Minimally Invasive Surgery

Hope and Hype Follow Heart-Surgery Method That's Easy on Patients

Cutting Just a 3-Inch Hole May Revolutionize Care, But Some Urge Caution

Marketing Wars Break Out

The $30 billion-a-year business of open-heart surgery is on the threshold of its most momentous advance -- and one of its most ferocious marketing battles -- since doctors began the life-saving operations three decades ago.

In the past few months, surgeons at more than 200 U.S. hospitals have begun using new, patient-friendly techniques that reduce the pain, recovery time and perhaps the cost of bypass surgery, one of medicine's most common and most invasive procedures. The conventional method requires doctors to make a neck-to-navel incision in a patient's chest, sawing through the breast bone and cracking open the rib cage to reach the heart to replace clogged arteries or repair faulty valves. The new approach uses newly designed instruments to operate through just a three-inch opening in the chest.

A growing number of heart experts are convinced that these minimally invasive techniques will fundamentally alter the clinical and economic landscape of open-heart surgery. Some enthusiasts say the new technology could explode in the next three or four years to be used in more than half of the one million procedures performed world-wide each year.

"This is a sea change in cardiac surgery," says Delos "Toby" Cosgrove, chairman of thoracic and cardiovascular surgery at the renowned Cleveland Clinic. Skeptical when reports of the new approach first surfaced less than two years ago, doctors at the clinic now offer four different minimally invasive procedures. "The genie is out of the bottle, and it will never go back in," Dr. Cosgrove says.

Such ambitious declarations reflect both the hope and the hype that are fanning excitement and tense debate. Some doctors contend that both the potential market and the cost savings of the new surgery are much exaggerated. They worry that patients could be imperiled by rapid adoption of a new technology that aims to replace well-established procedures. The American Heart Association recently cautioned that the surge of interest is rushing ahead of scientific data.

Commerce, almost as much as medicine, drives this revolution. Companies are racing to develop and market equipment for the minimally invasive heart operations, vying for a piece of what they see as a lucrative market. Hospitals, seeking to protect one of their most profitable and prestigious franchises, are rushing to embrace the new techniques; at least one has put up billboards touting the new procedure.

And some heart surgeons see an opportunity to recapture patients lost by the tens of thousands to angioplasty, a nonsurgical balloon-inflating technique for opening clogged arteries.

The hard commercial push troubles some experts. "This is being propelled in part by the hypercompetitive nature of the business we're in. We're doing all of this, and we don't even know if it works," says James Field, managing director of Advisory Board Co.'s Cardiology Roundtable, a consultancy in Washington, D.C.

For all the excitement, only about 2,000 patients have had the new operations so far -- compared with 10 million open-heart operations world-wide in the past 25 years. The old-fashioned way has an impressive track record: Its mortality rate is 4% or less at most of the 900 U.S. medical centers. And recent studies show the repairs can last 15 years or more in 90% of patients.

"The reason [the standard method] has been so spectacularly successful is because of the long-term benefits," says Daniel Ullyot, director of cardiac surgery at Peninsula Hospital in Burlingame, Calif. He worries that the new techniques might sacrifice those long-term advantages for the short-term gain of reduced hospital stays and faster recovery.

Yet the path to market acceptance for much new medical technology treads a thin line between pioneering innovation and rash experimentation. Otherwise, few advances could be made.

Feeding the fever are two rival equipment makers, both start-up companies in California, that use different medical approaches but ply them with equal fervor. Heartport Inc., in Redwood City, has developed a $5,000-a-procedure kit of instruments used to stop the heart while performing bypass surgery or repairing defective valves. CardioThoracic Systems Inc. in Cupertino markets devices, priced at $1,850 an operation, that enable surgeons to do bypass operations on a beating heart, thereby avoiding the need to put patients on a heart-lung machine, which adds as much as $2,300 to the cost of each bypass operation.

Both companies launched their product lines in January. So intense is their rivalry that each has cast doubt on the safety of the other's approach.

The spat isn't damping doctors' enthusiasm, though. Duke University, Johns Hopkins, Indiana Heart Institute, Cedars Sinai Medical Center in Los Angeles and Lenox Hill Hospital in New York are among heart centers that offer at least one of the new approaches. The techniques have been adopted by high-volume heart surgeons in Orlando, Fla., Charlotte, N.C., Nashville, Tenn., and Redding, Calif. Hospital chain Columbia/HCA Healthcare Corp. has launched its own CardioThoracic training program so surgeons at its 95 open-heart programs can beat competitors to the market.

