According to a new study published ahead-of-print in the Journal of Thoracic and Cardiovascular Surgery, St Jude Medical’s Trifecta aortic valve has a similar haemodynamic performance to that of a healthy aortic valve and is “easy to implant”.
Conducted at 31 medical centres in the USA, Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a FDA pre-market approval study. Data from the study was used to secure European CE Mark approval in 2010, FDA approval in 2011 as well as regulatory approval of the Trifecta valve in Japan in 2012.
According to a company press release, the results of study highlighted the outstanding haemodynamic performance of the Trifecta valve, further confirmed safety, and described its ease of use. The study is one of the largest, multicentre, prospective studies ever conducted on a surgical aortic heart valve.
The press release reported that other findings in the study included: uniformly low gradients, which indicates exceptional valve function across all sizes for a stented tissue heart valve; favourable haemodynamics in the Trifecta valve, which led to a low incidence of severe prosthesis-patient mismatch with 94.8% of patients free from this condition at one year; improved blood flow through the Trifecta heart valve, which led to a significant decrease in left ventricular mass over the course of one year; and an extremely low rate of paravalvular leak and minimal valve regurgitation. Additionally, despite the advanced age of patients and their high risk profile, study results demonstrated a survival rate of 94.5% at two years, which compares favourably to comparative technologies
Joseph E. Bavaria, Roberts-Measey endowed professor and vice-chief of cardiovascular surgery at the University of Pennsylvania, served as lead author of the journal article. He said: “The Trifecta valve provides an exceptional hemodynamic profile and the strong clinical results support outstanding one-to-two-year performance data. Additionally, the valve has shown minimal leakage. I have used this valve for more than five years and have found it easy to implant and very reliable, making it an excellent choice for managing patients who require valve replacement.”
A three leaflet tissue valve constructed from a polyester and tissue-covered titanium stent, the Trifecta valve serves as a replacement for the aortic valve. The valve features leaflets made of pericardial tissue that are attached to the exterior of the stent. This design allows the leaflets to open more fully and efficiently, mimicking the haemodynamic performance of a healthy aortic heart valve. It also limits tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact, which helps protect the valve against mechanical wear. A polyester sewing cuff connects the valve to the annulus of the aortic valve. Finally, the valve also features Linx AC Technology, an anti-calcification treatment designed to reduce tissue mineralisation.