PACING
Usefulness of mechanical transvenous dilation and location of areas of adherence in patients undergoing coronary sinus lead extraction
Cardiac and Thoracic Department, Azienda Ospedaliero-Universitaria Pisana and University of Pisa, Via Paradisa 2, 56124 Cisanello, Pisa 56100, Italy
Manuscript submitted 18 May 2006. Accepted after revision 20 August 2006.
* Corresponding author. Tel: +39 050 995333; fax: +39 050 995329. E-mail address: m.g.bongiorni{at}med.unipi.it
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Abstract |
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Aims Few data have been currently reported on the outcome of coronary sinus (CS) lead removal, particularly using mechanical dilation (MD). We aimed to evaluate feasibility, safety, and effectiveness of CS lead extraction, focusing on MD usefulness, in the event that lead traction (LT) was ineffective.
Methods and results We studied 37 consecutive patients (30 males, mean age 68.1, range 52–80), who underwent left ventricle (LV) pacing lead removal; the indication for extraction was local infection in 16 patients (43.3%), sepsis in 11 patients (29.7%), and lead malfunction in 10 patients (27%). The procedure was first attempted by LT, followed, if unsuccessful, by MD using polypropylene sheaths. All CS leads (time from implant 19.5 ± 16.5, range 2–84 months) were successfully removed; LT was effective (LT group) in 27 patients (73%) and ineffective in 10 patients (27%), for whom MD was necessary (MD group). There were no major complications. The areas of adherence were in the CS in only one patient. No differences were noted in the data analysed between LT and MD groups; in particular, time from implant was similar in the two groups (MD vs. LT group: 17 ± 8.9 vs. 20.4 ± 18.6 months; P = ns).
Conclusion Our study suggests that CS leads, after medium-term implantation, can be effectively and safely removed using MD with polypropylene sheaths, in the case of unsuccessful LT. No pre-operative elements predictive of LT failure could be identified. Areas of adherence were rarely located in the CS or its tributaries.
Key Words: Resynchronization therapy, Lead extraction
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Introduction |
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Placement of permanent cardiac leads in the coronary sinus (CS) and its tributaries is the preferred implantation technique in patients undergoing cardiac resynchronization therapy (CRT). As the number of biventricular device implants increased over time, so did the need for CS lead extraction. System failure and infection are possible complications of CS lead implantation1
; in the former, lead repositioning can be attempted, although complete device extraction is often required if local or systemic infection is diagnosed.2 Extensive data are available on conventional pacing and defibrillation lead extraction, whereas only limited experience with CS leads has been reported.3–6 However, despite the potential risk of complications associated with the thin wall of the CS and of its tributaries, previous experience of extraction of cardiac leads has not confirmed these concerns; in fact, no serious complications occurred in these patients.4–6 The main limitations of the previous reports on CS lead extraction were the small cohorts of patients and the short time interval from implantation to removal; still, the patients treated successfully with lead traction (LT) were the majority and very scarce data have been published on the feasibility of mechanical dilation (MD) of areas of adherence using polypropylene sheaths. We report our experience on left ventricle (LV) pacing lead removal, with the aim to evaluate feasibility, safety, and effectiveness of this procedure, focusing on MD usefulness, in the event that LT was ineffective. We also searched for pre-operative factors predictive of LT failure.
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Methods |
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Population study
We studied 37 consecutive patients who underwent LV pacing lead removal between December 2000 and February 2006. Patients and lead characteristics are shown in Table 1. The indication for lead extraction was local infection in 16 patients (43.3%), sepsis in 11 patients (29.7%), and lead malfunction in 10 patients (27%), including high threshold in 6/10, diaphragmatic stimulation in 1/8, dislodgement in 2/8, and lead fracture in 1/8.
