CD&D National Editor

Researchers at the University of Pennsylvania School of Medicine (Philadelphia) have concluded that the cost of implantable cardioverter defibrillators (ICDs) for prevention of sudden cardiac arrest (SCA) and death in elderly patients, though considerable, nonetheless provides "real value" to the U.S. healthcare system.

Lead researcher Peter Groeneveld, MD, said that aside from the initial substantial costs of implantation of the devices, the healthcare costs associated with ICD recipients after six months were "almost identical" to non-recipients of similar demographics.

Sudden cardiac arrest is a leading cause of death in the U.S., ending the life of about 350,000 Americans each year. And ICDs have been shown to be effective in preventing death from cardiac arrest.

In 2005, Medicare and other payers expanded coverage of the devices for primary prevention purposes - that is, for patients with heart disease at greater risk of sudden death, but who have not yet experienced heart stoppage.

The Pennsylvania researchers examined healthcare data from a nationally representative sample of 14,250 Medicare beneficiaries over age 66 who were treated for congestive heart failure at more than 2,000 academic and community hospitals nationwide.

The study was among the first to analyze the health outcomes and costs associated with primary prevention ICDs for patients outside of a clinical trial setting.

The research was supported by an unrestricted grant from the Institute for Health Technology Studies (InHealth; Washington), a non-profit organization that supports research and analysis of the economic, social and health effects of patient access to medical technology innovation.

Groeneveld, assistant professor of general internal medicine at Penn, and his co-authors reported their findings in the April issue of Heart Rhythm, the journal of the Heart Rhythm Society (Washington).

They found that, on average, patients receiving ICDs for primary prevention had a 38% lower mortality rate than patients who did not. Some 13% of patients who received ICDs died in the first year after implantation, compared with 23% of patients who did not receive ICDs.

During the second year, the gap widened further, as 17% of ICD recipients died, compared with 29% who did not receive such a device.

The study indicated that the average cost for ICD recipients in the first 30 days after initial hospitalization was about $42,000 more than for patients who received other treatments for CHF, which is comparable to cost estimates from previous clinical studies.

Excluding the costs of implantation, after six months the total healthcare costs for ICD recipients were roughly $1,700 higher than for patients who did not receive an ICD. But after six months, the costs associated with both patient groups were almost identical.

In a podcast discussion with Martyn Howgill, MD, executive director of InHealth, Groeneveld said that the study subject were carefully selected to reflect similar demographics between ICD recipient and non-recipient groups, and represented Medicare patients in all 50 states and the District of Columbia.

Saying the study population was followed to see what happened to them clinically and in terms of cost utilization, Groeneveld noted that ICDs offered "a definite survival benefit," and that once the roughly $42,000 in implantation costs were accounted for, the ICD group's healthcare costs averaged about $1,700 higher in the first six months after implantation, then were essentially comparable with costs in the non-implant group thereafter.

He said the clinical benefits provided were "exceptional," adding the observation that ICDs are "a good deal for healthcare in this country," providing "real value at this cost."

Groeneveld told Howgill that, "even through these devices have been approved [by the Centers for Medicare & Medicaid Services] for primary prevention use for over three years, much less than 50% of the eligible Medicare population has received them.

"This study confirms, through real-world experience among thousands of patients, what clinical trials among hundreds of patients found, which is that ICDs enable patients to live longer, at a reasonable cost to society."

Groeneveld said that expanding the use of ICDs to a larger number of recipients offers "a tremendous opportunity to provide substantial benefits, and ... in a manner which is economically acceptable."

Groeneveld said expansion of the implantation of ICDs in eligible patients would be "a good investment for [this] country in terms of healthcare."

He said the findings "show that the overall economic value delivered by the ICD is acceptable by U.S. standards for healthcare expenditures, further substantiating Medicare's decision to expand coverage of ICDs for primary prevention patients. This is particularly relevant to policymakers, healthcare providers and payers who face difficult decisions about the use of innovative medical technology in the face of rising healthcare costs."

In addition to the InHealth grant, Groeneveld was supported by a Research Career Development Award from the Health Services Research and Development Service of the Department of Veterans Affairs.

Donor stem cells explored in post-heart attack therapy

Physician scientists at the Texas Heart Institute (THI) at St. Luke's Episcopal Hospital (Houston) in late April reported the initial results of what they say is the world's first clinical trial to treat heart attack patients with a type of stem cell that promotes better healing while also acting to stave off CHF which many patients develop following a heart attack.

