Post-market study evaluating the Lotus valve system demonstrates low paravalvular aortic regurgitation rates

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A study evaluating the Boston Scientific Lotus valve system has demonstrated a low rate of paravalvular aortic regurgitation for a transcatheter aortic replacement valve, plus a cardiovascular mortality rate of less than 2% at 30 days.

Thirty-day results for the first 250 patients in the RESPOND post-market study were presented at EuroPCR 2015 (19–22 May, Paris, France) by Nicolas M Van Mieghem, co-principal investigator, Erasmus Medical Center in Rotterdam, the Netherlands. Key findings include the following:

  • More than 95% of patients at hospital discharge had no or trace paravalvular aortic regurgitation (PVL), less than 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 (EOA), measures used to assess the haemodynamic performance of the valve, were 10.1 +/- 3.7mmHg and 1.9cm2 +/- 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 favourable long-term survival.”

In addition, rates and predictors for PVL were reported from the REPRISE II Extended Cohort by Daniel Blackman, Leeds General Infirmary, Leeds, UK. Key findings in the trial, involving 250 patients evaluated at 30 days post implantation, include the following:

  • Nearly 86% of patients had either no PVL or trace PVL; less than 14% had mild PVL and less than 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 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.

“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, global chief medical officer, Boston Scientific.

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