We now know that patients with atrial fibrillation (a-fib) are five times more likely to suffer a stroke, which means that risk reduction has taken center stage. Newer oral anticoagulants and enhanced surgical techniques have provided more treatment options than ever before - and when it comes to medical devices, a new era is dawning.
“Device implants are becoming an attractive option for reducing the risk of stroke without the need to be on anticoagulation and in patients who are at high risk of bleeding while on anticoagulants,” says Walid Saliba, MD, Director of the Electrophysiology Lab in the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic.
Three innovative devices are currently under investigation or newly approved:
Watchman® (Boston Scientific) is a device designed to close off the left atrial appendage (LAA) to reduce the risk of stroke. Currently in its last phase of investigation, Dr. Saliba says that many hope that the device will receive FDA approval within a matter of months.
"The good thing about Watchman is that so far it is the only device that has been looked at in a large clinical trial and has been shown to be equal—if not superior—to warfarin for stroke reduction," he says. Patients who receive the device would only need to take warfarin for 45 days after the implant.
"The procedure is a fairly easy one for an electrophysiologist, requiring only an overnight hospital stay and a couple of follow-ups," Dr. Saliba says.
The LARIAT® suture delivery system (SentreHEART) is an FDA-approved option similar to the surgical ligation of the LAA, says Dr. Saliba.
“By using a transseptal approach and an epicardial approach, the LAA is actually caught and ligated by using a preformed knot on a catheter,” he explains. “That also is a fairly easy procedure for an electrophysiologist.”
There is not any data yet demonstrating whether the procedure reduces the risk of stroke, but Dr. Saliba says that extrapolation from the surgical literature suggests that this is probable.
The AMPLATZER™ Cardiac Plug (St. Jude Medical) is another option, similar to the Watchman, that is currently being investigated. The device was engineered to occlude the LAA at the base of the orifice, regardless of LAA anatomy.
"These devices are things that we are very excited about for the future,” Dr. Saliba says. “Down the road, it may even be possible to place one of them in conjunction with an a-fib ablation."
To refer a patient to the Cardiac Electrophysiology and Pacing Section at Cleveland Clinic, please call toll-free 800.223.2273, ext. 46697 or contact us online.