WATCHMAN Patient

Who Is WATCHMAN For?

Man crossing river on hike

See Which of Your NVAF Patients Can Benefit from WATCHMAN

Appropriate patients may have one or more of the following:

  • A history of major bleeding while taking therapeutic anticoagulation therapy
  • Prior inability to maintain a stable therapeutic International Normalized Ratio (INR) or to comply with regular INR monitoring AND unavailability of an approved alternative anticoagulation agent
  • A medical condition, occupation, or lifestyle placing the patient at high risk of major bleeding due to trauma

For full information regarding WATCHMAN patient selection factors, please see the WATCHMAN Device Directions for Use (DFU).

WATCHMAN Device implanted

Device Indications for Use

The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
  • Are deemed by their physicians to be suitable for warfarin; and
  • Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

Payer coverage policies may not be consistent with BSC device labeling. In some cases, payer policies may include procedures, indications or criteria (such as a specific definition of CHAD2 or CHA2DS2-VASc scores or contraindication to warfarin) which may differ from the FDA label. The Centers for Medicare and Medicaid Services (CMS) established a national coverage determination (NCD) for percutaneous LAAC therapy on February 8, 2016 – Visit www.cms.gov to review the NCD criteria in their entirety. For patients who are not covered by Medicare, please refer to the specific payer’s policy in seeking prior authorization for medical necessity for the WATCHMAN Therapy.

WATCHMAN candidate Frank and granddaughter

Major Bleeding Risk

Frank has health problems resulting from a fall that put him at risk for major bleeding

 

Age: 80; Involved Grandfather; NVAF, Congestive Heart Failure, Hypertension, Diabetes

CHA2DS2-VASc score: 5; HAS-BLED score: 2

Although patient is suitable for warfarin, he is currently taking 15 mg rivaroxaban daily

Frank has a history of recurrent falls, resulting in both a broken hip and cerebral contusion after falling on separate occasions. His physician believes his medical condition places him at high risk of major bleeding secondary to trauma*

Frank's physician determined he is a potential candidate for a WATCHMAN Implant

Case description for educational purposes; not a real patient case.

*Some studies of patients with a history of falls, or at risk for falls and head trauma, have shown that the benefits of anticoagulation therapy to reduce the risk of stroke outweigh the risk of major, life-threatening bleeding. An individualized benefit and risk assessment should be made in such patients2-4

WATCHMAN candidate Catherine

Difficulty Maintaining INR Range

Catherine has challenges with medication costs and being adequately controlled on OACs

 

Age: 68; Retired, Volunteer; NVAF, Hypertension, Vascular Disease

CHA2DS2-VASc score: 4; HAS-BLED score: 3

Currently taking 5 mg warfarin and 100 mg of aspirin daily

Catherine is unable to comply with regular INR monitoring due to her proximity to the clinic and cannot afford novel oral anticoagulant (NOAC) medication

Catherine's physician determined she is a potential candidate for a WATCHMAN Implant

Case description for educational purposes; not a real patient case.

WATCHMAN candidate Gwen

Lifestyle Creates Potential Bleed Risk

Gwen's lifestyle may elevate the risk of major bleeding

 

Age: 65; Home Health Aide; NVAF, Diabetes

CHA2DS2-VASc score: 3; HAS-BLED score: 3

Although patient is suitable for warfarin, she is currently taking 150 mg dabigatran twice daily

Gwen's physician determined her active lifestyle, which includes horseback riding, places her at risk of major bleeding secondary to trauma

Gwen's physician determined she is a potential candidate for a WATCHMAN Implant

Case description for educational purposes; not a real patient case.

WATCHMAN candidate John

Occupation Elevates Bleed Risk

The Combination of John Working as a Commercial Fisherman and His Warfarin Regimen Prompt Concerns About Bleeding Risks

 

Age: 55; commercial fisherman; NVAF, Hypertension, Diabetes

CHA2DS2-VASc score: 2; HAS-BLED score: 2

Currently taking 5mg warfarin daily

John's physician feels that his work as a fisherman puts him at risk of major bleeding secondary to trauma.

John's physician determined he is a potential candidate for a WATCHMAN Implant

Case description for educational purposes; not a real patient case.

See the Benefits of WATCHMAN from the Physician's Perspective

Watch physicians discuss how the WATCHMAN Implant offers patients with non-valvular atrial fibrillation (NVAF) an important alternative to long-term oral anticoagulant therapy.

Implanting Centers

Do you have a patient who may be a candidate for receiving the WATCHMAN implant?

Find an implanter in your area

References: 

  1. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61(2):755-759. 2. American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Persons. J Am Geriat Soc. 2011;59(1):148-157. http://www.americangeriatrics.org/files/documents/health_care_pros/JAGS.Falls.Guidelines.pdf. 3. Sellers MB, Newby LK. Atrial fibrillation, anticoagulation, fall risk, and outcomes in elderly patients. Am Heart J. 2011;161(2):241-246. 4. Donzé J, Clair C, Hug B, et al. Risk of falls and major bleeds in patients on oral anticoagulation therapy. Am J Med. 2012;125(8):773-778.

WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System

INDICATIONS FOR USE

The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
  • Are deemed by their physicians to be suitable for warfarin; and
  • Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

CONTRAINDICATIONS

Do not use the WATCHMAN Device if:

  • Intracardiac thrombus is visualized by echocardiographic imaging.
  • An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
  • The LAA anatomy will not accommodate a device. See Table 46 in the DFU.
  • Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
  • There are contraindications to the use of warfarin, aspirin, or clopidogrel.
  • The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN Device is contraindicated.


WARNINGS

  • Device selection should be based on accurate LAA measurements obtained using fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0°, 45°, 90°, 135°).
  • Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria.
  • If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE.
  • The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period.
  • Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion.
  • For single use only.  Do not reuse, reprocess, or resterilize.


PRECAUTIONS

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.
  • The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the device.
  • Use caution when introducing the WATCHMAN Access System to prevent damage to cardiac structures.
  • Use caution when introducing the Delivery System to prevent damage to cardiac structures.
  • To prevent damage to the Delivery Catheter or device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.
  • If using a power injector, the maximum pressure should not exceed 100 psi.
  • In view of the concerns that were raised by the RE-ALIGN1 study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation.


ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection/pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, Myocardia erosion, Nausea, Oral bleeding, Pericardial effusion/tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency/failure, Surgical removal of the device, Stroke – Ischemic, Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions. There may be other potential adverse events that are unforeseen at this time. 

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

Sources:
1. Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.