title: Complications Related to Cardiac Rhythm Management Device Therapy and Their Financial Implication: A Prospective Single-Center TwoYear Survey.
abstract: BACKGROUND
  Cardiac rhythm management devices (CRMDs) have proven their clinical effectiveness for patients with heart rhythm disorders. Little is known about safety and complication rates during the implantation of these devices. This study demonstrated the complication rates related to CRMD implantation, and estimated the additional hospital stay and cost associated with the management of complications.
  
  
  METHODS
  During a period of one year, a total of 464 consecutive recipients underwent CRMD implantation and were followed for 2 years. Finally, data were analyzed for 398 patients who completed the two-year follow up, resulting in a total of 796 patient-years.
  
  
  RESULTS
  Of the 201 patients with initial pacemaker (PM) implantations, 6 (2.99%) had seven complications (5 patients had lead dislodgement, 1 of them twice), and 1 patient developed pocket infection. Of the 117 PM replacements, 1 (0.85%) patient developed a complication (pocket erosion). Two patients with complications (1 with an initial PM and 1 with a replacement) died before completing the follow up for reasons unrelated to cardiac causes. There were no complications in either initial implantations (69 patients) or replacements (11 patients) of implantable cardioverter-defibrillators. The average prolongation of the hospital stay was 7 days, ranging from 1 to 35 days, resulting in 17,411 of total additional direct hospital costs.
  
  
  CONCLUSIONS
  This study found relatively low rates of complications in patients undergoing CRMD implantation, initial or replacement, in our center, compared with other studies. The additional hospitalization days and costs attributable to these complications depend on the nature of the complication.
authors: Department of Cardiology, Heraklion University Hospital, Crete, Greece.
authors: John
authors: J
authors: Fanourgiakis
authors: Emmanuel
authors: E
authors: Simantirakis
authors: Nikolaos
authors: N
authors: Maniadakis
authors: Emmanuel
authors: E
authors: Kanoupakis
authors: Stavros
authors: S
authors: Chrysostomakis
authors: Georgia
authors: G
authors: Kourlaba
authors: Gregory
authors: G
authors: Chlouverakis
authors: Panos
authors: P
authors: Vardas
mesh_terms: D001145:Arrhythmias, Cardiac / Q000191:economics / Q000628:therapy*; D017281:Cost of Illness; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000191:economics; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000191:economics*; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects* / Q000191:economics; D011183:Postoperative Complications; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome