Sex-related differences in patients presenting with heart failure-related cardiogenic shock.

BACKGROUND: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of all CS cases. Nevertheless, there is a lack of evidence on sex-related differences in HF-CS, especially regarding use of treatment and mortality risk in women vs. men. This study aimed to investigate potential differences in clinical presentation, use of treatments, and mortality between women and men with HF-CS. METHODS: In this international observational study, patients with HF-CS (without acute myocardial infarction) from 16 tertiary-care centers in five countries were enrolled between 2010 and 2021. Logistic and Cox regression models were used to assess differences in clinical presentation, use of treatments, and 30-day mortality in women vs. men with HF-CS. RESULTS: N = 1030 patients with HF-CS were analyzed, of whom 290 (28.2%) were women. Compared to men, women were more likely to be older, less likely to have a known history of heart failure or cardiovascular risk factors, and lower rates of highly depressed left ventricular ejection fraction and renal dysfunction. Nevertheless, CS severity as well as use of treatments were comparable, and female sex was not independently associated with 30-day mortality (53.0% vs. 50.8%; adjusted HR 0.94, 95% CI 0.75-1.19). CONCLUSIONS: In this large HF-CS registry, sex disparities in risk factors and clinical presentation were observed. Despite these differences, the use of treatments was comparable, and both sexes exhibited similarly high mortality rates. Further research is necessary to evaluate if sex-tailored treatment, accounting for the differences in cardiovascular risk factors and clinical presentation, might improve outcomes in HF-CS.

Clinical presentation, shock severity and mortality in patients with de novo versus acute-on-chronic heart failure-related cardiogenic shock.

AIMS: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of CS cases. Whether patients with de novo HF and those with acute-on-chronic HF in CS differ in clinical characteristics and outcome remains unclear. The aim of this study was to evaluate differences in clinical presentation and mortality between patients with de novo and acute-on-chronic HF-CS. METHODS AND RESULTS: In this international observational study, patients with HF-CS from 16 tertiary care centres in five countries were enrolled between 2010 and 2021. To investigate differences in clinical presentation and 30-day mortality, adjusted logistic/Cox regression models were fitted. Patients (n = 1030) with HF-CS were analysed, of whom 486 (47.2%) presented with de novo HF-CS and 544 (52.8%) with acute-on-chronic HF-CS. Traditional markers of CS severity (e.g. blood pressure, heart rate and lactate) as well as use of treatments were comparable between groups. However, patients with acute-on-chronic HF-CS were more likely to have a higher CS severity and also a higher mortality risk, after adjusting for relevant confounders (de novo HF 45.5%, acute-on-chronic HF 55.9%, adjusted hazard ratio 1.38, 95% confidence interval 1.10-1.72, p = 0.005). CONCLUSION: In this large HF-CS cohort, acute-on-chronic HF-CS was associated with more severe CS and higher mortality risk compared to de novo HF-CS, although traditional markers of CS severity and use of treatments were comparable. These findings highlight the vast heterogeneity of patients with HF-CS, emphasize that HF chronicity is a relevant disease modifier in CS, and indicate that future clinical trials should account for this.

Association between left ventricular ejection fraction, mortality and use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock.

BACKGROUND: Currently, use of mechanical circulatory support (MCS) in non-ischaemic cardiogenic shock (CS) is predominantly guided by shock-specific markers, and not by markers of cardiac function. We hypothesise that left ventricular ejection fraction (LVEF) can identify patients with a higher likelihood to benefit from MCS and thus help to optimise their expected benefit. METHODS: Patients with non-ischaemic CS and available data on LVEF from 16 tertiary-care centres in five countries were analysed. Cox regression models were fitted to evaluate the association between LVEF and mortality, as well as the interaction between LVEF, MCS use and mortality. RESULTS: N = 807 patients were analysed: mean age 63 [interquartile range (IQR) 51.5-72.0] years, 601 (74.5%) male, lactate 4.9 (IQR 2.6-8.5) mmol/l, LVEF 20 (IQR 15-30) %. Lower LVEF was more frequent amongst patients with more severe CS, and MCS was more likely used in patients with lower LVEF. There was no association between LVEF and 30-day mortality risk in the overall study cohort. However, there was a significant interaction between MCS use and LVEF, indicating a lower 30-day mortality risk with MCS use in patients with LVEF ≤ 20% (hazard ratio 0.72, 95% confidence interval 0.51-1.02 for LVEF ≤ 20% vs. hazard ratio 1.31, 95% confidence interval 0.85-2.01 for LVEF > 20%, interaction-p = 0.017). CONCLUSION: This retrospective study may indicate a lower mortality risk with MCS use only in patients with severely reduced LVEF. This may propose the inclusion of LVEF as an adjunctive parameter for MCS decision-making in non-ischaemic CS, aiming to optimise the benefit-risk ratio.

