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Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

May 2007

Clinical Business Strategies

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Olympus America Inc.
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STERIS
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TSK Products, Inc.
Uni-med


 

To stent or not to stent?

Materials managers must be proactive in cardiac debate

by Nick Sears, M.D.

Controversy has roiled the field of interventional cardiology in recent weeks following the release of a study that raised questions about the value of using coronary artery stents to treat stenoses, or narrowing of the arteries around the heart.

Because stenting is now the most popular procedure for addressing acute heart disease and because many of its proponents – notably physicians, hospitals and device manufacturers – have an interest in preserving that popularity, don’t expect the turmoil to diminish anytime soon.

Nonetheless, material managers should monitor the debate and begin working with physicians and administrators to determine what impact recent developments may have on their hospital’s cardiac program. While it obviously is not the purchasing manager’s job to drive the hospital’s cardiac strategy, failure to properly anticipate potential market changes and their impact on the acquisition of cardiac catheterization laboratory equipment and devices could prove costly in the months and years ahead.

Balloons and scaffolds

A little history might be helpful in understanding the current firestorm surrounding stents: Angioplasty, or the use of balloon catheters to open clogged arteries, emerged in the early 1980s as a breakthrough alternative to highly invasive bypass surgery. The process involved threading a balloon-tipped catheter inserted through the femoral artery into a coronary artery, inflating the balloon which in turn cracked the plaque build-up and relieved the obstruction in that vessel. Although this technique proved highly effective, the results frequently didn’t last and multiple angioplasties often were required.

As a result, a new device called the stent – essentially a wire mesh tube or scaffold – was introduced in the early 1990s to resolve the issue of restenosis, or the re-narrowing or reformation of plaque. The stent was an important advancement and further reduced the necessity of risky and expensive bypass surgery.

But in about 10-to-15 percent of the cases, restenosis continued to occur within and around the stent. The solution to this problem was a new generation of stents rolled out in 2002 that included embedded, time-released medication designed to reduce inflammation and preclude reformation of plaque. Known as drug-eluting stents, the devices were hailed as a revolutionary advance in interventional cardiology and quickly became the tool of choice for many heart specialists.

Not surprisingly, stent prices increased dramatically after the drug-platform technology was introduced, to about $2,500 per unit from $900-$1,000 for a bare-metal stent.

Drugs equally effective?

Questions about the efficacy of drug-eluting stents began to surface last year, but a much greater controversy exploded in late March following the release of a five-year study at the American College of Cardiology annual meeting. The study, which compared bare-metal stent outcomes with those produced by oral medication, surveyed more than 2,200 patients suffering from blocked arteries and persistent chest pain. The headline-grabbing conclusion: Using angioplasty and stents in addition to drug therapy produced no significant reduction in heart attack or death. In other words, stenting was no more effective than blood-thinning and cholesterol-reducing drugs.

On a separate front, recent studies performed in Europe have demonstrated better long-term outcomes in surgically treated patients compared to patients who were treated with an interventional (stenting) procedure.

About 800,000 Americans receive stents each year, and only time will tell whether physicians and patients will now think twice before going the stent route. Some of the biggest names in cardiology are squaring off over the issue, and more studies undoubtedly will be required to produce conclusive evidence on the value of stents one way or the other.

Supply and demand

In the meantime, purchasing managers should initiate communications with cardiology service line managers, physicians and administrators to determine if the cardiology department plans any changes in response to these studies. It is important to know if physicians are likely to perform fewer stents in the foreseeable future. A reduction obviously would affect stent purchasing, particularly if the devices are purchased in bulk. Because stents have a limited shelf life, failure to adjust quantities purchased in the face of a reduction in procedures could lead to expensive, stranded inventory.

Purchasing managers can strengthen their case with physicians by explaining to them how stents are purchased, including whether discounts are obtained for quantity, how much lead time is required on orders and how much money the organization spends annually for the devices. This information will help the physician better understand the importance of accurately projecting demand. At the same time, the purchasing manager should point out that savings in one area could help fund important new department or hospital purchases in another.

Some thought also should be given to the hospital’s open heart surgery capacity in the event that a dip in stent procedures produces a commensurate increase in bypass operations.

Perhaps most importantly, managers, administrators and physicians should keep an ear to the ground in an attempt to assess what stent candidates are saying, thinking and feeling about the stent-versus-drugs debate. The cardiology department may be gearing up for business as usual, but patients with a choice between medication and angioplasty may have other ideas. Time and further study will determine the appropriate therapeutic interventions.

Of course, it is highly unlikely that the stent will disappear anytime soon as a key tool in combating heart disease. But with the cardiology environment expected to remain in flux for sometime to come, forward-thinking purchasing managers and organizations would do well to have a plan in place that allows the hospital to respond quickly to whatever changes the market brings.

Nick Sears, M.D., is Chief Medical Officer for MedAssets Inc. He is a board-certified cardiovascular surgeon and physician executive.