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.     

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 investigator's early experience.     

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.     

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.     

Multicenter experience with transvenous lead extraction of active fixation coronary sinus leads

Background/Objective: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited. Methods: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported. Results: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3–23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes. Conclusions: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations. (PACE 2012; 35:641–647)     

Nonthoracotomy implantable defibrillator lead extraction: results and comparison with extraction of pacemaker leads

Extraction of pacemaker leads has been demonstrated to be successful and safe in experienced hands using current tools. Whether application of such techniques and tools yield similar results among patients undergoing extraction of nonthoracotomy implantable defibrillator leads is unknown. This report describes a retrospective analysis of indications, techniques used, and outcome of patients who had a single ventricular nonthoracotomy implantable defibrillator lead extracted at The Cleveland Clinic Foundation. Results were compared to a matched population of patients undergoing extraction of ventricular pacemaker leads from a national registry and to the experience with pacemaker lead extraction at The Cleveland Clinic Foundation. Successful complete extraction of ventricular nonthoracotomy implantable defibrillator leads, in the absence of major complications, was achieved in 96.9% of attempts to extract leads from 161 patients. Clinical success was achieved in 98.1% of patients. Failure occurred in three patients. Two patients had major complications, including one death. The most common indication for extraction was infection (46.6%), followed by lead failure (34.2%). Procedure (140.8 vs 171.2 minutes, P<0.01) and fluoroscopy (9.9 vs 11.0 minutes, P<0.01) times compared favorably with those obtained from the pacemaker lead extraction database. Use of LASER did not influence the safety of the procedure or fluoroscopy times. Extraction of ventricular nonthoracotomy implantable defibrillator leads using currently available tools is a complex but effective procedure. In experienced hands, excellent success rates should be achieved with a low incidence of complications.     

Pacemaker and Defibrillator Lead Extraction: Predictors of Mortality during Follow‐Up

Background: Extraction of cardiac implantable electric devices is an accepted procedure when systems become infected or malfunction. However, there is an associated morbidity and mortality. We report our 5‐year experience and identify predictors of mortality, and long‐term follow‐up. Methods: We analyzed extraction data from January 2003 to November 2007. Extraction methods used were: locking stylets, telescoping sheaths ± laser, and femoral work stations. Results: One hundred and eighty‐three cases were referred, aged 65 ± 16 years (range 28–83); 76% were males. Mean implant time was 75 months (range 4–312 months) and indications were: pocket infection (48%), nonfunctioning lead (22%), erosion through skin (18%), endocarditis/septicemia (11%), bilateral superior vena cava thrombosis (0.5%), and painful lead (0.5%). The number of leads extracted were 369, with complete removal in 90.7% and partial in 7.6%. There were no intraoperative deaths but five (2.7%) died within the same admission as their extraction from overwhelming sepsis. Twelve deaths (6.6%) occurred during an average follow‐up of 965 days (range 40–1670). Multivariate logistic regression demonstrated that C‐reactive protein preprocedure was predictive of acute in‐hospital mortality. Conclusions: Intravascular lead extraction is a safe and efficient method of removing leads. However, there is a subgroup of patients with systemic sepsis with raised inflammatory markers who are at high risk of in‐hospital mortality. Long‐term follow‐up demonstrates mortality which is a marker of the underlying etiology for device implantation, with heart failure patients particularly at risk. (PACE 2010; 33:209–216)     

