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  WATCHMAN  
Implanter

PATIENT MUST HAVE:


  • A CHADS2 score  >2 or CHA2DS2-VASc score >3
  • A formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with non-valvular atrial fibrillation (NVAF) prior to LAAC. Additionally, the shared decision making interaction must be documented in the medical record
  • A suitability for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision-making, as LAAC is only covered as a second line therapy to oral anticoagulants. The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) of medical professionals. The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program
  • The procedure must be performed by an interventional cardiologist(s), electrophysiologist(s) or cardiovascular surgeon(s) that meet the following criteria:
    • Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and
    • Has performed > 25 interventional cardiac procedures that involve transseptal puncture through an intact septum; and
    • Continues to perform > 25 interventional cardiac procedures that involve transseptal puncture through an intact septum, of which at least 12 are LAAC, over a two year period
  • The patient is enrolled in, and the MDT and hospital must participate in a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients and 2) tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAC:
    • Operator-specific complications
    • Device-specific complications including device thrombosis
    • Stroke, adjudicated, by type
    • Transient Ischemic Attack (TIA)
    • Systemic embolism
    • Death
    • Major bleeding, by site and severity

 

For more information, please see CMS NCD

 

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