An American College of Cardiology (ACC; Bethesda, Maryland) demonstration project on improving the adherence to cardiovascular clinical guidelines by health care providers did just that, demonstrating "that we can make guidelines come alive in practice," according to the project's principal investigator.

Kim Eagle, MD, of the University of Michigan (Ann Arbor, Michigan), outlined the results of the Guidelines Applied in Practice (GAP) Project during last month's ACC annual scientific sessions in Orlando, Florida. "ACC developed this initiative to close the gaps between clinical guidelines and what we do," Eagle said.

The ACC collaborated with the Southeast Michigan Quality Forum Cardiovascular Subgroup and the Michigan Peer Review Organization to create a "toolkit" of materials designed to make it easier for hospitals to put the clinical guidelines developed jointly by the ACC and the American Heart Association (AHA; Dallas, Texas) into practice.

Eagle's study group assessed the impact of the use of the toolkit materials on care given to more than 800 acute myocardial infarction patients in 10 participating southeastern Michigan hospitals. Measuring patient care before and after implementation of widespread use of the materials, Eagle said use of the pocket-sized toolkit showed "highly significant improvement" in the patients studied.

He noted, "For virtually all of the key quality indicators we were interested in, we saw either a positive trend or a significant improvement in adherence." Among the guidelines included in the GAP materials: use of beta blockers within 24 hours of arriving at the hospital, use of aspirin within 24 hours, prescribing aspirin on hospital discharge, advising that patients stop smoking and other dietary, lifestyle and medication changes. In all cases, figures of use of the various recommended ACC/AHA guidelines jumped substantially with implementation of the toolkit process.

Eagle referred to the "triangle of care" that involves the doctor, nurse and patient, and said that "this [the GAP Project} may be one of the first quality improvement initiatives where patients played a big role."

He added, "We learned that hospitals are interested in partnering with national organizations to deliver better patient care." The GAP Project showed, he said, "that if you use these tools, adherence to quality care guidelines goes up."

He said that all of those involved in the project "are very excited about the future of GAP." Systemization in the use of such clinical guidelines, Eagle said, "has a great opportunity in U.S. health care."

Eagle said that the ACC's steering committee for the GAP program hopes to expand the project, with possibilities including taking the acute MI project statewide in Michigan, as well as developing new projects based on other guidelines.Plans also call for the toolkit to be put on the ACC web site to broaden its use. "The whole idea is to share as much as we can so that others can take advantage of part or all of this program in their own hospitals," Eagle said

George Beller, MD, outgoing president of the ACC, demonstrated the commitment to the effort at the top levels of the professional society by referring to the GAP Project during the opening news conference of this year's scientific sessions and in his presidential address.

During another session on improving the quality of cardiovascular care, this one dealing with prevention of medical errors, Eagle said that the medical environment is "ripe" for errors. Citing the "explosion of knowledge in the last 10 to 20 years," and adding in a surge in numbers of both outpatient and visits, he said, "you're dealing with a perfect environment for more medical errors and an increase in serious medical errors."

He added that one of the most common causes of errors is physicians relying too heavily on their memory and not enough on systems that improve information access.

Over-50s systolic pressure is key

Which is the blood pressure number – the top one or the bottom one – that physicians and their patients need to pay more attention to? For older people, the higher, systolic blood pressure number is too frequently overlooked, according to a study published in the March issue of Hypertension: Journal of the American Heart Association, and conducted by researchers at the University of California, Irvine. The study indicates that most people age 50 and older with high blood pressure have elevated systolic blood pressure (top number), but normal diastolic blood pressure (bottom number) – a condition known as isolated systolic hypertension (ISH). These results suggest that physicians and patients need to increase emphasis on systolic blood pressure in the management of hypertension.

High blood pressure affects more than 50 million Americans and is defined in adults as blood pressure greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic. In ISH, the systolic blood pressure reading is elevated, while the diastolic reading is normal. Led by Stanley Franklin, MD, the study found that 80% of participants with hypertension age 50 and older suffered from ISH. Franklin, a professor of medicine at UC-Irvine, said that the previous focus has been on diastolic pressure control in preventing cardiovascular problems. "This [new] study," he said, "contributes to the developing body of research emphasizing the importance of controlling systolic blood pressure."

These findings came from an analysis of nearly 20,000 individuals taking part in the National Health and Nutrition Examination Survey (NHANES III) conducted by the National Institutes of Health (Bethesda, Maryland) from 1988 to 1994. Of those participants with hypertension, 74% were 50 and older. The study also revealed that 24% of the participants suffered from hypertension. Only 27% of the hypertensive study participants were treated to the recommended blood pressure goals of 140/90, and 48% of the hypertensive study participants were not being treated for the condition at all.

FDA asks for BiDil confirmatory study

NitroMed (Bedford, Massachusetts) received a letter from the FDA requesting a confirmatory study before the company's drug BiDil can be approved as a heart therapeutic for African-American heart failure patients. If finally approved, BiDil would be the first heart failure drug specifically indicated for use in African-Americans, said Michael Loberg, CEO of privately held NitroMed. BiDil is a combination drug containing isosorbide dinitrate (ISDN) and hydralazine hydrochloride. NitroMed acquired BiDil's new drug application and related intellectual property in 1999 from Jan Cohn, a professor at the University of Minnesota (St. Paul, Minnesota).

