Mechanical Circulatory Support in Heart Failure

Background: Extracorporeal life support (ECLS) therapy for refractory postcardiotomy cardiogenic shock (rPCS) is associated with high early mortality rates. This study aimed to identify negative predictors of mid-term survival and to assess health-related quality of life (HRQoL) and recovery of the survivors. Methods: Between 2017 and 2020, 142 consecutive patients received ECLS therapy following cardiac surgery. The median age was 66.0 [57.0–73.0] years, 67.6% were male and the median EuroSCORE II was 10.5% [4.2–21.3]. In 48 patients, HRQoL was examined using the 36-Item Short Form Survey (SF-36) and the modified Rankin-Scale (mRS) at a median follow-up time of 2.2 [1.9–3.2] years. Results: Estimated survival rates at 3, 12, 24 and 36 months were 47%, 46%, 43% and 43% (SE: 4%). Multivariable Cox Proportional Hazard regression analysis revealed preoperative EuroSCORE II (p = 0.013), impaired renal function (p = 0.010), cardiopulmonary bypass duration (p = 0.015) and pre-ECLS lactate levels (p = 0.004) as independent predictors of mid-term mortality. At the time of follow-up, 83.3% of the survivors were free of moderate to severe disability (mRS < 3). SF-36 analysis showed a physical component summary of 45.5 ± 10.2 and a mental component summary of 50.6 ± 12.5. Conclusions: Considering the disease to be treated, ECLS for rPCS is associated with acceptable mid-term survival, health-related quality of life and functional status. Preoperative EuroSCORE II, impaired renal function, cardiopulmonary bypass duration and lactate levels prior to ECLS implantation were identified as negative predictors and should be included in the decision-making process. Full article

(1) Background: Cardiogenic shock (CS) is associated with high morbidity and mortality. Frailty and cardiovascular diseases are intertwined, commonly sharing risk factors and exhibiting bidirectional relationships. The relationship of frailty and non-acute myocardial infarction with cardiogenic shock (non-AMI-CS) is poorly described. (2) Methods: We retrospectively analyzed the National Inpatient Sample from 2016 to 2020 and identified all hospitalizations for non-AMI-CS. We classified them into frail and non-frail groups according to the hospital frailty risk score cut-off of 5 and compared in-hospital outcomes. (3) Results: A total of 503,780 hospitalizations for non-AMI-CS were identified. Most hospitalizations involved frail adults (80.0%). Those with frailty had higher odds of in-hospital mortality (adjusted odds ratio [aOR] 2.11, 95% confidence interval [CI] 2.03–2.20, p < 0.001), do-not-resuscitate status, and discharge to a skilled nursing facility compared with those without frailty. They also had higher odds of in-hospital adverse events, such as acute kidney injury, delirium, and longer length of stay. Importantly, non-AMI-CS hospitalizations in the frail group had lower use of mechanical circulatory support but not rates of cardiac transplantation. (4) Conclusions: Frailty is highly prevalent among non-AMI-CS hospitalizations. Those accompanied by frailty are often associated with increased rates of morbidity and mortality compared to those without frailty. Full article

Heart failure, a common clinical syndrome caused by functional and structural abnormalities of the heart, affects 64 million people worldwide. Long-term mechanical circulatory support can offer lifesaving treatment for end-stage systolic heart failure patients. However, this treatment is not without complications. This review covers the major complications associated with implantable mechanical circulatory support devices, including strokes, pump thrombosis and gastrointestinal bleeding. These complications were assessed in patients implanted with the following devices: Novacor, HeartMate XVE, CardioWest, Jarvik 2000, HeartMate II, EVAHEART, Incor, VentrAssist, HVAD and HeartMate 3. Complication rates vary among devices and remain despite the introduction of more advanced technology, highlighting the importance of device design and flow patterns. Beyond clinical implications, the cost of complications was explored, highlighting the difference in costs and the need for equitable healthcare, especially with the expected rise in the use of mechanical circulatory support. Future directions include continued improvement through advancements in design and technology to reduce blood stagnation and mitigate high levels of shear stress. Ultimately, these alterations can reduce complications and enhance cost-effectiveness, enhancing both the survival and quality of life for patients receiving mechanical circulatory support. Full article

