Real World Research Articles

Real world data on SVT ablation in Denmark Higher risk of need for reablation in todays patient population a Nationwide registry based Danish study

Abstract Introduction Supraventricular tachycardias (SVTs) are a common reason for healthcare contacts and can have significant impact on patient’s quality of life. Today, ablation therapy is considered the treatment of choice for many cardiac tachyarrhythmias, and it is increasingly utilized to treat SVT-patients with chronic symptoms. Ablation therapy for SVTs is considered a safe procedure with high periprocedural success rates. However, recent studies on today’s patient population have shown a tendency towards higher age and more comorbidity, which might affect these success rates. Therefore, there is a need to explore more real-world data on long-term outcomes of catheter ablations in today’s population. Purpose To examine the long-term success rates of ablation therapy by investigating risk of reablation in patients treated for either an accessory pathway (AP), atrioventricular nodal re-entry tachycardia (AVNRT) or ectopic atrial tachycardia (EAT). Methods Using Danish nationwide registries, patients of 18 years or older who underwent RFA for AP, AVNRT or EAT between January 1st 2010 and January 1st 2019 were included. Comorbidities and use of antiarrhythmic drugs were analyzed. The cumulative incidences of reablation for either AP, AVNRT or EAT were estimated at 5-year follow-up. Results Figure 1 shows the baseline characteristics of the study population. A total of 5.905 patients were included in the study, with a median age of 52 [38, 65], and 47% were male. Among them, the AP group comprised 1.575 patients, with a mean age of 42 [29, 55], and 61% were male. The AVNRT group consisted of 3.598 patients, with a mean age of 56 [43, 67], and 42% were male. In the EAT group, there were 732 patients, with a mean age of 57 [42, 67], and 44% were male. The comorbidity burden was generelly higher in EAT patients, who also had the highest use of antiarrhythmic drugs. Figure 2 shows the 5-year cumulative incidence of reablation for AP, AVNRT or EAT-patients. Risk of reablation after 5 years was 12%, 5% and 12% for AP-, AVNRT- and EAT patients respectively. After 1 year the risk was 9%, 3% and 9% for AP-, AVNRT- and EAT patients respectively. Conclusion Despite the generally safe nature of ablation therapy with high periprocedural success rates, our findings highlight a notable risk of reablation, particularly for AP and EAT patients, after 5 years of follow-up.Baseline Characteristics5year cumulative incidence of reablation

Real world data after the implementation of coronary computed tomography angiography in Swedish primary care to rule out coronary artery disease, a cross-sectional study based on pre-test probability

Abstract Background In primary care, most patients with of non-acute chest pain will neither receive a heart related diagnosis nor be referred to a cardiologist. Studies indicate a better cardiovascular prognosis in chest pain patients referred to Coronary Computed Tomography Angiography (CCTA) as compared to risk stratification solely based on risk prediction instruments(1). CCTA is recommended since 2019 for low to intermediate cardiovascular (CV) risk patients(2). In the study setting, the primary care has implemented CCTA as first line test for patients with suspected obstructive coronary artery disease (CAD) and a Pre-Test Probability (PTP) of <15% and any CV risk factor, with PTP mandatorily entered in the referral letters. Purpose To study the outcome of CCTA based on referred PTP values categorised into <5%, 5-15% and >15%. We hypothesized that the presence of significant stenosis would be on par with the mean PTP. Methods In this cross-sectional retrospective cohort study, all consecutive clinical referrals for a CCTA from primary health care centres with a catchment area of ~470 000 inhabitants in the country of Sweden between 1 June 2021 and 7 Dec. 2022, with PTP estimates and completed CCTA were included. CCTA findings were stratified as normal, atheromatosis, or significant stenosis (≥50% coronary lumen obstruction). Patient baseline characteristics routinely registered on the day of CCTA was retrieved from a nationwide quality registry, SWEDEHEART(3). Pearsons’s Chi2 and one-way ANOVA was used to test differences in group distributions. Results During the study period, 381 patients with a PTP had obtained CCTA, of which 75% (n=286) had PTP <15%. The mean age was 60 years (standard deviation [SD] 11), 70% were female, 30% were prescribed lipid-lowering medication and 47% anti-hypertensives (Table 1). In total, the mean PTP was 12.4% (SD 8.7) and in 18% a suspected significant stenosis was identified. (Figure 1). Among patients referred with PTP 5-15%, the presence of suspected significant stenosis was 12% and cardiology consultation was less frequently described than for PTP <5 or ≥15% (14% vs 33% vs 44%, p < 0.001). Conclusions This study indicates that PTP is an efficient means to select patients for CCTA in primary care. In total, about 1/5 had a suspected significant stenosis, which often requires further investigations, and about 4/5 could be reassured that symptoms were not due to coronary artery disease. In 31% atheromatosis was identified, potentially facilitating counselling on CV prevention. We conclude that CCTA is a clinically effective option for primary care physicians to rule out CAD in patients with low PTP.Figure 1Table 1

