WATCHMAN Device implanted

Learn More About The WATCHMAN Implant Procedure

An Overview of How WATCHMAN Works

  • The WATCHMAN Implant procedure usually lasts about an hour and the patient is typically in the hospital for a day
  • The WATCHMAN Implant procedure is typically performed under general anesthesia in a catheterization laboratory setting using a standard transseptal technique
  • A transesophageal echocardiogram (TEE) is performed to measure the left atrial appendage (LAA) to determine which size WATCHMAN Device to be implanted
  • After the interatrial septum is crossed using a standard transseptal access system, the WATCHMAN Access Sheath is advanced over a guidewire into the left atrium. The Access Sheath is then advanced into the distal portion of the LAA over a pigtail catheter
  • The WATCHMAN Delivery System is prepped, inserted into the Access Sheath, and slowly advanced under fluoroscopic guidance. WATCHMAN is then deployed into the LAA. The device release criteria are confirmed via fluoroscopy and TEE prior to releasing the device
  • By closing off the LAA, the risk of stroke may be reduced and, over time, patients may be able to stop taking anticoagulants

In the Prevail Trial, WATCHMAN was Implanted Successfully in 95% of Patients1

The animation below shows how the WATCHMAN device is implanted in the left atrial appendage.

Video length: approximately 4 minutes.

*Reasons for aborted implantation attempts were: the patient did not stop anticoagulation before the procedure; pre-implant transesophageal echocardiography (TEE) revealed a new LAA thrombus; LAA size and shape were not optimal for the device; and occurrence of an adverse event that forced the procedure to stop.1

The WATCHMAN Implant is the Only FDA‑Approved Device Proven to Safely and Effectively Reduce Stroke Risk in Patients with NVAF

  • Procedural complication rates of only 4.2% were reported in the PREVAIL randomized controlled trial for both new and experienced operators
    • Procedure-related complications were defined as a composite of cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications occurring in the first 7 days after implant
WATCHMAN Physicians

WATCHMAN is Implanted at Top Medical Institutions across the Country

  • More than 250 major medical centers across the US are certified to implant WATCHMAN
  • The WATCHMAN physician training program involves multiple phases including didactic training, imaging training, training in patient selection, device selection, complication management, and optional physician proctoring
    • Individual physicians and/or the collective physician-team must be proficient in transseptal skills prior to entering the WATCHMAN Training Program  

Referring a Patient

Thinking about referring one of your NVAF patients? Here's what you need to know.

See which of your NVAF patients could benefit from WATCHMAN

Selecting appropriate patients

References: 

  1. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12. 2. Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol.2015;65(24):2614-2623. 

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.