- Email: [email protected]
Outcomes of lead extraction in young adults
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Outcomes of lead extraction in young adults Mikhael F. El-Chami, MD, FACC, FHRS,* Michael N. Sayegh, BS,† Adarsh Patel,‡ Jad El-Khalil,§ Yaanik Desai,† Angel R. Leon, MD,* Faisal M. Merchant, MD* From the *Department of Medicine, Division of Cardiology, Section of Electrophysiology, Emory University School of Medicine, Atlanta, Georgia, †Emory University School of Medicine, Atlanta, Georgia, ‡ Emory University, Atlanta, Georgia, and §Georgia State University, Atlanta, Georgia. BACKGROUND Extraction of pacemaker and defibrillator leads in young adults may be technically challenging because of more extensive fibrosis and calcification in this patient population. OBJECTIVE The purpose of this study was to examine outcomes of lead extraction (LE) in young adults at our institution. METHODS We retrospectively identified all patients who underwent LE at our institution between January 1, 2007, and May 31, 2016. Patients were divided by age into 2 groups: o40 years (group 1, n ¼ 84) or ≥40 years (group 2, n ¼ 690). Outcomes were determined by medical records review. RESULTS Patients in group 2 had a higher overall average number of leads extracted per procedure compared to group 1 (1.64 ± 0.80 vs 1.45 ± 0.64; P o.001). Lead dwell time was similar in the 2 groups (5.7 ± 5 years vs 5.6 ± 4.3 years; P ¼ .95). The younger cohort tended to require femoral extraction techniques more
Introduction Improvements in cardiac surgery and cardiovascular care have resulted in an increase in the number of patients with congenital heart disease (CHD) surviving to adulthood.1 These patients often develop conduction system disease or ventricular arrhythmia necessitating permanent pacemaker2 or implantable cardioverter–defibrillator (ICD) insertion.3 In addition, young patients with inherited channelopathy or cardiomyopathy may require ICD insertion for prevention of sudden cardiac death.4 Effective lead management represents an essential component of the long-term care of patients with cardiac implantable electronic devices (CIEDs), particularly younger patients with higher expected long-term survival.5 Patients surviving many years with CIEDs demonstrate higher rates of lead failure, with 40% of implanted ICD leads failing within 8 years after insertion.6 This rate of lead failure is Dr. El-Chami is a consultant for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Address reprint requests and correspondence: Dr. Mikhael El-Chami, Department of Medicine, Division of Cardiology, Section of Electrophysiology, Emory University School of Medicine, 6th Floor Medical Office Tower, 550 Peachtree St NE, Atlanta, GA 30308. E-mail address: [email protected].
1547-5271/$-see front matter B 2017 Heart Rhythm Society. All rights reserved.
frequently (9.5% vs 4.4%; P ¼ .055). Extraction procedural success (group 1: 94.1%, group 2: 94.9%; P ¼ .792), major complications (group 1: 0%, group 2: 1.3%; P ¼ 1), and periprocedural mortality (group 1: 0%, group 2: 0.86%; P ¼ 1) were similar in the 2 groups. CONCLUSION LE can be performed safely and effectively in young adults. Despite the lower number of leads extracted per procedure and the similar lead dwell time, younger adults more frequently required the use of femoral extraction tools, thus highlighting the importance of performing these procedures in centers with advanced expertise in extraction techniques. KEYWORDS Lead extraction; Femoral extraction; Outcomes; Young adults; Congenital heart disease (Heart Rhythm 2017;0:0–4) rights reserved.
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higher in young patients with CIEDs.7 Lead management of failed leads involves revision, removal, or active extraction.8 In younger patients, specific considerations including preservation of the contralateral subclavian vein for future access and minimizing the number of indwelling transvenous leads favor LE instead of adding more leads5 as a preferred strategy. Although revision offers a viable option in patients with malfunctioning leads, the management of CIED infection usually requires LE.8,9 Chronic indwelling pacing and defibrillating leads promote fibrosis and calcification in younger patients, making LE more challenging and risky in this patient population.5,10 Small case series have addressed the outcomes of lead extraction (LE) in pediatric and younger patients.7,11–13 However, few data exist on the outcomes of LE in these patients as they reach their 3rd and 4th decades of life. Therefore, we chose to assess the outcome of LE in patients younger than 40 years with CHD, channelopathy, or DCM at our institution.
