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ORIGINAL ARTICLE
Transcatheter Closure of Atrial Septal Defects in Adolescents
and Adults: Technique and Difficulties
Mulyadi M. Djer1, Nuvi N. Ramadhina1, Nikmah S. Idris1, Dedi Wilson1,
Idrus Alwi2, Muhammad Yamin2, Ika P. Wijaya2
Department of Child Health, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta
Indonesia. 2 Department of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo
Hospital, Jakarta, Indonesia.
1
Correspondence mail:
Department of Child Health, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital.
Jl. Diponegoro no. 71, Jakarta 10430, Indonesia. email: [email protected].
ABSTRAK
Tujuan: mengevaluasi tindakan penutupan atrial septal defect (ASD) transkateter pada remaja dan dewasa.
Metode: studi seri kasus terhadap pasien yang menjalani tindakan penutupan ASD transkateter di RS Cipto
Mangunkusumo Jakarta tahun 2002 sampai 2013. Sebelum penutupan, dilakukan ekokardiografi transesofagus,
pengukuran hemodinamik, dan angiografi. Tes oksigen dilakukan jika tekanan arteri pulmonal lebih dari 2/3
tekanan aorta. Jika respons tes oksigen negatif, uji oklusi dengan alat penutup dilakukan. Jika tidak didapatkan
kenaikan tekanan arteri pulmonal dan atrium kanan, alat penutup di-release. Hasil: subjek berjumlah 54 orang,
7 (13%) di antaranya lelaki, dan 14 (26%) adalah remaja. Median berat badan 49 (26-75) kg dan ukuran ASD
21 (9.4-39.6) mm. Tindakan dilakukan dalam anestesi umum pada 26% pasien. Tes oksigen dilakukan pada
6/54 (11%) dan tes oklusi pada 1 (2%) pasien. Penutupan ASD berhasil dilakukan pada semua pasien dengan
teknik biasa (31%), right pulmonary vein assisted (65%), left pulmonary assisted (2%), atau cutting long sheath
(2%). Tidak ditemukan residual ASD atau komplikasi serius. Median waktu floroskopi adalah 29 (SB 18) menit,
waktu prosedur 109 (SB 36) menit, dan lama rawat 1 (1-3) hari. Kesimpulan: penutupan ASD pada remaja dan
dewasa memiliki angka keberhasilan tinggi.
Kata kunci: penutupan transkateter, atrial septal defect, hipertensi pulmonalis, tes oksigen, tes oklusi.
ABSTRACT
Aim: to evaluate the results of transcatheter closure of atrial septal defect (ASD) in adolescents and adult.
Methods: a case series of patients undergoing transcatheter closure of ASD in RS Cipto Mangunkusumo, Jakarta
during 2002 -2013. Transesophageal echocardiography, hemodynamic study, and angiography were performed
before the procedure. Oxygen test was done if PA pressure was more than 2/3 of aortic pressure, followed by an
occlusion test if no response observed to determine whether the device could be released. Results: we enrolled
54 patients, of whom 26% were adolescents and 3% were males. Median body weight was 49 (26-75) kg and ASD
size was 21 (9.4-39.6) mm. The procedure was done under general anesthesia in 26% of patients. Oxygen test
was applied in 11% patients and occlusion test in 2% of patient. Transcatheter closure of ASD was successful in
all patients using common technique (31%), right pulmonary vein-assisted (65%), left pulmonary assisted (2%),
and cutting long sheath (2%). There was neither residual ASD nor complications observed. Mean fluoroscopy
and procedure time were 29 (SD 18) and 109 (SD 36) minutes, respectively. Median hospital stay was 1 (1-3)
day. Conclusion: transcatheter closure of ASD in adolescents and adults is safe and effective.
Key words: transcatheter closure, atrial septal defect, device, oxygen test, occlusion test, pulmonary
hypertension.