Real world experience in treatment of chronic hepatitis C in patients with compensated and decompensated cirrhosis

Real world experience in treatment of chronic hepatitis C in patients with compensated and decompensated cirrhosis

Per Segment Plane Sweep Line Segment Intersection on the GPU

Polygon overlay operations are used for various purposes such as GIS searches and queries, VLSI and basic geometric operations of intersection, union and difference. There have been recent research articles presenting algorithms using the GPU to perform line segment intersection for geometric operations. We present two parallel algorithms implemented on the GPU that focus on the active list portion of the traditional serial plane sweep algorithm. The first algorithm uses a single block of threads to simulate the active list data structure in hardware; this algorithm is slow due to GPU thread block size limitations and synchronization points, but demonstrates favorable time complexity. The second algorithm uses dynamic parallelism to remove synchronization and scales to utilize available GPU hardware (single GPU). We perform experiments on both synthetic and real world data sets. The presented results show improvement in execution time with respect to recent algorithms, and low memory usage compared to recent algorithms. We achieve speedups of up to 38.8 over the serial sweep line algorithm on real world data.

Enhancing real world data interoperability in healthcare: A methodological approach to laboratory unit harmonization

ObjectiveThe primary aim of this study is to address the critical issue of non-standardized units in clinical laboratory data, which poses significant challenges to data interoperability and secondary usage. Despite UCUM (Unified Code for Units of Measure) offering a unique representation for laboratory test units, nearly 60% of laboratory codes in healthcare organizations use non-standard units. We sought to design, implement and test a methodology for the harmonization of units to the UCUM standards across a large research network. MethodsUsing dimensional analysis and a curated equivalence table, the proposed methodology harmonizes disparate units to UCUM standards. The process focused on identifying and converting non-UCUM conforming units, with the goal of enhancing data comparability and interoperability across different systems. ResultsThe methodology successfully achieved over 90% coverage of laboratory data with units in UCUM standards across the TriNetX research network, a significant improvement from baseline measurements. This enhancement in unit standardization directly contributed to increased interoperability of laboratory data, facilitating more reliable and comparable data analysis across various healthcare organizations. ConclusionThe successful harmonization of laboratory data units to UCUM standards represents a significant advancement in the field of biomedical informatics. By demonstrating a practical and effective approach to overcoming the challenges of non-standardized units, our study contributes to the broader efforts to improve data interoperability and usability for secondary purposes such as research and observational studies. Future work will focus on addressing the remaining gaps in unit standardization and exploring the implications of this methodology on clinical outcomes and research capabilities.

Half of implantable cardioverter-defibrillator patients remain at risk of painful shocks in the last moments of life

Abstract Background Patients with implantable cardioverter-defibrillators (ICDs) are at risk of receiving painful shocks near the end of life due to ongoing tachytherapy. Position papers of various international societies emphasize the need for advance care planning and timely deactivation of tachytherapy. This study aims to assess the real world practice of deactivating ICD tachytherapy prior to death over a consecutive 18-year period and strives to identify areas for improvement. Methods Medical records were reviewed of all patients who were carriers of an ICD or CRT-D and under follow-up at our university medical center. Those who deceased between 2006 and 2023 were identified from the municipal civil registry and their follow-up data were extracted from electronic patient records. The cause of death and status of ICD therapy at the time of death was analysed. Results During the study period, 1724 patients with an ICD expired (mean age 73 ± 10 years; 265 (15%) females; 1396 (81%) primary prevention; median time from initial ICD implantation 7.5 [interquartile range: 4 to 12] years. Baseline characteristics of patients who had tachytherapy deactivated prior to death did not differ significantly from those who did not. Overall, 769 (43%) devices were deactivated before death. The proportion of patients with deactivated tachytherapy prior to death gradually increased over time, surpassing to just >50% in the past decade (p<0.001), Figure 1. Causes of death differed between the two groups (p=0.022), Figure 2. The majority of patients with deactivated tachytherapy prior to death died due to: heart failure (38%); non-cardiac causes (23%) e.g. myocardial infarction or valvular disease; malignancy (23%) and other non-cardiac causes such as infectious diseases, stroke and trauma (31%). However, substantial proportions of patients dying from causes that could potentially be identified as an end-of-life phase, remained at risk of shocks in the last moments of life due to active tachytherapy (30% heart failure, 11% malignancy, 25% other non-cardiac causes). Conclusions The rate of patient with deactivated ICD tachytherapy before death doubled within the initial 4 years of the study period and more or less stabilized thereafter, thus leaving nearly half of ICD patients susceptible to painful shocks in their final moments of life. This underlines the necessity of timely advance care planning, including discussions regarding discontinuation of ICD therapy during the end-of-life phase.

