Key result
The Medtronic 5086 MRI pacing lead was associated with a higher 30-day rate of pericarditis, effusion, tamponade, or death compared to the 5076 lead (12.3% vs 2.2%; OR 6.3; 95% CI 1.3-30.8; P=0.02).
Why the study?
Does the MR-conditional Medtronic 5086 pacing lead increase the risk of early lead-related complications compared to the previous generation 5076 lead in patients undergoing pacemaker implantation?
Population
157 patients undergoing pacemaker implantation at a single high-volume tertiary care hospital.
Comparison
Implantation of two Medtronic CapSureFix MRI… vs Implantation of two Medtronic CapSureFix Novus…
Design
Case-control
Follow-up
30 days
Authors
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May warrant caution with the 5086 lead; leaves open need for larger studies on MR-conditional lead safety.
Case-Control (n=157)
No
Does the MR-conditional Medtronic 5086 pacing lead increase the risk of early lead-related complications compared to the previous generation 5076 lead in patients undergoing pacemaker implantation?
Odds Ratio: 6.3 (95% CI 1.3–30.8)
Absolute Event Rate: 12.3% vs 2.2%
p-value: p=0.02
The newer MR-conditional Medtronic 5086 pacing lead is associated with a significantly higher risk of early major complications and lead dislodgement compared to the older 5076 lead.
Elmouchi et al. (2013) conducted a case-control in Pacemaker implantation (n=157). Medtronic CapSureFix MRI SureScan 5086 MRI pacing lead vs. Medtronic CapSureFix Novus 5076 pacing lead was evaluated on Pericarditis, pericardial effusion, cardiac tamponade, or death within 30 days of implant (OR 6.3, 95% CI 1.3-30.8, p=0.02). The Medtronic 5086 MRI pacing lead was associated with a higher 30-day rate of pericarditis, effusion, tamponade, or death compared to the 5076 lead (12.3% vs 2.2%; OR 6.3; 95% CI 1.3-30.8; P=0.02).
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