Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up

Figures

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  FIGURE 1. Preprocedural computerized tomography angiography assessment of transcatheter tri-cuspid valve replacement. (A) The diameter and perimeter of the tricuspid annulus (TA) were determined. (B) Measurements of the distance from the septal valve to the apex of the right ventricle, the height of the right atrium, and its relationship with the TA; the angle between the TA and the ventricular septum was 90° ± 10°. (C–E) Computer simulation of the LuX-Valve implant to observe the location of the anchor points and to measure the thickness of the ventricular septum in this position (30 mm below the TA). (F) Materialize Mimics 21.0 software (Materialize, Leuven, Belgium) was used to analyze the position and the angle of the delivery system on a 2-dimensional image. (G) The position of the right intercostal incision was determined with a digital 3-dimensional image. (H) The shape and the release position of the LuX-Valve were observed using 3-dimensional virtual models. (I) Simulation using fluoroscopic images provided an ideal projection angle for the transcatheter tricuspid valve replacement.

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  FIGURE 2. The LuX-Valve (Ningbo Jenscare Biotechnology, Ningbo, China) is self-expandable. The stent is made of a nickel–titanium alloy and the biological leaflet is bovine pericardium. The bio-prosthesis is implanted via the right atrial approach and fixed in the tricuspid annulus with its own unique anchoring device, independent of the radial support force. The part of the prosthesis located in the right atrium also prevents paravalvular leakage. (A) Right atrial view of the LuX-Valve. The four parts of the LuX-Valve stent include (a) the interventricular anchor, (b) two graspers, (c) the annulus skirt, and (d) the right atrial disc. (B) Lateral view of the LuX-Valve. (C) The delivery system of the LuX-Valve.

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  FIGURE 3. Guidance using transesophageal echocardiography (TEE) and fluoroscopic imaging in transcatheter tricuspid valve replacement. (A) TEE and fluoroscopy showed severe tricuspid re-gurgitation. (B) LuX-Valve guided by TEE was used to deliver the bioprosthesis to TA via the right intercostal approach. (C) The delivery system released the interventricular anchor and 2 graspers, and the graspers were guided by TEE to clamp the anterior leaflet. (D) The annulus skirt and the atrium disc were released in turn, and the position of the implant was adjusted by TEE to ensure that there was no obvious paravalvular leakage. (E) The bioprosthesis was completely re-leased after fixation with the interventricular anchor. (F) Postoperative computerized tomography angiography and TEE showed that tricuspid regurgitation disappeared immediately.

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  FIGURE 4. Postprocedural evaluation of the interventricular anchor. (A) A multislice computed tomography scan showed the precise positions of the two graspers. (B) The incision of the right atrium (the red circle) corresponds with Figure 1F. (C) The right heart is outlined in green; the left heart, in purple; the mechanical valve, in blue, and the LuX-Valve is yellow. (D) The yellow area in the red circle is the interventricular anchor. (E) The 3-dimensional reconstructed image from the right atrial plane demonstrates that the LuX-Valve is located in the normal position.

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  FIGURE 5. Postprocedural evaluation showed reduced severity of triscuspid regurgitation and improved clinical, functional, and quality-of-life outcomes. (A) Assessment of severity of tricuspid regurgitation. P-value calculated from the Wilcoxon signed rank test. (B) Comparison of New York Heart Association functional class pre-and post-procedures. P-value calculated from the Wilcoxon signed rank test. (C) Assessment of the 6-min walk test distances. P-value deter-mined from the paired Student t-test. (D) Assessment using the Kansas City Cardiomyopathy Questionnaire. P-value determined from the paired Student t-test.