The stem cells used in this study are known as mesenchymal precursor stem cells. And they are allogeneic, meaning that they have been taken from the bone marrow of a healthy donor and grown in cultures to provide a plentiful supply. This is considered the first use of the allogenic "off the shelf" cells for this application. These cells are injected directly into the heart with a special catheter, called a noga catheter, and appear not to provoke rejection by the recipient or cause inflammation, according to the researchers.

The study is sponsored by Angioblast Systems (New York), provider of the cells, and the U.S. sister company of Mesoblast (Melbourne, Australia.)

James Willerson, MD, president-elect and medical director at THI, told Cardiovascular Devices & Drugs that what makes these particular stem cells different is that they are not rejected when taken from a donor and injected into another person.

"If I gave you my stem cells, your body would probably reject them — that's why we try to use the patient's own stem cells. But in this case there is evidence to suggest that these [allogenic] cells are not rejected among different individuals. So we could take the cells from an olympian, or someone in great health, and inject them directly into the patient's injured heart, and they wouldn't reject them."

Willerson explained that the procedure involves insertion of the noga catheter "via an arterial route —when it touches the inner wall of the heart, it measures electrical potential, and provides an assessment of the wall motion in that particular region of the heart. We can identify sites of the heart that are reversibly injured, as opposed to scar or normal regions. The stem cells are injected directly into those regions."

The first patient to receive the treatment was a 65-year-old male. He had had a heart attack treated with angioplasty to open the obstructed vessel, with placement of a stent. The stem cell procedure was administered in a cath lab 10 days after the heart attack, and he was discharged from the hospital two days after receiving this experimental treatment.

"Our pre-clinical trials have established that 10 days after the heart attack is the optimal time to give this treatment," said Emerson Perin, MD, PhD, director of THI's stem cell center and director of clinical research for cardiovascular medicine at THI.

"The heart is still inflamed in the days just after a heart attack," he noted. "If we wait too late, the heart will have too much scar tissue, and its ability to pump will already be compromised." Willerson made the point that every person is a product of two cells which develop into billions of stem cells that have the innate ability to form our bodies.

"All of us have stem cells in our bodies, just not in sufficient numbers to perform the healing we need. I believe we were meant to learn of the powerful potential of stem cells and build on it. In the coming years, this could be an accepted stem cell therapy at hospitals. Ultimately, stem cell research could give us the ability to regenerate whole hearts," Willerson said.

Perin and Willerson said that they and their team have developed a network of several hospitals to identify patients who may fit the criteria to be enrolled in this trial. "With this study, we hope to find a way to help patients before they get so sick," said Perin.

Angioblast received FDA approval to launch the stem cell trial in May 2007. The trial is using catheters provided by Angioblast's partners, Cordis (Miami Lakes, Florida) and Biosense Webster (Diamond Bar, California).

Mesoblast and Angioblast also are conducting a pilot clinical trial in Australia using autologous cells as therapy for coronary artery disease, and Mesoblast has reported successful long-term results in its osteoarthritis preclinical trials, presenting its data last month in Singapore at BioMedical Asia 2008.

Darapladib seen boosting power of cholesterol lowering drugs

Despite widespread use of cholesterol-lowering drugs, a significant number of cardiac patients continue to suffer heart attacks and stroke despite the general use of cholesterol-lowering drugs. And it has been theorized that high levels of an enzyme found in coronary plaques may be to blame, by making plaques more likely to rupture and block blood flow.

Research out of the University of Pennsylvania School of Medicine (Philadelophia)and other sites internationally indicates that the drug darapladib may offer a way of combatting that problem. The investigators found that the drug may be a useful adjunct to treatment with statin drugs.

These findings, published in a recent issue of the Journal of the American College of Cardiology, show that the drug safely and effectively lowers the activity of Lp-PLA2, an enzyme associated with inflammation activity and an increased risk for heart attack and stroke. And the researchers say that these trial results may pave the way for an important addition to the drugs doctors use to treat heart dissease.

Lead author, Emile Mohler, MD, irector of vascular medicine and associate professor of edicine at Penn, said, "This is an exciting new area of medical treatment for cardiovascular disease. It is hoped that this drug will stabilize artery plaque and prevent heart attack and stroke."

