New HRS Guidance on Lead Management, Extraction

Patrice Wendling

September 19, 2017

WASHINGTON, DC — A new consensus statement released this week by the Heart Rhythm Society (HRS) and nine other medical societies provides physicians practical clinical advice on cardiac implantable electronic device (CIED) lead management and extraction[1].

According to chair Dr Fred Kusumoto (Mayo Clinic, Jacksonville, FL), the new document updates the 2009 HRS recommendations for facilities and training in what was then the emerging issue of lead extraction "but takes a more general approach to think about lead management as an entire topic as opposed to just the one subtopic of lead extraction."

The 2017 consensus statement also involved a much larger, global group of cardiologists and electrophysiologists that had a wider breadth of interest and expertise, which is reflected in the various societies endorsing the document such as the Infectious Diseases Society of America, he said. "Something like this really needs to have worldwide collaboration to identify best practices as opposed to being US-centric."

In 2013, the European Society of Cardiology weighed in on lead extraction but only with recommendations for training, while a 2015 American Heart Association/American College of Cardiology statement simply outlined the number of lead extractions necessary for competence.

One of the key messages in the new HRS document is that lead management requires nuanced care and evaluation, Kusumoto said. This includes a lead model and clinical-scenario-specific strategy of increased surveillance and management for CIED leads known to have higher-than-expected failure rates. The expert panel cites several well-known examples of lead recalls and advisories including the Medtronic Fidelis lead in 2007 and the St Jude (now Abbott) Riata ICD leads in 2011.

"The Riata family of leads exemplifies the decision-making challenges faced by clinicians, because the mechanical externalization rate for select models can be as high as 25% to 30%, whereas electrical failure rates range from 2% to 4%," they write.

The document features indications for infectious and noninfectious lead extraction and a table with several patient scenarios and the reasoning behind each of the management strategies. For example, lead abandonment was deemed the better option for an 86-year-old cancer patient with complete heart block and a 14-year-old pacemaker, whereas lead extraction and replacement was best for a 46-year-old woman with complete heart block and a mechanical mitral valve.

"This is really the epitome of patient-centered care, where the physician really needs to act as the translator of the medical literature and weigh the pros and cons of each strategy to decide what the next step would be," Kusumoto said.

Similarly, when there is concern for device infection, evaluation needs to be on a case-by-case basis, he added. The consensus statement recommends transesophageal echocardiography for patients with suspected systemic CIED infection and complete device and lead removal for all patients with definite CIED system infection or with valvular endocarditis without definite involvement of the lead(s) and/or device.

The selection of the appropriate antimicrobial agent, however, should be based on identification and in vitro susceptibility testing.

"Certain bacteria like Staphylococcus aureus are more virulent and will stick to the leads, while gram-negative rods like E coli are not very sticky and even if you are bacteremic with one of those bacteria, it is unlikely to seed the leads and ultimately require extraction," Kusumoto explained. "So the point again is nuanced care and the involvement of experts from different specialties to address that particular patient's care."

Perhaps the most contentious issue during development of the consensus statement was choosing between lead abandonment and the risk of lead extraction, he said. One new class IIb recommendation that acknowledges the failure rate of leads and dynamic patient conditions is that "lead removal may be considered in the setting of normally functioning nonrecalled pacing or defibrillation leads for selected patients after a shared decision-making process."

Another new class IIb recommendation states that "lead abandonment or removal can be a useful treatment strategy if a lead becomes clinically unnecessary or nonfunctional."

"The issues are changing because, for example, it used to be that if you had abandoned leads it precluded you from getting magnetic resonance imaging, and while that's still probably true, there's emerging data from single centers suggesting you can get by without any change in clinical outcomes with regard to doing MR imaging in those patients with abandoned leads," Kusumoto said. "So not only is the technology changing, but our knowledge and management of patients is obviously evolving quickly. It's a rapidly changing landscape, and the question is to be an early adopter or to rely on data that's tried and true."

The experts note that the introduction of the subcutaneous ICD and retrievable leadless pacemakers like the Nanostim (Abbott) and Micra Transcatheter Pacing System (Medtronic) are part of the changing landscape but write that available data remain limited.

"In the near future, we're still going to be putting devices in with leads, but with the new technology coming at us, I'm hopeful that some of the things we bring up here we're only going to have to address over the next decade and will become less and less relevant 10 to 15 years from now," Kusumoto concluded.

Kusumoto reported no relevant financial relationships. Disclosures for the coauthors are listed in the paper.

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