{"id":5206,"date":"2010-12-10T10:01:51","date_gmt":"2010-12-10T15:01:51","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=5206"},"modified":"2011-07-19T17:45:22","modified_gmt":"2011-07-19T21:45:22","slug":"heart-failure-death-statistics-don%e2%80%99t-believe-what-you-read-on-the-internet","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/12\/10\/heart-failure-death-statistics-don%e2%80%99t-believe-what-you-read-on-the-internet\/","title":{"rendered":"Heart Failure Death Statistics: Don\u2019t Believe What You Read on the Internet"},"content":{"rendered":"

Well-known science journalist Mary Knudson is the author of <\/em>HeartSense<\/em><\/a>, a blog about heart failure, from which the following post is taken. In this post, she takes issue with\u00a0the grim and outdated prognosis\u00a0data presented to the public\u00a0by a prominent heart failure website.<\/em><\/p>\n

In its website section on heart failure facts<\/a>, the Heart Failure Society of America directly\u00a0addresses the question all people with heart failure and their loved ones desperately want to know:<\/p>\n

“Q: What is the prognosis for a patient with heart failure?”<\/em><\/p>\n

“A:\u00a0Less than 50% of patients are living\u00a05 years after their initial diagnosis, and\u00a0less 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.\u201d<\/em><\/p><\/blockquote>\n

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. \u00a0Implanted 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.<\/p>\n

I also felt uneasy reading the HFSA answer that tied \u201cpoor prognosis\u201d to \u201cinsufficient private and government funding.\u201d \u00a0That seemed to have a political tinge to it, out of place in an answer to worried patients and family members. \u00a0Many conditions can cause heart failure, and many factors\u00a0can contribute to a poor prognosis,\u00a0including these: \u00a0the doctor did not order the most effective medications that could have prevented progression; the patient didn\u2019t\u00a0correctly take\u00a0appropriately prescribed medications because she couldn\u2019t afford them or was unreliable; the patient didn\u2019t observe a low-sodium, low-fat diet and get regular exercise; and, frequently, the patient has other significant health problems. \u00a0Also, despite excellent care,\u00a0the patient’s heart may be too damaged from a heart attack or\u00a0a genetic malfunction to successfully pull out of heart failure. \u00a0But I doubt any doctor ever tells a patient\u2019s family, \u201cYour husband and father is in late-stage heart failure and has only a few months to live because the government didn\u2019t fund heart failure research.\u201d<\/p>\n

Working on the assumption that I could ask\u00a0about the source of\u00a0 HFSA’s grim prognosis and get an answer, I contacted HFSA. \u00a0I sent\u00a0two e-mails to Cheryl Yano, HFSA’s longtime executive director, explaining that I was writing this report on heart failure death statistics\u00a0but did not get a reply, so I called. \u00a0She would not talk to me.<\/p>\n

Loreen Anderza,\u00a0the 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. \u00a0It is “a consensus of experts in the field. \u00a0They have no source for it,” she said, after putting me on hold\u00a0while she spoke\u00a0to Cheryl Yano. \u00a0I asked if Ms. Yano would discuss whether heart failure is becoming\u00a0a chronic condition that can be managed for most people,\u00a0and Ms. Anderza said that Ms. Yano is not the right person to talk to because she is not an MD. \u00a0I asked who at HFSA I could talk to, and she said Ms. Yano had no one to recommend. \u00a0Ms. Anderza said that everyone uses the same numbers and suggested that I ask the American Heart Association if they know\u00a0the source for the scary prognosis on the HFSA website.<\/p>\n

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:<\/p>\n

\u201cThis is out of date. \u00a0It is based on Framingham data and several trials, largely dating back 10 to 20 years.\u201d<\/p>\n

The Framingham Heart Study<\/strong><\/p>\n

The Framingham Heart Study<\/a> 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\u00a0on the risk factors for developing heart disease. \u00a0The 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. \u201cParticipants with heart failure often undergo treatment between clinic visits and before death, and these interventions are not captured in our clinic visits,\u201d said Daniel Levy MD, director of the Framingham Heart Study,\u00a0explaining the absence of information on\u00a0treatments used by heart failure patients who died.<\/p>\n

Many internet sites, including HFSA’s,\u00a0base their prognoses\u00a0on a Framingham heart failure\u00a0study <\/a>published October 31, 2002, in the New England Journal of Medicine<\/em>. \u00a0Even the American Heart Association\u2019s Heart Disease and Stroke Statistics 2010 Update quotes the Framingham heart failure study death rates.\u00a0I examined the framingham report on heart failure and found that the prognosis the study gives is based on a very small number of deaths.<\/p>\n

