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. 2022 May 27;14(5):e25402. doi: 10.7759/cureus.25402

Table 3. Data extraction table.

  Author Year of publication Location Type of study Device Sample size Age range Follow-up Complete Device Closure (efficacy) ASD size Occluder size Aortic rim Other rims Complications (safety & efficacy) Intervention Associated factors/comments
  Intraprocedural Post-op Follow-up At last follow-up
[12] Yifan Li et al 2021 China Clinical Trial Absnow Biodegradable Occluder n = 5 3.1-6.5 years 3 years 40% (⅖) Clinical closure 80% (⅘) 5-30mm 4-8mm larger than defect size   sufficient rims: device 4-6mm larger than defect   floppy rims/multiple defects: device 7-8mm larger than defect   In general, PLLA device 2mm larger than metal device for same defect   Sufficient   superior to mitral valve by 7mm   superior to coronary sinus, SVC, IVC, & pulmonary vein by 5mm Right atrial disk malformation - 12 months n = 1 (36 months) -  
Residual shunt > 4mm, RV enlargement - -
Residual shunt 2-4mm - - n = 2 (36 months) - -
[13] Jun-Yi Wan et al 2017 Taiwan Case Report Amplatzer Septal Occluder n = 1 7 years - - 12mm 16mm ❌   Erosion → fistula - - n = 1 (1 month) Fistula closed w/ PDA occluder device (Lifetech Scientific) -
[14] Yasuko Onakatomi et al 2019 Japan Case Report n = 1 7 years 5 years - 20mm 24mm ❌   Erosion → pericardial effusion, cardiac tamponade w/ collapsed RV, shock - - n = 1 (5 years, 10 months) Tear(s) repaired, device removed, ASD patch closure -
[15] Zai-Qiang Zhang et al 2021 China Case Report n = 1 16 years - - 6mm 12mm ❌ Sufficient   5mm from right pulmonary veins, SVC, os of coronary sinus, & mitral valve Erosion/perforation → moderate pericardial effusion, hemopericardium, shock - - n = 1 (3 months) Tear(s) repaired, device removed, ASD patch closure -
[16] Wen-long Zhang et al 2021 China Case Report n = 1 5 years - - 15.2mm x 13.6mm 15mm ❌ Sufficient   5mm from right pulmonary veins, SVC, os of coronary sinus, & mitral valve Erosion/perforation → pericardial effusion, hemopericardium, red thrombosis - - n = 1 (1 month) Tear(s) repaired, device removed, ASD patch closure -
[17] Bharti Sharma et al 2019 India Retrospective Cohort Study n = 45 8-38 months 1-36 months 95% (43/45) - equal to/ up to 10% more than ASD diameter ❌   in most cases Sufficient   SVC rim, IVC rim, posterior rim > 4mm   AV valve/mitral rim > 7mm Trauma to anterior mitral leaflet → Grade II MR Grade II MR continued - n = 1 (18 months) MV repaired -
Conduction block n = 1 (Transient Mobitz Type I AV Block) - - IV steroids, atropine -
- n = 1 (2:1 AV block) - Oral steroids, NSAIDs -
[18] Mehdi Ghaderian et al 2019 Iran Prospective Cohort Study n = 35 6-14 months 29 months 77% (27/35) ≥6mm equal to ASD diameter for ASD < 10mm   1-2mm > ASD diameter for ASD > 10mm ❌   (deficient in 28.3%; n = 321) Sufficient Arrhythmia n = 2 (PSVT) - - - Resolved immediately without treatment
Cerebral thrombosis → seizure, right sided hemiparesis - n = 1; (after 8 hours) - Treatment initiated immediately & symptoms corrected during follow-ups ASD size larger & duration of procedure longer than other patients