"Surgeons now talk about market share and competition," notes Wesley D. Sterman, Heartport's chief executive. "Those who want to compete effectively are knocking on the door to learn these procedures."

Heartport says its devices have been used in about 500 cases so far and it plans to train more than 200 surgery teams this year. CardioThoracic, meanwhile, says 170 doctors using its gear did beating-heart surgery on 900 patients in the first quarter. It expects 400 doctors will be on board by year end.

The two companies teach doctors to use the methods in just two or three days. They also circulate press kits and video news releases to help hospitals trumpet the techniques to local media.

Marketing wars are breaking out. When the leading cardiac-surgery group in Orlando adopted the Heartport approach, the area's two largest hospitals jousted to be first to use it. The Orlando Regional Medical Center won bragging rights, beating out local rival Florida Hospital by a few hours. The hospital scored six days of local TV news coverage as reporters tracked the patient's recovery. It even had the patient and his surgeon appear at a rock 'n' roll bash sponsored by the local American Heart Association.

Few people understand the techniques' promise as viscerally as Pearl Vance. A decade ago Mrs. Vance, now 77 years old, underwent quadruple-bypass surgery the conventional way. After doctors wired her chest back together, she spent 10 days in the hospital. It was four months before she could resume all her normal activities.

Then late last year, her chest pains returned and Mrs. Vance reluctantly braced herself for another ordeal. But instead of cracking open her chest, Mark Groh, a heart surgeon at Memorial Mission Hospital in Asheville, N.C., made a three-inch incision under her left breast. He stopped her heart, using Heartport instruments inserted through another small incision in her groin, then bypassed two reclogged vessels using long, thin instruments and sewed her up, leaving a barely visible scar.

Less than 48 hours later, she went home. By the next day, the only pain reliever she needed was Tylenol. A few days later, she went grocery shopping with her grandson. "If you've ever had your rib cage sawed in two and pulled open, you don't want to open that door again," Mrs. Vance says.

Her case also seems to support claims from both companies that the techniques will lead to cost savings. But skeptics say the financial case isn't yet clear. The new approach may reduce in-patient stays, but a hospital's overall costs could actually rise, particularly with Heartport gear, because of the need for equipment purchases and additional expensive time in the operating room. Heartport says its method will be proved cost-effective.

Some insurers are skeptical. Prudential HealthCare, a unit of Prudential Insurance Co. of America, won't endorse the new technique until more evidence of the benefits is amassed. "It certainly looks promising, but there's a lot more to a procedure than just helping patients get home from the hospital," says Arthur Levin, a Prudential executive. In any case, most of the procedures are probably reimbursed because claims coding doesn't distinguish minimally invasive surgery from any other open-heart surgery.

Coronary-artery bypass is the primary open-heart operation. Using vessels harvested from the leg, arm or chest, doctors reroute blood flow around blockages in the arteries that feed the heart. Laying open the chest gives surgeons unfettered access. By stopping the organ and letting a heart-lung machine take over, doctors can do delicate stitching of tiny vessels on a still and bloodless surface.

Since the procedure was developed more than 25 years ago, survival rates and durability of the repairs have improved greatly because of advances in heart-lung machines, in methods to chill and preserve the heart, and surgical techniques.

But hospitals, after reducing the average stay to roughly five days, aren't likely to budge it further because of the big chest incision. And 6% of bypass patients suffer stroke or other complications, apparently because of the heart-lung machine. Other problems can include postsurgical depression and a rare but severe infection that impedes recovery.

The most telling sign of open-heart surgery's drawbacks is the popularity of balloon angioplasty. Even though 40% of angioplasty cases fail within six months and at least 20% of patients have another procedure, more than 350,000 heart patients in the U.S. choose this much-less-invasive technique each year.

To physicians like John Stevens, these shortcomings suggested an opportunity. As a doctor-in-training in the late 1980s, he learned a minimally invasive gallbladder-surgery technique that let the patient go home the next day, in contrast to the standard method that involved a month-long recuperation. One patient had surgery on a Thursday and went rock-climbing the next weekend. "That just stuck in my mind," Dr. Stevens says.

