Transvenous Lead Extraction in Pediatric Patients　― Is It the Same Procedure in Children as in Adults? ―

Andrzej Kutarski; Maria Miszczak-Knecht; Monika Brzezinska; Mariusz Birbach; Wojciech Lipiński; Aneta Maria Polewczyk; Wojciech Jacheć; Anna Polewczyk; Łukasz Tułecki; Konrad Tomków; Paweł Stefańczyk; Dorota Nowosielecka; Katarzyna Bieganowska

doi:10.1253/circj.CJ-22-0542

Abstract

Background: Cardiac implantable electronic devices (CIED) are very rare in the pediatric population. In children with CIED, transvenous lead extraction (TLE) is often necessary. The course and effects of TLE in children are different than in adults. Thus, this study determined the differences and specific characteristics of TLE in children vs. adults.

Methods and Results: A post hoc analysis of TLE data in 63 children (age ≤18 years) and 2,659 adults (age ≥40 years) was performed. The 2 groups were compared with respect to risk factors, procedure complexity, and effectiveness. In children, the predominant pacing mode was a single chamber ventricular system and lead dysfunction was the main indication for lead extraction. The mean implant duration before TLE was longer in children (P=0.03), but the dwell time of the oldest extracted lead did not differ significantly between adults and children. The duration (P=0.006) and mean extraction time per lead (P<0.001) were longer in children, with more technical difficulties during TLE in the pediatric group (P<0.001). Major complications were more common, albeit not significantly, in children. Complete radiographic and procedural success were significantly lower in children (P<0.001).

Conclusions: TLE in children is frequently more complex, time consuming, and arduous, and procedural success is more often lower. This is related to the formation of strong fibrous tissue surrounding the leads in pediatric patients.

Permanent cardiac pacing in the pediatric population started 60 years ago as epicardial pacing,¹ but the relatively short functioning time of epicardial leads stimulated the development of intracardiac pacing in children.²^–⁵ Infants and children represent less than 1% of all pacemaker recipients and constitute a specific group of patients requiring a different strategy than adults.²^,³^,⁶^,⁷ This is related to anatomical conditions, but most of all to somatic growth and life expectancy. It is known that, in young patients, extraction and replacement of leads will be required in the future. Previous studies on pacing in children compared with adults suggest that endocardial lead failure is primarily due to somatic growth; with time, the leads become too short, the insulation becomes brittle and cracks, and constant strain on the lead limits the lead tip-endocardium interface, leading to a deterioration in pacing conditions.⁸^–¹²

The formation of a fibrous capsule around the leads progresses for months and years, increasing the risk of venous occlusion.¹³^–¹⁵ Although failed epicardial leads may be left in place on the heart, it is not recommended that non-functional endocardial leads are abandoned.¹⁶^–²⁰ Earlier reports on transvenous lead extraction (TLE) in children did not compare the procedures with those performed in adults.⁸^–¹²^,²¹^–²⁷ A literature review and personal observations indicate that TLE may differ according to the specific characteristics of children and adults.

Thus, the aim of the present study was to determine the differences and specific characteristics of lead extraction in children compared with adults.

Methods

Study Population

The medical data of the patients, their current CIED, pacing history, and TLE procedure were prospectively entered into a large computer database maintained by the author. Data from 3,344 patients who underwent TLE between March 2006 and September 2020 were reviewed. The inclusion criteria were implantation and TLE at ≤18 years of age (children) or ≥40 years of age (adults). In all, 2,722 patients met these inclusion criteria. There were 63 children in the children’s group (16 girls, 47 boys; age range 5–18 years; mean [±SD] age 14.89±3.02 years). The adult group consisted of 2,659 patients (1,685 males, 994 females; age range 40–99 years; mean [±SD] age 66.49±9.38 years).

Definitions

TLE was defined as the removal of leads with a >1 year implant duration using TLE-dedicated tools. Indications for TLE, type of success, and periprocedural complications were defined according to the 2017 Heart Rhythm Society (HRS) and 2018 European Heart Rhythm Association (EHRA) expert consensus statements on lead extraction.²⁸^,²⁹ Full radiological success was defined as the total removal of the lead shown on X-ray; cases in which <4 cm of lead remained where considered a partial radiological success.

Defining the Risk Factors for Major Complications

We compared the occurrence of conventional risk factors for periprocedural complications (e.g., the number of leads extracted per patient, multiple lead extractions, the need for a combined approach, high-voltage [HV] and coronary sinus [CS] leads, pacing mode, the extraction of abandoned leads, non-left subclavian approach [right or both sides], combined subclavian+femoral, femoral-only, jugular-only, or any other combined approach with supplementary cardiac surgery) between the pediatric and adult groups. The risk of complications was determined using the SAFeTY TLE score (where S is the sum of lead dwell times, A is anemia, Fe is female sex, T is treatment [previous procedures], and Y is young patients),³⁰ and the number of expected major complications in the 2 groups was determined using the online SAFeTY TLE score calculator (http://usuwanieelektrod.pl/akalkulator/).

Defining Procedural Complexity

Procedural complexity was evaluated on the basis of the time taken for the procedure, as well as the occurrence of problems such as venous entry site obstruction, Byrd dilator collapse/torsion, extracted lead fracture, strong lead-to-lead adhesion, the need for an alternative venous access site, and/or the loss of a free-floating distal lead fragment. Procedure complexity was also evaluated on the basis of the need to use metal sheaths, lasso catheters, or baskets.

The outcomes and the percentage of major complications are presented in compliance with the current definitions (i.e., HRS and EHRA).²⁸^,²⁹^,³¹^–³³

To date, the first author has personally performed over 3,700 TLE procedures, and was an experienced operator when the TLE database was created. The learning curve had no effect on the SAFeTY TLE score, and the appearance of unexpected difficulties depends primarily on the duration of the implant and the degree of scarring of the connective tissue.

Lead Extraction Procedure

Lead extraction procedures were performed using a mechanical system, namely polypropylene Byrd dilator sheaths (Cook^® Medical, Leechburg, PA, USA), primarily via the subclavian vein on the side of the implanted device. Only if technical difficulties arose was a different vascular access site and/or additional tools (e.g., Evolution [Cook^® Medical], TightRail [Spectranetix/Phillips, Colorado Springs, CO, USA], lassos, basket catheters) used. Laser cutting sheaths were not used. Over the 14 years of performing these procedures, the instrumentation only expanded to include mechanical rotational catheters (Evolution and TightRail), but because these systems were rarely used, their appearance did not influence the results.

TLE in children was performed in The Children’s Memorial Health Institute (Departments of Cardiology and Cardiac Surgery), which is Poland’s pediatric referral center, whereas TLE in adults was performed in the 2 oldest and biggest TLE referral centers in Poland. In both study groups, lead extraction was performed by a team consisting of the same experienced TLE operator (a cardiologist specializing in pacemaker implantation), a second operator (a cardiologist or pediatric cardiologist experienced in pacing therapy), a cardiac surgeon (whose presence as a co-operator was mandatory during TLE in children), an anesthesiologist (general anesthesia was mandatory in children), and an echocardiographer, if available.³⁴^–³⁶

Statistical Analysis

The Shapiro-Wilk test showed that most continuous variables were normally distributed. For uniformity, all continuous variables are presented as the mean±SD. Categorical variables are presented as counts and percentages. Because of the disproportionate number of patients in the 2 groups in this study, the significance of differences between the 2 groups was determined using the non-parametric Chi-squared test with Yates correction or the non-parametric Mann-Whitney U test, as appropriate. P<0.05 was considered statistically significant. Univariable and multivariable logistic regression analyses were used to determine the predictors of complete procedural success in both groups. The multivariate model included uncorrelated variables that reached P<0.05 in the univariate analysis. Statistical analyses were performed using Statistica version 13.3 (TIBCO Software Inc., Cracow, Poland).

