Previously abandoned leads tend to complicate infections caused by cardiac implantable electronic devices (CIEDs), according to research published in JACC: Clinical Electrophysiology.
Investigators from the Cardiac Electrophysiology and Infectious Disease sections at the Cleveland Clinic in Ohio hypothesized that abandoned leads would complicate CIED infection management, particularly transvenous lead extraction. They noted that use of CIEDs has grown in recent years due to their expanding indications and better outcomes for patients with heart disease and comorbid conditions. However, with these devices come system changes, revisions, or upgrades that require more interventions for patients, and these interventions may increase risk of infection.
The researchers defined the primary end point as successful removal of both the device and all lead material from the vascular space, in the absence of a major complication or death. A total of 1386 patients undergoing transvenous lead extraction at the Cleveland Clinic were included in the study. They were divided into 2 groups: patients with previously abandoned leads (n=323) and patients without previously abandoned leads (n=1063).
Device pocket or endovascular infection was present in 67.8% and 32.2% of group 1 patients, respectively (vs 58% and 42% in group 2; P =.02). The researchers noted that more group 1 patients had vegetations with transthoracic (12.4% vs 7.2%; P =.02) or transesophageal (30.8% vs 22.3%; P =.02) echocardiograms, despite the higher occurrence of pocket infections. Overall, lead vegetations were evident in 27% of group 1 patients compared with 16.9% of group 2 patients (P =.002), and when present, vegetations were larger in group 1 patients.
The total number of leads in group 1 was 1010 vs 2133 leads in group 2, with a higher lead burden in group 1 (median 3 leads) vs group 2 (median 2 leads). The leads in place in group 1 were more likely to be pacer leads (83.4% vs 73.1%) than defibrillator leads (16.6% vs 26.9%; P <.0001), and the leads in group 1 were also considerably older (median lead age in group 1: 2291 days vs median lead age in group 2: 1549 days). Overall procedural times were significantly longer for group 1 vs group 2 patients (eg, extraction and fluoroscopy).
Lead material was more likely to be left behind in the vascular space of patients in group 1 due to unsuccessful removal (11.5% vs 2.9%; P <.0001), and the patients were more likely to experience major and minor complications during extraction. Thirteen percent of patients in group 1 failed to achieve the primary end point compared with 3.7% of patients in group 2 (P <.0001).
The investigators conducted a sensitivity analysis to determine if the outcomes would be different in patients with or without abandoned leads but with a similar total number of endovascular leads. These patients had 2 or 3 endovascular leads in place—the point at which both sets of patients (with or without abandoned leads) overlapped. The patients who were excluded for having less than or more than 2 or 3 endovascular leads included 1 patient in the group with abandoned leads (who had 1 lead in place) and 9 patients in the group without abandoned leads (who had 4 or more leads in place).
According to the authors, this study is of clinical relevance due to the fact that “lead abandonment at the time of system revisions or upgrades is widely practiced with continued controversy regarding management of superfluous leads” and will become more of an issue as more patients need upgrades and revisions.
They concluded, “Any discussion with patients about the risks of extracting redundant leads vs lead abandonment should account for the added complexity of managing possible future CIED infections.”
The researchers noted that the findings may underestimate the real-life occurrence of failure and complication rates outside of their large volume tertiary care center. Also, the observational nature of this study could not control for possible bias in the data collected. Finally, the issue of lead abandonment or extraction in relation to CIED infections is unlikely to be addressed in randomized controlled trials.
Hussein AA, Tarakji KG, Martin DO, et al. Cardiac implantable electronic device infections: added complexity and sub-optimal outcomes with previously abandoned leads. JACC Clin Electrophysiol. 2016. doi:10.1016/j.jacep.2016.06.009.