Introduction. CLINICAL RESEARCH Leads and Lead Extraction

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1 Europace (2011) 13, doi: /europace/euq400 CLINICAL RESEARCH Leads and Lead Extraction Percutaneous extraction of cardiac pacemaker and implantable cardioverter defibrillator leads with evolution mechanical dilator sheath: a single-centre experience Ali Oto, Kudret Aytemir, Hikmet Yorgun, Uğur Canpolat*, Ergün Barış Kaya, Giray Kabakçı, Lale Tokgözoğlu, and Hilmi Özkutlu Cardiology Department, Hacettepe University Faculty of Medicine, 06100, Sıhhıye, Ankara, Turkey Received 17 July 2010; accepted after revision 30 September 2010; online publish-ahead-of-print 17 November 2010 Aims The growing problem with endocardial lead infections and lead malfunctions has increased the interest in percutaneous lead removal technology. In this report, we present our initial experience in percutaneous lead extraction with a novel hand-powered sheath, the Evolution mechanical dilator sheath.... Methods During 13 months between June 2009 and July 2010, 41 leads in 23 patients were removed. All of the extracted leads and results were.12 months old, and indications for extraction were based on the recommendations of the Heart Rhythm Society. The leads were removed by using the Evolution mechanical dilator sheath (Cook Medical) with the rotational cutting force only, without laser or radiofrequency energy. Indications for lead removal included cardiac device infection in 7 (30.4%) cases, lead malfunction in the 15 (65.2%) cases, and lead displacement in the remaining 1 case (4.4%). In 14 (60.9%) cases, the extracted device was a pacemaker, and implantable cardioverter defibrillators (ICD) in 9 (39.1%) of them. Among 41 leads, 25 (60.9%) were right ventricular, 14 (34%) were atrial, and 2 (4.8%) were coronary sinus electrode. The median time from the preceding procedure was 74 months ( months). Complete procedural success with Evolution system alone was achieved in 19 (82%) patients (35 leads). Four leads were completely removed with snaring and in two leads, partial success was achieved with a remaining ventricular tip smaller than 1.5 cm. Clinical success was 100%, and all of the patients discharged uneventfully without a major complication.... Conclusions Our experience confirms that the mechanical technique with Evolution system is an effective first-line method for chronically implanted pacemaker/icd leads. Continued investigation is required to evaluate success and complication rates in comparison with other techniques Keywords Evolution mechanical sheath Percutaneous lead extraction Introduction Over the past two decades, broadening the indications of implantable cardioverter defibrillators (ICD) and pacemakers (PM) with the proven efficacy of cardiac resynchronization therapy caused an exponential rise in the implantation of cardiac devices. Consistent with this trend, an increasing number of lead extraction procedures are eventually required. Lead extraction procedures have increased as a result of lead failure, infection, lead lead interactions, venous stenosis or thrombosis, chronic pain at the device or lead insertion site, life-threatening arrhythmias secondary to retained leads, and the need to upgrade to a new technology. 1 After implantation, transvenous device leads usually undergo fibrotic encapsulation by activation of different cellular and humoral immune mechanisms. 2 Although manual traction may be an effective way to remove the leads implanted,1 year back, chronically implanted leads develop fibrous attachments to surrounding structures and require more advanced extraction systems. * Corresponding author. Tel: ; Fax: , dru_canpolat@yahoo.com Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com.

