WATCHMAN is for people with atrial fibrillation not caused by a heart valve problem who need an alternative to an anticoagulant. This website is intended to provide patients and caregivers with some information about the WATCHMAN Implant. It may help prepare you for talking to your doctor about your options for reducing stroke risk.
Important Safety Information
The WATCHMAN Device is a permanent implant designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.
With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the WATCHMAN™ Closure Device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis, transient ischemic attack device embolization, fluid around the heart and need for open heart surgery. In rare cases death can occur.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the WATCHMAN Device.
- National Stroke Association. Making the Afib-Stroke Connection. Published 2012. Accessed September 1, 2016.
- Harvard Health Publications. Atrial fibrillation. http://www.health.harvard.edu/heart-health/atrial-fibrillation-common-serious-treatable. Harvard University Medical School. Published November 2011. Accessed August 25, 2016.
- Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
- Cleveland Clinic. Atrial fibrillation (Afib). http://my.clevelandclinic.org/services/heart/disorders/arrhythmia/atrial-fibrillation-afib. Published May 2015. Accessed August 25, 2016.
- National Stroke Association. Making the Afib-Stroke Connection. https://www.stroke.org/sites/default/files/resources/Afib-Connection%20for%20hcp.pdf. Published 2012. Accessed September 1, 2016.
- Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.