Patients Who Do Not Meet Criteria for ICD Face Greater Risks
Implantable Cardioverter-Defibrillators (ICDs) have been shown effective for preventing sudden cardiac events in patients with advanced systolic heart failure. However, a new study published in the Journal of the American Medical Association finds that some ICDs are implanted without meeting the appropriate guidelines for use. Patients who do not meet criteria are at greater risk of negative health effects.
Risk Greatest At Time of Placement of ICD Device
An ICD is a small device that is placed in the chest or abdomen and uses electrical pulses to control heart rate in patients with ventricular tachyarrhythmias. It was approved for use by the FDA in 1985.
Patients who do not meet the criteria for ICD placement include those with NYHA Class IV symptoms (severe limitations due to heart failure), an MI (heart attack) within 40 days before implantation, coronary artery bypass grafting (CABG) surgery within 3 months before implantation, or newly diagnosed heart failure.
Sana M. Al-Khatib MD MHS, of the Duke Clinical Research Institute in North Carolina, and colleagues conducted a study that included about 111,000 patients who had received an ICD. The cases for the study were submitted to the National Cardiovascular Data Registry-ICD Registry between January 2006 and June 2009.
Of the total number receiving initial primary prevention ICD implants, over 25,000 – or about 22.5% - were for a non-evidence-based indication, primarily heart attack or newly diagnosed heart failure.
Post-procedure complications were higher in those who received the non-evidence-based ICD. The authors find that one excess complication occurred for every 121 non-approved ICD placed. Also, patients who received an ICD “off-label” had a significantly higher risk of in-hospital death than those who received the device for approved purposes.
“These complications could have significant effects on patients’ quality of life and health care use, including length of hospital stay and costs. While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit,” the authors write.
In an accompanying editorial, Drs. Alan Kadish and Jeffrey Goldberger, both of the Feinberg School of Medicine at Northwestern University, say that to improve public health, the cardiovascular care community must act on the data from this important study.
“It is likely that all physicians require further education to understand the rationale for the guidelines and potential alternative approaches when a patient does not meet guidelines for ICD implantation,” they write.
Consumers who have already received an ICD against guidelines shouldn’t be concerned, commented Dr. Johnathan Steinberg to ABC News. The devices carry little risk once implanted, however, there are serious risks to explantation (taking the device out), even if the ICD wasn’t needed in the first place.
Al-Khatib SM, et al "Non–evidence-based ICD implantations in the United States" JAMA2011; 305: 43-49.
Kadish A, Goldberger J "Selecting patients for ICD implantation are clinicians choosing appropriately?" JAMA 2011; 305: 91-92