Left atrial low-voltage areas, but not volume, predict the recurrence of atrial fibrillation in repeat ablation procedures.

INTRODUCTION: Left atrial (LA) low voltage areas (LVA) are a controversial target in atrial fibrillation ablation procedures. However, LVA and LA volume are good predictors of arrhythmia recurrence in ablation-naïve patients. Their predictive value in progressively diseased pre-ablated atria is uncertain. METHODS: Consecutive patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT), who were scheduled for repeat LA ablation, were enrolled in the prospective Bernau ablation registry between 2016 and 2020. All patients received a complete LA ultrahigh-density map before ablation. Maps were analyzed for LA size, LVA percentage and distribution. The predictive value of demographic, anatomic, and mapping variables on AF recurrence was analyzed. RESULTS: 160 patients (50.6% male, 1.3 pre-ablations, 60% persistent AF) with complete LA voltage maps were included. Mean follow-up time was 16 ± 11 months. Mean recorded electrograms (EGMs) per map were 9754 ± 5808, mean LA volume was 176.1 ± 35.9 ml and mean rate of LVAs <0.5 mV was 30.6% ± 23.1%. During follow-up recurrence rate of AF or AT >30 s was 55.6%. Patients with recurrence had a significant higher percentage of LVAs (40.0% vs. 18.8%, p < .001) but no relevant difference in LA volume (172 vs. 178 mL, p = .299). ROC curves revealed LVA as a good predictor for recurrence (AUC = 0.79, p < .001) and a cut-off of 22% LVAs with highest sensitivity (73.0%) and specificity (71.8%). Based on this cut off, event free survival was significantly higher in the Low LVA group (p < .01). CONCLUSION: Total LVA percentage has a good predictive power on arrhythmia recurrence in a cohort of advanced scarred left atria in repeat procedures independent of the applied ablation strategy. Left atrial volume seems to have minor impact on the rhythm outcome in our study cohort.

Outcome and microbiological findings of patients with cardiac implantable electronic device infection.

INTRODUCTION: Infections associated with cardiac implantable electronic devices (CIEDs) are a multifactorial disease that leads to increased morbidity and mortality. OBJECTIVE: The aim was to analyze patient-, disease- and treatment-related characteristics including microbiological and bacterial spectrum according to survival status and to identify risk factors for 1- and 3-year mortality in patients with local and systemic CIED infection. METHODS: In a retrospective cohort study, we analyzed data from patients with CIED-related local or systemic infection undergoing successful transvenous lead extraction (TLE). Survival status as well as incidence and cause of rehospitalization were recorded. Microbiology and antibiotics used as first-line therapy were compared according to mortality. Independent risk factors for 1- and 3-year mortality were determined. RESULTS: Data from 243 Patients were analyzed. In-hospital mortality was 2.5%. Mortality rates at 30 days, 1- and 3 years were 4.1%, 18.1% and 30%, respectively. Seventy-four (30.5%) patients had systemic bacterial infection. Independent risk factors for 1-year mortality included age (OR 1.05 [1.01-1.10], p = 0.014), NT-proBNP at admission (OR 4.18 [1.81-9.65], p = 0.001), new onset or worsened tricuspid regurgitation after TLE (OR 6.04 [1.58-23.02], p = 0.009), and systemic infection (OR 2.76 [1.08-7.03], p = 0.034), whereas systemic infection was no longer an independent risk factor for 3-year mortality. Staphylococcus aureus was found in 18.1% of patients who survived and in 25% of those who died, p = 0.092. There was a high proportion of methicillin-resistant strains among coagulase-negative staphylococci (16.5%) compared to Staphylococcus aureus (1.2%). CONCLUSIONS: Staphylococci are the most common causative germs of CIED-infection with coagulase-negative staphylococci showing higher resistance rates to antibiotics. The independent risk factors for increased long-term mortality could contribute to individual risk stratification and well-founded treatment decisions in clinical routine. Especially the role of tricuspid regurgitation as a complication after TLE should be investigated in future studies.

Immunogenicity and tolerability of COVID-19 vaccination in peritoneal dialysis patients-A prospective observational cohort study.

