Innovative Collections

DOI: 10.19102/icrm.2012.030208

Brian Olshansky, MD, FHRS, FACC, FAHA

Editor-in-Chief

Another Tip of an Iceberg? Data from Belfast Raises Concern about the Tendril Lead

A weak link in any cardiac rhythm management device is the pacemaker or defibrillator lead(s). Several lead recalls have occurred. Recently, Lau and colleagues,¹ from Belfast, provided important evidence to the world pacing and defibrillation community warning of risks to patients related to problems with the St. Jude Riata lead. One abstract altered our world.

Their first observations, reported some time ago, indicated something was amiss with the Riata lead.² Other reports indicated various problems^3–13 even though some would say that these issues were “clinically acceptable,”¹⁴ especially when the lead was implanted in a non-apical position (with regard to perforation, at least).¹⁵

Now, we are in the midst of a potentially serious recall of the Riata lead directly related to information that arose from rather humble observations made in Belfast. The long-term risks and the best methods to ameliorate those risks are emerging, but are by no means certain.¹⁶

In this present case report,¹ Dr. Lau raises concerns regarding a St. Jude pacing lead. Two years after implantation of a St. Jude Tendril ST 1788/ST lead, extraction was performed due to the presence of suspected infective endocarditis. Upon extraction, evidence for an external insulation breach was present near the lead tip in this non-apical lead implant. Based on the information available, and considering that there may have been trauma to the lead during the extraction process, the removed lead appeared to show evidence for a highly suspicious, and ongoing, “inside-out” abrasion that was associated with disruption of the outer insulation. It was unlikely that this abrasion was due to the removal process.

These data raise concern about the Tendril pacemaker lead. The pacemaker and lead system appeared to be functioning within acceptable limits on interrogation so there was no way to know that this was actually occurring. This type of lead failure has been reported only with defibrillation leads previously.

Similar to issues raised several years ago in a singular case report by the same investigative group that many may have simply passed by, we now know that there can be serious problems with the Riata lead. Our level of concern about the Tendril lead is now raised by the observations made in this case report.

I congratulate, and thank, Dr. Lau for bringing these observations to our attention. No one likes to hear about potentially serious lead issues, but we are better off knowing than remaining in the dark. It will be important to pay careful attention to any further problems with Tendril leads. Hopefully, this case report does not reflect a larger and more serious issue that could be with us for years to come.

Brian Olshansky, MD, FHRS, FACC, FAHA
brian-olshansky@uiowa.edu
Professor of Medicine
Cardiac Electrophysiology
University of Iowa Hospitals
Iowa City, IA

References

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