TAVR Shown to Be Safe in Treating Patients With Bicuspid Valves
March 17, 2019—The American College of Cardiology (ACC) announced that findings from a trial studying transcatheter aortic valve replacement (TAVR) treatment of bicuspid valves in patients at intermediate or high surgical risk were presented by Lead Investigator Raj Makkar, MD, at the ACC's 68th Annual Scientific Session being held March 16–18 in New Orleans, Louisiana.
In the announcement, Dr. Makkar commented, “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.” Dr. Makkar is Associate Director of Cedars-Sinai Heart Institute in Los Angeles, California.
In this study, investigators analyzed data from the Society of Thoracic Surgeons/ACC TVT registry of more than 80,000 patients who underwent TAVR between 2015 and 2018. They matched 2,691 patients who had a bicuspid valve with an equal number of patients with a tricuspid valve based on 25 variables (in an effort to make the two groups as similar as possible) and compared outcomes between the two groups.
ACC reported that rates of death from any cause were similar between the two groups at 30 days and 1 year after the procedure, with 2.6% and 2.4% of those in the bicuspid and tricuspid groups, respectively, dying within 30 days and 10.8% and 12.1% of those in the bicuspid and tricuspid groups, respectively, dying within 1 year. There were also no significant differences between the two groups in terms of how well the replacement valve functioned.
Patients with a bicuspid valve showed a 50% higher risk of any type of stroke at 30 days, which occurred in 2.4% of these patients compared with 1.6% in the tricuspid group. Although this is a significant difference, the stroke rate of 2.4% is still considered relatively low, according to the investigators.
Dr. Makkar stated, “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.”
Although procedural complication rates were low overall, patients with a bicuspid valve were significantly more likely to have their procedure converted from TAVR to open heart surgery because of problems encountered during the procedure, which occurred in 0.9% of patients in the bicuspid group and 0.4% of patients in the tricuspid group. Dr. Makkar noted that further research is needed to understand why these complications were more common in those with a bicuspid valve.
“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,” advised Dr. Makkar in the ACC announcement. He also explained that the study included only patients who were considered at intermediate or high risk for open heart surgery. He advised further that determining the risks and benefits of TAVR in younger, lower-risk patients with bicuspid aortic stenosis would require a randomized trial.