Transcatheter aortic valve replacement (TAVR) procedures performed using the Hydra transcatheter aortic valve (THV) are associated with favorable one-year outcomes, according to new findings published in JACC: Cardiovascular Interventions.
The Hydra THV, manufactured by Vascular Innovations, is a self-expanding system specifically designed to provide easy access to the coronary arteries. Researchers tracked data from 157 patients who underwent TAVR with the Hydra THV from May 2014 to November 2018. Patients were treated at one of 18 different facilities from a variety of countries, including Greece, Lithuania and Thailand.
The mean patient age was 79.2 years old, and 58.6% of patients were women.
Overall, the device success rate was 82.8%. After 30 days, the team found, 11 patients had died, and nine of those deaths were cardiovascular deaths. Five of those 11 deaths were related to the Hydra THV. At one year, meanwhile, there had been 23 total deaths and 13 cardiovascular deaths.
In addition, patients saw “significant improvements” in both effective orifice area and mean aortic valve gradient. Moderate or severe paravalvular leak was seen in 6.3% of patients at 30 days and 6.9% of patients after one year. Permanent pacemaker implantation was needed for 11.7% of patients after 30 days and 12.4% after one year.
The team did highlight one additional finding related to patient outcomes.
“Coronary occlusion has become a rare complication during TAVR,” wrote lead author Audrius Aidietis, of the Vilnius University Hospital Santaros Clinics in Lithuania, and colleagues. “However, it was reported in two cases in the Hydra CE study caused by inappropriate high valve implantation. It is recommended to implant the valve 3 to 5 mm below the aortic annulus and also ensure that the coronary arteries take off at least 10 mm above the annulus level.”
Aidietis et al. also called for additional research focused on larger patient populations and longer-term patient outcomes.
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