The porcine abattoir blood model-Evaluation of platelet function for in-vitro hemocompatibility investigations.

BACKGROUND: The major obstacle of blood-contacting medical devices is insufficient hemocompatibility, particularly thrombogenicity and platelet activation. Pre-clinical in-vitro testing allows for the evaluation of adverse thrombogenicity-related events, but is limited, among others, by the availability and quantity of human blood donations. The use of animal blood is an accepted alternative for several tests; however, animal and particularly abattoir blood might present species-specific differences to human blood as well as elevated blood values, and pre-activated platelets due to stressed animals and non-standardized blood collection. MATERIAL & METHODS: To this end, we investigated porcine abattoir blood in comparison to human donor blood with the focus on platelet pre-activation and remaining activation potential. By means of light transmission aggregometry, aggregation kinetics of platelet rich plasma after stimulation with three different concentrations of each adenosine diphosphate (ADP) (5 µM, 10 µM, 20 µM) and collagen (2.5 µg/ml, 5 µg/ml, 10 µg/ml) were monitored. RESULTS: The activation with collagen revealed no significant differences in platelet behavior of the two species. In contrast, stimulation with ADP resulted in a lower maximum aggregation and a high disaggregation for porcine abattoir blood. The latter is a species-specific phenomenon of porcine platelets. Variations within each study cohort were comparable for human and abattoir pig. CONCLUSION: The similarities in platelet activation following collagen stimulation and the preservation of the porcine-specific reaction to ADP prove a general functionality of the abattoir blood. This finding provides a first step towards the complete validation of the porcine abattoir blood model.

Intraoperative transit time flow measurements during off-pump coronary artery bypass surgery: The impact of coronary stenosis on competitive flow.

BACKGROUND: Combining preoperative angiography findings with intraoperative transit time flow measurements (TTFM) may improve patency of coronary artery bypass grafts. Nevertheless, graft flow might be impaired by native coronary flow based on the severity of stenoses, with inferior long-term outcomes. This study investigates the impact of left anterior descending artery (LAD) stenosis on competitive flow measured in left internal mammary artery (LIMA) grafts during off-pump coronary artery bypass grafting. METHODS: Fifty patients were included in this prospective single-center cohort study. LAD stenosis was assessed with quantitative coronary analysis (QCA) and stratified into three groups based on its severity. TTFM of LIMA grafts were performed with LAD open and temporarily occluded. Change in mean graft flow after LAD snaring was the primary endpoint. Secondary endpoints included further TTFM parameters, clinical outcomes, and competitive flow index (CFI), defined as the ratio of mean graft flow with open or closed LAD. RESULTS: Mean LAD stenosis as objectified with QCA was 58 ± 15%. Mean LIMA graft flow increased from 20 ml/min with open LAD to 30 ml/min with snared LAD (p < .001). TTFM cut-off values for graft patency improved in 26%-42% of patients after LAD occlusion. Median CFI was 0.66 (IQR: 0.56-0.82). Postoperative myocardial infarction occurred in 2.0% of patients, 120-day mortality was 0%, and 2-year mortality was 6.0%. CONCLUSIONS: Routine snaring of the LAD with CFI calculation during coronary artery bypass grafting is useful to detect significant competitive flow in LIMA grafts, potentially preventing unnecessary intraoperative graft revisions.

Noninfectious sternal wound inflammation after coronary artery bypass grafting in a patient with myelodysplastic syndrome: A no-touch approach.

Pyoderma gangrenosum (PG) is a rare, chronic inflammatory noninfectious dermatosis. It is associated with underlying systemic or hematological diseases such as myelodysplastic syndrome (MDS) and can be triggered after surgery. Recognition and diagnosis of PG can be difficult as it can mimic a wound infection. Misdiagnosis could lead to invasive procedures which worsen the disease and have possible disastrous aftermath. A 74-year-old male with a history of MDS presents with an atypical sternal wound inflammation. Diagnosis confirmed PG after skin biopsy. No surgical or invasive procedures were performed and the patient was treated on an outpatient basis with prednisolone, clobetasol cream, and cyclosporine. This case shows the importance of a rapid diagnosis of the disease. Awareness is required for the diagnosis of PG in a wound with pronounced livid borders, without improvement after antibiotic treatment or worsening after debridement. Rapid diagnosis and treatment reduce high healthcare costs, morbidity, and mortality.

A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol.

Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation.

Objective Quantification of In-Hospital Patient Mobilization after Cardiac Surgery Using Accelerometers: Selection, Use, and Analysis.

