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Glutaraldehyde preservation is the gold standard for cardiovascular biological prosthesis. However, secondary calcifications and the absence of tissue growth remain major limitations. Our study assessed in vitro and in vivo the biocompatibility of human (fascia lata, pericardium) and porcine tissues (pericardium, peritoneum) treated with a physicochemical procedure for decellularization and non-conventional pathogens inactivation. Biopsies were performed before and after treatment to assess decellularization (HE/Dapi staining/DNA quantification/MHC I/alpha gal immunostaining) and mechanical integrity. Forty-five rats received an abdominal aortic patch of native cryopreserved tissues (n = 20), treated tissues (n = 20) or glutaraldehyde-preserved bovine pericardium (GBP, control, n = 5). Grafts were explanted at 4 weeks and processed for HE/von Kossa staining and immunohistochemistries for lymphocytes (CD3)/macrophages (CD68) histomorphometry. 95% of decellularization was obtained for all tissues except for fascia lata (75%). Mechanical properties were slightly altered. In the in vivo model, a significant increase of CD3 and CD68 infiltrations was found in native and control implants in comparison with decellularized tissues (p

The advantages of the femtosecond laser for micromachining of materials have been widely demonstrated allowing the laser micromachining to reach a level of accuracy in the micrometer range level. However, most of the current femtosecond laser micromachining applications are for flat surfaces, 2D or 2.5D, requiring different kinds of machining: drilling, cutting, and texturing, for more and more exotic materials. Biomedical implants are a part of those new objects requiring very high level of accuracy and surface finish, and for complex geometries: cylindrical or hemispherical shapes. LASEA has developed a system combining femtosecond laser with 7 simultaneously moving axes: 5 mechanical axes and 2 galvanometric axes. This combines the 3D micromachining offered by the 5 axes with the fast scanning. The laser parameters and strategies are controlled owing to laser specific developed functionalities. Another challenge to overcome is the research of laser parameters which is time and material consuming. In order to make this research more efficient, LASEA has developed a tool named LS-Plume which simulates the profiles for different sets of parameters. In this work, we focus mainly onto biomedical implants, such as stent cutting and hip implants texturing. The characterisation of the stents was carried out based on computed X-ray tomography, after processing and balloon inflation. Fast texturing of 3D part is also demonstrated and evaluated. Different biocompatible materials have been characterised and used by the tool LS-Plume. Showing a good match between a simulated and measured profiles.

OBJECTIVES Our goal was to assess the aortic leaflet free margin length (FML) and geometric height (gH) in a normal aortic valve (AV), aorta dilatation and aortic leaflet prolapse. METHODS We measured the FML and gH intraoperatively in 132 patients operated on for aortic insufficiency, aortic dilatation, endocarditis or fibroelastoma. Patients were divided into 3 groups: normal tricuspid AV (group 1, n = 12), aortic dilatation (group 2, tricuspid = 43, bicuspid = 18) and leaflet prolapse (group 3, tricuspid = 32, bicuspid = 27). The FML and gH were compared between the groups and between the leaflets within each group. RESULTS In a normal tricuspid AV, the mean FML and gH were 34.7 ± 3.1 mm and 18.8 ± 1.7 mm, respectively. In group 2 tricuspid, the FML and gH were greater than those in group 1 (FML 43.7 ± 4.4, P CONCLUSIONS In aortic dilatation and leaflet prolapse, FML and, to a lesser extent, gH increased significantly compared to those of normal AV function. FML and gH dimensions also depended on the valve configuration (tricuspid/bicuspid). These data provide new insight into the pathomorphology of AV disease and will serve to further develop new methods of AV repair based on intraoperative measurements of the FML.

Increasingly often, the surgeon operates remotely. More and more, he/she does neither see nor touch the patient directly but acts with miniaturized systems, such as catheters and robotic instruments. This reduces intervention time and accelerates the patient’s recovery. This paper reports the ergonomic contribution to the design of a device for the resection of stenosed aortic valves and the implantation of a new aortic bioprosthesis. In high-risk contexts as in cardiac surgery, high fidelity prototypes are necessary to allow clinical trials. An association between engineers and ergonomists becomes essential, because the prototype becomes a key stage of the design process. We suggest a triangulation of methods (heuristic inspection, task analysis and usability testing) to produce a high-fidelity prototype reliable for clinical trials. The clinical trials themselves then constitute a preliminary step for further improving the device.

