- Email: [email protected]
A highly effective technique for transseptal endocardial left ventricular lead placement for delivery of cardiac resynchronization therapy
A highly effective technique for transseptal endocardial left ventricular lead placement for delivery of cardiac resynchronization therapy Giulia Domenichini, MD, PhD, Ihab Diab, MD, MRCP, Niall G. Campbell, PhD, MRCP, Mehul Dhinoja, FRCP, Ross J. Hunter, PhD, MRCP, Simon Sporton, MD, FRCP, Mark J. Earley, MD, FRCP, Richard J. Schilling, MD, FRCP From the St. Bartholomew’s Hospital, Barts Health NHS Trust, London, United Kingdom. BACKGROUND Implantation of a left ventricular (LV) lead fails in 5% to 10% of patients in whom cardiac resynchronization therapy (CRT) is attempted. Alternatives for delivery of CRT are surgical epicardial and endocardial transvenous leads. Endocardial transseptal LV lead delivery is challenging because of the absence of dedicated equipment designed for this procedure. OBJECTIVE The purpose of this study was to describe a new technique for delivery of a transseptal LV lead. METHODS This dual approach from the right femoral vein and left subclavian vein involves use of an Endrys transseptal needle and Mullins sheath to deliver a gooseneck snare from the left subclavian vein into the right atrium that can then be used to deliver a deflectable sheath into the left atrium. An active fixation lead is advanced into the LV through the sheath and screwed into the lateral wall. RESULTS The procedure was performed successfully in 12 patients in whom transvenous LV lead implantation had previously failed. The Endrys transseptal needle, ideally suited for this technique,
Introduction Cardiac resynchronization therapy (CRT) has significantly improved the lives of heart failure patients, with improvements in functional class, hospitalization rates, and mortality.1–3 Unfortunately, CRT implantation fails in 5% to 10% of patients because of an inability to deliver a left ventricular (LV) lead transvenously, either at de novo implantation or when an existing lead fails.4–6 The established alternative for transvenous pacing is surgical epicardial LV lead placement under a general anesthetic, which may carry unacceptably high morbidity and mortality for some frail heart failure patients.7,8 Surgical LV leads also may have a higher risk for lead failure in the long term compared to transvenous leads.9
facilitated passage of the gooseneck snare into the left atrium with no difficulty. Median procedure time was 148 minutes (interquartile range [IQR] 113–176 minutes), and median fluoroscopy time was 16 minutes (IQR 10–19 minutes). There was no need for repeat procedures after median follow-up of 97 days (IQR 36–313 days). CONCLUSION This approach using an Endrys needle and a gooseneck snare provides a reliable and effective alternative technique for delivery of an endocardial LV lead that is delivered easily through a deflectable sheath inserted transseptally into the LV. KEYWORDS Transseptal endocardial left ventricular lead; Cardiac resynchronization therapy ABBREVIATIONS CRT ¼ cardiac resynchronization therapy; INR ¼ international normalized ratio; IQR ¼ interquartile range; LA ¼ left atrium; LV ¼ left ventricle; LSCV ¼ left subclavian vein; RA ¼ right atrium; RFV ¼ right femoral vein; SVC ¼ superior vena cava (Heart Rhythm 2015;12:943–949) I 2015 Heart Rhythm Society. All rights reserved.
Endocardial LV lead implantation for delivery of CRT was first described in a case report in 1998.10 Over the past 16 years, fewer than 150 cases were reported in individual case reports and small case series. This procedure still is not widely used for delivery of CRT, probably because of procedural difficulties, perceived potential complications, and the need for lifelong oral anticoagulation. A number of techniques with varying difficulty and complexity have been described. In this article we describe a novel and relatively simple technique for delivery of an endocardial LV lead via the transseptal route.
Methods Patients
Drs. Domenichini and Diab contributed equally to this work. Address reprint requests and correspondence: Prof. Richard J. Schilling, Department of Cardiology, St. Bartholomew’s Hospital, 11th Floor, Glouchester House, Bartholomew Close, West Smithfield, London, EC1A 7BE, United Kingdom. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
Patients were offered this procedure if they had a class 1 indication for CRT,11 and an attempt at conventional LV lead placement via the coronary sinus had failed. All options were explained to the patient, including surgical LV lead placement and no further attempt at CRT. The technique described http://dx.doi.org/10.1016/j.hrthm.2015.01.038
944 here was explained to the patient in detail, including the need for lifelong anticoagulation. All patients consented to the procedure, and the study underwent local review approval.
Implantation technique The procedure was routinely performed under local anesthesia with conscious sedation. Patients were anticoagulated with warfarin (international normalized ratio [INR] 2.0–3.5) at the time of the procedure. Immediately before the transseptal puncture a bolus of 5000 units of heparin was given intravenously. The implantation technique is shown in Figure 1. A Medtronic Attain deflectable coronary sinus sheath (model 6227DEF) is advanced through a left subclavian vein (LSCV) puncture and positioned in the superior vena cava (SVC). A 250-mm gooseneck snare (eV3) is advanced through the sheath and left opened in either the SVC or the right atrium (RA). A Mullins transseptal sheath (Cook
Heart Rhythm, Vol 12, No 5, May 2015 Medical) is advanced from the right femoral vein (RFV) through the open snare into the SVC over a 0.035-inch guidewire. The guidewire and the Mullins dilator are withdrawn, and an Endrys transseptal needle and its customized dilator are advanced through the Mullins sheath (and thus also through the snare). The Endrys transseptal needle consists of two needles, one inside the other. The outer needle is blunt, whereas the inner needle is sharp and is delivered through the outer needle in order to puncture the atrial septum. The snare is advanced as far inferiorly as possible over the Mullins sheath. A transseptal puncture is then performed in the usual manner to deliver the Mullins sheath and the Endrys dilator into the left atrium (LA). The inner (sharp) component of the Endrys needle is removed, and a 0.035-inch guidewire is advanced through the outer needle (blunt) and into the left upper pulmonary vein. The Mullins sheath and the Endrys dilator are withdrawn into the RA (leaving the outer Endrys needle in the LA) and the snare is tightened around the outer needle distal to end of the
Figure 1 The implantation technique in a patient who had previous transvenous and surgical epicardial leads. A: The gooseneck snare (a) is advanced through the Medtronic Attain deflectable sheath, which was introduced via the left subclavian vein. A 0.035-inch guidewire is introduced from the femoral vein access and is manipulated to pass through the gooseneck snare. Over this 0.035-inch guidewire, the Mullins sheath (b) is introduced into the right atrium. B: A transseptal puncture is made, and a 0.035-inch guidewire is placed in the left upper pulmonary vein through the Endrys outer needle (c). C: The snare is advanced into the left atrium (LA) and the Attain sheath (d) is advanced over the snare. D: The snare is removed, leaving the Attain sheath (d) in the LA. E: Left anterior oblique view. An active fixation lead (e) is advanced through the sheath into the LV and screwed into the lateral wall. The sheath is next split and removed. F: All 3 leads are seen: the previous transvenous lead (f) now lying in the main coronary sinus, the surgical epicardial lead (g), and the new active fixation lead (e), which is screwed into the endocardium opposite the failed surgical epicardial lead.
