WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System
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 oral antocoagulation
Have an appropriate rationale to seek a non-pharmacologic alternative to oral antocoagulation, taking into account the safety and effectiveness of the device compared to such drugs.
Contraindicated:
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.
Existence of contraindications for percutaneous catheterization procedures or conditions 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.
Device selection is based on accurate LAA measurements obtained using fluoro and ultrasound guidance.
TEE is recommended in multiple angles.
If thrombus is observed on the device, anticoagulation therapy is recommended until resolution of thrombus is demonstrated by TEE.
The potential for device embolization exists with cardioversion <30 days following device implantation.
Endocarditis prophylaxis is required for 6 months following device implantation.
Its safety and effectivenes has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.
The Watchman device has a high device implant success of 95.6% and low rate of major complications including: pericardial tamponade at 1%, procedure related stroke at 0.078%, device embolization at 0.24% and procedure related death at 0.078%.
Potential adverse events associated with the use of a left atrial appendage closure device or implantation procedure include: 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, 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, Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions.