根据手术风险的欧洲经导管主动脉瓣植入队列的一年结果。
One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk.
机构信息
Department of Cardiac, Thoracic and Vascular Science, Interventional Cardiology, University of Padova, Italy (G.T., M.M.).
Department of Interventional Cardiology, Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Massy, France (T.L.).
出版信息
Circ Cardiovasc Interv. 2019 Jan;12(1):e006724. doi: 10.1161/CIRCINTERVENTIONS.118.006724.
BACKGROUND
Transcatheter aortic valve implantation is increasingly being used in patients at lower risk for surgery. We aimed to assess the distribution of surgical risk score categories in current clinical practice and their relationship with clinical outcomes and the calibration and discrimination power of both the logistic EuroSCORE (logES) and EuroSCORE II. The SOURCE 3 study is a European prospective registry of patients with severe aortic stenosis treated with the commercially available SAPIEN 3 transcatheter heart valve.
METHODS AND RESULTS
Out of 1785 patients, 518 patients (low-surgical risk) had a baseline logES <10%, 691 (intermediate-surgical risk) had a logES 10% to 20%, and only 576 patients (high-surgical risk) had a logES ≥20%. Even if low-risk patients were younger compared with the other groups, the mean age was about 80 years old in each risk category. At 1 year, all-cause mortality was 10.3%, 11.4%, and 17.1% in low-, intermediate-, or high-surgical risk patients, respectively, while cardiac mortality was 5.3%, 7.7%, and 11.4%, respectively. Observed mortality rates were substantially lower than that predicted with logES. The observed/predicted mortality ratio was 0.26 in low-surgical risk patients, 0.08 in intermediate-surgical risk patients, and 0.12 in high-surgical risk patients. Similar observations were obtained with EuroSCORE II.
CONCLUSIONS
In this real-world setting, two-thirds of SAPIEN 3 transcatheter heart valve treated transcatheter aortic valve implantation patients had a logES <20 but were still considered appropriate transcatheter aortic valve implantation candidates by the heart team, mainly because of older age and less frequently because of conditions not captured by risk scores. logES and EuroSCORE II had poor discrimination and calibration power in this transcatheter aortic valve implantation cohort.
CLINICAL TRIAL REGISTRATION
URL: https://clinicaltrials.gov . Unique identifier: NCT02698956.
背景
经导管主动脉瓣植入术越来越多地用于手术风险较低的患者。我们旨在评估当前临床实践中手术风险评分类别的分布情况，以及它们与临床结局的关系，以及逻辑 EuroSCORE（logES）和 EuroSCORE II 的校准和区分能力。SOURCE 3 研究是一项针对接受商业上可获得的 SAPIEN 3 经导管心脏瓣膜治疗的严重主动脉瓣狭窄患者的欧洲前瞻性登记研究。
方法和结果
在 1785 名患者中，518 名（低手术风险）基线 logES<10%，691 名（中手术风险）logES 为 10%至 20%，仅有 576 名（高手术风险）logES≥20%。即使低危患者比其他组年轻，但每个风险组的平均年龄都在 80 岁左右。在 1 年时，低、中、高手术风险患者的全因死亡率分别为 10.3%、11.4%和 17.1%，而心脏死亡率分别为 5.3%、7.7%和 11.4%。观察到的死亡率明显低于 logES 预测的死亡率。低手术风险患者的观察/预测死亡率比值为 0.26，中手术风险患者为 0.08，高手术风险患者为 0.12。用 EuroSCORE II 也得到了类似的观察结果。
结论
在这个真实世界的环境中，三分之二的 SAPIEN 3 经导管心脏瓣膜治疗的经导管主动脉瓣植入术患者 logES<20，但仍被心脏团队认为是合适的经导管主动脉瓣植入术候选者，主要是因为年龄较大，而不是因为风险评分未涵盖的情况。logES 和 EuroSCORE II 在这个经导管主动脉瓣植入术队列中区分能力和校准能力都较差。
临床试验注册
网址：[URL]。唯一标识符：NCT02698956。
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