The European multicentre study conducted by Edwards Lifesciences has demonstrated the benefits of its Intuity valve system in facilitating small-incision surgery for aortic valve replacement (AVR).
The CE-marked Intuity valve system features a balloon-expandable frame for rapid deployment, benefiting patients by enabling small-incision surgical approaches and reducing operative times.
The prospective single-arm TRITON trial treated 152 consecutive patients in need of surgical AVR with the Intuity valve system and found that the rate of procedural success was 97.3%.
At one year, the Intuity valve system showed single-digit mean gradients in all valve sizes and a low incidence of paravalvular leaks, a small pressure gradient across the aortic valve is normal.
Patients treated with the Edwards valve system had a survival rate of 98.6% at 30 days and 94% freedom from death at one year, as determined by the Kaplan-Meier curve.
Using the Intuity valve system, the mean aortic cross-clamp times and mean bypass times were reduced by 48% and 39%, respectively, compared to times noted in the Society of Thoracic Surgeons' (STS) Adult Cardiac Database.
Medical University of Vienna cardiac surgery chair and professor Günther Laufer said that in addition to establishing low rates of mortality and morbidity and a reproducible valve replacement procedure with the Intuity valve system, the study supported the opportunity to use the system with less-invasive surgical approaches.
"We also see promise in the performance of the Edwards Intuity valve system due to the early, excellent hemodynamic results and the design inspired by the proven platform of Edwards' family of surgical valves," Laufer added.