Cardiac surgery patients infrequently mobilize during their hospital stay. It is unclear for patients why mobilization is important, and exact progress of mobilization activities is not available. The aim of this study was to select and evaluate accelerometers for objective qualification of in-hospital mobilization after cardiac surgery. Six static and dynamic patient activities were defined to measure patient mobilization during the postoperative hospital stay. Device requirements were formulated, and the available devices reviewed. A triaxial accelerometer (AX3, Axivity) was selected for a clinical pilot in a heart surgery ward and placed on both the upper arm and upper leg. An artificial neural network algorithm was applied to classify lying in bed, sitting in a chair, standing, walking, cycling on an exercise bike, and walking the stairs. The primary endpoint was the daily amount of each activity performed between 7 a.m. and 11 p.m. The secondary endpoints were length of intensive care unit stay and surgical ward stay. A subgroup analysis for male and female patients was planned. In total, 29 patients were classified after cardiac surgery with an intensive care unit stay of 1 (1 to 2) night and surgical ward stay of 5 (3 to 6) nights. Patients spent 41 (20 to 62) min less time in bed for each consecutive hospital day, as determined by a mixed-model analysis (p < 0.001). Standing, walking, and walking the stairs increased during the hospital stay. No differences between men (n = 22) and women (n = 7) were observed for all endpoints in this study. The approach presented in this study is applicable for measuring all six activities and for monitoring postoperative recovery of cardiac surgery patients. A next step is to provide feedback to patients and healthcare professionals, to speed up recovery.

ECMOve: A Mobilization Device for Extracorporeal Membrane Oxygenation Patients.

Extracorporeal membrane oxygenation (ECMO) is a temporary lifesaving treatment for critically ill patients with severe respiratory or cardiac failure. Studies demonstrated the feasibility of in-hospital mobilizing during and after ECMO treatment preventing neuromuscular weakness and impaired physical functioning. Despite more compact mobile ECMO devices, implementation of ambulatory ECMO remains labor-intensive, complex, and challenging. It requires a large multidisciplinary team to carry equipment, monitor and physically support the patient, and to provide a back-up wheelchair in case of fatigue. Moreover, there is no adequate solution to ensure the stability of the patient's cannula and circuit management during ambulation. We developed a system contributing to improvement and innovation of current ambulatory ECMO patient programs. Our modular cart-in-cart system carries necessary ECMO equipment, features an extendable walking frame, and contains a folding seat for patient transport. An adjustable shoulder brace with lockable tubing-connectors enables safe fixation of the blood tubing. ECMOve provides safety, support, and accessibility while performing ambulatory ECMO for both patient and caregiver. Prototype evaluation in a simulated intensive care unit showed feasibility of our design, but needs to be evaluated in clinical care.

A mobilization poster stimulates early in-hospital rehabilitation after cardiac surgery: a prospective sequential-group study.

BACKGROUND: Patients infrequently mobilize at the surgical ward after cardiac surgery. Inactivity results in prolonged hospital stay, readmissions and increased cardiovascular mortality. Next, the course of in-hospital mobilization activities for patients is unclear. The aim was to evaluate early mobilization after heart surgery with a mobilization poster on the Activity Classification Guide for Inpatient Activities score from the American College for Sports Medicine (ACSM). Second, to develop a Thorax Centrum Twente (TCT) score to assess distinctive activities performed. METHODS: A poster was developed for the Moving is Improving! study to stimulate hospital mobilization after heart surgery. In this sequential-group study at a cardiothoracic surgery ward, 32 patients were included in the usual care group and 209 patients in the poster mobilization group. Change of ACSM and TCT scores over time were both defined as primary endpoints. Secondary endpoints included length of stay and survival. A subgroup analysis for coronary artery bypass grafting (CABG) was performed. RESULTS: ACSM score increased during hospital stay (p < 0.001). No significant increase of ACSM score was observed with a mobilization poster (p = 0.27), nor in the CABG subgroup (p = 0.15). The poster increased mobility to chair, toilet, corridor (all p < 0.01) and cycle ergometer (p = 0.02) as measured by the activity-specific TCT scores, without differences in length of stay or survival. CONCLUSIONS: ACSM score measured day-to-day functional changes, without significant differences between the poster mobilization and usual care group. Actual activities measured with the TCT score did improve. The mobilization poster is now new standard care, and effects in other centers and other departments should be assessed. TRIAL REGISTRATION: This study does not fall under the ICMJE trial definition and was not registered.

