Department of Internal Medicine I with Cardiology and Intensive Care, St Josef Hospital Braunau, Braunau am Inn, Austria.
Center for Medical Data Science, Medical University of Vienna, Vienna, Austria.
Eur J Cardiothorac Surg. 2024 Jul 1;66(1). doi: 10.1093/ejcts/ezae214.
Limited data are available from randomized trials comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgery in patients with different risks and with follow-up of at least 4 years or longer. In this large, population-based cohort study, long-term mortality and morbidity were investigated in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis using a surgically implanted bioprosthesis (surgical/biological aortic valve replacement; sB-AVR) or TAVR.
Individual data from the Austrian Insurance Funds from 2010 through 2020 were analysed. The primary outcome was all-cause mortality, assessed in the overall and propensity score-matched populations. Secondary outcomes included reoperation and cardiovascular events.
From January 2010 through December 2020, a total of 18 882 patients underwent sB-AVR (n = 11 749; 62.2%) or TAVR (n = 7133; 37.8%); median follow-up was 5.8 (95% CI 5.7-5.9) years (maximum 12.3 years). The risk of all-cause mortality was higher with TAVR compared with sB-AVR: hazard ratio 1.552, 95% confidence interval (CI) 1.469-1.640, P < 0.001; propensity score-matched hazard ratio 1.510, 1.403-1.625, P < 0.001. Estimated median survival was 8.8 years (95% CI 8.6-9.1) with sB-AVR versus 5 years (4.9-5.2) with TAVR. Estimated 5-year survival probability was 0.664 (0.664-0.686) with sB-AVR versus 0.409 (0.378-0.444) with TAVR overall, and 0.690 (0.674-0.707) and 0.560 (0.540-0.582), respectively, with propensity score matching. Separate subgroup analyses for patients aged 65-75 years and >75 years indicated a significant survival benefit in patients selected for sB-AVR in both groups. Other predictors of mortality were age, sex, previous heart failure, diabetes and chronic kidney disease.
In this retrospective national population-based study, selection for TAVR was significantly associated with higher all-cause mortality compared with sB-AVR in patients ≥65 years with severe, symptomatic aortic stenosis in the >2-year follow-up.
在不同风险的患者中,经导管主动脉瓣置换术(TAVR)与手术的结局比较的随机试验数据有限,且随访时间至少为 4 年或更长。在这项大型基于人群的队列研究中,使用经外科植入的生物假体(外科/生物主动脉瓣置换术;sB-AVR)或 TAVR 对患有严重主动脉瓣狭窄的患者进行主动脉瓣置换(AVR),研究了长期死亡率和发病率。
对 2010 年至 2020 年奥地利保险基金的个人数据进行了分析。主要结局是全因死亡率,在总体人群和倾向评分匹配人群中进行评估。次要结局包括再次手术和心血管事件。
2010 年 1 月至 2020 年 12 月,共有 18882 例患者接受了 sB-AVR(n=11749;62.2%)或 TAVR(n=7133;37.8%);中位随访时间为 5.8(95%置信区间 5.7-5.9)年(最长 12.3 年)。与 sB-AVR 相比,TAVR 的全因死亡率更高:风险比 1.552,95%置信区间(CI)1.469-1.640,P<0.001;倾向评分匹配风险比 1.510,1.403-1.625,P<0.001。sB-AVR 的估计中位生存期为 8.8 年(95%CI 8.6-9.1),而 TAVR 为 5 年(4.9-5.2)。总体而言,sB-AVR 的估计 5 年生存率为 0.664(0.664-0.686),而 TAVR 为 0.409(0.378-0.444),经倾向评分匹配后,分别为 0.690(0.674-0.707)和 0.560(0.540-0.582)。对于年龄在 65-75 岁和>75 岁的患者的单独亚组分析表明,在这两组患者中,选择 sB-AVR 与生存率显著提高相关。其他死亡率预测因素包括年龄、性别、既往心力衰竭、糖尿病和慢性肾脏病。
在这项回顾性全国基于人群的研究中,在>2 年的随访中,与 sB-AVR 相比,年龄≥65 岁、有症状的严重主动脉瓣狭窄患者选择 TAVR 与全因死亡率显著升高相关。