Extraction of SelectSecure leads compared to conventional pacing leads in patients with congenital heart disease and congenital atrioventricular block Emma Shepherd,* Graham Stuart, FRCP,*† Rob Martin, FRCP,*† Mark A. Walsh, MRCPCH*† From the *Bristol Royal Hospital for Children, Bristol, United Kingdom, and †Bristol Heart Institute, Bristol, United Kingdom. BACKGROUND SelectSecure™ pacing leads (Medtronic Inc) are increasingly being used in pediatric patients and adults with structural congenital heart disease. The 4Fr lead is ideal for patients who may require lifelong pacing and can be advantageous for patients with complex anatomy. OBJECTIVE The purpose of this study was to compare the extraction of SelectSecure leads with conventional (stylette-driven) pacing leads in patients with structural congenital heart disease and congenital atrioventricular block. METHODS The data on lead extractions from pediatric and adult congenital heart disease (ACHD) patients from August 2004 to July 2014 at Bristol Royal Hospital for Children and the Bristol Heart Institute were reviewed. Multivariable regression analysis was used to determine whether conventional pacing leads were associated with a more difficult extraction process.
age at the time of extraction was 17.6 ⫾ 10.5 years, mean weight was 47 ⫾ 18 kg, and mean lead age was 5.6 ⫾ 2.6 years (range 1–11 years). Complex extraction (partial extraction/femoral extraction) was more common in patients with conventional pacing leads at univariate (P o .01) and multivariate (P ¼ .04) levels. Lead age was also a significant predictor of complex extraction (P o .01). CONCLUSION SelectSecure leads can be successfully extracted using techniques that are used for conventional pacing leads. They are less likely to be partially extracted and are less likely to require extraction using a femoral approach compared with conventional pacing leads. KEYWORDS SelectSecure pacing lead; Lead extraction; Pediatrics; Congenital heart disease; Pacemaker; Congenital heart block ABBREVIATIONS ACHD ¼ adult structural congenital heart disease
RESULTS A total of 57 patients underwent pacemaker lead extractions (22 SelectSecure, 35 conventional). No deaths occurred. Mean
(Heart Rhythm 2015;12:1227–1232) I 2015 Heart Rhythm Society. All rights reserved.
Introduction
patients.10,11 Because the SelectSecure has a solid core, the lead must be extracted without the use of a locking stylet.10 Data on lead extraction in pediatric and adult congenital heart disease (ACHD) patients are limited, particularly in relation to SelectSecure extractions.2,12,13 An understanding of the outcomes associated with lead extraction, along with the nuances required for each type of lead, is essential to optimize our choice of pacing lead.2,14 We report our tertiary center experience on extraction of SelectSecure leads compared to conventional (stylette-driven) pacing leads in a cohort of pediatric and ACHD patients.
In recent years, permanent transvenous pacemaker and defibrillator implantation have become therapeutic modalities frequently used in children and young adults with structural congenital heart disease.1–4 With increasing life expectancy in this subset of patients, lead extraction is inevitable, and a parallel increase in the need for extraction has been observed.2,5,6 Although transvenous leads are more reliable than epicardial leads, concern remains regarding long-term vascular complications.4 Removal of dysfunctional leads improves vessel patency, but extraction of chronically implanted leads is a complex procedure associated with significant morbidity and, in some cases, mortality.4 The SelectSecure™ (Medtronic Inc, Minneapolis, MN) is a lumenless lead with a smaller diameter (4.1Fr) that has been implanted since 2004.1,7–9 The smaller lead diameter makes it ideal for transvenous pacing in younger Address reprint requests and correspondence: Dr. Mark Walsh, Bristol Royal Hospital for Children, Upper Maudlin St, Bristol, BS2 8BJ, United Kingdom. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
Methods This single institutional retrospective study was conducted with the approval of the Research Ethics Board at University Hospitals Bristol NHS Foundation Trust. Pediatric and ACHD patients who had undergone lead extraction between August 2004 and July 2014 were included in the study. A list of these patients was obtained from the cardiac database at the Bristol Royal Hospital for Children and the Bristol Heart Institute. Patients were included in the study if the initial lead http://dx.doi.org/10.1016/j.hrthm.2015.03.004
1228 was implanted during childhood or if the pacemaker lead was implanted as an adult with structural congenital heart disease. Patients in whom the SelectSecure lead was extracted at the same time as a defibrillator lead were not included. Echocardiogram reports were reviewed, predominantly looking for postextraction effusions. The reported grade of tricuspid regurgitation was assessed after the extraction and compared to the previously reported grade of tricuspid regurgitation. Clinical details in relationship to the extraction, including any radiographic imaging performed around the time of extraction, also were reviewed. Given the low incidence of major complications, we chose a composite end-point of complex extraction as the primary outcome variable. This was defined as either a partial extraction (leaving some or all of the lead in situ) or the need to extract using a femoral approach. The method of extraction was also assessed, examining whether a cutting sheath was required and the type of cutting sheath used. The 2 cutting sheaths used were the polypropylene telescoping sheath (Cook, Bloomington, Indiana) and the Evolutions (Cook, Bloomington, IN). The Perfectas electrosurgical dissection sheath (Cook) was used for 14 cases before the Evolution was used. Major complications of pericardial effusion requiring intervention, need for surgical extraction, or death were recorded. Minor complications consisted of bleeding, hematoma formation, infection, prolonged length of stay (42 days), and hypotension. Bleeding was defined as minor if blood loss was documented in the procedure note (estimated to be o50 mL) and major if it was associated with hypotension or required blood transfusion.
Statistical analysis Demographic data are presented as mean ⫾SD. A Fisher exact test was used to test for significance in categorical variables between groups. Outcome variables were all tested at the univariate level using logistic regression. Variables of clinical significance were then entered into a generalized estimating equation (PROC GENMOD), and odds ratios were calculated where appropriate. Given that lead age and lead type were confounding variables (due to the recent trend to implant SelectSecure leads), the interaction between these 2 variables was entered into our final model. P o.05 was considered significant. All statistical analysis was performed using SAS (version 9.2, SAS Institute, Cary, NC).
Results From August 2004 to July 2014, a total of 623 pacemaker leads were implanted in pediatric and ACHD patients at Bristol Royal Hospital for Children and the Bristol Heart Institute. A total of 57 lead extractions were performed during the same time period. Of these, 22 were SelectSecure leads and 35 were conventional pacing leads. Lead extractions were performed by 3 operators (GS, RM, MW). There was no difference between operators for the outcome of complex extraction (partial/femoral extraction) (P = .58).