Coronary Sinus Lead Extraction

TYERS, G.F.O., et al .: Coronary Sinus Lead Extraction. Complications are reported more frequently with the implantation of coronary sinus (CS) than other types of leads, and attempts to extract CS leads may also be associated with increased risks. The authors have performed nonthoracotomy lead extraction (LE) since 1981 and maintained a detailed database. By November 2001, 796 leads had been removed from 401 patients. We undertook review of our CS-LE experience to evaluate prevalence, safety, and efficacy. Of 14 patients referred for CS-LE, 7 were treated in the last year. In six the lead had been placed in the CS intentionally, and in eight inadvertently. One recent patient treated with biventricular pacing was septic and died before LE was undertaken. In nine men and four women (mean age 66 years) had one each CS lead and a total of 34 LEs (2.6/patient). Four CS leads had been in place for <6 months (mean 1.5 month), whereas nine had been in place for between 6 months and 27 years. Several LE methods were used, from simple traction to the use of intraluminal locking stylets and powered sheaths. Complete removal of all leads was achieved in all patients. CS-LE required a mean of 13 minutes, including 1.8 minutes of fluoroscopy. There were no serious complications during the procedures, and the mean hospital stay was 4 days. (PACE 2003; 26[Pt. II]:524–526)     

Pacemaker lead prolapse through the pulmonary valve in children

BACKGROUND: Transvenous pacemaker leads in children are often placed with redundant lead length to allow for anticipated patient growth. This excess lead may rarely prolapse into the pulmonary artery and potentially interfere with valve function. We sought to determine the response to lead repositioning on pulmonary valve insufficiency. METHODS: Retrospective reviews of demographics, lead type, implant duration, and radiography and echocardiography. RESULTS: A total of 11 pediatric patients were identified with lead prolapse through the pulmonary valve, of which nine patients underwent procedures to retract and reposition the lead (age at implant 9 +/- 4 years, age at revision 13 +/- 4 years). The implant duration prior to revision was 4 +/- 3 years. Two leads required radiofrequency extraction sheaths for removal, two pulled back using a snare, while five leads were simply retracted and repositioned. Tricuspid regurgitation was none/trivial (three), mild (four), or moderate (two) and only two improved with repositioning or replacement. Pulmonary regurgitation preoperatively was mild (three), mild-moderate (two), or moderate (four) compared with trivial (three), mild (four), and moderate (two) after revision. Patients with longer-term implanted leads had less improvement in pulmonary insufficiency. Two patients had mild pulmonary stenosis from lead-related obstruction. CONCLUSIONS: Prolapse of transvenous pacing leads into the pulmonary artery can occur when excess slack is left for growth. Leads can often be repositioned, but may require extraction and replacement, particularly if chronically implanted and adherent to valve apparatus. Lead revision does not always resolve pulmonary insufficiency, potentially leaving permanent valve damage.     

Large, single-center experience in transvenous coronary sinus lead extraction: procedural outcomes and predictors for mechanical dilatation

Background: The aim of this study was to evaluate procedural outcomes of coronary sinus (CS) lead extraction, focusing on predictors and need for mechanical dilatation (MD) in the event that manual traction (MT) is ineffective. Methods: The study assessed results in 145 consecutive patients (age 69 ± 10 years; 121 men)—a total of 147 CS pacing leads—who underwent transvenous CS lead removal between January 2000 and March 2010. Results: All leads but one (99%) (implantation time 29 ± 25 months) were successfully removed. MT was effective in 103 (70%), and MD was necessary in the remaining 44 (30%) procedures. In multivariate analyses, unipolar design (odds ratio [OR] 3.22, 95% confidence interval [CI] 1.43–7.7; P = 0.005) and noninfective indication (OR 4.8, 95% CI 1.8–13, P = 0.002) were independent predictors for MD (P < 0.0001), with a predictive trend for prior cardiac surgery (OR 2.2, 95% CI 0.98–5.26; P = 0.06). Five (3.4%) complex procedures required a transfemoral vein approach (TFA) or repeat procedure. No deaths occurred, and there was one major complication (0.7%), cardiac tamponade, after MT. No complication predictors were identified. Conclusions: CS leads were safely and effectively removed in nearly all patients, and 70% were removed with MT alone; 30% required MD. Preoperative predictors suggesting the need for MD or TFA were noninfective indication and unipolar lead design. Complications were rare, and there was no predictable pattern among MT or MD removal techniques. (PACE 2012; 35:215–222)     

Laser assistance for extraction of chronically implanted endocardial leads: infectious versus noninfectious indications

