REVIEW ARTICLE
Endovascular extraction techniques for pacemaker and lCD lead extraction (Part I) F.A. Brackel, A. Meijer', B. van Gelder'
In the last few years, comprehensive endovascular techniques have been developed to extract chronically implanted pacemaker and defibrillator leads. It is important that referring physician have knowledge of the advantages and limitatons of the different techniques. In this paper we discuss the techniques and results of the currently used endovascular extraction techniques. (Neth Heart J 2001;9:23-30.)
Key words: pacemaker, implanted, defibrillator, lead extraction, laser, review Recently introduced pacemaker leads can often be extracted with traction alone as they float freely within the veins and myocardium. Later on, fibrous encapsulation ofthe lead develops. The lead becomes incorporated into the intimal layer of the vessel wall and is covered with endothelial cells towards the vessel lumen.' These adhesions are commonly found at sites where the lead is in contact with the vessel wall (figure 1) or the myocardium (figure 2) and can occur along the whole length ofthe lead.'14 Until the advent of comprehensive endovascular techniques, surgical removal with or without extracorporal circulation was the only reliable technique to extract chronically implanted leads.5-9 Although there are no large databases available, a number of authors have reported their experience with surgical removal ofleads. The perioperative mortality with infected leads ranged from 2.4%-17%. Hence, although effective, surgery itself constitutes an important risk, especially for compromised patients. Since then, a variety of endovascular lead extraction F.A. Bracke. A. Mejer. B. van Gelder. 'Department of Cardiology, Catharina Hospital, P0 Box 1350, 5602 Z4 Eindhoven.
Address for correspondence: F.A. Bracke. E-mail: [email protected]
Netherlands Heart Joumal, Volume 9, Number 1, Aprl 2001
techniques have been reported in the literature. Some of them deal with exceptional circumstances or have never attracted many followers.'0-25 We will discuss the principal endovascular techniques that are currently used. Traction Slight traction can be sufficient to remove recently implanted leads. However, the encapsulation of the lead occurs not only at its tip but also along any part of it. Thus when traction is used, the fibrous encapsulation often provides sufficient friction to prevent the force applied from being transmitted to the tip of the lead. When more force is needed, the tensile strength of the insulation or the conductor can be exceeded resulting in stretching or rupture. The lead may sever leaving part of it indwelling in the venous circulation.26 These severed and denuded leads have a higher incidence of thrombofibrotic complications especially when infected.27-30 Active fixation leads may have a better chance at extraction than passive fixation leads, especially if they are isodiametric and can be unscrewed before extraction. The fibrous encapsulation around the tines has a restraining effect on the lead at the myocardium and, once dislocated, this bulbous tip will not pass easily through the fibrous envelope.2' Invagination of the myocardium may complicate unopposed traction.26 Besides arrhythmias and hypotension, this can cause myocardial rupture or avulsion of a tricuspid valve leaflet.3'34 To avoid this, prolonged graded traction has been introduced.35-37 For this purpose, increasing weights are connected to the proximal end ofthe lead. They are guided over a pulley, or to keep the patient ambulatory, fixed under tension to the skin using rubber bands and adhesive tape. Nevertheless, complications similar to those with direct traction have been described, including death.38
Locking stylets To avoid unwinding of the conductor coil or rupture of the insulation during traction, a locking stylet is introduced into the central lumen of the lead. It consists of a straight non-expandable wire with a deflecting mechanism at the tip that can be locked into the 23
Endovascular extraction techniques for pacemaker and ICD lead extraction
coil close to the tip ofthe lead (figure 3). Traction via the locking stylet is almost directly applied at the tip, bypassing most of the conductor and the insulation. Locking mechanisms differ between manufacturers and recently introduced locking devices can be unlocked and repositioned if necessary. There are still limitations to the use of a locking stylet. If the conductor is broken or distorted, e.g. with subclavian crush syndrome, it is not possible to introduce the stylet. It can also lack grip and dislocate during traction or too much force can damage the delicate locking mechanism. Further, as traction is still exerted via the distal conductor coil, this can unwind or disconnect from the electrode. As with direct traction, there is the risk of invagination of the myocardium. What it does not do either is provide the solution of pulling the tip, which is sometimes bulbous, through the fibrous sheaths along the body ofthe lead once it is freed from the myocardium. Conventional intravascular counter-traction To overcome the limitations of a locking stylet, additionally telescoping synthetic sheaths can be advanced over the lead. The fibrous bindings within the veins or myocardium can be mechanically disrupted, and at the same time enough room is created to remove the lead.39'40 The outer sheath also functions as a guiding catheter facilitating the movement of the inner sheath and alignment of the inner sheath and the lead. It is important to use a locking stylet as the leads are often too fragile to withstand the traction necessary to counter the forces applied to advance the sheath. Once the distal electrode is reached, the larger bore outer sheath can be positioned against the myocardium to prevent inversion during traction on the lead, a manoeuvre called counter-traction (figure 4). By pulling on the locking stylet, the tip of the lead is pulled inside the outer sheath. The force is thus concentrated at a small area of the scar tissue and myocardium sur-
Figure 1. Autopsy specimen. Fibrous tissue covering the pacemaker lead in the subclavian vein. (Courtesy ofDr Willem de Voogt.)
rounding the lead without gross displacement of the myocardium. Although counter-traction prevents invagination ofthe myocardium and diminishes the chance of rupture, perforation of the myocardium is still possible, especially in the thin-walled atrium.4'42 Together with the telescoping sheaths, an inferior vena cava or transfemoral approach has been developed. A long 16 F sheath is introduced via the femoral vein and positioned close to the lead to be extracted. Then, a retriever is inserted through the sheath to grab and secure the lead close to the tip (figure 5). The isodiametric proximal part of the lead (with the connector cut off) is pulled down through the fibrous scar tissue. The outer sheath is then advanced over the doubled up lead to disrupt the scar tissue, while the lead is kept under tension by the retriever. When the sheath reaches the tip, counter-traction is applied to free the tip. In comparison with the superior approach, only a short distance of scar tissue needs to be disrupted as the proximal isodiametric part of the lead can be simply pulled down. Therefore, although no locking stylet is used to reinforce the lead, the shorter distance to cover decreases the chance of elongating the lead. The technique is especially useful to remove severed and indwelling leads or as back-up after failed superior attempts.43 Laser-assisted extraction Recently, a laser sheath that replaces the inner sheath was introduced to disrupt the fibrous bindings.43-46 The sheath consists of optic fibres spirally warped between the inner and outer tubing of the sheath. At the tip of the device the fibres are arranged in a ring (figure 6). Pulsed laser light is emitted from the fibres to ablate the tissue. For this purpose, the device is connected to a 308 nm XeCl excimer laser (Spectranetics CVX-300), which delivers pulsed light at a maximum fluence of 60 mJ/mm2 and a 40 Hz repetition rate. The ablation
Figure2. Autopsy specimen. Fibrous encapsulation ofthe terminal part of a pacemaker lead in the right ventricle. (Courtesy of Dr
Willem de Voogt.) 24
Netherlands Heart Joumal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
outer sheath
fibrous tisse
Figure 3. Locking stylet. The tip of the stylet has a deflecting mechanism that can locked into the inner coil of the lead once the stylet is positioned at the tip of the lead. The depicted stylet (Wilkoff stylet, Cook Inc., In) can be unlocked and repositioned or retrieved if necessary.
mechanism combines photochemical destruction of cellular structures with explosive photo-thermal vaporisation ofcellular water, which creates transient microbubbles to mechanically disrupt the tissue. As the penetration depth of 308 nm light in vascular tissue is approximately 100 micron, it is completely absorbed in the tissue immediately in front ofthe tip. This results in an ablation depth, depending on the applied force, between 2 and 15 microns per pulse in the experimental setting.47 The influence offorce is explained by increasing the mechanical effect of the micro-bubbles entrapped beneath the tip of the device in creating microscopic tears. The ablation results in a shearing of the fibrous bindings, often leaving a rim of scar tissue around the
g _
Figure 4. Counter-traction. The outer sheath is positioned against the myocardium to prevent invagination of the heart during traction on the lead. In this way, the force applied is also effectively concentrated around the tip of the lead.
