Kaplan-Meier analysis of freedom from extraction or death in patients with an accufix J retention wire atrial permanent pacemaker lead: A potential management tool

David T. Kawanishi, Jeffrey A. Brinker, Russell Reeves, G. Neal Kay, Jay Gross, Guy Pioger, Jean Claude Petitot, Anne Esler, Gary Grunkemeier

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Morbidity (36 cases) and mortality (6 cases) have been reported in patients with Accufix J retention wire atrial leads. This has resulted in ongoing patient fluoroscopic monitoring as well as lead extractions. The estimated implanted worldwide population is 40,860. Estimating the size of the remaining population at risk is an important tool for assessing patient management guidelines. Results: The Kaplan-Meier method can be used to calculate the cumulative probability of remaining free of extraction and death for patients based on implant duration. The individual Kaplan-Meier curves for lead extraction and patient survival can also be computed. Based on the Multicenter Study (MCS) population of 2,298 patients, the probability that a patient is alive with the lead still implanted at 5 years implant duration is 52.5%. The event-free survival rate at 5 years implant duration is 81.3%. The corresponding probability of remaining free from injury due to the J-wire is 99.9% at 5 years implant duration. Assuming similar rates of death and extraction, these results can be extrapolated to the world wide population. Conclusions: The management of Accufix patients must consider patient longevity, the probability of J-wire morbidity/mortality, and the probability of extraction complication morbidity/mortality. The probability of remaining at risk as a function of time from implant can be calculated from the events known in the MCS patient population. These event-free survival estimates can be used to identify subsets of the population at greater or lesser risk based on various clinical parameters.

Original languageEnglish (US)
Pages (from-to)2318-2321
Number of pages4
JournalPACE - Pacing and Clinical Electrophysiology
Volume21
Issue number11 II
DOIs
StatePublished - Nov 1998
Externally publishedYes

Keywords

  • Clinical follow-up
  • Device failure
  • Kaplan-Meier statistics
  • Lead extraction
  • Permanent pacemaker lead

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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