Unsuccessful linguistic validation of the Symptom Questionnaire for assessing quality of life in Polish patients with pelvic vein disorders.

Pelvic venous disorder (PeVD) is a prevalent chronic condition characterized by the presence of varicose veins in the pelvis, leading to the development of chronic pelvic pain. Despite the growing interest in assessing quality of life in PeVD, well-designed and validated disease-specific questionnaires are missing. The objective of this study was a linguistic and clinical validation of the Symptom Questionnaire (SQ) in a cohort of Polish females with pelvic vein incompetence. The Polish version of SQ was developed using a standardized validation process that involved a back-and- forth translation protocol. A total of 58 female patients diagnosed with pelvic varicose veins, representing diverse educational back- grounds, participated in the study. Multiple issues were observed during linguistic validation, primarily originating from disparities between the Polish and British healthcare systems, as well as differing levels of sexual health education of those two populations. Cronbach α was calculated separately for each part of the questionnaire with results exceeded 0.6 for each section. Test-retest analysis indicated most Pearson correlation coefficients surpassing 0.70. The absolute agreement consistency between pretest and post-test measures, evaluated using the Intra Class Correlation (ICC), exceeded 0.8 in three sections and 0.7 in the remaining three sections. However, the clinical validation failed due to the lack of standardized score calculation proposed by the authors of the questionnaire and inaccurately assigned values in the answer key for five questions. Consequently, the practical utility of SQ in daily clinical settings remains uncertain, highlighting the urgent need for the development of a new, user-friendly questionnaire specifically tailored to assess the quality of life in individuals with PeVD.

Angiogenic and Microvascular Status Alterations after Endovascular Revascularization of Lower Limb Arteries among Patients with Diabetic Foot Syndrome: A Prospective 12-Month Follow-Up Study.

Peripheral arterial disease (PAD)-induced ischemia is an important component of diabetic foot syndrome (DFS). The results of revascularization of the lower extremity arteries (including percutaneous transluminal angioplasty [PTA]) do not always give satisfactory long-term results, which is due to many factors. The aim of the study was to investigate the alterations in selected circulating angiogenic factors and microcirculation parameters in 41 patients with DFS following PTA and analyze their relationships with clinical outcomes during 1-year follow-up. Our study revealed a general decrease in pro-angiogenic factor levels after PTA and their subsequent stabilization during subsequent observation. The results indicated a significant association between plasma circulating FGF-2 level and poor outcomes (including the incidence of restenosis/reocclusion of treated arteries) during 12 months of observation. The perioperative changes in FGF-2 showed a significant association with LDF alterations after PTA. Follow-up 1-3 months post-intervention showed a tendency towards elevated TcpO2, VEGF-A, and VEGF-R2 levels in patients free from adverse events. These results may provide a basis for further research on the potential use of selected circulating angiogenic factors for monitoring the treatment of patients with DFS following PTA.

Circulating Angiogenic Factors and Ischemic Diabetic Foot Syndrome Advancement-A Pilot Study.

Despite clear evidence of inadequate angiogenesis in ischemic diabetic foot syndrome (DFS) pathogenesis, angiogenic factor level changes in patients with ischemic DFS remain inconsistent. This study aimed to assess circulating angiogenic factors concerning ischemic DFS advancement and describe their relationships with patients' clinical characteristics, microvascular parameters, and diabetic control. The study included 41 patients with ischemic DFS (67.3 (8.84) years; 82.9% males). Angiogenic processes were assessed by identifying circulating concentrations of five pro- and two anti-angiogenic factors. We found that penetrating ulcers were related to a significantly higher FGF-2 level (8.86 (5.29) vs. 5.23 (4.17) pg/mL, p = 0.02). Moreover, plasma FGF-2 showed a significant correlation with the SINBAD score (r = 0.32, p = 0.04), platelet count (r = 0.43, p < 0.01), white cell count (r = 0.42, p < 0.01), and age (r = -0.35, p = 0.03). We did not observe any significant linear relationship between the studied biomarkers and microcirculatory parameters, nor for glycemic control. In a univariate analysis using logistic regression, an increase in plasma FGF-2 was tied to greater odds of high-grade ulcers (OR 1.16; 95% CI 1.02-1.38, p = 0.043). This suggests that circulating FGF-2 may serve as a potential biomarker for predicting DFU advancement and progression. It is necessary to conduct further studies with follow-up observations to confirm this hypothesis.

Impact of Blood-Flow-Restricted Training on Arterial Functions and Angiogenesis-A Systematic Review with Meta-Analysis.

Despite growing evidence of the significant influence of blood-flow-restricted (BFR) training on different body functions, its impact on the vascular system, especially the arteries, is controversial. Therefore, the objective of our study was to analyze how BFR exercise, compared to other types of exercise without the restriction of blood flow, influences arterial functions and angiogenesis in adults. Studies comparing the effect of BFR versus non-BFR training on arterial parameters were divided into three categories: endothelial function, angiogenesis, and other vasculature functions. The search was based on Cochrane Library, PubMed®, and Embase, and 38 studies were included. The meta-analysis revealed a more significant improvement in flow-mediated dilatation (FMD) (p = 0.002) and the production of the primary angiogenesis biomarker vascular endothelial growth factor (VEGF) (p = 0.009) after BFR compared to non-BFR training (p = 0.002). The analysis of the pulse wave velocity, ankle-brachial index, systolic blood pressure, and heart rate did not show significant differences in changes between BFR and non-BFR training. The other parameters examined did not have sufficient data to be included in the meta-analysis. The results obtained present trends that suggest significant impacts of BFR training on endothelial functions and angiogenesis. There is still a lack of multicenter randomized clinical trials including many participants, and such studies are necessary to confirm the advantage of BFR over non-BFR activity.

Vascular Inflammatory Markers as Predictors of Peripheral Arterial Disease Patients' Quality-of-Life Changes after Endovascular Treatment.

The association between chronic inflammation and depression, anxiety, anhedonia, and quality of life (QoL) has been recently emphasized. However, the pathophysiology of this relationship remains unsolved. This study aims to assess the dependence between vascular inflammation represented by eicosanoid concentration and quality of life in patients with peripheral arterial disease (PAD). A total of 175 patients undergoing endovascular treatment due to lower limbs ischemia were covered with eight years of observation after the endovascular procedure, including ankle-brachial index (ABI), color Doppler ultrasound examination, urinary leukotriene E4 (LTE4), thromboxane B2 (TXB2) and 5-Hydroxyeicosatetraenoic acid (5-HETE) measurement and quality-of-life assessment with VascuQol-6. The baseline concentrations of LTE4 and TXB2 reversely correlated with preoperative VascuQol-6 and were predictive of the postoperative values of VascuQol-6 at each follow-up. At every follow-up timepoint, the results of VascuQol-6 reflected the LTE4 and TXB2 concentrations. Higher concentrations of LTE4 and TXB2 were correlated with lower life quality during the next follow-up meeting. Changes in VascuQol-6 at eight years vs. preoperative values were reversely related to the preoperative concentrations of LTE4 and TXB2. This is the first study to confirm that changes in life quality in PAD patients undergoing endovascular treatment are highly dependent on eicosanoid-based vascular inflammation.

Stimulation of the Vascular Endothelium and Angiogenesis by Blood-Flow-Restricted Exercise.

Blood-flow-restricted exercise (BFRE) has been gaining constantly increasing interest in rehabilitation, but its influence on endothelial functions has not been well studied yet. Our aim is to examine the influence of low-resistance BFRE on endothelial functions and angiogenesis. This prospective cross-over study involved 35 young healthy adults. They conducted a 21-min low-resistant exercise with blood flow restricted by pressure cuffs placed on arms and tights. They also did the same training but without blood flow restriction. Endothelial parameters and angiogenesis biomarkers were evaluated before and up to 20 min after exercise. Both types of exercise increased Flow-Mediated Dilatation (FMD) but elevation after BFRE was more significant compared to the controls. The stiffness index decreased only after BFRE, while the reflection index decreased significantly after both types of exercise but was higher after BFRE. Platelet endothelial cell adhesion molecule (PECAM-1) and vascular endothelial growth factor receptor 2 (VEGFR-2) concentrations were increased by both exercise types but elevations were higher after BFRE compared to the controls. Only BFRE elevated the mean serum CD34 protein concentration. Based on these results, we can assume that low-resistance BFR exercise stimulates angiogenesis and improves endothelial functions more significantly compared to the same training performed without blood flow restriction.

Klippel-Trenaunay Syndrome: Employment of a New Endovascular Treatment Technique-Mechanochemical Ablation Using the Flebogrif System.

BACKGROUND: Klippel-Trenaunay syndrome (KTS) is characterized by a triad of symptoms; varicose veins and venous malformations (VMs), capillary malformations (port-wine stain), and soft tissue and bone hypertrophy. Herein, we retrospectively studied six patients with KTS who underwent treatment with the Flebogrif system and evaluated their outcomes. METHODS: Six KTS patients aged 16-22 years who had undergone 18 non-thermal ablations using the Flebogrif system were enrolled. All patients underwent multistage foam sclerotherapy with 3% polidocanol at 3-4-week intervals. RESULTS: Venous clinical severity score (VCSS) analysis showed improvement in the patients' clinical condition. All patients reported a significant improvement in aesthetic outcomes. One patient presented with recanalization of ablated marginal veins during the 24-month follow-up period. Patients could return to full activity within 7-10 days after the procedure. None of the patients experienced serious systemic complications. CONCLUSION: The use of the Flebogrif system in treating various forms of chronic venous insufficiency, including in patients with KTS, provides a high success rate with a high closure rate.

