Antithrombotic drug removal with hemoadsorption during off-pump coronary artery bypass grafting.

BACKGROUND: Patients requiring coronary artery bypass grafting (CABG) are often loaded with antithrombotic drugs (AT) and are at an increased risk for perioperative bleeding complications. Active AT removal by a hemoadsorption cartridge integrated in the cardiopulmonary bypass circuit is increasingly used in this setting to reduce bleeding, and herein we describe the extension of this application in patients on AT undergoing off-pump coronary artery bypass (OPCAB). METHODS: Ten patients (80% male; mean age: 67.4 ± 9.2years) were treated with ticagrelor (eight patients), rivaroxaban and ticagrelor (one patient), and rivaroxaban (one patient) prior to OPCAB surgery. AT's were discontinued one day before surgery in nine patients and on the day of surgery in one patient, and all patients were also on aspirin. The cohort mean EuroSCORE-II was 2.9 ± 1.5%. A hemoadsorption cartridge was integrated into a dialysis device (n=4) or a stand-alone apheresis pump (n=6) periprocedural, for a treatment time of 145 ± 33 min. Outcome measures included bleeding according to Bleeding Academic Research Consortium (BARC)-4 and 24-hour chest-tube-drainage (CTD). RESULTS: Mean operation time was 184 ± 35 min. All patients received a left internal thoracic artery with a mean of 2.3 ± 0.9 total grafts. One patient had a BARC-4 bleeding event and there were no surgical re-explorations for bleeding. Mean 24-hours CTD was 680 ± 307mL. During follow-up of 19.5 ± 17.0 months, none of the patients died or required further reinterventions. No device-related adverse events were reported. CONCLUSIONS: Hemoadsorption via a stand-alone apheresis pump during OPCAB surgery was feasible and safe. This innovative and new approach showed favorable bleeding rates in patients on antithrombotic drugs requiring bypass surgery.

A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

Improved early risk stratification of deep sternal wound infection risk after coronary artery bypass grafting.

BACKGROUND: Deep sternal wound infection (DSWI) following open heart surgery is associated with excessive morbidity and mortality. Contemporary DSWI risk prediction models aim at identifying high-risk patients with varying complexity and performance characteristics. We aimed to optimize the DSWI risk factor set and to identify additional risk factors for early postoperative detection of patients prone to DSWI. METHODS: Single-centre retrospective analysis of patients with isolated multivessel coronary artery disease undergoing myocardial revascularization at Paracelsus Medical University Nuremberg between 2007 and 2022 was performed to identify risk factors for DSWI. Three data sets were created to examine preoperative, intraoperative, and early postoperative parameters, constituting the "Baseline", the "Improved Baseline" and the "Extended" models. The "Extended" data set included risk factors that had not been analysed before. Univariable and stepwise forward multiple logistic regression analyses were performed for each respective set of variables. RESULTS: From 5221 patients, 179 (3.4%) developed DSWI. The "Extended" model performed best, with the area under the curve (AUC) of 0.80, 95%-CI: [0.76, 0.83]. Pleural effusion requiring intervention, postoperative delirium, preoperative hospital stay > 24 h, and the use of fibrin sealant were new independent predictors of DSWI in addition to age, Diabetes Mellitus on insulin, Body Mass Index, peripheral artery disease, mediastinal re-exploration, bilateral internal mammary harvesting, acute kidney injury and blood transfusions. CONCLUSIONS: The "Extended" regression model with the short-term postoperative complications significantly improved DSWI risk discrimination after surgical revascularization. Short preoperative stay, prevention of postoperative delirium, protocols reducing the need for evacuation of effusion and restrictive use of fibrin sealant for sternal closure facilitate DSWI reduction. TRIAL REGISTRATION: The registered retrospective study was registered at the study centre and approved by the Institutional Review Board of Paracelsus Medical University Nuremberg (IRB-2019-005).

