Cardiac perforation and lead dislodgement after implantation of a MR-conditional pacing lead: a single-center experience.
OBJECTIVE
The purpose of our study was to determine if the rate of lead-related complications was increased with the Medtronic CapSureFix MRI™ SureScan™ 5086 MRI pacing lead (5086; Medtronic Inc., Minneapolis, MN, USA) compared to the previous generation of Medtronic CapSureFix Novus™ 5076 pacing lead (5076).


BACKGROUND
The 5086 lead is a newly introduced active-fixation pacemaker lead designed to be used conditionally in a magnetic resonance (MR) scanner. This lead has specific design changes compared to the previous generation of 5076 pacing leads.


METHODS
This study was a retrospective case control study of 65 consecutive patients implanted with two 5086 leads compared to 92 consecutive control patients implanted with two 5076 leads over a 14-month period at a high-volume tertiary care hospital.


RESULTS
Pericarditis, pericardial effusion, cardiac tamponade, or death within 30 days of implant were seen in eight patients from the 5086 cohort and two from the 5076 cohort (odds ratio 6.3, 95% confidence interval 1.3-30.8, P = 0.02). Lead dislodgement occurred in four of the 5086 patients and in none of the 5076 patients (P < 0.03).


CONCLUSIONS
In a high-volume center, the incidence of pericarditis, cardiac perforation, tamponade, death, and lead dislodgement was significantly higher with the MR-conditional Medtronic 5086 lead when compared to the previous generation Medtronic 5076 lead.
Frederik Meijer Heart and Vascular Institute, Spectrum Health, Grand Rapids, Michigan; Department of Internal Medicine, Michigan State University College of Human Medicine, Grand Rapids, Michigan.
Darryl A
DA
Elmouchi
Shelly
S
Rosema
Stacie M
SM
Vanoosterhout
Mohsin
M
Khan
Alan T
AT
Davis
Andre J
AJ
Gauri
Bohuslav
B
Finta
Alan K
AK
Woelfel
Nagib T
NT
Chalfoun
D000368:Aged; D004567:Electrodes, Implanted / Q000009:adverse effects*; D004868:Equipment Failure; D004869:Equipment Safety; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology* / Q000517:prevention & control; D006335:Heart Injuries / Q000209:etiology* / Q000517:prevention & control; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D010493:Pericarditis / Q000209:etiology / Q000517:prevention & control; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000517:prevention & control; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014950:Wounds, Penetrating / Q000209:etiology* / Q000517:prevention & control
cardiac tamponade; complications; magnetic resonance imaging; pacemakers