From medical therapy to mechanical support: strategies for device selection and implantation techniques.

Cardiogenic shock (CS) is a complex clinical syndrome with a high risk of mortality. The recent, rapid development of temporary mechanical circulatory support (tMCS) has altered CS treatment. While catecholamines remain the cornerstone of CS therapy, tMCS usage has increased. According to shock severity, different treatment strategies including catecholamines alone, catecholamines and tMCS, or multiple tMCS might be used. State-of-the-art implantation techniques are necessary to avoid complications linked to the invasive nature of tMCS. In particular, bleeding and access-site complications might counteract the potential haemodynamic benefit of a percutaneous ventricular assist device. In this review, we describe the role of catecholamines in CS treatment and present the different tMCS devices with an explanation on how to use them according to CS aetiology and severity. Finally, an overview of the best practice for device implantation is provided.

From escalation to weaning strategies: how to integrate the ECMELLA concept.

The additional implantation of a micro-axial flow pump (mAFP) in patients receiving extracorporeal life support by a veno-arterial extracorporeal membrane oxygenation (V-A ECMO) for cardiogenic shock (CS) has gained interest in recent years. Thus far, retrospective propensity score-matched studies, case series, and meta-analyses have consistently shown an improved survival in patients treated with the so-called ECMELLA concept. The pathophysiological context is based on the modification of V-A ECMO-related side effects and the additive benefit of myocardial unloading. From this point of view, knowledge and detection of these pathophysiological mechanisms are of utmost importance to successfully manage mechanical circulatory support in CS. In this article, we describe best practices for the indication of the two devices as well as escalation and de-escalation approaches including implantation and explantation strategies that are key for success.

Differential utilization of Impella devices, extracorporeal membrane oxygenation, and combined therapies as escalation and de-escalation strategies.

Cardiogenic shock (CS) is a life-threatening condition characterized by a state of inadequate systemic tissue perfusion caused by cardiac dysfunction. When to implement, change, or remove the use of a temporary mechanical circulatory support (tMCS) in patients with CS is dependent on the aetiology and severity. Here, patient scenarios underlying the need to escalate, de-escalate, wean, or bridge from tMCS devices are taken into consideration by interdisciplinary heart failure and CS teams. This includes a comprehensive review of and focus on the rationale for specific device escalation and de-escalation strategies, device selection, and general management.

Differences between cardiogenic shock related to acute decompensated heart failure and acute myocardial infarction.

AIMS: The present analysis from the multicentre prospective Altshock-2 registry aims to better define clinical features, in-hospital course, and management of cardiogenic shock complicating acutely decompensated heart failure (ADHF-CS) as compared with that complicating acute myocardial infarction (AMI-CS). METHODS AND RESULTS: All patients with AMI-CS or ADHF-CS enrolled in the Altshock-2 registry between March 2020 and February 2022 were selected. The primary objective was the characterization of ADHF-CS patients as compared with AMI-CS. In-hospital length of stay and mortality were secondary endpoints. One-hundred-ninety of the 238 CS patients enrolled in the aforementioned period were considered for the present analysis: 101 AMI-CS (80% ST-elevated myocardial infarction and 20% non-ST-elevated myocardial infarction) and 89 ADHF-CS. As compared with AMI-CS, ADHF-CS patients were younger [63 (IQR 59-76) vs. 67 (IQR 54-73) years, P = 0.01], but presented with higher creatinine [1.6 (IQR 1.0-2.6) vs. 1.2 (IQR 1.0-1.4) mg/dL, P < 0.001], bilirubin [1.3 (IQR 0.9-2.3) vs. 0.6 (IQR 0.4-1.1) mg/dL, P = 0.01], and central venous pressure values [14 mmHg (IQR 8-12) vs. 10 mmHg (IQR 7-14),P = 0.01]. Norepinephrine was the most common catecholamine used in AMI-CS (79.3%), whereas epinephrine was used more commonly in ADHF-CS (65.5%); 75.8% vs. 46.6% received a temporary mechanical support in AMI-CS and ADHF-CS, respectively (P < 0.001). Length of hospital stay was longer in the latter [28 (IQR 13-48) vs. 17 (IQR 9-29) days, P = 0.001]. Heart replacement therapies were more frequently used in the ADHF-CS group (heart transplantation 13.5% vs. 0% and left ventricular assist device 11% vs. 2%, P < 0.01 and 0.01, respectively). In-hospital mortality was 41.1% (38.6% AMI-CS vs. 43.8% ADHF-CS, P = 0.5). CONCLUSIONS: ADHF-CS is characterized by a higher prevalence of end-organ and biventricular dysfunction at presentation, a longer hospital length of stay, and higher need of heart replacement therapies when compared with AMI-CS. In-hospital mortality was similar between the two aetiologies. Our data warrant development of new management protocols focused on CS aetiology.

