Author: Krupa Desai, MD – Children’s Hospital of Philadelphia; Chinwe Unegbu, MD – Children’s National Hospital
A six-year-old child with a secundum atrial septal defect (ASD) presents for a transcatheter ASD device closure. Transthoracic echocardiographic imaging reveals a large ASD with moderate right atrial and ventricular enlargement. What is the MOST LIKELY reason that a Gore Septal Occluder may be preferred versus the Amplatzer Septal Occluder for closure of this defect?
Correct!
Wrong!
Question of the Week 328
Atrial septal defects (ASD) are one of the most common congenital cardiac defects in the pediatric population. ASD closure is indicated when the resultant left to right shunt leads to right ventricular volume overload and/or a ratio of total pulmonary blood flow to systemic blood flow (Qp:Qs) greater than or equal to 1.5: 1. Additional indications for ASD closure include cyanosis and/or embolic episodes secondary to right to left shunting. Possible contraindications to ASD closure include evidence of pulmonary hypertension with an elevated pulmonary vascular resistance and reduced right ventricular compliance or function.
ASDs can be closed either surgically or percutaneously via transcatheter intervention. The decision regarding which method of closure to pursue is based on several factors including anatomic criteria, device specific limitations, and possible complications. Transcatheter techniques and device properties have become more refined and as a result, ASD device closure is now accepted as the preferred treatment of choice. Transcatheter closure has excellent clinical efficacy as well as a lower complication rate compared to surgical closure. However, surgical closure is still preferred in patients who have a low body weight, a defect greater than 38mm in diameter, deficient rims, and/or multiple/complex defects.
Transcatheter device closure of an ASD in the cardiac catheterization lab usually involves the following steps:
1. A hemodynamic cardiac catheterization and assessment of the morphologic characteristics of the defect.
2. Establishment of a procedural strategy for device implantation including an imaging modality (i.e.TEE, ICE, TTE, etc.).
3. Selection of the optimal device type and size.
4. Device implantation with appropriate surveillance of potential complications.
5. Post implantation assessment.
Large defects represent the main source of challenge for the transcatheter ASD device closure procedure. In this circumstance, problems arise secondary to difficulty in correctly sizing the defect or from the prolapse of left atrial disk of the closure device into the right atrium before proper positioning in the septum. Large defects are frequently associated with rim deficiency. Patients with deficient rims are at risk for device dislodgment, embolization, erosion, and/or encroachment into nearby cardiac structures as an ASD is surrounded by vital cardiac structures throughout its circumference.
Balloon sizing is performed in order to select the correct device. It also provides information about the compliance of the rims. The balloon stretched diameter or balloon occlusive diameter is used to approximate the defect size, but the stop flow diameter (SFD) measurement is standardly recommended to avoid oversizing. In devices such as the Amplatzer Septal Occluder (ASO) (St. Jude Medical, St. Paul, MN, USA), the recommended device size is usually the same or slightly larger (<2 mm) than the SFD. Ultimately, the selection for device size should be individualized by assessing for rim deficiency and evaluating the spatial relationship of nearby structures.
There are many commercially available devices for percutaneous ASD closure. The first device developed was the Amplatzer Septal Occluder (ASO). More recent devices include the Gore Cardioform Septal Occluder (GSO) (WL Gore & Associates, Inc., Flagstaff, AZ, USA), the Figulla Flexible Occlutech device, the Cardioseal/Starflex, and the bioabsorbable devices (Biostar or Biotrek). The ASO is a self-centering device with the ability to close defects from 4 to 38mm due to its diameter size while the GSO is a non-self-centering device with the ability to close defects from 15 to 18mm.
The ASO was the first self-expanding double-disk device. The device allows for straightforward deployment as it is self-centering, repositionable, and recapturable. With a self-centering device, the waist sits inside the ASD and completely occupies the defect. The edges of the device remain at a fixed distance from the atrial free wall regardless of the timing of the cardiac cycle. Therefore, an oversized device may tent the atrial free wall throughout the cardiac cycle making it vulnerable to trauma. The self-centering characteristic of the ASO necessitates device selection to closely approximate the defect diameter. A stop-flow diameter sizing technique is recommended for the ASO.
