1. Prevalence and Predictors of Off-label Use of Cardiac Resynchronization Therapy: A Report from the ICD Registry TM Adam S. Fein * MD, Yongfei Wang ¥ MS, Jeptha P. Curtis ¥ MD, Frederick A. Masoudi MD, MSPH, Paul D. Varosy MD, Matthew R. Reynolds * MD, MSc, and on behalf of the NCDR Discussion Multiple randomized trials have shown that cardiac resynchronization therapy (CRT) in carefully selected patients leads to improved cardiac function, symptoms, quality of life, and survival. Recent literature has shown that CRT use in clinical practice frequently does not adhere to evidence-based consensus guidelines. We sought to define the extent and nature of device implantation outside consensus guidelines using data from the ICD Registry, and investigate which patient and provider related factors are most strongly associated with off-label CRT usage. BackgroundFigure 1: Investigational Design Table 2: Factors Associated with Off-Label CRT Implantation (Hierarchical Logistic Regression) Results Table 1: Baseline Demographic Characteristics of Study Cohort Figure 2: Time Trend of Off-Label CRT-D Implantation Overall, 27.7% of devices were placed without meeting all three of the consensus criteria, most often due to NYHA Class 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 2. 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 From the ICD 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. Methods More than one in four patients receiving CRT devices in the US from 2006-2008 did not meet guideline based indications. With recent trials showing benefit for CRT in patients with asymptomatic heart failure, even if implants in NYHA Class I /II patients are considered on-label, nearly 20% of implants in that period would still have been off-label. The patterns of this practice are not easily explained by physician or hospital characteristics. The risk-benefit of CRT implantation in at least some of these patients remains questionable CRT-D Implantations between 1/06 to 06/08 n = 105,543 Previous pacemaker (n= 13,622) or ICD (n= 23,479) ICD for Secondary Prevention (n=14,431) or history of cardiac arrest (n =954), sustained VT (n=1,035), or syncope (n=5,420) EF was >35% (n = 601) NYHA Class was < III (n=6,081) QRS duration 120 ms without a need for ventricular pacing (n=7,619) OFF-Label CRT-D Implantation Group 33,408 CRT-D Implantations in Adherence with ACC/AHA Guidelines Exclusions CRT-D Implantations Identified as Study Cohort (n=46,198) Investigating the use of CRT in clinical practice using a large, national patient registry, our study had four main findings: 1)A substantial proportion of patients in general practice received new CRT placement outside clinical guideline recommendations from 2006-08. 2)This pattern of overuse is pervasive, and not easily explained by geographic, hospital, or physician factors. 3)Guideline non-adherence for CRT implantation varies by gender, race, history of atrial fibrillation, and a prior pattern of invasive cardiac interventions. 4)There was no significant trend toward increasing or decreasing adherence to guideline-based indications over the time period of this study. *Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; ¥ Yale University School of Medicine, New Haven, CT; Denver Veterans Affairs Medical Center, University of Colorado Denver; Denver Health Medical Center & University of Colorado Denver For more information go to www.ncdr.com or email ncdrresearch@acc.orgwww.ncdr.com