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Safety, Efficacy, and Performance of Implanted Recycled Cardiac Rhythm Management (CRM) Devices in Underprivileged Patients

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  • Disclosures: All authors have no disclosures.

Address for reprints: Christian Machado, M.D., Division of Cardiac Electrophysiology, Providence Hospital and Medical Center, 16001 W. Nine Mile Road, Southfield, MI 48705. Fax: 248-849-2853; e-mail: cmachado@comcast.net

Abstract

Introduction: Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice.

Methods: Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device.

Results: Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up.

Conclusions: Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. (PACE 2011; 653–658)

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