Methods We retrospectively identified patients who underwent LE at our institution between January 1, 2007, and May 31, 2016. http://dx.doi.org/10.1016/j.hrthm.2017.01.030
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We defined LE using the Heart Rhythm Society (HRS) consensus statement as the extraction of any lead implanted for more than 1 year, a lead (irrespective of its implant duration) whose removal requires specialized extraction tools, or any lead extracted through access from a vein other than the one used for implant.8 Leads that did not fit the described definition were excluded from this analysis. The indication for LE and the technical approach taken were at the discretion of the individual operator. The indications for LE included (1) device-related infections (pocket infection or systemic infection); (2) lead malfunction; (3) upgrade of an existing CIED to a device requiring additional leads when venous occlusion required sacrificing an existing lead for access; and (4) physician and patient preference to remove a functioning but recalled lead. We defined procedural outcomes according to the HRS consensus statement, including procedural success as the complete removal of the lead(s) and lead material without any major complication or death.8 We defined clinical success as the removal of the targeted lead(s) or lead material despite retention of a small portion/fragment that did not negatively impact the clinical goals of the procedure, including major complications or death. We defined procedural failure as failure to achieve the above-defined procedural or clinical success, or major complication or death. During the first part of the study period (2007–2011), LE was performed in the electrophysiology laboratory with the patient under conscious sedation. There was no formal protocol in place for mobilization of a backup surgical team. Starting in mid-2012, an extraction protocol was introduced. Extraction of leads with a dwell time ≥5 years or any extraction that was considered high risk was performed with the patient under general anesthesia and, if possible, in the hybrid operating room. All LEs were performed by a standby cardiac surgical team. Transesophageal echocardiography was performed at the discretion of the operator during LE. Table 1
Our first-line approach to LE is the superior approach, relying mainly on laser-powered sheaths followed by mechanical tools. The femoral approach is mainly used as a alternate strategy if the superior approach is not completely successful. During the period of interest, a total of 7 electrophysiologists with variable levels of experience performed LE at our center. All of the extractors trained in the same institution and followed our general institutional approach to LE. Patients were divided into 2 groups based on age at the time of extraction: group 1 was o40 years and group 2 was ≥40 years. The Emory University Institutional Review Board approved the study protocol. Primary endpoints include the incidence of periprocedural death or major complications as defined by the HRS consensus statement (procedural death, need for urgent surgery, hemopericardium requiring drainage, or hemothorax requiring a chest tube). Secondary endpoints included the incidence of procedural and clinical success.
Statistical methods Continuous variables are given as mean ± SD, and categorical data are given as frequencies and percentages. A 2-tailed P o.05 was considered significant. Statistica (Statsoft, Tulsa, OK) was used to perform statistical analyses.
Results Retrospective analysis identified a total of 84 patients in group 1 and 690 in group 2. Mean age in group 1 was 30.3 ± 6 years compared to 66.2 ± 12.3 years in group 2 (P o.001). Patients in group 2 had more comorbidities compared to those in group 1 (Table 1). They were more likely to have coronary artery disease (45.2% vs 3.6%; P o.001), chronic kidney disease (stage III or worse) (21.3% vs 10. 7%, P ¼ .021), hypertension (67.3% vs 28.6%; P o.001), and
Baseline patient characteristics
Age (years) Male sex Height (cm) Weight (kg) Left ventricular ejection fraction (%) Coronary artery disease Chronic kidney disease Hypertension Diabetes mellitus No. of leads extracted per procedure ICD leads extracted per procedure Dwell time of oldest extracted lead (years) Indication for extraction Infection Lead dislodgment Lead malfunction Upgrade Other
Age o40 years (n ¼ 84)
Age ≥40 years (n ¼ 690)
P value
30.3 ± 6 49 (58.3) 170.6 ± 11.1 84.9 ± 21.4 40.8 ± 18.8 3 (3.6) 9 (10.7) 24 (28.6) 11 (13.1) 1.45 ± .64 0.68 ± .47 5.7 ± 5
66.2 ± 12.3 460 (66.7) 173.2 ± 12.4 88.3 ± 25.1 36.2 ± 16.5 312 (45.2) 147 (21.3) 464 (67.3) 214 (31) 1.64 ± .80 0.71 ± .45 5.6 ± 4.3
o.001 .144 .084 .260 .064 o.001 .021 o.001 o.001 .017 .0.172 .953
23 (27.4) 0 (0) 52 (61.9) 4 (4.8) 5 (5.9)
249 (36.1) 21 (3) 326 (47.3) 67 (9.7) 20 (2.9)
.146 .15 .015 .16 .178
Values are given as mean ± SD or n (%) unless otherwise indicated. ICD ¼ implantable cardioverter–defibrillator.
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Extraction in Young Adults
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diabetes (31 vs 13.1; P o.001). The older group had more leads extracted per procedure (1.64 ± 0.80 vs 1.45± 0.64; P o.017) (Table 1). Lead dwell time was similar in the 2 groups (5.6 ± 4.3 vs 5.7 ± 5; P ¼ .95), and younger patients were more likely to undergo LE for lead failure (61.9% vs 47.3%; P ¼ .015). From the entire cohort, 49 of 774 (6.3%) were removed with simple traction (i.e., no locking stylets or any other tools). In the young cohort, it was 4 of 84 (4.8%) with a mean dwell in the simple tractions of 3.12 ± 1.16 years. In the older cohort, 45 of 690 (6.5%) were removed with simple traction, with a mean dwell of 3.87 ± 3.29. The difference in rates of simple traction extraction was not significant (P ¼ .64). The clinical diagnoses leading to CIED implantation in the younger group included 25 patients (29.8 %) with CHD, 25 (29.8%) with DCM, 11.9% of the younger patients with hypertrophic cardiomyopathy (HCM), and 11.9% with inherited channelopathy. The remaining 16.7% had other diagnoses, including vasovagal syncope, arrhythmogenic right ventricular cardiomyopathy, sinus node dysfunction, iatrogenic AV block or sinus node damage, Lyme disease, and prolonged nocturnal AV block. Procedural outcomes were similar in the 2 groups (Table 2). Clinical success was 100% in group 1 and 96.8% in group 2 (P ¼ .157). Complete procedural success was equivalent in the 2 groups (94.1% vs 94.9%; P ¼ .792). We observed a trend toward an increased need for femoral LE in the younger cohort compared to the older cohort (9.5% vs 4.4%; P ¼ .055). Major procedural complications were similar in the 2 groups (0% in group 1 vs 1.3% in group 2; P ¼ 1). Periprocedural mortality was also similar (0% in group 1 vs 0.9% in group 2; P ¼ 1). Nine patients (1.16%) experienced major procedural complications, which included 6 deaths (0.78%), all in group 2. Two patients suffered tears in the superior vena cava (SVC) that resulted in hemothorax and death despite urgent surgery. Two other patients had SVC tears with pericardial tamponade; one died despite urgent surgery and the second survived urgent surgical repair. One patient had cardiac perforation resulting in pericardial tamponade and death despite surgery. One patient developed a pericardial effusion that was drained percutaneously, and one patient had a hemothorax successfully drained by chest tube insertion. One patient developed PEA arrest at the start of surgery but before LE; this was attributed Table 2
Procedural outcomes
Laser Mechanical Femoral approach Clinical success Procedural success Major complications Death
Age o40 years (n ¼ 84)
Age ≥40 years (n ¼ 690)
P value
38 (45.2) 18 (21.4) 8 (9.5) 84 (100) 79 (94.1) 0 (0) 0 (0)
307 (44.5) 92 (13.3) 30 (4.4) 668 (96.8) 655 (94.9) 9 (1.3) 6 (0.87)
.908 .067 .055 .157 .792 1.000 1.000
to progressive cardiogenic shock and resulted in periprocedural death. One patient had PEA arrest at the end of a prolonged procedure under general anesthesia (LE and reimplantation). There was no clear evidence of pericardial effusion. The extraction did not require mechanical or laser sheath technique. The patient had advanced cardiomyopathy, and the death was attributed to cardiogenic shock. No deaths or major procedural complications occurred in the younger cohort.
Discussion This report describes the outcomes of LE in a cohort of patients younger than 40 years. The younger group of patients represents a wide spectrum of younger adults with CHD, DCM, or inherited conditions followed in an adult arrhythmia clinic. Approximately 60% of the patients had CHD (29.8%) and DCM (29.8%). The remainder had either channelopathy (11.9%) or HCM (11.9%). The younger cohort had less comorbidity than the older group (Table 1) and left ventricular ejection fraction tended to be higher (40.8% vs 36.2%), reflecting the inclusion of patients with channelopathy or HCM and normal left ventricular systolic function. Despite the younger age, lead dwell time in the younger group was similar to that in the older cohort (5.7 vs 5.6 years). Younger patients had fewer leads extracted per procedure (Table 1). The main indication for LE in the young cohort was lead malfunction (62%), consistent with prior reports.7,9,13 The higher rate of lead failure in young individuals may be attributed to the higher level of physical activity and growth in stature seen in patients with CHD who receive a CIED relatively early in life.9,12 Table 2 shows that the clinical and procedural outcomes of LE were similar in the 2 groups (100% vs 96.8; P ¼ .157; and 94.1% vs 94.9%; P ¼ .792, respectively). Of note, no death occurred in the younger cohort compared to a mortality rate of 0.87% in the older cohort. Although the difference in mortality between the 2 cohorts was not significant (P ¼ 1), it is conceivable that this study was not powered to detect a difference in this outcome (lowfrequency event). Few studies have addressed the outcome of LE in pediatric cohorts with CHD, and no large studies have investigated the outcome of LE in young patients as they reach their 3rd and 4th decades of life. Zartner et al14 reported outcomes in 22 patients (average age 12.9 years) undergoing LE, achieving clinical success in 89% and procedural success in 79%. A similar report of 30 patients (mean age 12 years) described extraction success in 74%.15 Cooper et al reported12 95% successful extraction of 21 leads in 14 patients (average age 17 years). Friedman et al13 reported outcomes of LE in young patients (median age 13 years), with procedural success in 94.4%. A large multi-institutional registry following 878 pediatric and young patients with an ICD for more than 5 years noted that 137 patients required LE.7 Mean lead dwell time
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Table 3 Outcomes in patients o40 years stratified by presence of CHD (including congenital AV block) CHD (n ¼ 25) No CHD (n ¼ 59) P value Age at extraction (years) 28.6 ± 6.8 Lead dwell time (years) 7.9 ± 6.3 Procedural success 22 (88) Clinical success 25 (100) Femoral approach 1 (4)
831.1 ± 5.5 4.6 ± 3.8 57 (97) 59 (100) 7 (12)
.08 .02 .15 1 .42
CHD ¼ congenital heart disease.
