PACING
Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial
1 Cardiology Department, Na Homolce Hospital, Roentgenova 2, Prague 5 150 30, Czech Republic; 2 Cardiac Arrhythmia Service, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
Manuscript submitted 16 April 2006. Accepted after revision 1 November 2006.
* Corresponding author. Tel: +0044 1664 822869; fax: +420 25727 2693. E-mail address: petr.neuzil{at}homolka.cz
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Abstract |
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Aims The purpose of this prospective randomized study was to evaluate the safety and efficacy of transvenous pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction with an electrosurgical dissection sheath (EDS) system in a single-centre experience.
Methods Over 10 years, 462 patients have undergone transvenous lead extraction in our institution. From these, 120 consecutive patients (with 161 leads) were randomized to either radiofrequency (RF) current supported extraction or standard countertraction lead removal (60 patients in each arm, 96 men and 24 women). The mean age of randomized patients was 62.7 ± 9.6 years. In 16 patients, we explanted 17 ICD leads. The average time from the date of implantation to the extraction procedure was 73.4 ± 15.7 months. The most common reason for lead extraction was infection (95.6%).
Results The complete extraction of 78 leads (93%) was achieved in the RF group and 56 leads (73%) with the standard transvenous lead extraction system by counter-traction (P < 0.01). Among these leads, we successfully removed nine of 10 ICD leads (90%) in the RF group and only four of seven ICD leads (57%) in the standard group. We also observed a significant reduction in the time taken for the successful removal of pacemaker and ICD leads using the RF system (9.6 ± 6.2 min versus 21 ± 9 min, P < 0.01). Partial success was achieved in six patients with the RF system and in 11 with standard sheaths. In those cases where we failed to remove the lead from the body we sent all but one patient to cardiac surgery.
Serious complications were associated with the standard system in two patients, both of whom developed septic pulmonary embolization. Serious bleeding occurred in three patients, one with standard and two with the EDS lead extraction system.
Conclusion The EDS extraction system is significantly more effective and quicker. However, the standard counter-traction method is still an effective alternative when used in a highly experienced centre.
Key Words: Electrosurgical dissection sheaths, Transvenous lead extraction, Pacemaker infection
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Introduction |
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There are several reasons why it may become necessary to remove pacemaker and implantable cardioverter-defibrillator (ICD) leads. The most common indications for lead extraction are pacemaker infection, lead dysfunction, and vein obstruction. However, fibrotic tissue encapsulating chronically implanted leads may prevent their release from the vascular system.
In the last 10 years, several tools and techniques for transvenous lead extraction, including excimer laser (The Spectranetics Coorporation, Colorado Springs, CO, USA) and electrosurgical dissection sheaths (EDS) using radiofrequency (RF) energy (Cook Vascular Incorporated, Vandergrift, PA, USA) have been developed with success rates exceeding 90%.1
These recently developed systems help to dissolve gently sometimes rigid, fibrotic tissue without a high risk of perforation of the vein or heart2,3 (Figure 1). The PLEXES trial has already proved the superiority of excimer laser over standard telescopic extraction sheaths.4
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The cost associated with laser technology has limited its use to highly advanced centres. The EDS system, however, seems to be highly effective and less expensive to use. Based on our > 10 years experience with the standard transvenous lead removal technique, we decided to investigate whether the sheaths using RF energy might help to improve the routine practice of transvenous lead extraction in a single centre. To test the efficacy of the RF lead extraction system, we carried out a prospective randomized single centre study with complete lead removal as the primary endpoint. We compared the EDS system with the already accepted ‘low tech’ method of transvenous counter-traction using telescopic polymer sheaths.
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Methods |
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In this study, we randomized patients who had indications for pacemaker or ICD lead extraction. After obtaining written informed consent we enrolled the patients into the study. Lead extraction and other procedures were performed in accordance with normal practice, following Czech Cardiology Society guidelines and with the approval of our hospital's Ethics Committee.
