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Original Research |

Reuse of Explanted, Resterilized Implantable Cardioverter-Defibrillators: A Cohort Study

Behzad B. Pavri, MD; Yash Lokhandwala, MBBS, DM; Gaurav V. Kulkarni, MD; Mandar Shah, MBBS; Bharat K. Kantharia, MD; and Daniel A.N. Mascarenhas, MD
[+] Article and Author Information

From Thomas Jefferson University Hospital and Drexel University School of Medicine, Philadelphia, Pennsylvania; Holy Family Hospital, Mumbai, India; Loyola University Medical Center, Maywood, Illinois; and University of Texas Health Science Center at Houston, Houston, Texas.

Disclaimer: Dr. Pavri had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. None of the study investigators has any current or future financial interest in the use of resterilized ICDs obtained from the United States.

Acknowledgment: The authors thank all of the donor patients and their families; the many physicians who sent explanted devices; Lipeeka Parulekar, MBBS, and Louella Farro, BA, for assistance with data collection and retrieval; Sanjay Hinge, CSSD Technician, for device packaging and resterilization; and Maruti Naukudkar, BSc, and Bhavesh Chavan, BSc, for device checking and cataloging.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1236.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available from Dr. Pavri (address below).

Requests for Single Reprints: Behzad B. Pavri, MD, Thomas Jefferson University Hospital, 925 Chestnut Street, Suite 200, Philadelphia, PA 19107.

Current Author Addresses: Dr. Pavri: Thomas Jefferson University Hospital, 925 Chestnut Street, Suite 200, Philadelphia, PA 19107.

Drs. Lokhandwala and Shah: Holy Family Hospital, St Andrew's Road, Bandra (West), Mumbai 400 050, India.

Dr. Kulkarni: Loyola University Medical Center, 2160 South 1st Avenue, Maywood, IL 60153.

Dr. Kantharia: University of Texas Health Science Center at Houston, 7000 Fannin Street, Houston, TX 77030.

Dr. Mascarenhas: Coventry Cardiology Associates, 1000 Coventry Drive, Phillipsburg, NJ 08865.

Author Contributions: Conception and design: B.B. Pavri, G.V. Kulkarni, B.K. Kantharia, Y. Lokhandwala.

Analysis and interpretation of the data: B.B. Pavri, Y. Lokhandwala.

Drafting of the article: B.B. Pavri, G.V. Kulkarni, B.K. Kantharia, D.A.N. Mascarenhas, Y. Lokhandwala.

Critical revision of the article for important intellectual content: B.B. Pavri, Y. Lokhandwala, G.V. Kulkarni, M. Shah, B.K. Kantharia, D.A.N. Mascarenhas.

Final approval of the article: B.B. Pavri, G.V. Kulkarni, B.K. Kantharia, D.A.N. Mascarenhas.

Provision of study materials or patients: B.B. Pavri, Y. Lokhandwala, M. Shah, B.K. Kantharia, D.A.N. Mascarenhas.

Statistical Expertise: B.B. Pavri.

Administrative, technical, or logistic support: B.B. Pavri, M. Shah, B.K. Kantharia, D.A.N. Mascarenhas.

Collection and assembly of data: B.B. Pavri, Y. Lokhandwala, G.V. Kulkarni, M. Shah, B.K. Kantharia, D.A.N. Mascarenhas.


Ann Intern Med. 2012;157(8):542-548. doi:10.7326/0003-4819-157-8-201210160-00004
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Chinese translation

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.

Figures

Grahic Jump Location
Figure.

Timeline of device explantation in the United States, transport to and reimplantation in Mumbai, and subsequent follow-up.

Means (SDs) and ranges of time between stages are shown. ERI = elective replacement indicator; ICD = implantable cardioverter-defibrillator.

Grahic Jump Location

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