The relationship between pulse waveform analysis indices, endothelial function and clinical outcomes in patients with peripheral artery disease treated using percutaneous transluminal angioplasty during a one-year follow-up period.

BACKGROUND: Several predictors of clinical outcomes after percutaneous transluminal angioplasty (PTA) interventions in patients with peripheral arterial disease (PAD) have been investigated. Indices of endothelial function, arterial pulse waveform analysis (aPWA) and markers of peripheral artery ischemia were among the most commonly examined. The aim of the current study was to assess the relationship between potential predictors of clinical outcomes after peripheral artery PTA during a 1-year follow-up period. METHODS: The study included 72 individuals with PAD at a mean age of 66.3 ± 7.2 (79.1% males). All patients underwent PTA of the peripheral arteries. Among them, 42.8% presented critical limb ischemia (CLI). During the first visit and at 1 month and 6 months after PTA, endothelial function and aPWA measurements were taken. Ankle-brachial index (ABI), toe-brachial index (TBI) and physical evalu-ation of the limbs took place during the first visit and at 1, 6 and 12 months after the PTA. The study endpoints included myocardial infarction, amputation, death, stroke and reintervention. All subjects included in the study were observed for 386 days after the PTA. RESULTS: A significant improvement was noted in walking distance after PTA at the following time points, as well as transient improvement of ABI and flow-mediated dilatation (FMD) and no significant change in aPWA indices and reactive-hyperaemia index (RHI). The mean ABI, TBI, FMD and RHI values did not correlate with each other at baseline. There were 25 study endpoints which occurred in 16 patients during the follow-up period (22.2%). Patients with CLI, hypercholesterolemia, lower dias-tolic blood pressure, higher subendocardial viability ratio, a greater number of pack-years and lower TBI at baseline presented significantly poorer clinical outcomes in terms of endpoint events. CONCLUSIONS: Endothelial function assessed as FMD and reactive hyperemia-peripheral arterial tonometry (RH-PAT) before PTA in patients with advanced PAD do not predict clinical outcomes during the 1-year follow-up.

Impact of pre-operative glycated haemoglobin A1C level on 1-year outcomes of endovascular treatment in patients with critical limb ischemia in the course of diabetes mellitus.

INTRODUCTION: Peripheral arterial occlusive disease (PAOD) is a disease with worldwide increasing occurrence. Diabetic patients are greatly exposed on the risk of PAOD and its complications. The aim of the study was to check the influence of preoperative HbA1C on the outcomes of patients with diabetes undergoing PAOD related endovascular treatment. MATERIAL AND METHODS: The study was conducted among 59 patients with PAOD referred from the diabetic foot outpatient for endovascular treatment. They were included in one-year observation based on follow-up visits in 1, 3, 6 and 12 months a er angioplasty and divided into 2 groups basing on their preoperative glycaemia. The clinical condition of the lower limbs was assessed by use of the Rutherford classification, ankle-brachial index (ABI) and toe-brachial index (TBI). Changes in patients' quality of life (QoL) were also evaluated. RESULTS: Reintervention within 12 months were less frequent in patients with HbA1C ≤8.0% than in HbA1C >8.0% patients (9.09% vs. 35.48%, p = 0.03). TBI of the treated limb was lower in patients with elevated than in patients with proper glycaemia at 6 month [0.2 (0.0-0.38) vs. 0.38 (0.31-0.46); p <0.008] and 12 month follow-up [0.17 (0.0-0.27) vs. 0.32 (0.25-0.38); p <0,001]. The rate of healed ulcerations after 6 months was higher in patients HbA1C ≤8.0% (45.0% vs. 16.13%; p = 0.02) and they had significantly greater improvement of QoL. CONCLUSION: Results of this study shows that preoperative level of glycaemia is an important factor for long-term prognosis in diabetic patients with PAOD. Elevated HbA1C level decreases significantly long-term improvement of QoL in DM patients undergoing endovascular treatment.

Air pollution may affect the assessment of smoking habits by exhaled carbon monoxide measurements.

