Europace Advance Access originally published online on January 9, 2006
Europace 2006 8(2):118-121; doi:10.1093/europace/euj029
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PACING
Clinical surveillance of a tined, bipolar, silicone-insulated ventricular pacing lead
Heart Institute Sheba Medical Center, Tel Hashomer 52621 Israel ; Tel Aviv University Tel Aviv Israel ; Heart Institute, Soroka Medical CenterBen Gurion University Beer Sheba Israel
Manuscript submitted 26 May 2004. Accepted after revision 8 September 2005.
Corresponding author. Tel/fax: +972 3 5356605. E-mail address: mglikson{at}post.tau.ac.il
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Abstract |
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 Top Abstract IntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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Aims This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy.
Methods and results Three hundred and thirty leads were implanted and had complete follow-up with us for a minimum of 60 months or up to failure, removal, and/or patient death (mean 40 months, range: 1 day to 81 months). Thirty-two patients (9.6%) had spontaneous lead-related complications: 7 (2.1%) occurred during the first week; 25 (7.6%) had chronic complications, of which 20 (6.1%) necessitated re-operations; 3 (0.9%) were lead material failures. Of the 110 re-operations (90 pacemaker replacements and 20 operations due to complications), 7 additional cases (6.4%) were complicated by unique connector damage that occurred during disconnection of the lead from the connector block. The Kaplan–Meier estimated 5-year lead survival free of lead material failure and free of any significant lead complication were 97.9 and 87%, respectively.
Conclusion The S80TB lead demonstrates an acceptable rate of acute and chronic spontaneous complications and very few lead material failures over 5 years of follow-up. However, there seems to be a relatively high incidence of connector damage during disconnection from the connector block. Extra caution is required during those procedures in patients with this lead.
Key Words: Pacemaker lead, Pacemaker follow-up, Lead surveillance
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Introduction |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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S80TB is a bipolar, silicone-insulated, transvenous ventricular lead with a tined passive fixation mechanism and platinum–iridium tip (6 mm2
area) covered with a microporous layer of sintered platinum, manufactured by Sorin Biomedica (Italy). It is introduced by a 10F sheath without guide wire, according to the recommendations of the manufacturer. According to the manufacturer, more than 100 000 leads of this type have been implanted worldwide (mostly in Europe) since their introduction in 1988.
Governmental regulations and patient safety render surveillance of permanent pacing leads an important issue.1,2 Potential information sources on lead performance include: governmental tracking systems,3 manufacturers' data (such as studies on long-term lead usage4), and reports of experience from various institutions.5,6 To the best of our knowledge, no such data exists regarding the S80TB lead. Recent publications on malfunction of polyurethane-insulated leads7,8 have increased the interest in silicone-coated ventricular leads. We therefore conducted the current retrospective analysis of prospectively collected data to assess long-term results with the S80TB lead (Sorin) by analysing the initial rate of success with implantation, rates of acute and chronic complications, and rate of lead failure, in a large population of patients who had undergone this lead implantation at our medical centre.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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From December 1994 to December 1998, 330 model S80TB leads, manufactured by Sorin were implanted in the ventricular position. Routes of implantation were: left subclavian vein, 215; left cephalic vein, 8; right subclavian vein, 62; right cephalic vein, 30; and not documented, 15. All implantations were performed by one of four experienced implanters. Patients included 131 females and 199 males, with mean age of 72.3 years (range: 22–94 years) at implantation.
Intra-operative measurements were made in the bipolar pacing and sensing configuration with Medtronic atrioventricular (A-V) pacing system analyzer, model 5311B (Medtronic Inc., Minneapolis, MN, USA). Patients were monitored in the hospital for 24–48 h; chest radiography and determination of impedance, pacing and sensing thresholds were performed routinely prior to discharge. Pacemaker clinical follow-up visits were scheduled at 2 weeks, 3 months, and every 6 months post-implantation for all patients and standard interrogation was performed including impedance measurement, and sensing and pacing thresholds were evaluated on every second visit. Special follow-up visits with complete evaluation were scheduled whenever there was a suspicion of any pacing lead malfunction or complication as defined below.
Patients were followed for at least 5 years or to an endpoint such as death, loss of follow-up or lead failure with replacement or abandonment (mean 40 months, range: 1 day–81 months).
