May 27, 2020
TAVR Shown to Be Safe to Treat Bicuspid Valve Disease
May 27, 2020—The American College of Cardiology (ACC) announced the publication of a study demonstrating that transcatheter aortic valve replacement (TAVR) appears to be a safe treatment option with low complication rates for many patients with a bicuspid aortic valve that needs replacing.
The study, which was published online by John K. Forrest, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions, found that patients with bicuspid valves and at increased risk for surgery had 30-day and 1-year mortality and stroke rates that were similar to patients with tricuspid valves.
According to the ACC, the investigators used data from the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy registry to analyze 932 patients with bicuspid valve disease who underwent TAVR with either the Evolut R or Evolut Pro devices (Medtronic) between July 2015 and September 2018.
The patients in the study were at increased surgical risk based on a number of factors, including their age and whether they had medical conditions such as diabetes, previous surgery, stroke, or peripheral vascular disease. The majority of bicuspid patients in this study were at intermediate or high surgical risk.
Comparing the bicuspid patients with similar patients with tricuspid valve disease who underwent TAVR during that same time period, the investigators found similar rates of death from any cause at 30 days (2.6% vs 1.7%) and 1 year (10.4% vs 12.1%) and similar rates of stroke at 30 days (3.4% vs 2.7%) and 1 year (3.9% vs 4.4%).
“No one’s valve works as well at age 70 as it does at age 20, but in patients with a bicuspid aortic valve, it’s more likely to wear out and require replacement,” noted Dr. Forrest in the ACC announcement. He continued, “This study suggests TAVR is a viable option for patients with bicuspid valve disease who are at increased surgical risk. It will be very important to continue to monitor these patients to see how the valves perform in 10 or 15 years.” Dr. Forrest is Director of the Structural Heart Disease Program at Yale University School of Medicine and Yale New Haven Hospital in New Haven, Connecticut.