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Acta Medica Indonesiana - The Indonesian Journal of Internal Medicine
Vol 45 • Number 3 • July 2013
Transcatheter closure of atrial septal defects in adolescents and adults
INTRODUCTION
Atrial septal defect (ASD) is the second most
common acyanotic congenital heart disease that
presents at any age.1,2 It may be undetected until
adolescence or adulthood. Patients with isolated
atrial septal defects will have good outcomes if
the diagnosis and management are suitable for
the conditions. The size of the defect and relative
diastolic filling properties of the right ventricle
should be considered in every case. Surgical
repair for adult cases of ASD and its results
appear less favorable than intervention closure
using device.3-6
Transcatheter ASD closure has been shown
to be feasible and safe in children, but data in
adults are less established.7-11 Amplatzer septal
occluder (ASO) is one of the devices that was
already recommended by US Food and Drugs
Administration (FDA) for ASD closure.12-16 The
benefits of using transcatheter closure compared
to surgical closure are short hospital stay, no need
for cardiopulmonary bypass (CPB), and no scar
at the chest wall.3-6
Interartrial communication between the left
atrium and right atrium brings the blood from
the left atrium to the right atrium, resulting
in lung overflow. The body respons to this
condition by increasing the pulmonary pressure
which could lead to pulmonary hypertension.
The ideal age for ASD closure is preschool
age between 4 and 5 years old,1,2 and delay in
ASD closure until adolescense or adult age is a
challenge. The aim of this study was to evaluate
the result of transcatheter closure of atrial septal
defect (ASD) in adolescents and adults in Cipto
Mangunkusumo Hospital Jakarta, Indonesia.
METHODS
This study was a case series noncomparative from a group of adolescents and
adults who underwent transcatheter ASD
closure with the Amplatzer® septal occluder
at the Integrated Cardiovascular Services, RS
Dr. Cipto Mangunkusumo since 2002 until
2013. The diagnosis of ASD was established
by the history, physical examination, chest
radiography, electrocardiography and confirmed
by transthoracic echocardiography. All patients
underwent 2D transthoracic echocardiography
to assess defect location, size with respect to
anterior and posterior rim length. Colour Doppler
echocardiography was performed to examine the
shunts, left-to-right shunt, bidirectional shunt or
right-to-left shunt.
Continuous-wave echocardiography was
done to measure the pressure gradient from
tricuspid valve in order to predict pulmonary
arterial pressure. Once the diagnosis of ASD
was established, all patients underwent the transesophageal echocardiography (TEE) to assess
ASD morphology in more details, including the
shunt and the length of anterior and posterior rim.
If the posterior rim length was more than 5 mm,
the patients underwent cardiac catheterization
to study the hemodynamic and angiography. All
catheterization procedures in adolescents were
carried out under general anaesthesia whereas
in adults, they were done with local anaesthesia
and sedation.
All patients underwent cardiac catheterization
of the right and the left heart. The sheaths were
introduced into the right femoral artery, right
femoral vein, and left femoral vein. Pressure and
oxygen saturation (with 21% oxygen fraction)
were taken from inferior vena cava (IVC), right
atrium (RA), superior vena cava (SVC), right
ventricle (RV), and pulmonary artery (PA) for the
right-heart study and from the aorta, left ventricle
(LV), and left atrium (LA) for the left-heart study.
The flow ratio of pulmonary to systemic shunt
was calculated. A pigtail diagnostic catheter
was placed at the right pulmonary artery (RPA)
for angiography to measure the size of ASD.
If pulmonary pressure was more than 2/3
systemic pressure, the oxygen test procedure was
performed by giving 100% oxygen with respect
to reversibility of the pulmonary hypertension. In
patients with low pulmonary to systemic flow and
high pulmonary pressure after oxygen test, the
Amplatzer® septal occluder was deployed at the
ASD site for 20 minutes (occlusion test) and the
pulmonary artery and right atrial pressures were
observed. If the pulmonary artery and right atrial
pressures were stable, the device was released.
