New HRS/ACC/AHA Statement on ICDs in Patients Who Are Not Included or Well Represented in Clinical Trials
The ACC, the Heart Rhythm Society (HRS) and the American Heart Association (AHA) have released an expert consensus statement on the use of implantable cardioverter defibrillators (ICDs) in patients who are not included or not well represented in clinical trials. The statement provides a first-of-its-kind direction on ICD therapy since the patient populations are not specifically included in existing guidelines. The statement was released May 9 during Heart Rhythm 2014, and simultaneously published in the Journal of the American College of Cardiology .
For years ICDs have served as an effective means of stopping life-threatening abnormal heart rhythms and an important treatment option for patients who are at risk of sudden cardiac arrest. While a great number of patient populations have experienced the benefits of the device, there are however, still those who fall outside the standard guidelines for treatment.
Performing a comprehensive literature search, the authors of the statement developed a series of recommendations, providing an explanation of the reasoning and research used to make each one. Key among these recommendations were situations for which ICD therapy might be beneficial in selected populations: in patients with an abnormal troponin that is not due to a myocardial infarction, within 40 days after a myocardial infarction, within the first 90 days after revascularization, and in the first nine months after initial diagnosis of nonischemic cardiomyopathy.
In addition to these new treatment guidelines, the authors also evaluated the utility of an atrial lead in a patient requiring ICD therapy without cardiac resynchronization therapy (CRT), providing recommendations for specific scenarios where CRT is not indicated or not desired and a physician must choose between a single or dual-chamber ICD.
Ultimately the goal of all the recommendations is to help improve the consistency and overall quality among hospitals and health care providers, leveraging the benefits of ICD therapy to an even larger population.
"Without exception, guidelines help clinicians make important decisions when it comes to ICD therapy, however, we must continue to refine our understanding of who benefits from ICD implantation in order to optimize patient care," said Fred M. Kusumoto, MD, FACC, lead author of the statement. "Because guidelines are mainly determined by the outcomes of large clinical trials, smaller patient populations or unique circumstances are typically not provided with indications for treatment. This document will serve as a new guide for clinicians so that many more, if not all, patients receive the right treatment at the right time."
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