Edwards Lifesciences has announced that new data from the European multicentre TRITON trial studying the Edwards Intuity valve system highlights several benefits, including the facilitation of small-incision surgery for aortic valve replacement, a high procedural success rate, and consistent and sustained haemodynamic valve performance at one year. The data were presented on 2 May at the Emerging Technologies and Techniques Forum at the American Association for Thoracic Surgery’s 92nd Annual Meeting in San Francisco, USA.
The Edwards Intuity valve system leverages a proven valve platform and features an innovative balloon-expandable frame for rapid deployment. Rapid deployment aortic valve replacement may benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery.
In the prospective, single-arm TRITON trial, six European centres treated 152 consecutive patients in need of surgical aortic valve replacement; the rate of procedural success for patients receiving the Edwards Intuity valve was 97.3%. Surgeons performed 86 isolated aortic valve replacement 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% at 30 days and, at one year, the Kaplan-Meier curve demonstrated 94% freedom from death.
The data also demonstrated shortened procedures, as characterised by reductions in cross-clamp times and the time patients spent on cardiopulmonary bypass. For isolated aortic valve replacement cases, mean aortic cross-clamp times were reduced by 48%, and mean bypass times by 39%, compared to times noted in the Society of Thoracic Surgeons’ Adult Cardiac Database.
“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, chair and professor, cardiac surgery, Medical University of Vienna.
Edwards also announced at the meeting that it received CE mark in Europe for a valve with the GLX next-generation tissue technology, which is designed to enhance anti-calcification, enable a smaller valve profile and improve ease of use.
The Edwards Intuity valve system received CE mark in Europe in February 2012. This and GLX are investigational and not currently available for sale or use in the United States.