Hemocompatibility-related Adverse Events in Patients With Temporary Mechanical Circulatory Support: The Scoring Haemostasis Events and Assessment for Risk (SHEAR) Score.

Evaluation of treatment outcomes in patients supported by temporary mechanical circulatory support (tMCS) currently relies mainly on mortality, which may not sufficiently address other patient benefits or harms. Bleeding and thrombosis are major contributors to mortality. Still, current bleeding scores are not designed for critically ill patients undergoing tMCS, only consider selected populations, and do not account for the high heterogeneity among bleeding and thrombotic adverse events. To improve clinical management, a group of European experts has proposed a revised scoring system based on the MOMENTUM 3 Hemocompatibility Score and the Society of Cardiac Angiography and Interventions (SCAI)classification of cardiogenic shock. The new system termed the Scoring Haemostasis Events and Assessment for Risk (SHEAR) score, is divided into a baseline characterization stage and four escalating scoring stages encompassing all aspects of clinical relevance. This report summarizes the literature on hemocompatibility-related adverse events associated with tMCS, including bleeding, stroke, vascular access complications, hemolysis, thrombosis, and device failure. The SHEAR score provides a simple and rapid bedside scoring system aiming to provide a univocal tool to increase physician awareness of hemocompatibility complications at baseline and beyond, improve clinical research, and enable the capture of device-related complications that will inform relevant outcomes beyond mortality.

Science of left ventricular unloading.

The concept of left ventricular unloading has its foundation in heart physiology. In fact, the left ventricular mechanics and energetics represent the cornerstone of this approach. The novel sophisticated therapies for acute heart failure, particularly mechanical circulatory supports, strongly impact on the mechanical functioning and energy consuption of the heart, ultimately affecting left ventricle loading. Notably, extracorporeal circulatory life support which is implemented for life-threatening conditions, may even overload the left heart, requiring additional unloading strategies. As a consequence, the understanding of ventricular overload, and the associated potential unloading strategies, founds its utility in several aspects of day-by-day clinical practice. Emerging clinical and pre-clinical research on left ventricular unloading and its benefits in heart failure and recovery has been conducted, providing meaningful insights for therapeutical interventions. Here, we review the current knowledge on left ventricular unloading, from physiology and molecular biology to its application in heart failure and recovery.

Transcatheter edge-to-edge mitral valve repair for post-myocardial infarction papillary muscle rupture and acute heart failure: A systematic review.

Papillary muscle rupture (PMR) is a rare complication of acute myocardial infarction (AMI) associated with high mortality and morbidity. Surgery is the gold-standard treatment for these patients, but it is burdened by a high perioperative risk due to hemodynamic instability. Mitral transcatheter edge-to-edge repair (M-TEER) was reported to be safe and effective in unstable patients with significant mitral regurgitation. However, data in patients with post-AMI PMR are limited to a few case reports. In this review, we summarized all data available regarding percutaneous treatment of post-AMI PMR. These results show that M-TEER is safe and effective in this setting with low in-hospital mortality and complications and high rate of significant mitral regurgitation reduction.

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.

Recognizing patients as candidates for temporary mechanical circulatory support along the spectrum of cardiogenic shock.

A growing body of evidence indicates that the benefits of temporary mechanical circulatory support (tMCS) in patients with cardiogenic shock (CS) is dependent on its aetiology and timing of implantation. As such, appropriate diagnosis, screening, selection, and treatment is crucial to achieving good outcomes with tMCS. Here, the latest guidance on CS phenotypes and diagnostics for correctly identifying tMCS candidates is discussed. This includes comprehensive overviews of patient screening with attention given to differences in CS presentation between the sexes, and contraindications for mechanical circulatory support.

Right Ventricular Function After Minimally Invasive Mitral Valve Surgery.

