Lead removal in young patients in view of lifelong pacing

Transcription

1 Europace (2010) 12, doi: /europace/euq059 CLINICAL RESEARCH Leads and Lead Extraction Lead removal in young patients in view of lifelong pacing Peter A. Zartner*, Walter Wiebe, Nicole Toussaint-Goetz, and Martin B. Schneider Department of Cardiology, Deutsches Kinderherzzentrum Sankt Augustin, Arnold Janssen Straße 28, D Sankt Augustin, Germany Received 16 November 2009; accepted after revision 5 February 2010; online publish-ahead-of-print 10 March 2010 Aims In young patients with or without a congenital heart disease, transvenous leads for pacemakers or implantable cardioverter defibrillators can cause later vascular obstruction or infection. Removal of non-functional leads is controversial as it bears the risk of vascular disrupture and embolizations. We report the data of a single centre for paediatric cardiology on efficiency and safety of transvenous lead removal.... Methods Between May 2005 and August 2009 in 22 patients with a mean age of 12.9 years (range: years) removal of and results 28 transvenous leads (mean lead age: 5.1 years) was attempted. The main indications for removal were vascular obstruction, increased threshold, and lead dislocation. Commercially available retraction tools were used, if necessary. Twenty-five leads (89%) were retrieved with clinical success, of which 22 (79%) were removed with complete procedural success. In three leads the lead tips were retained, while three leads could not be retrieved. No major complications occurred. Additional interventions such as recanalization, balloon dilation, or stent implantation were performed as indicated. Procedure and X-ray times could be correlated to the implant age of the leads.... Conclusion Using non-electrical techniques, transvenous lead removal can be performed with a success rate of 89% in young patients. In the case of vessel obstructions, lead replacement combined with revascularization should be performed early, as the older the lead, the more prolonged and more hazardous the extraction procedure becomes. The use of new leads and precautionary implantation techniques may facilitate later lead removal Keywords Children Congenital heart disease Transvenous lead replacement Extraction tools Vascular complications Introduction Owing to improved surgical techniques, young patients with a congenital heart disease (CHD) who require the implantation of a pacemaker (PM) or an implantable cardioverter defibrillator (ICD) 1,2 are gaining an increasingly positive prognosis in long-term outcome. Smaller device sizes and thinner lead bodies facilitate implantation also in children with a congenital bradyarrhythmia. However, transvenous leads in particular, while presenting better long-term characteristics than epicardial leads, can cause vascular complications during the patient s growth. Reserve loops, set to facilitate further growth adaptation of the lead system, can promote adhesions of the lead body to the vessel walls. 3 At any age, but even more so in small children owing to the reduced vessel diameter, 4 there is the risk of vascular thrombosis accompanied by venous bypass circulation back to the heart. As only for the adult patient group is material suitable for more complex explantation procedures available, in the past, inactive leads have been left in place in many young patients. To reduce the lifelong risk of vascular complications caused by inactive and abandoned leads, their removal seems to be indicated, but extraction bears the hazard of vessel disrupture or loss of lead fragments. 5,6 As young patients prospectively require transvenous pacing leads for several decades to come, removal and replacement of all transvenous leads is attempted in our patients when new leads are needed. We retrospectively report our data and the mid-term outcome of our patients, oriented on the recent recommendations. 7 Study population Between May 2005 and July 2009 (interval 4.3 years), 85 patients with a mean age of 11.5 years (range: 9 days to 37.5 years) * Corresponding author. Tel: þ , þ ; fax: þ , p.zartner@asklepios.com Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oxfordjournals.org.

