Pediatr Cardiol (2018) 39:445–449
https://doi.org/10.1007/s00246-017-1771-x
ORIGINAL ARTICLE
Predictive Factors for Patients Undergoing ASD Device Occlusion
Who ‘‘Crossover’’ to Surgery
Venkatachalam Mulukutla1 • Athar M. Qureshi1 • Ricardo Pignatelli1
Frank F. Ing1,2
Received: 10 March 2017 / Accepted: 2 November 2017 / Published online: 15 November 2017
Ó Springer Science+Business Media, LLC, part of Springer Nature 2017
Abstract The aim of this study was to define characteris-
tics of those patients who are referred for device closure of
an Atrial septal defect (ASD), but identified to ‘‘crossover’’
surgery. All patients who underwent surgical and device
(Amplatzer or Helex occluder) closures of secundum ASDs
from 2001 to 2010 were reviewed and organized into three
groups: surgical closure, device closure, and ‘‘crossover’’
group. 369 patients underwent ASD closure (265 device,
104 surgical). 42 of the 265 patients referred for device
closure ‘‘crossed over’’ to the surgical group at various
stages of the catheterization procedure. The device group
had defect size measuring 14.2 mm (mean) and an ASD
index (Defect Size (mm)/BSA) of 14.0 compared to the
corresponding values in the surgical group (20.1 mm, ASD
index 25.9) (P \ 0.001) and in the ‘‘crossover’’ group
(20.7 mm, 22.6 ASD index) (P \ 0.001). 79 patients in the
device group had a deficient rim, and 86% were located in
the retroaortic region. 33 patients in the ‘‘crossover’’ group
had deficient rims with 70% deficiency in the posterior/
inferior rim. The device group with deficient rims had an
ASD index of 14.7 compared with the crossover group ASD
index of 23.8 (P \ 0.001). Comparing the device and
‘‘crossover’’ groups, an ASD index greater than 23.7 had a
90% specificity in ‘‘crossing over’’ to surgery. The cross-
over and surgical groups had statistically larger ASD defect
& Venkatachalam Mulukutla
cmulukutla@yahoo.com
1
Department of Pediatrics, Section of Pediatric Cardiology,
Baylor College of Medicine, Texas Children’s Hospital, 6621
Fannin Street, Houston, TX 77030, USA
2
Present Address: Division of Cardiology, Children’s Hospital
of Los Angeles, 4650 Sunset Blvd, MS #34, Los Angeles,
CA 90027, USA
•
size indexes compared with the device group. Deficient rim
in the posterior/inferior rim is associated with a large ASD
size index which is a predictive factor for crossing over to
surgery. Catheterization did not negatively impact surgical
results in the ‘‘crossover’’ group.
Keywords Secundum atrial septal defect
Transcatheter
closure
Background
Atrial septal defects (ASDs) occur in approximately 1 out
of every 1500 live births, and secundum ASDs account for
75% of the pathology [1–3]. In 2001, the FDA approved
the Amplatzer septal occluder (ASO) for transcatheter
closure of ASDs, and over the last decade, long-term fol-
low-up of transcatheter closure have shown to be equally
efficacious and safe compared with surgical closure
[1, 4, 5].
However, there are some patients who proceed to the
cardiac catheterization laboratory for device closure, but
‘‘crossover’’ to surgery. The patient characteristics, clinical
course, outcomes, and predictive factors of this ‘‘cross-
over’’ group have not been well defined. We hypothesized
that the ‘‘crossover’’ group would have different charac-
teristics including a statistically significant difference in
ASD index (defect size in the greatest length (mm)/body
surface area), and the ASD index could help predict which
patients would ‘‘crossover’’ to surgery. In addition, we
hypothesized that the anatomy of the ‘‘crossover’’ group
would be different compared with the device group.
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Methods
All patients who underwent surgical and device closure of
secundum atrial septal defects (ASDs) at Texas Children’s
Hospital from 2001 to 2010 were identified utilizing the
Texas Children’s Hospital Cardiology database. Institu-
tional board review approval was obtained for this study.
Patients with secundum ASDs who underwent Amplatzer
Septal Occluder (St. Jude Medical) or Gore Helex septal
occluder (Gore Medical) device closure, as well as those
who underwent surgical closure were included in the study.
Patients who underwent device closure with other occlusive
devices were excluded as they are not available or FDA
approved currently. Exclusion criteria included any patients
with a genetic syndrome, sinus venosus, atrial septal defect,
