The first transcatheter aortic valve replacement device designed specifically to control aortic regurgitation performs well at 2 years in advance of randomized trial, reported investigators.
WASHINGTON — A phase 3 randomized trial will soon begin for the first transcatheter aortic valve replacement device for the treatment of aortic valve regurgitation after promising results in a 2-year initial study.
The rate of cardiovascular mortality, which was 6.2% at 1 year, remained relatively stable climbing to just 7.4% after 2 years. The rate of nondisabling stroke remained unchanged at 4.1% from year 1 to 2 and that of disabling stroke climbed from 1.7% at 1 year to 2.3%. This is consistent with highly favorable and progressive improvements in left ventricular remodeling. For left ventricular end-systolic diameter and volume, a large improvement relative to baseline at 30 days was followed by further improvements at 6 months and 1 year. Although no further improvement was seen after 2 years, there was also no decline.
Cardiac Surgery Aortic Insufficiency Aortic Valve Insufficiency Aortic Regurgitation Congenital Heart Disease Transcatheter Aortic Valve Replacement TAVR Transcatheter Aortic Valve Implantation TAVI Percutaneous Aortic Valve Replacement Heart Failure Heart Aortic Valve Arrhythmia Cardiomyopathy Stroke Cerebrovascular Accident CVA - Cerebrovascular Accident
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