HRS updates guidelines for lead management in implantable devices
The Heart Rhythm Society issued an expert consensus statement addressing lead management for patients with CV implantable electronic devices, including indications for extraction, outcomes and follow-up, and lead survival.
The statement is an update to the 2009 Heart Rhythm Society lead extraction clinical document and is based on literature searches on common clinical situations for lead management.
“What’s important about this document compared to the prior document in 2009 is that this document takes a step back and looked at lead management as a whole, of which lead extraction is one portion,” Fred M. Kusumoto, MD, FHRS, FACC, director of heart rhythm services at Mayo Clinic in Jacksonville, Florida and professor at Mayo Clinic School of Medicine in Rochester, Minnesota, told Cardiology Today. “The new recommendations are those that deal with lead management and also the diagnosis of or the management of patients with suspected lead infections.”
Lead survival, failure rates
Regarding lead survival, the statement gives a moderate recommendation for increased management and surveillance for patients who have CV implantable electronic devices (CIEDs) that have higher-than-expected failure rates, which have been identified by real-product performance reports and world registry data.
A class I recommendation has been given to leave abandoned leads in a condition to prevent retraction and allow for future extraction.
“One of the other things that we often consider as a lead management strategy is lead abandonment, where we just leave the lead in place,” Kusumoto said. “The main issue here is that we provide recommendations that allow either lead abandonment or extraction. It’s really up to the physician based on an individual patient’s condition to make the decision on the best strategy.”
It is strongly recommended to discuss the risks and benefits of lead removal or abandonment with the patient before the procedure, and the decision should be based on the patient’s comorbidities, preferences, available programming options and future vascular access, Kusumoto and colleagues wrote.
Removing or abandoning the lead is reasonable if the lead becomes nonfunctional or clinically unnecessary, according to the statement.
It is recommended to take two sets of blood cultures before starting antibiotics in patients with suspected CIED infections to provide accurate therapy and reduce the duration, in addition to gram stain and cultures of the explanted lead and generator pocket tissue upon removal of the device.
Transesophageal ECG should be performed in patients with a suspected systemic CIED infection to identify either the absence or presence of lead infection or endocarditis, though it can be useful in patients with CIED pocket infections with or without positive blood cultures.
Evaluation by a physician who has experience in CIED lead extraction and infection is recommended for patients with document CIED infection. It is also reasonable for patients with a suspected infection.
Other imaging modalities, such as PET and CT scans, may be reasonable for patients with a potential CIED infection that was not confirmed using other methods.
Noninfectious device removal
Complete device and lead removal should be performed in patients with definite CIED system infection, valvular endocarditis that does not involve the lead and/or the device, and recurrent or persistent fungemia or bacteremia after antibiotic therapy. Patients who have had the CIED removed due to infection are recommended a course of antibiotic therapy.
Epicardial patches and leads should be removed completely for patients with confirmed infected fluid around the intrathoracic part of the lead.
“Sometimes it’s pretty straightforward decision on whether to extract if the pocket and the lead is infected, but in many other cases, it’s incredibly subtle and very difficult, and nuanced decision-making is critical with the physician discussing the issues and the various courses of action with the patient,” Kusumoto told Cardiology Today.
Removing the device or the lead is reasonable for patients with unmanageable, severe chronic pain where it was inserted or otherwise related to the device.
“Although these are possible etiologies for chronic pain at the device site and/or lead insertion site, it is important to keep in mind that this clinical scenario can be multifactorial, and a careful and individualized treatment plan is necessary,” Kusumoto and colleagues wrote.
Lead removal is beneficial for patients with clinically significant thromboembolic events, superior vena cava stenosis or occlusion, planned stent deployment in a vein with a transvenous lead and life-threatening arrhythmias, according to the statement. It is also reasonable for patients with ipsilateral venous occlusion, a device location that is in the path of planned radiation therapy for a malignancy and those that require device implantation with four or more leads on one side or through the superior vena cava. Lead removal may be considered for patients whose devices have failed and pose a threat, those that require an MRI and for rare clinical situations where it needs to be removed after a shared decision-making process.
Information on success and complication rates in addition to extraction programs is beneficial for the patient and should be available for them before any lead removal procedure.
“The document stresses that individualized management is required when thinking about these issues, and that’s why we have a patient information or patient example table to have a clinician address some of the issues that are there when making a decision with regards to abandonment or extraction,” Kusumoto said. – by Darlene Dobkowski
For more information:
Fred M. Kusumoto, MD, FHRS, FACC, can be reached at firstname.lastname@example.org.
Disclosure: Kusumoto reports no relevant financial disclosures. Please see the statement for all other authors’ relevant financial disclosures.