CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 3, May/June 2014
AFRICA
115
Our indications for device implantation are the presence
of a secundum ASD (diameter
≤
30 mm), left-to-right shunt
with Qp/Qs ratio
≥
1.5, presence of right ventricular volume
overload, and symptoms associated with the defect (arrhythmias,
transient ischaemic attack). On the other hand, indications
for surgical repair are the presence of associated congenital
cardiac anomalies requiring surgical repair (including primum
ASD, sinus venosus ASD and multiple defects that would
not be adequately covered by a device), pulmonary vascular
resistance
≥
7 Woods units, haemodynamic instability, intra-
cardiac thrombi, contra-indications to antiplatelet agents, and
insufficiency of the rims. The patients were fully informed on the
treatment options and then decided with their cardiologists which
option they would choose.
Device implantation was performed under general anaesthesia
and guidance with continuous TEE monitoring. Defect diameters
were measured by TEE. The appropriate-sized device was then
screwed on the cable and advanced inside the correct-sized
sheath (6–14 F). The sheath is usually positioned over the guide
wire inside the left upper pulmonary vein or in the middle of
the left atrium. The Occlutech Figulla ASD occluder (Occlutech
International, Sweden, 6–40 mm, 3-mm increments) was used
in all patients.
Under fluoroscopic andTEE guidance, both left and right discs
were deployed in sequence across the defect. After deployment
of the device, the geometry of the device and the presence of a
residual shunt were evaluated. The configuration of the tissue
adjacent to the device, including the ascending aorta, atrio-
ventricular valves, pulmonary vein, superior vena cava, inferior
vena cava and coronary sinus were observed. Before releasing the
device, a gentle ‘Minnesota wiggle’ was performed to verify the
stability of the device. Final examination by TEE was performed
to verify the device location and any residual shunting.
Unfractioned heparin was administered to keep the activated
clotting time (ACT) at
>
250 seconds during the entire procedure.
We also used appropriate antibiotics before and after the
procedure.
Patients are usually observed overnight and discharged home
the following day. All patients were instructed on prophylaxis
for infective endocarditis for a total of six months after device
placement.Aspirin 300mg (for sixmonths) and clopidogrel 75mg
(for three months) were initiated after closure. Before discharge,
a chest X-ray, electrocardiography and echocardiography were
performed.
The patients undergoing surgical treatment were operated
on under general anaesthesia using the standard approach. The
right atrium was opened following median sternotomy and
the ASD closed by primary suture or pericardial patch under
cardiopulmonary bypass. The patients were then taken to the
intensive care unit, and the following day to the postoperative
ward for recovery, until their condition had stabilised, after which
they were discharged.
Post-procedure records up to discharge from the hospital
and routine three-month results related to the end-points were
compared. Three months after the procedure, all patients in the
study underwent a physical examination, electrocardiogram,
chest radiograph and transthoracic echocardiogram with colour
Doppler.
The primary end-point was rhythm disturbances, residual
ASD, infection, or any cardiovascular procedure-related major or
minor complications, excluding death. The secondary end-point
was death related to both procedures.
Patients were considered to have had successful ASD closure
if they had no or
<
2-mm-wide colour jet residual shunts as
assessed by colour Doppler echocardiography. Early efficacy was
successful closure of the defects by device or operation without
moderate (2–4-mm-wide colour jet) or large (
≥
4-mm-wide
colour jet) residual shunts, or major complications after discharge
from hospital (cerebral embolism, cardiac perforation with
tamponade, endocarditis, repeat operation, cardiac arrhythmias
requiring permanent pacemaker placement or long-term anti-
arrhythmia medication, device embolisation requiring immediate
surgical removal or death due to the procedure).
Safety was defined as the absence of death or complications.
Minor complications included device embolisation with
percutaneous retrieval, pericardial effusion requiring medical
management, evidence of device-associated thrombus formation
without embolisation (with or without treatment), cardiac
arrhythmia with treatment, phrenic nerve injury, access-
site haematoma, other vascular access-site complications,
retroperitoneal haematoma, surgical wound complications or
infection.
Statistical analysis
All the available data were analysed by the SPSS program
(Statistical Package for Social Sciences for Windows 17.0)
(Chicago, IL, USA). Descriptive statistical methods (number,
percentage, mean, standard deviation) were used on the data.
Differences in variables were analysed using the independent
samples
t-
test and chi-square tests as appropriate, and
p
-values
<
0.05 were considered significant.
Results
A total of 163 patients with complete medical records from
the 229 patients who were treated for secundum ASDs were
registered in the study. Table 1
summarises the baseline clinical
and demographic characteristics of the two groups, together
with the results obtained. Mean age for the device group was 24
±
0.35 years, whereas it was 28.46
±
0.7 years for the surgery
group. In the device group, the median defect diameter assigned
to percutaneous closure was 14.5 mm (range 4–28 mm), whereas
it was 25 mm (range 3–46 mm) for surgical closure.
The mean pulmonary and systemic blood flow (Qp/Qs) ratio
in the device group was 1.82
±
0.46 and in the surgery group
Table 1. Demographic and baseline characteristics
of the patients.
Surgery
Device
p-
value
Patients (
n
)
121
42
0.258
Male,
n
(%)
105 (87)
42 (100)
Female,
n
(%)
16 (13)
0 (0)
Mean age (years)
24.46
±
0.7
24
±
0.35
0.554
Mean EF (%)
65
±
0.36 63.9
±
0.43
0.108
Mean Qp/Qs
2.2
±
0.03 1.82
±
0.46
<
0.05
Mean PAP (mmHg)
33.8
±
0.89 28.2
±
1.34
<
0.05
EF, ejection fraction; PAP, pulmonary artery pressure; Qp/Qs, pulmo-
nary-to-systemic flow ratio.