BACKGROUND: In peritoneal dialysis (PD) patients, information on the immunogenicity and tolerability of SARS-CoV-2 vaccination is still scarce. We compared the immunogenicity and tolerability of SARS-CoV-2 vaccination of PD patients with that of medical personnel. METHODS: In a prospective observational cohort study, PD patients and immunocompetent medical personnel were evaluated for SARS-CoV-2 spike-IgG- and Nucleocapsid-IgG-antibody-levels before, 2 weeks after the first, and 6 weeks after the second SARS-CoV-2 vaccination and vaccine tolerability after the first and second vaccination. RESULTS: In COVID-19-naïve PD patients (N = 19), lower SARS-CoV-2-spike-IgG-levels were found compared with COVID-19-naïve medical personnel (N = 24) 6 weeks after second vaccination (median 1438 AU/ml [25th-75th percentile 775-5261] versus 4577 [1529-9871]; p = 0.045). This finding resulted in a lower rate of strong vaccine response (spike-IgG ≥ 1000 AU/ml) of COVID-19-naïve PD patients compared with medical personnel (58% versus 92%; p = 0.013), but not for seroconversion rate (spike-IgG ≥ 50 AU/ml: 100% vs. 100%; p > 0.99). After first vaccination, COVID-naïve PD patients presented with significantly fewer side effects than medical personnel (number of any side effect: 1 [1-2] vs. 4 [1-7]; p = 0.015). A similar pattern with slightly decreased frequencies of side effects was observed for tolerability of second SARS-CoV-2 vaccination in PD patients and medical personnel (number of any side effects: 1 [1-1] vs. 2 [1-5]; p = 0.006). CONCLUSIONS: SARS-CoV-2 vaccination in COVID-19-naïve PD patients appeared to induce a very high rate of seroconversion but a substantially lower rate of patients with a strong response compared with medical personnel. Vaccination appeared to be safe in the PD patients studied.

Incidence and risk factors for acute kidney injury in patients with cardiac implantable electronic devices undergoing transvenous lead removal.

BACKGROUND: This study aimed to investigate the incidence and potentially modifiable risk factors of acute kidney injury (AKI) in patients with cardiac implantable electronic devices (CIED) admitted for removal of infected and non-infected transvenous leads. MATERIALS AND METHODS: In this observational cohort study, data from 147 consecutive patients with CIED undergoing transvenous lead removal were analyzed. Study endpoint was AKI according to the KDIGO criteria. Multivariable logistic regression analysis was performed to identify independent risk factors for AKI. RESULTS: Lead removal was performed due to systemic infection (50.3%), isolated pocket infection (34.0%), pocket or lead perforation without infection (13.6%), and endocarditis (2.0%). Out of 147 patients, 34 (23.1%) developed AKI (82.4% stage 1, 8.8% stage 2, and 8.8% stage 3). There was no difference regarding incidence of AKI when separated by infectious vs. non-infectious lead status (25.5 vs. 25.0%) p = 0.605. Defibrillator lead type (HR 24.55, CI 2.41 - 249.97, p = 0.007), necessity to perform laser-assisted lead removal (HR 5.41, CI 1.12 - 26.13, p = 0.035), and time from initial implantation to lead removal (HR 1.01, CI 1.00 - 1.02, p = 0.013) were independent risk factors for AKI. Also, AKI was associated with in-hospital mortality (HR 8.44, CI 2.08 - 34.33, p = 0.003). CONCLUSION: Almost a quarter of patients undergoing transvenous lead removal developed AKI. Independent modifiable risk factors for AKI were identified. The role of procedure-related risk factors for AKI, such as lead type and use of laser, needs further evaluation in these patients.

Urinary Neutrophil Gelatinase-Associated Lipocalin/Hepcidin-25 Ratio for Early Identification of Patients at Risk for Renal Replacement Therapy After Cardiac Surgery: A Substudy of the BICARBONATE Trial.

