Transcatheter aortic valve replacement (TAVR) is associated with similar outcomes for low-risk patients with bicuspid and tricuspid aortic stenosis (AS), according to a new analysis published in JAMA.
“The recent pivotal low-risk randomized clinical trials expanded the indication of TAVR toward AS patients who have lower surgical risk and are younger; however, these trials excluded bicuspid anatomy,” wrote lead author Raj R. Makkar, MD, of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, and colleagues. “Previously published registries on outcomes of TAVR in bicuspid AS were limited to small sample size or older patients who were at higher risk for surgery. Given that bicuspid anatomy was frequently present in younger and low-risk patients undergoing surgery, the data on outcomes of TAVR in bicuspid AS are crucial to guide the treatment of bicuspid AS in these low-risk patients.”
The group assessed data from more than 3,000 propensity-matched pairs of low-risk patients who underwent TAVR with a balloon-expandable valve for bicuspid AS or tricuspid AS. All patients were treated from June 2015 to October 2000 at one of 684 U.S. facilities. The mean patient age was 69 years old, and 69.8% of patients were men. Patients undergoing bicuspid AS and tricuspid AS had the same mean predicted risk of mortality: 1.7%.
Overall, the authors found “no significant difference” between the two groups’ mortality rates after 30 days or one year. Patients with bicuspid AS had a 30-day mortality rate of 0.9% and one-year mortality rate of 4.6%. Patients with tricuspid AS, meanwhile, had a 30-day mortality rate of 0.8% and one-year mortality rate of 6.6%.
Stroke rates were also similar after 30 days (1.4% for bicuspid AS vs. 1.2% for tricuspid AS) and one year (2.0% vs. 2.1%).
“There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics, and moderate or severe paravalvular leak,” the authors added.
The team did note that their work had certain limitations. It was based on observational data, for instance, and there was “incomplete follow-up” that was likely made worse due to the COVID-19 pandemic. Also, the authors emphasized, they were focused on balloon-expandable valves only, meaning the findings don’t represent other available valve types.
Even with these limitations in mind, however, the group highlighted the importance of its findings, noting that even more work is needed.
“Because of the potential for selection bias and absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of TAVR for bicuspid AS in patients at low surgical risk,” they wrote.
Read the full study here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.