Introduction
Secundum atrial septal defect (ASD) is a common
congenital heart disease and accounts for about 6% -10% of all
congenital cardiac defects.(1) Since 1976, when
King and associates(2) attempted the first
transcatheter closure of a secundum ASD in humans, device closure
has evolved significantly. Since then, significant device development and
modifications have been made.(3) Previous reports have shown
that it is easy to use and has a high success closure rate.(3-6)
The advantages of percutaneous closure over surgical closure was shown
by some studies in older children and adults including avoidance of
cardiopulmonary bypass, decreased complication rates, shorter hospital
stays,(7,8) and greater cost-effectiveness.(9)
The multiple roles of intra procedural Transesophageal
echocardiography(TEE) include confirmation of inter atrial septal anatomy, size
of the defect by measuring the minimal and maximal diameter of the defect using
atrial end-diastolic frames in different angles.(8,9) In the
presence of a very floppy and mobile rim, measurement of defect diameter should
be made between steadier and firm rims and the color flow jet width across the
defect,(1,3,9) monitoring of the procedure, pre and post
closure assessment of adjacent cardiac structures, including the mitral and
aortic valves, systemic and pulmonary veins, and direct visualization of device
position and stability.(7-9)
In this study our experience with percutaneous
closure of ASD by means of different devices, stressing the role of TEE
measurement without the need of the balloon stretch diameter in device
selection.
Methods
This
was a retrospective study of 105 patients that had secundum atrial septal defect
with hemodynamically significant left to right shunt ≥1.5:1 that were admitted
for the attempt of trans-catheter closure of the septal defect using different devices at Queen Alia Heart Institute, between
December 2010 and December 2012. All
closures were performed under general anesthesia in the catheterization
laboratory. We reviewed the medical records for the size of the defect measured
by the TEE at the time of closure (that was done by the same cardiologist for
all the closures) and the size of the device selected, looked for any immediate
complications and reviewed the follow up transthoracic echocardiography for
leaking devices or any other reported complication.
In the catheterization laboratory, TEE was used
to demonstrate the defect to the interventional team, to measure the diameter of
the defect and to help with the selection of the device size. During closure TEE
was used in monitoring the opening and placement of the discs and waist of the
device in the atrial septum and checking the position of the implanted device and
its relation to nearby structures prior to the withdrawal of the delivery
catheter; and finally, for evaluation of Residual Flow (RF) whenever present.
After implantation, the patients stayed in the ward
for observation until the next morning, being discharged after performing electrocardiography
(ECG), and transthoracic echocardiogram. Salicylic acid was prescribed at a
dose of 5 mg/kg/day for six months, and prophylaxis for infectious endocarditis
was indicated for six months. The protocol for follow-up consisted of clinical
evaluation, ECG, and echocardiography scheduled for one month, three months,
six months and 12 months after implantation.
The Closure Protocol
All patients were given Salicylic acid at a dose
of 5mg/kg/day three days prior to device closure. A written consent was signed
by the patient or the care giver after explaining the procedure including the
expected complications. All patients were sent to the catheterization
laboratory after full evaluation by the anesthesiologist. All closures were
done under general anesthesia regardless of age.
The technique of deployment of the devices was similar
to that described in the literature for Amplatzer septal occluder device.(4)
TEE was performed in each patient after endotracheal intubation and assisted
ventilation under general anesthesia. Dimensions of the defect were measured in
various imaging planes. The minimal and maximal diameter of the defect was
measured using atrial end-diastolic frames in 0°, 35°, 90°, and 110-135°. In the presence of a very floppy and mobile
rim, measurement of defect diameter was made between steadier and firm rims and
the color flow jet width across the defect was also measured to provide
supplementary information. The largest dimension was used to select device
size.
Procedural success was defined as the ability to close
ASD percutaneously with no or insignificant residual shunt on echocardiography.
