Randomized, controlled trials have shown the effectiveness of implantable cardioverter-defibrillators (ICDs) for preventing sudden cardiac death in patients with advanced systolic heart failure but a new study shows that far too many patients receiving ICDs do not meet evidence-based guidelines for receipt of an ICD, and that these patients had a significantly higher risk of in-hospital death than individuals who met criteria for receiving an ICD.

The study included more than 100,000 patients who received ICDs and found that about 20 percent did not meet evidence-based guidelines.   In times of growing concern about cost versus quality of health care, there will be increased focus on ways to optimize health care, including cost and benefit. 

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 but “The degree to which physicians in routine clinical practice follow these evidence-based recommendations is not clear,” the authors write in the January 5th issue of JAMA about the results (JAMA. 2011;305[1]:43-49).

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 postprocedure 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.

“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 write. 

Any adverse event and death were significantly higher in patients who received a non-evidence-based device. 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). Also, there was substantial variation in  non-evidence-based ICDs by site. 

The proportion of ICD implants performed by the different types of physician specialty was 66.6 percent for electrophysiologists, 24.8 percent for nonelectrophysiologist cardiologists, 2.6 percent for thoracic surgeons, and 6.1 percent for other specialists. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20.8 percent) than nonelectrophysiologists (24.8 percent for nonelectrophysiologist cardiologists; 36.1 percent for thoracic surgeons; and 24.9 percent for other specialties). There was no clear decrease in the rate of non-evidence-based ICDs over time.

“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,” the researchers  write.  
“… more efforts should focus on enhancing adherence to evidence-based practice.”