Beruflich Dokumente
Kultur Dokumente
Original Article
A
trial septal defect (ASD) is a common form of
3DWLHQWVUHFHLYHGHLWKHUWUDQVFDWKHWHUFORVXUHZLWK$62
or surgical closure procedures. Data was obtained from patients FRQJHQLWDOKHDUWGLVHDVHDFFRXQWLQJIRU
medical records. RIFRQJHQLWDOFDUGLDFGHIHFWVRIZKLFKLV
Results $WRWDORIVHFXQGXP$6'FDVHVZHUHLQFOXGHGLQWKLV secundum ASD. Surgery has become the standard
VWXG\FRQVLVWLQJRIVXEMHFWVZKRXQGHUZHQWWUDQVFDWKHWHUFORVXUH therapy for secundum ASD closure procedure, with
SURFHGXUHE\$62DQGVXEMHFWVZKRXQGHUZHQWVXUJLFDOFORVXUH low mortality rates and excellent survival in long term
procedure. Procedure efficacies of surgery and ASO were not signifi-
FDQWO\GLIIHUHQWYVUHVSHFWLYHO\3 +RZHYHU follow-up. However, surgery has significant morbidity
VXEMHFWVZKRXQGHUZHQWVXUJLFDOSURFHGXUHVKDGVLJQLILFDQWO\PRUH related to sternotomy, cardiopulmonary bypass,
FRPSOLFDWLRQVWKDQVXEMHFWVZKRXQGHUZHQWWUDQVFDWKHWHUFORVXUH residual scars, trauma, and other complications.3,4
SURFHGXUHYVUHVSHFWLYHO\25&,WR Children undergoing cardiac procedures typically have
3 +RVSLWDOVWD\VZHUHDOVRVLJQLILFDQWO\ORQJHUIRU
surgical patients than for transcatheter closure patients (6 days vs
GD\VUHVSHFWLYHO\3,QDGGLWLRQDOOVXUJLFDOVXEMHFWV
required intensive care. Transcatheter closure had a mean total cost From the Department of Child Health, University of Indonesia Medical
RI6') million Rupiahs while the mean cost of surgery was School, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
6' PLOOLRQ5XSLDKV36LQFHWKH$62GHYLFH
FRVWUHSUHVHQWHGRIWKHWRWDOFRVWRIWUDQVFDWKHWHUFORVXUHWKH Reprint requests to: Mazdar Helmy, Department of Child Health,
mean cost of transcatheter closure procedure without the device University of Indonesia Medical School, Cipto Mangunkusumo Hospital,
-O 'LSRQHJRUR -DNDUWD 7HO (PDLO rheza80@
itself was less costly than surgery.
gmail.com
maldevelopment of the chest wall because of altered previously. The device is typically collapsed into
size and position of the underlying cardiac chambers, a delivery catheter and delivered through a long
possibly leading to future breast and pectoral muscle sheath positioned in the left atrium after percutaneous
maldevelopment.5 entry of the femoral vein. Under fluoroscopic and
Non-surgical and less invasive approaches with transesophageal echocardiographic (TEE) guidance,
transcatheter devices were developed to occlude both discs of the device are deployed across the defect,
secundum ASD. Amplatzer septal occluder (ASO) and then released.
is one of the most widely used devices in transcatheter Surgery typically involves general anesthesia with
closure procedure. In Indonesia, transcatheter the aid of a cardiopulmonary bypass (CPB) machine.
closure of secundum ASD has been performed in The right atrium is usually opened after median
Cipto Mangunkusumo Hospital (CMH), Jakarta, thoracotomy or anterolateral right thoracotomy. The
VLQFH IROORZHG E\ RWKHU FDUGLRORJ\ FHQWHUV defect is then closed either by direct suture or by
VXFKDV6DUGMLWR+RVSLWDO<RJ\DNDUWDDQG6RHWRPR pericardial patch.
Hospital, Surabaya. All centers reported that Treatment success was determined on the basis
transcatheter closure using ASO have had excellent of transthoracic echocardiography immediately after
complete closure rates and can be used with few procedure (for transcatheter closure) and at 24-hours
complications. after the procedure or at the time of discharge from
We aimed to compare two secundum ASD clo- KRVSLWDOIRUERWKJURXSV6XEMHFWVZHUHFRQVLGHUHGWR
sure procedures, transcatheter closure using ASO and have successful ASD closure if they had no or trivial
surgical closure, in terms of efficacies, complications, PP FRORU MHW ZLGWK RU VPDOO FRORU MHW ZLGWK
lengths of hospital stay, and total costs. PP UHVLGXDO VKXQWV 6XEMHFWV ZLWK PRGHUDWH
FRORUMHWZLGWKPPRUODUJHFRORUMHWZLGWK!
mm) residual shunts, those who had reintervention
Methods procedures or those who died were considered to have
failed procedures.
