与基准相当，再次血管重建率分别为13.0%和21.4%，但无论支架血栓形成的定义是否包括可能病例（3.2%和3.9%）还是仅包括确定或很可能的病例（2.7%和3.1%），其发生率都被认为较高。我们未发现任何可补救的支架血栓形成风险因素，但也未能按年份或术者确定显著差异。然而，对纽约州死亡风险十分位数图的目视检查显示，8例死亡患者中有2例为异常值，本可考虑进行全面的同行评审。
我们建议其他低手术量的介入项目将所有接受PCI的患者纳入数据库，即使不是像美国心脏病学会国家心血管数据注册研究这样的国家级数据库，也可建立自己的本地注册研究，获取随访期间的生存和心脏事件信息，计算并进行风险调整后的住院或30天死亡率，利用对个体患者风险的客观评估在结果不利时识别异常值，并可能作为在选择PCI之前将患者分诊至适当治疗的一种手段。
