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Background: Circulatory support with a catheter-based microaxial flow pump (mAFP) plays a major role in the treatment of severe cardiogenic shock. In most patients who fail to recover while on temporary mechanical circulatory support (tMCS) and who are not eligible for heart transplantation, durable left ventricular assist device (dLVAD) implantation is usually considered a reliable option. This study aimed to describe the outcome of dLVAD therapy following mAFP support and to identify predictors of mortality., Methods: This was a retrospective analysis of data from a multicenter registry on patients who underwent dLVAD implantation following tMCS with a mAFP between January 2017 and October 2022 (n = 332) from 19 European centers., Results: Patients were supported with an Impella 5.5 (n = 92), 5.0 (n = 153) or CP (n = 87) and were transitioned to a HeartWare HVAD (n = 128) or Heartmate 3 (n = 204) during the same period. One hundred and twenty-five patients (39.2%) also required extracorporeal life support before and/or during mAFP therapy. The 30-day and 1-year survival were 87.8% and 71.1%, respectively. The following risk factors for 1-year mortality were identified: age (odds ratio [OR], 1.02), specifically age over 55 years (OR, 1.09), body mass index >30 kg/m 2 (OR, 2.2), female sex (OR for male sex, 0.43), elevated total bilirubin (OR, 1.12), and low platelet count (OR, 0.996)., Conclusions: Based on the identified risk factors, a risk score for estimating 1-year mortality was calculated to optimize patient selection for dLVAD implantation., Competing Interests: M.O. is a member of the advisory board for A biomed. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2024 The Author(s).)

Severe mitral insufficiency is a feared complication that develops in 10-12% of patients with myocardial infarction and ST elevation. It results from the rupture of the papillary muscle or is secondary to an acute remodelling of the left ventricle in its entirety or of the infarcted region. The mortality of patients with acute clinical onset reaches 50%. The ideal treatment of acute mitral insufficiency is controversial and still a source of debate. Most of these patients are at high surgical risk or inoperable; therefore, they are treated conservatively and have a poor prognosis. In these candidates, percutaneous treatment of insufficiency with percutaneous edge to edge can be considered an alternative., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Patients with LVAD require continuous monitoring and care, and since Implanting Centers (ICs) are more experienced in managing LVAD patients than other healthcare facilities, the distance between patient residency and IC could negatively affect the outcomes., Methods: Data of patients discharged after receiving an LVAD implantation between 2010 and 2021 collected from the MIRAMACS database were retrospectively analyzed. The population was divided into two groups: A (n = 175) and B (n = 141), according to the distance between patient residency and IC ≤ or >90 miles. The primary endpoint was freedom from Adverse Events (AEs), a composite outcome composed of death, cerebrovascular accident, hospital admission because of GI bleeding, infection, pump thrombosis, and right ventricular failure. Secondary endpoints were incidences of mortality and complications. All patients were followed-up regularly, according to participating center protocols., Results: Baseline clinical characteristics and indications for LVAD did not differ between the two groups. The mean duration of support was 25.5 ± 21 months for Group A and 25.7 ± 20 months for Group B (p = 0.79). At 3 years, freedom from AEs was similar between Group A and Group B (p = 0.36), and there were no differences in rates of mortality and LVAD-related complications., Conclusions: Distance from the IC does not represent a barrier to successful outcomes as long as regular and continuous follow-up is provided., (© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Interest in the use of mechanical circulatory support for patients presenting with cardiogenic shock is growing rapidly. The Impella (Abiomed Inc), a microaxial, continuous-flow, short-term, ventricular assist device (VAD), requires meticulous postimplantation management. Because systemic anticoagulation is needed to prevent pump thrombosis, patients are exposed to increased bleeding risk, further aggravated by sepsis, thrombocytopenia, and high shear stress-induced acquired von Willebrand syndrome. The precarious balance between bleeding and thrombosis in percutaneous VAD-supported cardiogenic shock patients is often the main reason that patient outcomes are jeopardized, and there is a lack of data addressing optimal anticoagulation management strategies during percutaneous VAD support. Here, we present a parallel anti-Factor Xa/activated partial thromboplastin time-guided anticoagulation algorithm and discuss pitfalls of heparin monitoring in critically ill patients. This review will guide physicians toward a more standardized (anti)coagulation approach to tackle device-related morbidity and mortality in this critically ill patient group., Competing Interests: Funding Support and Author Disclosures Drs Vandenbriele, Meyns, Chieffo, Schrage, and Westermann have received research and/or travel funding, as well as speaker fees, from Abiomed outside of this paper. Dr Vandenbriele has received grant support from University Hospitals Leuven (Klinische onderzoeks-en opleidingsraad); and is funded by MRC Uk (MR/V037633/1). Dr Polzin has received support from the Forschungskommission of the Medical Faculty of the Heinrich Heine University (No. 18-2019) and from the German Research Foundation (PO 2247/2-1 and SFB1116). Dr Vranckx has received personal fees from Bayer, Daiichi-Sankyo, and CLS Behring. Dr Schrage has received speaker fees from AstraZeneca. Dr Chieffo has received consultant/speaker fees from Abbott, Biosensor, Boston Scientific, Edwards, and Magenta. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

