Heart valve and haemodynamic monitoring company Edwards Lifesciences Corporation, has announced that new data from the European multi-centre TRITON trial studying the Edwards Intuity valve system points to several important benefits. These include the facilitation of small-incision surgery for aortic valve replacement (AVR), a high procedural success rate, and consistent and sustained haemodynamic valve performance at one year.
According to Edwards Lifesciences, its Edwards Intuity valve system leverages a proven valve platform and features an innovative balloon-expandable frame for rapid deployment. Rapid deployment AVR is thought to benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery.
The following data were presented during the Emerging Technologies and Techniques Forum at the American Association for Thoracic Surgery’s 92nd Annual Meeting in San Francisco.
In the prospective, single-arm trial, six European centers treated 152 consecutive patients in need of surgical AVR.
The rate of procedural success for patients receiving the Edwards Intuity valve was 97.3 percent. Surgeons performed 86 isolated AVR procedures, with about half of these cases using small-incision approaches. The system also showed single-digit mean gradients at one year in all valve sizes, and a low incidence of paravalvular leaks — a small pressure gradient across the aortic valve is normal and indicative of good haemodynamic performance.
Valve-related mortality rates were low; the survival in this group of patients was 98.6 percent at 30 days and, at one year, the Kaplan-Meier curve demonstrated 94 percent freedom from death.
The data also demonstrated shortened procedures, as characterized by reductions in cross-clamp times and the time patients spent on cardiopulmonary bypass. For isolated AVR cases, mean aortic cross-clamp times were reduced by 48 percent, and mean bypass times by 39 percent, compared to times noted in the Society of Thoracic Surgeons’ (STS) Adult Cardiac Database. Several published studies indicate that a shorter duration of aortic cross-clamping is associated with a reduction in mortality and morbidity after AVR.
“In addition to establishing low rates of mortality and morbidity and a reproducible valve replacement procedure with the Edwards Intuity valve system, the study gives us confidence in the opportunity to use this system with less-invasive surgical approaches. We also see promise in the performance of the Edwards Intuity valve system due to the early, excellent haemodynamic results and the design inspired by the proven platform of Edwards’ family of surgical valves,” said Günther Laufer, M.D., chair and professor, cardiac surgery, Medical University of Vienna.
US Regulatory status
The EDWARDS INTUITY valve system received CE Mark in Europe in February 2012. It and the newly CE marked GLX tissue technology valve are investigational and not currently available for sale or use in the United States.
Source: Edwards Lifesciences Corporation