Gunnar Olson's five-mile constitutionals along the back roads of Michigan's Upper Peninsula provide daily testimony to the latest miracle wrought by inventive heart surgeons.
Only a few months ago, a clogged coronary artery left him barely able to walk 100 feet.
A retired dairy farmer, Olson, 54, is painfully familiar with surgeons' handiwork. He has endured a quadruple bypass operation, a half-dozen balloon angioplasties and seven coronary stents over the past five years to prop open the arteries nourishing his heart. But this winter, when Olson struggled to cover the 30-yard path to his garage workshop, his cardiologist suggested a radical new solution to revive a key artery: minimally invasive cardiac surgery.
Instead of cracking Olson's chest wide open to bypass the blocked vessel, new techniques might let a surgeon repair his heart through a small incision between his ribs, his cardiologist told him. What's more, the surgeon could operate while Olson's heart was still beating, avoiding a heart-lung machine.
Olson quickly agreed to the chance for surgery that promised less pain and trauma, a speedier recovery and comparable results. In February, he traveled to Columbia Hospital at Medical City Dallas, where Michael Mack, M.D., a medical school classmate of Olson's cardiologist, performed the new operation.
And so it's easy to understand why Olson's voice cracks with emotion as he recalls these events and the wizardry of his doctors. And why patients around the country are entreating surgeons to work this new magic on them.
But some experts question whether the minimally invasive surgery is as effective as standard procedures for most patients. They say some doctors and hospitals may be driven to the new technique more by uninformed consumer demand than solid clinical evidence.
And on top of that, it is far from clear whether the new surgery is even cheaper or more lucrative as promoters tout.
Something exciting. None of those weighty questions seem very important to patients confronting heart surgery, though.
Thanks to the minimally invasive approach, Olson left the hospital in two days instead of five days or longer, which is typical of traditional bypass surgery. By the third day, he was well enough to fly home. In a matter of weeks instead of months, Olson had resumed taking daily walks and building hot-rod tractors that compete in pulling competitions across the Midwest.
A veteran of many surgeries, Olson is now a confirmed believer in minimally invasive bypass.
"I've had them both ways, and I would definitely recommend it because it's so much less dangerous and the recovery is so much quicker," he says.
Olson's case highlights the excitement and promise of the new approach. Mack, his surgeon, asserts the technique is more than a curiosity: "I feel more confident than a year ago that there is some staying power to this."
Compared with the more than 300,000 bypass operations performed annually, fewer than 3,000 have ever been done with minimally invasive techniques. Widely available for only six months, the procedures are now being offered by several hundred hospitals.
Patient preference, physician and hospital competition, and the promise of dramatically reduced recovery times are fueling a mania for the new techniques many think will eventually transform heart surgery forever.
To some, the shift seems long overdue. Orthopedic, gynecological and general surgeons have been steadily switching to operating through small holes-resulting in shortened hospital stays, lower treatment costs and increased patient satisfaction. Even as cardiologists have moved onto surgeons' turf with minimally invasive procedures of their own, such as angioplasty, heart surgeons have clung to open surgical techniques.
But with the advent of tools that make minimally invasive heart surgery possible, surgeons such as Mack are eager to duplicate the success of other specialties.
At stake is a chunk-estimates vary as to how large it could be-of the $20 billion-plus annual market for heart bypass and heart valve procedures.
Hope and hype. Other surgeons experienced with the new techniques caution, however, that high expectations are running far ahead of medicine's ability to deliver.
"I think it's a mistake to be disseminating these techniques and touting them as proven when they're not, " says Laman Gray Jr., M.D., a cardiothoracic surgeon who has performed more than 50 minimally invasive heart operations at Jewish Hospital in Louisville, Ky. "The biggest benefit is the appeal to the patient, but I think it's being hyped out of reality right now."
For instance, the type of bypass surgery Olson had is suitable for a small fraction of patients with heart problems, about 5% of those who now undergo open bypass surgery, surgeons say. Alternative minimally invasive approaches that stop the heart can treat a wider variety of disease. But they require a heart-lung machine, which many surgeons say neutralizes one of the greatest advantages of the new approach.
