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NIVETHABSC .CT
TYPES OF ASD
 Secundum ASD: 80% of ASDs, located in the region of the fossa ovalis and its
surrounding
 Primum ASD : 15%, located near the crux, the atrioventricular (AV) valves are
typically malformed resulting in various degree of regurgitation.
 Superior sinus venosus defect :5% located near the SVC entry associated with
partial or complete connection on right pulmonary veins to RA or SVC
 Inferior sinus venosus defect : <1% located near the IVC entry
 Unroofed coronary sinus :<1% separation from the LA can be partially or completely
missing
Since its first attempt in 1976 by Mills and King
Transcatheter closure has become an accepted alternative to surgical
repair for ostium secundum atrial septal defects (ASDs)
Complex ASD, which is usually defined as defects >38 mm in diameter
and/or deficient rims other than antero-superior, are often not
considered amenable to transcatheter closure and referred for surgery
Transcatheter closure has become an accepted alternative to surgical
repair for ostium secundum atrial septal defects (ASD).
However, large ASDs (>38 mm) and defects with deficient rims are
usually not offered transcatheter closure but are referred for surgical
closure.
Transcatheter closure also remains controversial for other complicated
ASDs with comorbidities, additional cardiac features and in small
children.
 Its ideal to have TEE guidance during the procedure as well
 A guidewire is introduced the femoral vein into the IVC and further through the
RA,across the ASD into LA
 The tip of the wire is then placed in the pulmonary vein and a long venous
sheath is introduced
 Once the sheath is in position, the device attached to the delivery cable is
introduced into the sheath under water to avoid air bubbles in the system
 Bubbles in the system can get embolized during delivery with air emboli going
into systemic circulation
 If its reaches the cerebral circulation transient giddiness and altered
sensorism can occur
 ST segment elevation and hypotension may occur if the air bubbles
find their way into the coronary circulation
 Once the device reaches the LA, the left atrial disc of the device is
released first and brought in contact with the left atrial side of ASD
 When the position is judged ideal, the right atrial disc is allowed to form
by withdrawal of sheath
 Once the two discs are in position with the waist across the ASD, slight
wiggling is done to make sure that the device is perfectly fitting and
has no tendency for dislodgement
 Position is confirmed by TEE with special care to see that the device
does not interfere with the function of the AV valves
 Once everything is fine ,the device is released by unscrewing the
delivery cable
 ASD closure is indicated in the presence of a significant left-to-right shunt, defined by
a significant right heart enlargement due to volume overload, regardless of symptoms
 After transoesophageal echocardiography under general anaesthesia was the
exclusive imaging method for more than 10 years, recent innovations are now towards
imaging guidance modalities.
 Intracardiac echocardiography , and more recently TOE, have been introduced as
acceptable alternative imaging guidance methods. They both carry the advantage of
obviating the need for general anaesthesia.
 Small defects with no right ventricular volume overload are not considered for closure,
unless there is evidence of right-to-left shunting causing significant hypoxaemia
and/or paradoxical embolism
 Closure of an ASD should not be performed in cases with pulmonary vascular
resistances >8 Wood units.
 Patients with a pulmonary artery pressure less than two-thirds of systemic arterial
pressure, pulmonary vascular resistance less than two-thirds of systemic resistance,
or a positive response to pulmonary vasodilator testing can be considered for ASD
closure .
 Transcatheter closure of a very large oval atrial septal defect.
(A) Very large atrial septal defect with maximum diameter measured at 44 mm on
transoesophageal echocardiography;
(B) 3D reconstruction demonstrates the crescent shape of the defect with a much
smaller transverse diameter;
(C) transthoracic echocardiography in 4-chambers view shows good position of the
device after successful closure with a 40 mm Amplatzer ASO. ASO, Amplatzer septal
occluder.
 Large atrial septal defect that is measured at 21 mm on transesophageal
echocardiography
(A) in a 9.7 kg, 11-month-old infant with failure to thrive.
(B) The transoesophageal echocardiography diameter is confirmed with the sizing
balloon under fluoroscopy. After a 22 mm Amplatzer ASO is successfully implanted
post-procedure transthoracic echocardiography in 4 chambers view confirms good
position of the device and demonstrates a new mild mitral regurgitation that is
functional, due to the sudden increase in left ventricular volume
(C) This mild mitral regurgitation will disappear after a few weeks on follow-up
echocardiography.
