Transcatheter aortic valve replacement (TAVR) procedures appear to be safe for low-risk patients with bicuspid aortic valve disease, according to a new study published in JAMA Cardiology.
The researchers relied on outcomes after 30 days, however, and studies focused on long-term outcomes are still needed before TAVR can be recommended for such patients across the board.
The analysis included data from 150 low-risk patients with severe bicuspid aortic valve stenosis undergoing TAVR with a self-expanding valve. All procedures occurred from December 2018 to October 2019 and met established criteria for aortic valve replacement. The average patient age was 70.3 years old, and 52% of study participants were male.
Overall, the device success rate was more than 95%. After 30 days, the rate of all-cause mortality or disabling stroke was just 1.3%. One patient experienced acute coronary obstruction following the implant, “which was successfully treated by conversion to open surgery.” A new pacemaker was needed for 15% of patients, and one patient had to be hospitalized again due to heart block.
“Transcatheter aortic valve replacement in low-risk patients with bicuspid aortic valve stenosis achieved favorable early results, with high device success and low rates of death or disabling stroke.” wrote lead author John K. Forrest, MD, Yale University School of Medicine in New Haven, Connecticut, and colleagues. “Longer-term outcomes are needed, and carefully constructed randomized clinical trials comparing TAVR with surgery in this patient population should be considered prior to any changes in clinical guidelines for patients with bicuspid aortic valve disease undergoing aortic valve replacement.”
The team plans on following up with the study’s participants for 10 years. Click here to read the full analysis.