Technical limitations notwithstanding, minimally invasive cardiac surgery has already captured the public's imagination. Primed by the routine success of laparoscopic surgery (See story, p. 46), more patients facing heart operations want the no-fuss, no-muss heart surgery they have heard about.
"Many people come in asking about it-they're very savvy about it," says Mehmet Oz, M.D., a cardiothoracic surgeon at Columbia Presbyterian Medical Center in New York.
And hospitals more eager than ever to cater to patient desires are reluctant to turn them away for lack of a program. In light of growing consumer demand, even one surgeon who has performed a few operations can mean a competitive marketing edge, Oz says (See story, p. 58).
"It's too important a marketing tool for hospitals not to have a little experience," Oz says. "If your institution has zero experience, then you'll have to admit it, and that puts you at a disadvantage, compared to the guy across town who has done six."
As time goes on, a successful minimally invasive heart surgery program is likely to distinguish top from average medical centers, Oz says. "A hospital that wants to stay cutting-edge, and most with heart centers are interested in that," needs to offer minimally invasive cardiac surgery, he advises.
So while the medical debate heats up over the proper role for minimally invasive heart surgery, many surgeons and their hospitals, fearful of being left behind, aren't waiting for final answers to get going. A fast start, they reason, will confer a long-term competitive advantage.
"The genie's out of the bottle, and you can't get it back in," declares Samuel Navarro, an analyst with UBS Securities, New York. "The camps are divided between old-timers who think it's moving too fast and the younger guys who want to move forward."
But if past adoption of new techniques is any guide, generational competition among surgeons will ultimately speed rather than slow their growth, many surgeons say.
Limitations. Conservative surgeons argue that the techniques, regardless of some trailblazers' enthusiasm, need years of refinement before the operations become routine.
"You're taking difficult surgery and really making it hard," says Jewish Hospital's Gray. Hard-pressed to demonstrate significant medical advantages of the less-invasive techniques today, Gray says he is confident they will eventually come.
Even after the techniques are refined, though, the most avid boosters concede that minimally invasive approaches are likely to claim only a fraction, perhaps in the range of one in four, of the procedures now performed by traditional means. Even the most passionate optimists say that within 10 years minimally invasive approaches might be used in half of heart surgeries. Simply put, the price for operating through small holes is paid in limits on a surgeon's ability to maneuver and perform his work. For many complex operations, that price will remain too high to change.
Profit picture. Currently, the minimally invasive techniques fall into two camps, defined by whether the operation is done on a stilled or beating heart. A key factor fueling consumer demand is that both approaches spare patients the painful and cosmetically unappealing cracking of the breast bone. But they differ in the extent of heart repair that can be made and whether a heart-lung machine must be used.
The beating-heart approach is championed by CardioThoracic Systems, a Cupertino, Calif.-based maker of disposable instruments that cost about $1,500 per case. Its minimally invasive direct coronary artery bypass, or MIDCAB, approach has been prominently embraced by Columbia/HCA Healthcare Corp. and Tenet Healthcare Corp.
The system relies on a special retractor and stabilizing platform to spread the ribs directly above the heart, allowing a surgeon unobstructed access to the artery to be bypassed while that part of the heart muscle is held still. Because the patient's heart continues to beat, the crutch of the heart-lung machine can be eliminated.
Avoiding a heart-lung machine reduces the risk of many serious complications, such as stroke, a problem in about one in 25 bypasses. And surgery without assistance from a heart-lung machine halves the time spent in intensive care, while saving about $1,500 in direct operating room costs. Perhaps most appealing to patients and their employers, an operation without a heart-lung machine also reduces lingering side effects, cutting recuperation in half.
Another California start-up, Heartport, based in Redwood City, has developed a set of disposable tools that let a surgeon operate on a stilled heart without cracking open a patient's chest. A heart-lung machine is connected to an artery through tubes threaded through the patients' groin instead of the chest.
