Abbott's Portico transcatheter aortic valve replacement (TAVR) system has reduced severe aortic stenosis in a real-world, international, multicenter, 941-patient study.
Image: Abbott’s new study on safety of Portico TAVR shows positive results. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
The study was carried out 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 related with low rates of stroke, death and leaks between patients’ natural heart tissue and the Portico valve.
Results from the PORTICO I study were presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT) held in San Diego, California.
Abbott claims that results at one year were consistent with the 30 day results reported earlier this year.
The Portico transcatheter valve is a minimally invasive alternative to surgical aortic valve replacement for patients with severe aortic stenosis. These partients are high-risk candidates for open-heart surgery.
Aortic stenosis is life-threatening valve disease where the aortic valve opening in the heart narrows and restricts blood flow from the left ventricle to the aorta. It is estimated that more than one in eight people of age 75 and above have moderate or severe aortic stenosis, which can reduce the pumping ability of the heart.
Generally, symptoms do not appear for decades for most patients, but once symptoms start appearing, it could result in shortness of breath, fatigue and ultimately heart failure, without surgical intervention.
Results from the study, at one year, show that the 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% and 6.6, respectively. Disabling stroke was seen in 2.2% of patients and myocardial infarction in 2.5%. Mean aortic valve area increased from baseline (0.72 ± 0.37 cm2) to 30 days (1.79 ± 0.48 cm2) and was durable at one year (1.74 ± 0.49 cm2).
Moderate paravalvular leak was low, decreasing from 3.9% of patients at 30 days to 2.6% of patients at one year. The proportion of patients classified with severe heart failure (NYHA Class III/IV[4]) decreased from 63.8% at baseline to 7.7% at one year, the Illinois-based healthcare company stated.
Abbott’s structural heart business chief medical officer Neil Moat said: “These real-world data demonstrate that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis.
“Portico reduces the need for open-heart surgery to replace an aortic valve, and is an important part of Abbott’s mission to provide life-changing technologies to treat people with structural heart diseases.”