Cardiac Perforation and Lead Dislodgement after Implantation of a MR-Conditional Pacing Lead: A Single-Center Experience
Financial disclosures: DE, AG, BF, NC, report modest support from either or all: Medtronic, Biotronik, St. Jude Medical. The remaining authors have no financial disclosures.
Funding source: No funding sources to report.
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).
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.
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.
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).
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.