was 1.9 ± 1.5 years. Half of the leads were extracted using simple traction, whereas another 23% required use of only a locking stylet. In comparison, our series included use of laser or mechanical rotational sheaths in 67% of patients, possibly reflecting the longer lead dwell time in our patients (5.7 years). Major complications in the multi-institutional registry occurred in 4% of LEs compared with 1.3% in our series. McCanta et al11 compared outcomes of 35 LEs in 22 CHD patients to an age- and gender-matched cohort without CHD undergoing LE. LE using the subclavian approach succeeded in 74% of the CHD group vs 92% of the nonCHD group (P ¼ .02). Interestingly, the procedural success rate in the CHD group increased to 92% when “bailout” femoral extraction techniques were used. We found similar procedural and clinical success in our CHD patients (Table 3) as in those in the younger group without CHD. The need for a femoral approach did not differ between the 2 subgroups, suggesting that LE in younger individuals tends to require more sophisticated LE techniques irrespective of the presence of CHD. The need for a femoral approach in ≈10% of patients more likely results from age at implantation and lead dwell time rather than the clinical diagnosis. Our observed LE procedural success rate of 94% is consistent with other recent reports on LE in young patients.7,11 We described the need for femoral LE technique in approximately 10% of our patients. McCanta et al11 reported that 17% of leads required a femoral approach. The need for such techniques reflects the challenging nature of LE in this group of patients. It is conceivable that the calcifications and adhesions more commonly encountered in younger individuals make the tools used for extraction (i.e., laser) less effective. It also underscores the need for expertise in femoral extraction when performing LE in young patients to ensure complete device removal and maximize patient safety.
Study limitations This was a retrospective single-center report. Our observations might not necessarily reflect the experience in different centers with various levels of expertise in LE or somewhat different patients. The presence of 7 different extractors with
varying levels of experience in LE could have affected the outcome of LE procedures. Transesophageal and/or transthoracic echocardiography were not routinely performed before or after LE in our center, so the incidence of tricuspid regurgitation and its severity were not formally assessed.
Conclusion LE in young patients with a CIED who have CHD, DCM, or other inherited diseases can be safely and successfully performed in a high-volume center having expertise in femoral extraction.
References 1. Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol 2001;37:1170–1175. 2. Singh HR, Batra AS, Balaji S. Cardiac pacing and defibrillation in children and young adults. Indian Pacing Electrophysiol J 2013;13:4–13. 3. Vehmeijer JT, Brouwer TF, Limpens J, Knops RE, Bouma BJ, Mulder BJ, de Groot JR. Implantable cardioverter-defibrillators in adults with congenital heart disease: a systematic review and meta-analysis. Eur Heart J 2016;37:1439–1448. 4. Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2013;61:e6–e75. 5. Maytin M, Epstein LM, Henrikson CA. Lead extraction is preferred for lead revisions and system upgrades: when less is more. Circ Arrhythm Electrophysiol 2010;3:413–424; discussion 424. 6. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of 410 years. Circulation 2007;115:2474–2480. 7. 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. 8. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085–1104. 9. Link MS, Hill SL, Cliff DL, Swygman CA, Foote CB, Homoud MK, Wang PJ, Estes NA 3rd, Berul CI. Comparison of frequency of complications of implantable cardioverter-defibrillators in children versus adults. Am J Cardiol 1999;83:263–266. A265–A266. 10. Smith MC, Love CJ. Extraction of transvenous pacing and ICD leads. Pacing Clin Electrophysiol 2008;31:736–752. 11. McCanta AC, Kong MH, Carboni MP, Greenfield RA, Hranitzky PM, Kanter RJ. Laser lead extraction in congenital heart disease: a case-controlled study. Pacing Clin Electrophysiol 2013;36:372–380. 12. Cooper JM, Stephenson EA, Berul CI, Walsh EP, Epstein LM. Implantable cardioverter defibrillator lead complications and laser extraction in children and young adults with congenital heart disease: implications for implantation and management. J Cardiovasc Electrophysiol 2003;14:344–349. 13. Friedman RA, Van Zandt H, Collins E, LeGras M, Perry J. Lead extraction in young patients with and without congenital heart disease using the subclavian approach. Pacing Clin Electrophysiol 1996;19:778–783. 14. Zartner PA, Wiebe W, Toussaint-Goetz N, Schneider MB. Lead removal in young patients in view of lifelong pacing. Europace 2010;12:714–718. 15. Dilber E, Karagoz T, Celiker A. Lead extraction in children and young adults using different techniques. Med Princ Pract 2009;18:356–359.
