Search

Background: Whether age impacts the recently demonstrated survival benefit of microaxial flow pump (mAFP) treatment in patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock (CS) is unknown., Objectives: The purpose of this study was to assess the impact of age on mortality and complication rates in patients with STEMI-related CS randomized to standard care or mAFP on top of standard care., Methods: This is a secondary analysis of the Danish-German Cardiogenic Shock (DanGer Shock) trial, an international, multicenter, open-label trial, in which 355 adult patients with STEMI-related CS were randomized to receive a mAFP (Impella CP) plus standard care or standard care alone. The primary outcome of 180-day all-cause mortality is analysed according to age and intervention., Results: From lowest to highest age quartile, the median ages (range) were: 54 (31-59), 65 (60-69), 73 (70-76), and 81 (77-92) years. There were no differences in blood pressure, lactate level, left ventricular ejection fraction or shock severity at randomization across age groups. Mortality increased from lowest to highest quartile (31%, 47%, 61%, and 73%, respectively; log-rank p<0.001), with an adjusted odds ratio (OR) for death at 180 days of 7.85 (95% CI, 3.37-19.2; p<0.001) in the highest quartile compared to the lowest. The predicted risk of mortality was higher in the standard-care group until approximately 77 years, after which the predicted risk became higher in the mAFP group (p-interaction=0.2). In patients younger than 77 years, a reduced 180-day mortality was observed in patients randomized to the mAFP (OR, 0.45; 95% CI, 0.28-0.73; p=0.001), opposed to patients aged 77 years or older (OR, 1.52; 95% CI, 0.57-4.08; p=0.40), p=0.028 for interaction. Complications were more frequent in the mAFP group, but there were no apparent differences in incidence of complications across all ages., Conclusions: This exploratory secondary analysis of the DanGer Shock trial demonstrates that elderly patients with STEMI-related CS experience high mortality and may not attain the same benefit from routine treatment with a mAFP as younger patients. Incorporating age as a factor in patient selection may enhance the overall benefit of this therapy. (DanGer Shock, NCT01633502)., (Copyright © 2024. Published by Elsevier Inc.)

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive., Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions., Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints., Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths)., Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Importance: Mechanical circulatory support with a microaxial flow pump (MAFP) has been shown to improve survival in ST-elevation myocardial infarction-induced cardiogenic shock (STEMI-CS). Understanding the impact on hemodynamic stability over time is crucial for optimizing patient treatment., Objective: To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS., Design, Setting, and Participants: This was a substudy of the Danish-German (DanGer) Shock trial, an international, multicenter, open-label randomized clinical trial. Patients from 14 heart centers across Denmark, Germany, and the UK were enrolled. Inclusion criteria for the trial were STEMI and systolic blood pressure less than 100 mm Hg or ongoing vasopressor treatment, left ventricular ejection fraction less than 45%, and arterial lactate level greater than 2.5 mmol/L. Of the enrolled patients, after exclusions from death in the catheterization laboratory or immediately on intensive care unit (ICU) admission, the remaining patients had serial recordings of hemodynamics, arterial lactate, and use of vasoactive drugs. Patients who were in comas after cardiac arrest and patients with mechanical complications or right ventricular failure were excluded. Data were analyzed from May to September 2024., Interventions: MAFP and standard of care or standard of care alone., Main Outcomes and Measures: Hemodynamic status in terms of heart rate and blood pressure, metabolic status in terms of arterial lactate concentration, and vasoactive-inotropic score (VIS). The clinical events during the first 72 hours were as follows: death from all causes, escalation of mechanical circulatory support, and discharge alive from the ICU., Results: From 355 enrolled patients, 324 (mean [IQR] age, 68 [58-75] years; 259 male [80%]) underwent ICU treatment (169 [52%] in the MAFP group, 155 [48%] in the standard-care group). Baseline characteristics were balanced. There was no difference in heart rate between groups, and mean arterial pressure was above the treatment target of 65 mm Hg in both groups but was achieved with a lower VIS in the MAFP group. No difference in arterial lactate level was found between groups at randomization, but on arrival to the ICU, the MAFP group had significantly lower arterial lactate levels compared with the standard-care group (mean difference, 1.3 mmol/L; 95% CI, 0.7-1.9 mmol/L), a difference that persisted throughout the first 24 hours of observation. The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours (95% CI, 5-18 hours) before the standard-care group., Conclusions and Relevance: Use of a MAFP reduces the use of vasopressors and inotropic medication while maintaining hemodynamic stability and achieving faster normalization of lactate level in patients with STEMI-CS., Trial Registration: ClinicalTrials.gov Identifier: NCT01633502.

