PMC10097917_01
Intraprocedural rotational intracardiac Echo by Ultra ICE (mechanical 9F/9 MHz 360  scan probe, Ultra ICE , EP technologies, BSC, CA, United States) in the parasagittal long axis ("four chamber") plane showing septum primum aneurysm, NobleStitch EL sealing system (radiopaque polypropylene knot, yellow arrow), laceration of the septum primum next to the knot (red arrowhead) (A,B) and the guidewire (orange arrow) crossing the septal fenestration (red asterisk) (C). S1, septum primum; S2, septum secundum; RA, right atrium; LA, left atrium; RSVP, right superior pulmonary vein; Tr, tricuspid valve.
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F1
Afterward, contrast transthoracic and transesophageal echocardiography (cTTE/TEE) and contrast Transcranial Doppler (cTCD) were performed at the Cardiology Department of this institution confirming "spontaneous severe right-to-left shunt (RLS) via a PFO 17.5 mm in length, >5 mm in width associated with abnormally redundant fenestrated septum primum aneurysm (ASA) protruding predominantly to the right atrium in basal conditions and to the left atrium during the cardiorespiratory cycle" (Supplementary Figure S1). The tearing of the aneurysmatic septum primum, next to the KwiKnot and probably induced by the stretching of the NobleStitch  device, and the septal defect were clearly visible by rotational intracardiac echo (Figures 1A-C).
Intraprocedural rotational intracardiac Echo by Ultra ICE (mechanical 9F/9 MHz 360  scan probe, Ultra ICE , EP technologies, BSC, CA, United States) in the parasagittal long axis ("four chamber") plane showing procedural steps (A-C) of implantation of Flex II UNI occluder (Occlutech GmbH, Jena, Germany) with equally sized discs (28.5 mm x 28.5 mm) (orange asterisk); (D) after agitated saline solution injection from the femoral vein, no residual shunt immediately after device release. RA, right atrium; LA, left atrium; DS, delivery sheath across the septal fenestration.
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F2
II UNI occluder (Occlutech GmbH, Jena, Germany) with equally sized discs (28.5 mm x 28.5 mm) was successfully implanted under intracardiac echo (Figures 2A-C) and fluoroscopic guidance (Figures 3A-F) across the septal defect, "sandwiching" the KwiKnot between the two discs and covering the septum primum laceration next to the knot. Intraprocedural agitated saline injection from the femoral vein confirmed abolition of the interatrial residual shunt (Figure 2D).
Fluoroscopic steps of implantation of Flex II UNI occluder (Occlutech GmbH, Jena, Germany) with equally sized discs (28.5 mm x 28.5 mm) under rotational intracardiac echo by Ultra ICE (black asterisk). (A-C) left and right disc opening; (D,E) pull and push maneuver to test device stability; (F) device deployed. Red arrow, radiopaque polypropylene knot.
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F3
II UNI occluder (Occlutech GmbH, Jena, Germany) with equally sized discs (28.5 mm x 28.5 mm) was successfully implanted under intracardiac echo (Figures 2A-C) and fluoroscopic guidance (Figures 3A-F) across the septal defect, "sandwiching" the KwiKnot between the two discs and covering the septum primum laceration next to the knot. Intraprocedural agitated saline injection from the femoral vein confirmed abolition of the interatrial residual shunt (Figure 2D).
Two-dimensional TTE color Doppler in apical four-chambers (A) and parasternal short-axis (B) views showing a correct and stable position of the equally sized discs nitinol device (red asterisk) without residual shunt. cTCD confirming abolition of the interatrial shunt both in basal conditions (C) and after adequate Valsalva maneuver (D). TTE, transthoracic echocardiography; cTCD, contrast transcranial Doppler.
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F4
cTTE and cTCD at 1- and 6-month follow-up confirmed the stable position of the nitinol double-disc device without residual shunt (Figure 4).