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Ann Intern Med. 2012 Oct 16;157(8):542-8. doi: 10.7326/0003-4819-157-8-201210160-00004.

Reuse of explanted, resterilized implantable cardioverter-defibrillators: a cohort study.

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  • 1Thomas Jefferson University Hospital, 925 Chestnut Street, Suite 200, Philadelphia, PA 19107, USA.

Abstract

BACKGROUND:

Implantable cardioverter-defibrillators (ICDs) often have clinically useful battery life remaining when explanted because of upgrades, infection, or patient death.

OBJECTIVE:

To show that explanted ICDs can be resterilized and reused.

DESIGN:

Retrospective cohort study.

SETTING:

Multicenter ICD acquisition and single-center ICD reimplantation.

PATIENTS:

Indigent persons in India who had class I indications for cardiac resynchronization therapy with an ICD and were unable to afford such a device.

MEASUREMENTS:

Device longevity after reimplantation, device-related complications, number of appropriate therapies, patient clinical characteristics, and deaths.

RESULTS:

Eighty-one consecutive consenting patients (mean age, 52.6 years; 66 male patients) received 106 explanted devices. Twenty-two patients received a second device and 3 patients received a third device after the prior one reached replacement voltage. Mean time to ICD replacement was 1287.4 days. Follow-up data were available for 75 of 81 (92.6%) patients. Mean follow-up duration for all devices was 824.9 days. No infectious complications occurred; 1 lead dislodgement and 1 lead fracture required repeated surgery. Appropriate therapy (shocks or antitachycardia pacing) was delivered by 64 of 106 (60.4%) devices in 44 of 81 (54.3%) patients. Nine of 81 (11.1%) patients died; mean time from implantation to death was 771.3 days.

LIMITATIONS:

This is a retrospective report of a single-center experience with a modest number of patients and devices. Follow-up data were missing for 6 patients. No records were kept of the number of devices obtained through postmortem versus antemortem explantation or whether explantation was due to infection or upgrade. Complete data were not available on exact battery voltage at the time of reimplantation, left ventricular ejection fraction, or number of inappropriate shocks. A control group was not possible.

CONCLUSION:

Explanted ICDs with 3 or more years of estimated remaining battery life can be reused after they are cleaned and resterilized. These devices functioned normally and delivered life-saving therapies, without an increased risk for complications. These preliminary data deserve further validation and, if confirmed, could have important societal and economic implications.

PRIMARY FUNDING SOURCE:

None.

PMID:
23070487
[PubMed - indexed for MEDLINE]
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