BACKGROUND: Acute kidney injury requiring renal replacement therapy (AKI-RRT) is strongly associated with mortality after cardiac surgery; however, options for early identification of patients at high risk for AKI-RRT are extremely limited. Early after cardiac surgery, the predictive ability for AKI-RRT even of one of the most extensively evaluated novel urinary biomarkers, neutrophil gelatinase-associated lipocalin (NGAL), appears to be only moderate. We aimed to determine whether the NGAL/hepcidin-25 ratio (urinary concentrations of NGAL divided by that of hepcidin-25) early after surgery may compare favorably to NGAL for identification of high-risk patients after cardiac surgery. METHODS: This is a prospective substudy of the BICARBONATE trial, a multicenter parallel-randomized controlled trial comparing perioperative bicarbonate infusion for AKI prevention to usual patient care. At a tertiary referral center, 198 patients at increased kidney risk undergoing cardiac surgery with cardiopulmonary bypass were included into the present study. The primary outcome measure was defined as AKI-RRT. Secondary outcomes were in-hospital mortality and long-term mortality. We compared area under the curve of the receiver operating characteristic (AUC-ROC) of urinary NGAL with that of the urinary NGAL/hepcidin-25 ratio within 60 minutes after end of surgery. We compared adjusted AUC and performed cross-validated reclassification statistics of the (logarithmic) urinary NGAL/hepcidin-25 ratio adjusted to Cleveland risk score/EuroScore, cross-clamp time, age, volume of packed red blood cells, and (logarithmic) urinary NGAL concentration. The association of the NGAL/hepcidin-25 ratio with long-term patient survival was assessed using Cox proportional hazard regression analysis adjusting for EuroScore, aortic cross-clamp time, packed red blood cells and urinary NGAL. RESULTS: Patients with AKI-RRT (n = 13) had 13.7-times higher NGAL and 3.3-times lower hepcidin-25 concentrations resulting in 46.9-times higher NGAL/hepcidin-25 ratio early after surgery compared to patients without AKI-RRT. The NGAL/hepcidin-25 ratio had higher AUC-ROC compared with NGAL for risk of AKI-RRT and in-hospital mortality (unadjusted AUC-ROC difference 0.087, 95% confidence interval [CI], 0.036-0.138, P < .001; 0.082, 95% CI, 0.018-0.146, P = .012). For AKI-RRT, the NGAL/hepcidin-25 ratio increased adjusted category-free net reclassification improvement (cfNRI; 0.952, 95% CI, 0.437-1.468; P < .001) and integrated discrimination improvement (IDI; 0.040, 95% CI, 0.008-0.073; P = .016) but not AUC difference. For in-hospital mortality, the ratio improved AUC of the reference model (AUC difference 0.056, 95% CI, 0.003-0.108; P = .037) and cfNRI but not IDI. The urinary NGAL/hepcidin-25 ratio remained significantly associated with long-term mortality after adjusting for the model covariates. CONCLUSIONS: The urinary NGAL/hepcidin-25 ratio appears to early identify high-risk patients and outperform NGAL after cardiac surgery. Confirmation of our findings in other cardiac surgery centers is now needed.

Neutrophil Gelatinase-Associated Lipocalin Measured on Clinical Laboratory Platforms for the Prediction of Acute Kidney Injury and the Associated Need for Dialysis Therapy: A Systematic Review and Meta-analysis.

RATIONALE & OBJECTIVE: The usefulness of measures of neutrophil gelatinase-associated lipocalin (NGAL) in urine or plasma obtained on clinical laboratory platforms for predicting acute kidney injury (AKI) and AKI requiring dialysis (AKI-D) has not been fully evaluated. We sought to quantitatively summarize published data to evaluate the value of urinary and plasma NGAL for kidney risk prediction. STUDY DESIGN: Literature-based meta-analysis and individual-study-data meta-analysis of diagnostic studies following PRISMA-IPD guidelines. SETTING & STUDY POPULATIONS: Studies of adults investigating AKI, severe AKI, and AKI-D in the setting of cardiac surgery, intensive care, or emergency department care using either urinary or plasma NGAL measured on clinical laboratory platforms. SELECTION CRITERIA FOR STUDIES: PubMed, Web of Science, Cochrane Library, Scopus, and congress abstracts ever published through February 2020 reporting diagnostic test studies of NGAL measured on clinical laboratory platforms to predict AKI. DATA EXTRACTION: Individual-study-data meta-analysis was accomplished by giving authors data specifications tailored to their studies and requesting standardized patient-level data analysis. ANALYTICAL APPROACH: Individual-study-data meta-analysis used a bivariate time-to-event model for interval-censored data from which discriminative ability (AUC) was characterized. NGAL cutoff concentrations at 95% sensitivity, 95% specificity, and optimal sensitivity and specificity were also estimated. Models incorporated as confounders the clinical setting and use versus nonuse of urine output as a criterion for AKI. A literature-based meta-analysis was also performed for all published studies including those for which the authors were unable to provide individual-study data analyses. RESULTS: We included 52 observational studies involving 13,040 patients. We analyzed 30 data sets for the individual-study-data meta-analysis. For AKI, severe AKI, and AKI-D, numbers of events were 837, 304, and 103 for analyses of urinary NGAL, respectively; these values were 705, 271, and 178 for analyses of plasma NGAL. Discriminative performance was similar in both meta-analyses. Individual-study-data meta-analysis AUCs for urinary NGAL were 0.75 (95% CI, 0.73-0.76) and 0.80 (95% CI, 0.79-0.81) for severe AKI and AKI-D, respectively; for plasma NGAL, the corresponding AUCs were 0.80 (95% CI, 0.79-0.81) and 0.86 (95% CI, 0.84-0.86). Cutoff concentrations at 95% specificity for urinary NGAL were>580ng/mL with 27% sensitivity for severe AKI and>589ng/mL with 24% sensitivity for AKI-D. Corresponding cutoffs for plasma NGAL were>364ng/mL with 44% sensitivity and>546ng/mL with 26% sensitivity, respectively. LIMITATIONS: Practice variability in initiation of dialysis. Imperfect harmonization of data across studies. CONCLUSIONS: Urinary and plasma NGAL concentrations may identify patients at high risk for AKI in clinical research and practice. The cutoff concentrations reported in this study require prospective evaluation.

