FDA approved WATCHMAN Left Atrial Appendage Closure Device is a first-of-its-kind, proven alternative to long-term warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation. The WATCHMAN™ LAAC Device is designed specifically for the left atrial appendage. Featuring an intra-LAA design to avoid contact with the left atrial wall, the WATCHMAN device is engineered to conform to the unique anatomy of the LAA to reduce embolization risk. The device offers a new stroke risk reduction option for patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy alternative.
It is intended for percutaneous, transcatheter closure of the left atrial appendage (LAA). Patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism, are suitable for warfarin and seek a non-pharmacologic alternative to warfarin may be eligible for this device. By closing off the LAA, the risk of stroke may be reduced and, over time, patients may be able to stop taking warfarin.
The WATCHMAN Device implant procedure is typically performed under general anesthesia in a catheterization laboratory setting using a standard transseptal technique. The LAAC implant procedure usually lasts about an hour and the patient is typically in the hospital for 24 hours following the procedure.
A transesophageal echocardiogram (TEE) is performed to measure the left atrial appendage (LAA) to determine which size device to be implanted. After the inter-atrial 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. The WATCHMAN Device 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.
For people with irregular heart rhythm, known as atrial fibrillation, blood thinners, or anticoagulants, are often prescribed. The watchman will be an option to permanently fix the concern of blood clots forming in the heart, which could lead to a stroke. This device may not be a fix for all patients, because there are some qualifications to be eligible for the procedure but it will be an option for many patients with irregular heart rhythms.
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