Mechanical Circulatory Support Implantation Research Articles

Use of intraaortic balloon pump in cardiogenic shock patients.

The relevance of the use of intra-aortic balloon pump (IABP) in cardiogenic shock (CS) has been discussed over the past years. The aim of this study is to describe asingle-centre 10-year experience with IABP and analyse the risk factors for 30-day mortality. The data for this single-centre, observational, retrospective study were drawn from records dated from January 2012 to May 2022 pertaining to patients presenting with CS, treated with IABP and hospitalised at the Department of Acute Cardiology, Institute for Clinical and Experimental Medicine, Prague. Among the patients included in the study, 87% patients presented with newly developed heart failure. The leading cause of CS was acute myocardial infarction accounting for 86% of cases. Hospital mortality was recorded at 39% and the 30-day mortality reached 43%. Upon multi-variable analysis, only the vasoactive inotropic score on day 5 emerged as astatistically significant predictor for 30-day mortality (p=0.0055). Cox regression analysis revealed that the presence of mechanical complications was the only variable identified as yielding astatistically significant impact on the 30-day survival (Log-rank p=0.014, HR 2.19, 95% CI: 1.15‒4.15). There was no statistically significant difference in the 30-day mortality across the SCAI classes. The main cause of CS was anewly developed acute heart failure secondary to acute myocardial infarction. Despite the implementation of mechanical circulatory support, both in-hospital and 30-day mortality rates remained high. Increased vasoactive inotropic score and presence of mechanical complications were identified as significant predictors the 30-day survival (Tab. 6, Fig. 1, Ref. 36). Text in PDF www.elis.sk Keywords: cardiogenic shock, IABP, risk factors, mortality, Czech Republic, AMICS.

SCAI SHOCK stage classification: valid for all indications and devices in patients with short-term mechanical circulatory support?

Abstract Funding Acknowledgements None. Background The Society for Cardiovascular Angiography and Intervention (SCAI) SHOCK stage has demonstrated prognostic value in patients with cardiogenic shock (CS), including patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. It has also been validated in different scenarios as acute coronary syndrome -ACS- or out-of-hospital cardiac arrest. Purpose Our objective was to study the prognostic value of SCAI SHOCK stage in different indications and etiologies requiring different types of short-term mechanical circulatory support (MCS). Methods Retrospective analysis of consecutive patients supported with VA-ECMO or Impella CP® in a referral center. We studied the SCAI SHOCK stage at MCS implantation according different devices, indication and etiology, and its relationship with in-hospital and follow-up survival. Results 263 patients were included between 2014-March 2023 (Table). The SCAI SHOCK stage was less advanced in complex high risk percutaneous coronary intervention (CHIP-PCI) indication and more advanced in postcardiotomy shock, myocarditis, pulmonary embolism (PE), refractory cardiac arrest or electric storm (Figure A). In-hospital survival was 41.1% and it was significantly lower as SCAI SHOCK stage increased (A 83.9%, B 100%, C 66.7%, D 39.2%, E 24.5%; p=0.000), as well as in follow-up for a median time of 24.5 [47] months (figure B). This association was maintained with both types of devices separately: VA-ECMO (A 80%, B 100%, C 33.3%, D 38.9%, E 24.5%, p=0.001) and Impella (A 84%, B 100%, C 75%, D 42.9%, E 25%, p=0.005). Regarding the indication and etiology for MCS, SCAI SHOCK classification was significantly related with survival in CS indication, as well as in ACS and heart failure (HF) etiology (Figure B). However, no relationship between SCAI and survival was observed in indications as CHIP-PCI (A 83.9%, B 100%, C 50%; p=0.386), electrical storm (C 0%, D 100%, E 70%; p=0.075) and postcardiotomy shock (D 35.6%, E 20%; p=0.470), neither in etiologies as PE (D 0%, E 28.6%; p=1), infective endocarditis (D 28.6%, E 0%; p=1), myocarditis (D 100%, E 0%; p=0.250),and other causes of cardiac arrest (D 0%, E 25%; p=1), nor in patients admitted for elective cardiac surgery. Conclusions SCAI SHOCK stage classification showed prognostic value in patients with short-term MCS indicated by diverse etiologies, including both VA-ECMO and Impella CP devices. The prognostic value was maintained for the indication of CS, and in ACS and HF etiologies, but not in electrical storm, CHIP-PCI, PE, myocarditis or postcardiotomy shock. Studies are needed to validate this classification in other settings.TableFigure

Preparation for implantation of mechanical circulatory support: psychological adjustment and treatment of mental disorders in the pre- and postoperative period.

