Moderate Sedation Shows Promise for TAVR Patients

May 6, 2016—An analysis from the Society for Thoracic Surgeons and the American College of Cardiology transcatheter valve therapy registry, the STS/ACC TVT Registry, demonstrated that moderate sedation use is associated with improved patient outcomes, including lower 30-day mortality and shorter hospital stays, for percutaneous transfemoral transcatheter aortic valve replacement (TAVR) procedures, as compared to traditional general anesthesia. The study was presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 scientific sessions in Orlando, Florida.

SCAI noted that TAVR has become the therapy of choice for patients who are considered at extreme or high risk for standard open surgical aortic valve replacement, with recent data supporting extension of the therapy into intermediate-risk populations. Although general anesthesia has been typically administered during these cases, rates of moderate sedation use for this minimally invasive technique are increasing.

The study’s Senior Investigator Jay Giri, MD, commented in the SCAI announcement, “TAVR is revolutionary, but the question we asked ourselves is: what novel techniques are being employed to make the therapy even better and as noninvasive as possible? Now that we are routinely treating patients without incisions, is moderate sedation a safe and effective option for TAVR?” Dr. Giri is an assistant professor of cardiovascular medicine in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania.

As summarized in the SCAI announcement, investigators compared the effectiveness of moderate sedation and general anesthesia use among STS/ACC TVT Registry patients between April 2014 and June 2015. The registry is composed of all United States TAVR patients and elective cases treated via percutaneous transfemoral approach. All registry patients were included in the analysis. A total of 10,997 patients were assessed, of which 1,737 (15.8%) received moderate sedation.

The investigators reported that both patient groups had nearly equal rates of TAVR success (98.4% vs 98.6%; P = .46), but found that moderate sedation patients experienced lower rates of 30-day mortality (2.92% vs 4.08%; P = .035), 30-day mortality or stroke (4.8% vs 6.4%; P = .019), and briefer hospital stays (6 ± 10.7 days vs 6.7 ± 9.6 days; P < .0001).

Propensity-matched analyses, which accounted for factors known to predict 30-day TAVR mortality, confirmed lower 30-day mortality (2.96% vs 4.01%; P < .0001) and 30-day mortality or stroke (4.8% vs 6.36%; P < .0001) among the moderate sedation patients. Nationally, 5.9% of moderate sedation patients converted to general anesthesia. This was comparable to the 5.2% rate observed at the University of Pennsylvania Health System, noted Dr. Giri. 

Dr. Giri stated, “These compelling data show that moderate sedation is both safe and effective. While it is important to assess each patient individually, using moderate sedation could result in a better experience and better clinical outcomes for patients. A broad shift toward moderate sedation for TAVR could have profound implications for care pathways, costs, and the future of this technology.”