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Atrial Fibrillation, Strokes and the WATCHMAN Implant

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by J.Adderton J.Adderton (Member) Writer Verified

J.Adderton has 20 years experience .

80 Likes; 6 Followers; 28 Articles; 24,202 Visitors; 183 Posts

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Recently, I noticed an increase in patients undergoing the WATCHMAN procedure to reduce the risk of stroke with Atrial Fibrillation (AFib). It was not until my father was scheduled for the procedure that I set out to understand how the device worked. This article will provide an overview of the WATCHMAN implant and how it dramatically reduces the risk of stroke with Afib.

Atrial Fibrillation, Strokes and the WATCHMAN Implant

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

atrfib-01.jpg.ad3747ffc8b03d9ee71d5c1c6e531fc3.jpg

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

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RN MSN with over 20 years nursing experience in diverse settings. Enjoys writing articles for students and on substance use disorders in nursing.

80 Likes; 6 Followers; 28 Articles; 24,202 Visitors; 183 Posts

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572 Likes; 3 Followers; 25,921 Visitors; 5,224 Posts

This is a timely article for me. My Dad was visiting me for Thanksgiving this year and had a severe stroke. He has been on Coumadin for 25 years, and was very compliant with his regime. His INR was therapeutic, yet he still developed an enormous blood clot in his carotid artery. Because of his INR, he was not eligible for TPA; he had to be care flighted to a facility that could do a thrombectomy. We lost valuable time for that transfer. Dad is progressing in his recovery, but will probably not ever be completely back to normal.

 One of the cardiologists mentioned that we might want to check out this procedure down the line. I had not yet taken the time to fully research this procedure. 

Thanks for posting.

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tnbutterfly is a BSN, RN and works as a Content/Community Director @ allnurses.

353 Likes; 13 Followers; 111 Articles; 192,521 Visitors; 5,285 Posts

I was very excited to hear about this product from a friend/nurse at my church who works with Boston Scientific.  I was diagnosed with Paroxysmal A-fib when I was in my 30's.  It took a while for a diagnosis since I was back in sinus rhythm before they could catch it on EKG.   

I experience this so infrequently and have always converted in the hospital without cardioversion...except for once.  I have been on Flecainide and ASA for years.  My cardiologist wanted me on Coumadin, however, I was very reluctant to do that since I also was diagnosed with mild Von Willebrand disease and have experienced marathon nosebleeds and bruising. 

I tried it for a few months, but the INR window for me was so narrow and I was anxious the entire time.  Finally, after much thought, I told the cardiologist that I was stopping the Coumadin as I felt the risk for bleeding outweighed the benefit of anticoagulation and since my episodes were so infrequent.  I can always tell when I am in A-fib.  The last episode was 6 years ago.

I know I may not always know when I am in A-fib unless it is extended in duration and am at higher risk for stroke.  But I still am concerned about taking an anticoagulant.  So hearing about this product gives me hope that this may be an alternative for me.   At least I will explore this option.

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128 Likes; 1 Follower; 31,455 Visitors; 1,719 Posts

Thank you very much for this information.  I had heard of this device but hadn't got round to doing more research yet.  This information is very useful.

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traumaRUs has 25 years experience as a MSN, APRN and works as a Asst Community Manager @ allnurses.

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When I worked in HF this was a valuable tool for those with AFib, especially for those who can not tolerate anticoagulation 

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J.Adderton has 20 years experience.

80 Likes; 6 Followers; 28 Articles; 24,202 Visitors; 183 Posts

On 2/15/2019 at 10:21 AM, tnbutterfly said:

I was very excited to hear about this product from a friend/nurse at my church who works with Boston Scientific.  I was diagnosed with Paroxysmal A-fib when I was in my 30's.  It took a while for a diagnosis since I was back in sinus rhythm before they could catch it on EKG.   

I experience this so infrequently and have always converted in the hospital without cardioversion...except for once.  I have been on Flecainide and ASA for years.  My cardiologist wanted me on Coumadin, however, I was very reluctant to do that since I also was diagnosed with mild Von Willebrand disease and have experienced marathon nosebleeds and bruising. 

I tried it for a few months, but the INR window for me was so narrow and I was anxious the entire time.  Finally, after much thought, I told the cardiologist that I was stopping the Coumadin as I felt the risk for bleeding outweighed the benefit of anticoagulation and since my episodes were so infrequent.  I can always tell when I am in A-fib.  The last episode was 6 years ago.

I know I may not always know when I am in A-fib unless it is extended in duration and am at higher risk for stroke.  But I still am concerned about taking an anticoagulant.  So hearing about this product gives me hope that this may be an alternative for me.   At least I will explore this option.

Thanks for sharing your story.  There are probably many who read this and can relate to your experience.  

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