Cardiac Catheterization Laboratory and Cardiology, ASST Spedali Civili Brescia and Department of Medical and Surgery Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.
Catheter Cardiovasc Interv. 2023 Nov;102(6):1132-1139. doi: 10.1002/ccd.30813. Epub 2023 Sep 5.
BACKGROUND: Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. AIMS: To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). METHODS: The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. RESULTS: Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure [BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. CONCLUSIONS: The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.
背景：关于经导管心脏瓣膜（THV）在二叶式主动脉瓣（BAV）狭窄中的耐用性，目前数据有限。
目的：评估经导管主动脉瓣植入术（TAVI）治疗二叶式主动脉瓣狭窄患者的 4 年临床和超声心动图结果。
方法：bicuSpid TAvi duraBILITY（STABILITY）注册研究是一项意大利多中心注册研究，纳入了 2011 年 1 月至 2017 年 12 月期间因严重主动脉瓣狭窄（AS）而接受 TAVI 治疗的所有连续的 BAV 患者。主要观察终点为 4 年时的全因死亡率，超声心动图测量值的随时间变化以及根据瓣膜主动脉研究协会（VARC）-3 更新定义的 THV 耐用性。
结果：研究人群包括 109 例患者（50%为女性；平均年龄 78±7.5 岁），平均胸外科医师协会预测死亡率评分（STS-PROM）为 5.1±4.3%。中位随访（FU）时间为 4.1 年[四分位距（IQR）：2.8-5.1]。Kaplan-Meier 估计的 4 年全因死亡率累计发生率为 32%。与基线相比，TAVI 后跨瓣平均压差显著降低（54±16 比 10±5mmHg；p<0.001），而 4 年时则显著升高（13±6.4mmHg，p=0.03）。血流动力学瓣膜功能障碍（HVD）的累计发生率为 4%。6 例患者符合 HVD 标准：3 例为中度，3 例为重度 HVD。3 例严重 HVD 均为临床相关（生物瓣失效[BVF]），其中 2 例患者接受了再次介入治疗（TAVI 中再次 TAVI），1 例患者因感染性心内膜炎而死于瓣膜相关死亡。
结论：STABILITY 注册研究表明，在接受 TAVI 治疗的严重 AS 和 BAV 患者中，术后临床获益可能会持续，4 年的 FU 期间随时间推移逐渐增加。严重 HVD 和 BVF 的低发生率可能支持 THV 在 BAV 患者中也具有良好耐用性的假设。
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