Disparities in SGLT2i utilization among heart failure patients with different ejection fraction in China: findings from chinese cardiovascular association database-heart failure center registry

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended for heart failure (HF) patients regardless of left ventricular ejection fraction (LVEF). Although Chinese HF guidelines still recommend traditional renin–angiotensin–aldosterone system inhibitors, beta blockers, mineralocorticoid receptor antagonists, the Chinese Cardiovascular Association (CCA) HF Center Registry has launched a project to promote the guideline-directed medical therapy (GDMT) for HF patients in China. However, data on the utilization of GDMT in Chinese HF patients is scarce, especially SGLT2i. Purpose We aimed to investigate the usage status of SGLT2i in HF patients with different LVEFs and explore associated factors with SGLT2i adoption in hospitalized HF Chinese patients. Methods This is a retrospective real world study using data from the CCA Database-HF Center Registry. The study included HF patients hospitalized in 52 secondary or tertiary hospitals, including 26 accredited heart failure centers (HFC) and 26 non-accredited heart failure centers (NHFC). Centers that meet the 25 quality control standards established by CCA can be accredited as HFC. We evaluated the use rate of SGLT2i overall and by HF type, as well as the change of SGLT2i usage rate at discharge during the study period from 1st July 2022 to 31st March 2023. LASSO and multivariable logistic regression were also used to explore associated factors of SGLT2i adoption at discharge. Result We included 8,843 hospitalized HF patients: 5,326 (60.2%) were male, 2,980 (33.7%) HFrEF, 1,624 (18.4%) HFmrEF, 3,653 (41.3%) HFpEF and 586 (6.6%) lacked EF data. Overall, SGLT2i were adopted in 3,666 (41.5%) HF patients at discharge (58.1% in HFrEF, 45.3% in HFmrEF, 28.8% in HFpEF). Overall, the usage rate of SGLT2i at discharge rose from 35.2% to 50.2%. Specifically, for HFrEF patients, there was a rise from 56.2% to 64.4%. For HFmrEF and HFpEF patients, the usage rate increased from 37.5% to 54.4% and from 22.2% to 35.7%, respectively (Figure 1). The usage rate of SGLT2i was higher in HFC compared with NHFC (47.1% vs. 35.8%, p<0.001). In multivariable logistic regression, older age, new-onset heart failure, hospital location, etc. were associated with a lower usage rate of SGLT2i at discharge. In contrast, HFC, dilated cardiomyopathy, obesity, etc. were associated with a higher utilization rate of SGLT2i (Figure 2). HF classification by LVEF was also an independent influencing factor even after adjusting other factors; when HFrEF was used as a reference, the use rate of SGLT2i was lower in HFmrEF (OR 0.79, 95% CI 0.69 - 0.91) and HFpEF (OR 0.44, 95% CI 0.39 - 0.49). Conclusion In clinical practice in China, the usage rate of SGLT2i for HF treatment is increasing but needs to be further improved. Disparities exist in usage rates among HF patients with different LVEFs. Addressing this disparity necessitates a targeted approach, emphasizing increased utilization in HF patients regardless of LVEF.SGLT2i usage rate in HFFactors affecting SGLT2i adoption in HF

Investigation of age-related in-hospital outcomes of left atrial appendage occlusion in germany

Abstract Background The aim of this study was to assess demographics, in-hospital mortality and baseline characteristics of hospital cases with a left atrial appendage occlusion (LAAO) procedure in relation to patient age. Methods This is a retrospective observational analysis of all German in-hospital cases from 2016 to 2022 with a coded LAAO procedure using the Diagnose Related Groups (DRG) statistics database of the Research Data Center of the Federal Statistical Office. Results In total 40435 cases were observed in the investigated time period. Over the 5 years studied we found a significant shift towards an older patient collective. Compared to 28,3% in 2016, in 2022 40,1% of all patients were over 80 years of age (a rise of 152 %). Cases of patients with over 85 years of age increased from 7.7 % to 11.4 % during the same time period. We observed an in-hospital death rate for patients <70, 70-75, 80-85 and >85 years of age in 0.8, 1.0, 1.4 and 2.2 % respectively. Further we saw significant higher rates of intensified care treatment, pericardial effusion, acute kidney injury and red blood cell transfusion for patients >80 years of age. In unadjusted and adjusted logistic regression models age was significantly associated with a higher rate of in-hospital death. Conclusions In this study we present real world data from a health-care-system level. Our main findings were an increasing age in patients undergoing LAAO procedures and an independent association of age with in-house mortality and complications. This data provides a further basis to balance risks and benefits of LAAO procedure as a preventive treatment.

