There have been significant advances in interventions to prevent stroke, one of the most feared diseases, but when or even if they will be available to those who need them remains in doubt. 

As an interventional cardiologist, I am encouraged by the prospects of two different approaches to treat stroke.  But the rigors of U.S. regulatory approval have held back the introduction of these new medical interventions, while increasingly restrictive coverage may continue to limit access to them even once they are approved. 


In fact, an important decision this week from Medicare regarding a new device to prevent strokes appears to follow this trend toward restrictive coverage.  

This is worrisome because stroke, in which a loose blood clot lodges in and damages the brain, is one of the most feared and costly diseases we face. Most people fear damage to the brain more than they do damage to the lungs or heart. An estimated 6.6 million Americans have had a stroke, and another 795,000 people have a new or recurrent stroke every year. The medical and lost productivity costs of stroke are projected to increase to $140 billion by 2030. 

Depending on where in the brain the clot lodges and how much tissue it damages, stroke can cause vision problems, memory loss, speech or language problems, behavior changes, and paralysis on one side of the body or even from the neck down. The consequences can be devastating – some people feel  that surviving a stroke may be worse than not surviving at all. 

People with risk factors such as high blood pressure, high cholesterol, or an abnormal heartbeat called atrial fibrillation are most prone to stroke. Common approaches to lowering the risk of stroke are using drugs, diet and exercise to reduce high blood pressure or cholesterol levels. But there are two other conditions that increase the risk for stroke for which changes in lifestyle or medication are inadequate to treat. 

One is the left atrial appendage (LAA), a small, useless sac in the muscle wall of the top left chamber of the heart. As blood pools in this pouch, clots can form that can travel to the brain and cause a stroke. Evidence suggests in patients with atrial fibrillation this sac is the most common source of clots resulting in stroke. People with atrial fibrillation are five to seven times more likely to have a stroke than the general population. 

LAA closure devices – there are three in development in the U.S. – could change the clinical approach to preventing stroke in patients with atrial fibrillation. A catheter-delivered heart implant designed to close the LAA received approval earlier this year from the U.S. Food and Drug Administration (FDA) and this week received what appears to be a restrictive coverage determination from Medicare. Two other devices, one that plugs the LAA and another that essentially seals it shut, have been widely used outside the U.S. but are not specifically FDA approved for use with stroke patients in the U.S.­ 

For my patients with atrial fibrillation, LAA closure devices offer new hope as an alternative to blood thinners, which may be ineffective or intolerable due to risk of bleeding, restriction of activities or other potential side effects.  New data is bearing out this hope that when compared to blood thinners, LAA devices can reduce bleeding risks and related costs and disability. As a result, patients and their families are hoping Medicare, which strongly influences coverage decisions by private insurers, will make access to this new procedure as broad as possible. To help prevent stroke for the many patients at risk for clots but poor candidates for blood thinners, we must ensure access to this procedure.  

The other condition that can lead to stroke is carotid artery disease, which occurs when the blood vessels in the neck are narrowed by plaque. Plaque increases risk of stroke by restricting blood flow to the brain and potentially causing a clot to enter the brain. While blood thinners and other medications can treat this condition, some carotid arteries can become so blocked that an open surgical procedure called endarterectomy is recommended to remove the plaque.  

An alternative, minimally invasive, procedure called carotid stenting has been developed in which a mesh tube called a stent is inserted through a catheter into the carotid artery to prop it open. To date, carotid stenting has been mostly limited to patients who are too frail to tolerate the open surgery.  But the landmark CREST trial showed that younger, healthier patients do better with stents than surgery. I have patients who do not tolerate blood thinners well or do not want to undergo the stress and recovery of open surgery on their neck. They should not be denied access to carotid stenting based on outdated coverage determinations. Let’s hope this less invasive procedure will soon be an option for more people. 

Given the rising costs of healthcare, it is understandable that Medicare wants to ensure  that before they agree to pay, new therapies should be, if not significantly more safe or effective, at least as good a value as existing therapies. But too often the importance of patient choice and potential quality-of-life benefits are left out of these coverage decisions.  

If we become too restrictive, innovation will dry up – there is evidence it already is drying up – as entrepreneurs will decide the opportunity for success is not enough to overcome the risk of failure, especially given the enormous cost of developing, testing and winning regulatory approval for new therapies. We cannot let the short-term savings of being overly restrictive in approving and paying for novel therapies short circuit the long-term benefits of potential advances, especially in treating a devastating disease like stroke. 

Reilly is vice-chairman, Department of Cardiology and Director, Cardiology Fellowship Program, Ochsner Medical Center, New Orleans.