[Treatment, clinical course, and cross-sectoral information transmission in patients with acute-on-chronic kidney injury]. / Behandlung, klinischer Verlauf und sektorenübergreifende Informationsübermittlung bei Patienten mit akut-auf-chronischer Nierenschädigung.

BACKGROUND: Delayed diagnosis and undertherapy of acute-on-chronic kidney injury (AKI-on-CKD) may trigger multiple organ injury and worsen clinical outcome. OBJECTIVES: This study focused on description of in-hospital care and cross-sectoral information transmission of patients with AKI-on-CKD including subgroup analyses (under surgical vs. non-surgical and nephrology vs. non-nephrology care). MATERIALS AND METHODS: At a university clinic, we analysed clinical measures and documentation in patients with AKI-on-CKD. Cox regression was performed to identify independent risk factors for in-hospital-mortality and 180-day mortality. RESULTS: In 38 (25.3%) of 150 patients, progressing AKI-on-CKD was found. Nineteen patients (12.7%) received acute dialysis. Thirty patients (20.0%) died in hospital. Systemic hypotension (n = 76, 50.7%) and nephrotoxins (n = 26, 17.3%), both considered as causes for AKI-on-CKD, were treated in 36.8 and 19.2%, respectively, of affected patients. Fluid balance was documented in one third of patients. Nephrology referral was requested in 38 (25.3%) of patients (median 24.0 h after AKI-on-CKD start). Acute renal complications (n = 74, 49.3%) were an independent risk factor for in-hospital mortality (ExpB 6.5, p = 0.022) or 180-day mortality (ExpB 3.3, p = 0.034). Rarely, outpatient physicians were informed about AKI-on-CKD (n = 42, 28.0%) or renal function follow-up was recommended (n = 14, 11.7% of surviving patients). CONCLUSIONS: Care gaps in therapy and cross-sectoral information transmission in patients with AKI-on-CKD were identified.

Perioperative Hemodynamic Instability and Fluid Overload are Associated with Increasing Acute Kidney Injury Severity and Worse Outcome after Cardiac Surgery.

PURPOSE: The study aimed to investigate patients' characteristics, fluid and hemodynamic management, and outcomes according to the severity of cardiac surgery-associated acute kidney injury (CSA-AKI). METHODS: In a single-center, prospective cohort study, we enrolled 282 adult cardiac surgical patients. In a secondary analysis, we assessed preoperative patients' characteristics, physiological variables, and medication for intra- and postoperative fluid and hemodynamic management and outcomes according to CSA-AKI stages by the Renal risk, Injury, Failure, Loss, End-stage renal disease (RIFLE) classification. Variables of fluid and hemodynamic management were further assessed with regard to the need for postoperative renal replacement therapy (RRT) and in-hospital mortality by the area under the curve for the receiver operating characteristic (AUC-ROC) and multivariate regression analysis. RESULTS: Patients with worsening RIFLE stage, were significantly older, had lower estimated glomerular filtration rate and higher body mass index, more peripheral vascular and chronic obstructive pulmonary disease, atrial fibrillation, and prolonged duration of cardiopulmonary bypass (all p < 0.01). Patients with more severe AKI stage stayed longer in the intensive care and hospital, had higher in-hospital mortality, and requirement for RRT (all p < 0.001). Also, with worsening RIFLE stage, patients had lower intraoperative mean arterial pressure (MAP); p = 0.047, despite higher doses of norepinephrine (p < 0.001). The intraoperative MAP showed the best discriminatory ability (AUC-ROC: >0.8) for and was independently associated with RRT and in-hospital mortality. Moreover, with increasing AKI severity, patients received significantly more fluid infusion, and required higher dose of furosemide; nonetheless, they had increased postoperative fluid balance. CONCLUSIONS: In this cohort, reduced MAP and increased fluid balance were independently associated with increased mortality and need for RRT after cardiac surgery.

