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New Tools May Help to Make Heart-Bypass Surgery Safer

Page One Feature

New Tools May Help to Make Heart-Bypass Surgery Safer

By RON WINSLOW
Staff Reporter of THE WALL STREET JOURNAL
 

BERNE, Switzerland -- As Thierry Carrel stands over his patient in operating room No. 1 at University Hospital here, he may be poised at the threshold of a new era in heart surgery.

For more than three decades, surgeons have used needle and thread to sew new blood vessels into patients during coronary-bypass operations, which are typically performed through a massive incision in the chest. The vessels are used to reroute blood around blockages in the arteries that feed the heart. And the procedure's success hinges largely on the surgeon's skill at stitching them into place.

But at the moment, Dr. Carrel isn't using his sewing talents. Instead, he takes a device loaded with a vein, inserts it into a small hole he has just cut in the patient's aorta and pushes a button. Click. The device, which resembles a long-handled screwdriver, releases a tiny web of wires that unfolds to form a star-shaped rivet. In less than 10 seconds, Dr. Carrel has attached the vein to the aorta mechanically. That compares with the three to five minutes it might have taken him to make the same attachment with stitches.

Foreign Debut

Dr. Carrel is one of a handful of surgeons in Europe and Canada who have used the device during the past several months on a total of about 1,000 patients. St. Jude Medical Inc., the U.S. company that makes the product, rolled it out quietly in Europe last fall, but has largely kept it under wraps. Now, that is about to change.

On Thursday, St. Jude plans to announce that the Food and Drug Administration has approved the device for use in the U.S. That makes the St. Paul, Minn., company the early front-runner in an emerging race to equip doctors to perform "sutureless" bypass surgery. If surgeons embrace the new technology, it could transform the procedure by triggering wider use of techniques designed to make the operation easier on the patient and reduce the incidence of serious side effects.

St. Jude calls its new product the aortic connector. While it is designed to make just one type of the various critical attachments that bypass surgery requires, the company is planning to introduce a full line of connectors over the next year or two, aiming to automate the entire vessel-grafting process. The typical bypass operation involves three or four vessel grafts in which a doctor performs five to seven individual sewing procedures.

'Not Going to Fly Anymore'

As the first to the market, St. Jude faces several hurdles in winning acceptance of its device. Among them: the added cost of using it and the long-term track record of conventional heart surgery, which is impressive enough that many doctors may feel little need to meddle with it. But there also are compelling arguments for heart surgeons to adopt sutureless connectors. Leading the list is the growing push to make bypass surgery -- one of medicine's most invasive operations -- more patient-friendly.

"For 35 years, we've been doing bypass surgery the same way and gotten away with it," says Hani Shennib, a heart surgeon at McGill University Health Center in Montreal. "That's not going to fly anymore. Patients really want to have the same outcome as surgery but with procedures that are a lot less invasive."

The most promising strategy along those lines is beating-heart surgery, in which the surgeon operates on the heart as it continues to pump blood. The goal is to avoid putting the patient on a heart-lung machine, or the "pump," as surgeons call it. Time on the pump, which takes over the heart's function so surgeons can operate on a still organ, has been associated with complications arising from bypasses.

A Moving Target

But the beating-heart technique, which emerged in the mid-1990s, is used in only about 20% of the more than 700,000 bypass surgeries performed world-wide each year. The main reason: the painstaking work of suturing bypass vessels into place -- which surgeons call "the anastomosis" -- is much harder to do on a beating heart. Devices that automate the process could make beating-heart surgery much less challenging and potentially more popular.

"The only reason you put a patient on a pump is to accommodate the guy tying the knots," says St. Jude's Daniel J. Sullivan, the aortic connector's chief inventor. "We're the first ones to go after the sewing process as an issue."

