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Bypassing The Trauma


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BYPASSING THE TRAUMA

Each year, half a million Americans endure open-heart surgery and learn firsthand that its name is far too gentle for a procedure so violent: Surgeons must make at least a foot-long incision in the chest and crack open the sternum just to get near the heart for a typical bypass operation. Even when the repair works perfectly, the painful recovery from such trauma can take months, with risks of infection and other complications.

Now, a Silicon Valley startup has pioneered what could be the most significant advance in heart surgery in decades: Over the past five months, surgeons at Stanford University have used technology from Redwood City (Calif.)-based Heartport Inc. to perform single- bypass procedures on three patients--without ever opening their chests. Rather, they made a handful of tiny incisions and used a series of novel catheters, sophisticated imaging microscopes, and other special instruments to operate through narrow tubes, or "ports."

It's a revolutionary approach, and early results are cause for great optimism. Although the first patient, on Apr. 1, developed a complication that required further surgery, the next two walked out of Stanford Medical Center in just a few days. Stanford has more surgeries scheduled, and heart surgeons elsewhere are eager to try the technique. "This is a tremendous advance," says Dr. Greg H. Ribakove, a cardiovascular surgeon at New York University Medical Center. Surgeons "should cause the least amount of pain and trauma for the most amount of help, and that's what this is," he says.

Just as important, the "port-access" procedure, which Heartport was set to announce Aug. 24, could jolt the multibillion-dollar economics of heart surgery. Today, hospitals charge from $20,000 to $60,000 for open-heart procedures. Port access promises to reduce hospital stays and limit complications, likely lowering costs for insurers and employers footing the hefty bills. Says Michael J. Strauss, president of Washington-based reimbursement consultants Health Technology Associates: "The potential to improve patient outcomes and save resources is huge."

CAUTIOUS. Within three months, medical centers at NYU and Johns Hopkins University will begin performing these procedures; another half-dozen major institutions are lining up to follow. For now, though, the nascent operation is being performed only on single-bypass patients. Heartport Chief Executive Wesley D. Sterman notes the procedure will likely stay in clinical testing through 1997. Such testing is crucial: Uneven training of surgeons has complicated and delayed the adoption of many new technologies, and high-profile flops with port access by overanxious docs would be disastrous. Sterman vows to move cautiously, but if current progress continues, he expects the Food & Drug Administration to give Heartport the green light to work on more complex bypass operations, as well as valve surgeries and eventually, most heart procedures.

Port-access heart surgery is the latest in a string of impressive "minimally invasive" procedures that have transformed many surgical procedures in recent years. The challenge: The risk of infection and difficulty of recuperation is directly related to the extent of trauma from surgery. So medical researchers have focused on making patients happier and cutting costs by disrupting healthy tissue as little as possible. Small-incision surgeries have become standard for removing diseased gallbladders, as well as for orthopedic operations that can put athletes back on the field within weeks.

As visualization technologies have improved, surgeons get increasingly clear, even three-dimensional looks inside the body, allowing them to precisely manipulate long-handled instruments through tubes. In this way, they can complete a bypass operation just as they would through an open chest: In each of Heartport's three surgeries, an existing artery was detached from the chest wall, then spliced and stitched into a diseased coronary artery, allowing blood to bypass a blockage.

But rather than having to wire the rib cage back together and close the huge incision, surgeons just made a few quick stitches at each port, most of them a centimeter or two wide. Heartport patient Paul C. Vogel of Saratoga, Calif., says that just a couple of hours after his surgery, he felt almost no pain. The next morning, the 55-year-old retired Lockheed Martin Corp. administrator walked to the waiting room to visit with his twin granddaughters.

Heartport founders Sterman and Dr. John H. Stevens, both 35, were Stanford medical school classmates and friends in the mid-1980s, and they watched as technology made a growing list of surgeries safer. After snagging his M.D., Sterman veered off to business school, then worked briefly in venture capital; Stevens pressed on and became a heart surgeon at Stanford.

They kept dreaming of making cardiac surgery less traumatic, but a huge biological obstacle blocked the way. Most open-heart procedures require surgeons to stop a beating heart and hook up tubes and machines that take over the organ's job during surgery. The risk of working on a wiggling, throbbing mass of heart muscle is extremely high in an open procedure--and would be virtually impossible through ports.

KEEPING COOL. The two doctors founded Heartport in 1991, based on a hunch on how to overcome the beating-heart problem. After huddling with other clinicians and an engineering team, Sterman and Stevens developed special catheters that snake up through veins and arteries in the groin. In hundreds of trial runs with animals, they refined a technique of applying chemicals through these catheters that temporarily stopped the heart and kept it cool. Other tubes recirculated the blood through external machines.

After the first procedure, Stevens refined the techniques, shaving almost three hours off his operating time in the subsequent two surgeries. It's no cakewalk: Even with the heart still, surgeons must get used to doing this work in tight quarters and through surgical scopes, he explains. Heartport also developed novel sutures and instruments, such as cauterizers armed with their own tiny vacuums to suck smoke out. Stevens admits his first procedure was "scary" because of all the new variables.

Medical technologies are a hot property on Wall Street these days, and Sterman says he's swamped with calls from bankers who would like to take Heartport public. The company has no competition now, and Sterman claims he has a raft of patents and pending claims on the technology. But he plans to wait until 1996 for an initial public offering, partly because the company is well funded, having raised $25 million from blue- ribbon venture-capital firms, including Kleiner Perkins Caufield & Byers and Sierra Ventures. Crows Sierra partner Petri Vainio: "This has the potential to be the medical device deal of the decade." Not to mention what it could mean for hundreds of thousands of very sick patients.

NO PAIN, BIG GAIN

New "port-access" heart surgery could provide dramatic benefits over traditional open-heart operations:

PORT ACCESS

4-7 tiny incisions

7-10 hours*

Alert within hours

2 days

1-2 weeks

Unclear, but should be

significantly lower

*Eventually should decline to 4 hours DATA: HEARTPORT

OPEN HEART

PROCEDURE One 12- to 15-inch incision, requiring opening the sternum

and rib cage

OPERATING TIME 4 hours

PATIENT COMFORT Substantial pain

HOSPITAL STAY 5-7 days

RECUPERATION 4-12 weeks

COST $20,000-$60,000By Joan O'C. Hamilton in Redwood City, Calif.


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