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Transseptal Endocardial LV Lead for CRT Delivery
sheath and dilator so that when the dilator is advanced back into the LA over the guidewire and outer needle, the snare is pushed into the LA. The snare is released from the outer blunt needle, which is withdrawn, and the snare is tightened around the 0.035-inch guidewire in the LA. The sheath, dilator, and outer needle are withdrawn into the RA so that the Medtronic Attain sheath can be advanced over the snare into the LA. Both the snare (from the LSCV) and the wire in the pulmonary vein (from the RFV) are removed, leaving the Attain sheath in the LA. The sheath is manipulated across the mitral valve into the LV and directed toward the lateral wall by clockwise rotation. An active fixation lead (Medtronic 5076 CapSureFix 85 cm, silicon insulated), with straight stylet inside, is advanced through the sheath to be screwed into the endocardium of the lateral wall of the LV. Finally, the Medtronic sheath is split, and the LV lead secured to the muscle in the pocket and connected to the CRT device. The Endrys transseptal needle and its use are described in greater detail in the Appendix.
Results This procedure was performed successfully in all 12 cases attempted. Baseline, procedural, and follow-up data are given in Table 1. Five patients had previous transvenous and/or surgical epicardial CRT, with excellent response to CRT that eventually failed with subsequent transvenous attempts failing to deliver a new LV lead. The reasons for CRT failure were loss of LV capture (patients 1 and 2), rising LV pacing threshold close to generator change (patient 3), unmanageable phrenic stimulation (patient 4), and LV lead displacement from the target vein occurring twice (patient 10). The other 7 patients were de novo implants after failure of exhaustive attempts at transvenous implantation (median procedure time 225 minutes, interquartile range [IQR] 178– 276 minutes). Table 1
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Nine patients already were taking warfarin: 5 for atrial fibrillation, 3 for previous LV thrombus, and 1 for previous recurrent deep vein thrombosis. Only 3 patients were started on warfarin specifically for the endocardial LV lead implant. Median procedure time was 148 minutes (IQR 113–176 minutes), and median fluoroscopy time was 16 minutes (IQR 10–19 minutes). Patient 9 had a long procedure time and a long fluoroscopy time (Table 1). The procedure initially was planned using an alternative technique, with the transseptal puncture performed from above through the coronary sinus sheath. This alternative procedure ultimately was unsuccessful, and the approach described here was used successfully as a “bailout” solution. In all patients, the electrical parameters of the endocardial LV lead were satisfactory at implant and were stable over time. Only one procedural complication occurred: a pocket hematoma in a patient with a subpectoral generator, which resolved without intervention. There was no need for repeat procedures during median follow-up of 97 days (IQR 36–313 days). Echocardiographic assessment of mitral valve function and LV systolic function, as well as echocardiographic review to rule out any LV thrombus formation, was not performed systematically after endocardial LV lead implant. In 3 patients who underwent transthoracic echocardiography during followup, no changes in mitral valve function or grade of mitral regurgitation and no LV thrombus formations were documented after median time from implant of 207 days (IQR 41– 264 days). LV ejection fraction increased markedly in patients 4 and 6 (from 20% and 18% to 27% and 28%, respectively), and a substantial reduction in LV ejection fraction (from 31% to 22%) occurred in patient 5 in the context of symptomatic persistent atrial fibrillation with only intermittent biventricular pacing due to high ventricular rate. Symptomatic improvement was seen in 10 of 12 patients. However, one of the patients who initially
Baseline, procedural, and follow-up data
Patient no.
1
2
3
4
5
6
7
8
9
10
11
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Age (years) 70 90 38 67 80 74 80 76 70 76 75 84 Gender M M F F M M M M F F F M Device CRT-P CRT-P CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D Ischemic heart disease No Yes No No Yes Yes Yes Yes No Yes No Yes Left ventricular ejection fraction (%) 20 40 23 20 31 18 15 29 24 35 31 30 QRS morphology LBBB Paced LBBB LBBB Paced LBBB LBBB Paced LBBB LBBB LBBB Paced New York Heart Association functional class 3 3 3 3 3 3 3 2 2–3 3 3 3 245 180 145 Procedure time (minutes) 165 155 150 130 120 110 95 100 430* 11 18 16 Fluoroscopy time (minutes) 17 20 7 15 12 19 10 9 78* † 4.7 8.9 25.0 5.2 R wave (mV) 17.8 8 10.3 17.0 8.6 6.1 6.5 Pacing impedance (Ω) 589 756 394 440 513 557 540 615 532 587 577 680 0.5 0.75 0.5 ‡ 0.5 0.5 0.4 0.4 0.4 Implant pacing threshold ([email protected] ms) 0.5 0.5 0.8 0.5 ‡ Follow-up duration (days) 134 556 337 372 242 74 120 41 66 34 33 34 0.75 0.5‡ 0.5 0.5 0.5 0.8 0.5 Follow-up pacing threshold ([email protected] ms) 0.75 0.6 0.8 0.75‡ 0.5 CRT-D ¼ cardiac resynchronization therapy–defibrillator; CRT-P ¼ cardiac resynchronization therapy–pacemaker; LBBB ¼ left bundle branch block. * Patient 9 had very long procedure and fluoroscopy times because of an attempt at a different procedure involving transseptal puncture from above through the coronary sinus sheath. This alternative procedure ultimately was unsuccessful, and the approach described here was used successfully as a “bailout” solution. † No underlying rhythm. ‡ [email protected] ms.
