Europace Advance Access published online on May 16, 2007
Europace, doi:10.1093/europace/eum082
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Single-centre experience with coronary sinus lead stability and long-term pacing parameters
Department of Internal Medicine, University Hospital, Olomouc, Czech Republic
Manuscript submitted 13 December 2006. Accepted after revision 30 March 2007.
* Corresponding author: Cardiocenter, Hospital 
eské Bud
jovice, B. Nmcové 585/54, 370 87 eské Budjovice, Czech Republic. Tel: +420 588443201. E-mail address: alanbulava{at}seznam.cz
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Abstract |
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Aims To compare both short- and long-term stability and pacing parameters of CS leads. Long-term maintenance of coronary sinus (CS) pacing lead position has not yet been assessed by serial X-ray digital imaging.
Methods and results Using X-ray digital imaging in anteroposterior and left lateral views, we performed analysis of the CS lead position at the end of the implantation procedure, 48 h following implantation and after 12 months in 93 consecutive patients. Attain OTW leads, QuickSite leads and EasyTrak leads were implanted in 44, 12 and 37 cases, respectively. X-ray detectable late CS lead dislodgement was observed in 8 cases (8.6%) during 12-months follow-up. Dislodgment was once accompanied by loss of capture and need for repositioning. Another two major dislodgements occurred without any threshold change. Five (5.4%) minor dislocations occurred with either a decrease or an increase in pacing threshold. Left ventricular (LV) pacing threshold was changed by 
1 V after 12 months in 14 patients (15%) when compared to values 48 h after implantation. All but one case of 1 V threshold change (either positive or negative) occurred without any radiological evidence of lead displacement. LV pacing threshold was significantly higher than RV pacing threshold at both baseline and during follow-up. Leads from all three manufacturers had comparable pacing thresholds 12 months following implantation.
Conclusion The position of CS leads may change during 1-year follow-up. However, it rarely required reoperation in the selected group of patients. Long-term pacing parameters between different manufacturers are comparable. Increase in pacing threshold is not a reliable marker of CS lead dislodgement.
Key Words: CS lead stability, Long-term performance, Biventricular pacing
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Introduction |
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Cardiac resynchronization therapy (CRT) through atrio-biventricular pacing has become an established form of advanced heart failure treatment.1
Typical positioning of the left ventricular (LV) pacing lead is in the lateral or posterolateral branch of the coronary sinus (CS).2 Various studies report a CS lead dislodgment rate between 6 and 14%.3–5 Combined results of over 2000 patients from a multi-centre study program showed a need for reoperation in 8% of patients during a 6-month follow-up period.6 The reasons for revision included mainly CS lead dislodgement with loss of capture, or increased LV pacing threshold without obvious lead dislocation. During regular pacemaker testing, increased pacing threshold is always suspicious of electrode displacement and requires performing a chest X-ray, which either confirms or disproves the presumption of dislocation. Yet little is known about the real dislodgment rate among the patient population without any clinically relevant problem and assessment of the long-term CS lead stability based on serial X-ray digital imaging. The aim of our study was to prospectively follow stability of the CS leads and to compare their immediate and long-term pacing parameters. Comparison between different manufacturers was also performed.
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Methods |
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Using standardized X-ray digital imaging in anteroposterior and left lateral views, we performed an analysis of the position of the CS pacing lead immediately at the end of the implantation procedure, 48 h following implantation, and after 12 months in all consecutive patients who had undergone successful implantation of a biventricular pacemaker or defibrillator due to advanced congestive drug-refractory heart failure. Pacing parameters of both the LV and right ventricular (RV) leads were also measured. Threshold tests were performed at 0.5 ms pulse width in ‘pseudo-bipolar’ (LV tip against RV ring) configuration.
We divided displacements into major (dislocation with loss of capture (threshold > 7.5 V), dislocation into another CS branch or dislocation from a distal branch position to a very proximal position near branch takeoff) and minor (displacement within the branch itself). The latter we divided into Group A (the lead does not change position, but rather significantly changes the shape of its helix, curvature or tip pointing) and Group B (the lead moves in or out within the CS branch, but not to the proximity of the branch takeoff).
