Department of Cardiology and Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Eur Heart J Qual Care Clin Outcomes. 2019 Jul 1;5(3):242-251. doi: 10.1093/ehjqcco/qcy048.
AIMS: To describe temporal trends in adoption and performance of transcatheter aortic valve implantation (TAVI) in Switzerland over a period of 5 years. METHODS AND RESULTS: Between 2011 and 2015, a total of 3493 patients were consecutively included in the SwissTAVI Registry (NCT01368250) and analysed for the purpose of this study. The primary outcome measure was all-cause mortality at 1 year after TAVI. Over the 5-year period, a six-fold increase in the number of procedures was observed, whereas the baseline surgical risk estimated by the Society of Thoracic Surgeon (STS) score declined (from 6.8 ± 4.4% to 4.6 ± 3.6, P < 0.001). Overall, 1-year mortality amounted to 12.8%; mortality was highest in the first annual cohorts (14.6%, 14.8%, and 15.9% in 2011, 2012, and 2013, respectively) and decreased to 13.4% in 2014 and 9.7% in 2015. While rates of cerebrovascular events, peri-procedural myocardial infarction, moderate/severe paravalvular regurgitation, and Stage 3 acute kidney injury did not significantly change over time, a significant reduction in life threatening or major bleeding was noted at 30-day follow-up during the latest compared with earlier years of recruitment. CONCLUSION: This long-term recruitment analysis of a national TAVI registry showed rapid adoption paralleled by a progressive decrease of patients' baseline risk profile. Early and late survival significantly improved over time as did the rate of life threatening or major bleeding.
目的:在 5 年时间内,描述瑞士经导管主动脉瓣植入术(TAVI)采用和实施的时间趋势。
方法和结果:在 2011 年至 2015 年间,共有 3493 例患者连续纳入瑞士 TAVI 注册研究(NCT01368250)并进行了本研究分析。主要终点是 TAVI 后 1 年的全因死亡率。在 5 年期间,手术数量增加了 6 倍,而胸外科医师协会(STS)评分估计的基线手术风险下降(从 6.8±4.4%降至 4.6±3.6,P<0.001)。总体而言,1 年死亡率为 12.8%;第 1 年度队列的死亡率最高(2011 年、2012 年和 2013 年分别为 14.6%、14.8%和 15.9%),随后在 2014 年降至 13.4%,2015 年降至 9.7%。虽然脑血管事件、围手术期心肌梗死、中重度瓣周漏和 3 期急性肾损伤的发生率在时间上没有显著变化,但在最新的招募年份与之前的年份相比,在 30 天随访时,危及生命或大出血的发生率显著降低。
结论:这项全国性 TAVI 注册研究的长期招募分析显示,采用速度很快,患者的基线风险状况逐渐降低。早期和晚期生存率随着危及生命或大出血发生率的降低而显著提高。
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