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Figure 2 Same patient as shown in Figure 1. Top: Twelve-lead ECG obtained after endocardial left ventricular lead placement showing a biventricular paced rhythm with a QRS duration of 120 ms. Bottom: Older ECG after surgical LV lead placement showing a biventricular paced rhythm with a QRS duration of 150 ms. Note that both ECGs are very similar and show an identical QRS axis in the frontal and horizontal planes, as both leads are pacing the same left ventricular segment. In this patient, the endocardial lead seems to deliver better electrical resynchronization compared with the epicardial lead in the same segment as evidenced by the narrower QRS duration.
improved subsequently deteriorated due to a progressive increase in polymorphic ventricular ectopy that reduced his biventricular pacing percentage substantially. One ischemic stroke episode, fully recovered afterward, occurred 10 months after endocardial LV lead implant in patient 4 in the context of temporary suboptimal management of anticoagulation treatment (irregular INR checks with suspected subtherapeutic anticoagulation levels in between).
Discussion When an LV lead cannot be delivered epicardially via the coronary sinus, the transseptal approach for endocardial placement is a useful alternative. The main challenge is to
perform a transseptal puncture from the LSCV. In the initial reports, transseptal puncture was performed from the right internal jugular vein, followed by insertion of the LV lead, which was then tunneled over the clavicle to the left-sided device.10,12 Most approaches described since have used dual access in which the transseptal puncture was performed from the RFV, followed by (1) implanting the lead from the RFV, then grabbing the lead connector with a snare introduced through the LSCV and pulling it out through the vein to be connected to the generator in the pectoral area13; (2) introducing the lead from the LSCV, then grabbing it with a snare introduced from the RFV and forcing it through the septum over a wire introduced earlier into the LA14; or (3) dilating the transseptal puncture, then “picking” the hole using a deflectable mapping catheter or other preshaped
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catheter/wire introduced from the left or right subclavian vein and railroading a sheath into the LA through which the LV lead is delivered.15 We describe a simpler and more practical technique that requires skills electrophysiologists already have and that prevents potential damage to the lead if a snare is applied to it in an attempt to force it into the LA or force it out through the subclavian vein. It avoids the use of a deflectable mapping catheter, which adds to the cost of the implantation. In addition, it allows the use of a deflectable, splittable sheath to direct and position the lead into the LV easily. Use of the Endrys transseptal needle by interventional cardiologists has been popular for many decades but for some reason has not gained widespread popularity among electrophysiologists. The Endrys transseptal needle makes this technique possible because of the coaxial arrangement of a blunt and sharp set of needles. Both of these needles extend well beyond the transseptal sheath tip, and the sharp puncturing needle component of the Endrys needle is delivered to the septum via the outer needle not by the sheath. The outer needle can be safely left exposed in the LA, particularly if protected by a guidewire, and is sufficiently supportive to allow a snare to be closed around it and advanced over it. Use of the outer needle to facilitate progression of the snare into the LA differentiates our approach from the technique previously described by Patel and Worley,16 in which the LV delivery catheter is pushed by the transseptal apparatus through the interatrial septum over a guidewire (previously advanced into the LA after transseptal puncture by using the Brockenbrough needle) to which it is closely anchored by the snare. In particular, the support offered by the outer needle allows the snare to be pushed easily over the guidewire through the interatrial septum and also far enough into the LA to be safely followed by the deflectable catheter with only minimal risk of losing transseptal access. Animal and human studies have suggested that transseptal endocardial LV leads for delivery of CRT have a number of advantages over epicardial leads (transvenous or surgical).17–20 Endocardial LV pacing provides a wider choice of stimulation sites, which may become significant if LV lead targeting to a specific segment assumes a greater importance in the future. Optimal thresholds are easy to obtain and are comparable to those obtained in the right ventricle. Lead dislodgment rates are low, and phrenic nerve capture is never an issue. There also is evidence that endocardial stimulation of the LV lead is more physiologic as activation of the ventricular wall proceeds from endocardium to epicardium, leading to less arrhythmogenicity, better synchronization of the LV, and hemodynamic superiority compared to epicardial leads. This may be seen clinically as a narrower QRS complex with endocardial compared to epicardial CRT. This was demonstrated in one of our patients (Figure 2). Potential risks of thromboembolism and stroke, however, need to be considered. About one third of patients in whom a pacing lead was inadvertently placed into the LV during routine pacing present with thromboembolic events,21 so lifelong anticoagulation is recommended for patients
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implanted with an endocardial LV lead. Rademakers et al22 recently investigated the occurrence of thromboembolic complications after endocardial LV lead implant in patients anticoagulated with coumarin and documented an estimated incidence of 6.1 thromboembolic events per 100 patientyears. The main factor influencing the thromboembolic risk was a subtherapeutic INR level (INR range 3.5–4.5 in this series) at the time of thromboembolism (mean INR value 1.9 ⫾ 0.6, range 1.2–2.6). This finding highlights the importance of strict adherence to anticoagulation treatment in patients implanted with an endocardial LV lead. One of our patients experienced a thromboembolic event 10 months after endocardial LV lead implant that apparently was related to suspected subtherapeutic INR values. However, there is no consensus regarding the optimal INR levels to be achieved in these patients who also could require individualized approaches based on their own clinical characteristics and comorbidities given the wide spectrum of INRs in which these thromboembolic events have been documented so far.
Figure 3 A, B: Endrys transseptal needle set. The inner sharp needle (a), the outer blunt needle (b), the dilator (c) and the Mullins transseptal sheath (d). C: The Endrys inner sharp needle (a) and the outer blunt needle (b). D: The Endrys outer blunt needle tip (b). E: Brockenbrough transseptal needle: needle tip (e) and shoulder (f).
