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, MDf,
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
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Figure 1 Cartoon depicting the occluder component of the second, third and fourth generation buttoned device. The occluder (Occ) in all devices is composed of an x-shaped wire skeleton covered with 1/16-inch polyurethane foam. In the second generation device (left) a 2 mm string loop is attached to the center of the occluder. The loop is closed with a knot (button) made radiopaque. This radiopaque button (ROB) can easily be visualized by fluoroscopy. In the first generation device (not shown), the button was not radiopaque. A folded 0.008-inch nylon thread (NT) passes through the hollow loading wire (LW) after passing through the loop in the center of the occluder. In the third generation device (middle) an extra loop is added immediately beneath the radiopaque button. This modification converted the eccentric button of the second generation device to be aligned straight, thus making it easier to button the Occ and counter-occluder across the atrial septum. In the fourth generation device (right), the button loop is replaced with two "spring" radiopaque buttons (RB), mounted 4 mm apart. The intent was to reduce unbuttoning seen with earlier generation devices.
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Figure 2 Selected video frames from transesophageal echocardiographic studies performed during an over-the-wire implantation of a fourth generation buttoned device. a) Atrial septal defect (ASD) is shown (arrow). b) and c) The occluder (Occ) component of the device at various positions in the left atrium (LA) and the Amplatz wire (AW) passing through the ASD and Occ is seen. d) The Occ on the left atrial side with a tiny residual shunt (TRS) is shown (arrow).
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Figure 3 Selected frames from a cineradiogram obtained during an over-the-wire implantation of a fourth generation buttoned device across the atrial septum. a) and b) Postero-anterior views showing an Amplatz guide wire (AW) positioned into a left pulmonary vein. The occluder is delivered into the left atrium (a) with tip of the sheath (Sh) in the right atrium. Radiopaque buttons (B) and loading wire (LW) are seen within the sheath. b) The counter-occluder (COc) is delivered into the right atrium and buttoned. Note that the radiopaque wire of the COc is past the radiopaque buttons.
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Figure 4 Flow chart of patients taken to cardiac catheterization laboratory with intent to occlude ASD.
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Figure 5 Graph showing actuarial event-free rates after tranvenous fourth generation buttoned device occlusion of atrial septal defects. The 95th confidence intervals were cath: 0.6%; one day: 1.2%; one month: 1.6%; six months: 2.0%; one year: 2.7%; two years: 3.9%; three years: 5.9%; four years: 8.2% and five years: 20%.
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Figure 6 Time course of residual atrial shunts following buttoned device (fourth generation) occlusion of atrial septal defects. Percent of patients with residual shunts (NRS/NE) = 100, where NRS is the number of subjects with residual shunt and NE is the number of subjects examined at a particular follow-up interval. The NRS/NE at varying intervals are as follows: one day: 115/417; one month: 113/333; six months: 100/310; one year: 82/280; two years: 43/177; three years: 11/88; four years: 5/48 and five years: 0/8. Note gradual decrease in percent of patients with residual shunt.
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Figure 7 Bar graphs comparing the total complication and unbuttoning and effective occlusion rates with each cohort. Note significant decrease (p < 0.00) in major complication rate with the fourth generation device, which appears to be largely related to a decrease (p < 0.001) in unbuttoning rate. Effective occlusion, defined as no or trivial residual shunt (4), has remained similar (p > 0.1).
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Figure 8 Graph comparing event-free rates after successful device implantation. This was done so as to assess difference, if any, following first, second and third generation versus fourth generation buttoned device occlusion of secundum atrial septal defects. The fourth generation (Gen) data are depicted by filled squares and the first, second and third generation by unfilled squares. The number of subjects available for follow-up at each specified follow-up interval are shown at the bottom of the graph, appropriately keyed. Note that there is no difference (p > 0.1) by log-rank test between the two cohorts.
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