背景:2019年,美国食品和药物管理局(FDA)批准经导管主动脉瓣置换术(TAVR)用于有症状的严重三尖瓣主动脉瓣狭窄的低危患者。然而,二叶主动脉瓣(BAV)患者仅纳入关键低风险TAVR试验的单臂登记,导致此子组的数据有限。
方法:LRT(低风险TAVR)试验由研究者发起,prospective,多中心研究和第一个FDA批准的研究性设备豁免试验,以评估TAVR在有症状的重度BAV狭窄的低危患者中球囊扩张或自扩张瓣膜的可行性。该分析报告了2年的随访,评估全因死亡率的主要结局并评估临床结局.
结果:从2016年到2019年,共有72名低风险患者被诊断为有症状,6个中心的重度BAV狭窄患者接受TAVR治疗.6名患者失访。在2年的随访中,死亡率为1.5%(66例患者中的1例).在剩下的65名患者中,4例经历非致残性中风(6.2%),2例(3.1%)发生感染性心内膜炎。在30天的随访之后,不需要新的永久性起搏器,没有病人,包括心内膜炎患者,需要主动脉瓣再介入。在2年的超声心动图随访(n=65),27.8%的BAV患者出现轻度主动脉瓣反流,没有表现出中度或重度反流。平均主动脉梯度为12.1±4.1mmHg,平均瓣膜面积为1.7±0.5cm²。
结论:2年的随访证实,TAVR在二叶主动脉瓣狭窄患者中的临床效果良好,建立其明显的安全性。
BACKGROUND: In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup.
METHODS: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes.
RESULTS: From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm².
CONCLUSIONS: The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.