Europace Advance Access published online on August 14, 2008
Europace, doi:10.1093/europace/eun207
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Minimal invasive coronary sinus lead reposition technique for the treatment of phrenic nerve stimulation
csDepartment of Cardiology, Heart Center, Semmelweis University, Gaál J Street 9, H-1122 Budapest, Hungary
Manuscript submitted 16 May 2008. Accepted after revision 19 July 2008.
* Corresponding author. Tel: +36 20 9274 937; fax: +36 1 458 6842. E-mail address: merkely.bela{at}kardio.sote.hu
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Abstract |
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Aims: Phrenic nerve stimulation (PNS), which is often intolerable for the patient, is a known complication of resynchronization therapy. We describe a new, minimal invasive method for treating PNS.
Methods and results: Untreatable PNS was found in nine cardiac resynchronization therapy patients with distal coronary sinus (CS) lead position 6 ± 6 (0.5–17) months after the implantation. Ablation catheter and Amplatz Left 2 type guiding catheter were introduced into the right atrium via the right femoral vein. Coronary sinus was cannulated with the Amplatz catheter, and on a normal guide wire, a coronary stent was introduced beside the lead into the side branch in seven cases or a bigger stent into the CS in two patients. The ablation catheter was looped around the CS lead in the atrium with bent tip and was drawn backward together with the CS electrode. New lead positions were evaluated with electrophysiological measurements, and the suitable position was stabilized with inflation of the stent. Pericardial effusion was not detected on post-operative echocardiography. After repositioning, suitable pacing parameters were registered (threshold: 1.6 ± 1.1 V; 0.5 ms, impedance: 565 ± 62 ohm). Phrenic nerve stimulation was not found with 7.5 V; 1.5 ms pacing. During follow-up (7.7 ± 4.6 months), stable pacing threshold and impedance values were measured; transient and reprogrammable PNS was present in only one patient.
Conclusion: Coronary sinus electrode reposition using the femoral approach seems to be a safe and effective procedure, which means smaller burden for the patients compared with the established reposition operation. The technique can be used successfully if the CS lead is in a distal position.
Key Words: Resynchronization, Dislocation, Phrenic nerve stimulation, Electrode replacement, Coronary sinus, Stent
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Introduction |
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Cardiac resynchronization therapy (CRT) is a widely accepted therapeutic option for patients with severe, drug refractory heart failure combined with interventricular and intraventricular conduction delay. Biventricular stimulation decreases mechanical dissynchrony, improves the mechanical function of the heart, the quality of life and decreases mortality, as it was reported in several studies.1
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Left ventricular (LV) electrodes are mainly implanted transvenously into the side branches of the coronary sinus (CS). Despite the continuous development in lead technology, dislocation rate of the CS electrodes is 
5–9%.1,4,5 Especially, distal dislocation of the lead in the side branch of the CS or distal lead position may result in phrenic nerve stimulation (PNS). If reprogramming the device cannot solve the problem, PNS is often intolerable for the patient and re-operation is necessary. Operations with re-opening the pacemaker pocket (lead repositioning, exchange of the device) co-exist with a higher risk for pocket infection. Therefore, avoiding pacemaker pocket opening during management of PNS would be favourable. In this study, a new, minimal invasive method is described for treating PNS caused by distal CS lead position.
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Methods |
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After obtaining an informed consent, minimal invasive CS lead reposition was performed in nine CRT patients with PNS and distal CS lead position. The consent form and the protocol were approved by the Hungarian Scientific and Research Ethics Committee of the Medical Research Council. In our patient group, PNS was not found using 10 V; 0.5 ms pacing in supine body position during the CRT implantation. In eight of nine patients, PNS was already detected in the early post-operative period; in one case only after 3 months. Minimizing PNS by changing pacing amplitude and pulse duration was attempted but failed in all cases. Established reposition operation was offered as an alternative to all patients, and heart surgery back-up was available. From the nine patients (three females, six males, age 62 ± 6 years), three were referred from other hospitals. Distal dislocation of the CS lead was observed in three patients. In the other six patients, visible dislocation was not observed on control fluoroscopy, and the lead was implanted originally in a distal position. The implanted CS leads were Corox OTW 75 UP Steroid (Biotronik, Berlin, Germany; n = 5), Attain OTW 4193-78 (Medtronic, Minneapolis, MN, USA; n = 3), and Attain OTW 4193-88 (Medtronic; n = 1). Distal electrode position was proved by X-ray examination. The lead reposition was performed 6 ± 6 (0.5–17) months after the CRT implantation. The second and third longest intervals between implantation and reposition were 14 and 11 months, respectively.