Exploring Meditron-7b performance on a small-scale purpose made dataset in human nutrition queries

Abstract The interest in Large Languages Models (LLMs) has been rapidly evolving over the last years, boosting concerns about their potential to improve the efficiency and effectiveness of clinical, educational and research work in medicine. In this study, we aimed to test the performance of MEDITRON, a recently released suite of open-source LLMs with 7B parameters adapted to the medical domain, on a small sample of human nutrition queries. To facilitate our assessment, we curated a specialized dataset comprising a diverse range of human nutrition-related queries, which have been manually collected from various medical databases and nutrition exams. The dataset was adapted for the scope of our analysis to encompass variations in language complexity, query types, and semantic nuances commonly encountered in real-world settings. Additionally, to ensure a standardized and clinically relevant context for our evaluations, we engineered a specialized prompt designed to mimic interactions with a highly esteemed physician specializing in nutrition, food science, and diet-related disorders. The prompt guided the generation of nutrition-related queries in a structured format, enabling MEDITRON to provide responses consistent with the latest advancements in medical research. Our preliminary findings revealed promising capabilities of MEDITRON in understanding medical language, providing contextually appropriate responses to several human nutrition related questions. Through this study, we add valuable insights to the ongoing discussion around the deployment of LLMs in public health, highlighting their potential to improve access to essential human nutrition literacy. Key messages • Design of LLMs tools holds the potential to improve healthcare in clinical, research and education applications. • Further evidence is needed to foster their actual integration in real world settings.

Prediction of incident major adverse cardiac events in patients starting haemodialysis for end stage kidney disease, using clinical laboratory cardiac biomarkers - a real world analysis.

Abstract Background and Aims Despite its many advantages, haemodialysis (HD) is associated with increased cardiovascular mortality and morbidity, with some studies reporting 48% higher mortality within 2 years of starting HD. Cardiac biomarkers provide insight into cardiac structure and function, including myocyte stress, inflammation and fibrosis. We aimed to investigate the prognostic significance of routine cardiac biomarkers (troponin and natriuretic peptides) in the prediction of incident major adverse cardiac events (MACE) within 5 years if commencing HD. Methods A retrospective cohort study was performed using electronic medical records from a global federated research network from the US. The network was searched on 26th February 2023. The cohorts commenced HD post-diagnosis of end-stage kidney disease. Data censoring for MACE was invoked prior to the index event of HD. Cardiac biomarkers were the first reported result within 3 months of starting HD. Cohorts were grouped according to biomarker-specific thresholds and 1:1 propensity-score matched for age, gender and co-morbidities (hypertension, diabetes mellitus and smoking status). Logistical regression produced odds ratios with 95%CI for 5-year incident MACE. MACE was defined, a priori, as a composite of ischaemic heart disease, angina pectoris, acute myocardial infarction, heart failure, AF, stroke and all-cause mortality. All statistical analysis was performed on the online platform. Results The results are shown Tables 1(Troponin I and BNP alone) and 2 (Combined Troponin I and BNP). Results that reached statistical significance (p<0.05) are shown. Conclusion Routinely available cardiac biomarkers can predict MACE and cardiac outcomes in incident HD, although results differ between markers of myocyte injury (troponin) and stress (BNP). A combined approach may prove most beneficial. The results suggest the clinical need for CV mortality and morbidity risk profiling in incident dialysis using a combination of clinical and laboratory variables and the need for prospective validation.Table 1Table 2

