Leading Medicine Magazine, Vol. 1, No. 1, Winter 2002

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A UKRAINIAN ODYSSEY

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Keeping Revolutionize the Treatment of Heart Disease 0

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often seek the best physicians and nursing care when choosing a hospital. However, what they rarely consider is that obtaining treatment at a hospital that has a highly regarded reputation for research may open doors to the hltest treatment options not available anywhere else.

The Methodist DeBakey Heart Center has a longstanding commitment to research and discovery of the causes of cardiovascular disease as well as solutions that offer patients a longer and better quality of life.

With more than $15 million in cat·diovascular research ftmding from the National Institutes of Health, American Heart Association and other sources, Methodist and .its affiliated medical school, Baylor ColJege of Medicine, one of the premier medical schools in the U.S. , comprise one of the top cardiac research centers in the country.

At any one time, there are more than 100 studies in progress at Methodist.

Some of the major ones currently under way examine causes ai1d treatment options for patients who suffer from congestive heart failure .

' Guillermo Torre, M.D. , Ph.D. , a cardiologist at the Methodist DeBakey Heart Center, is leading a clinical study that examines how the body's natural reaction to inflammation can help jump start the body's repair process.

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WINTER 2002

byJill Reynolds

A small amount of blood is drawn from the patient and simultaneously exposed to ultn1violet light, temperature and ozone, which slightly damage the cells.

The u·eated blood is then re-injected into the patient.The body senses the need to repair and begins to decrease inflammation in the body.

Torre said inflammation is the body's response to injury and this treatment uses the body's natural anti-inflammation capacity to heal itself.

A similar study that utilizes the same u·eatment to decrease injury to the body after patients are removed from the heart-Jung madline used du.ring open-hea.rt surgery will begin soon.

In the first known study of its kind, Torre and his associates are investigating the effectiveness of left ventricular assist devices (LVADs) to aid in the healing process.These devices assist an ailing he.u;- and take over much of the effort needed to pump blood through the heart's chambers, allowing it to "rest."

1

Clinical observation has shown that the heart can repair itself and the LVAD can eventually be removed.The heart shows improvement ftmctionally, celJularly and molecularly. This study holds great promise for patients who currently see a heart transplant as their only option.

Seven other heart centers are participating in this Methodist-initiated and led study including Cleveland Clinic, University of Michigan, University of

WWWMl:.'THODISTHEALTH.COM

Minnesota, Texas Heart Institute, University of Pittsburgh, Temple University and Columbia University.

Another area of focus is arrhythmias or irregular heartbeats.Two current studies are testing the vaJue of drng therapy to treat atrial fibrillation, the most common arrhythmia.

When an irregular heartbeat occurs, the blood can clot, possibly lodging in an artery in the brain, and lead to stroke.

AtriaJ fibrillation accounts for more than one-third of strokes in people over age 65 and currently there is no therapy oth er than the use of blood thinners to eliminate the chance of clotting.

1

Methodist cardiologist Craig Pratt, M.D. , is evaluating such drug therapies.

Two studies he initiated are testing the effectiveness of a drug that will block the potassium channels in the heart muscle cells, benefiting patients by keeping their heartbeats more regular.

A similar study is examining the combination of this drug with an implantable cardiac defibrillator, a d evice that shocks the ventricles in the heart to keep it pwnping w h en it senses a slowd own or irregularity. More than 1,200 patients are participating in these Lwo studies in the United States, Canada and Europe.

A third Pratt study is testing the only FDA-approved implantable cardiac defibrillator developed to stimulate the atria of the heart. This sn1dy begins in March, 2002, and will test whether the device can prevent atrial fibrillation and heart failure, and reduce the amount of time patients spend in the h ospital.

Physicians at Methodist are among the leaders in identifying hereditary genetic abnormalities associated with cardiac disease. These studies have b een critical in both th e understanding and diagnosis of these diseases and fo rmulate the best promise for approaching their treatment.

• Cardiologist Robert Roberts, M.D., and his colleagues have developed a highly specialized laboratory, which attempts to find the genetic abnormalities associated w ith cardiac disease in

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families. In recent year s, it bas become clear that the same genetic abnormality may manifest itself differently in differe nt patients. Cardiologist A.]. Marian, M.O., has found "modifyin g genes" that are respon sible, in part, for this phen omenon. Marian and Roberts have recently received a large grant from the National Heart, Lung and Blood Institute to study modifying genes in cardiac genetic abnormalities.

Heart cente r physicians have a long history of providing revolutionary care to patients with heart disease.This tradition of innovative treatment continues today and while researd1 studies are a strong emphasis, patient care is the highest p riority.

