Transcatheter aortic valve replacement (TAVR) with the Portico® valve (Abbott) was found to be safe and associated with low rates of stroke, death or paravalvular leakage at one-year follow-up, according to the real-world PORTICO I study in patients with symptomatic, severe aortic stenosis. The one-year results were presented during the 30th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium held in San Diego from 21-25 September 2018 with simultaneous publication in the Journal of the American College of Cardiology (JACC).

“Portico® offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high-level of confidence. These one-year results in a real-world setting give us assurance that Portico® is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery.” said Lars Søndergaard, M.D., DMSc, Rigshospitalet, Copenhagen, Denmark and principal investigator of the trial.

The ongoing, prospective, long-term, real-world, international, multicenter, PORTICO I trial (NCT01802788) recruited 941 symptomatic, severe aortic stenosis patients at high-risk for open-heart surgery. All participants were treated with the self-expanding, repositionable Portico® TAVR system via a transfemoral access. The primary objective of the study was to investigate the all-cause mortality at one year. Secondary objectives included the device performance, the improvement in functional capacity, and the adverse event (AE)-rates observed at 30 days and one-year post placement, and annually thereafter for up to five years.

The one-year results of the PORTICO I study indicated that patients who received a Portico® valve had low rates of all-cause mortality (12.1%), cardiovascular mortality (6.6%), disabling stroke (2.2%), and myocardial infarction (2.5%). Participants had significantly improved haemodynamic performance. The mean aortic valve area increased from 0.72 cm² (±0.37 cm²) at baseline to 1.79 cm² (±0.48 cm²) at 30 days (1.79 ± 0.48 cm²) which was sustained at the one-year mark, measuring 1.74 cm² (±0.49 cm²). Moderate paravalvular leak decreased from 3.9% of patients at 30 days to 2.6% of patients at one year. The proportion of patients classified with NYHA Class III/IV heart failure decreased from 63.8% at baseline to 7.7% after one year.

References

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