Wessler Benjamin S, Weintraub Andrew R, Udelson James E, Kent David M
Division of Cardiology and the CardioVascular Center, Tufts Medical Center.
Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Medical Center.
Struct Heart. 2020;4(4):295-299. doi: 10.1080/24748706.2020.1782549. Epub 2020 Jul 9.
One third of high- and prohibitive-risk TAVR patients remain severely symptomatic or die 1 year after treatment. There is interest in identifying individuals for whom this procedure is futile and should not be offered.
We performed a systematic review of the highest reported stratum of risk in TAVR clinical predictive models (CPMs). We explore whether currently available predictive models can identify patients for whom TAVR is futile, based on a quantitative futility definition and the observed and predicted outcomes for patients in the highest stratum of risk.
17 TAVR CPMs representing 69,191 treated patients were published from 2013 to 2018. When reported, the median number of patients in the highest stratum of risk was 569 (range 1 to 1759). Observed mortality for this risk stratum ranged from 9% at 30 days to 59% at 1 year after TAVR. Statistical confidence in these observed event rates was low. The highest predicted event rates ranged from 11.0% for in-hospital mortality to 75.1% for the composite of mortality or high symptom burden 1 year after TAVR.
No high-risk TAVR group in currently available TAVR CPMs had an appropriate event rate and adequate statistical power to meet a quantitative definition of futility.
三分之一的高风险和极高风险经导管主动脉瓣置换术（TAVR）患者在治疗后1年仍有严重症状或死亡。确定哪些患者进行该手术是徒劳的且不应接受该手术是人们所关注的。
我们对TAVR临床预测模型（CPM）中报告的最高风险分层进行了系统评价。我们基于定量的无效性定义以及最高风险分层患者的观察和预测结果，探讨目前可用的预测模型是否能够识别出TAVR手术徒劳的患者。
2013年至2018年发表了17个代表69191例接受治疗患者的TAVR CPM。报告时，最高风险分层的患者中位数为569例（范围1至1759例）。该风险分层的观察到的死亡率在TAVR术后30天为9%，1年时为59%。对这些观察到的事件发生率的统计置信度较低。最高预测事件发生率在TAVR术后住院死亡率为11.0%，1年时死亡或高症状负担的复合发生率为75.1%。
目前可用的TAVR CPM中没有高风险TAVR组具有合适的事件发生率和足够的统计效力来满足无效性的定量定义。
