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Safety and effectiveness of transvenous extraction for ePTFE-coated leads: A retrospective comparative study
Connor C Barrett1, Ethan S Wagner2, Robert D Lewis3
1Duke University School of Medicine, Durham, North Carolina.
Background:
The Heart Rhythm Society statement on the Reliance high-impedance advisory recommended shared decision making regarding lead management decisions given concerns of risk associated with extraction from long dwell times and calcification.
Objective:
This study aimed to evaluate the safety and effectiveness of extraction of advisory Reliance leads.
Methods:
We conducted a single-center, retrospective study comparing extraction of Reliance and non-Reliance implantable cardioverter-defibrillator (ICD) leads. The primary endpoint was the extraction failure rate and the main safety endpoint was the major adverse event rate. A sensitivity analysis was performed with a matched control cohort selected with Mahalanobis distance nearest-neighbor matching. Predictors of abnormal impedance were evaluated with least absolute shrinkage and selection operator and Firth penalized regression.
Results:
Among 87 Reliance patients (88 leads) and 220 non-Reliance patients (controls, 257 leads), the mean age was 58.5 ± 14.4 (Reliance) vs 60.1 ± 14.5 years (non-Reliance) (P = .33). Body mass index, diabetes mellitus, left ventricular ejection fraction, previous sternotomy, and estimated glomerular filtration rate were similar in both groups (P > .05 for all). There was no difference in the extraction failure rate (Reliance 2.3% vs control 3.2% [P = .59] vs matched controls 3.4% [P = .26]). There was no difference in the major adverse event rate (Reliance 3.4% vs control 2.7% [P = .72] vs matched controls 1.1% [P = .62]). After adjustment, Reliance procedures required less extraction time, less rotational cutting tool use, and fewer clicks with similar use and amount of laser. High previous impedance, dual-coil configuration, and low body mass index were predictors of abnormal impedance among Reliance leads.
Conclusion:
The safety and efficacy of extraction of Reliance ICD leads were similar to the extraction of non-Reliance ICD leads. Reliance procedure times were shorter, and there was less rotational cutting tool use.
