Implantable cardiac devices may not help patients with advanced heart failure, a Saint Louis University study found.
"Overuse of these devices is a disservice to patients, because it puts them through unnecessary procedures and creates unrealistic expectations for the device," lead author Paul Hauptman said.
The researchers looked at in-hospital mortality rates of patients who received cardiac resynchronization device (biventricular pacemaker) and implantable cardioverter defibrillator.
While the pacemaker coordinates the contractions of the heart, the defibrillator is meant to prevent sudden cardiac death.
"This is a first, but very important, step in better defining who should get these devices," Hauptman said. "This study will have implications for cost-effectiveness, quality and appropriateness of care, and the experience patients and their families have with the disease."
Device implantation should be limited to those who are expected to have, at the very least, a one year life expectancy Hauptman stressed, according to EurekAlert.
"Although a rigorous, cost-effective study is still needed, our data suggest these procedures are being performed on patients who are unlikely to derive benefit," Hauptman said.
Using a national database from 2004-2005 of nearly 28,000 patients from 240 hospitals, the researchers identified two red flags that were associated with higher risk of in-hospital mortality. According to the researchers, these red flags need to be considered when deciding whether or not a patient is a good candidate for the devices.
Patients who received inotropic therapy before or after the procedure were at the highest risk for in-hospital mortality. Inotropic drugs alleviate the symptoms of advanced heart failure by making the heart pump more vigorously. However, because the drugs potentially increase the risk of death, they are used as for symptom control and as a palliative measure for the most severely sick patients.
"In our analysis, 24.1 percent of patients who receive inotropic drugs, whether or not they received a cardiac device,, die before leaving the hospital," Hauptman said. "Clearly, patients who need, or will likely need, inotropic therapy are very ill and unlikely to receive long-term benefit from these devices.
"Future guidelines regarding the appropriate use of these devices should incorporate the ongoing or anticipated need for inotropic therapy."
Another red flag in their research was the timing of the procedure. Most patients received the devices on the first day of their hospitalization, indicating that it was an elective procedure. Patients, who received the devices after an extended hospitalization, indicating the procedure was likely non-elective, were at risk for in-hospital mortality.
Co-authors of the study include Jason Swindle, M.P.H., Thomas Burroughs, Ph.D., and Mark Schnitzler, Ph.D., of Saint Louis University Center for Outcomes Research.
The study was funded by a grant from the National Institutes of Health. The findings were published in the June 2008 issue of The American Heart Journal