3D-Printing to Plan Complex Transcatheter Paravalvular Leaks Closure

Abstract

Background: Percutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to select an appropriate device. We aim to explore the additional value of 3D printing in predicting device related adverse events including mechanical valve leaflet blockade, risk of device embolization and residual shunting.

Methods: From the FFPP registries (NCT05089136 and NCT05117359), we included 11 transcatheter PVL closure procedures from three centers for which 3D printed models were produced. Cardiac CT was used for segmentation for 3D printed models (3D-heartmodeling, Caissargues, France). Technology used a laser to fuse very fine powders (TPU Thermoplastic polyurethane) into a final part-laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed using a set of occluders.

Results: PVLs were located around aortic prostheses in six cases, mitral prostheses in four cases and tricuspid ring in one case. The device chosen during the simulation on the 3D printed model matched the one implanted in eight cases. In the three other cases, a similar device type was chosen during the procedures but with a different size. A risk of prosthesis leaflet blockade was identified on 3D printed models in four cases. During the procedure, the occluder was removed before release in one case. In another case the device was successfully repositioned and released. In two patients, leaflet impingement was observed post-operatively and surgical device removal had to be performed.

Conclusion: In a case-series of complex transcatheter PVL closure procedures, hands-on simulation testing on 3D printed models proved its usefulness to plan and facilitate these challenging procedures.

Keywords: 3D printing; interventional cardiology; multimodality imaging; paravalvular leak; percutaneous; prosthetic valve; transcatheter.

Figure 2

Case 1: A 71-year-old patient with a mechanical mitral valve and a large single postero-septal paravalvular leak (PVL). (A) 2D-CT view: a gap (arrow) is seen between the prosthetic ring and the ventricular wall; (B) 3D TEE view of the mitral valve from the left atrium showing in 3D color-doppler a posterior septal PVL (arrow); (C) 3D printed model showing the double-leaflets mitral mechanical prosthesis in atrial (left panel, in a same view as (B)) and ventricular view (panel right). The PVL location and morphology are well depicted. (LA-left atrium, LV-left ventricle, Ao-aorta).

Figure 3

Case 1: Testing of different plugs on the 3D printed model. (A) An 8 mm Amplatzer Vascular Plug II with adequate compression but residual leakage is suspected; (B) Amplatzer Septal Occluder 4 mm: interference with the mitral prosthesis leaflet (see Video S1); (C) Amplatzer Duct Occluder 2: 6-4, unstable when performing a tug test (D) Amplatzer Valvular Plug III 12-3: good apposition of the device without residual gap on atrial view (see Video S2), (E) Amplatzer Valvular Plug III 12-3 in ventricular view showing a close contact with the disc depending on the orientation of the device (see Video S3).

Figure 4

Case 1: per procedural imaging. (A) Per procedural 3D TEE in atrial view: Amplatzer Valvular Plug III 3–12 mm blocks the internal prosthetic disc (red arrow); (B) traction of the device to adjust its positioning allowing to free the prosthetic disc movements. The position is similar to the simulation on 3D printed model; (C) late control CT, good device positioning without leaflet impairment, no residual mitral paravalvular gap, the plug is located as on 3D printed model simulation.

Figure 5

Case 2: A 67-year-old patient with a large paravalvular mechanical mitral leak. (A) 3D printed model showing a large PVL (red arrow) in atrial view in an antero-septal position; (B) testing of an Amplatzer Septal Occluder device showing prosthetic leaflet impairment; (C) testing of a Paravalvular Leak Device Rectangular 14 Waist. Position and defect sealing seem adequate, but risk of disc interference is suspected; (D) testing of an Amplatzer Valvular Plug 3 14 × 5 mm. Optimal result is expected; (E) 3DTEE view: Amplatzer Valvular Plug III 10 × 5 mm was inserted with a residual leak requiring a second AVPII 10 mm placed subsequently; (F) two vascular plug: AVP III and AVPII 10mm with minor inferior residual leak.

