The ACC Foundation (ACCF) and Heart Rhythm Society (HRS), along with key specialty societies, on Feb. 28 released appropriate use criteria (AUC) for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT)
This is the first document to use the updated ACCF AUC Methodology which was released Feb. 21. "The goal of this document is to help inform medical decisions and assist clinicians and stakeholders in understanding areas of both consensus and uncertainty, while identifying areas where there are gaps in knowledge that warrant further research," noted Andrea M. Russo, MD, FACC, writing committee co-chair and director of Electrophysiology and Arrhythmia Services at Cooper University Hospital..
The document provides assessed levels of appropriateness for implanting ICDs and CRTs in 369 real-life case scenarios, with the goal of enhancing physician and patient decision making and improving care and health outcomes. Of the scenarios, 45 percent were deemed Appropriate, 33 percent were rated May Be Appropriate, and 22 percent were deemed Rarely Appropriate.
Six areas are covered within the document: ICDs for primary prevention, ICDs for secondary prevention, comorbidities, CRT devices, generator replacements with pre-existing cardiovascular implantable electronic devices, and dual- vs. single-chamber ICDs.
"The AUC document was made possible only because of tremendous efforts made by the writing group and reviewers of the paper," said Andrew E. Epstein, MD, FACC, member of the writing committee and professor of medicine, Electrophysiology Section, Cardiovascular Division, University of Pennsylvania. "Hundreds of clinical scenarios were constructed, appropriateness graded by a panel, reviewed and rechecked again. The paper represents a consensus of appropriateness based on the best clinical evidence available and experience of expert physicians in the device field."
The writing group notes that the new AUC "should be used in conjunction with the ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities and the 2012 focused update, and are meant to provide additional guidance concerning the decision to implant ICDs and CRT devices in a variety of clinical scenarios that may or may not be represented in the guidelines, often providing additional guidance in areas where there are gaps in guidelines."
"The decision to implant an ICD or CRT devise is often complex, based on clinical evidence and clinical judgment, while taking into account comorbidities and other individual patient factors," added Russo. "While this document was designed to help inform clinical decision making, it does not establish 'rules' by which decisions should be made in clinical practice. Health care providers and other stakeholders should continue to acknowledge the pivotal role of clinical judgment in determining whether device implantation is indicated for an individual patient."
"Appropriate use of ICDs has been garnering attention over the past few years, and this document helps address some of these concerns," said Mark Kremers, MD, FACC, FHRS, member of the writing committee and chair of the ICD Registry steering committee. “While there is a mandate from the Centers for Medicare & Medicaid Services that all Medicare Primary Prevention ICD implants be tracked in the NCDR’s ICD Registry™, we are fortunate that 80 percent of the centers enroll all their patients. Thus, 90 percent of all implants are entered into the Registry ensuring that we have robust and representative data.”
The AUC were developed in collaboration with the American Geriatrics Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance.
The document was published online Feb. 28 and will appear in the March 26 print issue of the Journal of the American College of Cardiology.