Boston Scientific's Lotus TAVR System Demonstrates Low PVL Rates

May 20, 2015—Boston Scientific Corporation announced that a study evaluating the company’s Lotus transcatheter aortic valve replacement (TAVR) system demonstrated an extremely low rate of paravalvular aortic leak (PVL) plus a cardiovascular mortality rate of < 2% at 30 days. 

Nicolas M. Van Mieghem, MD, presented the 30-day results for the first 250 patients in the RESPOND postmarket study at the EuroPCR 2015 conference in Paris, France. Dr. Van Mieghem, who is with Erasmus Medical Center in Rotterdam, the Netherlands, is the study’s Coprincipal Investigator. 

Also at EuroPCR, Daniel Blackman, MD, reported the rates and predictors for PVL with the Lotus device from the REPRISE II extended cohort. Dr. Blackman is with Leeds General Infirmary in Leeds, United Kingdom.

Boston Scientific advised that the Lotus valve system is an investigational device and is not available for sale in the United States. The Lotus device has received European CE Mark approval and is available for sale in Europe and in countries that recognize the CE Mark.  

As summarized by the company, the RESPOND trial’s key findings include:

• > 95% of patients at hospital discharge had no or trace PVL, < 5% had mild PVL, and no patients exhibited moderate or severe PVL (as assessed by an independent core lab); 
• The cardiovascular mortality rate was 1.6% at 30 days; and
• The mean pressure gradient and effective orifice area were 10.1 ± 3.7 mm Hg and 1.9 cm² ± 0.4 (both P < .001 vs baseline).

In Boston Scientific’s press release, Dr. Van Mieghem commented, “These first postmarket study data from the RESPOND trial demonstrate that the Lotus valve system can be used in clinical practice with an excellent safety profile and unprecedented low PVL rates. The absence of PVL is associated with favorable long-term survival.”

The REPRISE II extended cohort involved 250 patients who were evaluated at 30 days after implantation. Key findings include:

• Approximately 86% of patients had either no PVL or trace PVL, < 14% had mild PVL, and < 1% had moderate PVL (as assessed by an independent core lab);
• No patients had severe PVL; and
• Significant independent predictors of PVL included device annulus area ratio and calcium volume.

Strong performance results from both studies continue to reinforce TAVR with the Lotus valve as a less invasive treatment alternative for patients with severe aortic valve stenosis who are considered to be at high risk for surgical valve replacement, stated Boston Scientific.