Overuse of Implantable Heart Defibrillators Putting Patients at Risk

A new study finds that <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">implantable cardioverter-defibrillators (ICDs) may be overused. According to the study, published in the January 5 issue of the Journal of the American Medical Association (JAMA), about 20 percent of patients receiving ICDs don’t meet evidence-based guidelines for their use. What’s more, those patients had a significantly higher risk of in-hospital death than individuals who met criteria for receiving an ICD.

Implantable defibrillators administer an electrical shock to a heart that is beating erratically to jolt it back into a normal rhythm. Practice guidelines do not recommend use of an ICD for primary prevention in patients recovering from a heart attack or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure.

For this study, researchers examined a registry of implants maintained by the American College of Cardiology that covers an estimated 95 percent of all US implants. The researchers found that of 111,707 initial primary prevention ICD implants that occurred during the study period, 25,145 were for a non-evidence-based indication (22.5 percent). Of these, 9,257 were in patients within 40 days of a heart attack (36.8 percent) and 15,604 were in patients with newly diagnosed heart failure (62.1 percent).

The risk of in-hospital death was significantly higher in patients who received a non-evidence-based device than in patients who received an evidence-based device (0.57 percent vs. 0.18 percent). The risk of any post-procedure complication was significantly higher in the non-evidence-based ICD group at 3.23 percent compared with 2.41 percent in the evidence-based group.

Any adverse event and death were significantly higher in patients who received a non-evidence-based device, according to the study. The median (midpoint) length of hospital stay was significantly longer for patients who received a non-evidence-based ICD compared with patients who received an evidence-based ICD (3 days vs. 1 day).

“Although the absolute difference in complications between the 2 groups is modest, these complications could have significant effects on patients’ quality of life and health care use, including length of hospital stay and costs. Importantly, these complications resulted from procedures that were not clearly indicated in the first place. 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 wrote.

The researchers asserted that more efforts should focus on enhancing adherence to evidence-based practice when it comes to the implantation of ICDs.

This entry was posted in Defective Medical Devices, Health Concerns. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.