Europace Advance Access originally published online on July 24, 2007
Europace 2007 9(10):875-877; doi:10.1093/europace/eum151
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CARDIAC RESYNCHRONISATION THERAPY
Stabilization of the coronary sinus lead position with permanent stylet to prevent and treat dislocation
Cardiology Department, Shiraz University of Medical Sciences, Shiraz, Iran
Manuscript submitted 25 May 2007. Accepted after revision 4 July 2007.
* Corresponding author. Cardiology Department, Namazee Hospital, Zand Avenue, PO Box 71935-1334, Shiraz, Iran. Tel: +98 711 2277181; fax: +98 711 2277182.E-mail address: draslani{at}yahoo.com
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Abstract |
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Aims Coronary sinus (CS) leads used for cardiac resynchronization have undergone development in the last years. However, dislocation rate remained high. We explain a simple method to stabilize the CS lead position.
Methods and results Thirty-five patients (11 females, aged 60 ± 9.2 years) were treated with this method. An over-the-wire left ventricular (LV) pacing lead system was introduced and lodged in the vessel. Then, a stiff stylet was inserted and kept into the CS lead and end of the stylet was cut by a scissor (permanent stylet technique). Pacing and sensing properties of all leads were checked and the guiding sheath was removed. Control echocardiography did not show pericardial effusion. The mean LVpacing threshold was 1.2 ± 0.8 V and the mean impedance was 625 ± 143 
at the implantation. During follow-up (12.5 ± 2.5 months), there were no statistically significant changes in pacing threshold and impedance when compared with the implantation measurements. At the last patient visit, the mean LV pacing threshold was 1.1 ± 0.8 V and the mean impedance was 620 ± 140 . Impedance measurements did not suggest lead insulation failure. No LV lead dislocations were detected in our 35 cases during the follow-up.
Conclusion Permanent stylet technique seems to be a safe and effective procedure to stabilize CS lead position as demonstrated by our 1-year long follow-up results.
Key Words: Coronary sinus lead, Dislocation, Retained stylet
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Introduction |
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Cardiac resynchronization therapy (CRT) is an established treatment for patients with severe drug refractory heart failure combined with inter- and intraventricular conduction delay. Biventricular stimulation decreases mechanical dyssynchrony, improves mechanical function of the heart and quality of life, and decreases mortality, as reported in recent studies.1
–3 Left ventricular (LV) electrodes are mainly implanted transvenously into side branches of the coronary sinus (CS). Epicardial screw-in leads via thoracotomy are used less frequently. The main difficulties of the transvenous technique are to reach the optimal lead position and to avoid electrode dislocation. The dislocation rate is described to be 
5–9%.1,4,5 Following myocardial infarction or cardiac surgery, even microdislocation can cause clinically important increase in the pacing threshold. Microdislocation may also result in phrenic nerve stimulation. Dislocation of the electrode often needs re-operation. In the present study, we described a novel and simple approach using a retained stylet technique to stabilize the position of the LV electrode. |
Methods |
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Patients
Cardiac resynchronization therapy was performed in 35 patients (11 females, 24 males, age 60 ± 9.2 years). All patients met standard criteria for CRT.6
–8 Surgical implantation was offered as an alternative to all patients and heart surgery backup was available in all cases. All patients gave informed written consent. Thirty patients were in New York Heart Association (NYHA) class III and five patients were in NYHA class IV functional stage before the implantation. All of them were on optimal drug treatment for heart failure (beta-blocker, ACE-inhibitor or angiotensin II receptor blocker, and diuretics). The underlying diseases were ischaemic heart disease in 13 and primary dilated cardiomyopathy in 22 patients. Eleven patients also had chronic atrial fibrillation. Biventricular ICD (CRT-D) was implanted because of documented sustained ventricular tachyarrhythmia in three patients. Transthoracic echocardiography was performed in all cases before and immediately after the procedure and at first post-operative day to detect potential pericardial effusion. Control electrophysiological measurements (pacing threshold, pacing impedance, and phrenic nerve stimulation threshold) were completed at first post-operative day, and then at every 6 months as far as possible or at any patient visit. Fluoroscopic images were repeated at 1 and 6 months of follow-up to verify (minor) dislocations.
Implantation procedure
In all 35 patients, the left cephalic vein was dissected. A right ventricular lead (Medtronic, Inc., Minneapolis, MN, USA) was introduced and actively fixed to the right ventricular apical wall. After a double left subclavian venous puncture, a right atrial active fixation lead (5076, Medtronic, Inc.) was introduced and positioned in the right atrial appendage. After testing pacing and sensing properties of these leads, a 10 F sheath was introduced in the left subclavian vein. Through this sheath, a 9 F long guiding sheath (Attain 6216, Medtronic, Inc.) was introduced, in order to cannulate the CS. In 15 patients, access to the CS was achieved without a CS sheath. Coronary sinus venogram was performed using occlusion balloon after the cannulation of the CS. After analysing the CS angiograms, the ideal side branch to place the LV lead was chosen. In our cases, this was either a posterolateral (n = 19) or a mid-lateral (n = 16) branch.