No reimbursement policy and implantable loop recorders in the real world setting

Abstract Background Prolonged heart rhythm evaluation is indicated in patients with suspected arrhythmias. Routine electrocardiographic Holter monitoring is often associated with poor adherence and may lead to little to no clinically relevant findings. Implantable loop recorders (ILRs) are small, subcutaneous cardiac devices providing semi-continuous electrocardiographic recording. Despite strong evidence supporting their effectiveness, ILRs are yet to be fully reimbursed by the National Health Fund- the public insurer in Poland. Purpose We aimed to investigate the feasibility, as well as the diagnostic yield of ILRs in a real world setting of a tertiary cardiovascular center. Methods We retrospectively analyzed data of consecutive patients admitted for ILR implantation between March 2013 nad November 2023. Hospitalization and procedural costs were covered by the clinic's statutory and hospital funds and not by the National Health Fund, the public payer. All patients were remotely monitored for device follow-up. Baseline demographic characteristics, as well as data regarding observation period, clinical outcomes and safety were collected. Results Data for 51 ILR implants in 50 patients was assessed. Insertion success rate was 100% on first attempt with no complications. Mean age was 54,43 ±18,56 years old. 52,94% of patients were female. Coronary artery disease was present in 21,57% patients, hypertension in 50,98%, diabetes in 13,73%. The indications for ILR implantation were unexplained syncope (n= 42; 82,35%), palpitations (n= 16; 31,37%), ischemic stroke of unknown origin (n= 6; 11,76%), monitoring of ventricular arrhythmia (n= 2; 3,92%). Mean time between occurrence of first symptoms and ILR implantation was 80,86 ±112,95 months. Mean monitoring period was 1067,62 ±668,89 days. 23 (45,1%) patients had an actionable event detected. Mean time to clinical outcome was 190,34 ±514,85 days. Based on the obtained recordings, in 13 (25,49%) patients a cardiac electronic device was implanted and 6 (11,76%) underwent an electrophysiological procedure. Time to intervention was 435,17 ± 542,9 days and 338,8 ± 273,44 days, respectively. ILR prompted medication modification in 14 (27,45%) patients. Antiarrhythmic drugs were modified in 6 (11,76%) patients. Oral anticoagulation was initiated in 3 (5,88%) patients. Mean time to any pharmacotherapy modification was 654,68 ± 604,32 days. Skin infections occurred in 2 patients, leading to early device removal. Conclusions This is the first study to present a comprehensive evaluation of ILR patients in Poland, along with a substantial observation period. We report a high prevalence of treatable cardiac conditions in patients with previous unsuccessful diagnostic work up. In the light of the upcoming favourable changes in governmental healthcare policy, demonstrating evidence supporting ILR application in everyday clinical practice is crucial for advocating their wider utilization and reimbursement.

Gender differences in the treatment with PCSK9 monoclonal antibodies real world experience from a dedicated prevention clinic

Abstract Background Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAb) lower low-density lipoprotein cholesterol (LDL-C) levels and reduce atherosclerotic cardiovascular disease (ASCVD). There are gender differences in PCSK9 biological characteristics, which are not properly addressed in current data. Purpose Examining gender differences in treatment with PCSK9 mAb. Methods A retrospective study based on data from the Prevention Cardiology Clinic in Rabin Medical Center. Included were patients prescribed with PCSK9 mAb (evolocumab or alirocumab), for primary or secondary prevention. Data included medical background and treatment variables. Response to treatment was evaluated by changes in LDL-C at 3 and 12 months. Data was analyzed by gender. Results Study included 246 patients (mean age 67y, ASCVD 78.8%, mean baseline LDL-C 128.2 mg/dL). Women (42% of cohort) prescribed with PCSK9 mAb were older than men (69 vs. 65 years, respectively; p<0.001). The dominant indication for PCSK9 mAb for both genders was secondary prevention, while primary prevention indication was more prevalent in women vs. men (39.4% vs. 16.3%, respectively; p<0.001). Statin intolerance was observed in 82.4% and 58.6% were treated with combination therapy with PCSK9 mAb, without significant gender differences. Baseline mean LDL-C was higher among women vs. men (138.9 vs. 117.3 mg/dL; p<0.001). Overall, high adherence was observed (91.8% and 79.7% at 3 and 12 months, respectively). After 1-year, adherent men had lower LDL-C levels than women (46.8 mg/d and 61.9 mg/dL, respectively; P=0.001), and were more likely to reach their LDL-C therapy goals; below 70 mg/dL (76.1% vs. 62.2%, respectively; P=0.032) and below 55 mg/dL (60.1% vs. 39.8% respectively; P=0.003). Conclusions In patients treated with PCSK9 mAb, gender differences exist in prescription age, indications, baseline LDL-C and achieved LDL-C goals. In this study adherence to PCSK9 mAb was higher than reported before, possibly due to surveillance in a dedicated prevention clinic.LDL-C & Non-HDL-C levels under PCSK9 mABSex Differences in acheived LDL-C goals