BACKGROUND: Powered sheaths, including Excimer laser sheaths, were introduced for the removal of transvenous pacing and defibrillator leads. The purpose of this study was to develop an algorithm to better predict which patients are likely to benefit from these devices. METHODS: We reviewed 283 consecutive patients in whom a total of 500 leads (302 pacing and 198 defibrillator leads) were extracted over a 5-year period at our operative facilities. Laser assist was utilized whenever moderate traction failed. RESULTS: In 128 patients, 203 leads were removed for noninfectious indication. In 155 patients, 297 leads for infectious indications, including sepsis 22% (111), pocket infection 23% (115), and erosion 14% (71). Laser assistance was required for 6%+/- 5% (+/- 95% confidence interval) of septic leads, 51%+/- 7% of leads associated with erosion or pocket infection and 60%+/- 7% of noninfected leads (P = 0.001). Laser assistance was necessary more often for leads implanted >12 months (53%+/- 5%) than 12 months or less (6%+/- 5%) (P = 0.001) and for ventricular (52%+/- 6%) compared to atrial (35%+/- 7%) leads (P = 0.001). CONCLUSIONS: Chronically implanted leads (>12 months), especially noninfected leads and leads associated with erosion or pocket infection, should be referred for extraction with powered sheaths to ensure successful removal. However, leads that are associated with systemic sepsis can generally be removed without powered sheaths.     

Laser lead extraction: predictors of success and complications

BACKGROUND: Paralleling the rise in pacemaker and defibrillator implantations, lead extraction procedures are increasingly required. Concerns regarding failure and complications remain. METHODS AND RESULTS: A total of 200 lead extraction procedures were performed at the Montreal Heart Institute between September 2000 and August 2005. In 23 patients, all leads were removed by traction with a locking stylet. A total of 270 leads were extracted using a laser sheath system (Spectranectics, Colorado Springs, CO, USA) in 177 procedures involving 175 patients (74% male), age 62+/-16 years. Procedural indications were: infection 88 (50%), dysfunction 54 (30%), upgrade 21 (12%), and other 14 (8%). Overall, 241 leads (89%) were successfully extracted, 7 (3%) were partially extracted (< or = 4 cm retained), and 22 (8%) were non-extractable. In multivariate analyses, predictors of failed extraction were longer time from implant (OR 1.16 per year, P=0.0001) and history of hypertension (OR 5.2, P=0.0023). Acute complications occurred in 14 of 177 procedures (7.9%): 8 (4.5%) minor and 6 (3.4%) major, with one death. In multivariate analyses, the only predictor of acute complications was laser lead extraction from both right and left sides during the same procedure (OR 9.4, P = 0.0119). In addition, 3 of 10 patients with failed or partially extracted infected systems eventually required open chest explantation because of endocarditis. CONCLUSION: Most leads not amenable to manual traction may be successfully extracted by a percutaneous laser sheath system. While most complications are minor, major complications including death may occur. Older leads are at higher risk for failed extraction. Endocarditis may ensue if infected leads are incompletely removed.     

Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year

Introduction: Lead implant duration is a predictor of extraction sheath (ES) use in transvenous lead extraction (TLE). Most operators agree that leads with short implant durations can be extracted easily but data regarding defibrillator (implantable cardioverter‐defibrillator [ICD]) leads and newer generation leads with backfilled coils are limited. Methods and Results: We performed a retrospective study of consecutive patients undergoing TLE of leads with implant durations of ≤ 2 years at a single, high‐volume center. Patient and lead characteristics, indications, and ES use were analyzed. Between January 2000 and January 2011, 139 patients underwent TLE meeting inclusion criteria. Mean implant duration was 13.2 ± 6.4 months. The cohort was 67% male with a mean age of 63 years (16–93) and left ventricular ejection fraction of 36 ± 17%. Indications for extraction included infection (51%), lead malfunction (27%), device upgrade (13%), and other indications (venous occlusion, severe chronic pain at site of device or lead, advisory leads, etc., 9%). Extraction was achieved with simple traction alone in 68% of the 239 leads removed. ES assistance with laser or femoral sheaths was employed in 32% of cases. ES use increased significantly with longer implant duration (P = 0.0004). In multivariate analysis, young age, the presence of an ICD, and increasing implant duration were the strongest predictors of the need for ES assistance for successful lead removal. There was no statistically significant difference in ES use between older and newer generation ICD leads (P = 0.68). Conclusions: While leads with short implant durations may be extracted easily, the need for ES assistance is significant and frequently unpredictable even with newer generation ICD leads. Thus, operators should be fully prepared to use all available methods of extraction in every case regardless of implant duration. (PACE 2011; 34:1615–1620)     