 Patient selection is an important initial step for a successful treatment. Procedure in the
catheterization laboratory may be summarized stepwise;
(I) Hemodynamic study and assessment of morphologic characteristics of the defect;
(II) Establishment of procedural strategy including procedure-guiding modality and
equipment to be used;
(III) Selection of optimal type and size of device;
(IV) Device implantation with cautions for potential complications including air embolism,
damage to cardiac/vascular structures;
(V) Post-implantation assessment of the final result. After a successful procedure,
appropriate patient education and follow-up are also essential parts of the treatment.
Details and special considerations for each step of the procedure have well been
described previously. There are individual issues which are often in debate including
procedure-guiding modalities, sizing the defect, and closing complex defects.
Issues on imaging guidance and defect sizing
 Transthoracic echocardiography (TTE) may also be used especially in patients with good
windows for echocardiography such as small children
 There has been debate on the necessity of balloon sizing for selection of device size. Balloon
sizing may be skipped in suitable defects with sufficient surrounding rims
 however, it has long been regarded as an essential step of the procedure.Indeed, balloon
sizing may provide more information than averaged size of the defect including compliance
of surrounding rims and presence of additional defect.
 While the balloon stretched diameter or balloon occlusive diameter were used in balloon
sizing in the past, currently stop flow diameter (SFD) is recommended as the standard
measurement to avoid oversizing
 In self-centering devices such as the Amplatzer Septal Occluder (ASO) the
recommended device size is the same or slightly larger (<2 mm) than the SFD.
Nevertheless, the selection for device size should be individualized considering
deficiency of rims, spatial relationship with nearby cardiac structures and size of the
heart.
 In cases with aortic rim deficiency, the usual recommendation is to avoid an
“oversized” device because of the potential risk of erosion
 On the other hand, in cases with inferior vena cava (IVC) rim deficiency with higher
risk of device embolization, use of an “undersized” device should be avoided. In case
of using a non-self-centering device such as the Gore Septal Occluder (GSO)a device
twice the size of the defect is recommended, and the GSO is not recommended for
defects >18 mm
Complex lesions
 Large defect
 Large size of the defect may be the most common cause of difficulties in ASD closure
using a device. The main problems are prolapse of left atrial (LA) disk of the device
into the right atrium (RA) before proper positioning in the septum and difficulty in
sizing the defect.
 Device size is frequently selected by estimation rather than measurement of balloon
diameter due to non-visualization of the whole defect in a single echocardiographic
plane, difficulty in stabilization of the sizing balloon (melon-seeding or milking) and
unavailability of sizing balloon larger than 34 mm.
 Rim deficiencies
The locations of rim
deficiencies:
(A)aortic rim,
(B) IVC rim,
(C) SVC rim deficiency
(D) posterior rim,
(E) atrioventricular
valve rim.
 Deficiency in the surrounding rim(s) is frequently associated with large defects, and
may potentially increase the risk of complications such as device embolization,
erosion and encroachment of device onto nearby cardiac structures.
 Aortic rim (antero-superior rim ) deficiency is most common rim deficiency and
device implantation is frequently interfered by LA disk prolapse. Erosion risk is higher
in aortic rim deficiency as well as device oversizing ,thus device selection has to be
refrained from undue oversizing.
 IVC rim (posteroinferior rim ) deficiency is second most common among rim
deficiencies and associated with higher risk of device embolization . In case with this
rim deficiency, under-sizing of the device may further increase the risk of device
embolization, and should be avoided.
 Superior vena cava (SVC) rim (posterosuperior rim) deficiency is a rare condition
and may interfere with device positioning.When the rim deficiency is extended from
SVC rim to aortic rim, this indicates the defect is located superiorly in the atrial roof
and may carry higher risk of erosion .
 In case with posterior rim deficiency, In the presence of rim deficiency in large area
from IVC to posterior rim, the risk of device embolization is very high and this
condition may preclude device closure.
 In atrioventricular valve rim deficiency, encroachment of device onto the mitral
and/or tricuspid valve is a potential problem. This is a concern especially in infants
and young children because of the inherent design of Amplatzer-type devices which
have a relatively larger disk-rim width in smaller devices .
