In Reply: Dr Poole and colleagues note that our definition of ICD implantation within 3 months of a new HF diagnosis as non–evidence based does not accurately reflect the CMS reimbursement criteria or the 2008 guidelines for ICDs.1 We specifically avoided using “non–guideline based” because the guidelines do not explicitly exclude patients with new-onset HF from receiving a primary prevention ICD. However, these guidelines emphasize that recommendations for primary prevention ICDs apply only to patients whose left ventricular ejection fraction remains low despite optimal medical therapy.1 Because achieving optimal medical therapy in patients with newly diagnosed HF is an iterative process, these guidelines imply that ICD therapy is not recommended for such patients until that process has had time to be completed.1 This is clinically important because some of these patients show so much improvement in their left ventricular function with medications that an ICD could be avoided. HF duration in clinical trials of primary prevention ICDs was much longer than 3 months, and the largest and longest trial of ICD therapy in HF patients excluded patients with HF of less than 3 months.2- 4 Thus, implanting an ICD in patients with newly diagnosed HF is non–evidence based.
Al-Khatib SM, Mark D, Hammill S. ICD Implantation and Evidence-Based Patient Selection—Reply. JAMA. 2011;305(15):1537-1540. doi:10.1001/jama.2011.460