Treatment of patients with advanced heart failure (HF) with the use of left ventricular assist devices (LVADs) improves the quality of life and the length of survival. Despite the undeniable benefits associated with improved physical performance, as a result of the decrease of the underlying disease symptoms, it carries the risk of complications in the area of the patient's somatic and psychological status. Long-term circulatory failure can contribute to a weakening of the adaptative mechanism and consequently lead to a variety of emotional disruptions. Patients must face the fear of imminent physical, family, and social changes that LVAD requires. They may experience sleep disorders, mood disorders, anxiety disorders, and in the early postoperative period also disorders of consciousness with a pattern of delirium. For this reason, it is advisable to provide multidisciplinary medical care for the patient at all stages of treatment, including regular monitoring of general health and mental health. This article presents risk factors for psychiatric disorders in patients with LVADs and ways of pharmacological and non-pharmacological management when these factors are identified and disorders are diagnosed.

(1202) - Aortic Root Thrombosis After Temporary Mechanical Circulatory Support Implantation - A Case Report

(1202) - Aortic Root Thrombosis After Temporary Mechanical Circulatory Support Implantation - A Case Report

Impact of the Timing of Mechanical Circulatory Support on the Outcomes in Myocardial Infarction-Related Cardiogenic Shock: Subanalysis of the PREPARE CS Registry.

(1) Background: Mechanical circulatory support (MCS) in myocardial infarction-associated cardiogenic shock is subject to debate. This analysis aims to elucidate the impact of MCS's timing on patient outcomes, based on data from the PREPARE CS registry. (2) Methods: The PREPARE CS prospective registry includes patients who experienced cardiogenic shock (SCAI classes C-E) and were subsequently referred for cardiac catheterization. Our present analysis included a subset of this registry, in whom MCS was used and who underwent coronary intervention due to myocardial infarction. Patients were categorized into an Upfront group and a Procedural group, depending on the timing of MCS's introduction in relation to their PCI. The endpoint was in-hospital mortality. (3) Results: In total, 71 patients were included. MCS was begun prior to PCI in 33 (46%) patients (Upfront), whereas 38 (54%) received MCS during or after the initiation of PCI (Procedural). The groups' baseline characteristics and hemodynamic parameters were comparable. The Upfront group had a higher utilization of the Impella® device compared to extracorporeal membrane oxygenation (67% vs. 33%), while the Procedural group exhibited a balanced use of both (50% vs. 50%). Most patients suffered from multi-vessel disease in both groups (82% vs. 84%, respectively; p = 0.99), and most patients required a complex PCI procedure; the latter was more prevalent in the Upfront group (94% vs. 71%, respectively; p = 0.02). Their rates of complete revascularization were comparable (52% vs. 34%, respectively; p = 0.16). Procedural CPR was significantly more frequent in the Procedural group (45% vs. 79%, p < 0.05); however, in-hospital mortality was similar (61% vs. 79%, respectively; p = 0.12). (4) Conclusions: The upfront implantation of MCS in myocardial infarction-associated CS did not provide an in-hospital survival benefit.

Peripartum Cardiogenic Shock and Mechanical Circulatory Support

Despite remarkable improvements in the past two decades, the annual cardiovascular mortality rate has remained higher for women than for men. Pregnant women represent an underinvestigated population in clinical research, and the mechanisms of long-term cardiovascular complications in women with obstetric complications remain to be elucidated. Regarding advanced heart failure during pregnancy, interventional approaches are effective but still underutilised. Percutaneous mechanical circulatory support is a valuable option for peripartum cardiogenic shock, although its use during pregnancy is still limited. Survival rates have improved in recent years, but further emphasis on the importance of early recognition and initiation of heart failure treatment in this patient group is warranted. The aims of this review are to summarise the current literature on the implementation of mechanical circulatory support in cardiogenic shock during pregnancy and delivery and to understand the role of percutaneous ventricular assist devices in the management of such conditions.

