Download Twenty-Seven Years Experience With Transvenous Pacemaker

Original Article
Twenty-Seven Years Experience With Transvenous
Pacemaker Implantation in Children Weighing <10 kg
Laura Konta, MD, PhD; Mark Henry Chubb, MBBS, MA, MRCP, MRCPCH;
Julian Bostock, PhD; Jan Rogers, HNC; Eric Rosenthal, MD, FRCP
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Background—Epicardial pacemaker implantation is the favored approach in children weighing <10 kg in many units.
The high incidence of premature failure and fractures with earlier epicardial leads led our unit to undertake transvenous
pacemaker implantation in neonates and infants from 1987. To date there have been no long-term follow-up reports of
what is for many a controversial strategy.
Methods and Results—Between 1987 and 2003, 37 neonates and infants—median age 6.7 months (1 day to 3 years) and
median weight 4.6 kg (2.7–10 kg)—had a permanent transvenous pacing system implanted. Pacing leads were placed
into the right ventricular apex/outflow tract through a subclavian vein puncture with a redundant loop in the atrium. Three
patients were lost to follow-up, 4 patients died from complications of cardiac surgery, and 2 patients had their system
removed. At long-term follow-up in 28 patients at a median of 17.2 (range, 11.2–27.4) years, 10 patients have a single
chamber ventricular pacemaker, 14 a dual chamber pacemaker, 3 a biventricular pacemaker, and 1 has a single chamber
implantable cardioverter defibrillator. Subclavian vein patency was assessed in 26 patients. The overall subclavian vein
occlusion rate was 10 of 13 (77%) <5 kg and 2 of 13 (15%) >5 kg during long-term follow-up. After a median of 14.3
(range, 13.4–17.6) years of pacing, 7 patients continue with their original lead.
Conclusions—Transvenous pacing in infants <10 kg results in encouraging short- and long-term clinical outcomes.
Subclavian vein occlusion remains an important complication, occurring predominantly in those weighing <5 kg. (Circ Arrhythm Electrophysiol. 2016;9:e003422. DOI: 10.1161/CIRCEP.115.003422.)
Key Words: biological pacemakers ◼ defibrillators, implantable ◼ infant ◼ infant, newborn ◼ subclavian vein
I
n children <10 kg, transvenous pacing developed in our unit
in the 1980s in response to several factors. Epicardial leads
at the time were prone to early loss of capture, a high fracture
rate and high thresholds leading to short generator survival
and the need for early reoperation. Abdominal generators were
prone to migration into the peritoneal cavity or bowel.1 Cardiac
strangulation was also an occasional occurrence.2 In addition,
the surgical thrust in our unit was to the repair of structural
lesions and reliance on cardiology support for pacemaker
implantation. Early reports demonstrated that transvenous systems could be implanted with good short-term results, and this
approach became the preferred route for pacemaker implantation in a few centers.3–5 Despite the early encouraging results,
there has been little in the way of longer term follow-up in the
literature.6–11 We now present the only long-term report of this
strategy in a consecutive series of patients from a single center
followed up for a minimum of 11 years over a 27-year period.
years) with a median weight of 4.6 (range, 2.7–10) kg. The indications
for pacing were congenital complete heart block (CHB) in 22 (isolated
in 18—that is without congenital heart disease apart from an atrial septal
defect or patent arterial duct), postoperative CHB in 13, reflex anoxic
seizures in 1, and long-QT syndrome in 1 patient (Table 1).
See Editorial by Saarel and Aziz
The 22 patients with congenital CHB received their pacemaker at
a median age of 2.4 months (range, 1 day to 13.9 months)—7 within
the first month of life—because of low heart rates and signs of heart
failure. In 13 patients, a pacemaker was implanted for postoperative
CHB at a median age of 6.9 (range, 1.8–27) months. At the initial
pacemaker implant, 19 patients were <5 kg. Follow-up extended for a
minimum of 11 years until September 2014.
