Cardiac perforation and lead dislodgement after implantation of a MR-conditional pacing lead: a single-center experience

Abstract

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.

Keywords: cardiac tamponade; complications; magnetic resonance imaging; pacemakers.