In addition, proponents say, mechanical connectors could make bypass surgery safer by reducing the risk of stroke and other neurological side effects that recent studies have linked to the operation. In February, Duke University researchers reported that 42% of bypass patients suffer such problems as loss of memory, confusion and inability to pay attention for as long as five years after the surgery. About 3% of bypass patients suffer a debilitating stroke as a result of the procedure. Some doctors say a connector could help doctors avoid clamping the aorta, a step in the surgery that is believed to be a key cause of such brain damage.

Another potential benefit: consistency of surgical results. "Hand-sewn bypass grafts are irregular. Every one is a little different," says Robert Emery, a Minneapolis heart surgeon who served as a paid consultant to St. Jude in developing its device. "With this thing, every one is the same."

St. Jude isn't alone in seeing a big opportunity for such technology. Johnson & Johnson, in a venture with Bypass Inc., of Israel, has tested a "sutureless anastomotic device" in small-scale human trials. J&J says it has begun discussions with the FDA about what would be required to gain approval. Tyco International Ltd.'s U.S. Surgical unit and Abbott Laboratories' Perclose unit both are developing mechanical connectors, as are several smaller closely held companies.

"A lot of people think this is going to be a big deal in coronary surgery," says Dr. Emery.

In the U.S., St. Jude plans to sell its new device only to hospitals whose surgeons have been trained in its use. As a result, the company, which had $1.18 billion in revenue last year, is projecting to sell only a few million dollars worth of the connectors this year. In years ahead, St. Jude hopes the devices will become a major contributor to its revenue and profit growth.

The St. Jude product includes a cutter that makes a round hole in the aorta for attaching the replacement vessel, rather than the jagged opening left by the punch that surgeons now typically use for that job. The wire rivet that the device deploys is made of a stable metal and is designed to expand slightly to fill the hole as it clamps the vessel to the aorta.

But St. Jude must persuade surgeons that the device will match or improve on the success rate of conventional bypass surgery. Death rates from the procedure are only about 3% at most hospitals. For the vast majority of patients, the surgery is an effective treatment for angina, the severe chest pain caused by blocked coronary arteries. And it could take several years to show whether mechanical vein attachments are as durable as sewn ones.

Even the product's fans say that its cost could be a deterrent, because insurers usually pay doctors and hospitals a fixed amount for bypass operations. St. Jude plans to charge between $400 and $450 for the single-use devices. Assuming a full line of connectors becomes available, that could add more than $2,000 to the cost of a typical bypass operation. St. Jude says that shorter operating times and other savings will partly offset the additional cost.

A device that diminishes the value of a surgeon's suturing skills could be hard to sell to some members of a profession in which "good hands" are a hallmark of stature. "Doing the anastomosis is the essence of our specialty," says David Fullerton, chief of cardiothoracic surgery at Northwestern Memorial Hospital in Chicago. During his decade of surgical training, Dr. Fullerton says he would hone his technique during off hours by tying surgical knots in his shoelaces, and by slicing open chicken breasts and sewing them up before popping them on the grill.

"For most of us, it took so much effort to acquire these skills, we're reluctant to give them up," he adds.

That isn't to say that St. Jude's device will banish sutures from the operating room anytime soon. For one thing, the new connector is designed only for attaching saphenous veins -- replacement blood vessels that are harvested from a patient's leg -- and then only to attach the end of the vein upstream from the blockage being bypassed. For now, surgeons who use the device will need to stitch the other end of the vein to an artery on the heart, below the obstruction.

St. Jude is at work on a second device to make this lower, or distal, connection. That's a trickier task for the surgeon because there the diameter of the leg vein is typically much wider than the vessel it is being connected to, requiring special care to make sure the anastomosis doesn't leak. In addition, that graft, which typically can take a surgeon 10 minutes to 15 minutes to complete, often must be connected to harder-to-reach areas on the side or back of the heart.

In Berne, Dr. Carrel and his colleague Friedrich Eckstein have used St. Jude's distal connector in about 20 patients so far, with encouraging results. St. Jude says it hopes to have this second device on the market in the U.S. by mid-2002. Among other things, it is designed to eliminate the problem of mismatched vessel diameters.