Background: In the Danish-German Cardiogenic Shock (DanGer Shock) trial, use of a microaxial flow pump (mAFP) in patients with ST-segment elevation myocardial infarction (STEMI)-related CS led to lower all-cause mortality but higher rates of renal replacement therapy (RRT). In this prespecified analysis, rates and predictors of acute kidney injury (AKI) and RRT were assessed., Methods: In this international, randomized, open label, multicenter trial, 355 adult patients with STEMI-CS were randomized to mAFP (N=179) or standard care alone (N=176). AKI was defined according to Risk, Injury, and Failure, sustained Loss and End-stage kidney disease (RIFLE) criteria and assessed using logistic regression models. Use of RRT was assessed accounting for the competing risk of death using Fine-Gray subdistribution hazard models., Results: AKI (RIFLE≥1) was recorded in 110 patients (61%) in mAFP group and 79 (45%) in control group (p<0.01); RRT was used in 75 (42%) and 47 (27%) patients, respectively (p<0.01). About 2/3 of the RRTs were initiated within the first 24h from admission (n=48 (64%) in mAFP group, n=31 (66%) in control group). Occurrence of AKI and RRT were associated with higher 180-day mortality in both study arms. At 180 days, all patients alive were free of RRT. mAFP use was associated with higher rates of RRT, even when accounting for competing risk of death (subdistribution hazard: 1.67 [1.18-2.35]). This association was largely consistent among prespecified subgroups. Allocation to mAFP was associated with lower 180-day mortality irrespective of AKI or RRT (p=0.8 for interaction). Relevant predictors of AKI in both groups comprised reduced left ventricular ejection fraction, baseline kidney function, shock severity, bleeding events, and positive fluid balance. In addition, predictors of AKI specific to mAFP were suction events, higher pump speed, and longer duration of support., Conclusions: Shock severity, allocation to mAFP, and device-related complications were associated with an increased risk of AKI. AKI was generally associated with higher mortality, but the allocation to mAFP consistently led to lower mortality rates at 180 days irrespective of the occurrence of AKI with or without RRT initiation.

