Life Flow One
The Solution For Heart Disease
by
Karl Loren
By RALPH T. KING JR.
Staff Reporter of THE WALL STREET JOURNAL
PALO ALTO, Calif. -- Open-heart surgery has become all but routine in recent years, although still physically traumatic. A few years ago, medical entrepreneurs decided to remove a lot of the trauma, too. "Minimally invasive" operations became heart surgery's next big thing.
One plan was to operate through a tiny "keyhole" cut in the chest. Patients treated this way could be out of the hospital in short order, then back to normal activities within days instead of months.
Some doctors at Stanford University developed a procedure that promised all this. And a start-up company, Heartport Inc., promoted it in a marketing blitz. Hundreds of surgeons, some impressed that prestigious Stanford was linked to the procedure, gave the method a whirl.
The new company's stock rose. Heart patients heard about its procedure on television and in the press, and began asking for it. Their hopes and those of the surgeons soared.
Now for a reality check.
At least half of the 500 surgeons trained in the Heartport surgical procedure have abandoned it.
Stanford doctors have come in for criticism for having a financial interest in the company even as they were testing its surgical procedure on patients.
Meanwhile, the Food and Drug Administration, which allowed the procedure and equipment onto the market without full-scale testing, is looking into the matter and trying to decide what to do.
And the company, its sales and stock price down, has stopped promoting a key part of its original surgery kit. It has shuffled its management and begun offering a surgical tool that relies on more conventional principles.
Minimally invasive heart surgery still is considered very promising in medicine. But as the Heartport case shows, there may be dangers in rushing it.
Marketing Push
Many new medical devices and procedures go through a slow, incremental process where a small number of doctors work out the kinks under careful supervision before the device is widely marketed. But Heartport, which was in hot competition with another company, pushed heart surgeons to sign up for its procedure.
"I have never felt pressure quite that strong," says Denton Cooley, the renowned transplant surgeon at Texas Heart Institute in Houston.
"This technology was overhyped," says Bartley Griffith, chief of cardiothoracic surgery at the University of Pittsburgh Medical Center. "It got out too fast to too many people, and it was still evolving. Most surgeons who used it felt that it wasn't quite ready for prime time."
With its new way of doing bypass and valve-repair surgery, Dr. Griffith says, Heartport "took a very simple, straightforward procedure and made it quite hair-raising." His hospital quit using the technique after just seven cases, when one patient died from a hemorrhage and one had a stroke. Dr. Cooley calls the procedure "a stunt" and has never used it.
Some Do Fine
Their criticism isn't shared by all. Some doctors say skill is all that's needed to make Heartport's technique a success. Daniel Schwartz, an assistant professor of heart surgery at the University of Southern California, is an enthusiastic user of the procedure. "It's working great. I'm very familiar with the system and I've had no problems with it," he says.
Heartport maintains that its procedure is safe. Still, Frank Fischer, who took over as chief executive in the management shake-up a year ago, acknowledges some problems. "In retrospect, the issue was widespread exposure," he says. "It was an ease-of-use issue, a learning-curve issue. From pure 20/20 hindsight, you could call it a mistake, but it depends on what you know at the time."
Heartport, based in Redwood City, Calif., and first called Stanford Surgical Technology Inc., was founded in 1991 by two Stanford-trained doctors, John Stevens and Wesley Sterman. Dr. Stevens went on to become a Stanford faculty member. Inspired by keyhole surgery on gallbladders and other organs, they sought an alternative to standard heart surgery that entailed cutting open a patient's chest from the neck to the solar plexus.
Besides the thin surgical instruments themselves, their principal tool was a specialized catheter for use while patients' hearts were stopped. In conventional surgery, the chest is wide open, giving ready access to arteries and veins for plugging in the heart-lung machine. But this surgery didn't open the chest. Instead, catheters attached to the machine snaked their way up from the groin.
Moreover, blood from the heart-lung machine was forced up an artery from the groin all the way to a spot above the heart, traveling counter to the normal direction of blood flow in the artery.
