Longitudinal durability of transcatheter aortic valve replacements (TAVR) is “excellent,” according to a recent study published in JAMA Cardiology, and is similar to surgical bioprostheses used to treat severe aortic stenosis.
The Placement of Aortic Transcatheter Valves (PARTNER) Trial analyzed laboratory-generated data from the echocardiograms of 2,795 patients who suffered from severe aortic stenosis, Pamela S. Douglas, MD, and colleagues wrote in their paper. Those thousands of individuals were divided into three cohorts for the trial: high-risk patients randomized to either TAVR or surgical aortic valve replacement (SAVR) were placed in the PARTNER 1A trial; inoperable patients randomized to medical treatment or TAVR were placed in 1B; and continued access patients. All subjects were fitted with a first-generation SAPIEN THV device.
“TAVR is a safe and effective treatment for severe aortic stenosis,” Douglas and colleagues wrote in the study. “However, given the relatively recent introduction of transcatheter heart valves, to our knowledge, data on their durability are sparse.”
All patients, who were an average age of 85 at the time and majority male, were tested at the preimplantation stage, then seven days, one and six months, and one, two, three, four and five years after successful implantation of TAVR or SAVR, Douglas and co-authors wrote. Of the original study population, five-year echocardiogram data were available for a total of 473 patients who underwent the procedures.
Main outcomes of the study included death or reintervention for aortic valve structural indications, which was measured using aortic valve mean gradient, effective orifice area, Doppler velocity index and evidence of hemodynamic deterioration, the study stated.
In just a few months post-TAVR, results showed positive changes in the patients, including a decrease of 2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index and an increase of 0.09 cm-squared in effective orifice area.
Researchers found relative stability at the three- and five-year mark for patients, and moderate to severe transvalvular regurgitation showed up in 89 patients after TAVR and continued to increase. Reintervention occurred in just one patient following SAVR and 30 following TAVR.
Negative reports were few and far between, Douglas and colleagues wrote, with abnormal findings proving rare in the case of both aortic valve replacements.
“This large, core laboratory evaluation of 2,483 patients receiving TAVR and 313 receiving SAVR in the PARTNER 1 Trial demonstrates excellent longitudinal durability of the SAPIEN THV using both population hemodynamic trends as well as case reviews of reintervention and patients with large adverse changes between echocardiograms,” the authors wrote. “Abnormal findings in individual patients suggestive of valve thrombosis or structural deterioration were rare in this protocol-driven database and require further investigation."