Aims: The optimal timing for implementing mechanical circulatory support (MCS) in cardiogenic shock (CS) remains indeterminate. This study aims to evaluate patient characteristics and outcome associated with the time interval between CS onset and veno-arterial extracorporeal membrane oxygenation (VA-ECMO) implementation., Methods and Results: In this study, patients with CS treated with MCS at 15 tertiary care centres in three countries were enrolled. Patients treated with MCS were stratified into early (<2 h), intermediate (2-12 h) and delayed (≥12-24 h) MCS implantation by using the time interval between CS onset and MCS device implementation. Adjusted logistic and Cox regression models were fitted to assess the association between timing of MCS implementation, patient characteristics and 30-day mortality. A total of 330 patients with CS treated with VA-ECMO and/or microaxial flow pump were included in this study; 20.9% received early, 55.8% intermediate, and 23.3% delayed MCS. Although crude 30-day mortality was slightly lower in patients with early MCS (58.1% vs. 64.7% vs. 64.3%), adjusted analyses showed no significant association between timing of MCS implantation and 30-day all-cause mortality (hazard ratio [HR] for early vs. intermediate MCS: 0.93, 95% confidence interval [CI] 0.59-1.46, p = 0.74; HR for early vs. delayed MCS: 1.29, 95% CI 0.78-2.13, p = 0.33). Moreover, the incidence of complications, related and unrelated to MCS, did not differ significantly among groups., Conclusion: In this exploratory study of patients with CS treated with MCS, the timing of device implantation within 24 h after CS onset was not associated with mortality. This supports a restrictive MCS approach, reserving its application for patients experiencing CS deterioration despite conventional therapy., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: The use of microaxial percutaneous left ventricular assist devices (pLVADs) in cardiogenic shock (CS) has increased in recent years, despite limited evidence, and data on sex disparities are particularly scarce. This study aimed to compare short-term outcomes between males and females., Methods: Data were retrospectively collected from the Dresden Impella Registry, which is a large, prospective, single-centre registry that consecutively enrolled patients who received microaxial pLVAD. Inclusion criteria were CS due to left ventricular failure with serum lactate >4 mM. Patients with pLVAD other than Impella CP were excluded. The primary endpoint was the composite of all-cause mortality at 30 days or requirement of renal replacement therapy (RRT). Secondary endpoints were the components of the primary endpoint alone. Propensity score matched (PSM) analysis was used to adjust for baseline characteristics., Results: A total of 319 male (69 years; body mass index, 26.7 kg/m 2 ) and 113 female patients (74 years; 27.9 kg/m 2 ) were included in the study. The primary composite endpoint occurred less frequently in female patients in the unmatched analysis (♂ 75.9% [n=239] vs ♀ 64.4% [n=72]; p=0.040) but not in the PSM analysis (♂ 81.1% [n=73] vs ♀ 68.9% [n=42]; p=0.056). However, females less frequently required RRT in both analyses (♂ 48.2% [n=126] vs ♀ 25.9% [n=25]; p=0.001; PSM: ♂ 49.1% [n=36] vs ♀ 23.3% [n=12]; p=0.007). All-cause mortality did not differ between the cohorts., Conclusions: This study showed no differences in all-cause mortality at 30 days between male and female patients receiving microaxial pLVAD in CS. Larger studies are required to confirm whether female sex is associated with reduced requirement of RRT in CS treated with microaxial pLVAD., Competing Interests: Conflicts of Interest J.M. reports personal fees from Abiomed, outside the submitted work. S.J. reports personal fees from Abiomed, outside the submitted work. F.W. reports personal fees from Abiomed, Abbott, Biotronik, Boston Scientific, Corvia, MSD, NeoVasc, outside the submitted work. N.M. reports personal fees from Abiomed, Edwards LifeScience, Medtronic, Biotronik, Novartis, Sanofi Genzyme, Bayer, Pfizer, and AstraZeneca, outside the submitted work. A.L. reports grants from Novartis, personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, Astra Zeneca, Novartis, Pfizer, Abiomed, Bayer, Boehringer, and other from Picardia, Transverse Medical, Claret Medical, outside the submitted work. The other authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS., Methods: In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295., Findings: Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control., Interpretation: The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only., Funding: The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung., Competing Interests: Declaration of interests HT is the current president of the German Cardiac Society. JEM reports lecture fees from Abbott and Boehringer Ingelheim; institutional research grants from Abiomed and Novo Nordisk Foundation; travel support from Abiomed; equipment from Abiomed; and served as a data and safety monitoring board member for DanHeart. JB reports speaker fees from Resuscitec and Getinge. DB reports payment for travel expenses from Abiomed; and institutional support for steering committee membership. MF reports grants paid to their institution from the European Commission. HE reports speaker fees from Novartis; and travel expenses from Abbott paid to their institution. PO reports speaker fees from Getinge, Abiomed, Fresenius, Edwards Lifesciences, and AOP; and is the president of the Czech Society of Cardiology. PCS reports lecture fees from Abiomed and Abbott; and institutional research support from Abiomed. JP reports institutional research grants from the German Cardiac Society, Schwiete Foundation, German Heart Research Foundation, and Maquet. CH reports lecture fees from Abiomed. MH reports research support paid to their institution from the Heart Center Leipzig. AP reports lecture fees and institutional research grants from Abiomed. NM reports lecture fees from Abbott, Abiomed, AstraZeneca, B Braun, Biotronik, the British Society of Cardiovascular Imaging, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi Genzyme; grants paid to their institution from Abiomed; and unrestricted educational grants from Abiomed and BSCI. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background/purpose: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI., Methods: All consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m 2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed., Results: We included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03-1.91])., Conclusions: Routine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI., Competing Interests: Declaration of competing interest Christina Eckrich has no conflict of interest. Sandra Erbs has no conflict of interest. Norman Mangner reports speaker's honoraria from Edwards, Medtronic, Novartis, Sanofi Genzyme, and Astra Zeneca, consultant honoraria from Biotronik, outside the submitted work. Felix Woitek has no conflict of interest. Philipp Kiefer has no conflict of interest. Florian Schlotter has no conflict of interest. Georg Stachel has no conflict of interest. Sergey Leontyev reports personal fees from St. Jude Medical and Medtronic, outside the submitted work. David Holzhey reports personal fees from Symetis and Medtronic, outside the submitted work. Michael A. Borger reports speakers' honoraria and consulting fees from Edwards Lifesciences, Medtronic, and CryoLife, outside the submitted work. Axel Linke reports grants and personal fees from Medtronic, personal fees from St. Jude Medical, grants from Claret Medical, personal fees and other from Claret Medical, personal fees from Boston Scientific, personal fees from Bard, personal fees from Edwards, outside the submitted work. Stephan Haussig reports speakers' honoraria and consulting fees from Edwards Lifesciences, Abbott, Cardiac Dimensions, and Boston Scientific, outside the submitted work, (Copyright © 2024. Published by Elsevier Inc.)