During this period, there were 3 primary epicardial implants in
patients <10 kg: a 2.2-kg neonate with congenital CHB (thought to be
too small for a transvenous system) who died at 6 months with bronchiolitis; a 6.3-kg girl with a complete AV septal defect and postoperative CHB (transvenous implanter not available) whose epicardial
system was replaced at 2.2 years with a transvenous system; and a 6.6
kg single ventricle patient with congenital CHB who was undergoing
palliative surgery.
Methods
Patients
Pacemaker Implantation
A transvenous pacemaker system was implanted in 37 neonates and infants <10 kg between April 1987 and July 2003 at the Evelina London
Children’s Hospital. The median age was 6.7 months (range, 1 day to 3
Pacemakers (36 ventricular demand with rate response [VVIR] and 1
dual chamber [DDD]) were implanted under general anesthesia with
the same technique used in older patients. The 37 ventricular leads
Received April 23, 2015; accepted December 1, 2015.
From the Department of Paediatric Cardiology, Evelina London Children’s Hospital, London, United Kingdom (L.K., M.H.C., J.B., J.R., E.R.); and
Division of Imaging Sciences and Biomedical Engineering, King’s College London, London, United Kingdom (M.H.C.).
Correspondence to Eric Rosenthal, MD, FRCP Department of Paediatric Cardiology, Evelina London Children’s Hospital, St Thomas’s Hospital,
Westminster Bridge Rd, London SE17EH, United Kingdom. E-mail [email protected]
© 2016 American Heart Association, Inc.
Circ Arrhythm Electrophysiol is available at http://circep.ahajournals.org
1
DOI: 10.1161/CIRCEP.115.003422
2 Konta et al Transvenous Pacemaker Implantation in Infants
WHAT IS KNOWN
• Transvenous pacing has been used in infants weighing
<10 kg with good short-term results, but no longterm reports are available.
• Epicardial pacemaker implantation is currently the
favored approach for infants weighing <10kg in
many units.
WHAT THE STUDY ADDS
• Transvenous
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pacing has an encouraging long term
outcome in infants weighing <10 kg, with documented venous patency at up to 25 years and original lead
survival up to 17.6 years.
• Weight <5 kg appears to be a risk factor for subclavian vein occlusion, while occlusion in those weighing 5–10 kg was similar to that in older pediatric
patients.
• Although epicardial approach is standard, a singlelead transvenous pacing system can be implanted
in infants when an open surgical procedure is not
optimal.
(4–6.6F; 10 unipolar and 27 bipolar) were inserted via a subclavian
vein (SCV) puncture using 4F to 7F sheaths and positioned in the
right ventricular apex or outflow tract (Table 2). Initially, passive
fixation leads were used (24/37), but after 1997, predominantly active fixation leads were chosen. After obtaining satisfactory pacing
and sensing parameters, a redundant lead loop was advanced into the
atrium to prevent lead tension during growth and the lead was secured
with an absorbable suture. In the single DDD system, the unipolar
4F screw-in atrial lead was implanted through an ipsilateral axillary
vein cut down. The generator was placed in a pocket in the anterior
abdominal wall in 6 patients, in a prepectoral pocket in 23 patients,
and in a subpectoral pocket in 8 patients. An abdominal pocket was
the preferred option until 1988 and in the patient with a dual-chamber
system; pacing leads were then tunneled subcutaneously to the generator site. Until 1990, there were several different operators, but thereafter all new and follow-on procedures were performed by a single
operator (E.R.). SCV patency was assessed with a venogram during
subsequent generator or pacemaker system change procedures.
the patient to go home for palliative care and the patient
died at 7 months of age. A patient with left atrial isomerism developed suppurative pericarditis at 6 weeks of age
because of the temporary epicardial pacing wires after an
AV septal defect repair. A dual-chamber transvenous pacemaker system was implanted because of poor cardiac function and failure of the epicardial leads, but the patient died
7 days later from the ongoing sepsis. A patient with double
outlet right ventricle, transposition of the great arteries, and
subpulmonary stenosis died 18 months after cardiac surgery
and endocardial pacemaker implantation because of heart
failure. The fourth patient with levo-transposition of the
great arteries paced at 3 months of age, died at another center after cardiac surgery at 3 years of age. No deaths were
related to pacemaker malfunction or pacemaker-related
infections. The pacing system was removed in 2 patients
with postoperative CHB: in 1 patient, the system was
removed because of infective endocarditis at a time that his
conduction system had recovered. The other patient underwent heart transplantation 9 years after repair of transposition and a ventricular septal defect. Of the original cohort,
28 underwent long-term follow-up (Figure 1).