A Machine Learning Model for the Accurate Prediction of 1-Year Survival in TAVI Patients: A Retrospective Observational Cohort Study.

BACKGROUND: predicting the 1-year survival of patients undergoing transcatheter aortic valve implantation (TAVI) is indispensable for managing safe early discharge strategies and resource optimization. METHODS: Routinely acquired data (134 variables) were used from 629 patients, who underwent transfemoral TAVI from 2012 up to 2018. Support vector machines, neuronal networks, random forests, nearest neighbour and Bayes models were used with new, previously unseen patients to predict 1-year mortality in TAVI patients. A genetic variable selection algorithm identified a set of predictor variables with high predictive power. RESULTS: Univariate analyses revealed 19 variables (clinical, laboratory, echocardiographic, computed tomographic and ECG) that significantly influence 1-year survival. Before applying the reject option, the model performances in terms of negative predictive value (NPV) and positive predictive value (PPV) were similar between all models. After applying the reject option, the random forest model identified a subcohort showing a negative predictive value of 96% (positive predictive value = 92%, accuracy = 96%). CONCLUSIONS: Our model can predict the 1-year survival with very high negative and sufficiently high positive predictive value, with very high accuracy. The "reject option" allows a high performance and harmonic integration of machine learning in the clinical decision process.

Ten years' experience with the sutureless aortic valve replacement: incidence and predictors for survival and valve durability at follow-up.

OBJECTIVES: Aortic valve replacement with a sutureless prosthesis [sutureless aortic valve replacement (Su-AVR)] is an option for patients with severe aortic valve stenosis. However, data regarding long-term outcomes and prosthesis durability are still lacking. METHODS: All consecutive patients who successfully underwent Su-AVR with the Perceval valve in our centre between 2010 and 2020 were included in the analysis and followed prospectively with echocardiography. Risk factor analysis was performed to assess variables associated with worse survival and bioprosthetic valve failure. RESULTS: Study population consisted of 547 patients: the mean age was 76.4 (5.2) years, 51% were female and the mean logistic EuroSCORE was 13% (11). The median survival was 7.76 years [95% confidence interval (CI) = 6.9-8.6]. Risk factor analysis identified age [hazard ratio (HR) 1.06, 95% CI 1.03-1.11; P < 0.001), EuroSCORE II (HR 1.08, 1.02-1.13; P < 0.001), baseline dialysis (HR 2.14, 95% CI 1.4-4.4; P = 0.038) and postoperative acute kidney injury ≥2 (HR 8.97, 95% CI 4.58-17.6; P < 0.001) as factors significantly correlated with worse survival. The reported HRs for age are per 1 year and for EuroSCORE II is 1 percentage point. Structural valve deterioration (SVD) was observed in 23 patients, of whom 19 underwent reintervention (median freedom from SVD 10.3 years). In multivariable Cox analysis, age (HR 0.89, 95% CI 0.82-0.95; P < 0.001) was found to be a significant predictor of SVD. Overall, 1.8% was referred for prosthetic valve endocarditis (confirmed or suspected) during follow-up. One patient showed moderate non-SVD and none developed prosthetic valve thrombosis. CONCLUSIONS: The sutureless valve represents a reliable bioprosthesis for aortic valve replacement in patients with a 10-year life expectancy. Younger age at the time of implant is the only factor associated with the risk of long-term SVD.

A New Apheresis Device for Antithrombotic Drug Removal during Off-Pump Coronary Artery Bypass Surgery.

