Left-ventricular assist devices (LVADs) are a major therapeutic option in advanced heart failure (adHF), improving survival rates and quality of life (QoL). Complications, however, can alter their prognosis. Specialized telemonitoring could facilitate LVAD follow-ups and improve outcomes. This study aimed to evaluate the usefulness of telemonitoring for LVAD patients. Patients, followed up with a web application (SateliaLVAD), were included in a national retrospective study at nine tertiary hospitals in France. Characteristics and detected hospitalization risk alerts data were collected. The risk of hospitalization was categorized based on a clinical algorithm (green: no risk, orange: heightened risk, and red: emergent contact with patient and possible hospitalization). In total, 161 patients were included (male: 82.0%, mean age: 62.2 years). Indications for LVAD were mainly ischemic cardiomyopathy (82.0%) and bridge to transplant (50.3%). The mean follow-up duration lasted 19.9 [1-45] months with 76 (47.2%) patients continuing telemonitoring. Compliance was high (79.0%). The main reason for cessation was death (30.6%). Total hospitalization risk alerts detected by telemonitoring were: orange alerts (n = 8265, 72.3%) and red alerts (n = 1613, 14.1%) with 48.5% of cases resolved (orange: 50.8% vs. red: 54.8%). The most frequent type of resolved alert was for a measured risk of cardiac decompensation (orange: 2227 vs. red: 382). To our knowledge, this is the first extensive study to describe the follow-up of LVAD patients by a dedicated telemonitoring application. Telemonitoring as a specific follow-up tool may be feasible for this subpopulation. Future randomized studies on specific prospective evaluations such as survival and QoL are needed.

We had previously established an adequate cryopreservation process for hepatocyte spheroids for the development of an off-the-shelf bioartificial liver (BAL) system. The purpose of this study is to evaluate the efficacy of a BAL system containing cryopreserved immobilized porcine hepatocyte spheroids in a porcine model of acute liver failure (ALF). ALF pigs were divided into three groups. The control group consisted of treatment-naïve pigs (n = 5), the blank group consisted of pigs that were attached to the BAL system not containing hepatocyte spheroids for 12 h (n = 5), and the BAL group consisted of pigs that were attached to the BAL containing hepatocyte spheroids for 12 h (n = 5). Analysis of specific oxygen uptake rates showed that the hepatocytes sustained vigorous activity throughout the 12-h period of BAL operation. Median survival time of pigs was 24.0 h in the BAL group, 17.0 h in the blank group, and 15.0 h in the control group. The BAL group showed significantly prolonged survival according to Kaplan-Meier survival analysis compared to the blank group (p = 0.04) and control group (p = 0.04). Serum ammonia levels were significantly increased in the blank group (p < 0.01) and control group (p < 0.01), compared to the BAL group during the treatment period of the porcine ALF models. Prothrombin time (PT) was significantly lower in the BAL group compared to the blank group (p = 0.04) and control group (p = 0.01). A BAL system with a bioreactor containing cryopreserved immobilized hepatocyte spheroids showed effective clearance of serum ammonia, preservation of renal function, and improved survival in a porcine model of ALF.

The artificial urinary sphincter (AUS) is currently the gold standard treatment for stress urinary incontinence in men, and it's also a treatment option for women in Europe. UroActive is a new electronic device that offers remotely adjustable settings, including device pressure. This study aims to compare the range of Maximal Urethral Closure Pressures (MUCPs) covered by UroActive with those covered by the current AMS800 in male and female cadavers. Six cadavers (3 males and 3 females) were implanted with an occlusive cuff (OC) positioned around the bulbar urethra in men and around the bladder neck in women. A MUCP measurement was performed for each of the 3 different AMS800 Pressure-Regulating Balloons (PRBs): 51-60, 61-70, and 71-80 cmH2O, that were successively connected to the OC. The AMS800 PRB was then replaced by the UroActive Control Unit (CU), and MUCP measurements were performed at set pressures from 10 to 150 cmH2O. UroActive device remained fully functional (wireless communication, calibration) throughout the study period. UroActive CU achieved MUCPs values that encompassed the entire range observed with the 3 different AMS800 PRBs. A strong positive correlation between set device pressures sent to UroActive CU and MUCPs was noted in both males (r2 = 0.984) and females (r2 = 0.948). The findings suggest that UroActive provides a wide adjustable range of urethral closure pressures, potentially offering an alternative to AMS800 for managing stress urinary incontinence in both men and women. Further clinical studies are necessary to confirm its safety and effectiveness in patients.

A major reason for the failure of bioprosthetic heart valves is calcification. Various pretreatment methods are developed to reduce the calcification behavior. The effectiveness of these methods has so far been investigated in expensive and time-consuming large animal studies. To provide a cost-effective, animal- and possibly also time-saving method, we developed an accelerated dynamic invitro calcification test method. We validated this method using a comparative study of two differently pretreated groups of porcine heart valve bioprostheses. Each group contained N = 4 identical aortic bioprostheses. Calcification onsets, progression, and extent were detected by high-speed video (HSV) documentation and microscopy. Structural identification of the deposits was carried out by X-ray powder diffraction (XRD). Semi-destructive quantification of the calcifications was done by μ-CT as well as destructive chemical quantification via colorimetry and complexometry. The histomorphologic localization of the calcifications was examined by von Kossa staining. Structural analysis of the deposits indicated "biological apatite" for both test groups. Histological examination revealed localization of the calcifications in the spongiosa zone of the cusps. Quantification of the calcifications showed a distinctly stronger calcification tendency of the No-T6 compared to the anti-calcifying pretreated T6 bioprostheses. We developed and validated a novel and unique test method for invitro calcification assessment. The quantitative calcification tendencies of the two test groups are comparable with the results of an invivo study in sheep. The structural findings are in line with published invivo observations. The histomorphological localization appears as known for porcine prostheses.

