ORLANDO — Moderate sedation may be the safer alternative to general anesthesia for patients undergoing transcatheter aortic valve replacement (TAVR), a registry study suggested.
TAVR patients had similar rates of procedural success with either anesthesia type (98.2% for moderate versus 98.5% for general sedation, P=0.46). Some patients converted from moderate to general anesthesia (5.9%).
On propensity-matched analysis, however, those with moderate sedation had lower 30-day mortality (2.96% versus 4.01%, P<0.001) and 30-day mortality or stroke rates (4.80% versus 6.36%, P<0.001), Jay Giri, MD, MPH, of the University of Pennsylvania Health System in Philadelphia, reported at late-breaking trial session at the Society for Cardiovascular Angiography and Interventions (SCAI) meeting.
“This compelling data shows 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,” Giri said in a press release. “A broad shift towards moderate sedation for TAVR could have profound implications for care pathways, costs and the future of this technology.”
“Importantly, what I think we’re seeing here are several learning curves that are all intertwined. There is a big learning curve for how to use sedation and there’s wide variation in practice for TAVR,” said panelist and former SCAI president Ted E. Feldman, MD, of Illinois’ Evanston Hospital. “At the same time, the device and sheath sizes were changing prodigiously, so there’s an interplay of a lot of learning curves here.”
Feldman commented that his points don’t “take away from the value of the study at all. It makes it more interesting to see how this all changes in the future.”
Investigators examined data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. The analysis included 10,997 patients who underwent elective TAVR via a transfemoral approach from 2014 through 2015.
Of those participants, 15.8% received moderate sedation. Giri noted that a trend toward shorter hospital stays was also found for this group (6.0 days versus 6.7 days, P<0.001), though it dissipated upon multivariable adjustment.
“It brings up the point that there’s more to how patients move through the hospital after TAVR than just treating them percutaneously or just giving them moderate sedation. There’s more to those care pathways — in terms of nursing protocols and other characteristics that might be unique to individual institutions — than just how you carry out a procedure in the room,” he argued.
Additionally, he pointed to April 2014 as the “inflection point” for when TAVR with moderate anesthesia started to gain traction in U.S. practice.
The presenter noted several limitations to his study. There was room for potential bias on both the patient and the institutional levels, Giri said, as well as a lack of adjudication for the stroke and conversion data. “It is possible that more patients were converted” beyond what was shown, he noted.
Yet the trend to opt for moderate anesthesia may be part of a bigger shift in TAVR, Giri suggested. He cited a prior study that found no difference in safety or success rates between TAVR patients who got the standard approach done in the hybrid operating room under general anesthesia with femoral cutdown, transesophageal echocardiography [TEE], and intensive care unit [ICU] recovery versus a minimalist alternative done in the cath lab with minimal anesthesia, no TEE, percutaneous access, and ICU or stepdown recovery.
What’s more, the minimalist approach was associated with shorter procedure times, reduced lengths of stay, and slashed hospital costs in that older study, he noted.
Giri’s group is currently working on a full analysis of the TVT Registry with an eye toward finding potential interactions for gender, valve type, BMI, and extreme risk, among other subgroups.
For now, “rates of moderate anesthesia for TAVR are rising. The technique is associated with similar procedural success, shorter hospital stay, and lower 30-day mortality compared to traditional general anesthesia,” he concluded.
Giri disclosed institutional grants from St. Jude Medical.
Society for Cardiovascular Angiography and Interventions
Hyman M, et al “Moderate vs. general anesthesia for transcatheter aortic valve replacement: an STS/ACC transcatheter valve therapy registry analysis” SCAI 2016; Abstract 14823.