With the heart stopped, a surgeon can replace valves, an operation performed more than 60,000 times annually by all methods, as well as perform multiple vessel bypasses. But Heartport's disposable tools cost about $5,000 per case, and surgeons must buy a package of 30 kits to start, although the company says the price also includes training costs. And because a heart-lung machine is needed, much of the cost and recuperative benefits of the beating-heart approach are lost.
CardioThoracic Systems and Heartport went public last year at $22.25 and $39 per share, respectively, but after an initial flush of enthusiasm, investors drove the companies' stock prices down to $14 and $24 on the NASDAQ exchange last month. Coming off the sidelines, a host of established companies, including U.S. Surgical Corp., Baxter International, Medtronic and Genzyme are developing a variety of competing tools, both disposable and reusable, that analysts and surgeons agree will lower prices while advancing the state of the art.
"It's too good an idea-to work through small holes-not to do it," says Mike Mussallem, president of Baxter's cardiovascular group. But he cautions that manufacturers and surgeons working toward that goal ought not to "trivialize the challenge that's in front of them."
Even before competition among devicemakers begins to take a bite out of instrument prices, hospitals could find the new cardiac surgery techniques to be quite profitable.
Average charges under Medicare for traditional single-vessel bypass were $46,549 in 1995, according to the Center for Health Industry Performance Studies. But with the beating-heart method, in particular, hospitals should be able to shave enough in ICU and ancillary costs over traditional approaches to make the start-up hassles and instrument costs worthwhile, proponents say.
Until payers revise procedure codes to reflect reduced costs for the minimally invasive approach, efficient surgeons and hospitals stand to reap a rich reward. That's the scenario that played out for several years after minimally invasive surgery revolutionized gallbladder removal.
"For the next year or two, it's a windfall profit for a hospital," says Mack of Columbia Hospital at Medical City.
Patient lure. Even now, when scarcely one in 20 patients qualifies for minimally invasive surgery, such a program can help a hospital by feeding patients to existing cardiac-care programs, Oz and other surgeons say. More often than not, self-referring patients turn out to be well-suited for traditional surgeries.
Regardless of their treatment course, having a minimally invasive surgery program helps bring new patients through the doors.
That marketing insight rings true with for-profit Columbia.
Columbia Hospital at Medical City, where Olson had his surgery, serves as the tertiary cardiac-care center for 16 Columbia hospitals in northern Texas. To referring primary-care physicians and cardiologists, it's important for Medical City to be seen as a leader, says Stephen Corbiel, president and chief executive officer.
"We need to be a world-class type of heart center," Corbiel says. "For us to be able to claim that, we have to be on the cutting edge of technology."
To emphasize the point, Medical City is one of two Columbia hospitals training surgeons from throughout the for-profit chain in the beating-heart surgical techniques. Already more than 90 Columbia heart surgery teams have been trained in the techniques-about 40% of all the teams trained thus far by CardioThoracic Systems.
Besides burnishing its image, Medical City is finding the new surgical approach already makes economic sense.
Preliminary indications from the more than 100 minimally invasive surgeries already performed at Medical City show promising gains in reducing overall length of stay and intensive-care and operating room time.
"Everything is pointing to very good savings with super outcomes," Corbiel says. A more thorough cost-effectiveness study is under way.
No blind faith. To be sure, the new techniques have their limitations. Operating on a beating heart poses severe technical challenges for surgeons. And threading the heart-lung machine through the groin, as is done in the stilled-heart approach, was first tried decades ago but has found limited use because of frequent side effects.
For all the enthusiasm among patients and some Wall Street analysts, many medical experts emphasize that minimally invasive cardiac surgery is hardly ready for widespread use.
"If you go blindly and take on faith what you hear, you're going to get into trouble," says Jewish Hospital's Gray.
Furthermore, even when performed perfectly, the techniques have significant clinical limitations and face formidable competition from alternative procedures.
