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The Watchman™ Procedure: Leading-Edge Care for Atrial Fibrillation

The AMITA Health Heart & Vascular Institute is one of only two institutions in the Chicago suburbs that offers the Watchman™ procedure to reduce risk of stroke in patients with AFib.

Patients with atrial fibrillation (AFib) have a high risk of stroke due to the formation of blood clots in the atria and, more commonly, in the left atrial appendage (LAA). Compared to those in sinus rhythm, the risk of stroke is five-fold higher in patients with nonvalvular AFib and twentyfold higher in those with valvular AFib, and the risk increases with both age and the presence of co-morbid conditions.

While anticoagulant medications decrease the risk of stroke in patients with AFib, long-term use also increases the risk of bleeding. In some patients, it may be difficult to find the right dose of anticoagulant medication or side effects may limit their use. Still other patients may have underlying conditions or take other medications for which blood thinners are contraindicated. In patients who are not able to take anticoagulant medications, surgical approaches have been used to physically “close off” the LAA with sutures or staples to prevent clot formation, but these have had variable success in terms of reducing stroke risk.

The Watchman™ Procedure

The Watchman™ left atrial appendage occlusion procedure was developed as a minimally invasive alternative to surgery to reduce the risk of stroke in patients with non-valvular AFib who are unable to take anticoagulant medications. In this image-guided procedure, a small nickel and titanium pouch-like device with a permeable fabric cover is used to block the entrance to the LAA off the left atrium. The device is inserted percutaneously via a guiding sheath through a vein in the upper leg, and positioned within the LAA opening. As the catheter is retracted, the device expands to seal off the LAA. The device is left in place indefinitely.

Pivotal clinical trials leading to FDA approval of the Watchman™ device demonstrated it to be as effective as anticoagulant medications (warfarin) for reducing the risk of stroke, systemic embolism and cardiovascular death. A recent registry of all Watchman™ procedures performed in the United States since March 2015 (in approximately 3,800 patients) reported a very low complication rate of less than one percent.

Watchman™ at the AMITA Health Heart & Vascular Institute

The Watchman™ procedure is performed at the AMITA Health Heart & Vascular Institute by a multidisciplinary team, consisting of an interventional cardiologist, electrophysiologist, general cardiologist and anesthesiologist. Patients with AFib who are referred to the AMITA Health Heart & Vascular Institute as potential candidates for the Watchman™ procedure undergo a multi-step screening process, including imaging to assess LAA size and shape. A nurse navigator provides patients with information about what to expect and helps guide the patient through all pre-operative testing, the procedure itself and follow-up.

“Our success with the Watchman™ device is in large part because of our collaborative approach to patient care, which allows us to anticipate and quickly address any issues as a cohesive team.”

 – Mohammed Khan, MD, Electrophysiologist

Patients will undergo general anesthesia and the entire procedure takes approximately one hour. Patients typically recover with a single overnight stay in the hospital and return home the next day. The AMITA Health Heart & Vascular Institute has a robust follow-up program in which the nurse navigator closely coordinates with referring physicians to adjust medications and quickly address any complications.

The team at the AMITA Health Heart & Vascular Institute has performed 10 Watchman™ procedures since starting its program in February 2016. Outcomes have been stellar with no complications, and all patients have been able to stop taking anticoagulant medications.

Andrei Pop, MD

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Mohammed Khan, MD

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William Gries, MD

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References

  1. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/ HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014;64:e1-e76.

  2. Boston Scientific. Watchman Left Atrial Appendage Closure Device. http://www.watchman.com/hcp/home.html. Accessed December 9, 2016.

  3. Reddy VY, Sievert H, Halperin J, et al, PROTECT AF Steering Committee and Investigators: Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.

  4. Holmes DR, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial
    Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL Trial. J Am Coll Cardiol. 2014;64(1):1-12.

  5. Reddy VY, Gibson DN, Kar S, et al. Post-FDA approval, initial US clinical experience with Watchman left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2016 Nov 2. doi: 10.1016/j.jacc.2016.10.010. [Epub ahead of print]

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