ostium primum atrial septal defect, patent foramen ovale, or
complex congenital anatomy along with a secundum ASD.
Patients reviewed were organized into three groups: sur-
gical closure, device closure, and the ‘‘crossover’’ group. The
‘‘crossover’’ subgroup was further subdivided into four
subgroups: TEE (transesophageal echocardiogram) only,
TEE and catheterization, TEE with device attempt, and TEE
with device placement. Variables reviewed included age,
body surface area (BSA) at closure, size of defect (mm),
ASD anatomy, number of days in the hospital, residual
shunts, pericardial effusions, appropriate placement of
device, need for repeat procedure, and any subsequent
complications. Surgical operative notes, interventional pro-
cedure records, and hospital course were reviewed. All
patient clinic visits and echocardiograms were reviewed
retrospectively over a 1-year period following the procedure.
Echocardiograms were interpreted blindly by a cardiologist
for pericardial effusions, residual shunts, and deficient rims.
A deficient rim was defined as a rim \ 5 mm around the
atrial septal defect in any one of the following locations:
superior, inferior, posterior, or retroaortic. Deficient rims
were identified by transesophageal echocardiogram at the
time of the procedure and again reviewed retrospectively by
an independent echocardiographer. Postoperative pericar-
dial effusions confirmed by echocardiogram, which were
treated with high dose aspirin, were considered significant.
Statistical analysis was performed using SPSS (IBM
SPSS Statistics). An Anova was used to determine statistical
difference between the three groups. The paired t test was
used to analyze the statistical difference between individual
groups. Data were normally distributed and reported as
means with standard deviation. Because we compared mul-
tiple groups, a Bonferroni correction was used, and we
established a statistical significance of a P value \ 0.02.
A ROC curve was constructed comparing the crossover and
device groups using the ASD index for sensitivity and
specificity.
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Pediatr Cardiol (2018) 39:445–449
Results
A total of 369 patients who underwent ASD closure and
met inclusion criteria at Texas Children’s Hospital from
2001 to 2010 were identified. Table 1 describes the char-
acteristics of the 369 patients (265 device and 104 surgical)
who underwent ASD closure. Of the device closure group,
only three patients had a Gore Helex septal occluder (Gore
Medical). The other patients in the device closure group
had an Amplatzer Septal Occluder (St. Jude Medical)
placed. 42 of the 265 patients referred for device closure
‘‘crossed over’’ to the surgical group at various stages of
the catheterization procedure.
Device and Surgical Group
The device group mean age (13.5 years ± 13) and the
surgical group mean age (8.2 years ± 7.8) were statisti-
cally significant (P \ 0.001). The number of hospital days
spent in the hospital in the device group (1 day) versus the
surgical group (5 days) was statistically significant
(P \ 0.001). The ASD index, defined as the size of the
defect in millimeters at its greatest length divided by the
patient’s body surface area, was 14.2 mm/m2 (± 6.9) for
the device group and 25.9 mm/m2 (± 12.6) for the surgical
group and was significant (P \ 0.001). There were no
deaths in either group.
Crossover Group
The ‘‘crossover’’ group mean age (10.9 years ± 7.8) and
BSA (1.05 m2 ± 0.44) were larger than the surgical
cohorts but smaller than the device group. The ‘‘crossover’’
group had a statistically significant difference in ASD
index (Size/BSA; 22.6 ± 10.7) compared with the device
group (P \ 0.001), but this was not statistically significant
when comparing the surgical and ‘‘crossover’’ groups.
An ROC curve comparing the ‘‘crossover’’ and device
groups was constructed to evaluate sensitivity and speci-
ficity. The area under the curve was 0.76. The ASD index
of 10.5 mm/m2 was 91% sensitive in identifying which
patient should undergo catheterization but only 63% spe-
cific. An ASD index of 23.7 mm/m2 was 90% specific in
identifying those patients that ‘‘crossed over’’ but only 44%
sensitive.
Crossover Subgroups
As shown in Table 2, the ‘‘crossover’’ groups were further
subdivided, and there were no statistically significant dif-
ferences when comparing age, BSA, number of hospital
days, defect size, or ASD index (size/BSA).
Pediatr Cardiol (2018) 39:445–449 447

