Cooper Heart Institute Introduces Atrial Isolation Device for Stroke Prevention

The Cooper Heart Institute has begun an innovative pilot study designed to prevent strokes– without anticoagulation– in patients with atrial fibrillation. Atrial fibrillation (AF) is the cardiac arrhythmia most commonly linked to ischemic stroke. AF patients have a 5% risk of stroke, five times greater than comparable same age patients who are in sinus rhythm. Evidence gathered from transesophageal echocardiography (TEE) has demonstrated that most ischemic strokes associated with AF are secondary to embolism or thrombi forming in the left atrial appendage.

Atrial HeartAnticoagulation with warfarin is considered the standard of care in this patient population. However, the proven benefits of warfarin for prevention of embolic events have not translated into widespread utilization. According to the Archives of Internal Medicine, (Arch Int Med 1996; 156: 2537) 82% of atrial fibrillation patients are eligible, but only 33% are anticoagulated. The difference appears multi-factorial, including various contraindications, inconvenience and fear of anticoagulation.

The pilot study utilizes the WATCHMAN®‚ Left Atrial Appendage Filter System from Atritech™, an atrial appendage isolation device that allows for the percutaneous closure of the left atrial appendage. The WATCHMAN® deploys a rounded, self-expanding device to prevent embolization of clots lodged in the appendage. The WATCHMAN® isolates the appendage and over a period of weeks is re-endothelialized.

“Complication rates have been low,” says Zoltan Turi, M.D., director of the Cooper Structural Heart Disease Program. “ Placement of the atrial isolator is performed using a transseptal puncture, a procedure that requires a degree of technical expertise. At Cooper, we have considerable transseptal experience. Our interventionalists have performed over 1,000 transseptal procedures when closing patent foreman ovales (PFO’s), atrial septal defects (ASD’s), and performing mitral valvuloplasty,” adds Dr. Turi.

Inclusion Criteria :

  • > 18 years
  • Chronic or paroxysmal atrial fibrillation requiring anticoagulation
  • Must have a history of one or more of the following: > 75 years of age, a history of congestive heart failure, hypertension, diabetes, or prior stroke with complete recovery

Exclusion Criteria:

  • Patients not eligible for warfarin therapy
  • Patient marked mitral annular calcification or complex aortic arch atheroma
  • Transient atrial fibrillation (such as early post-op CABG)
  • Symptomatic carotid disease
  • LVEF < 35%
  • Permanent pacemaker with more than one lead

Patients must be willing to continue oral anticoagulation for a minimum of 45 days after the procedure. In addition, a baseline TEE must be performed at 45 days and six months.

“The WATCHMAN® system is available under an investigational device exemption from the FDA,” says Dr. Turi. “The device appears to be a potentially important tool for patients with AF who are sub-optimal candidates for anticoagulation.”

The study is being conducted at only ten sites nationwide: Cooper University Hospital, Abbott-Northwestern, Minneapolis; Cleveland Clinic; Mayo Clinic; Prairie Heart Institute, Springfield, Illinois; Riverside Hospital, Columbus Ohio; St. Vincent’s Hospital, Indianapolis; University of California, Davis; University of Pittsburgh; and William Beaumont, Royal Oak, Michigan.

For more information about the WATCHMAN® device pilot study, or to speak with Dr. Turi, please call: (856) 342-3491.