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April 20, 2004

JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

THIS WEEK'S CONTENT

JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, April 20, 2004)


JAMA NEW RELEASES

>   'OFF-PUMP' CORONARY BYPASS SURGERY HAS SIMILAR OUTCOMES, LOWER COST, THAN CONVENTIONAL BYPASS SURGERY

>   DONOR LIVERS NOT CONSISTENTLY ALLOCATED ACCORDING TO MEDICAL NEED

>   IMPROVEMENTS IN PRESCRIBING MEDICATIONS FOR ELDERLY PATIENTS WITH HIGH BLOOD PRESSURE COULD RESULT IN BETTER OUTCOMES AND COST SAVINGS


INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA video news release is on "off-pump" coronary artery bypass surgeries. The release will be fed Tuesday, April 20, from 9:00 - 9:30 a.m. ET on Telstar 6, Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Telstar 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).

Please Note: Our e-mail has changed to mediarelations{at}jama-archives.org

JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ONLINE

Go to www.jamamedia.org for more information and to apply for access.

Please Note: The FOR THE MEDIA Web site now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org

EMBARGOED FOR RELEASE: 3 P.M. CT, TUESDAY, April 20, 2004
Media Advisory: To contact John D. Puskas, M.D., M.Sc., call Cindy Sanders at 404-686-8538. To contact editorialist Eric D. Peterson, M.D., M.P.H., call Richard Merritt at 919-660-1309.

'OFF-PUMP' CORONARY BYPASS SURGERY HAS SIMILAR OUTCOMES, LOWER COST, THAN CONVENTIONAL BYPASS SURGERY

CHICAGO—Coronary artery surgery performed "off-pump", i.e., keeping the heart beating and not using the cardiopulmonary bypass machine, has similar outcomes after one year, and costs less, when compared to conventional coronary artery bypass grafting (CABG) using cardiopulmonary bypass, according to a study in the April 21 issue of the Journal of the American Medical Association (JAMA).

To try to avoid some of the complications attributable to cardiopulmonary bypass, U.S. surgeons performed approximately 21 percent of coronary artery bypass operations off-pump in 2002, according to background information in the article. In off-pump operations, the heart is kept beating, and with the help of a device, the beating heart is stabilized while the surgeon places the bypass grafts around the blocked arteries. During a conventional CABG surgery, a heart-lung machine allows the heart to stop and pumps blood throughout the body, and keeps the body stabilized. Concerns remains about the technical difficulty of off-pump coronary artery bypass (OPCAB), including the possibility of imprecise grafting and incomplete revascularization compromising patient outcomes, and long-term graft patency (keeping the graft open).

John D. Puskas, M.D., M.Sc., of the Emory University School of Medicine and Emory Center for Outcomes Research, Atlanta, and colleagues conducted the Surgical Management of Arterial Revascularization Therapies (SMART) trial, designed to compare graft patency, clinical outcomes, health-related quality of life, and costs in unselected patients referred for elective, isolated CABG surgery and randomized to OPCAB or CABG with cardiopulmonary bypass. The study included 197 patients who had follow-up at 30 days; 185 of those had follow-up at 1 year. The study was conducted between March 10, 2000, and August 20, 2001, at a U.S. academic center.

The researchers found that graft patency was similar for OPCAB and conventional CABG with cardiopulmonary bypass at 30 days and at 1 year. Rates of death, stroke, heart attack, angina, and reintervention were similar at 30 days and 1 year. "There were no significant differences in health-related quality of life. Mean total hospitalization cost per patient at hospital discharge was $2,272 less for OPCAB and $1,955 less at 1 year," the authors write.

"These results from the SMART trial demonstrate that OPCAB may provide complete revascularization that is durable and cost-effective relative to CABG with cardiopulmonary bypass when performed on unselected patients undergoing elective, isolated CABG," the researchers conclude.
(
JAMA. 2004;291:1841-1849. Available post-embargo at jama.com)

Editor's Note: The research for this article was supported by grants from Medtronic Inc., and the Carlyle Fraser Heart Center Foundation (Atlanta). Dr. Puskas is a consultant for Medtronic Inc. (Minneapolis).