Early Reinterventions
There were 4 early reinterventions within 6 months of the
initial system placement. In 1, there was threatened skin erosion with a relatively bulky generator, which was moved to
the abdomen. In 1, who had been paced on day 1 of life after
several months of in utero steroids, the wound broke down and
was resutured at 4 months of age. In 1 patient, the lead was
found on echocardiography to have passed through a patent
foramen ovale into to the left ventricle and was successfully
repositioned 2 days later. In only 1 patient in this series was
there a lead displacement (passive fixation lead), and a new
lead was placed 3 months after the initial implant.
Table 1. Indications for Pacemaker Implantation
Arrhythmia
Congenital complete heart block
N
Structural Lesions
22 (59%)
Statistics
Isolated
18
The SCV occlusion rate was tested for those <5.0 kg and those >5.0
kg in weight at the time of their procedure. Odds ratios and 95% confidence intervals (CI95) for proportions and differences were calculated using the Exact Method of Calculating Confidence Interval for
the Difference between 2 proportions based on the binomial distribution (Stata version 13.1; StataCorp, College Station, TX). A Kaplan–
Meier lead survival curve was prepared using Graphpad Prism 6.0
software (GraphPad, La Jolla, CA).
L-TGA
2
…
CHD
2
TOF (1), VSD* (1)
Results
Pacemaker implantation was uneventful in all 37 patients
with good pacing and sensing characteristics. Follow-up
was lost in 3 patients of whom 2 were from abroad. There
were 4 patients who died, 3 of whom had postoperative
CHB. In 1 withdrawal of care, followed repair of anomalous
pulmonary venous drainage, ventricular septal defect, and
coarctation of the aorta. Fungal sepsis developed postoperatively, and a transvenous pacemaker was implanted to allow
Postoperative complete heart block
PDA (4), PDA and ASD (1)
13 (35%)
VSD
8
TGA (2), TGA and COA (1),
DORV (1), PDA (2), CoA+TAPVD
(1), ASD (1)
AVSD
4
LAI (1), left AV valve
replacement (1)
Subaortic stenosis
1
ASD and VSD
Reflex anoxic seizures
1
…
Long-QT syndrome
1
…
*Patient had chickenpox with suspected myocarditis in utero. ASD indicates
atrial septal defect; AVSD, atrioventricular septal defect; CHD, congenital heart
defect, CoA, coarctation of the aorta; DORV, double outlet right ventricle; LAI, left
atrial isomerism; L-TGA, levo-transposition of the great arteries; PDA, patent ductus
arteriosus; TAPVD, total anomalous pulmonary venous drainage; TGA, transposition
of the great arteries; TOF, tetralogy of fallot; and VSD, ventricular septal defect.
3 Konta et al Transvenous Pacemaker Implantation in Infants
Table 2. Pacemaker Leads Used at the First Pacemaker
Implantation
Lead Model
N
Size (F) Fixation
Polarity
Steroid
Eluting
Ventricular
1 and a new lead was placed in a septal position in 1. The old
ventricular lead was removed completely in 1 and partially in
the other with powered sheaths, allowing placement of atrial
and ventricular leads through the original SCV. In 1 patient
with good pacing and sensing characteristics, the pacemaker
was upgraded to an epicardial DDD system during cardiac
surgery for prosthetic mitral valve replacement at 10.9 years
after the initial pacemaker.
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Biotronic PE69/4DNP
3
5
P
U
No
Siemens 424M/60
3
4.8
P
U
No
Biotronic TIR-60-BP
1
6.6
P
B
No
Siemens1050T
1
6
P
B
No
Battery End of Life as the First Intervention
Medtronic CapSure SP 4024
2
5.8
P
B
Yes
Vitatron Slimtine
2
5
P
U
No
The first reintervention was battery end of life in 16 patients
at a median 5.9 (range, 4.1–12.9) years after the initial
implantation. In 11 patients, only the generator was changed
at a median 6.0 (range, 4.1–12.9) years. In 1, the lead was
advanced at the generator change because of straightening of
the ventricular lead (loss of the atrial loop) and in 1 the system
was upgraded to a dual-chamber system by adding an atrial
lead at 4.2 pacing years.
