Boston Scientific Reports Solid Postmarket Study Data on its TAVI Device at EuroPCR

A new study evaluating the Boston Scientific Lotus Valve System demonstrated an extremely low rate of paravalvular aortic regurgitation (leakage) for a transcatheter aortic replacement valve, plus a cardiovascular mortality rate of less than two percent at 30 days.

The 30-day results for the first 250 patients in the RESPOND postmarket study were presented at EuroPCR 2015 in Paris by Nicolas M. Van Mieghem, M.D., co-principal investigator, Erasmus Medical Center in Rotterdam, the Netherlands.

Key findings include the following:
• More than 95 percent of patients at hospital discharge had no or trace paravalvular aortic regurgitation (PVL), less than 5 percent 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 percent at 30 days; and
• The mean pressure gradient and effective orifice area (EOA), measures used to assess the hemodynamic performance of the valve, were 10.1 +/- 3.7 mmHg and 1.9 cm2 +/- 0.4

“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,” said Van Mieghem.  “The absence of PVL is associated with favorable long-term survival.”

In addition, rates and predictors for PVL were reported today from the REPRISE II Extended Cohort by Daniel Blackman, M.D., Leeds General Infirmary, Leeds, England.

Key findings in the trial, involving 250 patients evaluated at 30 days post implantation, include the following:
• Nearly 86 percent of patients had either no PVL or trace PVL; less than 14 percent had mild PVL and less than 1 percent 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 this therapy 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, according to Boston Scientific bigwigs.

“These results are further evidence that the Lotus valve design, its precise placement and redeployment capabilities and its low rates of paravalvular regurgitation can make a significant and meaningful difference in the lives of patients,” said Keith D. Dawkins, M.D., global chief medical officer, Boston Scientific.

The Lotus Valve System is a differentiated next-generation transcatheter aortic valve implantation (TAVI) device, consisting of a pre-attached, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.  According to the company, it is the first TAVI device to offer controlled mechanical expansion, allowing the valve to be fully deployed, assessed and then released, providing improved control during the procedure.  The early valve function provides hemodynamic stability throughout the procedure and if necessary, the valve can be completely repositioned at any time prior to release.  The device also features a unique seal designed to minimize the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.

In the United States, the Lotus Valve System is an investigational device and not available for sale. It does have CE mark.

Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart.  Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow.  Aortic stenosis is a common problem affecting approximately three percent of the population older than the age 65 and five percent of people older than 75.  From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.

Boston Scientific is based in Marlborough, Mass.