A joint committee of the American College of Cardiology (ACC; Bethesda, Maryland), the American Heart Association (AHA; Dallas, Texas) and the North American Society of Pacing and Electrophysiology (NASPE; Natick, Massachusetts) last month issued a 48-page document updating earlier guidelines for implantation of pacemakers and implantable cardioverter defibrillators (ICDs) that could provide incremental increase in the use of such devices. The guidelines especially recommend the devices for those who have recovered from a heart attack but whose hearts have impaired pumping ability. And the document, because it was produced by a panel of clinicians, should have "a major impact on the treatment of arrhythmias," according to Gabriel Gregoratos, MD, chair of the group that wrote the new guidelines and director of cardiology consultant services at the University of California, San Francisco.

While greater use of ICDs is being generally recognized and accepted in cardiovascular care, translating this knowledge into newer practice had been "controversial – consuming hours and hours, days and weeks on that front," said Mark Schoenfeld, MD, president of NASPE and associate professor of medicine at Yale University School of Medicine (New Haven, Connecticut). He said that the controversy came, in part, was a fallout from reimbursement issues.

"People have been in a quandary, from the caregivers' standpoint," Schoenfeld said. "Even though the medical literature would dictate and warrant defibrillator implant, their hands have been constrained," he said, the product of delays in both FDA approvals and reimbursement by Medicare. "Physicians have been caught in the difficult situation of knowing what may best serve a patient but not have the guidelines clearly delineated," he said. He added: "I do believe CMS [the Centers for Medicare & Medicaid Services] and the third-party payers will follow these guidelines. What else can they follow? These guidelines address the medical and scientific facts."

Written in 1998, the original guidance for these treatments was characterized by Schoenfeld as "groundbreaking, because it identified the indications for both pacemakers and defibrillators and what indications were appropriate for implantation." But, he added, "So much has happened since that time period. There have been remarkable discoveries over the intervening four years." Overall, the new guidelines could help drive access to this technology for an estimated 200,000 to 300,000 people, and even more, who could benefit from them.

Schoenfeld reported that the guidelines were shaped over a period of at least two years as new data came out from clinical trials reporting the risk-reducing benefits of this technology. In particular, he pointed to MADIT II (for Multi-center Automatic Defibrillator Implantation Trial) data from Guidant (Indianapolis, Indiana), released this past March, showing that in heart attack patients with an ejection fraction of 30% or less, an ICD can still reduce the risk of death by nearly one-third, even if the heart's rhythm appears to be normal day-to-day. Until now, however, ICDs had been recommended only for those patients who had presented with at least a mild arrhythmia or when special testing could provoke such an arrhythmia. The MADIT II study has been among the most influential of recent trials, garnering headlines for being halted last year, before its completion, because of its broad success. And this past July, the FDA approved expanded uses for Guidant's ICDs.

Another recommendation of the guidelines is the approval of biventricular pacing for patients whose hearts not only pump with too little force, or ejection fraction, but that also fail to beat in synchrony from the left to right side. Thus, the guidelines support the use of new biventricular technologies addressing this market.

While Schoenfeld said that the update document is likely to promote broader use of these technologies, he called the guidelines a "work in progress." He said that there will need to be "fine tuning" and further updates and that "some of the original data will be more fully clarified" in future documents. In particular, "there will be a better definition of the role of device therapy in patient populations that have long been vexing," he said.

The full document has been posted on the websites of the ACC, AHA and NASPE, and it will be published in the Oct. 16 issue of the Journal of the American College of Cardiology and the Oct. 15 issue of Circulation, the journal of the American Heart Association.

Cost of women's heart disease assessed

The cost to treat a woman suffering heart disease averages $423,000 over the individual woman's lifetime, according to estimates of a report released last month by the Society for Women's Health Research (Washington). That finding comes from a study conducted for the group by Analysis Group|Economics (Boston, Massachusetts), which examined three diseases that appear to put an extra burden on women's health. The other two diseases were diabetes, estimated at a $233,000 average total lifetime cost, and stress urinary incontinence, at $58,000 average lifetime cost. The group noted that the high cost for treating heart disease in women is further driven by related conditions often coexisting with heart disease, such as hypertension, hypercholesterolemia and obesity – with similar co-morbidities complicating the treatment of diabetes and urinary incontinence.

Phyllis Greenberger, president and CEO of the Society for Women's Health Research, characterized the cost estimates for all three conditions as "staggering," and she said that the findings provide "a much-needed call to action." She added, "The study helps us raise awareness of the need for women to educate themselves about their potential health risks, understand the importance of disease prevention and the need for more research to advance treatments and therapies, as well as prepare themselves financially." She said that the study conveys the need for policy makers to provide more resources for additional clinical research, sex-based healthcare information and access to preventive care for women.

Another recent study raising issues concerning women and heart disease confronts the larger mortality risk for women following heart surgery, with researchers looking at the records of 7,000 patients who had heart surgery in 20 California hospitals. They found that females under the age of 21 had a 51% higher incidence for death than young men. The results were reported in Circulation, the journal of the American Heart Association.

The study reinforces previous knowledge indicating that adult women have at least a 50% higher rate of death than male patients as a result of heart surgery. Ruey-Kang Chang, MD, principal investigator at the Harbor-UCLA Research and Education Institute and lead author, said the study attempted to determine if the same was true for children. He said that the same differential between males and females in this population came as "a surprise." He and his colleagues have launched new studies that will drill down into the issue of gender differences in this sector, and Chang said, "If we know where the differences are coming from, we can change the way we practice."