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PERIGON: Novel surgical aortic valve shows positive 1-year outcomes
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A novel pericardial surgical aortic valve was associated with positive 1-year outcomes in patients with aortic valve disease, according to findings presented at the European Association for Cardio-Thoracic Surgery Annual Meeting.
For the PERIGON pivotal trial, researchers evaluated performance of the valve (Avalus, Medtronic) in 753 patients with moderate or greater aortic stenosis or aortic regurgitation.
Safety endpoints included death, thromboembolism, valve thrombosis, hemorrhage, paravalvular regurgitation and endocarditis. Effectiveness endpoints included NYHA functional class and hemodynamic performance.
Of the 753 patients enrolled, 749 had a baseline evaluation, 686 (mean age, 71 years; 74% men) had an evaluation just after the procedure, 683 had an evaluation at discharge, 613 had an evaluation at 3 to 6 months and 270 had an evaluation at 1 year, Robert Klautz, MD, head of the department of cardiothoracic surgery at Leiden University Medical Center in the Netherlands, said at the meeting.
At 1 year, rates of the following were low: thromboembolism (2.2%), valve thrombosis (0%), all paravalvular leak (0.5%), major paravalvular leak (0%), endocarditis (1%), all hemorrhage (3.7%) and major hemorrhage (2.7%), according to Klautz.
At discharge, 88% of patients were assigned an antiplatelet agent, 44% were assigned warfarin and 34% were assigned both, but at 1 year, those numbers fell to 82% for antiplatelets, 19% for warfarin and 10% for both, he said.
At 1 year, 96% of patients were free from death, 99% were free from CV death and 99% were free from valve-related death, he said.
Only 11% of patients were NYHA class I at discharge, but that figure rose to 70% at 3 to 6 months and 71% at 1 year, with nearly 75% of patients improving at least one NYHA class at 1 year, according to the researchers.
Mean aortic gradient improved from 42.3 mm Hg at baseline to 12.6 mm Hg at 1 year, whereas effective orifice area improved from 0.9 cm3 at baseline to 1.5 cm3 at 1 year.
“The 1-year outcomes from the PERIGON trial demonstrate how the advanced design elements of Avalus contribute to positive valve performance and clinical outcomes,” Klautz said in a press release.
The device is not yet approved for use in the United States. – by Erik Swain
Reference:
Klautz R. Innovations in treatment of aortic valve disease. Presented at: European Association for Cardio-Thoracic Surgery Annual Meeting; Oct. 1-5, 2016; Barcelona, Spain.
Disclosure: The study was funded by Medtronic. Klautz reports receiving institutional research grants from Edwards Lifesciences and Medtronic, and receiving reimbursement travel and presentation-related expenses from several companies.