Arnold Suzanne V, Spertus John A, Lei Yang, Green Philip, Kirtane Ajay J, Kapadia Samir, Thourani Vinod H, Herrmann Howard C, Beohar Nirat, Zajarias Alan, Mack Michael J, Leon Martin B, Cohen David J
Saint Luke's Mid America Heart Institute, Kansas City, MO.
Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):591-7. doi: 10.1161/CIRCOUTCOMES.113.000354. Epub 2013 Sep 10.
Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components.
Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR.
Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR.
经导管主动脉瓣置换术（TAVR）已成为重度主动脉瓣狭窄患者瓣膜置换的一种侵入性较小的选择。尽管已建议不应将TAVR用于功能无法改善或无法从该手术中获得有意义生存获益的患者，但对于如何最好地识别此类患者尚无指导意见。这一过程的第一步是定义一个不良结局，然后可将其作为后续病例识别的基础。我们试图评估TAVR术后不良结局的潜在定义，该定义应同时包含死亡率和生活质量成分。
利用463例接受TAVR的患者的数据，这些患者作为主动脉经导管瓣膜置入（PARTNER）试验的一部分，我们使用堪萨斯城心肌病问卷评估6个月死亡率和生活质量结局，以探索不良结局的潜在定义。然后，我们通过检查每位患者基线和6个月堪萨斯城心肌病问卷评分之间 的关系，比较了每个潜在定义的优缺点。基于这些分析，我们认为TAVR术后不良结局的最合适定义是：（1）死亡；（2）堪萨斯城心肌病问卷总体汇总评分<45；或（3）堪萨斯城心肌病问卷评分下降≥10分，这最能反映未达到TAVR的治疗目标。
利用PARTNER试验中大量患者的经验数据，我们提出了一个TAVR术后不良结局的定义，该定义将死亡率和生活质量指标结合为一个单一的复合终点。在未来研究中使用这个终点（或其他类似终点）可以促进预测模型的开发，这可能有助于识别TAVR的不良候选患者，并为这些患者及其家属提供TAVR术后功能恢复的适当预期。