Background and Objectives: The hemoadsorption device CytoSorb® (CytoSorbents Inc., Princeton, NJ, USA) has been shown to efficiently remove ticagrelor from whole blood in vitro. A promising clinical experience was made with the integration of the hemoadsorption cartridge on the cardiopulmonary bypass (CPB) circuit during cardiac surgery to reduce adverse events. Materials and Methods: In this report, we describe a novel approach using a new apheresis platform, PUR-01 (Nikkisio Co., Ltd., Tokyo, Japan), which was used as the extracorporeal circuit where CytoSorb® could be installed for the removal of ticagrelor during off-pump coronary artery bypass (OPCAB) procedures. Results: In a 74-year-old male (index case) with coronary artery disease and dual antiplatelet therapy, hemoadsorption was initiated with a skin incision for OPCAB surgery and was continued for 221 min to eliminate ticagrelor. The blood volume that had circulated through the CytoSorb® was 39.04 L in total. Thus far, this treatment strategy has been used in four cases with CHD and DAPT who needed OPCAB surgery. The intraoperative and postoperative courses were uneventful in all patients. No device-related adverse events occurred. Conclusions: The combination of the PUR-01 apheresis pump and hemoadsorption with the CytoSorb® column during OPCAB procedures appears to be safe and effective in eliminating antiplatelet drugs.

Single-Centre Retrospective Evaluation of Intraoperative Hemoadsorption in Left-Sided Acute Infective Endocarditis.

BACKGROUND: Cardiac surgery in patients with infective endocarditis (IE) is still associated with high mortality and morbidity; an already present inflammation might further be aggravated due to a cardiopulmonary bypass-induced dysregulated immune response. Intraoperative hemoadsorption therapy may attenuate this septic response. Our objective was therefore to assess the efficacy of intraoperative hemoadsorption in active left-sided native- and prosthetic infective endocarditis. METHODS: Consecutive high-risk patients with active left-sided infective endocarditis were enrolled between January 2015 and April 2021. Patients with intraoperative hemoadsorption (Cytosorbents, Princeton, NJ, USA) were compared to patients without hemoadsorption (control). Endpoints were the incidence of postoperative sepsis, sepsis-associated death and in-hospital mortality. Predictors for sepsis-associated mortality and in-hospital mortality were analysed by multivariable logistic regression. RESULTS: A total of 202 patients were included, 135 with active left-sided native and 67 with prosthetic valve infective endocarditis. Ninety-nine patients received intraoperative hemoadsorption and 103 patients did not. Ninety-nine propensity-matched pairs were selected for final analyses. Postoperative sepsis and sepsis-related mortality was reduced in the hemoadsorption group (22.2% vs. 39.4%, p = 0.014 and 8.1% vs. 22.2%, p = 0.01, respectively). In-hospital mortality tended to be lower in the hemoadsorption group (14.1% vs. 26.3%, p = 0.052). Key predictors for sepsis-associated mortality and in-hospital mortality were preoperative inotropic support, lactate-levels 24 h after surgery, C-reactive protein levels on postoperative day 1, chest tube output, cumulative inotropes and white blood cell counts on postoperative day 2, and new onset of dialysis. Multivariate regression analysis revealed intraoperative hemoadsorption to be associated with lower sepsis-associated (OR 0.09, 95% CI 0.013-0.62, p = 0.014) as well as in-hospital mortality (OR 0.069, 95% CI 0.006-0.795, p = 0.032). CONCLUSIONS: Intraoperative hemoadsorption holds promise to reduce sepsis and sepsis-associated mortality after cardiac surgery for active left-sided native and prosthetic valve infective endocarditis.

Left Atrial Appendage Amputation for Atrial Fibrillation during Aortic Valve Replacement.