Statistical analysis was performed using SPSS for MS Windows software. Continuous variables are expressed as mean ± standard deviation. Multiple comparisons of thresholds between manufacturers were made by non-parametrical Kruskal–Wallis test followed by Mann–Whitney test for inter-manufacturer comparisons. Multiple comparisons of thresholds over time within one manufacturer were performed using non-parametrical Friedman test followed by Wilcoxon signed ranks test. P-value < 0.05 was considered statistically significant.
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Results |
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Successfully implanted consecutive patients (93) with a follow-up of at least 1 year were analysed. All patients suffered from symptoms of congestive heart failure despite optimal medical treatment (Table 1). There was one unsuccessful cannulation of the CS (the patient was sent to cardiosurgery for epicardial lead placement) and one serious CS dissection requiring termination of the procedure, but without a cardiac tamponade. Successful implant was performed during the second attempt 4 weeks later. Thus, the first attempt success rate achieved 98% and overall transvenous successful CS lead placement reached 99%.
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Attain OTW leads (Model 4193, Medtronic) were implanted in 44 cases, QuickSite leads (Model 1056K, St Jude Medical) in 12 cases and EasyTrak 2 (Model 4517, Guidant) or EasyTrak 3 (Model 4524, Guidant) in 37 cases. All CS leads were implanted in either the posterolateral or lateral region of the left ventricle above its mid-ventricular segment (as reassured in the right anterior oblique projection). RV leads (Model 1788, St Jude Medical) were implanted either in the RV apex (earlier implants) or in the mid-portion of the inter-ventricular septum (later implants).
There were 8 (8.6%) total CS lead dislodgements, of which 3 (3.2%) were classified as major: once with loss of capture and need for repositioning and twice without any significant threshold change. Of the two latter cases, one dislocation occurred early after implantation (i.e. within 48 h, Figure 1) and the other major dislocation was into another lateral branch of the CS—this was determined by analysis of the CS angiogram and new lead position in anteroposterior, left and right oblique views. Five (5.4%) minor dislocations occurred with either a decrease or an increase in pacing threshold (Figures 2 and 3, Table 2). None of dislocations produced different 12-lead ECG pattern of biventricular pacing or phrenic nerve stimulation except for the one major dislocation leading to loss of LV capture. Thus, late CS lead dislodgement based on the planned X-ray imaging at the prespecified 12-month follow-up point was observed in 7 cases (7.5%) without obvious symptoms and/or suspicion of CS lead displacement based on electrical parameters. In these cases, we cannot precisely determine the exact time of dislocation.
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At 12 months, the thresholds between all three manufacturers were comparable (Table 3). Comparison of thresholds at the end of implantation procedure showed significantly lower thresholds for Medtronic Attain OTW leads when compared to both Guidant EasyTrak leads and St Jude Medical Quick Site leads. At 48 h, however, Attain OTW leads had significantly lower threshold only when compared to QuickSite leads. Attain OTW leads significantly increased their pacing threshold over time: values both at 48 h and at 12 months after implantation were significantly increased when compared to implantation. Both EasyTrak leads and QuickSite leads did not show any significant changes in pacing threshold over time (Table 3).
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LV pacing threshold was changed by
1 V after 12 months in 14 patients (15%) when compared to baseline values 48 h after implantation. In 13 cases, this change (either positive or negative) occurred without any radiological evidence of dislodgement (Table 4).
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In all patients, LV pacing threshold was significantly higher than RV pacing thresholds both at implantation (0.85 ± 0.68 vs. 0.67 ± 0.33, P = 0.02) and at 48 h and 12 months following implantation, respectively (0.99 ± 0.66 V vs. 0.71 ± 0.37 V, P < 0.001 and 1.11 ± 0.88 V vs. 0.85 ± 0.37 V, P = 0.011, respectively).
