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Reusing explanted ICDs may be safe, effective
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New data suggest that reuse of explanted cardioverter defibrillators with at least 3 years of remaining battery life is safe and effective, which may help patients who are otherwise unable to afford this therapy, researchers said.
“Nowhere are disparities in health care more evident than in the rates of implantable cardioverter defibrillator (ICD) use around the world,” Behzad B. Pavri, MD, of Thomas Jefferson University Hospital, and colleagues wrote in the Annals of Internal Medicine, noting that cost and cultural differences are largely responsible for these discrepancies.
Possible reuse
ICDs often have useful battery life, as explantation may be related to upgrades, infection or patient death. To determine whether these explanted devices can be resterilized and reused, the researchers conducted a retrospective cohort study involving multicenter ICD acquisition and single-center ICD reimplantation at Holy Family Hospital in Mumbai, India. The explanted ICDs were transported in researchers’ baggage from the United States to India.
Of 81 patients (mean age, 52.6 years; 66 men) who received 106 explanted, resterilized devices, 22 received a second device and three patients received a third device. The mean time to ICD replacement was 1,287.4 days, the researchers reported.
Follow-up data were available for 75 of the 81 patients, with a mean follow-up duration of 824.9 days. The researchers found no infectious complications, one lead dislodgment and one lead fracture that required repeat surgery. Sixty-four of the 106 ICDs (60.4%) delivered appropriate therapy, including shocks or antitachycardia pacing, in 44 patients (54.3%). Nine patients (11.1%) died during the study, with mean time from implantation to death being 771.3 days.
The researchers acknowledged the study’s limitations, such as its retrospective nature, modest size and that it was a single-center experience. Moreover, certain data, including complete information on exact battery voltage at the time of implantation or records on the number of devices obtained through postmortem vs. antemortem explantation, were unavailable. However, if larger studies confirm these findings, they said, “there could be important humanitarian and economic effects for the citizens of low- and middle-income nations.”
Careful interpretation
In an accompanying editorial, Paul Farmer, MD, PhD, and Gene Bukhman, MD, PhD, both of Harvard Medical School, said moving forward requires caution, as some may view ICD reimplantation as providing substandard care.
“Those who seek to redress local and transnational health disparities need more financial and institutional support for such efforts. One of the key ingredients of this work is a set of ethical guidelines to well-intentioned efforts to introduce new technologies to those who need them most. Flagship projects must remain free of the taint of the secondhand, in part by making it clear when devices can be safely reused. If this is true of ICDs and other implanted devices, practitioners and regulatory agencies should work harder to alter recommendations where regulation is most stringent. This will help make it clear to even the most skeptical audiences that equity of access and outcomes need to be modern medicine’s highest goal,” they wrote.
For more information:
Farmer P. Ann Intern Med. 2012;157:591-592.
Pavri BB. Ann Intern Med. 2012;157:542-548.
Disclosure: See study for a full list of researchers’ disclosures. Bukhman reports receiving grants from the Medtronic Foundation. Farmer reports no relevant financial disclosures.
Perspective
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Troy Rhodes, MD, PhD, FHRS
In the US, ICDs and pacemakers are currently FDA-labeled as single use devices and are discarded following removal for infection, revision, or death. Although ideally medical devices of all types could be reused and implanted in another patient, this approach would require a major fundamental shift in medical care in the US. Certainly, as noted in this study, these devices may have several years of remaining battery life, which could benefit another patient or the same patient in the case of extraction for device infection. However, the feasibility of implementing this process in the US would have significant hurdles related to medical liability, manufacturer warranties, confirming long term device reliability, safety and efficacy, as well as the American public overlooking the stigma of receiving a secondhand device. There is no doubt that reusing devices would be beneficial to patients and would have significant financial savings for the health care system.
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