A Novel Puncturable Atrial Septal Defect Occluder

Figures

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  Figure 1. The Schematic Diagrams and Actual Pictures of the ReAces Device (A) A schematic diagram top view of the device. (B) A schematic diagram section view of the device, including the (1) left disc, (2) right disc, (3) waist, (4) central hole, (5) polyethylene terephthalate membrane, (6) nickel-titanium connecting wire, and (7) interconnecting piece. (C) Left atrial side view of the actual device. (D) Right atrial side view of the actual device.

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  Figure 2. Fluoroscopy-Guided Atrial Septal Defect Creation and Subsequent Closure With the ReAces Device in Animal (A) The trailing end of a 0.014-inch percutaneous transluminal coronary angioplasty wire was successfully inserted through the atrial septum and accessed the left atrium under the support of an atrial septal puncture sheath. (B) A balloon was used for atrial septal dilation under the support of a 0.035-inch super-stiff guidewire. (C) The left disc was deployed and the delivery sheath was withdrawn until the left disc apposed the atrial septum. (D) The right disc was deployed. (E, F) The delivery system was separated from the occluder and the device deployed.

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  Figure 3. Evaluation of the Atrial Septal Repuncture by Epicardial Echocardiography (A) The central hole of occluder was thin on 60 days after ReAces implantation, and no atrial septal shunt was found. (B) Two-dimensional echocardiography showed that the 14F sheath was successfully inserted into the left atrium through central hole after the repuncture of atrial septum at central hole. (C) Three-dimensional echocardiography showed that the sheath successfully accessed the left atrium through central hole. (D) A shunt was seen after the atrial septum repuncture.

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  Figure 4. Gross Observations of the Occluder After Implantation (A) Occluder disc in the right atrium. (B) Occluder disc in the left atrium. Complete endothelialization on the left and right discs of the occluder was found, and the central hole could be clearly visualized. (C) A paraffin-embedded occluder sample explanted on 45 days after the implantation. The center of the occluder is very thin and transparent. (D) Complete endothelialization on the occluder surface was still found, and the residual defect on the central hole at the site of repuncture by 14-F sheath could be clearly seen.

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  Figure 5. TTE and CT Angiography Images of the Occluder After Implantation (A to C) The transthoracic echocardiography (TTE) and computed tomography (CT) images of a patient at 90 days after implantation of puncturable occluder. (A) The apical 4-chamber view by TTE. (B) Aortic short-axis view by TTE. (C) CT angiography image. All the images showed that the occluder had excellent morphology and fit the atrial septum well. The area of the central hole was substantially thinner than surrounding framework area (arrow). (D) CT image at 6 months after the implantation of a conventional occluder; as compared with the puncturable occluder, the atrial septum was substantially thicker for the conventional occluder (distance between the 2 arrows).