The SAPIEN transcatheter heart valve and surgical aortic valve replacement (SAVR) are highly durable options for patients with heart failure, according to an analysis of the Placement of Aortic Transcatheter Valves (PARTNER; Clinicaltrials.gov identifier: NCT00530894) trial published in JAMA Cardiology.
Investigators evaluated echocardiogram data of participants in the PARTNER trial, all of whom were randomly assigned to receive either SAVR or transcatheter aortic valve replacement (TAVR) or TAVR vs medical treatment. The researchers compared the PARTNER trial data with data from continued access observational studies of patients who received TAVR. A total of 2795 patients were included, but only 424 patients who received TAVR and 49 patients who received SAVR had 5-year echocardiogram data available in the final analysis.
Favorable changes in hemodynamics were observed in the initial months following TAVR. Patients in the TAVR group experienced a decrease of −2.9 mm Hg in aortic valve mean gradient. There was a significant change in aortic valve mean gradient at 5 years vs preimplantation (10.3 mm Hg vs 47.7 mm Hg, respectively; P <.001). Ejection fraction was numerically higher at 5 years vs preimplantation in the TAVR group, but this change was not considered significant (54.0% vs 52.7%, respectively; P =.12).
Conversely, patients receiving SAVR experienced no significant hemodynamic changes. Reintervention rates for patients with TAVR and SAVR were 0.8% vs 0.3%, respectively. The investigators noted that echocardiogram evidence of severely abnormal hemodynamics was low and not considered to be associated with reintervention or mortality for either valve replacement strategy.
According to the investigators, some of the echocardiograms in the analysis may have been incomplete and/or had poor image quality, which may have limited the overall findings.
The investigators concluded, “There is longitudinal durability of both transcatheter and surgical aortic valve replacements, with rare findings of adverse hemodynamics or valve deterioration.”
Disclosures: This study was funded by Edwards Lifesciences, the manufacturer of the SAPIEN heart valve.
Douglas PS, Leon MB, Mack MJ, et al. Longitudinal hemodynamics of transcatheter and surgical aortic valves in the PARTNER trial [published online September 27, 2017]. JAMA Cardiol. doi:10.1001/jamacardio.2017.3306