经导管主动脉瓣置换术对中危外科手术风险严重主动脉瓣狭窄患者健康状况的影响：PARTNER S3i 试验结果。
Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial.
机构信息
Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
出版信息
JACC Cardiovasc Interv. 2018 Jun 25;11(12):1188-1198. doi: 10.1016/j.jcin.2018.02.032. Epub 2018 May 30.
OBJECTIVES
The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).
BACKGROUND
In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.
METHODS
Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.
RESULTS
Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.
CONCLUSIONS
Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.
目的
本研究旨在评估经导管主动脉瓣置换术（TAVR）中使用 SAPIEN 3 瓣膜（S3-TAVR）与上一代 TAVR 装置或外科主动脉瓣置换术（SAVR）相比是否能改善生活质量（QoL）。
背景
在中危外科手术风险的严重主动脉瓣狭窄患者中，使用 SAPIEN XT 瓣膜（XT-TAVR）进行 TAVR 的 QoL 与 SAVR 相似。与 SAPIEN XT 相比，SAPIEN 3 瓣膜具有更低的输送轮廓和减少瓣周漏的改进。
方法
在 2014 年 2 月至 12 月期间，1078 例中危外科手术风险伴严重主动脉瓣狭窄的患者在 PARTNER S3i（经导管主动脉瓣置换）试验中接受了 S3-TAVR。使用堪萨斯城心肌病问卷、医疗结局研究 36 项简短形式和 EQ-5D 在基线、1 个月和 1 年评估 QoL。使用倾向评分分层法比较 S3-TAVR 患者与 PARTNER 2A 试验中 SAVR 和 XT-TAVR 组的 QoL 结果，以调整治疗组之间的差异。
结果
与基线相比，S3-TAVR 在 1 年内与 QoL 的显著改善相关。在 1 个月时，S3-TAVR 的 QoL 优于 SAVR 或 XT-TAVR（校正后的堪萨斯城心肌病问卷整体综合评分差异分别为 15.6 和 3.7 分；p<0.001）。在 1 年时，S3-TAVR 与 SAVR 和 XT-TAVR 的 QoL 差异缩小，但仍具有统计学意义（校正差异分别为 2.0 和 2.2 分；p<0.05）。一般 QoL 结果也相似。
结论
在中危外科手术风险伴严重主动脉瓣狭窄的患者中，S3-TAVR 在 1 个月和 1 年时与 XT-TAVR 和 SAVR 相比均能改善 QoL。
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