Safety of Conscious Sedation for Transcatheter Aortic Valve Replacement Without an Anesthetist.

ABSTRACT

OBJECTIVES: To compare the safety of performing transfemoral transcatheter aortic valve replacement (TAVR) under conscious sedation without an anesthetist present (TAVR-NA) vs TAVR performed with an anesthetist supervising sedation (TAVR-A). BACKGROUND: In almost all United States and European centers, TAVR-A represents the standard of care. There are limited data on the safety of TAVR-NA. METHODS: The prospective Mater TAVR database was analyzed. Patients undergoing transfemoral TAVR under conscious sedation were identified and divided into 2 groups, ie, TAVR-NA and TAVR-A. Demographics, procedural characteristics, and clinical outcomes for each group were assessed and compared. RESULTS: From a cohort of 300 patients who underwent transfemoral TAVR under conscious sedation, TAVR-NA and TAVR-A were performed in 85 patients and 215 patients, respectively. Baseline variables were similar except for a higher median Society of Thoracic Surgeons score in the TAVR-NA group vs the TAVR-A group (5.1% vs 4.4% in the TAVR-A group; P=.05). TAVR-A patients had a higher rate of conversion to general anesthesia (4.2% vs 1.2% in the TAVR-NA group; P=.29), with 1 patient in each group requiring conversion to emergency surgery. In-lab and in-hospital complication rates were similar in the TAVR-NA and TAVR-A groups (7.1% vs 6.5% [P=.86] and 8.2% vs 12.1% [P=.34], respectively). The Kaplan-Meier estimate of freedom from mortality and/or stroke at 1 month was comparable between both groups (96.5% vs 97.7%; P=.57). CONCLUSIONS: In this modest-sized transfemoral TAVR cohort with a low conversion rate to emergency surgery, TAVR-NA was associated with safety outcomes that were equivalent to TAVR-A. In healthcare systems where access to TAVR may be limited by anesthetic resources, TAVR-NA appears to be a reasonable option to enable the application of this therapy.