This was a prospective randomized study evaluating the efficacy of RF dissecting sheaths for transvenous extraction of pacemaker/ICD leads as a single centre trial. Our experience with transvenous lead extraction is based on more than 10 years' clinical practice with a total of 462 patients (323 males, 139 females, and mean age 65.6 ± 11.2 years). No left ventricle pacing leads were included.
During the last 2.5 years we have included 120 consecutive patients who had had their leads implanted for at least 6 months. The primary endpoint was the complete extraction of the leads and the recovery of the patients. The secondary endpoint was the rate of complications.
We randomized 60 patients to the RF procedure group and 60 patients to the standard procedure group; 96 men and 24 women. One hundred and sixty one leads were explanted (84 in the RF and 77 in the standard group). A patient was crossed over to the other technique when we failed to remove the lead. Patients were referred for the extraction procedure from within our institution, outside hospitals, and pacemaker clinics. Infective complications were the dominant indication for lead removal. The most common infecting organisms responsible for lead system infection were Staphylococcus epidermidis and Staphylococcus aureus.5,6 Transoesophageal echocardiography (TOE) revealed lead endocarditis in 16/120 (13%) patients. The size of the vegetations was 7–25 mm. In three patients with documented endocarditis and vegetations > 20 mm we elected to use long-term antibiotic therapy. After regression of vegetation size (vegetations < 10 mm after treatment), patients were then randomized. No patient was excluded from transvenous extraction or sent directly for cardiac surgery due to the size of the vegetations.
The most prevalent indication for lead extraction in our patients was pacemaker pocket infections. In two cases there was a suspicion of complete or partial obliteration of the venous system (with more than two implanted leads) (Figure 2). Demographic information of all patients included in this study is shown in Table 1.
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For the standard removal procedure we used dilators PER 100TM and PER 200TM, Byrd dilator sheath sets and Femoral workstationTM including Liberator Universal locking styletTM (Cook Vascular Inc.), as well as the Vasco Extor systemTM (VascoMed–Institut für Katehetertechnologie GmbH, Binzen, Germany). In the last 3 years the EDS system PerfectaTM (Cook Vascular Inc.) has also been used in our centre for chronically implanted leads. The system contains four different sizes of the double sheaths –7, 9, 11, and 13 F—designed specifically for ICD lead removal. The system includes an interface adapter for a 25 W energy source working with a standard RF surgical generator Valleylab® (Valleylab, Inc., Boulder, Colorado, US) as previously described.3
The extraction procedure was performed with temporary interruption of chronic anticoagulation therapy and using antibiotics as a prophylaxis. The procedure was performed using analgesia and sedation with local anaesthesia. General anesthesia was not undertaken. After surgical opening of the pacemaker or ICD pocket, the proximal lead connector was cut and a locking stylet (LiberatorTM) was introduced and anchored in the most distal part of the lead as close as possible to the lead insertion site into the myocardium. When using the standard counter-traction system, various telescopic dilators of different sizes were introduced gradually over the lead body including undamaged insulation which mechanically released its encapsulation in the veins and at the endocardium. After getting as close as possible to the site of lead insertion with the dilator, effective counter-traction could be performed without invagination of the right ventricular or atrial wall.
When patients were randomized to the EDS extraction system, after locking stylet insertion the most appropriate sizing of RF sheaths was used; typically, 9 F sheaths for bipolar pacing leads and 13 F for ICD leads. Short repeated bursts of RF energy using light forward pressure were applied on the sheath. Slow twisting of the sheath helps to release the tightest adhesions and fibrous encapsulations (Figure 1). Specifically when RF dilators were used, we carefully ligated the insulation of the lead to protect against short-circuits. This could happen during bipolar RF energy application where contact might accidentally be made with the naked spiral wire of the lead when we are forced to dissolve the fibrous tissue and break the lead insulation. Previously attempted lead extractions were excluded.