This was a retrospective analysis study on children Complications were defined as untoward
DJHG\HDUVZLWKVHFXQGXP$6'DQGDGPLWWHG consequences of the closure procedure, either
WRWKH&DUGLRORJ\&HQWHURI&0+IURP-DQXDU\ during the procedure or within 24 hours after the
WR 'HFHPEHU 6XEMHFWV KDG UHFHLYHG HLWKHU SURFHGXUHXQWLOWKHVXEMHFWZDVGLVFKDUJHGIURPWKH
transcatheter closure using ASO or surgical repair, KRVSLWDOSRVWSURFHGXUH0DMRUFRPSOLFDWLRQVZHUH
and were grouped accordingly. The inclusion criteria defined as life-threatening, or requiring immediate
was the presence of secundum ASD with a large left- intervention or invasive treatment, such as cerebral
WRULJKWVKXQW4S4V!:HH[FOXGHGSDWLHQWV embolism, cardiac perforation, pericardial effusion,
with other congenital cardiac anomalies, other ASD pneumothorax or pleural effusion requiring drainage,
(primum, sinus venosus, or sinus coronarius), partial arrhythmias requiring pacemaker or cardioversion,
anomalous pulmonary venous drainage, any type of device embolization requiring surgical removal, or
serious infection prior to the procedure, or malignancy. death due to the procedure. Minor complications were
:HFROOHFWHGWKHIROORZLQJGDWDIURPVXEMHFWVPHGLFDO defined as requiring only conservative treatment, such
records: demographic characteristics, baseline clinical as device embolization with percutaneous retrieval,
data, success and complication rates, lengths of arrhythmias with medical treatment, fever or wound
hospital stay, and total cost of procedure. complications.
The Amplatzer septal occluder consists of Length of hospital stay was defined as the total
two expandable round discs, with a 4-mm long KRVSLWDOVWD\UHTXLUHGIRUHDFKVXEMHFWIURPWKHWLPH
FRQQHFWLQJ ZDLVW DQG PDGH RI LQFK of admission for the ASD closure procedure until the
Nitinol wire. The prothesis is filled with polyester VXEMHFWZDVGLVFKDUJHGIURPWKHKRVSLWDO
mesh to facilitate thrombosis. The device size ranges Total costs of procedures were calculated by
IURP PP A detailed description of the summing patient charges for procedure operating
transcatheter closure technique has been reported theatre, equipment usage, pharmacy, blood products,
ASO device, supporting examinations (laboratory 0RVW VXEMHFWV ZHUH XQGHUQRXULVKHG DQG WKH PRVW
and radiology investigations, electrocardiography, and common clinical manifestations in both groups were
echocardiography), hospital stay, and medical fees. failure to thrive, respiratory infection, and exercise
Cost-minimization analysis was used to compare the intolerance.
total costs between the two procedures. Non-medical /DUJHUPHGLDQ$6'GLDPHWHUZDVVHHQLQVXEMHFWV
or indirect costs were not taken into account. ZKRXQGHUZHQWVXUJLFDOFORVXUH>PHGLDQPP@
Measured variables are described as proportion, FRPSDUHG WR VXEMHFWV ZKR XQGHUZHQW WUDQVFDWKHWHU
mean (standard deviation) or median and range, as FORVXUH>PHGLDQPP@3 7KH
appropriate. Differences between continuous data degree of left-to-right-shunting was comparable in
were assessed by independent t-test or Mann-Whitney ERWKJURXSV4S4V!7KHPHGLDQSURFHGXUH
U test as appropriate, while differences between GXUDWLRQ IRU VXEMHFWV ZKR XQGHUZHQW WUDQVFDWKHWHU
binary data were assessed by using chi-square test or FORVXUHGLGQRWVWDWLVWLFDOO\GLIIHUHQWZLWKVXEMHFWVZKR
)LVKHUVH[DFWWHVWDVDSSURSULDWH$3YDOXH XQGHUZHQWVXUJLFDOFORVXUH>UDQJHPLQ
was considered to be statistically significant. YVUDQJHPLQUHVSHFWLYHO\3 @
+RZHYHUWKHPHGLDQGXUDWLRQRIDQHVWKHVLDIRUVXEMHFWV
who underwent transcatheter closure was shorter
Results WKDQWKDWRIVXEMHFWVZKRXQGHUZHQWVXUJLFDOFORVXUH
>UDQJHPLQYVUDQJHPLQ
$ WRWDO RI VXEMHFWV ZLWK VHFXQGXP $6' ZHUH UHVSHFWLYHO\3 @,QWUDQVFDWKHWHUFORVXUHWKH
enrolled in the study. Figure 1 shows the patient VL]HRIGHYLFHVXVHGUDQJHGIURPWRPPPHGLDQ
IORZGLDJUDPIRUHQUROOPHQW7KHUHZHUHVXEMHFWV PP DQG LQ WKH VXUJLFDO FORVXUH VXEMHFWV PRVW
ZKRXQGHUZHQWWUDQVFDWKHWHUFORVXUHDQGVXEMHFWV XQGHUZHQW FRQYHQWLRQDO WKRUDFRWRP\ 2QO\ RI
who underwent surgical repair. Table 1 shows the VXEMHFWVKDGDQWHURODWHUDOULJKWWKRUDFRWRP\DQGPRVW
demographic and baseline clinical data for each group. of them were female.
