Charles L. Byrd

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management: This document was endorsed by the American Heart Association (AHA)

Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, Ohio State University, Division of ardiovascular Medicine, Columbus, OH, Broward General Medical Center, Fort Lauderdale, FL, University Hospital, ivision of Cardiovascular Medicine, Pisa, Italy, University of Miami, Cardiothoracic Surgery, Miami, FL, St. Thomas esearch Institute, University of Tennessee College of Medicine, Nashville, TN, Brigham and Women’s Hospital, Boston, A, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, Sahlgrenska University ospital, Gothenburg, Sweden, University of Medical Sciences, Poznan, Poland, Providence St. Joseph Medical enter, Burbank, CA, American Heart Association Representative.

Pacemaker Lead Extraction With the Laser Sheath: Results of the Pacing Lead Extraction With the Excimer Sheath (PLEXES) Trial

OBJECTIVES The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction. BACKGROUND Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments. METHODS A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Recommendations for Extraction of Chronically Implanted Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training

The procedure of lead removal has recently matured into a definable, teachable art with its own specific tools and techniques. It is now time to recognize and formalize the practice of lead removal according to the current methods of medicine and the health care industry. In addition, since at this time the only prospective scientific study of lead extraction is the PLEXES trial, we suggest that studies relating to the techniques of and indications for lead extraction be designed. Recommendations for a common set of definitions, for a framework of training and reviewing physicians in the art, for general methods of reimbursement, and for consistency among clinical trials have been made. Implementation of these recommendations will require additional effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry.

Clinical study of the laser sheath for lead extraction: the total experience in the United States.

BYRD, C.L., et al.: Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. The laser sheath uses optical fibers, delivering pulsed ultraviolet excimer laser light, to vaporize fibrotic tissue binding intravenous cardiac leads to the vein or heart wall during lead extraction from the implant vein. The total investigational experience with laser sheaths is reported. During the period from October 1995 to December 1999, 2,561 pacing and defibrillator leads were treated in 1,684 patients at 89 sites in the United States with three sizes of laser sheath. Endpoints were complete removal of the lead, partial removal (leaving the tip behind), or failure (abandoning the lead, onset of complications, change to transfemoral or transatrial approach). Minimal follow‐up at 30 days was recorded. Of the leads, 90% were completely removed, 3% were partially removed, and the balance were failures. Major perioperative complications (tamponade, hemothorax, pulmonary embolism, lead migration, and death) were observed in 1.9% of patients with in hospital death in 13 (0.8%). Minor complications were seen in an additional 1.4% of patients. Multivariate analysis showed that implant duration was the only preoperative independent predictor of failure; female sex was the only multivariate predictor of complications. Success and complications were not dependent on laser sheath size. At follow‐up, various extraction related complications were observed in 2% of patients. The learning curve showed a trend toward fewer complications with experience. Lead extraction with the laser sheath can be safely practiced with high success rates. Success is independent of laser sheath size. Major complications can be expected in < 2% of patients, and occur more often during an investigators early experience.

Five-Years Experience with Intravascular Lead Extraction

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1.299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4–7 years, and 31 % of leads 8–24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%. including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke). With experienced operators, appropriate precautions, and appropriate patient selection, modern techniques allow the successful extraction of up to nearly 98% of intravascular leads with a relatively low incidence of complications.

Intravascular Extraction of Problematic or Infected Permanent Pacemaker Leads: 1994–1996

Of the 400,000–500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5‐year period (1989–1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix® or Encor® leads (46%), or other causes (2%). Patients were 64 ± 17 years of age (range 5–96); 59% were men, 41% women. Leads were implanted 47 ± 41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P < 0.0001), less experienced physicians (P < 0.0001), ventricular leads (P < 0.005), noninfected patients (P < 0.0005), and younger patients (P < 0.0001). Major complications were reported for 1.4% of patients (< 1% at centers with > 300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P < 0.005) and with less experienced physicians (P < 0.005); risk of major complications was higher for women (P < 0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.

Initial Experience With Larger Laser Sheaths for the Removal of Transvenous Pacemaker and Implantable Defibrillator Leads

BACKGROUND In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath. METHODS AND RESULTS In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.

