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Pain management and patient education interventions to increase physical activity in people with intermittent claudication (PrEPAID): a feasibility randomised controlled trial in the UK.3 months agoTo explore the feasibility and acceptability of pain management (transcutaneous electrical nerve stimulation (TENS)) and patient education (PE) to increase physical activity in people with peripheral arterial disease and intermittent claudication (IC).
Feasibility randomised controlled trial with embedded process evaluation.
One secondary care UK vascular centre.
56 community-dwelling adults with a history of stable IC and ankle-brachial pressure index ≤0.9 were recruited via claudication clinics.
Participants randomised to 6 weeks of: TENS+PE, TENS, Placebo TENS+PE or Placebo TENS. PE was a 3-hour workshop plus three follow-up phone calls. The TENS machine was worn during walking (TENS: 120 Hz, 200 μs, intensity 'strong but comfortable'; Placebo TENS: intensity below sensation threshold).
Primary feasibility outcomes included rates of recruitment, retention and adherence. Acceptability of the intervention and trial procedures was explored with semistructured interviews. Measures of walking capacity, walking behaviour, quality of life, disease perception and pain were recorded at baseline, end of intervention (6 weeks) and follow-up (3 months).
56 participants were randomised from 95 who completed baseline screening. Of the 39 excluded, 97% (38/39) had >20% variability in absolute claudication distance. All participants received their allocated intervention. Outcome completion was 91% at 6 weeks and 80% at 3 months. Attendance at group education was 96% with 63% taking follow-up phone calls. Compliance with TENS was 70% according to participant-completed logs. Interviewed participants (n=9) were generally positive about the acceptability of the interventions and trial procedures; however, experience of TENS use was mixed. Some participants were dissatisfied with the size of the device and electrode wires.
The PrEPAID (Pain management and Patient Education for Physical Activity in Intermittent claudication) trial was feasible to run; however, 40% of potential participants were excluded at screening due to issues of research fidelity rather than participant suitability or willingness to participate. A future definitive trial should consider a revised primary outcome measure and smaller wireless TENS machines.
ClinicalTrials.gov, NCT03204825. Registered on 2 July 2017.
Chief Scientist Office, Scottish Government. Translational grant award (TCS/16/55).Cardiovascular diseasesAccessCare/ManagementAdvocacyEducation -
Cancer prevention and interception with antidiabetic and anti-obesity drugs: current and future perspectives.3 months agoObesity and type 2 diabetes are major risk factors for cardiovascular diseases and multiple malignancies, and epidemiology reveals an increasing burden of obesity-related cancers,in particular liver, pancreatic and endometrial. Obesity is also clearly associated with an increased risk of breast cancer, particularly in postmenopausal women. Chronic hyperinsulinemia, systemic inflammation, and metabolic dysregulation create a tumor-promoting environment, emphasizing the need for interventions that target metabolic health and can provide cancer prevention or interception. This review examines the potential cancer-preventive effects of antidiabetic and anti-obesity drugs, summarizing current preclinical and clinical evidence on their mechanisms and efficacy. Among these agents, metformin has been extensively studied, demonstrating anticancer properties through AMP-activated protein kinase activation, mammalian target of rapamycin inhibition, and reduced insulin-like growth factor 1 signaling. Glucagon-like peptide-1 receptor agonists, including semaglutide and tirzepatide, promote weight loss, insulin sensitivity, and anti-inflammatory effects, with emerging evidence suggesting direct tumor-suppressive actions. Sodium-glucose cotransporter 2 inhibitors modulate tumor metabolism by reducing glucose availability and mitigating systemic inflammation. Other agents, including dipeptidyl peptidase-4 inhibitors, thiazolidinediones, sulfonylureas, and alpha-glucosidase inhibitors, have shown mixed evidence regarding their potential anticancer effects, necessitating further investigation. While observational studies and meta-analyses suggest a potential reduction in cancer risk with certain antidiabetic and anti-obesity agents, randomized controlled trials specifically assessing cancer prevention are limited. Additionally, long-term safety concerns, including potential tumor-promoting effects in specific contexts, warrant further investigation. Future research should focus on large-scale clinical trials and mechanistic studies to validate the oncologic benefits and risks of these agents.Cardiovascular diseasesAccessCare/Management
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Evaluation of a Virtual Home Health Heart Failure Program: Mixed Methods Study.3 months agoHeart failure is a prevalent and debilitating condition, affecting millions globally and imposing a significant burden on patients, families, and health care systems. Despite advancements in medical treatments, the gap in effective, continuous, and personalized supportive care remains glaringly evident. To address this pressing issue, virtual health care services delivered by interdisciplinary teams represent a promising solution. Understanding the outcomes and experience of remote monitoring-enabled interdisciplinary chronic disease management programs can inform resource allocation and health care policy decisions.
