Cardiac Perforation and Lead Dislodgement after Implantation of a MR‐Conditional Pacing Lead: A Single‐Center Experience

Abstract

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.

Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta‐Analysis

“…Lateral or anterolateral atrial or apical right ventricular lead positions were associated with elevated risk of lead perforation in some studies. Similarly, lead perforation was more frequent in female recipients and in patients with more advanced age . Further predictors were use of previous temporary PM lead, treatment with oral steroids, or with aspirin/thienopyridines .…”

“…Of all identified studies, only one was a randomized controlled clinical trial, whereas the remainder were post‐hoc analyses of randomized trials or observational retrospective or observational prospective studies . The vast majority were single‐center observations, with the exception of 8 multicenter studies, and 2 were based on national or industrial registries . Individual studies used different definitions of lead perforation including signs of periprocedural pericarditis, asymptomatic pericardial effusion, or pericardial tamponade (Tables and ).…”

Increased Perforation Risk with an MRI‐Conditional Pacing Lead: A Single‐Center Study

“…The above‐mentioned lead structure modifications resulted in heavier and stiffer leads with a larger diameter (lead body diameter of 2.3 mm compared with 1.9 mm of the 4076 lead) and unusual horizontal pitch of the bipolar conductor. As a result, the 5086 MRI SureScan leads transfer more torque than non‐MRI SureScan leads . Accordingly, during the last few years concerns have been raised regarding lead‐associated complications and a higher need for re‐intervention procedures, although the initial EnRhythm MRI and ADVISA MRI studies did not show increased lead‐associated complications or re‐interventions.…”

Malfunction of an MRI-Conditional Pacemaker Following an MRI

“…Nevertheless, concerns remain that these devices could be susceptible to the MRI environment and they have been branded as “MRI conditional” (rather than “MRI safe”). Additionally, MRI-conditional pulse generators are based on earlier platforms, their leads are more prone to dislodgment and perforation,10, 11 and they are more expensive (in most settings) as compared with legacy devices.…”