Role of Genetic Polymorphisms in the Development of Complications in Patients with Implanted Left Ventricular Assist Devices: HeartWare, HeartMate II, and HeartMate 3

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.

Abstract 13454: Safe Large Bore Access via the Third Part of the Axillary Artery for Mechanical Circulatory Support Implantation

For patients in cardiogenic shock, percutaneous mechanical circulatory support devices (MCSD) have emerged as critical tool to improve hemodynamics and optimize end-organ perfusion; successfully bridging patients to recovery, decision or transplantation. The most commonly utilized MCSD is the femoral intra-aortic balloon pump (IABP). However, femoral access hampers the patient's mobility, quality of life, and capacity to participate in rehabilitation. The advent of the axillary artery approach has served to circumvent limitations associated with the femoral artery approach. However, optimum anatomical placement of IABP within the axillary artery (axIABP) is a topic of debate considering its proximity to the brachial plexus. Here, we report our experince with percutaneous access of the third poriton of the axillary artery which showed promising results with minimal device related complications or adverse events. Methods/Results: Between 2017-2023, a total of 89 patients in cardiogenic shock underwent percutaneous axIABP placement at the Mayo Clinic, MN. All demographic, clinical, and periprocedural data were obtained from hospital chart review and recorded in a database under IRB approval. Indications for axIABP support was determined by multidisciplinary assessment. Complications encountered in the cohort included infection at site 6.7% (n=6), device malfunction [rupture, fracture, leak] 8.98%(n=8), and balloon migration 5.61% (n=5). One patient developed local erythema, 4 (4.49%) patients developed significant vascular complications, including access site bleeding in two patients 2.24%, arterial thrombosis in three patients 3.37%, and self-limited intracranial bleeding in one patient 1.12%. Of note, no nerve injury or damage was observed in the entire patient cohort. Conclusion: Our study highlights the feasibility of percutaneous axIABP in the third portion of the axillary artery, while assessing safety profile and ease of removal. Notably in our review, we did not encounter any brachial nerve damage. Ultrasound was pivotal in identifying and avoiding nerves and nerve bundles during initial access. In conclusion, this approach of axIABP insertion is feasible and can be leveraged for delivery of future innovation in MCSD

OC 60.3 Prevention of Hemorrhage after Implantation of Mechanical Circulatory Support with a Purified Von Willebrand Factor Concentrate: Results of the Early Terminated Randomized Controlled PHAM Trial

OC 60.3 Prevention of Hemorrhage after Implantation of Mechanical Circulatory Support with a Purified Von Willebrand Factor Concentrate: Results of the Early Terminated Randomized Controlled PHAM Trial

TCT-115 Safe Large-Bore Access via the Third Part of the Axillary Artery for Mechanical Circulatory Support Implantation

TCT-115 Safe Large-Bore Access via the Third Part of the Axillary Artery for Mechanical Circulatory Support Implantation

Right ventricular global dysfunction score: a new concept of right ventricular function assessment in patients with heart failure with reduced ejection fraction (HFrEF).

Right ventricular (RV) function is currently being evaluated solely according to the properties of RV myocardium. We have tested a concept that in patients with heart failure with reduced ejection fraction (HFrEF), RV assessment should integrate the information about both RV function as well as size. A total of 836 stable patients with HFrEF (LVEF 23.6 ± 5.8%, 82.8% males, 68% NYHA III/IV) underwent echocardiographic evaluation and were prospectively followed for a median of 3.07 (IQRs 1.11; 4.89) years for the occurrence of death, urgent heart transplantation or implantation of mechanical circulatory support. RV size (measured as RV-basal diameter, RVD1) was significantly associated with an adverse outcome independent of RV dysfunction grade (p = 0.0002). The prognostic power of RVD1 was further improved by indexing to body surface area (RVD1i, p < 0.05 compared to non-indexed value). A novel parameter named RV global dysfunction score (RVGDs) was calculated as a product of RVD1i and the degree of RV dysfunction (1-4 for preserved RV function, mild, moderate and severe dysfunction, respectively). RVGDs showed a superior prognostic role compared to RV dysfunction grade alone (ΔAUC >0.03, p < 0.0001). In every subgroup of RVGDs (<20, 20-40, 40-60, >60), patients with milder degree of RV dysfunction but more dilated RV had similar outcome as those with more severe degree of RV dysfunction but smaller RV size (all p > 0.50), independent of tricuspid regurgitation severity and degree of pulmonary hypertension. RV dilatation is a manifestation of RV dysfunction. The evaluation of RV performance should integrate the information about both RV size and function.