Heart Rhythm, Vol 12, No 6, June 2015 Baseline patient demographics are listed in Table 1. Mean age at which patients underwent lead extraction was 17.6 years for both groups. There were 35 males and 22 females. A total of 30 patients who had congenital heart disease underwent explantation; the rest of the patients had congenital complete atrioventricular block. Of the 35 conventional pacing leads that were extracted, 19 were active fixation leads, and all of them were steroid eluting (see Online Supplemental Table 1). Mean lead age was 4.1 ⫾ 2.6 years for the SelectSecure group and 6.7 ⫾ 2.6 years for the conventional pacing lead group, which was significantly different (P o .01). The indications for extraction are listed in Table 1. Lead failure (defined as complete failure of sensing/pacing) was an indication in 10 patients. For 14 patients, the indication for extraction was suboptimal sensing/pacing thresholds in addition to the radiographic appearance of lead tension. For 17 patients, the lead was replaced because of radiographic evidence of lead tension in addition to anticipated patient growth in the presence of a normally functioning lead, usually at the time of a generator change. There were no significant differences in the indication for extraction between the 2 groups. The devices were most commonly implanted in the left suprapectoral region, followed by the left axilla, which was not significantly different between the groups. Most patients underwent a single lead extraction; only 4 patients had more than 1 lead extracted, which was not significantly different between groups.
Table 1 Comparison of patient characteristics between conventional pacing lead and SelectSecure lead groups Variable Weight at explant (kg) Age at explant (y) Lead age (y) Gender, male Congenital heart block Congenital heart disease Indication Lead failure* System upgrade† Growth‡ Infection Redundant Other Device position Left suprapectoral Left axillary Other No. of leads 1 2 3
SelectSecure (n ¼ 22)
Conventional leads (n ¼ 35)
P
48.6 ⫾ 20.1 17.6 ⫾ 10.5 4.1 ⫾ 2.6 11 10 12
46.3 ⫾ 18.3 17.6 ⫾ 10.8 6.7 ⫾ 2.6 24 17 18
.83 .9 .01 .17 .9 .71
3 5 7 1 2 4
7 9 10 0 3 6
.7 .8 .7 .38 .9 .9
14 4 4
20 7 8
.97 .9 .9
21 1
32 2 1
.9 .9
* Complete capture/sensing failure. †
Suboptimal sensing/pacing in addition to radiographic appearance of lead. No concerns regarding lead performance; however, significant patient growth anticipated.
‡
Shepherd et al
Extraction of SelectSecure Leads vs Conventional Pacing Leads
Extraction methods All lead extractions were performed in a hybrid operating room/catheter laboratory. General anesthesia and arterial monitoring were used for all patients. Transesophageal echocardiography was not routinely used, although transthoracic echocardiography was immediately available if required. For the SelectSecure extractions, the leads were dissected out using electrocautery (PlasmaBlades, Medtronic). The surrounding tissue was separated from the lead up to the clavicle, and gentle traction was then applied. For leads that were in situ for less than 2 years, minimal traction was required. If the lead did not come out with gentle traction, polypropylene sheaths of various lengths were advanced over the lead. In cases in which this was unsuccessful, the Evolution cutting sheath was used to extract the lead. Nine of the SelectSecure leads were removed with gentle traction alone, 7 required polypropylene sheaths, and 6 were extracted using the Evolution cutting sheath. Only 2 of the conventional pacing leads were extracted using manual traction. Of note, when using the Evolution cutting sheath on a SelectSecure lead there is a significant mismatch between the diameter of the lead and sheath, so considerable bleeding through the sheath can occur when entering the vessel lumen. One patient who underwent a SelectSecure lead extraction had a monosomy 13-associated hemophilia disorder with a very high bleeding risk. Two SelectSecure leads had been implanted 6 years earlier for congenital atrioventricular block. A pacemaker generator change had been planned; however, we elected to also replace the ventricular lead because there was inadequate slack for growth noted on chest radiography. After taking appropriate precautions with blood products and clotting factors, the lead extraction was performed. Because of the patient’s high risk for bleeding, we were hesitant to use cutting sheaths. The lead was extracted using gentle traction over approximately 30 minutes.
Complications No deaths occurred. There was 1 pericardial effusion that required drainage and 1 surgical extraction in the conventional pacing lead group (Table 2). Hospital stay was not significantly different between groups and was mostly less than 2 days. Intraoperative bleeding (estimated to be o50 mL) was seen in 2 of the SelectSecure extractions and in 1 of the conventional pacing lead extractions. None of these episodes required a blood transfusion. Complications such as hypotension, infection, and hematoma were uncommon and not significantly different between groups. All patients underwent transthoracic echocardiography before and after extraction. We looked for evidence of increased tricuspid regurgitation as judged by echocardiography immediately after the lead extraction was performed. There was no increase in the amount of procedure-related tricuspid regurgitation in the SelectSecure group. Five patients who had extraction of
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Table 2 Details of extraction including complications after lead extraction
Variable
Conventional SelectSecure leads P value (n ¼ 22) (n ¼ 35) (odds ratio)
Lead age (y) 4.1 ⫾ Patient related Prolonged length of 3 stay (42 days) Bleeding 2 Minor 2 Major 0 Hypotension 1 Hematoma 1 Increased tricuspid 0 regurgitation Infection 0 Pericardial effusion 0 Surgical extraction 0 Death 0 Lead related Partial extraction 1 Femoral extraction 0 1 Complex extraction* Procedure related Fluoroscopy time 15.6 ⫾ (min) 348 ⫾ Radiation dose (μGy m2) Procedural time (min) 139 ⫾
2.6
6.7 ⫾ 2.6
.01
5
.38
1 1 0 2 2 5
.31 .85 .57 .06
2 1 1 0
.26 .43 .43 NS
10 6 13
.03 .07 o.01
12.1 23.3 ⫾ 15.2 .07 (0.9–9.7) 237
552 ⫾ 312 .07 (0.9–5.7)
61
167 ⫾ 69
12 (0.8–4.7)
* Composite end-point of femoral extraction/partial extraction.