"We don't put anyone into a clinical trial wh o isn 't already receiving the op timal care," said Susan McRee, study coordinator for many of the treatments being researc hed for congestive h eart failure. "The studies give our patients another alternative." •

researchers and physicians continue the tradition of research, conducting a wide range of studies: basic science studies, which look at cellular and molecular causes of and treatments for disease translational studies, which utilize the knowledge gained from basic science to develop a treatment, and clinical studies, which put the treatments into practice, bringing the science to the bedside For example, a physician may discover the genetic cause for high cholesterol in a basic science study; a translational study may develop a drug which reduces cholesterol; and, a clinical study may see how effective a drug is in treating patients. •

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- . With .,seEs'e Life Saving Devices

By Den ny Angelle

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may be just a heartbeat away from the presidency, but Vice President Dick Chen ey's own heartbeat was found to be a little too fast in the summer of 2001. So it was big news when the self-professed workaholic was given a high-tech heart regulating device, or pacemaker, to help slow down his h eart rhythm.

In talking w ith news rep orters at the time, he called the imp lantable device he received a "pacemaker plus" and called attention not only to the number of Americans w ho have a need for this advanced treatment, but also to the importance of awareness of a potentially fatal form of irregu lar h eartbeat called ventricular tachycardia.

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The team of physicians who treated Che ney are electrop hysiologists, physicians w ho study and treat the electrical activity of the heart. "The electrical pulses in the heart control heart rhythm and w hen there is a

6 • WINTER 2002

Implantable defibrillators serve a dual p urpose-to cor rect p otentially life threatening rapid arrhytlunia, as Ch en ey had, and to p revent the heart from beating too slowly.

"The so-called pacemake r plus is an implantable cardioverter defibrillator (JCD), w hich is a pacemake r equipped with a device that can shock a heart beating too fast in to "Tbe electrical pulses its nonnal rhythm," said Nasir. "In the heart control beart rbythm, addition to patie nts w ho have suffe red from cardiac arrest, these and when there is a devices are now approved for use disruption of that rbytl:nn, in patients, who after evaluation, tbat's wben we go to work." are judged to be at high risk for cardiac arrest." disruption of that rhythm, that's w hen we go to work," said Nadim Nasir,Jr., M.D., a cardiac electrop hysiologist at The Me thodist Hospital and Baylor College of Medicine.

Pacemakers are battery-powered devices usually given to people whose hearts beat too slowly at times.

As many as 5 million Americans may suffer from congestive heart failure, a weakening of the heart muscle that affects the heart 's ability to pump blood . About a third of these also have an arrhythmia that affec ts the lower d1ambers of the heart and could become fatal . Patients w ith congestive

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heart failure are particularly prone to sudden death from dangerous arrhythmias, which cim occur unpredictably and can kill a patient with congestive heart failure . An ICD may prove lifesaving to some of these p atients.

Nasir predicts that a combination of drug therapy and preventive use of the ICD will give these patients the best chance to continue active and productive lives.

2001 , Nasir has used CRT in six

patients. "I've seen really dramatic results in patients with this therapy."

The therapy is available only to a limited number of patients with selected forms of heart failure, Nasir added. And currently the present technology makes the surgical implantation very time consuming.

"We are back at the point where technology is again serving medicine by providing smaller, more efficient devices;' he said. "It's the cardiac electrophysiologist's job to learn how to use iliese more efficiently and find ways to apply these therapies to more wd more patients who will benefit from them." •

Another exciting new front in the field of electrophysiology is cardiac resynchronization technology (CRl).

This is a treatment that uses an implantable device to improve the pumping efficiency of the heart. hl healthy people, the four d1ambers of the heart contract in a coordinated fashion to move blood through the body. In patients with heart failure, however, the electrical impulses that coordinate the contractions of the heart's chan1bers may be impaired , further reducing the efficiency of the already weakened muscle.

"When this happens, in about half of these people, the two ventricles (lower d1ambers) don't contrnct at the same time. Then you have worsened symptoms, like shortness of breath, fatigue and swelling around the feet and ankles," said Nasir.

Cardiac resynchronization involves a specialized pacemaker that is implanted under the skin in the upper chest.

Three wires connect the various parts of the heart to a computer in the pacemaker tO restore appropriate tin1ing or resynchronize the contractions of the ventricles by sending tiny electrical impulses to the heart muscle.

Re&-ynchronizing the contractions of the ventricles can help the heart pump blood more efficiently ,ll1d reduce heart failure symptoms wd improve patients' quality of life.