The rapid institution of mechanical circulatory support (MCS) during cardiogenic shock secondary to severe biventricular failure is strongly recommended. Despite the introduction of less-invasive devices and adequate anticoagulation protocols, the presence of vascular complications in patients treated with MCS has not yet been eliminated. Here, the authors report a 60-year-old patient treated with the Bi-Pella approach for biventricular failure. Despite anticoagulant therapy, the patient developed a floating thrombosis in the inferior vena cava extending to the right atrium after the Impella RP removal. Considering the thrombus instability and the risk of pulmonary embolism, the patient was treated urgently for a percutaneous mechanical thrombectomy using the AngioJet thrombectomy system. The procedure was completed without intraoperative complications, and both the completion angiography and transesophageal echocardiography showed complete thrombus removal. No procedure-related complications occurred, but the patient died from progressive worsening of left ventricular failure on the 16th postoperative day. In the case of proximal extensive deep vein thrombosis with an increased risk of pulmonary embolism, the use of percutaneous mechanical thrombectomy could be a therapeutic option, even in critically ill patients, due to its minimally invasive nature and low rates of complications., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: This study aims at better defining the profile of patients with a complicated versus noncomplicated postoperative course following isolated tricuspid valve (TV) surgery to identify predictors of a favorable/unfavorable hospital outcome., Methods: All patients treated with isolated tricuspid surgery from March 1997 to January 2020 at our institution were retrospectively reviewed. Considering the complexity of most of these patients, a regular postoperative course was arbitrarily defined as a length-of-stay in intensive care unit less than 4 days and/or postoperative length-of-stay less than 10days. Patients were therefore divided accordingly in two groups., Results: One hundred and seventy-two patients were considered, among whom 97 (56.3%) had a regular (REG) and 75 (43.6%) a non-regular (NEG) postoperative course. The latter had worse baseline clinical and echocardiographic characteristics, with higher rate of renal insufficiency, previous heart failure hospitalizations, cardiac operations, and right ventricular dysfunction. NEG patients more frequently needed tricuspid replacement and experienced a greater number of complications (p < .001) and higher in-hospital mortality (13% vs. 0%, p < .001). The majority of these complications were related to more advanced stage of the tricuspid disease. Among most important predictors of a negative outcome univariate analysis identified chronic kidney disease, ascites, previous right heart failure hospitalizations, right ventricular dysfunction, previous cardiac surgeries, TV replacement and higher MELD scores. At multivariate analysis, liver enzymes and diuretics' dose were predictors of complicated postoperative course., Conclusion: In isolated TV surgery a complicated postoperative course is observed in patients with more advanced right heart failure and organ damage. Earlier surgical referral is associated to excellent outcomes and should be recommended., (© 2021 Wiley Periodicals LLC.)

