New appropriate-use criteria outline how implantable cardioverter defibrillators and cardiac resynchronization therapy may be employed in any of 369 clinical scenarios.
Written by a joint committee of the American College of Cardiology and the Heart Rhythm Society, along with other specialty groups, the document focuses on the treatments’ uses in primary and secondary prevention and on how to gauge their use in the face of specific comorbidities It was published in the Feb. 28 issue of the Journal of the American Association of Cardiology (J. Am. Coll. Cardiol. 2013;61 [doi:10.1016/j.jacc.2012.12.017]).
Two years in the making, the criteria are based on a review of 61 clinical trials with widely differing inclusion and exclusion criteria encompassing an extremely broad group of patients. The writing group was cochaired by Dr. Andrea M. Russo, professor of medicine at UMDNJ/Robert Wood Johnson Medical School, and Dr. Raymond F. Stainback of Baylor College of Medicine, Houston. Although they cover a plentitude of situations, the paper represents a much-simplified universe, said Dr. Paul Hauptman, a member of the technical committee involved in the document’s construction.
In fact, an early draft of the criteria contained recommendations for many more clinical situations, Dr. Hauptman said in an interview. "It could have been double or even triple this number. The complete paper tries to bring some semblance of order to the decision-making process."
The clinical scenarios covered in the document fall into one of six areas: implantable cardioverter defibrillators (ICDs) for secondary prevention, ICDs for primary prevention, comorbidities, cardiac resynchronization therapy (CRT) devices, generator replacement, and dual- versus single-chamber ICDs.
Despite their detailed focus, the criteria must be seen – and used – as a guide, not as a cookbook. The individual patient’s situation must always be the primary point of decision-making, said Dr. Hauptman, professor of internal medicine and assistant dean of clinical-translational research at Saint Louis (Mo.) University.
What the document doesn’t take into account is just as important as what it does, he noted. "Patient preference still has to come into play. We can never forget that at the end of the day, our patient needs to be a full partner in the decision process."
Each of the 369 indications was scored on a scale of 1-9. Just under half of the scenarios (45%) received a rating of appropriate, 33% were rated "may be appropriate," and 22% "rarely appropriate." This is the first guideline to use this updated methodology (J. Am. Coll. Cardiol. 2013;61 [doi:10.1016/j.jacc.2013.01.025]). The criteria committee noted that, in this case, the rating of possibly appropriate may reflect the state of research as much as the true clinical utility.
"It is important to recognize ... that ratings in this middle category may represent either the lack of sufficient data to inform the decision or the fact that, depending on other clinical factors not considered in the brief scenario, device implantation may or may not be considered beneficial. The wide breadth of scenarios rated as ‘May Be Appropriate’ raises the importance of recognizing the role of applying clinical judgment to decision-making when encountering patients who broadly meet these criteria."
A rating of "appropriate" doesn’t mean that the treatment is mandatory. However, a rating of "rarely appropriate" is a strong judgment indicator. "Scenarios for which there were data showing harm, or nodata were available, and medical judgment deemed device therapy ill-advised were categorized [thus]. For example, comorbidities including life expectancy and cognitive function impacted appropriateness ratings," the authors wrote.
They maintained that the document’s primary impetus is to guide good medical care, not to be a reimbursement guide. "Some of the scenarios that are deemed ‘appropriate’ ... may not currently qualify for insurance coverage. For patients, physicians, and insurers, these distinctions are of critical importance because commitment to patient-centered care may warrant implantation of a device appropriate for the individual patient’s situation, but it may not fit precisely into a covered indication as defined by coverage policy and requires use of best clinical judgment."
The criteria committee, however, acknowledged that payers may use the document as such. In this light, they suggested that clinical information should support each treatment decision, whatever its appropriateness rating.
For example, "services rendered for ‘rarely appropriate’ indications should be considered in the context of the clinical situation. Namely, supporting documentation that informed the clinical decision should be sought, as other factors beyond those described in the brief clinical scenarios included in this document may have entered into clinical decision-making."
Dr. N.A. Mark Estes, director of the New England Cardiac Arrhythmia Center at Tufts Medical Center, Boston, said that the document’s intended purpose and its actual use may squeeze physicians in the middle.