© 2004 by European Society of Cardiology
REVIEW
Incidence of venous obstruction following insertion of an implantable cardioverter defibrillator. A study of systematic contrast venography on patients presenting for their first elective ICD generator replacement
aDepartment of Medicine–Cardiology, University of Bonn Sigmund-Freud-Strasse 25, 53105 Bonn, Germany; bDivision of Cardiovascular and Interventional Radiology, The Johns Hopkins Hospital Baltimore, MD, USA; cDivision of Cardiology, The Johns Hopkins Hospital Baltimore, MD, USA; dDepartment of Cardiology, University Hospital of Mannheim Mannheim, Germany; eDepartment of Medicine–Cardiology, Academic Hospital Villingen Villingen, Germany
Manuscript submitted 8 April 2003. Accepted after revision 4 September 2003.
*Corresponding author. Tel.: +49-228-287-5507; fax: +49-228-287-4323. E-mail address: lars.lickfett{at}ukb.uni-bonn.de (L. Lickfett).
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Abstract |
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AIMS: The number of implantable cardioverter defibrillator (ICD) implantations, as well as follow-up procedures such as generator exchanges, lead revisions and lead system upgrades, is ever-increasing. Lead revisions and implantation of additional leads require venous access at the site of the previous ICD implantation. The aim of our study was therefore to evaluate the incidence of venous obstruction after chronic transvenous ICD system implantation.
METHODS AND RESULTS: One hundred and five consecutive patients admitted for their first elective ICD generator replacement were included. All patients underwent bilateral contrast venography and the images were analyzed by two attending radiologists. Venous obstruction was classified as moderate stenosis (50–75% diameter reduction), severe stenosis (>75%) or total occlusion. Venous obstruction of various degrees was found in 25% of the patients. Complete occlusion was found in 9%, severe stenosis in 6% and moderate stenosis in 10% of the patients. The incidence of venous obstruction was increased in patients with a pacemaker prior to the initial ICD system implantation (67%). No difference was found in patients with a single defibrillator lead compared with patients who had an additional superior vena cava (SVC) shocking coil. However, the presence of a second shocking coil in the SVC incorporated in a single ICD lead was associated with an increased incidence of venous obstruction. No difference was found between silicone and polyurethane insulated leads.
CONCLUSION: This study shows that venous obstruction occurs relatively frequently after ICD implantation. Therefore, contrast venography should always be obtained if malfunction of a preexistent lead is suspected or a system upgrade is considered.
Key Words: implantable cardioverter defibrillator, venous obstruction, contrast venography
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Introduction |
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The treatment of ventricular tachyarrhythmias was revolutionized by the introduction of implantable cardioverter defibrillators (ICD) to clinical use in 1980 [1]
. Widening of indications and technological advances resulted in a dramatic increase in ICD implantations. It has been estimated that the number of ICDs implanted worldwide in the year 2002 should have exceeded 100,000 [2]. Follow-up procedures like generator exchanges and ICD lead revisions are also expected rapidly to increase. Another procedure, which is increasingly performed, is the implantation of additional pacing leads to upgrade single chamber to dual chamber systems or to enable biventricular pacing [3–5]. The latter procedures depend on unimpeded venous access at the site of the previous ICD implantation. Data on the incidence of venous obstruction following ICD implantation are scarce. This issue was well addressed in patients who had undergone implantation of a pacemaker system [6–10]. Different results may be anticipated with ICD leads due to their greater diameter and complexity. The available information is derived mostly from acute observations [11,12] or post-mortem studies [13]. Only one small-scale study examined patients with chronically implanted ICD leads by means of contrast angiography [14]. However, it is not known if contrast venography is justified in all patients presenting for elective ICD generator replacement. The aim of our study was therefore to evaluate the frequency of chronic venous obstruction after transvenous ICD system implantation in a larger number of patients.
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Methods |
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All consecutive patients (n=105) admitted at the University of Bonn for their first elective ICD generator replacement due to battery depletion between 3/1995 and 11/2000 were included in the study. Patients with only epicardial leads were not included. Patient characteristics are summarized in Table 1. No patient had a history of thrombophilia or exhibited symptoms or clinical signs of venous obstruction at the time of generator replacement. The initial ICD implantation took place between 10/1991 and 11/1997. The ICD generator replacement took place between 3/1995 and 11/2000. The first ICD system was in place for an average of 47±12 months. The various lead configurations at the time of initial implantation are shown in Table 2. Sixty-three patients had one transvenous lead and 42 patients had two transvenous leads. No patient had more than two transvenous leads. The ICD systems of 30 patients included a subcutaneous array. The characteristics of the implanted transvenous leads, including insulation material, fixation mechanism and number of incorporated shocking coils are shown in Table 3. The ICDs of nine patients were dual chamber systems, including a right atrial pacing lead.
