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.
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.