Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, MO (S.V.A.).
Duke University, Durham, NC (P.M., S.V., A.M.V., A.S.K.).
Circ Cardiovasc Interv. 2023 Jul;16(7):e013080. doi: 10.1161/CIRCINTERVENTIONS.123.013080. Epub 2023 Jun 26.
Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements.
Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time.
Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all <0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80-0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes.
While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes.
在过去的十年中，经导管主动脉瓣置换术的术后结果得到了显著改善。在此期间，许多患者和手术相关因素也发生了变化，使得厘清这些改善的驱动因素变得极具挑战性。
在 2012 年至 2018 年期间，在美国胸外科医师学会/美国心脏病学会经导管瓣膜治疗注册中心接受经导管主动脉瓣置换术的患者中，我们研究了患者因素变化、器械改良、经验/技术的提高以及围手术期护理的进步对经导管主动脉瓣置换术术后结果改善的相对贡献。中介物簇包括人口统计学因素、非心血管合并症、心血管合并症、器械相关因素和非器械相关手术因素。我们使用逻辑回归，连续调整中介物簇，以检查每个因素对随时间推移观察到的结果改善的贡献。
在 596 个治疗地点接受经导管主动脉瓣置换术的 161196 名患者中，结果从 2012 年到 2018 年稳步改善，包括 30 天死亡率（6.7%至 2.4%）、30 天复合不良事件（25.3%至 10.5%）和 1 年死亡率（19.9%至 10.1%；均<0.001）。在序贯模型中，未经调整的 30 天死亡率的优势比为每年 0.82（95%CI，0.80-0.84），随着每个协变量簇的加入，该比值逐渐减弱。大部分改善归因于器械因素和非器械手术因素。30 天复合不良事件的结果相似，尽管观察到的时间改善未完全由测量因素解释，这表明技术技能的提高是另一个中介因素。与 30 天结果相反，患者和手术相关因素的每个簇都同样有助于 1 年死亡率的时间改善，这表明患者因素对长期结果的影响更大。
尽管美国接受经导管主动脉瓣置换术的患者年龄越来越小、健康状况越来越好、风险越来越低，但对短期结果改善最重要的因素与器械技术和手术因素的进步有关，而患者特征的变化对 1 年结果的改善影响更大。
