title: Increased perforation risk with an MRI-conditional pacing lead: a single-center study.
abstract: BACKGROUND
  Magnetic resonance imaging (MRI) has been considered contraindicated in patients with cardiac pacemakers (PPMs). Recently, Medtronic (MDT) MRI SureScan PPM (Medtronic Inc., Minneapolis, MN, USA) and leads were introduced into clinical practice in the United States of America.
  
  
  OBJECTIVE
  To compare MDT CapSureFix 5086 MRI SureScan lead-associated perforation and dislodgement rates with MDT non-MRI SureScan active fixation leads.
  
  
  METHODS
  We retrospectively analyzed the records of all patients implanted with MDT CapSureFix 5086 MRI SureScan leads as well as all patients implanted with MDT 4076 and 5076 leads at our institution from April 2011 to April 2014.
  
  
  RESULTS
  Four of 72 patients implanted with MDT CapSureFix 5086 MRI SureScan leads (5.5%) had evidence of lead perforation, necessitating pericardiocentesis in three cases and lead revision in one case. Three of the four perforations were delayed perforations, presenting more than 3 weeks postimplant. Two patients implanted with MDT CapSureFix 5086 MRI SureScan leads (2.8%) had lead dislodgement. Of 420 patients implanted with MDT non-MRI SureScan leads, there were two perforations (0.47%) and four dislodgements (0.9%). There were significantly increased lead perforations associated with MDT CapSureFix 5086 MRI SureScan leads (P = 0.005) and a nonsignificant trend toward increased dislodgements (P = 0.18) when compared with MDT non-MRI SureScan leads.
  
  
  CONCLUSIONS
  In contradiction to prior studies, this retrospective study suggests an increased perforation rate with MDT CapSureFix 5086 MRI SureScan leads. Most perforations were delayed perforations, presenting more than 3 weeks postimplant. Higher volume prospective studies with longer follow-up are needed to confirm our findings.
authors.affiliation: Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Moshe Rav
authors.initials: MR
authors.lastname: Acha
authors.forename: John J
authors.initials: JJ
authors.lastname: Keaney
authors.forename: Steven A
authors.initials: SA
authors.lastname: Lubitz
authors.forename: David J
authors.initials: DJ
authors.lastname: Milan
authors.forename: Moussa
authors.initials: M
authors.lastname: Mansour
authors.forename: Kevin E
authors.initials: KE
authors.lastname: Heist
authors.forename: Leon M
authors.initials: LM
authors.lastname: Ptaszek
authors.forename: Jagmeet P
authors.initials: JP
authors.lastname: Singh
authors.forename: Dan
authors.initials: D
authors.lastname: Blendea
authors.forename: Theofanie
authors.initials: T
authors.lastname: Mela
mesh_terms: D000368:Aged; D004567:Electrodes, Implanted / Q000009:adverse effects*; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D006335:Heart Injuries / Q000209:etiology*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States; D014950:Wounds, Penetrating / Q000209:etiology*
keywords: imaging; pacing