Objectives: The aim of this study was to evaluate the impact of edge-to-edge PMVR on short and mid-term clinical outcomes in patients with CS and severe MR., Background: Severe mitral regurgitation (MR) in the setting of cardiogenic shock (CS) is associated with three times higher risk of 1-year mortality. In refractory CS, edge-to-edge percutaneous mitral valve repair (PMVR) can be a potential therapeutic option., Methods: We retrospectively included consecutive patients with refractory CS and concomitant severe MR treated with MitraClip® system. CS was defined according to the criteria used in the SHOCK trial and procedural success according to Mitral Valve Academic Research Consortium (MVARC) criteria. The 30-day and 6-month mortality were the primary and secondary endpoints respectively., Results: Thirty-one patients (median age 73 years [interquartile range, IQR 66-78], 25.8% female), STS mortality score 37.9 [IQR 30.4-42.4]), with CS and concomitant severe MR treated with edge-to-edge PMVR were retrospectively enrolled. Procedural success was 87.1%. Thirty-day and 6-month survival rates were 78.4 and 45.2% respectively. Univariate Cox Regression Model analysis showed that procedural success was a predictor of both 30-day (HR = 0.12, 95% CI 0.03-0.55, p < .01) and 6-month survival (HR = 0.22, 95% CI 0.06-0.84, p = .027)., Conclusions: Edge-to-edge PMVR in patients with CS and concomitant severe MR was associated with good procedural safety and success with acceptable short and mid-term survival rates. It could be considered a bailout option in this setting of patients., (© 2021 Wiley Periodicals LLC.)

Background: Myocarditis lacks systematic characterization in COVID-19 patients., Methods: We enrolled consecutive patients with newly diagnosed myocarditis in the context of COVID-19 infection. Diagnostic and treatment strategies were driven by a dedicated multidisciplinary disease unit for myocarditis. Multimodal outcomes were assessed during prospective follow-up., Results: Seven consecutive patients (57% males, age 51 ± 9 y) with acute COVID-19 infection received a de novo diagnosis of myocarditis. Endomyocardial biopsy was of choice in hemodynamically unstable patients ( n = 4, mean left ventricular ejection fraction (LVEF) 25 ± 9%), whereas cardiac magnetic resonance constituted the first exam in stable patients ( n = 3, mean LVEF 48 ± 10%). Polymerase chain reaction (PCR) analysis revealed an intra-myocardial SARS-CoV-2 genome in one of the six cases undergoing biopsy: in the remaining patients, myocarditis was either due to other viruses ( n = 2) or virus-negative ( n = 3). Hemodynamic support was needed for four unstable patients (57%), whereas a cardiac device implant was chosen in two of four cases showing ventricular arrhythmias. Medical treatment included immunosuppression (43%) and biological therapy (29%). By the 6-month median follow-up, no patient died or experienced malignant arrhythmias. However, two cases (29%) were screened for heart transplantation., Conclusions: Myocarditis associated with acute COVID-19 infection is a spectrum of clinical manifestations and underlying etiologies. A multidisciplinary approach is the cornerstone for tailored management.

We herein characterize the immunopathological features of two Italian COVID-19 patients who underwent bilateral lung transplantation (bLTx). Removed lungs underwent histopathological evaluation. Gene expression profiling (GEP) for immune-related signatures was performed on lung specimens and SARS-CoV-2-stimulated peripheral blood mononuclear cells (PBMCs). Cytokine levels were measured on lungs, bronchoalveolar lavage fluids and in culture supernatants. Pathological assessment showed extensive lung damage with the pattern of proliferative to fibrotic phases, with diffuse alveolar damage mimicking usual interstitial pneumonia (UIP). Lungs' GEP revealed overexpression of pathogen recognition receptors, effector cytokines and chemokines, immune activation receptors and of the inflammasome components. Multiplex cytokine analysis confirmed a proinflammatory state, with high levels of monocyte/macrophage chemotactic and activating factors and of IL-6 and TNF-α. A similar profile was observed in SARS-CoV-2-stimulated PBMCs collected 7 days after transplant. The pattern of tissue damage observed in the lungs suggests that this may represent the output of protracted disease, resembling a diffuse UIP-like picture. The molecular immune profiling supports the paradigm of a persistent proinflammatory state and sustained humoral immunity, conditions that are maintained despite the iatrogenic immunosuppression.

