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

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.