CardioExchange Archive

Well-known science journalist Mary Knudson is the author of HeartSense, a blog about heart failure, from which the following post is taken. In this post, she takes issue with the grim and outdated prognosis data presented to the public by a prominent heart failure website.

In its website section on heart failure facts, the Heart Failure Society of America directly addresses the question all people with heart failure and their loved ones desperately want to know:

“Q: What is the prognosis for a patient with heart failure?”

“A: Less than 50% of patients are living 5 years after their initial diagnosis, and less than 25% are alive at 10 years. Poor prognosis can be attributed to a limited understanding of how the heart weakens and insufficient private and government funding.”

I was startled to see those grim statistics on the HFSA website, given that clinical studies published in peer-reviewed journals have shown that ACE inhibitors and beta blockers prolong the lives of people with heart failure and that these medicines have become standard recommended therapy.  Implanted defibrillators known as ICDs that prevent sudden death by shocking the heart when the heart goes into a chaotic rhythm; cardiac resynchronization therapy (CRT), which corrects abnormal beating of the left ventricle; and other effective treatments have also grown in use.

I also felt uneasy reading the HFSA answer that tied “poor prognosis” to “insufficient private and government funding.”  That seemed to have a political tinge to it, out of place in an answer to worried patients and family members.  Many conditions can cause heart failure, and many factors can contribute to a poor prognosis, including these:  the doctor did not order the most effective medications that could have prevented progression; the patient didn’t correctly take appropriately prescribed medications because she couldn’t afford them or was unreliable; the patient didn’t observe a low-sodium, low-fat diet and get regular exercise; and, frequently, the patient has other significant health problems.  Also, despite excellent care, the patient’s heart may be too damaged from a heart attack or a genetic malfunction to successfully pull out of heart failure.  But I doubt any doctor ever tells a patient’s family, “Your husband and father is in late-stage heart failure and has only a few months to live because the government didn’t fund heart failure research.”

Working on the assumption that I could ask about the source of  HFSA’s grim prognosis and get an answer, I contacted HFSA.  I sent two e-mails to Cheryl Yano, HFSA’s longtime executive director, explaining that I was writing this report on heart failure death statistics but did not get a reply, so I called.  She would not talk to me.

Loreen Anderza, the HFSA administrative assistant who answered the phone, said there is no specific source for the HFSA statement on how long people with heart failure can expect to live.  It is “a consensus of experts in the field.  They have no source for it,” she said, after putting me on hold while she spoke to Cheryl Yano.  I asked if Ms. Yano would discuss whether heart failure is becoming a chronic condition that can be managed for most people, and Ms. Anderza said that Ms. Yano is not the right person to talk to because she is not an MD.  I asked who at HFSA I could talk to, and she said Ms. Yano had no one to recommend.  Ms. Anderza said that everyone uses the same numbers and suggested that I ask the American Heart Association if they know the source for the scary prognosis on the HFSA website.

Instead I contacted the president of HFSA, Barrie M. Massie, MD, Chief of the Cardiology Division at the San Francisco Veterans Affairs Medical Center, who responded in an e-mail:

“This is out of date.  It is based on Framingham data and several trials, largely dating back 10 to 20 years.”

The Framingham Heart Study

The Framingham Heart Study supported by the National Heart Lung and Blood Institute, one of the National Institutes of Health, is an ongoing project begun in 1948 that has enrolled over 14,000 members of three generations and periodically issues reports on the risk factors for developing heart disease.  The study has provided many important findings, including the risks of cigarette smoking, cholesterol, and high blood pressure, but it is designed to find information on all forms of heart disease, and its ability to track heart failure patients is quite limited. Original Framingham participants are seen at a clinical visit every two years, and their offspring are seen every four years. “Participants with heart failure often undergo treatment between clinic visits and before death, and these interventions are not captured in our clinic visits,” said Daniel Levy MD, director of the Framingham Heart Study, explaining the absence of information on treatments used by heart failure patients who died.

Many internet sites, including HFSA’s, base their prognoses on a Framingham heart failure study published October 31, 2002, in the New England Journal of Medicine.  Even the American Heart Association’s Heart Disease and Stroke Statistics 2010 Update quotes the Framingham heart failure study death rates. I examined the framingham report on heart failure and found that the prognosis the study gives is based on a very small number of deaths.

The study followed 323 people who developed heart failure between 1990 and 1999.  At 5 years,  86 of the 145 men (59%)and 80 of the 178 women (45%) were dead.  The study did not determine whether these men and women died of heart failure or other causes, said Dr. Levy, the study’s lead author. The findings included data going back 15 or 20 years, and the study was conducted before ACE inhibitors and beta blockers, proven to prolong life in heart failure, were in use.