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Lead extraction technique
The procedures were performed in the Electrophysiology Laboratory under local anaesthesia or sedation using intravenous propofol. Continuous arterial blood pressure monitoring was performed via an arterial line placed in the left radial artery; a temporary pacemaker was placed in the right ventricle, through a 6 F introducer positioned in the left femoral vein. Electrocardiographic and oxygen saturation monitoring were performed. After device removal, the leads were examined visually and by fluoroscopy in their intravascular segment; the proximal end was clipped and a standard stylet was introduced. Lead extraction was then attempted using gentle LT. If LT was unsuccessful, we used a modified Byrd technique7
with a superior approach, and we performed MD at the areas of adherence using a specific extraction kit (Cook Intravascular Inc., Leechburg, PA, USA). For dilation, a single polypropylene inner sheath with an internal diameter as near as possible to the lead body diameter was initially used; if unsuccessful, the dilator was replaced with another of larger diameter, subsequently using the smaller one, once dilation had proceeded.2 Alternatively, if the leads were intravascular and free floating or when the removal through the implant vein was not possible, we performed a femoral vein approach; if necessary, we used other intravascular tools (Catchers and Lassos, Osypka, Grentzig-Whylen, Germany; Tip Deflecting Wire, Cook Intravascular Inc.).
Lead re-implantation technique
In our centre, CRT was performed on the same day as the extraction in the case of lead malfunction, whereas it was performed a median of 2 days (range 2–198 days) after removal due to infection. In the former group, the entry site did not change after lead extraction and the polypropylene sheath was often used to advance the guidewire to the right atrium; in the latter group, re-implantation was performed contralaterally. All patients underwent CS venography before LV lead reimplantation. Once the delivery system was engaged into the CS, we advanced a 6 F balloon-tipped luminal catheter into the vein. At that point, we inflated the balloon and the contrast agent was injected into the CS. Images were taken in the postero-anterior, right anterior oblique, and left anterior oblique views and subsequently stored in an archive. In this way, the patency of the venous system was evaluated in order to decide which branch to use for re-implantation, which was usually localized in the posterior or lateral LV wall.
Statistical analysis
Results are presented as mean ± SD, median with range, or frequencies of patients. Unpaired two-tailed 
test, Mann–Whitney test, and Fisher's exact test were used when appropriate. Statistical significance was defined at P < 0.05.
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Results |
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All LV pacing leads were successfully removed (Table 2). In 27 patients (73%), the CS lead was removed by LT (LT group). In one of these (intravascular free-floating fractured catheter), we used a femoral vein approach. The lead was grasped using a tip-deflecting wire and the proximal end was brought into the inferior vena cava; then, after capturing the proximal end by Catcher (Dr Osypka GmbH, Rheinfelden, Germany), the lead was successfully removed by LT. In 10 patients (27%), MD was necessary (MD group) and one of this subset of patients also required a femoral vein approach. In this patient, an area of adherence in CS was present and the angle between the CS and the right atrium did not allow the dissection of fibrous binding sites with a superior approach (Figure 1A). The lead was cut at the proximal end and it was grasped and brought into the inferior vena cava using a tip-deflecting wire, introduced in the femoral vein; then, the proximal end was captured and exposed out of the femoral introducer by a Lasso. Once the lead was held, the short size of the patient allowed a successful dilation of the area of adherence of the CS lead with an extra-long 7 F polypropylene sheath (Figure 1B).
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Areas of adherence were in the subclavian vein in six patients, in the innominate vein in three patients, in the superior vena cava in two patients, and in the right atrium in two patients; an area of adherence within the CS was found in only one patient (Figure 2). There was only one minor complication8
: in one patient, ventricular fibrillation occurred during temporary pacemaker placement prior to lead extraction; this patient was successfully treated by DC shock.
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Data analysis showed no differences between the LT and the MD group (Table 3). Twenty-nine patients underwent successful CS lead re-implantation; in particular, we performed the re-implantation in 8 of the 10 patients with lead malfunction and in 21 of the 27 patients with lead infection. With regard to the former group, one patient with lead malfunction (i.e. dislodgement) did not receive another CS lead due to lack of response to CRT before CS lead dislodgement, whereas another patient with high threshold did not need re-implantation, since an epicardial lead for LV pacing was implanted prior to CS lead removal. In the latter group, six patients were transferred to the hospitals from where they had originally been referred, for CS lead re-implantation. On the basis of the post-extraction venograms, we were always able to find a suitable vein for CS lead implantation. Of interest, thrombosis or occlusion of the CS did not occur in any of the patients. However, data regarding how many patients underwent extraction and re-implantation in the same CS branch are not available. After re-implantation, no serious complications occurred in the peri-operative period. Two patients developed a pocket haematoma. No system failures were observed during follow-up (median 17 months).
