Positive clinical data for Medtronic’s investigational Avalus pericardial aortic surgical valve were presented yesterday at the 2016 European Cardio-Thoracic Surgery (EACTS) annual meeting (1-5 October, Barcelona, Spain). The results from the PERIGON (Pericardial surgical aortic valve replacement) pivotal trial showed low rates of adverse valve-related events, high survival and improved haemodynamic performance at one year for the device.
According to a press release, the trial is one of the largest, most comprehensive, and modern data sets of surgical aortic valve replacement patients. It is a single arm, non-randomised, prospective study of approximately 1,300 patients from 40 clinical sites across Europe, Canada, Japan and the USA. In the cohort presented at EACTS, outcomes of 270 patients were analysed at the one-year endpoint. The vast majority (91%) of patients were at low mortality risk for open heart surgery (STS ≤4%), with the remaining 8% at intermediate risk (STS = 4-8%) and <1% at high risk (STS≥8%). At one year, all patients showed low rates of all-cause mortality (3.6 %) and cardiac death (1.1%).
The primary analysis demonstrated positive clinical outcomes at one year, with low linearised rates of thromboembolism (2.2%), endocarditis (1%), all paravalvular leaks (0.5%), all haemorrhages (3.7%) and major haemorrhages (2.7%). No thrombosis, haemolysis, severe paravalvular leaks or structural valve deterioration were observed at one year.
Additionally, patients treated with the supra-annular design of the Avalus valve also experienced improved haaemodynamic (blood flow) performance with mean aortic gradients improving from 42.3mmHg at baseline to 12.6mmHg at one year. Also, nearly three-fourths of patients improved one or two NYHA Functional Classes from baseline to one year across all valve sizes.
PERIGON co-principal investigator and study presenter, Robert Klautz (Department of cardiothoracic surgery at the Leiden University Medical Center, The Netherlands) says: As surgical aortic valve replacement remains one of the most important treatment options for patients, the one-year outcomes from the PERIGON trial demonstrate how the advanced design elements of Avalus contribute to positive valve performance and clinical outcomes. The value of this large, contemporary dataset is that it allows surgeons to better understand treatment for today’s SAVR patients, as opposed to data from older studies that may not be as representative.”
The Avalus valve is not approved for commercial use in the United States or Europe.