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Portico valve stacks up against commercially available TAVR valves
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SAN FRANCISCO — In the Portico IDE study, 30-day safety and 1-year effectiveness of the Portico transcatheter aortic valve replacement system was noninferior to contemporary commercially available valves in the U.S. for treatment of patients with severe aortic stenosis at high or extreme risk for surgery.
“These findings suggest the Portico valve may provide an additional transcatheter heart valve type to treat high and extreme risk patients with severe aortic stenosis and help expand patient access to this potentially life-saving procedure,” Gregory P. Fontana, MD, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, said at TCT 2019.
Safety and effectiveness were evaluated in 750 patients (mean age, 83 years; 52% women; mean Society of Thoracic Surgeons score, 6.5%) at 69 sites who were enrolled from May 2014 to June 2019. Patients were randomly assigned to undergo TAVR with the Portico valve (Abbott) and a first-generation delivery system or any FDA-approved and commercially approved TAVR system during the study period. These valves included Sapien (Edwards Lifesciences) and CoreValve (Medtronic), and subsequently two more iterations in each portfolio before completion of enrollment, Fontana said.
Portico was noninferior to commercially available valves for the prespecified primary safety composite endpoint of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis or major vascular complications at 30 days (13.8% vs. 9.6%; P for noninferiority = .03), according to results presented here.
The study also met the primary effectiveness composite endpoint of all-cause mortality or disabling stroke at 1 year (14.9% vs. 13.4%; P for noninferiority = .006), Fontana said.
Procedural success was comparable between the two groups, at 96% with Portico vs. 98% with commercially available TAVR systems.
“The trial met both safety and effectiveness endpoints. Major vascular complications occurred with greater frequency in the Portico valve group, driving the difference in safety profile. Safety and effectiveness improved in the second half of the trial in the Portico valve group,” he said.
Fontana also reported results in a separate 100-patient cohort who underwent Portico valve implantation using the newer FlexNav delivery system. In this cohort, the primary safety endpoint of major vascular complications at 30 days was 7% and 14.6% of patients required a new permanent pacemaker implantation. There were no deaths or disabling strokes. The safety profile was comparable with that of the commercially available valves evaluated in the randomized study, Fontana said.
In other findings, the Portico valve was associated with improved hemodynamics, including larger valve areas and smaller gradients, but a higher rate of moderate paravalvular leak compared with the other valves studied, according to Fontana.
“A next-generation valve with design modifications to reduce paravalvular leak is currently being tested in clinical trials,” Fontana said.
The Portico valve features an intra-annular, self-expanding design; is fully recapturable, repositionable and retrievable; large-cell geometry; and minimal protrusion into the left ventricular outflow tract. The valve is not currently approved in the United States. – by Katie Kalvaitis
Reference:
Fontana GP. Late-Breaking Trials 2. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosures: The PORTICO study was funded by Abbott. Fontana reports he receives grant/research support from Abbott and Medtronic and consultant fees/honoraria from Abbott, LivaNova and Medtronic.
Perspective
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David J. Moliterno, MD, FACC
The Portico, a new transcatheter heart valve, showed in this high-risk cohort that there are limitations in regard to all other valves in which it was compared. Notably, in the second half of the study, the Portico valve looked to have fewer problems than it did in the first half of the study, which may reflect more operator experience. That can be an encouraging sign for a first-generation device. I like to see head-to-head comparisons between the devices, and that’s what the Portico investigators have done. As this device evolves and operators get more experience with it, I suspect it will become a better technology.
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