2 544 A. Oto et al. Despite improvements in endovascular extraction tools, the intervention is a complex procedure requiring an experienced personnel, and it is still associated with morbidity and even mortality. 3,4 Various methods have been used in lead extraction including manual traction, extended weight or forceps-assisted traction, laser devices, radiofrequency devices, mechanical extraction systems, and even open-chest surgery. A recently developed hand-powered device, the Evolution mechanical dilator sheath (Cook Medical, Bloomington, IN, USA), is a flexible plastic sheath with a threaded metal distal tip, which allows the system to pass through the adhesions. Although the rotational mechanism allows the sheath to move along the lead body by cutting fibrous adhesions, the outer telescoping polymer sheath protects the venous wall from the metal cutting tip when fibrous attachments were not met. Additionally, a shorter Evolution w Shortie mechanical dilator sheath is produced with a sharper blade to facilitate venous access in patients with extensive scarred or calcified tissue under clavicle. 5 In this report, we aimed to present our experience, in terms of effectiveness and safety of the Evolution sheath in chronically implanted leads. Methods Study population The study cohort comprised 23 consecutive patients who underwent lead extraction procedure in our department between June 2009 and July An informed consent was taken from each patient. Data were consecutively collected case-by-case and entered into a computerized database. A total of 41 leads were extracted using a handpowered mechanical sheath marketed as the Evolution (Cook Medical). The indications for lead extraction were based on the Heart Rhythm Society s (HRS) recommendations (NASPE 2000, HRS Expert Consensus Document 2009). The main indications for lead extraction were lead malfunction or device infection. Lead malfunctions were established on the basis of clinically significant alterations in pacing, sensing, and lead impedance. The cardiac device infection may involve the generator pocket, the leads (with or without endocardium), or both components. Clinical evidence of device infection included local signs of infection or inflammation at the generator pocket (e.g. erythema, warmth, fluctuance, wound dehiscence, tenderness, purulent drainage, or erosion of the generator leads through the skin). Presence of device-related endocarditis was confirmed when valvular or lead vegetations were detected by echocardiography, or if the Duke criteria for infective endocarditis were met. A cardiac device infection was microbiologically confirmed based on positive cultures from the generator site, lead(s), and/or blood (in the presence of local infective signs at the generator, no other cause of bacteraemia, and resolution of the infection with device removal). 6,7 Lead extraction technique The lead extraction procedure was performed in the cardiac catheterization laboratory under conscious sedation and local anaesthesia, with non-invasive blood pressure and oxygen saturation monitoring, 1,8 and a cardiothoracic surgery team standby. A thorough evaluation of PM/ ICD was performed before the intervention including the assessment of the degree of pacemaker dependency, and temporary transvenous pacing was established if necessary. After the skin preparation, the generator pocket was opened and the pacemaker generator was disconnected from the leads. The leads were separated from the scar tissue by blunt dissection. If manual traction was not successful, a systematic approach using locking stylet (Liberator Universal Locking Stylet, Cook Medical) and mechanical dilator sheaths was used for both atrial, right ventricular, and coronary sinus leads. The Evolution mechanical dilator sheath was then positioned over the lead (Figure 1). The operator pulls the handle of the dilator sheath which causes rotation of the cutting tip. The dilator sheath moves along the lead body by cutting fibrous adhesions via the distal metal tip. The outer polymer sheath covers the distal tip while advancing over the lead in the tracts free from adherences to protect venous wall from damage. When fibrous attachments met, the cutting tip uncovered from the outer sheath. Once the fibrous attachments are cut, the outer sheath is advanced until another area of attachment is encountered. After the release of leads from fibrous tissue, the leads were pulled back into the sheath and removed (Figure 2). In case of free floating lead, remnants after extraction, the femoral approach with Multisnare (Multi-Snare, PFM, Köln, Germany) or Needle s eye snare (Cook Vascular, Leechburg, PA, USA) attempted to grasp the remaining parts and pulled down into the inferior vena cava. For patients requiring replacement of their lead, a new lead system was implanted through the same vein in case of lead malfunction. In case of device infection, the subclavian vein on the opposite side was used after the eradication of infectious microorganism according to the recommendations of current guideline by HRS. 1 In PM-dependent patients, re-implantation was performed in the same session if the extraction was due to non-infectious causes. In cardiac device infection, a temporary PM was implanted through the contralateral jugular vein that has no valvular or lead-associated vegetations until the blood cultures drawn within 24 h of extraction procedure remain negative for at least 72 h. During the first 48 h after the procedure, the follow-up period was characterized by continuous Figure 1 The Evolution sheath. This is a flexible sheath with a distal threaded metal tip. A handle is attached to the plastic sheath proximally that rotates the sheath, allowing the threaded metal end to run through adhesions.