Bioethics Committee Approval

All adult and pediatric patients aged >16 years and the parents/legal guardians of pediatric patients ≤16 years of age provided written informed consent to undergo TLE and for anonymous data from their medical records to be used in medical research. This study was approved by the Bioethics Committee of the Regional Chamber of Physicians in Lublin (No. 288/2018/KB/VII).

Results

Patient Characteristics and Indications for TLE

Table 1 summarizes the clinical characteristics and indications for TLE in the 2 study groups. The sample size of the 2 groups differed, with children accounting for a small proportion of candidates for TLE (63 children; 1.88%). Generalized device-related and pocket infections were significantly less common indications for lead extraction in the pediatric compared with adult group (6.35% vs. 22.38% [P=0.04] and 1.59% vs. 9.89% [P=0.047], respectively). In children, TLE was performed primarily due to mechanical lead damage with electrical failure, whereas the proportion of adults with this indication for TLE was significantly smaller (25.6%), despite having received more implantable cardioverter-defibrillator (ICD) leads, which are more prone to failure. The remaining indications for TLE were increased pacing threshold, perforation, cancer, loss of indications for pacing, and symptomatic superior vena cava (SVC) occlusion in only a few cases (Table 1).

Table 1. Clinical Characteristics of the Study Group

	Children (n=63)	Adults (n=2,659)	P value
Patient age at TLE (years)	14.89±3.02	66.49±9.38	<0.001
Age at first implantation (years)	6.86±3.87	58.44±11.51	<0.001
Female sex	16 (25.40)	994 (37.38)	<0.001
Etiology
IHD, MI	0 (0.00)	1,507 (56.68)	<0.001
Congenital, channelopathies, neurocardiogenic, post-surgery	61 (96.83)	696 (26.18)	<0.001
LVEF (%)	63.36±7.84	47.81±15.48	<0.001
LVEF
Low (30–40%)	2 (3.17)	531 (19.97)	0.002
Very low (<30%)	0 (0.00)	398 (14.97)	0.002
Diabetes (any)	0 (0.00)	561 (21.10)	<0.001
Renal failure (any)	0 (0.00)	543 (20.42)	0.001
Previous sternotomy	23 (36.51)	400 (15.04)	0.001
Indications for TLE
Systemic infection	4 (6.35)	595 (22.38)	<0.004
Local (pocket) infection	1 (1.59)	263 (9.89)	0.047
Mechanical lead damage (electric failure)	43 (68.25)	682 (25.65)	<0.001
Lead dysfunction^A	5 (7.94)	331 (12.45)	0.378
Lead dysfunction caused by (usually dry) perforation	3 (4.76)	289 (10.87)	0.180
Change of pacing mode/upgrading, downgrading	0 (0.00)	163 (6.13)	0.079
Abandoned lead/prevention of abandonment (AF, overmuch of leads)	2 (3.17)	87 (3.27)	0.752
Threatener/potentially threatener lead (loops, free ending, left heart, LDTVD)	1 (1.59)	80 (3.01)	0.779
Other (MRI indication, cancer, pain of pocket, loss of indication for pacing/ICD)	2 (3.17)	66 (2.48)	0.952
Recapture venous access (symptomatic occlusion, SVC syndrome, lead replacement/upgrading)	2 (3.17)	101 (3.80)	0.938

Unless indicated otherwise, data are given as the mean±SD or n (%). ^ALead dysfunction including exit/entry block, dislodgement, and extracardiac pacing. AF, atrial fibrillation; ICD, implantable cardioverter-defibrillator; IHD, ischemic heart disease; LDTVD, lead dependent tricuspid valve dysfunction; LVEF, left ventricular ejection fraction; MI, myocardial infarction; MRI, magnetic resonance imaging; SVC, superior vena cava; TLE, transvenous lead extraction.