Normal ablation catheter (CelsiusTM B-curve 36H-37R, Biosense Webster, Diamond Bar, CA, USA) and Impulse Flextrusion Shaft (Amplatz Left 2 type) guiding catheter (Boston Scientific, Tijuana, Mexico) were introduced into the right atrium via the right femoral vein. The CS or its side branch containing the implanted CS lead was cannulated with the Amplatz catheter. After performing venogram, first a normal guide wire (PT Graphix; Boston Scientific, Miami, FL, USA) and a bare metal coronary stent were introduced into the target side branch (Figure 1), or if it was not possible, a bigger stent (Express Vascular 6.0*14 or 18 mm, Boston Scientific Ireland Ltd, Galway, Ireland) was introduced into the CS near the ostium of the side branch. The ablation catheter was looped around the atrial part of the CS lead with bent tip, then the catheter and the CS electrode were drawn backward slowly into the direction of the inferior vena cava (Figure 2). The position of the lead tip was continuously controlled with fluoroscopy. When the lead tip was withdrawn 0.5–1 cm, the new position was evaluated with the pacing threshold testing option of the implanted devices (Stratos LV n = 3, Stratos LV-T n = 3, and Kronos LV-T n = 3; Biotronik, Berlin, Germany) using ICS 3000 external pacemaker programmer (Biotronik, Berlin, Germany). The new lead position was accepted as final result when there was no PNS even using 7.5 V pacing voltage with 0.5, 1.0, and 1.5 ms pulse width, and pacing threshold was not higher than 3.5 V; 0.5 ms. If the first position was not acceptable, the lead was pulled back even further proximally.
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After accepting the new position, the CS lead was stabilized by inflating the previously positioned stent with a pressure of 6–14 atmospheres (Figure 2). The duration of balloon inflation was 4–6 s. In the CS side branches, the distance between the tip of the lead and the distal end of the stent was 5–30 mm. Theoretically, the distal stent position may provide the maximal stability for the pacing tip, but the stent never covered the tip of the lead. The diameter of the stent (2.75, 3.0, or 3.5 mm) was chosen according to the diameter of the target CS side branch, which was measured on the CS venogram. Trimaxx (Abbott Vascular Devices, Redwood City, CA, USA; n = 4), ProKinetic (Biotronik, Bülach, Switzerland; n = 1), S670 (Medtronic; n = 1), and Tsunami Gold (Terumo Corporation, Tokyo, Japan; n = 1) stents were applied. The length of the stents used was 9–13 mm. After stent implantation, pacing and PNS thresholds were measured again in all cases, and both the Amplatz guide catheter and the ablation catheter were removed (Figure 3). Compression dressing was applied above the site of the femoral venous puncture for 4 h.
Transthoracic echocardiography was performed in all cases before and immediately after the procedure and on the first post-operative day to detect potential pericardial effusion. Control electrophysiological measurements (pacing threshold, pacing impedance, and PNS threshold) were taken on the first post-operative day, then after 6 months, or at any patient visit.
Additional antiplatelet or anticoagulant therapy was not used after CS side branch stenting, only the previous anticoagulant and/or antiplatelet treatment was continued. Because of poor LV function or atrial fibrillation, seven patients had already been treated with acenocoumarol, three of them were also on clopidogrel treatment due to previous coronary stenting. Two patients had only received either aspirin or clopidogrel therapy.
Statistical results are presented as mean ± SD. Changes in the LV pacing threshold and pacing impedance at implantation and at the last patient visit were analysed using ANOVA for repeated measurements. Statistical significance was considered at P < 0.05. Statistical analyses were performed using SPSS 13 software.
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Results |
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Since September 2005, altogether 309 transvenous LV leads have been implanted for CRT in our centre. Distal CS lead dislocation or too distal CS lead position causing PNS was found in six cases (1.9%). Three other patients were referred from other hospitals. In six more cases (1.9%), PNS was eliminated successfully by reprogramming the device. Proximal lead dislocation was detected in two cases. Minimal invasive CS electrode repositioning was attempted in all cases with distal lead position and PNS after the first procedure, which was performed in November 2006.
The coronary sinus was cannulated successfully via the right femoral vein in all nine patients. Guide wire and coronary stent were introduced into the target side branch in seven cases. In the other two patients, we were not able to introduce neither the guide wire nor the stent into the lateral side branch because of occlusion or tortuosity of the ostium of the side branch. In these two cases, bigger stents (Express Vascular 6.0*14 or 18 mm, Boston Scientific) were positioned into the middle part of the CS, proximally to the ostium of the lateral, but distally from the ostium of the posterior side branch, which may ensure the venous flow through collaterals in the case of a potential stent occlusion. If there is any chance to anchor the lead using another method, CS main stem stenting should be avoided.
Withdrawing the CS lead with the ablation catheter was successful, and acceptable new lead position was achieved in all cases. PNS was not detected using the maximal voltage and different pulse durations. The mean LV pacing threshold was 1.6 ± 1.1 V; 0.5 ms and the mean pacing impedance was 565 ± 62 ohm at the implantation. The final lead position was stabilized with stenting, the stent was inflated in the side branch in seven patients, and in the main stem of the CS in two cases. Duration of the whole procedure was 28 ± 9.5 (18–42) min and fluoroscopy time was 11.5 ± 7.4 (4–22) min. Post-operative echocardiography did not reveal pericardial effusion in any case.