3 Extraction of cardiac pacemaker and ICD leads 545 Figure 2 (A) Fibrous material adherent to pacing lead at multiple sites. (B) Fibrous tissue was avulsed from the ventricular wall during the extraction process. Figure 3 Fluoroscopic view of implantable cardioverter defibrillators electrode covered by the Evolution sheath (A). After the fibrous adhesions were eliminated by the cutting tip of Evolution TM sheath, implantable cardioverter defibrillators electrode was pulled back into the sheath and extracted successfully (B). non-invasive blood pressure, oxygen saturation, and electrocardiographic monitoring with echocardiographic evaluation just after the intervention, before discharge. At the first month follow-up, a thorough device interrogation was added to the patient assessment with clinical evaluation, electrocardiography, chest X ray, and transthoracic echocardiography when necessary. Procedural/clinical success and complications The success of extraction was determined by means of complete procedural (radiographic) and clinical criteria. Complete procedural success was defined as the removal of all lead components from the vascular space, without any major complication. Clinical success is defined as the removal of all targeted leads and lead material from the vascular space, or retention of a small portion of the lead (,4 cm) that does not negatively impact the outcome goals of the procedure. This may be the tip of the lead or a small part of the lead (conductor coil, insulation, or the latter two combined) when the residual part does not increase the risk of perforation, embolic events, perpetuation of infection, or cause any undesired outcome. Complications were defined as major or minor, according to previously published guidelines. 1 Statistical analysis Continuous data are expressed as means + SD, median, and ranges, and all categorical data are expressed as percentages. Statistical analysis is performed using SPSS statistical software (version 15.0; SPSS Inc., Chicago, IL, USA). P, 0.05 is considered significant. Results From June 2009 to July 2010, a total of 41 endovascular leads were extracted from 23 patients who were admitted to our Cardiology Department. Eighteen patients were male (78%) and the mean age was In 14 (60.9%) cases, the extracted device was a pacemaker, and ICD in 9 (39.1%) of them. Among 41 leads, 25 (60.9%) were right ventricular, 14 (34%) were atrial, and 2 (4.8%) were coronary sinus electrodes. The indications for lead extraction were cardiac device infection in 7 (30.4%) cases, lead malfunction in the 15 (65.2%) cases, and lead displacement in the remaining 1 case (4.4%). All of the leads were removed by the Evolution sheath but additional femoral snare system was Table 1 Baseline characteristics of the study population Parameters n Age, years, mean + SD (range) 58, (31 80) Male gender, n (%) 18 (78) Coronary artery disease, n (%) 9 (39) Hypertension, n (%) 5 (21.7) Diabetes mellitus, n (%) 2 (8.6) Heart failure, n (%) 9 (39) Implanted device, n (%) Single-chamber pacemaker 2 (8.6) Dual-chamber pacemaker 11 (47.8) Biventricular pacemaker 1 (4.3) Single-chamber ICD 5 (21.7) Dual-chamber ICD 3 (13) Biventricular ICD 1 (4.3) Indications for initial device implantation, n (%) Dilated cardiomyopathy, syncope, and VT 9 (39) Complete heart block 2 (8.6) Symptomatic second-degree heart block 1 (4.3) Sick sinus syndrome 10 (43.8) Cardiac arrest survivor, VT 1 (4.3) ICD, implantable cardioverter defibrillator; VT, ventricular tachycardia. required in six patients (Figure 3). The baseline characteristics of the study population are presented in Table 1. Leads were inserted through the left subclavian vein in all patients except in one patient, where it was inserted through the right subclavian vein, and right femoral access was used when the snare was needed as an additional tool to completely remove the leads. In one patient, a ventricular rate responsive PM was upgraded to a biventricular PM. In 13 (56.5%) patients, a PM or ICD was implanted in the same session. The median time from lead implantation to lead removal was 74 months (range months). The characteristics of extracted devices and procedures are presented in Table 2. Complete procedural success without further intervention was achieved in 19 (82%) patients (35 leads). In the remaining six