Figure 6

Case 3: PVL after Perceval Bio-prosthesis implantation. (A) Aortic TTE view: incomplete expansion of the prosthetic framework against the annular aortic wall (left) causing large PVL (*); (B) cardiac CT of the Perceval prosthesis showing an invagination of the prosthetic armature in a same view as (A); (C) 3D printed model in superior aortic view showing the gap between the aortic wall and the invaginated prosthetic armature (C1); testing of an Amplatzer Valvular Plug III 14 × 5 mm (C2) showing residual gap and obstruction of the left coronary ostium ((C3)-red arrow); simulation of a TAVI valve-in-valve which allowed complete apposition of the Perceval framework to the aortic wall (C4); (D) TAVI valve-in-valve procedure: implantation of an Edwards balloon expandable prosthesis (D1) into Perceval armature without residual leakage (D2).

Figure 7

Case 4: complex aortic PVL secondary to paravalvular abscess. (A) Aortic PVL in color doppler TEE view; (B) multilobed abscess (white arrows) with large PVL.; (C) 3D printed model reproducing the multilobed abscesses and the paravalvular leakage with a complex tract with a with a ventricular outlet (*); (D,E) testing of an AVP 2–10 mm device and AVP 3-10 × 5 mm with a residual PVL (E); (F,G) testing of a 14 mm Amplatzer Valvular Plug 3 device which occludes the leak but has an interference with the leaflet (G); (H,I) procedural implantation of AVP 3 14 × 5 mm with no residual leakage and normal flow through the aortic prosthesis; (J,K) day one: Increased trans prosthetic gradient with turbulent aliasing flow (K) due to a leaflet blockage requiring rapid surgical management.

Figure 8

Case 5. (A,B) Paravalvular residual leak posteriorly (red arrow), in a patient with a previous history of transcatheter PVL closure treated by an AVP3 3–12 mm device (*): 3D TEE views; (C) PVL Closure with two additional AVP3 devices: 5–14 and 5–12 mm (black arrow); (D) normal opening of the mechanical leaflets and no residual gap at the end of the procedure on 3D TEE view. Note the two AVP 3 devices (black arrow) and the previous one (*); (E) atrial view of the 3D printed model showing the PVL close to the hinge of the mechanical mitral discs. Note the 3D print of the pre-existing AVP 3 (*); (F) post procedural simulation on 3D printing model: using the same AVP 3 devices: demonstrating a disc interference (blue arrow) in ventricular view; (G) 3D volume rendering of the prosthesis with a partial blockage of the external disc (blue arrow), in both ventricular and atrial view, occurred late in the postoperative period, similar to testing on the 3D printed model. (H) Internal Disc blockage in 2D CT view (blue arrow).

Figure 9

Case 6: Tricuspid PVL. (A) Prior Mechanical mitral prosthesis and tricuspid annuloplasty with massive residual tricuspid regurgitation; (B) valve-in-ring procedure with Sapien 3 29 mm implanted in the Carpentier Tricuspid ring 36 mm with a septal superior residual gap closed by the insertion of two AVP2 devices.; (C) fluoroscopic view of valve-in-ring prosthesis and two AVP2 14 mm devices without residual tricuspid regurgitation during contrast injection; (D–F) pre-operative step by step simulation. (D) Valve-in-ring implantation. (E) A first AVP2 is positioned with residual PVL. Implantation of a second AVP2 with complete closure.

Figure 1

Three-dimensional printing workflow: (A) 2D cardiac tomography (CT). Each cardiac structure of interest has been segmented: aortic wall, mechanical aortic valve prothesis, left myocardium, annular calcification (*). A diastasis is observed between the mechanical aortic prosthesis (P) and the aortic wall (Ao) corresponding to a paravalvular leak (PVL) (red arrow). (B) CT full volume rendering of the segmented structures. The mechanical aortic valve is displayed in green. The PVL is seen from a left ventricular view. (C) A standard triangle language (STL) file was created from segmented structures. The PVL is seen from the aorta (black arrow). (D) Three-dimensionally printed model derived from the STL. Visualization of the aortic root, aortic valve (P) and the PVL (black arrow). PVL: paravalvular leak; Ao: aortic; LV: left ventricle; P: prosthesis.