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Background and Objectives: Percutaneous coronary intervention (PCI) is a proven therapy for acute myocardial infarction (AMI) cardiogenic shock (CS). Dual anti-platelet therapy (i.e., aspirin plus an oral P2Y12 inhibitor) is recommended in patients treated with PCI. However, CS patients present severe hemodynamic instability, deranged hemostatic balance, and the need for invasive mechanical circulatory support (MCS) alongside invasive procedures, resulting in an increased risk of both bleeding and thrombotic complications, leaving uncertainty about the best anti-thrombotic treatment. Recently, the parenteral short-acting P2Y12 inhibitor has been increasingly used in the acute cardiac care setting, mainly in light of its favourable pharmacokinetic profile and organ-independent metabolism. Materials and Methods: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we performed a systematic review and single-arm meta-analysis of the safety and efficacy outcomes (i.e., rates of major bleeding, occurrence of stent/any thrombosis, and hospital survival) of all existing original studies reporting on the intravenous administration of cangrelor in AMI-CS patients. Results: Ten studies (678 patients with CS) published between 2017 and 2023 were included in the present review: nine were observational and one had a randomized design. Percutaneous revascularization was performed in >80% of patients across the studies. Moreover, 26% of patients were treated with temporary MCS, and in all studies, concomitant systemic anticoagulation was performed. Cangrelor was administered intravenously at the dosage of 4 mcg/kg/min in 57% of patients, 0.75 mcg/kg/min in 37% of patients, and <0.75 mcg/kg/min in 6%. The pooled rate of major bleeding was 17% (11–23%, confidence interval [CI]), and the pooled rate of stent thrombosis and any thrombosis were 1% (0.3–2.3% CI) and 3% (0.4–7% CI), respectively. Pooled hospital survival was 66% (59–73% CI). Conclusions: Cangrelor administration in AMI-CS patients was feasible and safe with a low rate of thromboembolic complications. Haemorrhagic complications were more frequent than thrombotic events. Nevertheless, to date, the optimal dosage of cangrelor in this clinical context still remains not universally recognized.

Impella and VA-ECMO are two possible therapeutic courses for the treatment of patients with cardiogenic shock (CS). The study aims to perform a systematic literature review and meta-analyses of a comprehensive set of clinical and socio-economic outcomes observed when using Impella or VA-ECMO with patients under CS. A systematic literature review was performed in Medline, and Web of Science databases on 21 February 2022. Nonoverlapping studies with adult patients supported for CS with Impella or VA-ECMO were searched. Study designs including RCTs, observational studies, and economic evaluations were considered. Data on patient characteristics, type of support, and outcomes were extracted. Additionally, meta-analyses were performed on the most relevant and recurring outcomes, and results shown using forest plots. A total of 102 studies were included, 57% on Impella, 43% on VA-ECMO. The most common outcomes investigated were mortality/survival, duration of support, and bleeding. Ischemic stroke was lower in patients treated with Impella compared to the VA-ECMO population, with statistically significant difference. Socio-economic outcomes including quality of life or resource use were not reported in any study. The study highlighted areas where further data collection is needed to clarify the value of complex, new technologies in the treatment of CS that will enable comparative assessments focusing both on the health impact on patient outcomes and on the financial burden for government budgets. Future studies need to fill the gap to comply with recent regulatory updates at the European and national levels.

Aims Artificial intelligence (AI) has emerged as a potential useful tool to support clinical treatment of heart failure, including the setting of mechanical circulatory support (MCS). Modern Impella pumps are equipped with advanced technology (SmartAssist), enabling real‐time acquisition and display of data related to both pump performance and the patient's haemodynamic status. These data emerge as an ‘ideal’ source for data‐driven AI applications to predict the clinical course of an ongoing therapeutic protocol. Yet, no evidence of effective application of AI tools in the setting of Impella support is available. On this background, we aimed at identifying possible future applications of AI‐based tools in the setting of temporary MCS with an Impella device. Methods We explored the state of research and development at the intersection of AI and Impella support and derived future potential applications of AI in routine Impella clinical management. Results We identified different areas where the future implementation of AI tools may contribute to addressing important clinical challenges in the setting of Impella support, including (i) early identification of the best suited pathway of care according to patients' conditions at presentation and intention to treat, (ii) prediction of therapy outcomes according to different possible therapeutic actions, (iii) optimization of device implantation procedures and evaluation of proper pump position over the whole course of support and (iv) prevention and/or rationale management of haemocompatibility‐related adverse events. For each of those areas, we discuss the potential advantages, challenges and implications of harnessing AI‐driven insights in the setting of MCS with an Impella device. Conclusions Temporary MCS with an Impella device has great potential to benefit from the integration of AI‐based tools. Such tools may indeed translate into groundbreaking innovation supporting clinical decision‐making and therapy regulation, in particular in complex scenarios such as the multidevice MCS strategy.