Secondary erythrocytosis / polycythemia due to sodium glucose co-transporter 2 inhibitors: a real world heart failure cohort

Abstract Background Sodium glucose co-transporter 2 inhibitors (SGLT2-i) are one of the four pillars of guideline-directed medical therapy in heart failure with reduced ejection fraction and preserved ejection fraction according to the current ESC and AHA/ACC heart failure guidelines 1,2. As a result, there has been a significant increase in their use worldwide. Although SGLT2 inhibitors are known to increase hemoglobin and hematocrit levels, there is a lack of data on the burden of erythrocytosis or polycythemia in pivotal trials 3,4. Purpose In this retrospective cohort study, we investigated the prevalence and clinical outcomes of SGLT2-i related erythrocytosis in a tertiary heart failure outpatient clinic. Methods We reviewed clinical data from heart failure patients treated with an SGLT2 inhibitor at our tertiary centre between September 2019 and October 2023. Patients were included if they were taking SGLT2-i continuously for more than one month. Data were collected on Hb/Hct levels at baseline before initiation of SGLT2-i, at peak levels during therapy and at the last follow-up. Erythrocytosis was defined according to the 2017 WHO classification as Hb> 10.3 mmol/L and/or Hct> 49% in men and Hb> 10.0 mmol/L and/or Hct> 48% in females. Results A total of 173 patients with heart failure were included (median age 58 [49-66] years, 65% male). One hundred and fifty-six patients (90%) were using dapagliflozin, while 16 patients (9%) were using empagliflozin. The overall prevalence of SGLT2i related erythrocytosis was 39/173 (22.5%; median age 60 and 82% males). Eleven (6.3%) patients had pre-existing erythrocytosis at baseline. During a mean follow-up of 14±10 months, 28/173 (16.2%) patients developed new onset erythrocytosis. The median time to the peak of the Hb/Hct level was 6.5 months. Although the group with erythrocytosis had significantly higher Hb and Hct at baseline compared to the group without erythrocytosis (Hb 9.7 mmol/L ± 1.0 vs. 8.5 mmol/L ± 1.0; p<0.001 in men and 9.1 mmol/L ± 0.8 mmol/L vs. 8.1 ± 0.8; p=0.006 in females), they also experienced a significantly greater median increase in Hb from baseline to peak (1.05 mmol/L vs. 0.60mmol/L; p=0.01) (see Figure 1) There were significantly more males (82% vs 60%; p=0.01) in the erythrocytosis group compared to the non-erythrocytosis group. In addition, the prevalence of OSAS was significantly higher in the group with erythrocytosis compared to the group without erythrocytosis (31% vs. 8%; p<0.001). Conclusion Secondary erythrocytosis or polycythemia is common in patients with chronic heart failure. It is particularly common in men and in patients with obstructive sleep apnoea syndrome (OSAS). There were no excess thrombotic or thromboembolic events, probably because of the routine use of anticoagulants/antiplatelets and limited follow-up. To avoid unnecessary haematological referrals and potential clinical adverse events, increased awareness among clinicians is needed.Table 1.Baseline and clinical outcomesFig1.Hemoglobin levels over time

Assessment of safety, efficacy and learning curve of intravascular lithotripsy in real world practice within a high volume calcium modification centre