Heart valve diseases remain a leading cause of death in industrialized nations. Polycarbonate urethane (PCU) is a promising material for heart valve prostheses due to its biocompatibility and low calcification tendency. However, the impact of processing methods on calcification remains unclear. PCU patches were fabricated via hot pressing or solution casting. Both groups (n = 3 each), along with bovine pericardium patches as positive controls (n = 3), were incubated for 10 weeks in a custom invitro calcification fluid. Calcification, cytocompatibility, and material properties were assessed using light and electron microscopy, infrared spectroscopy, and gel permeation chromatography (GPC). Calcification was observed in hot-pressed PCU and control patches but not in solution-cast PCU. Both PCU types showed comparable cytocompatibility. Spectroscopy and GPC revealed chemical and structural changes in hot-pressed PCU, likely promoting calcification. Hot pressing alters the chemical structure of PCU and increases its calcification propensity without affecting cytocompatibility. These findings highlight the importance of process control and invitro screening during heart valve material development.

Normothermic machine perfusion (NMP) of donor kidneys provides an opportunity not only for organ preservation but also for therapeutic intervention to reduce ischemia-reperfusion injury (IRI) and support tissue repair. Sevoflurane, a volatile anesthetic known to protect against IRI in other organ systems, has not previously been explored in the context of kidney NMP. This study aimed to establish a stable and reproducible porcine kidney NMP model incorporating sevoflurane delivery. Different administration techniques and oxygenator setups were evaluated to identify the most effective method of sevoflurane application. Administering sevoflurane directly as a liquid into the perfusate resulted in excessive gas formation and unstable drug concentrations. In contrast, using a vaporizer connected to an Inspire 8F M oxygenator allowed for stable and reproducible sevoflurane levels over a 90-min perfusion period, while maintaining sufficient oxygenation. This method proved to be a reliable approach for sevoflurane delivery in kidney NMP. However, oxygenators exposed to sevoflurane should not be reused due to the risk of membrane damage. These findings support the feasibility of using sevoflurane in kidney NMP and provide a platform for further investigation into its potential to improve renal graft outcomes.

The influence of operating modes on pump-induced hemolysis in continuous-flow left ventricular assist devices (LVADs) can be assessed using computational fluid dynamics (CFD) simulations alongside power law models derived from shearing device experiments. However, this conventional method incurs high computational costs, limiting the exploration of diverse operating conditions and hindering online hemolysis prediction. This work presents a CFD-free and trial-based methodology for determining online-capable hemolysis models for continuous-flow LVADs. The trial-based hemolysis model is based on a modified power law model, with parameters identified from LVAD hemolysis trials. The dynamic behavior is modeled using the Lagrangian approach. Specifically, this model was determined for the Sputnik1 LVAD and integrated with a lumped-parameter model of the LVAD-supported cardiovascular system. Subsequently, hemolysis was predicted across various operating modes and patient conditions. The RMSE and the R2 of the modified power law fit were 18.4 [%·mL/h] and 0.69, respectively. The relative error introduced by the Lagrangian approach was below 0.7%. For the Sputnik1, hemolysis decreased with reduced speed. Additionally, lower systemic resistance and diminished left ventricular contractility were associated with lower hemolysis, whereas speed modulation increased hemolysis across most profiles. The proposed hemolysis model allows to assess various LVAD operating modes and patient conditions, assisting in the selection of low-hemolysis treatment strategies. For Sputnik1 patients, it is advisable to maintain low pump speed and systemic resistance, while speed modulation should be reserved for those with low hemolysis markers. Integrating this model with online flow sensing would enable online hemolysis prediction.

Normothermic machine perfusion (NMP) could serve as a platform to assess deceased-donor kidney viability before transplantation, yet it remains unclear which parameters indicate renal viability. As vascular integrity is important for adequate renal function after transplantation, this study aimed to investigate the influence of warm ischemic injury on vascular smooth muscle cell (VSMC) responsiveness to vasoactive drugs during NMP. Fourteen porcine kidneys (n = 7 per group) were exposed to either 30 or 60 min of warm ischemia (WI), followed by 3.5 h of cold machine perfusion. After cold perfusion, kidneys underwent 4 h of NMP (37°C). During NMP, vasoactive drugs were sequentially infused into the renal artery at 30-min intervals, starting with epoprostenol (10 μg), followed by dopamine (1 mg), sodium nitroprusside (2 mg), acetylcholine (1 mg), norepinephrine (10 μg), and finally verapamil (2.5 mg). Renal blood flow during NMP changed significantly in both groups after administration of dopamine, acetylcholine, norepinephrine, and verapamil, but not following epoprostenol and sodium nitroprusside infusion. In kidneys subjected to 30 min of WI, the response to dopamine and norepinephrine was more pronounced, and oxygen consumption and blood pH were higher compared to kidneys that sustained 60 min of WI. This study indicates that prolonged WI damage diminishes the contractility of VSMCs through the α-adrenergic receptors. Our findings suggest that the renal vascular responses to dopamine and norepinephrine, as well as decreased oxygen consumption and blood pH, could serve as objective indicators to quantify warm ischemic injury during renal NMP.