lead. It is clear that the blunt tip of the laser sheath is not suited for primary mechanical disruption ofthe fibrous bindings and that applying more force than necessary to assure good contact with the tissue does not improve efficacy but does increase the risk of complications. As with conventional sheaths, the outer sheath facilitates the movement of the laser sheath by reducing friction with the surrounding tissue (figure 7). The laser sheath is advanced under fluoroscopy guidance up to the distal electrode. Then counter-traction is applied using the outer sheath, as it is not advisable to ablate beyond the tip of the lead in order to avoid perforation. Also, the laser has no influence on the synthetic material ofpacemaker leads. Therefore, it cannot ablate through
Figure 5. Transfemoral approach. Panel a. A basket cathtr and its sheath are deployed outside the long outer sheath. The deflecting wire that is inserted througb the baskecatheter is used to mobilise the kad and pull it inside the basket ifxcwary. Oncepart of the lead is inside the basket, the own sheath basket's isforwarded to secure the keai Panel b. The kad issecured in the baska Tbe deflectingguide wire bas not been pulkd back in this case.
Netherlands Heart Journal, Volume 9, Number 1, April 2001
25
Endovascular extraction techniques for pacemaker and ICD lead extraction
pacemaker ieaac Figure 6. Laser sheath. The opticflbres are concentrically arranged at the tip of the sheath. Note that the tip of the sheath is blunt and not suitable for mechanical disruption offibrous tissue.
the tines of a passive fixation lead or damage the insulation of pacemaker leads except for mechanical damage through forceful manipulation. To accommodate for different sizes of leads, 12, 14 and 16 F sheaths are available. Results
Although traction and graded traction for lead extraction have been reported on for more than 30 years, no reports in the literature describe a large enough population to adequately judge the effectiveness and complication rate of these techniques. Locking stylets are often used together with other techniques but have also been reported as a standalone extraction tool. Alt et al. reported their experience with the VascoExtor stylet (VascoMed GmbH, Weil am Rhein, Germany) in 150 leads in 105 patients, (110 ventricular leads, 40 atrial; passive fixation with tines in 109 leads). Complete removal was possible in 81% of cases, partial removal in 12%. Manolis et al. reported success with the same device in 24 out of25 leads: in 81% with the sole use of a stylet, in 19% with additional tools.48 No serious complications were reported in both reports. Conventional counter-traction technique with either a superior or an inferior approach are reported in the US Lead Extraction Database.4' Complete removal was achieved in 86.8% and partial removal in 7.5% of 2195 leads (table 1). Major complications occurred in 2.5% ofthe 1299 patients: haemo-pericardium or tamponade 1.2%, haemothorax 0.5% and pulmonary embolism 0.2%. Eight patients died during the procedure (0.6%). In a paper describing their experience with lead extraction between 1994 and 1996, Byrd et al. reported complete removal in 93% and partial removal in 5% of 3540 leads in 2338 patients. Major complications occurred in 33 patients (1.4%) including thoracotomy in 14 patients, peri-cardial drainage in 11 patients, transfusions in four patients and one death.42 26
Figure 7. Laser sheath and outer sheath as they are advanced over the pacemaker lead.
Kennergren reported the results of laser sheath extraction of 179 leads in 149 patients from a European multicentre study (104 atrial, 57 ventricular, one superior vena cava ICD and 17 ventricular ICD leads). Complete extraction was achieved in 89.5% of the leads, 6% were partially extracted and 4.5% of the extractions failed. Three out ofthe eight failures were completely removed by a femoral non-laser approach, one with an alternative superior approach and one with thoracotomy. Complications included ventricular perforation in one patient that did not need surgery; two other perforations were related to the reimplantation of leads and required surgery. There were no fatal complications. In a registry of 1463 patients undergoing laser sheath extraction of2249 leads, complete success was achieved in 90% and partial success in 3% of leads.46 There were major complications in 3.4% of patients, including tamponade (1.4%) and haemothorax (0.3%). Twelve patients died (0.8%), mostly as the result oftamponade. Byrd et al. reported an increased risk of failed or partial extraction with increasing implant duration (doubling every three years).42 Extraction was more likely to be successful with increasing physician's experience, atrial leads and infected leads. Implant duration was not linked with complications in any of the cited papers, but major complications reported for extraction of Accufix leads (Telectronics Pacing Systems Inc. Englewood, Co, USA) increased from 2% at one-year implant duration to 8.3% with an implant duration of more than five years as reported by the Accufix Resarch Institute (data available on www.accufix.com). Physician's experience, number of leads extracted and female sex, however, have been associated with an increased risk of complications.4'42 What is the pr technique for lead extraction? There is only one trial comparing techniques in a randomised fashion. In the Plexus trial, 465 leads were Netherlands Heart Journal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
Table . Success and complication rates of conventional and laser sheath endovascular extraction techniques.
Conventional sheaths Smith et al. Patients Leads Complete removal Partial removal Failure Complications Death
Laser sheath Relser et al. 1463 2249 90.0% 7.0% 3.0% 3.4% 0.8%
1299 2195 86.8% 7.5% 6.8% 2.5% 0.6%
randomised between the laser sheath and conventional sheaths.44 All investigators had experience with the conventional technique. Crossover from non-laser to laser was allowed in case of failure of the non-laser approach. Initial attempts at extraction were successful in 94% of leads with the laser sheath against 64% of leads with the conventional sheaths. However, there was a 33.5% crossover from conventional techniques to laser. This reflected the greater predictability oflaserassisted lead extraction as perceived by the investigators, hence the low threshold for abandoning conventional sheaths if success was not swiffly obtained. If no crossover was allowed, a success rate in the non-laser group comparable with the published databases on conventional extraction would have been expected.4'42 In the Plexus trial, tamponade or haemothorax occurred in three patients randomised to the laser group, one of whom died. Two patients in the laser group and one patient in the non-laser group had venous thrombotic complications. The complication rates for both laser and non-laser counter-traction techniques are comparable. This probably results from both techniques using counter-traction with perforation and tamponade often related to this part ofthe procedure. The limitations ofthe Excimer laser sheath are the poor performance with calcified fibrous bindings and with sharp bends in fixated leads. Although calcification is more likely in leads with long implant duration, it is not always visible during fluoroscopy. If encountered, oversizing the laser sheath can encompass the calcification around the lead and allow ablation through softer tissue. In right-sided implants, there can sometimes be an unexpected sharp bend once the junction of the subdavian and brachiocephalic vein is reached when the lead is fixated at that site. If the relatively stiff laser sheath cannot be aligned with the lead, it will plough into the lead and become obstructed. In this situation, experience, patience, taking care to align the sheath with the lead and ifnecessary oversizing the sheath will often solve the problem. In contrast, if stalled using locking stylets or telescoping sheaths, only increasing the force will improve the chance of success but at a higher incidence of lead disruption or incomplete removal. Nevertheless, the
Netherlands Heart Joumal, Volume 9, Number 1, Aprl 2001
Catharina experience 65 122 99.2% 0.0% 0.8% 4.6% 0.0%
femoral workstation has proven to be very useful in the case of severed indwelling leads not attainable with a superior approach or of laser failure. However, there is no endovascular back-up technique if a femoral approach fails as the lead is severed and pulled into the circulation. Catharina experdence In our centre, we extracted 122 leads in 65 patients from May 1997 until February 2000. There were 47 atrial leads, 74 ventricular leads (including 9 ICD leads) and one single pass lead. Time from implant averaged 6.2 5.2 years. With intact leads, our strategy was to apply traction first (preferably with a locking stylet) taking care to disrupt neither the lead nor the stylet. If this did not succeed, we used a laser sheath. In a patient presenting with a severed indwelling lead, we used a femoral workstation. Using this strategy, traction was effective in 35 leads and a laser sheath was necessary in 82 leads. For indwelling leads we used a femoral workstation in four leads and a snare in one lead (a severed lead migrated into the pulmonary arteries). Primary success with the laser sheath was 90% (74 leads). The reasons for laser failure were equipment problems in two leads, disintegration of a lead disrupted during a previous extraction attempt in one lead and failure to negotiate the curve from the right subclavian to the right brachiocephalic vein in five leads. Subsequently, five ofthose eight failures were removed with a femoral workstation, one with traction, one with surgery and one abandoned. Thus, the overall success of lead extraction was 99%. Complications occurred in three patients who were all treated with the laser sheath. There was pericardial tamponade after perforation of the atrium during extraction needing acute surgery in two patients. In one patient this was the result of counter-traction while removing an atrial lead, in the other of perforation at the junction of the superior vena cava and the right atrium during extraction of a ventricular lead in an elderly patient on chronic corticosteroids. Both patients recovered well after acute surgery to control the bleeding. Avulsion ofthe left internal mammary artery occurred in one patient.43-49 Normally the mammary artery is protected from damage by its posterior course ±
27
Endovascular extraction techniques for pacemaker and ICD lead extraction
Number of leads 35 30252015 10 50 0-6 6-12 12-24 24-48 48-96 Time from Inplant In months
>96
* Laser sheath or femoral workstation O Traction, including locking stylet
Figure 8. Extraction technique according to implant duration.
