The Wall Street Journal
Tuesday, May 4, 2004

Bypass Surpasses Angioplasty in Study
By Thomas M. Burton

     In the past decade, angioplasty has displaced bypass surgery as the primary treatment for blocked coronary arteries.  Angioplasty –sliding a balloon into the artery- is now done more than a million times a year in the U.S., compared with about 300,000 bypass surgeries.  The reason is that angioplasty is minimally invasive, requiring a mere slit in the groin and one night in the hospital, as opposed to a cracking open of the chest for surgery, followed by five to seven days in the hospital and six weeks of recovery.

     But a study to be published this month in the journal circulation concludes that coronary bypass surgery has longer-lasting benefits than does angioplasty-at least in the high-risk patients.  In the study, researchers at the Cleveland clinic followed 6,033 heart patients for five years after surgery or angioplasty, and found the risk of death was more than twice as high in the angioplasty group.

     The new research, which involves seriously ill heart patients, raises questions about the wisdom of the overwhelming trend toward angioplasty.  It has broad implications for heart patients, their doctors and potentially, the medical device industry.  An estimated 500,000 Americans each year die of coronary heart disease a condition that affects about 13 million people in the U.S. overall.  Cleveland Clinic doctors estimate that at least 25% of them, or more than three million patients, are in the high-risk group the study discusses.

     Past studies have shown angioplasty – which often involves placing a wire-mesh stent in a coronary artery – in comparable to surgery in avoiding deaths over time.  And given that hospitals generally charge $23,000 to $30,000 for bypass surgery, versus $12,000 to $15,000 for angioplasty, physicians have increasingly recommended the less-invasive, less expensive angioplasty.  This in turn has fueled a huge industry.  Companies including Boston Scientific Corp., Guidant Corp, and Johnson & Johnson generated nearly $6 billion in worldwide sales in 2003, selling the angioplasty assembly of wires, balloons and catheters, as well as the mesh stents.

     But some of those earlier studies suggested that diabetes patients with heart disease tended to have better survival with bypass surgery.  Also, patients with significant heart failure - meaning a decrease in the hearts pumping power – were generally excluded from earlier studies comparing stents and angioplasty versus surgery.  All this prompted the Cleveland Clinic to look more closely at higher-risk patients.

     The study was limited to patients with “multi-vessel” blockages in two or more of the three coronary arteries, and additional health factors like diabetes or heart failure.  Also, the surgeries were performed at a leading clinic where heart-surgery results are among the best in the world.  To duplicate such results, a patient would have to look to a similarly high-caliber facility.

     In the study, researchers analyzed high-risk coronary patients treated at the clinic from 1995 to 1999.  Half had moderate to severe heart failure or diabetes.  There were 931 deaths during the five years of follow-up.  The patients hadn’t been randomly assigned to a treatment, but got the treatment their doctors recommended.  Since the more severely ill patients tended to be referred to surgery, all cases were “risk-adjusted” for the severity of illness so that the two treatments could be fairly compared.

     Authors of the study included cardiologists, interventional cardiologists who do angioplasty and stent procedures and heart surgeons.

     The conclusion was that surgery “was associated with better survival” in “patients with multi-vessel coronary artery disease and many high-risk characteristics.”  Specifically, death was 2.3 times as likely to occur among angioplasty/stent patients over five years as in surgery patients.  About 70% of angioplasty patients got stents.

     “On the basis of these date, if I’m facing a person with multi-vessel disease, I’m leaning toward surgery,” says Michael S. Lauer, a Cleveland Clinic cardiologist who does neither surgery nor angioplasty.  In such risky patients, he says, “the concern is long-term life expectancy.”

     Since the last case studied occurred in December 1999, it preceded the advent of drug-coated stents, which are designed to prevent tissue from growing into the coronary artery and re-blocking it.  These new stents could conceivably make a difference in angioplasty survival rates for high-risk patients.  But there’s no research yet directly on point, and in the view of the researchers, drug-coated stents wouldn’t likely change the results.

     “I am not so convinced that they truly affect mortality,” says study co-author Sorin J. Brener, an interventional cardiologist who does angioplasty and stent procedures.  “This result is surprising and certainly not what I was looking for.  We were hoping to see the death rates identical.”

     These new findings may stem from the nature of the two procedures and of the disease itself.  Coronary disease means that fatty plaque is building at multiple points within arteries that supply blood to the heart.  It is a diffuse disease, growing at numerous sites in coronary arteries and other vessels throughout the body.

