PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：可从随机试验中获得有限的数据，这些试验比较了经导管主动脉瓣置换术（TAVR）和手术在不同风险患者中的结局，随访时间至少为4年或更长。在这个大的，基于人群的队列研究，研究了使用手术植入生物假体(sB-AVR)或TAVR进行主动脉瓣置换术(AVR)治疗严重主动脉瓣狭窄的患者的长期死亡率和发病率.
方法：分析了2010年至2020年奥地利保险基金的个人数据。主要结果是全因死亡率，在总体和倾向得分匹配的人群中进行评估。次要结果包括再次手术和心血管事件。
结果：从2010年1月到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年（95%CI5.7-5.9）（最长12.3年）。与sB-AVR相比，TAVR的全因死亡率风险更高：风险比（HR）1.552，95％置信区间（CI）1.469-1.640，p<0.001；倾向评分匹配HR1.510，1.403-1.625，p<0.001。sB-AVR的估计中位生存期为8.8年（95％CI8.6-9.1），TAVR为5年（4.9-5.2）。sB-AVR的5年生存率估计为0.664（0.664-0.686），TAVR的5年生存率为0.409（0.378-0.444），和0.690（0.674-0.707）和0.560（0.540-0.582），分别,倾向得分匹配。对年龄在65-75岁和>75岁的患者的单独亚组分析表明，两组中选择sB-AVR的患者均有显着的生存益处。死亡率的其他预测因素是年龄，性别,以前的心力衰竭,糖尿病,和慢性肾病。
结论：在这项基于人群的国家回顾性研究中，在≥65岁的重度患者中,与sB-AVR相比,选择TAVR与全因死亡率显著相关,症状性主动脉瓣狭窄>2年随访。
方法：分析了2010年至2020年奥地利保险基金的个人数据。主要结果是全因死亡率，在总体和倾向得分匹配的人群中进行评估。次要结果包括再次手术和心血管事件。
结果：从2010年1月到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年（95%CI5.7-5.9）（最长12.3年）。与sB-AVR相比，TAVR的全因死亡率风险更高：风险比（HR）1.552，95％置信区间（CI）1.469-1.640，p<0.001；倾向评分匹配HR1.510，1.403-1.625，p<0.001。sB-AVR的估计中位生存期为8.8年（95％CI8.6-9.1），TAVR为5年（4.9-5.2）。sB-AVR的5年生存率估计为0.664（0.664-0.686），TAVR的5年生存率为0.409（0.378-0.444），和0.690（0.674-0.707）和0.560（0.540-0.582），分别,倾向得分匹配。对年龄在65-75岁和>75岁的患者的单独亚组分析表明，两组中选择sB-AVR的患者均有显着的生存益处。死亡率的其他预测因素是年龄，性别,以前的心力衰竭,糖尿病,和慢性肾病。
结论：在这项基于人群的国家回顾性研究中，在≥65岁的重度患者中,与sB-AVR相比,选择TAVR与全因死亡率显著相关,症状性主动脉瓣狭窄>2年随访。