The study followed 323 people who developed heart failure between 1990 and 1999.\u00a0\u00a0At 5 years,\u00a0 86 of the 145 men\u00a0(59%)and\u00a080 of the 178 women (45%) were dead. \u00a0The study did not\u00a0determine 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\u00a0was conducted\u00a0before ACE inhibitors and beta blockers, proven to prolong life in heart failure, were in use.<\/p>\n

The\u00a0authors also looked at deaths by decade going back to the 1950s. They note that\u00a0there 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, \u201cthere is optimistic evidence that we have improved treatment for people with heart failure,\u201d Dr. Levy said in a telephone interview, though he would not estimate by how much.<\/p>\n

Other Clues to Heart Failure Prognosis<\/strong><\/p>\n

In preparing this article, I\u00a0talked to eight nationally known cardiologists\u00a0to get a sense of where heart failure stands as a treatable\u00a0versus a progressively fatal condition. Not all are quoted. One cardiologist who asked not to be identified because he knew what he was saying was \u201ccontroversial,\u201d commented on the annual AHA Heart Disease and Stroke Statistics Update: \u00a0\u201cThese are not really current data. \u00a0They are estimates extrapolated from the NHANES (the\u00a0CDC’s National Health and Nutrition Examination Survey) . . . with changes based on changing size and age of the population. \u00a0Hence, they are unlikely to be accurate and will not reflect real or measured changes. \u00a0Consider 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.\u201d<\/p>\n

NHANES annually surveys about 5,000 people in the U.S.\u00a0and estimates results for the national population. The AHA Heart Disease and Stroke Statistics 2010 Update<\/a> bases its estimated incidence of heart failure and prognosis of life expectancy largely on NHANES and the Framingham Heart Study of the 1990s.<\/p>\n

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. \u00a0Both Dr. Massie and Alice Macette, MD, chief of the National Heart Lung and Blood Institute\u2019s Heart Failure and Arrhythmias Branch, point to improved life expectancy for the people in the placebo groups of these trials \u2014 those\u00a0receiving the existing standard therapy against which the new treatment is being tested.<\/p>\n

\u201cFor 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<\/a> and one on use of CRT for mild to moderate heart failure<\/a>) reported this week at the American Heart Association. \u00a0“In fact,” she said, “the improvement of heart failure outcomes has helped set the bar higher for any new therapy being tested.\u201d Dr. Massie agreed. \u00a0\u201cIf you compare the placebo groups over time, there is a substantial decline in the placebo group mortalities,\u201d he said. \u00a0\u201cUsed to be up to 20% per year and now is close to 8% per year. \u00a0This 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.\u201d<\/p>\n

I also asked cardiologists to judge from their own experience how treatable heart failure has become. \u00a0Edward K. Kasper, MD, Director of Clinical Cardiology at Johns Hopkins Hospital and a specialist in heart failure, (disclosure:\u00a0\u00a0Dr. Kasper was my co-author on\u00a0Living Well with Heart Failure, the Misnamed, Misunderstood Condition)<\/em> said \u201cI expect most to improve with modern therapy for at least some period of time – say 75%.\u201d<\/p>\n

\u201cIndeed there have been great advances and people do live longer, but progress has been slow and we need to do better,\u201d said Dr. Massie.<\/p>\n

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 <\/a>this question:<\/p>\n

\u201cIn your own\u00a0experience, 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?\u201d<\/p>\n

\u201cI agree,\u201d she replied. She pointed to a study of 2,029 \u00a0people in the general population in Olmsted County, Minnesota, who were classified according to how sick they were.\u00a0\u00a0Because this was a random sample, it included healthy people (stage 0). \u00a0Stage 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. \u00a0Survival at 5 years was 99% in stage 0, 97% in stage A, 96% in stage B, 75% in stage C,\u00a0but dropped to 20% in stage D, the smallest group with only 5 people. The study was published online March 12, 2007, in Circulation<\/a>. \u00a0\u201cIt is only those patients who present with intractable symptoms that do poorly,\u201d Dr. Jessup said.<\/p>\n

Needed: \u00a0A Huge National Prospective Study or a National Registry<\/strong><\/p>\n

Although\u00a0its numbers are small, the Minnesota study\u00a0provides\u00a0a 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\u00a0 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. \u00a0Much could be learned\u00a0from such a study, including:<\/p>\n