Shared Decision-Making: An evidence-based cornerstone of WATCHMAN
What is Shared Decision-Making?
- Shared decision-making is a collaborative process that allows patients and their physicians to make treatment decisions together
- The process considers the best scientific evidence available, as well as the patient's values and preferences1
The Role of Shared Decision-Making in LAAC Procedures2
- A formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool is recommended for patients with non-valvular atrial fibrillation (NVAF) prior to LAAC
- The shared decision-making interaction must also be documented in the medical record
- The patient must be suitable 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
Why is Shared Decision-Making Important?
The Centers for Medicare and Medicaid Services (CMS) encourages the use of an evidence-based tool in discussions about LAAC therapy because it helps:
- Compare the risks and benefits to oral anticoagulants
- Determine and document the appropriateness of LAAC as a non-pharmacological treatment option
- Uncover barriers to change that include physical pain, emotional difficulties, financial concerns and lack of confidence in one's ability to change
- Address any barriers to develop a realistic personal prevention plan with specific and achievable outcomes
Shared Decision-Making Resources
The following resources will help you have more productive conversations with your patients about the risks and benefits to anticoagulation treatment for non-valvular atrial fibrillation.
- Centers for Medicare & Medicaid Services. Decision memo for percutaneous left atrial appendage (LAA) closure therapy (CAG-00445N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281&ExpandComments=n&DocID=CAG-00445N&bc=gAAAAAgAAgAAAA%3d%3d&. Published February 8, 2016. Accessed May 20, 2016. 2. . Barry MJ, Edgman-Levitan S. Shared decision making—the pinnacle of patient-centered care. N Engl J Med. 2012;366(9):780-781. 3. Agency for Healthcare Research and Quality. U.S. Department of Health & Human Services. http://www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/index.html. Accessed May 20, 2016.
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.
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.
- 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 (see step 14).
- 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.
- 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.
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.
- Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.