The purpose of this study was to evaluate the clinical and behavioral outcomes of patients undertaking a Virtual Home Health Heart Failure Program (VHHHFP) and explore the experiences of patients and health care practitioners (HCPs).
The VHHHFP is a virtual postdischarge support service for patients with heart failure that includes an intensive 3-month period followed by a maintenance period delivered by an interdisciplinary team. A mixed methods study was conducted with patients and HCPs. Self-reported outcome data (KCCQ-12 [Kansas City Cardiomyopathy Questionnaire-12], PHQ-4 [Patient Health Questionnaire-4], PAM-13 [Patient Activation Measure-13], and PREMs [Patient Reported Experience Measures]) were obtained from the records of patients (N=49) who completed the intensive phase of the VHHHFP, and interviews were conducted with patients (n=9) and HCPs (n=6). A paired t test was used to compare quantitative data before and after the 3-month intervention, and a thematic qualitative analysis was undertaken of interview data.
Thirty-one of the 55 (77.5%) patients completed the baseline and 3-month follow-up KCCQ-12 assessment. The mean KCCQ-12 summary score at 3 months was 72.20 (SD 20.2), which was significantly higher than the mean summary score at baseline of 50.51 (SD 17.59; P<.001). These findings were similar for the KCCCQ-12 subscales: physical limitations (mean 47.09, SD 29.7 and mean 69.43, SD 22.6; P<.001), quality of life (mean 43.75, SD 21.7 and mean 62.91, SD 25.7; P<.001), symptom frequency (median 60.40, IQR 1-100 and median 91.70, IQR 35.40; P<.001), and social limitation (median 50.0, IQR 1-100 and median 82.50, IQR 32.50; P<.001). The PHQ-4 measure of psychological health was completed by 32 (80%) patients. The median scores at baseline and follow-up for total distress (median 1.50, IQR 0-7 and median 0.0, IQR 0-8; P<.02), and the anxiety subscale (median 1.0, IQR 0-6 and median 0.0, IQR 0-4; P<.02) reduced over time. Six hospital admissions were recorded (10.2% of 49 patients) within 30 days. Nine patient interviews aligned with the value-based health care (VBHC) Capability, Comfort, and Calm (CCC) framework. Three themes were identified, which are as follows: (1) enhanced patient capability, (2) improved patient comfort, and (3) positive influences on calm. Six health care professionals shared experiences of the VHHHFP, with three emerging themes: (1) improved patient capability through shared decision-making, (2) improving capability through care practices, and (3) promoting comfort and calm through virtual coordination and collaboration.
The use of technologies to support the management of HF is an area of growth. This study contributes to the understanding of how remote patient monitoring with interdisciplinary chronic disease support, integrated into an existing system, can improve clinical outcomes for patients.Cardiovascular diseasesAccessCare/ManagementAdvocacy -
Association of triglyceride-glucose index and estimated glucose disposal rate with outcomes in patients with acute myocardial infarction: Cumulative effect and mediation analysis.3 months agoThe triglyceride-glucose (TyG) index and the metabolic score for insulin resistance (METS-IR) are insulin resistance indicators based on different metabolic parameters. However, their cumulative effect on the outcomes of patients with acute myocardial infarction (AMI) remains unclear. This study aims to investigate whether the combined assessment of the TyG index and METS-IR can improve risk stratification and prognostic prediction in AMI patients.