Transvenous pacemaker lead removal is safe and effective even in large vegetations: an analysis of 53 cases of pacemaker lead endocarditis

Background: The aim of this study was to investigate whether transvenous lead removal is safe and effective in patients with lead vegetations greater than 1 cm in size. Methods: From 1991 to 2005, a total of 53 patients underwent pacemaker or ICD lead removal for vegetations. Transvenous lead removal using locking stylets and sheaths was performed in 30 patients (56.6%) and was found to be effective in 29 of those patients. In 1 patient, due to rupture of the lead, open heart removal of the ventricular lead remnant and tricuspid valve repair had to be performed due to persistent infection. In 23 of these patients, transesophageal echocardiography (TEE) verified vegetations greater than 1 cm in size. The remaining patients underwent primary lead removal using sternotomy and extracorporeal circulation (ECC). Pacemaker pocket infection was found in 16 patients (55.2%) of the transvenous study group and in 11 patients (45.8%) of the ECC group (P = 0.72). Results: Perioperative mortality was 5.7% (3 patients); all of them underwent primary ECC removal and had severe endocarditis of the tricuspid valve. None of the patients who underwent transvenous lead removal died and there were no further complications such as pericardial tamponade or major pulmonary embolism requiring further interventions, even in patients demonstrating large vegetations. Conclusions: This study demonstrates that transvenous lead removal is a safe and highly effective procedure for the removal of infected pacemaker and ICD leads, even in patients with large vegetations. Embolism to the lung proceeds mainly without further complications; however, patients with vegetations that might obstruct a main stem of the pulmonary artery should undergo ECC removal.     

Ancillary tools in pacemaker and defibrillator lead extraction using a novel lead removal system

A previous report described our preliminary experience with a highly successful pacing lead removal system (VasoExtor). Extending this experience, we found it necessary to use additional tools to enhance the success of percutaneous lead extraction with this system. In the present series, we used the standard locking stylets (S and K), and recently, one newer type of stylet (Magic) over the last 3 years in 34 patients to extract 48 pacemaker leads in 31 patients and 3 defibrillator (ICD) leads in 3 patients. Lead extraction was carried out in 23 men and 11 women (aged 64 +/- 17 years) because of pacemaker infection (n = 21), pacemaker (n = 8) or ICD (n = 3) lead malfunction, or prior to ICD implant (n = 2). Leads were in place for 3.5 +/- 3.7 years. Infections, involving pocket and lead(s), were due to S. epidermidis (n = 13), S. aureus (n = 6), S. aureus plus E. coli (n = 1), for fungi (n = 1). Of the 48 pacing leads, 31 were ventricular, 15 atrial, and 2 were VDD leads. The ICD leads were two double-coil leads (CPI) and one single-coil lead (Telectronics). Using the S (n = 12), K (n = 8), or Magic (n = 3) stylets, all pacing leads in 23 patients and the ICD leads in 2 patients were successfully removed from a subclavian approach using the locking stylets. However, in nine (26.5%) patients ancillary tools were required. In four patients, lead fragments were captured with use of a noose catheter, a pigtail catheter, and a bioptome from a right femoral approach. In two patients, locking could not be effected and a noose catheter from the right femoral vein was used, aided by a pigtail and an Amplatz catheter and a bioptome to remove three leads. In a patient with an ICD lead, a combined subclavian (stylet S) and right femoral approach (noose catheter) was required. In a patient with a dysfunctional ventricular lead 12 years old, a motor drive unit was used to facilitate the exchange of locking stylets, but extraction failed. In another patient, a fragment of a dysfunctional ventricular lead remained intravascularly despite resorting to a femoral approach. Finally, lead removal was completely (32/34, 94%) or partially (1/34, 3%) successful in 33 (97%) of 34 patients for 50 (98%) of 51 leads without complications. In conclusion, to enhance the success of pacing or ICD lead extraction with use of the VascoExtor locking stylets, an array of ancillary tools were required in more than one fourth of patients.     