to the subclavian vein. Probably, during implantation the needle entered the vein posteriorly, close to the mammary artery. As the laser sheath follows the implanted lead it severed the mammary artery before entering the subclavian vein. A false aneurysm was created in the left subpectoral region with the blood re-entering the circulation through the entrance in the vena subclavia created by the laser. Angiographic embolisation of the proximal mammary artery and surgical clipping of the distal mammary artery controlled the bleeding. The patient recovered well. Leads implanted less than six months could all be extracted with traction including the use of a locking stylet (figure 8). However, from six months on, more than two thirds of the leads needed a laser sheath for extraction. These data implicate that with an implant time longer than six months it is not advisable to attempt extraction if traction is the only available tool. Conditions for lead extraction A venous angiogram is very useful to anticipate difficulties during extraction. Although often asymptomatic, venous obstruction is present in 8 to 21% ofpacemaker patients.30'50-55 This may influence the choice of extraction technique. Conventional sheaths will have difficulty in passing longer obstructions and if only a locking stylet is used it may be impossible to retrieve the tip, which is often bulbous, through the ob-struction. In theory, the laser should be best equipped to pass these obstructions and secure access to the central venous circulation. As both surgeons and cardiologists perform lead extractions, they are performed in the operating room as well as in the catheterisation laboratory. The latter is often equipped with superior fluoroscopy and, important to the cardiologist, readily available. We, however, choose to do all extractions in the operating room under general anaesthesia with the patient prepared for thoracotomy and with the cardiac surgeon on stand-by. In our experience with tamponade in two patients, thoracotomy was performed immediately and the
28
bleeding swiftly controlled with both patients recovering without sequellae. We cannot imagine the same good outcome if the patients had to be transferred to another room, however nearby, and still had to be intubated and prepared for thoracotomy. We therefore prefer the safety ofthe operating room and have learned to live with its inconveniences. In this context, transoesophageal echocardiography during lead extraction is very useful to detect pericardial effusion before serious haemodynamic deterioration occurs. It is important to realise that, as with any procedure of some complexity, a learning curve exists for lead extraction. Byrd et al. reported that the risk of incomplete or failed extraction increased with less experienced physicians (odds ratio 2.0953 for less than 20 procedures) as did major complications (odds ratio 2.5686 for less than 50 procedures).42 In our series of 82 leads extracted with the laser sheath, four out of the five laser failures that were not the result of equipment dysfunction or previously disrupted leads occurred during the first 17 leads. Solving alignment problems of laser sheath and leads and the understanding ofthe necessary restraint to apply mechanical force improved our results. Conclusion Endovascular counter-traction techniques, including the laser sheath, have proven to be effective for extraction of chronically implanted pacemaker leads. Although the complication rate is low, it is only acceptable for indications that are vital or have a risk of serious morbidity. In all other instances, it is probably better to abandon a superfluous lead. Consulting a centre experienced in lead extraction before procedures that may necessitate extraction is strongly advised. Damaging or severing a lead during an improvised extraction attempt will jeopardise any future attempt. Moreover, severed leads have a higher complication rate than any number of non-infected properly abandoned leads. Any centre involved in lead extraction should have different extraction tools available, as no single technique will suffice to maintain a high success rate and form an experienced team to execute these procedures. Almost all fatal outcomes of lead extraction occurred during procedures performed in the catheterisation room. Therefore, these procedures should be limited to the operation room with adequate surgical stand-by. References 1 2 3 4
5
Lagergren H, Dahlgren S, Norderstam H. Cardiovascular tissue response to intracardiac pacemaking. Acta Chir Scand 1966; 132:696-704. Robboy SJ, Harthorne JW, Leinbach RC, Sanders CA, Austen WG. Autopsy findings with permanent pervenous pacemakers. Circulation 1969;39:495-501. BeckerAE, Becker MJ, Claudon DG, Edwards JE. Surface thrombosis and fibrous encapsulation of intravenous pacemaker catheter electrode. Circulation 1972;46:409-12. Spittell PC, Hayes DL. Venous complications after insertion of a transvenous pacemaker. Mayo Clin Proc 1992;67:258-65. Brodman R, Frame R, Andrews C, Furman S. Removal of infected transvenous leads requiring cardiopulmonary bypass or inflow
Netherlands Heart Journal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
6 7
8
9 10 11
12
13 14
15 16
occlusion. J Thorac Cardiovasc Surg 1992;103:649-54. Vogt PR, Sagdic K, Lachat M, Candinas R, von Segesser LK, Turina MI. Surgical management ofinfected permanent transvenous pacemaker systems: ten year experience.JCard Surg 1996;11:180-6. Wllhelm MJ, Schmid C, Hammel D, et al. Cardiac pacemaker infection: surgical management with and without extracorporeal circulation. Ann Thorac Surg 1997;64:1707-12. Byrd CL, Schwartz SJ, Sivina M, Yahr WZ, Greenberg JJ. Technique for the surgical extraction of permanent pacing leads and electrodes. JThorac Cardiovasc Surg 1985;89:142-4. 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. Caudill CC, Clinch B, Krueger SK, Gard JR, Turk KT, Wison CS. Percutaneous extraction of a fractured, exposed atrial 'J' lead retention wire. Cathet Cardiovasc Diagn 1996;37:342-6. Cope C, Larrieu AJ, Isaacson CS, Wolk LA, Ghosh SC, Rothkopf B. Transfemoral removal of a chronically implanted pacemaker lead: report of a case. Ann Thorac Surg 1986;42:329-30. Ebe K, Funazaki T, Aizawa Y, Shibata A, Fukuda T. Experimental study about removal of the implanted tined polyurethane ventricular lead by radiofrequencywaves through the lead. Pacing Clin Electrophysiol 1991;14:1222-7. Enge I, Flatmark A. Percutaneous removal of intravascular foreign bodies by the snare technique. Acta Radiol Diagn (Stockh) 1973;14:747-54. Espinosa RE, Hayes DL, Vlietstra RE, Osborn MJ, McGoon MD. The Dotter retriever and pigtail catheter: efficacy in extraction of chronic transvenous pacemaker leads. Pacing Clin Electrophysiol 1993;16:2337-42. Foster CJ, Brownlee WC. Percutaneous removal of ventricular pacemaker electrodes using a Dormier basket. IntJ Cardiol l988; 21:127-34. Gould L, Maghazeh P, Giovanniello J. Successful removal of a severed transvenous pacemaker electrode. Pacing Clin Electrophys-