Multiple defects
Real time 3-dimensional (RT3D)
echocardiography is very useful to
assess morphologic
characteristics for multiple defects
Note : the similarity between the
realistic image from RT3D
echocardiography (A)
actual image of the defect from the
surgical field (B).
Careful observation of
fluoroscopic image with balloon
sizing may provide additional
anatomic information on the
defects and intervening septum
Currently available devices for atrial septal
defect closure.
(A) Amplatzer Septal Occluder;
(B) Occlutech Figulla Flex II device;
(C) Gore Cardioform Septal Occluder;
(D) Cocoon Septal Occluder;
(E) CeraFlex ASD device;
(F) Nit Occlud ASD-R device;
(G) Cardi-O-Fix Septal Occluder;
(H) Ultracept II ASD Occluder
(I) Carag Bioresorbable Septal occluder.
The ASO is the first self-expanding double-disk device with central
connecting waist composed of nitinol-wire-mesh. The disks and waist
were sewn with a Dacron patch to promote complete occlusion and
endothelialization.
 The device allowed easy and straightforward deployment due to its
self-centering, repositionable, and recapturable characteristics.
 The ASO solved many limitations of previous devices such as the non-
negligible rate of residual shunt and frame fracture, and is regarded as
a prototype device for many newer devices.
The device size is determined by the waist size; there are 27 device
sizes from 4 to 40 mm.The corresponded delivery sheath sizes range
from 6 to 12 French (Fr).
 Reported risk factors include aortic rim deficiency, superiorly located
ASD, over-sizing of device, septal malalignment, dynamic ASD and
lower patient weight: device size ratio
Recommendations to avoid erosion should be followed and
comprehensive evaluation by echocardiography during follow-up is
warranted
The ASO “cribriform” is a specially designed non-self-centering device
for multi-fenestrated defects with 4 available sizes from 18 to 40 mm.
Figulla Flex II ASD Occluder is the third generation Occlutech device for ASD
closure with a flexible titanium-oxide coated nitinol-mesh and double-disk
design similar to ASO.
 FSO has minimized metal contents especially in the LA disk and no clamping
hub on the LA disk, which may provide more flexible and less traumatic
feature.
The FSO has a distinct release mechanism resembling a bioptome which
enables flexible movement between the device and delivery cable. The
delivery cable is also shapeable for a better alignment between the device
and septum.
There are 20 device size options from 4 to 40 mm.
The largest study with FSO, the IRFACODE study, showed a 98%
success rate in 1395 patients and a 97.3% complete closure rate at 1
year. The major complication rate was minimal.
Erosion has not yet been reported with this device. The disadvantages
are its relatively limited size options (20 vs. 27 sizes in ASO) and
requirement of a slightly larger delivery sheath than in ASO devices.
A fenestrated device for closure of ASD with pulmonary hypertension or
risk of masked left ventricular restriction is available on an order-made
basis.
The GSO is a non-self-centering double disk device composed of platinum filled
nitinol wire framework covered with an expanded polytetrafluoroethylene (ePTFE)
membrane to promote rapid endothelialization.
The GSO is preloaded as a package of the device and whole delivery system. The
delivery system has improved for easier delivery and position compared to that of
the previous Helex Septal Occluder (HSO).
There are 4 device sizes from 15 to 30 mm with 5-mm increments. It is generally
recommended that the device size should be more than twice the defect size and
the GSO is not suitable for defects over 18 mm due to the non-self-centering
feature.
Owing to its flexibility with minimal metal content which may prevent erosion, the
device is preferred to close smaller defects especially with aortic rim deficiency or
those in small children .
Clinical studies verified efficacy and safety of this device in closing ASDs with
various morphologies such as aortic rim deficiency, septal aneurysm and
multiple defects in selected patients with feasible anatomy
The Gore Cardioform ASD Occluder (GAO) is a self-centering version of GSO
which consists of a helical nitinol-wire frame covered with ePTFE to treat
larger ASDs. The available sizes are 27, 32, 37, 44, and 48 mm and designed
to treat defects from 8 to 35 mm. Although this device is not commercially
available yet, the initial clinical result showed the safety and efficacy of the
GAO.
The risk factor for procedural failure in GAO implantation was a larger defect
size, especially a size larger than 27 mm by balloon sizing.
