A roundup of breaking cardiac news

Improving cardiac rehabilitation through performance measures

In an effort to increase cardiac rehabilitation (CR) referrals and standardize care delivery in these programs, performance measures jointly developed by the American Association of Cardiovascular and Pulmonary Rehablitation (AACVPR), the American College of Cardiology (ACC), and the American Heart Association (AHA) were released in early October 2007.

In a press release announcing these performance measures, Randal Thomas, MD, director of the Cardiovascular Health Clinic at the Mayo Clinic and chair of the writing committee for the measures, commented that "the benefits of CR have been demonstrated in the medical literature but healthcare professionals continue to underutilize CR services. The new CR performance measures are a stimulus—a systematic solution—to apply these services more appropriately."

Michael W. Rich, MD, an associate professor of medicine at Washington University School of Medicine and a member of the Cardiology Review editorial board, agrees that CR is often overlooked. "Cardiac rehabilitation is unquestionably underutilized, especially considering that there is a large body of evidence attest[ing] to its benefits, including a 25% to 30% reduction in mortality after myocardial infarction or cardiac surgery." However, Rich also wondered "whether the publication of the performance measures will be effective in increasing awareness or referral rates."

So far, it is too early to tell. "Hospitals are beginning to insert language about referral to cardiac rehabilitation into their discharge instructions and order sets," says Marjorie King, MD, a member of the CR performance measures writing committee and director of cardiac services for the Helen Hayes Hospital, West Haverstraw, NY. "In our county," Dr King notes that recently "the cardiac rehabilitation program provided handouts for staff and patients at the acute care hospitals." Despite these encouraging first steps, Dr Randal cautioned that "the adoption of the performance measures will take time."

In addition to the adoption of these measures, there is the question of paying for them as well. Dr King noted that although "several insurers have been interested in the AACVPR Program Certification process as a way to define quality cardiac rehabilitation" programs in the past, she is not aware of any insurers presently using the Set B measures,which are included in the Program Certification.

Finally, although data collection and analysis is required of CR programs under the performance measures, it is not currently possible to use this data to provide consumers with information to evaluate programs.

How the performance measures measure up

AACVPR/ACC/AHA Performance Measures on Cardiac Rehabilitation for Referral to and Delivery of Cardiac Rehabilitation/Secondary Prevention Services

Two sets of CR performance measures— known as —were developed over a 1.5-year development period. The first seeks to improve referral of eligible cardiovascular disease (CVD) patients, and the second is aimed at stimulating CR programs to deliver CR services appropriately to all eligible patients.

The first set of CR measures stipulates referral to outpatient CR prior to discharge for all eligible hospitalized patients with a qualifying CVD event, and referral of outpatients who received a qualifying diagnosis in the past year but have not participated in CR.

The second set of CR measures involves structure- and process-based measures to be implemented by CR programs. These measures are designed to ensure patient safety (eg, through a medically supervised exercise program, including an emergency response team), optimize patient care, and document CR program effectiveness. Both measures require significant communication and care coordination to work effectively, noted Dr Thomas.

In addition to the participating efforts of the AACVPR, the ACC, and AHA in drafting the measures, they have also been endorsed by 9 other medical societies.

Anemia measure predicts risk of death

Measuring the random variability of hemoglobin levels over time, rather than hemoglobin's absolute or temporal trend levels, may help better predict risk of death in patients receiving dialysis for end-stage renal disease (ESRD).

Journal of the American Society of Nephrology

These results are presented in a study conducted by Harold I. Feldman, MD, and colleagues of the University of Pennsylvania School of Medicine and published in the December issue of the . The authors analyzed data on nearly 35,000 dialysis patients to study the effects of hemoglobin variability (Hb-Var) on the risk of death. In a press release announcing the study, Dr Feldman noted that "hemoglobin variability—a measure of the stability of levels of hemoglobin among chronic hemodialysis patients—provides a novel way of thinking about and understanding the relationship between anemia and outcomes in ESRD."

For example, repeated drops in hemoglobin levels in dialysis patients—and thus in the ability to deliver adequate levels of oxygen to organs and tissues—may result in injury. The heart muscle (myocardium) and autonomic nervous system may be especially vulnerable, which may help to explain the increased rates of cardiovascular disease and death in ESRD patients.

The study identifies Hb-Var as a potentially valuable measure of the effects of low hemoglobin in ESRD, and lends new insights into how anemia affects outcomes in dialysis patients. Dr Feldman went on to say that "these findings may ultimately lead to health care practice changes regarding the management of anemia—for example, the type, dose, and timing of treatment with erythropoietin and iron—that might improve outcomes among hemodialysis patients."

J Am Soc Nephrol

The full study is available in . 2007;18:3164-3170.

Small study finds small change leads to big results

The American Journal of Kidney Diseases

Switching antihypertensive agents from morning to evening dosing decreased nocturnal blood pressure and proteinuria, according to a study in the December 2007 issue of .

Patients whose blood pressure does not decrease by at least 10% at night (nondipper patients) have increased cardiovascular morbidity and mortality, and this phenomenon is more prevalent in patients with chronic kidney disease (CKD). Roberto Minutolo, MD, and his coauthors from Second University of Italy, Naples, and University of California at San Diego Medical School, postulated that shifting antihypertensive drugs to evening dosing would restore circadian rhythm in these nondipper patients with CKD.

And while the study did indeed demonstrate this outcome, caution must be taken in generalizing from the data. First, this was an 8-week trial without a control, and the patient population was 32 individuals. Second, the patients studied did have controlled ambulatory blood pressure, which prevented confounding through blood pressure changes caused by treatment intensification.

NEW PRODUCT NEWS

Supplemental new drug approval for Avalide

The combination antihypertension drug Avalide was approved by the FDA for first-line use in patients with moderate-to-severe hypertension on November 19, 2007. Avalide was originally approved in 1997 for hypertension treatment, but it could not officially be prescribed until adequate blood pressure control was demonstrated to be unachievable through titration of the individual drugs comprising Avalide.

The approval is based on data from 2 clinical trials involving more than 1200 patients with moderate or severe high blood pressure. In the first double-blind, active-controlled, 7-week trial, patients with severe hypertension (mean baseline 172/113 mm Hg) were randomly treated with either Avalide 150/12.5 mg (n = 468) or irbesartan 150 mg monotherapy (n = 227). In the second double-blind, active-controlled, 12-week trial, patients with moderate hypertension (mean baseline 162/98 mm Hg) were randomly treated with Avalide 150/12.5 mg (n = 328), irbesartan 150-mg monotherapy (n = 106), or hydrochlorothiazide 12.5-mg monotherapy (n = 104). Both studies demonstrated statistically significant reductions in blood pressure.

In a press release announcing this approval, Dr Joel Neutel, Professor of Medicine, University of California in Irvine, noted that the use of initial combination therapy for severe hypertension is "based on the need to lower blood pressure within weeks rather than months."

Cardiology Review

Samuel Mann, MD, a professor of medicine at New York Presbyterian Hospital and a member of the

editorial board

, feels that this new indication is a welcome development. Avalide's use is "reasonable in people in whom the physician would want to start treatment with 2 drugs because of moderate-to-severe hypertension," as "it can help get to ideal blood pressure sooner." For those with mild hypertension, he cautioned, "it could lower their blood pressure too much. As long as the blood pressure is lowered somewhat, one doesn't have to race to get it all the way to normal overnight."