经导管主动脉瓣置换术后的舒张功能与临床结局：PARTNER 2 SAPIEN 3 注册研究。
Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry.
机构信息
Cardiovascular Research Foundation, New York, New York, USA; St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Quebec Heart and Lung Institute, Laval University, Québec City, Quebec, Canada.
出版信息
J Am Coll Cardiol. 2020 Dec 22;76(25):2940-2951. doi: 10.1016/j.jacc.2020.10.032.
BACKGROUND
Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis.
OBJECTIVES
The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).
METHODS
Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups.
RESULTS
Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01).
CONCLUSIONS
In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141).
背景
很少有研究评估舒张功能是否可以预测主动脉瓣狭窄患者的结局。
目的
作者旨在评估主动脉瓣狭窄患者行经导管主动脉瓣置换术（TAVR）后舒张功能障碍（DD）与结局之间的关系。
方法
对来自 PARTNER（经导管主动脉瓣置换术Placement of Aortic Transcatheter Valves）2 SAPIEN 3 注册研究的基线、30 天和 1 年及 2 年经胸超声心动图进行分析，分析工作由一个核心实验室联盟完成，并根据美国超声心动图学会（ASE）的 DD 分组标准进行分组。
结果
在纳入的 1750 例患者中，682 例（54.4%）存在 1 级 DD，352 例（28.1%）存在 2 级 DD，168 例（13.4%）存在 3 级 DD，51 例（4.1%）DD 分级不确定。基线 DD 分级的增加与 1 年和 2 年心血管（CV）死亡/再住院（均 p<0.002）和 2 年全因死亡（p=0.01）的增加相关，但与 1 年无关。在 TAVR 后 30 天，70.8%的患者 DD 分级得到改善/出现 1 级 DD。DD 分级改善≥1 级/出现 1 级 DD 的患者 1 年 CV 死亡/再住院风险降低（p<0.001），2 年生存率提高（p=0.01）。基线 3 级 DD 是 1 年 CV 死亡/再住院的预测因素（风险比：2.73；95%置信区间：1.07 至 6.98；p=0.04）。在 30 天时 DD 分级改善/出现 1 级 DD 可降低 1 年 CV 死亡/再住院风险（风险比：0.39；95%置信区间：0.19 至 0.83；p=0.01）。
结论
在 PARTNER 2 SAPIEN 3 注册研究中，基线 DD 是 TAVR 患者 2 年临床结局的预测因素。在 30 天时 DD 分级的改善与短期临床结局的改善相关。（PARTNER II 试验：主动脉瓣经导管置换术的放置 - II 期 - PARTNER II - PARTNERII - S3 中期 [PARTNERII S3i]；NCT03222128；PARTNER II 试验：主动脉瓣经导管置换术的放置 - II 期 - 高危和嵌套注册 7 [PII S3HR/NR7]；NCT03222141）。
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