Diagnostics & Imaging Week Associate

Early diagnosis and new treatments can help battle heart failure (HF) – a growing national problem that causes 1 million hospital admissions each year, according to new jointly developed guidelines released earlier this month by the American College of Cardiology (ACC; Bethesda, Maryland) and the American Heart Association (AHA; Dallas).

The document is available on the web sites of both organizations and will be published in the Sept. 20 issues of the Journal of the American College of Cardiology, and Circulation, the journal of the AHA.

The guidelines will be published along with the ACC/AHA Clinical Performance Measures for Adults with Chronic Heart Failure and the ACC/AHA Key Data Elements and Definitions for Measuring Clinical Measurements and Outcomes of Patients with Chronic Heart Failure (CHF).

Noting that new treatment approaches may also improve the quality of life for patients, the authors classified heart failure on a scale from risk factors to end-stage disease:

Stages A and B are when patients lack early signs or symptoms of heart failure, but are at risk because of risk factors or heart abnormalities, which could include a change in the shape or structure of the heart.

Stage C denotes patients with current or past heart failure symptoms such as shortness of breath.

Stage D designates patients with refractory heart failure who might be eligible for specialized advanced treatment – including cardiac transplantation – or compassionate end-of-life care such as hospice.

Notably, the guidelines also change the name of the condition from CHF to HF to reflect, what the authors said is “the broad spectrum of the disease.” Congestion occurs when the heart cannot efficiently pump or eject blood from its chambers. This causes fluid build-up in the lungs and heart, resulting in stiff, fluid-filled lungs and shortness of breath.

The panel dropped the word “congestive” because people can have few or no symptoms of congestion, and still have a severely abnormal heart with symptoms of fatigue and exercise intolerance caused by poor cardiac output, said guidelines co-author Mariell Jessup, MD, medical director of the heart failure and cardiac transplantation program and professor of medicine at the University of Pennsylvania Medical Center (Philadelphia), in a statement.

In recent years, doctors have recognized that many people with normal ejection fraction have heart failure. This often occurs because the heart pumps properly, but fails to fill adequately with blood, a condition called diastolic heart failure. These patients rarely have been included in clinical trials of new drugs and devices in the past, but they are the subjects of several new, ongoing trials. These trials should help settle the issue of whether their treatment should be the same as that for patients with reduced ejection fraction, the authors said.

The new practice guidelines also advocate the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) for an expanded patient population of heart failure patients. These devices are now being recommended as highest-level Class I therapies with the highest level of clinical evidence.

The guideline stipulates that ICDs should be used as a primary prevention therapy for heart failure patients with a low ejection fraction to save lives from sudden cardiac arrest (SCA), and as a secondary prevention therapy for heart failure patients with a low ejection fraction and a previous SCA or documented, sustained ventricular arrhythmias.

Additionally, the guidelines recommend the use of CRT for heart failure patients with cardiac dyssynchrony to improve symptoms, strengthen ejection fraction and reduce death. The previous ACC/AHA heart failure guideline updated in 2001 included ICDs only as a secondary prevention treatment and did not include recommendations for CRT use in heart failure patients.

“More treatments have made our decision-making far more complex since the last ACC/AHA heart failure guidelines only four years ago,” said Sharon Ann Hunt, MD, professor of cardiovascular medicine at Stanford University Medical Center (Palo Alto, California) and chair of the writing group that developed the new HF guidelines.

The ACC and AHA based their new HF guidelines on the outcomes of several studies confirming the efficacy of ICDs and CRT among certain heart failure patients, including the Medtronic (Minneapolis)-funded Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and Cardiac Resynchronization in Heart Failure (CARE-HF) studies.

“Medtronic is pleased that ACC and AHA formally support the use of ICDs and CRT for many heart failure patients,” said Steve Mahle, president of Medtronic’s Cardiac Rhythm Management business, in a company statement on the new guidelines. “We helped pioneer these therapies in partnership with physicians, and greater use of these device therapies will provide many benefits for thousands of heart failure patients, including a significant reduction in the risk of sudden death.”

The National Institutes of Health (Bethesda, Maryland)-sponsored SCD-HeFT trial showed that preventive implantation of ICDs reduced death by 23% in people with heart failure and low ejection fraction, compared to those who did not receive defibrillators.

Based on these and other compelling study results, the Centers for Medicare & Medicaid Services (Baltimore) tripled the number of Medicare recipients with heart failure and poor heart pumping function eligible to receive the protection of ICD therapy. The CARE-HF study demonstrated that CRT reduced combined all-cause mortality or unplanned cardiovascular hospitalization by 37%.

Other companies that stand to gain from the new ICD and CRT guidelines include Guidant (Indianapolis), St. Jude Medical (St. Paul, Minnesota), and Biotronik (Lake Oswego, Oregon).

The committee also recommended left ventricular assist devices (LVADs) be considered as permanent or destination therapy in selected patients.

LVADs are implanted mechanical devices that help pump blood through the heart and can be used as a reasonable permanent therapy in some end-stage heart failure patients who are not candidates for transplants, don’t respond to standard treatment and have a one-year survival outlook of less than 50%. The devices, which received FDA approval as permanent or destination therapy in November 2002, with Thoratec’s (Pleasanton, California) HeartMate VE device garnering that honor, were first used as a temporary measure to keep patients alive while awaiting a heart transplant.

“It’s going to be a whole new era in treating heart failure,” Jessup said. “Eventually, we’ll have portable artificial pumps that can take over the action of the heart.”

Other makers of LVADs include WorldHeart (Oakland, California) and Ventracor (Sydney, Australia), although neither of those companies yet has a destination approval in the U.S.

The guidelines also recommend that cardiologists introduce the subject of hospice care – support and comfort for dying patients and their families – for patients with end-stage HF.

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