Key result
The Medtronic MRI-conditional Revo SureScan Pacing System with 5086 leads significantly increased the rate of pacemaker lead dislodgement compared to conventional pacemakers (3% vs. 1%, OR 2.47).
Why the study?
Does the MRI-conditional Medtronic Revo SureScan Pacing System increase periprocedural complications compared to conventional pacemakers in adult patients?
Meta-Analysis (n=2,118)
Does the MRI-conditional Medtronic Revo SureScan Pacing System increase periprocedural complications compared to conventional pacemakers in adult patients?
The Medtronic MRI-conditional Revo SureScan Pacing System with 5086 leads is associated with significantly higher rates of lead dislodgement and pericardial complications compared to conventional pacemakers.
Answers are grounded in this paper and cite their sources.
Warrants caution selecting the Medtronic Revo SureScan system to reduce lead dislodgement; challenges presumed safety equivalence of this MRI-conditional platform.
BACKGROUND: The use of magnetic resonance imaging (MRI)-conditional permanent pacemakers has increased significantly. In this meta-analysis, we examine the safety of MRI-conditional pacing systems in comparison with conventional systems. METHODS: An electronic search was performed using major databases, including studies that compared the outcomes of interest between patients receiving MRI-conditional pacemakers (MRI group) versus conventional pacemakers (control group). RESULTS: Six studies (5 retrospective and 1 prospective non-randomised) involving 2,118 adult patients were identified. The MRI-conditional pacemakers, deployed in 969 patients, were all from a single manufacturer (Medtronic Pacing System with 5086 leads). The rate of pacemaker lead dislodgement (atrial and ventricular) was significantly higher in the MRI group (3% vs. 1%, OR 2.47 (95% CI 1.26; 4.83), p = 0.008). The MRI group had a significantly higher rate of pericardial complications (2% vs. 1%, OR 4.23 (95% CI 1.18; 15.10), p = 0.03) and a numerically higher overall complication rate in comparison with the conventional group (6% vs. 3%, OR 2.02 (95% CI 0.88; 4.66), p = 0.10) but this was not statistically significant. CONCLUSIONS: In this meta-analysis, the rates of pacemaker lead dislodgement and pericardial complications were significantly higher with the Medtronic MRI-conditional pacing system.
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Shurrab et al. (2018) conducted a meta-analysis in Permanent pacemaker indication (n=2,118). Medtronic MRI-conditional Revo SureScan Pacing System (5086 leads) vs. Conventional pacemakers was evaluated on Pacemaker lead dislodgement (atrial and ventricular) (OR 2.47, 95% CI 1.26-4.83, p=0.008). The Medtronic MRI-conditional Revo SureScan Pacing System with 5086 leads significantly increased the rate of pacemaker lead dislodgement compared to conventional pacemakers (3% vs. 1%, OR 2.47).
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