This retrospective cohort study included AMI patients admitted to Cangzhou People's Hospital from January to December 2018. The baseline TyG index and METS-IR were calculated for each patient. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCEs) during a 6-year follow-up, defined as a composite of all-cause mortality, coronary revascularization, and stroke. Logistic regression models and restricted cubic splines (RCS) were used to assess the association between TyG index, METS-IR, and the risk of MACCEs. Receiver operating characteristic (ROC) curves were applied to evaluate the discriminative ability of TyG index, METS-IR, and their combined predictive model (TyG index + BMI) for MACCEs. The area under the curve (AUC) was calculated to quantify predictive performance. Additionally, the net reclassification index (NRI) and integrated discrimination improvement (IDI) were computed to assess the incremental predictive value of TyG index + METS-IR beyond traditional risk factors. Subgroup analyses were conducted, and mediation analysis was performed to explore the potential mediating role of METS-IR in the relationship between TyG index and MACCEs.
A total of 1,899 patients were included in the study. Multivariable logistic regression analysis showed that TyG index (OR = 1.655, 95% CI: 1.305-2.100, P < 0.001) and METS-IR (OR = 1.026, 95% CI: 1.001-1.052, P = 0.048) were both independent risk factors for MACCEs. Further analysis showed that patients with both high TyG index and high METS-IR had the highest risk of MACCEs (OR = 1.908, 95% CI: 1.188-3.114, P = 0.008). ROC curve analysis demonstrated that the combined prediction of MACCEs using TyG index and METS-IR achieved an AUC of 0.625, which was significantly superior to METS-IR alone (AUC = 0.573, P DeLong = 0.003). When compared with the traditional risk prediction model (AUC = 0.696), incorporating TyG index and METS-IR significantly improved predictive performance (optimized AUC = 0.717, P DeLong = 0.038). This also resulted in notable enhancements in NRI (0.353, P < 0.001) and IDI (0.156, P < 0.001). Subgroup analysis revealed no significant interaction effects of sex, age, hypertension, or diabetes status on the association between TyG index, METS-IR, and MACCEs (P-interaction > 0.05). Mediation analysis indicated that METS-IR partially mediated the relationship between TyG index and MACCEs.
TyG index and METS-IR are predictors of adverse outcomes in AMI patients.Cardiovascular diseasesAccessAdvocacy -
"The message hurts, but it would be worse if nothing was said" - Communicating severe illness and the imminence of death to patients with end stage heart failure and their families - A longitudinal interview study.3 months agoDiscussions about severe illness and the coming death do not often take place with patients with heart failure and their family. We therefore aimed to investigate how patients with end-stage heart failure and their family who discussed terminal illness and the imminence of death with a physician, experienced such communication, how they handled life emotionally and practically after said discussions, and if/how this changed over time.
A longitudinal interview study. Ten patients with end-stage heart failure and their closest kin were visited by a physician at home and discussed terminal illness during one visit and the imminence of death during another visit. They were interviewed three times about how they experienced the communication and how they handled life in this situation and in relation to the discussions. The interviews were analysed using qualitative thematic analysis by Braun and Clarke.
Two main themes and five subthemes were found. The first theme was 'an honest and clear message hurts, but it would be worse if nothing was said', and the subthemes included information on the experiences of communication, the desired level of communication by patients and family members and factors facilitating communication. The second theme was 'A clear message helps in handling life' with the subthemes of coping psychologically and practically. The findings indicate that for some patients and family members it was hard to have discussions about end-stage heart failure and the imminence of death. However, they found the discussions important and were happy that the information was not withheld from them. The discussions helped in handling life and most patients and family seemed to have found a way to accept and handle the situation. Practical planning often did not start until they heard from the physician that death could come soon.
This study confirms that patients and family members want and appreciate discussions about severe illness and the imminence of death and find them important. This can encourage physicians to change behaviour and engage in honest discussions, and to educate and train colleagues to do the same.Cardiovascular diseasesAccessCare/ManagementAdvocacy -
Factors influencing the performance of cardiopulmonary resuscitation by lay rescuers: A qualitative study based on the Theory of Planned Behavior.3 months agoThis study investigated the underlying causes for the current low rate of cardiopulmonary resuscitation (CPR) implementation among lay rescuers. Specifically, the study aimed to identify the factors that influence both the intention to perform CPR and the subsequent translation of this intention into actual behavior. The ultimate goal was to propose strategies to significantly enhance the rate of bystander CPR.
A qualitative study employing purposive sampling was undertaken, with semi-structured interviews conducted between January 1, 2022, and May 20, 2022. The collected data were analyzed thematically using Nvivo software.
