Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Eur Heart J. 2024 Apr 1;45(13):1116-1124. doi: 10.1093/eurheartj/ehae043.
BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. METHODS: The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. RESULTS: Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4). CONCLUSIONS: In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.
背景和目的:经导管主动脉瓣置换术(TAVI)已成为严重主动脉瓣狭窄患者的一种可行治疗选择,适用于广泛的手术风险范围。北欧主动脉瓣介入(NOTION)试验是第一个将低手术风险的患者随机分配至 TAVI 或外科主动脉瓣置换术(SAVR)的试验。本研究的目的是报告 10 年后的临床和生物瓣的结果。
方法:NOTION 试验将 280 例患者随机分为 TAVI 组(自膨式 CoreValve 生物瓣,Medtronic Inc.)(n=145)或 SAVR 组(n=135)。主要复合终点为全因死亡率、卒中和心肌梗死的风险。生物瓣功能障碍(BVD)根据瓣膜学术研究联合会-3 标准分为结构性瓣衰败(SVD)、非结构性瓣功能障碍(NSVD)、临床瓣血栓形成或心内膜炎。严重 SVD 定义为(i)跨瓣压差≥30mmHg 且跨瓣压差增加≥20mmHg,或(ii)严重新瓣内反流。生物瓣失效(BVF)定义为因瓣膜相关原因死亡或在诊断为 BVD、主动脉瓣再介入或严重 SVD 后不明原因死亡的复合率。
结果:TAVI 和 SAVR 的基线特征相似:年龄 79.2±4.9 岁和 79.0±4.7 岁(P=0.7),男性占 52.6%和 53.8%(P=0.8),胸外科医生协会评分<4%的分别为 83.4%和 80.0%(P=0.5)。10 年后,TAVI 组和 SAVR 组的全因死亡率、卒中和心肌梗死的复合结局风险分别为 65.5%和 65.5%(风险比 [HR] 1.0;95%置信区间 [CI] 0.7-1.3;P=0.9),每个单独结局的风险无差异。TAVI 组和 SAVR 组分别有 1.5%和 10.0%(HR 0.2;95%CI 0.04-0.7;P=0.02)发生严重 SVD。严重 NSVD 的累积发生率分别为 20.5%和 43.0%(P<0.001),心内膜炎分别为 7.2%和 7.4%(P=1.0)。无患者发生临床瓣血栓形成。TAVI 组和 SAVR 组分别有 9.7%和 13.8%(HR 0.7;95%CI 0.4-1.5;P=0.4)的患者发生生物瓣失效。
结论:在严重主动脉瓣狭窄且手术风险较低的患者中,随机接受 TAVI 或 SAVR 治疗 10 年后,主要临床结局的风险无差异。与 SAVR 相比,TAVR 后严重生物瓣 SVD 的风险较低,而 BVF 的风险相似。
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