TAVI: Study finds low stroke rates with Medtronic’s CoreValve

A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years. The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days). Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients,” showed an overall stroke rate of 1.4% for the 1st day. The rate of stroke was 3.0% at 30 days and 5.6% at 2 years, according to the study. Although there were no significant predictors of periprocedural stroke or stroke/transient ischemic attack combined, the researchers found that acute kidney injury, major vascular complications and female gender were significant predictors of early stroke. Prior atrial fibrillation and major vascular complication predictive of for stroke/TIA combined, while coronary artery bypass graft surgery was the only significant predictor of late stroke, according to the study. “Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically rele...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Regulatory/Compliance CoreValve Inc. medtronic Source Type: news