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A patent foramen ovale is a defect in the wall between the two sides of the heart that allows the passage of blood and its contents. This course bypasses the lungs. (Courtesy Cleveland Clinic)

One controversial cause of some strokes is a small hole between the two sides of the heart known as a patent foramen ovale. Although rarely symptomatic for patients, this hole allows blood clots that occur in otherwise healthy individuals to bypass the lungs and lodge in critical arteries that serve the brain. In individuals without this defect, these small blood clots would normally lodge in the small vessels of the lungs and typically never lead to a disease state (see note at end for a more complete explanation). Because of the unresolved structural defect, conventional thinking considers these individuals at increased risk for future strokes that remains even after typical stroke prevention strategies.

Kurt Amplatz is an interventional radiologist who has spent his  career developing a number of devices to repair these patent foramen ovale and other defects using a catheter-based device that closes the hole with a permanent metal disc. The procedure is similar to cardiac catheterization procedures used for patients with coronary artery disease (e.g., heart attacks).

An Amplatzer occluder deployed on the end of a catheter. (Courtesy St. Jude Medical)

Two recent papers(1,2) in the New England Journal of Medicine report findings from long-term studies designed to demonstrate the expected benefit of using these “Amplatzer” devices versus traditional medical therapies (e.,g., aspirin, Coumadin®, Plavix®). The Journal effectively uses these two studies to demonstrate just how fine a line of improvement may be found with use of the devices and ultimately concludes that true believers and skeptics will likely not be swayed from their opinions by the limited findings of both studies.

What I found most interesting about this recent revival of the debate of catheter-based occlusion devices is the near-zero discussion of the cost component of these devices. The Amplatzer occluder used in these studies was not a one-time quick-fix for these patients but was a supplemental therapy that was often used in conjunction with traditional medical therapies. Although exact pricing is not available, the cost of the device alone adds an additional $3,000-5,000 to the cost of the patient’s care and insurance is usually billed an additional $10,000-$25,000 for the procedure.

With the current evidence, these devices add additional costs and procedural risks to a patient’s care without demonstrating definitive benefit. Addressing the escalating cost-problem in U.S. healthcare starts with regulatory authorities scrutinizing care scenarios such as this one to determine if we are getting value for money in procedural medicine.

Note on blood clots: Venous thromboembolisms are a major cause of morbidity and mortality. However, the specific sequence of events that produces small clots that the human body can easily degrade versus those that cause life-threatening events is poorly understood. Although any blood clot seen in the healthcare setting is typically treated as if it were potentially life-threatening, the general thinking is that small blood clots as in the example given above are somewhat routine in the older population and can resolve spontaneously if not symptomatic.