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Outcomes of lead extraction in young adults Mikhael F. El-Chami, MD, FACC, FHRS,* Michael N. Sayegh, BS,† Adarsh Patel,‡ Jad El-Khalil,§ Yaanik Desai,† Angel R. Leon, MD,* Faisal M. Merchant, MD* From the *Department of Medicine, Division of Cardiology, Section of Electrophysiology, Emory University School of Medicine, Atlanta, Georgia, †Emory University School of Medicine, Atlanta, Georgia, ‡ Emory University, Atlanta, Georgia, and §Georgia State University, Atlanta, Georgia. BACKGROUND Extraction of pacemaker and defibrillator leads in young adults may be technically challenging because of more extensive fibrosis and calcification in this patient population. OBJECTIVE The purpose of this study was to examine outcomes of lead extraction (LE) in young adults at our institution. METHODS We retrospectively identified all patients who underwent LE at our institution between January 1, 2007, and May 31, 2016. Patients were divided by age into 2 groups: o40 years (group 1, n ¼ 84) or ≥40 years (group 2, n ¼ 690). Outcomes were determined by medical records review. RESULTS Patients in group 2 had a higher overall average number of leads extracted per procedure compared to group 1 (1.64 ± 0.80 vs 1.45 ± 0.64; P o.001). Lead dwell time was similar in the 2 groups (5.7 ± 5 years vs 5.6 ± 4.3 years; P ¼ .95). The younger cohort tended to require femoral extraction techniques more
Introduction Improvements in cardiac surgery and cardiovascular care have resulted in an increase in the number of patients with congenital heart disease (CHD) surviving to adulthood.1 These patients often develop conduction system disease or ventricular arrhythmia necessitating permanent pacemaker2 or implantable cardioverter–defibrillator (ICD) insertion.3 In addition, young patients with inherited channelopathy or cardiomyopathy may require ICD insertion for prevention of sudden cardiac death.4 Effective lead management represents an essential component of the long-term care of patients with cardiac implantable electronic devices (CIEDs), particularly younger patients with higher expected long-term survival.5 Patients surviving many years with CIEDs demonstrate higher rates of lead failure, with 40% of implanted ICD leads failing within 8 years after insertion.6 This rate of lead failure is Dr. El-Chami is a consultant for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Address reprint requests and correspondence: Dr. Mikhael El-Chami, Department of Medicine, Division of Cardiology, Section of Electrophysiology, Emory University School of Medicine, 6th Floor Medical Office Tower, 550 Peachtree St NE, Atlanta, GA 30308. E-mail address: [email protected].
1547-5271/$-see front matter B 2017 Heart Rhythm Society. All rights reserved.
frequently (9.5% vs 4.4%; P ¼ .055). Extraction procedural success (group 1: 94.1%, group 2: 94.9%; P ¼ .792), major complications (group 1: 0%, group 2: 1.3%; P ¼ 1), and periprocedural mortality (group 1: 0%, group 2: 0.86%; P ¼ 1) were similar in the 2 groups. CONCLUSION LE can be performed safely and effectively in young adults. Despite the lower number of leads extracted per procedure and the similar lead dwell time, younger adults more frequently required the use of femoral extraction tools, thus highlighting the importance of performing these procedures in centers with advanced expertise in extraction techniques. KEYWORDS Lead extraction; Femoral extraction; Outcomes; Young adults; Congenital heart disease (Heart Rhythm 2017;0:0–4) rights reserved.
