Major predictors of fibrous adherences in transvenous implantable cardioverter-defibrillator lead extraction Luca Segreti, MD, * Andrea Di Cori, MD, * Ezio Soldati, MD, * Giulio Zucchelli, MD, PhD, * Stefano Viani, MD, * Luca Paperini, MD, * Raffaele De Lucia, MD, * Giovanni Coluccia, MD, * Sergio Valsecchi, PhD, † Maria Grazia Bongiorni, MD, FESC * From the * Second Cardiology Division, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy, and † Boston Scientific Italy, Milan, Italy. BACKGROUND Percutaneous removal of implantable cardioverter- defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead. OBJECTIVE The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extrac- tion and to identify potential predictors among patient and lead characteristics. METHODS We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013. RESULTS Procedural success rate was 99%, without major compli- cations. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart. CONCLUSION ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the pheno- menon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure. KEYWORDS Implantable cardioverter-defibrillator; Lead; extraction; Adherence; Internal jugular vein ABBREVIATIONS CI ¼ confidence interval; ICD ¼ implantable cardioverter-defibrillator; MD ¼ mechanical dilatation; MT ¼ manual traction; OR ¼ odds ratio (Heart Rhythm 2014;0:1–6) I 2014 Heart Rhythm Society. All rights reserved. Introduction In recent years, the growth of implantable cardioverter- defibrillator (ICD) implantations has led to an increase in ICD removal procedures for lead failure or infection. 1 Although safe and effective, transvenous lead extraction continues to be a challenging procedure. 2,3 Fibrous ingrowth, the main obstacle to lead removal, 4 may vary from patient to patient, affecting the complexity, duration, and outcomes of the procedure. Some factors have been suggested to increase the fibrous reaction, but until now no data have been systematically collected to describe the rate, location, and predictors of fibrous adherences in patients with ICD leads. The aim of the study was to analyze data collected from patients who underwent transvenous ICD lead extraction in our center and to describe, from a procedural standpoint, the occurrence and location of fibrous adherences and the potential predictive value of patient and lead characteristics. Methods Patient population and procedure We included and analyzed all consecutive patients who underwent a transvenous ICD lead extraction in our center from January 1997 to December 2013. In accordance with the Guiding Principles of the Declaration of Helsinki on studies involving humans, all patients gave informed consent to the procedure and to personal data collection. The study was approved by the Institutional Committee on Human Research at our institution. The extraction procedure has been previously described. 5,6 After device removal, the leads were examined visually and by fluoroscopy of their intravascular segment. The proximal end was then clipped and a standard stylet inserted into the lead. Lead extraction was attempted by gentle manual traction (MT). If this proved unsuccessful, we Dr. Valsecchi is an employee of Boston Scientific. Address reprint requests and correspondence: Dr. Luca Segreti, Second Cardiology Division, Cardiothoracic and Vascular Department, University Hospital of Pisa, via Paradisa, 2-56100 Pisa, Italy. E-mail address: lucasegreti@gmail. com. 1547-5271/$-see front matter B 2014 Heart Rhythm Society. All rights reserved. http://dx.doi.org/10.1016/j.hrthm.2014.08.011