medtronic corevalve evolut pro

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In addition to the intention-to-treat analysis, the researchers conducted a per-protocol analysis. “SMART will allow Medtronic to look for a more niche indication for their valve if it ultimately has higher mortality than Sapien in all-comers,” said Goldsweig. CRF is committed to igniting the next wave of innovation in research and education that will help doctors save and improve the quality of their patients’ lives. As individual endpoints, there was no difference in the risk of all-cause mortality or stroke at 30 days or 1 year. The Medtronic CoreValve™ Evolut™ R system is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be “However, these have to be weighed against the increase in paravalvular leak versus both [Sapien 3 and CoreValve Evolut] and the potential increase in cardiac death noted in SCOPE 2,” said Tamburino. Herrmann reports institutional grant support from Abbott Vascular, Ancora, Bayer, Boston Scientific, Edwards Lifesciences, Medtronic, Shockwave, University of Laval, and W.L. The primary endpoint is noninferiority with respect to all-cause mortality, stroke, or rehospitalization at 12 months and superiority of CoreValve Evolut over Sapien 3 with respect to hemodynamic performance. In addition to the intention-to-treat analysis, the researchers conducted a per-protocol analysis. Enter the email you used to register to reset your password. “But I think we would need some of that data before we would want to adopt it on faith that it is going to be better than Acurate neo,” said Herrmann. Receive the the latest news, research, and presentations from major meetings right to your inbox. , Howard Herrmann, MD (Hospital of the University of Pennsylvania/Penn Medicine, Philadelphia), said SCOPE 2 is the first trial comparing two self-expanding transcatheter heart valves, even though Acurate neo is not available in the United States (it has been approved in Europe since 2014). The study included 796 patients aged 75 years or older (mean 83.2 years; 68% women) with symptomatic severe aortic stenosis deemed at increased risk for mortality with surgical valve replacement (mean STS-PROM score 4.6%). In SCOPE II, the primary endpoint of death or stroke at 1 year occurred in 15.8% of patients treated with Acurate neo and 13.9% of those who received CoreValve Evolut, a difference that failed to meet the trial’s statistical benchmark for noninferiority (P = 0.0549). The studies provide consistent data establishing the safety and efficacy of the CoreValve system, and confirm its durability out to five years. In that comparison, Acurate neo was statistically noninferior to CoreValve with respect to the primary endpoint of death and stroke at 1 year (15.3% with Acurate neo vs 14.3% with CoreValve Evolut; At 30 days, there was a significantly increased risk of cardiac death among patients treated with Acurate neo (3.0% vs 1.0% with CoreValve Evolut; There was a bright spot, however, with the Acurate neo device associated with significantly less need for a new permanent pacemaker at 30 days (11.% vs 18.0% with CoreValve Evolut; To TCTMD, Tamburino said there are some theoretical advantages to the Acurate neo device, such as when a. prosthesis with supra-annular design is desired or when there might be a need for future access to the coronary arteries in patients with CAD. The Dublin-based med-tech giant also has begun a feasibility … The low pacemaker rate is also an upside. “The future is going to be understanding the nuances of these devices and so that we can tailor clinical decision-making to choose the best valve for each individual,” he said. However, as Tamburino pointed out in the press conference, the statistical plan did not allow them to claim noninferiority because the findings were inconsistent with the intention-to-treat analysis. The Evolut PRO system goes beyond the CoreValve™ and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve.

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