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higher in young patients with CIEDs.7 Lead management of failed leads involves revision, removal, or active extraction.8 In younger patients, specific considerations including preservation of the contralateral subclavian vein for future access and minimizing the number of indwelling transvenous leads favor LE instead of adding more leads5 as a preferred strategy. Although revision offers a viable option in patients with malfunctioning leads, the management of CIED infection usually requires LE.8,9 Chronic indwelling pacing and defibrillating leads promote fibrosis and calcification in younger patients, making LE more challenging and risky in this patient population.5,10 Small case series have addressed the outcomes of lead extraction (LE) in pediatric and younger patients.7,11–13 However, few data exist on the outcomes of LE in these patients as they reach their 3rd and 4th decades of life. Therefore, we chose to assess the outcome of LE in patients younger than 40 years with CHD, channelopathy, or DCM at our institution.
Methods We retrospectively identified patients who underwent LE at our institution between January 1, 2007, and May 31, 2016. http://dx.doi.org/10.1016/j.hrthm.2017.01.030
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We defined LE using the Heart Rhythm Society (HRS) consensus statement as the extraction of any lead implanted for more than 1 year, a lead (irrespective of its implant duration) whose removal requires specialized extraction tools, or any lead extracted through access from a vein other than the one used for implant.8 Leads that did not fit the described definition were excluded from this analysis. The indication for LE and the technical approach taken were at the discretion of the individual operator. The indications for LE included (1) device-related infections (pocket infection or systemic infection); (2) lead malfunction; (3) upgrade of an existing CIED to a device requiring additional leads when venous occlusion required sacrificing an existing lead for access; and (4) physician and patient preference to remove a functioning but recalled lead. We defined procedural outcomes according to the HRS consensus statement, including procedural success as the complete removal of the lead(s) and lead material without any major complication or death.8 We defined clinical success as the removal of the targeted lead(s) or lead material despite retention of a small portion/fragment that did not negatively impact the clinical goals of the procedure, including major complications or death. We defined procedural failure as failure to achieve the above-defined procedural or clinical success, or major complication or death. During the first part of the study period (2007–2011), LE was performed in the electrophysiology laboratory with the patient under conscious sedation. There was no formal protocol in place for mobilization of a backup surgical team. Starting in mid-2012, an extraction protocol was introduced. Extraction of leads with a dwell time ≥5 years or any extraction that was considered high risk was performed with the patient under general anesthesia and, if possible, in the hybrid operating room. All LEs were performed by a standby cardiac surgical team. Transesophageal echocardiography was performed at the discretion of the operator during LE. Table 1
Our first-line approach to LE is the superior approach, relying mainly on laser-powered sheaths followed by mechanical tools. The femoral approach is mainly used as a alternate strategy if the superior approach is not completely successful. During the period of interest, a total of 7 electrophysiologists with variable levels of experience performed LE at our center. All of the extractors trained in the same institution and followed our general institutional approach to LE. Patients were divided into 2 groups based on age at the time of extraction: group 1 was o40 years and group 2 was ≥40 years. The Emory University Institutional Review Board approved the study protocol. Primary endpoints include the incidence of periprocedural death or major complications as defined by the HRS consensus statement (procedural death, need for urgent surgery, hemopericardium requiring drainage, or hemothorax requiring a chest tube). Secondary endpoints included the incidence of procedural and clinical success.
Statistical methods Continuous variables are given as mean ± SD, and categorical data are given as frequencies and percentages. A 2-tailed P o.05 was considered significant. Statistica (Statsoft, Tulsa, OK) was used to perform statistical analyses.
Results Retrospective analysis identified a total of 84 patients in group 1 and 690 in group 2. Mean age in group 1 was 30.3 ± 6 years compared to 66.2 ± 12.3 years in group 2 (P o.001). Patients in group 2 had more comorbidities compared to those in group 1 (Table 1). They were more likely to have coronary artery disease (45.2% vs 3.6%; P o.001), chronic kidney disease (stage III or worse) (21.3% vs 10. 7%, P ¼ .021), hypertension (67.3% vs 28.6%; P o.001), and
Baseline patient characteristics
Age (years) Male sex Height (cm) Weight (kg) Left ventricular ejection fraction (%) Coronary artery disease Chronic kidney disease Hypertension Diabetes mellitus No. of leads extracted per procedure ICD leads extracted per procedure Dwell time of oldest extracted lead (years) Indication for extraction Infection Lead dislodgment Lead malfunction Upgrade Other
Age o40 years (n ¼ 84)
Age ≥40 years (n ¼ 690)
P value
30.3 ± 6 49 (58.3) 170.6 ± 11.1 84.9 ± 21.4 40.8 ± 18.8 3 (3.6) 9 (10.7) 24 (28.6) 11 (13.1) 1.45 ± .64 0.68 ± .47 5.7 ± 5
66.2 ± 12.3 460 (66.7) 173.2 ± 12.4 88.3 ± 25.1 36.2 ± 16.5 312 (45.2) 147 (21.3) 464 (67.3) 214 (31) 1.64 ± .80 0.71 ± .45 5.6 ± 4.3
o.001 .144 .084 .260 .064 o.001 .021 o.001 o.001 .017 .0.172 .953
23 (27.4) 0 (0) 52 (61.9) 4 (4.8) 5 (5.9)
249 (36.1) 21 (3) 326 (47.3) 67 (9.7) 20 (2.9)
.146 .15 .015 .16 .178
Values are given as mean ± SD or n (%) unless otherwise indicated. ICD ¼ implantable cardioverter–defibrillator.
