CD&D

The American Heart Association (AHA; Dallas) recently reported that U.S. deaths from heart disease and stroke dropped about 25% from 1999 to 2005, five years ahead of goals.

"This is wonderful news for the American public," Dan Jones, MD, AHA president told Cardiovascular Devices & Drugs. "When this goal was set in 1990s, it appeared to be an extraordinarily ambitious goal. But it’s been achieved. The good news and bad news is that a lot of the benefit is on the end of treating the disease. We’re much better at treating people than keeping them alive."

But in case we start applauding too loudly, he added: "We will start to lose some the progress because we have increases in diabetes, hypertension and obesity."

In 2010, the AHA set strategic goals for reducing deaths from coronary heart disease by 25% (which has been achieved) and for stroke (which has been nearly achieved), ahead of schedule.

A variety of factors have led to the reduction in deaths, which equates to 160,000 lives saved in 2005 — the most recent year for which data is available — compared to the 1999 baseline data.

"If I were pinned down to a single overriding cause for the reduction in deaths, I’d point to research," Jones said, referring to ongoing scientific investigations that have led to improvements in both medications and in technology. The development of evidence-based practice guidelines has helped healthcare providers know what is effective both for the treatment and prevention of heart attacks and strokes.

He also credited the use of medical device technology, saying that stents "that open arteries have been an important part of the improvement we’ve seen in heart and stroke mortality, and adding: "We need to continue to work on better approaches to help people survive."

If the current mortality trends hold, AHA analysts project a 36% decline in the age-adjusted coronary heart disease death rate and a 34% decline in the age-adjusted stroke death rate when the 2008 data are released in a few years — all of this underlined by the assumption that these figures may not hold true, given the current trends in risk factors.

Again, setting aside that assumption, the size of the U.S. population in 2008 also will be larger, so it is projected that the estimated lives saved in 2008 could be about 240,000.

Some of the advances are complex and others are simple, including getting patients to the hospital more quickly for timely angioplasty or thrombolysis, the development of more primary stroke centers and the dissemination of evidence-based clinical guidelines.

Among the practice measures cited as making a difference are better control of blood pressure and cholesterol levels, both with lifestyle change and with medications, according to the AHA. In addition, the reduction in smoking has made a difference, driven by a variety of strategies: tobacco excise taxes, clean indoor air legislation and smoking cessation efforts.

But not everyone is receiving these life-saving therapies.

Coronary heart disease age-adjusted death rates for women have dropped 26.9% since 1999. But, age-adjusted stroke death rates among women are down by only 23.7%, lower than the overall age-adjusted stroke death rate reduction and the age-adjusted stoke death rate reduction for men, which is 25.8%.

The age-adjusted death rate for blacks is down 23.8% for coronary heart disease (compared to 25.6% for whites) and 20.3% for stroke (compared to 25% for whites.)

These disparities in the outcomes for women and minority populations are echoed in the statistics for those living in certain parts of the country, such as the Stroke Belt in the South, and for those with lower incomes.

While there is progress on some risk factors for heart disease and stroke, others are not being reduced enough, because not meeting the AHA 25% reduction goal. The number of people with uncontrolled hypertension has fallen by 16% since the AHA set its 2010 strategic goals; the number of people with elevated blood cholesterol is down 19.2% and tobacco use is down just 15.4%.

Despite the encouraging news, heart disease and stroke remain the No. 1 and No. 3 causes of death in the U.S.

The AHA is formulating a new set of goals for 2020, Jones said, going on to list the top three drivers for continued improvement in death rates are:

• Continued investment in research.

• Provision of successful existing therapies to more people.

• Improvement in prevention.

"We have so much opportunity in terms of prevention," Jones said. "We need to work hard on lifestyle changes."

Hypertension study to feature use of electronic PHR

Electronic personal health record (PHR) systems are being pushed as alternatives for maintaining ... well, personal health records — until the time that a comprehensive, portable electronic medical record is developed. But can people actually use them, and do they result in improving the individual’s healthcare?

The Agency for Healthcare Research and Quality (AHRQ) has funded a study looking at these issues in terms of one of the nation’s leading chronic diseases, hypertension.