[Acute kidney injury - status of biomarkers in perioperative and critically ill patients]. / Akute Nierenschädigung - Stellenwert von Biomarkern bei perioperativen und intensivmedizinischen Patienten.

Acute kidney injury (AKI) impairs short- and long-term prognosis of affected patients even in case of apparantly mild course and 'full' recovery as measured by follow-up serum creatinine concentrations. Late or none intervention worsens prognosis. However, there are modifiable factors potentially contributing to preserved long-term renal function. Effective treatment is multifactorial and includes identification and reversal of AKI etiology and generation of a (micro)environment for optimal renal recovery. Available treatment options for AKI in perioperative and critically ill patients will be discussed in the setting of novel kidney biomarkers.

Sodium bicarbonate and renal function after cardiac surgery: a prospectively planned individual patient meta-analysis.

BACKGROUND: The effect of urinary alkalinization in cardiac surgery patients at risk of acute kidney injury (AKI) is controversial and trial findings conflicting. Accordingly, the authors performed a prospectively planned individual patient data meta-analysis of the double-blind randomized trials in this field. METHODS: The authors studied 877 patients from three double-blind, randomized controlled trials enrolled to receive either 24 h of intravenous infusion of sodium bicarbonate or sodium chloride. The primary outcome measure was a postoperative increase in serum creatinine concentration of greater than 25% or 0.5 mg/dl (> 44 µM/L) within the first five postoperative days. Secondary outcomes included the raw change in serum creatinine, greater than 50% and greater than 100% rises in serum creatinine, developing AKI (Acute Kidney Injury Network criteria), initiation of renal replacement therapy, morbidity, and mortality. RESULTS: Patients were similar in demographics, comorbidities, and cardiac procedures. Sodium bicarbonate increased plasma bicarbonate (P < 0.001) and urine pH (P < 0.001). There were no differences in the development of the primary outcome (Bicarbonate 45% [39-51%] vs. Saline 42% [36-48%], P = 0.29). This result remained unchanged when controlling for study and covariates (odds ratio [OR], 99% confidence interval [CI]: Bicarbonate vs. Control, 1.11 [0.77-1.60], P = 0.45). There was, however, a significant study-adjusted benefit in elective coronary artery bypass surgery patients in terms of renal replacement therapy (Bicarbonate vs. Control, OR: 0.38 [99% CI: 0.25-0.58], P < 0.0001) and the development of an Acute Kidney Injury Network grade = 3 (Bicarbonate vs. Control, OR: 0.45 [99% CI: 0.43-0.48], P < 0.0001). CONCLUSIONS: Urinary alkalinization using sodium bicarbonate infusion is not associated with an overall lower incidence of AKI; however, it reduces severe AKI and need for renal replacement therapy in elective coronary artery bypass patients.

Combination of biomarkers for diagnosis of acute kidney injury after cardiopulmonary bypass.

Novel acute kidney injury (AKI) biomarkers offer promise of earlier diagnosis and risk stratification, but have yet to find widespread clinical application. We measured urinary α and π glutathione S-transferases (α-GST and π-GST), urinary l-type fatty acid-binding protein (l-FABP), urinary neutrophil gelatinase-associated lipocalin (NGAL), urinary hepcidin and serum cystatin c (CysC) before surgery, post-operatively and at 24 h after surgery in 93 high risk patient undergoing cardiopulmonary bypass (CPB) and assessed the ability of these biomarkers alone and in combination to predict RIFLE-R defined AKI in the first 5 post-operative days. Twenty-five patients developed AKI. π-GST (ROCAUC = 0.75), lower urine Hepcidin:Creatine ratio at 24 h (0.77), greater urine NGAL:Cr ratio post-op (0.73) and greater serum CysC at 24 h (0.72) best predicted AKI. Linear combinations with significant improvement in AUC were: Hepcidin:Cr 24 h + post-operative π-GST (AUC = 0.86, p = 0.01), Hepcidin:Cr 24 h + NGAL:Cr post-op (0.84, p = 0.03) and CysC 24 h + post-operative π-GST (0.83, p = 0.03), notably these significant biomarkers combinations all involved a tubular injury and a glomerular filtration biomarker. Despite statistical significance in receiver-operator characteristic (ROC) analysis, when assessed by ability to define patients to two groups at high and low risk of AKI, combinations failed to significantly improve classification of risk compared to the best single biomarkers. In an alternative approach using Classification and Regression Tree (CART) analysis a model involving NGAL:Cr measurement post-op followed by Hepcidin:Cr at 24 h was developed which identified high, intermediate and low risk groups for AKI. Regression tree analysis has the potential produce models with greater clinical utility than single combined scores.