Complications were defined as acute if they occurred within 7 days of implantation. High chronic thresholds were defined as output values that would not allow maintenance of safety margin of voltage (2x), pulse duration (3x), or energy delivered (3x) during pacing at output values of 5 V at 0.5 ms.
Lead material failure was determined by capture or sensing malfunction and/or marked change in impedance (
250 
, >1500 , >30% decrease in comparison with implant values), radiographic evidence, unequivocal visual determination, or manufacturer analysis demonstrating failure of the lead material. Estimated 5-year survival rates free of lead failure or free of any complications were obtained using the Kaplan–Meier product limit method.9
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Results |
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Implantation data and acute complications
The mean implantation data were as follows: R-wave, 15.9±5.6 mV; pacing threshold, 0.52±0.22 V; impedance, 592.0±98.5
. Seven patients (2.1%) had acute complications that could be attributed to the lead, necessitating operative procedure in five of them (Table 1). The other two patients were treated by re-programming of the pacemaker and observation.
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Chronic lead-related complications and failures
Twenty-five patients (7.6%) developed chronic lead-related complications, with 20 patients (6.1%) requiring re-operation. A detailed description of the complications, their time of occurrence, and their management are listed in Table 2 and depicted in Fig. 1. Three of the complications were because of lead material failures, which occurred in 0.9% of the total study population.
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Of the 20 re-operations, 9 were repositioning procedures, and in 11 the lead was replaced. Four of the replacements were because of damage caused during disconnection of the lead from the pulse generator.
Over the follow-up period, 90 patients underwent pulse generator replacement operation (many because of a certain pacemaker model recall) and an additional 20 were re-operated because of chronic complications as listed earlier. Among these 110 operations, there were 7 cases (6.4% of operations) of lead connector damage, 4 among the cases operated for complications, and 3 among elective replacements. This unique type of damage occurred during unplugging of the lead connector from the connector block of the pacemaker in all seven cases, and involved insulation disruption at the point of its connection with the metal connector at its base.
Lead survival
The Kaplan–Meier9 estimated 5-year lead survival without material failure was 97.9% (95–100% confidence intervals). Probability of lead survival free of any lead-related complication was 91.0% at 3 years (88–95% confidence intervals) after implantation, and 87.0% after 5 years (79–95% confidence intervals) (Fig. 2A and B). This calculation does not include lead damage caused during re-operations.
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Discussion |
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S80TB is a non-steroid-eluting passive fixation, silicone-insulated lead, widely used in Europe and other parts of the world in the 1990s. We are not aware of any previous surveys looking at its short- and long-term performance. We therefore undertook this study to provide data on its performance in many patients that were implanted and regularly followed at our institution.
In this survey we have shown that implantation data for this lead are favourable, with acceptable rates of acute complications. These data are in the same range as implantation data of other ventricular leads, including active fixation and steroid-eluting leads.10–16 Chronic complications were also in the same range as other ventricular leads.5–11
There were only three instances of lead material failure during the follow-up period, which comply with the requirement of >95% 5-year failure-free survival quoted by Maloney et al.1
We found a relatively high rate of unique lead damage during its disconnection from the pulse generator in re-operations. This damage may be related to a relative weakness of lead insulation at the point of its connection with the connector, an issue which has not been previously described. It never occurred spontaneously, and was always related to re-operation procedures that involved unplugging of the lead from the connector block of the pulse generator. Although one may argue that this damage may be operator-dependent, we have not encountered this problem in any other lead models. We therefore recommend extra caution and avoidance of excessive pulling force when unplugging the lead from the pulse generator during battery replacements or other re-operations.
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Conclusions |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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S80TB is a bipolar silicone-insulated lead with favourable stable pacing and sensing thresholds, which demonstrates acceptable rates of acute and chronic complications, and a low incidence of lead material failure up to 81 months of follow-up. However, there seems to be a relatively high incidence of unique lead damage during unplugging from the pulse generator, which necessitates extra caution during re-operations.
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Acknowledgements |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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We are grateful to Ms Vivienne York for her editorial assistance.
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References |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsAcknowledgementsReferences |
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[2] http://www.fda.gov/cdrh/postsurv.
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