Watchman And Amplatzer Implantable Devices Superior To Medical Therapy For Stroke Prevention In Patients With Atrial Fibrillation

WATCHMAN AND AMPLATZER IMPLANTABLE DEVICES SUPERIOR TO MEDICAL THERAPY FOR STROKE PREVENTION IN PATIENTS WITH ATRIAL FIBRILLATION

If you have been diagnosed with a heart condition called nonvalvular atrial fibrillation and are going through episodes of discomfort in the chest, a rapid and irregular heartbeat, lightheadedness, and overall exhaustion, we highly recommend you seek out a cardiologist who is familiar with Watchman, Watchman FLX (Boston Scientific Corp.), and Amplatzer Amulet (Abbott Medical). Our review of available scientific research suggests that the Watchman devices have a more favorable clinical profile than the Amplatzer device.

For you to have an informed conversation with your doctor, we are here to provide some useful science and insights on different implantable devices for atrial fibrillation and in what ways they are superior to medical therapy, i.e., anticoagulation (blood thinners). Our aim is to breakdown the complicated jargon and properly equip you to have that crucial conversation with your doctor.

Based on our review of the extensive scientific literature available on this topic, we conclude that Watchman devices reduce all-cause mortality more than warfarin (blood thinner), but stroke or systemic embolism and major bleeding did not differ statistically between study groups at 5-year follow-up. Additionally, the Amplatzer™ occlude appears to have similar efficacy to the Watchman devices.

Quick Reviewer

Atrial fibrillation
Atrial fibrillation

Atrial fibrillation—or A-fib—is an abnormal heart rhythm due to irregular and rapid contractions of the upper two chambers of the heart (atria). If the cause is problem with the functioning of heart valves, which may be hereditary, it is called valvular atrial fibrillation. When valvular cause is ruled out, this type is called nonvalvular atrial fibrillation.

Abnormal atrial contraction can cause pooling of blood in the atria that leads to blood clot formation. Such a clot can dislodge and travel to the brain where it can block a blood vessel and cause stroke.

Most of the times, the left atrial appendage (LAA) of the heart may be the cause of nonvalvular A-fib. LAA is a small pouch extending from the main body of the left atrium. It’s a common site of blood pooling in A-fib. Closing or sealing off the LAA through the implantation of left atrial appendage closure (LAAC) devices does not allow blood clots to leave the heart and enter blood circulation. This prevents stroke and other complications.

According to the American College of Cardiology, about 90 percent of strokes in people with A-fib result from blood clots that form in the left atrial appendage (LAA).1

Anticoagulants, such as warfarin, are usually prescribed for A-fib. However, some people are better candidates for LAAC devices to prevent the risk of stroke and other complications that may arise due to A-fib.

Are LAAC Devices Superior to Anticoagulants?

Watchman 2 Device Illustration
Watchman 2 Device Illustration

Anticoagulants like warfarin are highly effective in reducing risk of stroke in a person having nonvalvular A-fib. However, LAAC devices are the best option for some people, such as:

  • Those with a history of bleeding disorder
  • Those who have a medical condition that puts them at risk of bleeding, like ulcer or uncontrolled hypertension
  • Those with an active lifestyle or who travel frequently and do not have access to healthcare at all times
  • Those who cannot afford to buy anticoagulants regularly

Left atrial appendage occlusion (LAAO)procedure is a permanent, one-time, minimally invasive surgery that is as effective as warfarin in stroke prevention. Moreover, it gives freedom to its patients from the long-term use of blood thinners and the risk of bleeding in the long run.

Are You Eligible for an LAAC Device?

You are a good candidate for an LAAC device if you:

  • Have A-fib not caused by issues to your heart valves
  • Have been advised blood thinners, like warfarin, by your doctor
  • Can take such medicines but there is a risk of bleeding in the future due to certain medical conditions, like uncontrolled hypertension or ulcers, or your active lifestyle

You are not eligible for an LAAC device if you:

  • Cannot take blood thinning medications
  • Have been advised by your doctor to not undergo heart catheterization procedures
  • Are allergic to the materials used in implants, such as nitinol (nickel and titanium)
  • Have a left atrial appendage that is either too large or too small for the implant

What Are Your Options for Implantable LAAC Devices?