Single-chamber ventricular-mode cardiac pacing (VVI) was predominant in children (65.08%), whereas dual-chamber pacing (DDD) was most common in adults (44.57%). Consequently, adults had a significantly higher mean number of working leads (1.27 vs. 1.83; P<0.001) and total mean number of leads in the heart (1.37 vs. 1.98; P<0.001) than pediatric patients. Table 2 summarizes the most important data regarding pacing history in both groups. Interestingly, a history of previous TLE was more frequent in children than adults (Table 2).

Table 2. History of Pacing

Preoperative information	Children (n=63)	Adults (n=2,659)	P value
Mode of pacing
VVI	41 (65.08)	268 (10.08)	0.001
AAI	0 (0.00)	192 (7.22)	0.05
VDD	0 (0.00)	53 (1.99)	(0.50)
DDD	13 (20.64)	1,185 (44.57)	0.001
No. working leads	1.27±0.46	1.83±0.64	<0.001
Total no. leads implanted	1.37±0.60	1.98±0.77	<0.001
HV lead	9 (14.29)	839 (31.55)	0.005
Dual-coil ICD lead	3 (4.76)	443 (16.66)	0.019
CS lead	0 (0.00)	481 (18.09)	<0.001
History of previous TLE	7 (11.11)	126 (4.74)	0.04
No. CIED-related procedures before lead extraction	1.63±0.76	1.87±1.03	0.650

Unless indicated otherwise, data are given as the mean±SD or n (%). AAI, atrial pacing system; CIED, cardiac implantable electronic device; CS, coronary sinus; DDD, dual-chamber pacing system; HV, high voltage; ICD, implantable cardioverter-defibrillator; TLE, transvenous lead extraction; VDD, atrial-triggered ventricular single-lead pacing system; VVI, single-chamber ventricular-mode cardiac pacing.

Risk Factors for Major TLE-Related Complications

Analysis of risk factors showed significant differences in the number of leads extracted in 1 patient, multiple lead extractions, and the presence of a HV lead, all of which placed adult patients at higher procedure-related risk. Dwell times of the oldest extracted leads were comparable in children and adults (95.55 and 95.62 months, respectively; P=0.061). Differences in the cumulative dwell times of extracted leads between children and adults (8.85 vs. 13.16 years, respectively; P=0.033) provides supporting evidence for the explanation for the observed differences. In contrast, the mean dwell time of extracted leads was longer in children than in adults (94.20 and 89.90 months, respectively; P=0.022). The SAFeTY TLE score was significantly higher in children than adults (5.88±1.84 vs. 5.65±4.21, respectively; P=0.006; Table 3).

Table 3. Potential Risk Factors for MC of TLE

	Children (n=63)	Adults (n=2,659)	P value
No. leads extracted per patient	1.25±0.94	1.67±0.77	<0.001
No. leads extracted
1 or 2	62 (98.41)	2,345 (88.19)	0.021
≥3	0 (0.00)	312 (11.73)	0.007
Combined approach/cardiac surgery	0 (0.00)	2 (0.08)	0.828
Extraction of broken lead with too-long loop	3 (4.76)	67 (2.52)	0.479
HV lead extracted	1 (1.59)	788 (29.64)	<0.001
CS lead extracted	0 (0.00)	185 (6.96)	0.056
Dwell time of oldest extracted lead (months)	95.55±48.00	95.62±73.30	0.061
Mean (per patient) dwell time of extracted lead (months)	94.20±47.56	89.90±65.92	0.022
Cumulative dwell times of extracted leads (years)	8.85±4.59	13.16±12.57	0.033
SAFeTY TLE score	5.88±1.84	5.65±4.21	0.006

Unless indicated otherwise, data are given as the mean±SD or n (%). CS, coronary sinus; HV, high voltage; MC, major complications; SAFeTY TLE score, a scale of the risk of major complications during transvenous lead extraction (where S is the sum of lead dwell times, A is anemia, Fe is female sex, T is treatment [previous procedures], and Y is young patients).

