Download Stabilization of the coronary sinus lead position with permanent

Europace (2007) 9, 875–877
doi:10.1093/europace/eum151
Stabilization of the coronary sinus lead position with
permanent stylet to prevent and treat dislocation
Mohamad Bagher Sharifkazemi, and Amir Aslani*
Cardiology Department, Shiraz University of Medical Sciences, Shiraz, Iran
Received 25 May 2007; accepted after revision 4 July 2007; online publish-ahead-of-print 24 July 2007
KEYWORDS
Coronary sinus lead;
Dislocation;
Retained stylet
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 V 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 V. 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.
Introduction
Methods
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.
Patients
* Corresponding author. Cardiology Department, Namazee Hospital, Zand
Avenue, PO Box 71935-1334, Shiraz, Iran. Tel: þ98 711 2277181; fax: þ98
711 2277182.
E-mail address: [email protected]
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 postoperative day to detect potential pericardial effusion. Control electrophysiological measurements (pacing threshold, pacing impedance, and
phrenic nerve stimulation threshold) were completed at first postoperative 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
& The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: [email protected]
876
M.B. Sharifkazemi and A. Aslani
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 ¼ 19) or a mid-lateral (n ¼ 16)
branch.
Left ventricular lead implantation
Generally, ‘over-the-wire’ LV unipolar passive fixation electrodes
were applied (Attain, OTW 4193, Medtronic, Inc.; n ¼ 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).
Figure 1 Changes in left ventricular pacing threshold and pacing
impedance values (mean + SD) during the follow-up.
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.
Discussion
Results
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 V 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 V. 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
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 nonresponder 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
Stabilization of the CS lead position
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.
Conclusion
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.
877
References
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.
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.
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.
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.
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.
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.
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.
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.
15. Furman S. Repetitive left ventricular lead dislocation. Pacing Clin
Electrophysiol 2004;27:1588.
16. Love CC. Retention wire: D‘ej’a vu all over again? Pacing Clin
Electrophysiol 2004;27:1587.
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.