"This therapy has been approved for use just recently," said Nasir. "And we\re found it to be very effective." Since late

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"I believe as we continue to apply the therapy, the ease of implantation will increase. Additional research may help expand the use of this tllerapy to more patients who can benefit from this device," Nasir said. "This is a technology tllat can potentially help several h Lmdred thousand people a year."

Most of these new devices also offer ease in communicating medical information about a patient's condition to physicians. High-ted 1 pacemakers and !CDs can record information about the patient's heart and send it via cell phone or standard phone lines to a doctor's office.

Other forms of arrhythmia mwagement include catheter-based tedmiques, where a physician p laces a catheter in the heart to diagnose ,md treat various arrhythmias. Nasir says many of these therapies used alone or in combinations, can improve the quality of liJe for thousands of people.

Pictured above. tbis pacemaker (lo/tJ 1.vetgbs sli,gbtly over one ounce and is on{v a.fi'actton larger than most cwrent Reneraiton pacemakers. The current wmeration qf downsized dqjthrillators ( rigbt) weigbs approximatel:y 21/2 ounces.

Early dejlbrillato1s we1·e larger tban an average size man's band.

WINTER 2002 •

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and tend to naturally collapse soon after balloon angioplasty. The stent keeps the artery open, allowing the blood flow to return to the heart. But in many people, within six months following the stenting, too much tissue grows inside the ster1t, inhibiting the blood flow.

Albert Raizner, M.D. , medical director of the Methodist DeBakey Heart Center, was one of the first cardio logists in the United States to implant a stent during angioplasty. His pioneering clinical trials were significant in the development and use of stems in the early 1990s. He is now involved in multiple clinical trials studying d rug-coated stents as well as radiation therapy.

"These trials are significant because if stents remain open for more than a year, the patient has an excellent chance of never needing another treatment in the diseased area," Raizner said. "We are continuing to improve the treatment of coronary artery disease through these advancements."

As researchers continue to look for new and more effective ways to slow down the tissue growth that plugs arteties following angioplasty, Raizner and his colleagues are focusing on two of the most promising methods, radiation and drug-coated stents, which seem to be the future of coronary angioplasty.

Radiation therapy has been studied since 1995, with many methods investigated around the country. Some centers are investigating radiation therapy w ith gamma radiation, which

broadly shoots high doses of radiation into the arteries to slow down tissue growth. Unfortunately, this method exposes healthy tissue as well as the diseased area to radiation, making it a less attractive treatment option.

Raizner and his fellow researchers were involved in several recent clinical trials involving the use of beta radiation therapy. For patients whose arteries had re-narrowed, this radiation is delivered through a wire into their arteries. In his latest trial, the restenosis rate was 16 percent, a big advancement in this field. Beta radiation is safer and doesn 't expose unaffected tissue to radiation, Raiz.ner said.

At this time , Methodist researd1ers have determined that a radiation system, which uses a wire centered in the artery to deliver the radiation, is most effective. With the support of Raizner's researd1, this method was recently FDA approved.

Clinical trials are also under way for drug-coated scents. There are two types of coated stents, one coated with an antibiotic and o ne covered with an anti-cancer drug.

One trial, which completed enrollment in August 2001, is the Sitius trial which uses stents coated with the antibiotic Rapamycin. This trial has a five year follow-up so results w ill not be apparent for awhile. However, the pilot study, involving 50 patients, showed an amazing Opercent restenosis, Raizner said. While these results are encouraging, the pilot group is too small to be significant, he said.

WINTER 2002 a 9

A trial involving the anti-cancer drug Paclitaxel began enrolling 1,700 patients in January, making it the largest of its kind in the country. There is no data yet on that trial except for a pilot study in the United States, also involving approximately 50 patients. The restenosis rate for that study was also O percent.

"As far as advancements go, this could be the most promising yet," Raizner said.

"This could end restenosis."

Drug-coated stents are coated with medication and a polymer. Slowly the dmg is released into the artery, and researchers believe it will keep the tissue from building up. The amount of drug released from the stent is a much smaller dose delivered than medication intravenously or orally, which has been researched in the past.

The reason it is effective is because it releases from the stent directly into the tissue, rather than traveling through the body to get to the affected site.TI1ere are still a lot of questions about the safety and effectiveness of these drug-coated stents and that is why clinical trials are necessary, Raizner said.

In the next few months, there will be 50-100 centers nationwide studying coated stents. The focus on stent

__ ..,_ .. -

•

• .,.. - - - - -

research is all about reducing restenosis.

TI1e bottom line, Raizner said, is if a person continues to need repeat angioplasties, it will eventually lead to heart surgery.