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All patients underwent bilateral contrast venography as a routine evaluation prior to ICD generator replacement, because of the surgeons preference. Thirty to 50 ml of a non-ionic contrast medium was injected into a cubital vein. The contrast material flow in the axillary, subclavian and brachiocephalic vein, as well as the superior vena cava, was observed and recorded using a digital subtraction angiography system. Two attending radiologists analyzed the images. Venous obstruction was classified as moderate stenosis (50–75% diameter reduction), severe stenosis (>75%) or total occlusion (100%). The results were analyzed in a retrospective fashion.
Statistical analysis was performed to compare different lead configurations and insulation materials, with regard to the incidence of venous obstruction. A chi-square test was used for this purpose. A value of P
0.05 was considered statistically significant.
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Results |
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The findings of contrast venograms performed prior to the first elective ICD generator replacement are summarized in Table 4. No abnormality was found in 75% of the patients. The remaining 25% exhibited venous obstruction of various degrees. Complete occlusion was found in 9%, severe stenosis in 6% and moderate stenosis in 10% of the patients.
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The presence of a pacemaker prior to the initial ICD system implantation was associated with a significantly increased incidence of venous obstruction (P=0.001): six of nine patients (67%) with previous pacemaker implantation exhibited significant venous obstruction compared with 19 of 96 (20%) without a preceding pacemaker. In six patients the ICD was implanted at the same site after the pacemaker was removed. The pacemaker leads were abandoned in four and removed in the other two patients. Two of the four patients with abandoned pacemaker leads as well as the two patients with removed pacemaker leads had venous obstruction. A statistical analysis was not made, because of the very small patient groups. In three patients the ICD was implanted contralaterally to the previous pacemaker. The pacemaker leads were abandoned in one and removed in two patients. The patient with the abandoned pacemaker lead had bilateral occlusion of the brachiocephalic veins. The two patients with the removed pacemaker leads had normal venograms at the site of the previous pacemaker, but one patient had a moderate stenosis at the site of the ICD system. A statistical analysis was again not made, because of the very small patient groups.
There was no difference in the incidence of venous obstruction between patients with only one defibrillator lead (10/58=17%) and patients with a right ventricular ICD lead, as well as a separate SVC shocking coil (5/30=17%). However, venous obstruction was significantly (P=0.001) more frequent in patients who had received a single ICD lead with a second shocking coil in the SVC (8/18=44%), compared with those who had an ICD lead incorporating only a right ventricular shocking coil (3/40=8%). Patients with pacemakers prior to the initial ICD system were excluded from both analyses.
No difference in incidence of abnormal venograms was found according to the type of the lead insulation. This comparison was made solely in those patients who had a single ICD lead with only a right ventricular shocking coil. The reason for this was that the dual-coil leads found in the study were all silicone insulated (as Table 3 shows). None of seven patients with a silicone insulated single-coil ICD lead and three of 33 (9%) patients with a polyurethane insulated single-coil ICD lead, exhibited significant central venous obstruction (P=0.3828). Patients with pacemakers prior to the initial ICD system were once again excluded from this analysis.
No significant difference was found according to the site of implantation (left versus right, P=0.08) and the use of a cephalic versus a subclavian approach (p=0.5).
Previous pacemaker implantation and use of dual shocking coil leads remain risk factors for venous obstruction when only severe stenosis >75% and occlusion are evaluated (p=0.006 and p=0.04). Separate SVC shocking coils and a particular type of lead insulation were again no risk factors when only severe obstruction is considered (p=0.6 and p=0.5).
Six patients of the study population (6%) had venous obstruction at the site contralateral to the ICD system. The incidence of contralateral venous obstruction was significantly higher in patients who also had disease at the ICD site (four out of 25, 16%) than in patients who did not (two out of 80, 3%, p=0.01). Two of the four patients with bilateral venous obstruction had pacemakers implanted contralaterally to the site of the ICD implant. The two patients with venous obstruction only at the site contralateral to the ICD system had severe obstruction of the right subclavian vein.
Side effects of contrast venography were not observed in any of the 105 patients.
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Discussion |
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Our study evaluates the incidence of venous obstruction following chronic ICD implantation. Its main finding is that venous obstruction of various degrees occurs relatively frequently after ICD implantation. The incidence of a stenosis >75% was 14%, with 9% of patients having total occlusion of the brachiocephalic, subclavian, axillary vein or superior vena cava. Other important findings are that patients with a pacemaker implantation prior to the ICD system as well as patients who received an ICD lead with a second shocking coil in the SVC are more likely to develop venous obstruction. This is evident in both cases when any stenosis >50% or only severe stenosis >75% and total occlusion are taken into account.
The results of the present study confirm and extend those of an earlier study on 30 patients by Sticherling et al. [14], where systematic contrast venography was also used prior to ICD generator replacement. These authors reported that four of 30 patients (13%) exhibited a venous stenosis of more than 75%. Only one patient had a total occlusion of the subclavian vein.