Background: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI)., Methods: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed., Results: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001)., Conclusions: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail., Methods: In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months., Results: Among 758 randomized patients, 382 were assigned to DCB (23% women) and 376 to DES (30% women). In general, women were older, had more often diabetes mellitus and renal insufficiency, and presented more often with an acute coronary syndrome, whereas men were more often smokers, had multivessel disease and a previous history of acute myocardial infarction, and received a treatment with a statin. After 3 years, the primary clinical end point was not significantly different between groups (13% women vs. 16% men, HR 0.82; 95% CI 0.52-1.30; p = 0.40). There was no interaction between sex and coronary intervention strategy regarding MACE at 36 months (10% women vs. 16% men in DCB, 16% women vs. 15% men in DES; p interaction  = 0.31)., Conclusion: In small native coronary artery disease, there was no statistically significant effect of sex on the difference between DCB and DES regarding MACE up to 36 months., Clinical Trial Registration: URL: http://www., Clinicaltrials: gov . Unique identifier: NCT01574534., (© 2023. The Author(s).)

Heart failure with preserved ejection fraction (HFpEF) is characterized by biomechanically dysfunctional cardiomyocytes. Underlying cellular changes include perturbed myocardial titin expression and titin hypophosphorylation leading to titin filament stiffening. Beside these well-studied alterations at the cardiomyocyte level, exercise intolerance is another hallmark of HFpEF caused by molecular alterations in skeletal muscle (SKM). Currently, there is a lack of data regarding titin modulation in the SKM of HFpEF. Therefore, the aim of the present study was to analyze molecular alterations in limb SKM (tibialis anterior (TA)) and in the diaphragm (Dia), as a more central SKM, with a focus on titin, titin phosphorylation, and contraction-regulating proteins. This study was performed with muscle tissue, obtained from 32-week old female ZSF-1 rats, an established a HFpEF rat model. Our results showed a hyperphosphorylation of titin in limb SKM, based on enhanced phosphorylation at the PEVK region, which is known to lead to titin filament stiffening. This hyperphosphorylation could be reversed by high-intensity interval training (HIIT). Additionally, a negative correlation occurring between the phosphorylation state of titin and the muscle force in the limb SKM was evident. For the Dia, no alterations in the phosphorylation state of titin could be detected. Supported by data of previous studies, this suggests an exercise effect of the Dia in HFpEF. Regarding the expression of contraction regulating proteins, significant differences between Dia and limb SKM could be detected, supporting muscle atrophy and dysfunction in limb SKM, but not in the Dia. Altogether, these data suggest a correlation between titin stiffening and the appearance of exercise intolerance in HFpEF, as well as a differential regulation between different SKM groups.

Background: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear., Methods: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation., Results: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09)., Conclusions: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.)., (Copyright © 2024 Massachusetts Medical Society.)

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., (© 2024. The Author(s).)

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., (© 2023. The Author(s).)

Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, B. Braun, and Boston Scientific outside the submitted work. Dr Fassl has received speaker fees from CSL Behring and Edwards Lifesciences outside the submitted work. Dr Haussig has received speaker honoraria and consulting fees from Edwards Lifesciences, Abbott, and Boston Scientific outside the submitted work. Dr Linke has received grants from Novartis; personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer; and personal fees from Picardia, Transverse Medical, and Claret Medical outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Critical care cardiology (CCC) in the modern era is shaped by a multitude of innovative treatment options and an increasingly complex, ageing patient population. Generating high-quality evidence for novel interventions and devices in an intensive care setting is exceptionally challenging. As a result, formulating the best possible therapeutic approach continues to rely predominantly on expert opinion and local standard operating procedures. Fostering the full potential of CCC and the maturation of the next generation of decision-makers in this field calls for an updated training concept, that encompasses the extensive knowledge and skills required to care for critically ill cardiac patients while remaining adaptable to the trainee's individual career planning and existing educational programs. In the present manuscript, we suggest a standardized training phase in preparation of the first ICU rotation, propose a modular CCC core curriculum, and outline how training components could be conceptualized within three sub-specialization tracks for aspiring cardiac intensivists., Competing Interests: PL received speaker honoraria and consulting fees from Astra Zeneca, Bayer, Pfizer, Edwards Lifesciences, and research honoraria from Edwards Lifesciences outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Binzenhöfer, Gade, Roden, Saleh, Lanz, Sierra, Seifert, Scherer, Schrage, Haertel, Spieth, Mangner, Adler, Hoyer, Graf, Billig, Salem, Rangel, Speidl, Hagl, Hausleiter, Massberg, Preusch, Meder, Leistner, Luedike, Rassaf, Zimmer, Westermann, Zeymer, Schäfer, Thiele and Lüsebrink.)

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., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)