Conscious Sedation versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the NCDR® STS/ACC TVT Registry
Background—Conscious sedation is used during transcatheter aortic valve replacement (TAVR) with limited evidence as to the safety and efficacy of this practice.
Methods—The NCDR STS/ACC TVT Registry was used to characterize the anesthesia choice and clinical outcomes of all U.S. patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014 and June 30, 2015. Raw and inverse probability of treatment weighted (IPTW) analyses were performed to compare general anesthesia patients with conscious sedation patients on an intention-to-treat basis for the primary outcome of in-hospital mortality, and secondary outcomes including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, ICU and hospital length-of-stay, and rates of discharge to home. Post-hoc falsification endpoint analyses were performed to evaluate for residual confounding.
Results—Conscious sedation was used in 1,737/10,997 (15.8%) cases with a significant trend of increasing usage over the time period studied (p for trend <0.001). In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% versus 98.5%, p=.31). The conscious sedation group was less likely to suffer in-hospital (1.6% vs. 2.5%, p=0.03) and 30-day death (2.9% vs. 4.1%, p = 0.03). Conversion from conscious sedation to general anesthesia was noted in 102/1737 (5.9%) of conscious sedation cases. After IPTW adjustment for 51 covariates, conscious sedation was associated with lower procedural success (97.9% vs. 98.6%, p<0.001) and a reduced rate of mortality at the in-hospital (1.5% vs. 2.4%, p<0.001) and 30-day (2.3% vs. 4.0%, p<0.001) timepoints. Conscious sedation was associated with reductions in procedural inotrope requirement, ICU and hospital length of stay (6.0 vs. 6.5 days, p < 0.001), and combined 30-day death/stroke rates (4.8% vs. 6.4%, p <0.001). Falsification endpoint analyses of vascular complications, bleeding, and new pacemaker/defibrillator implantation demonstrated no significant differences between groups after adjustment.
Conclusions—In U.S. practice, conscious sedation is associated with briefer length of stay and lower in-hospital and 30-day mortality compared to TAVR with general anesthesia in both unadjusted and adjusted analyses. These results suggest the safety of conscious sedation in this population, though comparative effectiveness analyses using observational data cannot definitively establish the superiority of one technique over another.
- Received November 29, 2016.
- Revision received June 29, 2017.
- Accepted August 25, 2017.