Abstract Background There has been a rapid uptake in the use of intravascular lithotripsy (IVL) for calcium modification during percutaneous coronary intervention (PCI) due to its ease of use and excellent safety profile, particularly when compared to atherectomy devices. Purpose To review the adoption and safety of IVL in a high volume centre with established use of alternative calcium modification techniques Methods This was a retrospective analysis of all patients undergoing PCI from the introduction of IVL in January 2019 until December 2023. Patient demographics, comorbidity, procedure details and procedural complications were compared between IVL and non-IVL cases. Line charts were created to demonstrate the uptake and use of IVL per quarter compared with other established calcium modification strategies. A further line chart was created to compare the frequency of IVL use per quarter in more complex cases (left main intervention, ST elevation, treatment of in stent restenosis and in combination with rotational/orbital atherectomy). Results In the analysis timeframe there were 7,843 PCI cases performed, of which there were 301 IVL cases, 263 rotational/orbital atherectomy cases and 77 excimer laser atherectomy. IVL cases were older, more likely to have previous revascularisation (PCI (40.8% vs 57.1 % (p<0.001)) or bypass grafts 4.8% vs 8.0% (p=0.012)), diabetes mellitus (22.7% vs 33.6% (p<0.001)) and hypertension (45.4% vs 56.5% (p<0.001)). From a procedural perspective, treatment of left main and restenosis were more common with IVL compared with the rest of the cohort (7.0% vs 27.6% (p<0.001) and 8.3% vs 28.9% (p<0.001) respectively). IVL cases were more frequently guided by intracoronary imaging (intravascular ultrasound 35.9% vs 70.4% (p<0.001), optical coherence tomography 3.7% vs 18.9% (p<0.001)). Atherectomy was more frequent in IVL cases (excimer laser atherectomy 0.7% vs 7.3% (p<0.001) and rotational/orbital atherectomy 2.6% vs 22.9% (p<0.001)). Figure 1 shows the frequency of IVL use compared with other established calcium modification strategies per quarter and demonstrates the rapid and sustained uptake in IVL usage. Interestingly the use of other atherectomy techniques does not appear to have reduced. Figure 2 shows that IVL was quickly utilised in more complex calcification cases and again this has remained consistent since the introduction. Both figures demonstrate the short learning curve associated with IVL. Finally, there was no significant increase in perforation or slow/no reflow with IVL use (0.5% vs 0.7% (p=0.647) and 1.1% vs 1.3% (p=0.675) respectively) consistent with the published literature. There was an increase in documented coronary dissection with uncertain impact (3.4% vs 6.5% p=0.017). Conclusions IVL has become an essential tool within the calcium modification algorithm as a result of its ease of use, efficacy and excellent safety profile.Calcium modification per quarterFrequency of complex IVL cases

Baseline Clinical Factors Associated with Cessation of Growth Hormone Therapy in Patients with Severe Growth Hormone Deficiency - Real World Evidence

Background: Growth hormone replacement is indicated in adults with severe growth hormone (GH) deficiency, adult growth hormone deficiency assessment (AGHDA) score of at least 11 and are receiving treatment for other pituitary hormone deficiencies. There are no data looking at the cessation of GH replacement in adult patients with severe GH deficiency and the factors that predict the likelihood of patients continuing or stopping growth hormone replacement. Methods: We audited patients on the GH register between January 2006 and January 2023 in Hull University Teaching Hospitals NHS foundation Trust, a UK tertiary hospital. Baseline characteristics, the cause of GH deficiency, AGHDA score at diagnosis and the reason for stopping GH were collected. Proportions were compared between patients adhering to GH replacement and those who had ceased it. Logistic regression analysis was used to identify factors independently associated with cessation of GH. Results: The study comprised 141 adult patients with a mean age of 52 years, of which 75 (53%) were female. 54 (38%) individuals had discontinued GH replacement therapy. Predominant reasons for discontinuation were lack of therapeutic benefit (46%) and a change in clinical indication (26%). Among patients who discontinued GH therapy, the most frequent cause of GH deficiency was idiopathic (57%), while for those on GH replacement, pituitary surgery was the leading cause of GH deficiency (53%). Logistic regression analysis showed no baseline factor was statistically significantly associated with GH cessation, except female gender which had a borderline significance (P = 0.05). Conclusions: In this real-world investigation of patients with severe GH deficiency, over two in five individuals who discontinued GH therapy cited the absence of perceived benefits. We show a borderline association of female gender with GH cessation and large population-based studies will be needed to investigate this and other causes of GH cessation.

Learning to direct one's care: barriers and facilitators reported by people with tetraplegia.

Qualitative analysis of focus group data. Identifying barriers to and facilitators of learning to direct one's own care as a person with tetraplegia due to spinal cord injury (SCI). Community, in New Jersey and Georgia, USA. Three focus groups of veterans and civilians with SCI, involving 26 people with chronic (≥1 year) tetraplegia due to SCI who provided direction to caregivers on a daily basis. Content analysis was used to identify barriers and facilitators. Challenges to learning to direct one's care included: (1) lack of acceptance of lasting effects of SCI; (2) not yet understanding one's body post-SCI; (3) embarrassment; (4) being overwhelmed with information; (5) differences between the inpatient rehabilitation setting and the "real world"; (6) lack of capable and willing assistants; and (7) hesitance to criticize caregivers. Factors that helped participants become successful directors of care included: (1) experience living with SCI; (2) being observant; (3) communicating effectively; (4) developing confidence to advocate for one's own needs; (5) learning when to "let go" and when to speak up; and (6) learning from peers. Direction of care is a complex skill that is developed over time, and requires awareness of one's needs and preferences, self-confidence, and strong communication skills. Rehabilitation clinicians' efforts to prepare people with SCI to direct their own care effectively should cultivate awareness of one's body, identify strategies for communicating successfully with caregivers, and provide opportunities for practice of care direction skills and discussion with experienced peers.