CeraFlex (LifeTech Scientific Co., Shenzhen, China), the 4th generation ASD
device from LifeTech, is a nitinol-wire-mesh device coated with titanium
nitride.
This device is preloaded as a package and has a similar feature to other
nitinol-wire-mesh devices such as self-expanding property and double-disk
design with central waist. Ceraflex has couple of shared features with FSO; a
coated surface of nitinol-wire, flexible connection between the device and
delivery cable, and no hub on LA disk.
A total of 19 sizes are available from 6 to 42 mm with 2-mm increments, and
the delivery sheath sizes range from 8 to 14 Fr.
The disadvantages are its relatively limited size options (19 vs. 27 sizes in
ASO) and the requirement of a slightly larger delivery sheath than with ASO devices.
The Cocoon Septal Occluder is a self-expanding double-disk device consists
of a nano-platinum coated nitinol device filled with polypropylene fabric.
The device is quite similar to ASO in terms of device design except for the
nano-platinum-coated surface which prevents nickel release to the blood
stream , promotes biocompatibility and enhances radio-opacity on
fluoroscopy. There are 17 device options ranging from 8 to 40 mm with 2-mm
increments and the delivery sheath sizes range from 7 to 14 Fr.
European multicenter study reported an excellent result with procedural
success rate of 100% and no complication in 92 patients . This device has
been described as softest and lightest currently available device with less
metal-to-septum ratio than other devices .
The disadvantages are its relatively limited size options (17 vs. 27 sizes in
ASO) and the requirement of a slightly larger delivery sheath than with ASO
devices.
 Device embolization
 Device dislocation
 Rupture of atrial septum
 Development of thrombi in the device
 Risk of endocarditis ( rare)
 Arrhythmias (supra ventricular extrasystole,Atrial fibrillation ) occurs
early after intervention
 Acute pulmonary edema
 AV block
 Late perforation d/t erosion of atrial wall or aorta
 Potential complication include allergy reactions, Bronchospasm,
Aortic insufficiencies
 MR development d/t oversized mismatched device implantation (rare)
 Fracture of ASD device associate with MV perforation need SX removal
Cardiac catheterization  DEVICE  CLOSURE OF ASD.pptx

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Cardiac catheterization DEVICE CLOSURE OF ASD.pptx

  • 2. TYPES OF ASD  Secundum ASD: 80% of ASDs, located in the region of the fossa ovalis and its surrounding  Primum ASD : 15%, located near the crux, the atrioventricular (AV) valves are typically malformed resulting in various degree of regurgitation.  Superior sinus venosus defect :5% located near the SVC entry associated with partial or complete connection on right pulmonary veins to RA or SVC  Inferior sinus venosus defect : <1% located near the IVC entry  Unroofed coronary sinus :<1% separation from the LA can be partially or completely missing
  • 3. Since its first attempt in 1976 by Mills and King Transcatheter closure has become an accepted alternative to surgical repair for ostium secundum atrial septal defects (ASDs) Complex ASD, which is usually defined as defects >38 mm in diameter and/or deficient rims other than antero-superior, are often not considered amenable to transcatheter closure and referred for surgery
  • 4. Transcatheter closure has become an accepted alternative to surgical repair for ostium secundum atrial septal defects (ASD). However, large ASDs (>38 mm) and defects with deficient rims are usually not offered transcatheter closure but are referred for surgical closure. Transcatheter closure also remains controversial for other complicated ASDs with comorbidities, additional cardiac features and in small children.