Left ventricular assist device (LVAD) implantation is one of the mechanical circulatory support (MCS) treatments for advanced heart failure (HF) patients. MCS has emerged as a lifesaving therapy that improves patients’ quality of life. However, MCS remains limited by a paradoxical coagulopathy accompanied by thrombosis and bleeding. The mechanisms of MCS thrombosis are increasingly being defined, but MCS-related bleeding, which is related to shear-mediated alteration of platelet function, remains poorly understood. Complications might develop due to the high non-physiological shear stress in the device and as a consequence of individual variability in response to the antithrombotic therapy. Thromboelastography (TEG) and genotyping of gene polymorphisms that are involved in the coagulation cascade and in the metabolism of the antithrombotic therapy might be valuable sources of information for the reduction of complication development. The aim of the study was to identify genetic factors related to the development of device complications according to the implanted LVAD type. We compared the clinical and genetic data of HF patients (n = 98) with/without complications with three types of implanted devices: HeartWare HVAD (HW), HeartMate II (HMII), and HeartMate 3 (HM3). rs9923231 in VKORC1 (95%CI −6.28–0.22, p = 0.04) and rs5918 in ITGB3 genes (95%CI 0.003–4.36, p = 0.05) showed significant association with the TEG coagulation index parameter, which identified hyper- and hypo-coagulation states. The wild genotype of rs5918 in the ITGB3 gene prevailed in patients implanted with HM3 devices, which developed fewer complications than with HMII (p = 0.04). Individual genetic information could be useful in the management of patients with HF and the implantation of MCS to reduce the development of complications. Full article

Clinical or subclinical malnutrition occurs in 30% to 70% of patients with advanced heart failure and increases the risk of postoperative adverse events. The main objective of this study was to assess the nutritional status of patients prior to left ventricular assist device (LVAD) implantation using different methods of malnutrition assessment and to evaluate the relationship between nutritional status and postoperative adverse events. A retrospective cohort study included 120 patients aged 26–74 years referred for LVAD surgery. Preoperative nutritional status (NRS-2002—Nutritional Risk Score 2002, NRI—Nutritional Risk Index, PNI—Prognostic Nutritional Index; TLC—total lymphocyte count) and postoperative adverse events were assessed. Moderate to severe malnutrition was found in 55.8%, 43.3%, 40.0%, and 20% of all patients, respectively, according to the PNI, NRI, TLC, and NRS-2002 scores. Patients with a TLC < 1200 cells/m³ had a higher risk of postoperative acute renal failure [hazard ratio (HR): 2.5; 95% confidence interval (95% CI): 1.01–6.3] and death during the observation period [HR = 2.1; 95% CI: 1.2–3.5]. Moderate to severe malnutrition was also associated with a significantly increased risk of in-hospital death [for the NRI score, HR = 4.9 (95% CI: 1.1–22.0); for the PNI score, HR = 5.0 (95% CI: 1.1–22.3)]. In conclusion, moderate to severe malnutrition prior to LVAD implantation has been identified as a risk factor for postoperative acute renal failure and mortality. Assessment of nutritional risk may improve patient selection and early initiation of nutritional support. Full article