IntroductionThe treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses.Methods and analysisThis is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions.Ethics and disseminationAs of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Aims Impella malrotation—inlet orientation away from the left ventricular (LV) apex with normal console waveforms and proper device depth—is commonly observed and possibly associated worse haemodynamics. This study aimed to characterize the haemodynamic consequences of Impella malrotation in cardiogenic shock (CS) patients. Methods and results We included 100 CS patients (60 ± 12 years; 79.0% males) with available echocardiography during Impella support and pulmonary artery catheter assessment before and during (at 48 h) Impella support. Impella malrotation was identified in 36%. At 48 h, malrotation patients had higher pulmonary artery wedge pressure (PAWP, 16.0 ± 8.2 vs. 13.0 ± 4.6 mmHg; P = 0.033), higher systolic pulmonary artery pressure (PAP, 35.0 ± 11.3 vs. 29.5 ± 9.0 mmHg; P = 0.015), higher diastolic‐PAP (19.3 ± 8.1 vs. 15.1 ± 6.1 mmHg; P = 0.007), higher mean‐PAP (25.7 ± 9.1 vs. 20.8 ± 6.8 mmHg; P = 0.005), higher right atrial pressure (10.3 ± 4.8 vs. 7.7 ± 4.3 mmHg; P = 0.009), higher pulmonary vascular resistance index (4.78 ± 2.75 vs. 3.49 ± 1.94 WUm2; P = 0.020) and higher pulmonary artery elastance (0.91 ± 0.60 vs. 0.67 ± 0.40 mmHg/mL; P = 0.045). Serum lactate at 48 h was higher in malrotation patients (6.63 ± 6.25 vs. 3.60 ± 4.21 mmol/L; P = 0.004). Malrotation patients presented larger LVEDD during support (52 ± 10 vs. 46 ± 11 mm; P = 0.006), higher rates of aortic regurgitation (AR, 86 vs. 56%; P = 0.004) and higher increase in AR severity (+0.94 ± 0.92 vs. + 0.46 ± 0.95; P = 0.016). No significant differences were found in major adverse outcomes. Conclusions In CS patients, Impella malrotation is associated with suboptimal unloading of the LV, worse pulmonary haemodynamics and worse indexes of right ventricular afterload. In CS patients, Impella malrotation is associated with suboptimal unloading of the LV, worse pulmonary haemodynamics and worse indexes of right ventricular afterload. AR, aortic regurgitation; AV, aortic valve; dPAP, diastolic pulmonary artery pressure; LV, left ventricular; LVEDD, left ventricular end‐diastolic diameter; mPAP, mean pulmonary artery pressure; PaE, pulmonary artery elastance; PAPi, pulmonary artery pulsatility index; PAWP, pulmonary artery wedge pressure; PVRi, pulmonary vascular resistance index; RA, right atrium; RAP, right atrial pressure; RV, right ventricle; sPAP, systolic pulmonary artery pressure.

Formal assessment of myocardial viability (MV) is challenging in acute myocardial infarction‐related cardiogenic shock (AMI‐CS) patients receiving Impella mechanical circulatory support, as the cardiac magnetic resonance gold standard technique is not feasible due to the metallic components of the device. 18‐fluorodesoxyglucose metabolic myocardial positron emission tomography (18FDG‐PET) may represent a valid and feasible alternative to obtain semi‐quantitative and objective evidence of MV during Impella support. We hereby report the first series of sequential AMI‐CS patients who received 18FDG‐PET scanning to assess MV during Impella support to demonstrate the safety and feasibility of this approach. In this cohort no adverse events occurred during 18FDG‐PET scans, and all images were of excellent quality. This study provides a pragmatic guidance on how to perform this imaging modality during Impella support and finally confirms the safety and feasibility of this advanced imaging method also in this vulnerable cohort of patients.