1. Watchman Device (Boston Scientific)

How safe is this device?

Today, the safe use of Watchman implant is backed by more than 10 years of clinical studies in over 2000 patients and more than 20,000 procedures have been performed successfully in patients.

“In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality has declined.”2

According to the manufacturer, it is a one-time, minimally invasive procedure that permanently reduces the risk of stroke without worrying about a lifetime of blood thinners. Moreover, the 5-year outcomes of the PREVAIL and PROTECT AF trials have demonstrated that:

“LAAC with Watchman provides stroke prevention in nonvalvular A-fib comparable to warfarin, with additional reductions in major bleeding, particularly stroke, and mortality.”3

How is the procedure done?

Under general anesthesia, a small cut is made in your upper leg. The Watchman device, by means of a narrow tube, is inserted through the incision and guided towards your heart. It is placed in the left atrial appendage in the upper left chamber of the heart to occlude it. Following the procedure, you can leave hospital the next day and are prescribed warfarin for 45 days. This method of implantation is the same for both Watchman FLX as well as Amplatzer Amulet device.

 
WATCHMAN AND AMPLATZER IMPLANTABLE DEVICES SUPERIOR TO MEDICAL THERAPY FOR STROKE PREVENTION IN PATIENTS WITH ATRIAL FIBRILLATION

Watchman Device User Reviews

2. Watchman FLX Device (Boston Scientific)

The Watchman FLX device is a next-generation implant and is different from the Watchman device in:

  • Its new, fully rounded design allows the surgeon to safely enter the left atrial appendage and place the implant within it.
  • It can be repositioned and redeployed within the LAA for correct and precise placement.
  • It seals off the LAA faster and more completely, providing long-term stability and effectiveness.
  • The Watchman FLX device comes in variable sizes and, thus, can treat different structural variations of the LAA.
Watchman FLX Device (Boston Scientific)
Watchman FLX Device (Boston Scientific)

Watchman FLX Device User Reviews

3. Amplatzer Amulet Device (Abbott Medical)

The Amplatzer Amulet device has been recently approved by the FDA for use in the United States. According to the manufacturer, it has a dual seal technology that effectively occludes the left atrial appendage, minimizing risk of device displacement–related complications in the long run. Moreover, it comes in a wide range of sizes to ensure a precise fit across different LAA structural variations in patients.

Amplatzer Amulet Device User Reviews

How safe is this device?

A recent large meta analysis analyzing various research studies conducted on over 2000 patients revealed that the effectiveness of Amplatzer Amulet device in preventing stroke in patients with nonvalvular A-fib is similar to the Watchman and Watchman FLX devices in terms of safety and efficacy. However, the Amulet occluder was associated with a higher incidence of procedure-related complications5.

Additionally, a multicenter randomized control trial of 1878 patients with nonvalvular A-fib in 2021 demonstrated that:

“The Amplatzer Amulet Occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular A-fib compared with the Watchman device. Procedure-related complications were higher with the Amulet Occluder and decreased with operator experience.”6

Amplatzer Amulet Device (Abbott Medical)
Amplatzer Amulet Device (Abbott Medical)

Frequently Asked Questions

How successful is the watchman procedure for AFib?

Watchman procedure has a success rate ranging from 50% to 90%. This suggests that the Watchman treatment is generally beneficial in lowering the risk of stroke in people with AFib.

Can you still have a stroke with a watchman?

Death, Stroke, and Device Embolisation Can Happen Years After Implantation.

Does Watchman stop atrial fibrillation?

The WATCHMAN operation and left atrial appendage closure device are a first-of-their-kind, proven alternative to the regularly used blood thinner warfarin in patients with atrial fibrillation or an irregular heart beat.

