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View Public Comments for Implantable Cardioverter Defibrillators (CAG-00157R4)

Lampert, Rachel
Professor of Medicine (Cardiology)
Yale School of Medicine

There are three areas I would like to see addressed in any reconsideration of the NCD for ICDs.

First, current coverage for ICDs in patients with non-ischemic cardiomyopathy should not be impacted by the recent DANISH study which did not show benefit in this group. This study was deeply flawed by the fact that over half of the patients in each group received CRT. The results therefore do not address benefit in NICM pts requiring ICDs for primary prevention. This group was addressed in the SCD-HeFT in which NICM was a predefined subgroup. There was significant benefit from the ICD in that study, as well as in a recent meta-analysis.

Second, while benefit in subpopulations such as the elderly or those with renal dysfunction has been questioned, robust meta-analyses do show benefit of the ICD in these populations

Finally, there are currently several subpopulations in whom the ICD is not currently covered, which leads to suboptimal care. A major source is the exclusion of all patients for time periods after MI or revascularization. There should be an exception made for those in whom bradycardia pacing is needed urgently as implantation of one device after the MI, and then an upgrade later, puts a patient at high risk of infection and other implant complications