conventional leads demonstrated an increased amount of tricuspid regurgitation (P ¼ .06). Of these patients, 3 had moderate tricuspid regurgitation and 2 had mild tricuspid regurgitation (see Online Supplemental Table 2). Three patients had only an atrial lead extracted (1 in the SelectSecure group), and no change in the severity of tricuspid regurgitation was noted in these patients after the procedure. Procedure-related tricuspid regurgitation did not require any treatment, and the severity did not increase over the time period of the study. Mean fluoroscopy times tended to be shorter (15.6 ⫾ 12.1 minutes vs 23.3 ⫾ 15.2 minutes, P ¼ .07), radiation doses were lower (348 ⫾ 237 μGy vs 552 ⫾ 312 μGy, P ¼ .07), and procedural times shorter (139 ⫾ 61 minutes vs 167 ⫾ 69 minutes) for the SelectSecure extractions; however, the differences were not statistically significant. On a total of 11 occasions part of the lead was left behind, in most cases part of the tip of the lead. The most common place for the tip to lodge was the ventricle, followed by the left subclavian vein at the extraction point. Ten of the leads that were partially extracted were in the conventional group, with only 1 in the SelectSecure group (P ¼ .03). Six of the conventional pacing leads required extraction using a femoral approach, all of which were performed using a Needle’s Eye Snares (Cook Medical). None of the SelectSecure leads required extraction using a femoral approach (P ¼ .07). The composite end-point of a complex extraction (partial extraction/femoral extraction) was significantly
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Figure 1 Lead age of the SelectSecure and conventional pacing lead groups and complex (partial/femoral extraction)/noncomplex extractions. SelectSecure lead age is lower than that of the conventional pacing group; however, there is considerable overlap of lead age between the non-complex SelectSecure extractions and the complex conventional pacing lead extractions.
higher in the conventional pacing lead group (13/35) compared to the SelectSecure group (1/22; P o .01). Figure 1 shows both groups of patients divided into complex and noncomplex extractions plotted against lead age.
Multivariate analysis Variables that were significant at the univariate level and variables believed to be clinically important were entered into a multivariate analysis for the outcomes of both a complex extraction (partial extraction/femoral extraction) and for increased procedure-related tricuspid regurgitation (Table 3). Variables of lead age, presence of congenital heart disease, multiple leads, age of patient, and type of lead were entered into the model. For the outcome of complex extraction, only lead age (P ¼ .02) and use of conventional pacing leads (P ¼ .04) were risk factors for a complex extraction. A separate model run using the interaction factor between lead age and lead type demonstrated that the interaction factor was not significant (P ¼ .43). For the outcome of increased tricuspid regurgitation, only the presence of congenital heart disease (P ¼ .16) and use of conventional pacing leads (P ¼ .09) approached statistical significance.
Discussion This study examined the results of SelectSecure lead extractions and compared them to conventional stylettedriven pacing leads. Although the incidence of major complications was low, SelectSecure leads were less likely to require extraction using a femoral approach and were less likely to be partially extracted. Leads that were in situ longer were more likely to undergo a complex extraction (partial extraction/femoral extraction); however, the type of lead used was an independent risk factor for this outcome. With extractions being one of the more hazardous procedures performed in the catheterization laboratory, this has important implications for the choice of pacing lead that we implant in this patient group.5,9,14,15
Heart Rhythm, Vol 12, No 6, June 2015 With the advent of smaller generators and leads, we are seeing an increasing number of pediatric patients who have undergone transvenous pacing from a young age.16,17 In a recent study looking at 5521 lead extractions, the 30-day mortality was 2.2%, and the risk of a major complication was 1.8%. Lead age was a significant predictor of mortality/major complications, as was the use of mechanical sheaths.18 The mean age of lead extracted was 4.7 years, which is similar to our study. Although comorbid conditions such as infection, cardiovascular disease, and bleeding disorders likely account for some of the mortality difference seen between this study and similar pediatric studies,2,19 the use of mechanical sheaths likely also plays a role. Nine of 22 SelectSecure leads in our study were extracted using traction alone, whereas only 2 of the conventional pacing leads were extracted in this manner. This alone confers an advantage in terms of reducing lead extraction-related complications. It is likely that the smaller lead causes less fibrosis and adherence to the vessel wall, thus making it possible in more cases to extract without a cutting sheath.20 It also is possible that, with patience, more of the SelectSecure leads could be removed with gentle traction alone. This may be the best way of extracting these leads, as most of the cutting sheaths are designed for bigger leads, and the mismatch in sheath/lead size may result in an increased risk of vessel perforation. Garnreiter et al13 showed that these leads can be removed using manual traction alone, with the oldest lead in this cohort being 4 years. Nevertheless, in many cases a cutting sheath will still be required for extensively fibrosed leads having many adhesion points. Also, given that the oldest SelectSecure lead in our study is only 9 years, it remains to be seen whether these leads will come out with traction alone when they have been in situ for longer periods of time. Our study showed that the overall risk of a major complication from lead extraction in pediatric and ACHD patients was low. Minor complications were more common; however, it was difficult to demonstrate significant differences between the groups given the small number of patients in the study. Patients with conventional pacing leads were much more likely to have a complex extraction, which involves either a partially extracted lead or the need to extract using a femoral approach. The reason for this likely is multifactorial, with factors such as a smaller lead, less vessel fibrosis, a solid lead core, and less vessel stenosis all likely to account for the difference. As with other studies, lead age Table 3 Multivariate regression model demonstrating risk factors for a complex extraction (either partial extraction or femoral extraction) and also increased tricuspid regurgitation
Lead age Congenital heart disease 41 lead Age procedure Conventional pacing lead
Risk factors for complex extraction
Risk factors for increased tricuspid regurgitation
P¼ P¼ P¼ P¼ P¼
P¼ P¼ P¼ P¼ P¼
.02 .47 .20 .20 .04
.40 .16 .32 .49 .09
Shepherd et al
Extraction of SelectSecure Leads vs Conventional Pacing Leads
was also a strong predictor of having a complex extraction.18 One could argue that this is a confounding bias given that SelectSecure leads have been implanted only since 2004. In the multivariable analysis, however, use of conventional pacing leads was still significant even with lead age in the model. In addition, as show in Figure 1 there is significant overlap in lead age between patients in the SelectSecure group who had noncomplex extractions and those in the conventional pacing group who had complex extractions. Bharmanee et al21 looked at how SelectSecure affected valve integrity and found that these leads were much less likely to cause increased valve regurgitation after implantation. We noted that there was an increase in procedure-related tricuspid regurgitation when extracting conventional pacing leads. This likely is related to the smaller size of the SelectSecure leads, which have a lesser tendency to adhere to cardiac structures such as the tricuspid valve. The only surgical extraction was performed on a patient with a conventional pacing lead that had formed a small loop in the heart that was adherent to the tricuspid valve. It was not possible to dissect apart the loop using the cutting sheath. There was a trend toward decreased procedural times and radiation exposure in the SelectSecure group; however, this was not statistically significant. It is possible that by attempting to extract more SelectSecure leads with traction alone, this difference would be more pronounced. Given that many of these patients will require multiple procedures, exposure to less ionizing radiation during extraction would seem like a significant advantage to using these leads.22
Study limitations This is a retrospective study and comes with the confounding bias of this particular type of study. One of the main limitations is the relatively short duration that the SelectSecure leads have been in situ. In pediatric patients, regular replacement usually is necessary to facilitate patient growth; pacing leads in adult patients are often in situ for much longer periods. Although lead age in our study is comparable to that in other studies, it is possible that the results of this study may not apply to patients with older pacing leads. Also, we cannot completely exclude that the lower incidence of complex extraction (partial extraction/femoral extraction) in the SelectSecure group is related to lead age. It is noteworthy that patients with structural ACHD are less likely to have a significant cardiac perforation due to sternal adhesions related to cardiac surgery, This may limit the wider application of this study given the significant proportion of these patients in our cohort.