Procedure Complexity

Both skin-to-skin and sheath-to-sheath times were longer in children than adults (63.04 vs. 61.18 min [P<0.001] and 15.57 vs. 14.81 min [P=0.006], respectively; Table 4). The need for additional tools was more common in the pediatric than adult population (metal sheath, 15.87% vs. 6.88% [P=0.012]; lasso catheter, 12.70% vs. 3.23% [P<0.001]; Table 4). Unexpected technical problems during TLE were also more common in children than in adults (38.10% vs. 19.59%; P<0.001; Table 4). The reasons for a prolonged procedure duration included venous entry site obstruction (19.05% vs. 7.07% in children and adults, respectively; P<0.001) and lead fracture during extraction (19.05 vs. 5.64%, P<0.001; Table 4).

Table 4. Procedure Complexity and Procedural Outcome

	Children (n=63)	Adults (n=2,659)	P value
Procedure duration (min)
Skin-to-skin	63.04±14.17	60.18±25.87	<0.001
Sheath-to-sheath	15.57±14.04	14.81±22.75	0.006
Extraction time per lead^A (min)	14.73±14.38	8.65±12.24	<0.001
Technical problems during TLE	24 (38.10)	521 (19.59)	<0.001
Obstruction of venous entry site	12 (19.05)	188 (7.07)	<0.001
Byrd dilator collapse/torsion/“fracture”	5 (7.94)	77 (2.90)	0.052
Lead fracture during extraction	12 (19.05)	150 (5.64)	<0.001
Evolution or TightRail	1 (1.59)	30 (1.13)	0.794
Metal sheath	10 (15.87)	183 (6.88)	0.012
Lasso catheter/snare	8 (12.70)	86 (3.23)	<0.001
Basket catheter	0 (0.00)	34 (1.28)	0.742
Pacemaker dependence^B	10 (15.87)	442 (16.62)	0.990
Radiographic success
Complete	52 (82.54)	2,545 (95.71)	<0.001
Partial^C	9 (14.29)	93 (3.50)	<0.001
Unsuccessful	2 (3.17)	93 (3.50)	0.834
Clinical success
Clinical procedural success	61 (96.83)	2,545 (95.71)	0.907
Planned supplementary cardiac surgery	0 (0.00)	41 (1.54)	0.639
Planned supplementary TLE	1 (1.59)	49 (1.84)	0.745
Permanently disabling complications or death	1 (1,59)	18 (0,68)	0.391
MC
Hemopericardium	1 (1.59)	35 (1.32)	0,710
TV damage	1 (1.59)	9 (0.34)	0.572
SVC damage	0 (0.00)	5 (0.18)	0.726
Rescue cardiac surgery	1 (1.59)	33 (1.24)	0.742
Stroke	0 (0.00)	1 (0.04)	0.888
Death – procedure related	0 (0.00)	7 (0.26)	0.683
Total MC	2 (3.18)	54 (2.03)	0.854
Procedural success
Complete procedural success	52 (82.54)	2,544 (95.68)	<0.001
Lack of complete radiographic success	10 (15.87)	97 (3.65)	<0.001
Permanently disabling complication or death	1 (1.59)	18 (0.68)	0.391

Unless indicated otherwise, data are given as the mean±SD or n (%). ^ASheath-to-sheath/number of extracted leads. ^BTemporary pacing during the procedure. ^CDefined as a retained tip or a residual <4-cm lead fragment. TV, tricuspid valve. Other abbreviations as in Tables 1,3.

Outcomes and Complications of TLE

Radiographic Success Complete radiographic success was obtained significantly less frequently in children than in adults (82.54% vs. 95.71%; P<0.001; Table 4). Partial radiographic success was more frequent in children than in adults (14.29 vs. 3.50%; P<0.001; Table 4).

Clinical Success The clinical success rates were similar in children and adults (96.83% vs. 95.71%, respectively; P=0.907; Table 4). This can be accounted for by the fact that most TLE procedures in children were performed for non-infectious indications, and the retention of small (<4 cm) portions of the lead did not preclude clinical success.

