Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China.
Department of Anesthesia, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China.
Herz. 2021 Feb;46(1):63-70. doi: 10.1007/s00059-018-4778-z. Epub 2019 Jan 29.
In the West, the safety and efficacy of the Lotus valve have been demonstrated; however, data in the Chinese population are still lacking. Few studies have compared the clinical outcomes of transcatheter aortic valve replacement (TAVR) with the Lotus valve in patients with bicuspid or tricuspid aortic valve stenosis. Our aim was to assess TAVR outcomes with the Lotus aortic valve in a Chinese patient cohort.
In total, 23 symptomatic, high-surgical risk patients with severe aortic valve stenosis were enrolled. Among them, nine patients (39%) had bicuspid aortic valves, and three patients had a large annulus dimension. The Lotus valve was successfully implanted in all patients. To facilitate accurate positioning, partial re-sheathing was attempted in ten patients (43.5%), while one patient had a full retrieval. One-year clinical follow-up was completed in all patients.
There were no deaths, strokes, or major adverse cardiac and cerebrovascular events in 22 of the 23 patients at 30 days; the all-cause mortality rate at 1 year was 4.4% (1 of 23 patients). The mean aortic valve gradient decreased from 51.5 ± 8.8 mm Hg at baseline to 13.4 ± 4.9 mm Hg (p < 0.001) and the valve area increased from 0.6 ± 0.2 cm to 1.5 ± 0.4 cm (p < 0.001) at 30 days. Paravalvular leakage was absent or mild (22%), and no patient had severe paravalvular leakage. Six patients (26.1%) required a postprocedural pacemaker. There was no difference regarding the procedural and the 1‑year outcomes between patients with bicuspid and tricuspid aortic valve stenosis.
Our single-center experience demonstrated that the Lotus valve is feasible and effective for Chinese patients with aortic valve stenosis, including atypical cases with bicuspid aortic valves or large aortic annulus size.
在西方，Lotus 瓣膜的安全性和有效性已得到证实；然而，中国人群的数据仍缺乏。很少有研究比较经导管主动脉瓣置换术（TAVR）与 Lotus 瓣膜在二叶式主动脉瓣或三叶式主动脉瓣狭窄患者中的临床结果。我们的目的是评估 Lotus 主动脉瓣在一个中国患者队列中的 TAVR 结果。
共有 23 名有症状、高手术风险的严重主动脉瓣狭窄患者入组。其中，9 名患者（39%）有二叶式主动脉瓣，3 名患者主动脉瓣环较大。所有患者均成功植入 Lotus 瓣膜。为了便于准确定位，10 名患者（43.5%）尝试部分重新护套，1 名患者完全取回。所有患者均完成了 1 年临床随访。
23 名患者中有 22 名在 30 天内无死亡、中风或主要心脏和脑血管不良事件；1 年总死亡率为 4.4%（23 名患者中有 1 名）。主动脉瓣跨瓣压差从基线时的 51.5±8.8mmHg 降至 13.4±4.9mmHg（p<0.001），瓣口面积从 0.6±0.2cm 增加至 1.5±0.4cm（p<0.001）。瓣周漏为无或轻度（22%），无患者发生严重瓣周漏。6 名患者（26.1%）需要术后起搏器。二叶式主动脉瓣和三叶式主动脉瓣狭窄患者的手术和 1 年结果无差异。
我们的单中心经验表明，Lotus 瓣膜对中国主动脉瓣狭窄患者是可行和有效的，包括二叶式主动脉瓣或主动脉瓣环较大的非典型病例。