Conclusion The SelectSecure pacing lead appears to be easier to extract, is less likely to be partially extracted, and is less likely to require extraction using a femoral approach. Although the initial results are promising, whether these leads will be
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extractable with a low complication rate when they have been in situ for longer periods of time remains to be seen.
Appendix Supplementary data Supplementary data associated with this article can be found in the online version at http://dx.doi.org/10.1016/j.hrthm. 2015.03.004.
References 1. Cantu F, De Filippo P, Gabbarini F, Borghi A, Brambilla R, Ferrero P, Comisso J, Marotta T, De Luca A, Gavazzi A. Selective-site pacing in paediatric patients: a new application of the Select Secure system. Europace 2009;11:601–606. 2. Cecchin F, Atallah J, Walsh EP, Triedman JK, Alexander ME, Berul CI. Lead extraction in pediatric and congenital heart disease patients. Circ Arrhythm Electrophysiol 2010;3:437–444. 3. Gabbarini F, Agnoletti G. Selective-site pacing in paediatric patients: use of the SelectSecure System and risk of vein occlusion. Europace 2010;12:1286–1289. 4. Zartner PA, Wiebe W, Toussaint-Goetz N, Schneider MB. Lead removal in young patients in view of lifelong pacing. Europace 2010;12:714–718. 5. Bongiorni MG, Blomstrom-Lundqvist C, Kennergren C, Dagres N, Pison L, Svendsen JH, Auricchio A; Scientific Initiative Committee EHRA. Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey. Europace 2012;14:783–786. 6. Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol 2012;5:252–257. 7. Chakrabarti S, Morgan GJ, Kenny D, Walsh KP, Oslizlok P, Martin RP, Turner MS, Stuart AG. Initial experience of pacing with a lumenless lead system in patients with congenital heart disease. Pacing Clin Electrophysiol 2009;32:1428–1433. 8. Kenny D, Walsh KP. Noncatheter-based delivery of a single-chamber lumenless pacing lead in small children. Pacing Clin Electrophysiol 2007;30:834–838. 9. Khan A, Zelin K, Karpawich PP. Performance of the lumenless 4.1-Fr diameter pacing lead implanted at alternative pacing sites in congenital heart: a chronic 5year comparison. Pacing Clin Electrophysiol 2010;33:1467–1474. 10. Gammage MD, Lieberman RA, Yee R, Manolis AS, Compton SJ, Khazen C, Schaaf K, Oleson KA, Crossley GH; Worldwide SelectSecure Clinical Investigators. Multi-center clinical experience with a lumenless, catheter-delivered, bipolar, permanent pacemaker lead: implant safety and electrical performance. Pacing Clin Electrophysiol 2006;29:858–865. 11. Tuzcu V. Implantation of SelectSecure leads in children. Pacing Clin Electrophysiol 2007;30:831–833. 12. Atallah J, Erickson CC, Cecchin F, et al. Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation 2013;127:2393–2402. 13. Garnreiter J, Whitaker P, Pilcher T, Etheridge S, Saarel E. Lumenless pacing leads: performance and extraction in pediatrics and congenital heart disease. Pacing Clin Electrophysiol 2015;38:42–47. 14. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverterdefibrillator and pacemaker lead extraction. Europace 2010;12:395–401. 15. McLeod KA. Cardiac pacing in infants and children. Heart 2010;96:1502–1508. 16. Walsh EP. Practical aspects of implantable defibrillator therapy in patients with congenital heart disease. Pacing Clin Electrophysiol 2008;31(Suppl 1):S38–S40. 17. Silvetti MS, Drago F, Di Carlo D, Placidi S, Brancaccio G, Carotti A. Cardiac pacing in paediatric patients with congenital heart defects: transvenous or epicardial? Europace 2013;15:1280–1286. 18. Brunner MP, Cronin EM, Duarte VE, et al. Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm 2014;11:799–805. 19. Khairy P, Roux JF, Dubuc M, Thibault B, Guerra PG, Macle L, Mercier LA, Dore A, Roy D, Talajic M, Page P. Laser lead extraction in adult congenital heart disease. J Cardiovasc Electrophysiol 2007;18:507–511. 20. Figa FH, McCrindle BW, Bigras JL, Hamilton RM, Gow RM. Risk factors for venous obstruction in children with transvenous pacing leads. Pacing Clin Electrophysiol 1997;20:1902–1909. 21. Bharmanee A, Zelin K, Singh H, Karpawich P. Improved atrioventricular valve integrity with use of the newer 4.1 French diameter pacing lead in the young with and without congenital heart. Circulation 2013;128:A12056. 22. Walsh MA, Noga M, Rutledge J. Cumulative radiation exposure in pediatric patients with congenital heart disease. Pediatr Cardiology 2014;36:289–294.
