WATCHMAN patient eligibility

Do you know if your non-valvular atrial fibrillation (AFib) patients are eligible for a WATCHMAN Implant? Start by taking this 4-in-1 eligibility screener and risk score calculator to see if your patient qualifies.

Screen your patient now

Who is a WATCHMAN candidate?

The WATCHMAN Implant may be suitable for a broad range of non-valvular AFib patients and may be appropriate for those who:

  1. Are at an increased risk for stroke based on CHA2DS2-VASc score and are recommended for anticoagulation therapy*
  2. Are suitable for short-term anticoagulants†
  3. Have a clinically supported need to seek a non-pharmacologic alternative to anticoagulation therapy

    Note: Does not apply to patients who receive the WATCHMAN Implant concomitantly or sequentially with an AFib ablation**

    Coverage remains unchanged. Under the CMS NCD, the patient must be deemed unable to take long-term OAC and meet all criteria in NCD 20.34 to be eligible for coverage. Commercial payer coverage policy requirements will vary.

The WATCHMAN Implant may be right for a broad range of patient types

ACC, HRS and SCAI recognize the following example scenarios that support alternatives to long-term oral anticoagulation (OAC):1-3

Past Bleed

Patients who have a history of major or minor bleeding episodes in the past

Increased risk of future bleed
  • Patient’s occupation or activities increase their risk of falling or bleeding
  • Patient takes other medications beyond OACs that increase bleeding risk
  • Patient has an increased bleeding risk not reflected by the HAS-BLED score or other factors caused by side effects of OACs
Increased Risk of Stroke

Patient has a history of stroke due to:

  • Poor compliance with OAC therapy
  • Inability to maintain internal normalized ratio (INR)

Note: This is not an exhaustive list. For a full list of example scenarios mentioned in the 2015 Consensus memorandum submitted on the proposed NCD during the process of establishing CMS coverage for LAAC, see here.

WATCHMAN patient profiles

See examples of different types of AFib patients who may be appropriate candidates for the WATCHMAN Implant

Previous bleed
Future bleed risk
Patient with previous major bleeding

Patient is at risk for stroke and has had a previous major bleeding event.

Drug interaction
Previous bleed
Patient with multiple conditions/medications

Patient has concomitant meds and should not add another anticoagulant.

Future bleed risk
Stroke risk
Patient with high risk of future bleed

Patient has a history of frequent falls, with difficulty maintaining therapeutic range.

Non-compliant
Lifestyle and occupation
Stroke risk
Patient struggling with non-compliance

Patient is at risk for stroke but declines oral anticoagulants (OACs).

Learn more
Understanding clinical data and trials

Explore the efficacy and clinical outcomes of the WATCHMAN Implant

View clinical evidence

*Increased Risk = CHA₂DS₂-VASc ≥ 2 in men, ≥ 3 in women. CMS coverage criteria requires a CHA₂DS₂-VASc score ≥ 3. Providers are encouraged to read the decision memo in its entirety for additional detail

†Option for immediate DAPT-only post-implant drug regimen for standalone WATCHMAN procedures.

**In the OPTION trial, sequential LAAC was a minimum of 90 days post AFib ablation (as a protocol-driven blanking period).

References:

  1. 2015 Consensus public comment submitted on the proposed NCD during the process of establishing CMS coverage for LAAC. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=281&bc=AAAAAAAAQAAA&%20
  2. Documentation supporting medical necessity is required for coverage.
  3. Blankenship J, et al., ACC/HRS/SCAI National Coverage Determination Memorandum to CMS, December 2015.
WATCHMAN FLX Pro Device Brief Summary

SH-2332809-AA