[19] Zakaria Jalal et al 2018 France Retrospective Cohort Study n = 1,326 0.7 - 18 years 6 months - 18 years 95.32% (1,264/1,326) 5-40mm by Echocardiogram   6-42mm by balloon sizing 4-40mm ❌   (deficient in 28.3%; n = 321) Rim deficiencies:   posterior - 14.2% (n = 161)   anteroinferior - 9.8% (112)   posterosuperior - 2.2% (n = 25)   inferior - 13.6% (n = 155)   superior - 4.3% (n = 49) Device embolization n = 7 n = 10 - Device removed -
Unstable device n = 5 - - Device removed -
AV valve damage n = 2 - - Device removed -
Conduction block n = 2 (reversible AVB) - - Device removed -
- n = 5 (2 CAVB, 2 AVB II, 1 AVB 1) - Device removed (n = 2; one patient with CAVB, and another patient with persistent asymptomatic suprahisian AVB II)   Remaining (n = 3) resolved spontaneously/with systemic corticosteroids -
Trivial residual shunts n = 47 - - - -
Arrhythmias - n = 8 n = 3 Anti arrhythmic drugs (n = 5)/catheter ablation (n = 2)/electrical cardioversion (for AF, n  = 1) -
Pulmonary hypertension - n = 2 (after 1 month) - - -
Transient ischemic stroke - n = 2 (after 3 months) - Antiplatelet therapy Occurred while receiving anti platelet therapy; no thrombus
Migraine/headache - n = 15 - - -
Atypical chest pain - n = 3 - - -
[20] Han-Fan-Qiu et al 2019 China Retrospective Cohort Study Amplatzer Septal Occluder & Domestic ASD Device (Shanghai Shape Memory Alloy Co., Ltd., Shanghai, China; modified from Amplatzer ASD occluder) n = 45 2-7 years 12-15 months 100% - 1-2mm > ASD diameter - Sufficient Device embolization - n = 1 - Device removed, surgical ASD closure -
Arrhythmias - n = 11 - - Transient
Hematoma at access site - n  = 3 - - -
[8] Yangyang Han et al 2020 China Retrospective Cohort Study Domestic ASD Device (Shanghai Shape Memory Alloy Co., Ltd., Shanghai, China; modified from Amplatzer ASD occluder) n = 88 0-3 years 26-86 months 94.31% (83/88) - - - Sufficient   ≥5mm distance from defect edge to coronary sinus, SVC, IVC, pulmonary vein   7mm distance from defect edge to AV flap Device embolization n = 1 - - Device removed, surgical ASD closure Device embolization → cardiac arrest & blood flow interruption → minor brain complication → improved after treatment
Oblique position of device on relatively large defect n = 1 - - Device removed, surgical ASD closure one week later -
Unstable device n = 3 - - Reimplantation with larger device -
Arrhythmias n = 8 [+ AVB I (n = 3); + AF (n = 5)] - - - Transient
[21] Priya Pradhan et al 2021 India Retrospective Cohort Study Amplatzer Cribriform Septal Occluder n = 16 2.5-10.5 1-60 months 68.75% (11/16) Multiple fenestrations ≥3 with major defect <12mm ≥1.5 x FSL (fenestrated septal length) but < TSL (total septal length) - Sufficient   rim ≥4mm from defect to SVC/IVC, coronary sinus, mitral valve, RUPV Residual shunt < 3mm - - n = 3 - -
[22] Basil (Vasilios) D. Thanopoulos et al 2021 Greece Retrospective Cohort Study Cocoon Septal Occluder n = 1853 2-14 years 12 - 84 months 99.4% (1800/1853) - equal to ASD diameter ❌   in 5.1% (n = 95) Sufficient Device embolization n = 8 - - Device removed -
Conduction block n = 16 (15 AVB I & II, 1 CAVB) - - - -
Arrhythmias n = 31 (atrial) - n = 38 (atrial) - -
Migraine/headache - n = 25; (after 1-2 weeks) - Acetaminophen -
