A Novel Transcatheter Device for the Edge-to-Edge Treatment of Tricuspid Regurgitation: A Preliminary Evaluation.

Tricuspid regurgitation (TR) is the most common pathology of the tricuspid valve (TV), with significant mortality in severe cases. A well-established strategy to treat TR is represented by the clover surgical technique, which consists of stitching together the free edges of TV leaflets, producing a clover-shaped valvular orifice. Transcatheter treatments for TR constitute a valuable alternative for high-risk patients. In this work we investigated haemodynamic performances and safety of a novel device (StarTric device (STD)) aiming to perform the clover technique via percutaneous access. To assess haemodynamic performances, STD and clover were applied on porcine pathological TVs and tested. Fluid dynamic indexes of both strategies were compared to the pathological model. To evaluate device safety, forces exchanged between device and leaflets were compared to the extraction force (EF) required to STD to completely pass through the leaflet. Clover technique and STD induced a comparable TV backflow reduction (48% and 47%, respectively), with associated increase of TV flow in all tested conditions. Diastolic transvalvular pressure similarly increased indicating a reduction, though not significant, of the valvular orifice. Forces ranged from 1N to 1.71N, compared to an EF of 22.16 ± 8.6N. Force varied significantly amongst different working conditions (normotensive, mild, and severe hypertensive) for each leaflet, whilst no significative variation was found on different leaflets in the same working condition. In the adopted experimental scenario, STD demonstrated comparable efficacy to the surgical strategy in restoring TV haemodynamic. The forces acting on the leaflets following STD implantation were far lower when compared to EFs.

Empty vein ablation innovative technique for chronic venous disease treatment: proof of concept and ex-vivo analysis.

BACKGROUND: Sclerotherapy is among the mainstays of chronic venous disease treatment, yet its occlusion rate remains suboptimal compared to thermal tumescent techniques. An innovative three-balloons catheter has been developed to allow sclerotherapy in empty vein conditions (empty vein ablation technique, EVA). Aim of this investigation was to describe the EVA technical aspects and related ex-vivo effects on vein wall. METHODS: Two samples from jugular veins of an adult sheep were treated by EVA or foam sclerotherapy (FS, Tessari method). Primary outcome was the percentage of circumferential intima treated by EVA or FS; secondary outcomes were intima and media thickness modifications after treatment. RESULTS: Intact circumferential residual intima were 6.07±2.94% and 16.55±0.70% after EVA and FS, respectively (P=0.020). Despite the average intima and media thickness did not differ between treatments, EVA demonstrated a homogenous damage throughout the vein segment, while FS effect was less destructive distally to the injection site, because moving away from the injection site and floating, it has a less contact with internal surface of the vein. CONCLUSIONS: EVA seems to overcome chemical ablation limits as flushing effect and the increases vein wall/sclerosant agent contact effect compared to FS. Ex-vivo encouraging results need in-vivo validation to evaluate other points like deactivation of sclerosing agent by blood protein and the contact time control between SA and the vein wall. If we have further confirmations in vivo we might think we have a potential higher occlusion rate compared to FS, paving the way for future clinical trials.