A femoral approach was preferred only in those cases where we had released the distal tip of the pacing or ICD leads from the site of insertion but had failed to withdraw it through the subclavian vein. In these cases we used the Femoral workstationTM (Cook Vascular Inc.) preferably after surgical venotomy of the femoral vein to permit passage of the oversized sheath into the femoral vein. Cardiac surgery was considered in those cases when we completely failed to withdraw the leads through the subclavian or femoral venous system.
Some years ago, Byrd et al. defined the extraction procedure to be successful when complete lead removal was achieved and partially successful when a distal fragment of the pacing lead remained fixed (
4 cm).7 The extraction was considered unsuccessful if a distal fragment remained > 4 cm or if the extraction of the pacing or ICD leads was incomplete.
In five cases where pacing leads had been implanted for > 8 years, we introduced a pigtail catheter into the pericardium—through a puncture of the non-separated pericardial sac to control haemorrhage into the pericardium and development of cardiac tamponade. In 12 patients, we used intracardiac echocardiography (ICE) to monitor the lead extraction procedure (Cypress, Acuson Siemens Medical Solutions, Siemens-Ultrasound, Inc., Mountain View, California, US) with 10 F ultrasound catheters.
Special attention was given to the evaluation of potential complications, which may occur during or immediately after the extraction procedure. This included continuous blood pressure monitoring and transthoracic echocardiography within 1 h after transferring the patient to the high dependency unit. We performed all procedures with a cardiac surgeon standing-by.
Statistical analysis
Data were compared using Student's t-test at 95% confidence interval. 
2 analysis was used for cathegorical variables. A P value of < 0.05 was considered significant.
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Results |
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One hundred and sixty one leads (144 pacemaker and 17 ICD) were extracted from the 120 patients. In the EDS group 84 leads (10 ICD) required extraction. Complete success was achieved with 78 leads (9 ICD), which represents a success rate 93%. In the second group, where the standard extraction system was used, there were 77 leads (7 ICD) requiring extraction. We achieved a complete lead extraction of 56 leads (4 ICD), which represents a success rate of 73%. The EDS system was significantly more effective than the standard counter-traction technique (P < 0.001).
Partial success was achieved in 6 (7%) leads with the EDS system and in 11 (14%) with standard sheaths (NS).
Only one ICD lead in EDS group, 10 pacemaker and three ICD leads in standard group failed to be extracted. These patients were crossed over to the other device. Using the EDS system, we successfully finished the procedure in five pacemaker and two ICD leads (see Table 2).
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We also observed a significant reduction in the time of traction to complete the successful removal of pacemaker and ICD leads using the EDS system (9.6 ± 6.2 min versus 21 ± 9 min, P < 0.01).
One hundred and twelve leads were ventricular pacing leads (one was designed as a single VDD lead as shown in Figure 2), 32 were atrial pacemaker leads, and 17 were ICD leads. The average time between lead implantation and extraction was 73 ± 15.7 months; the time was slightly longer in patients randomized to RF dissecting sheath technique but not significantly different (P = 0.75). The mean time of implantation was 85 ± 17 months in EDS group vs. 74 ± 11 in the standard group. Thus, the qualitative characteristics of the leads requiring removal reflects pacing and ICD practice in the last 10 years. Among ventricular pacing leads, passive fixation slightly prevailed compared with active fixation (74 vs. 55) (see Table 1). All 17 ICD leads had active fixation. Similarly, passive fixation atrial leads also prevailed in comparison with active fixation (23 vs. 9). A similar distribution was found for unipolar and bipolar electrodes (82 vs. 62). We found no differences between the type of fixation and unipolar vs. bipolar lead systems in terms of the success of the procedure. When we failed to remove the leads completely with the RF extraction system (in 11 cases, it was because the dilator would not pass through the costoclavicular space and over the tight curve of the axillary vein), we went into the superior vena cava. In only five cases, we failed to release the lead from the site of insertion after reaching this point with a sheath. In all but one of these cases this occurred with ventricular bipolar leads.
