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

Impact of Recalls on ICD Utilization . Introduction: Underutilization of ICDs is well documented. It has been hypothesized that device recalls, and the resultant negative publicity, may contribute. Methods and Results: 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. Conclusions: A recent well‐publicized lead recall had minimal impact on ICD utilization either overall or for primary prevention. (J Cardiovasc Electrophysiol, Vol. 23, pp. 861‐865, August 2012)     

Passage through the carotid sheath: An alternative path to the pre-spinal route for direct repair of contralateral C7 to the lower trunk in total brachial plexus root avulsion injury

Context:In surgical management of global brachial plexus injuries, direct repair of contralateral C7 (cC7) to the anterior division of the lower trunk, can produce good extrinsic finger flexion. The pitfalls associated with the pre-spinal passage have, perhaps, proved to be a deterrent for using this technique routinely.Aims:The aim of this study is to demonstrate an alternative to pre-spinal route for cC7 transfer in brachial plexus avulsion injuries.Methods:We noted that the mobilised lower trunk, which reaches the level of the scalenus anterior by passage deep to the clavicle, can be brought to the suprasternal notch when brought out from below the clavicle. This area was dissected in two cadavres, and safe passage was found through the carotid sheath with the common carotid artery medially and the internal jugular vein with the vagus nerve laterally. The cC7 root dissected medial to the scalenus anterior muscle can be directly transferred along this path to the subcutaneous plane at the suprasternal notch. This study allowed us to execute a direct repair in ten clinical cases of global brachial plexus injuries. In each case, the passage was prepared rapidly and uneventfully. The repair was technically simple and could be performed comfortably using suitable fine suture materials. In none of these cases, did we need to shorten the humerus.Results:The clinical outcome of this technique is awaited.Conclusions:We advocate carotid sheath route to approximate the cC7 to the injured lower trunk in global palsies, as the risks associated with the pre-spinal route can be readily avoided.KEY WORDS: Anterior division of lower trunk, brachial plexus injury, carotid sheath route, contralateral C7, direct repair, finger flexion