Editor’s note: The following guest post by Mary Knudson originally appeared on her blog, Heart Sense: A Blog About Heart Failure. Knudson worked for 17 years as a medical writer for The Baltimore Sun and currently teaches science and medical writing at Johns Hopkins University. Along with Edward Kasper, clinical chief of cardiology at Johns Hopkins Hospital, she is the co-author of the highly praised book, Living Well with Heart Failure .
By Mary Knudson
In its website section on heart failure facts, the Heart Failure Society of America directly faces 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 percent of patients are living five years after their initial diagnosis and less than 25 percent 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 lives of people with heart failure and in the last decade those 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 the last decade.
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 directed to worried patients and family members about how long someone can live with a diagnosis of heart failure. Many conditions can cause heart failure in which the heart is not pumping out enough blood to meet the needs of the body. When a patient with heart failure has a poor prognosis, there can be any number of reasons, including these: the doctor did not order the most effective medications that could have prevented progression of the heart failure, the patient didn’t faithfully take the correctly prescribed medications either because she couldn’t afford them or was not reliable, 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, a patient may have a heart too damaged from a heart attack or from a genetic malfunction to be able 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 enough grant money for heart failure research.”
Working on the assumption that a journalist or a person with heart failure or, for that matter, any member of the public could ask what HFSA’s source is for its grim prognosis and get an answer, I contacted HFSA. I sent an e-mail to Cheryl Yano, HFSA longtime executive director, explaining that I was writing this blog report on heart failure death statistics, and then a second e-mail, but did not get a reply, so I called. She would not talk to me.
Loreen Anderza, 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 to speak to Cheryl Yano. I asked if Ms. Yano would talk to me about whether or not heart failure is becoming more of a chronic condition that can, for most people be managed, 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 what the source is for the scary prognosis that is 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 10-20 years.”
The Framingham Heart Study
The Framingham Heart Study supported by the National Heart Lung and Blood Institute, part 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 about the risk factors for developing heart disease. The study here has provided many important findings including the risk of cigarette smoking, cholesterol, and high blood pressure, and much more. But the study is set up 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 a clinic visit and before death and these interventions are not captured in our clinic visits,” said Daniel Levy MD, director of the Framingham Heart Study. Therefore his report did not have information on what treatments heart failure patients who died were using.
Many sites on the internet including HFSA that offer a prognosis for heart failure base their projections on a Framingham study published in 2002 in the New England Journal of Medicine that used data going back 15 to 20 years ago. Even the American Heart Association’s Heart Disease and Stroke Statistics 2010 Update quotes the Framingham death rates for heart failure.
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 — 86 deaths of men and 80 deaths of women. This study occurred before the modern therapy of ACE inhibitors and beta blockers which are proven to prolong life in heart failure.
The Framingham study followed 323 people (145 men and 178 women) who developed heart failure between 1990 and 1999. Dead in five years were 59% ( 86) of the men and 45% (80) women. The study did not learn whether these men and women died of their heart failure or of some other cause, said Dr. Levy, lead author of the report that appeared October 31, 2002 in theNew England Journal of Medicine.
The Framingham study on heart failure deaths also looked at deaths in decades going back to the 1950s and said that “Overall, there was an improvement in the survival rate after the onset of heart failure of 12 percent per decade.”
In the decade since the Framingham study of the 1990s, “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
I talked to eight nationally known cardiologists in preparing this article, to get a sense of where heart failure stands as a treatable condition vs 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 NHANES (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, a part of the Centers for Disease Control (CDC) surveys about 5,000 people in the United States a year and estimates results for the national population. The AHA Heart Disease and Stroke Statistics 2010 Update here 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 the improving life expectancy for people in the placebo group of these trials — those who are on the existing standard therapy against which the new treament is being tested. “For instance in the SOLVD study of 1991 which first showed the benefit of ACE-inhibitor drugs, the three-year survival rate was about 65% in the group receiving placebo, whereas three-year survival rates were approximately 80% (or greater) in two studies (one on eplerenone and one on use of CRT for mild to moderate heart failure)reported this week at the American Heart Association here and here dealing with heart failure patients of varying degrees of severity,” said Dr. Macette. In fact, the improvement of heart failure outcomes has helped set the bar higher for any new therapy being tested,” she said.
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: I co-authored Living Well with Heart Failure, the Misnamed, Misunderstood Condition with him) 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 found here if heart failure has become more of a chronic condition:
Question: “From your own patient experience, do you find that most people diagnosed with heart failure will be able to manage their condition, keeping it from advancing, or even improve with the right treatments?”
“I agree,” she replied. She pointed to a study of 2,029 people taken from the general population in Olmsted County, Minnesota. Study participants were classified according to how sick they were. Since this was a random sample, it included healthy people called stage 0. Stage A had risk factors for heart failure, stage B showed 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, and dropped to 20% in stage D, by far the smallest group with only 5 people. The study published March 12, 2007 online in Circulation can be found here. “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
The Minnesota study, though still small numbers, gives some window into a more accurate prognosis for heart failure.
But the only way doctors and patients and their families will get a really accurate handle on prognosis with current therapies is if a huge prospective study is undertaken or at least a national registry that includes tens of thousands of patients seen at many academic centers and those seen in the community by both cardiologists and general practitioners. The study or registry should include a variety of races and ethnic backgrounds, male and female. Much could be learned by such a study, including this information:
- modern survival rates of deaths due to heart failure
- percent of people with heart failure who die suddenly from ventricular fibrillation
- possible geographic differences in death rates
- a large database of what treatments patients were on when they died
- a library of 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 outdated prognosis for heart failure is still there with not even an asterisk explaining how old and outdated the data are on which it is based.