According to one-year results from the PORTICO I study, which were presented during a late-breaking session at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA) and simultaneously published in the Journal of the American College of Cardiology, were consistent with 30-day results reported earlier this year, with data used to support CE mark for Portico, and with data and results from other commercially available transcatheter aortic valve implantation (TAVI).
In this study, at one year, patients who received a Portico valve had low rates of mortality, stroke, paravalvular leak, and sustained significantly improved haemodynamic performance. All-cause and cardiovascular mortality were 12.1% and 6.6%, respectively; disabling stroke was observed in 2.2% of patients and myocardial infarction in 2.5%. Mean aortic valve area increased from baseline (0.72±0.37cm2) to 30 days (1.79±0.48cm2) and was durable at one year (1.74±0.49cm2). Moderate paravalvular leak was low, decreasing from 3.9% of patients at 30 days to 2.6% of patients at one year. The proportion of patients classified with severe heart failure (NYHA Class III/IV4) decreased from 63.8% at baseline to 7.7% at one year.
Lars Sondergaard (Rigshospitalet, Copenhagen, Denmark), principal investigator of the study, says: “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.”
Neil Moat, chief medical officer of Abbott’s structural heart business, comments: “These real-world data demonstrate that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis. Portico reduces the need for open-heart surgery to replace an aortic valve, and is an important part of Abbott’s mission to provide life-changing technologies to treat people with structural heart diseases.”
The PORTICO I trial is an ongoing, prospective, long-term study of patients with symptomatic, severe aortic stenosis treated with the self-expanding, repositionable Portico transcatheter aortic valve via a transfemoral access. The primary endpoint is all-cause mortality at one year. Secondary endpoints include device performance, improvement in functional capacity, and adverse event rates at 30 days, one year, and annually thereafter, for five years. The study is evaluating 941 patients treated between April 2013 and September 2017 at 61 sites across 14 countries in Europe, Australia and Canada.