Failure was defined as inability to close ASD percutaneously with atrial septal
occluder. Following the procedure, patients were monitored for 24 hours in the
ward and echocardiographic evaluation was done before discharge. Patients were
discharged 24 hours after the procedure. Low dose of aspirin (5 mg/kg/day) was
given for six months. Infective endocarditis prophylaxis was advised for six
months after the device implantation.
Results
The patient population consisted of 54 (52%)
females and 51(48 %) males (Table I). All the patients underwent the attempt of
device closure. It was successfully implanted in 102/105 patients (97%). All patients showed good rims (any rim equals
or more than 5 mm) all over except for the anterior superior (retro aortic) one
which was insufficient in 29/105 (27.6%) of our cases and yet the closure was
done successfully in all of them (100%). One patient developed device
embolization despite demonstrating stability during the “push pull” maneuver,
and the stability of the device by TEE post procedure with no residual flow. It
was detected the second day in the descending aorta by transthoracic
echocardiography. The device was retrieved successfully by snaring through the
femoral artery using gooznech snare with surgical closure of the ASD. The other
two patients were sent to surgical closure due to multiple failed attempts in
device closure.
The
mean age was 16.5 years with a range between 6-63 years. The defect size was
between five and 28 millimeter with a mean of 14 millimeter. The device size
was between six and 30 millimeter with a mean of 17 and a mean of device upsizing
of 3.5mm ± 2.5mm, median of 3mm. The devices used were as follows: Occlutech
Figulla ASD occluder device (n=81), Amplatzer Septal Occluder device (n=14),
Cera septal defect occluder device (n=6) and Figulla Flex II device (n=2) (Table
I).
Table I: Demographic and clinical
features of ASD patients (N=105)
|
Age median
(range)
|
12 years (6-71)
|
|
Gender
Males
females
|
51(48%)
54 (52%)
|
|
The maximum diameter
of defect as measured by TEE
|
13mm (5-28)
|
|
Selected
device diameter
|
16mm (6-32)
|
|
Device
type
Occlutech Figulla
Amplatzer
Cera
Figulla Flex 2
|
81 (79%)
14 (13%)
6 (6%)
2 (2%)
|
During follow up of these patients, none had
serious complications like late embolization, mitral, aortic or tricuspid regurgitations,
significant pericardial effusion or significant tachyarrhythmia.
Discussion
ASD closure via transcatheter route was
pioneered by King and Mills in 1975.(2) Since then percutaneous closure is the
preferred way for ASD closure over the surgical approach, by both patients and
physicians, due to its simple technique and the negligible morbidity and
mortality.(7, 8)
The success of
percutaneous closure of ASD is directly related to the proper selection of the
patients for implantation. Defects should be of the secundum type, located in
the central portion of the atrial septum, with thick borders large enough to
sustain the device, except for the anterior superior rim which seemingly if it
is absent it is not a contraindication for a closure trial,(10)
and as was shown by our patients in whom the closure was done successfully in
all of them; success rate of 100%. In addition, to patient selection, TEE has
been used for the continuous monitoring during the procedure, providing
additional safety and significantly reducing radiation-exposure, the TEE also helped
in verifying the position of the Device in relation to the ASD and evaluating
residual shunt (RS),(11) the impact of the device on
neighboring structures like the mitral, tricuspid and aortic valves immediately
after implantation. TEE is therefore
important in conjunction with this procedure.
Over the years, with increasing experience with trans-catheter closure, device selection was the most
important part in transcatheter closure. Larger devices carry the risks of
mushrooming deformity of the device, affecting near structures, and other
serious complications, such as cardiac erosion(12,13) while
smaller devices carries the risk of instability, distal embolization and
residual shunt.(14,15) So, device sizing and not the device
type was the crucial point in ASD closures. In our institution we are using
different devices with no significant differences in deployment, and
complications. We did not encountered any of the above mentioned complications
of erosions, mushrooming nor fatal atrial arrhythmias, only one case of
embolization that was detected the second day and may be attributed to the
floppy posterior rim and the insufficient oversizing that was needed to ensure
the stability of the device.