Objective: The aim of this study is to evaluate the open transaxillary placement of the Impella 5.0 with a modified surgical technique., Methods: From January to July 2018, nine patients (eight males; mean age 60 years) underwent surgical transaxillary Impella 5.0 (Abiomed Inc., Danvers, MA) implantation. Patient and periprocedural data were recorded in a prospectively maintained institutional database. The primary endpoint was technical success. The secondary endpoints were: neurological complications (peripheral or central), bleeding, and wound infection, duration of Impella support, and device failure requiring device replacement., Results: Assisted technical success was 100%. The right axillary artery was used in 8/9 cases. Three patients (all on extracorporeal membrane oxygenation) suffered from access site bleeding which required surgical reintervention. One patient suffered from peripheral neurological dysfunction which recovered in 1 month and one patient had a local hematoma which was managed conservatively. The median length of treatment was 16 days (range 8-35). Five patients had myocardial recovery and the Impella could be explanted; the remaining were transitioned to a durable left ventricular assist device with an uneventful postoperative course. Hospital mortality was 33%., Conclusions: Open Impella 5.0 device implantation through the axillary artery is safe and effective; technical success was 100% and low rates of major complications are reported., (© 2019 Wiley Periodicals, Inc.)

Purpose: Confounders in randomized controlled trials (RCTs) reporting significant effects on mortality in critically ill patients using non-surgical techniques have not been systematically explored. We aimed to identify factors unrelated to the reported intervention that might have affected the findings and robustness of such trials., Methods: We searched Pubmed/MEDLINE for all RCTs on any non-surgical interventions reporting an effect on unadjusted mortality in critically ill patients between 1/1/2000 and 1/12/2015. We assessed: the number needed to treat/harm (NNT or NNH), sample size, trial design (blinded/unblinded, single or multinational, single or multicenter (sRCT or mRCT)), intention to treat (ITT) analysis, and countries of origin., Results: Almost half of RCTs were sRCTs. Median sample size was small, and 1/3 were not analyzed according to ITT principle. Lack of ITT analysis was associated with greater effect size (p=0.0028). Harm was more likely in mRCTs (p=0.002) and/or in blinded RCTs (p=0.003). Blinded RCTs had double sample size (p=0.007) and an increased NNT/NNH (p=0.002). Finally, mRCTs had higher NNT (p=0.005) and NNH (p=0.02), and harm was only detected in studies from Western countries (p=0.007)., Conclusions: These observations imply that major systematic biases exist and affect trial findings irrespective of the intervention being studied., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: Standard inotropic treatment is often necessary in end-stage heart failure but may be harmful. We performed a meta-analysis of randomized controlled trials to investigate the effect of repeated administration of levosimendan on survival in patients with chronic heart failure., Methods and Results: Four investigators independently searched in CENTRAL, Google Scholar MEDLINE/PubMed, Scopus and the Cochrane Central Register of clinical trials to identify any randomized study ever performed with intermittent levosimendan intravenous administration in adult patients with chronic heart failure with no restrictions on dose or time of administration. Data from a total of 326 patients from six randomized controlled studies using intermittent levosimendan in a cardiological setting were included in the analysis. Levosimendan was associated with a significant reduction in mortality at the longest follow-up available [32 of 168 (19 %) in the levosimendan group 46 of 133 (35 %) in the control arm, RR = 0.55 (95 % CI 0.37-0.84), p for effect = 0 0.005, p for heterogeneity = 0.3, I (2) = 23.4 %, NNT = 6 with 5 studies included]. Brain natriuretic peptide values, ejection fraction and number of patients with New York Heart Association ≥ III status were similar in survivors of both groups., Conclusions: A large randomized trial is necessary to confirm the promising beneficial effects of intermittent levosimendan administration on the mid-term survival of patients with chronic heart failure.