4 546 A. Oto et al. Table 2 Device and procedure-related characteristics of the patients Implanted device... Pacemaker, n (%) 14 (60.9) ICD, n (%) 9 (39.1) Time from implant, months (median) 74 (25 180) Cardiac leads per patient, n (%) One lead 8 (34.7) Two leads 12 (52.2) Three leads 3 (13.1) Indications for removal, n (%) Pocket erosion and infection 7 (30.4) Lead failure 15 (65.2) Lead displacement 1 (4.4) Transvenous lead type, n (%) Atrial 14 (34.1) Ventricular 14 (34.1) Defibrillation coil 11 (26.8) Coronary sinus 2 (4.9) ICD, implantable cardioverter defibrillator. ventricular leads (three ICD and three PM electrodes), an additional snaring system was required because of lead fracture. Right femoral access was used for snaring, and remaining parts of ventricular electrode tips were removed successfully except for two ventricular electrode tips ( 1.5 cm segment), which remained inside. A Needle s Eye snare was used to grasp a cut lead in two patients and Multisnare was used in four patients. An overall complete procedural success was achieved in 21 patients (91%) with a clinical success of 100%. None of the patients had major complications during or at early follow-up. We observed only one event classified as minor complication: one patient had haematoma at the PM pocket requiring drainage. We observed five adverse events which did not detoriate the clinical status of our patients: paroxysmal atrial fibrillation and non-sustained ventricular tachycardia in two patients in whom sinus rhythm was achieved with anti-arrhythmic medications, transient hypotension that spontaneously resolved in one patient, and spontaneously resolved post-procedural haematoma in one patient. Discussion In this single-centre study, we have shown that the extraction of chronic endovascular leads using Evolution system was an effective first-line method. The recommendations of HRS were adhered in the definition of the indications for lead extraction procedures. In recent years, the frequency of lead extraction has increased worldwide, as a consequence of the growing prevalence of patients using PM/ICD. Infection of the pacing system is the leading cause of lead removal in adult patients. 9 However, in our patient group, most of the subjects had lead malfunction inconsistent with the established literature. Those results should be interpreted in the light of single-centre experience and a small number of patients enrolled in our study. Furthermore, there is a growing number of lead failure cases due to trauma to the lead and subsequent damage to the insulation or wire components. 10 Several methods for percutaneous lead extraction procedures were reported including simple traction, traction devices, mechanical sheaths, telescoping sheaths, rotating threaded tip sheath, electrosurgical, and laser extraction systems. 1 Newer methods for lead extraction using laser or radiofrequency methods have also been used with high success rates; however, these techniques are not available in the majority of centres Therefore, the use of different approaches described previously depends on the patient s clinical presentation, operator s skills and experience, and locally available material mainly based on the budget provided for such procedures. Laser extraction systems are more costly than the Evolution system. In our study group, the Evolution system was used as a first-line method instead of laser extraction because of the availability and budget problems by governmental health insurance policies. For the past two decades, enormous progress in lead extraction techniques has been made. Instead of continuous traction, new techniques known as counter-traction have been developed which are composed of mechanical systems for the removal of fibrous adhesions in the venous system. In addition to the introduction of locking stylets to improve tensile properties during traction, new techniques have also been developed to shorten the procedural time by ablating the surrounding fibrous tissue around the lead including radiofrequency and laser energy systems. In the PLEXES (Pacemaker Lead Extraction with the Excimer Sheath) trial, 301 patients with 465 chronically implanted pacemaker leads were randomized into a laser sheath and a nonlaser cohort in which the procedural success was reported to be 94% in the laser group and 64% in the non-laser group, with an associated major complication rate of 1.96% in the laser group. 11 In the retrospective LExICon study examining the safety and efficacy of laser-assisted lead extraction in a large series of consecutive patients, complete procedural success rate was 96.5% and clinical success rate was 97.7%, with a major adverse event rate of 1.4%. 