Impact of a Recent Lead Recall on Utilization of Implantable Cardioverter Defibrillators: Data from the NCDR ICD Registry™

Abstract

Underutilization of ICDs is well documented. It has been hypothesized that device recalls, and the resultant negative publicity, may contribute. To determine if the October 2007 recall of the Medtronic Fidelis lead was associated with a decrease in volume of ICD procedures in the United States, we analyzed data submitted to the ICD Registry™ between July 2006 and December 2008. Time-series analyses were performed comparing actual and predicted implant volumes following the recall, using monthly data from July 2006 to September 2007 to establish a trend line. Observed data points falling outside the 95% CIs from the trend line were considered statistically significant. The study cohort includes 173,616 implantations in 658 hospitals. Before October 2007, an average of 5,952 devices, 4,910 for primary prevention, were implanted per month. Following the recall, the average monthly number of implants was modestly lower at 5,623 (P = 0.05), 4,601 for primary prevention (P = 0.01.) However, as volume was decreasing prior, in time-series analysis, the observed monthly implant volume for primary prevention devices differed from expected based on the trend line for only 1 month. The proportion of Medtronic implants declined from 51.1% in the 15 months prior to the recall to 45.8% in the 15 months of the recall or after (P < 0.01), falling outside the 95% CI of the trend line for 3 months in time-series analysis. A recent well-publicized lead recall had minimal impact on ICD utilization either overall or for primary prevention.