title: Clinical routine implantation of a dual chamber pacemaker system designed for safe use with MRI: a single center, retrospective study on lead performance of Medtronic lead 5086MRI in comparison to Medtronic leads 4592-53 and 4092-58.
abstract: OBJECTIVE
  We report our experience concerning lead performance and re-surgery rate of the Medtronic EnRhythm MRI SureScan pacemaker system (MRI-PM) in comparison to standard pacemaker (PM) systems and leads used at our institution.
  
  
  METHODS
  All patients (except patients with transvenous left ventricular leads) with successful PM implantation performed at our institution from 1 March 2009 to 31 October 2009 were included in this analysis and followed until mid January 2010. Lead measurements (assessed at implantation, prehospital discharge interrogation (1st follow-up) and at the first scheduled out-patient follow-up (2nd follow-up) were compared between atrial leads 4592-53 cm and 5086MRI-52 cm (lead group 1), and between ventricular leads 4092-58 cm and 5086MRI-52 cm/-58 cm (lead group 2), respectively. Causes for re-operations were assessed and compared between patients with standard dual chamber PM (DC-PM) and the MRI-PM.
  
  
  RESULTS
  A total of 140 patients (VVI-PM: 36 patients; DDD-PM: 102 patients; biventricular PM: 1 patient) were successfully implanted with a PM within the implantation period. Two patients with transvenous left ventricular leads were excluded from further analysis. In an atrial position, lead 4592 was implanted in 51 patients and lead 5086MRI-52 cm was implanted in 40 patients, respectively. Ventricular leads were lead 4092-58 cm (64 patients) and lead 5086MRI (41 patients), respectively. Patients were followed for 26 ± 11 weeks. Comparison of lead measurements of lead group 1 showed significant differences for pacing impedance and pacing threshold at implantation, and for sensing at the 2nd follow-up. Comparison of lead measurements within lead group 2 showed significant differences for pacing impedance at implantation, for pacing threshold at the 1st follow-up, and for sensing, pacing threshold, and impedance at the 2nd follow-up. All assessed mean values were favorable for all leads at any follow-up. The number of re-operations was high in both dual chamber PM groups, but did not differ significantly between the two groups (DC-PM: 5 patients, 8.5%; MRI-PM: 5 patients, 13.2%).
  
  
  CONCLUSIONS
  Our study demonstrates favorable lead measurements of lead model 5086MRI in comparison to lead 4592 and 4092 in a short-term follow-up. The number of re-operations was higher in the MRI-PM group, but not statistically different in comparison with the standard dual chamber PM group.
authors: Department of Cardiology, Hospital of St. Pölten-Lilienfeld, Propst Führer-Str. 4, 3100, St. Pölten, Austria. christian.wollmann@stpoelten.lknoe.at
authors: C G
authors: CG
authors: Wollmann
authors: K
authors: K
authors: Thudt
authors: P
authors: P
authors: Vock
authors: S
authors: S
authors: Globits
authors: H
authors: H
authors: Mayr
mesh_terms: D000368:Aged; D001317:Austria / Q000453:epidemiology; D002056:Burns / Q000453:epidemiology; D015897:Comorbidity; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005260:Female; D006333:Heart Failure / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging / Q000295:instrumentation* / Q000706:statistics & numerical data*; D008297:Male; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D019919:Prosthesis Implantation / Q000706:statistics & numerical data*; D012086:Reoperation; D012189:Retrospective Studies; D018570:Risk Assessment