Data from an observational cohort study suggest that the presence of abandoned leads in patients with cardiac implantable electronic devices (CIEDs) should no longer be an absolute contraindication to MRI.
In the study, which spanned 7 years and included 139 consecutive patients, adverse events were few, mild, and transient. The results were published online February 17 in JAMA Cardiology.
Dr Robert Schaller
Evidence is growing that MRI can be done safely in the presence of abandoned leads, thus calling into question the need to make them an absolute contraindication, lead author Robert D. Schaller, DO, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, told theheart.org | Medscape Cardiology.
Protocols for MRI have been in place for patients with MRI-conditional devices, and recent data suggest that scanning patients with nonconditional or legacy devices is safe. This has led to changes in Centers for Medicare & Medicaid Services (CMS) reimbursement policies for MRI in patients with legacy CIED systems, Schaller said.
However, abandoned leads have been thought to act as antennae that result in tissue heating and arrhythmia induction, and they have been excluded from CMS reimbursement due to a paucity of safety data.
An earlier study from researchers at the Mayo Clinic, Rochester, Minnesota, showed no evidence of myocardial injury, as measured by cardiac troponin T, in 80 patients who underwent 97 MRI scans with 90 abandoned leads in place during the scans.
“We are the second paper, the largest one, so I think there’s enough data now for more programs to open up in order to replicate our data, with the eventual goal being for government regulators like the CMS and medical societies to finally question whether or not this is an absolute contraindication,” Schaller said.
“We felt that abandoned leads were probably safe, the risk was overblown, so in certain situations, when the patient really needed an MRI, we would go ahead and do it, informing the patient there is enhanced risk but we don’t know for sure, and they would be part of our registry. Every time we did it, nothing bad happened, so eventually we started doing it in all comers who needed an MRI and there were no safety issues,” he said.
The current cohort study included 139 consecutive patients (110 men, mean age 65.6 years) who underwent 1.5-T MRI with at least 1 abandoned lead between January