The authors also looked at deaths by decade going back to the 1950s. They note that there was an overall improvement of 12% per decade in survival rates after the onset of heart failure. In the decade since those data were reported, “there is optimistic evidence that we have improved treatment for people with heart failure,” Dr. Levy said in a telephone interview, though he would not estimate by how much.

Other Clues to Heart Failure Prognosis

In preparing this article, I talked to eight nationally known cardiologists to get a sense of where heart failure stands as a treatable versus a progressively fatal condition. Not all are quoted. One cardiologist who asked not to be identified because he knew what he was saying was “controversial,” commented on the annual AHA Heart Disease and Stroke Statistics Update:  “These are not really current data.  They are estimates extrapolated from the NHANES (the CDC’s National Health and Nutrition Examination Survey) . . . with changes based on changing size and age of the population.  Hence, they are unlikely to be accurate and will not reflect real or measured changes.  Consider them propaganda for those that thrive on high event rates. These data are useful for those seeking investment in development programs for heart failure treatment.”

NHANES annually surveys about 5,000 people in the U.S. and estimates results for the national population. The AHA Heart Disease and Stroke Statistics 2010 Update bases its estimated incidence of heart failure and prognosis of life expectancy largely on NHANES and the Framingham Heart Study of the 1990s.

One clue to how long people with heart failure live comes from clinical studies that try to prove a new drug or device is better than standard care at prolonging lives.  Both Dr. Massie and Alice Macette, MD, chief of the National Heart Lung and Blood Institute’s Heart Failure and Arrhythmias Branch, point to improved life expectancy for the people in the placebo groups of these trials — those receiving the existing standard therapy against which the new treatment is being tested.

“For instance, in the SOLVD study of 1991, which first showed the benefit of ACE-inhibitor drugs, the 3-year survival rate was about 65% in the placebo group,” said Dr. Macette. And 3-year survival rates were approximately 80% (or greater) in two studies dealing with heart failure patients of varying degrees of severity (one on eplerenone and one on use of CRT for mild to moderate heart failure) reported this week at the American Heart Association.  “In fact,” she said, “the improvement of heart failure outcomes has helped set the bar higher for any new therapy being tested.” Dr. Massie agreed.  “If you compare the placebo groups over time, there is a substantial decline in the placebo group mortalities,” he said.  “Used to be up to 20% per year and now is close to 8% per year.  This low (death) event rate has made the conduct of clinical trials hugely expensive, which is why there are far fewer of these and even fewer positive ones.”

I also asked cardiologists to judge from their own experience how treatable heart failure has become.  Edward K. Kasper, MD, Director of Clinical Cardiology at Johns Hopkins Hospital and a specialist in heart failure, (disclosure:  Dr. Kasper was my co-author on Living Well with Heart Failure, the Misnamed, Misunderstood Condition) said “I expect most to improve with modern therapy for at least some period of time – say 75%.”

“Indeed there have been great advances and people do live longer, but progress has been slow and we need to do better,” said Dr. Massie.

I asked Mariell Jessup MD, chair of the American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure in Adults this question:

“In your own experience, do you find that most people diagnosed with heart failure will be able to manage their condition, keeping it from advancing, or even improving it with the right treatments?”

“I agree,” she replied. She pointed to a study of 2,029  people in the general population in Olmsted County, Minnesota, who were classified according to how sick they were.  Because this was a random sample, it included healthy people (stage 0).  Stage A had risk factors for heart failure, stage B had cardiac structural or functional abnormalities found by testing but were not experiencing symptoms, stage C had symptoms of heart failure, and stage D had end-stage heart failure.  Survival at 5 years was 99% in stage 0, 97% in stage A, 96% in stage B, 75% in stage C, but dropped to 20% in stage D, the smallest group with only 5 people. The study was published online March 12, 2007, in Circulation.  “It is only those patients who present with intractable symptoms that do poorly,” Dr. Jessup said.

Needed:  A Huge National Prospective Study or a National Registry

Although its numbers are small, the Minnesota study provides a window into more accurate prognosis for heart failure. But the only way doctors, patients, and families will get a really accurate picture of the prognosis with current therapies is from a huge prospective study or, at least, a national registry including many thousands of patients seen at  academic centers and in the community by both cardiologists and general practitioners. The study or registry should include both sexes and a variety of races and ethnicities.  Much could be learned from such a study, including:

• modern survival rates and deaths due to heart failure and not some other cause
• percentage of heart patients who experience sudden death due to ventricular fibrillation
• possible geographic differences in death rates
• treatment regimen up to and at time of death
• information on genetics of heart failure

Such a study or registry should have no funding from pharmaceutical companies.

Just before publishing this article, I checked the website of the Heart Failure Society of America.  The unnecessarily scary prognosis for heart failure is still there, without even an asterisk explaining how old and outdated are the data on which it is based.