High-Versatility Left Ventricle Pump and Aortic Mock Circulatory Loop Development for Patient-Specific Hemodynamic in Vitro Analysis

The importance of experimental setups able to reproduce cardiac functions was well established in the field of clinical innovations. The mock circulatory loops acquired rising relevance, and the possibility to have a complete reproduction of different and specific fluid dynamic conditions within the setup is pivotal. A system with enough versatility to reproduce the physiologic range of both flows and pressures is required. This study describes the design of a versatile setup composed by a custom pulsatile left ventricular pump system and a 3D-printed mock circulatory loop for the in vitro analysis of a patient-specific case of an aortic complex. The performances of the pump were validated first with a set of test flow profiles. It was demonstrated that the system was able to cover a wide range of aortic and mitral flows. Second, the pump system was inserted within the full mock circulatory loop. A patient-specific case was reproduced, both in terms of flow and pressure profiles. A successful validation of the flow and pressure waveforms was obtained by using patient-specific in vivo data from magnetic resonance analysis

The hemodynamic effect of Modified Blalock–Taussig Shunt morphologies: a computational analysis based on reduced order modeling

The Modified Blalock Taussig Shunt (MBTS) is one of the most common palliative operations in case of cyanotic heart diseases. Thus far, the decision on the position, size, and geometry of the implant relies on clinicians' experience. In this paper, a Medical Digital Twin pipeline based on reduced order modeling is presented for fast and interactive evaluation of the hemodynamic parameters of MBTS. An infant case affected by complete pulmonary atresia was selected for this study. A three-dimensional digital model of the infant's MBTS morphology was generated. A wide spectrum of MBTS geometries was explored by introducing twelve Radial Basis Function mesh modifiers. The combination of these modifiers allowed for analysis of various MBTS shapes. The final results proved the potential of the proposed approach for the investigation of significant hemodynamic features such as velocity, pressure, and wall shear stress as a function of the shunt's morphology in real-time. In particular, it was demonstrated that the modifications of the MBTS morphology had a profound effect on the hemodynamic indices. The adoption of reduced models turned out to be a promising path to follow for MBTS numerical evaluation, with the potential to support patient-specific preoperative planning

Patient blood management in cardiac surgery: The “Granducato algorithm”

Background: Patients undergoing cardiac surgery are subject to severe alterations of the coagulation system. The four cardiac surgery centers in Tuscany (Italy)structured and shared an algorithm (Granducato Patient Blood Management algorithm, G-PBMa)with predefined interventions for patient blood management. The aim of the study is to analyze the impact of that algorithm on the transfusion needs and bleeding-related outcomes in a large patient population. Methods: Multicenter retrospective observational study on 3839 patients undergoing cardiac surgery at the four cardiac centers in Tuscany. The G-PBMa was released at the end of 2015 and it was structured in three parts: pre-, intra-, and post-operative. The year 2014, before the G-PBMa (1955 patients)and the year 2016 (1884 patients)after the G-PBMa in place were compared. Logistic regression analyses were used. Results: The main changes introduced were the routine application of viscoelastic tests in bleeding patients (+72%)and the use of fibrinogen and prothrombin complex concentrate (+67%). The G-PBMa resulted in a significant reduction in the overall transfusion rate and in the transfusion rate of the separate blood products (relative risk for transfusions: 0.75, 95% confidence interval 0.65–0.85, P = 0.001). For preoperative hemoglobin values of between 8 and 10 g/dL, the absolute difference in RBC transfusion rate before and after the G-PBMa introduction ranged around 15%–17%. The G-PBMa introduction determined lower (P = 0.02)chest drain blood loss, lower (P = 0.001)postoperative acute kidney injury and shorter (P = 0.001)hospital stay. Conclusions: The G-PBMa was effective in reducing blood loss, transfusion requirements, and resulted in a better outcome

Initial results of clinical trial with a new left ventricular assist device (LVAD) providing synchronous pulsatile flow

ObjectivesA multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a new pulsatile implantable LVAD (BestBeat), smaller and lighter than similar devices, capable of providing synchronous and counterpulsating flow with respect to the LV of end-stage heart failure patients. Preliminary clinical results are reported.MethodsThe new BestBeat LVAD was used, consisting of an implantable pulsatile blood pump, electromechanically driven by a ball screw mechanism, and a wearable electronic controller and power sources. The clinical trial was conducted at 5 European centers. Adult patients affected by CHF in NYHA Class IV despite optimized medical treatment were enrolled. The primary study endpoint was survival at 90 days. Further study endpoints were maintenance of adequate LVAD pump flow and a minimum rate of adverse events during support.ResultsAs of June 2008, 6 patients received the implant. Cumulative support time was 3.7 years, median support time 176 days. All patients who completed the study survived except for one, who died after 48 days, due to combined infection and cerebrovascular accident. Another two patients died: one from intracranial bleeding 113 days after implant, and one from septic shock after 123 days. Hemodynamic improvement with Cl&gt;2.0 l/min/m2and recovery of end-organ function expressed by consistent improvement of BUN, creatinine and bilirubin were reached in all patients. No device failure was observed. There was no bleeding requiring re-exploration, no hemolysis and only two device-related infections (both in one patient). Neurologic events were reported, the most serious ones occurring in patients with pre-implant respiratory and kidney failure. Three patients were discharged home. Two patients were successfully transplanted, one after 6 months and one after 13 months on device.ConclusionsGood performance and efficacy of the device were observed; the endpoints of the study were achieved, and its safety was consistent with expectations. The ongoing study will allow further conclusions to be drawn.</jats:sec

Intravenous amino acid therapy for kidney protection in cardiac surgery a protocol for a multi-Centre randomized blinded placebo controlled clinical trial. The PROTECTION trial

Background: Postoperative acute kidney injury (AKI) is frequent in cardiac surgery patients. Its pathophysiology is complex and involves decreased renal perfusion. Preliminary clinical evidence in critically ill patients shows that amino acids infusion increases renal blood flow and may decrease the incidence and severity of AKI. We designed a study to evaluate the effectiveness of perioperative continuous infusion of amino acids in decreasing AKI. Methods: This is a phase III, multi-center, randomized, double-blind, placebo-controlled trial. Adults undergoing cardiac surgery with cardiopulmonary bypass (CPB) are included. Patients are randomly assigned to receive either continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day or placebo (balanced crystalloid solution) from the operating room up to start of renal replacement therapy (RRT), or ICU discharge, or 72 h after the first dose. The primary outcome is the incidence of AKI during hospital stay defined by KDIGO (Kidney Disease: Improving Global Outcomes). Secondary outcomes include the need for, and duration of, RRT, mechanical ventilation; ICU and hospital length of stay; all-cause mortality at ICU, hospital discharge, 30, 90, and 180 days after randomization; quality of life at 180 days. Data will be analyzed in 3500 patients on an intention-to-treat basis. Discussion: The trial is ongoing and currently recruiting. It will be one of the first randomized controlled studies to assess the relationship between amino acids use and kidney injury in cardiac surgery. If our hypothesis is confirmed, this practice could reduce morbidity in the studied population. Study registration: This trial was registered on ClinicalTrials.gov with the trial identification NCT03709264 in October 2018