Previous reports in ICD patients
Venous thrombosis has been described since the early days of ICD therapy. In one of the first published series of patients, Marchlinski et al. [11] described one case of 14 with transvenous leads, exhibiting perioperative symptomatic thrombosis of the subclavian vein. A post-mortem autopsy study by Singer et al. [13] found that four of 23 patients (17%) who had undergone transvenous implantation of a superior vena cava spring defibrillation electrode, as well as a right ventricular sensing electrode, exhibited large thrombi adherent to the spring electrode. Two of the patients had experienced asymptomatic pulmonary emboli as demonstrated by autopsy. A later study by Schwartzman et al. [12] on 170 patients, who had undergone transvenous ICD system implantation between 1991 and 1994, reported three patients with subclavian vein thrombosis, which was diagnosed due to symptoms, perioperatively in two patients and after 60 days in the other patient. As with the study by Marchlinski et al. patients were not systematically evaluated for presence of venous obstruction, but rather presented clinically with painful arm swelling. In contrast to these patient series, other ICD system follow-up studies did not describe symptomatic venous obstruction complicating transvenous ICD implantation [15–17].
Previous reports in pacemaker patients
Venous obstruction following permanent transvenous pacemaker implantation has been described for many years. A summary of venographic studies can be found in a review by Spittell and Hayes [6]. Stoney et al. [7] performed 34 venograms in 32 patients admitted for an elective generator replacement (single lead system) and found normal venograms in 7 (22%), mild obstruction <50% in 5 (16%), moderate stenosis between 50 and 90% in 15 (47%) and total occlusion in 7 patients (22%). Mitrovic et al. [8] performed venograms on 100 patients, three to five years after single chamber pacemaker implantation and described 61% normal findings, 24% partial obstructions and 15% total occlusions. Another study by Antonelli et al. [9] used a serial approach examining 40 patients 1–6 months, 6–12 months and 12–18 months after pacemaker implantation (eight dual chamber systems). At the time of the third venography 8% of patients had complete occlusion, 27% had partial obstruction and 65% had a normal venogram. All patients with occlusion on the third venogram already had an occlusion on the first one. A recent study by Oginosawa et al. [10] reported a 14% incidence of asymptomatic venous obstruction even before pacemaker implantation as well as a 33% incidence at a follow-up venography 44 months post-implantation. It is remarkable that the reported incidence of occlusion and high degree obstruction decreased between these four studies, which were published between 1976 and 2002. The incidence of both occlusion (9%) and moderate to high degree obstruction (16%) in our study on ICD patients, was lower than in any of these four pacemaker studies and also lower than in the ICD study on 30 patients by Sticherling et al. [14]. It is remarkable that early symptomatic venous obstruction is clinically rarely recognized. A recent prospective study, which followed 200 patients for a mean of 540 days after device implantation reported only two patients with clinically recognized acute subclavian vein thrombosis [18].
An important result of our study, is that the majority of patients with a history of pacemaker implantation prior to the ICD system, exhibited venous obstruction. This finding is not surprising in view of the venogram results of pacemaker studies discussed above. It underlines the importance of contrast venography prior to ICD implantation in these patients. Our study also reveals that the incidence of venous obstruction is significantly higher in patients who received an ICD lead with a second shocking coil in the SVC (44%), compared with those who had an ICD lead incorporating only a right ventricular coil (8%). This has not previously been described. The only study published with a similar design, but a smaller ICD patient group [14], did not find a significant difference between these lead configurations. However, only four of those patients had a single-coil lead and 26 had a dual-coil lead implanted. The size of these populations might have been too small to detect a difference between both systems. It is known that extraction of dual-coil leads is generally more difficult than extraction of single-coil leads, because of adhesions between the SVC wall and the lead. It can be assumed that the SVC coil induces not only wall adhesions, but also sclerotic reorganisation of the venous wall with resulting stenosis and obstruction.
Clinical implications
The present study demonstrates that venous access is possible in most cases after initial ICD system implantation, either for lead revision or implantation of an additional lead with the goal of upgrading a preexistent system. In our study, 85% of patients had normal venogram findings or only moderate obstruction following chronic ICD lead implantation. However, preceding pacemaker implantation should raise suspicion about the presence of venous obstruction.
Based on our findings we would recommend venography in all patients who present for an ICD generator replacement and exhibit signs of lead malfunction or require implantation of additional leads for upgrading to dual chamber or biventricular systems.
For prevention of venous occlusion following ICD implantation, the use of a single-coil rather than a dual-coil lead should be considered in patients with no or only mild structural heart disease. The benefit of chronic oral anticoagulation for prevention of venous obstruction following ICD system implantation is unclear. This question should be addressed in future studies.
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References |
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[1] Mirowski M., Reid P.R., Mower M.M., Watkins L., Gott V.L., Schauble J.F., et al. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980; 303: 322–324.[Web of Science][Medline]
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