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Ann Thorac Surg 1997;64:175-180
© 1997 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Telectronics 330-801 Atrial Lead Extraction via the Subclavian Approach

Section of Electrophysiology, Division of Cardiology, Department of Medicine, and Department of Thoracic and Cardiovascular Surgery, Loyola University of Chicago Medical Center, Maywood, Illinois

Accepted for publication January 30, 1997.

	Abstract

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Background. The Telectronics 330-801 atrial J (801) lead was recalled after reports implicated lead fracture/retention wire protrusion in patient mortality and morbidity. Recent reports suggest that 801 lead extraction may be associated with substantial morbidity and, possibly, excess mortality. We hypothesized that the 801 lead could be extracted using the subclavian approach with a high success rate and acceptable morbidity.

Methods. We analyzed the clinical outcomes in 60 consecutive patients who underwent 801 lead extraction.

Results. Sixty patients (34 women) with a mean age of 67 ± 14.8 years had 18 class I, 13 class II, and 29 class III fractures. The lead age was 39 ± 17 months. The subclavian approach was successful in 58 of 60 patients (96%). Complications, three major and eight minor, occurred in 10 of 60 patients (16%). All complications were successfully treated. There were no deaths. Only concurrent ventricular lead extraction was associated with complications (p = 0.008 by Fisher's exact test).

Conclusions. Telectronics 801 leads can be successfully extracted using the subclavian approach with acceptable short-term morbidity, low mortality, and excellent long-term results.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
See also page 180.

In November 1994, Telectronics initiated a recall of its line of "Accufix" active fixation atrial J bipolar pacing leads. These polyurethane-insulated leads (model 330-801 and others) employed a flat, metal alloy, J-shaped wire embedded between the outer coaxial conductor and the outer polyurethane sheath to retain its shape. The wire was welded to the ring electrode. Unfortunately, there were several reports in which a fractured retention wire was implicated in at least two patients deaths, and several other instances of pericardial tamponade [1–4]. These observations prompted the recall of all model 330-801 (801) leads [5].

Because more than 42,000 801 leads had been implanted worldwide, appropriate and prudent guidelines applicable to such a large population needed to be formulated. Unlike previous pacemaker lead recalls, where the concern was lead longevity or lead function, this lead posed a potential risk that is independent of pacing characteristics and was potentially harmful based upon its structural components. Criteria other than pacemaker-dependency, lead impedance, sensing characteristics, and pacing thresholds needed to be developed and verified to determine which patients should have the 801 lead extracted [6– 11].

Soon after the recall began, we hypothesized that the 801 lead could be extracted using standard countertraction technique via the superior vena cava (SVC) approach with low mortality, acceptable morbidity, and a high success rate. Based upon our previous experience with lead extraction, we offered lead extraction to patients with 801 leads, before formulating more general guidelines that could apply to larger populations [6, 12, 13]. Our initial stance, early into the recall, as well as our previous experience with lead extraction, led to us being identified as a local 801 lead extraction center. We report our experience.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Study Patients and Preoperative Care
Sixty consecutive patients referred for 801 lead extraction between December 1994 and September 1995 were evaluated. We made no attempt to determine eligibility for operation based upon fracture status, sex, or age, although these variables were tabulated for analysis. All patients were admitted on the day of operation unless their clinical care required admission (examples: pacing system infection, prosthetic valve patients being anticoagulated with heparin). All patients received standard preadmission testing and a complete history and physical examination. A tentative operative plan was formulated before admission to facilitate elective revision of other leads or replace the pulse generator at the same setting. Informed consent was obtained from all patients. Pacemaker-dependent patients received a temporary, right ventricular apex transvenous pacing wire. All patients received prophylactic intravenous antibiotics, generally, a single dose of intravenous vancomycin on call to the operating room.

Extraction Procedure
The extractor was a qualified cardiovascular thoracic surgeon with considerable previous pacemaker lead extraction experience. All pacemaker lead extractions were performed in an operating room with capabilities of immediate cardiopulmonary bypass. All patients had general anesthesia with endotracheal intubation. All patients received continuous monitoring of a surface lead electrocardiogram, arterial blood pressure, and oxygen saturation. The patients were prepared and draped for access to both subclavian veins, as well as the chest and the femoral veins. Thus, emergent pericardiocentesis or emergent sternotomy could be performed with partial or total cardiopulmonary bypass. Portable fluoroscopy was used for all cases.

