The use of moderate sedation leads to better clinical outcomes compared with general anaesthesia for patients undergoing transcatheter aortic valve replacement (TAVR).
Researchers conducted the largest observational study of minimally invasive transfemoral TAVR to find whether the use of moderate sedation is associated with improved patient outcomes, specifically evaluating 30-day mortality and length of hospital stays, compared with traditional general anaesthesia.
The findings were presented as a late-breaking clinical trial at the 2016 Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI).
For patients who are at extreme or high risk for open heart surgery, TAVR has become the preferred therapy for severe aortic stenosis. While general anaesthesia has been typically administered during these cases, the use of moderate sedation for TAVR is increasing.
Most of the developments associated with TAVR over the past decade have been focused on the device, technology and procedural techniques. However, there has been a push to improve the process of the procedure.
“More recently the field has moved toward use of an even more minimally invasive TAVR procedure, in which physicians are able to insert the new valve through the groin with no incisions at all,” said senior author Jay Giri, MD, University of Pennsylvania, Philadelphia, Pennsylvania. “Since there is no longer a definitive need for a surgical incision, we had to ask the question of whether there was a need for general anaesthesia, the full sedation of a patient requiring breathing tube and nonresponsive unconsciousness.”
The researchers used the STS/ACC TVT Registry to evaluate elective cases treated via a percutaneous transfemoral approach from April 2014 to June 2015 in order to compare the effectiveness of moderate sedation to general anaesthesia. A total of 10,997 patients were assessed with 1,737 receiving moderate sedation (15.8%).
Results showed that while both patient groups had nearly equal rates of TAVR procedural success, moderate sedation patients experienced lower rates of 30-day mortality, 30-day mortality or stroke, and briefer hospital stays.
“This data shows that moderate sedation is both safe and effective, and has potential to become the choice approach for TAVR,” said Dr. Giri. “These results support our hypothesis that moderate sedation can lead to better clinical outcomes, and could have significant implications for patient care and for the process of the TAVR procedure.”
Importantly, the researchers also conducted a propensity-matched analysis which accounted for 51 factors known to predict 30-day TAVR mortality, such as age, gender, and heart failure status. The analysis further confirmed that moderate sedation was associated with lower 30-day mortality and 30-day mortality or stroke.
“This additional analysis was conducted in order to evaluate whether moderate sedation is successful across a variety of patients, and not just a relatively healthy group that was selected for this novel technique,” said Dr. Giri. “While it is nearly impossible to account for all factors that could lead to needing general anaesthesia, the 51 comorbidities and clinical characteristics we were able to account for still brought us to the same outcome — moderate sedation is associated with better clinical outcomes for patients undergoing percutaneous transfemoral TAVR.”