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Concerns about the Riata® ST (St. Jude Medical) ICD Lead

In the past year (including three additional case reports in this issue),1–3 reports of perforations with both active and passive fixation St. Jude Medical Riata ST implantable cardioverter defibrillator (ICD) leads (Sylmar, CA, USA) have appeared in the literature.4–6 In some cases, the authors did not report the event directly either to the manufacturer or to the Food and Drug Administration (FDA), believing they were isolated events. It was only when multiple case reports emerged from different geographic areas and were submitted for publication that editors recognized a problem that seemed to be neither isolated nor rare. Thus, a series of events such as these demonstrates not only the value of case reports, but also underscores the obligation of a physician to report important (particularly adverse) events even when an overall pattern is not yet established. When implantable devices are involved, the importance and value of registries providing long term followup and guidance cannot be emphasized strongly enough.7,8 A review of the MAUDE database reports just 15 cases of perforation with the Riata lead with one reported death; this may be a reflection of underreporting. Now back to the lead. What is particularly troublesome about this lead is not only the perforation but its late presentation. Sometimes the lead perforation does not come to clinical attention until it is well beyond the right ventricular free wall. Furthermore with the Riata, the movement continues until it protrudes out several cm into adjacent tissue. This factor seems to distinguish it from a small perforation in which only the tip of the lead penetrates the right ventricular wall. It could result in ventricular asystole if a patient is pacemaker dependent or in failure to successfully defibrillate, both resulting in sudden death. If perforation does not occur in the first three months, can we stop worrying? We do not yet know the answer to this question.