EDITORIAL: OFF-PUMP BYPASS SURGERY

In an accompanying editorial, Eric D. Peterson, M.D., M.P.H., and Daniel B. Mark, M.D., M.P.H., of the Duke Clinical Research Institute and the Department of Medicine, Duke University Medical Center, Durham, N.C., write that early randomized comparisons such as the SMART trial demonstrate the proof of concept for OPCAB.

"In the right hands and for the right patients, OPCAB offers safe, complete, and durable revascularization that may reduce complications relative to conventional CABG with cardiopulmonary bypass. The question of whether OPCAB should become the new standard for coronary bypass surgery rests on the generalizability of these findings. A large, multicenter randomized trial of CABG with cardiopulmonary bypass compared with OPCAB surgery would address many important questions.

"First, and most important, it could clarify whether the SMART trial findings may be extrapolated to the larger community of experienced cardiac surgeons in practice. Second, a larger multicenter trial could be powered to address any potential difference of these procedures on important patient outcomes, something these smaller, single-center studies were not able to do. Finally, such a study could compare results in important patient subgroups. Specifically, the observational literature suggests that the benefits of OPCAB may be greater in those with higher surgical risks (including elderly patients, those with renal impairment, and patients with significant carotid disease). However, existing trials have generally underenrolled these higher-risk subgroups," the editorialists write.
(JAMA. 2004;291:1897-1899. Available post-embargo at jama.com)

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org (please note new email address).

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EMBARGOED FOR RELEASE: 3 P.M. CT, TUESDAY, April 20, 2004
Media Advisory: To contact James F. Trotter, M.D., call Dana Berry at 303-315-5571.

DONOR LIVERS NOT CONSISTENTLY ALLOCATED ACCORDING TO MEDICAL NEED

CHICAGO—A new study suggests that donor livers are not always distributed according to a patient's need, but may be retained by some organ procurement organizations with smaller waiting lists and transplanted into less sick patients, according to a study in the April 21 issue of the Journal of the American Medical Association (JAMA).

According to background information in the article, the Model for Endstage Liver Disease (MELD) score was implemented in February 2002 to serve as the basis for the liver allocation system used by the United Network for Organ Sharing. The MELD score is an objective scoring system of medical characteristics predictive of prognosis, with minimal emphasis on waiting time as a priority for transplantation. However, recommendations to increase and standardize the size of the area of organ allocation has not been implemented. Consequently, there is great disparity in the patient populations served by organ procurement organizations (OPOs) across the country. In some regions of the United States, an OPO may serve as few as 1.2 million people, whereas in other areas, the population covered by the OPO is nearly 18 million. The smallest OPO has fewer than 10 patients listed for liver transplantation, whereas the largest has more than 2000.

James F. Trotter, M.D., and Michael J. Osgood, B.S., of the University of Colorado Health Sciences Center, Denver, conducted a study to determine whether there is a difference in MELD scores for liver transplant recipients receiving transplants in small vs. large OPOs. The researchers reviewed data from the U.S. Scientific Registry of Transplant Recipients between February 28, 2002, and March 31, 2003. Transplant recipients (n=4,798) had end-stage liver disease and received deceased-donor (DD) livers. The authors examined MELD score distribution (range, 6-40), graft survival, and patient survival for liver transplant recipients in small (less than 100) and large (100 or greater on the waiting list) OPOs.

The researchers found that the distribution of patients' MELD scores listed for transplantation was the same in large and small OPOs; 92 percent had a MELD score of 18 or less, 7 percent had a MELD score between 19 and 24, and only 2 percent of listed patients had a MELD score higher than 24. The proportion of patients receiving transplants in small OPOs and with a MELD score higher than 24 was significantly lower than that in large OPOs (19 percent vs. 49 percent). Patient survival rates at 1 year after transplantation for small OPOs (86.4 percent) and large OPOs (86.6 percent) were not statistically different, and neither were graft survival rates in small OPOs (80.1 percent) and large OPOs (81.3 percent).