In 1992, he co-founded Heartport to try to do the same for heart patients. Part of the firm's equipment is a device to stop the heart by inserting a balloon into the aorta and inflating it, then injecting potassium and other agents. This mimics the standard procedure, giving surgeons a stable heart to work on through the small incision.

Meanwhile, some surgeons were trying a potentially trickier approach: bypass operations on beating hearts. The technique is patterned after a procedure pioneered by Federico Benetti, an Argentine surgeon whose hospital couldn't afford a $150,000 heart-lung machine. Initially, doctors tried his procedure on patients too sick to withstand the rigors of having their hearts stopped. They soon decided that a broader group of patients could benefit by not going "on the pump."

CardioThoracic was founded in mid-1995 by Dr. Benetti, former Heartport engineer Chuck Taylor and venture-capital entrepreneur Richard Ferrari, who became chief executive. The trio roughed out some ideas on what tools might be useful in a beating-heart procedure, including a device resembling a bent, two-pronged fork that presses down on the heart to stabilize the area where the doctor works.

Both companies went public a year ago, and in a few months Wall Street bid up their shares to a combined value of $1.3 billion. Amid the technology-stock correction, they have slipped to about $750 million, but that is still before the companies have shown any profits.

Even before the companies began marketing three months ago, the differences in their techniques set off intense debate over safety and economics. Some surgeons are particularly skeptical that joining tiny blood vessels on the surface of the heart can be done as successfully while the heart is beating -- the CardioThoracic way -- as when it is stopped.

Surgeon Steven Colvin and colleagues at New York University Medical Center have performed about 100 surgeries using the heart-stopping tools of Heartport, and he questions the CardioThoracic method. During a recent Heartport operation, Dr. Colvin peered through magnifying goggles as he performed the delicate task of joining the replacement vessel to a coronary artery, using a tiny needle and barely visible sutures. "At this point, if you're doing it `beating-heart' you're cursing a mile-aminute," he remarked.

But Heartport's technique hasn't escaped criticism, either. "At $5,000 a pop, they are selling a more complex and more expensive system [than is currently used] to put a patient on a heart-lung machine, all to make a smaller incision," says Paul Corso, a surgeon at Washington, D.C., Hospital Center. "I haven't seen any credible numbers [from] outside the company which show a cost savings or an improved result."

The companies' rivalry erupted at an investors conference in New York in February. Analysts in the Heartport camp spread details about a televised training course for beating-heart surgery in which several patients had complications right on camera. "It was an extremely low blow, poorly handled and not responsive to supporting an emerging industry," says CardioThoracic's Mr. Ferrari, who says none of the patients died and the worst case didn't involve his company's equipment. He publicly retaliated, telling attendees of a dinner he had had with surgeons who described two fatalities involving Heartport equipment. Heartport says its death rates are "well within" the range of conventional surgery.

Such sniping is bound to continue until more data are accumulated. CardioThoracic seems to be ahead for now, with more than 1,500 cases in all and 80 new centers adopting the procedure in just the past month. But for now its tools can be used only for operations that involve bypassing just one or possibly two clogged arteries -- about 20% of bypass operations. Most surgeons consider stopping the heart essential for the other 80% of surgeries, involving triple and quadruple bypass, as well as for the smaller number of valve-repair operations.

Both companies hope to gain ground by targeting balloon angioplasty. Mr. Ferrari notes that 30% of the bypass operations performed in the first quarter using CardioThoracic instruments involved patients who had undergone angioplasty that didn't work.

Now, far bigger players aim to cash in. Medtronic Inc. of Minneapolis has begun marketing a $10,000 reusable device called the Octopus that helps still a beating heart. Baxter Inc. of Deerfield, Ill., and U.S. Surgical Corp. in Norwalk, Conn., are entering the fray.

For all the one-upmanship and market muscle, patients themselves may emerge as the most significant drivers of this looming revolution in heart care. Donald Payne of Florida, a 59-year-old fire-safety consultant and the star patient who grabbed six days of TV coverage after undergoing the new surgery in Orlando, found his doctor on the Internet. He was willing to hold off a month for the operation so the doctor could be trained in the Heartport method.

Mr. Payne figures the wait was well worth it. He had surgery on Jan. 7 and left the hospital 36 hours later, taking nothing but an over-the-counter painkiller. Ten days later, he was on the golf course.

This article originally appeared in The Wall Street Journal on 4/22/97.

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