Abstract 3040: Prevalence and Predictors of “Off-label” Use of Cardiac Resynchronization Therapy in Patients Enrolled in the NCDR ICD Registry
Introduction: Recent literature has shown that CRT use in clinical practice frequently does not adhere to evidence-based consensus guidelines. We investigated “off-label” CRT-defibrillator usage in the NCDR-ICD registry to explore which factors are most strongly associated with this practice.
Methods: From the NCDR registry, we defined a cohort of 46,198 patients who had a first-time implantation of a CRT-D for primary prevention between January 2006 and June 2008. We defined “off-label” implants as those in which the EF was >35%, the NYHA Class was <III, or the QRS duration was ≤120 ms in the absence of a need for ventricular pacing. The relationships between patient, implanting physician, and hospital characteristics with off-label use of CRT were explored with univariate statistics and hierarchical logistic regression modeling.
Results: Overall, 27.7% of devices were placed without meeting all three of the consensus criteria, most often due to NYHA Class <III (13.2% of implants) or QRS duration ≤120 ms (16.7%). CRT recipients had an EF>35%, a QRS ≤100 ms, or NYHA Class ≤I heart failure in 8.0% of cases. Factors significantly associated with off-label vs. guideline adherent device usage are shown in the table⇓. AF/flutter, previous PCI, and the performance of an EP study prior to implant were associated with increased odds of off-label use, while diabetes, increasing age, female sex, and nonischemic cardiomyopathy were associated with decreased odds. Physician and hospital factors were not associated with the likelihood of off-label use in multivariate analysis.
Conclusions: More than one in four patients receiving CRT devices in the US do not meet guideline based indications. The patterns of this practice are not easily explained by physician or hospital characteristics. The added risk and expense of CRT implantation in these patients is currently questionable.