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

Abstract

In contradiction to prior studies, this retrospective study suggests an increased perforation rate with MDT CapSureFix 5086 MRI SureScan leads. Most perforations were delayed perforations, presenting more than 3 weeks postimplant. Higher volume prospective studies with longer follow-up are needed to confirm our findings.

Leadless Pacemakers: practice and promise in congenital heart disease

“…Early reports suggested a perforation rate up to 4% leading to revision of the implant protocol but overall the perforation rate was 1.5% in the 526 patients in the total cohort. This appears comparable to the rate observed with transvenous leads (0.6 to 5.0%) [11,18,19]. but the large diameter of the Nanostim is more likely to cause clinically significant tamponade and is a particular concern in the older patient group which represents the largest group of potential recipients for the current single chamber device.…”

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 ).…”

“…The most important patient‐related factors turned out to be age, gender, BMI, and any conditions that influence the myocardial wall thickness/resistance, including anatomical position, right ventricular pressure, or concomitant medications such as steroids . Supporting this notion, 2 publications independently demonstrated that septal right ventricular positions are safer than apical lead placements, probably due to the higher myocardial thickness …”

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.…”