Impact of BASILICA on the thrombogenicity potential of valve-in-valve implantations.

Subclinical leaflet thrombosis is becoming a major concern in valve-in-valve procedures, whereby a transcatheter aortic valve device is deployed inside a failed bioprosthetic surgical valve. Blood flow stagnation and prolonged residence times in the neo-sinuses have been suggested as possible explanations for leaflet thrombosis. The BASILICA technique, which was originally developed to treat coronary flow obstruction, has also been proposed as an alternative to reduce the risk of thrombus formation. The aim of this study is to understand the impact of BASILICA on the valve-in-valve thrombogenicity using computational fluid dynamics simulations. To this end, two Eulerian and two Lagrangian approaches were employed to estimate near-wall stagnation measures in eight valve-in-valve models. The models included an intact or lacerated Sorin Mitroflow surgical valve, and either a SAPIEN or Evolut transcatheter aortic valve device. The Lagrangian approaches predicted a high number of particles and vortices concentration in the proximal areas of the neo-sinuses, while the Eulerian approaches did so in the distal areas. As a consequence, this study demonstrated that Lagrangian approaches are better predictors of subclinical leaflet thrombosis, since they match experimental and clinical findings. Additionally, the SAPIEN valve possess a higher risk for developing leaflet thrombosis, and two lacerations are shown to provide the best results in terms of development of vortices and accumulation of particles within the neo-sinuses. This study highlights the potential of computational modeling in aiding clinicians in their decision-making in valve-in-valve and BASILICA procedures.

The effect of clinically recommended Evolut sizes on anchorage forces after BASILICA.

Coronary artery obstruction (CAO), a fatal complication of transcatheter aortic valve replacement (TAVR), is commonly found after Valve-in-Valve implantation inside a degenerated bioprosthetic valve. Leaflet laceration (BASILICA technique) has been proposed to prevent CAO and to potentially reduce the risk of leaflet thrombosis. We have previously demonstrated that this technique can reduce the anchorage forces of the TAVR device, which may lead to future complications. In this short communication, we hypothesize that the anchorage force reduction can be minimized by implanting a TAVR with a larger diameter, if two sizes are clinically recommended. We evaluated this hypothesis by employing finite element models of the deployments of the Evolut 26 and 29 mm inside a 27 mm Mitroflow valve, with and without leaflet lacerations. The results show that a laceration substantially decreases the contact area between the Evolut stent and the Mitroflow valve. The larger Evolut has a larger contact area and stronger anchorage forces. Additionally, the anchorage forces are less sensitive to additional lacerations in the larger Evolut (29 case). The results suggest that a larger self-expending device can ensure stronger anchorage and can lower the risk of possible migration, when TAVR is performed in a lacerated bioprosthesis.

Novel Design of Peripheral Infusion Catheter Improves the Kinetics of Intravenous Drug Release.

Short peripheral catheters are ubiquitous in today's healthcare environment, enabling effective and direct delivery of fluids and medications intravenously. A commonly associated complication of their use is thrombophlebitis-thrombus formation-involved inflammation of the vein wall. A novel design of a very short peripheral catheter showed promising results in a pig model in reducing the mechanical irritation to the vein wall. Here, the kinetics of drug release through the novel catheter was compared to a standard commercial catheter using experimental and computational models. In a good agreement, in vitro and in silico models reveal the superiority of the novel catheter design with faster washout time, favorable spatial distribution within the vein, and substantially lower wall shear stress. We submit therefore that the novel design has an improved drug removal profile compared to the conventional catheter and can potentially reduce chemical irritation to the vein wall and minimize the risk for thrombophlebitis. CLINICAL RELEVANCE: Short peripheral catheters are ubiquitous in today's healthcare environment, allowing effective and direct delivery of fluids and medications intravenously. It is well known, however, that prolonged exposure to an irritant drug may lead to its absorption in the endothelial layer lining the vein wall, promoting among other, thrombophlebitis that may lead to increased morbidity, delayed treatment, and prolonged hospitalization. There have been multiple calls to consider low infusion rates with various infusion protocols and to place the catheter tip as central as possible to promote faster drug clearance and reduce the potential vessel damage, but the requisite device had not been available, and the short peripheral catheter is still, and for decades, the standard of care. Towards this end, we recently introduced a novel very short peripheral catheter design, and here, we demonstrate using experimental and computational models its favorable spatial and temporal drug-releasing profiles compared with the standard catheter. The clinically potential relevance is underscore both by the more efficient perfusion of IV drugs and lower irritation to the vein wall at the site of injection. Graphical abstract.

Numerical models for assessing the risk of leaflet thrombosis post-transcatheter aortic valve-in-valve implantation.

Leaflet thrombosis has been suggested as the reason for the reduced leaflet motion in cases of hypoattenuated leaflet thickening of bioprosthetic aortic valves. This work aimed to estimate the risk of leaflet thrombosis in two post-valve-in-valve (ViV) configurations, using five different numerical approaches. Realistic ViV configurations were calculated by modelling the deployments of the latest version of transcatheter aortic valve devices (Medtronic Evolut PRO, Edwards SAPIEN 3) in the surgical Sorin Mitroflow. Computational fluid dynamics simulations of blood flow followed the dry models. Lagrangian and Eulerian measures of near-wall stagnation were implemented by particle and concentration tracking, respectively, to estimate the thrombogenicity and to predict the risk locations. Most of the numerical approaches indicate a higher leaflet thrombosis risk in the Edwards SAPIEN 3 device because of its intra-annular implantation. The Eulerian approaches estimated high-risk locations in agreement with the wall sheer stress (WSS) separation points. On the other hand, the Lagrangian approaches predicted high-risk locations at the proximal regions of the leaflets matching the low WSS magnitude regions of both transcatheter aortic valve implantation models and reported clinical and experimental data. The proposed methods can help optimizing future designs of transcatheter aortic valves with minimal thrombotic risks.

Numerical models of valve-in-valve implantation: effect of intentional leaflet laceration on the anchorage.

Transcatheter aortic valve implantation (TAVI) is currently recommended in practice guidelines for patients who are at intermediate to high surgical risk for surgical aortic valve replacement. Coronary artery obstruction is a fatal complication of TAVI that occurs in up to 3.5% of the implantations inside a failed surgical bioprosthetic valve (valve-in-valve, ViV). A new technique to address this problem is intentional laceration of the bioprosthetic leaflets, known as BASILICA. In this technique, the leaflets are lacerated to prevent coronary obstruction and may also help in preventing leaflet thrombosis. Our hypothesis is that this technique may harm the circumferential stress in the surgical valve and weaken the anchorage of the TAVI device. This study aims to compare the anchorage post-ViV implantations, with and without lacerations, using numerical modelling. Deployments of TAVI stents (Medtronic Evolut PRO; Edwards SAPIEN 3) inside an externally mounted surgical bioprosthetic valve (Sorin Mitroflow) were modelled by finite element analysis. The results show that each laceration reduces the contact area of the TAVI stent with its landing zone and that the anchorage contact force weakens. The BASILICA technique has lesser effect on the anchorage contact area and forces in the SAPIEN than in the Evolut cases, because the balloon inflation is less sensitive to the deployment region. TAVI stent migration was not found in any of the models. These results can help expanding the use of leaflet laceration by choosing a better matched TAVI devices for the BASILICA technique.