A Cook extraction kit (Cook Pacemaker Corporation, Leechburg, PA) was used to extract all leads using the SVC approach [14– 22]. An interlocking stylet was placed in all leads. With the interlocking stylet in place, gentle traction was applied to the lead. This simple maneuver was occasionally sufficient to dislodge the lead from the right atrial wall. Polypropylene sheaths were then inserted into the subclavian vein. If there were dense adhesions, particularly near the clavicle, the metal sheaths were used to enter the subclavian vein. The polypropylene sheaths or metal sheaths were never passed beyond the subclavian vein on the right or the innominate vein on the left. Teflon sheaths (less stiff than either polypropylene or metal sheaths) were then exchanged out for the polypropylene or metal sheaths. Once the angle was manipulated with the Teflon sheath, it was passed as close to the tip of the lead as possible. The sheath was held firmly, and with intermittent gentle pulling, the lead was extracted. It was extremely important to have arterial monitoring at this point because the tugging can lead to hypotension. Once the lead was removed, a guidewire was then passed down the sheath to the right atrium. A standard introducer was placed over the guidewire. It was important to pass the guidewire past the areas of any adhesions in the vein. Once the lead was positioned, it was often necessary to place a hemostatic stitch around the lead because of the large size of the sheath that is used for extraction. The inferior vena cava approach was not employed. In the few instances that the SVC approach was unsuccessful, direct surgical explantation was performed via limited thoracotomy during the same period of general anesthesia.

Once the 801 lead was extracted, if there was a previous indication, then the ventricular lead was extracted (planned ventricular lead extraction). Otherwise, threshold testing was performed on all ventricular leads. If pacing thresholds were unacceptably high or sensing was poor, in the extracting physician's judgement, then the ventricular lead was also extracted using the same technique (unplanned ventricular lead extraction). The replacement atrial and ventricular leads used, were, as a general rule, steroid-eluting tined leads. Occasionally, if the subclavian vein could not be recannulated or the pacing leads could not be advanced into the right heart, then the contralateral subclavian area was used.

Postoperative Care
All patients received a postoperative chest roentgenogram and electrocardiogram. Originally, postoperative two-dimensional echocardiography was employed on a case-by-case basis. After pericardial tamponade developed 14 hours postoperatively in 1 patient, subsequent patients received a two-dimensional echocardiogram before discharge. Unless there was a compelling clinical reason, anticoagulation with heparin and warfarin was avoided in the perioperative period. All patients were followed up by the referring cardiologist.

Statistical Analysis
We reviewed the inpatient charts and contacted each patient's referring physician or the physician's pacemaker-knowledgeable representative to collect long-term outcome data. We considered patient age, sex, lead longevity at time of extraction, fracture status, success rate, planned and unplanned ventricular lead extraction, and complications as primary end points [10]. The preoperative agenda was used to distinguish planned versus unplanned ventricular lead extraction. Comparison of discrete variables was performed with Fisher's exact test (two-tailed), or with the Pearson ² test as applicable. A p value of 0.05 was considered significant.

	Results

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Demographics
The cohort was 60 consecutive patients who were referred for 801 lead extraction. Follow-up was obtained on all patients. The mean age was 67 ± 14.8 years (range, 36 to 89 years). Thirty-four of 60 patients were women (57%). The mean implant longevity was 39 ± 17 months (range, 4 to 82 years). There were 18 class I (no fracture), 13 class II (fracture without retention wire protrusion), and 29 class III fractures (protrusion of retention wire). There were no instances of wire migration (class IV). The mean fracture class was 2.2 ± 0.9.

Outcome
The 801 lead was successfully extracted in 58 of 60 patients (96%). Both patients in whom the SVC approach extraction was unsuccessful had uncomplicated thoracotomy extraction of the lead during the same anesthesia. These 2 patients had longer than average lead longevity (58 and 74 months). Both patients were noted to have heavy calcifications of the caudal clavicular periosteum, and in both instances, the 801 leads were heavily scarred into the right atrium. There were no complications associated with the thoracotomy extractions, and both patients were discharged from the hospital within 5 days.

Ventricular Lead Extraction
Eighteen of 60 patients (30%) underwent concurrent extraction of the ventricular lead. All extracted ventricular leads were passive-fixation leads. Planned ventricular lead extraction was performed in 8 cases (44% of ventricular lead extractions). Indications included lead fracture (2), lead recall with or without fracture (3), infection (2), and supernumerary ventricular lead (1). Unplanned ventricular lead extraction was performed in 10 cases (56% of ventricular lead extractions). Indications included unexpectedly high thresholds (6) or loss of vascular access (4). Loss of vascular access is defined as the inability to effectively replace the atrial lead from the site of atrial lead extraction. The patients with unplanned ventricular lead extraction were undistinguishable from the rest of the cohort in terms of baseline characteristics. All had functional pacemakers before the extraction procedure.

