Abbott's Portico TAVR System Evaluated at 30 Days in Real-World Setting
June 4, 2018—Abbott Structural Heart recently announced that data from the PORTICO I study of treatment with the company's Portico transcatheter aortic valve replacement (TAVR) therapy were presented at EuroPCR 2018 held May 22–25 in Paris, France. The Portico transcatheter aortic valve is a minimally invasive treatment for patients diagnosed with severe aortic stenosis who are not candidates for open heart surgery.
The PORTICO I study is a real-world, multicenter, prospective, single-arm study with independent adjudication of clinical events and independent echocardiography core-lab analysis. The study will follow patients annually through 5 years in a real-world setting after being treated with Portico to assess long-term clinical outcomes.
According to Abbott, the findings showed favorable short-term clinical outcomes for safety and performance that were consistent with the Portico CE Mark study results that supported European regulatory approval that was announced in 2012.
The Portico TAVR device was associated with excellent clinical outcomes at 30 days, including low rates of death, disabling stroke, and paravalvular leak. Additional benefits observed included reduction in New York Heart Association (NYHA) class severity, low rates of bleeding, and improvements in a 6-minute walk test, allowing patients to return to their previous lifestyles and activity faster.
In the study, 941 patients were treated at 61 centers across the European Union, Canada, and Australia. At 30 days, the study showed patients who received Abbott's TAVR therapy had very low rates of all-cause mortality (2.7%) and disabling stroke (1.7%).
At 30 days after implantation, study patients had excellent hemodynamic performance (8.6 mm Hg), a measurement of forward blood flow resistance, and effective orifice area—or large valve opening—of (1.8 cm2), allowing blood to easily flow from the left ventricle of the heart to the aorta. Nearly all patients (96.1%) experienced none-to-mild paravalvular leak, which may result after a mitral or aortic valve replacement procedure. The percentage of patients in NYHA class III/IV significantly decreased from 64% to 13.1%, indicating improved mobility, and clinical measures showed a mean improvement of 26 meters in the 6-minute walk test. No severe aortic valve regurgitation, or leak, based on independent core lab-assessed echocardiographic analysis, was seen at 30 days.
The study's Principal Investigator, Professor Francesco Maisano, MD, who is from Universitätsspital Zürich in Switzerland, commented in the company's announcement, "Patients with severe aortic stenosis require timely treatment to reduce symptoms and improve clinical outcomes and quality of life. These new data reinforce that treatment with the Portico valve is safe in a real-world setting—with robust clinical results—and confirm that Portico is an excellent solution for patients at increased risk for surgery."
Abbott Structural Heart advised that Portico recently received regulatory approval in Europe for a sheathless introduction of the Portico valve, allowing physicians to deliver it without an arterial introducer sheath, making it easier for physicians to insert the device in patients with severe disease and complex anatomies. The smaller size of the valve may lower the risk of serious adverse events and vascular complications such as internal damage to the arteries.