Use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock.

AIMS: Despite its high incidence and mortality risk, there is no evidence-based treatment for non-ischaemic cardiogenic shock (CS). The aim of this study was to evaluate the use of mechanical circulatory support (MCS) for non-ischaemic CS treatment. METHODS AND RESULTS: In this multicentre, international, retrospective study, data from 890 patients with non-ischaemic CS, defined as CS due to severe de-novo or acute-on-chronic heart failure with no need for urgent revascularization, treated with or without active MCS, were collected. The association between active MCS use and the primary endpoint of 30-day mortality was assessed in a 1:1 propensity-matched cohort. MCS was used in 386 (43%) patients. Patients treated with MCS presented with more severe CS (37% vs. 23% deteriorating CS, 30% vs. 25% in extremis CS) and had a lower left ventricular ejection fraction at baseline (21% vs. 25%). After matching, 267 patients treated with MCS were compared with 267 patients treated without MCS. In the matched cohort, MCS use was associated with a lower 30-day mortality (hazard ratio 0.76, 95% confidence interval 0.59-0.97). This finding was consistent through all tested subgroups except when CS severity was considered, indicating risk reduction especially in patients with deteriorating CS. However, complications occurred more frequently in patients with MCS; e.g. severe bleeding (16.5% vs. 6.4%) and access-site related ischaemia (6.7% vs. 0%). CONCLUSION: In patients with non-ischaemic CS, MCS use was associated with lower 30-day mortality as compared to medical therapy only, but also with more complications. Randomized trials are needed to validate these findings.

Left ventricular assist device implants in patients on extracorporeal membrane oxygenation: do we need cardiopulmonary bypass?

OBJECTIVES: Implanting a durable left ventricular assist device (LVAD) in a patient on extracorporeal life support (ECLS) is challenging. The goal of this study was to compare the results of patients from a European registry who had a durable LVAD implanted with or without transition from ECLS to cardiopulmonary bypass (CPB). METHODS: A total of 531 patients on ECLS support who had an LVAD implant between January 2010 and August 2018 were analysed; after 1:1 propensity score matching, we identified and compared 175 patients in each group. RESULTS: The duration of preoperative ECLS was 7 [standard deviation (SD) 6] vs 7 (SD 6) days in patients with or without CPB (P = 0.984). The surgical time was longer in the CPB group [285 (SD 72) vs 209 [SD 75] min; P ≤ 0.001). The postoperative chest tube output was comparable [1513 (SD 1311) vs 1390 (SD 1121) ml; P = 0.3]. However, re-exploration for bleeding was necessary in 41% vs 29% of patients with or without CPB (P = 0.01) and a significantly higher number of packed red blood cells and fresh frozen plasma [8 (SD 8) vs 6 (SD 4) units; P = 0.001 and 6 (SD 7) vs 5 (SD 5) units; P = 0.03] were administered to patients operated on with CPB. A postoperative mechanical right ventricular support device was necessary in 50% vs 41% of patients (P = 0.08). The stroke rate was not significantly different (P 0.99). No difference in survival was observed. CONCLUSIONS: Omitting CPB for an LVAD implant in patients on ECLS is safe and results in shorter operating time, less re-exploration for bleeding and fewer blood products. However, no survival benefit is observed.

Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review.

Aim: The impact on safety and efficacy outcomes of Impella 5.0 in cardiogenic shock (CS) has not been systematically assessed. Materials & methods: We conducted a systematic review of the literature (PROSPERO protocol: CRD42020164680) to critically appraise available evidence on Impella 5.0 comparative safety, efficacy and effectiveness. Results: Of 244 retrieved citations, 17 original articles met the a priori defined inclusion criteria. All included studies had a retrospective study design and, overall, reported on, respectively, 52 and 67 different safety and efficacy/effectiveness outcomes. Thirty-day survival rates ranged from 40 to 94%, myocardial recovery from 18 to 93%. Conclusion: Impella 5.0 provides a full cardiac support, it is associated with a lower rate of vascular complications, it represents a valuable bridge-to-decision and allows for resolution of intercurrent clinical conditions. As available data suggest Impella 5.0 good performance in CS of various etiologies, more solid evidence will come from much-needed large-scale all-comer registries and prospective multicenter randomized trials.

Cardiogenic shock (CS) is a life-threatening condition in which the heart cannot pump enough blood to meet the body's needs. Despite advances in biomedical research and technology, CS is still associated with high mortality. Some devices (Intra-aortic balloon pump (IABP), Impella, Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO), placed through vascular accesses, can support the heart in the failing phase. The aim of this systematic review of the scientific literature is to evaluate safety, efficacy and effectiveness of Impella 5.0 in CS.

[Percutaneous mitral valve repair in acute mitral regurgitation]. / Plastica mitralica transcatetere per il trattamento dell'insufficienza mitralica acuta.

Acute mitral regurgitation is a life-threatening pathology. Nowadays, percutaneous mitral valve repair with the MitraClip device offers, in selected patients, a safe and effective therapeutic alternative to open surgery. Hereby, we report the case of an 82-year-old woman with lateral ST-elevation myocardial infarction determining severe acute mitral regurgitation, who was treated with an urgent MitraClip procedure. Moreover, we discuss echocardiographic assessment of acute mitral regurgitation and we review available literature and possible management of this complex scenario.

Intensive care unit management of percutaneous mechanical circulatory supported patients: the role of imaging.

The clinical management of patients on Impella support requires multimodality monitoring and imaging. Upon intensive care unit admission, echocardiography is essential to ensure correct pump positioning/guide repositioning, to monitor acute myocardial infarction/device-related cardiac complications and to evaluate baseline left and right ventricular function. Over time, the echocardiographic assessment of myocardial viability has become an essential target for guiding mechanical circulatory support escalation and long-term strategies. The recognition and grading of any valvular dysfunction and damage in Impella patients are challenging, as the device interferes with the colour Doppler signal, and the loading conditions of the left ventricle are modified by the pump. Valvular disease in such patients is often secondary, and correct identification is pivotal for future therapeutic strategies. The emerging use of newer techniques, including speckle-tracking echocardiography, is of increasing interest in the imaging of critically ill patients.

Escalation and de-escalation of mechanical circulatory support in cardiogenic shock.

Cardiogenic shock (CS) is a clinical entity that includes a wide spectrum of different scenarios. Mechanical circulatory support (MCS) plays a fundamental role in the contemporary treatment of CS, and device selection is a key element in determining optimal treatment in this complex population. Cardiac support with mechanical devices should allow reduction and complete weaning from inotropes. Persistence of elevated left ventricular (LV) filling pressures, pulmonary congestion, metabolic decompensation, and end-organ damage during current MCS are criteria for MCS escalation. Precise diagnosis of the underlying cause of right ventricular (RV) failure is fundamental for undertaking the correct escalation strategy. In the setting of both MCS escalation and de-escalation, it is important to select a strategy in relation to long-term perspectives (bridge-to-recovery, bridge-to-LV assist device, or bridge-to-heart transplantation). Small retrospective studies have demonstrated that the BiPella approach is feasible, reduces cardiac filling pressures and improves cardiac output across a range of causes of CS. Simultaneous LV and RV device implantation and lower RV afterload may be associated with better outcomes in biventricular CS, but prospective studies are still required.

Weaning from Impella and mobilization of Impella patients.