Cluster analysis of volatile organic compounds - A pilot study in patients with severe acute decompensated heart failure.

INTRODUCTION: Acute decompensated heart failure (ADHF) is a global health problem and early detection of high-risk patients for effective treatment is important. Exhaled breath analysis and measurement of volatile organic compounds (VOCs) may be a fast and cost-effective non-invasive diagnostic and screening tool complementing measurement of cardiac biomarkers. Another technique to detect and characterize VOCs is the ion mobility spectrometry (IMS) not requiring vacuum or sample pretreatment. METHODS: This prospective controlled proof-of-concept study prospectively enrolled adult patients with severe ADHF at the University Hospital Heart Centre Brandenburg. Severe ADHF was defined as patients presenting with symptomatic acute decompensation and NTproBNP >7000 pg/dL. Cardiac patients with NT-proBNP 220 pg/dL served as control. A gas chromatography ion mobility spectrometer (GC-IMS) of the type "MultiMarkerMonitor™" from GRAUPNER medical solutions GmbH was used. Measurement was performed at T0 (within 24 h of admission), T1 (after 3-5 days) and T2 (after 8-10 days). RESULTS: Forty patients were enrolled in the study, 20 patients with severe ADHF and 20 control patients. In patients with severe ADHF, three clusters with significantly altered maximum peak heights were detected compared to control. There was no change in the peak height of clusters 8, 9 and 206 at the time points T1 and T2 (all p > 0.50). Also, NT-proBNP was stable over time (p = 0.247). Sixteen control patients (16/20, 80 %) and four with severe ADHF (4/20, 20 %) presented without cluster deviation. Patients with deviation in at least two clusters had longer hospital stay, 11 days (5.0-15.0) compared to those without deviation, 4 days (2.0-9.5), p = 0.028. CONCLUSION: Longer-term follow-up studies are needed to assess the stability and clinical significance of the identified clusters by IMS and their diagnostic and prognostic relevance.

Usability and accuracy of two different aortic annulus sizing software programs in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs 'Valve Assist 2' (GE Healthcare) and 3mensio 'Structural Heart' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users. METHODS: Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group. RESULTS: Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ2 (1) = 21.10, p < 0.001, φ = 0.579). CONCLUSION: The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.

Acceptance of Telemedicine by Specialists and General Practitioners in Cardiology Care: Cross-Sectional Survey Study.

BACKGROUND: In the coming years, telemedicine will play a key role in health care. Especially in rural areas with weak infrastructure, telemedicine could be crucial to providing adequate and personalized medical care. OBJECTIVE: We investigated the acceptance and preferences of telemedicine among cardiologists, internists, and general practitioners. In addition, we aimed to identify knowledge, explore factors that influence the decision to adopt or reject this technology, and create starting points for demand-oriented further research. METHODS: We conducted a web-based survey between May 2021 and February 2022. The 34-item questionnaire covered a wide range of questions regarding knowledge, acceptance, and use of telemedicine in cardiology care. Participants (cardiologists, internists, and general practitioners) were contacted through their professional email addresses, through a QR code published in a regional health journal, and through X (formerly known as Twitter). After exclusion of questionnaires with missed values, multidimensional scaling and k-means clustering were performed. Participants were divided into 3 clusters (C1, C2, and C3) based on their attitudes toward telecardiology. C1 uses telemedicine for personal health and clinical practice; C2 shows reluctance; C3 uses telemedicine mainly clinically. RESULTS: We contacted 929 physicians. Of those 12.1% (112/929) completed the questionnaires. Participants were 56% male (54/97), 29% female (28/97), and 2% (2/97) diverse (median age 50 years). About 16% (18/112) of the respondents currently use telemedicine daily, 14.3% (16/112) 3-4 times a week, and 43% (48/112) did not use telemedicine at all. Overall, 35.1% (34/97) rated their knowledge of telemedicine as very good or good. Most of the respondents replied that telemedicine could support cardiology care in monitoring of blood pressure and electrocardiograms (57/97, 58.8%, both), consultation (57/97, 58.8%), and extending follow-up time (59/97, 60.8%). Reported barriers to implementation were mostly administration (26/97, 26.8%), inadequate reimbursement (25/97, 25.8%), and the purchase of technology equipment (23/97, 23.7%). Attitudes toward telemedicine in clinical practice were closely related to the number of patients being treated per annual quarter: C3 (median 1350, IQR 1000-1500) versus C1 (median 750, IQR 300-1200) and C2 (median 500, IQR 105-825). The differences between clinical caseloads of C1-C3 members were significant: C1 versus C2 (P=.03), C1 versus C3 (P=.02), and C2 versus C3 (P<.001). Most participants (87/112, 77.7%) would like to expand telemedicine approaches in the future. In the field of cardiology, the participants reported a high suitability of telemedicine. The willingness to train in telemedicine is high to very high for > 50% of the participants. CONCLUSIONS: Our results indicate generally moderate use but positive attitudes toward telemedicine among participating physicians with a higher clinical caseload. The lack of a structural framework seems to be a barrier to the effective implementation of telecardiology.

