Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve : A Chinese single-center experience.

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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 cm2 to 1.5 ± 0.4 cm2 (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.

CONCLUSION: 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.