Objectives: The aim of this study was to analyze outcomes in patients undergoing surgery for ventricular septal rupture (VSR) after myocardial infarction (MI) and the preoperative use of extracorporeal life support (ECLS) as a bridge to surgery. Methods: We included patients undergoing surgery for VSR from January 2009 until June 2021 from two centers in Germany. Patients were separated into two groups, those with and without ECLS, before surgery. Pre- and intraoperative data, outcome, and survival during follow-up were evaluated. Results: A total of 47 consecutive patients were included. Twenty-five patients were in the ECLS group, and 22 were in the group without ECLS. All the ECLS-group patients were in cardiogenic shock preoperatively. Most patients in the ECLS group were transferred from another hospital [n = 21 (84%) vs. no-ECLS (n = 12 (57.1%), p = 0.05]. We observed a higher number of postoperative bleeding complications favoring the group without ECLS [n = 6 (28.6%) vs. n = 16 (64%), p < 0.05]. There was no significant difference in the persistence of residual ventricular septal defect (VSD) between groups [ECLS n = 4 (16.7%) and no-ECLS n = 3 (13.6%)], p = 1.0. Total in-hospital mortality was 38.3%. There was no significant difference in in-hospital mortality [n = 6 (27.3%) vs. n = 12 (48%), p = 0.11] and survival at last follow-up between the groups (p = 0.50). Conclusion: We detected no statistical difference in the in-hospital and long-term mortality in patients who received ECLS as supportive therapy after MI-induced VSR compared to those without ECLS. ECLS could be an effective procedure applied as a bridge to surgery in patients with VSR and cardiogenic shock. Full article

Purpose: The withdrawal of HVAD in 2021 created a concern for the pediatric population. The alternative implantable centrifugal blood pump HeartMate 3 has since been used more frequently in children. This paper analyses the outcome of children on LVAD support provided with an HVAD or HM3. Methods: A retrospective analysis of the EUROMACS database on children supported with VAD < 19 years of age from 1 January 2009 to 1 December 2021 was conducted. All patients with an LVAD and either an HVAD or HM3 were included. Patients with missing data on VAD status and/or missing baseline and/or follow up information were excluded. Kaplan–Meier survival analysis was performed to evaluate survival differences. Analyses were performed using Fisher’s exact test. Results: The study included 150 implantations in 142 patients with 128 implants using an HVAD compared to 28 implants using an HM3. Nine patients (6%) needed temporary right ventricular mechanical support, which was significantly higher in the HM3 group, with 25% (p: 0.01). Patients in the HVAD group were significantly younger (12.7 vs. 14.5 years, p: 0.01), weighed less (45.7 vs. 60 kg, p: <0.000) and had lower BSA values (1.3 vs. 1.6 m², p: <0.000). Median support time was 204 days. Overall, 98 patients (69%) were discharged and sent home, while 87% were discharged in group HM3 (p: ns). A total of 123 children (86%) survived to transplantation, recovery or are ongoing, without differences between groups. In the HVAD group, 10 patients (8%) died while on support, whereas in 12% of HM3 patients died (p: 0.7). Conclusions: Survival in children implanted with an HM3 was excellent. Almost 90% were discharged and sent home on the device. Full article

(1) Background: Fluid resuscitation is a necessary part of therapeutic measures to maintain sufficient hemodynamics in extracorporeal membrane oxygenation (ECMO) circulation. In a post-hoc analysis, we aimed to investigate the impact of increased volume therapy in veno-arterial ECMO circulation on renal function and organ edema in a large animal model. (2) Methods: ECMO therapy was performed in 12 female pigs (Deutsche Landrasse × Pietrain) for 10 h with subsequent euthanasia. Applicable volume, in regard to the necessary maintenance of hemodynamics, was divided into moderate and extensive volume therapy (MVT/EVT) due to the double quantity of calculated physiologic urine output for the planned study period. Respiratory and hemodynamic data were measured continuously. Additionally, renal function and organ edema were assessed by blood and tissue samples. (3) Results: Four pigs received MVT, and eight pigs received EVT. After 10 h of ECMO circulation, no major differences were seen between the groups in regard to hemodynamic and respiratory data. The relative change in creatinine after 10 h of ECMO support was significantly higher in EVT (1.3 ± 0.3 MVT vs. 1.8 ± 0.5 EVT; p = 0.033). No major differences were evident for lung, heart, liver, and kidney samples in regard to organ edema in comparison of EVT and MVT. Bowel tissue showed a higher percentage of edema in EVT compared to MVT (77 ± 2% MVT vs. 80 ± 3% EVT; p = 0.049). (4) Conclusions: The presented data suggest potential deterioration of renal function and intestinal mucosa function by an increase in tissue edema due to volume overload in ECMO therapy. Full article