Aims The initial bundle of cares strongly affects haemodynamics and outcomes in acute decompensated heart failure cardiogenic shock (ADHF‐CS). We sought to characterize whether 24 h haemodynamic profiling provides superior prognostic information as compared with admission assessment and which haemodynamic parameters best predict in‐hospital death. Methods and results All patients with ADHF‐CS and with available admission and 24 h invasive haemodynamic assessment from two academic institutions were considered for this study. The primary endpoint was in‐hospital death. Regression analyses were run to identify relevant predictors of study outcome. We included 127 ADHF‐CS patients [65 (inter‐quartile range 52–72) years, 25.2% female]. Overall, in‐hospital mortality occurred in 26.8%. Non‐survivors were older, with greater CS severity. Among admission variables, age [odds ratio (OR) = 1.06; 95% confidence interval (CI): 1.02–1.11; Padj = 0.005] and CPIRAP (OR = 0.62 for 0.1 increment; 95% CI: 0.39–0.95; Padj = 0.034) were found significantly associated with in‐hospital death. Among 24 h haemodynamic univariate predictors of in‐hospital death, pulmonary elastance (PaE) was the strongest (area under the curve of 0.77; 95% CI: 0.68–0.86). PaE (OR = 5.98; 95% CI: 2.29–17.48; Padj < 0.001), pulmonary artery pulsatility index (PAPi, OR = 0.77; 95% CI: 0.62–0.92; Padj = 0.013) and age (OR = 1.06; 95% CI: 1.02–1.11; Padj = 0.010) were independently associated with in‐hospital death. Best cut‐off for PaE was 0.85 mmHg/mL and for PAPi was 2.95; cohort phenotyping based on these PaE and PAPi thresholds further increased in‐hospital death risk stratification; patients with 24 h high PaE and low PAPi exhibited the highest in‐hospital mortality (56.2%). Conclusions Pulmonary artery elastance has been found to be the most powerful 24 h haemodynamic predictor of in‐hospital death in patients with ADHF‐CS. Age, 24 h PaE, and PAPi are independently associated with hospital mortality. PaE captures ventricular (RV) afterload mismatch and PAPi provides a metric of RV adaptation, thus their combination generates four distinct haemodynamic phenotypes, enhancing in‐hospital death risk stratification.

Acute right heart failure (RHF) represents a critical entity with significant morbidity and mortality. This review examines the role of percutaneous right ventricular assist devices (pRVADs) as a cornerstone of therapy in cases refractory to conventional management. Devices such as the Impella RP and dual‐lumen cannulas provide targeted haemodynamic support, with indications in various clinical scenarios, including acute myocardial infarction, post‐cardiac surgery, myocarditis, and after left ventricular assist device (LVAD) implantation. Successful implementation requires meticulous haemodynamic assessment, including parameters derived from pulmonary artery catheterization and echocardiography, to guide patient selection, optimize device placement, and monitor therapeutic response. The manuscript highlights contemporary weaning strategies, emphasizing recovery of right ventricular function, stabilization of systemic haemodynamics, and restoration of end‐organ perfusion. While no universal protocols exist, this review presents a pragmatic framework informed by available evidence and expert consensus. Furthermore, the potential complications of pRVAD use—ranging from thromboembolism and haemolysis to device‐specific issues such as migration and tricuspid valve damage—are discussed alongside preventive and management strategies. Key challenges in RHF management, including the interplay between right and left ventricular function, the impact of pulmonary vascular resistance, and the use of adjunctive pulmonary vasodilators, are addressed. The review underscores the absence of durable right ventricular assist devices and the need for innovation to close this therapeutic gap. Multidisciplinary collaboration among intensivists, cardiologists, and cardiac surgeons is critical to optimizing outcomes. This review provides actionable insights to assist clinicians in navigating the complexities of acute RHF, fostering a tailored and evidence‐based approach to this high‐risk population. This is an overview of percutaneous mechanical circulatory support options for acute right heart failure, illustrating key clinical scenarios, device types, and principles of tailored device selection based on haemodynamics and underlying pathology.

Severe Coronavirus disease 2019 (COVID-19) is characterized by acute respiratory distress syndrome (ARDS) which may lead to long-lasting pulmonary sequelae in the survivors. COVID-19 shares common molecular signatures with interstitial lung diseases (ILDs), including pro-angiogenic and tissue-remodeling mechanisms mediated by vascular endothelial growth factor receptor (VEGF-R), fibroblast growth factor receptor (FGF-R), and platelet-derived growth factor receptor (PDGF-R). Nintedanib mainly targets these factors and is approved for ILDs. Therefore, we administered nintedanib through compassionate use to three patients with COVID-19 pneumonia requiring extra-corporeal membrane-oxygenation (ECMO). Here, we describe our experience in an attempt to explore the role of nintedanib in lung recovery in COVID-19. Three obese patients aged between 42 and 52 years were started on nintedanib due to difficulty in obtaining lung function restoration and weaning from ECMO support following the removal of orotracheal intubation (OTI). Soon after the start of the treatment, systemic inflammation and respiratory function rapidly improved and ECMO support was withdrawn. Serial chest CT scans confirmed the progressive lung amelioration, also reflected by functional tests during follow-up. Nintedanib was well-tolerated by all the three patients at the dosage used for ILDs and continued for 2–3 months based on drug availability. Although caution in interpreting events is required; it is tempting to speculate that nintedanib may have contributed to modulate lung inflammation and remodeling and to sustain lung repair. Altogether, nintedanib appears as a promising agent in patients with severe COVID-19 and delayed respiratory function recovery, for whom molecularly targeted therapies are still lacking. Clinical trials are necessary to confirm our observations.