Left ventricular unloading via percutaneous assist device during extracorporeal membrane oxygenation in acute myocardial infarction and cardiac arrest.

INTRODUCTION: A feared complication of an acute myocardial infarction (AMI) is cardiac arrest (CA). Even if return of spontaneous circulation is achieved, cardiogenic shock (CS) is common. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) supports patients with CS and is often used in conjunction with an Impella device (2.5 and CP) to off-load the left ventricle, although limited evidence supports this approach. METHODS: The goal of this study was to determine whether a mortality difference was observed in VA-ECMO alone versus VA-ECMO with Impella (ECPELLA) in patients with CS from AMI and CA. A retrospective chart review of 50 patients with AMI-CS and CA and were supported with VA-ECMO (n = 34) or ECPELLA (n = 16) was performed. The primary outcome was all-cause mortality at 6-months from VA-ECMO or Impella implantation. Secondary outcomes included in-hospital mortality and complication rates between both cohorts and intensive care unit data. RESULTS: Baseline characteristics were similar, except patients with ST-elevation myocardial infarction were more likely to be in the VA-ECMO group (p = 0.044). The ECPELLA cohort had significantly worse survival after VA-ECMO (SAVE) score (p = 0.032). Six-month all-cause mortality was not significantly different between the cohorts, even when adjusting for SAVE score. Secondary outcomes were notable for an increased rate of minor complications without an increased rate of major complications in the ECPELLA group. CONCLUSIONS: Randomized trials are needed to determine if a mortality difference exists between VA-ECMO and ECPELLA platforms in patients with AMI complicated by CA and CS.

In Patients with Cardiogenic Shock, Extracorporeal Membrane Oxygenation Is Associated with Very High All-Cause Inpatient Mortality Rate.

Background: The goal of this study was to evaluate the effect of extracorporeal membrane oxygenation (ECMO) on mortality in patients with cardiogenic shock excluding Impella and IABP use. Method: The large Nationwide Inpatient Sample (NIS) database was utilized to study any association between the use of ECMO in adults over the age of 18 and mortality and complications with a diagnosis of cardiogenic shocks. Results: ICD-10 codes for ECMO and cardiogenic shock for the available years 2016-2020 were utilized. A total of 796,585 (age 66.5 ± 14.4) patients had a diagnosis of cardiogenic shock excluding Impella. Of these patients, 13,160 (age 53.7 ± 15.4) were treated with ECMO without IABP use. Total inpatient mortality without any device was 32.7%. It was 47.9% with ECMO. In a multivariate analysis adjusting for 47 variables such as age, gender, race, lactic acidosis, three-vessel intervention, left main myocardial infarction, cardiomyopathy, systolic heart failure, acute ST-elevation myocardial infarction, peripheral vascular disease, chronic renal disease, etc., ECMO utilization remained highly associated with mortality (OR: 1.78, CI: 1.6-1.9, p < 0.001). Evaluating teaching hospitals only revealed similar findings. Major complications were also high in the ECMO cohort. Conclusions: In patients with cardiogenic shock, the use of ECMO was associated with the high in-hospital mortality regardless of comorbid condition, high-risk futures, or type of hospital.

Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Premorbid functional status in patients requiring veno-arterial extracorporeal membrane oxygenation after cardiac surgery.

Assessment of a patient's functional status prior to undergoing cardiac surgery may be a useful marker for predicting outcomes when postoperative veno-arterial extracorporeal membrane oxygenation (V-A ECMO) is required. In this short communication, we present retrospective data on 83 patients at a single center who required V-A ECMO after cardiac surgery. Our results did not show a statistically significant association between premorbid functional status and mortality, though age was predictive of mortality. Future studies should explore other markers of functional status and relationships with additional outcomes.

Artificial heart valve reinforced with silk woven fabric and poly (ethylene glycol) diacrylate hydrogels composite.