Complete Procedural Success As indicated in Table 4, complete procedural success was achieved significantly less frequently in children than adults (82.54% vs. 95.68%; P<0.001), primarily due to the lack of complete radiographic success. Permanently disabling complications were more common, albeit not significantly, in children (Table 4).

Multivariable regression analysis revealed that, of the parameters tested, only patient age at first implantation and extracted lead break or rupture during extraction influenced complete procedural success of TLE in the pediatric group. Each 1-year increase in age at first implantation increased the probability of achieving complete procedural success by 32.1% (odds ratio [OR] 1.321; P=0.049). Conversely, a break or rupture of the extracted lead decreased the probability of achieving complete procedural success by 90.9% (OR 0.091; P=0.006).

Major Complications All 7 (0.26%) procedure-related deaths occurred in adults (Table 4). Other major complications were found at a similar rate between the pediatric and adult groups: hemopericardium (1.59% vs. 1.32%, respectively; P=0.710), severe tricuspid valve damage (1.59% vs. 0.49%, respectively; P=0.754), and rescue cardiac surgery (1.59% vs. 1.24%, respectively; P=0.742). Interestingly, there was no SVC damage in children, compared with 5 (0.18%) adults in whom SVC damage was seen. All major complications appeared more often in children than in adults (3.18% vs. 2.03%; Table 4), although the difference did not reach statistical significance.

In the adult patients, multivariable regression shown that each 1-year increase in dwell time of the oldest lead and break or rupture of the extracted lead decreased the probability of achieving complete procedural success by 5.6% (OR 0.944; P=0.046) and 95.3% (OR=0.944; P<0.001), respectively (Table 5).

Table 5. Univariable and Multivariable Logistic Regression Analysis of Factors Affecting the Complete Procedural Success of TLE

	Implantation and TLE at <19 years of age				Implantation and TLE at 40–80 years of age
	Univariable		Multivariable		Univariable		Multivariable
	OR (95% CI)	P value	OR (95% CI)	P value	OR (95% CI)	P value	OR (95% CI)	P value
Patient age (SD)
During TLE	1.280 (1.037–1.579)	0.019			0.980 (0.956–1.005)	0.122
At first system implantation	1.388 (1.064–1.810)	0.014	1.321 (1.001–1.764)	0.049	1.045 (1.022–1.068)	0.000	0.987 (0.957–1.018)	0.413
Female sex	1.250 (0.288–5.425)	0.761			0.853 (0.566–1.285)	0.446
Etiology^A	0.517 (0.121–2.205)	0.363			0.559 (0.361–0.865)	0.009	0.805 (0.461–1.408)	0.447
LVEF	0.987 (0.901–1.082)	0.779			0.984 (0.971–0.998)	0.025	1.005 (0.986–1.025)	0.602
Abandoned lead presence	N	N			0.399 (0.234–0.678)	0.001	1.101 (0.320–3.795)	0.878
Pacemaker
AAI, VVI, VDD system	N	N			0.399 (0.234–0.678)	0.001	1.334 (0.378–4.709)	0.654
DDD, CRT-P system	0.732 (0.162–3.306)	0.679			0.517 (0.343–0.779)	0.002	1.158 (0.401–3.344)	0.786
ICD – CRT-D system	2.047 (0.221–18.956)	0.520			2.599 (1.491–4.533)	0.001	1.567 (0.527–4.660)	0.419
No. leads in the system before TLE	1.286 (0.296–5.589)	0.732			0.719 (0.529–0.977)	0.035	1.071 (0.428–2.683)	0.883
No. leads in the heart before TLE	1.121 (0.367–3.420)	0.838			0.573 (0.455–0.721)	0.000	0.709 (0.297–1.691)	0.438
No. procedures before lead extraction (SD)	1.416 (0.523–3.834)	0.485			0.607 (0.530–0.695)	0.000	0.893 (0.683–1.168)	0.408
Dwell time of oldest lead before TLE	0.959 (0.814–1.130)	0.608			0.893 (0.869–0.918)	0.000	0.944 (0.892–0.999)	0.046
Mean implant duration before TLE	0.967 (0.816–1.147)	0.697			0.880 (0.852–0.909)	0.000
Dwell time of oldest lead extracted	0.937 (0.796–1.104)	0.429			0.892 (0.867–0.917)	0.000
Calculator of risk of MC TLE – number of points	1.541 (0.900–2.638)	0.107			0.834 (0.799–0.871)	0.000	0.962 (0.879–1.053)	0.402
Technical problems (any) during TLE	0.270 (0.072–1.020)	0.049	0.320 (0.077–1.325)	0.109	0.183 (0.121–0.275)	0.000
Block in lead venous entry (subclavian region)	0.558 (0.120–2.602)	0.449			0.333 (0.193–0.575)	0.000	0.852 (0.424–1.712)	0.653
Extracted lead break/rupture during extraction	0.063 (0.012–0.328)	0.001	0.091 (0.016–0.519)	0.006	0.028 (0.017–0.047)	0.000	0.047 (0.026–0.087)	0.000
No. big technical problems	0.479 (0.126–1.821)	0.270			0.169 (0.112–0.255)	0.000

