brain, but the WATCHMAN Implant was better than warfarin in terms of the number of strokes caused by bleeding into the brain. In making treatment recommendations, doctors should consider the benefits and risks of anticoagulant medications and the WATCHMAN Implant for each individual patient, including the chance that either kind of stroke (a stroke caused by a blocked blood vessel or a stroke caused by bleeding) might occur. The PREVAIL study also tested a new training program that was designed for doctors who had not previously performed a WATCHMAN Implant. The PREVAIL study found that these new operators could safely implant the WATCHMAN Implant. Another study of 566 patients called the CAP Registry also confirmed that the WATCHMAN Implant could be implanted successfully and safely. In all of the WATCHMAN® clinical trials, approximately 92% of patients were able to stop taking their warfarin 45 days after implant, and over 99% were able to stop taking warfarin by 1 year following the implant procedure. In the studies that compared patients who received the WATCHMAN Implant to those who continued on warfarin, the overall serious bleeding rates were similar in WATCHMAN patients and warfarin patients. The risk of serious bleeding was higher in WATCHMAN patients versus warfarin patients within several months of the implantation procedure but lower beginning 6 months after the implantation procedure. As with any procedure, there are risks associated with the implant, the implant procedure itself, and the medications that are prescribed during and after the implant procedure. You should discuss with your doctor if these risks outweigh the benefit you may receive from a WATCHMAN Implant. Potential harmful events (in alphabetical order) which may be associated with the use of the WATCHMAN Implant or implantation procedure include but are not limited to: Air embolism (leak of air bubbles into the bloodstream which may cause damage to organs) Airway trauma (damage to your airways) Allergic reaction to the contrast dye, anesthetic, WATCHMAN Implant material, or medications Altered mental status (change in mental status) Anemia (thin blood) requiring transfusion Anesthesia risk Angina (chest pain) Anoxic encephalopathy (change in mental status from a lack of oxygen reaching the brain) Arrhythmias (heart rhythm abnormalities) Atrial septal defect (hole in wall between upper chambers of the heart)
brain, but the WATCHMAN Implant was better than warfarin in terms of the number of strokes caused by bleeding into the brain. In making treatment recommendations, doctors should consider the benefits and risks of anticoagulant medications and the WATCHMAN Implant for each individual patient, including the chance that either kind of stroke (a stroke caused by a blocked blood vessel or a stroke caused by bleeding) might occur. The PREVAIL study also tested a new training program that was designed for doctors who had not previously performed a WATCHMAN Implant. The PREVAIL study found that these new operators could safely implant the WATCHMAN Implant. Another study of 566 patients called the CAP Registry also confirmed that the WATCHMAN Implant could be implanted successfully and safely. In all of the WATCHMAN® clinical trials, approximately 92% of patients were able to stop taking their warfarin 45 days after implant, and over 99% were able to stop taking warfarin by 1 year following the implant procedure. In the studies that compared patients who received the WATCHMAN Implant to those who continued on warfarin, the overall serious bleeding rates were similar in WATCHMAN patients and warfarin patients. The risk of serious bleeding was higher in WATCHMAN patients versus warfarin patients within several months of the implantation procedure but lower beginning 6 months after the implantation procedure. As with any procedure, there are risks associated with the implant, the implant procedure itself, and the medications that are prescribed during and after the implant procedure. You should discuss with your doctor if these risks outweigh the benefit you may receive from a WATCHMAN Implant. Potential harmful events (in alphabetical order) which may be associated with the use of the WATCHMAN Implant or implantation procedure include but are not limited to: Air embolism (leak of air bubbles into the bloodstream which may cause damage to organs) Airway trauma (damage to your airways) Allergic reaction to the contrast dye, anesthetic, WATCHMAN Implant material, or medications Altered mental status (change in mental status) Anemia (thin blood) requiring transfusion Anesthesia risk Angina (chest pain) Anoxic encephalopathy (change in mental status from a lack of oxygen reaching the brain) Arrhythmias (heart rhythm abnormalities) Atrial septal defect (hole in wall between upper chambers of the heart)
watchman-educational-hand-out.docx