St. Jude Medical, Inc. is trumpeting results published in The Journal of Thoracic and Cardiovascular Surgery. Its Trifecta™ biological pericardial aortic valve has demonstrated positive results which St.Jude says highlight the outstanding hemodynamic performance of the Trifecta valve. The study is one of the largest, multi-center, prospective studies ever conducted on a surgical aortic heart valve.
Trifecta is a three-leaflet tissue valve constructed from a polyester and tissue-covered titanium stent. The leaflets are made of pericardial tissue that are attached to the exterior of the stent in order to allow them to open more fully than other designs. This is intended to mimic the hemodynamic performance of a healthy aortic heart valve and limit tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact, which helps protect the valve against mechanical wear.
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. FDA pre-market approval (PMA) study.
Study findings include uniformly low gradients, indicative of exceptional valve function across all sizes for a stented tissue heart valve. Favorable hemodynamics in the Trifecta valve seem to have resulted in a very low incidence of severe prosthesis-patient mismatch with 94.8 percent of patients free from this condition at one year.
The results also showed that the Trifecta heart valve demonstrated a significant decrease in left ventricular(LV) mass over the course of one year, a high LV mass being indicative of valvular insufficiency and one of the most important predictors of heart failure, cardiovascular morbidity and mortality. An extremely low rate of paravalvular leak and minimal valve regurgitation was reported.
Overall, despite the advanced age of patients and their high risk profile, these study results demonstrated a survival rate of 94.5 percent at two years, which authors say compares favorably to comparative technologies.
Dr. 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.
“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,” said Dr. Bavaria. “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.”
“The Trifecta valve was designed specifically to address some of the fundamental limitations of previous aortic valves,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These outstanding study results offer additional evidence of the value these valves can have for patients with aortic heart disease.”
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.
Source: St.Jude Medical, Inc., Business Wire