An initial study demonstrated a high success rate of ASD closure (95.7%) with few reported major adverse events (1.6%) with the ASO. The subsequent MAGIC study and IMPACT registry reported compatible success and complication rates. The risk of device erosion has become increasingly concerning as it may be fatal and may be delayed. The exact rate of device erosion is estimated to be 0.1 to 0.3%.
The GSO is a non-self-centering double disk device composed of a platinum filled nitinol wire framework covered with an expanded polytetrafluoroethylene membrane to promote rapid endothelialization. When the GSO is fully deployed it assumes a double-disc configuration that bridges the septal defect to prevent shunting of blood between the right and left atria. To effectively close the ASD, the discs must be approximately twice the diameter of the ASD. The GSO is preferred for closure of small defects, particularly those with aortic rim deficiency, due to its flexibility with minimal metal content which may prevent erosion. Clinical studies have verified the efficacy and safety of GSO in closing ASDs with various morphologies. The GSO can adjust to contraction of the atrial chamber because it is a non-self-centering device.
All of the ASD percutaneous closure devices have excellent efficacy and safety profiles. Serious adverse effects occur in less than 1% of patients and more than 95% of the defects can be closed safely. Major catheterization complications specific to this procedure may appear even after completion of the procedure, such as stroke and AV block. The activated clotting time should be at least 250 seconds throughout the procedure, and heparin should never be reversed at the conclusion of the procedure because it increases the risk of thrombus formation on the device. The most common complication reported to the manufacturers and the FDA is device embolization. Device embolization most commonly occurs in the cardiac catheterization laboratory or during the first 24 hours after device placement. The opposite is true of device-related erosion, which is rarely appreciated in the cardiac catheterization laboratory. However, the risk increases significantly during the first 96 hours with sporadic cases reported after 6 months to several years after implantation. To date, device erosion has been noted with the ASO. It is typically, although not exclusively, seen in cases where either the ASO was oversized or there was deficient anterosuperior or retro-aortic rim. Erosion occurring in cases without device oversizing remains of significant concern. To further minimize the risk of erosion, correct device sizing by carefully and non-aggressively employing the stop-flow balloon diameter method is recommended. Patients with aortic rim deficiency spanning 30º or more should not be selected for device closure.
To date, there are no known cases of erosion with the GSO, however, long term follow-up data is unavailable due to it recently being commercially approved. There is a new GSO now available that is a hybrid of the ASO and original GSO allowing for decreased incidence of device erosion and the ability to close ASDs measuring greater than or equal to 18mm as demonstrated in the ASSURED clinal study.
The correct answer is that the GSO has a low likelihood of device erosion compared to the ASO. The GSO device has not demonstrated any cases of device erosion to date. GSO does not require minimal rim for deployment and rim deficiency may be a contraindication to placement. ASO and GSO are both placed with guidance by echocardiography. ASO and GSO require anticoagulation due to risk of device thrombosis. The devices have metal and/or polyester mesh components so most patients are started prophylactically on aspirin and/or clopidogrel. Dual antiplatelet therapy is typically continued post-procedurally for 3 months and aspirin for up to 6 months (device endothelialization).
