### 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 mast 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 language | English (US) |
---|---|

Pages (from-to) | 2318-2321 |

Number of pages | 4 |

Journal | PACE - Pacing and Clinical Electrophysiology |

Volume | 21 |

Issue number | 11 II |

State | Published - 1998 |

Externally published | Yes |

### Fingerprint

### Keywords

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

### ASJC Scopus subject areas

- Cardiology and Cardiovascular Medicine

### Cite this

*PACE - Pacing and Clinical Electrophysiology*,

*21*(11 II), 2318-2321.

**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.** / Kawanishi, D. T.; Brinker, J. A.; Reeves, R.; Kay, G. N.; Gross, Jay N.; Pioger, G.; Petitot, J. C.; Esler, A.; Grunkemeier, G.

Research output: Contribution to journal › Article

*PACE - Pacing and Clinical Electrophysiology*, vol. 21, no. 11 II, pp. 2318-2321.

}

TY - JOUR

T1 - Kaplan-Meier analysis of freedom from extraction or death in patients with an Accufix J retention wire atrial permanent pacemaker lead

T2 - A potential management tool

AU - Kawanishi, D. T.

AU - Brinker, J. A.

AU - Reeves, R.

AU - Kay, G. N.

AU - Gross, Jay N.

AU - Pioger, G.

AU - Petitot, J. C.

AU - Esler, A.

AU - Grunkemeier, G.

PY - 1998

Y1 - 1998

N2 - 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 mast 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.

AB - 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 mast 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.

KW - Clinical follow-up

KW - Device failure

KW - Kaplan-Meier statistics

KW - Lead extraction

KW - Permanent pacemaker lead

UR - http://www.scopus.com/inward/record.url?scp=0031724707&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031724707&partnerID=8YFLogxK

M3 - Article

C2 - 9825340

AN - SCOPUS:0031724707

VL - 21

SP - 2318

EP - 2321

JO - PACE - Pacing and Clinical Electrophysiology

JF - PACE - Pacing and Clinical Electrophysiology

SN - 0147-8389

IS - 11 II

ER -