Simulators and Simulations for Extracorporeal Membrane Oxygenation: An ECMO Scoping Review.

High-volume extracorporeal membrane oxygenation (ECMO) centers generally have better outcomes than (new) low-volume ECMO centers, most likely achieved by a suitable exposure to ECMO cases. To achieve a higher level of training, simulation-based training (SBT) offers an additional option for education and extended clinical skills. SBT could also help to improve the interdisciplinary team interactions. However, the level of ECMO simulators and/or simulations (ECMO sims) techniques may vary in purpose. We present a structured and objective classification of ECMO sims based on the broad experience of users and the developer for the available ECMO sims as low-, mid-, or high-fidelity. This classification is based on overall ECMO sim fidelity, established by taking the median of the definition-based fidelity, component fidelity, and customization fidelity as determined by expert opinion. According to this new classification, only low- and mid-fidelity ECMO sims are currently available. This comparison method may be used in the future for the description of new developments in ECMO sims, making it possible for ECMO sim designers, users, and researchers to compare accordingly, and ultimately improve ECMO patient outcomes.

Sex-stratified patterns of emergency cardiovascular admissions prior and during the COVID-19 pandemic.

The COVID-19 pandemic has had a significant impact on global public health, with long-term consequences that are still largely unknown. This study aimed to assess the data regarding acute cardiovascular hospital admissions in five European centers before and during the pandemic. A multicenter, multinational observational registry was created, comparing admissions to the emergency departments during a 3-months period in 2020 (during the pandemic) with the corresponding period in 2019 (pre-pandemic). Data on patient demographics, COVID-19 test results, primary diagnosis, comorbidities, heart failure profile, medication use, and laboratory results were collected. A total of 8778 patients were included in the analysis, with 4447 patients in 2019 and 4331 patients in 2020. The results showed significant differences in the distribution of cardiovascular diseases between the two years. The frequency of pulmonary embolism (PE) increased in 2020 compared to 2019, while acute heart failure (AHF) and other cardiovascular diseases decreased. The odds of PE incidence among hospitalized patients in 2020 were 1.316-fold greater than in 2019. The incidence of AHF was 50.83% less likely to be observed in 2020, and the odds for other cardiovascular diseases increased by 17.42% between the 2 years. Regarding acute coronary syndrome (ACS), the distribution of its types differed between 2019 and 2020, with an increase in the odds of ST-segment elevation myocardial infarction (STEMI) in 2020. Stratification based on sex revealed further insights. Among men, the incidence of AHF decreased in 2020, while other cardiovascular diseases increased. In women, only the incidence of STEMI showed a significant increase. When analyzing the influence of SARS-CoV-2 infection, COVID-positive patients had a higher incidence of PE compared to COVID-negative patients. COVID-positive patients with ACS also exhibited symptoms of heart failure more frequently than COVID-negative patients. These findings provide valuable information on the impact of the COVID-19 pandemic on acute cardiovascular hospital admissions. The increased incidence of PE and changes in the distribution of other cardiovascular diseases highlight the importance of monitoring and managing cardiovascular health during and post pandemic period. The differences observed between sexes emphasize the need for further research to understand potential sex-specific effects of COVID-19 on cardiovascular outcomes.

Use of the Left Radial Artery as Vascular Access for Coronary Angiography and as a Bypass Conduit: A Clinical Dilemma?

PURPOSE: International coronary revascularization guidelines recommend both, transradial vascular access for coronary angiography/intervention and use of the radial artery as a conduit for coronary artery bypass grafting (CABG). These recommendations may pose a clinical dilemma, as transradial access exposes these arteries to vascular trauma which makes them potentially unsuitable as future grafts. In this study, we investigated the awareness and views of cardiologists on these guideline recommendations. METHODS: We performed semi-structured interviews with 50 cardiologists from 19 centers, who regularly perform coronary angiographies or interventions, and outlined clinical scenarios to evaluate their preference of vascular access. In addition, we assessed whether preference was related to sub-specialization. RESULTS: The interviewed cardiologists had 16 ± 9.3 years of professional experience. There were 23 (46%) cardiologists from 7 centers without percutaneous coronary intervention facilities, and 27 (56%) cardiologists from 12 interventional centers. All 50 (100%) cardiologists indicated familiarity with the guidelines, yet 28 (56%) said not to be familiar with the aforementioned dilemma, and 9 (18%) stated there was no dilemma at all. Responses did not differ significantly between interventional (n = 28) and non-interventional (n = 22) cardiologists; however, if the right radial artery was unavailable (e.g., occluded), interventional cardiologists more often said to prefer access via the left radial artery (18/28 (64%) vs. 5/22 (23%), p = 0.001). CONCLUSION: More than half of the interviewed cardiologists indicated that they had not realized that left transradial access preceding CABG may preclude later use of this artery as a conduit. Notably, in case of unavailability of the right radial artery, interventional cardiologists preferred left transradial access more often than non-interventional cardiologists.

