Background

Although the mechanically expanding Lotus transcatheter heart valve (THV) has been recently withdrawn from the market, the valve has been successfully implanted in a significant number of patients, and long-term outcome beyond 3 years remains unknown.

Objective

Our aim was to investigate the long-term (≥ 3-year) performance of the Lotus THV with respect to different components of bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) using standardized definitions.

Methods

This study included 229 patients treated with transcatheter aortic valve replacement (TAVR) using the Lotus THV at two centers in Germany between November 2013 and February 2017. The median clinical follow-up period of all patients was 3.3 years (IQR 1.0 - 4.6 years). Long-term echocardiographic follow-up at 4.6 years (IQR 3.9 - 5.0; range: 3.0 - 6.7 years) was complete in 61.2%. The principal endpoints were all-cause mortality and long-term BVF after at least 30 days. All possible cases of BVF and bioprosthetic valve dysfunction (BVD) were independently adjudicated.

Results

All-cause mortality at three and five years was 31.6% (95% confidence interval [CI]: 25.6% - 38.6%) and 52.2% (95% CI: 44.5% - 60.4%), respectively. The cumulative incidence of BVF adjusted for all-cause mortality after five years was 6.7% (95% CI: 3.6% - 11.1%). Eight patients required aortic valve reintervention. Among survivors at five years, effective orifice area was 1.6 cm² ± 0.4 cm² and the mean transprosthetic pressure gradient was 13.3 mmHg ± 6.3 mmHg. The cumulative incidence of structural vale deterioration (SVD) adjusted for all-cause mortality after five years was 4.9% (95% CI: 2.4% - 8.8%). There were 12 reported cases of endocarditis, resulting in a relatively high cumulative incidence at five years of 6.4% (95% CI: 3.4% - 10.6%), and 14 cases of clinically relevant valve thrombosis with a cumulative incidence at five years of 6.8% (95% CI: 3.9% - 10.7%).

Conclusion