Major complications associated with transcatheter atrial septal occluder implantation: A review of the medical literature and the manufacturer and user facility device experience (MAUDE) database

Congenital Heart Disease

Volumn 2, Issue 4, 2007, Pages 256-264

  Delaney, Jeffrey W ^a   Li, Jennifer S ^a   Rhodes, John F ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

ASD; Atrial Septal Defect; Catheterization; Complication; Device; PFO

Indexed keywords

ARTIFICIAL EMBOLISM; ATRIOVENTRICULAR BLOCK; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; CONFERENCE PAPER; DATA BASE; DEATH; DEVICE; ENDOCARDITIS; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART ATRIUM SEPTUM DEFECT; HEART SURGERY; HEART TAMPONADE; HEMOPERICARDIUM; HUMAN; IMPLANT; INCIDENCE; MEDLINE; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; PERICARDIAL EFFUSION; PRIORITY JOURNAL; SAFETY; SURGICAL TECHNIQUE; THROMBOEMBOLISM; THROMBUS; TRANSIENT ISCHEMIC ATTACK; UNITED STATES;

DATABASES, FACTUAL; EMBOLISM; EQUIPMENT FAILURE; HEALTH CARE SECTOR; HEART CATHETERIZATION; HEART SEPTAL DEFECTS, ATRIAL; HUMANS; MEDLINE; PROSTHESES AND IMPLANTS; THROMBOSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34547469060     PISSN: 1747079X     EISSN: 17470803     Source Type: Journal    
DOI: 10.1111/j.1747-0803.2007.00107.x     Document Type: Conference Paper

References (22)

1. King TD, Mills NL. Nonoperative closure of atrial septal defects. Surgery. 1974; 75: 383-388.
2. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K, Amplatzer investigators. 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.
3. O'Shea JC, Kramer JM, Califf RM, Peterson ED. Sharing a commitment to imIrove cardiovascular devices: Part I: identifying holes in the safety net. Am Heart J. 2004; 147: 977-984.
4. Chessa M, Carminati M, Butera G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol. 2002; 39: 1061-1065.
5. Levi DS, Moore JW. Embolization and retrieval of the amplatzer septal occluder. Catheter Cardiovasc Interv. 2004; 61: 543-547.
6. Wang JK, Tsai SK, Wu MH, Lin MT, Lue HC. Short- and intermediate-term results of transcatheter closure of atrial septal defect with the amplatzer septal occluder. Am Heart J. 2004; 148: 511-517.
7. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of amplatzer septal occluder device after closure of secundum atrial septal defects: Review of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv. 2004; 63: 496-502.
8. Carminati M, Giusti S, Hausdorf G, et al. A European multicentric experience using the CardioSEAL and STARFlex double umbrella devices to close interatrial communications holes within the oval fossa. Cardiol Young. 2000; 10: 492-499.
9. Kaulitz R, Peuster M, Jux C, Paul T, Hausdorf G. Transcatheter closure of various types of defects within the oval fossa using the double umbrella device (CardioSEAL)-feasibility and echocardiographic follow-up. Cardiol Young. 2001; 11: 214-222.
10. 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 1000 consecutive patients. J Am Coll Cardiol. 2004; 43: 302-309.
11. Anzai H, Child J, Natterson B, et al. Incidence of thrombus formation on the CardioSEAL and the amplatzer interatrial closure devices. Am J Cardiol. 2004; 93: 426-431.
12. Butera G, Carminati M, Chessa M, et al. CardioSEAL/STARflex versus amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defects. Am Heart J. 2004; 148: 507-510.
13. Pinto FF, Sousa L, Fragata J. Late cardiac tamponade after transcatheter closure of atrial septal defect with CardioSEAL device. Cardiol Young. 2001; 11: 233-235.
14. Hong TE, Thaler D, Brorson J, Heitschmidt M, Hijazi ZM. Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder. Initial and intermediate-term results of the U.S. multicenter clinical trial. Catheter Cardiovasc Interv. 2003; 60: 524-528.
15. Harper RW, Mottram PM, McGraw DJ. Closure of secundum atrial septal defects with the amplatzer septal occluder device: Techniques and problems. Catheter Cardiovasc Interv. 2002; 57: 508-524.
16. Meier B, Lock JE. Contemporary management of patent foramen ovale. Circulation. 2003; 107: 5-9.
17. Preventza O, Sampath-Kumar S, Wasnick J, Gold JP. Late cardiac perforation following transcatheter atrial septal defect closure. Ann Thorac Surg. 2004; 77: 1435-1437.
18. Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J. Cardiac perforation after device closure of atrial septal defects with the amplatzer septal occluder. J Am Coll Cardiol. 2005; 45: 1213-1218.
19. Pinto F, Sousa L, Fragata J. Late cardiac tamponade after transcatheter closure of atrial septal defect with CardioSEAL ® device. Cardiol Young. 2001; 11: 233-235.
20. Grayburn P, Schwartz B, Anwar A, Hebeler R. Migration of an amplatzer septal occluder device for closure of atrial septal defect into the ascending aorta with formation of an aorta-to-right atrial fistula. Am J Cardiol. 2005; 96: 1607-1609.
21. Raghu A, Kawalsky D, Feldman M. Embolic stroke due to a left atrial thrombus two years after placement of an atrial septal defect closure device. Am J Cardiol. 2006; 98: 1294-1296.
22. Peterson ED, Hirshfeld JW, Ferguson TB, Kramer JM, Califf RM, Kessler LG. Sharing a commitment to improve cardiovascular devices: Part II: sealing holes in the safety. Net Am Heart J. 2004; 147: 985-990.