3. were examined, and heart rate and blood pressure (BP) were
measured in the right arm with the subject in a sitting position. Right
and left lower-extremity limb length was measured from the anterior
superior iliac crest to the plantar surface of the heel. The sites of
maximum Doppler signal for the radial and posterior tibial arteries
were located and marked. Supine systolic blood pressure in all 4
extremities was measured with a Doppler probe and an appropriately
sized cuff on the proximal arm or thigh. The residual resting systolic
coarctation gradient was calculated as the difference in systolic BP
between the right arm and the lower extremity with the highest
measured systolic BP.
Subjects underwent exercise treadmill testing with a standard
Bruce protocol with continuous ECG monitoring. Once fatigued,
subjects immediately assumed a supine position. BP cuffs were
applied simultaneously to each extremity, and systolic BP was
determined with a Doppler probe over the previously marked pulse
site. BP was measured in succession: right arm, right leg, left leg, and
finally left arm. A large-volume air pump allowed rapid cuff
inflation such that all 4 measurements were complete within 1
minute. Resting heart rate and right arm BP were again recorded with
the subject in a sitting position 10 minutes after exercise termination.
Magnetic resonance angiography was performed and interpreted
by a pediatric radiologist who was blinded to the patient’s treatment
history. Measurements of the aorta were obtained in both anteropos-
terior and lateral views just distal to the left common carotid artery,
at the isthmus, at the coarctation repair site, and at the diaphragm. An
aneurysm was defined as an area of dilation that was 150% of the
aortic diameter at the diaphragm or a discrete saccular dilation at the
site that was not present before intervention.4
Subjects who could not be reached or were unable to return for
follow-up evaluation as part of the present study were classified as
group II. For these subjects, the most recent clinical records were
reviewed for aortic arch imaging results and any additional interven-
tions performed since initial BA or surgery.
Comparison of treatment strategies with regard to BP, exercise
performance, and magnetic resonance angiography measurements
was performed with a 2-tailed Student t test. Categorical data
comparisons were performed with a Fisher exact test. Nonparametric
data were compared by the Mann-Whitney U test. Differences were
considered statistically significant for PϽ0.05. All data are ex-
pressed as meanϮSD unless otherwise stated.
Results
Among the 36 original participants randomized to BA
(nϭ20) or surgery (nϭ16), 21 subjects returned for evalua-
tion (11 BA, 10 surgery) between April 2001 and November
2002. The demographics for these group I subjects are
summarized in Table 1. At the time of follow-up evaluation,
there were no significant differences in height, weight, age,
time since initial intervention, or right versus left leg length
between treatment groups. Information gathered from the
most recent clinical records for group II subjects included
data for the remaining 9 BA and 6 surgical subjects (Table 2).
The combined demographics for all subjects initially enrolled
are summarized in Table 3 (groups I and II combined).
Group I Baseline BP Measurements
None of the group I subjects were taking antihypertensive or
other cardiovascular medications at the time of evaluation.
Average resting BPs and coarctation gradients were not
statistically different for either treatment strategy. Relief of
obstruction was achieved with both treatment modalities with
no significant systolic BP gradient measured at rest.
Group I Exercise Testing
Exercise performance for group I subjects is summarized in
Table 4. The range in systolic BP gradient with exercise was
14 to 128 mm Hg for the BA group and Ϫ17 to 152 mm Hg
for the surgical group. The mean difference in BP between
TABLE 1. Long-Term Follow-Up Patient Demographics (Group I)
Demographic
Balloon
Angioplasty Surgery P
No. of subjects 11 10 NS
Age at follow-up, y 20.6Ϯ2.4 18.6Ϯ1.8 NS
Time since initial intervention, y 13.7Ϯ1.9 13.8Ϯ1.2 NS
Age at initial treatment, y 6.8Ϯ2.0 4.9Ϯ1.5 0.02
Weight at initial treatment, kg 23.5Ϯ9.8 17.7Ϯ2.7 NS
Body surface area at initial treatment, m2
0.9Ϯ0.2 0.7Ϯ0.1 NS
Balloon diameter, mm 12.8Ϯ2.2 NA
NA indicates not applicable.
TABLE 2. Chart Review Patient Demographics (Group II)
Demographic Balloon Surgery P
No. of subjects 9 6 NS
Age at follow-up, y 12.5Ϯ4.5 14.3Ϯ3.6 NS
Time since initial intervention, y 6.8Ϯ4.3 7.2Ϯ2.6 NS
Age at initial treatment, y 5.7Ϯ2.0 7.1Ϯ2.4 NS
Body surface area at initial treatment, m2
0.8Ϯ0.1 0.9Ϯ0.2 NS
Weight at initial treatment, kg 19.5Ϯ5.1 22.8Ϯ6.5 NS
Balloon diameter, mm 12.6Ϯ2.5 NA
NA indicates not applicable.