The founders recruited a group of Stanford medical-school faculty members, including the chief of heart surgery, Bruce Reitz, to test their catheters on dogs before moving on to people. The team published in medical journals. Heartport gave most of them stock, although Dr. Reitz didn't take any. It went public in 1996.
The marketing blitz began at the start of 1997. The company was striving to meet a first-year sales goal and beat CardioThoracic Systems Inc. of Cupertino, Calif., which had a different minimally invasive procedure.
Many surgeons liked Heartport's pitch, including two days of free training, patient referrals and public-relations support. Within weeks, more than 200 doctors were on a list to be trained. The unresponsive were bombarded with sales calls and faxes, in a marketing program led by former Genentech Inc. marketer Richard Brewer. Genentech has just agreed to a record $50 million fine related to a marketing program that Mr. Brewer led there; the agreement, in federal court in San Francisco, settled criminal charges of promoting human growth hormone for unapproved uses. Mr. Brewer, who wasn't cited by name in the charges, didn't return phone calls seeking comment.
Signing On
In Los Angeles, the "glamour" of the new method appealed to doctors at Cedars-Sinai Medical Center, which sought to distinguish itself from rivals, says Alfredo Trento, chief of heart surgery. "You always hear hospitals say they have something new to offer. For them, it's marketing and image and so forth."
The glamour soon faded. The hospital backed away from Heartport after one of 11 Heartport patients died and two others eventually required heart transplants, say members of Dr. Trento's staff. He, like many other Heartport dropouts, doesn't cite bad patient outcomes as a reason for giving up the procedure, but rather its difficulty, along with the $5,000 cost of the single-use equipment. "We still get requests all the time from patients who've seen it on TV," he says.
Publicity also drew patients to Mohammad Gharavi of Los Robles Medical Center in Thousand Oaks, Calif. His profile in a local newspaper attracted Pamela Junkins, 61 years old, who liked the idea of surgery without unsightly scars. But she suffered an aortic dissection -- the rupture of the body's biggest artery -- and died, according to a suit filed by her family against Dr. Gharavi in Ventura County, Calif., superior court. The case is pending.
"It's upsetting that this happened to Mrs. Junkins," Dr. Gharavi says, "but I don't think there is one person or one instrument or one procedure to blame." He adds, "If we had done it the regular way, she probably wouldn't have had a dissection, but she might have had a stroke or some other problem."
Mortality Rates
In defense of its procedure's safety, Heartport says that patient deaths voluntarily reported to it by surgeons have never exceeded the death rates found in open-chest heart surgery. However, its patients are younger, by three to five years, and evidently less sick; that's because Heartport cautions doctors to screen out patients with severe heart disease.
In part because its data don't reflect a randomized study, the company's mortality comparison is "probably invalid," six Baylor College of Medicine faculty members wrote in the Journal of Thoracic and Cardiovascular Surgery. Heartport says that although the data are incomplete, covering about one-third of the 8,000 or so cases done to date, "there's a lot of thoroughness in gathering the information."
At a May 1997 medical conference in Paris, Stanford's heart-surgery chief, Dr. Reitz, gave an upbeat presentation about the future of procedures such as Heartport's. He didn't mention a Heartport valve-repair operation he himself had done less than two weeks earlier, in which the patient, a 47-year-old carpenter and avid backpacker, suffered an apparent stroke and ended up brain-damaged and with little use of his arms and legs.
"We weren't adequately informed of the risks," charges the patient's wife, Maryann Valentine. In his current state, she says, her husband is "well aware of what's gone on and he would much prefer to be dead."
Dr. Reitz declines to discuss the case, over which he faces a suit pending in Santa Clara County, Calif., superior court, but he says that "I made no attempt to hide my complications" at the conference. Still, before the end of 1997, Dr. Reitz stopped using Heartport for valve or bypass surgery, and he used it for the last time for any kind of heart surgery in August 1998.