If the pulmonary pressure increased during the
occlusion test, the device was withdrawn.
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Amplatzer® septal occluder was chosen
for ASD closure, made from nitinol (nickel and
titanium) wire mesh with retention discs on the
left-side and right side, which were connected
with a waist, so it resembles the letter of”H”. The
nitinol wire mesh has a diameter of 0.004 inches.
Inside the nitinol wire mesh, there are dacron
layers which are favourable for thrombosis that
will lead to ASD closure. The device is selfexpandable and could be compressed under
a catheter and can re-shape again after being
deployed. It was designed to allow the discs
to emerge at the ASD side. The device size was
shown as the waist size. The left-sided disc
retention width was 7 mm more than the device’s
waist. The right-sided disc is slightly smaller
than the left-sided disc. For ASD closure with
this device, we need a delivery sheath or along
sheath or a Mullin sheath, a delivery cable, a
loading catheter, and a plastic versa.
Transesophageal echocardiography was
performed in all patients to assess the ASD size
and posterior rim length. After TEE, the defect
size in stretch condition was confirmed with
balloon sizing. The balloon was inflated until
there was no flow across the defect (stop flow
technique) and the waist was measured using
the balloon marker. The device size was 2 mm
larger than the streched diameter if the waist
on balloon was clearly seen. If there was no
anterior rim, the device size was 4 mm larger
than the streched diameter. After balloon sizing,
the balloon was withdrawn and the delivery
sheath was introduced from right femoral vein
to the left pulmonary vein with guidance of
the Amplatzer® super-stiff wire. The dilator
delivery sheath was withdrawn. The device was
then screwed at the tip of the delivery cable and
compressed inside the loading catheter. After
that, it was introduced into the delivery sheath
and the cable was pushed into the sheath. Using
the fluoroscopy guidance, the delivery cable
was advanced into the left atrium until the left
atrial disc emerged and spontaneously reshaped.
Then, the delivery system was withdrawn until
the right atrium disc touch the atrium septum,
then the sheath alone was withdrawn further
over the delivery cable to allow the right atrial
disc to emerge and reshape on the right atrial
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side. Device position was assessed with TEE.
If the device was not in a good position, it was
retrieved into the delivery sheath and we redeployed the device. If this procedure did not
succed, we deployed the device using the left
or right pulmonary vein assisted techniques. If
these techniques also did not work, we cut the
curve edge of the delivery sheath, leaving only
the straight part. Using the RPV or LPV-assisted
technique, the collapsed device was placed into
the pulmonary vein, then the delivery sheath
was withdrawn until the device was completely
uncovered by the sheath. After this, the delivery
cable was pushed to open the right disc, then by
further pushing the cable, the left disc reshaped
by itself after slipped out from the pulmonary
vein. After the device was deployed at the atrium
septum, blood flow in the pulmonary veins and
mitral valve was assessed before the delivery
cable was unscrewed to release the device. The
stability of the device was then tested by gently
pulling and pushing the cable several times. If the
device was stable, we unscrewed the plactic versa
counter clock-wise with fluoroscopy guidance
until the device was released from the delivery
cable. On the left anterior oblique 700 projection,
RPA angiogram was performed to evaluate the
shunt from LA to RA.
Patients underwent follow-up examinations,
including chest radiography in antero-posterior
(AP) and lateral positions and echocardiography
to measure the pressure gradient across the
tricuspid valve. Patient was given aspirin 5 mg/
kg daily peroral for 6 months.
All data were processed using SPSS 17.0
version for Window. All data were expressed as
mean (SD), or median and range.
RESULTS
During the study period, 54 patients, of
whom 14 were adolescents (12-18 years-old)
were referred for atrial septal defect closure.
Baseline patients characteristics are shown in
Table 1. Females outnumbered males by a ratio
of almost 7:1. Most patients (59%) were within
level I or II functional class.