138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 T1170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194
El-Chami et al 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211Q9 212 213 214 215 216 217 218 219 T2 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251
Extraction in Young Adults
3
diabetes (31 vs 13.1; P o.001). The older group had more leads extracted per procedure (1.64 ± 0.80 vs 1.45± 0.64; P o.017) (Table 1). Lead dwell time was similar in the 2 groups (5.6 ± 4.3 vs 5.7 ± 5; P ¼ .95), and younger patients were more likely to undergo LE for lead failure (61.9% vs 47.3%; P ¼ .015). From the entire cohort, 49 of 774 (6.3%) were removed with simple traction (i.e., no locking stylets or any other tools). In the young cohort, it was 4 of 84 (4.8%) with a mean dwell in the simple tractions of 3.12 ± 1.16 years. In the older cohort, 45 of 690 (6.5%) were removed with simple traction, with a mean dwell of 3.87 ± 3.29. The difference in rates of simple traction extraction was not significant (P ¼ .64). The clinical diagnoses leading to CIED implantation in the younger group included 25 patients (29.8 %) with CHD, 25 (29.8%) with DCM, 11.9% of the younger patients with hypertrophic cardiomyopathy (HCM), and 11.9% with inherited channelopathy. The remaining 16.7% had other diagnoses, including vasovagal syncope, arrhythmogenic right ventricular cardiomyopathy, sinus node dysfunction, iatrogenic AV block or sinus node damage, Lyme disease, and prolonged nocturnal AV block. Procedural outcomes were similar in the 2 groups (Table 2). Clinical success was 100% in group 1 and 96.8% in group 2 (P ¼ .157). Complete procedural success was equivalent in the 2 groups (94.1% vs 94.9%; P ¼ .792). We observed a trend toward an increased need for femoral LE in the younger cohort compared to the older cohort (9.5% vs 4.4%; P ¼ .055). Major procedural complications were similar in the 2 groups (0% in group 1 vs 1.3% in group 2; P ¼ 1). Periprocedural mortality was also similar (0% in group 1 vs 0.9% in group 2; P ¼ 1). Nine patients (1.16%) experienced major procedural complications, which included 6 deaths (0.78%), all in group 2. Two patients suffered tears in the superior vena cava (SVC) that resulted in hemothorax and death despite urgent surgery. Two other patients had SVC tears with pericardial tamponade; one died despite urgent surgery and the second survived urgent surgical repair. One patient had cardiac perforation resulting in pericardial tamponade and death despite surgery. One patient developed a pericardial effusion that was drained percutaneously, and one patient had a hemothorax successfully drained by chest tube insertion. One patient developed PEA arrest at the start of surgery but before LE; this was attributed Table 2
Procedural outcomes
Laser Mechanical Femoral approach Clinical success Procedural success Major complications Death
Age o40 years (n ¼ 84)
Age ≥40 years (n ¼ 690)
P value
38 (45.2) 18 (21.4) 8 (9.5) 84 (100) 79 (94.1) 0 (0) 0 (0)
307 (44.5) 92 (13.3) 30 (4.4) 668 (96.8) 655 (94.9) 9 (1.3) 6 (0.87)
.908 .067 .055 .157 .792 1.000 1.000
to progressive cardiogenic shock and resulted in periprocedural death. One patient had PEA arrest at the end of a prolonged procedure under general anesthesia (LE and reimplantation). There was no clear evidence of pericardial effusion. The extraction did not require mechanical or laser sheath technique. The patient had advanced cardiomyopathy, and the death was attributed to cardiogenic shock. No deaths or major procedural complications occurred in the younger cohort.