948 Another concern is a potential interaction with the mitral valve leading to leaflet damage and insufficiency or mitral valve endocarditis if the leads become infected. This has not yet been described in the existing case series of transseptal LV leads20,22–26 (and also excluded in our patients who had echocardiographic assessments after implant), possibly because of the small size of pacing leads and biocompatible lead insulation with low friction coefficients. Furthermore, there is no evidence that right-sided leads interact adversely with the tricuspid valve in the majority of paced patients. Lead-dependent tricuspid valve damage and significant insufficiency have been reported in only 3% of patients with a permanent pacemaker.27 Finally, there are concerns that if extraction of a long-standing endocardial lead is needed, this may potentially be a more difficult procedure with higher risks. It is currently recommended that extraction of inadvertent LV leads be undertaken surgically in the majority of cases (unless detected very early after implantation), and, by extrapolation, this also should apply to transseptal LV leads to avoid dislodgment and embolism of debris during extraction.21 In view of these potential risks, this procedure currently is reserved for symptomatic patients in whom alternative routes for LV lead implantation have failed. However, the potential for a better clinical response has rekindled interest in endocardial leads as a possible alternative in the future for patients who have shown no response to conventional epicardial CRT. In the meantime, more research into their long-term safety and efficacy is needed.
Conclusion We describe a simple technique for delivery of a pacing lead to the endocardium of the LV. This technique may be considered the first option for patients in whom conventional CRT procedures fail. More studies are needed to demonstrate the long-term safety of this approach and whether there is any hemodynamic superiority of endocardial pacing in humans.
Appendix The Endrys transseptal needle set (Cook Medical) includes 3 components (Figures 3A–3D): the inner sharp needle (a), the outer blunt needle (b), and the dilator (c) (also in A and B is the Mullins transseptal sheath (d), Cook Medical). The needles have a central lumen and a coaxial arrangement. The direction of the bend is indicated by the needle arrows (Figure 3B). When the needles are advanced through the transseptal sheath (already positioned in the SVC), the inner needle is kept well hidden in the outer needle, which is advanced inside the customized plastic dilator to prevent accidental damage to the transseptal sheath itself (the Mullins transseptal sheath and its dilator are not braided and thus are at risk of perforation if the Endrys needle set is advanced through it). All equipment is then pulled back together until the dropdown into the fossa ovalis is seen. The transseptal puncture is performed by first advancing the inner
Heart Rhythm, Vol 12, No 5, May 2015 needle through the interatrial septum and confirming the position in the LA by inspection of the pressure trace. The needle and sheath are then advanced together approximately 1 cm before withdrawing the inner needle. The outer needle is advanced another 1 cm before being fixed and passing the dilator and then sheath into the LA. Having dilated a tract across the interatrial septum, the sheath and dilator are withdrawn, leaving only the outer needle straddling the interatrial septum so that the procedure can be completed as described. An example of a Brockenbrough needle (BRK transseptal needle, St. Jude Medical) is shown in Figure 3E. There are 2 components: the sharp tip needle (e) and the shoulder (f), which prevents the needle from advancing far beyond the introducer tip. The main difference between the Brockenbrough needle and the Endrys needle is the presence of the outer needle in the latter. From the point of view of the technique described in this article, the greater length of the blunt outer needle can be left to straddle the interatrial septum with a low risk of cardiac perforation. The outer needle then gives greater support and allows a wire to be passed through its lumen once the inner needle is removed. This allows more support during the progression of the snare through the interatrial septum and far enough into the LA to be safely followed by the deflectable catheter with only minimal risk of losing the access.
References 1. Linde C, Leclercq C, Rex S, et al. Long-term benefits of biventricular pacing in congestive heart failure: results from the MUltisite STimulation in cardiomyopathy (MUSTIC) study. J Am Coll Cardiol 2002;40:111–118. 2. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L, Cardiac Resynchronization-Heart Failure Study I. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539–1549. 3. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350:2140–2150. 4. Fatemi M, Etienne Y, Castellant P, Blanc JJ. Primary failure of cardiac resynchronization therapy: what are the causes and is it worth considering a second attempt? A single-centre experience. Europace 2008;10:1308–1312. 5. Bisch L, Da Costa A, Dauphinot V, Romeyer-Bouchard C, Khris L, M'Baye A, Isaaz K. Predictive factors of difficult implantation procedure in cardiac resynchronization therapy. Europace 2010;12:1141–1148. 6. Leon AR, Abraham WT, Curtis AB, Daubert JP, Fisher WG, Gurley J, Hayes DL, Lieberman R, Petersen-Stejskal S, Wheelan K, Program MS. 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;46:2348–2356. 7. Doll N, Piorkowski C, Czesla M, Kallenbach M, Rastan AJ, Arya A, Mohr FW. Epicardial versus transvenous left ventricular lead placement in patients receiving cardiac resynchronization therapy: results from a randomized prospective study. Thorac Cardiovasc Surg 2008;56:256–261. 8. Miller AL, Kramer DB, Lewis EF, Koplan B, Epstein LM, Tedrow U. Event-free survival following CRT with surgically implanted LV leads versus standard transvenous approach. Pacing Clin Electrophysiol 2011;34:490–500. 9. Tomaske M, Gerritse B, Kretzers L, Pretre R, Dodge-Khatami A, Rahn M, Bauersfeld U. A 12-year experience of bipolar steroid-eluting epicardial pacing leads in children. Ann Thorac Surg 2008;85:1704–1711. 10. Jais P, Douard H, Shah DC, Barold S, Barat JL, Clementy J. Endocardial biventricular pacing. Pacing Clin Electrophysiol 1998;21:2128–2131. 11. European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA), Brignole M, Auricchio A, Baron-Esquivias G, et al. ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac
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20. Morina-Vazquez P, Roa-Garrido J, Fernandez-Gomez JM, Venegas-Gamero J, Pichardo RB, Carranza MH. Direct left ventricular endocardial pacing: an alternative when traditional resynchronization via coronary sinus is not feasible or effective. Pacing Clin Electrophysiol 2013;36:699–706. 21. Rodriguez Y, Baltodano P, Tower A, Martinez C, Carrillo R. Management of symptomatic inadvertently placed endocardial leads in the left ventricle. Pacing Clin Electrophysiol 2011;34:1192–1200. 22. Rademakers LM, van Gelder BM, Scheffer MG, Bracke FA. Mid-term follow up of thromboembolic complications in left ventricular endocardial cardiac resynchronization therapy. Heart Rhythm 2014;11:609–613. 23. Jais P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haissaguerre M, Clementy J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol 2000;23: 1744–1747. 24. Morgan JM, Scott PA, Turner NG, Yue AM, Roberts PR. Targeted left ventricular endocardial pacing using a steerable introducing guide catheter and active fixation pacing lead. Europace 2009;11:502–506. 25. Elencwajg B, Lopez Cabanillas N, Cardinali EL, Barisani JL, Trainini J, Fischer A, Worley S. The Jurdham procedure: endocardial left ventricular lead insertion via a femoral transseptal sheath for cardiac resynchronization therapy pectoral device implantation. Heart Rhythm 2012;9:1798–1804. 26. Betts TR, Gamble JH, Khiani R, Bashir Y, Rajappan K. Development of a technique for left ventricular endocardial pacing via puncture of the interventricular septum. Circ Arrhythm Electrophysiol 2014;7: 17–22. 27. Polewczyk A, Kutarski A, Tomaszewski A, Brzozowski W, Czajkowski M, Polewczyk M, Janion M. Lead dependent tricuspid dysfunction: analysis of the mechanism and management in patients referred for transvenous lead extraction. Cardiol J 2013;20:402–410.