"In summary, we report that a significantly smaller proportion of adult DD liver transplant recipients in OPOs with small waiting lists receive transplants and have a MELD score higher than 24 compared with recipients in large OPOs. The most likely explanation for this disparity is that DD livers are preferentially retained for transplantation in the local OPO, where the number of patients with high MELD scores is numerically smaller than that in large OPOs. Although this disparity does not reflect the mandate of the final rule, there may be advantages for selected patients. Transplant professionals should be aware of this disparity and its implications as they continue to amend regulations for organ allocation," the authors conclude.
(
JAMA. 2004;291:1871-1874. Available post-embargo at jama.com)

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org

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EMBARGOED FOR RELEASE: 3 P.M. CT, TUESDAY, April 20, 2004
Media Advisory: To contact Michael A. Fischer, M.D., M.S., call Melanie Franco at 617-534-1600.

IMPROVEMENTS IN PRESCRIBING MEDICATIONS FOR ELDERLY PATIENTS WITH HIGH BLOOD PRESSURE COULD RESULT IN BETTER OUTCOMES AND COST SAVINGS

CHICAGO—Adherence to evidence-based prescribing guidelines for hypertension (high blood pressure) could result in substantial savings in prescription costs for elderly patients, and up to $1.2 billion nationally, according to a study in the April 21 issue of the Journal of the American Medical Association (JAMA).

"More than 60 percent of Americans aged 65 years and older have hypertension," the authors provide as background information in the article. "Estimates of the cost of its treatment have ranged from $7 billion to $15.5 billion per year." The authors also note that costs of medications for chronic conditions continue to escalate, particularly for the elderly and that the proportion of seniors without insurance coverage has increased in recent years, as well.

Michael A. Fischer, M.D., M.S., and Jerry Avorn, M.D., from Brigham and Women's Hospital, Harvard Medical School, Boston, analyzed medication use patterns in 133,624 hypertensive patients in a state drug assistance program for elderly patients in Pennsylvania during 2001. The researchers "evaluated every antihypertensive regimen in light of the clinical history of each patient and then estimated the potential cost savings to the health care delivery system that could have been realized through adherence to evidence-based recommendations."

"The patients studied filled more than 2.05 million prescriptions for antihypertensive medications in 2001, at an annual program cost of $48.5 million ($363 per patient)," the researchers found. "We identified 815,316 prescriptions (40 percent) for which an alternative regimen appeared more appropriate according to evidence-based recommendations. Such changes would have reduced the costs to payers in 2001 by $11.6 million (nearly a quarter of program spending on antihypertensive medications), as well as being more clinically appropriate overall."

The researchers found that "calcium channel blockers had the highest average cost ($33.39 per prescription) and the highest total spending ($17 million); ACE inhibitors were the second costliest class ($10.5 million). Beta-blockers were the most commonly prescribed antihypertensive drug, but average cost ($15.62) and total spending ($8 million) were lower than for ACE inhibitors or calcium channel blockers. Thiazides (diuretics) were among the least expensive medications ($5.33 per prescription) but accounted for only 4.3 percent of prescriptions."

"Adherence to evidence-based prescribing guidelines for hypertension could result in substantial savings in prescription costs for elderly patients with hypertension that would amount to savings of about $1.2 billion annually," the authors suggest. "Identification of similar areas in which prescribing can be improved will be critical for the affordability of prescription drug benefit programs," they conclude.
(
JAMA. 2004;291:1850-1856. Available post-embargo at jama.com)

Editor's Note: This work was supported in part by a grant from the National Institute on Aging.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org

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JAMA REPORTS

BEATING HEART SURGERY EVALUATED

VIDEO:
Nat sound Dr. Puskas entering Mr. Boyd's hospital room


AUDIO:
"Good morning Mr. Boyd, how are you?"

