Darryl A Elmouchi 1 , Shelly Rosema , Stacie M Vanoosterhout , Mohsin Khan , Alan T Davis , Andre J Gauri , Bohuslav Finta , Alan K Woelfel , Nagib T Chalfoun . Show Affiliations »
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. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.
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. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.
Entities: Disease
Species
Keywords:
cardiac tamponade; complications; magnetic resonance imaging; pacemakers
Mesh: See more »
Year: 2013
PMID: 24215291 DOI: 10.1111/pace.12293
Source DB: PubMed Journal: Pacing Clin Electrophysiol ISSN: 0147-8389 Impact factor: 1.976