Other advancements on the horizon include devices that will keep debris from flowing down heart vessels and causing heart attack. This procedure is being tested on patients who have had bypass and vein grafts. Raizner is involved in trials for a stent lined with p lastic and a device attached to the catheter which works like a filter, trapping debris in the bloodstream.

"The advancements have come quickly in our field and it is not an understatement to say tJiat we will someday soon solve the problem of restenosis for most patients who undergo the lifesaving procedure," Raizner said.

Another area of research with promising results for improving clinical outcomes for angioplasty is the combination of drug therapy with stenting. Neal S. Kleiman, M.D., Methodist DeBakey Heart Center cardiologist and director of the Applied Platelet Physiology Laboratory at Methodist and Baylor College of

Medicine, is leadi ng clinical trials studying the use of a variety of blood thinners for angioplasty patients and those with chest pain.

His research lies in the relationship between angioplasty, stenting and dotting.

This laboratory, recognized nationally as a select site for platelet research, examines the effects of antiplatelet therapy, the use of medications to prevent platelets from clumping together and blood from clotting, in patients with coronary artery disease who undergo angioplasty procedures.

Kleiman has been the principal investigator and/or collaborating investigator in a multitude of pivotal studies and multi-center trials related to arterial thrombosis, the formation of blood clots in the artery, and clotting and angioplasty, d1at have altered the management of patients with chest pain m1dergoing catheterization.

Studies have shown that anti.platelet t11erapy with heparin and aspirin significantly reduces the incidence of death, heart attack or need for another urgent procedure in patients undergoing angioplasty procedures as well as those with chest pain.

- - ~ ~ ........... 4 9 , ~

How angioplasty works: A tiny balloon is attached to a catheter and threaded, usually through the groin area, through an artery to the site of blockage near the heart. Once at the blockage, the balloon is inflated to clear the clog. Often, tiny stents are deployed after a second balloon is inflated to hold the artery open and prevent re-blockage. •

Who needs angioplasty?

Angioplasty is necessary when an artery or arteries are blocked, restricting blood flow to the heart. Angioplasty is performed when it is determined that the procedure can effectively open up the clogged artery, preventing the need for open heart surgery. Bypass surgery is necessary when multiple arteries are blocked or previous catheterizations have proven unsuccessful. •

10 •

WINTER 2002

WWW.M.ETHODIST HEALTH.COM

NEAL S.

KLliIMAN,

M.D.

1- Blocked artery 2- Balloon in wte,y witb balloon deflated

During angioplasty, patients are given blood thinners to prevent the likelihood of clotting during and after the procedure which may result in the re-occurrence of chest pain and other complications.

But with blood thinners, there is always a chance of bleeding, so Kleiman's research centers around finding alternative medications that are effective and safe. Currently he is studying two drugs, Angioma.."'r andArgatroban.

Also, Kleiman is presently conducting clinical trials studying a new gene therapy method to treat patients with coronary artery clisease who have chest

WWWMETHODISTHEALTH.COM

4-Stent in place

pain and cannot be treated with angioplasty or coronary artery bypass surgery.

It is hopeful that this new therapy will stinmlate new blood vessel growth in tl1e heart to improve blood flow and reduce cl1est pain in patients with limited options for other types of treatment.

"We are looking at numerous ways to treat coronary heart disease, the leading killer of An1ericans," Klein1an said.

"Research has led to numerous advancements in this area and continued research like we do at Methodist and Baylor is critical if we are to successfully win the fight against this disease." •

\VINTER 2002

a

11

h e busy street feeds the Texas Medical Center with its lifeblood-patients coming to hospitals in their cars. People have used this pipeline for decades to come to the place where they hope to discover exactly what is ailing them.

But now the street is choked with traffic jams as workers painstakingly lay the tracks that will become Houston's first commuter rail line. High above the tangle of cru·s and iron rails are two p hysicians at The Methodist Hospital w ho, like that rail line, represent the future.

Joseph Caselli, M.D., who offices in Methodist's Fondren/ Brown Building, is the world's most successful surgeon at repairing a condition called thoracoabdominal aortic aneurysms. In fact, in 2000 he became the acknowledged leader in this type of aneurysm repair, having successfully performed more of these procedures than anyone else in the world during his 14-year career at Methodist.

Across the street, there is a new doctor in town- Alan Lumsden, M.D., also a surgeon, who is internationally known as a leader in performing minimally invasive aortic aneurysm repair using catheters and scanning devices.

Under the umbrella of the Methodist DeBakey Heart Center, these two veterans are combining their considerable skills and knowledge to offer patients the best chance to 12 •

WINTER 2002

WWW.METHODISTHEALTH.COM

survive an aor tic aneurysm. Together, they are the face of the futur e to stop a killer.