BACKGROUND: Occluding the left atrial appendage (LAA) during cardiac surgery reduces the risk of ischemic stroke; nonetheless, it is currently only softly recommended with "may be considered" by the current guidelines. We aimed to assess thromboembolic risk after LAA amputation in patients with atrial fibrillation (AF) and aortic stenosis undergoing biological aortic valve replacement (AVR) as primary cardiac surgery. METHODS: Two cohorts were generated retrospectively: patients with AF undergoing AVR alone or combined with revascularization either with LAA amputation or without. Data were collected from the hospital-specific data system. Follow-up was completed by telephone interview or in person. Thirty-day and follow-up results were compared in patients with vs. without LAA amputation. RESULTS: One hundred and fifty-seven patients were investigated retrospectively, and seventy-four pairs were matched with regard to baseline characteristics. Patients with LAA amputation exhibited a lower incidence of cumulative and late ischemic stroke (6.4% vs. 25%, p = 0.028 and 3.2% vs. 20%, p = 0.008, respectively; hazard ratio 0.30; 95% confidence interval 0.11; 0.84; p = 0.021) during follow-up of 48 months vs. patients without intervention during follow-up of 45 months, p = 0.494. No significant differences were observed in postoperative stroke, 2 (2.7%) vs. 3 (4.1%), p = 1.000, re-exploration for bleeding 3 (4.1%) vs. 6 (8.1), p = 0.494 or late pericardial effusion 2 (2.7%) vs. 3 (4.1%), p = 1.000, in-hospital 2 (2.7%) vs. 4 (5.4%), p = 0.681 and all-cause mortality 15 (23.8%) vs. 9 (15%), p = 0.315 in patients with vs. without LAA amputation, respectively. CONCLUSIONS: A combination of leading aortic stenosis and AF in patients undergoing isolated or combined biological AVR represents a subpopulation with excessive thromboembolic risk. Concomitant LAA amputation during cardiac surgery reduces the risk of ischemic stroke without posing an additional periprocedural risk for the patient. Therefore, the minimal invasive approach at the expense of omitting LAA amputation should be discouraged to maximize the clinical benefits of AVR in this setting.

Surgical aortic valve replacement in patients aged 50-69 years-insights from the German Aortic Valve Registry (GARY).

OBJECTIVES: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement. METHODS: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention. RESULTS: In total.3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up. CONCLUSIONS: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients.

Artificial intelligence-based early detection of acute kidney injury after cardiac surgery.

OBJECTIVES: This study aims to improve the early detection of cardiac surgery-associated acute kidney injury using artificial intelligence-based algorithms. METHODS: Data from consecutive patients undergoing cardiac surgery between 2008 and 2018 in our institution served as the source for artificial intelligence-based modelling. Cardiac surgery-associated acute kidney injury was defined according to the Kidney Disease Improving Global Outcomes criteria. Different machine learning algorithms were trained and validated to detect cardiac surgery-associated acute kidney injury within 12 h after surgery. Demographic characteristics, comorbidities, preoperative cardiac status and intra- and postoperative variables including creatinine and haemoglobin values were retrieved for analysis. RESULTS: From 7507 patients analysed, 1699 patients (22.6%) developed cardiac surgery-associated acute kidney injury. The ultimate detection model, 'Detect-A(K)I', recognizes cardiac surgery-associated acute kidney injury within 12 h with an area under the curve of 88.0%, sensitivity of 78.0%, specificity of 78.9% and accuracy of 82.1%. The optimal parameter set includes serial changes of creatinine and haemoglobin, operative emergency, bleeding-associated variables, cardiac ischaemic time and cardiac function-associated variables, age, diuretics and active infection, chronic obstructive lung and peripheral vascular disease. CONCLUSIONS: The 'Detect-A(K)I' model successfully detects cardiac surgery-associated acute kidney injury within 12 h after surgery with the best discriminatory characteristics reported so far.

Risk of conduction disturbances following different transcatheter aortic valve prostheses: the role of aortic valve calcifications.