iol 1981;4:713-5. 17 Grabenwoeger F, Dock W, Pinterits F, Appel W. Fixed intravascular foreign bodies: a new method for removal. Radiology 1988;
167:555-6. 18 Kratz JM, Leman R, Gillette PC. Forceps extraction of permanent pacing leads. Ann Thorac Surg 1990;49:676-7. 19 Krause E, Pels M, Kreuzer J. Riskolose Entfemung von zentral embolisierten Venenkathetern und Schrittmachersonden mit einem Judkin-Katheter. Chirurg 1977;48:184. 20 Krupienicz A, Janczak J. Two cases of successful percutaneous chronic pacemaker lead extraction using a long vascular sheath. Pacing Clin Electrophysiol 1995;18:1081. 21 Madigan NP, Curtis JJ, Sanfeippo JF, Murphy TJ. Difficulty of extraction of chronically implanted tined ventricular endocardial leads. JAm Coll Cardiol 1984;3:724-31. 22 Peters R, Wohl B, Fisher M, Carlner N, Plotnick G. Non-operative removal of a tined-tip endocardial pacemaker catheter. Pacing Clin Electrophysiol 1982;5:129-31. 23 Roberts DH, Bellamy CM, Ramsdale DR. Removal of a fractured temporary pacemaker electrode using endomyocardial biopsy forceps. Pacing Clin Ekctrophysiol 1989;12:1835-6. 24 Smith CW, Messenger JC, Schaner SP, Renner JW. Cardiac pacemaker electrodes: improved methods of extraction. Work in progress. Radiology 1994;193:739-42. 25 Witte J, Munster W. Percutaneous pacemaker lead-transsecting catheter. Pacing Clin Ekctrophysiol 1988;11:298-301. 26 Hubbell DS, Tyler GRJ, Zoble RG. Polyurethane sheath disintegration causing impaction of pacer lead and shock during attempted removal. Pacing Clin Ekctrophysiol 1986;9:527-30. 27 Lewis AB, Hayes DL, Holmes DRJ, Vlietstra RE, Pluth JR, Osborn MJ. Update on infections involving permanent pacemakers. Characterization and management. J Thorac Cardiovasc Surg
1985;89:758-63. 28 Mohlna JE. Undertreatment and overtreatment of patients with infected antiarrhythmic implantable devices. Ann Thorac Surg
1997;63:504-9. 29 Mazzetti H, DussautA, Tentori C, Dussaut E, Lazzari JO. Superior vena cava occlusion and/or syndrome related to pacemaker leads. Am HeartJ 1993;125:831-7. 30 Mitrovic V, Thormann J, Schlepper M, Neuss H. Thrombotic complications with pacemakers. Int J Cardiol 1983;2:363-74. 31 Furman S, Behrens M, Andrews C, Klementowicz P. Retained
Netherlands Heart Joumal, Volume 9, Number 1, April 2001
pacemaker leads. JThorac Cardiovasc Surg 1987;94:770-2. 32 Jarvinen A, Harjula A, Verkkala K Intrathoracic surgery for retained endocardial electrodes. Thorac Cardiovasc Surg 1986; 34:94-7. 33 Frandsen F, Oxhoj H, Nielsen B. Entrapment of a tined pacemaker electrode in the tricuspid valve. A case report. Pacing Clin Electrophysiol 1990;13:1082-3. 34 Lee ME, Chaux A, MatloffJM. Avulsion of a tricuspid valve leaflet during traction on an infected, entrapped endocardial pacemaker electrode. The role ofelectrode design. JThorac Cardiovasc Surg 1977;74:433-5. 35 BilgutayAM, Jensen NK, Schmidt WR, Garamella JJ, Lynch MF. Incarceration of transvenous pacemaker electrode. Removal by traction. Am HeartJ 1969;77:377-9. 36 Imparato AM, Kim GE. Electrode complications in patients with permanent cardiac pacemakers. Ten years' experience. Arch Surg
1972;105:705-10. 37 Schmidt G, Wirtzfeld A, Himmler FC, et al. Dauerzugbehandlung infizierter inkarzerierter Schrittmacherelektroden. Dtsch Med Wochenschr 1980;105:1609-14. 38 Garcia-Jimenez A, Botana AC, Gutierrez CJ, Galban RC, Alvarez D, I, Navarro PF. Myocardial rupture after pulling out a tined atmial electrode with continuous traction. Pacing Clin Electrophysiol 1992;15:5-8. 39 Brodell GK, Castle LW, Maloney JD, WilkoffBL. Chronic transvenous pacemaker lead removal using a unique, sequential transvenous system. Am J Cardiol 1990;66:964-6. 40 Goode LB, Byrd CL, Wilkoff BL, et al. Development of a new technique for explantation of chronic transvenous pacemaker leads: five initial case studies. Biomed Instrum Technol 1991;25:50-3. 41 Smith HJ, Fearnot NE, Byrd CL, WilkoffBL, Love CJ, Sellers TD. Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database. Pacing Clin Electrophysiol 1994;17:2016-20. 42 Byrd CL, WdkoffBL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol 1999;22:1348-57. 43 Bracke FA, Meijer A, Gelder B van. Learning curve characteristics of pacing lead extraction with a laser sheath. Pacing Clin Electro-
physiol 1998;21:2309-13. 44 WslkoffBL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results ofthe pacing lead extraction with the excimer sheath (PLEXES) trial. JAm Coil Cardiol 1999;33:1671-6. 45 Kennergren C. First European experience using excimer laser for the extraction of permanent pacemaker leads. Pacing Clin Elec-
trophysiol 1998;21:268-70. 46 Reiser C, Byrd CL, WllkoffBL, et al. Pacing Lead Extraction With the Excimer Sheath Trial: Final Report [abstr]. Pacing Clin Electrophysiol 1998;22:708. 47 Reiser C, Taylor KD, Lippincott RA. Large laser sheaths for pacing and defibrillator lead removal. Lasers Surg Med 1998;22:42-5. 48 Manolis AS, Maounis TN, Chiladakis J, Vassilikos V, Melita-Manolis H, Cokkinos DV. Successful percutaneous extraction of pacemaker leads with a novel (VascoExtor) pacing lead removal system.
AmjCardiol 1998;81:935-8. 49 Bracke FA, Gelder B van, Meijer A. Arteriovenous fistula after injury of the left internal mammary artery during extraction of pacemaker leads with a laser sheath. Pacing Clin Electrophysiol 1999; 22:833-4. 50 Balau J, Buysch KH, Marx E, Seling A, Knieriem H. Thrombose der vena subclavia nach transvenoser schrittmacherimplantation.
Radiologe 1971;11:50-3. 51 Marx E, Schulte HD, Balau J, Buysch KA. Phlebographische und klinische Fruh- und Spatbefunde bei transvenos implantierten Schrittmacherelektroden. ZKreislaufforsch 1972;61:115-23. 52 Stoney WS, Addlestone RB, Alford WCJ, Burrus GR, Frist RA, Thomas CSJ. The incidence ofvenous thrombosis following longterm transvenous pacing. Ann Thorac Surg 1976;22:166-70. 53 Antonelli D, Turgeman Y, Kaveh Z, Artoul S, Rosenfeld T. Shortterm thrombosis after transvenous permanent pacemaker insertion. Pacing Clin Ekctrophysiol 1989;12:280-2. 54 Pauletti M, Di Ricco G, Solfanelli S, Marini C, Contini C, Giuntini C. Venous obstruction in permanent pacemaker patients: an isotopic study. Pacing Clin Ekctrophysiol 1981;4:36-42. 55 Zuber M, Huber P, Fricker U, Buser P, Jager K Assessment ofthe subclavian vein in patients with transvenous pacemaker leads. Pacing Clin Ekctrophysiol 1998;21:2621-30.