The present study describes the preparation of woven silk fabric (WSF) and poly(ethylene glycol) diacrylate (PEGDA) hydrogel composite reinforced artificial heart valve (SPAHV). Interestingly, the longitudinal and latitudinal elastic modulus of the SPAHV composite can achieve at 54.08 ± 3.29 MPa and 23.96 ± 2.18 MPa, respectively, while its volume/mass swelling ratio and water permeability was 1.9 %/2.8 % and 3 mL/(cm2∙min), respectively, revealing remarkable anisotropic mechanical properties, low water swelling property and water permeability. The in vitro & in vivo biocompatibility and anti-calcification ability of SPAHV were further examined using L929 mouse fibroblasts and Sprague Dawley (SD) male rat model under 8 weeks of subcutaneous implantation. The expression of pro-inflammatory cytokine TNF-α and anti-inflammatory cytokine IL-10 was determined by immunohistochemical staining, as well as the H&E staining and alizarin red staining were accessed. The results showed that the composites possess better biocompatibility, resistance to degradation and anti-calcification ability compared to the control group (p < 0.05). Thus, the SPAHV composite with robust mechanical properties and biocompatibility has potential application for artificial heart valves.

Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model.

BACKGROUND: The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. METHODS: Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. RESULTS: All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves. CONCLUSIONS: The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.

Three-dimensional fluid-structure interaction simulation of the Wheatley aortic valve.

Valvular heart diseases (such as stenosis and regurgitation) are recognized as a rapidly growing cause of global deaths and major contributors to disability. The most effective treatment for these pathologies is the replacement of the natural valve with a prosthetic one. Our work considers an innovative design for prosthetic aortic valves that combines the reliability and durability of artificial valves with the flexibility of tissue valves. It consists of a rigid support and three polymer leaflets which can be cut from an extruded flat sheet, and is referred to hereafter as the Wheatley aortic valve (WAV). As a first step towards the understanding of the mechanical behavior of the WAV, we report here on the implementation of a numerical model built with the ICFD multi-physics solver of the LS-DYNA software. The model is calibrated and validated using data from a basic pulsatile-flow experiment in a water-filled straight tube. Sensitivity to model parameters (contact parameters, mesh size, etc.) and to design parameters (height, material constants) is studied. The numerical data allow us to describe the leaflet motion and the liquid flow in great detail, and to investigate the possible failure modes in cases of unfavorable operational conditions (in particular, if the leaflet height is inadequate). In future work the numerical model developed here will be used to assess the thrombogenic properties of the valve under physiological conditions.

Overset meshing in combination with novel blended weak-strong fluid-structure interactions for simulations of a translating valve in series with a second valve.

Mechanical circulatory support (MCS) devices can bridge the gap to transplant whilst awaiting a viable donor heart. The Realheart Total Artificial Heart is a novel positive-displacement MCS that generates pulsatile flow via bileaflet mechanical valves. This study developed a combined computational fluid dynamics and fluid-structure interaction (FSI) methodology for simulating positive displacement bileaflet valves. Overset meshing discretised the fluid domain, and a blended weak-strong coupling FSI algorithm was combined with variable time-stepping. Four operating conditions of relevant stroke lengths and rates were assessed. The results demonstrated this modelling strategy is stable and efficient for modelling positive-displacement artificial hearts.

Total artificial heart implantation as a bridge to transplantation in the United States.

OBJECTIVES: Although the SynCardia total artificial heart (SynCardia Systems, LLC) was approved for use as a bridge to transplantation in 2004 in the United States, most centers do not adopt the total artificial heart as a standard bridging strategy for patients with biventricular failure. This study was designed to characterize the current use and outcomes of patients placed on total artificial heart support. METHODS: The United Network of Organ Sharing Standard Transplant Research File was queried to identify total artificial heart implantation in the United States between 2005 and 2018. Multivariable Cox regression models were used for risk prediction. RESULTS: A total of 471 patients (mean age, 49 years; standard deviation, 13 years; 88% were male) underwent total artificial heart implantation. Of 161 transplant centers, 11 centers had cumulative volume of 10 or more implants. The 6-month cumulative incidence of mortality on the total artificial heart was 24.6%. The 6-month cumulative incidence of transplant was 49.0%. The 1-year mortality post-transplantation was 20.0%. Cumulative center volume less than 10 implants was predictive of both mortality on the total artificial heart (hazard ratio, 2.2, 95% confidence interval, 1.5-3.1, P < .001) and post-transplant mortality after a total artificial heart bridge (hazard ratio, 1.5, 95% confidence interval, 1.0-2.2, P = .039). CONCLUSIONS: Total artificial heart use is low, but the total artificial heart can be an option for biventricular bridge to transplant with acceptable bridge to transplant and post-transplant survival, especially in higher-volume centers. The observation of inferior outcomes in lower-volume centers raises questions as to whether targeted training, center certifications, and minimum volume requirements could improve outcomes for patients requiring the total artificial heart.

