Today, St. Jude Medical will be proactively informing physicians and patient of the withdrawal of their older-generation QuickSite and QuickFlex silicone left ventricular pacing leads (Models 1056T, 1058T, 1156T and 1158T) from the market after reports have surfaced of externalized conductors.
According to their notification, there have been 39 confirmed cases out of 171,000 leads sold worldwide.
While none of the pacing leads have demonstrated evidence of malfunction, the nature of this malfunction is important because it can occur without detection unless the patient undergoes fluoroscopic (x-ray) evaluation.
The newer versions of the unipolar QuickFlex (Model 1056K) and QuickFlex Micro (Model 1258T) and Quartet model 1458Q are NOT subject to this recall because their construction utilizes St. Jude’s Optim insulation rather than silicone insulation.
For St. Jude Medical, this latest revelation comes at a difficult time as physicians are still trying to deal with the management of St. Jude’s earlier-generation recalled silicone defibrillator leads, the Riata and Riata ST.
The revelation that this externalization can now affect St. Jude’s bradycardia left ventricular pacing leads will no doubt affect physician’s device selection. It is also clear that St. Jude Medical’s portfolio of products for their lucrative cardiac rhythm management division will be significantly impacted.
For patients with these left ventricular pacing leads, follow-up of their system may involve x-ray evaluation on an intermittent basis, but I do not think that St. Jude and its physician advisory board will recommend removal of these leads, given the risks of infection and trauma that might be inherent to that procedure.
More likely, careful routine follow-up of these leads will be all that is required for now with the addition of at least one surveillance x-ray evaluation of the patient’s LV lead and RV lead systems.