Weaning of patients from Impella is complex and includes evaluation of the underlying disease, which is essential for estimating the potential for heart recovery. Monitoring during the weaning phase with echocardiography and pulmonary artery catheters will be discussed, as well as the use of intravenous and oral heart failure drugs. Patients who are candidates for weaning must be stable, without inotropes, and must have recovered from acute end-organ damage. Coronary artery disease and valvular heart diseases should be appropriately addressed before weaning to take the maximum advantage of haemodynamic stability provided by the support and to maximize the possibility of weaning. Tips and tricks for the mobilization of Impella patients will also be discussed.

Inflow cannula obstruction of the HeartWare left ventricular assist device: what do we really know?

In the setting of HeartWare left ventricular assist device (HVAD, Medtronic) implantation, pre-pump blood flow obstruction has been described due to intraventricular thrombus formation occluding the inflow cannula. This phenomenon often evolves in suboptimal pump performance, and requires prompt management to prevent its progression. However, to date, effective strategies and tools for the diagnosis and management of this complication are poorly described. We report a case of HVAD inflow cannula obstruction that drove later in-pump thrombosis and, eventually, complete cannula occlusion, and discuss gap of knowledge and limitations of currently available diagnostic and therapeutic tools in this scenario. Furthermore, we reinforce the value of time-frequency analysis of the HVAD log files to early identify abnormal pump operation associated with inflow cannula obstruction despite unremarkable trends of pump parameters.

Long-term clinical effects of recanalization of chronic coronary total occlusions in patients with left ventricular systolic dysfunction.

OBJECTIVES: The aim of the present analysis is to evaluate the clinical impact of chronic total occlusions (CTOs) recanalization in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: According to contemporary knowledge, patient selection for percutaneous CTO revascularization is not yet standardized. In particular, data on outcomes in patients with LV systolic dysfunction undergoing percutaneous coronary intervention (PCI) for CTO are scarce. METHODS: From a total of 2,421 consecutive patients with at least one CTO, 436 patients with ejection fraction (EF) ≤45%, who were referred for coronary angiography between January 1998 and September 2014, were selected. Patients with successful recanalization of the target CTO were assigned to CTO-revascularized group and those with failed or not attempted recanalization to the CTO-not revascularized (CTO-NR) group. Study endpoints were all-cause death, cardiac death, and occurrence of myocardial infarction on follow-up. RESULTS: Out of 436 CTO patients with reduced EF, 228 (52.3%) were successfully recanalized and 208 patients (47.7%) were not, either due to CTO-PCI failure (n = 106, 24.3%) or because CTO-PCI was not attempted (n = 102, 23.4%). At long-term follow-up, CTO-NR patients had significantly higher rate of overall (p = .021) and cardiac mortality (p = .035) compared to those successfully revascularized. CONCLUSION: In patients with systolic LV dysfunction (EF ≤ 45%), CTO revascularization was associated with significant lower rate of total and cardiac mortality compared to those with nonrevascularized CTO.

Bridging INTERMACS 1 patients from VA-ECMO to LVAD via Impella 5.0: De-escalate and ambulate.

PURPOSE: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) stabilizes patients in refractory cardiogenic shock. However, ECMO-related complications strongly affect the outcome, especially if a long-term LVAD is needed. METHODS AND MATERIALS: We describe a new strategy in management of INTERMACS 1 patients consisting in early weaning from VA-ECMO with axillary Impella 5.0 as a bridge to LVAD implantation. Nine patients in two European centres are described. RESULTS: All patients were implanted with VA-ECMO for initial hemodynamic and metabolic stabilization. After a median time of 8 days, Impella 5.0 was implanted. Impella support allowed in all patients weaning from inotropes and from VA-ECMO (after a median time of 22 h). No patients had right ventricular failure after ECMO-weaning and most patients were mobilized and orally fed (88.9%) during Impella support. All patient underwent LVAD implantation after a median Impella time of 17 days. Only one patient had right-ventricular failure after LVAD implantation. All patients were discharged from hospital after a median time of 40 days. CONCLUSION: Early weaning from VA-ECMO with Impella 5.0 as a bridge to LVAD is a safe and effective strategy in management of INTERMACS 1 patients. This approach minimizes ECMO-related complications and allows patient mobilization and right ventricular function optimization before LVAD implantation.