Current and future options for adult biventricular assistance: a review of literature.

In cardiogenic shock various short-term mechanical assistances may be employed, including an Extra Corporeal Membrane Oxygenator and other non-dischargeable devices. Once hemodynamic stabilization is achieved and the patient evolves towards a persisting biventricular dysfunction or an underlying long-standing end-stage disease is present, aside from Orthotopic Heart Transplantation, a limited number of long-term therapeutic options may be offered. So far, only the Syncardia Total Artificial Heart and the Berlin Heart EXCOR (which is not approved for adult use in the United States unlike in Europe) are available for extensive implantation. In addition to this, the strategy providing two continuous-flow Left Ventricular Assist Devices is still off-label despite its widespread use. Nevertheless, every solution ensures at best a 70% survival rate (reflecting both the severity of the condition and the limits of mechanical support) with patients suffering from heavy complications and a poor quality of life. The aim of the present paper is to summarize the features, implantation techniques, and results of current devices used for adult Biventricular Mechanical Circulatory Support, as well as a glance to future options.

Enhanced Anticoagulation of Hierarchy Liquid Infused Surfaces in Blood Flow.

Liquid infused surfaces (LIS) hold remarkable potential in anticoagulation. However, liquid loss of LIS in the bloodstream remains a challenge toward its clinical application. Here, micronano hierarchy structures are obtained on the titanium alloy substrate by regulating the microspheres' distribution. When the gap between the microspheres is smaller than the diameter of the red blood cell (RBC), the LIS is more stable under the blood wash and presents a better anticoagulation performance. The proper interval is found to prevent the RBCs from entering the gap and remove the liquid on the surface. The retained thickness of the liquid film is measured by the atomic force microscopy (AFM) technique. The LIS is applied on the front guide vane of an artificial heart pump and exhibits significant improvement on anticoagulation in the blood circulation in vitro for 25 h. The techniques and findings can be used to optimize the anticoagulation performance of LIS-related biomedical implant devices.

Biomechanical Scaffolds of Decellularized Heart Valves Modified by Electrospun Polylactic Acid.

Enhancing the mechanical properties and cytocompatibility of decellularized heart valves is the key to promote the application of biological heart valves. In order to further improve the mechanical properties, the electrospinning and non-woven processing methods are combined to prepare the polylactic acid (PLA)/decellularized heart valve nanofiber-reinforced sandwich structure electrospun scaffold. The effect of electrospinning time on the performance of decellularized heart valve is investigated from the aspects of morphology, mechanical properties, softness, and biocompatibility of decellularized heart valve. Results of the mechanical tests show that compared with the pure decellularized heart valve, the mechanical properties of the composite heart valve were significantly improved with the tensile strength increasing by 108% and tensile strain increased by 571% when the electrospinning time exceeded 2 h. In addition, with this electrospinning time, the composite heart valve has a certain promoting effect on the human umbilical vein endothelial cells proliferation behavior. This work provides a promising foundation for tissue heart valve reendothelialization to lay the groundwork for organoid.

Effects of biventricular shunt on pump characteristics in a maglev total artificial heart.