^ACongenital, channelopathies, neurocardiogenic, or cardiosurgical. CI, confidence interval; CRT, cardiac resynchronization therapy; N, calculation not possible due to the distribution of the variables; OR, odds ratio. Other abbreviations as in Tables 1–3.

Results of the analyses of the relationships between the success of the procedure and the child’s age and body size are presented in the Supplementary Table.

Discussion

The technique of lead extraction was developed in the late 1980s.³⁷ Procedural safety is determined primarily by center volume; therefore, TLE should be performed only in high-volume centers with >30 procedures per year.²⁸^,²⁹^,³⁶^–³⁹ Pediatric patients account for a negligible proportion of the population receiving CIEDs.²^–⁷ However, over their lifetime, children with pacemakers will have to undergo many interventions to replace units or leads. For this reason, understanding the principles and techniques of lead extraction procedures in children, procedural risk factors, and possible complications are key to the successful management of patients,⁸^–¹²^,²¹^,²⁷ especially because this problem will need to be addressed primarily by cardiologists in adult patients. In our judgment, presenting in this study pediatric population it is an inflated rate, because at the time of the study TLE in adults was performed in many centers in Poland, whereas TLE in pediatric patients was performed by 1 team. The adult group in the present study consisted of adults aged ≥40 years at the time of their CIED implantation and extraction. It is our opinion that this group best represents typical adult candidates for lead extraction. Infectious indications for CIED removal were decidedly less frequent in children than in adults. This difference was not associated with the number of CIED-related procedures or lead dwell time. It may be related to where implantation and replacement procedures are performed: in children, CIED implantations are performed in operating theaters, whereas in adults the procedures are performed in electrophysiology laboratories. Mechanical lead damage was the main indication for TLE among children, even though adults had ICD and other leads that were potentially more prone to failure. This was attributed to age-related changes in body size (causing a loss of slack in the lead) and the high level of physical activity among children. Both factors have been found to cause lead dysfunction.⁸^–¹²^,²¹^–²⁶ Even an adequate amount of slack does not help avoid strain on the lead (as previously thought), and lead adhesion to cardiac structures makes the extraction procedure more difficult (Figures 1–3).⁸^–¹²^,²¹^–²⁶

Figure 1.

Strained leads caused by body growth. Close contact of the lead with vein and heart structures induces the growth of strong scars and makes lead extraction difficult. (A) Partial destruction of the PB passive lead is visible (unnatural increase in the tip-ring distance). (B) In most children, the tip of the lead was no longer in its initial location. This may be due, in part, to right ventricle apex pull-up. (C) Continuous lead pooling can cause dysfunction. Lead pulling appears to be 1 of the main mechanisms (apart from mechanical failure) of lead failure (a gradual increase in the stimulation threshold due to loss of proper contact between the tip and myocardium). Lat, lateral view; PA, posterior-anterior view.

Figure 2.