Prophylactic perioperative sodium bicarbonate to prevent acute kidney injury following open heart surgery: a multicenter double-blinded randomized controlled trial.

BACKGROUND: Preliminary evidence suggests a nephroprotective effect of urinary alkalinization in patients at risk of acute kidney injury. In this study, we tested whether prophylactic bicarbonate-based infusion reduces the incidence of acute kidney injury and tubular damage in patients undergoing open heart surgery. METHODS AND FINDINGS: In a multicenter, double-blinded (patients, clinical and research personnel), randomized controlled trial we enrolled 350 adult patients undergoing open heart surgery with the use of cardiopulmonary bypass. At induction of anesthesia, patients received either 24 hours of intravenous infusion of sodium bicarbonate (5.1 mmol/kg) or sodium chloride (5.1 mmol/kg). The primary endpoint was the proportion of patients developing acute kidney injury. Secondary endpoints included the magnitude of acute tubular damage as measured by urinary neutrophil gelatinase-associated lipocalin (NGAL), initiation of acute renal replacement therapy, and mortality. The study was stopped early under recommendation of the Data Safety and Monitoring Committee because interim analysis suggested likely lack of efficacy and possible harm. Groups were non-significantly different at baseline except that a greater proportion of patients in the sodium bicarbonate group (66/174 [38%]) presented with preoperative chronic kidney disease compared to control (44/176 [25%]; p = 0.009). Sodium bicarbonate increased urinary pH (from 6.0 to 7.5, p<0.001). More patients receiving bicarbonate (83/174 [47.7%]) developed acute kidney injury compared with control patients (64/176 [36.4%], odds ratio [OR] 1.60 [95% CI 1.04-2.45]; unadjusted p = 0.032). After multivariable adjustment, a non-significant unfavorable group difference affecting patients receiving sodium bicarbonate was found for the primary endpoint (OR 1.45 [0.90-2.33], p = 0.120]). A greater postoperative increase in urinary NGAL in patients receiving bicarbonate infusion was observed compared to control patients (p = 0.011). The incidence of postoperative renal replacement therapy was similar but hospital mortality was increased in patients receiving sodium bicarbonate compared with control (11/174 [6.3%] versus 3/176 [1.7%], OR 3.89 [1.07-14.2], p = 0.031). CONCLUSIONS: Urinary alkalinization using sodium bicarbonate infusion was not found to reduce the incidence of acute kidney injury or attenuate tubular damage following open heart surgery; however, it was associated with a possible increase in mortality. On the basis of these findings we do not recommend the prophylactic use of sodium bicarbonate infusion to reduce the risk of acute kidney injury. Discontinuation of growing implementation of this therapy in this setting seems to be justified. TRIAL REGISTRATION: ClinicalTrials.gov NCT00672334 Please see later in the article for the Editors' Summary.

Which Factors Influence the Immensely Fluctuating CRT Implantation Rates in Europe? A Mixed Methods Approach Using Qualitative Content Analysis Based on Expert Interviews.

(1) Background: Cardiac resynchronisation therapy (CRT) is nowadays an indispensable treatment option for heart failure. Although the indication is subject to clear cross-national guidelines by the European Society of Cardiology (ESC), there is immense variation in the number of implantations per 100,000 inhabitants in Europe, especially in German-speaking countries (Germany, Austria and Switzerland). The aim of the present study was to identify possible factors for these differences using a qualitative research approach. (2) Methods: Semi-standardized interviews were conducted with 11 experts in the field of CRT therapy (3 experts from Germany, 4 from Austria and 4 from Switzerland) using a pre-prepared interview template and analysed according to Mayring's qualitative content analysis. (3) Results: The main factors identified were the costs of purchasing the devices and the financing systems of the respective healthcare systems, although cost pressure still seems to play a subordinate role in the German-speaking countries. Moreover, "lack of implementation of ESC guidelines", "insufficient training" and "lack of medical infrastructure" could be excluded as potential reasons. (4) Conclusions: Economic factors, but not a lack of adherence to ESC guidelines, seem to have a major influence on the fluctuating implantation figures in German-speaking countries, according to the unanimous assessment of renowned experts.