VIDEO:
B-roll: Edmond Boyd being looked at by Dr. Puskas in his hospital room


AUDIO:
72-YEAR-OLD EDMOND BOYD IS LUCKY TO BE ALIVE. HE WAS TURNED DOWN BY ANOTHER HOSPITAL FOR TRADITIONAL BYPASS SURGERY BECAUSE HIS HEALTH WAS SO POOR. THE ARTERIES TO HIS HEART WERE 95-PERCENT BLOCKED AND BOTH HIS HEART AND LUNGS WERE IN BAD SHAPE. BUT THAT WAS THEN AND THIS IS NOW.

VIDEO:
SOT/FULL
Super @ :20
Edmond Boyd
Off-pump bypass patient


AUDIO:
"I feel great, I feel like I'm 17 years old again."

VIDEO:
B-roll: Dr. Puskas in hospital room with staff


AUDIO:
DR. JOHN PUSKAS WITH THE EMORY UNIVERSITY SCHOOL OF MEDICINE WAS ABLE TO PERFORM AN OFF-PUMP CORONARY ARTERY BYPASS ON BOYD, GIVING HIM A SECOND CHANCE AT LIFE. .

VIDEO:
Nat sound of Dr. Puskas listening to Edmond Boyd's heart


AUDIO:
"Sounds good."

VIDEO:
B-roll of Dr. Puskas working in his office
GFX: JAMA cover


AUDIO:
DR. PUSKAS AND COLLEAGUES JUST COMPLETED A RANDOMIZED STUDY THAT FOLLOWED BYPASS PATIENTS FOR ONE YEAR. HALF THE 200 PATIENTS WERE GIVEN A BYPASS USING THE TRADITIONAL HEART/LUNG MACHINE. THE OTHER HALF HAD A BYPASS USING AN OFF-PUMP, OR BEATING HEART PROCEDURE. THE RESULTS OF THE STUDY ARE IN THIS WEEK'S JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
Super @ :54
John Puskas, M.D., M.Sc.
Crawford Long Hospital
Emory University School of Medicine


AUDIO:
"This is the first time it has ever been demonstrated that unselected patients irrespective of their heart problems could have an operation without the heart/lung machine and have their bypass grafts stand up the same way we expect them to stand up with the traditional operation."

VIDEO:
B-roll of Dr. Puskas with colleague looking over heart films
Shots of a new device used in off-pump procedure


AUDIO:
DURING A TRADITIONAL BYPASS THE HEART/LUNG MACHINE LITERALLY KEEPS THE BODY ALIVE. THE HEART IS ACTUALLY STOPPED AND THE MACHINE PUMPS THE BLOOD THROUGHOUT THE BODY. IN THE OFF-PUMP PROCEDURE THE HEART CONTINUES TO PUMP-- BUT WITH THE HELP OF A DEVICE IT IS KEPT AS STILL AS POSSIBLE AND OUT OF THE WAY OF THE SURGEON. THIS AND OTHER STUDIES HAVE FOUND THE PROCEDURE SAFE AND RELIABLE, BUT THIS STUDY TESTED TO SEE IF THE OFF-PUMP BYPASSES LASTED.

VIDEO:
SOT/FULL
John Puskas, M.D., M.Sc.
Crawford Long Hospital
Emory University School of Medicine


AUDIO:
"Importantly, we found that all the patients in both groups had very similar patency of the bypass grafts. That means the same proportion of bypasses were open in one group as compared to the other."

VIDEO:
B-roll Edmond Boyd with nurse


AUDIO:
PATIENTS AND HOSPITAL STAFF HAD NO IDEA WHO HAD WHAT KIND OF SURGERY. SO EVERYONE GOT THE EXACT SAME FOLLOW-UP CARE. THOSE WHO GOT THE OFF-PUMP PROCEDURE IN THIS STUDY LEFT THE HOSPITAL ON AVERAGE ONE-DAY EARLIER, SAVING 23-HUNDRED DOLLARS PER PATIENT.
THIS IS LAURA MEEHAN REPORTING.

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