A Membrane Modification Technique for Left Atrial Appendage Occlusion

Figures

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  Figure 1. Photographs of the Test Device and the Control Device Images of the left atrial appendage occlusion devices outside of the body (A, B), on transesophageal echocardiography (TEE) (C, D), and on digital subtraction angiography (E, F), respectively. The red arrows point to the device on the TEE and digital subtraction angiography images. CAU = caudal; PET = polyethylene terephthalate; RAO = right anterior oblique.

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  Figure 2. Study Flowchart Between April 2019 and November 2019, a total of 236 patients (with 118 patients assigned to each group) with nonvalvular atrial fibrillation were enrolled. The full analysis set (FAS) included all randomized patients except those who withdrew their consent. PPS = per-protocol set; TEE = transesophageal echocardiography.

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  Figure 3. Subgroup Analysis of the Effectiveness Endpoints Successful left atrial appendage (LAA) sealing rate (A) and clinical success rate (B). Small devices included the test device models 1818, 1824, 2121, and 2424 (for every model, the first 2 digits and the last 2 digits represent the diameter [in millimeters] of the anchor and cover-disc, respectively), and the control devices with diameters (in millimeters) of 21 and 24, respectively. Medium devices included the test device models 2127 and 2727, and the control device with a diameter (in millimeters) of 27. Large devices included the test device models 1830, 2133, 2430, 2436, 2733, 2740, and 3030, and control devices with diameters (in millimeters) of 30 and 33, respectively. AF = atrial fibrillation.

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  Figure 4. Photographs of DRT Detected by TEE Six cases of device-related thrombus (DRT) were identified at the 3-month (A to F) and 5 cases at the 12-month (G to K) transesophageal echocardiography (TEE) examinations in the control group. No cases of DRT were found in the test group. LAAO = left atrial appendage occlusion.

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  Figure 5. Comparisons of the Rate of DRT Between the 2 Groups The incidence of DRT in the control group at the 3-month and 12-month visits detected by TEE was 5.7% (6/105) and 4.6% (5/108), respectively. No cases of DRT occurred in the test group. The incidence of DRT was not related to hypertension, diabetes mellitus, peripheral vascular disease, bleeding, or violation of anticoagulant/antithrombotic therapy. Error bars are 95% CIs. PVD = peripheral vascular disease; other abbreviations as in Figures 3 and 4.

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  Central Illustration. A Randomized Controlled Trial of the Membrane-Modified Left Atrial Appendage Occluder The intervention, methods, and final outcomes of the trial are summarized. The bottom figure shows that the incidence of device-related thrombus in the control group at the 3- and 12-month visits was 5.7% (6 of 105) and 4.6% (5 of 108), respectively. No cases of device-related thrombus occurred in the test group. LAAC = left atrial appendage closure; TEE = transesophageal echocardiography. Error bars are 95% CIs.