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Adverse Events Drop With Fuller Accounting of Evolut Low Risk Trial


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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. ....

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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. ....

France General , Gilles Montalescot , Andrew Goldsweig , Adnan Chhatriwalla , Baylor Scott White , Joao Cavalcante , Bristol Myers Squibb , Michael Mack , David Cohen , American College Of Cardiology , Phd Centre Hospitalier Universitaire Piti , Md University Of Nebraska Medical Center , Heart Center , Md Saint Luke Mid America Heart Institute , Md Minneapolis Heart Institute , American College , Centre Hospitalier Universitaire Piti , Francis Hospital , Evolut Low Risk Trial , Nebraska Medical Center , Baylor Scott , White Heart Hospital , Minneapolis Heart Institute , Saint Luke , Mid America Heart Institute , Kansas City ,

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 l ....

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