Discussion This report describes the outcomes of LE in a cohort of patients younger than 40 years. The younger group of patients represents a wide spectrum of younger adults with CHD, DCM, or inherited conditions followed in an adult arrhythmia clinic. Approximately 60% of the patients had CHD (29.8%) and DCM (29.8%). The remainder had either channelopathy (11.9%) or HCM (11.9%). The younger cohort had less comorbidity than the older group (Table 1) and left ventricular ejection fraction tended to be higher (40.8% vs 36.2%), reflecting the inclusion of patients with channelopathy or HCM and normal left ventricular systolic function. Despite the younger age, lead dwell time in the younger group was similar to that in the older cohort (5.7 vs 5.6 years). Younger patients had fewer leads extracted per procedure (Table 1). The main indication for LE in the young cohort was lead malfunction (62%), consistent with prior reports.7,9,13 The higher rate of lead failure in young individuals may be attributed to the higher level of physical activity and growth in stature seen in patients with CHD who receive a CIED relatively early in life.9,12 Table 2 shows that the clinical and procedural outcomes of LE were similar in the 2 groups (100% vs 96.8; P ¼ .157; and 94.1% vs 94.9%; P ¼ .792, respectively). Of note, no death occurred in the younger cohort compared to a mortality rate of 0.87% in the older cohort. Although the difference in mortality between the 2 cohorts was not significant (P ¼ 1), it is conceivable that this study was not powered to detect a difference in this outcome (lowfrequency event). Few studies have addressed the outcome of LE in pediatric cohorts with CHD, and no large studies have investigated the outcome of LE in young patients as they reach their 3rd and 4th decades of life. Zartner et al14 reported outcomes in 22 patients (average age 12.9 years) undergoing LE, achieving clinical success in 89% and procedural success in 79%. A similar report of 30 patients (mean age 12 years) described extraction success in 74%.15 Cooper et al reported12 95% successful extraction of 21 leads in 14 patients (average age 17 years). Friedman et al13 reported outcomes of LE in young patients (median age 13 years), with procedural success in 94.4%. A large multi-institutional registry following 878 pediatric and young patients with an ICD for more than 5 years noted that 137 patients required LE.7 Mean lead dwell time
252 Q10 253
254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308
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4 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 QT3 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362
Table 3 Outcomes in patients o40 years stratified by presence of CHD (including congenital AV block) CHD (n ¼ 25) No CHD (n ¼ 59) P value Age at extraction (years) 28.6 ± 6.8 Lead dwell time (years) 7.9 ± 6.3 Procedural success 22 (88) Clinical success 25 (100) Femoral approach 1 (4)
831.1 ± 5.5 4.6 ± 3.8 57 (97) 59 (100) 7 (12)
.08 .02 .15 1 .42
CHD ¼ congenital heart disease.
was 1.9 ± 1.5 years. Half of the leads were extracted using simple traction, whereas another 23% required use of only a locking stylet. In comparison, our series included use of laser or mechanical rotational sheaths in 67% of patients, possibly reflecting the longer lead dwell time in our patients (5.7 years). Major complications in the multi-institutional registry occurred in 4% of LEs compared with 1.3% in our series. McCanta et al11 compared outcomes of 35 LEs in 22 CHD patients to an age- and gender-matched cohort without CHD undergoing LE. LE using the subclavian approach succeeded in 74% of the CHD group vs 92% of the nonCHD group (P ¼ .02). Interestingly, the procedural success rate in the CHD group increased to 92% when “bailout” femoral extraction techniques were used. We found similar procedural and clinical success in our CHD patients (Table 3) as in those in the younger group without CHD. The need for a femoral approach did not differ between the 2 subgroups, suggesting that LE in younger individuals tends to require more sophisticated LE techniques irrespective of the presence of CHD. The need for a femoral approach in ≈10% of patients more likely results from age at implantation and lead dwell time rather than the clinical diagnosis. Our observed LE procedural success rate of 94% is consistent with other recent reports on LE in young patients.7,11 We described the need for femoral LE technique in approximately 10% of our patients. McCanta et al11 reported that 17% of leads required a femoral approach. The need for such techniques reflects the challenging nature of LE in this group of patients. It is conceivable that the calcifications and adhesions more commonly encountered in younger individuals make the tools used for extraction (i.e., laser) less effective. It also underscores the need for expertise in femoral extraction when performing LE in young patients to ensure complete device removal and maximize patient safety.
Study limitations This was a retrospective single-center report. Our observations might not necessarily reflect the experience in different centers with various levels of expertise in LE or somewhat different patients. The presence of 7 different extractors with
varying levels of experience in LE could have affected the outcome of LE procedures. Transesophageal and/or transthoracic echocardiography were not routinely performed before or after LE in our center, so the incidence of tricuspid regurgitation and its severity were not formally assessed.
Conclusion LE in young patients with a CIED who have CHD, DCM, or other inherited diseases can be safely and successfully performed in a high-volume center having expertise in femoral extraction.
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