Study: Many physicians not following ICD guidelines
JAMA study was based on NCDR
Many physicians are making the decision to implant defibrillators specifically, implantable cardioverter defibrillators (ICDs) in patients in cases where established guidelines based on the results of previous clinical trials do not appear to support implantation, according to a recent study.
The study was published Jan. 5 in the Journal of the American Medical Association (JAMA) and titled "Non-Evidence-Based ICD Implantations in the United States."1
The study authors analyzed data from the National Cardiovascular Data Registry's (NDCR's) ICD Registry, which was initiated in 2006 and is maintained by the American College of Cardiology in Washington, DC. The study was designed to determine, in part, the extent to which physicians "in routine clinical practice" follow established evidence-based guidelines.
Of the 111,707 patients who met the study criteria and for whom all data was available and who received an ICD implant between Jan. 1, 2006, and June 30, 2009 22.5% were implanted based on a non-evidence-based indication. Those non-evidence-based implantations included implantation within 40 days of a myocardial infarction, implanting an ICD within three months of coronary artery bypass graft (CABG) surgery, and in patients with newly diagnosed heart failure.
"Patients who received a non-evidence-based ICD were significantly older and had more comorbid disease than patients who received an evidence-based ICD. . . In addition, patients who received a non-evidence-based ICD were more likely to belong to a racial minority group (other than black) and to receive a dual chamber ICD," the authors write.
The risk of in-hospital death was also significantly higher in those patients receiving a non-evidence-based ICD vs. an evidence-based device, the study showed. Such patients "are more likely to have worse intermediate and long-term outcomes including mortality. However, this finding needs to be confirmed by future studies," the authors write.
The ACC's President Ralph Brindis, MD, MPH issued formal comments regarding the study.
"The study being published . . . in the Journal of the American Medical Association will, without a doubt, have major implications for physicians and hospitals in their evaluation of their practice patterns related to ICD implantation for primary prevention of sudden cardiac death," the statement reads.
"The study indicates that there are substantial variations among hospital ICD implantation strategies. This variation clearly demonstrates an opportunity for improvement in care. It is our hope that feedback and education to hospitals and clinicians about this important data will change practice patterns to benefit our patients," Brindis said.
What is the impact?
In an editorial that addressed the study results and was also published in the Jan. 5 issue of JAMA, authors Alan Kadish, MD, and Jeffrey Goldberger, MD write that the study's findings should be used "to inform public health policies toward the appropriate use of this life-saving but expensive technology."2
"The first question that needs to be addressed involves the reliability of the data. The ICD Registry is a well-audited tool that is robust and provides important information. . . Nonetheless, some variables in the registry may not be accurate. For example, more physicians self-reported being board-certified electrophysiologists in the ICD Registry than have actually been board-certified," Kadish and Goldberger write.
In an interview with Medical Ethics Advisor, Brindis suggested that the study results may suggest the need for fine-tuning the established ICD guidelines for implantation and the indications for which an ICD is considered appropriate treatment. However, there is also the necessary component of additional education needed to better inform physicians about the requirements of standards of care, he says.
"Clinical guidelines are just that: They guide us as to what probably is best for our patients, but every patient has nuances that are different; and we appreciate that, and so they're not carried down from Mt. Sinai etched in granite," Brindis tells MEA. "But they offer huge guidance and direction for clinicians."
Brindis says "the most fascinating part" of the paper is the "graph that shows that the variation between hospitals in the rate of not following the guidelines was as low as essentially zero, but as high as 50%. So, in my mind, it would tell even a skeptic that we have opportunities for improvement in how we do things."
Brindis points out that from an educational perspective, another interesting finding of the paper was that "the rate of 'inappropriateness' was also dependent on the level of training and expertise of the [implanting physician]," he says.
The data that is being fed back to hospitals from the ACC's NCDR will require those institutions to "reexamine their own care locally and try to understand their own variations locally in terms of improving how we utilize these technologies," Brindis notes.
Ethical issues involved
The paper is important in determining "the variations of potential overuse" of ICDs; however, Brindis notes that the "registries are not really geared up in terms of issues of underuse, which requires a . . . different type of data set."
"So, I'm concerned, ethically, particularly with some of the understanding that we've learned from the registry related to socioeconomic and racial disaparities that there's a huge population out there not afforded the opportunities of the implantable defibrillator for primary prevention," Brindis explains.
Another issue of ethical concern related to guidelines, although not addressed in the JAMA paper, is that you could conceivably meet the clinical practice guidelines for an implant, but if a patient is 85 or 90 years old with substantial co-morbidities, Brindis explains that as a clinician who works with families, "We might ask: 'Is this the right thing to do?'"
"This raises the question of how involved we are in decision-making. In other words . . . it could be totally appropriate to implant a defibrillator based on the guidelines criteria in a 91-year-old. You and I might say, 'Is that the right thing to do? Are you really prolonging the life of a 91-year-old in a manner that you would want?'"
From an ethics perspective, Brindis suggests that physicians specializing in cardiovascular disease should utilize "more and more the concept of shared decision-making with patients, with families, and the physicians, with true education understanding the risks of the procedure, the benefits of the procedure, how much longer it would theoretically prolong one's life, what are the downsides of inappropriate shocks, what does it mean to die suddenly vs. not die suddenly. . . I actually do not believe yet that these important conversations are routinely had across the nation."
- Al-Khatib SM et al. Non-Evidence-Based ICD Implantations in the United States. JAMA 2011;305:43-49.
- Kadish A, Goldberger J. Selecting Patients for ICD Implantation. JAMA 2011;305(1):91-92.
- Ralph Brindis, MD, MPH, President of the American College of Cardiology; Senior Advisor for Cardiovascular Disease for Northern California Kaiser; Clinical Professor of Medicine at the University of California, San Francisco; and Affiliated Faculty Member of the UCSF Philip R. Lee Institute for Health Policy Studies. E-mail: firstname.lastname@example.org.