Every good Boy Scout knows that a little manual pressure, well-applied, is the best way to stop bleeding fast.
Believe it or not, that traditional prescription still holds for hundreds of thousands of patients undergoing the latest interventional cardiac procedures each year.
For everything from basic angiograms to the insertion of the slickest coronary stents, doctors typically use a large artery in the patient's groin as an on-ramp to run catheters deep inside the body. But although the doctor might finish the work in under an hour, stopping arterial bleeding and stabilizing the patient can take the better part of a day. It even can involve an overnight stay.
Unfortunately, advances in the devices used to perform delicate work inside blood vessels until recently have outpaced the development of aids to patient recovery. About 45 minutes of Scout-style manual pressure usually is followed by motionless bed rest and a wound dressing compressed with a clamp, or even a heavy sandbag, for hours at a time. As barbaric as they sound, the old techniques are at least tried and true.
But the current state of affairs is a shame for patients. Many say the discomfort during recovery from the sizable holes punched in their arteries is tougher to take than the procedures themselves.
And many healthcare providers, too, would welcome quicker solutions to sealing arterial punctures. Stabilizing patients faster means less fuss and quicker discharge from the hospital, even fewer overnight stays. Fail-safe artery closers also mean that anticoagulants used to minimize side effects wouldn't have to be discontinued so soon.
Enter a trio of companies bent on changing the way these wounds are managed. Datascope in Montvale, N.J., and Kensey-Nash in Exton, Pa., have developed collagen protein plugs that expand to fill the wound. The body absorbs the plugs weeks after their sealing work is done. Another firm, Menlo Park, Calif.-based Perclose, makes a miniature suturing tool that fits inside the hole left by a catheter, enabling cardiologists to suture the wound from below the skin.
Closing arterial punctures is a major task. More than 1.1 million angiograms and 419,000 angioplasties were performed in the U.S. in 1995, according to the most recent data available from the American Heart Association.
All told, the market for arterial blood stoppers eventually could top $500 million a year, according to BT Alex. Brown in Boston.
Priced from about $150 to $375, the devices aren't cheap. But even by the most conservative estimates they cut postoperative recovery time in half-to two to four hours from six to eight. Some doctors cite even better results.
Using such devices after many common cardiac procedures can mean the difference between filling a bed and same-day discharge. In all cases, doctors and nurses are freed earlier to see other patients.
In addition, the short time to recovery can allow for important changes in scheduling. Some ambulatory cases, such as angiograms, can be scheduled late into the afternoon, instead of being restricted to the morning. That means bustling cardiac catheterization laboratories can be used more efficiently.
For providers, a few minutes here and there add up. "Initially, some hospitals may balk at the upfront costs, but the busy centers are realizing their throughput can radically improve," says Andrew Jay, an industry analyst with BT Alex. Brown. He believes the market for arterial closure devices could hit the $500 million mark in five to seven years.
A lack of reimbursement for the surgical add-on hasn't helped the new products gain support. Nevertheless, sales are starting to take off. In 1997, Jay estimates, the arterial sealers market was about $20 million. This year the companies are on track to quadruple sales to $80 million. By 1999 more than $200 million worth of the new gizmos likely will be sold.
Patient reaction is positive at the centers where the devices are in use. "From the patient comfort standpoint, it certainly is a real advance," says Jeffrey Moses, M.D., chief interventional cardiologist at 652-bed Lenox Hill Hospital in New York.
Moses uses both the Perclose and Kensey-Nash devices on a large and growing number of patients who get angioplasties and stents. But, he adds, the products would have a wider following if they cost less. "The economics of it are still up in the air," he says. "If they cost $99, I would use them on everybody."
Moses says the Perclose device is a little tricky to master but "nifty." With practice, it can seal an artery in two minutes, and the results can be dramatic. "When you're done with it, you can sit the patient up and put (him) in a wheelchair," Moses says.
Also popular is Angio-Seal, a device made by Kensey-Nash and marketed by Sherwood Davis & Geck. Angio-Seal's blood-stopping plug, approved by the Food and Drug Administration in September 1996, is held in place by an absorbable anchor threaded inside the artery. A suture on a pulley binds the collagen plug tightly against the puncture.
Datascope's VasoSeal, approved by the FDA in September 1995, is an unanchored protein plug. Its sales have been slow compared with the competition's.
For all their clinical promise, the devices are likely to become standard practice only after most hospitals are paid primarily on a capitated basis, observers say.
Arterial wound closure could make outpatient angioplasty a reality, for instance. But for now, observers say, many hospitals are reluctant to forgo reimbursement for inpatient procedures by doing them that way.