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In three cases, the subclavian approach was unsuccessful or only partially successful due to the difficulties in (i) advancing the extraction dilator through the upper thoracic aperture, i.e. from the axillary and subclavian veins into the superior vena cava (SVC) and (ii) shortening of the lead body which prevented appropriate locking stylet insertion into the lumen of the lead and the use of dilators (either EDS or standard) to dissect away the firm fibrous adhesions attached to the lead insulation. In all these three cases, the removal procedure was continued using femoral vein access to introduce snares, baskets, or deflectable mapping catheters to catch the lead body and withdraw it through the femoral vein as is shown in Figure 3. Another picture shows one of these cases with tightly connected atrial and ventricular leads, which could not be separated and prevented extraction via the route of original entry; in this case, the femoral approach (Figure 4) was again used. Due to insufficient data from the original implanting procedure in a relatively high number of our randomized patients we could not compare how vein access—either subclavian vein puncture or cephalic vein preparation—affected our results. In two patients, the pacing leads had originally been placed through the external jugular vein. Both were easily removed with the EDS system in one and the standard system in the other.
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The average time in hospital for those patients in this randomized study was 6 ± 4.6 days. If the patients remained on prolonged antibiotic therapy, the average time spent in the hospital increased to 17 ± 6 days.
We achieved complete cure of infection in both groups after complete or partial lead extraction. In two cases with total or subtotal occlusion of the venous system, venous flow was restored with long-term improvement. In one of these two patients, we elected to use a minimally invasively placed epicardial pacing lead due to symptomatic atrioventricular block with life threatening syncope.
The most serious complication, leading to prolonged hospitalization, was septic pulmonary embolism immediately following the procedure in two patients in whom TEE had confirmed lead endocarditis before the procedure. In both cases, this complication significantly prolonged hospitalization. In three other patients, sepsis developed within 1–3 h after the procedure. In three patients, blood transfusion was required due to extensive bleeding from the pacemaker pocket. There were no other serious complications, deaths, or cardiac tamponade. In 12 patients, where we used ICE to monitor the pericardium, no effusion was observed and on the following day transthoracic echocardiography showed no abnormal findings.
We left 10 patients without implantation of a new pacemaker system after lead extraction because Holter ECG monitoring as well as exercise stress testing showed adequate chronotropic response. In one patient who had SVC syndrome, angioplasty was performed.
Surgical extraction was necessary in six patients when we failed to remove leads in the EDS group, the standard group or after crossover. There were no complications in these patients. Surgical extraction was not performed in one patient who made a complete recovery after pacemaker pocket infection. Two patients randomized to the transvenous standard lead extraction group required tricuspid valve valvuloplasty after successful transvenous lead removal (3 and 6 months after procedure); in both patients, serious tricuspid valve regurgitation developed due to disruption of the tricuspid valve apparatus.
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Discussion |
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In this prospective randomized single centre trial, we have shown a significant improvement and higher efficacy when using the RF lead extraction system compared with the standard method. We achieved 93% complete lead removal with the RF system compared with 73% using the standard polymer telescopic sheaths. Despite 10 years' experience in our centre with standard transvenous extraction, with the RF dissection sheath technique, the same team of operators achieved better results.
In both groups of patients with similarly long implantation times, transvenous extraction was associated with a remarkably low risk of life-threatening complications. Nevertheless, life-threatening complications remain possible with this procedure implying that they have to be considered during the extraction and therefore these procedures should not be performed without the close cooperation of cardiac surgeons.
The relatively high percentage of complete extraction success achieved by both methods of transvenous extraction may be attributed to the large numbers performed over a long period mainly by two operators.
Byrd described the relationship between unsuccessful extraction and the duration of pacemaker lead implantation as early as in 1992. A two-fold increase has been reported for every 3 years of implantation.8 Furthermore, the risk of vein obliteration increases with the time after the primary implantation of the pacing system and with the number of pacing leads introduced.