Objectives Aortic cusp free margins are a central target in most aortic valve repair operations to optimize valve coaptation. The objective of this anatomical study was to analyse the normal dimensions of free margin length (FML) and coaptation surface and to analyse their relationship with other valve and root dimensions in normal tricuspid aortic valves. Methods We analysed 25 aortic root homografts. Eight valve and root measurements were obtained from fresh specimens including the length of the free margin while applying appropriate tension on the structures. The valves were then fixed with formalin in the diastolic position under pressure to allow measurement of the coaptation surface. In addition to normal values, we analysed the correlations and ratios between the different measures. Results The mean FML was 34.3 ± 3.1 mm. The FML was similar between the 3 cusps and correlated with all other valve and root measures. The ratio of the FML to the geometric height was 1.81, and the free edge length/sinotubular junction was 1.29. The mean coaptation surface was 122 ± 21 mm2 per cusp and corresponded to 41% of the cusp surface. The central coaptation length was 3.3 ± 0.8 mm, and the lateral coaptation length was 5.9 ± 0.6 mm. The total coaptation surface per specimen was 184 ± 32 mm2. Conclusions We described the normal dimensions of the FML and coaptation surface in the tricuspid aortic valve. These measurements will serve in the further development of an objective method of free margin shortening based on intraoperative measurements of the FML to treat cusp prolapse and low coaptation after valve-sparing surgery.

OBJECTIVES Porcine small intestinal submucosa extracellular matrix (CorMatrix; CorMatrix Cardiovascular, Rosewell, GA) is a relatively novel tissue substitute used in cardiovascular applications. We investigated the biological reaction and remodelling of CorMatrix as a tri-leaflet valved conduit in a pig model. We hypothesized that CorMatrix maintains a durable architecture as a valved conduit and remodels to resemble surrounding tissues. METHODS We fashioned the valved conduit using a 7 × 10 cm 4-ply CorMatrix sheet and placed it in the thoracic aorta of seven landrace pigs for 3, 4, 5 and 6 months. Biodegradation, replacement by native tissue, strength and durability were examined by histology, immunohistochemistry and mechanical testing. RESULTS Four pigs, one per time frame, completed the study. The conduit lost its original architecture as a tri-leaflet valve due to cusp immobility, subsequent attachment to the wall segment and consequent maintenance of a thick arterial wall-like structure. Scaffold resorption was incomplete, with disorganized inconsistent spatial and temporal degradation even at 6 months. Fibrosis, scarring and calcification started at 4 months and chronic inflammation persisted. The partially remodelled scaffold did not resemble the aortic wall, suggesting impaired remodelling. Mechanical testing showed progressive weakening of the tissues over time, which were liable to breakage. CONCLUSIONS CorMatrix is biodegradable; however, it failed to remodel in a structured and anatomical fashion in an arterial environment. Progressive mechanical and remodelling failure in this scenario might be explained by the complexity of the conduit design and the host's chronic inflammatory response, leading to early fibrosis and calcification.

Transcatheter aortic valve implantation was introduced into clinical practice in 2002 as a rescue approach in patients presenting with symptomatic severe aortic stenosis but not eligible for conventional aortic valve replacement. This technique allows implantation of a balloon expandable bioprosthesis without resection of the native aortic valve. Several complications are described as a consequence of the residual highly calcified valve being squeezed against the aortic wall by the stent of the implant. This can result in deformation of the metal stent and paravalvular leakage, risk of occlusion of the coronary ostia, or central and peripheral embolization of valvular debris. To avoid these complications, many authors suggest the possibility to resect and remove the native aortic valve before transcatheter aortic valve implantation. In this field, different authors have described possible techniques and different sources of energy to resect the calcified valve. In this article, we review the development of these experimental techniques and discuss future prospects in this field.