For single-vessel disease, the prime target of the beating-heart approach, angioplasty combined with stenting is an even less-invasive rival. Furthermore, with a few exceptions, the beating-heart method has so far been limited to one of three coronary vessels.
While a stilled-heart approach offers more surgical flexibility-including valve replacement and bypassing multiple vessels-it relies on a heart-lung machine, which involves many of the same risks and costs of the traditional approach. As a result, even the most optimistic advocates don't see the minimally invasive approaches completely replacing open surgery.
"In 10 years, about one-quarter of (cardiac surgery) procedures . . . will be done with some sort of minimally invasive techniques," estimates Columbia's Oz. Even with almost monthly advances in techniques, Oz says, the mainstreaming of the procedures will take time: "One thing I'm sure of is that next year it won't be 25%."
Training rush. Curious about what the future holds, surgeons are flocking to be schooled in the new techniques. Company-sponsored courses are on track to have trained about 500 surgical teams by year-end in a variety of the minimally invasive approaches.
That would make a significant dent among the approximately 2,500 heart surgeons at the 900 hospitals throughout the country that offer cardiovascular surgery.
Gray counsels that a wiser course would be for a limited number of research-oriented surgeons at 10 or 20 major heart centers to refine the techniques before they're broadly available.
Although the rush is likely to continue unabated, Columbia's Mack thinks many colleagues are overly concerned about being left behind. Enabling technology is improving rapidly and will make it easier for later entrants to perform the new techniques. Sitting back while the tools and methods settle down might ultimately make the most sense.
Proving success. While doctors debate, payers and medical societies are also sizing up minimally invasive surgery.
Conventional bypass surgeries' long-term success in healing diseased hearts places a heavy burden of proof on advocates of the minimally invasive approach.
For instance, more than nine in 10 coronary artery bypass grafts made with conventional surgery last longer than 10 years, surgeons say. Those who question the long-term results of minimally invasive bypass ask whether those grafts will work as well and as long.
"Minimally invasive surgeries are always attractive because they reduce morbidity and pain-and that's great," acknowledges Naomi Aronson, technology evaluation director at the national Blue Cross and Blue Shield Association. But unless the new surgeries' outcomes are comparable to the tried-and-true methods, a mass movement to the techniques could be a mistake. She warns against hastily trading proven successes with traditional heart surgery for a few days' reduction in hospital stays.
Aronson is overseeing a Blues assessment of minimally invasive heart surgery that is scheduled to be completed next month.
"I want to look at the big picture," Aronson says. "Who are the patients? What else is available? Are we really going to improve their care and outcomes, and do we have the evidence to back that up?"
Similarly, the American Heart Association endorsed in an advisory statement last fall the establishment of a patient registry to evaluate the new procedures. Namely, do the artery grafts made with the minimally invasive techniques work in the intermediate and long term, and does the heart muscle escape damage during the procedure?
While the long-term questions have yet to be answered, hospitals that want to forge ahead would do well to pinpoint a single surgical team to lead the way. That way, limited patient volume can be funneled to one surgeon to help hone his or her skills.
And high-quality training programs are a must. Proper credentialing, including plenty of hands-on assistance from more experienced surgeons, is important in avoiding mistakes and complications with the delicate new techniques.
Ultimately, nearly everyone agrees heart surgeons will embrace the minimally invasive techniques as part of an expanded armamentarium. Applying minimally invasive procedures when conventional surgery is ill-advised or angioplasty hasn't worked strikes most surgeons as a sensible approach. Already, minimally invasive techniques are prompting patients who had been too elderly or sick to withstand standard bypass to take advantage of the new options, several surgeons say. As techniques improve, broader substitution for traditional operations can begin.
That preliminary results with the new techniques have not equaled those of the old standards should not be cause for concern, says William R. Mayfield, M.D., an Atlanta-area surgeon developing advanced endoscopic techniques for heart surgery.
"That just tells me we're working with first-generation instrumentation, a lack of training and a lack of standardization," he says. "I'm very confident we'll soon be able to match open-heart surgery."