CLINICAL PERSPECTIVES We describe a new technique for implanting a transseptal endocardial LV lead that is delivered through a deflectable sheath inserted transseptally into the LV using an Endrys needle and a gooseneck snare. This procedure was performed successfully in all 12 patients in whom it was attempted without the need for repeat procedures after median follow-up of 97 days (IQR 36–313 days). Improvement in heart failure symptoms was experienced by 10 of 12 patients. This technique represents a reliable and effective option for CRT delivery in patients with previous failed conventional CRT procedures. It also could represent a solution for CRT nonresponder patients. However, further studies are required to establish the long-term safety and to confirm the clinical advantages of endocardial vs epicardial pacing for CRT delivery.
Introduction Cardiac resynchronization therapy (CRT) has significantly improved the lives of heart failure patients, with improvements in functional class, hospitalization rates, and mortality.1–3 Unfortunately, CRT implantation fails in 5% to 10% of patients because of an inability to deliver a left ventricular (LV) lead transvenously, either at de novo implantation or when an existing lead fails.4–6 The established alternative for transvenous pacing is surgical epicardial LV lead placement under a general anesthetic, which may carry unacceptably high morbidity and mortality for some frail heart failure patients.7,8 Surgical LV leads also may have a higher risk for lead failure in the long term compared to transvenous leads.9
facilitated passage of the gooseneck snare into the left atrium with no difficulty. Median procedure time was 148 minutes (interquartile range [IQR] 113–176 minutes), and median fluoroscopy time was 16 minutes (IQR 10–19 minutes). There was no need for repeat procedures after median follow-up of 97 days (IQR 36–313 days). CONCLUSION This approach using an Endrys needle and a gooseneck snare provides a reliable and effective alternative technique for delivery of an endocardial LV lead that is delivered easily through a deflectable sheath inserted transseptally into the LV. KEYWORDS Transseptal endocardial left ventricular lead; Cardiac resynchronization therapy ABBREVIATIONS CRT ¼ cardiac resynchronization therapy; INR ¼ international normalized ratio; IQR ¼ interquartile range; LA ¼ left atrium; LV ¼ left ventricle; LSCV ¼ left subclavian vein; RA ¼ right atrium; RFV ¼ right femoral vein; SVC ¼ superior vena cava (Heart Rhythm 2015;12:943–949) I 2015 Heart Rhythm Society. All rights reserved.
Endocardial LV lead implantation for delivery of CRT was first described in a case report in 1998.10 Over the past 16 years, fewer than 150 cases were reported in individual case reports and small case series. This procedure still is not widely used for delivery of CRT, probably because of procedural difficulties, perceived potential complications, and the need for lifelong oral anticoagulation. A number of techniques with varying difficulty and complexity have been described. In this article we describe a novel and relatively simple technique for delivery of an endocardial LV lead via the transseptal route.
Methods Patients
Drs. Domenichini and Diab contributed equally to this work. Address reprint requests and correspondence: Prof. Richard J. Schilling, Department of Cardiology, St. Bartholomew’s Hospital, 11th Floor, Glouchester House, Bartholomew Close, West Smithfield, London, EC1A 7BE, United Kingdom. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
Patients were offered this procedure if they had a class 1 indication for CRT,11 and an attempt at conventional LV lead placement via the coronary sinus had failed. All options were explained to the patient, including surgical LV lead placement and no further attempt at CRT. The technique described http://dx.doi.org/10.1016/j.hrthm.2015.01.038
944 here was explained to the patient in detail, including the need for lifelong anticoagulation. All patients consented to the procedure, and the study underwent local review approval.
Implantation technique The procedure was routinely performed under local anesthesia with conscious sedation. Patients were anticoagulated with warfarin (international normalized ratio [INR] 2.0–3.5) at the time of the procedure. Immediately before the transseptal puncture a bolus of 5000 units of heparin was given intravenously. The implantation technique is shown in Figure 1. A Medtronic Attain deflectable coronary sinus sheath (model 6227DEF) is advanced through a left subclavian vein (LSCV) puncture and positioned in the superior vena cava (SVC). A 250-mm gooseneck snare (eV3) is advanced through the sheath and left opened in either the SVC or the right atrium (RA). A Mullins transseptal sheath (Cook
Heart Rhythm, Vol 12, No 5, May 2015 Medical) is advanced from the right femoral vein (RFV) through the open snare into the SVC over a 0.035-inch guidewire. The guidewire and the Mullins dilator are withdrawn, and an Endrys transseptal needle and its customized dilator are advanced through the Mullins sheath (and thus also through the snare). The Endrys transseptal needle consists of two needles, one inside the other. The outer needle is blunt, whereas the inner needle is sharp and is delivered through the outer needle in order to puncture the atrial septum. The snare is advanced as far inferiorly as possible over the Mullins sheath. A transseptal puncture is then performed in the usual manner to deliver the Mullins sheath and the Endrys dilator into the left atrium (LA). The inner (sharp) component of the Endrys needle is removed, and a 0.035-inch guidewire is advanced through the outer needle (blunt) and into the left upper pulmonary vein. The Mullins sheath and the Endrys dilator are withdrawn into the RA (leaving the outer Endrys needle in the LA) and the snare is tightened around the outer needle distal to end of the
Figure 1 The implantation technique in a patient who had previous transvenous and surgical epicardial leads. A: The gooseneck snare (a) is advanced through the Medtronic Attain deflectable sheath, which was introduced via the left subclavian vein. A 0.035-inch guidewire is introduced from the femoral vein access and is manipulated to pass through the gooseneck snare. Over this 0.035-inch guidewire, the Mullins sheath (b) is introduced into the right atrium. B: A transseptal puncture is made, and a 0.035-inch guidewire is placed in the left upper pulmonary vein through the Endrys outer needle (c). C: The snare is advanced into the left atrium (LA) and the Attain sheath (d) is advanced over the snare. D: The snare is removed, leaving the Attain sheath (d) in the LA. E: Left anterior oblique view. An active fixation lead (e) is advanced through the sheath into the LV and screwed into the lateral wall. The sheath is next split and removed. F: All 3 leads are seen: the previous transvenous lead (f) now lying in the main coronary sinus, the surgical epicardial lead (g), and the new active fixation lead (e), which is screwed into the endocardium opposite the failed surgical epicardial lead.