Switching from Premixed Insulin to Insulin Degludec/Insulin Aspart for the Management of Type 2 Diabetes Mellitus: Implications of a Real-World Study on Insulin Degludec Dosing.

When switching from premixed insulin to insulin degludec/aspart (IDegAsp), IDegAsp usually starts at the same dose as the premixed insulin according to limited clinical experience or at a dose according to clinician discretion. The dose of insulin degludec used in the real world after switching has been poorly investigated. A retrospective analysis was conducted on patients with type 2 diabetes who switched from premixed insulin to IDegAsp from October 2016 to December 2023. Repeated measures analysis of variance was used to compare changes in insulin dose, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial blood glucose (PBG) before and after switching. Sixty-six patients with prior low-ratio premixed insulin and 22 with prior mid-ratio premixed insulin were included. Among the low-ratio insulin users, the total daily dose of insulin degludec (IDeg) decreased by 21.43% and 19.05% at 3 and 6months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). Conversely, among mid-ratio insulin users, the IDeg daily dose increased by 10.71% and 32.14% at 3 and 6months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). In all patients, HbA1c levels decreased by 0.70%, FBG decreased by 1.00mmol/l, and PBG decreased by 1.61mmol/l after 6months of switching (all p < 0.05); the total daily insulin dose and injection frequency significantly decreased after switching (both p < 0.05); age and disease duration did not affect IDegAsp effects on HbA1c reduction. In the setting of transition to IDegAsp from premixed insulin, the dose of basal insulin in the premixed formulation can be a valuable reference for adjusting insulin degludec dose. IDegAsp is superior to premixed insulin in blood glucose control with reduced total daily dose and injection frequency. IDegAsp could be the best choice for the management of diabetes in elderly patients.

Ontological and Axiological Foundations of the Meaning of Human Life in Nicolai Hartmann's Philosophy

The subject of this article is Nicolai Hartmann's conception of the ontological and axiological foundations of the meaning of human life. Referring to both Hartmann's major and minor, I analyze his conception of human meaning in the dimension of individual life and in the historical dimension. I begin my discussion with a brief overview of Hartmann's relation to the earlier metaphysics of meaning. Then, I focus on identifying the ontological foundations of meaning. In this section, I specifically present Hartmann’s understanding of the laws of real being, his critique of ontological monism, and, of particular importance, his critique of teleological monism. I also reconstruct the most important elements of Hartmann’s conception of man as a spiritual being, comprising the personal spirit of the objective spirit and the objectified spirit. Another point of consideration is the question of the axiological basis of meaning. For Hartmann, humans construct their specific position in the world by introducing axiological criteria and axiological points of view into the real world. As Hartmann argues, man is the intermediary between ideal values and the real world. The final point of consideration is the problem of historical meaning.

Empowering computing students through multidisciplinary project based learning (PBL): Creating meaningful differences in the real world

Project-based learning (PBL) has become essential in bridging the gap between theoretical education and the practical skills required by modern industries, especially in computing and multidisciplinary fields. This study employs a mixed-methods approach, using the 'Instructional Materials Motivation Survey' (IMMS) and the Kirkpatrick model, to evaluate PBL's effectiveness in enhancing key competencies such as problem-solving, practical application, time management, and confidence. The findings demonstrate that PBL significantly improves these skills, preparing students for professional environments. However, challenges such as managing project timelines, enhancing workflow strategies, and integrating domain-specific knowledge are highlighted as areas needing attention. This study aims to refine PBL practices, making them more effective in aligning education with industry demands. The insights from this research contribute to the ongoing development of educational strategies that better prepare students for the complexities of the modern workforce.

Modelling the Sea Surface of Cardigan Bay

The aim of this project was to model the sea surface of Cardigan Bay, to be able to expand upon QinetiQ’s current wave models, used within their radar assurance activities. The sea surface can cause unwanted detections, which is referred to as clutter. The sea is not the only source of clutter such as litter and birds, have an impact on the returns detected by the radar. This project explored two different approaches, modelling the propagation of waves and modelling the distribution of energy across the sea surface. The first approach explored two open source models, WAVEWATCH III and SWAN, and after having technical errors, two real world, existing examples of where these models were implemented were researched. This research showed a lot of promise, and would be worth expanding upon. The second approach looked into two recognised equations for calculating the energy density of the waves, and then calculating the significant wave height. Overall, modelling the propagation of waves would produce more representative results, particularly SWAN which was a model designed for coastal waters, however to set up the wave models fell outside of the scope of this project.