Watchman Implant

watchman  in physician handThe WATCHMAN™ implant is a device utilized as an alternative to long-term warfarin medication to reduce stroke risk in patients with non-valvular atrial fibrillation. This procedure offers patients with non-valvular atrial fibrillation (AF) an alternative to long-term warfarin medication.

How the WATCHMAN™ Implant Works

watchman deployedThe WATCHMAN™ implant closes off an area of the heart called the left atrial appendage (LAA) to keep harmful blood clots that can form there from entering the bloodstream and potentially causing a stroke. By closing off the LAA, the risk of stroke may be reduced and, over time, patients may be able to stop taking warfarin.

WATCHMAN now available at the International Heart Institute of Montana

Illustration of implanted WATCHMAN Device

The WATCHMAN™ device is a breakthrough treatment for nonvalvular atrial fibrillation. Approved by the Food and Drug Administration and the Centers for Medicare & Medicaid Services, WATCHMAN is an alternative to long-term anticoagulation that occludes the left atrial appendage (LAA) and significantly reduces stroke risk.

Approximately 90 percent of thrombi causing CVAs in AFib patients originate in the LAA. Traditionally, stroke prevention in AFib involves prescribing warfarin or a novel oral anticoagulant (NOAC). Warfarin and NOACs carry the possibility of devastating iatrogenic hemorrhage, particularly in patients who are at risk for bleeding.

Now, extensive clinical investigations show that left atrial appendage occlusion with the WATCHMAN™ device is comparable to warfarin in the prevention of stroke and systemic emboli. Short-term anticoagulation is prescribed post-procedure; however, after endothelialization of the device, anticoagulation for AFib can be stopped for life.

Inclusion criteria

  • Nonvalvular AFib
    • AAFib in the absence of rheumatic mitral stenosis, a mechanical or bioprosthetic mitral valve, or mitral valve repair
  • CHA2DS2-VASc ≥ 3 or CHADS2 ≥ 2
    • Increased risk for thromboembolism based on CHADS2 or CHA2DS2-VASc and recommended for anticoagulation therapy
  • Suitable for short-term warfarin
  • Appropriate rationale to seek nonpharmacologic alternative to warfarin
    • e.g. HAS-BLED ≥ 3
    • Labile INRs
    • Medical condition, occupation or lifestyle placing patient at high risk for bleeding from trauma

Exclusion criteria

  • Valvular AFib
    • Rheumatic mitral stenosis
    • Bioprosthetic or mechanical mitral valve
    • Mitral valve repair
  • Intracardiac thrombus
  • ASD or PFO repair or closure device present
  • Nonaccommodating LAA anatomy
  • Contraindications to warfarin, ASA or Clopidogrel
  • Any customary contraindications to cardiac catheterization procedures
  • Known hypersensitivity to device

Procedure

  • WATCHMAN™ is a percutaneous jellyfish-shaped device that permanently closes off the left atrial appendage.
  • The one-hour procedure is done at the International Heart Institute at Providence St. Patrick Hospital in Missoula.
  • There is an anticipated one-night inpatient post-procedure stay.
  • Endothelialization of the device typically takes between 45 days and six months.

FDA recommended anticoagulation*

  • From 0 to 45 days: 81 mg ASA + warfarin (INR 2-3)
  • From day 45 to six months: 325 mg ASA + 75 mg clopidogrel
  • Six months and beyond: 325 mg ASA daily for life

*The anticoagulation regimen may vary with each patient, as deemed appropriate by his or her medical team.

Resources

Links and downloads

Video: WATCHMAN Implantation Technique