It's not a pill. It's called WATCHMAN
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The WATCHMAN Difference
WATCHMAN is a one-time, minimally invasive procedure for people with atrial fibrillation not caused by a heart valve problem (also known as non-valvuar AFib) who need an alternative to blood thinners.
Non-valvular Afib can mean a lifetime of blood thinners. It can also mean a lifetime of worry about issues like bleeds and falls. More than 100,000 people have left blood thinners behind with WATCHMAN.
Meet Dr. Adam Rosenbluth
Dr. Rosenbluth is a clinical cardiologist who’s been in practice for over 16 years. Dr. Rosenbluth referred appropriate patients for the WATCHMAN Implant during the clinical trials. And he continues to counsel patients about this life-changing procedure today. In the video below, he explains how WATCHMAN works and describes the WATCHMAN procedure.
How WATCHMAN Works
To understand how WATCHMAN works, it helps to know more about the connection between atrial fibrillation and stroke.
Atrial fibrillation, or AFib, affects your heart’s ability to pump blood normally. This can cause blood to pool in an area of the heart called the left atrial appendage, or LAA. There, blood cells can stick together and form a clot. When a blood clot escapes from the LAA and travels to another part of the body, it can cut off the blood supply to the brain, causing a stroke.1,2
In people with AFib not caused by a heart valve problem, more than 90% of stroke-causing clots that come from the heart are formed in the LAA.1 That’s why closing off this part of the heart is an effective way to reduce stroke risk.
The WATCHMAN Implant fits right into your LAA. It’s designed to permanently close it off and keep those blood clots from escaping. WATCHMAN is about the size of a quarter and made from very light and compact materials commonly used in many other medical implants.
Science always looks for ways to make effective treatments even better. WATCHMAN is no exception. The WATCHMAN FLX design is an advancement that enables the implant to fit a greater number of patients, giving more people than ever a safe, effective alternative to blood thinners should they need one.
In a clinical trial, 96% of people were able to stop taking blood thinners just 45 days after the WATCHMAN procedure.3
The WATCHMAN Procedure
WATCHMAN is implanted into your heart in a one-time procedure. It’s a permanent device that doesn’t have to be replaced and can’t be seen outside the body.
To implant WATCHMAN, your doctor makes a small cut in your upper leg and inserts a narrow tube, as done in a standard stent procedure. Your doctor then guides WATCHMAN into the left atrial appendage (LAA) of your heart. The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.
Due to the risk of having a medical procedure, patients should not be considered for WATCHMAN if they are doing well and expect to continue doing well on blood thinners.
Questions about WATCHMAN?
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After the Procedure
Following the WATCHMAN procedure, you’ll take blood thinners for 45 days or until your LAA is permanently closed off. During this time, heart tissue will grow over the implant to form a barrier against blood clots. Your doctor will monitor this process by taking pictures of your heart to see when you can stop taking your blood thinner.
Your doctor will then prescribe a medicine called clopidogrel (also known as Plavix®) and aspirin for you to take for 6 months. After that, you’ll continue to take aspirin on an ongoing basis. A very small number of patients may need to keep taking blood thinners long term.
In a clinical trial:
- 96% of patients were able to stop taking blood thinners just 45 days after the procedure3
Studies of WATCHMAN
WATCHMAN is the only device of its kind approved by the U.S. Food and Drug Administration (FDA) for reducing the risk of stroke in people with atrial fibrillation not caused by a heart valve problem.
More than 100,000 WATCHMAN procedures have been performed worldwide. With almost 20 years of clinical trial and real world experience - including 10 clinical trials - WATCHMAN has a proven safety record.
In a post FDA approval analysis, major complications occurred in 0.5% of cases from time of implant to 7 days post-implantation or hospital discharge, which is a similar rate to a cardiac ablation procedure.3
As with any medical procedure, there are risks involved with WATCHMAN. See the Important Safety Information below for a list of possible complications, and ask your cardiologist about the risks and benefits of WATCHMAN.
WATCHMAN is for people with atrial fibrillation not caused by a heart valve problem who need an alternative to blood thinners. This website is intended to provide patients and caregivers with some information about the WATCHMAN Implant. It may help prepare you for talking to your doctor about your options for reducing stroke risk.
Important Safety Information
The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.
With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device.
- Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
- National Stroke Association. Making the Afib-Stroke Connection. https://www.stroke.org/sites/default/files/resources/Afib-Connection%20for%20hcp.pdf. Published 2012. Accessed September 1, 2016.
- PINNACLE FLX 12-month primary safety and efficacy endpoint results, Doshi, SK. presented at HRS 2020 Science.