29
Endovascular extraction techniques for pacemaker and lCD lead extraction (Part I) F.A. Brackel, A. Meijer', B. van Gelder'
In the last few years, comprehensive endovascular techniques have been developed to extract chronically implanted pacemaker and defibrillator leads. It is important that referring physician have knowledge of the advantages and limitatons of the different techniques. In this paper we discuss the techniques and results of the currently used endovascular extraction techniques. (Neth Heart J 2001;9:23-30.)
Key words: pacemaker, implanted, defibrillator, lead extraction, laser, review Recently introduced pacemaker leads can often be extracted with traction alone as they float freely within the veins and myocardium. Later on, fibrous encapsulation ofthe lead develops. The lead becomes incorporated into the intimal layer of the vessel wall and is covered with endothelial cells towards the vessel lumen.' These adhesions are commonly found at sites where the lead is in contact with the vessel wall (figure 1) or the myocardium (figure 2) and can occur along the whole length ofthe lead.'14 Until the advent of comprehensive endovascular techniques, surgical removal with or without extracorporal circulation was the only reliable technique to extract chronically implanted leads.5-9 Although there are no large databases available, a number of authors have reported their experience with surgical removal ofleads. The perioperative mortality with infected leads ranged from 2.4%-17%. Hence, although effective, surgery itself constitutes an important risk, especially for compromised patients. Since then, a variety of endovascular lead extraction F.A. Bracke. A. Mejer. B. van Gelder. 'Department of Cardiology, Catharina Hospital, P0 Box 1350, 5602 Z4 Eindhoven.
Address for correspondence: F.A. Bracke. E-mail: [email protected]
Netherlands Heart Joumal, Volume 9, Number 1, Aprl 2001
techniques have been reported in the literature. Some of them deal with exceptional circumstances or have never attracted many followers.'0-25 We will discuss the principal endovascular techniques that are currently used. Traction Slight traction can be sufficient to remove recently implanted leads. However, the encapsulation of the lead occurs not only at its tip but also along any part of it. Thus when traction is used, the fibrous encapsulation often provides sufficient friction to prevent the force applied from being transmitted to the tip of the lead. When more force is needed, the tensile strength of the insulation or the conductor can be exceeded resulting in stretching or rupture. The lead may sever leaving part of it indwelling in the venous circulation.26 These severed and denuded leads have a higher incidence of thrombofibrotic complications especially when infected.27-30 Active fixation leads may have a better chance at extraction than passive fixation leads, especially if they are isodiametric and can be unscrewed before extraction. The fibrous encapsulation around the tines has a restraining effect on the lead at the myocardium and, once dislocated, this bulbous tip will not pass easily through the fibrous envelope.2' Invagination of the myocardium may complicate unopposed traction.26 Besides arrhythmias and hypotension, this can cause myocardial rupture or avulsion of a tricuspid valve leaflet.3'34 To avoid this, prolonged graded traction has been introduced.35-37 For this purpose, increasing weights are connected to the proximal end ofthe lead. They are guided over a pulley, or to keep the patient ambulatory, fixed under tension to the skin using rubber bands and adhesive tape. Nevertheless, complications similar to those with direct traction have been described, including death.38
Locking stylets To avoid unwinding of the conductor coil or rupture of the insulation during traction, a locking stylet is introduced into the central lumen of the lead. It consists of a straight non-expandable wire with a deflecting mechanism at the tip that can be locked into the 23
Endovascular extraction techniques for pacemaker and ICD lead extraction
coil close to the tip ofthe lead (figure 3). Traction via the locking stylet is almost directly applied at the tip, bypassing most of the conductor and the insulation. Locking mechanisms differ between manufacturers and recently introduced locking devices can be unlocked and repositioned if necessary. There are still limitations to the use of a locking stylet. If the conductor is broken or distorted, e.g. with subclavian crush syndrome, it is not possible to introduce the stylet. It can also lack grip and dislocate during traction or too much force can damage the delicate locking mechanism. Further, as traction is still exerted via the distal conductor coil, this can unwind or disconnect from the electrode. As with direct traction, there is the risk of invagination of the myocardium. What it does not do either is provide the solution of pulling the tip, which is sometimes bulbous, through the fibrous sheaths along the body ofthe lead once it is freed from the myocardium. Conventional intravascular counter-traction To overcome the limitations of a locking stylet, additionally telescoping synthetic sheaths can be advanced over the lead. The fibrous bindings within the veins or myocardium can be mechanically disrupted, and at the same time enough room is created to remove the lead.39'40 The outer sheath also functions as a guiding catheter facilitating the movement of the inner sheath and alignment of the inner sheath and the lead. It is important to use a locking stylet as the leads are often too fragile to withstand the traction necessary to counter the forces applied to advance the sheath. Once the distal electrode is reached, the larger bore outer sheath can be positioned against the myocardium to prevent inversion during traction on the lead, a manoeuvre called counter-traction (figure 4). By pulling on the locking stylet, the tip of the lead is pulled inside the outer sheath. The force is thus concentrated at a small area of the scar tissue and myocardium sur-
Figure 1. Autopsy specimen. Fibrous tissue covering the pacemaker lead in the subclavian vein. (Courtesy ofDr Willem de Voogt.)
rounding the lead without gross displacement of the myocardium. Although counter-traction prevents invagination ofthe myocardium and diminishes the chance of rupture, perforation of the myocardium is still possible, especially in the thin-walled atrium.4'42 Together with the telescoping sheaths, an inferior vena cava or transfemoral approach has been developed. A long 16 F sheath is introduced via the femoral vein and positioned close to the lead to be extracted. Then, a retriever is inserted through the sheath to grab and secure the lead close to the tip (figure 5). The isodiametric proximal part of the lead (with the connector cut off) is pulled down through the fibrous scar tissue. The outer sheath is then advanced over the doubled up lead to disrupt the scar tissue, while the lead is kept under tension by the retriever. When the sheath reaches the tip, counter-traction is applied to free the tip. In comparison with the superior approach, only a short distance of scar tissue needs to be disrupted as the proximal isodiametric part of the lead can be simply pulled down. Therefore, although no locking stylet is used to reinforce the lead, the shorter distance to cover decreases the chance of elongating the lead. The technique is especially useful to remove severed and indwelling leads or as back-up after failed superior attempts.43 Laser-assisted extraction Recently, a laser sheath that replaces the inner sheath was introduced to disrupt the fibrous bindings.43-46 The sheath consists of optic fibres spirally warped between the inner and outer tubing of the sheath. At the tip of the device the fibres are arranged in a ring (figure 6). Pulsed laser light is emitted from the fibres to ablate the tissue. For this purpose, the device is connected to a 308 nm XeCl excimer laser (Spectranetics CVX-300), which delivers pulsed light at a maximum fluence of 60 mJ/mm2 and a 40 Hz repetition rate. The ablation
Figure2. Autopsy specimen. Fibrous encapsulation ofthe terminal part of a pacemaker lead in the right ventricle. (Courtesy of Dr
Willem de Voogt.) 24
Netherlands Heart Joumal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
outer sheath
fibrous tisse
Figure 3. Locking stylet. The tip of the stylet has a deflecting mechanism that can locked into the inner coil of the lead once the stylet is positioned at the tip of the lead. The depicted stylet (Wilkoff stylet, Cook Inc., In) can be unlocked and repositioned or retrieved if necessary.
mechanism combines photochemical destruction of cellular structures with explosive photo-thermal vaporisation ofcellular water, which creates transient microbubbles to mechanically disrupt the tissue. As the penetration depth of 308 nm light in vascular tissue is approximately 100 micron, it is completely absorbed in the tissue immediately in front ofthe tip. This results in an ablation depth, depending on the applied force, between 2 and 15 microns per pulse in the experimental setting.47 The influence offorce is explained by increasing the mechanical effect of the micro-bubbles entrapped beneath the tip of the device in creating microscopic tears. The ablation results in a shearing of the fibrous bindings, often leaving a rim of scar tissue around the
g _
Figure 4. Counter-traction. The outer sheath is positioned against the myocardium to prevent invagination of the heart during traction on the lead. In this way, the force applied is also effectively concentrated around the tip of the lead.