Adolescent patients (14 patients, 26%)
underwent catheterization intervention under
general anesthesia while adults with local
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Transcatheter closure of atrial septal defects in adolescents and adults
Table 1. Patients’ characteristics
Variables
Table 2. Device size and delivery techniques
Variables
Results
Age, median (range) years
30.1 (12-68)
Device size, median (range) mm
Body weight, median (range) kg
49.1 (26-75)
Balloon sizing, n (%)
Results
26 (14-38)
54 (100)
Technique
Gender
-- Male n(%)
7 (13)
Usual, n (%)
17 (31)
-- Female n(%)
47(87)
RPVAT, n (%)
35 (65)
Clinical data
-- Cephalgia n (%)
2 (4)
PVAT, n (%)
1 (2)
Cutting delivery sheath, n (%)
1 (2)
-- Heart failure
-- NYHA I n (%)
12 (22)
-- NYHA II n (%)
34 (37)
-- NYHA III n (%)
6 (11)
-- NYHA IV n (%)
0 (0)
Electrocardiography
-- RVH n (%)
24 (44)
-- Normal QRS axis, n (%)
38 (70)
-- RAD n (%)
16 (30)
Echocardiography
-- ASD size (TTE)
21 (9.4-39.6)
-- PG tricuspid valve (mmHg)
30 (23.8-44)
Catheterization data
-- ASD (balloon sizing)
26.4 (14-38)
-- PA pressure prior procedure
(mmHg)
28.1 (11-74)
-- PA pressure after procedure
(mmHg)
27.5 (14-76)
-- Flow ratio
3.1 (1.3-17.4)
-- PARI
2.2 (SD 1.1)
ASD, atrial septal defect; NYHA, New York Heart
Association; PARI, pulmonary artery resistance index;
PA, pulmonary artery; PG, pressure gradient; RAD, right
axis deviation; RVH; right ventricular hypertrophy; TTE,
transthoracic echocardiography
anaesthesia with sedation if necessary. The size
of ASD was mostly large with a median of 26.4
mm. Median PA pressure after the procedure
showed a little decrease compared to that before
procedure. The majority (88%) of patients had a
pulmonary artery pressure of less than two third
of aortic pressure.
All patients underwent a transcatheter
procedure and the ASD was closed by the
Amplatzer® septal occluder as shown in Table 2.
The largest device used was the Amplatzer®
device size number 38, whereas the most
common size used were number 36 and 18
(8 patients each), followed by number 24 (7
patients). The remainders used number 20 and
22 (5 patients each), 28 (4 patients), number 26,
30, 32 and 34 (each in 3 patients), number 38 (2
patients), and number 14, 16 and 21 (each in 1
patient). The right pulmonary-assisted technique
was the most common method used to deploy
the device. A minority of patients (2%) used the
cutting delivery sheath or left pulmonary assisted
technique.
ASD closure by using Amplatzer® septal
occluder was shown to be feasible and safe.
The results are shown on Table 3. Most patients
achieved complete closure immediately after
the procedure, only around 5% who showed
smoky residual shunt. The average length of the
procedure is about 100 minutes.
Table 3. Amplatzer septal occluder results
Variables
Results
Results ASO
-- Complete closure n (%)
51 (87.9)
-- Smoky residual n (%)
3 (5.2)
Fluoroscopy time
29.5 (18.1)
Procedure time
109 (36.7)
Complication
-- Bradycardia n (%)
3 (6)
-- SVT n (%)
2 (4)
Length hospital stay
-- 1 day n(%)
44 (81)
-- 2 days n(%)
9 (17)
-- 3 days n (%)
1 (2)
ASO, Amplatzer® septal occluder; SVT, supraventricular
tachycardia
No major complication was observed during
the procedure. Transient bradycardia occurred in
3 patients and spontaneously-resolved SVT in
2 patients. Almost all patients were discharged
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from hospital on the next day after procedure
and 9 were discharged on the second day. Only
1 patient was discharged on the third day because
of heparinisation due to pulseless dorsalis pedis
artery.