The mean follow-up period was 7.7 ± 4.6 (0.5–14) months. During this time, PNS was not detected in eight of the nine patients. In one case, PNS was apparent at double-pacing threshold voltage when the patient lied on the left side at 1 month after the procedure. X-ray showed stable lead position and decreasing of the pacing voltage successfully solved the problem while safe LV capture was verified by repeated pacemaker interrogation.
Electrophysiological measurements demonstrated stable pacing threshold and pacing impedance values, and there were no statistically significant changes in these parameters compared with the implantation measurements. On the last patient visit, the mean LV pacing threshold was 1.6 ± 1.4 V; 0.5 ms (P = ns). Impedance measurements (588 ± 54 ohm; P = ns) did not suggest any signs of insulation failure or damage to the CS lead. Neither worsening in the haemodynamical status, nor increase of tricuspid valve regurgitation or number of PVCs were observed after the intervention in our patient group.
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Discussion |
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Because of the variability of coronary venous anatomy,6
there are multiple reasons for difficult LV lead implants. These include inability to cannulate CS, inability to find an adequate sized CS side branch, and inability to find a stable position in a lateral vein without PNS.7 CRT has a failure rate at implantation and short-term follow-up between 10 and 15%.8 PNS is found in 13–18% of the CRT implantations and it is one of the main causes of intraoperative lead repositioning from an anatomically acceptable place.9–11 Pacing with 10 V and 0.5 ms threshold during the implantation may help to avoid subsequent PNS, but despite high-energy stimulation, intraoperative testing in a supine position cannot rule out later PNS in other body positions.12 Coronary sinus lead stability is crucial in biventricular stimulation. New methods like retained guide wire, CS leads with active fixation, or CS side branch stenting may help to anchor the lead in the desired position.13–15 Unstable lead position may result in increase of pacing threshold, loss of capture, and PNS.
Based on the available data in the literature, post-operative PNS can be present in 1.5–5% of the CRT patients.1,4,10–12,16 If reprogramming the device using different stimulating configurations (decreasing the pacing amplitude, increasing the pulse duration, changing the pacing poles—‘electric reposition’) fail to avoid the intolerable PNS, currently the established method to solve this problem is re-operation.
Operations with re-opening the pacemaker pocket (lead repositioning, exchange of the device) co-exist with higher risk for pacemaker infection even by single- or dual-chamber devices. Poor general condition of the heart failure patients, presence of more than two pacing leads, and frequently applied anticoagulation treatment can further increase the risk of infection.17,18 Minimally, invasive lead reposition with ablation catheter seems to be favourable, as it may allow to avoid the opening of the pacemaker pocket. Potential failure of this minimally invasive replacement method or a too proximal lead position after withdrawing does not hamper the electrophysiologist in switching to the established reposition operation. Infection risk is probably lower compared with the conventional operative replacement.
Stenting of the retracted lead was performed in all of our patients. Based on the experience of others and our working group, CS stenting seems to be effective and safe to stabilize the CS lead.15,19–22 After stent implantation, the electrode remained in the desired position even in patients who had had two or three dislocations before. Complications (e.g. rupture of the CS side branch, pericardial tamponade, and stent loss with possible dislodgement in the pulmonary circulation) have not been described until now. Although our results and the continuously increasing experience are encouraging, long-term performance of the stented LV leads is unknown. Mechanical damage of lead insulation may occur because of motions between the stent and the implanted lead, however significant changes in the pacing impedance was not observed in our patient group with CS stenting (n = 190, follow-up: 13 ± 10, 1–40 months). With stenting, a change from a removable to a potentionally not removable CS lead may be produced, because CS stent implantation may limit the ability of late lead removal. However, in two cases, it was possible to extract the stented LV lead successfully via the subclavian vein in our practice without any surgical intervention after 3 and 5 months, and the cardiac surgeon was able to extract a stented LV lead during heart transplantation 27 months after the implantation.
The longest interval between the CRT implantation and the lead reposition with catheter was 17 months. It is not known, whether this method is applicable if the lead was implanted more than 1.5 years before repositioning. In some cases, the lead can be very strongly anchored in the CS side branch which may prevent the retraction, but it is known that in such cases more invasive non-surgical retraction methods may also be unsuccessful. Development of more specialized devices to loop the lead may increase the force of retraction and further decrease the procedure time and X-ray duration.
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Conclusion |
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Withdrawing the CS lead with an ablation catheter and stabilization of the new position with stent implantation is a new, minimally invasive method for the treatment of distal dislocation or distal lead position causing PNS.
Based on the results of this observational study, this technique seems to be a safe and effective procedure, which means smaller burden for the patients compared with the established reposition operation, however longer follow-up and larger patient number would be favourable.
Conflict of interest: none declared.
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References |
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