2 Lead removal in children 715 underwent 100 implantations or revisions of their PM or ICD. The mean follow-up interval was 2.4 years (range: years). Forty-three (51%) patients showed morphological anomalies of the heart and had undergone cardiac surgery. Thirty-six patients were born with a congenital bradyarrhythmia (congenital complete atrioventricular block or sinus node disease) and six young patients presented with cardiac diseases such as cardiomyopathy, Kawasaki disease, and cardiac tumours. Out of this group, in 22 patients with a mean age of 12.9 years (range: years) and 44 transvenous leads implanted, 24 procedures were performed to maintain their transvenous systems. To achieve this, removal of 28 transvenous leads [mean period of implantation 5.1 years (range: 1 day to 22 years)] was attempted. Indications for lead removal were vascular obstructions (n ¼ 10 leads, mean lead age: 9.9 years), elevated or rising threshold (n ¼ 9, 3.5 years), system conversion for an ICD (n ¼ 2, 1.7 years), growth-related shortening of the lead (n ¼ 2, 3 years), and dislocation of the lead (n ¼ 5, 1.6 years). Five of the leads causing obstruction had previously been abandoned, with the cut proximal end sunken into the venous system by the patient s growth (drowned leads). Eight patients were cared for in other hospitals and were sent in only for system revision. Procedure In lumenless coaxial leads (model 3830 SelectSecure w, Medtronic Inc., Minneapolis, MN, USA) counter-clockwise rotation and continuous traction was successful for explantation in all cases. In all other leads, a mandrill was advanced as far as possible to check the integrity of the lead and soft traction was applied to observe adhesions. Then a locking stylet (Liberator w, Cook Medical Inc., Bloomington, IN, USA or VascoExtor w, Vascomed, Binzen, Germany) was advanced to secure fixation at the lead tip. If direct traction was not effective, dilator sheaths (Byrd w, Cook Medical Inc., Bloomington, IN, USA) were used to create counter-traction to the lead tip. As the diameter of the outer sheath used was 12 French (F), first attempts were performed using only the inner sheaths (9 F). If this was not effective, both sheaths were used in a telescope technique. 6 Electrosurgical sheaths (Perfecta w, Cook Medical Inc., Bloomington, IN, USA) were prepared for severe adhesions, but were not used. Drowned leads were caught with a forceps or a snare catheter, mobilized as far as possible and pulled into a long sheath inserted from the groin or the right subclavian vein to optimize the tensor angle towards the lead tip. Additional interventions such as recanalization, balloon dilation, or stent implantation were performed as indicated, using the channel of the extracted lead as a starting point (Figure 1). All procedures were performed under general anaesthesia, antibiotic prophylaxis, and with heparin 75 units/kg bodyweight. To intervene in emergency situations, a cardiac surgery team was on stand-by. In patients who underwent revascularization, anticoagulation therapy with warfarin was continued for at least 6 months. Results Out of 28, 25 (89%) transvenous leads were removed with clinical success during 24 procedures (Table 1). Complete procedural success was achieved in 22 leads (79%). Three drowned leads were removed with partial success with only the lead tips as remnants (one is shown in Figure 2). Eight leads were explanted without the use of further material. Seventeen leads [mean lead age 9.4 years (range: 4 22 years)] with intravascular adhesions were extracted using mechanical extraction tools. The use of only a locking stylet was successful in three ventricular and two atrial leads. In the 12 other leads dilator sheaths (Byrd w,cook Medical Inc., Bloomington, IN, USA) and long sheaths (Super ArrowFlex w, Arrow International Inc., Reading, MA, USA) of different diameters were used to dissect the adhesions. Figure 1 A 17-year-old female patient with swelling of her left arm showed thrombosis of the innominate vein with collateral flow. Successful lead removal using a locking-stylet and telescope sheath was performed. Before complete retraction of the lead, the lead tip was snared from the groin and a wire was advanced through the stenoses to secure the access for balloon dilation. Finally a new system with thinner leads was implanted in the same route.