References
1. de Hemptinne Q, Horlick EM, Osten MD, et al. Initial clinical experience with the GORE®CARDIOFORM ASD occluder for transcatheter atrial septal defect closure. Catheter Cardiovasc Interv. 2017; 90(3): 495-503. doi:10.1002/ccd.26907 -------------------- 2. Faccini A, Butera G. Atrial septal defect (ASD) device trans-catheter closure: limitations. J Thorac Dis. 2018; 10(Suppl 24): S2923-S2930. doi:10.21037/jtd.2018.07.128 -------------------- 3. Du ZD, Hijazi ZM, Kleinman CS, et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002; 39: 1836-1844.-------------------- 4. Fraisse A, Latchman M, Sharma SR, et al. Atrial septal defect closure: indications and contraindications. J Thorac Dis. 2018; 10(Suppl 24): S2874-S2881. doi:10.21037/jtd.2018.08.111 --------------------- 5. Olasinska-Wisniewska A, Grygier M. Antithrombotic/Antiplatelet Treatment in Transcatheter Structural Cardiac Interventions-PFO/ASD/LAA Occluder and Interatrial Shunt Devices. Front Cardiovasc Med. 2019; 6: 75. Published 2019 Jun 7. doi:10.3389/fcvm.2019.00075 -------------------- 6. Søndergaard L, Loh PH, Franzen O, et al. The first clinical experience with the new GORE® septal occluder (GSO). EuroIntervention 2013; 9: 959-963. -------------------- 7. Smith B, Thomson J, Crossland D, et al. UK multicenter experience using the Gore septal occluder (GSO(TM)) for atrial septal defect closure in children and adults. Catheter Cardiovasc Interv 2014; 83: 581-586. -------------------- 8. Santoro G, Castaldi B, Cuman M, et al. Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience. Int J Cardiol. 2021; 327: 68-73. doi:10.1016/j.ijcard.2020.11.029 -------------------- 9. Sommer RJ, Love BA, Paolillo JA, et al. ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect. Catheter Cardiovasc Interv. 2020; 95(7): 1285-1295. doi:10.1002/ccd.28728 -------------------- 10. Yang MC, Wu JR. Recent review of transcatheter closure of atrial septal defect. Kaohsiung J Med Sci. 2018; 34(7): 363-369. doi:10.1016/j.kjms.2018.05.001 --------------------- 11. Amin Z, Hijazi ZM, Bass JL, et al. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv. 2004; 63: 496-502. -------------------- 12. Krumsdorf U, Ostermayer S, Billinger K, et al. Incidence and clinical course of thrombus formation on atrial septal defect and patent foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol. 2004; 43: 302-309. -------------------- 13. Levi DS, Moore JW. Embolization and retrieval of the Amplatzer septal occluder. Catheter Cardiovasc Interv. 2004; 61: 543-547. --------------------- 14. Everett AD, Jennings J, Sibinga E, et al. Community use of the amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol 2009; 30: 240-247. --------------------- 15. Moore JW, Vincent RN, Beekman RH 3rd, et al. Procedural results and safety of common interventional procedures in congenital heart disease: initial report from the National Cardiovascular Data Registry. J Am Coll Cardiol . 2014; 64: 2439-2451. ---------------------- 16. Diab K, Kenny D, Hijazi ZM. Erosions, erosions, and erosions! Device closure of atrial septal defects: how safe is safe? Catheter Cardiovasc Interv. 2012; 80: 168-174. -------------------- 17. Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv . 2012; 80: 157-167. -------------------- 18. McElhinney DB, Quartermain MD, Kenny D, et al. Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study. Circulation. 2016; 133: 1738-1746.
ASDs can be closed either surgically or percutaneously via transcatheter intervention. The decision regarding which method of closure to pursue is based on several factors including anatomic criteria, device specific limitations, and possible complications. Transcatheter techniques and device properties have become more refined and as a result, ASD device closure is now accepted as the preferred treatment of choice. Transcatheter closure has excellent clinical efficacy as well as a lower complication rate compared to surgical closure. However, surgical closure is still preferred in patients who have a low body weight, a defect greater than 38mm in diameter, deficient rims, and/or multiple/complex defects.
Transcatheter device closure of an ASD in the cardiac catheterization lab usually involves the following steps:
1. A hemodynamic cardiac catheterization and assessment of the morphologic characteristics of the defect.
2. Establishment of a procedural strategy for device implantation including an imaging modality (i.e.TEE, ICE, TTE, etc.).
3. Selection of the optimal device type and size.
4. Device implantation with appropriate surveillance of potential complications.
5. Post implantation assessment.
Large defects represent the main source of challenge for the transcatheter ASD device closure procedure. In this circumstance, problems arise secondary to difficulty in correctly sizing the defect or from the prolapse of left atrial disk of the closure device into the right atrium before proper positioning in the septum. Large defects are frequently associated with rim deficiency. Patients with deficient rims are at risk for device dislodgment, embolization, erosion, and/or encroachment into nearby cardiac structures as an ASD is surrounded by vital cardiac structures throughout its circumference.
