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Ann Thorac Surg 2002;73:1893-1896
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

Laser-assist during extraction of chronically implanted pacemaker and defibrillator leads

^a Divisions of Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, USA
^b Division of Cardiology, Washington University School of Medicine, St. Louis, Missouri, USA

* Address reprint requests to Dr Moon, Division of Cardiothoracic Surgery, Washington University School of Medicine, 3108 Queeny Tower, 1 Barnes-Jewish Plaza, St. Louis, MO 63110-1013 USA
e-mail: moonm{at}msnotes.wustl.edu

Presented at the Poster Session of the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2002.

	Abstract

Top Abstract Introduction Material and methods Results Comment References

 
Background. Extraction of chronically implanted pacing and defibrillator leads has historically been difficult, occasionally requiring open surgical procedures. The purpose of this study was to evaluate the efficacy, safety, and potential need for percutaneous laser-assisted sheath techniques for extraction of chronically implanted leads.

Methods. From January 1999 to August 2001, 128 consecutive patients underwent extraction of 229 leads (138 pacing, 91 defibrillator) in the operating room 61 ± 44 (mean ± standard deviation) months after implantation. Common indications included erosion or pocket infection (41%), lead dysfunction (30%), and sepsis (13%).

Results. Laser techniques were used for 56% ± 4% (104 of 186) of long-term (implanted for more than 1 year) leads, compared with only 16% ± 6% (7 of 43) of short-term (implanted for less than 1 year) leads (p < 0.001). For infected leads, laser was used in 53% ± 5% (49 of 92) with erosion or pocket infections, compared with only 3% ± 4% (1 of 29) with sepsis (p < 0.001). Extraction was complete in 88%, near complete (retained tip) in 10%, and incomplete in 2%. Two patients required a later percutaneous femoral venous approach to remove mobile retained segments, but no patients required cardiac surgery for extraction. Complications included sternotomy for subclavian vein injury (1), chest tube for caval perforation (1), innominate vein thrombosis (1), and partial clavicle removal for subclavian vein repair (2). There were no procedure-related deaths.

Conclusions. Laser-assisted lead extraction is safe, but it is best performed in the operating room; it should be available for long-term leads, except when they are grossly infected, producing sepsis. Laser techniques have essentially eliminated the need for open surgical removal of retained leads.

	Introduction

Top Abstract Introduction Material and methods Results Comment References

 
Extraction of chronically implanted transvenous pacing and implantable cardioverter-defibrillator (ICD) leads has historically been difficult, occasionally requiring open cardiac surgical procedures [1–3]. Extensive fibrous adhesions routinely develop between adjacent leads and between the leads, venous endothelium, and atrial and ventricular endocardium. As a consequence, manual traction can be associated with major cardiovascular injury and the need for emergent open surgical repair or, more often, lead fracture with incomplete removal. The use of locking stylets and telescoping sheaths in the early 1990s was a significant advance, but even with these techniques, extraction remained challenging and occasionally dangerous [2–5]. Excimer laser sheaths have recently been introduced to help free encapsulating scar tissue and simplify extraction, and initial experience has been favorable [6–8], but the specific role and necessity for this new technology in various clinical settings remain unclear. The purpose of the current investigation was to determine the efficacy, safety, and potential need for percutaneous laser-assisted techniques for extraction of chronically implanted leads.

	Material and methods

Top Abstract Introduction Material and methods Results Comment References

 
This retrospective review includes 128 consecutive patients who underwent extraction of 229 pacemaker or ICD leads at Washington University Medical Center (Barnes-Jewish Hospital) from January 1999 to August 2001. There were 85 (66%) men and 43 (34%) women, with a mean age (± 1 standard deviation) of 64 ± 16 years (range, 20 to 90 years). An average of 1.8 ± 0.7 leads were extracted per patient; there was one lead extracted in 44 (34%) patients, two leads in 71 (55%), three leads in 10 (8%), and four leads in 3 (2%). Implant duration averaged 61 ± 44 months and was less than 3 months in 19 (8%) leads, 3 to 6 months in 12 (5%), 6 to 12 months in 12 (5%), 12 to 60 months in 76 (33%), and more than 60 months in 110 (48%). The most common types of lead extracted were atrial pacing leads (80 leads, 35%), followed by ventricular pacing leads (76, 33%), ventricular ICD leads (63, 28%), and superior vena caval ICD leads (11, 5%). Table 1 summarizes the indications for lead extraction categorized as mandatory (21%), necessary (77%), or discretionary (3%) [2]. The most common indications included erosion or pocket infection (41%), lead dysfunction (30%), and sepsis (13%).