[23] Hyam Mahmoud et al 2019 Romania Prospective Cohort Study n = 27 3-25 years 3-26 months 88.9% (24/27) 8-26mm by TEE   13.5-32mm by balloon sizing 8-32mm ❌ Sufficient   patients w/ deficient inferior/superior/posterior rims were excluded, especially if aortic rim also deficient Device embolization - n = 2; (after 12 hours) - Device removed Patients had < 5mm deficient posterior rim
AV femoral fistula - n = 2 - - Disappeared spontaneously
Hematoma at access site - n = 2 - - -
[24] Amal M. El-Sisi et al 2021 Egypt Retrospective Cohort Study Occlutech Accel Flex II Septal Occluder n = 30 5-18 years 5 years 100% 12-30mm 2-4mm larger than largest ASD diameter (10-33mm) - - Sinus tachycardia n = 2 - - -
Mild MR n = 2 - -
Mild AR n = 1 - -
Mild TR - - n = 11 - -
Mild PR - - n = 5 - -
[25] Murat Muhtar Yilmazer et al 2018 Turkey Prospective Cohort Study Solysafe Septal Occluder n = 25 5-12 years 5.2-7.2 years 88% (22/25) 6-21mm by TTE 7-23mm by TEE 8-26mm by balloon catheter 15mm for 4-12mm defects (n = 9) 20mm for 13-17mm defects (n = 8) → procedure failure in one 25mm for 18-22mm defects (n = 6) 35mm for 27-30mm defects (n = 2) → procedure failure in both - Sufficient   > 5mm inferior & superior rims Failure of device deployment n = 3 (1 aneurysmal floppy septum, 2 floppy rims) - - Device removed Device embolization (n = 1)
Residual shunt - - n = 1 (6 years) - -
Wire fraction - - n = 1 (6 years) - -
Left hemispheric infarct → right hemiparesis n = 1 - - Physical therapy -
Arrhythmia n = 1 (junctional rhythm) - - - Spontaneous resolution
Partial occlusion of right femoral vein n = 1 - - Heparin infusion → resolution -
[26] Gustaf Tangho¨j et al 2017 Sweden Retrospective Cohort Study Amplatzer (n = 212)   Gore occluder (n = 20)  Cardioseal (n= 4)   Occlutech Figulla Flex (n = 7  Cocoon/vascular innovations (n = 8)   Cardia atriasept (n = 1) n = 252 0 - 18 years - - 5-21mm in children <15kg   4-21mm in children >15kg 6-33mm in children <15kg   5-36mm in children >15kg - - Fatal device erosion - n = 1; (after 5 days) - - Emergent surgical procedure required in 4 patients
Arrhythmias n = 7 (2 major, 4 minor, 1 prolonged) - - Major arrhythmias required treatment
Pulmonary hypertension crisis n = 1 - - -
Hypotension n = 2 - - 1 required treatment
Bleeding n = 3 - - 2 required transfusion
[27] Seul Gi Cha et al 2021 Korea Retrospective Cohort Study Amplatzer Septal Occluder (n = 280)   Amplatzer Cribriform Septal Occluder (n = 2)   Amplatzer PFO Occluder (n = 1)   Cocoon Septal Occluder (n = 36)   Occlutech Figulla Flex II (n = 81)   Gore Cardioform Septal Occluder (n = 1) n = 407 2-5 years 3.6-140.8 months 86.7% (353/407) - 1-2mm > ASD diameter in TEE 0-1mm < balloon diameter in TEE ❌ MV rim > 5mm   IVC rim 3-5mm cutoff   SVC, PS, PI rims 1-3mm cutoff No multiple rim deficiency Device deployment failure n = 4 - - - Failure
MV problem n = 3 (MV compression) - - - Failure
- n = 1 (LA disk touching MV) - - -
Conduction block n = 1 (CAVB) - - - Failure
- n = 1 (CAVB) - - -
Device embolization - n = 1 - Device removal & reimplantation of larger device - successful -
RV failure - n = 1 - Device removed -
Misdiagnosis of PAPVR - n = 1 - Device removed -
Aggravation of MR - - n = 5 - -
Device leakage - - n = 44 - -
