Study: TAVR safe in patients with unusual valve anatomy
Data from a new study presented yesterday indicates that patients with unusual bicuspid aortic valves had a similar survival rate but a higher likelihood of stroke when treated with transcatheter aortic valve replacement technology.
Results from the study were presented at the American College of Cardiology 68th Annual Scientific Session in New Orleans.
Though most individuals are born with an aortic valve with three flaps, some are born with two fused together, creating a bicuspid valve, researchers said. Bicuspid aortic valves affect up to 1% of the general population, they added.
“Based on this study, patients with bicuspid aortic valve stenosis who are at intermediate or high risk for open heart surgery can be safely treated by balloon-expandable TAVR with an acceptable risk. Our study supports the notion that carefully selected patients with bicuspid aortic stenosis can avoid surgery and be treated with this less invasive option,” study lead author Dr. Raj Makkar of the Cedars-Sinai Heart Institute said in a press release.
In the study, investigators explored the use of TAVR in treating bicuspid patients at an intermediate or high risk of open heart surgery, adding that a bicuspid valve is the most common cause of aortic stenosis in younger patients.
Researchers analyzed data from the STS/ACC TVT registry, including more than 80,000 patients who underwent TAVR procedures between 2015 and 2018. Investigators compared results from 2,691 patients with a bicuspid valve against an equal number of patients with a tricuspid valve based on 25 variables to increase cross-group similarities.
Rates of death were similar between both groups, at 2.6% for bicuspid patients at 30 days and 2.4% for tricuspid patients, rising to 10.8% and 12.1% at one year, respectively. No significant differences in valve functionality were noted between the groups, researchers added.
Patients with a bicuspid valve had a 50% higher risk of stroke at 30 days, occurring in 2.4% of patients, compared to only 1.6% in tricuspid patients.
Rates of procedural complications were also low overall, though patients with bicuspid valves were significantly more likely to have their procedure converted from TAVR to open due to problems mid-procedure. Such conversions occurred in 0.9% of the bicuspid group and 0.4% of the tricuspid group, researchers said, adding that further research would need to be performed to understand why complications were more common for bicuspid patients.
“The results indicate that survival, stroke and valve function were very acceptable and similar to tricuspid aortic stenosis, which is the more common type of aortic stenosis. Using a CT scan prior to the procedure to predict which bicuspid valves should be triaged to surgery rather than TAVR is a crucial area of research,” Makkar said in prepared remarks.