For leads that were not easily removed with gentle traction, the CVX-300 Excimer laser system (Spectranetics Co, Colorado Springs, CO) was used. Published charts were consulted to estimate laser sheath size (12F, 14F, or 16F) [8], but 12F sheaths were rarely used for long-term leads. Although some leads may fit through a 12F sheath ex vivo, extensive fibrous scar formation can produce a diameter much greater than anticipated. The most common sheath sizes used were 16F (41%) and 14F (39%), followed by 12F (20%). The laser sheath was gently passed over the lead body until resistance was met below the clavicle. Excimer laser energy (5- to 10-second bursts), combined with gentle pressure on the sheath and withdraw traction on the locking stylet, allowed the sheath to advance. Typically, advancement through the soft tissue and into the subclavian or cephalic vein was smooth. In two cases, the lead had to be surgically dissected free from the clavicle to allow passage of the sheath. Dense binding sites typically included passage through the innominate vein if multiple leads were present (lead-to-lead fibrosis) and at the junction of the innominate vein and the superior vena cava (fibrous scar between the leads and caval wall at its bend). At these sites, advancement could be quite tedious, but with patience, the sheath would eventually ablate the scar tissue and pass into the atrium, from where it would generally pass into the ventricle without difficulty. The sheath was advanced over the lead until its tip was 0.5 cm from the ventricular or atrial endocardium, and countertraction was applied to withdraw the lead into the sheath. New leads were implanted in 73 (57%) patients, including 44 ICD and 29 pacemaker implants.

Data analysis
The primary endpoint of this study was complete removal of the lead through the implant vein. The secondary endpoint was near-complete removal, leaving behind only the distal electrode with or without a short segment (less than 1 cm) of conductor coil [4]. Continuous data are reported as mean ± 1 standard deviation and as clinically important ratios with 70% confidence limits. Continuous data were compared between groups using Student’s t test. Univariate analysis (² test) and multivariate stepwise regression analysis were used to determine the preoperative and intraoperative risk factors that were (1) independent predictors of the need for laser-assist during extraction, and (2) independent predictors of complete extraction (SigmaStat 2.03, SPSS Inc, Chicago, IL). Odds ratios are reported with 75% confidence intervals. Ten variables were analyzed: patient age; sex; duration of implant; number of leads extracted; implant chamber (superior vena caval, atrial, ventricular); device type (pacemaker, ICD); lead location (right, left); indication (mandatory, necessary, discretionary); noninfected versus infected (erosion, pocket infection, or sepsis); and sepsis versus no sepsis.

	Results

Top Abstract Introduction Material and methods Results Comment References

 
Extraction was complete in 201 (88%) leads, near complete (retained tip) in 24 (10%), and incomplete in 4 (2%). Of those with incomplete extraction, 2 patients underwent a later percutaneous femoral venous approach in the interventional radiology suite to remove small, mobile segments and prevent pulmonary embolization, and in the other 2 patients, the distal half of the lead was left in place without consequence. No patients required cardiac surgery for extraction. Complications included sternotomy for left subclavian vein injury (1), right chest tube for superior vena cava perforation (1), left subclavian vein thrombosis (1), and resection of the head of the clavicle for subclavian vein repair (2). There were no procedure-related deaths.

Laser-assist was required for 60 (47%) patients and 111 (48%) leads. Table 2 summarizes the influence of various lead characteristics on the need for laser-assist. Laser-assist was necessary more often for long-term than for short-term leads. Laser-assist was necessary for 56% ± 4% of leads in place for more than 1 year, compared with only 16% ± 6% of those in place less than 1 year (p < 0.001). For infected leads, laser-assist was used for 53% ± 5% with erosion or pocket infection, compared with only 3% ± 4% with sepsis (p < 0.001). Laser-assist was used for 56% ± 5% of noninfected leads (p < 0.04 versus infected leads). There was no significant difference in the need for laser-assist between ventricular pacing (55% ± 6%), ventricular ICD (49% ± 7%), and atrial pacing leads (48% ± 6%) (p > 0.65); however, passive superior vena caval coils rarely required laser-assist (1 of 11 leads). Multivariate regression analysis identified three factors as independent predictors of the need for laser-assist: (1) prolonged implant duration (p < 0.001); (2) nonseptic leads (p < 0.001, odds ratio = 34.2 [70% confidence interval, 16.4 to 71.9]); and (3) necessary or discretionary versus mandatory indications (p < 0.02, odds ratio = 1.9 [1.3 to 2.8]).