  • 5.  Its ideal to have TEE guidance during the procedure as well  A guidewire is introduced the femoral vein into the IVC and further through the RA,across the ASD into LA  The tip of the wire is then placed in the pulmonary vein and a long venous sheath is introduced  Once the sheath is in position, the device attached to the delivery cable is introduced into the sheath under water to avoid air bubbles in the system  Bubbles in the system can get embolized during delivery with air emboli going into systemic circulation  If its reaches the cerebral circulation transient giddiness and altered sensorism can occur
  • 6.  ST segment elevation and hypotension may occur if the air bubbles find their way into the coronary circulation  Once the device reaches the LA, the left atrial disc of the device is released first and brought in contact with the left atrial side of ASD  When the position is judged ideal, the right atrial disc is allowed to form by withdrawal of sheath  Once the two discs are in position with the waist across the ASD, slight wiggling is done to make sure that the device is perfectly fitting and has no tendency for dislodgement
  • 7.  Position is confirmed by TEE with special care to see that the device does not interfere with the function of the AV valves  Once everything is fine ,the device is released by unscrewing the delivery cable
  • 8.  ASD closure is indicated in the presence of a significant left-to-right shunt, defined by a significant right heart enlargement due to volume overload, regardless of symptoms  After transoesophageal echocardiography under general anaesthesia was the exclusive imaging method for more than 10 years, recent innovations are now towards imaging guidance modalities.  Intracardiac echocardiography , and more recently TOE, have been introduced as acceptable alternative imaging guidance methods. They both carry the advantage of obviating the need for general anaesthesia.  Small defects with no right ventricular volume overload are not considered for closure, unless there is evidence of right-to-left shunting causing significant hypoxaemia and/or paradoxical embolism
  • 9.  Closure of an ASD should not be performed in cases with pulmonary vascular resistances >8 Wood units.  Patients with a pulmonary artery pressure less than two-thirds of systemic arterial pressure, pulmonary vascular resistance less than two-thirds of systemic resistance, or a positive response to pulmonary vasodilator testing can be considered for ASD closure .
  • 10.
  • 11.  Transcatheter closure of a very large oval atrial septal defect. (A) Very large atrial septal defect with maximum diameter measured at 44 mm on transoesophageal echocardiography; (B) 3D reconstruction demonstrates the crescent shape of the defect with a much smaller transverse diameter; (C) transthoracic echocardiography in 4-chambers view shows good position of the device after successful closure with a 40 mm Amplatzer ASO. ASO, Amplatzer septal occluder.
  • 12.
  • 13.  Large atrial septal defect that is measured at 21 mm on transesophageal echocardiography (A) in a 9.7 kg, 11-month-old infant with failure to thrive. (B) The transoesophageal echocardiography diameter is confirmed with the sizing balloon under fluoroscopy. After a 22 mm Amplatzer ASO is successfully implanted post-procedure transthoracic echocardiography in 4 chambers view confirms good position of the device and demonstrates a new mild mitral regurgitation that is functional, due to the sudden increase in left ventricular volume (C) This mild mitral regurgitation will disappear after a few weeks on follow-up echocardiography.
  • 14.  Patient selection is an important initial step for a successful treatment. Procedure in the catheterization laboratory may be summarized stepwise; (I) Hemodynamic study and assessment of morphologic characteristics of the defect; (II) Establishment of procedural strategy including procedure-guiding modality and equipment to be used; (III) Selection of optimal type and size of device; (IV) Device implantation with cautions for potential complications including air embolism, damage to cardiac/vascular structures; (V) Post-implantation assessment of the final result. After a successful procedure, appropriate patient education and follow-up are also essential parts of the treatment. Details and special considerations for each step of the procedure have well been described previously. There are individual issues which are often in debate including procedure-guiding modalities, sizing the defect, and closing complex defects.
  • 15. Issues on imaging guidance and defect sizing  Transthoracic echocardiography (TTE) may also be used especially in patients with good windows for echocardiography such as small children  There has been debate on the necessity of balloon sizing for selection of device size. Balloon sizing may be skipped in suitable defects with sufficient surrounding rims  however, it has long been regarded as an essential step of the procedure.Indeed, balloon sizing may provide more information than averaged size of the defect including compliance of surrounding rims and presence of additional defect.  While the balloon stretched diameter or balloon occlusive diameter were used in balloon sizing in the past, currently stop flow diameter (SFD) is recommended as the standard measurement to avoid oversizing
  • 16.  In self-centering devices such as the Amplatzer Septal Occluder (ASO) the recommended device size is the same or slightly larger (<2 mm) than the SFD. Nevertheless, the selection for device size should be individualized considering deficiency of rims, spatial relationship with nearby cardiac structures and size of the heart.  In cases with aortic rim deficiency, the usual recommendation is to avoid an “oversized” device because of the potential risk of erosion  On the other hand, in cases with inferior vena cava (IVC) rim deficiency with higher risk of device embolization, use of an “undersized” device should be avoided. In case of using a non-self-centering device such as the Gore Septal Occluder (GSO)a device twice the size of the defect is recommended, and the GSO is not recommended for defects >18 mm
  • 17. Complex lesions  Large defect  Large size of the defect may be the most common cause of difficulties in ASD closure using a device. The main problems are prolapse of left atrial (LA) disk of the device into the right atrium (RA) before proper positioning in the septum and difficulty in sizing the defect.  Device size is frequently selected by estimation rather than measurement of balloon diameter due to non-visualization of the whole defect in a single echocardiographic plane, difficulty in stabilization of the sizing balloon (melon-seeding or milking) and unavailability of sizing balloon larger than 34 mm.
