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Will
Carotid Artery Stenting Get Expanded Coverage by Medicare? |
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February 14, 2007 -- Medicare is currently considering expanding coverage for a procedure known as carotid artery stenting (CAS). The first carotid stent system, manufactured by Guidant (now part of Abbott) was approved not quite three years ago. CAS competes with the open surgical procedure known as carotid endarterectomy (CEA) and has been shown in a number of clinical trials to have similar outcomes in select groups of patients. The goal of both procedures is to avoid stroke. Stroke is the third leading cause of death in the United States. Stroke is also the main cause of serious and long-term disability. Approximately 70 percent of all strokes occur in people age 65 and older. Stroke has several causes, but a major one is blockage of the carotid arteries in the neck. These arteries provide blood flow to the brain. Carotid arteries become blocked in the same way that coronary arteries do: through vascular disease, or atherosclerosis. The risk factors are also the same: high blood pressure, high cholesterol, obesity, inactivity, smoking, etc. Likewise, the treatments are similar. There's medical management to control blood pressure, statins to lower cholesterol, antiplatelets to keep the blood from clotting. If medical management wasn't sufficient, the only other option, until just a few years ago, was a carotid endarterectomy (CEA) -- an invasive surgical procedure in which the artery in the neck is opened through an incision and "cleaned out", removing the plaque. This procedure was usually performed by a vascular surgeon and CEA has been one of the most commonly performed vascular operations. But just as has been the case in coronary artery disease, the minimally invasive endovascular approach of opening the artery from within, using a catheter, balloon and stent, was extended to the carotid artery as a less invasive procedure which accomplished the same outcome. One major difference from the heart procedure was the need for a way to keep plaque (or embolic material) from dislodging and swiftly traveling upstream to the brain, causing a stroke. To reduce this possibility, a number of filter-type devices were invented and currently, all approved carotid stents are actually a two-part system: the stent, along with a filter, or embolic protection device. Because carotid artery stenting is important for patients who cannot tolerate an open surgical procedure, Mary Bellack of Guidant Corporation sent a letter to Medicare on March 31, 2006 requesting an expansion of coverage. Such an expansion is important not only to Medicare patients, but to all patients because insurance carriers tend to follow Medicare's coverages. Guidant is now owned by Abbott and is part of Abbott Vascular. Abbott currently markets two carotid stent systems, their own Xact/Emboshield system, and the Guidant-developed Acculink/Accunet. Other FDA-approved manufacturers are Boston Scientific, Johnson & Johnson / Cordis and eV3. The coverage decision would expand Medicare coverage to patients who are asymptomatic (have not had a stroke or TIA) but who have a blockage equal to or greater than 80%. Currently only symptomatic patients are covered, and they must have a blockage greater than 70%. Other groups are covered but only if they are part of a clinical trial or an FDA-approved post-market study. However, the proposed change would restrict coverage in patients who are 80 years or older, based on safety concerns. Coverage would be available, but only if the patients were enrolled in a post-market study to assess their outcomes. Abbott, the company with the majority market share in this field, and also the company that requested the expansion of coverage, issued a press release supporting the CMS decision to consider expansion. Boston Scientific, a company that only recently got a stent on the market, not only supports the expansion, but feels the coverage should not be restricted in the 80+-year-old population. However, perhaps erring on the side of safety, CMS decided to restrict coverage in the elderly until more and better data can be published regarding the outcomes of stenting in the 80+ age group. There recently were a number of European studies which showed a significantly higher mortality rate in carotid stenting over the surgical counterpart, although these studies have been criticized by many experts for having been done with inexperienced operators and sometimes without embolic protection devices. Most in the field are eagerly awaiting data from the CREST trial, a major large-scale multi-center study which will compare outcomes between surgery and stenting. Angioplasty.Org has provided a link (in the right side-bar) to send your opinion on expansion of the coverage directly to CMS. |
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