lead. It is clear that the blunt tip of the laser sheath is not suited for primary mechanical disruption ofthe fibrous bindings and that applying more force than necessary to assure good contact with the tissue does not improve efficacy but does increase the risk of complications. As with conventional sheaths, the outer sheath facilitates the movement of the laser sheath by reducing friction with the surrounding tissue (figure 7). The laser sheath is advanced under fluoroscopy guidance up to the distal electrode. Then counter-traction is applied using the outer sheath, as it is not advisable to ablate beyond the tip of the lead in order to avoid perforation. Also, the laser has no influence on the synthetic material ofpacemaker leads. Therefore, it cannot ablate through
Figure 5. Transfemoral approach. Panel a. A basket cathtr and its sheath are deployed outside the long outer sheath. The deflecting wire that is inserted througb the baskecatheter is used to mobilise the kad and pull it inside the basket ifxcwary. Oncepart of the lead is inside the basket, the own sheath basket's isforwarded to secure the keai Panel b. The kad issecured in the baska Tbe deflectingguide wire bas not been pulkd back in this case.
Netherlands Heart Journal, Volume 9, Number 1, April 2001
25
Endovascular extraction techniques for pacemaker and ICD lead extraction
pacemaker ieaac Figure 6. Laser sheath. The opticflbres are concentrically arranged at the tip of the sheath. Note that the tip of the sheath is blunt and not suitable for mechanical disruption offibrous tissue.
the tines of a passive fixation lead or damage the insulation of pacemaker leads except for mechanical damage through forceful manipulation. To accommodate for different sizes of leads, 12, 14 and 16 F sheaths are available. Results
Although traction and graded traction for lead extraction have been reported on for more than 30 years, no reports in the literature describe a large enough population to adequately judge the effectiveness and complication rate of these techniques. Locking stylets are often used together with other techniques but have also been reported as a standalone extraction tool. Alt et al. reported their experience with the VascoExtor stylet (VascoMed GmbH, Weil am Rhein, Germany) in 150 leads in 105 patients, (110 ventricular leads, 40 atrial; passive fixation with tines in 109 leads). Complete removal was possible in 81% of cases, partial removal in 12%. Manolis et al. reported success with the same device in 24 out of25 leads: in 81% with the sole use of a stylet, in 19% with additional tools.48 No serious complications were reported in both reports. Conventional counter-traction technique with either a superior or an inferior approach are reported in the US Lead Extraction Database.4' Complete removal was achieved in 86.8% and partial removal in 7.5% of 2195 leads (table 1). Major complications occurred in 2.5% ofthe 1299 patients: haemo-pericardium or tamponade 1.2%, haemothorax 0.5% and pulmonary embolism 0.2%. Eight patients died during the procedure (0.6%). In a paper describing their experience with lead extraction between 1994 and 1996, Byrd et al. reported complete removal in 93% and partial removal in 5% of 3540 leads in 2338 patients. Major complications occurred in 33 patients (1.4%) including thoracotomy in 14 patients, peri-cardial drainage in 11 patients, transfusions in four patients and one death.42 26
Figure 7. Laser sheath and outer sheath as they are advanced over the pacemaker lead.
Kennergren reported the results of laser sheath extraction of 179 leads in 149 patients from a European multicentre study (104 atrial, 57 ventricular, one superior vena cava ICD and 17 ventricular ICD leads). Complete extraction was achieved in 89.5% of the leads, 6% were partially extracted and 4.5% of the extractions failed. Three out ofthe eight failures were completely removed by a femoral non-laser approach, one with an alternative superior approach and one with thoracotomy. Complications included ventricular perforation in one patient that did not need surgery; two other perforations were related to the reimplantation of leads and required surgery. There were no fatal complications. In a registry of 1463 patients undergoing laser sheath extraction of2249 leads, complete success was achieved in 90% and partial success in 3% of leads.46 There were major complications in 3.4% of patients, including tamponade (1.4%) and haemothorax (0.3%). Twelve patients died (0.8%), mostly as the result oftamponade. Byrd et al. reported an increased risk of failed or partial extraction with increasing implant duration (doubling every three years).42 Extraction was more likely to be successful with increasing physician's experience, atrial leads and infected leads. Implant duration was not linked with complications in any of the cited papers, but major complications reported for extraction of Accufix leads (Telectronics Pacing Systems Inc. Englewood, Co, USA) increased from 2% at one-year implant duration to 8.3% with an implant duration of more than five years as reported by the Accufix Resarch Institute (data available on www.accufix.com). Physician's experience, number of leads extracted and female sex, however, have been associated with an increased risk of complications.4'42 What is the pr technique for lead extraction? There is only one trial comparing techniques in a randomised fashion. In the Plexus trial, 465 leads were Netherlands Heart Journal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
Table . Success and complication rates of conventional and laser sheath endovascular extraction techniques.
Conventional sheaths Smith et al. Patients Leads Complete removal Partial removal Failure Complications Death
Laser sheath Relser et al. 1463 2249 90.0% 7.0% 3.0% 3.4% 0.8%
1299 2195 86.8% 7.5% 6.8% 2.5% 0.6%
randomised between the laser sheath and conventional sheaths.44 All investigators had experience with the conventional technique. Crossover from non-laser to laser was allowed in case of failure of the non-laser approach. Initial attempts at extraction were successful in 94% of leads with the laser sheath against 64% of leads with the conventional sheaths. However, there was a 33.5% crossover from conventional techniques to laser. This reflected the greater predictability oflaserassisted lead extraction as perceived by the investigators, hence the low threshold for abandoning conventional sheaths if success was not swiffly obtained. If no crossover was allowed, a success rate in the non-laser group comparable with the published databases on conventional extraction would have been expected.4'42 In the Plexus trial, tamponade or haemothorax occurred in three patients randomised to the laser group, one of whom died. Two patients in the laser group and one patient in the non-laser group had venous thrombotic complications. The complication rates for both laser and non-laser counter-traction techniques are comparable. This probably results from both techniques using counter-traction with perforation and tamponade often related to this part ofthe procedure. The limitations ofthe Excimer laser sheath are the poor performance with calcified fibrous bindings and with sharp bends in fixated leads. Although calcification is more likely in leads with long implant duration, it is not always visible during fluoroscopy. If encountered, oversizing the laser sheath can encompass the calcification around the lead and allow ablation through softer tissue. In right-sided implants, there can sometimes be an unexpected sharp bend once the junction of the subdavian and brachiocephalic vein is reached when the lead is fixated at that site. If the relatively stiff laser sheath cannot be aligned with the lead, it will plough into the lead and become obstructed. In this situation, experience, patience, taking care to align the sheath with the lead and ifnecessary oversizing the sheath will often solve the problem. In contrast, if stalled using locking stylets or telescoping sheaths, only increasing the force will improve the chance of success but at a higher incidence of lead disruption or incomplete removal. Nevertheless, the
Netherlands Heart Joumal, Volume 9, Number 1, Aprl 2001
Catharina experience 65 122 99.2% 0.0% 0.8% 4.6% 0.0%
femoral workstation has proven to be very useful in the case of severed indwelling leads not attainable with a superior approach or of laser failure. However, there is no endovascular back-up technique if a femoral approach fails as the lead is severed and pulled into the circulation. Catharina experdence In our centre, we extracted 122 leads in 65 patients from May 1997 until February 2000. There were 47 atrial leads, 74 ventricular leads (including 9 ICD leads) and one single pass lead. Time from implant averaged 6.2 5.2 years. With intact leads, our strategy was to apply traction first (preferably with a locking stylet) taking care to disrupt neither the lead nor the stylet. If this did not succeed, we used a laser sheath. In a patient presenting with a severed indwelling lead, we used a femoral workstation. Using this strategy, traction was effective in 35 leads and a laser sheath was necessary in 82 leads. For indwelling leads we used a femoral workstation in four leads and a snare in one lead (a severed lead migrated into the pulmonary arteries). Primary success with the laser sheath was 90% (74 leads). The reasons for laser failure were equipment problems in two leads, disintegration of a lead disrupted during a previous extraction attempt in one lead and failure to negotiate the curve from the right subclavian to the right brachiocephalic vein in five leads. Subsequently, five ofthose eight failures were removed with a femoral workstation, one with traction, one with surgery and one abandoned. Thus, the overall success of lead extraction was 99%. Complications occurred in three patients who were all treated with the laser sheath. There was pericardial tamponade after perforation of the atrium during extraction needing acute surgery in two patients. In one patient this was the result of counter-traction while removing an atrial lead, in the other of perforation at the junction of the superior vena cava and the right atrium during extraction of a ventricular lead in an elderly patient on chronic corticosteroids. Both patients recovered well after acute surgery to control the bleeding. Avulsion ofthe left internal mammary artery occurred in one patient.43-49 Normally the mammary artery is protected from damage by its posterior course ±
27
Endovascular extraction techniques for pacemaker and ICD lead extraction
Number of leads 35 30252015 10 50 0-6 6-12 12-24 24-48 48-96 Time from Inplant In months
>96
* Laser sheath or femoral workstation O Traction, including locking stylet
Figure 8. Extraction technique according to implant duration.
