Increased perforation risk with an MRI-conditional pacing lead: a single-center study.

Area of Science:

• Cardiovascular Medicine
• Medical Device Technology
• Radiology

Background:

• Cardiac pacemakers (PPMs) were historically contraindicated for Magnetic Resonance Imaging (MRI).
• The introduction of Medtronic (MDT) MRI SureScan PPM and leads aimed to address this limitation.
• This study evaluates the safety of these newer MRI-compatible pacemaker leads.

Purpose of the Study:

• To compare lead perforation and dislodgement rates between MDT CapSureFix 5086 MRI SureScan leads and MDT non-MRI SureScan active fixation leads.
• To assess the safety profile of MRI-compatible pacemaker leads in clinical practice.

Main Methods:

• Retrospective analysis of patient records from April 2011 to April 2014.
• Inclusion of patients implanted with MDT CapSureFix 5086 MRI SureScan leads and MDT 4076/5076 non-MRI leads.
• Comparison of lead perforation and dislodgement events between the two lead types.

Main Results:

• A significantly higher perforation rate (5.5%) was observed with MDT CapSureFix 5086 MRI SureScan leads compared to non-MRI leads (0.47%) (P = 0.005).
• Three of the four perforations with MRI SureScan leads were delayed, occurring over 3 weeks post-implantation.
• A trend towards increased dislodgement rates was noted for MRI SureScan leads, though not statistically significant (P = 0.18).

Conclusions:

• This retrospective study suggests an increased risk of lead perforation with MDT CapSureFix 5086 MRI SureScan leads, contrary to some prior research.
• Delayed perforations represent a significant concern associated with these MRI-compatible leads.
• Further large-scale, prospective studies with extended follow-up are warranted to validate these findings and confirm lead safety.