According to results of the RESPOND post-market study, the Lotus transcatheter aortic valve implantation (TAVI) device is associated with—a press release reports—excellent safety and efficacy outcomes at 30 days post implantation. These data were presented by Volkmar Falk (German Heart Center, Berlin, Germany) at EuroPCR 2016.
Building on previously presented interim results with 250, 500 and 750 patients, the new RESPOND data from the full trial population of more than 1,000 patients continue to support the use of the Lotus valve in routine clinical practice. The press release states that the data show excellent device performance, a strong safety profile and extremely low rates of paravalvular leak.
Highlights from the RESPOND Study include:
- All-cause mortality at 30 days post-procedure was 2.2% in the as-treated population
- Disabling stroke at 30 days post-procedure occurred in 2.2% of patients
- Permanent pacemaker (PPM) implantation rate at 30 days was 30%
- Correct positioning of one valve in proper location was 99.7%
- Major vascular complications observed in only 2.1% of patients
- Less paravalvular leak than reported with competitive valve
- No/trivial paravalvular leak in 91.9% of patients and mild paravalvular leak in 7.7% of patients at hospital discharge
- Moderate paravalvular leak was only 0.3% and there was no severe paravalvular leak
- Paravalvular leak with Lotus similar to rates seen with surgical valve replacement.