Study of Portico transcatheter aortic heart valve in aortic stenosis published in Journal of the American College of Cardiology.- Abbott.

A study shows that patients with severe aortic stenosis and high surgical risk who were treated with a Portico transcatheter aortic heart valve, from Abbott, had a low risk for mortality and stroke at 1 year. 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 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. 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. The transcatheter aortic heart valve was approved in Europe approximately 6 years ago. It is not yet approved for use in the United States. Data were presented at TCT 2018. The study was simultaneously published in the Journal of the American College of Cardiology.

See: S�ndergaard L, et al. J Am Coll Cardiol. 2018; doi: 10.1016/j.jacc.2018.09.014.