title: Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.
abstract: BACKGROUND
  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.
authors.affiliation: Division of Cardiac Electrophysiology and Cardiology, Providence Hospital and Medical Center, Wayne State University, Southfield, Michigan 48705, USA.
authors.forename: Reema
authors.initials: R
authors.lastname: Hasan
authors.forename: Hamid
authors.initials: H
authors.lastname: Ghanbari
authors.forename: Dustin
authors.initials: D
authors.lastname: Feldman
authors.forename: Daniel
authors.initials: D
authors.lastname: Menesses
authors.forename: Daniel
authors.initials: D
authors.lastname: Rivas
authors.forename: Nicole C
authors.initials: NC
authors.lastname: Zakhem
authors.forename: Carlos
authors.initials: C
authors.lastname: Duarte
authors.forename: Christian
authors.initials: C
authors.lastname: Machado
mesh_terms: D001145:Arrhythmias, Cardiac / Q000517:prevention & control*; D017743:Equipment Reuse; D005260:Female; D006801:Humans; D008297:Male; D008507:Medically Underserved Area; D008875:Middle Aged; D009527:Nicaragua; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011475:Prosthesis Failure; D016896:Treatment Outcome; D014481:United States