Cardiologists Can Now Use Watchman Device for Stroke Prevention

The FDA panel voted 13-1 that the benefit to using the Watchman device outweigh the potential risks. This left atrial appendage closure technology can now be used for preventing ischemic strokes, as well as, reducing the bleeding risk in nonvalvular atrial fibrillation patients and systemic embolism

Richard A. Lange, from the University of Texas, was the only panel member to vote against the devices safety and effectiveness.

It seems that this device can now be used by a cardiologist to replace Warfarin if they wish. This is not the first time the device has come up for review with the agency. In 2010 the FDA issued sent out a non-approval letter after the advisory panel recommended against it because of concerns they had over the protect AF trial, so they requested a new trial be conducted.

Boston Scientific made its case for approval on the results of the new trial where patients who received the Watchman had similar outcomes to those taking Warfarin. However, Boston Scientific is also quick to point that the Watchman shouldn’t be considered as the first line of replacement but rather it should be considered as an alternative for would be eligible for Warfarin therapy but for one reason or another want a different option.

Your cardiologist can insert the Watchman device under a local or general anesthesia in a CAT lab using the transseptal technique. You can expect the procedure to take around an hour and then you will like stay in-hospital for 24 hours. The Watchman device is implanted permanently at/near the opening of the left atrial appendage. The purpose is for it to trap blood clots before they are able to exit the left atrial appendage.

There are a number of stroke prevention therapies that your cardiologist can use and the Watchman simply gives your cardiologist one more option. Warfarin has been the number one choice for a very long time, but for some patients it is simply not tolerated very well.

In patients that have atrial fibrillation, blood tends to clot and pool in the left atrial appendage. If a blood clot breaks off, it can cause a stroke. Since most blood clots are found in the left atrial appendage, closing it off makes sense and the use of the device means that the patient will no longer need to use Warfarin.

The use of the Watchman device will reduce the risk of stroke and therefore ultimately cardiovascular death. When the patient no longer needs to take Warfarin, it can also eliminate or reduce other events related to bleeding such as nosebleeds, bruising, gastrointestinal bleeding and hemorrhagic strokes, which is the most serious event of all. It also eliminates the need for the ongoing blood tests to measure clotting values of the blood.

Watchman Left Atrial Appendage Closure device is exciting new technology that could very well change the lives of many patients who up until now had only Warfarin to rely on.