OBJECTIVES: Right ventricular (RV) dysfunction is a significant cause of morbidity and mortality after cardiac surgery. Minimally invasive mitral valve surgery (MIMVS) increasingly is being performed. The authors aim was to evaluate postoperative RV function in patients who underwent MIMVS versus traditional mitral valve surgery. DESIGN: Six hundred seventy-five patients who underwent elective isolated mitral valve surgery at Centro Cardiologico Monzino from January 2016 to December 2019 were analyzed. After 1:1 propensity score matching, 60 patients were identified in the MIMVS (study group A) and 58 patients in the median sternotomy (control group B) and compared. SETTING: A university-affiliated scientific institute, monocentric. PARTICIPANTS: Patients. INTERVENTIONS: Mitral valve surgery. MEASUREMENTS AND MAIN RESULTS: No in-hospital deaths occurred. Aortic cross-clamp time (102 [87.5-119] v 83 [61-109] minutes, p = 0.0001), cardiopulmonary bypass duration (161.5 [142.5-181] v 105.5 [74-134] minutes, p < 0.0001) and intensive care unit stay (47 [44-72] v 45 [40-47] hours, p = 0.0015) were significantly longer in group A. The tricuspid annular plane systolic excursion was not different between group A and group B neither postoperatively (15 ± 3 v 14 ± 4 mm, p = 0.1) nor at three-month follow-up (18 ± 4 v 15 ± 3 mm, p = 0.3). No differences in peak postoperative lactates, inotropic score, central venous pressure, and pulmonary artery pulsatility index were observed. The length of hospital stay was significantly shorter in the minimally invasive group (ten [eight-13] v 12 [ten-17], p = 0.006). CONCLUSION: The authors study showed that the surgical strategy had no significant impact on postoperative RV function after mitral valve surgery.

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.

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.

Impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support.

BACKGROUND: The aim of this study was to evaluate the impact of the surgical approach on the postoperative outcome in patients who underwent left ventricular assist device (LVAD) implantation after having received veno-arterial extracorporeal life support (va-ECLS) using data from a European registry (ECLS-VAD). Five hundred and thirty-one patients were included. METHODS: A propensity score-adjusted outcome analysis was performed, resulting in 324 patients in the full sternotomy (FS) group and 39 in the less invasive surgery (LIS) group. RESULTS: The surgery lasted in median 236 min in the FS group versus 263 min in the LIS group (p = 0.289). The median chest tube output during the first 24 h was similar in both groups. Patients who underwent implantation with an FS required more blood products during the first 24 postoperative hours (median 16 vs. 12, p = 0.033). The incidence of revision due to bleeding was also higher (35.5 vs. 15.4%, p = 0.016). A temporary postoperative right ventricular assist device was necessary in 45.1 (FS) versus 23.1% (LIS) of patients, respectively (p = 0.067). No stroke occurred in the LIS group during the first 30 days after surgery (7.4% in the FS group). The incidence of stroke and of renal, hepatic, and respiratory failure during the follow-up was similar in both groups. The 30-day and one-year survival were similar in both groups. CONCLUSION: LIS for implantation of a durable LVAD in patients on va-ECLS implanted for cardiogenic shock is associated with less revision due to bleeding, less administration of blood products and absence of perioperative stroke, with no impact on survival.

Viscoelastic Blood Tests Use in Adult Cardiac Surgery: Meta-Analysis, Meta-Regression, and Trial Sequential Analysis.

OBJECTIVES: Postoperative hemorrhage in cardiac surgery is a significant cause of morbidity and mortality. Standard laboratory tests fail as predictors for bleeding in the surgical setting. The use of viscoelastic (VE) hemostatic assays thromboelastography (TEG) and rotational thromboelastometry (ROTEM) could be an advantage in patients undergoing cardiac surgery. The objective of this meta-analysis was to analyze the effects (benefits and harms) of VE-guided transfusion practice in cardiac surgery patients. DESIGN: A meta-analysis of randomized trials. SETTING: For this study, PubMed, EMBASE, Scopus, and the Cochrane Collaboration database were searched, and only randomized controlled trials were included. A systematic review and meta-analysis were performed in accordance with the standards set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using a random-effects model. PARTICIPANTS: The study comprised adult cardiac surgery patients. INTERVENTIONS: VE-hemostatic assays transfusion algorithm compared with transfusion algorithms based on clinicians' discretion. MEASUREMENTS AND MAIN RESULTS: Seven comparative randomized controlled trials were considered, including a total of 1,035 patients (522 patients in whom a TEG- or ROTEM-based transfusion algorithm was used). In patients treated according to VE-guided algorithms, red blood cell (odds ratio 0.61; 95% confidence interval [CI]: 0.37-0.99; p: 0.04; I2: 66%) and fresh frozen plasma transfusions (risk difference 0.22; 95% CI: 0.11-0.33; p < 0.0001; I2: 79%) use was reduced; platelets transfusion was not reduced (odds ratio 0.61; 95% CI: 0.32-1.15; p: 0.12; I2 74%). CONCLUSIONS: This study demonstrated that the use of VE assays in cardiac surgical patients is effective in reducing allogenic blood products exposure, postoperative bleeding at 12 and 24 hours after surgery, and the need for redo surgery unrelated to surgical bleeding.