The drug was tested at three different dosage levels in about 1,000 patients with coronary heart disease already taking a cholesterol-lowering statin drug. Among patients taking 160 mg of darapladib each day during the 12-week study, blood tests revealed a decrease in two important circulating biomarkers, suggesting a possible reduction in systemic inflammatory burden.

While the drug doesn't necessarily act to shrink the plaques that build inside coronary arteries and choke off blood supply to the heart, Mohler said the research suggests that darapladib may reduce plaque inflammation and therefore lower rates of clot formation and heart attacks among patients with coronary heart disease.

GlaxoSmithKline (Middlesex, UK) provided funding for the study, but it said that Mohler has no personal financial ties to the company.

IOM: Geriatric onslaught poised to overwhelm U.S. healthcare

As the U.S. healthcare system braces for a flood of aging Baby Boomers, the Institute of Medicine (Washington) sounded a shrill alarm in mid-April: There simply won't be enough resources or healthcare workers to cover this geriatric boom without immediate action. The country is woefully unprepared in geriatric care skills, and the current healthcare workforce is not large enough to meet older patients' needs, according to the IOM. So, the agency has crafted a blueprint to confront the looming crisis with release of a report, Retooling for an Aging America: Building the Health Care Workforce.

"We can't wait any longer. Given the demographic shift, virtually all healthcare providers need to be prepared to manage the common medical problems of old age," Carol Raphael, president/CEO of Visiting Nurses Services (New York) and a report co-author, told CD&D. "We don't believe we'll be able to produce sufficient geriatric specialists by 2030, so it's essential that all healthcare providers be prepared to manage aging people's needs. We do need to increase the number of geriatric care specialists for those with the most complex issues and then they should train everyone else."

Raphael is a member of the 15-member Institute of Medicine Committee on the Future Health Care Workforce for Older Americans, which is charged with developing an action plan to confront the "Boomer" healthcare flood. Her reference to the year 2030 is tied to the fact that the largest-ever proportion of older adults will increase from 12% of the U.S. population in 2005 to almost 20% by 2030. But the influx begins sooner, in just three more years, when the first of 78 million Boomers," born between 1946 and 1964, begins to turn 65.

The committee also calls on Medicare, Medicaid and other health plans to pay higher rates to boost recruitment and retention of geriatric specialists and care aides. The group targets the year 2030 for the necessary reforms to take hold.

Today's adults may be healthier and live longer, but they also tend to have more complex conditions and healthcare needs than younger patients, the report notes. The average 75-year-old American has chronic conditions, such as diabetes or hypertension, using four or more prescription medications. The committee found that dementia, osteoporosis, sensory impairment and other age-related conditions present provider challenges that aren't often encountered when tending to younger patients.

The IOM's work in the area of geriatrics isn't new — this is the 30th anniversary of its first report on the workforce for geriatric patients, titled Aging and Medical Education.

The current committee is calling for a three-pronged approach to a solution:

• Enhance the competence of all individuals in the delivery of geriatric care.

• Increase the recruitment and retention of geriatric specialists and caregivers.

• Redesign models of care and broaden provider and patient roles to achieve greater flexibility.

Committee chair John Rowe, professor of health policy and management at the Mailman School of Public Health, Columbia University (New York), said, "The sheer number of older patients in the coming years will require trying new models for delivering healthcare and the commitment of greater financial resources. If our aging family members and friends are to live as robustly as they can and in the best health possible, we must have a work force of adequate size and competency to take care of them."

IOM reports a shortage of healthcare workers in all fields, but the situation is worse in geriatrics because it attracts fewer specialists than other disciplines and experiences high turnover rates among direct-care workers such as nurse aides, home health aides, and personal care aides. Today, there are about 7,100 physicians certified in geriatrics in the U.S. Turnover among nurse aides averages 71% annually, and up to 90% of home health aides leave their jobs within the first two years.

Carotid bruits found to increase risk of heart attack

A sounde that blood makes when it passes over an obstruction in the carotid artery — called a carotid bruit — People who have a carotid bruit are at a significantly greater risk of cardiovascular death and heart attack, according to an article published in The Lancet. A bruit is usually detected with a stethoscope and is an indicator of arterial blockage.

