Atrial fibrillation (AFib) is the most commonly diagnosed arrhythmia, and it puts more than 2.7 million Americans at an increased risk for having a stroke. AFib patients are five times more likely to suffer a stroke, while 15-20% of all strokes are AFib-related. As the U.S. population ages, physicians will see more AFib cases, with the number expected to reach more than 12 million in 2030.
Doctors use various medications, including anticoagulants, to help control the irregular heart rate. While medications can help prevent blood clot formation, for certain patients, blood thinners may be too risky to use. That’s when cardiologists can turn to a surgical procedure to treat the patient instead.
A small, parachute-type device is placed in the left atrial appendage (LAA) to reduce the risk of thromboembolism in patients with nonvalvular atrial fibrillation who are not good candidates for long-term anti-coagulation medications. The FDA-approved device is inserted with a catheter and placed in the LAA, where it opens up like an umbrella. A thin layer of tissue then grows over the permanent device in about 45 days. This keeps the blood clots in the left atrial appendage from entering the bloodstream while also allowing many patients to discontinue use of blood thinners.
In non-valvular AFib, more than 90% of stroke-causing clots that come from the left atrium are formed in the LAA. The Watchman implant is a minimally invasive, one-time procedure designed to reduce the risk of strokes that originate in the LAA. It often takes less than 30 minutes to place the permanent implant, with an average hospital stay of one day or less – a much shorter recovery time compared to open heart surgery.
Several Novant Health hospitals are certified to do this procedure, and cardiologists doing the procedure are trained in multiple phases, including didactic training, imaging training, training inpatient selection, device selection and complication management.
The implant procedure is indicated for people who have AFib not caused by a heart valve problem (also known as non-valvular AFib), have been recommended for blood thinning medicines by their doctor, and can take short-term blood thinners but need an alternative. The LAA is permanently sealed after heart tissue grows over the Watchman implant. Patients remain on an OAC for at least 45 days post-procedure.
According to a clinical trial that evaluated the procedural safety and closure efficacy for one type of implant, the device had a low major complication rate and a high rate of effective LAA closure. Trial results found:
- Primary safety endpoint – 0.5% event rate
- Primary efficacy endpoint – 100% effective LAA closure
- 96.2% of patients able to discontinue blood thinner at 45-day follow-up
- 98.8% patients successfully implanted
- No hemorrhagic strokes through 12 months of follow-up
Key benefits of this procedure
- Long-term stability and complete seal of the LAA: The device’s frame allows for optimal device engagement with the tissue for long-term stability and a faster, complete seal of the LAA.
- Enhanced procedural performance: Fully rounded design offers physicians the ability to safely enter and maneuver within the LAA and to fully recapture, reposition and redeploy the device during the procedure.
- Broad patient population: Size range allows treatment of a wide range of patient anatomies, with a reported 98.8% of the cases have a successful implant.
Make a referral to one of our interventional cardiologists.