Stock Ownership
Although Dr. Reitz accepted no stock from Heartport -- only a consulting fee -- other Stanford faculty members who were testing the procedure got thousands of shares each. Dr. Stevens, as a co-founder, had 2.5 million shares, which after the 1996 public offering briefly became worth more than $100 million. Heartport says it disclosed doctors' stock ownership and other company ties to patients in consent forms and to medical journals. But some journals that published their research, while reporting that it was funded by Heartport, initially didn't mention that the researchers held stock in the company.
The editor of the Journal of Thoracic and Cardiovascular Surgery says maybe he was naive not to feel that stockholdings needed to be disclosed; he has changed his policy and now reports such ties. Another journal, the Annals of Thoracic Surgery, began to disclose Heartport stockholdings after being chastised by a reader for not doing so.
Disclosure or not, some doctors say that to use and test a medical device while owning stock in its manufacturer is unacceptable. "It's very problematic," says John C. Baldwin, dean of Dartmouth's medical school. "One's objectivity in decision-making in patient care is obscured by that situation ... I think it's improper."
Transplant pioneer Norman Shumway, who, as Dr. Reitz's predecessor, built Stanford's heart-surgery reputation, says, "I think it's wrong, I really do. I would never do it."
One Stanford team member, R. Scott Mitchell, says his sense of a financial conflict prompted him to quit Heartport research after the dog studies. But "other people here didn't feel as compromised," he observes.
Heartport says start-up makers of medical devices routinely give researchers stock in exchange for their ideas and their time, because few can pay cash. "It's an insurmountable conflict, but you just have to let the patients know what the issues are as candidly as possible," Dr. Stevens says. "The only way to counteract that is with optimal disclosure."
The Stanford Name
Dr. Reitz says the faculty members "were working in the lab trying to improve people's lives, and the business aspect was not motivating people at that time. I don't think our motivations were at all tainted." Other Heartport researchers who are still at Stanford didn't return phone calls seeking comment.
Stanford itself didn't invest in Heartport. But the association with its name was critical to the procedure. "The thing that made people stand up and take notice is that it had the Stanford stamp of approval," says Robert Tranbaugh, a surgeon at New York's Beth Israel Medical Center. "That p_____ me off more than anything else."
Dr. Stevens, while an assistant professor of heart surgery at Stanford, organized two educational conferences for surgeons, called the Stanford Symposium on Minimally Invasive Cardiac Surgery. Heartport consultants dominated the conferences, but the company's financial backing was scarcely mentioned in conference solicitations. A Montana surgeon, Alan Muskett, later wrote to a medical journal that he "felt deceived" by Stanford's sponsorship. He calls the Stanford conferences "a Heartport commercial."
Kenneth Melmon, a Stanford associate dean who approved the conferences, says he also feels deceived, having been unaware that Dr. Stevens had such a close tie to the company. "I'm disappointed," Dr. Melmon says. "It gives the perception that he was hiding it." Dr. Stevens says he disclosed all his Heartport ties in paperwork submitted to Dr. Melmon's office. It was "squeaky clean," he says.
'Achilles' Heel'
Meanwhile, some surgeons began to dispute the company's public statements and marketing. The loudest critic was Friedrich Wilhelm Mohr, a German surgeon picked by Heartport to conduct human tests prior to FDA clearance. At a Washington, D.C., conference two years ago, Dr. Mohr presented his results. Out of 51 patients, there were five deaths, one of which was clearly related to the procedure. One patient who died and one who survived had aortic dissections-rupture of the big artery-related to the procedure.
Aortic dissection has been the Heartport procedure's "Achilles' heel," says Dr. Reitz. Dr. Stevens himself had it happen to a patient of his in late 1996 -- an event that Heartport says led it to tell surgeons to screen out patients with very diseased arteries.