Complications
Eleven complications (three major and eight minor) developed in 10 of 60 patients (16%). The specific complications ran the complete range of those encountered in complex pacemaker patients (Table 1). We defined major complications as those that were potentially life threatening or requiring substantial excess hospitalization (pericardial tamponade, hemopneumothorax requiring chest tube drainage, and pacing system infection). We classified other complications as less severe. We did not consider retention of pacing lead tip in the endovascular space as a complication. This occurred in 2 cases. In both instances, the retention wire was extracted, there was no infection, and there were no sequelae associated with the pacing lead remanent. We elected not to count inability to extract the 801 lead using subclavian Cook extractor technique as a complication and instead defined those results as extraction failures. We weighed all complications equally for statistical analysis.

Complications developed in 7 of 18 patients (39%) who had concurrent ventricular lead extraction. A hemopneumothorax developed in 1 patient and was treated with chest tube drainage and blood transfusion while the patient was still in the operating room. That complication was thought to be caused by malposition of the guidewire that was inserted into the extraction sheath after the extraction, and local trauma due to the subsequently placed introducer for the replacement lead. The remaining seven complications encountered in 6 patients were classified as minor.

Complications developed in only 3 of 42 patients (7.1%) who did not require concurrent ventricular lead extraction. Two of the three complications were major. One patient had development of pericardial tamponade 14 hours after extraction, which responded to pericardial drainage, and the other patient had a late pacing system infection that required extraction of the entire pacing system several weeks later.

All complications were treated effectively with no long-term morbidity incurred to any patient, with the arguable exception of the pacing system infection. It is important to stress that a few of the patients in whom complications occurred had unavoidable indications for lead extraction, for example, infection. The patient in whom there was a hematoma had had similar hematomas after other invasive procedures (cardiac catheterization, peripheral angiography).

Age, sex, lead longevity, and extent of 801 lead fracture on screening fluoroscopy did not predict complications (Table 2). There was a trend toward women and older people having a higher complication rate. Concurrent ventricular lead extraction was associated with complications (Fisher's exact test p = 0.008). Most complications could not be related to the extraction of the 801 lead itself. Because of the small numbers in this study, subgroup analysis (planned versus unplanned ventricular lead extraction) was not done.

	Comment

Top Footnotes Abstract Introduction Material and Methods Results Comment References

The secondary extraction technique was chosen at the discretion of the extracting surgeon who preferred the open (thoracotomy) approach to the inferior vena cava approach. The open approach has been described as a reasonable method of extracting pacing leads [19]. In fact, it is potentially the preferred approach in rare patients. Since we began our study, literature has emerged that the inferior vena cava approach can be used successfully for extraction of the 801 lead, but that does not automatically make it preferable to open extraction in all instances. Again, no complications occurred in either patient who underwent open extraction, both of whom had extensive scarring of the lead in the right atrium as well as in the infraclavicular periosteum. Although the inferior vena cava approach may have allowed the lead remanent to slip through the clavicular periosteal fibrosis, it is not certain that lead tip would have necessarily been able to be freed from the wall of the right atrium. Still, others have described a high success rate using that approach as well as a combined approach [22, 23]. Preliminary data on extraction of leads using an Excimer laser sheath from the SVC approach (Byrd oral presentation, 1996 North American Society of Pacing and Electrophysiology meeting) have been very encouraging; however, it is impractical to assume that the standard Cook technique is no longer useful.

Complications
Most of the complications were not life-threatening and were similar in nature to those associated with any pacemaker lead extraction. There are several possible explanations for the complication rate in this series being higher than in those previously reported [24– 26]. No distinction was made between extraction-related complications and reimplantation-related problems. We were able to gather follow-up data that would be difficult or impossible to obtain in larger registries. Six of the 11 complications were discovered late after discharge. Many of the complications that we saw became apparent only on follow-up or because of the investigator's specific inquiry. Large, multicenter data bases could be limited by underreporting of late complications. There may be a difference in our SVC approach technique compared with other extractors: the femoral approach was not used as alternative extraction technique, and investigational extraction tools were not employed.