     In angioplasty, a thin wire with a miniature balloon on the end is snaked through the femoral artery in the groin, up the aorta and into the coronary artery.  The balloon is then expanded, pressing the plaque against the artery wall and widening the pathway.  Often, a wire stent is left at the site to keep the plaque from damming up the artery again.  But buildups of plaque and clots can occur elsewhere throughout the coronary artery. And thus the artery can clog once more.  The result can be a heart attack.

     In bypass surgery, as the name suggests, the entire bad artery is bypassed.  A section of artery or vein from elsewhere is used as a detour route to supply blood to the heart.  Thus, if more blockage occurs in the original artery, it doesn’t much matter.  “Bypass surgery really bypasses the problem,” Dr. Brener says.

     Of course, to experience the advantage of surgery, the patient must survive the operation.  Thus, it is essential for a patient to be treated by a skillful surgeon and cared for by top cardiac nurses.

     For patients looking to receive the best surgical care, it makes sense to seek out a leading academic medical center.  For instance, the Cleveland Clinic, which is unusual in that it publishes its data, last year, saw its dearth rate in bypass surgery fall to 0.6%.  In 1995 to 1999, that mortality rate was slightly higher, though it dropped from about 1.8% to about 1.12% during those years.  The national norm is about 3%, and is falling, according to Dr. Brener.

     Beyond that, Toby Cosgrove, the Cleveland Clinic’s chairman of cardiovascular and thoracic surgery, recommends asking how many cases the surgeon handles annually and what his or her mortality rate is.  He also recommends inquiring into whether the surgeon typically uses a stretch of artery, or of vein, to replace the coronary artery.

     “Arterial grafts tend to do better than vein grafts, says Dr. Cosgrove.  “Vein grafts get atherosclerosis and close over time.  The more arterial grafts you use, the better.”  The use of the saphenous vein, from the leg, is easier technically, in his view, but the trend is toward the use of an artery to replace blocked coronary arteries.

Memorial Hermann Foundation Windows, Page 3
Winter 2002

Surgeons on Leading Edge with Off-Pump Bypass Surgeries

While leading edge technology is often the province of academic medical cent3ers, two cardiovascular surgeons at one of Memorial Hermann’s community-based hospitals are embracing new technologies that can substantially improve outcomes for patient’s who require cardiac bypass surgery. Cardiovascular surgeon Dr. Donald Gibson, chief of staff at Memorial Hermann Memorial City, and member of the board of trustees of Memorial Hermann Healthcare System, and his partner Dr. Miguel Gomez, were among the first surgeons in Houston to perform “off-pump” heart bypass surgeries. Both of these experienced surgeons are enthusiastic about the remarkably improved outcomes for their patients

Until the past few years, all heart bypass patients were put on a heart-lung machine during surgery. This device allows surgeons to stop the heart from beating while they perform the delicate surgery on the heart’s blood vessels. The heart-lung machine temporarily serves as the patient’s heart and lungs, pumping blood through the machine to oxygenate the blood and then pumping the blood back into the body to deliver oxygen to the cells. Although used effectively in heart surgery for decades, putting patients on the heart-lung machine is not without risks, such as lung problems, fluid retention, stroke, abnormal heart rhythms, bleeding and death. But progressive physicians are always looking for better solutions for their patients

Now surgeons around the world, including Dr. Gibson and Dr. Gomez, have begun using devices that allow small sections of the heart to remain immobile, while the rest of the heart continues to beat normally and perform its important job of delivering blood to the rest of the body. Dr. Gibson explains how the device works. “The device is called an ‘Octopus,’ and it has suction cups that attach tot he heart muscle on either side of the artery on which we are working. The suction cups are attached to a flexible hose that is then connected to a stabilizing bar. While the rest of the heart beats, the one-inch square area that we work on stays perfectly still. When we are done with one area, we remove the suction cups and move them to the next area.” Says Dr. Gibson

The benefits are enormous, according to clinical studies done around the world, and according to Dr.Gibson’s and Dr. Gomez’s own two-year retrospective study on their patients. Dr. Gomez explains, “We have shorter post-operative length of stay, lower mortality and stroke rates, shorter ventilator use times and faster recovery times. This device minimizes the interference to the normal functioning of the heart, and it also usually shortens the time the patient is in surgery. Both of these are clearly better for our patients. And, shorter lengths of stay and quicker recoveries drive down costs, which is also a strong incentive.

