Cardiac Implantable Electronic Device Reutilization

Battery Life of Explanted Devices at a Tertiary Care Center

Lindsey Gakenheimer, B.S.; Joshua Romero, M.D.; Timir S. Baman, M.D.; Dan Montgomery, B.S.; Cydni A. Smith, B.A.; Hakan Oral, M.D.; Kim A. Eagle, M.D.; Thomas Crawford, M.D.

Disclosures

Pacing Clin Electrophysiol. 2014;37(5):569-575. 

In This Article

Discussion

Cardiovascular disease is the leading cause of death in the developing world.[3] It is estimated that about one million people die each year in the world due to lack of access to pacemaker therapy. The main finding of this study is that nearly 50% of devices explanted in a tertiary medical center for reasons other than ERI appear free from malfunctions and have >75% of the original battery life or at least 4 years of the battery life remaining. These devices could potentially be reutilized in patients in LMICs, where access to bradyarrhythmia therapy is extremely limited. The yield of reusable devices during non-ERI-related device procedures (~50%) is substantially higher than among devices reclaimed postmortem, where the yield of adequate battery life was only 21% for pacemakers and ICDs and 30% for CRT-Ds.[8] Should pacemaker or ICD reuse become widely embraced, these findings would inform refurbishing centers that devices obtained during non-ERI-related device procedures should be a major focus of their efforts. According to the National Cardiovascular Data Registry (NCDR), 63,522 devices, representing about 41% of all ICD generator procedures, were explanted annually in years 2010–2012 (Personal Communication, Paul Heidenreich, M.D., M.S. member, NCDR Science & Quality Oversight Committee, NCDR® ICD Registry™ October 11, 2012). If the yield of reusable ICD harvesting across the United States is similar to that at the University of Michigan, potentially as many as 10,000–13,000 devices with adequate battery life could be obtained each year for donation.

In our series, the largest number of reusable devices was due to infection followed by upgrade to CRT-D and heart transplantation or LVAD implantation. The rates of adequate battery life are similar among pacemakers, ICDs, and CRT-Ds (52%, 54%, and 48%, respectively). This is unlike in the setting of postmortem device collection, where CRT-D had substantially greater remaining longevity than pacemakers and ICDs.[8] The difference is likely explained by higher disease acuity of patients in whom care is escalated, as in upgrades to high voltage and resynchronization therapy. The extraction indications associated with the greatest chance of adequate battery are upgrade to ICD, patient request for device removal, and infection (odds ratio 163, 115, and 110, respectively). High battery voltages commonly found in these devices would likely translate into many years of use in patients with bradyarrhythmia. This would especially be the case for patients receiving an ICD or CRT-D device, for the defibrillator function in these donated devices would not be utilized.

Devices manufactured by SJM and BS/GDT were less likely to meet the criteria for reuse in this study, as indicated by the logistic regression analysis, although this did not reach statistical significance for BS/GDT. The reason for this is not clear. It is possible that some patients with Medtronic ICD generators underwent replacements in advance of reaching ERI due to concern about the Fidelis lead integrity.

Infected devices may be well suited for device reutilization because the vast majority of those devices are explanted within a few weeks of implantation.[9] Prior studies have shown that infected devices, when properly handled and sterilized, can be reutilized without significant complications.[10,11] Recently implanted devices may have 10- to 12-year projected longevity, highlighting the current waste of this costly resource. Infected devices must undergo a rigorous sterilization process. Further studies are needed to prospectively examine safety of device reuse from patients with device-related infections.

A recent study described an experience with reprocessed devices obtained antemortem in 17 patients.[12] Ten devices had been removed for device upgrades and seven for infections. During mean follow-up period of 68 ± 38 months, no device infection or device malfunction was observed. A meta-analysis compared the safety of new and reutilized devices in 2,270 patients across 18 trials.[13] It found that, at 10 years, the overall mortality of patients who received refurbished devices was no higher than the mortality of patients with new devices. Moreover, the infection rate of the refurbished devices was no higher than that with the new devices, around 1.97%. The malfunction rate was higher in refurbished devices, but it was still less than 1%. A rigorous, large prospective trial of safety and efficacy of device reuse is needed before device reuse can gain wider acceptance as a means of charitable support for patients in LMIC who cannot afford a new pacemaker.

One other issue must be considered, as it relates to device harvesting during non-ERI device change-out and upgrade procedures. Who is the owner the device? Is it the patient, the manufacturer, or the insurance scheme, which paid for the device—whether it be private insurance or Medicare/Medicaid? One can postulate that the patient is the owner of the device. Even if a third-party payment is considered, those funds are raised through premiums and taxes, thus indirectly paid by the patient.

The National Institutes of Health appear to support the idea of patient ownership in a consensus program regarding medical device ownership.[14] It seems intuitive that patient consent is required prior to donation. Previous research has found that about 90% of patients with a CIED are willing to donate them if provided the chance.[8,15] The manufacturers encourage device return for quality assurance and proper disposal. Centers of excellence interested in device reuse could return devices, which do not meet criteria for reuse, to the manufacturers to assist in the process of device analysis and proper disposal, especially of the lithium battery component. Such a collaborative approach would allow for donation of refurbished devices to needy patients in the LMICs, as well as foster quality assurance and proper device disposal.

It is important to note that CIED collection and evaluation is only the first step in a long and arduous journey to making device reuse a reality. A validated cleaning and sterilization protocol is needed to provide patients and physicians with some degree of confidence that the risk of infection would not be significantly higher than with brand new pacemaker implants. Additionally, given the unusual handling of the devices, functionality testing must also be developed and implemented to assure the integrity of the CIED prior to reimplantation. A party with experience in medical device reprocessing may be needed to carry out key processes, and to engage with regulatory bodies in the United States (i.e., U.S. Food and Drug Administration) and the recipient countries. Although implantation of reprocessed devices goes on in many countries, it often happens without the explicit sanctioning by the health authorities. A nonprofit organization may be created to raise funds necessary to collect, reprocess, and distribute previously used CIEDs. An additional role of the nonprofit would be to assess qualification and safety record of potential implanting centers and physicians, and to maintain a database of all devices received and distributed. In addition to cost of handling and shipping, depending on the local infrastructure and resources, partnerships with charitable organizations may help to cover the expense of the leads and disposables if these are not available at the implantation center. The implantation centers' role would be to assess the indications for CIED and patient's financial status, safely implant the devices, and provide follow-up monitoring and detailed documentation on all devices. In short, a great many legal and logistical obstacles will have to be overcome through a collaborative effort with multiple parties in order to offer safe device implantation in patients with greatest need.

Project My Heart Your Heart is committed to addressing these important issues by furthering research in safe device reuse and developing the necessary partnerships to allow implementation of this concept. This organization accepts devices from funeral homes, crematories, hospitals, and family members of deceased device patients. Potential donors can go to website www.myheartyourheart.org to enter their contact information and shipping address. This organization sends a prepaid self-addressed flat-rate United States Postal Service envelope containing biohazard bags for each device, instructions on device removal, and how to return devices to our center. We believe that the development of standardized protocols for collection, evaluation, and resterilization will make CIED reuse safe and efficacious.

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