Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
J Gastrointest Surg. 2012 Jan;16(1):89-102; discussion 102-3. doi: 10.1007/s11605-011-1753-x. Epub 2011 Nov 8.
Although mortality rates from pancreatectomy have decreased worldwide, death remains an infrequent but profound event at an individual practice level. Root-cause analysis is a retrospective method commonly employed to understand adverse events. We evaluate whether emerging mortality risk assessment tools sufficiently predict and account for actual clinical events that are often identified by root-cause analysis.
We assembled a Pancreatic Surgery Mortality Study Group comprised of 36 pancreatic surgeons from 15 institutions in 4 countries. Mortalities after pancreatectomy (30 and 90 days) were accrued from 2000 to 2010. For root-cause analysis, each surgeon "deconstructed" the clinical events preceding a death to determine cause. We next tested whether mortality risk assessment tools (ASA, POSSUM, Charlson, SOAR, and NSQIP) could predict those patients who would die (n = 218) and compared their prognostic accuracy against a cohort of resections in which no patient died (n = 1,177).
Two hundred eighteen deaths (184 Whipple's resection, 18 distal pancreatectomies, and 16 total pancreatectomies) were identified from 11,559 pancreatectomies performed by surgeons whose experience averaged 14.5 years. Overall 30- and 90-day mortalities were 0.96% and 1.89%, respectively. Individual surgeon rates ranged from 0% to 4.7%. Only 5 patients died intraoperatively, while the other 213 succumbed at a median of 29 days. Mean patient age was 70 years old (38% were >75 years old). Malignancy was the indication in 90% of cases, mostly pancreatic cancer (57%). Median operative time was 365 min and estimated blood loss was 700 cc (range, 100-16,000 cc). Vascular repair or multivisceral resections were required for 19.7% and 15.1%, respectively. Seventy-seven percent had a variety of major complications before death. Eighty-seven percent required intensive care unit care, 55% were transfused, and 35% were reoperated upon. Fifty percent died during the index admission, while another 11% died after a readmission. Almost half (n = 107) expired between 31 and 90 days. Only 11% had autopsies. Operation-related complications contributed to 40% of deaths, with pancreatic fistula being the most evident (14%). Technical errors (21%) and poor patient selection (15%) were cited by surgeons. Of deaths, 5.5% had associated cancer progression-all occurring between 31 and 90 days. Even after root-cause scrutiny, the ultimate cause of death could not be determined for a quarter of the patients-most often between 31 and 90 days. While assorted risk models predicted mortality with variable discrimination from nonmortalities, they consistently underestimated the actual mortality events we report.
Root-cause analysis suggests that risk prediction should include, if not emphasize, operative factors related to pancreatectomy. While risk models can distinguish between mortalities and nonmortalities in a collective fashion, they vastly miscalculate the actual chance of death on an individual basis. This study reveals the contributions of both comorbidities and aggressive surgical decisions to mortality.
尽管全球范围内胰腺切除术的死亡率有所下降,但在个体实践层面上,死亡仍然是一个罕见但严重的事件。根本原因分析是一种常用的回顾性方法,用于了解不良事件。我们评估新兴的死亡率风险评估工具是否足以预测和解释根本原因分析中经常确定的实际临床事件。
我们组建了一个由来自 4 个国家的 15 个机构的 36 名胰腺外科医生组成的胰腺外科死亡率研究小组。从 2000 年到 2010 年,我们收集了胰腺手术后 30 天和 90 天的死亡率。对于根本原因分析,每位外科医生“解构”了导致死亡的临床事件,以确定原因。接下来,我们测试了死亡率风险评估工具(ASA、POSSUM、Charlson、SOAR 和 NSQIP)是否可以预测那些将死亡的患者(n=218),并将其预测准确性与无死亡患者的切除术队列(n=1177)进行了比较。
从 11559 例胰腺外科医生进行的手术中,确定了 218 例死亡(184 例胰十二指肠切除术,18 例胰体尾切除术,16 例全胰切除术),外科医生的经验平均为 14.5 年。总的 30 天和 90 天死亡率分别为 0.96%和 1.89%。个别外科医生的死亡率范围为 0%至 4.7%。只有 5 例患者在手术中死亡,而其他 213 例患者在中位 29 天内死亡。患者平均年龄为 70 岁(38%年龄>75 岁)。90%的病例为恶性肿瘤,主要为胰腺癌(57%)。中位手术时间为 365 分钟,估计失血量为 700cc(范围为 100-16000cc)。分别有 19.7%和 15.1%的患者需要血管修复或多脏器切除。77%的患者在死亡前有各种主要并发症。87%的患者需要重症监护病房治疗,55%的患者需要输血,35%的患者需要再次手术。50%的患者在指数住院期间死亡,另有 11%的患者在再次住院后死亡。近一半(n=107)在 31 至 90 天之间死亡。只有 11%的患者进行了尸检。手术相关并发症导致 40%的死亡,其中最明显的是胰腺瘘(14%)。外科医生指出技术错误(21%)和患者选择不当(15%)。在死亡病例中,5.5%与癌症进展有关——所有死亡均发生在 31 至 90 天之间。即使经过根本原因审查,也无法确定四分之一患者的死亡最终原因——大多数死亡发生在 31 至 90 天之间。虽然各种风险模型可以预测死亡率,但与非死亡率相比,它们的区分度各不相同,而且在个体基础上,它们大大低估了实际的死亡几率。
根本原因分析表明,风险预测应包括(如果不是强调)与胰腺切除术相关的手术因素。虽然风险模型可以集体区分死亡率和非死亡率,但它们在个体基础上大大低估了实际的死亡机会。本研究揭示了合并症和积极手术决策对死亡率的影响。