Developed to reduce the risk of stroke for patients with an irregular heartbeat called atrial fibrillation who require blood thinning medications, Boston Scientific’s WATCHMAN device was approved in March by the FDA. Despite the proven efficacy, long-term use of blood thinners is not well-tolerated by all patients and carries a significant risk for bleeding complications. Nearly half of all AFib patients who are eligible for blood thinning medical treatments currently go untreated due to tolerance and adherence issues.
“We’re thrilled to be able to offer our patients a minimally invasive alternative to long-term use of blood thinners,” says interventional cardiologist Hursh Naik, MD, medical director of structural heart services and vice chair of cardiology at St. Joseph’s. St. Joseph’s is one of just 40 hospitals nationwide approved to use the innovative technology.
Dr. Naik says the device is implanted through a small incision in the groin and led through a catheter into a patient’s heart where it can filter potential blood clots. The minimally invasive procedure helps reduce pain and to expedite healing.
“The procedure is much different from open heart surgery and ranges from about 45 minutes to an hour and a half long,” explains Dr. Naik. “It typically requires only an overnight stay at the hospital, which is huge.”
WATCHMAN was approved by the FDA after years of testing and a robust clinical program which included more than 3,300 patients. Dignity Health’s director of cardiovascular research Nabil Dib, MD, played an active role in the clinical trials’ early stages. Results the multi-center clinical trials have shown that the device can be implanted safely and reduce the risk of stroke in eligible patients, while enabling most patients to discontinue blood thinning medications.
“For many patients, this is a tremendously beneficial alternative that doesn’t require major surgery,” says Dr. Dib. “It’s really a safety net that catches or blocks deadly blood clots before they reach the brain which eliminates the need for long-term blood thinners which have their own set of health risks.”
AFib affects more than five million people in the United States—about 70 percent of people with AFib are between the ages of 65 and 85. People with AFib have a five times greater risk of stroke because the irregular heartbeat causes blood to pool in the upper chambers of the heart which can lead to the formation of clots. — St. Joseph’s