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CLINICAL PERSPECTIVES This study compared extraction of the lumenless SelectSecure™ pacing leads to conventional stylette-driven pacing leads. It demonstrated that these leads are less likely to require extraction using a femoral approach and are more likely to be completely extracted. In addition, less procedure-related tricuspid regurgitation occurs after extraction of SelectSecure leads compared to conventional pacing leads. A significant proportion of the SelectSecure leads can be extracted using manual traction alone and do not require cutting sheaths. Although lead age is clearly a risk factor for a more complicated extraction, whether SelectSecure leads can be extracted as easily when they have been in place for longer periods of time remains to be seen. The apparent ease of extraction of these leads is advantageous for patients who require pacing from a young age because they are more likely to require pacemaker lead changes.
age at the time of extraction was 17.6 ⫾ 10.5 years, mean weight was 47 ⫾ 18 kg, and mean lead age was 5.6 ⫾ 2.6 years (range 1–11 years). Complex extraction (partial extraction/femoral extraction) was more common in patients with conventional pacing leads at univariate (P o .01) and multivariate (P ¼ .04) levels. Lead age was also a significant predictor of complex extraction (P o .01). CONCLUSION SelectSecure leads can be successfully extracted using techniques that are used for conventional pacing leads. They are less likely to be partially extracted and are less likely to require extraction using a femoral approach compared with conventional pacing leads. KEYWORDS SelectSecure pacing lead; Lead extraction; Pediatrics; Congenital heart disease; Pacemaker; Congenital heart block ABBREVIATIONS ACHD ¼ adult structural congenital heart disease
RESULTS A total of 57 patients underwent pacemaker lead extractions (22 SelectSecure, 35 conventional). No deaths occurred. Mean
(Heart Rhythm 2015;12:1227–1232) I 2015 Heart Rhythm Society. All rights reserved.
Introduction
patients.10,11 Because the SelectSecure has a solid core, the lead must be extracted without the use of a locking stylet.10 Data on lead extraction in pediatric and adult congenital heart disease (ACHD) patients are limited, particularly in relation to SelectSecure extractions.2,12,13 An understanding of the outcomes associated with lead extraction, along with the nuances required for each type of lead, is essential to optimize our choice of pacing lead.2,14 We report our tertiary center experience on extraction of SelectSecure leads compared to conventional (stylette-driven) pacing leads in a cohort of pediatric and ACHD patients.
In recent years, permanent transvenous pacemaker and defibrillator implantation have become therapeutic modalities frequently used in children and young adults with structural congenital heart disease.1–4 With increasing life expectancy in this subset of patients, lead extraction is inevitable, and a parallel increase in the need for extraction has been observed.2,5,6 Although transvenous leads are more reliable than epicardial leads, concern remains regarding long-term vascular complications.4 Removal of dysfunctional leads improves vessel patency, but extraction of chronically implanted leads is a complex procedure associated with significant morbidity and, in some cases, mortality.4 The SelectSecure™ (Medtronic Inc, Minneapolis, MN) is a lumenless lead with a smaller diameter (4.1Fr) that has been implanted since 2004.1,7–9 The smaller lead diameter makes it ideal for transvenous pacing in younger Address reprint requests and correspondence: Dr. Mark Walsh, Bristol Royal Hospital for Children, Upper Maudlin St, Bristol, BS2 8BJ, United Kingdom. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
Methods This single institutional retrospective study was conducted with the approval of the Research Ethics Board at University Hospitals Bristol NHS Foundation Trust. Pediatric and ACHD patients who had undergone lead extraction between August 2004 and July 2014 were included in the study. A list of these patients was obtained from the cardiac database at the Bristol Royal Hospital for Children and the Bristol Heart Institute. Patients were included in the study if the initial lead http://dx.doi.org/10.1016/j.hrthm.2015.03.004
1228 was implanted during childhood or if the pacemaker lead was implanted as an adult with structural congenital heart disease. Patients in whom the SelectSecure lead was extracted at the same time as a defibrillator lead were not included. Echocardiogram reports were reviewed, predominantly looking for postextraction effusions. The reported grade of tricuspid regurgitation was assessed after the extraction and compared to the previously reported grade of tricuspid regurgitation. Clinical details in relationship to the extraction, including any radiographic imaging performed around the time of extraction, also were reviewed. Given the low incidence of major complications, we chose a composite end-point of complex extraction as the primary outcome variable. This was defined as either a partial extraction (leaving some or all of the lead in situ) or the need to extract using a femoral approach. The method of extraction was also assessed, examining whether a cutting sheath was required and the type of cutting sheath used. The 2 cutting sheaths used were the polypropylene telescoping sheath (Cook, Bloomington, Indiana) and the Evolutions (Cook, Bloomington, IN). The Perfectas electrosurgical dissection sheath (Cook) was used for 14 cases before the Evolution was used. Major complications of pericardial effusion requiring intervention, need for surgical extraction, or death were recorded. Minor complications consisted of bleeding, hematoma formation, infection, prolonged length of stay (42 days), and hypotension. Bleeding was defined as minor if blood loss was documented in the procedure note (estimated to be o50 mL) and major if it was associated with hypotension or required blood transfusion.
Statistical analysis Demographic data are presented as mean ⫾SD. A Fisher exact test was used to test for significance in categorical variables between groups. Outcome variables were all tested at the univariate level using logistic regression. Variables of clinical significance were then entered into a generalized estimating equation (PROC GENMOD), and odds ratios were calculated where appropriate. Given that lead age and lead type were confounding variables (due to the recent trend to implant SelectSecure leads), the interaction between these 2 variables was entered into our final model. P o.05 was considered significant. All statistical analysis was performed using SAS (version 9.2, SAS Institute, Cary, NC).
Results From August 2004 to July 2014, a total of 623 pacemaker leads were implanted in pediatric and ACHD patients at Bristol Royal Hospital for Children and the Bristol Heart Institute. A total of 57 lead extractions were performed during the same time period. Of these, 22 were SelectSecure leads and 35 were conventional pacing leads. Lead extractions were performed by 3 operators (GS, RM, MW). There was no difference between operators for the outcome of complex extraction (partial/femoral extraction) (P = .58).