Background: Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno–arterial extracorporeal membrane oxygenation (VA–ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA–ECMO, clinical deterioration due to systemic inflammatory response syndrome (SIRS) resulting from the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur. To address this issue, cytokine adsorbers offer a valuable solution by eliminating blood proteins, thereby controlling SIRS and potentially improving hemodynamics. Consequently, a prospective, randomized, blinded clinical trial will be carried out with ECMOsorb. Methods and Study Design: ECMOsorb is a single-center, controlled, randomized, triple-blinded trial that will compare the hemodynamic effects of treatment with a VA–ECMO in combination with a cytokine adsorber (CytoSorb^®, intervention) to treatment with VA–ECMO only (control) in patients with cardiogenic shock (with or without prior cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support. Fifty-four patients will be randomized in a 1:1 fashion to the intervention or control group over a 36-month period. The primary endpoint of ECMOsorb is the improvement of the Inotropic Score (IS) 72 h after the intervention. Prognostic indicators, including mortality rates, hemodynamic parameters, laboratory findings, echocardiographic assessments, quality of life measurements, and clinical parameters, will serve as secondary outcome measures. The safety evaluation encompasses endpoints such as air embolisms, allergic reactions, peripheral ischemic complications, vascular complications, bleeding incidents, and stroke occurrences. Conclusions: The ECMOsorb trial seeks to assess the efficacy of a cytokine adsorber (CytoSorb^®; CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA–ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery. Full article

Background: The use of simultaneous veno-arterial extracorporeal membrane oxygenation (ECMO) with or without an Intra-Aortic Balloon Pump (IABP) is a widely used tool for mechanical hemodynamic support. Endothelial function, especially in relation to different cannulation techniques, is rarely investigated in the setting of extracorporeal life support (ECLS). In this study, we analyzed endothelial function in relation to hemodynamic and laboratory parameters for central and peripheral ECMO, with or without concomitant IABP support in a large animal model to gain a better understanding of the underlying basic mechanisms. Methods: In this large animal model, healthy female pigs with preserved ejection fraction were divided into the following groups related to cannulation strategy for ECMO and simultaneous IBAP support: control (no ECMO, no IABP), peripheral ECMO (pECMO), central ECMO (cECMO), pECMO and IABP or cECMO and IABP. During the experimental setting, the blood flow in the ascending aorta, left coronary artery and arteria carotis was measured. Afterwards, endothelial function was investigated after harvesting the right coronary artery, arteria carotis and renal artery. In addition, laboratory markers, such as creatine kinase (CK), creatine kinase muscle–brain (CK-MB), troponin, creatinine and endothelin were analyzed. Results: The blood flow in the ascending aorta and the left coronary artery was significantly lower in all discussed experimental settings compared to the control group. Of note, the cECMO cannulation strategy generated favorable hemodynamic circumstances with higher blood flow in the coronary arteries than pECMO regardless of flow circumstances in the ascending aorta. The concomitant usage of IABP did not result in an improvement of the coronary blood flow, but partially showed a negative impact on the endothelial function of coronary arteries in comparison to the control. These findings correlate to higher CK/CK-MB levels in the setting of cECMO + IABP and pECMO + IABP. Conclusions: The usage of mechanical circulatory support with concomitant ECMO and IABP in a large animal model might have an influence on the endothelial function of coronary arteries while not improving the coronary artery perfusion in healthy hearts with preserved ejection. Full article