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Transseptal Endocardial LV Lead for CRT Delivery
sheath and dilator so that when the dilator is advanced back into the LA over the guidewire and outer needle, the snare is pushed into the LA. The snare is released from the outer blunt needle, which is withdrawn, and the snare is tightened around the 0.035-inch guidewire in the LA. The sheath, dilator, and outer needle are withdrawn into the RA so that the Medtronic Attain sheath can be advanced over the snare into the LA. Both the snare (from the LSCV) and the wire in the pulmonary vein (from the RFV) are removed, leaving the Attain sheath in the LA. The sheath is manipulated across the mitral valve into the LV and directed toward the lateral wall by clockwise rotation. An active fixation lead (Medtronic 5076 CapSureFix 85 cm, silicon insulated), with straight stylet inside, is advanced through the sheath to be screwed into the endocardium of the lateral wall of the LV. Finally, the Medtronic sheath is split, and the LV lead secured to the muscle in the pocket and connected to the CRT device. The Endrys transseptal needle and its use are described in greater detail in the Appendix.
Results This procedure was performed successfully in all 12 cases attempted. Baseline, procedural, and follow-up data are given in Table 1. Five patients had previous transvenous and/or surgical epicardial CRT, with excellent response to CRT that eventually failed with subsequent transvenous attempts failing to deliver a new LV lead. The reasons for CRT failure were loss of LV capture (patients 1 and 2), rising LV pacing threshold close to generator change (patient 3), unmanageable phrenic stimulation (patient 4), and LV lead displacement from the target vein occurring twice (patient 10). The other 7 patients were de novo implants after failure of exhaustive attempts at transvenous implantation (median procedure time 225 minutes, interquartile range [IQR] 178– 276 minutes). Table 1
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Nine patients already were taking warfarin: 5 for atrial fibrillation, 3 for previous LV thrombus, and 1 for previous recurrent deep vein thrombosis. Only 3 patients were started on warfarin specifically for the endocardial LV lead implant. Median procedure time was 148 minutes (IQR 113–176 minutes), and median fluoroscopy time was 16 minutes (IQR 10–19 minutes). Patient 9 had a long procedure time and a long fluoroscopy time (Table 1). The procedure initially was planned using an alternative technique, with the transseptal puncture performed from above through the coronary sinus sheath. This alternative procedure ultimately was unsuccessful, and the approach described here was used successfully as a “bailout” solution. In all patients, the electrical parameters of the endocardial LV lead were satisfactory at implant and were stable over time. Only one procedural complication occurred: a pocket hematoma in a patient with a subpectoral generator, which resolved without intervention. There was no need for repeat procedures during median follow-up of 97 days (IQR 36–313 days). Echocardiographic assessment of mitral valve function and LV systolic function, as well as echocardiographic review to rule out any LV thrombus formation, was not performed systematically after endocardial LV lead implant. In 3 patients who underwent transthoracic echocardiography during followup, no changes in mitral valve function or grade of mitral regurgitation and no LV thrombus formations were documented after median time from implant of 207 days (IQR 41– 264 days). LV ejection fraction increased markedly in patients 4 and 6 (from 20% and 18% to 27% and 28%, respectively), and a substantial reduction in LV ejection fraction (from 31% to 22%) occurred in patient 5 in the context of symptomatic persistent atrial fibrillation with only intermittent biventricular pacing due to high ventricular rate. Symptomatic improvement was seen in 10 of 12 patients. However, one of the patients who initially
Baseline, procedural, and follow-up data
Patient no.
1
2
3
4
5
6
7
8
9
10
11
12
Age (years) 70 90 38 67 80 74 80 76 70 76 75 84 Gender M M F F M M M M F F F M Device CRT-P CRT-P CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D CRT-D Ischemic heart disease No Yes No No Yes Yes Yes Yes No Yes No Yes Left ventricular ejection fraction (%) 20 40 23 20 31 18 15 29 24 35 31 30 QRS morphology LBBB Paced LBBB LBBB Paced LBBB LBBB Paced LBBB LBBB LBBB Paced New York Heart Association functional class 3 3 3 3 3 3 3 2 2–3 3 3 3 245 180 145 Procedure time (minutes) 165 155 150 130 120 110 95 100 430* 11 18 16 Fluoroscopy time (minutes) 17 20 7 15 12 19 10 9 78* † 4.7 8.9 25.0 5.2 R wave (mV) 17.8 8 10.3 17.0 8.6 6.1 6.5 Pacing impedance (Ω) 589 756 394 440 513 557 540 615 532 587 577 680 0.5 0.75 0.5 ‡ 0.5 0.5 0.4 0.4 0.4 Implant pacing threshold ([email protected] ms) 0.5 0.5 0.8 0.5 ‡ Follow-up duration (days) 134 556 337 372 242 74 120 41 66 34 33 34 0.75 0.5‡ 0.5 0.5 0.5 0.8 0.5 Follow-up pacing threshold ([email protected] ms) 0.75 0.6 0.8 0.75‡ 0.5 CRT-D ¼ cardiac resynchronization therapy–defibrillator; CRT-P ¼ cardiac resynchronization therapy–pacemaker; LBBB ¼ left bundle branch block. * Patient 9 had very long procedure and fluoroscopy times because of an attempt at a different procedure involving transseptal puncture from above through the coronary sinus sheath. This alternative procedure ultimately was unsuccessful, and the approach described here was used successfully as a “bailout” solution. † No underlying rhythm. ‡ [email protected] ms.
