In Vitro Model for the Evaluation of Innovative Transcatheter Debridement Device (TDD): Pericardium-Based Scaffold and Stem Cells to Reproduce Calcificated Valves.

Aortic valve stenosis has become the most common valvular disease in elderly patients. Several treatments are available such as surgical aortic valve replacement and transcatheter aortic valve implantation. To date, however, there is a need to discover alternative treatments that can delay the disease progression and, therefore, the implant of a prosthetic valve. In this regard, a decalcification procedure based on the use of ultrasonic waves could represent an innovative solution in transcatheter cardiovascular therapies. In this article, we describe an innovative transcatheter debridement device (TDD) that uses low-intensity ultrasound shock waves for calcium ablation from the native aortic valve and bioprosthetic valve. Mesenchymal stem cells were seeded onto pericardium-based scaffolds and committed into an osteogenic phenotype. After treatment with TDD, cell proliferation was analyzed, as well as lactate dehydrogenase release and cell morphology. The release of calcium and inflammation events were detected. The results confirmed that the TDD was able to induce a safe decalcification without any adverse inflammatory events.

Lithotripsy of Calcified Aortic Valve Leaflets by a Novel Ultrasound Transcatheter-Based Device.

The increasing incidence of calcific aortic valve disease necessitates the elaboration of new strategies to retard the progression of the pathology with an innovative solution. While the increasing diffusion of the transcatheter aortic valve replacements (TAVRs) allows a mini-invasive approach to aortic valve substitution as an alternative to conventional surgical replacement (SAVR) in an always larger patient population, TAVR implantation still has contraindications for young patients. In addition, it is liable to undergo calcification with the consequent necessity of re-intervention with conventional valve surgery or repeated implantation in the so-called TAVR-in-TAVR procedure. Inspired by applications for non-cardiac pathologies or for vascular decalcification before stenting (i.e., coronary lithotripsy), in the present study, we show the feasibility of human valve treatment with a mini-invasive device tailored to deliver shockwaves to the calcific leaflets. We provide evidence of efficient calcium deposit ruptures in human calcified leaflets treated ex vivo and the safety of the treatment in pigs. The use of this device could be helpful to perform shockwaves valvuloplasty as an option to retard TAVR/SAVR, or as a pretreatment to facilitate prosthesis implantation and minimize the occurrence of paravalvular leak.

Sovering annuloplasty rings: experimental pathology in the sheep model.

INTRODUCTION: A new flexible annuloplasty ring (Sovering, Sorin Biomedica Cardio), both closed and open, has been designed and consists of radiopaque silicone core impregnated with barium sulfate and covered by a knitted polyester fabric coated with Carbofilm. The aim of the study was to test the biological compatibility of the new device in large animals in orthotopic position. METHODS: Ten Sovering rings were implanted in 10 female adult sheep, 7 mitral (3 open, 4 closed) and 3 tricuspid (all open). The size was 23-25 mm in the mitral and 28-30 mm in the tricuspid position, and the time in place varied from 63 to 110 days (mean = 89 +/- 14) and from 58 to 63 days (mean = 61 +/- 3), respectively. The morphological analysis consisted of gross, histological, immunohistochemical and ultrastructural investigations. RESULTS: The prosthetic ring appeared well implanted in the valve atrioventricular (AV) junction, encapsulated by a thin fibrous sheath without any evidence of thrombus deposition, fibrinous lining or exuberant fibrous tissue overgrowth. No adverse inflammatory reaction was observed, but rare lymphocytes, macrophages and foreign body giant cells. At electron microscopy, the fibrous tissue appeared to permeate deeply within the fabric network; reendothelization on the surface was noted and confirmed by immunohistochemistry. Sirius red staining at polarized light revealed a higher content of collagen type III in the mitral than in the tricuspid position. CONCLUSIONS: Sovering annuloplasty rings implanted in the AV valves of adult sheep showed excellent biocompatibility, fibrous encapsulation and reendothelization. The absence of thrombosis and exuberant fibrous tissue reaction supports the effective use of Carbofilm covering in annuloplasty devices.

Carbon-coated stents implanted in porcine iliac and renal arteries: histologic and histomorphometric study.

PURPOSE: To test in a pig model the biocompatibility and effectiveness of carbon-coated renal and iliac artery stent systems during implantation procedures and at different follow-up periods. MATERIALS AND METHODS: Twenty-two miniature pigs received carbon-coated balloon-expandable stainless-steel stents in their renal and iliac arteries. Animals were killed at 7, 30, or 180 days for evaluation of acute, subacute, and chronic biologic response to the implanted devices. Histologic, histomorphometric, and scanning electron microscopy (SEM) analyses were performed to assess inflammatory reaction, endothelialization process, and neointimal growth. RESULTS: Forty-four iliac stents and 42 renal stents were successfully implanted. Mural thrombi were not observed by angiography or histologic examinations. Histologically, no significant inflammatory reaction was detected: the stents appeared covered by a thin monolayer of endothelial cells even at 7-day follow-up. The neointima showed homogeneous growth and moderate thickness at 30-day and 180-day explantations (0.09 mm +/- 0.06 and 0.15 mm +/- 0.13, respectively, for renal arteries; 0.12 mm +/- 0.04 and 0.21 mm +/- 0.12, respectively, for iliac arteries). Internal and external elastic laminae were intact in 82 of 86 cases (95%) of stent-implanted arteries. Histologic validations were obtained with SEM observations for each follow-up group. CONCLUSIONS: This study showed good technical results of deployment of carbon-coated renal and iliac stents and very satisfactory biologic behavior in terms of tissue and hematologic compatibility. The devices do not induce thrombus formation.