DISCUSSION
Atrial septal defects can be undetected until
adolesence or adulthood. The main problem in
treating ASD in adults is pulmonary hypertension
or even Eisenmenger syndrome.1,2 Traditionally,
if a patient has Eisenmenger syndrome, it is
contraindicated to close the ASD by either
transcatheter procedures or surgery. But recently,
with new techniques in transcatheter closure, we
can perform an occlusion test to check whether
PA and RA pressures increase by closing the
ASD.17 If it happens, it means that the ASD itself
is needed as a rescue to permit blood from right
side of heart escaping to the left side because
the blood may not be possible to go to the lung
because of the very high resistance in the lung.
Using the occlusion technique, if the PA and RA
pressures increased after the ASD occlusion,
we can retrieve the device again. In contrast, in
surgical closure of ASD, surgeons are not able
to do occlusion test because they work when the
heart does not beat.3-6 If PH crisis happened after
the surgical closing, the patch cannot be taken out
and usually the patient will die. We performed an
occlusion test in a patient who did not response
to oxygen test. If there was no change in the PA
and RA pressures after 20 minutes, we planned to
release the device. In one case, we successfully
released the devise without any change in PA or
RA pressure. The symptoms of right heart failure
disappeared and the patient can be discharged
on the following day. Admosudigdo17 reported
the success of using occlusion technique in
all patients. Different from our study, he used
balloon sizing to close the defect temporarily
during testing. 17 The disadvantage of this
technique is that the inflated balloon is not stable
and easily slips to RA. Moreover, the inflated
balloon length is too long and sometimes it closes
the pulmonary veins during the test, resulting
in bradycardia.18 In this study we used the ASD
device in the occlusion test in such a way that
we deployed both disks in the ASD while it was
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Acta Med Indones-Indones J Intern Med
still attached to the cable in order to retrieve it
in case a pulmonary crisis occurred.
Because of transcatheter closure of ASD
needs TEE to evaluate the ASD and to confirm
the position of the device before the release,
we need cooperation of the patient. So, in
adolescents the procedure was done under
general anaesthesia. But in adults, we performed
the procedure under local anaesthesia. If the
patient was uncomfortable by the placement of
TEE probe into his mouth, we gave sedation. In
our series of 14 adolescents, we performed this
procedure under general anesthesia, while in 40
adults, we performed the transcatheter closure
using local anesthesia and sedation. Other study
also reported similar procedures performed in
various cardiac centers.7-16
Surgical closure of ASD in older adult has
been found to be associated with significant
mortality. 3-6 Transcatheter closure ASD is
significantly less invasive and results in less
complications in older adults, including in
patients with co-morbidities. In our 10 year
experience, the transcatheter closure of ASD using
Amplatzer® septal occluder were successfully
attempted in 54 patients. The average age was
30.1 years old and the eldest patient was 68 years
old. The presenting symptoms in adults were
limited exercise capacity graded with NYHA
functional class and cephalgia. Right ventricle
hypertrophy was found in 44% patients and right
axis QRS deviation was found in 30% of patients.
The ASD size varied from 9.4-39.6 mm and the
morphology led to different ways to approach
the ASD. In our study we did not have serious
complication like reported in other study.18-21
Technically, transcatheter closure of ASD in
adults is easier compared to children. In children,
there is a maximum size of the device that can
be implanted. Using a size over maximum size
will cause the device not open well into the heart
chambers because the space is not enough. Some
study reported that the maximum device that can
be used in children is less than or maximally
equal to the left atrial systolic dimension (LASD)
minus 14 mm. If the required device is larger
than maximal size possible for the child, we
cannot close it transcatheterly and we send the
patient to the surgeon. In adults, we can use the
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Transcatheter closure of atrial septal defects in adolescents and adults
largest size that is available, such as size number
38 mm or even 40 mm without any difficulty.
