Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement

Background: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate- and low-surgical risk. Methods: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. Results: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P <0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P <0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. Conclusions: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT03222128 and NCT02675114.