Medtronic Evolut TAVR System Demonstrates Excellent Outcomes in Study of Low-Risk Patients with Bicuspid Aortic Stenosis

ACC.20/WCC: Low Rates of Paravalvular Leak and High Survival Observed in Late-breaking Clinical Trial of Low-Risk Bicuspid Aortic Stenosis Patients

DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced late-breaking clinical data from the Low Risk Bicuspid Study assessing the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk. The study showed low rates of all-cause mortality or stroke at 30 days (1.3%) with a low rate of serious procedural complications, and no annular rupture or aortic dissection. The study was presented as part of the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) meeting.

Results from the 150-patient, single-arm study showed excellent outcomes at 30 days, with a 95.3% device success rate and a low rate of serious procedural complications including no annular ruptures or aortic dissection. In addition, results from the study showed:

•  Low rate of all-cause mortality (0.7%)
•  Low rate of disabling stroke (0.7%)
•  Exceptional hemodynamics with low mean AV gradients (7.6 ± 3.7 mm Hg), and large effective orifice area (2.3 ± 0.7 cm²)
•  No incidence of moderate or severe paravalvular leak (PVL) 
•  Low rate of major vascular complications (1.3%)
•  High utilization of the Evolut 34 mm (41.6% of patients in the study were implanted with this larger valve size)
•  New pacemaker rate (15.1%) was lower than in the Evolut Low Risk Trial

“These findings point to a potentially less invasive treatment for patients who otherwise would undergo open heart surgery due to their anatomical valve structure,” said Basel Ramlawi, M.D., chair of The Heart & Vascular Center at FACC Valley Health System in Winchester, Va., and co-primary investigator of the study who presented the data at the meeting. “We feel confident that these primary early outcomes provide additional evidence that the Evolut TAVR platform is a suitable treatment option for patients with bicuspid valves who have previously been left out of TAVR trials.”