This article is more than 5 years old. Information may no longer be current.
TAVR with moderate sedation confers positive outcomes
ORLANDO, Fla. — Transcatheter aortic valve replacement with moderate sedation produces similar results to transcatheter aortic valve replacement with general anesthesia, according to the results of a retrospective study presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
In the analysis of patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent elective transfemoral TAVR between April 2014 and June 2015, moderate sedation had similar procedural success, shorter length of stay and lower 30-day mortality compared with general anesthesia, Jay Giri, MD, MPH, assistant professor of medicine at Perelman School of Medicine and director of peripheral intervention, division of cardiovascular medicine, University of Pennsylvania, said during a presentation.
Jay Giri
Of the 10,997 patients studied, 15.8% received moderate sedation.
The purpose of the analysis was to characterize rates of moderate sedation use in U.S. TAVR cases, to compare effectiveness of moderate sedation vs. general anesthesia and to identify conversion rates, Giri said.
The primary outcome was 30-day mortality. Other outcomes of interest were procedural success, in-hospital mortality, length of stay and 30-day mortality or stroke.
Moderate sedation for TAVR was barely used in the United States at all before April 2014, but it grew to approximately 25% of cases by November 2015, Giri said.
Compared with those receiving general anesthesia, those receiving moderate sedation were older (82.4 years vs. 81.8 years; P = .01), more likely to have severe lung disease (14.6% vs. 12.7%; P = .04) and more likely to receive a self-expanding valve (47.1% vs. 38%; P < .0001), according to the researchers.
Compared with general anesthesia, moderate sedation was associated with similar procedural success (moderate sedation, 98.2%; general anesthesia, 98.5%; P = .31) but a shorter length of stay (6 days vs. 6.7 days; P < .0001) and lower rates of 30-day mortality (2.9% vs. 4.1%; P = .029), in-hospital mortality (1.6% vs. 2.5%; P = .03) and 30-day mortality or stroke (4.8% vs. 6.4%; P = .019), Giri said.
When the researchers performed a propensity-matched analysis, those who had moderate sedation still had lower rates of 30-day mortality (2.96% vs. 4.01%; P < .0001) and 30-day mortality or stroke (4.8% vs. 6.36%; P < .0001).
The data do not provide answers as to why mortality and stroke rates were lower in those with moderate sedation, researcher Howard C. Herrmann, MD, FACC, MSCAI, John Bryfogle Professor of medicine and surgery at the Perelman School of Medicine and health system director for interventional cardiology at the University of Pennsylvania Health System, said at a press conference.
Howard C. Herrmann
“There are limitations to propensity-weighting analyses,” said Herrmann, a member of the Cardiology Today’s Intervention Editorial Board. “We matched the groups for variables that were available to us in the registry and others we thought would be relevant, but that doesn’t mean that there aren’t other variables that are different between the two groups that we didn’t account for.”
Giri said a randomized controlled trial to show a difference in mortality would require 4,776 patients.
The conversion rate to general anesthesia of patients who began with moderate sedation was 5.9%.
In a future analysis, “we will be looking at the interactions to select moderate sedation vs. general anesthesia, especially by [pulmonary artery] pressures, choice of valve and low [ejection fraction], to see if there are some interactions that have play with the outcome here,” Giri said. – by Erik Swain
Reference:
Giri J, et al. Late-Breaking Clinical Trials – Part 3. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.
Disclosure: Giri reports receiving institutional research grants from St. Jude Medical. Herrmann reports receiving consultant honoraria for speaking from Edwards Lifesciences and research funding via his institution from Boston Scientific, Edwards Lifesciences, Medtronic and St. Jude Medical.