Balloon sizing of the defect was considered as the
most important part of trans-catheter closure of ASD.(15,16) The selected device is usually identical to
or two mm larger than the stretched balloon diameter (SBD) of the defect.(15-17)
However, there are many reported disadvantages of balloon sizing; it may cause
enlargement of the defect by tearing of the flap valve of the septum primum.(18,19)
Bradycardia and hypotension may occur during prolonged inflation of the balloon
due to the obstruction in diastolic filling.(20) In addition,
due to the 3dimentional shape of the ASD it may be inaccurate measurement secondary
to inadequate profiling of the defect and the measuring balloon catheter.(16)
However, ASD device closure is increasingly being done
successfully by trans-catheter closure techniques without balloon sizing using
various imaging modalities. Zanchetta et al, did not use balloon
sizing during trans-catheter closure of ASD, where waist diameter was chosen
based on the r value obtained from intracardiac echocardiographic images [r
= √(C2 + P2), C is the foci half-distance of the
fossa ovalis and P is its semi-latus rectum.(15) In another
study of Zanchetta, an equation of d = √ (a × b) was obtained, in
which a and b were major axes of intracardiac
echocardiography on aortic and four-chamber plane, respectively, and d
was the diameter of device used.(18) In a study by Amin and Daufors, balloon sizing was considered unnecessary and a device that was 2–4 mm larger than
intracardiac echocardiographic (ICE) diameter was chosen.(21)
In our institution we stopped using the balloon sizing
for closure since December 2010 and the success rate was high despite that. The
mean upsizing of the device was around 2.5mm± 3.5mm. The majority of the
upsizing were between 2-4 mm, the mean of 3mm, which correlate better with the
study done by Amin and Dauffers as mentioned before. We could not reach a
mathematical relationship between the ASD size and the device size as Zanchetta
et al. The larger upsizing that were done in our device selection depending on
color flow and the presence of floppy rims highlighting the importance of measuring
the defect from the firm rims by the TEE which provides better anatomic
information required for device closure as shown recently by a published study
assessing feasibility and safety of trans-catheter closure of ASD without
balloon sizing, the mean diameter of the device used in nonballoon sizing group
was larger than trans-catheter closure with balloon sizing.(22)
This highlights the importance of the better imaging obtained by TEE which is
the most important factor influencing the outcome. Sizing obtained by TEE is
adequate for successful device closure and may be superior to balloon sizing as
it avoids oversizing and is more physiological. Better imaging in these
patients may have been provided due to increasing experience in TEE that has
resulted in successful closure in the majority of these patients.
Limitations of the Study
This was not a randomized, controlled study. It was a
retrospective study documenting our experience in ASD device closure without
balloon sizing done by our pediatric cardiologist team using different devices.
It was done to emphasize the benefits of TEE imaging during device deployment.
Conclusion
Transcatheter closure of ASD is safe and effective.
Device size selection using TEE without balloon sizing is (with increasing
experience) accurate, safe and effective.
References
1.Stevenson JG. Transesophageal echocardiography.
In: Lai WW, Mertens LL, Cohen MS, et al editors. Echocrdiography
in Pediatric and congenital heart disease. UK; blacwell publishing ltd; 2009:
671-686.
2.King TD, Thomopson SL, Steiner C, Mills NL. Secundum atrial septal
defect: nonoperative closure during cardiac catheterization. JAMA 1976; 235:
2506-2509.
3. Masura J, Gavora P, Formanek A, Hijazi ZM. Transcatheter closure
of secundum atrial septal defects using the new self-centering Amplatzer septal
occluder: initial human experience. Cathet Cardiovasc Diagn 1997; 42: 388-393.
4.Thanopoulos BD, Laskari CV, Tsaousis GS, et
al.
Closure of atrial septal defects with the Amplatzer occlusion device:
preliminary results. J Am Coll Cardiol 1998; 31: 1110-1116.