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Figure 2 Same patient as shown in Figure 1. Top: Twelve-lead ECG obtained after endocardial left ventricular lead placement showing a biventricular paced rhythm with a QRS duration of 120 ms. Bottom: Older ECG after surgical LV lead placement showing a biventricular paced rhythm with a QRS duration of 150 ms. Note that both ECGs are very similar and show an identical QRS axis in the frontal and horizontal planes, as both leads are pacing the same left ventricular segment. In this patient, the endocardial lead seems to deliver better electrical resynchronization compared with the epicardial lead in the same segment as evidenced by the narrower QRS duration.
improved subsequently deteriorated due to a progressive increase in polymorphic ventricular ectopy that reduced his biventricular pacing percentage substantially. One ischemic stroke episode, fully recovered afterward, occurred 10 months after endocardial LV lead implant in patient 4 in the context of temporary suboptimal management of anticoagulation treatment (irregular INR checks with suspected subtherapeutic anticoagulation levels in between).
Discussion When an LV lead cannot be delivered epicardially via the coronary sinus, the transseptal approach for endocardial placement is a useful alternative. The main challenge is to
perform a transseptal puncture from the LSCV. In the initial reports, transseptal puncture was performed from the right internal jugular vein, followed by insertion of the LV lead, which was then tunneled over the clavicle to the left-sided device.10,12 Most approaches described since have used dual access in which the transseptal puncture was performed from the RFV, followed by (1) implanting the lead from the RFV, then grabbing the lead connector with a snare introduced through the LSCV and pulling it out through the vein to be connected to the generator in the pectoral area13; (2) introducing the lead from the LSCV, then grabbing it with a snare introduced from the RFV and forcing it through the septum over a wire introduced earlier into the LA14; or (3) dilating the transseptal puncture, then “picking” the hole using a deflectable mapping catheter or other preshaped
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catheter/wire introduced from the left or right subclavian vein and railroading a sheath into the LA through which the LV lead is delivered.15 We describe a simpler and more practical technique that requires skills electrophysiologists already have and that prevents potential damage to the lead if a snare is applied to it in an attempt to force it into the LA or force it out through the subclavian vein. It avoids the use of a deflectable mapping catheter, which adds to the cost of the implantation. In addition, it allows the use of a deflectable, splittable sheath to direct and position the lead into the LV easily. Use of the Endrys transseptal needle by interventional cardiologists has been popular for many decades but for some reason has not gained widespread popularity among electrophysiologists. The Endrys transseptal needle makes this technique possible because of the coaxial arrangement of a blunt and sharp set of needles. Both of these needles extend well beyond the transseptal sheath tip, and the sharp puncturing needle component of the Endrys needle is delivered to the septum via the outer needle not by the sheath. The outer needle can be safely left exposed in the LA, particularly if protected by a guidewire, and is sufficiently supportive to allow a snare to be closed around it and advanced over it. Use of the outer needle to facilitate progression of the snare into the LA differentiates our approach from the technique previously described by Patel and Worley,16 in which the LV delivery catheter is pushed by the transseptal apparatus through the interatrial septum over a guidewire (previously advanced into the LA after transseptal puncture by using the Brockenbrough needle) to which it is closely anchored by the snare. In particular, the support offered by the outer needle allows the snare to be pushed easily over the guidewire through the interatrial septum and also far enough into the LA to be safely followed by the deflectable catheter with only minimal risk of losing transseptal access. Animal and human studies have suggested that transseptal endocardial LV leads for delivery of CRT have a number of advantages over epicardial leads (transvenous or surgical).17–20 Endocardial LV pacing provides a wider choice of stimulation sites, which may become significant if LV lead targeting to a specific segment assumes a greater importance in the future. Optimal thresholds are easy to obtain and are comparable to those obtained in the right ventricle. Lead dislodgment rates are low, and phrenic nerve capture is never an issue. There also is evidence that endocardial stimulation of the LV lead is more physiologic as activation of the ventricular wall proceeds from endocardium to epicardium, leading to less arrhythmogenicity, better synchronization of the LV, and hemodynamic superiority compared to epicardial leads. This may be seen clinically as a narrower QRS complex with endocardial compared to epicardial CRT. This was demonstrated in one of our patients (Figure 2). Potential risks of thromboembolism and stroke, however, need to be considered. About one third of patients in whom a pacing lead was inadvertently placed into the LV during routine pacing present with thromboembolic events,21 so lifelong anticoagulation is recommended for patients
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implanted with an endocardial LV lead. Rademakers et al22 recently investigated the occurrence of thromboembolic complications after endocardial LV lead implant in patients anticoagulated with coumarin and documented an estimated incidence of 6.1 thromboembolic events per 100 patientyears. The main factor influencing the thromboembolic risk was a subtherapeutic INR level (INR range 3.5–4.5 in this series) at the time of thromboembolism (mean INR value 1.9 ⫾ 0.6, range 1.2–2.6). This finding highlights the importance of strict adherence to anticoagulation treatment in patients implanted with an endocardial LV lead. One of our patients experienced a thromboembolic event 10 months after endocardial LV lead implant that apparently was related to suspected subtherapeutic INR values. However, there is no consensus regarding the optimal INR levels to be achieved in these patients who also could require individualized approaches based on their own clinical characteristics and comorbidities given the wide spectrum of INRs in which these thromboembolic events have been documented so far.
Figure 3 A, B: Endrys transseptal needle set. The inner sharp needle (a), the outer blunt needle (b), the dilator (c) and the Mullins transseptal sheath (d). C: The Endrys inner sharp needle (a) and the outer blunt needle (b). D: The Endrys outer blunt needle tip (b). E: Brockenbrough transseptal needle: needle tip (e) and shoulder (f).