The study will give hundreds of patients with hypertension an electronic PHR, enabling them to post their blood pressure, weight, even what they eat in their medical record and e-mail their physicians when needed. Patricia Sodomka, director of Patient and Family Centered Care at the Medical College of Georgia (MCG; Augusta), and senior VP for patient and family-centered care for MCG Health, is the principal investigator of the study, funded by a $1.2 million grant from AHRQ.

“From a chronic illness standpoint, the literature is pretty clear,” Sodomka said. “The more involved and engaged I am in managing my own illness, the better my outcome. It just makes common sense.”
MCG researchers will work with hypertensive patients in the family medicine and internal medicine practices at MCGHealth to see if the PHR enhances patient involvement.

Dr. Peggy Wagner, research director for the MCG Department of Family Medicine and co-investigator in the study, said, “Our first measure is patient activation; if having ready access to information about yourself and to your physician makes you more activated as a patient and if you are more activated, does it lower your blood pressure?”

The enrollers will use the IQHealth system, a PHR developed by Cerner (Kansas City, Missouri). The researchers said that they will first do two “small” studies to acquire patient and physician feedback on how to make the device more patient-friendly.
This will be followed by a year-long study of 720 patients with hypertension, in which half the participants will use the refined PHR, with the remainder will receive standard treatment.

Study participants don’t have to have a computer; study coordinators will help those who don’t find where they can use one. However, one of the many questions being asked is whether or not having a computer affects use of the electronic personal health record.

“Hypertension, which is so pervasive in our society, is a great model because lifestyle has such an impact and the outcomes are relatively easy to measure,” Wagner said. “The hypothesis clearly is, if you have this electronic personal health record that is used by a patient and his primary care doctor, that the patient will be more likely to bring his hypertension under control.”

“Patient-care documentation systems today are dominantly in the hands of the providers and written from their perspective,” Sodomka said. “The shift is toward shared information systems with patients and families, where patients and families can put their own information in there, their observations, their tracking, documenting things that are important to them.”

Giving patients more responsibility and participation in their own healthcare, she said, “is a shift that is being made in healthcare, a huge shift and this study is part of that.”

The MCG Center for Patient and Family Centered Care also has received a $30,000 grant from the Institute for Healthcare Improve-ment/Robert Wood Johnson Foundation (Cambridge, Massachusetts) in 2005 to test the Cerner system, used under the brand name My HealthLink, in patients with multiple sclerosis.

The 12-month study found that patients liked having a secure electronic link to care givers and that the PHR is an effective tool in helping battle chronic disease.

Study offers favorable data for off-label use of DES

A study published in the New England Journal of Medicine in the last half of January is shining a favorable light on the off-label use of drug-eluting stents (DES) in certain cardiovascular procedures.

The study, which analyzed 6,500 patients over a one-year period, provides evidence that doctors can safely use DES to open up complicated blockages in coronary arteries, for which the devices weren’t originally designed – and can do a much better job of it than bare-metal stents. It was conducted by the National Heart, Lung, and Blood Institute Dynamic Registry.

“It’s the largest analysis to date relating to drug-eluting stents versus bare-metal stents,” Oscar Marroquin, MD, director of the Center for Interventional Cardiology Research at the University of Pittsburgh, who headed the study, told Cardiovascular Devices & Drugs.

Marroquin’s study follows hot on the heels of several studies released within the last few months that show support for DES. Boston Scientific (Natick, Massachusetts) and Johnson & Johnson (J&J; New Brunswick, New Jersey) released favorable findings at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) meeting last fall that supported the safety of DES.

And the Society for Cardiovascular Angiography and Interventions (SCAI; Washington) issued an updated report on the Swedish Coronary Angiography and Angiolasty Registry (SCAAR), which now says that longer-term data indicates that the use of DES is safe. This contradicts an initial report from SCAAR in late 2006.

According to Marroquin’s study, re-narrowing occurred more often in off-label uses than in approved ones (13% vs. 8%), the drug-secreting stents reducing the rate by about one-third, compared with bare-metal stents, in the year after the device was inserted. It also says that patients who have received a drug-coated stent in an off-label area had about the same chance of dying or having a heart attack as patients who received a bare-metal stent in the same place.