The Watchman is a one-time, minimally invasive, permanent operation that lasts a lifetime.

A sleep apnea implant, also known as hypoglossal nerve stimulation or upper airway stimulation therapy, treats sleep apnea by slightly moving your tongue to prevent it from obstructing your upper airway.

How common is stroke after watchman implant?

So far, WATCHMAN device failure leading to a stroke is uncommon. Device-related thrombosis, intradevice leak, device displacement to the aortic arch producing abrupt cardiac failure,11 and LAA perforation are uncommon.

What can We Conclude From This?

For many patients, Left Atrial Appendage Closure LAAC devices are superior to traditional medical therapy with blood thinners (warafarin or Coumadin). There are three different FDA-approved options in the market for LAAC devices. Our review of the scientific literature suggests that Watchman devices have a more favorable clinical profile than the Amplatzer Amulet. The choice of device ultimately depends on the individual patient’s medical history, heart structure, and other factors that may affect the safety and effectiveness of the procedure.

We hope that the information we have provided regarding the implantable devices will better help you to discuss the best suitable treatment option with your doctor and make an informed decision.

To your health!

Reference List

  1. Closing left atrial appendage reduces stroke risk from AFib. American College of Cardiology. Accessed March 9, 2023. https://www.acc.org/about-acc/press-releases/2017/03/18/08/47/sun-1045am-closing-left-atrial-appendage-reduces-stroke-risk-from-afib 
  2. Munir, MB, Khan, MZ, Darden, D, Pasupula, DK, Balla, S, Han, FT, Reeves, R, and Hsu, JC. Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States. J Cardiovasc Electrophysiol . 2020.
  3. Reddy, VY, Doshi, SK, Kar, S, Gibson, DN, Price, MJ, Huber, K, Horton, RP, Buchbinder, M, et al. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol . 2017;70(24):2964-2975.
  4. Basu Ray, I, Khanra, D, Shah, S, Char, S, Jia, X, Lam, W, Mathuria, N, Razavi, M, et al. Meta-analysis comparing Watchman(TM) and Amplatzer devices for stroke prevention in atrial fibrillation. Front Cardiovasc Med . 2020;7:89.
  5. Jaiswal V, Ang S, Shrestha A, Sharma P, Endurance E, Khan S, Mukherjee D, Jaiswal A, Chia J, Huang H, et al. Amplatzer amulet versus watchman device for percutaneous left atrial appendage closure: a systematic review and meta-analysis. European Heart Journal, Volume 44, Issue Supplement_1, February 2023, ehac779.017, https://doi.org/10.1093/eurheartj/ehac779.017
  6. Lakkireddy, D, Thaler, D, Ellis, CR, Swarup, V, Sondergaard, L, Carroll, J, Gold, MR, Hermiller, J, et al. Amplatzer Amulet Left Atrial Appendage Occluder versus Watchman Device for stroke prophylaxis (Amulet IDE): A randomized, controlled trial. Circulation . 2021;144(19):1543-1552.
  7. Boersma, LV, Ince, H, Kische, S, Pokushalov, E, Schmitz, T, Schmidt, B, Gori, T, Meincke, F, et al. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol . 2019;12(4):e006841.
  8. Holmes, DR, Jr., Reddy, VY, Gordon, NT, Delurgio, D, Doshi, SK, Desai, AJ, Stone, JE, Jr., and Kar, S. Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. J Am Coll Cardiol . 2019;74(23):2878-2889.
  9. Munir, MB, Khan, MZ, Darden, D, Pasupula, DK, Balla, S, Han, FT, Reeves, R, and Hsu, JC. Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States. J Cardiovasc Electrophysiol . 2020.
  10. Brouwer, TF, Whang, W, Kuroki, K, Halperin, JL, and Reddy, VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc . 2019;8(23):e013525. |
  11. Price, MJ, Reddy, VY, Valderrabano, M, Halperin, JL, Gibson, DN, Gordon, N, Huber, KC, and Holmes, DR, Jr. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv . 2015;8(15):1925-1932.
  12. Alkhouli, M, Busu, T, Shah, K, Osman, M, Alqahtani, F, and Raybuck, B. Incidence and clinical impact of device-related
    thrombus following percutaneous left atrial appendage occlusion: A meta-analysis. JACC: Clinical Electrophysiology .
    2018;4(12):1629-1637.
  13. Osmancik, P, Herman, D, Neuzil, P, Hala, P, Tabor ala, P, Poloczek, M, Stasek, J, et al. 4-Year outcomes after left atrial
    appendage closure versus nonwarfarin oral anticoagulation for atrial fibrillation. Journal of the American College of
    Cardiology . 2022;79(1):1-14.
  14. Osmancik, P, Herman, D, Neuzil, P, Hala, P, Taborsky, M, Kala, P, Poloczek, M, Stasek, J, et al. Left atrial appendage closure versus non-warfarin oral anticoagulation in atrial fibrillation: 4-year outcomes of PRAGUE-17. J Am Coll Cardiol . 2021.
  15. Osmancik, P, Herman, D, Neuzil, P, Hala, P, Taborsky, M, Kala, P, Poloczek, M, Stasek, J, et al. Left atrial appendage closure versus direct oral anticoagulants in high-risk patients with atrial fibrillation. J Am Coll Cardiol . 2020;75(25):3122-3135.
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    Watchman Implant Ensures Safety and Comfort