TABLE 3. Combined Group I and Group II Patient Demographics
Demographic
Balloon
Angioplasty Surgery P
No. of subjects 20 16 NS
Age at follow-up, y 16.9Ϯ5.4 17.0Ϯ3.3 NS
Time since initial intervention, y 10.6Ϯ4.7 11.3Ϯ3.7 NS
Age at initial treatment, y 6.3Ϯ2.0 5.7Ϯ2.1 NS
Weight at initial treatment, kg 21.7Ϯ8.1 19.9Ϯ5.2 NS
Body surface area at initial treatment, m2
0.8Ϯ0.2 0.8Ϯ0.2 NS
Balloon diameter, mm 12.7Ϯ2.3 NA
Time since initial intervention to aortic imaging, y 9.9Ϯ5.2 (nϭ19) 11.0Ϯ4.9 (nϭ13) NS
NA indicates not applicable.
3454 Circulation June 28, 2005
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4. upper and lower extremity with exercise exceeded 50 mm Hg
irrespective of initial treatment (PϽ0.001). BA subjects
developed a greater difference in BP between the lower
extremities than was seen among surgical subjects, which was
not present at rest. Heart rate and BP measurements 10
minutes after exercise for group I subjects are also summa-
rized in Table 4. The mean diastolic BP 10 minutes after
exercise was statistically higher for the BA subjects
(PϽ0.05).
Group I Magnetic Resonance Angiography
MRI of the aortic arch was declined by 1 group I surgical
subject because of claustrophobia. Quantitative, noninvasive
imaging of aortic arch dimensions among group I subjects
demonstrated no statistically significant differences between
treatment strategies. The ratio of the aortic diameter at the site
of initial intervention to the diameter of the aorta at the
diaphragm was 0.9Ϯ0.3 for the BA group and 0.9Ϯ0.2 for
the surgical group (PϭNS).
Repeat Interventions
Among the 20 subjects initially treated with BA, 3 underwent
repeat BA, and 3 underwent surgical repair (2 for aneurysm
resection). Two subjects initially treated surgically underwent
BA. One of these subjects later returned for repeat surgery.
Fisher exact test analysis of repeat interventions demon-
strated no difference between treatment groups (PϾ0.05).
Aneurysm Formation
Aneurysms were detected in 7 (35%) of the 20 BA subjects (4
diffuse, 3 discrete). No aneurysms were detected among the
16 surgical subjects (Pϭ0.011). Aneurysms were detected
among 4 BA subjects at a median of 1.03 (range 0.17 to 1.44)
years after their initial intervention. One of these subjects was
referred for elective surgical repair 6.8 years after initial BA
at the discretion of his cardiologist, at which time an
interposition graft was placed. No repeat interventions have
been performed on the other 3 subjects in whom aneurysms
were detected early. Late aneurysms developed in 3 addi-
tional BA subjects despite negative imaging performed Ϸ1
year after the initial procedure. An aneurysm was first
detected in 1 subject 6.4 years after initial intervention. This
subject was electively referred for surgical intervention 4.9
years later, at which time the aneurysm was resected and
patch aortoplasty performed. One subject who initially un-
derwent BA and subsequently underwent surgical resection
and end-to-end anastomosis for recurrent CoA 0.8 years after
BA had no evidence of aneurysm formation 8.4 years after
initial intervention. Repeat imaging performed 6.1 years later
(14.5 years after initial BA) demonstrated an aneurysm at the
former repair site. This subject has not yet been referred for
additional intervention. A third late aneurysm was detected
8.3 years after initial BA. No additional interventions have
been performed given a stable appearance for the past 8 years.
Discussion
Surgical technique for CoA has evolved to overcome ob-
served problems with persistent or recurrent obstruction or
aneurysm formation. An extended end-to-end anastomosis is
currently the preferred treatment for CoA during childhood in
some centers, with BA reserved only for recurrent obstruc-
tion. The report of BA in the treatment of native CoA in an
infant with congestive heart failure in 19835 initiated a
controversy that persists today. Although BA for CoA during
infancy is now rarely performed because of the high inci-
dence of recurrent obstruction, this alternative to surgery in
the treatment of CoA in children remains in widespread
practice. Acute and 1-year follow-up results of a prospective
comparison of BA and surgery for native CoA showed a
similar immediate gradient reduction but a higher risk of
aneurysm formation and possibly restenosis with BA among
36 patients aged 3 to 10 years.1 Because of the continued
controversy about the selection of BA or surgery for the
treatment of native CoA in children, we sought to examine
the long-term outcomes among this previously randomized
group of 36 subjects.