NitroMed said BiDil was an opportunity to apply the company's nitric oxide-based expertise to a late-stage product with a clearly defined medical need. The drug was evaluated based on two vasodilator heart failure trials (V-HeFT I and II), large-scale clinical studies in heart failure patients. Published analysis from V-HeFT I and II showed that BiDil provides a selective benefit to black patients with heart failure as compared to non-black patients receiving the drug. Data presented in both the BiDil NDA and recent published medical studies suggest that the racial disparities in mortality and therapeutic response rates in black heart failure patients may be due in part to ethnic differences in underlying pathophysiology.

Loberg said NitroMed will conduct a confirmatory clinical study to evaluate a composite of the quality of life, mortality and incidence of hospitalization in patients taking the drug vs. those on placebo. The trial will consist of 600 patients with Class II/IV heart failure, he said. He said he expects the confirmatory clinical study to begin during 2Q01 and to take at least a year to complete. Upon completion and approval, Loberg said he expects that NitroMed will have the capability to market BiDil for this indication on its own. Loberg said the company intends to continue studying BiDil for use in other patients.

Statistically, black patients are twice as likely as white patients to suffer from heart failure. In addition, death rates from heart failure are more than twice as high in black patients than in white patients. And the literature indicates that blacks are under-served in this sector.

NitroMed develops and commercializes nitric oxide (NO)-enhanced medicines. By controlling the delivery of NO, a well-known mediator of biological function, NitroMed has developed a technology platform known as NitRx for delivering therapeutically active NO. NitroMed's current clinical areas of focus for its NO-enhanced medicines are based in the treatment and/or prevention of sexual dysfunction, inflammation, and cardiovascular and gastrointestinal disorders.

Gene polymorph seen as MI indicator

Interleukin Genetics (Waltham, Massachusetts) said results of a study reported at last month's American College of Cardiology meeting indicated that individuals with an interleukin-1 (IL-1) gene polymorphism are up to five times more likely to have had a myocardial infarction (MI) before the age of 60, compared to individuals without the IL-1 polymorphism. The study was conducted in collaboration with investigators at the Mayo Clinic (Rochester, Minnesota) and the division of genomic medicine at the University of Sheffield (Sheffield, United Kingdom).

In the Mayo Clinic study, patients with a history of MI before the age of 60 were more than two times more likely to have one copy of the IL-1 gene polymorphism and five times more likely to have two copies of the polymorphism than patients without a history of MI. The risk due to the IL-1 gene polymorphism was independent of other standard risk factors for heart disease, including cholesterol. Approximately 8% of the Caucasian population has two copies of this IL-1 gene polymorphism. The specific IL-1 gene polymorphism that was associated with risk for MI has previously been shown by Interleukin Genetics to be involved in elevated inflammatory responses.

"This is one additional piece of evidence to support the value of our IL-1 SNPs (single nucleotide polymorphisms) in assessing risk for cardiovascular disease," said Dr. Philip Reilly, CEO of Interleukin. "We now know that this specific SNP is associated with increased inflammation and an increased risk for MI in individuals before the age of 60. Since this SNP is common in the population, we believe testing for it is valuable in helping to identify patients who should take certain medications to reduce their risk for MI." Interleukin Genetics develops predictive tests based on genetic factors that regulate control points in the inflammatory process.

Enhancements aid AED life-saving

Automatic external defibrillators (AEDs) save lives, and reduced costs and improved designs – including features making them easier to use – have improved their ability to save even more lives, according to a new study in the March 6 issue of the Journal of the American Medical Association. The researchers analyzed more than 100 journal papers detailing AED experience and found that recent advances in AED technology and design have simplified AED operation, reduced costs and improved accuracy and effectiveness in analyzing heart rhythms.

Rose Marie Robertson, MD, president of the American Heart Association (AHA), said that AEDs have reduced time to defibrillation, and she encouraged more research on public access to defibrillators, "including survival rates through hospital discharge, post-arrest quality of life and the costs of conducting such programs."

The AHA currently is funding, with the National Heart, Lung and Blood Institute (Bethesda, Maryland), a 2.5-year study to further analyze public access defibrillation programs.

Sirolimus stent coating under study

Cardiologists at the Lenox Hill Heart and Vascular Institute (New York) are investigating an immunosuppresive drug called sirolimus to determine its effectiveness as a stent coating to prevent in-stent restenosis. The study will follow more than 1,000 patients in 55 medical centers around the country. The first use of the coating in an interventional procedure was performed by Jeffrey Moses, MD, chief of interventional cardiology at the hospital, and Martin Leon, MD, CEO of the Cardiovascular Research Foundation, the institute's research arm. In the study, the stent is sprayed with a polymer that contains sirolimus, which has been shown to inhibit cell growth and is used to prevent the rejection of kidney transplants.

The drug is released slowly over a four-week period and appears to interrupt events that can lead to reblockage, primarily by preventing replication of cells rather than killing cells. Leon said that the study's preliminary data demonstrated formation of scar tissue at the site of the stent and reduction of restenosis.

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