Tag: lead

Class 1 Recall Issued for Boston Scientific S-ICD Lead

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Patients with a Boston Scientific S-ICD should be aware of a Class I recall of the 3501 Emblem subcutaneous electrode.  This model was manufactured from March 2016 through November 2020.
 
 
This same issue was the subject of a product advisory issued in December of 2020, but due to 26 serious injuries and one death associated with the device, the advisory was upgraded to a recall.   
 
 
Boston Scientific has a product lookup tool (www.BostonScientific.com/lookup) where you can look up your device and see if your specific lead is affected.  You can find your serial numbers on your registration card.
 
 
You can read the HCMBeat’s previous entry on this issue here. 
 

Safety of MRIs With Abandoned Leads

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Two posters presented at this weekend’s Heart Rhythm Society meeting in Chicago show that patients who have abandoned pacemaker or ICD leads may safely undergo MRI exams.

These posters follow the earlier MagnaSafe study which demonstrated the safety of MRI for patients with pacemakers and ICDs, but which excluded patients with abandoned leads from the findings.

The first, by researchers at Mayo Clinic, included 57 patients with 63 abandoned leads who underwent 70 MRI exams in a 1.5 Tesla machine.  The authors saw no clinical problems and no device malfunction following the scans.

The researchers also monitored blood troponin levels in 35 of the patients following the scans and did not see any elevation which could indicate distress to the heart from the scan.

The second poster, from the University of Pennsylvania, involved 24 patients with abandoned leads who underwent 34 MRI exams.  The results of this study also failed to demonstrate any clinical problems or patient discomfort resulting from the MRI scans.

With any luck, everyone will soon be able to obtain an MRI and will not be denied due to any kind of implantable cardiac device.

For an account of my personal experiences seeking MRI with an ICD, read this.

Yes We Scan! ICDs and MRIs

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Why MRI is Important:

Magnetic Resonance Imaging, or MRI, is one of the most important tools of modern medicine.  MRIs can be used to evaluate almost every kind of medical issue, from brain tumors to twisted ankles.  They provide clear images, and in some instances, also provide superior visualization.  Because they do not expose the imaging subject to radiation, they are generally preferred over CT scans, even when the two scans would reveal the same information.

MRI in HCM:

In the last several years, MRI has also become an important tool in the evaluation of hypertrophic cardiomyopathy (HCM).  The images resulting from MRI have proven superior in visualizing the size and structure of the heart and, when used with a contrast agent, MRIs are able to show the extent of scarring in the HCM heart.

MRI Hasn’t Been an Option for Many of Us:

MRI has been unavailable to those of us who have an implantable defibrillator or ICD to in order to protect us from sudden cardiac arrest.  Until recently, having an ICD was an absolute contraindication to MRI.  Newer MRI-safe ICD systems have been in use for the last few years, but that still leaves in place the contraindication for those of us who have older ICD units in place.  That problem is that older lead systems that were implanted along with old, non-MR compatible generators may be incompatible with the newer MR compatible technology, and it may not be possible to simply hook up these old leads to a new MRI compatible generator.  And, it is not as easy as you might think to extract old leads.  Scar tissue grows around these leads, making their removal an intricate and dangerous procedure that is best done only in carefully controlled circumstances by highly specialized physicians. Continue reading “Yes We Scan! ICDs and MRIs” →

Abandoned Leads Harder to Extract

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According to a recent study published in JACC: Clinical Electrophysiology, previously abandoned pacemaker and implantable defibrillator leads which have been capped off and left behind following replacement were harder to extract later.  These abandoned leads also made it more difficult to treat device infections.

When interviewed about the significance of these study results, several physicians knowledgeable in the field further emphasized that lead removal requires special skill and equipment not typical for the average physician who implants cardiac devices.  Hence, patients facing a potential lead extraction should consider their options carefully and seek care from a specialist in lead extraction.