Dr. Gibson and Dr. Gomez began doing these ”beating heart,” or “off-pump” bypass surgeries in September of 1999 on a few selected patients. The off-pump patients had such remarkably positive outcomes that within two months, they decided to do all bypass patients off-pump. Currently, they do approximately 97 percent of their bypass surgeries off-pump. Not only is this the highest percentage of off-pump bypasses being done in the Houston area, but it can also be compared to national averages of only 10 to 15 percent of all bypass surgery being done off-pump. Occasionally, because of other medical complications, they will use the heart-lung machine on a patient, but that is the rare exception.

Dr. Gibson believes that this sort of leading edge medicine is becoming more common I the community –based hospitals around the country. “Not all of the latest and greatest technology is concentrated in the academic medical centers. Many community hospitals are just as progressive, if not more so, with these new clinical procedures. We have great support here at Memorial Hermann Memorial City, and we plan on continuing to improve patient care in whatever ways we can.”

So, what does this new procedure mean to patients who might be needing bypass-surgery? “I saw an off-pump bypass patient sitting up in bed reading the newspaper in the evening of the day he had surgery.” Says Dr. Gomez. “That may not seem like a big accomplishment, but when you consider how major this surgery is, it is really quite remarkable.:

Houston Chronicle - This Week, Business Section
Thursday, June 27, 2002

New Surgical Method Gaining Popularity Among Cardiologists
By Doug Dodson, Chronicle correspondent

Heart bypass surgery is a risky proposition for any patient, but two doctors at Memorial Hermann Memorial City Hospital have implemented a new technique that significantly reduces the complications of the life saving procedure.

Doctors Donald Gibson and Miguel Gomez have successfully performed more than 750 off-pump or beating-heart bypass surgeries since 1999. The traditional procedure involves connecting a patient to a heart-lung machine, which substitutes for the patient’s own heart and lungs and allows surgeons to stop the heart from beating while they operate on its blood vessels.

Heart-lung machines, the doctors says, place patients at risk of potentially fatal complications such as stroke, abnormal rhythms, lung problems and fluid retention.

“The heart lung machine can cause a wide range of problems because it is not a normal state,” Gibson said. “The brain, lungs and kidneys are the three organs that do not tolerate the machine well.”

With the off-pump technique, Gibson and Gomez use a device called the Medtronic Octopus that immobilizes a small section of the heart while the rest of the heart beats normally, supplying blood to the body. The device utilizes a set of suction cups, which attach to the heart muscle on either side of the artery on which the surgeons operate.

“Once you attach the device to a small one-inch square area of the heart it becomes rigid and immobilizes that part of the heart,” Gibson said. “Once we are able to stabilize that area, we can operate on that artery while the rest of the heart is still beating normally.”

The results of the method, which was developed in Brazil in the early ‘90s, have amazed both Gibson and Gomez.

“In our experience it is remarkable better in that the complication rate is less and the recovery time is better,” Gomez said. “There is a dramatic difference coming out of the operating room. When you put a patient on a pump they come out of the operating room with drips of medicine that help the heart function properly, and they are on a ventilator. Right now, I would say over the last year about 50 percent of our patients come out of the operating room awake and breathing on their own, and I would say a great majority required no medicines to help the hearts function.”

Although the two surgeons began utilizing the new technique in 1999, they are still the only doctors in the Houston area who do 95 percent of their cases as off-pump bypass operations.

“Doctors can be conservative when treating patients, but I think at the same time it is a big paradigm shift,” Gomez said. “Heart surgery has been done on a still platform in the past. When you put the patient on the heart-lung machine you stop the heart. And to do the type of surgery we do now, the target is moving-and you have to change your thinking. Although we have this art attached, the target is not completely immobile, and some surgeons can have a little difficulty with that. It is a little more technically challenging.

The introduction of new medical techniques, especially involving invasive procedures, can take time to become established methods. But Gibson, points out, it is a proven method at Memorial City Hospital.

“It is still a relatively new procedure in this country.” Gibson said. “It has, however, been used extensively in Europe and in South America. What we are able to do is bring very progressive medicine, and high-quality medicine, to a community hospital to serve the needs of the people in the surrounding area. That’s the focus here.”

Nationally, only 10 to 15 percent of all bypass surgeries are performed off-pump.

“In 95 percent of our cases we don’t use the pump anymore,” Gomez said. “So I think this is a very revolutionary step in coronary artery bypass surgery. As time passes and the data continues to be collected, more and more people will come on boars. The way we are practicing medicine right now, today, will in 10 years be the way everybody practices medicine.”