3 716 P.A. Zartner et al. Table 1 List and position of the previously implanted transvenous leads, which underwent transvenous explantation procedures. Some leads failed identification, therefore only the lead design and position is listed Lead position... Atrial Ventricular... Removed leads Active fixation, bipolar 3 1 Active fixation, unipolar 1 Guidant Fineline 2 5 Medtronic Medtronic Sprint Fidelis 1 Passive fixation, bipolar 5 Passive fixation, unipolar 1 Total 8 17 Failed leads Active fixation, bipolar 1 Passive fixation, bipolar 1 Passive fixation, unipolar 1 Total 1 2 Three transvenous leads (implanted 9.5, 11, and 22 years ago) could not be retrieved owing to long segmental adhesions and their looped atrial course, which prevented sufficient advancement of a locking stylet to the lead tip. The oldest lead (22 years) had been torn-off before and even very gentle traction caused further damage to the lead body. This lead had to be abandoned to avoid uncontrollable embolizations of lead fragments. As there were no clinical symptoms related to all three leads, surgical removal was not indicated. Additional interventions included three revascularizations, beginning with lead removal to enter the obstructed vessel and seven balloon dilations. In one patient with a transposition of the great arteries after Mustard operation and a double-chamber ICD on the left shoulder, the Mustard baffle from the superior vena cava was highly stenotic and caused headaches and swelling. Both leads were extracted, the obstruction stented with two Cheatham-Platinum w stents (Numed, Hopkington, NJ, USA), and new leads were implanted as described in a similar case by Sadagopan et al. 8 The clinical symptoms disappeared. Early lead dislocation within the first 4 weeks after implantation had occurred four times, with lead model 3830 in three patients and a Fineline w (Boston Scientific, Natick, MA, USA) in a small child. 9 Retraction and replacement was possible without the use of additional tools. Furthermore, model 3830 lead was exchanged two times because of a slow increase of the ventricular threshold Figure 2 A 17-year-old female patient, born with a complete atrioventricular block, with a drowned unipolar ventricular lead, which shows a visible mass of connective tissue around the tip (left arrow) (A). Previous attempts at lead removal had led to the loss of the proximal lead body with elongation of the middle part, which was fixed by adhesions in the superior vena cava (left arrow) (A). The lead was snared from the groin and pulled out of the adhesions (B). It then was handed over to a sheath from the right subclavian vein (C). Again it was snared including the isolation as close to the lead tip as possible and counter traction was applied (D). The lead disruptured proximal to the tip (left arrow), which could not be snared (E). Saved piece of isolation with adhesions (F). (A and E are in anterior-posterior projection; B D are in left-lateral projection).

4 Lead removal in children 717 Figure 3 Lead age does not correlate with the length of the procedure or the X-ray time, as long as no lead removal was performed. The older the leads for removal get, the longer the procedure [coefficient of correlation (cc) ¼ 0.53] and the longer the X-ray time (cc ¼ 0.67) become. Linear trend lines with equations and stability index are added. of unknown cause. Explantation at 18 months and 2.4 years after implantation was necessary and both leads were replaced. CHDs were present in 51% of the cases, but did not affect the outcome of the lead removal procedures. All procedures undertaken for transvenous lead removal resulted in successful pacing with no procedure-related mortality. No major complications occurred during and after the procedures. As a minor complication, 7 pneumothorax requiring a chest tube occurred in one patient and secondary drainage of the implantation pocket was necessary in another patient. Mean procedure time for transvenous lead removal was 141 min (range: min), including all interventions necessary for vessel maintenance. Mean radiation time was 21 min (range: 2 63 min). The coefficient of correlation (cc) was 0.53 between lead age and procedure time and 0.67 between lead age and X-ray time (Figure 3). There was no correlation between the procedure or X-ray times in patients with only system revision, such as pacemaker exchange and growth adaptation of the lead [n ¼ 13, mean patient age 13.6 years ( years), mean dwell time of the leads: 5.9 years]. Mean procedure time in these cases was 99 min, mean X-ray time was 10.5 min (Figure 3). Discussion Removal of pacing and ICD leads in children and young patients using only mechanical techniques showed complete success in 22 of 28 (79%) leads. Overall clinical success was achieved in 25 of 28 (89%) leads including partial success in three leads with only the tips retained. Our results seem comparable with the reports of Dilber et al., 10 who reached complete success in a comparable patient group in 74% of the leads, while using mechanical extraction tools and a laser sheath if conventional extraction was not effective. The team of Moak et al. 11 routinely used a laser system in young patients with a CHD. Their complete success rate reached 91% (n ¼ 39) and partial success was achieved for the remaining four patients. The minimum diameter of a laser sheath of 