Nosocomial infections in patients requiring short-term mechanical circulatory support: characteristics, risk factors and prognosis

Abstract Funding Acknowledgements Type of funding sources: None. Background The use of short-term mechanical circulatory support (MCS) has been increasing in recent years. Infection is a frequent complications and seems to contribute to increased morbidity and mortality. Purpose Our objective was to describe the profile of infections in patients with short-term MCS, as well as factors related to their appearance and their prognostic influence. Methods Retrospective analysis of consecutive cases of venoarterial extracorporeal membrane oxygenator (VA-ECMO) or Impella CP® implantation in a referral center. We characterized the infections during the entire hospitalization and analyzed their relationship with different variables and survival. Infection as microbiological isolation (no colonization) or clinical suspicion that motivates antimicrobial therapy with therapeutic intent. Results 232 patients between 2014-sep 2022 (Table). A total of 104 (56.5%) patients presented infection, respiratory tract (other than pneumonia) (23.3%) was the most prevalent. The most frequently isolated microorganisms were Gram-negative bacteria and Staphylococcus aureus, with 8.2% multidrug-resistant bacteria (Figure). Infection appeared during MCS in 25% of patients, 13% after its removal, 11% at both times, and 6.1% of patients were already infected at MCS implant. Baseline characteristics and admission evolution depending on the presence of infection are described in table. Infections were significantly more frequent in cardiogenic shock indication and bridge to recovery intention, and non-percutaneous access. We observed a non-statistically significant trend towards more infections under VA-ECMO vs Impella CP® device. The following factors were associated with the appearance of infection: a longer time under MCS, endotracheal intubation (especially out-of-hospital), longer invasive mechanical ventilation (MV) and tracheostomy, right ventricular dysfunction, the need for vasoactive drugs, and corticosteroids treatment during more than 3 days. The appearance of infection was significantly associated with other complications (Table). At multivariate analysis a longer time under MCS (HR 1.15, IC95% 1.06-1.26, p=0.002) and MV (HR 1.06, IC95% 1.02-1.09, p=0,001) were independently related to infections. Overall in-hospital mortality was 59.8% (n=137), 3.9% due to infection. No direct relationship was observed between in-hospital mortality and the presence of infection (57.4% in infected patients vs 61.7% without infection, p=0.587). Patient already infected at MCS implantation had higher mortality (87.7% vs 57% during MCS vs 41.9% after MCS, p=0.030). Conclusions Infections in patients under short-term SCM are frequent, highlighting the upper respiratory tract infection. Longer support and ventilation time were independently related to infections. The development of infection was associated with other complications, but not with higher in-hospital mortality. Short-term MCS in already infected patients was related to high mortality.