In 5 patients, there were concomitant ventricular lead
changes at 4.7 to 6.2 pacing years. There was loss of the atrial
loop and inability to advance the lead in 3 abdominally sited
generators, which were then moved to a pectoral position. The
lead was changed from unipolar to bipolar to allow submuscular
position of the generator in 1. In 1 patient, a well-functioning
ventricular lead was damaged during the generator replacement.
In 3, a new ventricular lead was placed through the ipsilateral
SCV after a lead extraction. The ventricular lead could not be
extracted in the fourth, but the SCV was patent and new ventricular and atrial leads were placed via the ipsilateral SCV. In 1,
the lead was extracted through the femoral vein, allowing recanalization of the occluded SCV and ipsilateral lead replacement.
Vitatron Excellence+
8
5.7
P
B
Yes
Biotronik Y60-BP
2
6.6
A
B
No
Osypka K467-40
1
4
A
U
No
St Jude Tendril SDX 1488T
9
6.1
A
B
Yes
Medtronic CapSureFix Novus
5076
1
6.2
A
B
Yes
Medtronic CapSure Sense
4074
3
5.3
P
B
Yes
Intermedics Thinline EZ
438-10
1
5/7
A
B
No
1
4
A
U
No
Atrial
Osypka K467-40
Lead Changes Before End of Life of the First
Generator
A lead intervention was required in 6 patients before pacemaker generator battery depletion after a median 10.6 (range,
2.5–11.5) pacing years. In 1, the lead was advanced at 2.5
years because of straightening of the lead (loss of the atrial
loop). In 2 patients with increased pacing thresholds, the leads
were extracted—through the femoral vein in 1 at 4.1 years and
through the SCV in 1 at 9.2 years. An ipsilateral dual-chamber pacemaker was implanted in 1 and an ipsilateral singlechamber pacemaker in 1. In 2 patients with reduced exercise
tolerance at 11.0 and 11.5 years after the initial procedure, the
pacemakers were upgraded to dual-chamber systems and the
ventricular leads replaced—an insulation break was found in
Lead Survival
During long-term follow-up, ventricular pacing lead revision
was required in 21 of 28 patients at the first or subsequent
procedures. In 6 patients (21%), lead revision was not related
to lead malfunction or lead straightening (lead displacement
at 3 months in 1, pocket infection in 2 at 1.7 and 6.9 years,
skin erosion in 1 at 2.0 years, lead damage during elective
generator replacement in 1 at 4.7 years, and concomitant heart
surgery in 1 at 10.9 years).
Figure 1. Indication for the first reintervention after pacemaker implantation.
DDD indicates dual chamber; EOL, end of
life; and LV, left ventricle.
4 Konta et al Transvenous Pacemaker Implantation in Infants
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In 15 patients (54%), lead revision caused by lead malfunction (n=8), lead straightening (n=4) at generator replacement or system upgrade, the need to change from a unipolar
to bipolar lead to allow a submuscular implant (n=2) or the
need to move the apical pacing lead to a septal position (n=1)
occurred at a median of 9.2 (range, 4.1–14.3) years after the
initial pacemaker insertion. Particularly with abdominally
sited generators in the earlier years, loss of all the atrial loop
raised concerns that tension might contribute to eventual lead
failure during further growth and if advancement was not possible during a generator change, lead replacement was undertaken. The Kaplan–Meier survival rate of the original lead
excluding non–lead-related problems was 99.5% at 5 years,
72.7% at 8 years, and 59.1% at 10 years (Figure 2).
The original lead continues to function in 7 patients (25%)
at a median of 14.3 years of pacing (range, 13.4–17.6 years).
