Evolut Low Risk Bicuspid Study: Favorable Safety With TAVR in Patients With Bicuspid Valve

Transcatheter aortic valve replacement (TAVR) procedures had a high rate of success and low risk of death or disabling stroke at 30 days in patients with a bicuspid valve, according to results of a Late-Breaking Clinical Trial presented during ACC.20/WCC.

The Evolut Low Risk Bicuspid Study is the first to prospectively examine TAVR’s safety for treating severe aortic stenosis in relatively young, healthy patients who have a bicuspid valve. It also is one of the first studies involving such patients in which physicians used a newer self-expanding artificial valve.

“TAVR with a self-expanding prosthesis is a very viable and safe procedure in low-risk bicuspid patients and achieved excellent early results,” says Basel Ramlawi, MD, FACC, the study’s co-principal investigator. “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. On average, patients were 70 years old and had a Society of Thoracic Surgeons risk score of 1.4%. Thirty days after their procedure, just 1.3% of patients had died or experienced a disabling stroke, the study’s primary safety endpoint.

Patients had an overall device success rate of 95.3%, reflecting a low rate of major complications, ill-fitting valves or the need for additional procedures. The vast majority (99.3%) of patients survived the procedure, 96% showed correct positioning of the valve and 100% had mild or no aortic regurgitation.

Of patients with a Sievers type 0 valve, 84.6% had trace or no aortic regurgitation and the rest had only mild leaking, a high rate of success that Ramlawi says was somewhat unexpected due to the perceived complexity of operating on valves with this shape.

Along with not being a randomized comparison, the investigators note the study was conducted in medical centers with a high volume of TAVR procedures and whether similar results would be achieved in centers with less experience is not clear.

“This is the first study that shows the self-expanding valve works well for patients with both type 1 and type 0 bicuspid valves,” Ramlawi says. “The medical community has perceived type 0 bicuspid valves as more challenging to treat, so those data are especially encouraging.”

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: ACC Annual Scientific Session, acc20, Transcatheter Aortic Valve Replacement, Mitral Valve, Heart Valve Diseases, Stroke, Thrombosis, Hemodynamics, Endocarditis, Heart Failure

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