OBJECTIVES: To assess the impact of prosthesis choice and aortic valve calcifications on the occurrence of conduction disturbances after transcatheter aortic valve implantation (TAVI). METHODS: We retrospectively analyzed the preoperative clinical characteristics, electrocardiograms, contrast-enhanced multidetector computed tomography scans and procedural strategies of patients who underwent TAVI in our center between January 2012 and June 2017. Quantification of calcium volume was performed for each aortic cusp above (aortic valve) and below (left ventricular outflow tract, LVOT) the basal plane. Multivariate analysis was performed to evaluate risk factors for the onset of new bundle branch block (BBB), transient and permanent atrioventricular block (tAVB, pAVB). RESULTS: A total of 569 patients were included in the study. Six different prostheses were implanted (Edwards Sapien XT, n = 162; Edwards Sapien 3, n = 240; Medtronic CoreValve, n = 27; Medtronic CoreValve Evolut R, n = 21; Symetis Acurate, n = 56; Symetis Acurate neo, n = 63). The logistic regression analysis for BBB showed association with baseline left anterior hemiblock. The logistic regression for tAVB, found the prior valvuloplasty and the balloon post-dilatation associated with the outcome. Baseline left and right BBB, degree of oversizing, and LVOT calcification beneath the non-coronary cusp were associated with pAVB. Neither the prosthesis model, nor the use of a self-expandable prosthesis showed statistical significance with the above-mentioned outcomes on univariate analysis. CONCLUSIONS: LVOT calcification beneath the non-coronary cusp, baseline left anterior hemiblock, right BBB, balloon post-dilatation, prior valvuloplasty and oversizing are independently associated with postprocedural conduction disturbances after TAVI. Use of a self-expandable prosthesis may show a lower incidence of AVB, if applied in lower calcified aortic valves.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets.

Leaflet durability and costs restrict contemporary trans-catheter aortic valve replacement (TAVR) largely to elderly patients in affluent countries. TAVR that are easily deployable, avoid secondary procedures and are also suitable for younger patients and non-calcific aortic regurgitation (AR) would significantly expand their global reach. Recognizing the reduced need for post-implantation pacemakers in balloon-expandable (BE) TAVR and the recent advances with potentially superior leaflet materials, a trans-catheter BE-system was developed that allows tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop and anchorage achieved by plastic deformation even in the absence of calcification. Three sizes were developed from nickel-cobalt-chromium MP35N alloy tubes: Small/23 mm, Medium/26 mm and Large/29 mm. Crimp-diameters of valves with both bioprosthetic (sandwich-crosslinked decellularized pericardium) and polymer leaflets (triblock polyurethane combining siloxane and carbonate segments) match those of modern clinically used BE TAVR. Balloon expansion favors the wing-structures of the stent thereby creating supra-annular anchors whose diameter exceeds the outer diameter at the waist level by a quarter. In the pulse duplicator, polymer and bioprosthetic TAVR showed equivalent fluid dynamics with excellent EOA, pressure gradients and regurgitation volumes. Post-deployment fatigue resistance surpassed ISO requirements. The radial force of the helical deployment balloon at different filling pressures resulted in a fully developed anchorage profile of the valves from two thirds of their maximum deployment diameter onwards. By combining a unique balloon-expandable TAVR system that also caters for non-calcific AR with polymer leaflets, a powerful, potentially disruptive technology for heart valve disease has been incorporated into a TAVR that addresses global needs. While fulfilling key prerequisites for expanding the scope of TAVR to the vast number of patients of low- to middle income countries living with rheumatic heart disease the system may eventually also bring hope to patients of high-income countries presently excluded from TAVR for being too young.

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

OBJECTIVE: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. METHODS: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance. RESULTS: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups. CONCLUSION: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

Differences in the Treatment of Acute Coronary Syndrome in the Pre-COVID and COVID Era: An Analysis from Two German High-Volume Centers.