The pacing leads include 2 Vitatron Excellence +, 3 St Jude
Tendril, 1 Biotronik Y60-BP, and 1 Medtronic Capsurefix
Novus. The indications for pacing were congenital CHB in 5
and postoperative CHB in 2. A pacemaker generator change
was performed in 5 of these patients at a median 6.8 (range,
5.1–12.9) years of pacing, whereas 2 have not required any
intervention despite 100% pacing at 14.3 and 13.4 years of
pacing (both Regency generators; St Jude).
SCV Occlusion
There were no clinical symptoms of SCV occlusion. Venography was used to assess SCV patency in 26 patients during generator changes or lead revisions. In 2 patients who continue
with their original systems (see above), SCV patency has not
been formally assessed.
Subclinical SCV occlusion was documented in 10 patients
at a median 9.2 (range, 0.25–12.9) years of pacing at their
first reintervention (Figure 3). A new pacemaker system was
implanted using the contralateral SCV in 2 patients; the transvenous pacing system was changed to an epicardial system
in 2 (1 because of concomitant heart surgery and in 1 for a
pacemaker site infection); 3 had lead extraction (Figure 4)
and lead/s placed via the original SCV; 2 had only a generator change with lead advancement in 1 (Figure 5), and the
pacemaker system was removed and a new pacemaker system
deferred in 1 patient. Nine of these 10 patients were <5 kg at
the initial pacemaker implantation. Of the 16 patients with a
Figure 2. Kaplan–Meier (KM) curve of lead survival, starting with
22 leads. The KM survival estimate was 59.1% at 10 y. Patients
with pocket infection, early lead displacement, skin erosion, iatrogenic lead damage and concomitant surgery (n=6) as the reason
for lead revision are excluded.
patent SCV at their first generator or lead change at a median 6
(range, 2.1–14.4) years, 4 were <5 kg and 12 were >5 kg at the
initial pacemaker implantation. The SCV occlusion rate was
therefore 9 of 13 (69%) <5 kg (CI95, 42.4%–87.3%) and 1 of
13 (8%) >5 kg (CI95, 1.4%–33.3%) at the time of the first intervention (Figure 3). The difference of the proportion of SCV
occlusions between the 2 groups is 61% (CI95, 24.4%–80.7%).
The SCV was noted to be occluded in 2 more patients,
during further revisions to their pacemaker system at 13.7 and
17.1 years of pacing: a new ventricular lead was implanted
from the contralateral side in 1, and 3 new leads were
implanted through the occluded SCV in 1 for biventricular
pacing (Figure 6). One patient was <5 kg and 1 was >5 kg at
the initial pacemaker implantation. Overall, the SCV occlusion rate was 10 of 13 (77%) <5 kg (CI95, 49.7%–91.8%), and
2 of 13 (15%) >5 kg (CI95, 4.3%–42.2%; Figure 3). The difference between the 2 groups is 62% (CI95, 23.3%–80.1%). The
odds ratio of SCV occlusion in the <5 kg group are 18 times
those in the >5 kg group. In 1 patient at 25 years, the SCV
remains patent with 3 functioning and 2 partially extracted
redundant leads (Figure 7).
Long-Term Outcome
The 28 patients with long-term follow-up underwent a total
of 88 procedures including the initial pacemaker implantations, pacemaker generator changes, lead advancements, lead
changes±lead extraction, pacemaker upgrades to dual chamber, biventricular, and implantable cardioverter defibrillator
systems. At a follow-up of 11.2 to 27.4 (median, 17.2) years,
10 patients are paced VVI, 14 DDD, 3 biventricular, and 1 has
a VVI-implantable cardioverter defibrillator.
Discussion
Despite early encouraging reports of transvenous pacemaker
implantation in small children,3–5 concerns raised by SCV
occlusion and the need for many years of pacing resulted
in epicardial pacemaker implantation becoming the favored
approach in children <10 to 15 kg in many units.4,12–14 Transvenous pacing was, therefore, only practiced in a small number
of centers.6–11 To date, ours is the only single-center series of
transvenous pacing in children <10 kg with systematic follow-up and is therefore unique in documenting the long-term
follow-up over a minimum of 11 years ≤27 years.
Ward et al5 first reported the outcome of transvenous pacing via a SCV puncture in 5 children weighing 5.4 to 10 kg.
