Jan. 4, 2011 -- More than 20% of patients who receive implanted devices that help shock the heart out of dangerous rhythms (arrhythmias) get them when clinical guidelines suggest they are unlikely to benefit from the expensive and sometimes painful intervention, a study shows.
What’s more, these patients have a modestly but significantly higher risk of dying in the hospital compared to those who do meet clinical criteria for the devices.
“I thought it was a very important study, particularly because it captures information about 80% of all the defibrillator implants in the United States,” says Alan Kadish, MD, a cardiologist who is president and chief executive officer of Touro College in New York City. “What it shows is that about one-fifth of these implants were performed in people who are not expected to benefit from them.”
Kadish was the co-author of an editorial that accompanies the study, which is published in the Jan. 5 issue of The Journal of the American Medical Association.
Previous studies looking at the clinical use of implanted cardioverter defibrillators (ICDs) have come to similar conclusions, leading the Office of the Inspector General at the Department of Health and Human Services to launch an investigation last yearinto how people are being chosen to receive these devices at hospitals across the country. The stakes of the investigation are high since these devices can be lifesaving, but the cost of implantation of a single ICD can range from $30,000 to $40,000.
Evidence That ICDs Are Overused
For the study, Sana Al-Khatib, MD, MHS, from the Duke Clinical Research Institute in Durham, N.C., and colleagues analyzed information about 111,707 ICD implants submitted to the National Cardiovascular Data Registry, a database that captured information on nearly 80% of all patients who received ICD implants in the U.S. from January 2006 through June 2009.
They found that 25,145, or 22.5%, of devices were implanted in patients who did not meet published criteria for ICD use. The patients included those who were immediately recovering from a heart attack, in the early stages of heart failure, were within three months of bypass surgery, or had very advanced heart failure, meaning that they were so ill they were experiencing symptoms at rest and were unable to perform any physical activity without marked limitation.
Compared to patients who met clinical guidelines for ICD implantation, patients who did not meet recommendations for the devices, but who got them anyway, tended to be older and were more likely to have other serious health problems including end-stage kidney disease, diabetes, and chronic lung disease. The study also showed that patients who got ICDs outside of recommended guidelines were more likely to die in the hospital, had greater risks of complications after the implantation, and faced longer hospital stays than those who fell within the guidelines.
Specialists vs. Non-Specialists
When researchers further checked the data, they discovered that whether or not a device was implanted against guidelines could depend on the kind of doctor who was performing the procedure.
Electrophysiologists, doctors who specialize in treating problems with the heart’s rhythm, were less likely to implant devices in patients who didn’t meet recommendations than non-specialist cardiologists or thoracic surgeons.
However, study author Al-Khatib says the reasons why patients get the devices outside clinical guidelines are likely to be multifaceted.
“There may be a lack of awareness about the guidelines or a lack of knowledge, particularly among non-specialists,” Al-Khatib says, “or, at the end of the day, physicians may not agree with the guidelines.”
John Mandrola, MD, an electrophysiologist at Baptist Hospital East who blogs about health care, says, “Early on there were many cardiologists implanting devices because they were easy to do, well reimbursed, and the tone of the times was that ICDs were underused. Since ICD scrutiny is increased, doctors have still continued to use them inappropriately because they falsely believe in their benefits, and minimize the risks. They are trained to fight for life and perhaps uncomfortable talking with patients about end-of-life choices. When you deal with death -- the outcome of malignant arrhythmia -- it gets emotional. For a lot of cardiologists, death is the absolute enemy. These emotional overtones can affect science-based acceptance of ICD indications."
Risks of Improper Implantation
To attain maximal benefit, ICDs must be implanted in the right patients at the right time. For patients who get an ICD within 40 days of a heart attack, within 90 days of coronary artery bypass surgery, or in the earliest stages of heart failure, the risk is that the device may be implanted too early, before the heart has had a chance to recover. So some of these individuals may not benefit from implantation because their hearts ultimately heal and the device is never actually needed.
On the other end of the spectrum, patients in the most advanced stage of heart failure may be subjected to repeated, painful shocks without any lengthening of life.
“These are superb, lifesaving devices, but they do have downsides,” Kadish says.
Mandrola says patients who are told they need a defibrillator should make sure they understand why they need one and how the device could affect them. “Ask, ‘What are the benefits? What are the risks?’ And be sure the doctor knows your expectations about life expectancy and quality of life. The shocks are 750 volts, and they’re painful.”
Mandrola also recommends seeking out another opinion if you’re not sure you want an ICD. “Two doctors look at the same thing differently.”