A total of 29 lay rescuers participated in this study, and 11 thematic categories were identified across the four constructs of the Theory of Planned Behavior (TPB). Within the domain of attitudes, two primary themes emerged, each comprising two subthemes: (1) Emotional resistance to the death event and (2) recognition of the potential benefits of rescue, including the prospect of external rewards and the realization of intrinsic self-worth. For perceived norms, three themes were identified: (1) The bystander effect, (2) the encouraging influence of peers, and (3) personal motivation arising from one's career. With respect to perceived behavioral control (PBC), three themes and two subthemes emerged: (1) Consideration of potential consequences, encompassing concerns about legal disputes and the fear of disease transmission; (2) the dual impact of public opinion pressure; (3) low self-efficacy. Finally, in relation to actual control, three themes and two subthemes were demonstrated: (1) Acquisition of CPR skills; (2) the influence of situational factors at the scene, including both supportive elements such as public facilities or procedures and obstructive factors, such as a diminished sense of responsibility at specific locations; (3) the impact of the patient's condition.
This study extends the TPB in the context of bystander CPR interventions by (1) integrating both emotional (death anxiety) and cognitive dimensions of attitude formation under stress, (2) reconceptualizing PBC as context-dependent, influenced by legal risks and automated external defibrillator (AED) accessibility, and (3) addressing the tension between the bystander effect and moral obligation through normative adjustments. To improve intervention rates, it is crucial to target emotional barriers (virtual reality (VR)-based anxiety reduction) and address systemic constraints (AED availability and simplified Good Samaritan laws) while leveraging artificial intelligence tools to reinforce positive norms. Future work is encouraged to validate the model's cross-cultural applicability and assess interventions such as community AED programs and VR training aimed at bridging the gap between bystander hesitation and timely CPR delivery.Cardiovascular diseasesAccessCare/Management -
Sleep Characteristics in Individuals with Ehlers-Danlos Syndrome.3 months agoBackground/Objectives: The presence of Ehlers-Danlos Syndromes (EDSs) has significant effects on overall health and results in varying levels of pain and disability. The effects of sleep are not well documented in this population. The purpose of this study is to report the sleep characteristics of people with EDS. Methods: An electronic survey regarding sleep characteristics was created and distributed through the EDS website. Results: Sleep disturbance is common in people with EDS, with 65.3% of respondents sleeping fewer than 8 h and 26.2% averaging fewer than 6 h. Those who slept fewer than 6 h reported more days of poor mental and physical health days. Sleep aids were commonly used with 41.40% of patients regularly taking prescription medication to get to sleep. Sleep latency of greater than 30 min was also found in 67.5% of subjects. Conclusions: The results demonstrate an association between people with EDS and poorer sleep duration, increased sleep latency, and increased use of sleep aids including prescription sleep medication compared to the general population. While more research needs to be completed in this area, sleep may be an important aspect to address in the management of EDS.Cardiovascular diseasesMental HealthAccessAdvocacy
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National Trends in Admissions, Treatments, and Outcomes for Dilated Cardiomyopathy (2016-2021).3 months agoDilated Cardiomyopathy (DCM) is one of the leading causes of non-ischemic cardiomyopathy in the United States (US). The aim of our study is to analyze the general trends in DCM admissions between 2016 and 2021, and analyze social and healthcare disparities in terms of treatments and outcomes.
National Inpatient Sample (NIS) data for the years 2016 to 2021 were used for the analysis. General population trends were analyzed. Normality of data distribution was tested using the Kolmogorov-Smirnov test and homogeneity was assessed using Levine's test. One-way ANOVA was used after confirmation of normality of distribution to analyze social and healthcare disparities. Subgroup analysis was conducted, with the paired t-test for continuous variables and Fischer's exact t-test for categorical variables to analyze statistical differences. Multivariate regression analysis was conducted to analyze the association of factors that were significant in the one-way ANOVA and paired t/chi square tests. A two-tailed p-value < 0.05 was used to determine statistical significance.