App-based assessment of memory functions in patients after transfemoral aortic valve replacement.

BACKGROUND: Transfemoral aortic valve replacement (TAVR) is the standard treatment for elderly patients with aortic valve stenosis. Although safe and well-established, there is a risk of intraprocedural hemodynamic instability and silent cerebral embolism, which can lead to a decline in neurocognitive function and dementia. In clinical practice, comprehensive cognitive testing is difficult to perform. AI-assisted digital applications may help to optimize diagnosis and monitoring. METHODS: Neurocognitive function was assessed by validated psychometric tests using "∆elta -App", which uses artificial intelligence and computational linguistic methods for extraction and analysis. Memory function was assessed using the 'Consortium to Establish a Registry for Alzheimer's Disease' (CERAD) word list and digit span task (DST) before TAVR and before hospital discharge. The study is registered in the German Register of Clinical Trials (https://drks.de/search/de/trial/DRKS00020813). RESULTS: From October 2020 until March 2022, 141 patients were enrolled at University Hospital Heart Centre Brandenburg. Mean age was 81 ± 6 years, 42.6% were women. Time between the pre- and post-interventional test was on average 6 ± 3 days. Memory function before TAVR was found to be below average in relation to age and educational level. The pre-post TAVR comparison showed significant improvements in the wordlist repeat, P < 0.001 and wordlist recall test of CERAD, P < 0.001. There were no changes in the digital span test. CONCLUSIONS: Despite impaired preoperative memory function before TAVR, no global negative effect on memory function after TVAR was detected. The improvements shown in the word list test should be interpreted as usual learning effects in this task.

Care Bundle for Acute Kidney Injury in Cardiac Patients: A Cluster-Randomized Trial.

Detection and timely intervention of acute kidney injury (AKI) is a major challenge worldwide. Electronic alerts for AKI may improve process- and patient-related endpoints. The present study evaluated the efficacy of an AKI electronic alert system and care bundle. This is a two-arm, prospective, cluster-randomized, controlled trial enrolling patients with AKI (KDIGO criteria) and cardiac diseases. Patients were randomly assigned to a routine care group or intervention group (DRKS-IDDRKS00017751). Two hundred patients (age 79 years, 46% female) were enrolled, with 100 patients in each group. The primary endpoint did not differ between patients in the routine care group 0.5 (-7.6-10.8) mL/min/1.73 m2 versus patients in the intervention group 1.0 (-13.5-15.1) mL/min/1.73 m2, p = 0.527. Proportions of patients in both study groups with hyperkalemia, pulmonary edema, and renal acidosis were comparable. The stop of antihypertensive medication during hypotensive periods was more frequent in patients in the intervention group compared to patients in the control group, p = 0.029. The AKI diagnosis and text module for AKI in the discharge letter were more frequently documented in patients in the intervention group (40%/48% vs. 25%/34%, p = 0.034; p = 0.044, respectively). Continued intake of RAAS inhibitors and the presence of a cardiac device were independently associated with a less pronounced decrease in eGFR from admission to the lowest value. In this RCT, electronic alerts for AKI and a care bundle improved process- but not patient-related endpoints.

NT-proBNP/urine hepcidin-25 ratio and cardiorenal syndrome type 1 in patients with severe symptomatic aortic stenosis.

Background: This study aimed to determine whether novel and conventional cardiorenal biomarkers in patients before transcatheter aortic valve implantation may be associated with cardiorenal syndrome (CRS) type 1. Methods: Serum NT-proBNP and urine biomarkers (hepcidin-25, NGAL, IL-6) were measured before and 24 h after transcatheter aortic valve implantation. Results: 16/95 patients had CRS type 1. Those patients had longer length of stay in hospital (12.5 [9.0-16.0] vs 9.0 [8-12] days; p = 0.025) and were more frequently readmitted to hospital within 6 months after discharge (46.7 vs 15.6%; odds ratio: 4.7; 95% CI: 1.5-15.5; p = 0.007). The NT-proBNP/urine hepcidin-25 ratio (odds ratio: 2.89; 95% CI: 1.30-6.41; p = 0.009) was an independent modifier of CRS type 1. Conclusion: The NT-proBNP/urine hepcidin-25 ratio appears to be a modifier of risk of CRS type 1.