During follow-up of 12 to 30 months, there was 1 erosion
and 1 threshold rise requiring reintervention. Stojanov et al10
subsequently reported experience with transvenous pacing in
12 children weighing 2.25 to 10 kg between 1986 and 2003.
There was an excellent outcome with no lead malfunction,
infection, or venous obstruction over 3 months to 13 years.
Robledo-Nolasco et al11 also reported their experience with
transvenous pacing in 12 children <10 kg (5 patients <5 kg)
between 2001 and 2007. There was 1 lead dislodgement but
no venous occlusion over 4.6 years of follow-up.
In older children (mean ages, 5.3±3.9 and 9.2±4.7 years),
early- and intermediate-term complication rates after transvenous pacemaker implantation (after a median of 3–8 years)
5 Konta et al Transvenous Pacemaker Implantation in Infants
Figure 3. Subclavian vein patency documented at the first reintervention and weight at the initial pacemaker (PM) implantation. In 2
patients with an initially patent subclavian vein (SCV), occlusion was demonstrated at their third procedure.
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ranged from 14.5% to 24%.15,16 Pocket infections and erosions
were seen in 3% to 8%. Lead dislodgements, exit block, and
fractures were seen in 8.5% to 19%. Deaths were reported in
5% in 1 series of 155 children with pacemaker-related deaths
in one third of those.16 In a mixed series of 71 patients (mean
age, 5.3±4.2 years) followed up for 3.2±4 years with epicardial systems in 49 and transvenous systems in 22, there were
8 deaths, of which 2 were probably related to the pacing system.17 Pocket complications occurred in 6 (8.5%) patients and
lead complications in 6 (8.5%) patients. In a series of 119 epicardial pacemakers implanted at a mean age of 1.8 years with
a median follow-up of 6.4 years, there were pocket complications in 6.7% and lead fractures or exit block in 20%.18 Other
procedural complications included hemothoraces and pericardial effusions. We had 4 patients who required early reintervention because of complications (skin erosion/infection
in 2 and lead displacement/malposition in 2), 1 late pocket
infection, and 1 late endocarditis. We have not experienced
any lead fracture, exit block, or pacing-related mortality. The
overall complication rate in our cohort was 16% (6/37), which
is similar to or less than in older children followed up for a
much shorter period.
Steroid-eluting epicardial leads improved the effectiveness of epicardial pacing significantly. Cohen et al19 showed
that steroid-eluting epicardial leads had better chronic
pacing thresholds than nonsteroid epicardial leads in 123
children (<21 years) over a mean follow-up of 2.4 years.
The 5-year lead survival was 83% for steroid-eluting leads.
Tomaske et al20 showed excellent sensing and pacing thresholds with bipolar steroid-eluting epicardial leads in children
(<18.5 years) followed up to 12 years with ventricular lead
survival of 85% at 5 years. Paech et al21 recently reported
a single-center experience of 158 steroid-eluting bipolar
epicardial leads in 82 children and adults with congenital
heart disease—median follow-up of 3.3 years. Lead survival
at 5 years was reported to be 93%. However, despite the
improvement in epicardial lead characteristics, transvenous
pacemaker leads continue to have significantly lower thresholds and better longevity. Fortescu et al22 implanted 256 epicardial leads and 265 transvenous leads in pediatric patients
and patients with congenital heart disease (median age, 16.7
years). The estimated freedom from lead failure was 85% at
5 years with transvenous leads and 58% with steroid-eluting
epicardial leads.
There are few studies of epicardial lead outcomes in
children <10 kg. The majority of studies include this subset
in the much larger pediatric/congenital population making
comparisons difficult. Villain et al23 reported 34 neonates
and infants undergoing epicardial pacing in 2000. There
were 4 lead failures in the first year and 2 steroid-eluting
leads failed within 1 month of implant. They concluded that
epicardial leads should be replaced by transvenous leads at
Figure 4. A patient with congenital complete heart block received a transvenous pacemaker (PM) system at 3.6 kg (A). A patent arterial
duct plug was also placed. At 6 y of age, a threshold rise necessitated a pacing system revision. A venogram shows the occluded subclavian vein (SCV; B). The pacing lead was successfully removed with an evolution extraction system (C) through which 2 new guide wires
were inserted (D). New atrial and ventricular pacing leads were implanted through the occluded SCV (E).