    Rated 5.0 out of 5
    May 11, 2023

    I am 73 years old & had the watchman implant done on 05/02/2023 and I am quite confident in both the watchman working & sealing properly and my surgeon has done 100’s of these since they came out. Also my daughter worked almost 15 years on the heart floor at the hospital where she now is the night house supervisor and has seen many patients have this done with no problems. I feel fine & came home the next day with no discomfort. Lived out in the country & am considered a big fall risk patient as my balance is not what it used to be. No regrets & I will have none when they decide that I have to have a pacemaker either. Yes, the a-fib has my heart rate so slow It sometimes is all I can do to make a day. God has been good to this old man & I am thankful for the nurses & doctors who took care of me during the procedure. Easy peasy!

    Ray Shirley Baxter

    Unveiling the Watchman Implantation Dilemma

    Rated 5.0 out of 5
    May 8, 2023

    I had AFib. Recently cardioversion put me in a normal sinus rhythm. In three weeks I have had AFib for a total of 47 SECONDS… per my pacemaker report. Why would I still have been scheduled to have the Watchman implanted?

    Peggy Buchanan

    Remarkable Recovery My Watchman Implant Experience

    Rated 4.0 out of 5
    April 19, 2023

    One week ago I had my Watchman implant – the surgery took 90 minutes and post-surgery required that I lay flat on my back for four hours. I have not experienced any pain or discomfort. I was back to normal within two days following surgery, even though I felt perfect the morning following surgery. It was remarkable.

    Perry Jurgens

    Watchman Device Easy and painless procedure

    Rated 5.0 out of 5
    April 17, 2023

    I was a bit nervous before getting the Watchman Device implanted, but the whole process was surprisingly easy and painless. The doctors and nurses were very professional and made sure I was comfortable throughout the procedure. Afterward, I was able to go home the same day and didn’t experience any complications. I’m grateful for this device and the peace of mind it brings.

    Samuel

    Watchman FLX A Solution for Stroke Prevention

    Rated 5.0 out of 5
    April 10, 2023

    Watchman FLX is a revolutionary device that provides a new solution for stroke prevention in patients with atrial fibrillation (AFib). AFib is a heart condition where the heart beats irregularly, which can cause blood clots to form in the heart. If these clots travel to the brain, they can cause a stroke.

    It’s a small, flexible device implanted in the heart’s left atrial appendage. It blocks off this area where blood clots can form and reduce the risk of stroke in patients with AFib. The device is inserted through a small incision in the leg and is guided to the heart using a catheter.

    Thomas

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