12 F limited their patient group to 8.4 years and older. In our patient group 8 of 24 procedures were performed in children younger than 8 years with a vessel size not suited for large diameter sheaths. But as in this young age, the dwell time of the implanted leads is relatively short and obstructing adhesions were not found, retrieval with conventional tools could be performed with complete success in this group. Despite some early dislocations observed, the implantation of the coaxial, sheath-guided model 3830 lead has been found to be advantageous by Chakrabarti et al. 12 Besides being the thinnest lead currently available, its ability to transfer rotation along the lead body allows strong forces to unscrew the lead tip. As the lead does not lengthen under traction and has no ledges at its distal poles, in our experience its retrievability over the first 2 years is very much simplified, but long-term results are still missing. The duration and results of extraction of older leads were essentially influenced by the feasibility of advancing a mandrill or locking stylet down to the lead tip. 13 In leads with an atrial reserve loop to allow for patient s growth, proper placement of a locking stylet was difficult and in some cases impossible because of the high friction within the sharp curves of the lead body. Because of this observation we modified our reserve loop configuration in favour of a long saddle-like formation for the ventricular leads and a deep hammock for the atrial leads. To overcome intravascular adhesions, the inner sheath of a polypropylene dissection system has proved to be appropriate in older leads to cut out the lead body, but with an outer diameter of 9 F its use is restricted to the upper limbs of older children only. 14 Our

5 718 P.A. Zartner et al. youngest patient, who was treated successfully with this system, weighed 27 kg. The combination of inner and outer sheath requires a venous access of 12 F and is reserved for the nearly adult patient group. In drowned leads where a locking stylet cannot be used to establish counter-traction between the lead tip and the dissection sheath, complete success was difficult to achieve. In three of five leads, the tips could not be removed (Figure 2). Additional access from the groin with an incompressible wire-enforced long sheath proved to be helpful in this setting. In 3 of 22 patients we found complete vessel obstructions which were reopened by balloon dilation after lead removal (Figure 1), as this gave way for the passage of a guide wire and balloon catheter. A 17-year-old patient with two 13-year-old abandoned leads showed calcifications within her obstructed subclavian vein, suggesting a prior local infection. In two patients, the obstructions are attributed to the implanted leads, as no other causes were found. Despite the abandonment of non-functional leads being reported as a palliative option, 15 infections and vessel complications may occur. Late removal of those leads is strenuous, with long procedure and X-ray times. Complete procedural success is difficult to achieve, especially if the leads are cut and lead ends drawn into the vascular system by the patient s growth. Vascular perforation or rupture was not observed in any patient in this study. This may be owing to the young age of our patients and the more elastic condition of their vessel walls, as well as to pericardial adhesions as they occur after cardiac surgery. Refraining from the use of electrosurgical dissection sheaths or laser equipment with its relatively large diameters and stiff materials may have further reduced the risk of vascular disrupture. Friedman et al., 16 not yet disposing of such technical equipment, published very good results with no major complications. Nevertheless, several colleagues report the advantages of these techniques in experienced hands especially in older leads. 10,11,17 Conclusion Transvenous lead removal in children and young patients with and without a CHD can be performed safely and successfully for most of our patients. Locking stylets and telescope sheaths proved helpful in transvenous removal, especially using leads with an implantation age of over 8 years. In complex situations with drowned leads, multiple access routes are necessary to achieve an optimal tensor angulation for withdrawal from intravascular adhesions. Lead removal permits interventional revascularization and balloon dilation and is mandatory before stent implantation. Extraction of non-functional lead material, which presents a potential nucleus for vascular obstruction or infection, has to be considered with every system revision, as the duration of the procedure and X-ray times correlate with the lead age. Hence, attentive selection of lead material and anticipatory placement during implantation may further facilitate later lead removal. Funding There is no financial support or contract connected with this publication. Conflict of interest: none declared. References 1. Saul JP, Epstein AE, Silka MJ, Berul CI, Dick M, Dimarco JP et al. Heart Rhythm Society/Pediatric and Congenital Electrophysiology Society Clinical Competency Statement: training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients. Heart Rhythm 2008;5: Epstein AE, Dimarco JP, Ellenbogen KA, Estes NA III, Freedman RA, Gettes LS et al. 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