Heart Rhythm, Vol 12, No 6, June 2015 Baseline patient demographics are listed in Table 1. Mean age at which patients underwent lead extraction was 17.6 years for both groups. There were 35 males and 22 females. A total of 30 patients who had congenital heart disease underwent explantation; the rest of the patients had congenital complete atrioventricular block. Of the 35 conventional pacing leads that were extracted, 19 were active fixation leads, and all of them were steroid eluting (see Online Supplemental Table 1). Mean lead age was 4.1 ⫾ 2.6 years for the SelectSecure group and 6.7 ⫾ 2.6 years for the conventional pacing lead group, which was significantly different (P o .01). The indications for extraction are listed in Table 1. Lead failure (defined as complete failure of sensing/pacing) was an indication in 10 patients. For 14 patients, the indication for extraction was suboptimal sensing/pacing thresholds in addition to the radiographic appearance of lead tension. For 17 patients, the lead was replaced because of radiographic evidence of lead tension in addition to anticipated patient growth in the presence of a normally functioning lead, usually at the time of a generator change. There were no significant differences in the indication for extraction between the 2 groups. The devices were most commonly implanted in the left suprapectoral region, followed by the left axilla, which was not significantly different between the groups. Most patients underwent a single lead extraction; only 4 patients had more than 1 lead extracted, which was not significantly different between groups.
Table 1 Comparison of patient characteristics between conventional pacing lead and SelectSecure lead groups Variable Weight at explant (kg) Age at explant (y) Lead age (y) Gender, male Congenital heart block Congenital heart disease Indication Lead failure* System upgrade† Growth‡ Infection Redundant Other Device position Left suprapectoral Left axillary Other No. of leads 1 2 3
SelectSecure (n ¼ 22)
Conventional leads (n ¼ 35)
P
48.6 ⫾ 20.1 17.6 ⫾ 10.5 4.1 ⫾ 2.6 11 10 12
46.3 ⫾ 18.3 17.6 ⫾ 10.8 6.7 ⫾ 2.6 24 17 18
.83 .9 .01 .17 .9 .71
3 5 7 1 2 4
7 9 10 0 3 6
.7 .8 .7 .38 .9 .9
14 4 4
20 7 8
.97 .9 .9
21 1
32 2 1
.9 .9
* Complete capture/sensing failure. †
Suboptimal sensing/pacing in addition to radiographic appearance of lead. No concerns regarding lead performance; however, significant patient growth anticipated.
‡
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Extraction of SelectSecure Leads vs Conventional Pacing Leads
Extraction methods All lead extractions were performed in a hybrid operating room/catheter laboratory. General anesthesia and arterial monitoring were used for all patients. Transesophageal echocardiography was not routinely used, although transthoracic echocardiography was immediately available if required. For the SelectSecure extractions, the leads were dissected out using electrocautery (PlasmaBlades, Medtronic). The surrounding tissue was separated from the lead up to the clavicle, and gentle traction was then applied. For leads that were in situ for less than 2 years, minimal traction was required. If the lead did not come out with gentle traction, polypropylene sheaths of various lengths were advanced over the lead. In cases in which this was unsuccessful, the Evolution cutting sheath was used to extract the lead. Nine of the SelectSecure leads were removed with gentle traction alone, 7 required polypropylene sheaths, and 6 were extracted using the Evolution cutting sheath. Only 2 of the conventional pacing leads were extracted using manual traction. Of note, when using the Evolution cutting sheath on a SelectSecure lead there is a significant mismatch between the diameter of the lead and sheath, so considerable bleeding through the sheath can occur when entering the vessel lumen. One patient who underwent a SelectSecure lead extraction had a monosomy 13-associated hemophilia disorder with a very high bleeding risk. Two SelectSecure leads had been implanted 6 years earlier for congenital atrioventricular block. A pacemaker generator change had been planned; however, we elected to also replace the ventricular lead because there was inadequate slack for growth noted on chest radiography. After taking appropriate precautions with blood products and clotting factors, the lead extraction was performed. Because of the patient’s high risk for bleeding, we were hesitant to use cutting sheaths. The lead was extracted using gentle traction over approximately 30 minutes.
Complications No deaths occurred. There was 1 pericardial effusion that required drainage and 1 surgical extraction in the conventional pacing lead group (Table 2). Hospital stay was not significantly different between groups and was mostly less than 2 days. Intraoperative bleeding (estimated to be o50 mL) was seen in 2 of the SelectSecure extractions and in 1 of the conventional pacing lead extractions. None of these episodes required a blood transfusion. Complications such as hypotension, infection, and hematoma were uncommon and not significantly different between groups. All patients underwent transthoracic echocardiography before and after extraction. We looked for evidence of increased tricuspid regurgitation as judged by echocardiography immediately after the lead extraction was performed. There was no increase in the amount of procedure-related tricuspid regurgitation in the SelectSecure group. Five patients who had extraction of
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Table 2 Details of extraction including complications after lead extraction
Variable
Conventional SelectSecure leads P value (n ¼ 22) (n ¼ 35) (odds ratio)
Lead age (y) 4.1 ⫾ Patient related Prolonged length of 3 stay (42 days) Bleeding 2 Minor 2 Major 0 Hypotension 1 Hematoma 1 Increased tricuspid 0 regurgitation Infection 0 Pericardial effusion 0 Surgical extraction 0 Death 0 Lead related Partial extraction 1 Femoral extraction 0 1 Complex extraction* Procedure related Fluoroscopy time 15.6 ⫾ (min) 348 ⫾ Radiation dose (μGy m2) Procedural time (min) 139 ⫾
2.6
6.7 ⫾ 2.6
.01
5
.38
1 1 0 2 2 5
.31 .85 .57 .06
2 1 1 0
.26 .43 .43 NS
10 6 13
.03 .07 o.01
12.1 23.3 ⫾ 15.2 .07 (0.9–9.7) 237
552 ⫾ 312 .07 (0.9–5.7)
61
167 ⫾ 69
12 (0.8–4.7)
* Composite end-point of femoral extraction/partial extraction.
