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Page 8 of 18 Zimmermann et al. Vessel Plus 2019;3:31 I http://dx.doi.org/10.20517/2574-1209.2019.010

Table 1. Recent publications describing ASD device outcomes
Device name Manufacturer Approval Recent/ongoing studies n Significant findings
Cocoon Vascular CE Mark Lairakdomrong et al. [70] , 2013 - 63 100% closure at 12 mo, 3 early embolization
Concepts retrospective requiring surgical
Pakkret, Thanopoulos et al. [71] , 2014 - 92 100% closure at 6 mo, no adverse events
Thailand prospective observational
Ultrasept II Cardia CE Mark Mijangos-Vázquez et al. [72] , 2018 - 30 100% closure at 6 mo, no adverse events
retrospective
Eagan, MN, USA Bartel et al. [73] , 2010 - case series 2 2 reports of fabric erosion requiring surgical
removal
Aubry et al. [74] , 2014 - case series 9 2 out of 9 experienced fabric erosion requiring
surgical removal
Bozyel and Özcan [75] - 2017, 9 3 out of 9 patients with device required
retrospective surgical removal
Chamié et al. [76] , 2016 - case series 4 4 out of 70 developed early fabric erosion,
treated with device in device
Nit Occlude PFM Medical CE Mark Peirone et al. [77] , 2014 - prospective 73 98.6% closure at 11 mo, no adverse events
ASD-R Mepro observational
Köln, Germany Bulut et al. [78] , 2016 - prospective 30 98% closure at 10 mo, 1 erosion requiring
observational surgical removal
Ceraflex ASD CE Mark Astarcioglu et al. [79] , 2015 - prospective 58 100% closure at 6 mo, no adverse events
non-randomized
Apostolopoulou et al. [80] , 2018 - 183 100% closure at 22 mo, no adverse events
retrospective
Figulla Flex II Occlutech CE Mark Kenny et al. [81] , 2018 - prospective 107 94.4% closure at 6 mo, 1 device embolization
randomized
Jena, Germany Haas et al. [82] , 2016 - retrospective 1315 97.3% closure at 12 mo, 5 device
embolization, 3 AV block
Godart et al. [83] , 2014 - retrospective 31 90.3% closure at 36 mo, 1 device
embolization, 1 AV block
Roymanee et al. [84] , 2015 - 77 97.4% closure at 43 year, 2 device
retrospective embolization, non-inferiority to ASO
Aytemir et al. [62] , 2013 - retrospective 58 99.3% closure at 12 mo, 2 device
embolization, 4 embolic events, 2 device
thrombosis
Kim et al. [85] , 2019 - retrospective 152 100% closure at 25 mo
Cardioform WL Gore CE Mark GORE Assured Study, ongoing [86] 522 Clinical Trial NCT02985684, enrollment
complete, final results by 2022
Flagstaff, AZ, FDA PMA Hemptinne et al. [87] , 2017 - 26 100% closure at 6 mo, 5 wire frame fractures
USA retrospective
Kim et al. [85] , 2019 - retrospective 17 100% closure at 23 mo
Grohmann [88] - 2016, retrospective 173 95.4% closure at 20 mo, 4 device
embolization, 3 AV Block
Amplatzer St. Jude Medical CE Mark Turner et al. [89] , 2017 - prospective 1000 97.9% closure at 24 mo, 1 embolization, 3
cardiac erosion
St. Paul, MN, FDA Spies et al. [90] , 2007 - retrospective 170 100% closure at 12 mo, 4 embolization, 1 TIA,
USA
Tomar et al. [91] , 2011 - retrospective 529 100% closure at 56 mo, 96.7% symptom
free, 1 stroke
Kim et al. [85] , 2019 - retrospective 98 100% closure at 29 mo, 1 embolization
Post Market Surveilence (ASO 522) [92] 602 Clinical Trial NCT02353351, study terminated,
results not published yet

[93]
defects with a maximum defect diameter less than 38 mm . An example of balloon sizing as assessed
intraoperatively with balloon sizing as compared to real time TEE sizing can be seen in Figure 5. ASDs
typically give the appearance of with ellipsoidal geometry that varies throughout the cardiac cycle [94,95] .
Selection of optimal device size, particularly in patients undergoing the procedure without balloon sizing
or multiple defects, involves measuring the major axis diameter of the defect during of ventricular end
systole. More recently, real time 3D TEE is challenging the need for balloon sizing with stop-flow technique
as an adjunct to prevent underestimation of defect size or tissue rims [96,97] .