Left ventricular lead implantation
Generally, ‘over-the-wire’ LV unipolar passive fixation electrodes were applied (Attain, OTW 4193, Medtronic, Inc.; n = 35). In the targeted CS side branch, the wire was advanced as distally as possible. Afterwards, an over-the-wire LV pacing lead system was introduced and lodged in the vessel. Then, in patients with unstable position of the LV lead or intra-operative dislocations, a stiff stylet was inserted and kept into the CS lead and end of the stylet was cut off (‘permanent stylet technique’). Pacing and sensing properties of all leads were checked and the guiding sheath was removed. All devices were interrogated, an echocardiogram was performed, and chest X-rays were obtained 24 h after implantation. Signal amplitude, pacing threshold, and pacing impedance were measured with external device. The intra-operative pacing threshold was determined at 0.5 ms pulse width. The pacing impedance was measured at 3.6 V, 0.5 ms pacing values. Phrenic nerve stimulation was investigated in all cases.
Statistical analysis
Statistical results are presented as mean ± SD. Changes in LV pacing threshold and pacing impedance during the follow-up period (at implantation, at first post-operative day, at the 6th month, and at last patient visit) were analysed using analysis of variance for repeated measurements. Statistical significance was considered at P < 0.05. Statistical analyses were performed using SPSS 13 software (Chicago, IL, USA).
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Results |
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Coronary sinus lead implantation with permanent stylet has been performed in 35 cases to stabilize LV lead position. Echocardiography did not reveal pericardial effusion after CRT implantation in 35 patients. The mean follow-up period was 12.5 ± 2.5 months. During this time, two patients in NYHA functional class IV died because of the progression of heart failure (after 5 and 6 months). Electrophysiological measurements after CS lead implantation with permanent stylet demonstrated stable pacing threshold and pacing impedance values in every patient. The mean LV pacing threshold was 1.2 ± 0.8 V and the mean impedance was 625 ± 143
at the implantation. During follow-up, there were no statistically significant changes in pacing threshold and impedance when compared with the implantation measurements. At the last patient visit, the mean LV pacing threshold was 1.1 ± 0.8 V and the mean impedance was 620 ± 140 . Figure 1 presents the summarized data of LV pacing threshold and impedance at implantation, at the first day, at 6th month, and at the last follow-up visit. Results of impedance measurements did not suggest insulation failure or fracture of the LV electrode in any cases during follow-up. Clinically important pacing threshold increase could not be observed in 35 cases. Phrenic nerve stimulation was not apparent in any patients and X-ray showed stable lead position in these patients. Infection did not occur in cases during follow-up. After 6 months of follow-up, 28 patients improved by at least one NYHA functional stage.
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Discussion |
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Left ventricular lead implantation into the recommended lateral or posterolateral side branch of the CS is not feasible because of anatomical and/or technical limitations in up to one-third of the patients.9
Despite the development in the transvenous implantation technique, CS lead dislocation rate remained high (5–9%).1,4,5 An important cause of suboptimal lead position, lead dislocation, or extracardiac stimulation is the unstable electrode position in the target vein, which also could be a reason for the high number of non-responder patients to CRT (20–30%).2,9,10 Coronary sinus side branch stenting is a recently described implantation technique to stabilize the attained good LV electrode position. The successful adaptation of this procedure has been published in previous reports with short11,12 and long13 follow-up. De Cock et al.14 suggested a method for stabilization of those CS leads prone to dislocation in a way that they led the indwelling guidewire in place. This was called the ‘retained guidewire technique’. However, there was some concern on long-term safety about this method.15,16 Nägele et al.17 presented a case report of fractured retained guidewire after 2 years of implantation and confirmed the concerns of Furman15 and Love.16 Obviously, angioplasty guidewires are not manufactured to resist to the permanent mechanical stress, especially in the subclavicular region, and these wires were made for acute use. In the present study, we explain a new and simple method to prevent intra-operative and post-operative CS lead dislocation. Using this technique (permanent stylet method), after implantation of LV lead system into the CS, a stiff stylet is inserted and kept into the CS lead and end of the stylet is cut by a scissor. We started to use this technique in the cases of post-operative lead dislocation. The electrode remained in the desired position after using this method, even in patients who had sustained two or three dislocations before. Because complications had not been verified, we started to perform this technique in the cases of intra-operative dislocation or phrenic nerve stimulation as well. Finally, re-operation was not necessary in our 35 patients during the follow-up period. In our patients, impedance measurements did not suggest insulation failure or fracture of the LV electrode in any case during follow-up. Before using CS lead implantation with permanent stylet, we had a re-operation rate of 7.5% because of LV lead dislocation. After the use of permanent stylet technique, no LV lead dislocations were detected in our 35 transvenous CRT cases during the follow-up.
Limitations
This study is a non-randomized, uncontrolled, single-centre clinical study. Although our 1-year results seem to be favourable, long-term performance of the permanent stylet method is unknown.
