Abbott says study shows Portico safely reduced severe aortic stenosis
Abbott announced one-year results from a real-world, international, multicenter, 941-patient study of the company's Portico transcatheter aortic valve replacement system in patients with symptomatic, severe aortic stenosis - a life-threatening narrowing of the heart's aortic valve. At one year, implantation with the Portico valve was safe and associated with low rates of stroke, death and leaks between patients' natural heart tissue and the Portico valve. The one-year results from the PORTICO I study were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation in San Diego, and simultaneously published in the Journal of the American College of Cardiology. Results at one year were consistent with 30-day results reported earlier this year; with data used to support CE Mark; and with data and results from other commercially available TAVR valves. Portico is under investigation in the United States. "Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence," said Lars Sondergaard, M.D., DMSc, Rigshospitalet, Copenhagen, Denmark and principal investigator of the study. "These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery." In this study, at one year, patients who received a Portico valve had low rates of mortality, stroke, paravalvular leak, and sustained significantly improved hemodynamic performance. All-cause and cardiovascular mortality were 12.1 percent and 6.6 percent, respectively; disabling stroke was observed in 2.2 percent of patients and myocardial infarction in 2.5 percent. Mean aortic valve area increased from baseline to 30 days and was durable at one year. Moderate paravalvular leak was low, decreasing from 3.9 percent of patients at 30 days to 2.6 percent of patients at one year. The proportion of patients classified with severe heart failure decreased from 63.8 percent at baseline to 7.7 percent at one year.