Valve hemodynamic deterioration and cardiovascular outcomes in TAVR: A report from the STS/ACC TVT Registry.

Background Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes. Methods and Results Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). VHD was defined as an increase in mean aortic valve gradient >= 10 mm Hg. Eighteen-month cardiovascular outcomes were determined via linkage with Centers for Medicare & Medicaid Services claims. Backwards selection logistic regression was performed to determine predictors of VHD. Among 10,099 TAVRs with paired echocardiograms, the median age was 84 years and 48.7% were female, with Society of Thoracic Surgeons score distributions of <8% (61.7%), 8%-15% (28.8%), and >15% (9.5%). The incidence of VHD was 2.1% in the early cohort and 2.5% in the late cohort. There was no significant difference between those with and without VHD in either cohort in the combined end point of death/stroke/aortic valve reintervention or heart failure hospitalization or myocardial infarction. Independent predictors of VHD included chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, severe patient-prosthesis mismatch, increasing body mass index, and increasing baseline aortic valve gradient. Conclusions The incidence of VHD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months. Patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.