Therapeutic limitation in cardiogenic shock: lessons learnt from the Altshock-2 registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Mortality from cardiogenic shock (CS) shows great disparities (1). This evidence reflects variations in access to care and medical practice, related to the lack of clear guidelines for appropriate patient selection for mechanical circulatory support (MCS) application. In this regard, the results of most trials or meta-analyses were neutral on survival, and the costs in terms of patient morbidity/mortality are high and unproven (2). Accordingly, a judicious use of MCS is crucial for an adequate resource allocation and to avoid futility. Purpose To characterize trends in use of support devices and compare outcomes between CS patients included in a contemporary national Cardiac Intensive Care Units (CICUs) registry, treated or not with MCS. Methods 324 sequential patients admitted with CS at a CICUs network between March 2020 and August 2022 were identified. We categorized patients according to treatment with MCS (n=204; 63%) and medical therapy (n=120; 37%). We investigated differences in clinical, laboratory, hemodynamics, echocardiographic and prognostic scores on admission, at 24-hours and at discharge. In-hospital outcome and mid-term survival were described for each treatment cohort. Comparison of continuous variables was performed using Student’s t-test. For categorical variables, the χ2 statistic was used. Results CS was a complication of acute myocardial infarction in 141 patients (44%) and of acute on chronic heart failure in 124 patients (38%); 58 patients (18%) presented with other diagnosis. In MCS cohort, we reported more advanced Society for Cardiovascular Angiography and Interventions (SCAI) shock stages and MCS implantation was more prevalent within 24-hours in SCAI C (48,6% on admission; 51,2% at 24-hours). In-hospital mortality did not differ between the two groups (38% in MCS and 37% in medically treated patients, p=0,874). Chronic kidney disease (OR 2.1, 95%CI 1.2-3.5, p=0,009), elevated lactates and SCAI stage at 24-hours (OR and 95%CI were, respectively, 3.45, 1.99-5.97 and 3.67, 2.46-5.47, p&amp;lt;0,001) emerged as major independent predictors of in-hospital mortality in MCS subgroup. A significant protective association persisted for those monitored with pulmonary artery catheter (OR 0.61, 95%CI 0.51-0.92, p=0.001). Among the 196 patients evaluated at mid-term follow up MCS treatment had not markedly improved cumulative survival compared to medical treatment (51,9% in MCS subgroup versus 55,6% in medical therapy, p=0,806). Palliative care team was rarely engaged (14% in MCS cohort vs 27% in medical therapy, p=0,83). Conclusions In this nation-wide study, mortality in MCS patients was high and no statistically significant difference on in-hospital and mid-term survival emerged between patients receiving MCS compared to medical therapy. Hence, a prompt and constant risk-stratification is mandatory to exclude patients too sick to derive any benefits from invasive therapies, avoiding futility.

Severe cardiogenic shock and cardiac arrest due to fulminant cardiac sarcoidosis: a case report

BackgroundCardiac sarcoidosis is found to occur in approximately 5% of patients with sarcoidosis. Its presentation can typically range from complete heart block to ventricular arrhythmias. This condition can rarely present with severe heart failure and cardiogenic shock requiring aggressive and timely management strategies. Advanced imaging techniques are usually required to assist with its diagnosis.Case presentationA 70-year-old woman with a history of pulmonary sarcoidosis presented with non-ST elevation myocardial infarction, congestive hepatopathy, and acute renal failure. Left heart catheterization showed evidence of non-obstructive coronary artery disease, and right heart catheterization revealed severely elevated filling pressures and depressed cardiac index. She underwent aggressive diuresis and placement of an intra-aortic balloon pump in addition to initiation of inotropic and vasopressor support. While in the cardiac intensive care unit, she experienced frequent episodes of ventricular tachycardia and went into cardiac arrest requiring cardiopulmonary resuscitation. High clinical suspicion for cardiac sarcoidosis was confirmed by cardiac magnetic resonance imaging findings. After starting immunosuppressive therapy for cardiac sarcoidosis, she demonstrated clinical improvement.ConclusionPatients with cardiac sarcoidosis may remain asymptomatic or present with conduction abnormalities and arrhythmias. They rarely present with severe biventricular heart failure and cardiogenic shock, and in such cases, they require timely initiation of pharmacologic and device therapies, along with implementation of mechanical circulatory support.

Hospital Procedural Volume Predicts Short-term Outcomes for Patients Undergoing Procedures Requiring Large-bore Access.

Large-bore access procedures (LBP), such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and implantation of mechanical circulatory support (MCS), have been increasing in practice.1 While hospitals with a higher volume of TAVR procedures showed reduced in-hospital mortality and related complications,2 the relationship between procedural volume and outcomes for LBPs, collectively, has not been established, which is the goal of this research letter. This is a retrospective cohort study whereby all hospitalizations with patients undergoing LBP from 1 January 2016 to 31 December 2018, in the United States, were identified using the Nationwide Readmissions Database (NRD).3 LBPs included TAVR, EVAR, balloon aortic valvuloplasty (BAV), and implantation of MCS. Outcomes of interest were in-hospital mortality, vascular complications, major bleeding, and 30-day readmissions. Major bleeding was defined as bleeding requiring blood transfusion. The annualized hospital volume of LBP was analysed as both continuous and categorical variables (in quartiles) for the mentioned outcomes. Quartiles were chosen to ensure an equal number of hospitalizations in each volume category—quartile 1 (Q1), quartile (Q2), quartile 3 (Q3), and quartile 4 (Q4). Q1 was defined as a low-volume hospital and Q4 as a high-volume hospital. Outcomes were compared against Q1 by controlling for age, sex, comorbidities, and the Elixhauser Comorbidity Index, and the related odds ratio (OR) was estimated. Restricted cubic splines with hierarchical models were created to incorporate hospital characteristics as random effects in the model to help assess any nonlinear relationship between the hospital’s volume and outcomes. We also divided LBPs into TAVR and non-TAVR populations to determine if such outcomes also applied to the non-TAVR LBP. The present study did not require the institutional review board approval per institutional policy for de-identified publicly available dataset.