84 cases 42 cases
surgical closure transcatheter closure using ASO
70 cases 42 cases
surgical group ASO group
Analysis
2XWRIVXEMHFWVLQWKHWUDQVFDWKHWHUFORVXUH VXUJHU\WKH$6'GLDPHWHUZDVIRXQGWREHPPDQG
JURXS VXEMHFWV KDG FRPSOHWH FORVXUH DQG the defect was closed by direct suture.
VXEMHFWV KDG D VPDOO UHVLGXDO VKXQW DW WKH At the 24-hour follow up or at the time of hospi-
evaluation immediately after the procedure. In one WDOGLVFKDUJHVXEMHFWVLQWKHWUDQVFDWKHWHU
VXEMHFWWKHDWWHPSWWRGHSOR\GHYLFHIDLOHG7KH closure group had successful ASD closure (Table 2).
VXEMHFWRULJLQDOO\KDGDPP$6'GLDPHWHUDV 2QHVXEMHFWKDGGHYLFHPLJUDWLRQDWKRXUVDIWHU
measured by precatheterization TEE (balloon stretched the procedure, so he underwent surgical removal of
diameter), but after the device failed to deploy, the the device and surgical closure. In the surgical closure
VXEMHFWXQGHUZHQWUHLQWHUYHQWLRQZLWKVXUJHU\'XULQJ JURXSVXEMHFWVKDGVXFFHVVIXO$6'FORVXUH
Table 2%QORCTKUQPQHGHECE[DGVYGGPUWTIKECNENQUWTGCPFVTCPUECVJGVGTENQUWTGCVVJGJQWT
follow-up or at the time of hospital discharge
Procedures
Defect closure P value
Surgery (n = 70) ASO (n = 42)
Successful, n (%) 69 (99) 40 (95) 0.555
No residual shunt 66 (95) 40 (95)
Trivial residual shunt 1 (1) 0 (0)
Small residual shunt 2 (3) 0 (0)
Failed, n (%) 1 (1) 2 (5)
Moderate residual shunt 0 (0) 0 (0)
Large residual shunt 0 (0) 0 (0)
Reintervention 1 (1) 2 (5)
Death 0 (0) 0 (0)
Table 3. Comparison of complications in the surgical closure and transcatheter closure groups
Procedures
Complications Surgery ASO P value OR (95% CI)
(n = 70) (n = 42)
During procedure, n (%) 16 (23) 4 (9) 0.074 1.36 (1.03 to 1.8)
Post-procedure, n (%) 38 (54) 9 (21) 0.001 1.64 (1.24 to 2.18)
Total number of patients with complications, n (%) 42 (60) 12 (29) 0.001 1.61 (1.19 to 2.18)
Table 5. Comparison of patient charges between surgical closure and transcatheter closure
Procedures
Patient charges Surgery ASO P value
(n = 70) (n = 42)
Mean procedure (SD), Rupiah 4,151,000 (2,356,000) 2,878,000 (935,000) 0.030
Mean pharmacy (SD), Rupiah 18,162,000 (4,327,000) 40,331,000 (5,576,000) <0.0001
Mean supporting examination (SD), Rupiah 2,152,000 (985,000) 1,118,000 (568,000) <0.0001
Mean hospital stay (SD), Rupiah 2,333,000 (1,763,000) 669,000 (444,000) <0.0001
Mean medical fees (SD), Rupiah 20,228,000 (5,168,000) 7,762,000 (4,669,000) <0.0001
Mean total cost (SD), Rupiah 46,995,000 (9,246,000) 52,732,000 (6,716,000) <0.0001
Mean total cost (without ASO cost) (SD), Rupiah 46,995,000 (9,246,000) 24,160,000 (8,982,000) <0.0001
23. Butera G, Carminati M, Chessa M, Youssef R, Dragoo M, versus Amplatzer device implantation. Tex Heart Inst J.
Giamberti A, et al. Percutaneous versus surgical closure of
secundum atrial septal defect: comparison of early results 4XHN6&+RWD67DL%&0XMXPGDU67RN0<&RPSDULVRQRI
DQGFRPSOLFDWLRQV$P+HDUW- clinical outcomes and cost between surgical and transcatheter
24. Bialkowski J, Karwot B, Szkutnik M, Banaszak P, Kusa J, device closure of atrial septal defects in Singapore children.
Skalski J. Closure of atrial septal defects in children: surgery $QQ$FDG0HG6LQJDSRUH