Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit. using the WATCHMAN 2.5 device is feasible and non-inferior to TAVR followed by medical therapy on the composite endpoint of all-cause mortality, stroke, and major bleeding in patients with bothBased on past trials, AF typically is present in about 33%–40% of patients undergoing TAVR.
All patients were included in the analysis, although in the TAVR + LAAO group, 15 did not undergo LAAO for various reasons, and 8 were lost to follow-up or withdrew consent. For the TAVR + medical therapy arm, 21 did not have TAVR, were lost to follow-up, or withdrew consent. The risk of major or life-threatening bleeding was 35% greater in the first 6 months post-TAVR + LAAO, after which time the risk was actually 37% lower compared with the TAVR + medical therapy arm.
Designated discussant Megan Coylewright, MD, MPH, of Erlanger Heart and Lung Institute in Chattanooga, Tennessee, began by congratulating Kapadia"not just for this study, but for your leadership back in 2016 when you first thought up this study. This was an investigator-initiated study." "Of course, they have to live 2 years to say that they are not taking anticoagulation," he replied."So, if you take a retrospective analysis of saying the patients who are not on anticoagulation, how they are doing, of course, they are self-selected, but it is very unlikely that they are going to do as well without anticoagulation."
Finally, Coylewright asked if it is necessary to have a randomized trial for every combination of procedures to gain the evidence necessary to have reimbursement to provide these choices to patients for whom it would be an appropriate option."Or can we utilize our mandated national registries to provide continued evidence developments?" she wondered.
Source: Healthcare Press (healthcarepress.net)
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