conventional leads demonstrated an increased amount of tricuspid regurgitation (P ¼ .06). Of these patients, 3 had moderate tricuspid regurgitation and 2 had mild tricuspid regurgitation (see Online Supplemental Table 2). Three patients had only an atrial lead extracted (1 in the SelectSecure group), and no change in the severity of tricuspid regurgitation was noted in these patients after the procedure. Procedure-related tricuspid regurgitation did not require any treatment, and the severity did not increase over the time period of the study. Mean fluoroscopy times tended to be shorter (15.6 ⫾ 12.1 minutes vs 23.3 ⫾ 15.2 minutes, P ¼ .07), radiation doses were lower (348 ⫾ 237 μGy vs 552 ⫾ 312 μGy, P ¼ .07), and procedural times shorter (139 ⫾ 61 minutes vs 167 ⫾ 69 minutes) for the SelectSecure extractions; however, the differences were not statistically significant. On a total of 11 occasions part of the lead was left behind, in most cases part of the tip of the lead. The most common place for the tip to lodge was the ventricle, followed by the left subclavian vein at the extraction point. Ten of the leads that were partially extracted were in the conventional group, with only 1 in the SelectSecure group (P ¼ .03). Six of the conventional pacing leads required extraction using a femoral approach, all of which were performed using a Needle’s Eye Snares (Cook Medical). None of the SelectSecure leads required extraction using a femoral approach (P ¼ .07). The composite end-point of a complex extraction (partial extraction/femoral extraction) was significantly
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Figure 1 Lead age of the SelectSecure and conventional pacing lead groups and complex (partial/femoral extraction)/noncomplex extractions. SelectSecure lead age is lower than that of the conventional pacing group; however, there is considerable overlap of lead age between the non-complex SelectSecure extractions and the complex conventional pacing lead extractions.
higher in the conventional pacing lead group (13/35) compared to the SelectSecure group (1/22; P o .01). Figure 1 shows both groups of patients divided into complex and noncomplex extractions plotted against lead age.
Multivariate analysis Variables that were significant at the univariate level and variables believed to be clinically important were entered into a multivariate analysis for the outcomes of both a complex extraction (partial extraction/femoral extraction) and for increased procedure-related tricuspid regurgitation (Table 3). Variables of lead age, presence of congenital heart disease, multiple leads, age of patient, and type of lead were entered into the model. For the outcome of complex extraction, only lead age (P ¼ .02) and use of conventional pacing leads (P ¼ .04) were risk factors for a complex extraction. A separate model run using the interaction factor between lead age and lead type demonstrated that the interaction factor was not significant (P ¼ .43). For the outcome of increased tricuspid regurgitation, only the presence of congenital heart disease (P ¼ .16) and use of conventional pacing leads (P ¼ .09) approached statistical significance.
Discussion This study examined the results of SelectSecure lead extractions and compared them to conventional stylettedriven pacing leads. Although the incidence of major complications was low, SelectSecure leads were less likely to require extraction using a femoral approach and were less likely to be partially extracted. Leads that were in situ longer were more likely to undergo a complex extraction (partial extraction/femoral extraction); however, the type of lead used was an independent risk factor for this outcome. With extractions being one of the more hazardous procedures performed in the catheterization laboratory, this has important implications for the choice of pacing lead that we implant in this patient group.5,9,14,15
Heart Rhythm, Vol 12, No 6, June 2015 With the advent of smaller generators and leads, we are seeing an increasing number of pediatric patients who have undergone transvenous pacing from a young age.16,17 In a recent study looking at 5521 lead extractions, the 30-day mortality was 2.2%, and the risk of a major complication was 1.8%. Lead age was a significant predictor of mortality/major complications, as was the use of mechanical sheaths.18 The mean age of lead extracted was 4.7 years, which is similar to our study. Although comorbid conditions such as infection, cardiovascular disease, and bleeding disorders likely account for some of the mortality difference seen between this study and similar pediatric studies,2,19 the use of mechanical sheaths likely also plays a role. Nine of 22 SelectSecure leads in our study were extracted using traction alone, whereas only 2 of the conventional pacing leads were extracted in this manner. This alone confers an advantage in terms of reducing lead extraction-related complications. It is likely that the smaller lead causes less fibrosis and adherence to the vessel wall, thus making it possible in more cases to extract without a cutting sheath.20 It also is possible that, with patience, more of the SelectSecure leads could be removed with gentle traction alone. This may be the best way of extracting these leads, as most of the cutting sheaths are designed for bigger leads, and the mismatch in sheath/lead size may result in an increased risk of vessel perforation. Garnreiter et al13 showed that these leads can be removed using manual traction alone, with the oldest lead in this cohort being 4 years. Nevertheless, in many cases a cutting sheath will still be required for extensively fibrosed leads having many adhesion points. Also, given that the oldest SelectSecure lead in our study is only 9 years, it remains to be seen whether these leads will come out with traction alone when they have been in situ for longer periods of time. Our study showed that the overall risk of a major complication from lead extraction in pediatric and ACHD patients was low. Minor complications were more common; however, it was difficult to demonstrate significant differences between the groups given the small number of patients in the study. Patients with conventional pacing leads were much more likely to have a complex extraction, which involves either a partially extracted lead or the need to extract using a femoral approach. The reason for this likely is multifactorial, with factors such as a smaller lead, less vessel fibrosis, a solid lead core, and less vessel stenosis all likely to account for the difference. As with other studies, lead age Table 3 Multivariate regression model demonstrating risk factors for a complex extraction (either partial extraction or femoral extraction) and also increased tricuspid regurgitation
Lead age Congenital heart disease 41 lead Age procedure Conventional pacing lead
Risk factors for complex extraction
Risk factors for increased tricuspid regurgitation
P¼ P¼ P¼ P¼ P¼
P¼ P¼ P¼ P¼ P¼
.02 .47 .20 .20 .04
.40 .16 .32 .49 .09
Shepherd et al
Extraction of SelectSecure Leads vs Conventional Pacing Leads
was also a strong predictor of having a complex extraction.18 One could argue that this is a confounding bias given that SelectSecure leads have been implanted only since 2004. In the multivariable analysis, however, use of conventional pacing leads was still significant even with lead age in the model. In addition, as show in Figure 1 there is significant overlap in lead age between patients in the SelectSecure group who had noncomplex extractions and those in the conventional pacing group who had complex extractions. Bharmanee et al21 looked at how SelectSecure affected valve integrity and found that these leads were much less likely to cause increased valve regurgitation after implantation. We noted that there was an increase in procedure-related tricuspid regurgitation when extracting conventional pacing leads. This likely is related to the smaller size of the SelectSecure leads, which have a lesser tendency to adhere to cardiac structures such as the tricuspid valve. The only surgical extraction was performed on a patient with a conventional pacing lead that had formed a small loop in the heart that was adherent to the tricuspid valve. It was not possible to dissect apart the loop using the cutting sheath. There was a trend toward decreased procedural times and radiation exposure in the SelectSecure group; however, this was not statistically significant. It is possible that by attempting to extract more SelectSecure leads with traction alone, this difference would be more pronounced. Given that many of these patients will require multiple procedures, exposure to less ionizing radiation during extraction would seem like a significant advantage to using these leads.22
Study limitations This is a retrospective study and comes with the confounding bias of this particular type of study. One of the main limitations is the relatively short duration that the SelectSecure leads have been in situ. In pediatric patients, regular replacement usually is necessary to facilitate patient growth; pacing leads in adult patients are often in situ for much longer periods. Although lead age in our study is comparable to that in other studies, it is possible that the results of this study may not apply to patients with older pacing leads. Also, we cannot completely exclude that the lower incidence of complex extraction (partial extraction/femoral extraction) in the SelectSecure group is related to lead age. It is noteworthy that patients with structural ACHD are less likely to have a significant cardiac perforation due to sternal adhesions related to cardiac surgery, This may limit the wider application of this study given the significant proportion of these patients in our cohort.