The impact of temporary mechanical circulatory support strategies on thrombocytopenia

One common but not well-understood phenomenon of temporary mechanical circulatory support (MCS) use is thrombocytopenia. This clinical issue increases the risk of bleeding and the need for platelet transfusion. Additionally, heparin-induced thrombocytopenia must be considered as part of the differential diagnosis, which complicates patient management. In what follows, we analyze the degree and relative rate of platelet count drop with various temporary MCS strategies – Impella 5.5; Veno-venous Extracorporeal Membrane Oxygenation (VV ECMO); Veno-arterial ECMO (VA ECMO); Intra-aortic Balloon Pump (IABP) and Centrimag Biventricular Assist Device (BIVAD). A total of 337 cohort was investigated. 77 was included for analysis after strict exclusion criteria were utilized (platelet transfusions, bleeding complications, etc.). Repeated measure mixed effect and linear regression models were used to assess the percent platelet drop on implantation of MCS and recovery after explantation of MCS. A statistically significant mean percent drop occurred in MCS types – VA ECMO(−69.6%, p < 0.001), VV ECMO(−40.9%, p < 0.001), Impella 5.5(−20.9%, p = 0.01) and IABP(−28.3%, p = 0.01), except Centrimag BIVAD(−6.5%, p = 0.61). Platelet recovery to or above baseline occurred in VA ECMO(+107.0%, p = 0.42), Impella 5.5(+117.2%, p = 0.28), IABP(+108.3%, p = 0.37), VV-ECMO(163.3%, p = 0.01*) and Centrimag BIVAD(+100.1%, p = 0.99). These results show that the degree of thrombocytopenia depends on MCS device type and is reversible.

Abstract 12169: Re-Imagining Fontan Support: Novel Cavopulmonary Connection Can Accommodate Mechanical Circulatory Support, Augment Cardiac Output and Balance Hepatic Flow

Introduction: Improved Fontan survivorship requires novel treatments for late complications and inevitable failure. Typical total cavopulmonary connection (TCPC) shapes perform well in the short term yet competitive flows create challenges in providing mechanical circulatory support (MCS) due to two inflows/outflows. A novel, feasible Fontan shape, the Convergent Cavopulmonary Connection (CCPC), converges venous return to create a single inflow and outflow for easy institution of MCS, and maintains favorable hepatic flow distribution (HFD) and power loss. The impact of MCS on CCPC hemodynamic performance is still unknown. Hypothesis: In vitro implantation of a single MCS device into patient-specific CCPCs will be feasible and produce augmented cardiac output and acceptable HFD, compared to traditional TCPC. Methods: A benchtop mock circulatory flow loop using 60/40 glycerin equipped with inlet/outlet flow meters and outflow optical registers was used to analyze five 3D-printed TCPC and CCPC models derived from cardiac MRI images. Patient-specific flow conditions were applied to each model’s inlets/outlets. HFD was measured using an injection of blue tracer dye in the IVC and the optical concentration at the LPA and RPA outlets was compared. The CCPC models were also retrofitted to accommodate an Impella ventricular assist device (VAD) and PediPump VAD. HFD and cardiac index (CI) (IVC+SVC flow return) were compared with linear regression and paired t-test. Results: All CCPC HFD were within optimal range. Addition of either MCS device to the CCPC creates incremental increase of CI (p&lt;0.01) and significant improvement in HFD balance vs baseline TCPC (p=0.03), reflecting the dominance of the MCS mixing over anatomic influence on HFD. Conclusions: Patient-specific CCPC Fontan designs can successfully accommodate MCS implantation. Addition of MCS in benchtop testing shows improved CI and HFD, mitigating anatomic impact on HFD.