Table 1 Comparison of device, surgery, and crossover groups

Mean ± SD N Age (years) BSA Hospital days Defect size (mm) ASD Index (size/BSA)

Device closure 223 13.5 (13.0)** 1.16 (0.48)** 1 (0.18) 14.2 (5.5)*** 14.0 (6.9)***
Surgical closure 104 8.2 (7.8)** 0.89 (0.45)** 5.1 (2.4)* 20.1 (8.1)*** 25.9 (12.6)***
Crossover group 42 10.9 (7.8) 1.05 (0.44) 6.3 (4.8)* 20.7 (7.3)*** 22.6 (10.7)***
*P = 0.02
**P \ 0.001
***P \ 0.001 when compared to device closure group

Table 2 Comparison of crossover subgroups

Mean ± SD N Age BSA (m2) Hospital (length of stay- Defect size ASD Index (size/
(years) days) (mm) BSA)

Subgroup1 (TEE only) 15 9.6 (4.8) 1.03 (0.44) 7.4 (7.0) 21.6 (6.8) 24.7 (13.4)
Subgroup2 (TEE ? cath) 16 10.9 (11.4) 1.0 (0.50) 5.9 (3.4) 20.3 (6.6) 23.4 (8.7)
Subgroup3 (TEE ? device attempt) 7 12.5 (4.9) 1.15 (0.38) 5.9 (3.2) 21.9 (9.6) 20.6 (9.5)
Subgroup4 (TEE ? device 4 10.5 (4.8) 1.12 (0.47) 6 (0.5) 16.5 (9.3) 15.6 (7.6)
implanted)

Subgroup 1 included 15 patients who underwent a
transesophageal echocardiogram (TEE) and no catheteri-
zation due to unfavorable anatomy and deficient rims. The
deficient rims were in the following locations: 8 in the
inferior, 5 posterior, 1 superior, and 1 retroaortic.
In subgroup 2, patients had a TEE and catheterization
without device attempt. The patients crossed over due to
deficient rims in 12 of the 16 patient (75%), located in the
following locations: 5 inferior, 3 posterior, 3 retroaortic, and
1 superior. In 3 of the 16 patients (19%), the defect was too
big compared to septal length, and in 1 patient (6%), an
additional septal defect was found precluding device
placement.
In subgroup 3, patients had a device attempted but not
implanted. The device attempt was not successful due to
deficient rims in 6 of the 7 patients (87%); 3 retroaortic, 2
inferior, and 1 superior. In 1(14%) patient, an additional
ASD was discovered after device placement, but before
release.
In subgroup 4, all patients had device implanted and
released, but were later removed and surgically repaired.
Of the 4 patients, 3 had device removed at time of surgery.
In two patients, a significant additional ASD was discov-
ered after device release. In the first patient, the closure was
attempted of the second defect but was unsuccessful due to
its proximity to the right pulmonary vein. In the second
patient, a posterior ASD with insufficient posterior rim in
the other. In the third patient, an echocardiogram 1 week
later showed the device displaced anteriorly into the right
atrium, and the device was removed at surgery. In the
fourth patient, the device was found to have embolized to
the main pulmonary artery at 1-month follow-up and was
removed in the catheterization lab. The patient underwent
subsequent surgical closure 6 months later at an outside
institution.
After crossover to surgery, all patients had successful
surgical closure of ASD. The prevalence of post-op peri-
cardial effusions was similar between the ‘‘crossover’’
group 4/34 (9%) and the surgical group 9/104 (9%).
Device and ‘‘Crossover’’ Group with Deficient Rims
As shown In Table 3, patients in the device group and
‘‘crossover group’’ with deficient rims were compared. Of
the patients in the device group that underwent successful
ASD closure, 79 (35%) had deficient rims, and 86% (68/79)
were located in the retroaortic region. In the crossover group,
33 (77%) had deficient rims: 13 inferior, 10 retroaortic, 8
posterior, and 2 superior. The device group (14.7 mm/m2)
had a significantly lower ASD index score compared with the
‘‘crossover group’’ (23.8 mm/m2) (P \ 0.02).
Discussion
Secundum ASDs are one of the most common congenital
heart defects, and device and surgical closure of ASDs are
equally efficacious [7]. In our study, there were no deaths
and few complications. However, there were 42 patients
who ‘‘crossed over’’ to surgery from a possible device
closure. The procedural success of the device group was
91% (238/263); comparable to a large multicenter study