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Discussion |
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We report the largest single centre experience on extraction of LV pacing leads placed in CS tributaries. This study confirms the feasibility, effectiveness, and safety of CS lead removal when performed by experienced operators. There were no major complications; the apparent safety of this procedure may be due to the relatively small number of leads extracted and to the short time from implant to removal. This is similar to the other published studies on CS lead extraction (Table 4).4
–6 Only one study including CS leads with a long time from implant has been published. It reported a heterogeneous group of catheters: the majority of leads were defibrillator coils or right ventricular leads inadvertently placed in the CS, whereas only two leads were for LV pacing.3
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Lead traction was effective in the majority of cases; low propensity to fibrosis and poor fixation mechanism of LV pacing leads (preformed helix, spiral, tines, or simple bending) were felt to be possible explanations for the easy removal observed, especially for the catheters with a short time from implant.6
,9 In our hands, MD was necessary when tight adherence along the catheter course was found. We found them more commonly in the systemic veins, rather than inside the CS (Figure 2). This is particularly important and may explain the low incidence of complications with this procedure. In the presence of strong adhesions to the wall of CS vein or of its branches, developed after long-term pacing, currently available sheaths could potentially reach these fibrous binding sites with difficulty, while exposing patients to a significant risk of perforation.10 In the present experience, the inner sheaths are preferred to the telescopic sheaths in dissecting the fibrous binding sites, because the first are less traumatic and more flexible. When areas of adherence were found inside the CS, dissection through a transfemoral approach was chosen, as it allows a more favourable angle for dilation, with less risk of tear (Figure 1). New tools for MD inside the CS from an inferior approach could be very useful and should be implemented, particularly for patients with normal height. Analysis of the data showed no differences between the LT and the MD groups. In particular, no differences were found for age, sex, lead properties, median cardiac leads per patient, indication for extraction, prior cardiac surgery, lead or valve vegetations, and duration of infection. Time from implant was similar in the two groups. MD has rarely been necessary for recently implanted leads.
In conclusion, our study showed that CS leads, after medium-term pacing, can be safely and effectively removed by MD with polypropylene sheaths when LT was ineffective; we have not found pre-operative factors predictive of patients in whom MD may be necessary. Areas of adherence were present in less than one-third of our population; these were rarely localized within the CS and never in its branches.
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Acknowledgement |
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We would like to thank Niuton Koide for his assistance in the preparation of this manuscript.
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References |
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[1] Greenberg JM, Mera FV, DeLurgio DB, et al. Safety of implantation of cardiac resynchronization devices: A review of major biventricular pacing trials. Pacing Clin Electrophysiol 2003; 26: 952.
[2] Bongiorni MG, Giannola G, Arena G, et al. Pacing and implantable cardioverter-defibrillator transvenous lead extraction. Ital Heart J 2005; 6: 261–6.[Medline]
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[4] Kasravi B, Tobias S, Barnes MJ, Messenger JC. Coronary sinus lead extraction in the era of cardiac resynchronization therapy. Pacing Clin Electrophysiol 2005; 28: 51–3.[CrossRef][Medline]
[5] Burke MC, Morton J, Lin AC, et al. Implications and outcome of permanent coronary sinus lead extraction and reimplantation. J Cardiovasc Electrophysiol 2005; 16: 830–7.[CrossRef][Web of Science][Medline]
[6] De Martino G, Orazi S, Bisignani G, et al. Safety and feasibility of coronary sinus left ventricular lead extraction: a preliminary report. J Interv Card Electrophysiol 2005; 13: 35–8.[CrossRef][Web of Science][Medline]
[7] Bird C and Wilkoff B. Techniques devices for extraction of pacemaker: implantable cardioverter-defibrillator leads. In Ellenbogen KA, Kay GN, Wilkoff BN (Eds.). Clinical Cardiac Pacing and Defibrillation 2002; Philadelphia, PA, USA WB Saunders pp. 695–709.
[8] Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. Pacing Clin Electrophysiol 2000; 23: 544–51.[CrossRef][Medline]
[9] Bulava A and Lukl J. Postmortem anatomy of the coronary sinus pacing lead. Pacing Clin Electrophysiol 2005; 28: 736–9.[CrossRef][Medline]
[10] Rosenthal E and Cook A. Pacing lead adhesions after long-term ventricular pacing via the coronary sinus. Pacing Clin Electrophysiol 1999; 22: 1846–8.[CrossRef][Medline]
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