There were no specific complications proved to be associated with the protrusion of the retention wire. The 1 case of pericardial tamponade was encountered in a patient who had a class III fracture, but there was not a clear-cut association between the retention wire and the pericardial tamponade. There was no correlation between fracture status and complications. If this observation is confirmed with more patients, it suggests that the retention wire has little to do with the risks of SVC extraction. It is possible that retraction of the retention wire into the countertraction sheath may be protective.

The complication rate was low (3/42; 7.1%) in those patients who did not require concomitant ventricular lead extraction. The infection rate (1/60; 1.7%) is consistent with that encountered in any pacemaker population. There is little reason to believe that the infection was due to extraction technique itself.

Concurrent Ventricular Lead Extraction
The rate of concurrent ventricular lead extraction was quite high at 30%, and most complications were associated with concurrent ventricular lead extraction. Many of the ventricular lead extractions were planned in advance, but more were not. Most of the unplanned ventricular lead extractions were performed early in the series. In 4 cases, the ventricular lead was extracted because the subclavian vein could not be made to accommodate a guidewire, sheath, or replacement atrial pacing lead (loss of vascular access). The inability to use the subclavian vein after lead extraction was potentially due to the formation of a thrombus, the raising of an endothelial dissection flap, or prolapse of remaining fibrotic debris surrounding the lead as it is pulled back into the subclavian vein. In these instances, complications may have been avoided by using the Cook sheath as a conduit to the vasculature for the replacement lead. Although care was taken throughout the series to use the sheath as a venous conduit, it became a more central part of the technique as the series progressed.

In 6 cases of unplanned ventricular lead extraction, high ventricular pacing thresholds were found after the atrial lead was extracted. It is possible that some of these cases represent ventricular lead micro dislodgement due to atrial lead extraction. This is something to keep in mind when performing 801 lead extraction on pacemaker-dependent patients. Unfortunately, ventricular pacing thresholds were not documented before the extraction of the 801 lead. Therefore there was no systematic way to differentiate patients with chronically high ventricular pacing thresholds from those who may have had micro dislodgement of the ventricular lead. Finally, because most unplanned ventricular lead extractions were performed early into the series, they may represent a procedural learning curve to proper extraction of the 801 lead. Later in the series, the Cook extractor sheaths were advanced and kept further into the right atrium.

Study Limitations
There were several limitations to this study. It was a small cohort. Thoracotomy was used as the secondary extraction technique. Given the prospect of thoracotomy in instances of failure to extract the lead by the SVC approach, the extractor may have been more aggressive in persisting with the SVC approach than if alternative approaches such as the various femoral approaches or the Excimer laser had been used.

Historically, ventricular lead extraction has been enthusiastically pursued in our institution [27]. Leads with marginal functional characteristics have tended to be removed. Threshold data were not systematically collected before lead extraction. The complication rate associated with 801 lead extraction may have been skewed by the fact that concurrent ventricular lead extraction was common, and associated with complications.

The study reflects the results of a single seasoned operator who has had previous experience with lead extraction. As such, these data may actually underemphasize the potential for harm from the procedure.

Conclusions
Our study shows that the 801 lead can be extracted with a high success rate, acceptable morbidity, and low mortality using the SVC approach. Characteristics of the 801 lead did not predict complications of extraction, and the extracted 801 lead could not be implicated directly in any complication.

Accumulated data suggest that the risk of injury is actually higher from extraction process than from the lead itself, within the limits of the current practice of periodic fluoroscopic monitoring for signs of fracture and protrusion. We concur with the multicenter recommendations that 801 lead extraction should be reserved predominantly for those patients who are younger and have evidence of lead fracture or retention wire protrusion.

Pacemaker-dependent patients should receive a temporary transvenous pacing wire for pacing support. It is appropriate to assess ventricular lead pacing and sensing characteristics both before and after 801 lead extraction. Our data suggest that, when dealing with 801 lead extraction, ventricular leads with at least marginal pacing and sensing characteristics should be left in place. The extracting physician should be prepared to deal with immediate pericardial tamponade, great vessel rupture, and other surgical disasters when planning the procedure. An alternate extraction technique should be planned for before starting the procedure. Follow-up protocols should be arranged before extraction, to deal with late complications.

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Address reprint requests to Dr Telfer, Section of Electrophysiology, Loyola University Medical Center, 2160 S First Ave, Mayhood. IL 60153.

	References

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 

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This Article Abstract Alert me when this article is cited Alert me if a correction is posted 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): Bradford P. Blakeman Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Telfer, E. A. Articles by Blakeman, B. P. Search for Related Content PubMed PubMed Citation Articles by Telfer, E. A. Articles by Blakeman, B. P. Related Collections Related Article