Sheathless implantation of permanent coronary sinus-LV pacing leads

BACKGROUND: Implantation of CS-LV pacing leads is usually accomplished through specialized sheaths with additional use of contrast venography and other steps. Direct implantation at a target pacing site could provide a simplified procedure with appropriate leads. METHODS: A progressive CS-LV lead implant protocol was used, with initial attempts made to place the lead directly using only fluoroscopy and lead stylet or wire manipulation. Coronary sinus (CS) sheaths were only used later if direct lead placement failed. RESULTS: There were 105 attempted implants with 96% (101/105) success. Leads were implanted sheathlessly in 69% (70/101) cases. Pacing parameters and final lead position did not differ significantly between implants that did or did not require sheaths for implants. Three peri-procedural complications occurred in implants where sheaths were used. In 33% (33/101) of implants, the leads were placed without the use of sheaths or contrast venography in 20 minutes or less. CONCLUSIONS: Direct placement of the CS-LV pacing lead without sheaths can be accomplished successfully in a majority of implants and in < or =20 minutes in a third, without inferior pacing parameters. This may provide for shorter or less technically difficult or expensive procedures with low risk.     

Contributions of Advanced Techniques to the Success and Safety of Transvenous Leads Extraction

Purpose: We measured the proportion of intravascular leads, which can be extracted by simple traction versus with newer techniques, and examined the overall safety and success rate of lead extractions.
Methods: Between January 2005 and December 2007, 311 consecutive patients (mean age = 70 ± 14 years, 79% men) underwent extractions of 250 atrial, 318 ventricular, and 22 coronary sinus leads, in the surgical facilities of two experienced medical centers, under general anesthesia, at a mean of 7.2 ± 5.1 years (range 0.1–27.0) after lead implantation. Infection was the indication for extraction in 67.5% of cases. Complementary techniques were used when simple extraction with a locking stylet was unsuccessful.
Results: Simple traction, with or without a locking stylet, allowed the complete removal in 27.0% (95% confidence interval [CI] 22.1–31.9) of patients. A mechanical sheath, laser sheath, and/or lasso catheter were used in the remaining patients. The overall extraction success rate was 89.7% (95% CI 86.3–93.1). There was one procedure-related death (0.3%; 95% CI 0.0–1.0). Among five other deaths occurring within 10 days after the procedure, four were due to septic shock. Duration of lead implantation was the strongest independent predictor of major adverse events (P = 0.002) and incomplete lead extraction (P = 0.005).
Conclusion: In contrast with simple traction, advanced techniques allowed the complete extraction of nearly 90% of leads. In experienced hands and with surgical back-up, these techniques were safe. Patients presenting with infected implanted cardiac devices suffered a high rate of major adverse despite complete extraction of the lead(s).     