Gibson agrees

“All you have to do is look at the percentages,” he said. “Five years ago only one percent of cases were being done off pump and it is probably up to 25 percent now. And I think it will continue at that rate.”

Texas Medical Center News, Vol. 24, No.2
February 1, 2002

“Keeping the Beat” During Bypass Surgery
By David Mendel Memorial Herman Healthcare System

Most traditional bypass surgeries involve connecting a patient to a heart-lung machine which substitutes for the patient’s own heart and lungs and allows surgeons to stop the heart from beating while they perform delicate surgery on its blood vessels. But, some health care experts say that heart-lung machines place patients at risk for potentially fatal complications such as stroke, abnormal rhythms, lung problems, and fluid retention.

Drs. Donald Gibson and Miguel Gomez, cardiovascular surgeons at Memorial Hermann Memorial City Hospital, are demonstrating that patients whose hearts are allowed to continue beating during bypass surgery recover more quickly and better than those who undergo a traditional bypass.

Drs. Gibson and Gomez have successfully performed more than 600 “off-pump” or “beating –heart” bypass surgeries since 1999. That represents almost 97 percent of their bypass surgeries – the highest percentage of off-pump bypasses being performed in the Houston area. Nationally, only 10 to 15 percent of all bypass surgeries are performed off-pump.

With the off-pump technique, Drs. Gibson and Gomez use a device called an Octopus that immobilizes a small section of the heart while the rest of the heart beats normally, supplying blood to the body. Suction cups attach to the heart muscle on either side of the artery on which the surgeons operate.

An estimated 500,000 Americans undergo heart bypass surgery each year. Studies find that while more than 95 percent of the cases are successful, there remain serious side effects and occasional deaths, many resulting not from the surgery itself, but from the heart-lung machine.

“We take an aggressive approach to treating our patients,” said Dr. Gomez. “We consider every patient referred to us a candidate for off-pump bypass.”

“They recover faster, spend less time on the ventilator, experience fewer complications, have lower mortality and stroke rates and a shorter postoperative length of stay.” Said Dr. Gomez. “I checked on one off-pump bypass patient four hours after operating on him and he was sitting up in bed reading the newspaper. That’s incredible.”

Texas Healthcare • Houston
January 2002

The Beat Goes On for Patients of Two Memorial Hermann Heart Surgeons

HOUSTON – You expect to find unconventional medicine being practiced in the Texas Medical Center. But two Memorial Hermann doctors are quietly achieving medical milestones in one of Houston’s community hospitals. Drs. Donald Gibson and Miguel Gomez, cardiovascular surgeons at Memorial Hermann Memorial City Hospital, have successfully performed more than 600 "off-pump" or "beating-heart" bypass surgeries since 1999. That represents almost 97 percent of their bypass surgeries. Not only is this the highest percentage of off-pump bypasses being performed in the Houston area, it compares to a national average of only 10to15 percent of all off-pump bypass surgery.

Gibson and Gomez are demonstrating that patients whose hearts are allowed to continue beating during bypass surgery recover quicker and better than those who undergo traditional bypass. Traditional heart bypass involves connecting a patient to a heart-lung machine which substitutes for the patient’s own heart and lungs and allows surgeons to stop the heart from beating while they perform delicate surgery on its blood vessels. But heart-lung machines place patients at risk of potentially fatal complications such as stroke, abnormal rhythms, lung problems and fluid retention.

With the off-pump technique, Gibson and Gomez use a device called an Octopus that immobilizes a small section of the heart while the rest of the heart beats normally, supplying blood to the body. Suction cups attach to the heart muscle on either side of the artery on which the surgeons operate.

An estimated half-million Americans undergo heart bypass surgery each year. Studies show that while more than 95 percent of the cases are successful, there remain serious side effects and occasional deaths, many resulting not from the surgery itself, but from the heart lung machine.

Clinical studies conducted around the world and the Gibson and Gomez team’s own two-year retrospective study show enormous benefits for patients. “They recover faster, spend less time on the ventilator, experience fewer complications, have lower mortality and stroke rates and a shorter post-operative length of stay,” says Gomez. “I checked on one off-pump bypass patient four hours after operating on him and he was sitting up in bed reading the newspaper. That’s incredible.”

Dr. Gibson says it may come as a surprise that this surgery is being performed outside the medical center. “Many community hospitals are just as progressive as the academic medical centers, if not more so, with new clinical procedures. We have great support here at Memorial Hermann Memorial City and we plan to continue to improve patient care in whatever ways we can,” he says.