To date, carotid bruits have mostly been associated with bleeding events in the brain. However, there is a great deal of uncertainty about prognoses deriving from bruits, leading many organizations (such as the U.S. Preventive Services Taskforce and the Canadian Task Force) to stop recommending routine listening for carotid bruits.

Summarizing and evaluating the extant research related to carotid bruits, Dr. Christopher Pickett of Walter Reed Army Medical Center (Washington) and colleagues conducted a meta-analysis. They analyzed 22 studies with a total of 17,295 patients who were followed up for about four years, on average. The researchers found that the presence of a carotid bruit was associated with a doubling in the risk of suffering a heart attack compared to those without a bruit. Additionally, patients with a carotid bruit were 2.5 times as likely to die because of a cardiovascular-related event.

Four of the studies in the meta-analysis directly compared patients with and without bruits; in these analyses, similar findings held: those with bruits were more two times as likely to have a heart attack or die from cardiovascular causes.

"Our study has shown that the presence of a carotid bruit significantly increased the likelihood of cardiovascular death or heart attack.... Auscultation for carotid bruits in patients at high risk for heart disease could help select those that might benefit the most from an aggressive cardiovascular risk modification strategy," conclude the authors.

An accompanying "Comment," by Drs. Victor Aboyans and Philippe Lacroix of Dupuytren University Hospital (Limoges, France), includes a discussion of the efficacy of using the presence of carotid bruit for prognostic reasons in the offices of general practitioners and in poorer countries other methods of diagnosis are unavailable.

However, they caution that some patients will not express carotid bruit, but may have other clinical signs of cardiovascular disease. "Prospective studies on asymptomatic patients are needed to study the prognostic value of a combination of simple clinical signs such as neck and groin auscultation and pulse palpation," they conclude.

Vascular depression more often diagnosed with more 'Boomers'

Baby Boomers and those older than that group are being more frequently diagnosed as having a type of depression related to the cardiovascular system — in particular the blood vessels — known as vascular depresison, a condition that fails to respond to drug therapy.

New treatments for this problem, currently under development, were presented in early May at a U.S. National Institute of Mental Health symposium at the annual meeting of the American Psychiatric Association (Arlington, Virginia). Presenters said that vascular depression is a recently recognized type of depression that generally develops in patients older than age 60. The condition is associated with loss of blood supply to the brain.

"Mental health practitioners and patients should be aware of the relationship between vascular problems and depression, and should understand the value of preventing vascular changes that might lead to difficult-to-treat depressions, for example, through early recognition and treatment of high blood pressure," said Dr. John Newcomer, of Washington University (St. Louis), in a statement.

George Alexopoulos, MD, of Weill Cornell Medical College (White Plains, New York), and colleagues are investigating the specific brain abnormalities associated with blood vessel problems. Using a new MRI technique called diffusion tensor imaging, the researchers found that, in late life depression, higher blood pressure readings are linked to tiny white matter abnormalities, mainly in the brain's frontal lobes and in subcortical areas. Some of these abnormalities are associated with impairment in specific frontal lobe functions.

The same team also found that patients with major depression treated with the antidepressant citalopram were less likely to recover if they had cardiovascular disease or did poorly on a test of cognition requiring frontal lobe function.

They also found that patients with major depression who took the antidepressant escitalopram -- which is more potent than citalopram -- were less likely to recover if they had more of the tiny structural abnormalities in several areas of the frontal lobes and in subcortical structures.

"With further refinement, the findings may improve physicians' ability to predict who will fail to respond to antidepressants. Such patients may need close follow-up and different treatments such as psychotherapy or novel medications. Second, our findings can be used in the development of new treatments for those who do not respond to classical antidepressants," Alexopoulos said in a statement.

His team currently is studying how parts of the frontal lobes are activated when depressed patients perform cognitive tasks that activate this area.

Preliminary findings show that depressed older patients cannot activate these frontal lobe parts as efficiently as non-depressed older adults," Alexopoulos said.

In other research, a team at the University of Iowa (Ames) found that vascular depression can be treated with an experimental technique called repetitive transcranial magnetic stimulation (rTMS). They found that rTMS led to better remission rates than standard medication treatment and that increasing the number of magnetic pulses significantly improved remission rates.

"These findings suggest that this new method of treatment may be particularly useful for these late life onset depressions and that even greater response rates might be achieved by utilizing more pulses of magnetic stimulation," Dr. Robert Robinson, professor of psychiatry, said in a statement.

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