Intravascular Lead Extraction Using Locking Stylets and Sheaths

BYRD, C.L., ET AL.: Intravascular Lead Extraction Using Locking Stylets and Sheaths. Chronic lead extraction using intravascular countertraction techniques was studied in patients with over 65 different lead models including passive and active fixation devices. Indications for removal of 115 leads implanted 5 days to 264 months (mean 58 months) in 62 patients (mean 65 years) included septicemia, subcutaneous tissue infection, preerosion, free‐floating lead, lead trapped in valve, too many leads, pain, and vein thrombosis. The superior vena cava (SVC) approach was attempted in 101 leads and was successful in 82 attempts (71% of total leads). The inferior vena cava (IVC) approach via the femoral vein was required to extract 14 (12%) leads inaccessible to the SVC approach and the 19 leads that failed the SVC approach (29% of total leads). The SVC procedure includes a sized stylet locked at the tip and telescoping sheaths advanced over the lead to the heart. An IVC procedure includes placement of a 16 F sheath workstation via a femoral vein into the right atrium. A deflection catheter and Dotter snare in an 11 F sheath were advanced through the workstation into the right atrium. The lead was maneuvered into position, snared, and pulled into the workstation. For both the SVC and IVC approaches, the leads were removed by applying traction on the lead and countertraction with the sheaths. In experienced hands, these techniques have proven safe and effective for removing chronic transvenous leads.

Lead extraction. Indications and techniques.

Each of the extraction techniques and their ancillary tools was reported as used successfully; however, until now, no technique has been successful when used in more than a few isolated instances. The technique for intravascular countertraction and the associated tools described in this paper were devised and selected in an attempt to develop one technique to be used on all patients, with all types of leads, and with a very low complication rate. Its versatility permitted single or multiple lead extractions combined with the precision of selecting and extracting a specific lead. In our experience, as well as the experience of others, the techniques described in this paper have proved to be superior by minimizing the inherent risk and morbidity, allowing us to expand the indications for lead removal beyond septicemia and free-floating leads, to include infection, abandonment of pockets, and replacement of malfunctioning or fractured leads. Intravascular countertraction was a consistently safe and efficacious method of removing transvenous pacemaker leads regardless of the duration of the implant, thus permitting extractions in patients not considered candidates for a more extensive surgical procedure. Intravascular countertraction encompasses surgical and fluoroscopic techniques possessed by most physicians experienced in pacemaker and automatic implantable cardioverter defibrillator implants. However, there is a learning curve, predicating caution for the inexperienced physician. In addition, advanced surgical skills may be needed in handling associated conditions such as debridement and primary closure of chronically inflamed tissues, especially in submuscular pockets and sinus tracts in the neck. Although the potential for a cardiovascular complication is small, it does exist, and cardiovascular surgical backup is a recommended precaution.

Intravascular lead extraction using locking stylets, sheaths, and other techniques.

FEARNOT, N.E., ET AL.: Intravascular Lead Extraction Using Locking Stylets, Sheaths, and Other Techniques. Septicemia necessitates extraction of chronic pacemaker leads. Using locking stylets and sheaths to extract leads via the implantation vein (subclavian, cephalic, or jugular) and maneuvering devices, sheaths, and retrieval baskets via the femoral approach, extraction of 228 leads implanted 5 days to 240 months (mean 55 months) was attempted in 136 patients (mean 62 years) at 34 institutions. In addition to septicemia (9%) and infection (39Y0), total 48%, indications included prophylaxis/replacement (40%), and other (12%). Seventy‐seven leads were atrial, 151 ventricular; 147 were unipolar, 81 bipolar; 96 had silicone insulation, 127 polyurethane, 1 poly/silicone, and 2 undetermined. Fixation included tines or fins (1601, screw (401, flange (12), and other (16). One hundred and ninety‐four leads were completely extracted, 19 partly extracted, and 15 not extracted. Procedural complications were: torn atrium requiring open heart repair (1), hemothorax requiring a chest tube and blood transfusions (1), subacute hemothorax requiring drainage 18 days after discharge (1), thrombosis treated by drugs (1), and myocardial avulsion without sequela (1). Important observations included the significant training required due to the large number of possible clinical variables, and the need to be prepared for life‐threatening cardiovascular complications. With training, procedures done at higher volume and lower volume institutions met with similar success. Conclusion: Intravascular lead extraction is a viable technique whose benefits outweigh the risks, given the proper intensive training and open heart surgical backup, and may obviate the need for open heart surgery for lead extraction.