20% of people who receive ICDs (implantable cardioverter-defibrillators) do not meet evidence-based guidelines for their use, and were found to have a significantly higher risk of dying in hospital compared to those who did meet the criteria, researchers from Duke Clinical Research Institute revealed in JAMA (Journal of the American Medical Association).
An Implantable Cardiac Defibrillator or ICD is a device that is placed in the patient’s body and is designed to recognize specific types of arrhythmias (abnormal heart rhythms) and correct them. For example, an ICD may recognize and correct a rapid regular beating into the ventricles (ventricular tachycardia), or a rapid irregular beating of the ventricles (ventricular fibrillation). The ventricles are the bottom chambers of the heart. The ICD delivers precisely calibrated and timed electric shocks which restore normal heartbeat.
The authors explain that several studies have demonstrated how effective ICDs are in preventing sudden cardiac arrest in individuals with advanced systolic heart failure. However, ICDs are not recommended for primary prevention in those who are recovering from a coronary artery bypass graft surgery, a heart attack, or severe heart failure symptoms, according to practice guidelines. They are not recommended for patients with a recent diagnosis of heart failure either.
The authors wrote:
“The degree to which physicians in routine clinical practice follow these evidence-based recommendations is not clear.”
Sana M. Al-Khatib, M.D., M.H.S., and team set out to find out the characteristics and in-hospital outcomes of individuals who had received a non-evidence-based ICD. They gathered data from the National Cardiovascular Data Registry-ICD Registry between January 2006 and June 2009.
25,145 ICD initial primary prevention ICD implants, out of a total of 111,707 occurred among non-evidence based patients (22.5%), the researchers found. Of these, 36.8% (9,257) occurred in patients within 40 days of a heart attack and 62.1% (15,604) among those with newly diagnosed heart failure.
Non-evidence-based patients who received an implant had a 0.57% risk of dying in hospital, compared to a 0.18% risk among the evidence-based patients.
Non-evidence-based patients who received an implant had a 3.23% risk of a post-procedure complication, compared to 2.41% among the others.
The authors wrote:
“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 researchers found that the risk of any adverse event and death were considerably higher among the non-evidence-based device recipients, and their stay in hospital was longer (3 days compared to 1).
Below are the proportions of ICD implants performed by various medical specialists:
- Electrophysiologists 66.6%
- Non-electrophysiologist cardiologists 24.8%
- Thoracic surgeons 2.6%
- Other specialists 6.1%
The authors wrote:
“During this period of limited resources and due to the Centers for Medicare & Medicaid Services’ emphasis on quality improvement by promoting evidence-based care, it is increasingly important to assess hospital performance and to provide feedback to hospitals about their outcomes and compliance with clinical guideline recommendations. Providing such feedback to hospitals has the potential to improve adherence to practice guidelines and eventually patient outcomes.
.. more efforts should focus on enhancing adherence to evidence-based practice.”
Alan Kadish, M.D., of Touro College, New York, and Feinberg School of Medicine, Northwestern University, Chicago, and Jeffrey Goldberger, M.D., of the Feinberg School of Medicine, Northwestern University, Chicago, say that the cardiovascular care community needs to act on the findings of this study in order to improve public health.
They wrote:
“There are several important considerations. Further information and specific data are needed to characterize some of the issues, such as how well the National Cardiovascular Data Registry captures some of the subtleties of ICD indications and whether reasons for deviations from the guidelines can be captured accurately. Once this is accomplished, it is possible that prospective data entry in an online system can be developed to provide immediate feedback regarding the presence or absence of an evidence-based indication for an individual patient prior to ICD implantation.
“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. In addition, as a matter of public policy, health care organizations must assess whether quality of care and cost-effectiveness can be improved by mandating the Heart Rhythm Society’s guideline for formal training in an approved fellowship training program. If properly applied, the findings of the study by Al-Khatib et al may improve practice patterns and outcomes, with the unique opportunity to do so while lowering health care costs.”
Sana M. Al-Khatib, MD, MHS; Anne Hellkamp, MS; Jeptha Curtis, MD; Daniel Mark, MD, MPH; Eric Peterson, MD; Gillian D. Sanders, PhD; Paul A. Heidenreich, MD, MS; Adrian F. Hernandez, MD, MHS; Lesley H. Curtis, PhD; Stephen Hammill, MD
JAMA. 2011;305(1):43-49. doi: 10.1001/jama.2010.1915
Written by Christian Nordqvist