Meta-analysis of results of subvalvular repair for severe ischemic mitral regurgitation.

BACKGROUND AND AIM OF THE STUDY: The aim of this meta-analysis was to compare short- and long-term outcomes of patients undergoing mitral annuloplasty (MA) with or without papillary muscle surgery (PMS) for the treatment of ischemic mitral regurgitation (IMR). METHODS: A systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were performed. RESULTS: Nine studies met the inclusion criteria. This meta-analysis identified 478 patients: 228 patients underwent MA alone and 250 patients underwent concomitant PMS. Early mortality was similar between two groups (odds ratio [OR] 1.14, 95% confidence interval [CI], 0.51-2.53; P = .75). PMS was associated at follow-up with a higher freedom from cardiac-related events (P = .050); moreover, although both surgical techniques had a positive impact on ventricular remodeling, the PMS group showed a significant higher reduction of left ventricle end-diastolic diameter (OR, 4.89, 95% CI, 2.77-7.01; P < .001) and left ventricle end-systolic diameter values (OR, 4.11, 95% CI, 1.98-6.24; P < .001). Finally, PMS compared with MA alone was associated with a significant reduction of recurrent mitral regurgitation at follow-up (OR, 3.25, 95% CI, 1.60-6.59; P = .001). CONCLUSIONS: This meta-analysis demonstrated superiority in terms of ventricular remodeling of a combined approach encompassing PMS and MA over MA alone in IMR. Moreover, the association of subvalvular surgery with restrictive MA decreases the incidence of mitral regurgitation recurrence and cardiac-related events at follow-up.

Worldwide Opinion on Multicenter Randomized Interventions Showing Mortality Reduction in Critically Ill Patients: A Democracy-Based Medicine Approach.

OBJECTIVES: Democracy-based medicine is a combination of evidence-based medicine (systematic review), expert assessment, and worldwide voting by physicians to express their opinions and self-reported practice via the Internet. The authors applied democracy-based medicine to key trials in critical care medicine. DESIGN AND SETTING: A systematic review of literature followed by web-based voting on findings of a consensus conference. PARTICIPANTS: A total of 555 clinicians from 61 countries. INTERVENTIONS: The authors performed a systematic literature review (via searching MEDLINE/PubMed, Scopus, and Embase) and selected all multicenter randomized clinical trials in critical care that reported a significant effect on survival and were endorsed by expert clinicians. Then they solicited voting and self-reported practice on such evidence via an interactive Internet questionnaire. Relationships among trial sample size, design, and respondents' agreement were investigated. The gap between agreement and use/avoidance and the influence of country origin on physicians' approach to interventions also were investigated. MEASUREMENTS AND MAIN RESULTS: According to 24 multicenter randomized controlled trials, 15 interventions affecting mortality were identified. Wide variabilities in both the level of agreement and reported practice among different interventions and countries were found. Moreover, agreement and reported practice often did not coincide. Finally, a positive correlation among agreement, trial sample size, and number of included centers was found. On the contrary, trial design did not influence clinicians' agreement. CONCLUSIONS: Physicians' clinical practice and agreement with the literature vary among different interventions and countries. The role of these interventions in affecting survival should be further investigated to reduce both the gap between evidence and clinical practice and transnational differences.

Evaluation of the Nautilus Smart Extracorporeal Membrane Oxygenation in Patients With Hemostatic Alteration: A Case Series.

The intricate management of hemostatic disorders in extracorporeal membrane oxygenation (ECMO) assisted patients poses challenges, particularly when procoagulant administration is necessary. We hereby report the performance of the Nautilus* Smart ECMO Module in three patients with hemostatic disorders. We collected data from ECMO procedures with Nautilus* Smart ECMO Module and analyzed the performance: the operating pressures and resistance of the device in addition to the coagulation status of the patients. During the three procedures, partial pressure oxygen post-oxygenator (paO2) stayed above 100 mm Hg and partial pressure carbon dioxide post-oxygenator (paCO2) did not exceed 45 mm Hg. Membrane FiO2 (fractional inspired O2) did not exceed 75% and air flow remained within a 1:1 ratio with blood flow in veno-arterial ECMO (V-A) and within 1:2 in veno-venous ECMO (V-V). There was no evidence of excessive operating pressure for the device, with a pressure drop consistently below 28 mm Hg and a maximum peak resistance of 7 Δmm Hg/L/min. The Nautilus* Smart ECMO Module showed good performance in patients with hemostatic disorders despite the implications associated with procoagulant administration.