Severe left ventricular failure can progress to right ventricular failure, necessitating alternatives to heart transplantation, such as total artificial heart (TAH) treatment. Conventional TAHs encounter challenges associated with miniaturization and hemocompatibility owing to their reliance on mechanical valves and bearings. A magnetically levitated TAH (IB-Heart) was developed, utilizing a magnetic bearing. The IB-Heart features a distinctive biventricular shunt channel situated between the flow paths of the left and right centrifugal blood pumps, simplifying and miniaturizing its control system. However, the impact of these shunt channels remains underexplored. This study aimed to investigate the effects of shunt flow on pump characteristics and assess the IB-Heart's potential to regulate flow balance between systemic and pulmonary circulation. At a rotational speed of 2000 rpm and flow rate range of 0-10 L/min, shunt flow exhibited a minor impact, with a 1.4 mmHg (1.3%) effect on pump characteristics. Shunt flow variation of about 0.13 L/min correlated with a 10 mmHg pressure difference between the pumps' afterload and preload conditions. This variance was linked to changes in the inlet flow rates of the left and right pumps, signifying the ventricular shunt structure's capacity to mirror the function of an atrial shunt in alleviating pulmonary congestion. The IB-Heart's ventricular shunt structure enables passive regulation of left-right flow balance. The findings establish a fundamental technical groundwork for the development of IB-Hearts and TAHs with similar shunt structures. The innovative coupling of centrifugal pumps and the resultant effects on flow dynamics contribute to the advancement of TAH technology.

Case report-CARMAT: the first experience with the Aeson bioprosthetic total artificial heart as a bridge to transplantation in a case of post-infarction ventricular septal rupture.

Background: Post-infarction ventricular septal defects remain one of the most feared complications after myocardial infarction with high mortality rates. In special cases, surgical or interventional treatment strategies are technically not feasible and do not always lead to a good outcome. Case presentation: A 58-year-old male patient in cardiogenic shock with a very large ventricular septal (VSD) defect (4.9 cm × 5 cm) due to myocardial infarction was presented in our department. Acute stabilization was achieved using peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. Neither surgical nor interventional therapy was considered as a sufficient option due to the unsuitable anatomy of the VSD and the patient was listed for heart transplantation. After 2 weeks on ECMO, bleeding and infectious complications occurred. Due to organ shortage, urgent implantation of the bioprosthetic total artificial heart (TAH) Aeson device (CARMAT) remained the only useful strategy to achieve a mid- or long-term bridge to transplantation. After successful implantation and good recovery with the Aeson device, the patient was transplanted 4 weeks after implantation. Conclusion: Post-infarction ventricular septal defects are highly challenging and are commonly associated with a poor prognosis. The implantation of the new Aeson TAH device is a promising therapeutic option, allowing a safe and long-term bridging to heart transplantation.

Functional regeneration at the blood-biomaterial interface.

The use of cardiovascular implants is commonplace in clinical practice. However, reproducing the key bioactive and adaptive properties of native cardiovascular tissues with an artificial replacement is highly challenging. Exciting new treatment strategies are under development to regenerate (parts of) cardiovascular tissues directly in situ using immunomodulatory biomaterials. Direct exposure to the bloodstream and hemodynamic loads is a particular challenge, given the risk of thrombosis and adverse remodeling that it brings. However, the blood is also a source of (immune) cells and proteins that dominantly contribute to functional tissue regeneration. This review explores the potential of the blood as a source for the complete or partial in situ regeneration of cardiovascular tissues, with a particular focus on the endothelium, being the natural blood-tissue barrier. We pinpoint the current scientific challenges to enable rational engineering and testing of blood-contacting implants to leverage the regenerative potential of the blood.

Postoperative management and nursing care after implantation of a total artificial heart: Scoping review.

INTRODUCTION: End-stage heart failure (HF) is a condition whose only successful long-term treatment, with a survival of more than 10 years, is heart transplantation. However, limited organ availability and the progressive increase in the number of patients with advanced HF have served as an impetus for the development of implantable mechanical assistive devices. AIM: To provide an overview of postoperative management and nursing care after the implementation of a Total Artificial Heart (TAH). METHODS: A scoping review was carried out by consulting the PUBMED, CINAHL, and COCHRANE databases. From all the documents located, information was extracted on the date of publication, country of publication, type of study, and results of interest to answer the research question. In addition, the degree of recommendation was identified. RESULTS: Twenty-three documents were included in the scoping review. Results were classified in relation to: 1) description of the CAT SynCardia®; 2) nursing care in the immediate postoperative period (management of the device and management of hematological, infectious, nephrological, nutritional complications, related to immobilization, sleep-rest disturbances, psychological disorders, and patient and family education); and 3) follow-up at home. CONCLUSIONS: The complexity of implantation of the TAH, the multiple related complications that can arise during this process, both in the immediate post-operative and late, require a standardised and multidisciplinary management. The absence of standardised protocols raises the need for future studies to measure the effectiveness of care in patients with TAH. A multidisciplinary approach is crucial. Nurses must acquire autonomy and involvement in decision-making and develop competencies to address the patient's and family's physiological and psychosocial needs.