  • 18.
  • 19.
  • 20.  Rim deficiencies The locations of rim deficiencies: (A)aortic rim, (B) IVC rim, (C) SVC rim deficiency
  • 21. (D) posterior rim, (E) atrioventricular valve rim.
  • 22.  Deficiency in the surrounding rim(s) is frequently associated with large defects, and may potentially increase the risk of complications such as device embolization, erosion and encroachment of device onto nearby cardiac structures.  Aortic rim (antero-superior rim ) deficiency is most common rim deficiency and device implantation is frequently interfered by LA disk prolapse. Erosion risk is higher in aortic rim deficiency as well as device oversizing ,thus device selection has to be refrained from undue oversizing.  IVC rim (posteroinferior rim ) deficiency is second most common among rim deficiencies and associated with higher risk of device embolization . In case with this rim deficiency, under-sizing of the device may further increase the risk of device embolization, and should be avoided.
  • 23.  Superior vena cava (SVC) rim (posterosuperior rim) deficiency is a rare condition and may interfere with device positioning.When the rim deficiency is extended from SVC rim to aortic rim, this indicates the defect is located superiorly in the atrial roof and may carry higher risk of erosion .  In case with posterior rim deficiency, In the presence of rim deficiency in large area from IVC to posterior rim, the risk of device embolization is very high and this condition may preclude device closure.  In atrioventricular valve rim deficiency, encroachment of device onto the mitral and/or tricuspid valve is a potential problem. This is a concern especially in infants and young children because of the inherent design of Amplatzer-type devices which have a relatively larger disk-rim width in smaller devices .
  • 24. Multiple defects Real time 3-dimensional (RT3D) echocardiography is very useful to assess morphologic characteristics for multiple defects Note : the similarity between the realistic image from RT3D echocardiography (A) actual image of the defect from the surgical field (B).
  • 25. Careful observation of fluoroscopic image with balloon sizing may provide additional anatomic information on the defects and intervening septum
  • 26. Currently available devices for atrial septal defect closure. (A) Amplatzer Septal Occluder; (B) Occlutech Figulla Flex II device; (C) Gore Cardioform Septal Occluder; (D) Cocoon Septal Occluder; (E) CeraFlex ASD device; (F) Nit Occlud ASD-R device; (G) Cardi-O-Fix Septal Occluder; (H) Ultracept II ASD Occluder (I) Carag Bioresorbable Septal occluder.
  • 27.
  • 28.
  • 29. The ASO is the first self-expanding double-disk device with central connecting waist composed of nitinol-wire-mesh. The disks and waist were sewn with a Dacron patch to promote complete occlusion and endothelialization.  The device allowed easy and straightforward deployment due to its self-centering, repositionable, and recapturable characteristics.  The ASO solved many limitations of previous devices such as the non- negligible rate of residual shunt and frame fracture, and is regarded as a prototype device for many newer devices.
  • 30. The device size is determined by the waist size; there are 27 device sizes from 4 to 40 mm.The corresponded delivery sheath sizes range from 6 to 12 French (Fr).  Reported risk factors include aortic rim deficiency, superiorly located ASD, over-sizing of device, septal malalignment, dynamic ASD and lower patient weight: device size ratio Recommendations to avoid erosion should be followed and comprehensive evaluation by echocardiography during follow-up is warranted The ASO “cribriform” is a specially designed non-self-centering device for multi-fenestrated defects with 4 available sizes from 18 to 40 mm.