Reliability of EuroSCORE II on Prediction of Thirty-Day Mortality and Long-Term Results in Patients Treated with Sutureless Valves.

Background: EuroSCORE II (ES2) is a reliable tool for preoperative cardiac surgery mortality risk prediction; however, a patient's age, a surgical procedure's weight and the new devices available may cause its accuracy to drift. We sought to investigate ES2 performance related to the surgical risk and late mortality estimation in patients who underwent aortic valve replacement (AVR) with sutureless valves. Methods: Between 2012 and 2021, a total of 1126 patients with isolated aortic stenosis who underwent surgical AVR by means of sutureless valves were retrospectively collected from six European centers. Patients were stratified into three groups according to the EuroSCORE II risk classes (ES2 < 4%, ES2 4-8% and ES2 > 8%). The accuracy of ES2 in estimating mortality risk was assessed using the standardized mortality ratio (O/E ratio), ROC curves (AUC) and Hosmer-Lemeshow (HL) test for goodness-of-fit. Results: The overall observed mortality was 3.0% (predicted mortality ES2: 5.39%) with an observed/expected (O/E) ratio of 0.64 (confidential interval (CI): 0.49-0.89). In our population, ES2 showed a moderate discriminating power (AUC 0.65, 95%CI 0.56-0.72, p < 0.001; HL p = 0.798). Good accuracy was found in patients with ES2 < 4% (O/E ratio 0.54, 95%CI 0.23-1.20, AUC 0.75, p < 0.001, HL p = 0.999) and for patients with an age < 75 years (O/E ratio 0.98, 95%CI 0.45-1.96, AUC 0.76, p = 0.004, HL p = 0.762). Moderate discrimination was observed for ES2 in the estimation of long-term risk of mortality (AUC 0.64, 95%CI: 0.60-0.68, p < 0.001). Conclusions: EuroSCORE II showed good accuracy in patients with an age < 75 years and patients with ES2 < 4%, while overestimating risk in the other subgroups. A recalibration of the model should be taken into account based on the complexity of actual patients and impact of new technologies.

Ventilation strategies in cardiogenic shock: Insights from the AltShock-2 registry.

AIMS: To describe the use and the relation to outcome of different ventilation strategies in a contemporary, large, prospective registry of cardiogenic shock patients. METHODS AND RESULTS: Among 657 patients enrolled from March 2020 to November 2023, 198 (30.1%) received oxygen therapy (OT), 96 (14.6%) underwent non-invasive ventilation (NIV), and 363 (55.3%) underwent invasive mechanical ventilation (iMV). Patients in the iMV group were significantly younger compared to those in the NIV and OT groups (63 vs. 69 years, p < 0.001). There were no significant differences between groups regarding cardiovascular risk factors. Patients with SCAI B and C were more frequently treated with OT and NIV compared to iMV (65.1% and 65.4% vs. 42.6%, respectively, p > 0.001), while the opposite trend was observed in SCAI D patients (12% and 12.2% vs. 30.9%, respectively, p < 0.001). All-cause mortality at 24 h did not differ amongst the three groups. The 60-day mortality rates were 40.2% for the iMV group, 26% for the OT group, and 29.3% for the NIV group (p = 0.005), even after excluding patients with cardiac arrest at presentation. In the multivariate analysis including SCAI stages, NIV was not associated with worse mortality compared to iMV (hazard ratio 1.97, 95% confidence interval 0.85-4.56), even in more severe SCAI stages such as D. CONCLUSIONS: Compared to previous studies, we observed a rising trend in the utilization of NIV among cardiogenic shock patients, irrespective of aetiology and SCAI stages. In this clinical scenario, NIV emerges as a safe option for appropriately selected patients.

Cardiotoxicity, Cardioprotection, and Prognosis in Survivors of Anticancer Treatment Undergoing Cardiac Surgery: Unmet Needs.