	Comment

Top Abstract Introduction Material and methods Results Comment References

 
Although the importance of complete removal of obviously septic leads cannot be overemphasized [1, 9–12], in these patients complete removal is rarely a problem. In the current series, leads associated with systemic sepsis most often "fell out" with little effort; extraction was complete in 97% of patients with septic leads. Patients with erosion or pocket infections, however, often had leads that were densely adherent to the venous endothelium and atrial or ventricular endocardium, making it necessary to use laser-assist more often than with septic leads (53% versus 3%, p < 0.001). Laser-assist was very beneficial in this group, making complete removal possible in most cases; extraction was complete in 88% and was near complete in 12% of patients with erosion or a pocket infection. To date (mean follow-up 15 ± 8 months), we have had no instances of systemic or local infection arising from a retained tip or partial lead, regardless of the indication for extraction. Based on this experience, we now believe that leads that are difficult to remove and that require laser-assist throughout their course are unlikely to be infected at their endocardial insertion point. Thus, if lead extraction is near complete in a patient with a local infection, we do not pursue further measures for extraction unless we have reason to believe that systemic sepsis is present.

Laser techniques have essentially eliminated the need for open surgical removal of retained leads, except in the rarest of circumstances. In the current series, we did not hesitate to remove leads percutaneously even if vegetations were present. Klug and associates [13] reviewed 52 patients with infected pacemaker leads. Vegetations were present on 80% of leads and were larger than 10 mm in 36%. Pulmonary scintigraphy demonstrated distal embolization in 15%, but most were inconsequential. No deaths occurred, and only 1 patient with a 40-mm vegetation developed clinical evidence of septic embolization with hemodynamic changes. We also know from previous experience dealing with tricuspid valve endocarditis that septic pulmonary embolization is rarely a significant clinical problem [14]. Thus, we believe that an open surgical approach is not mandatory for infected leads and that leads associated with all but the largest of vegetations can be removed using laser-assist.

In the current series, all procedures were performed in the operating room with the patient prepared for emergent sternotomy. Although it is technically possible to perform lead extractions in a well-equipped catheterization laboratory with surgical backup, we believe that it is easier to deal with technical issues (control of bleeding, clavicular resection) and safer to perform the procedure under ideal surgical conditions. Although rare (1 of 128 patients in our series), we believe that patients who require emergent sternotomy would likely die if the extraction procedure were performed outside of the operating room (as certainly would have been the case in our patient).

Although we did not record the operative time required for lead extraction, it was most often performed in less than 5 to 10 minutes once the lead was identified, and the extraction rarely took longer than 15 minutes. Subjectively, laser-assist greatly simplified lead extraction and diminished the time and effort needed to remove chronically implanted leads, such that extraction was no longer the "rate-limiting step" of pacemaker or ICD revision or replacement. Wilkoff and coauthors [6] reported a mean extraction time of 11 ± 14 minutes, and Kennergren [7] reported a median extraction time of 10 minutes. In our experience, the learning curve has been steep; cardiothoracic surgery residents routinely become quite facile with the procedure in less than three to five cases.

The current study was subject to all the limitations inherent in a retrospective, nonrandomized review of surgical results, including potential selection bias as to which patients underwent laser extraction. However, our goal was to perform extraction without laser-assist if possible for cost considerations, and thus we do not believe that use of laser-assist was excessive or inappropriate. We did not record the mode of fixation in all patients and therefore did not include it in our analysis. Previous investigators have compared the difficulty of removing leads secured with active versus passive fixation and have noted no significant difference with long-term chronic leads [6, 15]. Subjectively, we noted that the degree of fibrosis at the distal tip of the lead was similar with active and passive fixation for long-term implants.

In summary, the current report demonstrated that lead extraction with laser backup is safe and associated with an excellent success rate for complete or near-complete extraction. Laser-assist should be available for long-term leads unless they are grossly infected, producing sepsis. Laser extraction technology has essentially eliminated the need for open surgical removal of retained leads, except in the most rare of circumstances. Septic leads can most often be extracted completely with gentle traction alone, but laser-assisted extraction is currently the method of choice for removal of noninfected chronically implanted leads and leads associated with erosion or a pocket infection.

	References

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13. Klug D., Lacroix D., Savoye C., et al. Systemic infection related to endocarditis on pacemaker leads. Clinical presentation and management. Circulation 1997;95:2098-2107.[Abstract/Free Full Text]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Marc R. Moon Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Moon, M. R. Articles by Gleva, M. J. Search for Related Content PubMed PubMed Citation Articles by Moon, M. R. Articles by Gleva, M. J. Related Collections Electrophysiology - arrhythmias