Findings included cusp overlap technique (COT) outcomes from the Optimize PRO clinical study and pooled analysis looking at Evolut Pro patients showing improvement in paravalvular leak (PVL) over time following hospital discharge. Investigators presented the new studies at PCR London Valves 2024.
One paired analysis looked at improvement in PVL over time post-TAVR with Evolut Pro in patients with severe symptomatic aortic stenosis (SSAS). It analyzed core lab echocardiographic data from 620 patients treated with Evolut Pro from multiple studies. The analysis demonstrated improvements in PVL severity after 30 days post-hospital discharge out to the three-year follow-up.
Thirty-day findings from the Optimize PRO global study demonstrated that the utilization of the COT with Evolut Pro and Pro+ devices led to more favorable procedural and clinical outcomes. The multi-center, post-market, prospective study took place across 50 centers around the world. It demonstrated low rates of new 30-day permanent pacemaker implantation (6.4% with COT compliance and 11.1% overall). It also showed no moderate or severe aortic regurgitation at discharge.
According to Medtronic, the studies come at a time of increasing need for TAVR as clinicians seek new clinical insights for the treatment of symptomatic severe aortic stenosis, specifically when it comes to procedural and clinical outcomes and common complications such as PVL.