Study Objective: To evaluate the relationship between continuous noninvasive monitoring of cerebral saturation (regional cerebral oxygen saturation [rSo2]) and occurrence of clinical and electroencephalographic (EEG) signs of cerebral ischemia during carotid cross-clamping., Design: Prospective clinical study., Setting: University hospital., Patients: Fifty ASA physical status II and III inpatients undergoing elective carotid endarterectomy with a cervical plexus block., Interventions: rSo2 was continuously monitored throughout surgery, while an independent neurologist evaluated the occurrence of both clinical and EEG signs of cerebral ischemia induced during carotid cross-clamping., Measurements and Main Results: rSo2 was recorded 1 and 3 minutes after clamping the carotid artery during a 3-minute clamping test. In 5 patients (10%), the carotid clamping test was associated with the occurrence of clinical and EEG signs of cerebral ischemia. All these patients were treated with the placement of a Javid shunt, which completely resolved the symptoms. In no patient was permanent neurological injury reported at hospital discharge. In 4 of these patients, EEG signs of cerebral ischemia were present at both observation times, and in one of them, the duration of cerebral ischemia was less than 2 minutes. The percentage rSo2 reduction from baseline during the carotid clamping test was 17% +/- 4% in patients requiring shunt placement and only 8% +/- 6% in those who did not require it (P = .01). A decrease in rSo2 15% or greater during the carotid clamping test was associated with a 20-fold increase in the odd for developing severe cerebral ischemia (odds ratio, 20; 95% confidence interval, 6.7-59.2) (P = .001); however, this threshold had a 44% sensitivity and 82% specificity, with only 94% negative predictive value., Conclusions: Continuous rSo2 monitoring is a simple and noninvasive method that correlates with the development of clinical and EEG signs of cerebral ischemia during carotid cross-clamping; however, we could not identify an rSo2 threshold that can be used alone to predict the need for shunt placement because of the low sensitivity and specificity.

Continuous positive end-expiratory pressure (CPAP) and Pressure Support Ventilation (PSV) are commonly used for the therapy of several forms of respiratory failure. CPAP and PSV can be delivered both during invasive respiratory treatment, by means of an endotracheal tube or tracheostomy, and during non invasive respiratory treatment. Non Invasive Ventilation (NIV) is commonly used for the therapy of several forms of respiratory failure (COPD, Weaning period from Invasive Mechanical Ventilation, Cardiogenic Edema,.) and the helmet could be a good new device to deliver it with a better compliance instead the common facial mask without increasing the nurses' workload.

Background: To evaluate the end tidal carbon dioxide estimation in nonintubated, spontaneously breathing patients using either conventional sidestream or microstream capnometers., Methods: Patients received a regional anesthesia technique, while the end tidal carbon dioxide partial pressure (EtCO2) was sampled through a nasal cannula (Nasal FilterLine, Nellcor, Plesanton, CA, USA) and measured using either a conventional sidestream capnometer with a 200 ml.min-1 aspiration flow rate, or a microstream capnometer (NBP-75, Nellcor Puritan Bennett, Plesanton, CA, USA) with an aspiration flow rate of 30 ml.min-1. After a 20 min period with stable hemodynamic variables (systolic arterial blood pressure within +/- 20% from baseline values), the EtCO2 was randomly recorded using one of the two capnometer while arterial blood was simultaneously drawn from the radial artery and analyzed for measurement of arterial CO2 partial pressure. Afterwards the nasal cannula was connected to the other capnometer and the procedure repeated. Both the capnometer and arterial blood gas analyzer were calibrated before each studied patient according to the manufacturer instructions. The same procedure was repeated at least two times in each patient., Results: A total of 120 pairs of EtCO2 and PaCO2 measurements were drawn from 30 adults (age: 69 +/- 5 years; weight: 70 +/- 10 kg; height: 160 +/- 10 cm): 60 using the conventional sidestream capnometer and 60 with the microstream one. The median arterial to end tidal CO2 tension difference was 4.4 mmHg (range: 0.28 mmHg) with the microstream capnometer and 7 mm Hg (range: 0-22 mmHg) with the conventional capnometer (p = 0.02)., Conclusion: The microstream capnometer provides a more accurate end tidal CO2 partial pressure measurement in nonintubated, spontaneously breathing patients than conventional sidestream capnometers, allowing for adequate monitoring of the respiratory function in nonintubated patients.