The influence of timing of coronary angiography on acute kidney injury in out-of-hospital cardiac arrest patients: a retrospective cohort study.

BACKGROUND: Acute kidney injury (AKI) is a frequent complication in cardiac arrest survivors and associated with adverse outcome. It remains unclear whether the incidence of AKI increases after the post-cardiac arrest contrast administration for coronary angiography and whether this depends on timing of angiography. Aim of this study was to investigate whether early angiography is associated with increased development of AKI compared to deferred angiography in out-of-hospital cardiac arrest (OHCA) survivors. METHODS: In this retrospective multicenter cohort study, we investigated whether early angiography (within 2 h) after OHCA was non-inferior to deferred angiography regarding the development of AKI. We used an absolute difference of 5% as the non-inferiority margin. Primary non-inferiority analysis was done by calculating the risk difference with its 90% confidence interval (CI) using a generalized linear model for a binary outcome. As a sensitivity analysis, we repeated the primary analysis using propensity score matching. A multivariable model was built to identify predictors of acute kidney injury. RESULTS: A total of 2375 patients were included from 2009 until 2018, of which 1148 patients were treated with early coronary angiography and 1227 patients with delayed or no angiography. In the early angiography group 18.5% of patients developed AKI after OHCA and 24.1% in the deferred angiography group. Risk difference was - 3.7% with 90% CI ranging from - 6.7 to - 0.7%, indicating non-inferiority of early angiography. The sensitivity analysis using propensity score matching showed accordant results, but no longer non-inferiority of early angiography. The factors time to return of spontaneous circulation (odds ratio [OR] 1.12, 95% CI 1.06-1.19, p < 0.001), the (not) use of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (OR 0.20, 95% CI 0.04-0.91, p = 0.04) and baseline creatinine (OR 1.05, 95% CI 1.03-1.07, p < 0.001) were found to be independently associated with the development of AKI. CONCLUSIONS: Although AKI occurred in approximately 20% of OHCA patients, we found that early angiography was not associated with a higher AKI incidence than a deferred angiography strategy. The present results implicate that it is safe to perform early coronary angiography with respect to the risk of developing AKI after OHCA.

Impact of Coronavirus Disease 2019 (COVID-19) Outbreak on Acute Admissions at the Emergency and Cardiology Departments Across Europe.

PURPOSE: We evaluated whether the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) pandemic was associated with changes in the pattern of acute cardiovascular admissions across European centers. METHODS: We set-up a multicenter, multinational, pan-European observational registry in 15 centers from 12 countries. All consecutive acute admissions to emergency departments and cardiology departments throughout a 1-month period during the COVID-19 outbreak were compared with an equivalent 1-month period in 2019. The acute admissions to cardiology departments were classified into 5 major categories: acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, and other. RESULTS: Data from 54,331 patients were collected and analyzed. Nine centers provided data on acute admissions to emergency departments comprising 50,384 patients: 20,226 in 2020 compared with 30,158 in 2019 (incidence rate ratio [IRR] with 95% confidence interval [95%CI]: 0.66 [0.58-0.76]). The risk of death at the emergency departments was higher in 2020 compared to 2019 (odds ratio [OR] with 95% CI: 4.1 [3.0-5.8], P < 0.0001). All 15 centers provided data on acute cardiology departments admissions: 3007 patients in 2020 and 4452 in 2019; IRR (95% CI): 0.68 (0.64-0.71). In 2020, there were fewer admissions with IRR (95% CI): acute coronary syndrome: 0.68 (0.63-0.73); acute heart failure: 0.65 (0.58-0.74); arrhythmia: 0.66 (0.60-0.72); and other: 0.68(0.62-0.76). We found a relatively higher percentage of pulmonary embolism admissions in 2020: odds ratio (95% CI): 1.5 (1.1-2.1), P = 0.02. Among patients with acute coronary syndrome, there were fewer admissions with unstable angina: 0.79 (0.66-0.94); non-ST segment elevation myocardial infarction: 0.56 (0.50-0.64); and ST-segment elevation myocardial infarction: 0.78 (0.68-0.89). CONCLUSION: In the European centers during the COVID-19 outbreak, there were fewer acute cardiovascular admissions. Also, fewer patients were admitted to the emergency departments with 4 times higher death risk at the emergency departments.

