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IMPACT OF THE MEDTRONIC FIDELIS LEAD RECALL ON UTILIZATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS: DATA FROM THE NCDR ICD REGISTRY
A14.E132 JACC March 9, 2010 Volume 55, issue 10A
CARDIAC ARRHYTHMIAS IMPACT OF THE MEDTRONIC FIDELIS LEAD RECALL ON UTILIZATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS: DATA FROM THE NCDR ICD REGISTRY ACC Poster Contributions Georgia World Congress Center, Hall B5 Tuesday, March 16, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Defibrillation/Implantable Antiarrhythmia Devices Abstract Category: Defibrillation/Implantable Antiarrhythmia Devices Presentation Number: 1245-137 Authors: Paras S. Bhatt, Jeptha Curtis, Yongfei Wang, Rachel Lampert, Yale University School of Medicine, New Haven, CT Background: Prior studies have demonstrated substantial underuse of ICDs in appropriate patients. Whether recalls may contribute to this underutilization has not been examined. Methods: To determine if the October 2007 recall of the Medtronic Fidelis lead was associated with a decrease in the volume of national ICD procedures, we analyzed data submitted to the NCDR ICD registry between January 2007 and December 2008, excluding patients with prior ICD or receiving a biventricular ICD. We evaluated monthly volume of ICD implants and compared the slope of ICD implants prior to the recall with the slope following. Analyses were stratified by indication (primary versus secondary). Finally, we assessed the association of the recall on the proportion of cases using Medtronic device. Results: The average monthly implant volume was 4891. While there was a modest trend towards decreased total and primary-prevention ICD implant volume during the overall time-period (p=0.16 and p=0.052 respectively), the slopes pre- and post-recall were not significantly different (p>0.1, see graph). The proportion of Medtronic implants declined from 50.0% in the 9 months prior to the recall to 45.5% in the 15 months after the recall (P<0.0001). Conclusions: Overall, total and primary prevention ICD implantation decreased slightly from January 2007 to December 2008. However, while the Fidelis recall was associated with a substantial decline in Medtronic market share, there was no significant impact on implant volume.
CARDIAC ARRHYTHMIAS IMPACT OF THE MEDTRONIC FIDELIS LEAD RECALL ON UTILIZATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS: DATA FROM THE NCDR ICD REGISTRY ACC Poster Contributions Georgia World Congress Center, Hall B5 Tuesday, March 16, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Defibrillation/Implantable Antiarrhythmia Devices Abstract Category: Defibrillation/Implantable Antiarrhythmia Devices Presentation Number: 1245-137 Authors: Paras S. Bhatt, Jeptha Curtis, Yongfei Wang, Rachel Lampert, Yale University School of Medicine, New Haven, CT Background: Prior studies have demonstrated substantial underuse of ICDs in appropriate patients. Whether recalls may contribute to this underutilization has not been examined. Methods: To determine if the October 2007 recall of the Medtronic Fidelis lead was associated with a decrease in the volume of national ICD procedures, we analyzed data submitted to the NCDR ICD registry between January 2007 and December 2008, excluding patients with prior ICD or receiving a biventricular ICD. We evaluated monthly volume of ICD implants and compared the slope of ICD implants prior to the recall with the slope following. Analyses were stratified by indication (primary versus secondary). Finally, we assessed the association of the recall on the proportion of cases using Medtronic device. Results: The average monthly implant volume was 4891. While there was a modest trend towards decreased total and primary-prevention ICD implant volume during the overall time-period (p=0.16 and p=0.052 respectively), the slopes pre- and post-recall were not significantly different (p>0.1, see graph). The proportion of Medtronic implants declined from 50.0% in the 9 months prior to the recall to 45.5% in the 15 months after the recall (P<0.0001). Conclusions: Overall, total and primary prevention ICD implantation decreased slightly from January 2007 to December 2008. However, while the Fidelis recall was associated with a substantial decline in Medtronic market share, there was no significant impact on implant volume.