Six examples of lead loops in the heart. (A) The loop is additionally forced by the use of a double-coil implantable cardioverter-defibrillator (ICD) lead. Note the distal coil in the tricuspid valve. (B–F) Planned loops created by pacing leads: passive leads (B,C,E) and active leads (D,F) located in the right atrium (A,C,E) or right ventricle (B,D,F). These loops were theoretically intended to prevent the lead from straining in the future while the child grows. However, they usually adhere to heart structures, and the extraction of such leads increases the risk of rupture of the removed lead and damage to the tricuspid valve and right atrium wall. This technique failed and was abandoned, but there are still some children with lead loops in their heart.

Figure 3.

Examples of ventricular lead replacement and system upgrading. (A) Strained, non-functioning lead before extraction. (B) The removed lead on the table. There is visible mineralization of connecting scar tissue. (C) The new DDD system that was implanted.

Although not confirmed in the present study, differences in the type of pacing systems possibly affect the level of difficulty and complexity of the procedure. Implant duration before TLE is considered the most significant risk factor for major complications and procedure difficulty. In the present study, the lead dwell time was longer in children. All conventional risk factors for major complications of TLE have been combined in the mean SAFeTY TLE score.³⁰ Although there was a statistically significant difference in the SAFeTY TLE score between the 2 groups, the observed effect was not strong, especially taking into account the small sample size of the children’s group.

Despite the fact that the pacemaker systems extracted in children were simpler and the procedural risk factors were similar in the 2 groups, comparative analysis of procedure complexity clearly showed that the procedures performed in pediatric patients were more difficult than those performed in adults. This was evidenced by longer procedure duration, technical difficulties, or the need to use additional tools. It is especially worth emphasizing that all the procedures were performed by the same operator. As a result of greater overall difficulty, pediatric patients were more likely to have had complications that negatively affected procedural effectiveness and radiographic success.

Although there were no between-group differences in the rate of clinical success, complete radiographic and procedural success were achieved less frequently in children than adults. In our judgment, the lower rate of procedural and radiographic success was the result of a more difficult procedure. Implant duration was similar in both groups (97 months). Although not always statistically significant, the risk factor profile suggested a higher procedural risk and lower effectiveness in the adult group. One factor that had a decisive effect on group differences was patient age at the time of implantation. Research has shown that lead-incited inflammatory response causing vascular fibrosis and the formation of fibrous tissue encasing the leads decrease markedly with age.²¹^,⁴⁰^–⁴² For this reason, TLE in the elderly is easier and the rate of complications is negligible.⁴³ The fibrotic capsules surrounding the leads can be evaluated before the procedure using 2 diagnostic tests: transesophageal echocardiography (TEE) and venography. The data used in the present study had been collected over period of 14 years and, due to changes in procedural standards over time, not all patients underwent TEE or venography. The thickness/density of scar tissue and increased calcification are likely to play a key role. The findings of the present study indirectly confirm this hypothesis.

Study Limitations

Lead extraction procedures were performed using mechanical systems only, without laser energy; if laser energy had been used, the outcomes may have been different. All the procedures were performed by the same operator, which allowed for better comparisons of procedure safety and effectiveness in children and adults. Conversely, a more general view of TLE safety and efficacy, especially in pediatric patients, was not possible.

Conclusions

There are four main conclusions of this study: (1) lead dysfunction is the main indication for extraction in children; (2) lead extraction in children is a different procedure to that in adults, being more complex and time consuming; (3) radiographic success in the pediatric population is frequently partial, with the lack of complete radiographic success reducing the rate of procedural success; and (4) major complications occur more frequently, albeit not significantly, in children than in adults (3.18% vs. 2.03%), although this difference may be coincidental.

Sources of Funding

This study did not receive any specific funding.

Disclosures

The authors have no conflicts of interest to declare.

IRB Information

This study was approved by the Bioethics Committee of the Regional Chamber of Physicians in Lublin, Poland (No. 288/2018/KB/VII).

Data Availability

The deidentified participant data will not be shared.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circj.CJ-22-0542

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