Human fitting of pediatric and infant continuous-flow total artificial heart: visual and virtual assessment.

Background: This study aimed to determine the fit of two small-sized (pediatric and infant) continuous-flow total artificial heart pumps (CFTAHs) in congenital heart surgery patients. Methods: This study was approved by Cleveland Clinic Institutional Review Board. Pediatric cardiac surgery patients (n = 40) were evaluated for anatomical and virtual device fitting (3D-printed models of pediatric [P-CFTAH] and infant [I-CFTAH] models). The virtual sub-study consisted of analysis of preoperative thoracic radiographs and computed tomography (n = 3; 4.2, 5.3, and 10.2 kg) imaging data. Results: P-CFTAH pump fit in 21 out of 40 patients (fit group, 52.5%) but did not fit in 19 patients (non-fit group, 47.5%). I-CFTAH pump fit all of the 33 patients evaluated. There were critical differences due to dimensional variation (p < 0.0001) for the P-CFTAH, such as body weight (BW), height (Ht), and body surface area (BSA). The cutoff values were: BW: 5.71 kg, Ht: 59.0 cm, BSA: 0.31 m2. These cutoff values were additionally confirmed to be optimal by CT imaging. Conclusions: This study demonstrated the range of proper fit for the P-CFTAH and I-CFTAH in congenital heart disease patients. These data suggest the feasibility of both devices for fit in the small-patient population.

Review of Implantable Left Ventricular Assist Devices.

Mechanical circulatory support has been an indispensable treatment for severe heart failure. While the development of a total artificial heart has failed, left ventricular assist devices (LVAD) have evolved from extracorporeal to implantable types. The first generation implantable LVAD (pulsatile device) was used as a bridge to transplantation, and demonstrated improvement in survival rate and activity of daily living. The evolution from the first-generation (pulsatile device) to the second-generation (continuous flow device: axial flow pump and centrifugal pump) has resulted in many clinical benefits by reducing mechanical failures and minimizing device size. Furthermore, third-generation devices, which use a moving impeller suspended by magnetic and/or hydrodynamic forces, have improved overall device reliability and durability. Unfortunately, there are still many device-related complications, and further device development and improvement of patient management methods are required. However, we expect to see further development of implantable VADs, including for destination therapy, in future.

Bio-SHARPE: Bioinspired Soft and High Aspect Ratio Pumping Element for Robotic and Medical Applications.

The advent of soft robots has solved many issues posed by their rigid counterparts, including safer interactions with humans and the capability to work in narrow and complex environments. While much work has been devoted to developing soft actuators and bioinspired mechatronic systems, comparatively little has been done to improve the methods of actuation. Hydraulically soft actuators (HSAs) are emerging candidates to control soft robots due to their fast responses, low noise, and low hysteresis compared to compressible pneumatic ones. Despite advances, current hydraulic sources for large HSAs are still bulky and require high power availability to drive the pumping plant. To overcome these challenges, this work presents a new bioinspired soft and high aspect ratio pumping element (Bio-SHARPE) for use in soft robotic and medical applications. This new soft pumping element can amplify its input volume to at least 8.6 times with a peak pressure of at least 40 kPa. The element can be integrated into existing hydraulic pumping systems like a hydraulic gearbox. Naturally, an amplification of fluid volume can only come at the sacrifice of pumping pressure, which was observed as a 19.1:1 reduction from input to output pressure. The new concept enables a large soft robotic body to be actuated by smaller fluid reservoirs and pumping plant, potentially reducing their power and weight, and thus facilitating drive source miniaturization. The high amplification ratio also makes soft robotic systems more applicable for human-centric applications such as rehabilitation aids, bioinspired untethered soft robots, medical devices, and soft artificial organs. Details of the fabrication and experimental characterization of the Bio-SHARPE and its associated components are given. A soft robotic squid and an artificial heart ventricle are introduced and experimentally validated.