The COVID-19 pandemic is placing a heavy burden on healthcare systems worldwide with the risk that acute cardiovascular diseases are treated too late. The present study aims to analyze patients with acute coronary syndrome in the current pandemic. A total of 966 patients (2019 n = 463, 2020 n = 503) can be evaluated. A comparison of patient care during and before the COVID-19 pandemic was made in terms of patient characteristics and pre- and in-hospital processes. Another aim is to show how many patients seek clinical care at a late stage of the disease. After Lockdown in Germany at week 12, 2020, there was a significant decrease in patients with an acute coronary syndrome (ACS), significant for STEMI cases in the first weeks after Lockdown (calendar week 13-16 2019 n = 43, 2020 n = 30; p = 0.02). The time from pain to first medical contact (time to FMC) is significantly extended during Lockdown, while internal clinical processes are unchanged. The rate of subacute myocardial infarction is numerically, but not significantly increased in calendar weeks 15, 2020 (p = 0.40) and 16 (p = 0,19). In addition, elderly patients avoid treatment for multifactorial reasons, and the longer overall pain to FMC may impact long-term mortality.

Improved creatinine-based early detection of acute kidney injury after cardiac surgery.

OBJECTIVES: This study aims to improve early detection of cardiac surgery-associated acute kidney injury (CSA-AKI) compared to classical clinical scores. METHODS: Data from 7633 patients who underwent cardiac surgery between 2008 and 2018 in our institution were analysed. CSA-AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Cleveland Clinical Score served as the reference with an area under the curve (AUC) 0.65 in our cohort. Based on that, stepwise logistic regression modelling was performed on the training data set including creatinine (Cr), estimated glomerular filtration rate (eGFR) levels and deltas (ΔCr, ΔeGFR) at different time points and clinical parameters as preoperative haemoglobin, intraoperative packed red blood cells (units) and cardiopulmonary bypass time (min) to predict CSA-AKI in the early postoperative course. The AUC was determined on the validation data set for each model respectively. RESULTS: Incidence of CSA-AKI in the early postoperative course was 22.4% (n = 1712). The 30-day mortality was 12.5% in the CSA-AKI group (n = 214) and in the no-CSA-AKI group 0.9% (n = 53) (P < 0.001). Logistic regression models based on Cr and its delta gained an AUC of 0.69; 'Model eGFRCKD-EPI' an AUC of 0.73. Finally, 'Model DynaLab' including dynamic laboratory parameters and clinical parameters as haemoglobin, packed red blood cells and cardiopulmonary bypass time improved AUC to 0.84. CONCLUSIONS: Model DynaLab' improves early detection of CSA-AKI within 12 h after surgery. This simple Cr-based framework poses a fundament for further endeavours towards reduction of CSA-AKI incidence and severity.

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. METHODS: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. RESULTS: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). CONCLUSIONS: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Impact of the coronavirus disease 2019 (COVID-19) pandemic on the care of patients with acute and chronic aortic conditions.

OBJECTIVES: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on acute and elective thoracic and abdominal aortic procedures. METHODS: Forty departments shared their data on acute and elective thoracic and abdominal aortic procedures between January and May 2020 and January and May 2019 in Europe, Asia and the USA. Admission rates as well as delay from onset of symptoms to referral were compared. RESULTS: No differences in the number of acute thoracic and abdominal aortic procedures were observed between 2020 and the reference period in 2019 [incidence rates ratio (IRR): 0.96, confidence interval (CI) 0.89-1.04; P = 0.39]. Also, no difference in the time interval from acute onset of symptoms to referral was recorded (<12 h 32% vs > 12 h 68% in 2020, < 12 h 34% vs > 12 h 66% in 2019 P = 0.29). Conversely, a decline of 35% in elective procedures was seen (IRR: 0.81, CI 0.76-0.87; P < 0.001) with substantial differences between countries and the most pronounced decline in Italy (-40%, P < 0.001). Interestingly, in Switzerland, an increase in the number of elective cases was observed (+35%, P = 0.02). CONCLUSIONS: There was no change in the number of acute thoracic and abdominal aortic cases and procedures during the initial wave of the COVID-19 pandemic, whereas the case load of elective operations and procedures decreased significantly. Patients with acute aortic syndromes presented despite COVID-19 and were managed according to current guidelines. Further analysis is required to prove that deferral of elective cases had no impact on premature mortality.