Say No to Watchman

Cardiology is on the brink of making a big mistake. We have embraced a new procedure called left atrial appendage isolation. You may be seeing the ads for a device called Watchman. Like this one> The appendage-closure idea was a good one: during atrial fibrillation (AF), blood can pool in the left atrial appendage, and this promotes clot formation. (The LA appendage has many nooks and crannies.) So… if we could put a device in there, see image, this would block clots from getting out and causing stroke.  Also, once the device has been in for months, the body walls it off and the patient can stop the anticoagulant drug (warfarin, or one of the new drugs, called NOACs). Here is the problem: The Watchman device does not prevent strokes. When compared in the best test of medicine, the randomized controlled trial (RCT), the device was inferior to warfarin. Another problem: advocates for the device have used selective reporting and publishing of trial results to alter the way patients and doctors perceive reality. This week I published a detailed critical appraisal of the evidence for Watchman. Here is the piece: Left Atrial Appendage Closure Should Stop Now. The three take-home messages from that post are: Take-home #1: In the first trial of Watchman v warfarin, called the PROTECT-AF study, complications were high. This finding, plus other irregularities led the FDA to reject the device and call for another trial. The second trial of Watchman v warfarin, called the PRE...
Source: Dr John M - Category: Cardiology Authors: Source Type: blogs