The rate of complications and in-hospital mortality was found to be high in patients undergoing transcutaneous lead extraction (TLE) for implantable device-related infections (DRI), and related mortality was found to be predicted by factors that include significant weight loss, congestive heart failure, and chronic kidney disease, according to a study published in JACC: Clinical Electrophysiology.
DRIs remain the most serious complication and most common indication for lead extraction in patients with Cardiac Implantable Electronic Devices. The rates of major adverse events (MAEs) in US adults who had undergone TLE for DRI between 2003 and 2015 were determined using data from the Agency for Healthcare Research and Quality’s National Inpatient Sample database. The primary study end point was in-hospital mortality, and the secondary end point was the rate of major periprocedural complications.
Of 12,257 unweighted observations representing 59,082 patients (95% CI, 58,982–59,182) undergoing TLE for DRI during the study period, 75% were >60 years, 70% were men, 76% were White, and 80% had ≥1 comorbid condition. The median length of hospital stay was 8 days (interquartile range, 5-14), and ≥1MAE occurred in 10.42% of TLE procedures.
Predictors of mortality included being ≥45 years, having congestive heart failure (adjusted odds ration [aOR], 3.28; 95% CI, 2.48-4.34), having chronic kidney disease (aOR, 2.09; 95% CI, 1.70-2.56), and low body weight (aOR, 4.02; 95% CI, 3.13-5.17). Independent predictors of mortality included pulmonary complications (aOR, 2.06; 95% CI, 1.25-3.40), vascular complications (aOR: 2.82; 95% CI: 1.26-6.28), and pericardial complications (aOR, 2.87; 95% CI, 1.79-4.61).
Study limitations included the retrospective nature, and the inability of the coding system used to distinguish between pacemaker lead and defibrillator lead extractions, which are associated with worse outcomes.
“The ‘real world’ data reveals higher rates of complications and in-hospital mortality in patients undergoing TLE for DRI compared [with] rates reported in clinical trials,” concluded the study authors. ”Attention should be focused on recognizing high risk patients and implementing strategies to reduce the complication rates in this population of patients with device related infections.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Hosseini SM, Rozen G, Kaadan MI, Galvin J, Ruskin JN. Safety and in-hospital outcomes of transvenous lead extraction for cardiac implantable device related infections: Analysis of 13 years of inpatient data in the United States [published online October 30, 2019]. JACC Clin Electrophysiol. doi: 10.1016/j.jacep.2019.08.020