A few years ago, new methods using laser extraction sheaths were introduced and have been demonstrated to be safe and highly efficient. However, the percentage of completely extracted pacemaker leads was not dramatically higher than that seen when using the standard counter-traction method in the hands of an experienced operator; and the percentage of complications, including deaths, was even higher compared with the standard method of transvenous extraction.9 In our institutional registry, we achieved nearly 75% success using the standard approach before the EDS era.
In the PLEXES (Pacing Lead Extraction with the Excimer Sheath) study, a total of 94% electrodes were completely extracted using laser-assisted extraction compared with 64% using a standard technique.10 In our study, we achieved the same level of successfully completed lead extractions but the number of our complications was much lower. In the PLEXES trial, five serious complications with the laser assisted procedure (two tamponade, one death, one haemothorax, one vein thrombosis, and one damage to the tricuspid valve) was not statistically significantly different from that in the control group (two vein thrombosis). It is questionable whether the low percentage of complications with the standard method of transvenous extraction is not a result of a less aggressive approach combined with a significantly lower efficacy which, in the PLEXES study, reached 64% and is, thus, less than that of some single centres.4,8,11 Our data are supported by the results of Dresing and Wilkoff from the Cleveland Clinic Foundation who reported 450 consecutive lead extractions.12 Laser was used for 354 leads and RF for 96 leads. Again, they observed no complications in the RF group but two deaths in the laser group. Procedure time in the RF group was significantly lower (130 ± 49 min versus 158 ± 65 min, P < 0.002). The importance of these results is compromised by the fact that the time from implantation to extraction was longer for laser extracted leads (8.2 ± 5.0 years vs. 6.6 ± 4.4 years, P < 0.005). Despite this fact, the authors concluded that the RF system is comparable with laser sheaths. The initial experience with 12 F laser sheaths revealed suboptimal success, but the current version using 14 or 16 F sheaths has increased the success of laser extraction.
Other retrospective analyses and registries have shown that complications are not directly dependent on the length of the insertion of a pacing lead.6,8 Complications are less frequent with a lower BSA (body surface area) but more common in females. As to the type of lead, it is only those with active fixation that are clearly associated with an increase in life-threatening complications.13
At present, there is no doubt that the complete extraction of the lead system is necessary in cases of infective complications. Klug14 reported that conservative treatment of infective complications is not helpful for patients. Extraction must be considered in all cases of documented lead endocarditis with bacterial vegetations exceeding 10 mm due to a high risk of septic pulmonary embolism. However, the same authors also indicated that there was a risk related to surgical procedures (two deaths).
Taking all the available data, the EDS system for lead removal seems to be a very promising procedure. The use of this system has been presented by Byrd in the EXCL multicentre study.3 Similar to the laser system, the RF extraction sheath overcomes the most common areas of dense fibrous adhesions—that is, the point of the entrance of innominate or subclavian vein into the SVC, right atrial SVC junction, at the tricuspid valve and in the right ventricle. In our experience, ICD leads cause the worst adhesions around the active coil, which may traverse the tricuspid valve.
Regarding transvenous extraction in patients with infective complications, there are no randomized studies comparing the effectiveness of lead extraction with conservative therapy. Lewis et al. reported 75 patients15 requiring lead extraction due to erosions or an abscess in the pocket of a pacemaker, 13 of these patients had positive blood cultures. Thirty-two patients were treated conservatively but only one was cured. In contrast, the other 43 patients underwent extraction of the entire stimulation system and all of these patients were cured. All 31 patients in whom the conservative therapy failed were subsequently successfully treated using transvenous extraction.
It seems that complete extraction of the entire pacing system is extremely important for complete cure. If only the pacemaker was extracted without removing the leads, infections persisted in a large percentage of cases (17–70%).16
Since 1994, no serious infective complications have been treated conservatively at our hospital, all patients have undergone lead extraction.
