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PORTICO I: Transcatheter aortic valve improves outcomes in severe aortic stenosis, high surgical risk

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Lars Søndergaard

SAN DIEGO — Patients with severe aortic stenosis and high surgical risk who were treated with a transcatheter aortic heart valve had a low risk for mortality and stroke at 1 year, according to data presented at TCT 2018.

The transcatheter aortic heart valve (Portico, Abbott) was approved in Europe approximately 6 years ago, Lars Søndergaard, MD, DMSc, professor of cardiology at University of Copenhagen in Denmark, said during the press conference. It is not yet approved for use in the United States.

Researchers analyzed data from 941 patients (mean age, 82 years; 66% women) with symptomatic severe aortic stenosis who were at high surgical risk. All patients were treated with the transcatheter aortic heart valve. The study was simultaneously published in the Journal of the American College of Cardiology.

“The Portico valve is a self-expanding technology,” Søndergaard said during the press conference. “It was actually the first valve that you could reposition onto about 80% deployment.”

The primary endpoint was all-cause mortality at 1 year. Patients were followed up at 30 days (n = 828), 1 year (n = 717) and annually up to 5 years.

At baseline, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.8%, and 85.2% of patients met at least one frailty assessment criteria.

The majority of procedures achieved device success (96%).

At 1 year, all-cause mortality occurred in 12.1% of patients (95% CI, 10.1-14.5), and 6.6% of patients died from CV-related causes (95% CI, 5.1-8.4). Disabling stroke occurred in 2.2% of patients at 1 year (95% CI, 1.4-3.4) and, importantly, only 0.6% had a stroke between 30 days and 1 year, Søndergaard said. MI occurred in 2.5% of patients (95% CI, 1.7-3.8). The rate of new pacemaker implantation was 21.3%.

Effective orifice area increased from 0.7 cm² at baseline to 1.8 cm² at 1 year.

There were no severe instances of paravalvular leakage at 30 days or 1 year. Moderate paravalvular leakage occurred in 4% of patients at 30 days and 2.6% of patients at 1 year.

Regarding NYHA class, 49% of patients improved by one function class and an additional 23% improved by two function classes.

Researchers compared the results from this study to those from FORWARD, which assessed the Evolut R valve (Medtronic), and Source 3, which assessed the Sapien 3 valve (Edwards Lifesciences). All three studies had similar rates of all-cause mortality, cardiac mortality and disabling stroke as well as hemodynamic performance of the transcatheter aortic heart valves at 1 year.

“PORTICO I data at 1 year confirms that it’s a safe and efficient device in a real-world, large case study,” Søndergaard said during the press conference. – by Darlene Dobkowski

References:

Søndergaard L, et al. Late-Breaking Clinical Science 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Søndergaard L, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.09.014.

Disclosures: The study was funded by Abbott. Søndergaard reports he received consultant fees and institutional research grants from Abbott, Bayer, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Please see the study for all other authors’ relevant financial disclosures.