WATCHMAN™ Procedure
Eisenhower Health offers the Watchman™ procedure to qualified patients.
The WATCHMAN Implant is the Only FDA Approved Device Proven to Safely and Effectively Reduce Stroke Risk in Patients with NVAF.
- The FDA approval of the WATCHMAN™ Implant is based on long-term data from numerous clinical trials involving more than 2,400 patients and more than 8,000 patient-years of follow-up.
- The WATCHMAN clinical program resulting in FDA approval consisted of multiple studies:
- An initial pilot study
- Two randomized clinical trials: PROTECT AF and PREVAIL
- CAP and CAP 2 registries
WATCHMAN Video
Eliminate Warfarin
The WATCHMAN™ Implant is an innovative one-time procedure designed to reduce the risk of strokes that originate in the left atrial appendage (LAA) and will enable patients to stop long-term use of warfarin.
- In the PREVAIL trial, WATCHMAN was implanted successfully in 95% of patients*
- The average procedure time is approximately 60 minutes, and patients typically stay in the hospital for 24 hours
- After just 45 days following implantation, 92% of patients were able to stop taking warfarin. At one year, the number increased to more than 99%(1)
*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)
Watchman Reduces Risk of Stroke, Bleeding and Mortality
Long Term Results Demonstrated WATCHMAN™ Reduces Risk of Stroke, Bleeding and Mortality
- Long-term results from a patient-level meta-analysis of the PROTECT AF (2,717 pt yrs) and PREVAIL (1,626 pt yrs) trials demonstrated that WATCHMAN offered:
- Comparable primary efficacy and all-cause stroke reduction
- Statistically significant reductions in disabling and fatal stroke (largely driven by reduction in hemorrhagic stroke), as well as mortality
- Notably, WATCHMAN has now demonstrated ischemic stroke reduction similar to that observed with warfarin in both the PROTECT AF and PREVAIL trials, as well as four additional registries, when accounting for differences in CHA2DS2-VASc score