BACKGROUND: Anticancer treatments are improving the prognosis of patients fighting cancer. However, anticancer treatments may also increase the cardiovascular (CV) risk by increasing metabolic disorders. Atherosclerosis and atherothrombosis related to anticancer treatments may lead to ischemic heart disease (IHD), while direct cardiac toxicity may induce non-ischemic heart disease. Moreover, valvular heart disease (VHD), aortic syndromes (AoS), and advanced heart failure (HF) associated with CV risk factors and preclinical CV disease as well as with chronic inflammation and endothelial dysfunction may also occur in survivors of anti-carcer treatments. METHODS: Public electronic libraries have been searched systematically looking at cardiotoxicity, cardioprotection, CV risk and disease, and prognosis after cardiac surgery in survivors of anticancer treatments. RESULTS: CV risk factors and disease may not be infrequent among survivors of anticancer treatments. As cardiotoxicity of established anticancer treatments has been investigated and is frequently irreversible, cardiotoxicity associated with novel treatments appears to be more frequently reversible, but also potentially synergic. Small reports suggest that drugs preventing HF in the general population may be effective also among survivors of anticancer treatments, so that CV risk factors and disease, and chronic inflammation, may lead to indication to cardiac surgery in survivors of anticancer treatments. There is a lack of substantial data on whether current risk scores are efficient to predict prognosis after cardiac surgery in survivors of anticancer treatments, and to guide tailored decision-making. IHD is the most common condition requiring cardiac surgery among survivors of anticancer treatments. Primary VHD is mostly related to a history of radiation therapy. No specific reports exist on AoS in survivors of anticancer treatments. CONCLUSIONS: It is unclear whether interventions to dominate cancer- and anticancer treatment-related metabolic syndromes, chronic inflammation, and endothelial dysfunction, leading to IHD, nonIHD, VHD, HF, and AoS, are as effective in survivors of anticancer treatments as in the general population. When CV diseases require cardiac surgery, survivors of anticancer treatments may be a population at specifically elevated risk, rather than affected by a specific risk factor.

Artificial intelligence, big data and heart transplantation: Actualities.

BACKGROUND: As diagnostic and prognostic models developed by traditional statistics perform poorly in real-world, artificial intelligence (AI) and Big Data (BD) may improve the supply chain of heart transplantation (HTx), allocation opportunities, correct treatments, and finally optimize HTx outcome. We explored available studies, and discussed opportunities and limits of medical application of AI to the field of HTx. METHOD: A systematic overview of studies published up to December 31st, 2022, in English on peer-revied journals, have been identified through PUBMED-MEDLINE-WEB of Science, referring to HTx, AI, BD. Studies were grouped in 4 domains based on main studies' objectives and results: etiology, diagnosis, prognosis, treatment. A systematic attempt was made to evaluate studies by the Prediction model Risk Of Bias ASsessment Tool (PROBAST) and the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD). RESULTS: Among the 27 publications selected, none used AI applied to BD. Of the selected studies, 4 fell in the domain of etiology, 6 in the domain of diagnosis, 3 in the domain of treatment, and 17 in that of prognosis, as AI was most frequently used for algorithmic prediction and discrimination of survival, but in retrospective cohorts and registries. AI-based algorithms appeared superior to probabilistic functions to predict patterns, but external validation was rarely employed. Indeed, based on PROBAST, selected studies showed, to some extent, significant risk of bias (especially in the domain of predictors and analysis). In addition, as example of applicability in the real-world, a free-use prediction algorithm developed through AI failed to predict 1-year mortality post-HTx in cases from our center. CONCLUSIONS: While AI-based prognostic and diagnostic functions performed better than those developed by traditional statistics, risk of bias, lack of external validation, and relatively poor applicability, may affect AI-based tools. More unbiased research with high quality BD meant for AI, transparency and external validations, are needed to have medical AI as a systematic aid to clinical decision making in HTx.

Cerebral Perfusion and Neuromonitoring during Complex Aortic Arch Surgery: A Narrative Review.

Complex ascending and aortic arch surgery requires the implementation of different cerebral protection strategies to avoid or limit the probability of intraoperative brain damage during circulatory arrest. The etiology of the damage is multifactorial, involving cerebral embolism, hypoperfusion, hypoxia and inflammatory response. These protective strategies include the use of deep or moderate hypothermia to reduce the cerebral oxygen consumption, allowing the toleration of a variable period of absence of cerebral blood flow, and the use of different cerebral perfusion techniques, both anterograde and retrograde, on top of hypothermia, to avoid any period of intraoperative brain ischemia. In this narrative review, the pathophysiology of cerebral damage during aortic surgery is described. The different options for brain protection, including hypothermia, anterograde or retrograde cerebral perfusion, are also analyzed, with a critical review of the advantages and limitations under a technical point of view. Finally, the current systems of intraoperative brain monitoring are also discussed.