Basel Ramlawi, M.D., chairman of The Heart and Vascular Center at Valley Health System in Virginia, director of the Advanced Valve and Aortic Center, and co-principal investigator for an American College of Cardiology (ACC) 2020 Scientific Session late-breaking trial that looks at the clinical implications of TAVR in patients who have bicuspid aortic valve leaflets offers an overview of the data from ACC.20.
Patients with bicuspid, or two-leaflet, aortic valves who undergo transcatheter aortic valve replacement (TAVR) procedures had a high rate of success and low risk of death or disabling stroke at 30 days, according to new data presented at the ACC 2020. The session was part of the virtual, online late-breaking presentations, since the live meeting was cancelled due to the spread of COVID-19.
TAVR has become increasingly popular in recent years as a less-invasive alternative to open-heart valve replacement surgery. However, few studies have examined its safety in patients with a bicuspid valve, a genetic variation of the aortic valve in some patients, rather than the typic three-leaflet valve. The condition affecting roughly 2-5 percent of people in which two of the three flaps in the aortic valve are fused together.
A bicuspid valve is more likely to become stenosis. Valve replacement, either through TAVR or open-heart surgery, is the main treatment option available for people with severe aortic stenosis, which causes fatigue and other symptoms and raises the risk of other heart problems when left untreated. The new study is the first to prospectively examine TAVR’s safety for treating severe aortic stenosis in relatively young, healthy patients—in whom open-heart surgery would pose a low risk—who have a bicuspid valve. It also is one of the first studies involving such patients in which doctors used a newer self-expanding artificial valve.
“This clearly has clinical implications with patients with bicuspid valves who want TAVR," said Basel Ramlawi, M.D., cardiothoracic surgeon at Valley Health System in Virginia and the study’s co-principal investigator. "TAVR with a self-expanding prosthesis is a very viable and safe procedure in low-risk bicuspid patients and achieved excellent early results. Though additional follow-up is necessary to determine long-term outcomes, early results suggest this procedure can be performed successfully in low-risk individuals with a good outcome.”
The study prospectively tracked 150 patients who underwent TAVR at 25 medical centers in the U.S.