Transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis is safe in low-risk patients with bicuspid aortic stenosis, according to late-breaking trial results presented Sunday at the American College of Cardiology Scientific Sessions 2020 virtual conference.
Basel Ramlawi, MD, a cardiothoracic surgeon and chairman of The Heart & Vascular Center at Valley Health System in Virginia, presented the results on behalf of the Medtronic Low-Risk Bicuspid investigators.
The prospective registry enrolled 150 patients at 25 high-volume centers across the U.S. Enrolled patients had an average age of 70 years and a Society of Thoracic Surgery (STS) mortality risk score of 1.4%. Patients with Sievers type 0 and 1 bicuspid valves were included.
Patients were treated with Medtronic’s Evolut R (23, 26, 29 or 34 mm) or the Evolut PRO (23, 26 or 29 mm) self-expanding transcatheter heart valve. Key anatomical exclusion criteria were significant ascending aortopathy requiring surgical repair, an ascending aorta diameter >4.5 cm and age <60 years.
At 30 days of follow-up after the procedure, 1.3% of patients had died or experienced a disabling stroke. Procedural success was also high at 95.3%, indicating a low complication rate. The design improvements from Evolut R to Evolut Pro, which added a sealing skirt on the bottom cells of the device, showed impressive results, with 100% of patients demonstrating mild or no aortic regurgitation within 7 days.
Speaking about the results, Ramlawi said: “This is the first study that shows the self-expanding valve works well for patients with both type 1 and type 0 bicuspid valves. The medical community has perceived type 0 bicuspid valves as more challenging to treat, so those data are especially encouraging.”
The trial was funded by Medtronic, maker of the self-expanding valves used in the study.