to the subclavian vein. Probably, during implantation the needle entered the vein posteriorly, close to the mammary artery. As the laser sheath follows the implanted lead it severed the mammary artery before entering the subclavian vein. A false aneurysm was created in the left subpectoral region with the blood re-entering the circulation through the entrance in the vena subclavia created by the laser. Angiographic embolisation of the proximal mammary artery and surgical clipping of the distal mammary artery controlled the bleeding. The patient recovered well. Leads implanted less than six months could all be extracted with traction including the use of a locking stylet (figure 8). However, from six months on, more than two thirds of the leads needed a laser sheath for extraction. These data implicate that with an implant time longer than six months it is not advisable to attempt extraction if traction is the only available tool. Conditions for lead extraction A venous angiogram is very useful to anticipate difficulties during extraction. Although often asymptomatic, venous obstruction is present in 8 to 21% ofpacemaker patients.30'50-55 This may influence the choice of extraction technique. Conventional sheaths will have difficulty in passing longer obstructions and if only a locking stylet is used it may be impossible to retrieve the tip, which is often bulbous, through the ob-struction. In theory, the laser should be best equipped to pass these obstructions and secure access to the central venous circulation. As both surgeons and cardiologists perform lead extractions, they are performed in the operating room as well as in the catheterisation laboratory. The latter is often equipped with superior fluoroscopy and, important to the cardiologist, readily available. We, however, choose to do all extractions in the operating room under general anaesthesia with the patient prepared for thoracotomy and with the cardiac surgeon on stand-by. In our experience with tamponade in two patients, thoracotomy was performed immediately and the
28
bleeding swiftly controlled with both patients recovering without sequellae. We cannot imagine the same good outcome if the patients had to be transferred to another room, however nearby, and still had to be intubated and prepared for thoracotomy. We therefore prefer the safety ofthe operating room and have learned to live with its inconveniences. In this context, transoesophageal echocardiography during lead extraction is very useful to detect pericardial effusion before serious haemodynamic deterioration occurs. It is important to realise that, as with any procedure of some complexity, a learning curve exists for lead extraction. Byrd et al. reported that the risk of incomplete or failed extraction increased with less experienced physicians (odds ratio 2.0953 for less than 20 procedures) as did major complications (odds ratio 2.5686 for less than 50 procedures).42 In our series of 82 leads extracted with the laser sheath, four out of the five laser failures that were not the result of equipment dysfunction or previously disrupted leads occurred during the first 17 leads. Solving alignment problems of laser sheath and leads and the understanding ofthe necessary restraint to apply mechanical force improved our results. Conclusion Endovascular counter-traction techniques, including the laser sheath, have proven to be effective for extraction of chronically implanted pacemaker leads. Although the complication rate is low, it is only acceptable for indications that are vital or have a risk of serious morbidity. In all other instances, it is probably better to abandon a superfluous lead. Consulting a centre experienced in lead extraction before procedures that may necessitate extraction is strongly advised. Damaging or severing a lead during an improvised extraction attempt will jeopardise any future attempt. Moreover, severed leads have a higher complication rate than any number of non-infected properly abandoned leads. Any centre involved in lead extraction should have different extraction tools available, as no single technique will suffice to maintain a high success rate and form an experienced team to execute these procedures. Almost all fatal outcomes of lead extraction occurred during procedures performed in the catheterisation room. Therefore, these procedures should be limited to the operation room with adequate surgical stand-by. References 1 2 3 4
5
Lagergren H, Dahlgren S, Norderstam H. Cardiovascular tissue response to intracardiac pacemaking. Acta Chir Scand 1966; 132:696-704. Robboy SJ, Harthorne JW, Leinbach RC, Sanders CA, Austen WG. Autopsy findings with permanent pervenous pacemakers. Circulation 1969;39:495-501. BeckerAE, Becker MJ, Claudon DG, Edwards JE. Surface thrombosis and fibrous encapsulation of intravenous pacemaker catheter electrode. Circulation 1972;46:409-12. Spittell PC, Hayes DL. Venous complications after insertion of a transvenous pacemaker. Mayo Clin Proc 1992;67:258-65. Brodman R, Frame R, Andrews C, Furman S. Removal of infected transvenous leads requiring cardiopulmonary bypass or inflow
Netherlands Heart Journal, Volume 9, Number 1, April 2001
Endovascular extraction techniques for pacemaker and ICD lead extraction
6 7
8
9 10 11
12
13 14
15 16
occlusion. J Thorac Cardiovasc Surg 1992;103:649-54. Vogt PR, Sagdic K, Lachat M, Candinas R, von Segesser LK, Turina MI. Surgical management ofinfected permanent transvenous pacemaker systems: ten year experience.JCard Surg 1996;11:180-6. Wllhelm MJ, Schmid C, Hammel D, et al. Cardiac pacemaker infection: surgical management with and without extracorporeal circulation. Ann Thorac Surg 1997;64:1707-12. Byrd CL, Schwartz SJ, Sivina M, Yahr WZ, Greenberg JJ. Technique for the surgical extraction of permanent pacing leads and electrodes. JThorac Cardiovasc Surg 1985;89:142-4. 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. Caudill CC, Clinch B, Krueger SK, Gard JR, Turk KT, Wison CS. Percutaneous extraction of a fractured, exposed atrial 'J' lead retention wire. Cathet Cardiovasc Diagn 1996;37:342-6. Cope C, Larrieu AJ, Isaacson CS, Wolk LA, Ghosh SC, Rothkopf B. Transfemoral removal of a chronically implanted pacemaker lead: report of a case. Ann Thorac Surg 1986;42:329-30. Ebe K, Funazaki T, Aizawa Y, Shibata A, Fukuda T. Experimental study about removal of the implanted tined polyurethane ventricular lead by radiofrequencywaves through the lead. Pacing Clin Electrophysiol 1991;14:1222-7. Enge I, Flatmark A. Percutaneous removal of intravascular foreign bodies by the snare technique. Acta Radiol Diagn (Stockh) 1973;14:747-54. Espinosa RE, Hayes DL, Vlietstra RE, Osborn MJ, McGoon MD. The Dotter retriever and pigtail catheter: efficacy in extraction of chronic transvenous pacemaker leads. Pacing Clin Electrophysiol 1993;16:2337-42. Foster CJ, Brownlee WC. Percutaneous removal of ventricular pacemaker electrodes using a Dormier basket. IntJ Cardiol l988; 21:127-34. Gould L, Maghazeh P, Giovanniello J. Successful removal of a severed transvenous pacemaker electrode. Pacing Clin Electrophys-