In adults, we can close all secundum ASD as
long as the posterior rim is sufficient, which is
at least of 7 mm length. Eventhough a patient
has no sufficient anterior rim, if the posterior
rim presents, we still can close the ASD by
transcatheter technique. In our series, all of the
patients underwent transcatheter closure of ASD
successfully.
The technique that we tried initially is the
common technique. Using this technique, we
opened first the left side of the device in the left
atrium, and then we withdrew all the system
until the left disk touched the atrial septum,
followed by withdrawing the sheath to open
the right disk. This technique only succeeded in
17/54 (31%) patients with ASD of less than 20
mm. In large ASD (more than 20 mm) during
the deployment the right disk, the left disk
will prolapse into the right atrium because the
right disk will be opened by pulling the left
disk to the right atrium.22,23 They reported that
to overcome prolapse of the left disk into the
right atrium, he used another technique, such
as right or left pulmonary assisted techniques
or by using a straight delivery sheath.22,23 By
right or left pulmonary vein technique we open
the collapse left disk inside the pulmonary vein,
followed by pulling the delivery sheath until
the collapsed device being uncovered out of the
sheath and then we push the delivery cable to
open up the right disk first. By further pushing
of the cable, the left disk will open by itself
after it slipped out from the pulmonary vein. He
reported that all of his patients who failed with
common technique have success closures using
this technique. In our series, we successfully
implanted the device using the right pulmonary
vein technique in 35/54 (65%) patient and the
left pulmonary vein technique in 1/54 (2%). In
1/54 (2%) patient, after trying all the described
techniques above, the device still prolapsed
into the right atrium. We finally used the last
technique using a straight delivery sheath by
cutting the curve of the delivery sheath, leaving
its straight. As an alternative to the cutted long
delivery sheath, we can use steerable long
delivery sheath (Fustar®). Literatures mentioned
successful results of closing of large ASDs using
the steerable long sheath.22,23
To choose the device to be implanted, some
experts did not use balloon sizing anymore.24
But in this study, we still use balloon sizing in
all patients. We inflated the balloon until the flow
through the ASD stops as monitored using the
TEE (the stop-flow technique). If the waist of
the balloon is seen clearly, the measured ASD
size is 2 mm above the waist diameter, but if
the waist is not clearly seen, we add at least 4
mm to the waist diameter. The disadvantage of
not using balloon sizing is that we overestimate
or underestimate the appropriate device size.
If the size is not appropriate, we have to take
another new device. Because the price of device
is expensive, so we should avoid this mistake. If
we used oversize device, it will cause erosion of
the atrial wall and the patient may suffer from
cardiac tamponade and urgent surgery must be
done as reported by some study.19,20
The co-morbidities of our series of case
mostly were mild pulmonary hypertension but
on the catheterization, the Qp:Qs ratio was
around 3.1 with pulmonary arterial resistance
index was 2.2. We only had one patient with
severe pulmonary hypertension. Symptomatic
improvement was observed in all patients and
most of the patients were discharged on the next
day after the procedure. Advanced modalities
and interventions for ASD closure should be
considered once the diagnostic is established,
irrespective of age.7-16
CONCLUSION
Transcatheter ASD closure using Amplatzer
septal occluder can be safely performed at any
age from adolescents to adults. Problems in
these age group are pulmonary hypertension
or arrhythmias. The difficulties of the ASD
morphology where its size and position and
the need to modified techniques to deploy
the device. Being significantly less invasive,
transcatheter closures using the Amplatzer ®
septal occluders are associated with fewer
complications especially in older adults with
the possibility of pulmonary hypertension.
The best outcome is achieved in patients with
less functional impairment and less elevated
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Mulyadi M. Djer
PA pressure. Morbidity is low and the patients
usually can be discharged from the hospital
within 24 hours after the procedure.
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