CardioSEAL/STARflex versus Amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defects.
BACKGROUND
The Amplatzer septal occluder (ASO) allows the percutaneous closure of small to very large atrial septal defects (ASDs). The CardioSEAL/STARflex (CS/SF) can be used only for closure of small to moderate ASDs (stretch size up to 18 mm). These 2 devices are widely used in clinical practice. Therefore, a comparison of their use in the closure of small to moderate ASDs is needed.


METHODS
From December 1996 to September 2002, 274 consecutive patients (mean age 20.3 +/- 17 years) underwent percutaneous closure of small to moderate ostium secundum ASDs. The CS/SF device was used in 121 patients, and the ASO was used in 153.


RESULTS
There were no differences in age, sex ratio, or pulmonary/systemic flow ratio. Stretch size of the defect was higher in the ASO group (13.6 +/- 3.5 mm vs 15.5 +/- 3.2 mm, P <.001). Procedure time and fluoroscopy time were shorter in patients treated with the ASO (61 +/- 21 vs 75 +/- 32 min, P <.0003, and 11.6 +/- 9 vs 23.8 +/- 17.4 min, P <.0001, respectively). Residual shunt at procedure and discharge was significantly more frequent in the CS/SF group (P <.0001). There were no differences in the complication rate for the 2 groups (CS/SF 4/121 vs ASO 6/153). Length of follow-up was longer in the CS/SF group (24 +/- 14 vs 16 +/- 9 months, P =.0001). Residual shunting was significantly more frequent in the CS/SF group during follow-up, while closure rate reached 100% after 1 month in ASO group.


CONCLUSIONS
The 2 devices are clinically safe and effective in ASD closure. However, percutaneous closure of small to moderate ASDs with ASO is quicker and provides an higher rate of complete occlusion.
Butera
Gianfranco
G
Department of Pediatric Cardiology, Istituto Policlinico San Donato, San Donato Milanese, Italy. gianfra.but@lycos.com
Carminati
Mario
M
Chessa
Massimo
M
Delogu
Angelica
A
Drago
Manuela
M
Piazza
Luciane
L
Giamberti
Alessandro
A
Frigiola
Alessandro
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D019736:Prostheses and Implants; D011474:Prosthesis Design; D016896:Treatment Outcome