Balloon sizing is performed in order to select the correct device. It also provides information about the compliance of the rims. The balloon stretched diameter or balloon occlusive diameter is used to approximate the defect size, but the stop flow diameter (SFD) measurement is standardly recommended to avoid oversizing. In devices such as the Amplatzer Septal Occluder (ASO) (St. Jude Medical, St. Paul, MN, USA), the recommended device size is usually the same or slightly larger (<2 mm) than the SFD. Ultimately, the selection for device size should be individualized by assessing for rim deficiency and evaluating the spatial relationship of nearby structures.
There are many commercially available devices for percutaneous ASD closure. The first device developed was the Amplatzer Septal Occluder (ASO). More recent devices include the Gore Cardioform Septal Occluder (GSO) (WL Gore & Associates, Inc., Flagstaff, AZ, USA), the Figulla Flexible Occlutech device, the Cardioseal/Starflex, and the bioabsorbable devices (Biostar or Biotrek). The ASO is a self-centering device with the ability to close defects from 4 to 38mm due to its diameter size while the GSO is a non-self-centering device with the ability to close defects from 15 to 18mm.
The ASO was the first self-expanding double-disk device. The device allows for straightforward deployment as it is self-centering, repositionable, and recapturable. With a self-centering device, the waist sits inside the ASD and completely occupies the defect. The edges of the device remain at a fixed distance from the atrial free wall regardless of the timing of the cardiac cycle. Therefore, an oversized device may tent the atrial free wall throughout the cardiac cycle making it vulnerable to trauma. The self-centering characteristic of the ASO necessitates device selection to closely approximate the defect diameter. A stop-flow diameter sizing technique is recommended for the ASO.
An initial study demonstrated a high success rate of ASD closure (95.7%) with few reported major adverse events (1.6%) with the ASO. The subsequent MAGIC study and IMPACT registry reported compatible success and complication rates. The risk of device erosion has become increasingly concerning as it may be fatal and may be delayed. The exact rate of device erosion is estimated to be 0.1 to 0.3%.
The GSO is a non-self-centering double disk device composed of a platinum filled nitinol wire framework covered with an expanded polytetrafluoroethylene membrane to promote rapid endothelialization. When the GSO is fully deployed it assumes a double-disc configuration that bridges the septal defect to prevent shunting of blood between the right and left atria. To effectively close the ASD, the discs must be approximately twice the diameter of the ASD. The GSO is preferred for closure of small defects, particularly those with aortic rim deficiency, due to its flexibility with minimal metal content which may prevent erosion. Clinical studies have verified the efficacy and safety of GSO in closing ASDs with various morphologies. The GSO can adjust to contraction of the atrial chamber because it is a non-self-centering device.
All of the ASD percutaneous closure devices have excellent efficacy and safety profiles. Serious adverse effects occur in less than 1% of patients and more than 95% of the defects can be closed safely. Major catheterization complications specific to this procedure may appear even after completion of the procedure, such as stroke and AV block. The activated clotting time should be at least 250 seconds throughout the procedure, and heparin should never be reversed at the conclusion of the procedure because it increases the risk of thrombus formation on the device. The most common complication reported to the manufacturers and the FDA is device embolization. Device embolization most commonly occurs in the cardiac catheterization laboratory or during the first 24 hours after device placement. The opposite is true of device-related erosion, which is rarely appreciated in the cardiac catheterization laboratory. However, the risk increases significantly during the first 96 hours with sporadic cases reported after 6 months to several years after implantation. To date, device erosion has been noted with the ASO. It is typically, although not exclusively, seen in cases where either the ASO was oversized or there was deficient anterosuperior or retro-aortic rim. Erosion occurring in cases without device oversizing remains of significant concern. To further minimize the risk of erosion, correct device sizing by carefully and non-aggressively employing the stop-flow balloon diameter method is recommended. Patients with aortic rim deficiency spanning 30º or more should not be selected for device closure.
To date, there are no known cases of erosion with the GSO, however, long term follow-up data is unavailable due to it recently being commercially approved. There is a new GSO now available that is a hybrid of the ASO and original GSO allowing for decreased incidence of device erosion and the ability to close ASDs measuring greater than or equal to 18mm as demonstrated in the ASSURED clinal study.
