经导管主动脉瓣置换术治疗低手术风险的年轻（<75 岁）重度主动脉瓣狭窄患者的 3 年结果。
Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.
机构信息
Centre Hospitalier Universitaire de Bordeaux, L'Unité Médico-Chirurgicale des Valvulopathies, Chirurgie Cardiaque, Université de Bordeaux, France (T.M.).
Clinique Pasteur, Toulouse, France (D.T., P.B.).
出版信息
Circ Cardiovasc Interv. 2024 Nov;17(11):e014018. doi: 10.1161/CIRCINTERVENTIONS.124.014018. Epub 2024 Oct 18.
BACKGROUND
Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.
METHODS
The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.
RESULTS
In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (<0.001) and lower rates of severe prosthesis-patient mismatch (<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.
CONCLUSIONS
Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.
REGISTRATION
URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.
背景
经导管主动脉瓣置换术（TAVR）是严重主动脉瓣狭窄患者手术的替代方法，但关于低危年轻患者的数据有限。本分析比较了接受 TAVR 与手术的低危患者（<75 岁）的结局。
方法
Evolut 低危试验将 1414 例低危患者随机分为经导管主动脉瓣置换术或手术治疗。我们比较了<75 岁的 TAVR 和手术患者在 3 年时全因死亡率或致残性卒中、相关临床结局和生物瓣性能的发生率。
结果
在<75 岁的患者中，352 例随机接受 TAVR，351 例接受手术。平均年龄为 69.1±4.0 岁（最小 51 岁，最大 74 岁）；胸外科医师学会预测死亡率为 1.7±0.6%。在 3 年时，TAVR 的全因死亡率或致残性卒中为 5.7%，手术为 8.0%（=0.241）。虽然 TAVR 和手术的全因死亡率没有差异，但 TAVR 的致残性卒中发生率较低（0.6%比 2.9%；=0.019），而手术与较低的起搏器植入率相关（7.1%比 TAVR 的 21.0%；<0.001）。两组的瓣膜再干预率（TAVR 1.5%，手术 1.5%，=0.962）均较低。与手术相比，TAVR 的瓣膜性能明显更好，平均主动脉梯度较低（<0.001），严重瓣周漏的发生率较低（<0.001）。两组的瓣膜血栓形成和心内膜炎发生率相似。残余≥中度瓣周漏的发生率无显著差异。
结论
接受经瓣环上、自膨式 TAVR 治疗的<75 岁低危患者 3 年全因死亡率与手术治疗的患者相当，致残性卒中发生率较低。接受 TAVR 治疗的患者瓣膜性能明显更好。
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