For individuals diagnosed with AFib, the risk of stroke is very real. In fact, a person with Afib is 5x more likely to suffer a stroke than someone with a regular heart rhythm. In order to order to understand how the implant works, you must first be familiar with the basics of Afib. In Afib, the heart’s atria flutter and send erradic electrical signal to the ventricles. As a result, blood pools and clots in the heart’s left atrial appendage (LAA). In non-valvular Afib, more than 90% of blood clots resulting in a stroke are formed in the LAA. A stroke occurs when these clots travel to the brain and prevent adequate blood flow. Afib is more common after age 50 and often occurs without symptoms.
Watch an animation of Afib from the American Heart Association
The goal of Afib treatment is to prevent clots from forming, control pulse rate and restore normal heart rhythm. Anticoagulants (warfarin, others) are given to prevent blood clots and reduce the risk of stroke. There are individuals that require blood thinners long-term. The risk of bleeding is higher when taking blood thinners. The Watchman implant is an alternative to long-term anticoagulant therapy for stroke prevention when the risk of bleeding outweighs the medication’s benefit.
The WATCHMAN device is for people meeting the following criteria:
Diagnosed with Afib not caused by a heart valve problem
Diagnosed with Afib and physician is recommending blood thinners
Are able to take warfarin but need an alternative
***Individuals may need an alternative to warfarin for the following:
History of serious bleeding while taking blood thinners
Are at risk for major bleeding to due lifestyle, occupation or physical condition
Take warfarin but have difficulty maintaining therapeutic PT/INR, have difficulty getting regular blood tests or cannot take a different type of anticoagulant
The WATCHMAN device is not for patients:
Who are unable to take warfarin, aspirin or clopidogrel
Who should not or cannot have a heart catheterization
Allergic to the device materials
With a LAA that is too large or small for the device to fit appropriately
Doing well and expect to continue doing well on anticoagulants.
"Ed is a 74-year-old patient with a long history of Afib. Over the years, Ed has undergone multiple cardioversions and cardiac ablations. Due to Ed’s high stroke risk, he was placed on warfarin and has been taking for several years. Ed has had multiple falls and remains a high fall risk secondary to vertigo. When Ed visits his cardiologist, he expresses fear of causing a major bleed because of his falls. However, he wants to continue to be active with his grandchildren and occasionally golf. The cardiologist explains the WATCHMAN procedure to Ed as an alternative to warfarin."
How It Works
The actual Watchman implant is about the size of a quarter and fits directly into the LAA. The implant permanently closes the LAA- preventing clots from leaving the heart and entering into the bloodstream. Since the implant is permanent, placed once and does not have to be replaced.
The Watchman procedure is minimally invasive and typically performed in a heart catheterization lab. The procedure is monitored by the medical team and utilizes imaging to visually guide the device in place. A thin catheter is inserted through a vein in the groin and guided into the heart’s right atrium. A second puncture is made in the muscle wall between the right and left atrium. The catheter is then advanced into the left atrium. The physician uses imaging to advance a smaller inner catheter, with the compressed device enclosed, into the LAA. Once the implant is in the right place, the implant will open- much like an umbrella. Within 45 days, a thin layer of tissue will grow over the implant.
Always a Risk
Any medical procedure carries risks and the Watchman is no exception. Review common risks here.
Clinical Studies and Evidence
The Food and Drug Administration approved the Watchman implant in 2016 based on long-term data from clinical trials. The trials ( PREVAIL study, PROTECT AF study and CAP Registry) included over 2400 patients and >8000 patient-years of follow-up. Data from the trials supporting FDA approval include:
Device successfully implanted in 95% of patients
45 days after implantation, 92% of patients were no longer taking blood thinners
>99% were no longer taking blood thinners by 1 year
Significant decrease in disabling and fatal strokes (largely due to the reduction in hemorrhagic stroke)
Demonstrated similar ischemic stroke reduction when compared to warfarin
Reduced major bleeding events vs warfarin by 72% at 6 months
In addition to clinical trials, the Watchman procedure has been performed over 20,000 times worldwide. It is the only device of its kind approved by the U.S. Food and Drug Administration.
What new and emerging advances in stroke prevention have you seen in your area of practice?
For additional information, visit www.watchman.com