Small Device, Big Difference
If you or a loved one has been diagnosed with atrial fibrillation (AFib), you know this common heart rhythm disorder comes with an increased risk for stroke. That’s why we help AFib patients who’re at risk of stroke live confidently with a device called the WATCHMAN FLX™.
The FLX is a small, parachute-shaped device that’s about the size of a quarter. While it doesn’t treat arrhythmias like AFib, it closes off the left atrial appendage, so blood clots cannot form there and travel into the bloodstream and brain to cause a stroke. Because more than 90% of stroke-causing blood clots come from the heart in people with non-valvular AFib, closing off the left atrial appendage can reduce the risk of stroke and, over time, allow patients to stop taking blood thinners. The WATCHMAN FLX is considered an alternative to anticoagulation medication and a lasting solution.
FAQs About the WATCHMAN Implant for AFib
- How do I know if I have AFib?
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AFib happens in the heart’s left atrium, which squeezes blood through the chambers of the heart. When the heart’s upper chambers receive abnormal electrical signals, the organ suffers, and it beats too fast and irregularly.
For most adults, a normal resting heart rate can range between 60 to 100 beats per minute. For people with AFib, the resting heartbeat could go up to 175 beats per minute. And because the blood isn’t being carried through the valves correctly, it can collect and cause clots which could travel to the brain, block the flow of blood and cause a stroke.
AFib usually affects people 30 and 60 years old and is caused by heart disease or a heart abnormality. It’s also associated with obesity, sleep apnea, diabetes, hypertension and underlying heart issues.
Sometimes AFib is discovered during routine physical exams when a doctor detects an abnormal heartbeat. Other people notice symptoms like:
- Chest pain
- Dizziness
- Racing heartbeat
- Shortness of breath
- Skipped heartbeat
- Weakness or fatigue
AFib can be treated very effectively, but early detection is key. If you experience any AFib symptoms, make an appointment with your doctor. They’ll review your family and personal medical history and perform a physical and an EKG to determine if AFib is the cause.
- What happens during the WATCHMAN device procedure?
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The WATCHMAN medical device procedure does not require open-heart surgery. Your surgeon will implant it using a minimally invasive procedure. Via a small cut in your upper leg, the surgeon will insert a catheter into a vein and guide it into the right atrium of the heart. From there, the surgeon will cross from the right side of the heart to the left, where the WATCHMAN device will be delivered into the left atrial appendage.
With the WATCHMAN in place, the surgeon releases it and it permanently seals off the left atrial appendage. The catheter is removed from your body and, over time, heart tissue will grow over the implant.
- What happens after the WATCHMAN surgery?
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Most patients stay in the hospital for one day after having the WATCHMAN device implanted. It’s common to have a sore throat from the breathing tube and the transesophageal echocardiogram that is done during the procedure. You may be sore or have bruising in one or both areas of the groin and you might have to remain on your back for up to eight hours so your providers can closely monitor your groin for bleeding or swelling.
If you take blood thinners, you’ll need to continue them to help reduce the risk of stroke until enough tissue grows and permanently closes off the left atrial appendage. Most patients stop taking blood thinners after 45 days, and if you’re on Coumadin, you’ll need to have your INR checked within the week and be closely monitored on a weekly basis to check the thinness of your blood.
Your first follow-up appointment will be at 45 days, with additional follow-ups at six months and one and two years.
- Is the WATCHMAN safer than blood thinners?
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Blood-thinning medications and anticoagulants like warfarin are effective in preventing and dissolving blood clots, but they come with potential issues. They can cause heavy bleeding, cause interactions with other medicine and require frequent blood tests. And blood thinners aren’t always an option for people with conditions that could cause internal bleeding. The WATCHMAN helps manage AFib without these issues.
- How effective is the WATCHMAN?
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The WATCHMAN medical device, which was approved in Europe in 2005 and is FDA-approved in the United States, has been implanted in over 10,000 patients around the world. It has also been studied in several clinical registries and two randomized clinical trials that included more than 2,400 patients.
The WATCHMAN device is comparable to warfarin in the reduction of stroke risk — it has shown an 85% reduction in hemorrhagic stroke, a 63% reduction in disabling stroke and a 56% reduction in cardiovascular death. Patients with the WATCHMAN device had a 71% relative reduction in major bleeding after six months compared to patients treated with warfarin.
After 45 days, most patients were able to stop taking warfarin, and over 99% were off of warfarin at one year.
More About the WATCHMAN FLX™
DISCLAIMER: 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, transient ischemic attack and, in some rare cases, death.
Be sure to talk with your doctor so you thoroughly understand all of the risks and benefits associated with the implantation of the device.