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CLINICAL STUDIES

Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devices

P. Syamasundar Rao, MD, FACC^*, Felix Berger, MD, Christian Rey, MD, Jorge Haddad, MD^||, Bernhard Meier, MDFACC, Kevin P. Walsh, MD^f, Jay S. Chandar, MD, FACC^#, Thomas R. Lloyd, MD, FACC^**, Jose Suarez de Lezo, MD, Rolando Zamora, MD, Eleftherios B. Sideris, MD^|| for the International Buttoned Device Trial Group

^* Saint Louis University School of Medicine, St. Louis, Missouri, USA
German Heart Institute, Berlin, Germany
Université de Lille, Lille, France
^|| Hospital do Coracão de Ribeirão, Ribeiräo Preto, Brazil
University Hospital, Bern, Switzerland
^f Alder Hey Children’s Hospital, Liverpool, United Kingdom
^# University of Miami/Jackson Memorial Hospital, Miami, Florida, USA
^** University of Michigan/C.S. Mott Children’s Hospital, Ann Arbor, Michigan, USA
Hospital Reina Sofia, Cordoba, Spain
University of Arizona Health Sciences Center, Tucson, Arizona, USA
^|| Athenian Institute of Pediatric Cardiology, Athens, Greece

Manuscript received July 30, 1999; revised manuscript received February 16, 2000, accepted March 28, 2000.

Reprint requests and correspondence: Dr. P. Syamasundar Rao, Professor of Pediatrics, Division of Pediatric Cardiology, Saint Louis University School of Medicine, 1465 South Grand Boulevard, Saint Louis, Missouri 63104-1095
raops{at}slu.edu

OBJECTIVES

The purpose of this study was to assess safety and effectiveness of the fourth generation buttoned device in closing atrial septal defects (ASDs) and to test the hypothesis that introduction of double button reduces unbuttoning rate without reducing effectiveness.

BACKGROUND

Because of the high unbuttoning rate (7.2%) with first, second and third generation buttoned devices, the device was modified (fourth generation) so that there were two radiopaque spring buttons 4 mm apart on the button loop attached to the occluder.

METHODS

During a four-year period ending in September 1997, 423 patients, ages 1.5 to 80 years (median 16 years), underwent closure of ASD at 40 medical centers around the world.

RESULTS

The ASD size varied between 5 and 30 mm (median 17 mm). The device size varied between 25 and 60 mm. Unbuttoning occurred in 4 (0.9%) of 423 patients. Effective occlusion, defined as no (n = 343) or trivial (n = 34) residual shunt on echo-Doppler studies performed within 24 h of the procedure, was demonstrated in 377 patients (90%). Thus, the unbuttoning rate (0.9 vs. 7.2%) decreased (p < 0.01) while effective occlusion rate (90 vs. 92%) remained unchanged (p > 0.1) with this device, compared with earlier generation devices. During follow-up from one month to five years (23 ± 15 months), 21 (5%) of 417 patients required surgical (n = 12) or transcatheter (n = 9) reintervention, mostly to treat significant residual shunt. In the remaining patients there was gradual reduction and disappearance of the residual shunt. No wire integrity problems were observed.

CONCLUSIONS

These data suggest that the fourth generation buttoned device is as effective as earlier generation devices, but without significant unbuttoning. Follow-up results remained good, with a reintervention-free rate of 89% at five years.

Abbreviations and Acronyms   ASD = atrial septal defect   ASDOS = atrial septal defect occluding system   BD = buttoned device   ECHO = echocardiogram   FDA = Food and Drug Administration   PFO = patent foramen ovale   Qp:Qs = pulmonary to systemic flow ratio

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