Lead Extraction in Young Patients With and Without Congenital Heart Disease Using the Subclavian Approach

Pacemaker lead removal using interlocking stylets and dilator sheaths has greatly reduced the need for major surgical intervention when lead extraction is required. Previous reports have shown the utility of this method in older patients, most of whom have anatomically normal hearts. The purpose of this study is to report the results of this technique in young patients with and with-out congenital heart disease. There were 13 patients (M:F = 7:6) aged 9–26 years (median 13). Congenital heart disease was present in 8 of 13 patients. A total of 17 leads required removal; they had been implanted for 54 ± 24 months (range 19–94). Leads were removed from the left subclavian vein (13) or right subclavian vein (4) only. Seventeen of 18 leads were completely removed and one partially retained in the left subclavian vein. New leads were implanted from the same vein in 11 of 13 patients. Interlocking stylets and metal or flexible dilator sheaths were used in all cases except two. There was one surgical complication: a late wound dehiscence, which was easily managed. No patient required a transfusion, and there was no structural damage noted in any patient on the postoperative echocardiogram. We conclude that lead removal using interlocking stylets and dilator sheaths from the subclavian approach is an effective technique that can be used in young patients, including those with congenital heart disease.     

Multi-center clinical experience with a lumenless, catheter-delivered, bipolar, permanent pacemaker lead: implant safety and electrical performance

PURPOSE: Reduced lead diameter and reliability can be designed into transvenous permanent pacing leads through use of redundant insulation and removal of the stylet lumen. The model 3830 lead (Medtronic Inc., Minneapolis, MN, USA) is a bipolar, fixed-screw, steroid-eluting, lumenless, 4.1-Fr pacing lead. Implantation can be performed in a variety of right heart sites using a deflectable catheter (Model 10600, Medtronic). Lead performance and safety were studied. METHODS: Two prospective trials of 338 implanted subjects from 56 global sites were conducted. Electrical and safety data were obtained at implant, pre-discharge, and up to 18 months post-implant. Leads were implanted at traditional and alternate right heart sites. RESULTS: The study enrolled 338 subjects (204 males, 70.6 +/- 11.6 years) followed-up for a mean of 10.2 months (range, 0-21.6). Mean P-wave amplitudes ranged from 3.2 mV at 3 months to 2.9 mV at 18 months, while mean atrial pulse width thresholds at 2.5 V ranged from 0.07 ms at 3 months to 0.09 ms at 18 months. Mean R-wave amplitudes ranged from 11.3 mV to 11.1 mV and mean ventricular pulse width thresholds at 2.5 V ranged from 0.10 ms to 0.14 ms. There were 22 ventricular and 12 atrial lead complications within 3 months post-implant. Survival from lead-related complications improved to a clinically acceptable rate in the cohort of patients when revised implant techniques were employed. CONCLUSIONS: With the use of recommended implant techniques, the study results support the electrical efficacy and safety of a catheter-delivered, lumenless lead in traditional or alternate right atrium or right ventricle sites through 18 months post-implant.     

Intravascular Extraction of Chronic Pacemaker Leads: Efficacy and Follow-Up

Extraction of chronic pacemaker leads has been recommended for infections, prevention of venous thrombosis, migration, and possible perforation. Success with constant traction techniques has been variable, and the cost and morbidity of open chest surgical procedures are prohibitive. Efficacy of a new system for lead extraction using intravascular techniques was analyzed. The system (Cook Pacemaker) uses a locking stylet, which is secured at the distal electrode by counterclockwise rotation to reinforce the lead and facilitate traction, and dilator sheaths that are used to free the lead from adhesions in the venous system. In a series of 56 patients (ages 19–88)who presented for lead extraction because of erosion (5), infection (14), lead replacement (35), or other (2), 86 leads were extracted. Thirty-two were atrial leads and 54 ventricular; 23 had active fixation and 63 passive. Average duration of implant was 58 ±42 months (range 1–264). Eighty-four leads were totally removed and two partially removed. For these two leads, the distal tip was not removed; in both cases the locking stylet was not secured at the distal electrode due to obstruction within the lead. Two patients developed arm edema following the procedure, which resolved with elevation. One patient developed a subclavian thrombosis, which resolved with warfarin anticoagulation. Four patients have expired due to unrelated causes. In conclusion, this intravascular approach for extraction of chronic leads is effective, and the procedure is safe when performed by experienced personnel.