Organization of outcome-based quality improvement in Dutch heart centres.

AIMS: Fourteen Dutch heart centres collected patient-relevant outcomes to support quality improvements in a value-based healthcare initiative that began in 2012. This study aimed to evaluate the current state of outcome-based quality improvement within six of these Dutch heart centres. METHODS AND RESULTS: Interviews and questionnaires among physicians and healthcare professionals in the heart centres were combined in a mixed-methods approach. The analysis indicates that the predominant focus of the heart centres is on the actual monitoring of outcomes. A systematic approach for the identification of improvement potential and the selection and implementation of improvement initiatives is lacking. The organizational context for outcome-based quality improvement is similar in the six heart centres. CONCLUSION: Although these heart centres in the Netherlands measure health outcomes for the majority of cardiac diseases, the actual use of these outcomes to improve quality of care remains limited. The main barriers are limitations regarding (i) data infrastructure, (ii) a systematic approach for the identification of improvement potential and the selection and implementation of improvement initiatives, (iii) governance in which roles and responsibilities of physicians regarding outcome improvement are formalized, and (iv) implementation of outcomes within hospital strategy, policy documents, and the planning and control cycle.

Randomized Trial of Miniaturized Versus Standard Extracorporeal Circulation in Aortic Valve Surgery.

BACKGROUND: Complications related to extracorporeal circulation remain serious. Although a minimal invasive extra corporeal circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. METHODS: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial. Patients who had undergone previous heart surgery and with preexisting kidney failure were excluded. The primary end point was postoperative blood loss after 12 hours and at drain removal. Secondary end points included intensive care and total length of stay and intubation time. At 1 hour and 12 hours after surgery, clinical laboratory data were determined. Early clinical outcomes and long-term survival were determined. RESULTS: MiECC patients (n = 63) had a significant lower blood loss (230 mL, 95% confidence interval: 203 to 261 mL) than regular patients (n = 62) after 12 hours (288 mL, 95% confidence interval: 241 to 344 mL, p = 0.04). A preservation of hemoglobin levels 1 hour and 12 hours after surgery in the MiECC group were observed (p < 0.001). No difference was found in early clinical outcomes and long-term survival. CONCLUSIONS: This randomized controlled trial compares MiECC and an advanced system for aortic valve replacement with blood loss as primary end point. We conclude that using MiECC is clinically equal for short- and long-term follow-up regarding blood loss. CLINICAL TRIAL REGISTRATION: NTR3378.

Supercritical carbon dioxide decellularised pericardium: Mechanical and structural characterisation for applications in cardio-thoracic surgery.

INTRODUCTION: Many biomaterials are used in cardio-thoracic surgery with good short-term results. However, calcification, dehiscence, and formation of scar tissue are reported. The aim of this research is to characterise decellularised pericardium after supercritical carbon dioxide (scCO2) processing as an alternative biological material for uses in cardio-thoracic surgery. METHODS: Porcine and bovine pericardium were decellularised using scCO2. Mechanical properties such as tensile strength, elastic modulus, fracture toughness and suture retention strength were determined. Ultrastructure was visualised using Scanning Electron Microscopy. Water uptake and swelling was experimentally determined. Commercially available glutaraldehyde treated bovine pericardium was used as gold standard for comparison. RESULTS: scCO2 decellularised porcine (and bovine pericardium) maintained their tensile strength compared to untreated native pericardium (13.3 ± 2.4MPa vs 14.0 ± 4.1MPa, p = 0.73). Tensile strength of glutaraldehyde treated pericardium was significantly higher compared to untreated pericardium (19.4 ± 7.3MPa vs 10.2 ± 2.2MPa, p = 0.02). Suture retention strength of scCO2 treated pericardium was significantly higher than glutaraldehyde treated pericardium (p = 0.01). We found no anisotropy of scCO2 or glutaraldehyde treated pericardium based on a trouser tear test. Ultrastructure was uncompromised in scCO2 treated pericardium, while glutaraldehyde treated pericardium showed deterioration of extracellular matrix. CONCLUSION: scCO2 processing preserves initial mechanical and structural properties of porcine and bovine pericardium, while glutaraldehyde processing damages the extracellular matrix of bovine pericardium. Decellularisation of tissue using scCO2 might give long-term solutions for cardio-thoracic surgery without compromising initial good mechanical properties.