Postmarket RESPOND Data Reported for Boston Scientific's Lotus TAVR Device

May 17, 2016—Results from the postmarket RESPOND study evaluating the Lotus valve (Boston Scientific Corporation) for transcatheter aortic valve replacement (TAVR) were presented by Prof. Volkmar Falk, MD, at the EuroPCR 2016 conference held May 17–20 in Paris, France. Prof. Falk is Director of the Department of Cardiothoracic Vascular Surgery at the German Heart Center in Berlin, Germany.

According to Boston Scientific, the data, which build on previously presented interim results for 250, 500, and 750 patients, demonstrate excellent outcomes of key safety and efficacy endpoints through 30 days after the procedure. 

The new RESPOND data from the full trial population of more than 1,000 patients continue to support the use of the Lotus TAVR device in routine clinical practice. The data show excellent device performance, a strong safety profile, and extremely low rates of paravalvular leak (PVL), which is associated with long-term survival, noted the company.

Boston Scientific reported that at 30-day follow-up, all-cause mortality was 2.2% in the as-treated population, disabling stroke occurred in 2.2% of patients, the rate of permanent pacemaker was 30%, correct positioning of one valve in proper location was 99.7%, and the rate of major vascular complications was 2.1%.

The company also advised that treatment with the Lotus valve resulted in less PVL than reported with competitive valves and similar rates as seen with surgical valve replacement. Non/trivial PVL was reported in 91.9% of patients and mild PVL was seen in 7.7% of patients at hospital discharge. The rate of moderate PVL was 0.3% and there was no severe PVL.