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Diverse experience with the CardioSEAL® and STARFlex® septal occluders

Published online by Cambridge University Press:  21 January 2005

Sotiria C. Apostolopoulou
Department of Paediatric Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece
Cleo V. Laskari
Department of Paediatric Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece
Maria Kiaffas
Department of Paediatric Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece
John Papagiannis
Department of Paediatric Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece
Spyridon Rammos
Department of Paediatric Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece


Apart from closure of atrial septal defects, there is little information concerning the use of the CardioSEAL family of occluders in congenitally malformed hearts. We review here our initial experience using the CardioSEAL and STARFlex occluders in 12 patients aged 17.3 ± 11.2 years, with a range from 4 to 34 years. Of the patients, 5 had fenestrated extracardiac Fontan procedures, 5 had persistent patency of the arterial duct, 1 had a leak across a Mustard baffle, and the final patient had a huge pulmonary arteriovenous malformation. We implanted successfully 9 CardioSEAL, and 3 STARFlex occluders, with sizes from 17 to 40 mm. In one patient, the occluder embolized to the right pulmonary artery, from where it was retrieved through the catheter. In two patients, there was a trivial residual leak immediately after implantation, but no patient had a residual leak after 6 months of follow-up. We noted improved ventricular dimensions, without any fractures of the arms of the occluders, perforations, or disturbances of flow after 2.4 ± 0.9 years of follow-up. We have demonstrated, therefore, the versatility of the CardioSEAL and STARFlex occluders, which have been used safely and effectively to close a variety of intra and extracardiac communications other than atrial septal defects.

Original Article
© 2004 Cambridge University Press

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King TD, Thompson SL, Steiner C, Mills NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976; 235: 25062509.Google Scholar
Rashkind WJ. Transcatheter treatment of congenital heart disease. Circulation 1983; 67: 711716.Google Scholar
Lloyd TR, Rao PS, Beekman III RH, Mendelsohn AM, Sideris EB. Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial). Am J Cardiol 1994; 73: 286291.Google Scholar
Chan KC, Godman MJ, Walsh K, Wilson N, Redington A, Gibbs JL. Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience. Heart 1999; 82: 300306.Google Scholar
Pedra CA, Pihkala J, Lee KJ, Boutin C, Nykanen DG, McLaughlin PR, Harrison DA, Freedom RM, Benson L. Transcatheter closure of atrial septal defects using the CardioSEAL implant. Heart 2000; 84: 320326.Google Scholar
Hausdorf G. STARFlex ASD closure: deployment, techniques, equipment. J Interv Cardiol 2001; 14: 6976.Google Scholar
Carminati M, Giusti S, Hausdorf G, Qureshi S, Tynan M, Witsenburg M, Hess J, Piechaud JF, Bonhoeffer P, Donti A, Ovaert C, Sievert H, Elzenga N, Talsma M, van Oort A, Ernst J, Gewillig M, De Geeter B. A European multicentric experience using the CardioSEAL and STARFlex double umbrella devices to close interatrial communications holes within the oval fossa. Cardiology in the Young 2000; 10: 519526.Google Scholar
Gamillscheg A, Beitzke A, Stein JI, Rupitz M, Zobel G, Rigler B. Transcatheter coil occlusion of residual interatrial communications after Fontan procedure. Heart 1998; 80: 4953.Google Scholar
Goff DA, Blume ED, Gauvreau K, Mayer JE, Lock JE, Jenkins KJ. Clinical outcome of fenestrated Fontan patients after closure: the first 10 years. Circulation 2000; 102: 20942099.Google Scholar
Patel HT, Cao QL, Rhodes J, Hijazi ZM. Long-term outcome of transcatheter coil closure of small to large patent ductus arteriosus. Catheter Cardiovasc Interv 1999; 47: 457461.Google Scholar
Bilkis AA, Alwi M, Hasri S, Haifa AL, Geetha K, Rehman MA, Hasanah I. The Amplatzer duct occluder: experience in 209 patients. J Am Coll Cardiol 2001; 37: 258261.Google Scholar
Moore JW, Murdison KA, Baffa GM, Kashow K, Murphy JD. Transcatheter closure of fenestrations and excluded hepatic veins after fontan: versatility of the Amplatzer device. Am Heart J 2000; 140: 534540.Google Scholar
Apostolopoulou SC, Papagiannis J, Hausdorf G, Rammos S. Transcatheter occlusion of atrial baffle leak after mustard repair. Catheter Cardiovasc Interv 2000; 51: 305307.Google Scholar
Apostolopoulou SC, Kelekis NL, Papagiannis J, Hausdorf G, Rammos S. Transcatheter occlusion of a large pulmonary arteriovenous malformation with use of a CardioSEAL device. J Vasc Interv Radiol 2001; 12: 767769.Google Scholar
Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA Occluder System. Circulation 1987; 75: 583592.Google Scholar
Hausdorf G, Kaulitz R, Paul T, Carminati M, Lock J. Transcatheter closure of atrial septal defect with a new flexible, self-centering device (the STARFlex occluder). Am J Cardiol 1999; 84: 11131116, A10.Google Scholar
Krichenko A, Benson LN, Burrows P, Moes CA, McLaughlin P, Freedom RM. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989; 63: 877880.Google Scholar
Hofbeck M, Bartolomaeus G, Buheitel G, Esser R, Gravinghoff L, Hoffmann W, Kienast W, Michel-Behnke I, Scharabrine EG, Schranz D, Schmaltz AA, Shakhov BE, Singer H, Lindinger A. Safety and efficacy of interventional occlusion of patent ductus arteriosus with detachable coils: a multicentre experience. Eur J Pediatr 2000; 159: 331337.Google Scholar
Cowley CG, Badran S, Gaffney D, Rocchini AP, Lloyd TR. Transcatheter closure of fontan fenestrations using the Amplatzer septal occluder: initial experience and follow-up. Catheter Cardiovasc Interv 2000; 51: 301304.Google Scholar
Sommer RJ, Recto M, Golinko RJ, Griepp RB. Transcatheter coil occlusion of surgical fenestration after Fontan operation. Circulation 1996; 94: 249252.Google Scholar
Zahn EM, Chang AC, Burke RP, Jacobs JP. Transcatheter closure of an extracardiac Fontan fenestration. Ann Thorac Surg 1998; 66: 260262.Google Scholar
Rueda F, Squitieri C, Ballerini L. Closure of the fenestration in the extracardiac Fontan with the Amplatzer duct occluder device. Catheter Cardiovasc Interv 2001; 54: 8892.Google Scholar