Effective relief of obstruction nearly 14 years after initial
treatment was demonstrated in the present study with both
BA and surgery. Baseline BP measurements and exercise
performance were also equivalent between the 2 groups,
perhaps as a result of the effective relief of aortic arch
obstruction. A statistically significant gradient with exercise
in subjects from both groups was noted and is most likely
related to the inherent vascular dysfunction of the upper
segment known to occur in association with coarctation.6–9
The more rapid normalization of diastolic BP among the
surgical subjects 10 minutes after exercise termination is
interesting but of unknown significance.
The potential development of aneurysms has long been
considered a major limitation to BA. A strikingly higher
TABLE 4. Group I Exercise Performance
Exercise Data Balloon Surgery P
Exercise duration, min 13.5Ϯ2.8 11.4Ϯ3.8 NS
Peak right arm BP, mm Hg 169Ϯ36 162Ϯ34 NS
Peak heart rate, bpm 193Ϯ14 184Ϯ25 NS
Right arm lower-extremity BP difference, mm Hg 53Ϯ33 55Ϯ45 NS
Right vs left lower-extremity BP difference, mm Hg 22Ϯ15 8Ϯ5 Pϭ0.01
10 minutes after exercise
Heart rate, bpm 99Ϯ14 97Ϯ14 NS
Systolic BP, mm Hg 118Ϯ12 118Ϯ12 NS
Diastolic BP, mm Hg 80Ϯ11 68Ϯ12 Pϭ0.03
Cowley et al Balloon Angioplasty vs Surgery for Coarctation 3455
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5. incidence of aneurysm formation after BA (35% versus 0%
for surgery) was seen in the present study, with the develop-
ment of 3 aneurysms more than 5 years after the initial
intervention. The 35% incidence of aneurysm formation
among BA patients in the present series is similar to some
early reports in which aneurysm formation occurred in 36%
to 43% of children treated with BA.10,11 More recently,
however, Walhout et al12 found no aneurysms among 32
children with native CoA treated with BA, but the duration of
follow-up was shorter than in the present study. The late
development of aneurysms in the present series demonstrates
the importance of long-term imaging in patients who have
undergone BA. The recently reported 8% incidence of aneu-
rysms among adolescents and adults treated with BA for
native coarctation is much lower than that observed in the
present study, but this may be due to a variety of factors,
including greater vessel wall thickness in older patients.13
Aneurysm formation after surgery in subjects initially treated
with BA, as occurred in 1 subject in the present study, has not
been widely reported. On the contrary, successful surgical
repair after BA in subjects who develop recurrent stenosis has
been described.14 However, the presence of an aneurysm may
complicate surgical intervention, in some cases necessitating
the use of interposition grafts or patches.
In addition to the higher incidence of aneurysm formation,
a greater discrepancy between right and left lower-extremity
BP with exercise was observed among subjects initially
treated with BA. This difference in lower-extremity BP with
exercise is most likely due to femoral artery injury sustained
at the time of intervention. Previous studies have reported the
incidence of iliofemoral stenosis or occlusion after aortic
valvotomy or coarctation BA to be 22% to 58%.15–17 Al-
though we found no associated higher incidence of lower-
limb-length discrepancy in the BA group, and no subjects
complained of asymmetric claudication, the potential for
progressive arterial insufficiency as previously reported may
prove problematic for these subjects.17 The current availabil-
ity of lower-profile balloon catheters may decrease the
incidence of this complication.
These data demonstrate good relief of obstruction and an
equivalent need for repeat interventions for both surgery and
BA in the treatment of CoA in childhood; however, a higher
incidence of aneurysm formation was observed among BA
subjects, with some aneurysms first detected more than 5
years after initial intervention. Although some clinicians may
consider these to be acceptable risks, knowing that future
surgery can still be performed among patients initially re-
ferred for BA, only 50% of subjects initially treated with BA
were free of detected aneurysms and had not been referred for
additional interventions compared with 87.5% of surgical
subjects (Pϭ0.03). Although caution is warranted in extrap-
olating the results of procedures initially performed on this
cohort of children nearly 20 years ago to the current era, the
relatively uncontrolled vascular tearing inherent to BA ap-
pears to be associated with the development of aneurysms,
some of which may develop late. Clinicians should consider
these differences in outcomes and the need for long-term
imaging studies among patients treated with BA when rec-
ommending treatment for native CoA during childhood.
Acknowledgment
This investigation was supported by Public Health Services research
grant number M01-RR00064 from the National Center for Research
Resources.
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