Even so, in doctors' voluntary reports on 610 early Heartport patients, aortic dissection occurred in 11 of them, a rate 10 times that seen in open-chest heart surgery. Reports on 1,063 later cases showed only eight, but that was still four times the rate in conventional heart surgery. These are the latest published data. The company says its unpublished data now show a rate close to that of open-heart surgery.
The Catheter
Dr. Mohr blamed the burst arteries on Heartport's centerpiece, its special catheter, which a surgeon puts in after first threading a guide wire up the aorta from the groin to the heart. Dr. Mohr said the wire and the catheter were "very stiff" and might cause artery damage, which could lead to a tear once blood began to flow -- pumped in a "retrograde" direction from the groin to the top of the aorta.
His thesis drew instant fire. A Heartport advocate at the meeting questioned his surgical skills, and Wall Street analysts challenged him. Dr. Mohr says Heartport prodded him to include more-positive data from other doctors if he was going to present his own negative data. They "wanted to imply I wasn't doing it right," he says. "The company doesn't like this data."
Replies Dr. Stevens: "The reality was that he had bad results and others didn't. He was very candid about a very tough experience, but then he concluded that everyone else must be underreporting."
Almost the very day Dr. Mohr spoke, the company introduced a modified catheter and guide wire that were more flexible. Heartport says the change didn't imply that the previous ones were defective, and it hasn't recalled them.
'Heartport Road Kill'
By early 1998, as reports of cases gone awry circulated, some surgeons coined a grim phrase for those who died or were injured during the surgery: "Heartport road kill." Dr. Stevens says he himself has been confronted with the term -- by a Stanford faculty member.
Demand for Heartport's system cooled so fast that, last May, the company abruptly brought in new management and cut back the staff. Mr. Fischer replaced Dr. Sterman as CEO; Dr. Sterman now is chairman. Heartport's sales in 1998 declined 20%. The stock closed Tuesday at $5.375, far off its high of $43.75.
Dr. Stevens, who had sold 12% of his Heartport stock for $7.4 million in 1997, stepped down from his post as technology officer in 1998 but remains a director. At Stanford, he has reduced his role to that of consulting assistant professor.
The FDA is looking anew at the procedure. When the agency approved it 2 1/2 years ago without requiring full clinical trials, its rationale was that the approach merely used previously approved devices in a slightly different way. But Pittsburgh's Dr. Griffith says, "This was not a substitute for one instrument but a whole new way of thinking about how to protect the heart in surgery and how to approach the heart. It was a technological leap that most surgeons were unprepared for."
In any case, he says, "even though you have FDA clearance, that doesn't mean you've got to sell it to everyone you can. It's better to take another year refining the system."
'Not Done Yet'
The FDA now is "concerned" about the number of death and injury reports, says Susan Alpert, director of its office of device evaluation. "We are looking into this to see if it's procedurally related and if the procedure can be changed to decrease the frequency of these events," Dr. Alpert says. "We are determining what actions need to be taken. We are not done yet."
In any event, Heartport no longer actively promotes the original catheter. It introduced a new model late last year that goes in close to the heart and sends blood along its natural path, instead of forcing it against the grain from the groin to the heart. But it continues to sell the old model for those who want it. The company says it now concentrates its marketing on fewer, better-trained surgeons.
One of them is Dr. Mohr. He says his latest 110 Heartport cases, using the early catheters, have produced just one fatal aortic dissection.
As for Dr. Reitz, Stanford's chief of heart surgery, he says he has no regrets about his involvement with Heartport. Dr. Shumway, who no longer practices surgery but still spends time at Stanford, says his successor "is a very fine gentleman, and I think to some extent he was used in this business." Dr. Shumway considers the proud reputation of the department he once ran, and says: "It's a little tarnished, isn't it?"
Responds Dr. Reitz: "A new field of cardiac surgery was being opened up. The many people that also worked at it here at Stanford were trying to advance that concept and trying to help people. And it's working out that way."
Then, after a pause, Dr. Reitz adds, "Though maybe not with the Heartport technique."
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