Devices for percutaneous closure of a secundum atrial septal defect
- Martin G St. John Sutton, MBBS, FRCP, FACC, FASE
Martin G St. John Sutton, MBBS, FRCP, FACC, FASE
- John Bryfogle Professor of Medicine
- University of Pennsylvania School of Medicine
- Section Editors
- Thomas P Graham, Jr, MD
Thomas P Graham, Jr, MD
- Section Editor — Congenital Heart Disease
- Emeritus Professor of Pediatric Cardiology
- Vanderbilt University School of Medicine
- John K Triedman, MD
John K Triedman, MD
- Section Editor — Pediatric Cardiology
- Professor of Pediatrics
- Harvard Medical School
- Heidi M Connolly, MD
Heidi M Connolly, MD
- Section Editor — Congenital Heart Disease
- Professor of Medicine
- Mayo Medical School
Atrial septal defect (ASD) is the most common congenital lesion in adults after bicuspid aortic valve, while a patent foramen ovale (PFO) can be detected in approximately 30 percent of normal adult hearts.
Percutaneous device closure is an effective, safe, and commonly employed alternative to surgical closure in patients with ostium secundum ASDs and PFOs that have appropriate indications and ideal anatomic characteristics. The limited data comparing surgical and percutaneous closure of a secundum ASD suggest that the rates of procedural success may be comparable or possibly better with surgery, but that the rate of complications and length of hospital stay may be reduced with the percutaneous approach.
This topic will review the characteristics of the Amplatzer, Gore HELEX, and CardioSEAL devices. Atrial septal defect closure is indicated largely to treat hemodynamic effects. PFO closure is indicated for platypnea-orthodeoxia syndrome; its efficacy for stroke prevention is not established. Indications for and efficacy of percutaneous repair of ASDs and PFOs and associated complications are presented separately. (See "Indications for closure and medical management of atrial septal defects in adults" and "Management and outcome of isolated atrial septal defects in children" and "Patent foramen ovale" and "Treatment of atrial septal abnormalities (PFO, ASD, and ASA) for prevention of stroke in adults".)
The United States Food and Drug Administration's (FDA) Center for Devices and Radiological Health approved the Amplatzer Septal Occluder (figure 1) for percutaneous secundum atrial septal defect (ASD) closure in December 2001 . The Gore HELEX Septal Occluder was approved for percutaneous closure of secundum ASDs in August 2006. Another device, the NMT Medical CardioSEAL Septal Occlusion System, was used off-label for ASD and patent foramen ovale (PFO) closure but is FDA-approved for use only for closure of certain complex ventricular septal defects.
The humanitarian device exemptions for two patent foramen occluder devices, the NMT Medical CardioSEAL STARFlex Septal Occlusion system and the AGA Medical AMPLATZER PFO occluder, were withdrawn in October 2006. These devices were subsequently available in the United States for investigational use only. NMT Medical, Inc ceased operations in 2011.
- Schwetz BA. From the Food and Drug Administration. JAMA 2002; 287:578.
- Thanopoulos BD, Laskari CV, Tsaousis GS, et al. Closure of atrial septal defects with the Amplatzer occlusion device: preliminary results. J Am Coll Cardiol 1998; 31:1110.
- Chan KC, Godman MJ, Walsh K, et al. 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; 82:300.
- Fischer G, Kramer HH, Stieh J, et al. Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder. Eur Heart J 1999; 20:541.
- 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.
- Jones TK, Latson LA, Zahn E, et al. Results of the U.S. multicenter pivotal study of the HELEX septal occluder for percutaneous closure of secundum atrial septal defects. J Am Coll Cardiol 2007; 49:2215.
- Pedra CA, Pihkala J, Lee KJ, et al. Transcatheter closure of atrial septal defects using the Cardio-Seal implant. Heart 2000; 84:320.
- Carminati M, Chessa M, Butera G, et al. Transcatheter closure of atrial septal defects with the STARFlex device: early results and follow-up. J Interv Cardiol 2001; 14:319.
- Jux C, Bertram H, Wohlsein P, et al. Interventional atrial septal defect closure using a totally bioresorbable occluder matrix: development and preclinical evaluation of the BioSTAR device. J Am Coll Cardiol 2006; 48:161.
- Mullen MJ, Hildick-Smith D, De Giovanni JV, et al. BioSTAR Evaluation STudy (BEST): a prospective, multicenter, phase I clinical trial to evaluate the feasibility, efficacy, and safety of the BioSTAR bioabsorbable septal repair implant for the closure of atrial-level shunts. Circulation 2006; 114:1962.
- Wilson W, Taubert KA, Gewitz M, et al. Prevention of Infective Endocarditis. Guidelines From the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007; 115 published online April 19, 2007. www.circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.183095v1 (Accessed on May 04, 2007).