A total of 5262 admissions for DCM were observed between 2016 and 2021. A general declining trend was observed in the total number of DCM admissions, with a 33.51% decrease in total admissions in 2021 compared to 2016. All-cause in-hospital mortality remained stable across the years (between 3.5% and 4.5%). A total of 15.3% of admissions had CRT/ICD devices in place. A total of 425 patients (8.07%) for DCM underwent HT, and 214 admissions for DCM (4.06%) underwent LVAD placements between 2016 and 2021 In terms of interventions for DCM, namely Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Devices (LVADs) and Heart Transplantations (HTs), significant variance was observed in the mean age of the admissions with admissions over the mean age of 55 had lower number of interventions. Significant variance in terms of sex was observed for DCM admissions receiving HT, with lower rates observed for females. In terms of quarterly income, patients belonging to the lowest fourth quartile had higher rates of LVAD and HT compared to general DCM admissions. In the multivariate regression analysis, age at admission had significant association with lower chances of receiving LVADs and HT among DCM admissions, and significant association with higher chances of all-cause mortality during the hospital stay.
A general declining trend in the total number of DCM admissions was observed between 2016 and 2021. Significant gender disparities were seen with lower rates of females with DCM receiving LVADs and HT. DCM admissions with mean age of 55 and above were found to have significantly lower rates of receiving LVADs and HT, and higher chances of all-cause mortality during the admission.Cardiovascular diseasesAccessCare/Management -
Engineering Nanoparticles and Bioscaffolds for Targeted microRNA Delivery in Cardiovascular Regeneration-A Comprehensive Review.3 months agoCardiovascular diseases, particularly myocardial infarction (MI), remain a leading cause of mortality worldwide, primarily due to the extensive loss of cardiomyocytes and the heart's limited regenerative capacity. MI, caused by obstructed blood flow, results in cardiac muscle damage, scar tissue formation, and ultimately, heart failure. While heart transplantation is the definitive treatment, its application is limited by donor shortages and the risk of immune rejection. This underscores the urgent need for regenerative strategies. MicroRNAs (miRNAs) play a crucial role in regulating myocardial healing post-ischemia, with specific miRNAs such as miR-92a, miR-126, and miR-145 shown to promote angiogenesis. However, the therapeutic application of miRNAs is hindered by delivery challenges at both extracellular and intracellular levels. This review explores the potential of nanoparticles (NPs) and engineered bioscaffolds to address these obstacles. We first examine the role of miRNAs in post-MI cardiovascular remodeling, followed by an overview of current challenges in miRNA-based therapy delivery. We then discuss the use of NPs and electrospun nanofibrous scaffolds in this context. Finally, we review existing cardiac bioscaffolds, their limitations, and future directions for developing optimized nanofibrous scaffolds for effective cardiac regeneration.Cardiovascular diseasesAccess
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Cardiovascular risk and achievement of target levels in low-density lipoprotein cholesterol in people living with HIV: insights from the DUALIS study.3 months agoThis post-hoc evaluation of the DUALIS study aimed to examine cardiovascular risk and the achievement of low-density lipoprotein cholesterol (LDL-C) targets in a virologically suppressed cohort of people living with HIV in Germany.
Baseline cardiovascular risk was assessed using the European Society of Cardiology (ESC)-Systematic COronary Risk Evaluation 2 (SCORE2)/SCORE2-Older Persons (OP) and the current ESC guideline-recommended LDL-C targets among participants aged ≥40 years in the DUALIS study. Risk categorization was based on the ESC-SCORE2/SCORE2-OP results and the presence of specific comorbidities indicative of high risk and very high risk of CVD. Participants were enrolled between July 2015 and June 2017.
The use of lipid-lowering therapy (LLT) was low in the DUALIS study, with 12 out of 188 participants (6%) receiving the treatment. The median ESC-SCORE2/SCORE2-OP was 5.0%. Overall, 92 participants (49%) had low-to-moderate CVD risk, 77 (41%) high risk, and 19 (10%) very high risk. Only one participant in the high-risk group and none in the very high-risk group met the guideline-recommended LDL-C targets. Even when using the less stringent LDL-C targets valid at the time of data collection (2016 ESC guideline), only 19.7% of the high-risk and none of the very high-risk participants met these targets. In addition, a strong correlation regarding the estimated CVD risk was observed between the D:A:D (R) and ESC SCORE2/SCORE2-OP scores (r = 0.95).
The achievement of guideline-recommended LDL-C targets was low in the high- and very high-CVD-risk groups in the DUALIS study, reflecting low utilization of LLT in clinical practice.Cardiovascular diseasesAccessCare/ManagementAdvocacy