5.Hijazi ZM, Cao Q, Patel HT, et al. Transesophageal
echocardiographic results of catheter closure of atrial septal defect in
children and adults using the Amplatzer device. Am J Cardiol 2000; 85:
1387-1390.
6.Cao QL, Radtke W, Berger F, et al. Transcatheter closure
of multiple atrial septal defects. Initial results and value of two- and
three-dimensional transoesophageal echocardiography. Eur Heart J 2000; 21:
941-947
7.Berger F, Vogel M, Alexi-Meskishvili V, et al. Comparison of results
and complications of surgical and Amplatzer device closure of atrial septal
defects. J Thorac Cardiovasc Surg 1999; 118:674-678.
8.Kim JJ, Hijazi ZM. Clinical outcomes and
costs of Amplatzer transcatheter closure as compared with surgical closure of
ostium secundum atrial septal defects. Med Sci Monit 2002; 8: CR787-CR791.
9. Vladimirio L. Vida MD, Joaquin Barnoya MD,
Mauricio O’Connell, MD, et al. Surgical versus percutaneous occlusion
of ostium secundum atrial septal defects. Results and cost-effective
considerations in a low-income countries. J Am Coll Cardiol 2006; 47(2):
326-331.
10.Thomas B, Silvana M. Contemporary
echocardiographic guiding tools for device closure of Interatrial
communications. Cardiovasc Diagn Ther
2013; 3(1):38-46.
11.Koneti NR, Shelke A, Arramraj SK, et al. Unexpexted difficulty
during Transcatheter device closure of atrial septal defect associated with
right aortic arch. Ann Pediatr Cardiol 2012; 5 (2); 185-187.
12 . Amin Z, Hijazi ZM, Bass JL, et al. Erosion of secundum
atrial septal defects: Review of registry of complications and recommendations
to minimize future risk. Catheter Cardiovasc Interv 2004; 63:496-502.
13. Divekar A, Gaamangwe
T, Shaikh N, et al. Cardiac perforation
after device closure of atrial septal defects with the Amplatzer septal
occluder. J Am Coll Cardiol 2005; 45: 1213–8.
14.Levi DS, Moore JW. Embolization and retrieval of the Amplatzer septal occluder. Cateter
Cardiovasc Interv 2004; 61: 543-571.
15.Zanchetta M, Onorato E, Rigatelli G, et al. Intracardiac echocardiography-guided transcatheter closure of secundum
atrial septal defect. J Am Coll Cardiol 2003; 42:1677–1682.
16.Saurabh
Kumar Gupta, S. Sivasankaran, S. Bijulal, et al. Trans-catheter
closure of atrial septal defect: Balloon sizing or no Balloon sizing – single
centre experience. Ann Pediatr Cardiol 2011; 4:28-33.
17.Fischer G, Kramer HH, Stieh J, et al. Transcatheter closure of
secundum atrial septal defects with the new self centering Amplatzer Septal
occluder. European Heart Journal 1999; 20: 541-549.
18.Zanchetta M. On line echocardiography
alone for Amlatzer Septal Occluder selection
and device deployment in adult patients with atrial septal defect.
Int L Crdiol 2004; 95: 61- 68.
19.Harikrishnan S, Narayanan NK, Sivasabramonian S. Sizing balloon-induced tear of the atrial septum. J Invasive Cardiol
2005; 17:546–547.
20.Rao PS, Langhough R. Relationship of echocardiographic, shunt flow, and angiographic size to
the stretched diameter of the atrial septal defect. Am
Heart J 1991; 122: 505-508.
21.Amin Z, Daufors DA. Balloon sizing is not necessary for closure of secundum atrial septal
defects. J Am Coll Cardiol 2005; 45:317.
22.Wang JK, Tsai SK,
Lin Smet AL. Transcatheter closure of atrial septal
defect without balloon sizing. Catheter Cardiovasc Interv 2008;71:214-221