6 Konta et al Transvenous Pacemaker Implantation in Infants
Figure 5. A transvenous pacemaker was implanted in a 4.3 kg infant for congenital complete heart block (A). At 8 y of age, at the time
of generator battery end of life, the chest x-ray shows the lead has straightened out (B). A venogram showed the subclavian vein was
occluded (C). As the original ventricular lead had good sensing and pacing characteristics, it was advanced through the occluded subclavian vein to form a new atrial loop to allow continued growth without tension on the lead (D).
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the end of life of the generator. A more favorable outcome
with steroid-eluting epicardial leads was described by Aellig
et al24 in 2007 in 22 patients. One ventricular lead displaced
at day 7 and 1 was replaced at 3.2 years. One pacemaker
migrated into the abdomen and required repositioning after
a year to prevent bowel complications. In another patient,
the pacemaker eroded into the bowel necessitating a laparotomy.25 Silvetti et al26 showed in a nonrandomized study
that epicardial pacing leads had a worse survival rate when
compared with transvenous pacing leads in children <1
year of age with a median weight of 3.7 (range, 1.5–7.5)
kg. Epicardial leads failed in 24% of 37 patients, whereas
transvenous leads failed in only 5% of 19 patients between
1984 and 1991.26 Cardiac strangulation by epicardial leads
continues to be reported.27
In our study using a variety of leads, the Kaplan–Meier
estimates for freedom from lead failure (excluding patients
with nonlead complications) was 95.5% at 5 years, 72.7% at
8 years, and 59.1% at 10 years of pacing. The 5-year lead survival is similar to transvenous pacing in older children, and
similar or better than epicardial steroid-eluting leads in older
children.19–22 Thus, lead survival even in small children—a
challenging setting with a rapidly growing child—is encouraging. At a median 14.3 years of pacing, 7 patients continued
with their original leads, suggesting that the atrial loop at the
initial implant allowed somatic growth and contributed to the
long pacing lead survival.
SCV Occlusion
Ours is the first study to document angiographically SCV
patency in a large consecutive series of pacemaker implants in
small children followed up over a long period. Bar-Cohen et
al28 performed contrast venography in 85 children and young
adults (median age, 15 years at implant) before a repeat pacemaker/implantable cardioverter defibrillator procedure. There
was a 13% SCV occlusion at a median interval of 6.5 years.
They were unable to implicate age, size, growth, or lead factors in this older population.28 We found that SCV occlusion
after multiple procedures during long-term follow-up was
more frequent in those weighing <5 kg at the time of the pacemaker implantation—10 of 13 (77%) <5 kg and 2 of 13 (15%)
>5 kg. The rate of SCV occlusion in those weighing 5 to 10 kg
was similar to that in considerably older patients.
We used a range of leads, the majority of which were
>5F in diameter. Since then 4.1F catheter delivered bipolar
leads have been developed, which are likely to have suited
the small patients described here, potentially reducing the
rate of SCV occlusion. The initial drawback was the need for
an 8.4F steerable catheter to allow lead positioning. Despite
favorable pacing parameters and SCV patency in older children, the large introducer sheath seemed to preclude its use
in small children.29,30 Subsequently, Kenny and Walsh31 was
able to deliver these leads through a 5F peel-away sheath, and
more recently fixed curve 7F delivery catheters have become
available. We now feel comfortable using these leads in small
Figure 6. A patient with congenital complete heart block received a pacemaker system at 6.9 kg. The initial ventricular lead was replaced with
a single pass lead through the original subclavian vein at the age of 6.5 y (A). At the age of 18 y, he developed left ventricular dysfunction and
was upgraded to biventricular pacing. The venogram showed an occluded subclavian vein (B). After extracting the single pass pacing
lead (apart from a tip in the right ventricle [RV]) 3 new leads (right atrium [RA], RV, and coronary sinus [CS]) were implanted (C).