[28] Safaa H. Ali et al 2017 Egypt Retrospective Cohort Study Amplatzer Septal Occluder, cribriform ASD occluder and delivery system (n = 132)   Figulla-Occlutech device (n = 3) n = 135   2 years 98.5% - 20-25% larger than ASD diameter 20% if all rims preserved (except retro-aortic) 25% if 2 rims deficient   equal to or 2mm larger than ASD diameter in children < 5 years ❌ Sufficient   > 5mm distance between defect edge to mitral & tricuspid valves, SVC, RUPV, & coronary ​​sinus Device embolization n = 1 - - Device removed, surgical ASD closure -
Hemopericardium, cardiac tamponade - n = 2 (1 with erosion, 1 without erosion) - Pericardiocentesis, device removed (for patient with erosion) -
Conduction block n = 2 (1 complete heart block, 1 II degree heart block) - - Oral steroids → resolved in 2 days Patient with II degree heart block had Down’s syndrome, IAS aneurysm, & multiple fenestrations closed by Cribriform device
Arrhythmias n = 2 - - Spontaneous resolution/resolution with catheter manipulation Transient
Rebleeding from access site n = 1 - - - -
Residual shunt 3mm - n = 1 - - -
[29] Mateusz T. Knop et al 2018 Poland Prospective Cohort Study Amplatzer Septal Occluder (n = 145)   Amplatzer Cribriform Septal Occluder (n = 2)   Cardi-O-Fix ASD Occluder (n = 2 n = 157 0-3 years 0.1-14.7 years 94.9% (49/157) - 20-30% larger than ASD diameter in centrally located defects an stable atrial septums ❌   residual/absent Sufficient   ≥5mm   excluding patients with residual/absent aortic rims accompanied by another floppy rim Arrhythmias n = 1 (major, SVT) - - Long-term anti arrhythmic therapy for 2 years -
n = 4 [minor; SVT (n = 2), extrasystole (n = 2)] - - SVT - adenosine bolus (n = 1); spontaneous resolution (n = 1) -
Conduction block n = 1 (AVB II) - - Steroids → resolved -
Respiratory tract infection - n = 5 - - -
Anemia - n = 1 - Transfusion -
Mitral valve insufficiency - - n = 2 - -
[30] S. Ackermann et al 2018 Switzerland Retrospective Cohort Study Amplatzer Septal Occluder (n = 312   Solysafe Septal Occluder (n = 45)   CeraFlex ASD Occluder (n = 11)   Gore Cardioform Septal Occluder (n = 13)   pfm NitOcclud ASD-R-Device (n = 18)   BioSTAR Device (n = 8)   HELEX Septal Occluder (n = 3) n = 397 3.8-10.6 years 1 year 96.47% (383/397) mean: 12.3-13.5mm mean: 13.6-15.1mm ❌   sufficient rims ≥5mm seen in n = 191 short/deficient rims seen in n = 160 Equipment failure n = 1 - - - -
Device embolization n = 3 n = 2 (within 24 hours) - Device removed Seen in Amplatzer Septal Occluder in patient with large defect >18mm
Arrhythmias n = 6 n = 4 (within 24 hours) - - -
Pericardial effusion - n = 2 (within 24 hours) - - -
Vascular access problems - n = 1 (within 24 hours) - - -
Impairment of neighboring cardiac structures - n = 3 (within 24 hours) - - -
Erosion - n = 2 (within 30 days) - - + fistula (n = 1)
Thrombus formation - n = 3 (within 30 days) - - -
Mild MR - n = 1 (within 30 days) - - -
Conduction block - n = 1 (within 30 days; transient AV block) - - -
Residual shunt n = 54 (16.5%; after 3 months) - (12% at one year) - Not hemodynamically significant
[31] Jacinta Ng et al 2019 Australia Case Report Not specified n = 1 18 years - - - - - - Corynebacterium diphtheria-infective endocarditis - - n = 1 (9 years) Antibiotics → symptoms resolved; warfarin for possible thrombus -