News | May 27, 2015

Boston Scientific Lotus Valve System Demonstrates Extremely Low PVL Rates

Thirty-day study results presented at EuroPCR 2015 also saw mortality rates under 2 percent

Boston Scientific, Lotus, PVL, RESPOND, REPRISE II, EuroPCR 2015

May 27, 2015 — 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. Study data also showed a cardiovascular mortality rate of less than 2 percent at 30 days.

Thirty-day results for the first 250 patients in the RESPOND Post-Market 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 (both p<0.001 vs. baseline).

 

"These first post-market 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.

For more information: www.bostonscientific.com

Related Content

News | Cardiovascular Clinical Studies

June 24, 2021 — Data captured in American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ...

Home June 24, 2021
Home
News | Cardiovascular Clinical Studies

January 27, 2021 — A New York Institute of Technology research team has secured a five-year $1.8 million grant from the ...

Home January 27, 2021
Home
News | Cardiovascular Clinical Studies

July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to ...

Home July 22, 2020
Home
News | Cardiovascular Clinical Studies

July 1, 2020 — Carag AG announced receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption ...

Home July 01, 2020
Home
News | Cardiovascular Clinical Studies

January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special ...

Home January 20, 2020
Home
News | Cardiovascular Clinical Studies

Environmental and lifestyle issues were popular this year, with pick up from both European Society of Cardiology (ESC) ...

Home December 23, 2019
Home
News | Cardiovascular Clinical Studies

November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have ...

Home November 26, 2019
Home
News | Cardiovascular Clinical Studies

July 10, 2019 — The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During ...

Home July 10, 2019
Home
News | Cardiovascular Clinical Studies

July 3, 2019 — The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to ...

Home July 03, 2019
Home
News | Cardiovascular Clinical Studies

November 19, 2018 — The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent ...

Home November 19, 2018
Home
Subscribe Now