Metformin treatment is associated with improved outcome in patients with diabetes and advanced heart failure (HFrEF)

The role of metformin (MET) in the treatment of patients with advanced HFrEF and type 2 diabetes mellitus (DM) is not firmly established. We studied the impact of MET on metabolic profile, quality of life (QoL) and survival in these patients. A total of 847 stable patients with advanced HFrEF (57.4 ± 11.3 years, 67.7% NYHA III/IV, LVEF 23.6 ± 5.8%) underwent clinical and laboratory evaluation and were prospectively followed for a median of 1126 (IQRs 410; 1781) days for occurrence of death, urgent heart transplantation or mechanical circulatory support implantation. A subgroup of 380 patients (44.9%) had DM, 87 of DM patients (22.9%) were treated with MET. Despite worse insulin sensitivity and more severe DM (higher BMI, HbA1c, worse insulin resistance), MET-treated patients exhibited more stable HF marked by lower BNP level (400 vs. 642 ng/l), better LV and RV function, lower mitral and tricuspid regurgitation severity, were using smaller doses of diuretics (all p < 0.05). Further, they had higher eGFR (69.23 vs. 63.34 ml/min/1.73 m2) and better QoL (MLHFQ: 36 vs. 48 points, p = 0.002). Compared to diabetics treated with other glucose-lowering agents, MET-treated patients had better event-free survival even after adjustment for BNP, BMI and eGFR (p = 0.035). Propensity score-matched analysis with 17 covariates yielded 81 pairs of patients and showed a significantly better survival for MET-treated subgroup (p = 0.01). MET treatment in patients with advanced HFrEF and DM is associated with improved outcome by mechanisms beyond the improvement of blood glucose control.

Implantation of mechanical circulatory support systems and heart transplantation in patients with end-stage heart failure : Consensus paper of the DGK, DGTHG

The treatment of patients with advanced heart failure requires interdisciplinary care in a qualified heart failure team, especially prior to and in the follow-up of mechanical circulatory support (MCS) implantation and heart transplantation (HTx). The basic prerequisite is the early specialized evaluation of symptomatic patients even under optimized heart failure treatment. Diagnostics and treatment are initially aimed at improving the prognosis. If the prerequisites for MCS or HTx treatment are present, possible contraindications and problems have to be evaluated in order to achieve an optimal risk-benefit ratio for the abovementioned complex treatments with limited resources. The optimal treatment is still HTx if the conditions are right, so this should be sought in all potential patients. At the same time, the optimal individual transplantation window should not be missed. The provision of a MCS system is a treatment performed with very good results for patients with exclusion criteria for HTx or with hemodynamic instability that prevents a longer waiting time for a donor organ. Short-term and medium-term survival is now comparable to HTx when carefully indicated. Timely implantation before the onset of manifest end-organ damage is crucial. Optimized implementation of advanced treatment requires professional structures that enable effective interdisciplinary cooperation between different sectors of health care.

Implantation mechanischer Unterstützungssysteme und Herztransplantation bei Patienten mit terminaler Herzinsuffizienz

The treatment of patients with advanced heart failure requires interdisciplinary care in a qualified heart failure team, especially prior to and in the follow-up of mechanical circulatory support (MCS) implantation and heart transplantation (HTx). The basic prerequisite is the early specialized evaluation of symptomatic patients even under optimized heart failure treatment. Diagnostics and treatment are initially aimed at improving the prognosis. If the prerequisites for MCS or HTx treatment are present, possible contraindications and problems have to be evaluated in order to achieve an optimal risk-benefit ratio for the abovementioned complex treatments with limited resources. The optimal treatment is still HTx if the conditions are right, so this should be sought in all potential patients. At the same time, the optimal individual transplantation window should not be missed. The provision of a MCS system is a treatment performed with very good results for patients with exclusion criteria for HTx or with hemodynamic instability that prevents a longer waiting time for a donor organ. Short-term and medium-term survival is now comparable to HTx when carefully indicated. Timely implantation before the onset of manifest end-organ damage is crucial. Optimized implementation of advanced treatment requires professional structures that enable effective interdisciplinary cooperation between different sectors of health care.