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Adverse Events Drop With Fuller Accounting of Evolut Low Risk Trial

email article Transcatheter aortic valve replacement (TAVR) with CoreValve and Evolut devices maintained good results in the Evolut Low Risk Trial through 2 years, with investigators now boasting complete follow-up and no more need to rely on Bayesian analysis. In 2019, a prespecified interim analysis of the trial found that the primary endpoint all-cause mortality or disabling stroke at 24 months occurred in 5.3% of TAVR recipients compared with 6.7% of the surgical group under Bayesian methods, demonstrating that TAVR was noninferior for efficacy. Now, with complete follow-up, 2-year event rates were 4.3% and 6.3%, respectively (log-rank P=0.084), such that TAVR looks, at least numerically, even better than before, said John Forrest, MD, of Yale University School of Medicine in New Haven, Connecticut, during a presentation at this year s virtual European Association of Percutaneous Cardiovascular Interventions (EuroPCR) meeting.

Apixaban Curbs Subclinical Thrombosis After TAVI in Patients Without Prior OAC

May 17, 2021 Use of apixaban (Eliquis; Bristol-Myers Squibb) following transcatheter aortic valve implantation does not significantly reduce the risk of subclinical valve thrombosis when compared with standard of care, according to a CT substudy from the ATLANTIS trial presented today. However, the results are nuanced, with investigators reporting an intriguing interaction between thrombus risk and prior oral anticoagulation indication. For patients without an indication for oral anticoagulation, use of apixaban as opposed to antiplatelet therapy was associated with a lower risk of subclinical valve thrombosis as measured by reduced leaflet motion (RLM) and hypoattenuated leaflet thickening (HALT). By contrast, for those with an indication for oral anticoagulation, apixaban failed to prevent subclinical valve thrombosis when compared with a vitamin K antagonist.

Medtronic Evolut TAVI Now Licensed for Both Bicuspid Aortic Valves at Intermediate or Greater Risk and for Low Risk of Surgical Mortality

Medtronic Evolut TAVI Now Licensed for Both Bicuspid Aortic Valves at Intermediate or Greater Risk and for Low Risk of Surgical Mortality Health Canada Issues Licence for Expanded Indications for Evolut TAVI Platform  Medtronic Canada ULC, a subsidiary of Medtronic plc ― the world’s largest medical technology, services, and solutions company ― has received a new expanded indication from Health Canada for its Evolut™ Transcatheter Aortic Valve Implantation system. Medtronic’s TAVI platform is currently the only system licensed for both bicuspid … Health Canada Issues Licence for Expanded Indications for Evolut TAVI Platform  Medtronic Canada ULC, a subsidiary of Medtronic plc (NYSE: MDT) ― the world’s largest medical technology, services, and solutions company ― has received a new expanded indication from Health Canada for its Evolut™ Transcatheter Aortic Valve Implantation (TAVI) system. Medtronic’s TAVI platform is currently the only system licensed for

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