948 Another concern is a potential interaction with the mitral valve leading to leaflet damage and insufficiency or mitral valve endocarditis if the leads become infected. This has not yet been described in the existing case series of transseptal LV leads20,22–26 (and also excluded in our patients who had echocardiographic assessments after implant), possibly because of the small size of pacing leads and biocompatible lead insulation with low friction coefficients. Furthermore, there is no evidence that right-sided leads interact adversely with the tricuspid valve in the majority of paced patients. Lead-dependent tricuspid valve damage and significant insufficiency have been reported in only 3% of patients with a permanent pacemaker.27 Finally, there are concerns that if extraction of a long-standing endocardial lead is needed, this may potentially be a more difficult procedure with higher risks. It is currently recommended that extraction of inadvertent LV leads be undertaken surgically in the majority of cases (unless detected very early after implantation), and, by extrapolation, this also should apply to transseptal LV leads to avoid dislodgment and embolism of debris during extraction.21 In view of these potential risks, this procedure currently is reserved for symptomatic patients in whom alternative routes for LV lead implantation have failed. However, the potential for a better clinical response has rekindled interest in endocardial leads as a possible alternative in the future for patients who have shown no response to conventional epicardial CRT. In the meantime, more research into their long-term safety and efficacy is needed.
Conclusion We describe a simple technique for delivery of a pacing lead to the endocardium of the LV. This technique may be considered the first option for patients in whom conventional CRT procedures fail. More studies are needed to demonstrate the long-term safety of this approach and whether there is any hemodynamic superiority of endocardial pacing in humans.
Appendix The Endrys transseptal needle set (Cook Medical) includes 3 components (Figures 3A–3D): the inner sharp needle (a), the outer blunt needle (b), and the dilator (c) (also in A and B is the Mullins transseptal sheath (d), Cook Medical). The needles have a central lumen and a coaxial arrangement. The direction of the bend is indicated by the needle arrows (Figure 3B). When the needles are advanced through the transseptal sheath (already positioned in the SVC), the inner needle is kept well hidden in the outer needle, which is advanced inside the customized plastic dilator to prevent accidental damage to the transseptal sheath itself (the Mullins transseptal sheath and its dilator are not braided and thus are at risk of perforation if the Endrys needle set is advanced through it). All equipment is then pulled back together until the dropdown into the fossa ovalis is seen. The transseptal puncture is performed by first advancing the inner
Heart Rhythm, Vol 12, No 5, May 2015 needle through the interatrial septum and confirming the position in the LA by inspection of the pressure trace. The needle and sheath are then advanced together approximately 1 cm before withdrawing the inner needle. The outer needle is advanced another 1 cm before being fixed and passing the dilator and then sheath into the LA. Having dilated a tract across the interatrial septum, the sheath and dilator are withdrawn, leaving only the outer needle straddling the interatrial septum so that the procedure can be completed as described. An example of a Brockenbrough needle (BRK transseptal needle, St. Jude Medical) is shown in Figure 3E. There are 2 components: the sharp tip needle (e) and the shoulder (f), which prevents the needle from advancing far beyond the introducer tip. The main difference between the Brockenbrough needle and the Endrys needle is the presence of the outer needle in the latter. From the point of view of the technique described in this article, the greater length of the blunt outer needle can be left to straddle the interatrial septum with a low risk of cardiac perforation. The outer needle then gives greater support and allows a wire to be passed through its lumen once the inner needle is removed. This allows more support during the progression of the snare through the interatrial septum and far enough into the LA to be safely followed by the deflectable catheter with only minimal risk of losing the access.
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20. Morina-Vazquez P, Roa-Garrido J, Fernandez-Gomez JM, Venegas-Gamero J, Pichardo RB, Carranza MH. Direct left ventricular endocardial pacing: an alternative when traditional resynchronization via coronary sinus is not feasible or effective. Pacing Clin Electrophysiol 2013;36:699–706. 21. Rodriguez Y, Baltodano P, Tower A, Martinez C, Carrillo R. Management of symptomatic inadvertently placed endocardial leads in the left ventricle. Pacing Clin Electrophysiol 2011;34:1192–1200. 22. Rademakers LM, van Gelder BM, Scheffer MG, Bracke FA. Mid-term follow up of thromboembolic complications in left ventricular endocardial cardiac resynchronization therapy. Heart Rhythm 2014;11:609–613. 23. Jais P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haissaguerre M, Clementy J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol 2000;23: 1744–1747. 24. Morgan JM, Scott PA, Turner NG, Yue AM, Roberts PR. Targeted left ventricular endocardial pacing using a steerable introducing guide catheter and active fixation pacing lead. Europace 2009;11:502–506. 25. Elencwajg B, Lopez Cabanillas N, Cardinali EL, Barisani JL, Trainini J, Fischer A, Worley S. The Jurdham procedure: endocardial left ventricular lead insertion via a femoral transseptal sheath for cardiac resynchronization therapy pectoral device implantation. Heart Rhythm 2012;9:1798–1804. 26. Betts TR, Gamble JH, Khiani R, Bashir Y, Rajappan K. Development of a technique for left ventricular endocardial pacing via puncture of the interventricular septum. Circ Arrhythm Electrophysiol 2014;7: 17–22. 27. Polewczyk A, Kutarski A, Tomaszewski A, Brzozowski W, Czajkowski M, Polewczyk M, Janion M. Lead dependent tricuspid dysfunction: analysis of the mechanism and management in patients referred for transvenous lead extraction. Cardiol J 2013;20:402–410.
CLINICAL PERSPECTIVES We describe a new technique for implanting a transseptal endocardial LV lead that is delivered through a deflectable sheath inserted transseptally into the LV using an Endrys needle and a gooseneck snare. This procedure was performed successfully in all 12 patients in whom it was attempted without the need for repeat procedures after median follow-up of 97 days (IQR 36–313 days). Improvement in heart failure symptoms was experienced by 10 of 12 patients. This technique represents a reliable and effective option for CRT delivery in patients with previous failed conventional CRT procedures. It also could represent a solution for CRT nonresponder patients. However, further studies are required to establish the long-term safety and to confirm the clinical advantages of endocardial vs epicardial pacing for CRT delivery.