15 When compared with laser-based systems, our procedural success seems to be a little bit lower with the Evolution system. This may be due to several factors including larger series of patients in the laser groups, learning curve for this method and preliminary experience with the Evolution system compared with laser-based systems. However, despite the superiority of laser-based extraction systems over non-laser methods, laser systems were not free of major complications. Furthermore, in the LExICon study centres with smaller case volumes tended to have a lower rate of successful extraction and higher major adverse event rates. 15 Moreover, lead extraction using conventional techniques may be achieved at half the cost of laser sheaths, which limited the use of laser-based systems. 16 The Evolution mechanical dilator system is a new tool for lead extraction. In a recent study by Hussein et al., 5 29 patients with 41 leads were evaluated for the safety and efficacy of Evolution for PM/ICD lead extraction, and the Evolution system was reported to be successful in 25 (86%) patients (33 leads). Our study results are similar to that study with a complete procedural success achieved in 19 (82%) patients (35 leads) and clinical

5 Extraction of cardiac pacemaker and ICD leads 547 success in all of the patients (100%). The rotational mechanism of the Evolution system allows the sheath to move along the lead body and the cutting tip advances through fibrous attachments. The Evolution sheath tip is protected by an outer sheath and uncovered only when its cutting activity is desired. This system has enough flexibility to follow the curve of the catheter to provide additional tissue protection. Furthermore, a new tool, the Evolution w Shortie mechanical dilator sheath, was designed to overcome the difficulties of venous access in cases of extensive scarred or calcified tissue around the leads, with a sharper blade and shorter handle increasing the physician s control. No major complication occurred, and all of the procedures were successfully completed in our study. Although the outer sheath provides a mechanical barrier to the electrodes, severance of leads and wrapping of coexisting leads were observed with the Evolution system in three of our patients, who had some of the oldest leads. In such cases, using a larger outer sheath or trying another extraction technique may be useful, such as the laser sheath for femoral extraction as mentioned previously. 5 A femoral extraction technique was used for the remaining parts of leads after the extraction of proximal segments with the Evolution system. In four patients, free floating distal parts of leads were removed with a Multisnare system and a Needle s Eye snare was use in two cases. Complete procedural success was achieved in four patients but only clinical success with a 1.5 cm distal tip remained at the right ventricular apex in the remaining two patients. In addition to mechanical sheaths, femoral snare systems contributed to procedural success with a clinical success rate of 100% in our patient population. These data also highlight the contribution of different lead extraction tools on procedural success rates. This study has some limitations. First, these results should be interpreted in the light of single-centre experience. This observational study was solely aimed to present our initial experience with the Evolution system as a first-line therapy for lead extraction. Therefore, these results should not be generalized. Also, our study was not designed to compare the safety or efficacy of the Evolution system with other lead extraction tools, especially laser sheaths. Our patient number is small; large-scale randomized studies are needed for better understanding of the safety and efficacy of this new method. In our patients, we used non-invasive blood pressure monitoring during the extraction. Although no complications occurred in our patient group, most experts prefer invasive monitoring of blood pressure to recognize haemodynamic changes. Finally, our experience suggests that the mechanical technique with a hand-powered sheath marketed as the Evolution can be used as a first-line method for chronically implanted PM/ICD leads. Despite the facility and cost effectiveness, these findings suggest that this approach can be used only by experienced electrophysiologists with an adequate cardiothoracic surgery team on standby to cope with any complications. Continued investigation is required to compare safety, success, and complication rates with other techniques. Conflict of interest: none declared. References 1. Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH et al. 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