Another model the company is developing would come into play when doctors use the internal mammary artery, located in the chest wall above the heart, as a bypass vessel. Surgeons often use that artery for bypassing the artery that feeds the heart's pumping chamber. Still another version of the device is aimed at the growing number of surgeons who prefer to use the radial artery taken from the arm as a bypass vessel.

St. Jude is counting on the line to transform it into a major player in the cardiac-surgery market. The company has long dominated the heart-valve market, and it also sells devices that combat heart-rhythm irregularities. But in the late 1990s, its executives launched a search for new technologies that promised future growth.

That search led to St. Jude's surprise announcement a year and a half ago that it was acquiring Vascular Science Inc., a closely held Minneapolis company that developed the connector under Mr. Sullivan's leadership. St. Jude paid $80 million for VSI and agreed to pay an additional $20 million if the newly acquired unit met certain development goals. But though the acquisition substantially diluted its earnings, St. Jude largely kept mum about what it was buying.

"We didn't want Guidant, Medtronic, Boston Scientific and every cab driver in New York making these things," says Terry L. Shepherd, St. Jude's chief executive, referring to rivals in the heart-device business.

Some doctors who are impressed by the device believe it won't win broad acceptance until a distal connector is available, so that surgeons can do both ends of their grafts without sutures.

However, St. Jude believes there is a robust market for the aortic connector alone, thanks in large part to its potential for reducing neurological side effects from surgery. During conventional bypass operations, when the heart is stopped, doctors clamp off the aorta to keep blood from backing up into the heart. But in patients with clogged coronary arteries, the aorta is often diseased too. That means its lining is layered with plaque, much like a rusty pipe. When the aorta is clamped, some of this gunk can be dislodged. When the clamp is released, the debris is picked up in the blood stream and can get carried to the brain.

"You get an old guy whose vessels look like a Drano commercial, and sometimes you hear an audible crunch" when the clamp is applied, says David Stump, a researcher at Wake Forest University, in Winston-Salem, N.C., who has studied the neurological side effects of heart surgery.

Material dislodged by clamps is believed to be one of the chief causes of brain-related side effects in bypass patients. In extreme cases, it can cause a major stroke, or even death. Just how serious and lasting the effects are depends on where in the brain the debris ends up, says Dr. Stump.

During beating-heart surgery, blood continues to flow through the aorta. But doctors use what they call a side-bite clamp to pinch off a portion of the vessel to stabilize the site for stitching. That, too, entails a risk of dislodging debris, and other complications. But with the connector, doctors will be able to connect vessels quickly enough to make such clamps unnecessary.

"The first and immediate impact of the St. Jude device is that you don't have to put a clamp on the aorta," says Michael Mack, a Dallas heart surgeon with no financial connection to the company. "That eliminates a potential source of stroke."

Whether that will prompt widespread use of the device is hard to gauge. Neurological problems can be caused by factors other than clamps, and St. Jude doesn't have any data as yet to demonstrate whether its device indeed cuts the risk of stroke or cognitive impairments. But with the neurological issue getting fresh attention, many doctors may not feel inclined to wait for hard data. "If you have a patient with a brain problem after an [otherwise] uncomplicated operation, that is disastrous," says Dr. Carrel, the Swiss heart surgeon.

Five years ago, when Mr. Sullivan and a small group of engineers started thinking about the connector, their goal was to develop technology for doing bypass surgery through the same type of catheters used in balloon angioplasty. In the angioplasty procedure, a balloon-tipped catheter is threaded through a small incision and into the heart, then inflated to open a blocked artery. But early on, it became clear that using sutures to attach vessel grafts via catheter wouldn't work. That set off the plan to develop a mechanical connector for conventional bypass surgery.

Still, Mr. Sullivan and others believe that the new technology will lay the groundwork for their original plan, eventually enabling doctors to do bypass surgery without cracking open the patient's chest.

Write to Ron Winslow at ron.winslow@wsj.com⁶

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