iol 1981;4:713-5. 17 Grabenwoeger F, Dock W, Pinterits F, Appel W. Fixed intravascular foreign bodies: a new method for removal. Radiology 1988;
167:555-6. 18 Kratz JM, Leman R, Gillette PC. Forceps extraction of permanent pacing leads. Ann Thorac Surg 1990;49:676-7. 19 Krause E, Pels M, Kreuzer J. Riskolose Entfemung von zentral embolisierten Venenkathetern und Schrittmachersonden mit einem Judkin-Katheter. Chirurg 1977;48:184. 20 Krupienicz A, Janczak J. Two cases of successful percutaneous chronic pacemaker lead extraction using a long vascular sheath. Pacing Clin Electrophysiol 1995;18:1081. 21 Madigan NP, Curtis JJ, Sanfeippo JF, Murphy TJ. Difficulty of extraction of chronically implanted tined ventricular endocardial leads. JAm Coll Cardiol 1984;3:724-31. 22 Peters R, Wohl B, Fisher M, Carlner N, Plotnick G. Non-operative removal of a tined-tip endocardial pacemaker catheter. Pacing Clin Electrophysiol 1982;5:129-31. 23 Roberts DH, Bellamy CM, Ramsdale DR. Removal of a fractured temporary pacemaker electrode using endomyocardial biopsy forceps. Pacing Clin Ekctrophysiol 1989;12:1835-6. 24 Smith CW, Messenger JC, Schaner SP, Renner JW. Cardiac pacemaker electrodes: improved methods of extraction. Work in progress. Radiology 1994;193:739-42. 25 Witte J, Munster W. Percutaneous pacemaker lead-transsecting catheter. Pacing Clin Ekctrophysiol 1988;11:298-301. 26 Hubbell DS, Tyler GRJ, Zoble RG. Polyurethane sheath disintegration causing impaction of pacer lead and shock during attempted removal. Pacing Clin Ekctrophysiol 1986;9:527-30. 27 Lewis AB, Hayes DL, Holmes DRJ, Vlietstra RE, Pluth JR, Osborn MJ. Update on infections involving permanent pacemakers. Characterization and management. J Thorac Cardiovasc Surg
1985;89:758-63. 28 Mohlna JE. Undertreatment and overtreatment of patients with infected antiarrhythmic implantable devices. Ann Thorac Surg
1997;63:504-9. 29 Mazzetti H, DussautA, Tentori C, Dussaut E, Lazzari JO. Superior vena cava occlusion and/or syndrome related to pacemaker leads. Am HeartJ 1993;125:831-7. 30 Mitrovic V, Thormann J, Schlepper M, Neuss H. Thrombotic complications with pacemakers. Int J Cardiol 1983;2:363-74. 31 Furman S, Behrens M, Andrews C, Klementowicz P. Retained
Netherlands Heart Joumal, Volume 9, Number 1, April 2001
pacemaker leads. JThorac Cardiovasc Surg 1987;94:770-2. 32 Jarvinen A, Harjula A, Verkkala K Intrathoracic surgery for retained endocardial electrodes. Thorac Cardiovasc Surg 1986; 34:94-7. 33 Frandsen F, Oxhoj H, Nielsen B. Entrapment of a tined pacemaker electrode in the tricuspid valve. A case report. Pacing Clin Electrophysiol 1990;13:1082-3. 34 Lee ME, Chaux A, MatloffJM. Avulsion of a tricuspid valve leaflet during traction on an infected, entrapped endocardial pacemaker electrode. The role ofelectrode design. JThorac Cardiovasc Surg 1977;74:433-5. 35 BilgutayAM, Jensen NK, Schmidt WR, Garamella JJ, Lynch MF. Incarceration of transvenous pacemaker electrode. Removal by traction. Am HeartJ 1969;77:377-9. 36 Imparato AM, Kim GE. Electrode complications in patients with permanent cardiac pacemakers. Ten years' experience. Arch Surg
1972;105:705-10. 37 Schmidt G, Wirtzfeld A, Himmler FC, et al. Dauerzugbehandlung infizierter inkarzerierter Schrittmacherelektroden. Dtsch Med Wochenschr 1980;105:1609-14. 38 Garcia-Jimenez A, Botana AC, Gutierrez CJ, Galban RC, Alvarez D, I, Navarro PF. Myocardial rupture after pulling out a tined atmial electrode with continuous traction. Pacing Clin Electrophysiol 1992;15:5-8. 39 Brodell GK, Castle LW, Maloney JD, WilkoffBL. Chronic transvenous pacemaker lead removal using a unique, sequential transvenous system. Am J Cardiol 1990;66:964-6. 40 Goode LB, Byrd CL, Wilkoff BL, et al. Development of a new technique for explantation of chronic transvenous pacemaker leads: five initial case studies. Biomed Instrum Technol 1991;25:50-3. 41 Smith HJ, Fearnot NE, Byrd CL, WilkoffBL, Love CJ, Sellers TD. Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database. Pacing Clin Electrophysiol 1994;17:2016-20. 42 Byrd CL, WdkoffBL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol 1999;22:1348-57. 43 Bracke FA, Meijer A, Gelder B van. Learning curve characteristics of pacing lead extraction with a laser sheath. Pacing Clin Electro-
physiol 1998;21:2309-13. 44 WslkoffBL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results ofthe pacing lead extraction with the excimer sheath (PLEXES) trial. JAm Coil Cardiol 1999;33:1671-6. 45 Kennergren C. First European experience using excimer laser for the extraction of permanent pacemaker leads. Pacing Clin Elec-
trophysiol 1998;21:268-70. 46 Reiser C, Byrd CL, WllkoffBL, et al. Pacing Lead Extraction With the Excimer Sheath Trial: Final Report [abstr]. Pacing Clin Electrophysiol 1998;22:708. 47 Reiser C, Taylor KD, Lippincott RA. Large laser sheaths for pacing and defibrillator lead removal. Lasers Surg Med 1998;22:42-5. 48 Manolis AS, Maounis TN, Chiladakis J, Vassilikos V, Melita-Manolis H, Cokkinos DV. Successful percutaneous extraction of pacemaker leads with a novel (VascoExtor) pacing lead removal system.
AmjCardiol 1998;81:935-8. 49 Bracke FA, Gelder B van, Meijer A. Arteriovenous fistula after injury of the left internal mammary artery during extraction of pacemaker leads with a laser sheath. Pacing Clin Electrophysiol 1999; 22:833-4. 50 Balau J, Buysch KH, Marx E, Seling A, Knieriem H. Thrombose der vena subclavia nach transvenoser schrittmacherimplantation.
Radiologe 1971;11:50-3. 51 Marx E, Schulte HD, Balau J, Buysch KA. Phlebographische und klinische Fruh- und Spatbefunde bei transvenos implantierten Schrittmacherelektroden. ZKreislaufforsch 1972;61:115-23. 52 Stoney WS, Addlestone RB, Alford WCJ, Burrus GR, Frist RA, Thomas CSJ. The incidence ofvenous thrombosis following longterm transvenous pacing. Ann Thorac Surg 1976;22:166-70. 53 Antonelli D, Turgeman Y, Kaveh Z, Artoul S, Rosenfeld T. Shortterm thrombosis after transvenous permanent pacemaker insertion. Pacing Clin Ekctrophysiol 1989;12:280-2. 54 Pauletti M, Di Ricco G, Solfanelli S, Marini C, Contini C, Giuntini C. Venous obstruction in permanent pacemaker patients: an isotopic study. Pacing Clin Ekctrophysiol 1981;4:36-42. 55 Zuber M, Huber P, Fricker U, Buser P, Jager K Assessment ofthe subclavian vein in patients with transvenous pacemaker leads. Pacing Clin Ekctrophysiol 1998;21:2621-30.
29