7 Konta et al Transvenous Pacemaker Implantation in Infants
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Figure 7. A patient with tetralogy of fallot and congenital complete heart block weighing 6.8 kg received a transvenous pacemaker system at 10 mo of age. At 25 y of age after several pacing systems, the pacemaker system was upgraded to a biventricular pacing system.
The venogram showed a patent subclavian vein (SCV) (A) and a new coronary sinus (CS) pacing lead was implanted (B). His SCV accommodates 5 leads including the current 3 working leads (*) and portions of 2 old V leads (†) that were partially removed during previous
procedures (B and C).
children, but our short experience does not allow comparison
with this report.
Lead Extraction
In earlier years, traction alone was used, whereas now telescoping or powered sheaths are used. The decision to extract
depends on the need to recanalize an SCV and the parent/
patient’s choice. If the SCV is widely patent, a failed lead
may simply be abandoned and a new lead/s placed or the lead
may be extracted. When the SCV is occluded, there is a lower
threshold for extraction of the lead although if this fails or
when the patient does not wish for an extraction, the contralateral side will be used for lead placement. A combined subclavian and femoral approach allows extraction with smaller
sheaths in the SCV.32 In the presence of infection, leads are
always removed and followed by contralateral or epicardial
lead placement.
Pacing Mode
We initially subscribed to the “one lead good – two leads better”
philosophy upgrading to a dual-chamber system at the earliest opportunity. With evidence that pacing could induce ventricular dysfunction when used early and at rapid rates33,34 we
changed strategy. Dual-chamber pacing was generally delayed
until the teens or for a clear clinical indication. Indeed, even
when 2 leads were placed through a previously occluded SCV,
the initial mode was usually VVI with rate response until the
patient needed dual-chamber function. Pacemakers were set to
VVI mode up to 90 beats per minute in neonates, reducing to
70 beats per minute by 1 year of age and subsequently as low
as 50 beats per minute over the next few years. Rate response
was introduced when the children became active from 3 to 4
years of age—initially VVI with rate response, ≤140 beats per
minute, and subsequently ≤170 beats per minute when older.
The rationale for this strategy was 3-fold. Single-chamber
systems are simpler to implant and program; battery usage is
considerably lower without any noticeable effect on exercise
tolerance and the greatly reduced number of paced beats per
24 hours may preserve left ventricular function.
Current Approach
More recently, the benefits of left ventricular pacing on left
ventricular function have become increasingly appreciated.35
Together with the higher venous occlusion rate in the smallest of infants, our approach has been modified such that,
transvenous pacing is no longer first line for patients <5 kg.
We now favor placement of steroid-eluting epicardial leads
on the left ventricle reserving transvenous pacing with a
4.1F lead for failure of the epicardial system or complications. Above 5 kg, a left ventricular epicardial approach is
preferred if concomitant surgery is being performed or has
recently been performed. For transvenous pacing, we use
4.1F pacing leads placing the lead on the right ventricular
septum or apex. Above 15 kg, we use transvenous magnetic
resonance imaging conditional leads.36
Conclusions
Our policy of transvenous pacing in children <10 kg, using
mainly 5 to 6.6F leads, has produced encouraging long-term
clinical benefit, with good lead survival, albeit with a high
venous occlusion rate in those <5 kg. Nevertheless, venous
patency at up to 25 years has been documented, in some
with multiple leads in the original vein. Even when the SCV
has been occluded, recanalization, especially using modern
extraction tools, has enabled ipsilateral pacemaker implantation by placing new leads through the occlusion in a proportion. Although the development of 4.1F transvenous leads
may further improve the patency rate of the SCV, in those <5
kg, we would currently advocate epicardial lead implantation
onto the left ventricle in the first instance.
8 Konta et al Transvenous Pacemaker Implantation in Infants
Sources of Funding
This study was part funded by the Olga Knightley Laser Heart Fund.
Disclosures
None.
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Twenty-Seven Years Experience With Transvenous Pacemaker Implantation in Children
Weighing <10 kg
Laura Konta, Mark Henry Chubb, Julian Bostock, Jan Rogers and Eric Rosenthal
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Circ Arrhythm Electrophysiol. 2016;9:e003422
doi: 10.1161/CIRCEP.115.003422
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