Conclusion The SelectSecure pacing lead appears to be easier to extract, is less likely to be partially extracted, and is less likely to require extraction using a femoral approach. Although the initial results are promising, whether these leads will be
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extractable with a low complication rate when they have been in situ for longer periods of time remains to be seen.
Appendix Supplementary data Supplementary data associated with this article can be found in the online version at http://dx.doi.org/10.1016/j.hrthm. 2015.03.004.
References 1. Cantu F, De Filippo P, Gabbarini F, Borghi A, Brambilla R, Ferrero P, Comisso J, Marotta T, De Luca A, Gavazzi A. Selective-site pacing in paediatric patients: a new application of the Select Secure system. Europace 2009;11:601–606. 2. Cecchin F, Atallah J, Walsh EP, Triedman JK, Alexander ME, Berul CI. Lead extraction in pediatric and congenital heart disease patients. Circ Arrhythm Electrophysiol 2010;3:437–444. 3. Gabbarini F, Agnoletti G. Selective-site pacing in paediatric patients: use of the SelectSecure System and risk of vein occlusion. Europace 2010;12:1286–1289. 4. Zartner PA, Wiebe W, Toussaint-Goetz N, Schneider MB. Lead removal in young patients in view of lifelong pacing. Europace 2010;12:714–718. 5. Bongiorni MG, Blomstrom-Lundqvist C, Kennergren C, Dagres N, Pison L, Svendsen JH, Auricchio A; Scientific Initiative Committee EHRA. Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey. Europace 2012;14:783–786. 6. Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol 2012;5:252–257. 7. Chakrabarti S, Morgan GJ, Kenny D, Walsh KP, Oslizlok P, Martin RP, Turner MS, Stuart AG. Initial experience of pacing with a lumenless lead system in patients with congenital heart disease. Pacing Clin Electrophysiol 2009;32:1428–1433. 8. Kenny D, Walsh KP. Noncatheter-based delivery of a single-chamber lumenless pacing lead in small children. Pacing Clin Electrophysiol 2007;30:834–838. 9. Khan A, Zelin K, Karpawich PP. Performance of the lumenless 4.1-Fr diameter pacing lead implanted at alternative pacing sites in congenital heart: a chronic 5year comparison. Pacing Clin Electrophysiol 2010;33:1467–1474. 10. Gammage MD, Lieberman RA, Yee R, Manolis AS, Compton SJ, Khazen C, Schaaf K, Oleson KA, Crossley GH; Worldwide SelectSecure Clinical Investigators. Multi-center clinical experience with a lumenless, catheter-delivered, bipolar, permanent pacemaker lead: implant safety and electrical performance. Pacing Clin Electrophysiol 2006;29:858–865. 11. Tuzcu V. Implantation of SelectSecure leads in children. Pacing Clin Electrophysiol 2007;30:831–833. 12. Atallah J, Erickson CC, Cecchin F, et al. Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation 2013;127:2393–2402. 13. Garnreiter J, Whitaker P, Pilcher T, Etheridge S, Saarel E. Lumenless pacing leads: performance and extraction in pediatrics and congenital heart disease. Pacing Clin Electrophysiol 2015;38:42–47. 14. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverterdefibrillator and pacemaker lead extraction. Europace 2010;12:395–401. 15. McLeod KA. Cardiac pacing in infants and children. Heart 2010;96:1502–1508. 16. Walsh EP. Practical aspects of implantable defibrillator therapy in patients with congenital heart disease. Pacing Clin Electrophysiol 2008;31(Suppl 1):S38–S40. 17. Silvetti MS, Drago F, Di Carlo D, Placidi S, Brancaccio G, Carotti A. Cardiac pacing in paediatric patients with congenital heart defects: transvenous or epicardial? Europace 2013;15:1280–1286. 18. Brunner MP, Cronin EM, Duarte VE, et al. Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm 2014;11:799–805. 19. Khairy P, Roux JF, Dubuc M, Thibault B, Guerra PG, Macle L, Mercier LA, Dore A, Roy D, Talajic M, Page P. Laser lead extraction in adult congenital heart disease. J Cardiovasc Electrophysiol 2007;18:507–511. 20. Figa FH, McCrindle BW, Bigras JL, Hamilton RM, Gow RM. Risk factors for venous obstruction in children with transvenous pacing leads. Pacing Clin Electrophysiol 1997;20:1902–1909. 21. Bharmanee A, Zelin K, Singh H, Karpawich P. Improved atrioventricular valve integrity with use of the newer 4.1 French diameter pacing lead in the young with and without congenital heart. Circulation 2013;128:A12056. 22. Walsh MA, Noga M, Rutledge J. Cumulative radiation exposure in pediatric patients with congenital heart disease. Pediatr Cardiology 2014;36:289–294.
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CLINICAL PERSPECTIVES This study compared extraction of the lumenless SelectSecure™ pacing leads to conventional stylette-driven pacing leads. It demonstrated that these leads are less likely to require extraction using a femoral approach and are more likely to be completely extracted. In addition, less procedure-related tricuspid regurgitation occurs after extraction of SelectSecure leads compared to conventional pacing leads. A significant proportion of the SelectSecure leads can be extracted using manual traction alone and do not require cutting sheaths. Although lead age is clearly a risk factor for a more complicated extraction, whether SelectSecure leads can be extracted as easily when they have been in place for longer periods of time remains to be seen. The apparent ease of extraction of these leads is advantageous for patients who require pacing from a young age because they are more likely to require pacemaker lead changes.