“When we say DES is safe — we mean that we didn’t see an increase in heart attacks or deaths following up to one year of placement,” he said. “We just received funding from the National Institutes of Health to observe the patients over a longer time period than a year.”

After a series of reports that linked DES to late stent thrombosis, the reputation of what was once called a novel approach was significantly tarnished. With nearly six million of the devices implanted, the use of DES fell from 80% to 60%. Even med-tech giant J&J felt the financial impact of the negative DES reports, slashing 4,820 jobs from its pharma unit and Cordis (Miami Lakes, Florida) subsidiary.

Marroquin doesn’t deny that DES have come under a lot of fire lately. In fact, he acknowledged that the controversy was the impetus driving the research for the study.

Donald Baim, MD, chief medical and scientific officer of the company, said in a statement that the data are consistent with a series of other large registry analyses comparing DES and BMS devices over the last year, and which have reasserted the underlying safety and efficacy of drug-eluting stents. “This series includes the most recent data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), which reversed the findings from the SCAAR group’s earlier analysis suggesting higher mortality with drug-eluting stents,” Baim said.

Evidence pushes possible CMS artificial heart reimbursement

The Centers for Medicare & Medicaid Services said early this month that it might reimburse the use of artificial heart devices for Medicare beneficiaries enrolled in FDA-approved studies. The CMS proposal to reimburse for implantation of an artificial heart would reverse the agency’s 22-year policy to not cover this technology.

“Our proposal relaxes a long-standing non-coverage policy, gives access to our beneficiaries and promotes evidence development through FDA-approved studies of this advanced technology,” Kerry Weems, CMS acting administrator, said in a statement.

Because patients with severe, bi-ventricular heart failure are extremely sick and at imminent risk of death, the device can be used to enable a patient to live until a donor heart becomes available for transplant or, for a non-transplant patient, to extend his or her life.

Because the device requires a portion of the patient’s own heart to be removed, an artificial heart patient must be supported by his or her device through the end of life or until heart transplantation, CMS said, apparently the basis of the agency’s non-coverage policy to date. The policy to not reimburse for the implantation of an artificial heart was put in place in 1986. Since then, two artificial heart device manufacturers have run clinical trials studying the outcomes of using their devices in these patients.

CMS said it believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the controlled clinical environment of an FDA-approved study. Greater evidence development allows CMS to provide faster and more effective coverage with more informed clinical decision-making, it said.

“This device may be able to help patients that otherwise have no treatment options available to them,” Weems said, and the agency plans to issue a final national coverage determination in May, following a 30-day public comment period.

The coverage, if approved, would include Abiomed’s (Danvers, Massachusetts) flagship product, AbioCor, as well as the CardioWest artificial heart from SynCardia Systems (Tucson, Arizona).

Richard Smith, a co-founder of SynCardia and technical director of the artificial heart program at University Medical Center (Tucson), told CD&D that the proposed coverage was anticipated because the company has been working with CMS “for awhile now” to get coverage of the CardioWest, which received FDA approval in 2004.

Smith said the company is hoping that when the policy is approved, it will fall into the same category as ventricular assist devices, which have the highest designation of reimbursement as a bridge-to-transplant device.

The CardioWest is covered by about half of insurers, including Aetna and Blue Cross/Blue Shield, according to SynCardia. With final CMS approval, most insurers then are more likely to cover the device, the company said.

The proposed decision also is positive for Abiomed and its AbioCor artificial heart, according to Michael Minogue, president/CEO and chairman. “This decision by CMS provides momentum towards making the technology available for chronic patients who require bi-ventricular support and have no other treatment options,” Minogue said.

Three insurance companies have existing coverage policies for the AbioCor, including Cigna and Humana, Abiomed noted. The device costs about $250,000.

Abiomed recently said it has selected four sites as AbioCor centers: the Johns Hopkins Hospital (Baltimore); Robert Wood Johnson University Hospital (New Brunswick, New Jersey); Texas Heart Institute at St. Luke’s Episcopal Hospital (Houston); and St. Vincent’s Hospital (Indianapolis).