BOULEVARD FOR BLOOD

1he aorta is the main boulevard for the body's blood supply.

This large pipe, about the diameter of a garden hose w hen healthy, delivers ox')'genated blood from the heart to the rest of the body. Arteries branch off from the aorta like side streets going to the brain, lungs, kidneys and legs.

High cholesterol and high blood pressure can cause the walls of the aorta to weaken and balloon out-think of a cartoon with a character standing on a garden hose. This bulging section of the aorta gets bigger and bigger until it rips and springs a leak or ruptures.

Because it typically happens in the abdomen, this condition is call.ed an abdominal aortic aneurysm- doctors call it a "triple A." When you rupnire an aneurysm , your chances of dying are extremely high.

Coselli, chief of cardiothoracic surgery at Methodist and Baylor College of Medicine, treats the aorta from stem to stern. Because of constantly improving imaging te chniques (X-ray, CT scans), abdominal aortic aneurysms are m ore often being discovered in their early stages.

Thro ugh an incision in die abdomen, the surgeon op ens the aorta and removes fatty buildup blocking the enlarged artery. He then sews a flexible nibe (graft) into place to support the weakened artery. Surgery to repair a triple A is risky, but Coselli performs more than 400 of diese operations a year. He has participated in more than 6,000 of these p rocedures- around half of them trip le A's- in bis career, m ore than :myone else. His success rate is very good.

"Methodist had a lo t to do with the development of vascular surgery. Dr. Stanley Crawford was a pioneer in p erforming complex aortic operations in large numbers.

I had an opp ortunity to work as Crawford's protege for seven years , mid so I've p icked up d1e mantle," said Coselli.

In the early days of the surgery, the mortality rate (percentage of people w ho died) was 80 percent. Due largely to Crawford's work, the mortality rate went down to 20 percent.Today, with Coselli's steady hand leading the way, the mortality rate is 5 percent.

unfolds itself inside the aneurysm and supports the weakened vessel walls.

This procedure requires patients to stay in the hospital for two days o r so, some have been released 24 hours after receiving this p rocedure. Open surgery requires patients to be hospitalized for a week and to recuperate for up to six weeks.

This system-the first new alternative for treating triple A in 40 years-has been proven to cut major complications by 50 percent. "This (surgery) is the future;' said Lumsden, who helped perfect the procedure for the last six years as chief of vascular surgery at the Emory University School of Medicine in Atlanta. "One of the main reasons I came here is because of th e work that Joe Coselli is doing. As we interface o ur expertise, the potential is huge. Between the two of us, we can offer patients everything."

For many p atients , surgery w ill always be the way to repair an aortic aneurysm. Lumsden said that not every case can be done using the endovascular technique. Women, for example, have very small arteries that a stent w ill not fit into.

"For aortic aneurysms that occur below the re nal arteries (which supply the kidneys) we can put in ru1 endovascular scent, but ,meurysms that go higher or involve the renal arteries, that's what Joe Coselli does," he explained. "He takes on the most difficult cases."

Coselli agrees that endovascular scenting is the wave of the funtre . "Unlike some things that come and go, I think that endovascular stenting is here to stay," he said. "In o ur work, radiologists take brru1ch arteries of the aorta and open them up with a balloon catheter. I do that during open surgery.''

CoseUi anticipates an increased emphasis o n combined procedures where part of the operation is open , d1e od1er part is done using an e ndovascular approach. "Then you have a lesser overall procedure and a reduced impact on the patient by combining the two phases at the same time," he added.

"As we

interface our expertise, the potential is huge.

Between the two of us, we can offer patients everything."

FROM THE L'\JSIDE Alan Lumsden, M.D. , also implants grafts to repair aortic aneurysms, but he does it a different way. He is an expert in p erfonning minimally invasive repair of aneurysms using endovascular (inside the blood vessels) methods.

In this p rocedure, two small incisions are made in the groin and the surgeon snakes a delivery catheter g uided by X-ray imaging to the ane urysm. From this catheter, the graft WWWMETHOOTSTHEALTH.COM

A NEW ROLE Wid1 the combined knowledge of Coselli, Lumsden and others on the Methodist DeBakey Heart Center team, the emphasis will now be on ways to perfect the endovascular stenting procedure and figure out new ways to make the procedure fit more people.

"Coselli is already doing things that marry the two methods of aneurysm repair," said Lumsden. "The surgeon is really the only one w ho can do that type of thing."

"The role of endografting will be far greater thru1 probably what we anticipate today;' predicts Coselli. "As the population ages and the numbers of people with these problems increase, we hope to offer m ore of diem less invasive methods of treatment." •

WLNTER 2002

a 13

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