The correct answer is that the GSO has a low likelihood of device erosion compared to the ASO. The GSO device has not demonstrated any cases of device erosion to date. GSO does not require minimal rim for deployment and rim deficiency may be a contraindication to placement. ASO and GSO are both placed with guidance by echocardiography. ASO and GSO require anticoagulation due to risk of device thrombosis. The devices have metal and/or polyester mesh components so most patients are started prophylactically on aspirin and/or clopidogrel. Dual antiplatelet therapy is typically continued post-procedurally for 3 months and aspirin for up to 6 months (device endothelialization).
References
1. de Hemptinne Q, Horlick EM, Osten MD, et al. Initial clinical experience with the GORE®CARDIOFORM ASD occluder for transcatheter atrial septal defect closure. Catheter Cardiovasc Interv. 2017; 90(3): 495-503. doi:10.1002/ccd.26907 -------------------- 2. Faccini A, Butera G. Atrial septal defect (ASD) device trans-catheter closure: limitations. J Thorac Dis. 2018; 10(Suppl 24): S2923-S2930. doi:10.21037/jtd.2018.07.128 -------------------- 3. Du ZD, Hijazi ZM, Kleinman CS, et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002; 39: 1836-1844.-------------------- 4. Fraisse A, Latchman M, Sharma SR, et al. Atrial septal defect closure: indications and contraindications. J Thorac Dis. 2018; 10(Suppl 24): S2874-S2881. doi:10.21037/jtd.2018.08.111 --------------------- 5. Olasinska-Wisniewska A, Grygier M. Antithrombotic/Antiplatelet Treatment in Transcatheter Structural Cardiac Interventions-PFO/ASD/LAA Occluder and Interatrial Shunt Devices. Front Cardiovasc Med. 2019; 6: 75. Published 2019 Jun 7. doi:10.3389/fcvm.2019.00075 -------------------- 6. Søndergaard L, Loh PH, Franzen O, et al. The first clinical experience with the new GORE® septal occluder (GSO). EuroIntervention 2013; 9: 959-963. -------------------- 7. Smith B, Thomson J, Crossland D, et al. UK multicenter experience using the Gore septal occluder (GSO(TM)) for atrial septal defect closure in children and adults. Catheter Cardiovasc Interv 2014; 83: 581-586. -------------------- 8. Santoro G, Castaldi B, Cuman M, et al. Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience. Int J Cardiol. 2021; 327: 68-73. doi:10.1016/j.ijcard.2020.11.029 -------------------- 9. Sommer RJ, Love BA, Paolillo JA, et al. ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect. Catheter Cardiovasc Interv. 2020; 95(7): 1285-1295. doi:10.1002/ccd.28728 -------------------- 10. Yang MC, Wu JR. Recent review of transcatheter closure of atrial septal defect. Kaohsiung J Med Sci. 2018; 34(7): 363-369. doi:10.1016/j.kjms.2018.05.001 --------------------- 11. Amin Z, Hijazi ZM, Bass JL, et al. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv. 2004; 63: 496-502. -------------------- 12. Krumsdorf U, Ostermayer S, Billinger K, et al. Incidence and clinical course of thrombus formation on atrial septal defect and patent foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol. 2004; 43: 302-309. -------------------- 13. Levi DS, Moore JW. Embolization and retrieval of the Amplatzer septal occluder. Catheter Cardiovasc Interv. 2004; 61: 543-547. --------------------- 14. Everett AD, Jennings J, Sibinga E, et al. Community use of the amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol 2009; 30: 240-247. --------------------- 15. Moore JW, Vincent RN, Beekman RH 3rd, et al. Procedural results and safety of common interventional procedures in congenital heart disease: initial report from the National Cardiovascular Data Registry. J Am Coll Cardiol . 2014; 64: 2439-2451. ---------------------- 16. Diab K, Kenny D, Hijazi ZM. Erosions, erosions, and erosions! Device closure of atrial septal defects: how safe is safe? Catheter Cardiovasc Interv. 2012; 80: 168-174. -------------------- 17. Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv . 2012; 80: 157-167. -------------------- 18. McElhinney DB, Quartermain MD, Kenny D, et al. Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study. Circulation. 2016; 133: 1738-1746.