The method of transvenous extraction ranks among those intervention procedures, which should be performed by high volume centres with sufficient experience and facilities. Performance of less than 20 procedures a year cannot guarantee appropriate effectiveness and safety. However, the RF electrosurgical dissection technique might improve the outcome of pacemaker lead extractions in smaller centres with less experienced operators and might help to overcome the initial learning curve. With this in mind, the Taskforce for Permanent Pacing and Arrhythmias of the Czech Cardiological Society reached a consensus recommending centres performing extraction to have experienced surgeons and a cardiosurgical team on site.17 This may become even more important now that biventricular pacing as treatment of heart failure patients has become established. Left ventricle leads will need to be extracted in the future and this may be a challenge for pacemaker centres.
We can conclude that electrosurgical RF dissection system can be used very effectively and safely and helps to overcome most of the difficulties in patients at higher risk of complications. Further development is needed for transvenous left ventricle lead extraction.
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References |
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[1] Meyers MR, Parsonnet V, Bernstein AD. Extraction of implanted transvenous pacing leads: a review of a persistent clinical problem. Am Heart J 1991; 121: 881–8.[CrossRef][Web of Science][Medline]
[2] Byrd CL, Love CJ, Wilkoff BL, et al. Extracting chronically implanted pacemaker leads using the spectranetics excimer laser: initial clinical experience. (Abstract). Pacing Clin Electrophysiol 1996; 19: 567.
[3] Byrd CL, Love CJ, Wilkoff BL, et al. A bipolar electrosurgical dissection sheath for lead extraction: results of the EXCL multicenter clinical study. (Abstract). Pacing Clin Electrophysiol 2001; 24: 560.
[4] Alt E, Neuzner J, Binner I, et al. Three-year experience with a stylet for lead extraction: a multicenter study. Pacing Clin Electrophysiol 1996; 19: 18–25.[CrossRef][Medline]
[5] Vogt PR, Sagdic K, Lachat M, et al. Surgical management of infected permanent transvenous pacemaker systems: ten years experience. J Card Surg 1996; 11: 180–6.[Web of Science][Medline]
[6] Bohm A, Banyai F, Preda I. The treatment of septicaemia in pacemaker patients. Pacing Clin Electrophysiol 1996; 19: 1105–11.[CrossRef][Medline]
[7] Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. North American Society of Pacing and Electrophysiology Lead Extraction Conference Faculty. Pacing Clin Electrophysiol 2000; 24: 544–51.
[8] Byrd CL, Wilkoff BL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994–1996. US extraction database. Pacing Clin Electrophysiol 1999; 22: 1348–57.[CrossRef][Medline]
[9] Epstein LM, Byrd CL, Wilkoff BL, et al. Initial experience with larger laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads. Circulation 1999; 100: 516–25.
[10] Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol 1999; 33: 1671–6.
[11] Smith HJ, Fearnot NE, Byrd CL, et al. Five years experience with intravascular lead extraction. US lead extraction database. Pacing Clin Electrophysiol 1994; 17: 2016–20.[CrossRef][Medline]
[12] Dresing T, Balaban K, Cole C, et al. Procedure and fluoroscopy duration for electrocautery assisted extraction of pacemaker leads. Pacing Clin Electrophysiol 2002; 25: 545.
[13] Bradle FA, Meijer A, van Geodet LM. Pacemaker lead complications: when is extraction appropriate and what can we learn from published data? Heart 2001; 85: 254–60.
[14] Klug D, Lacroix D, Savoye C, et al. Systemic infection related to endocarditis on pacemaker leads: clinical presentation and management. Circulation 1997; 95: 2098–107.
[15] Lewis AB, Hayes DL, Holmes DRJ, et al. Update on infections involving permanent pacemakers. Characterization and management. J Thorac Cardiovasc Surg 1985; 89: 758–63.[Abstract]
[16] Rettig G, Doenecke P, Sen S, et al. Complications with retained transvenous pacemaker electrodes. Am Heart J 1979; 98: 587–94.[CrossRef][Web of Science][Medline]
[17] Neuzil P, Taborsky M, Rezek Z, Niederle P. Transvenous extraction of pacing leads—contemporary trends (in Czech). Cor Vasa 1998; 40: 87–92.
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