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Table 3 Patients with deficient
Mean ± SD
rims
Device group with deficient rims
Crossover group with deficient rims
*P = 0.02
(95.7%) of the Amplatzer Septal Occluder (1998–2000)
[7, 8]. In the multicenter study, there were a comparable
number (36 patients) that were referred to catheterization,
and were unable to undergo the procedure due to unfa-
vorable anatomy or a technical failure [7]. Few studies
evaluated the ‘‘crossover’’ group. Understanding the
characteristics of these patients is important when
deciding which candidate would be suitable for device
occlusion.
One criterion that should be used is the ASD index
[defect size in the greatest length (mm)/body surface area
(m2)]. It facilitates an effective unified comparison in the
defects of young and old patients. An ASD index greater
than 23.7 mm/m2 was 90% specific in predicting those
patients that would ‘‘crossover,’’ but was only 44% sensi-
tive. There was a statistically significant difference in ASD
index when comparing the device group to the ‘‘crossover’’
and surgical groups. Despite the statistical differences
between the device and ‘‘crossover’’ groups, there were still
25 patients, who had successful closure in the catheteriza-
tion lab, with an ASD index greater than 23.7 mm/m2, and
64 patients with an ASD index greater than 21 mm/m2.
ASD index is an important predictive factor but not the only
factor when considering device closure. Based on our
results, an increasing ASD index can identify patients that
are at the highest risk of ‘‘crossing over’’; however, it does
not necessarily preclude a successful device closure pro-
cedure in the catheterization laboratory.
Another important factor is the location of the rim
deficiency. In one study by Du, et al., 23 patients with
deficient rims underwent attempted transcatheter closure
with procedural success in 17 [9]. Of the 23 patients, 20
had a deficient rim in the anterior or retroaortic rim, and
only 3 in the inferior or posterior rim [9]. In our study, over
79% (33/42) percent of patients that ‘‘crossed over’’ to
surgery had a deficient rim, and they were mostly located
in the posterior and inferior rims, 70% (23/33). In com-
parison, the device group had 35% of patients (79/223)
with deficient rims, and 86% were located in the retroaortic
region, while the ‘‘crossover’’ group had 30% (10/33) with
deficient rims in the retroaoartic region.
ASD index alone is a predictive factor for determining
who crosses over to surgery, but it is limited in that it has a
low sensitivity. It is a much stronger factor when in con-
junction with a deficient rim. It is our feeling that patients
with a large ASD index combined with deficient rims
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Pediatr Cardiol (2018) 39:445–449
N ASD Index (size/BSA)
79 (35%) 14.7* (6.3)
33 (77%) 23.8* (10.7)
located in the posterior/inferior septum have the highest
likelihood of ‘‘crossing over’’ to surgery. However, these
factors are not absolute contraindications to catheter-based
closure as indicated by the fact that 25 (10.9%) patients
with similar characteristics to the crossover group under-
went successful device placement. In addition, often fur-
ther imaging with TEE, intracardiac echocardiography
(ICE) and catheterization is needed to accurately assess
candidacy for device placement. Moreover, patient out-
comes were not negatively impacted by ‘‘crossing over’’ to
surgery.
Additional ASDs should be sought aggressively after
initial diagnosis. In our study, four patients ‘‘crossed over’’
to surgical closure after an additional ASD was found at
the time of catheterization, and this represented a signifi-
cant percentage (9%) of patients who ‘‘crossed over.’’
Additional defects in three of the four patients were found
after device deployment/release, and it was difficult to
close the additional defects in those situations. While
closure of multiple defects may be challenging and not
possible in some situations in the catheterization labora-
tory, closure of multiple defects with a single device or
multiple devices is often possible [8]. Recrossing around
acutely deployed devices may be challenging, as seen in
this series, and can result in ‘‘crossover’’ to the surgical
group. However, if identified beforehand, crossing multi-
ple defects with multiple wires and deploying devices
sequentially may allow for successful closure in the
catheterization laboratory.
Overall, the ‘‘crossover’’ group tolerated catheterization
well, and catheterization did not negatively impact surgical
results in the ‘‘crossover’’ group. The difference in hospital
stay between the surgical and ‘‘crossover’’ group was not
significant, and the incidence of postoperative pericardial
effusions was similar. The one case of late endocarditis in
the ‘‘crossover group’’ is the only known case at this time
[6]. In borderline cases, it may be reasonable to bring
patients to the cath lab to further evaluate suitability for
device closure.
Limitations of the study include that it is a retrospective
review of a single institution. There may be a bias in the
selection of patients that went to surgical or device closure
based on the family wishes or the referring cardiologist.
Furthermore, it is possible that there could be a bias from
an interventional cardiologist standpoint resulting in sur-
gical ‘‘crossover’’ in some cases. Finally, this study was not
Pediatr Cardiol (2018) 39:445–449
powered to evaluate the differences between the two device
types with regard to anatomic subtypes.
Conclusion
‘‘Crossover’’ and surgical groups had statistically larger
ASD defect sizes and indexes compared with the device
group. Deficient rim associated with a large ASD index or
located in the posterior/inferior septum is a predictive
factor for ‘‘crossing over’’ to surgery. Patients referred to
catheterization should have additional ASDs aggressively
sought after, prior to device closure. The ‘‘crossover’’
group tolerated catheterization well without negatively
impacting surgical results. The results of potential risk
factors resulting in crossing over to surgery pertain to the
current approved ASD device technology, and it is unclear
whether these risk factors will apply to future devices for
ASD closure or not.
Compliance with Ethical Standards
Conflict of interest The authors of the study have no conflicts of
interest to report.
Ethical Approval All procedures performed in studies involving
human participants were in accordance with the ethical standards of
the institutional and/or national research committee and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.
449
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