Cardiac Rhythm Management
Articles Articles 2012 February

Section Editor Commentary: Another Tip of an Iceberg?

 

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

Brian Olshansky

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 problems3–13 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.

References

  1. Kodoth V, Cromie N, McEneaney D, Wilson C, Lau E, Roberts MJ. Riata lead failure: A report from Northern Ireland Riata lead screening programme. Irish J Med Sci 2011; 180(Suppl 11):371–409.
  2. Lau EW, Shannon HJ, McKavanagh P. Delayed cardiac perforation by defibrillator lead placed in the right ventricular outflow tract resulting in massive pericardial effusion. Pacing Clin Electrophysiol 2008; 31:1646–1649.
  3. Chien WW, Chin J. Acute perforation in spite of implantation with an “antiperforation” defibrillator lead. Pacing Clin Electrophysiol 2009; 32:1598–1599
  4. Hermanides R, Ottervanger J, Elvan A, Ramdat Misier A. Life-threatening perforation of a defibrillation lead. Neth Heart J 2009; 17:113–114.
  5. Krebsbach A, Alhumaid F, Henrikson CA, Calkins H, Berger RD, Cheng A. Premature failure of a riata defibrillator lead without impedance change or inappropriate sensing: A case report and review of the literature. J Cardiovasc Electrophysiol 2011; 22:1070–1072.
  6. Lloyd MS, Shaik MN, Riley M, Langberg JJ. More late perforations with the riata defibrillator lead from a high-volume center: an update on the numbers. Pacing Clin Electrophysiol 2008; 31:784–785.
  7. Morrison TB, Ackerman MJ, Rea RF. Subacute perforation of the St. Jude Riata implantable cardioverter-defibrillator lead: a report of two pediatric cases. Pediatr Cardiol 2009; 30:834–836.
  8. Rordorf R, Canevese F, Vicentini A, et al. Delayed ICD lead cardiac perforation: Comparison of small versus standard-diameter leads implanted in a single center. Pacing Clin Electrophysiol 2011; 34:475–483.
  9. Vlay SC. Concerns about the Riata ST (St. Jude Medical) ICD lead. Pacing Clin Electrophysiol 2008; 31:1–2.
  10. Turakhia M, Prasad M, Olgin J, et al. Rates and severity of perforation from implantable cardioverter-defibrillator leads: a 4-year study. J Interv Card Electrophysiol 2009; 24:47–52.
  11. Erkapic D, Duray GZ, Bauernfeind T, De Rosa S, Hohnloser SH. Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol 2011; 22:1018–1022.
  12. Ellis CR, Rottman JN. Increased rate of subacute lead complications with small-caliber implantable cardioverter-defibrillator leads. Heart Rhythm 2009; 6:619–624.
  13. Danik SB, Mansour M, Singh J, et al. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm 2007; 4:439–442.
  14. Porterfield JG, Porterfield LM, Kuck KH, et al. Clinical performance of the St. Jude Medical Riata defibrillation lead in a large patient population. J Cardiovasc Electrophysiol 2010; 21:551–556.
  15. Corbisiero R, Armbruster R. Does size really matter? A comparison of the Riata lead family based on size and its relation to performance. Pacing Clin Electrophysiol 2008; 31:722–726.
  16. Hauser RG, McGriff D, Retel LK. Riata ICD lead failure: analysis of explanted leads with a unique insulation defect. Heart Rhythm 2011; DOI: 10.1016/j.hrthm.2011.12.019.

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