Recommendations and cautions
Guidewires (used in the retained guidewire technique) are prone to flexural fatigue and fracture. Although stylets (used in our technique) are stiffer than guidewires, there is no reason to believe a stylet will survive fracture. Given our experience, in the presence of lead instability or dislodgement during implant, the permanent stylet technique should be the last resort until longer term experience is gained.
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Conclusion |
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We suggest using permanent stylet technique as the last resort when: (i) post-operative or intra-operative lead dislocation occurs or (ii) if the electrode position is not stable enough and an alternative side branch is not available at the chosen location. Long-term performance of the permanent stylet method is unknown and longer experience is required.
Conflict of interest: none declared.
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References |
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[1] McAlister FA, Ezekowitz JA, Wiebe N, Rowe B, Spooner C, Crumley E, et al. Systematic review: cardiac resynchronization in patients with symptomatic heart failure. Ann Intern Med (2004) 141:381–90.
[2] Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al, Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med (2004) 350:2140–50.
[3] Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al, Cardiac Resynchronization-Heart Failure (CARE-HF) Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med (2005) 352:1539–49.
[4] Strickberger SA, Conti MD, Daoud EG, Havranek E, Mehra MR, Pina IL, et al, Council on clinical cardiology subcommittee on electrocardiography and arrhythmias and the quality of care and outcomes research interdisciplinary working group. Heart rhythm society: patient selection for cardiac resynchronization therapy: from the Council on Clinical Cardiology Subcommittee on Electrocardiography and Arrhythmias and the Quality of Care and Outcomes Research Interdisciplinary Working Group in collaboration with the Heart Rhythm Society. Circulation (2005) 11:2146–50.
[5] Koos R, Sinha AM, Markus K, Breithardt OA, Mischke K, Zarse M, et al. Comparison of left ventricular lead placement via the coronary venous approach versus lateral thoracotomy in patients receiving cardiac resynchronization therapy. Am J Cardiol (2004) 94:59–63.[CrossRef][Web of Science][Medline]
[6] Delnoy PP, Ottervanger JP, Luttikhuis HO, Nicastia DM, Elvan A, Misier AR, et al. Sustained benefit of cardiac resynchronization therapy. J Cardiovasc Electrophysiol (2007) 18:298–302.[CrossRef][Web of Science][Medline]
[7] Fung JW, Zhang Q, Yip GW, Chan JY, Chan HC, Yu CM. Effect of cardiac resynchronization therapy in patients with moderate left ventricular systolic dysfunction and wide QRS complex: a prospective study. J Cardiovasc Electrophysiol (2006) 17:1288–92.[CrossRef][Web of Science][Medline]
[8] Bleeker GB, Schalij MJ, Holman ER, Steendijk P, van der Wall EE, Bax JJ. Cardiac resynchronization therapy in patients with systolic left ventricular dysfunction and symptoms of mild heart failure secondary to ischemic or non ischemic cardiomyopathy. Am J Cardiol (2006) 98:230–5.[CrossRef][Web of Science][Medline]
[9] Yu CH, Fung JWH, Zhang Q, Sanderson JE. Understanding non responders of cardiac resynchronization therapy. Current and future perspectives. J Cardiovasc Electrophysiol (2005) 16:1117–24.[CrossRef][Web of Science][Medline]
[10] Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med (2002) 364:1845–53.
[11] Cesario DA, Shenoda M, Brar R, Shivkumar K. Left ventricular lead stabilization utilizing a coronary stent. Pacing Clin Electrophysiol (2006) 29:427–8.[CrossRef][Medline]
[12] Kowalski O, Pruszkowska-Skrzep P, Lenarczyk R, Prokopczuk J, Kalarus Z. Coronary sinus stenting for the stabilization of left ventricular lead during resynchronization therapy. Europace (2006) 8:367–70.
[13] Szilagyi S, Merkely B, Roka A, Zima E, Fulop G, Kutyifa V, et al. Stabilization of the coronary sinus electrode position with coronary stent implantation to prevent and treat dislocation. J Cardiovasc Electrophysiol (2007) 18:303–7.[CrossRef][Web of Science][Medline]
[14] De Cock CC, Jessurun ER, Allaart CA, Visser CA. Repetitive intraoperative dislocation during transvenous lead implantation: usefulness of the retained guidewire technique. Pacing Clin Electrophysiol (2004) 27:1589–93.[CrossRef][Medline]
[15] Furman S. Repetitive left ventricular lead dislocation. Pacing Clin Electrophysiol (2004) 27:1588.[CrossRef][Medline]
[16] Love CC. Retention wire: Deja vu all over again? Pacing Clin Electrophysiol (2004) 27:1587.[CrossRef][Medline]
[17] Nägele H, Hashagen S, Ergin M, Azizi M, Behrens S. Coronary sinus lead fragmentation 2 years after implantation with a retained guidewire. Pacing Clin Electrophysiol (2007) 30:438–9.[CrossRef][Medline]
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