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Discussion |
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CRT as an adjunctive therapy of congestive heart failure has an important impact on morbidity and mortality.4
,7 The biventricular implantation rate has been consistently increasing worldwide during the last few years and demand for data on the safety of the CRT implant procedure to estimate procedural risk are becoming more and more important for both patients and clinicians. Despite this fact, little is still known about the stability of leads implanted into the branches of the CS in the era of newer lead design. LV dislodgment rate was shown to be continuously decreasing, most likely due to increasing experience of operators: in one study from 30% in early years to 11% after 1999.3 But even in this large-scale single-centre experience, the suspicion of lead dislocation was evaluated on the basis of elevated pacing threshold and X-ray was performed secondarily to confirm this. A similar approach can be demonstrated in other studies with dislodgment rate being around 8%.6,8
In our study, we showed very low incidence of CS lead dislodgement leading to loss of LV capture requiring reoperation, which can be attributable to newer lead design (guide-wire driven leads, either pre-shaped or tined) and two experienced operators. In fact, only one patient (1%) required revision and repositioning of the lead during the 12-month follow-up period. Another patient is awaiting reoperation due to unacceptable high pacing threshold (6 V/0.5 ms) despite absence of CS lead dislodgment. In all remaining patients, LV dislodgement was detected solely on the planned X-ray according to the study protocol. An important finding was that in contrast to the RV leads, threshold changes in the LV leads were not a reliable marker of lead dislodgement. On the contrary, the vast majority of threshold changes of 1 V was not associated with any detectable lead dislodgement. This is an important observation since the best pacing site is still believed to be in the mid-ventricular segments of the lateral or posterolateral wall of the left ventricle2 and only routine X-ray imaging may show that pacing is occurring from a different site than intended. The long-term clinical significance of this observation remains to be determined.
Comparison of different brands of CS leads on the market was not a primary intention of our study, which is strictly limited by small numbers of implanted leads. However, the important finding was that although thresholds at implant may favour Medtronic Attain OTW leads, long-term pacing parameters are comparable. This finding promotes operator-based appropriate lead choice with respect to the individual CS anatomy regardless of the brand of implanted pacemaker.
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Conclusions |
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Major late CS lead displacements are relatively rare nowadays irrespective of different ‘fixation mechanisms’ of the leads and scarcely require reoperation, assuming that the lead remains stable in the early period of 48 h after implantation. Minor dislodgements do not require reoperation unless substantial increase in threshold or phrenic nerve stimulation occurs. Threshold change is not a reliable marker of CS lead dislodgement.
Conflict of interest: none declared.
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References |
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[1] Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Eng J Med (2002) 346:1845–53.
[2] Butter C, Auricchio A, Stellbrink C, et al. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation (2001) 104:3026–9.
[3] Alonso C, Leclercq C, D'Allonnes FR, et al. Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects. Heart (2001) 86:405–10.
[4] Cleland JGF, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Eng J Med (2005) 352:1539–49.
[5] Valls-Bertault V, Mansourati J, Gilard M, Etienne Y, Munier S, Blanc J-J. Adverse events with transvenous left ventricular pacing in patients with severe heart failure: early experience from a single centre. Europace (2001) 3:60–3.
[6] Leon AR, Abraham WT, Curtis AB, et al. Safety of transvenous cardiac resynchronization system implantation in patients with chronic heart failure: combined results of over 2,000 patients from a multicenter study program. J Am Coll Cardiol (2005) 46:2348–56.
[7] Salukhe TV, Francis DP, Sutton R. Comparison of medical therapy, pacing and defibrillation in heart failure (COMPANION) trial terminated early; combined biventricular pacemaker-defibrillators reduce all-cause mortality and hospitalization. Int J Cardiol (2003) 87:119–20.[CrossRef][Web of Science][Medline]
[8] Ricci R, Ansalone G, Toscano S, et al. Cardiac resynchronization: materials, technique and results. The InSync Italian Registry. Eur Heart J Suppl (2000) 2:J6–J15.[Web of Science]
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