  • 31. Figulla Flex II ASD Occluder is the third generation Occlutech device for ASD closure with a flexible titanium-oxide coated nitinol-mesh and double-disk design similar to ASO.  FSO has minimized metal contents especially in the LA disk and no clamping hub on the LA disk, which may provide more flexible and less traumatic feature. The FSO has a distinct release mechanism resembling a bioptome which enables flexible movement between the device and delivery cable. The delivery cable is also shapeable for a better alignment between the device and septum. There are 20 device size options from 4 to 40 mm.
  • 32. The largest study with FSO, the IRFACODE study, showed a 98% success rate in 1395 patients and a 97.3% complete closure rate at 1 year. The major complication rate was minimal. Erosion has not yet been reported with this device. The disadvantages are its relatively limited size options (20 vs. 27 sizes in ASO) and requirement of a slightly larger delivery sheath than in ASO devices. A fenestrated device for closure of ASD with pulmonary hypertension or risk of masked left ventricular restriction is available on an order-made basis.
  • 33. The GSO is a non-self-centering double disk device composed of platinum filled nitinol wire framework covered with an expanded polytetrafluoroethylene (ePTFE) membrane to promote rapid endothelialization. The GSO is preloaded as a package of the device and whole delivery system. The delivery system has improved for easier delivery and position compared to that of the previous Helex Septal Occluder (HSO). There are 4 device sizes from 15 to 30 mm with 5-mm increments. It is generally recommended that the device size should be more than twice the defect size and the GSO is not suitable for defects over 18 mm due to the non-self-centering feature. Owing to its flexibility with minimal metal content which may prevent erosion, the device is preferred to close smaller defects especially with aortic rim deficiency or those in small children .
  • 34. Clinical studies verified efficacy and safety of this device in closing ASDs with various morphologies such as aortic rim deficiency, septal aneurysm and multiple defects in selected patients with feasible anatomy The Gore Cardioform ASD Occluder (GAO) is a self-centering version of GSO which consists of a helical nitinol-wire frame covered with ePTFE to treat larger ASDs. The available sizes are 27, 32, 37, 44, and 48 mm and designed to treat defects from 8 to 35 mm. Although this device is not commercially available yet, the initial clinical result showed the safety and efficacy of the GAO. The risk factor for procedural failure in GAO implantation was a larger defect size, especially a size larger than 27 mm by balloon sizing.
  • 35. CeraFlex (LifeTech Scientific Co., Shenzhen, China), the 4th generation ASD device from LifeTech, is a nitinol-wire-mesh device coated with titanium nitride. This device is preloaded as a package and has a similar feature to other nitinol-wire-mesh devices such as self-expanding property and double-disk design with central waist. Ceraflex has couple of shared features with FSO; a coated surface of nitinol-wire, flexible connection between the device and delivery cable, and no hub on LA disk. A total of 19 sizes are available from 6 to 42 mm with 2-mm increments, and the delivery sheath sizes range from 8 to 14 Fr. The disadvantages are its relatively limited size options (19 vs. 27 sizes in ASO) and the requirement of a slightly larger delivery sheath than with ASO devices.
  • 36. The Cocoon Septal Occluder is a self-expanding double-disk device consists of a nano-platinum coated nitinol device filled with polypropylene fabric. The device is quite similar to ASO in terms of device design except for the nano-platinum-coated surface which prevents nickel release to the blood stream , promotes biocompatibility and enhances radio-opacity on fluoroscopy. There are 17 device options ranging from 8 to 40 mm with 2-mm increments and the delivery sheath sizes range from 7 to 14 Fr. European multicenter study reported an excellent result with procedural success rate of 100% and no complication in 92 patients . This device has been described as softest and lightest currently available device with less metal-to-septum ratio than other devices . The disadvantages are its relatively limited size options (17 vs. 27 sizes in ASO) and the requirement of a slightly larger delivery sheath than with ASO devices.
  • 37.  Device embolization  Device dislocation  Rupture of atrial septum  Development of thrombi in the device  Risk of endocarditis ( rare)  Arrhythmias (supra ventricular extrasystole,Atrial fibrillation ) occurs early after intervention  Acute pulmonary edema  AV block
  • 38.  Late perforation d/t erosion of atrial wall or aorta  Potential complication include allergy reactions, Bronchospasm, Aortic insufficiencies  MR development d/t oversized mismatched device implantation (rare)  Fracture of ASD device associate with MV perforation need SX removal