American College of Cardiology
American College of Cardiology
March 19, 2020
3 min read
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Conscious sedation confers better outcomes vs. general anesthesia in TAVR

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Neel M. Butala

Use of conscious sedation was linked to better outcomes, including mortality, length of stay and discharge to home, compared with general anesthesia in patients who had transcatheter aortic valve replacement, according to data selected for presentation at the American College of Cardiology Scientific Session.

Researchers also found that the magnitude of difference in outcomes was less than in previous studies, and that the use of conscious sedation in TAVR has risen over time. The results were simultaneously published in JACC: Cardiovascular Interventions.

“In recent years there has been considerable interest in the concept of minimalist TAVR, and a critical component of this approach is the use of conscious sedation rather than general anesthesia for the procedure. Despite considerable uptake of this approach, there have been little high-quality data on the choice of an anesthetic approach to TAVR,” Neel M. Butala, MD, MBA, advanced research fellow in medicine at Massachusetts General Hospital and Harvard Medical School, told Healio. “One of the few multicenter studies on this question was based on data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapeutics (TVT) registry from 2014 to 2015 and demonstrated significant benefits of conscious sedation in a propensity-adjusted analysis, including a 37% reduction in in-hospital mortality as well as substantial differences in length of stay and other relevant outcomes. There are, however, several issues with this study. We used the TVT registry to look at use of conscious sedation for TAVR in recent years. Additionally, we used a relatively novel statistical technique called instrumental variable analysis as the basis for the primary comparisons. This technique was derived from the field of economics and is unique because it is one of the only approaches to observational studies that allows one to address both measured and unmeasured confounding.”

Butala and colleagues analyzed 120,080 patients from the TVT registry (mean age, 82 years; 46% women) who underwent TAVR between 2016 and March 2019.

During the study period, use of conscious sedation rose from 33% to 64%, according to the researchers. However, they found, use of conscious sedation varied widely, as it was used in a median of 0% of cases in the lowest quartile by hospital use and in a median of 91% of cases in the highest quartile by hospital use.

“Despite all of this evidence in favor of conscious sedation for TAVR, there is still wide variation in use of conscious sedation for TAVR — 17% of U.S. centers continue to exclusively use general anesthesia for TAVR procedures,” Butala told Healio.

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After performing instrumental variable analysis, the researchers determined that compared with general anesthesia, conscious sedation was associated with less in-hospital mortality (adjusted risk difference [aRD], 0.2%; P = .01), less 30-day mortality (aRD, 0.5%; P < .001), shorter length of hospital stay (aRD, 0.8 days; P < .001) and more frequent discharge to home (aRD, 2.8%; P < .001).

“A more subtle point is that the degree of benefit is less than seen in prior studies, and when we repeat our analysis using a more standard approach that prior studies use, this suggests that prior approaches may be confounded and demonstrates the strength of instrumental variables,” Butala told Healio.

If more hospitals switched to routine use of conscious sedation in TAVR, lives, hospital utilization and costs would be saved, he said.

“Based on our estimates, we would project that if all U.S. centers used conscious sedation at a rate similar to the highest quartile in the TVT registry, this would result in approximately 40 fewer procedure-related deaths, approximately 80 fewer deaths at 30 days, approximately 12,000 fewer hospital days and cost savings of $25 million annually,” Butala said in an interview. “Based on this study’s findings, more effort is needed to disseminate knowledge of the benefits of conscious sedation for TAVR and encourage its use in the remaining centers performing TAVR primarily with general anesthesia.”

The move to conscious sedation might also be beneficial during the COVID-19 pandemic, he said.

“The tie in between our study and COVID-19, if anything, is that, if hospitals are not postponing TAVR procedures, they should at least do them under conscious sedation, as that can help reduce health care utilization, which is particularly important in times of capacity shortages,” Butala told Healio. – by Erik Swain

References:

Butala NM, et al. Abstract 1352-36. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).

Butala NM, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.03.008.

Disclosures: Butala reports he receives consultant fees from and has ownership interest in HiLabs. Please see the study for all other authors’ relevant financial disclosures.