BACKGROUND: While European air quality policies reduce ambient carbon monoxide (CO) concentrations in general, there are still areas affected by high environmental CO exposure from transportation, industry and burning low-quality fossil fuels. We investigated, how these CO amounts might influence exhaled CO measurements used to monitor the smoking status of healthy subjects. METHODS: A cross-sectional study of healthy adults living in areas of high air pollution (N = 742) and low air pollution (N = 197) in Poland. They completed a survey regarding their smoking habits and underwent necessary body measurements including exhaled CO concentration levels. RESULTS: Ambient CO levels were much higher in highly pollutes cities. Also exhaled CO levels in subjects from high pollution areas were significantly higher, independent of subject smoking status (8.25 ppm vs. 3.26 ppm). Smokers exhaled more CO than non-smokers. Although the duration of smoking did not affect the CO levels, they were proportional to the number of cigarettes smoked during the day, especially for higher amounts of cigarettes and in unpolluted areas. It was possible to differentiate active from passive smokers in all areas, but the difference for passive smokers vs. non-smokers was significant only in low pollution city inhabitants. CONCLUSIONS: Exhaled CO levels were confirmed to be a good indicator of smoking status and smoking pattern in healthy subjects. However, high environmental CO levels both increase baseline exhaled CO concentrations in non-smokers affecting their discrimination from passive smokers, and obscure categorizing cigarette consumption in heavy smokers. These findings add important evidence on both understanding of exhaled CO monitoring results and a significance of environmental CO exposure in areas with high pollution.

Clinical and linguistic validation of the Polish version of VascuQol: a disease-specific quality-of-life questionnaire assessing patients with chronic limb ischemia

INTRODUCTION Objective clinical assessments should include patient­reported outcome measures. VascuQol is an established disease­specific questionnaire assessing the quality of life in patients with peripheral artery disease (PAD). Quality­of­life questionnaires require geographical localization and validation. OBJECTIVES The goal of this study was to validate the Polish version of the VascuQol: a patient­reported health­related quality­of­life (HRQoL) instrument specific for PAD. PATIENTS AND METHODS The linguistic validation of VascuQol followed Mapi Institute methodology. Clinical validation process compared VascuQol, EQ­5D­3L, and SF­36 questionnaires in 100 patients with both intermittent claudication and critical limb­threatening ischemia. Cronbach α coefficients for reliability, receiver operating characteristic curves for clinical discriminative performance, standardized response means for responsiveness, and Pearson correlations for construct validity were evaluated. Additionally, in a separate cohort of 58 patients with stable disease, the test­retest was characterized with intraclass correlation, Bland­Altman analysis, and Pearson correlation coefficients. RESULTS VascuQol proved to perform better than SF­36 and EQ­5D­3L. Cronbach α coefficients showed good internal consistency (α values >0.9 for all summary scores). All test­retest Pearson r values for VascuQol were above 0.70. The intraclass correlation of absolute agreement consistency exceeded 0.8. The Bland­Altman 95% limits of agreement were between 2.72 and 4.87. There were strong and moderate correlations for total scores in all domains between VascuQol and SF­36, and for most of the domains between VascuQol and EQ­5D­3L. CONCLUSIONS The Polish version of VascuQol is a sensitive, accurate, and reliable tool for assessing HRQoL in patients with PAD.

Dynamics of below-the-knee arterial blood flow after endovascular revascularisation of peripheral arteries as a potential predictor of clinical outcomes during one-year follow-up.

BACKGROUND: Patients with advanced lower limb ischaemia are, at present, mainly treated using revascularisation. AIM: The aim of the study was to investigate whether the dynamics of blood flow in below-the-knee (BTK) arteries assessed by angiography correlate with clinical outcomes after a 12-month follow-up in patients with severe leg ischaemia treated per-cutaneously. METHODS: The current study enrolled 287 consecutive patients who underwent 302 endovascular procedures on the infrain-guinal arteries. The mean age of the included participants was 67.4 ± 10.4 years. After the procedure, blood flow in all patent BTK arteries was assessed using frame count (FC). Patients were then evaluated after one, three, six, and 12 months. During the follow-up visits, clinical condition was evaluated based on the Rutherford scale, ankle-brachial index, and the need for reintervention or amputation. RESULTS: Clinical improvement at the end of the follow-up period was observed in 242 (80.1%) cases and no improvement or worsening in was seen in 42 (13.0%) patients. In total, 66 (21.8%) reinterventions and 18 (6%) amputations during the follow-up period were recorded. Patients with higher FC in the tibial anterior artery experienced significantly better clinical improvement within the 12-month follow-up period (p = 0.02). Lower FC predisposed to worse clinical outcomes after an-gioplasty. Similar tendencies were found for the tibial posterior and fibular arteries but without statistical significance. CONCLUSIONS: The results suggest a negative relationship between FC observed on the final angiogram and clinical outcomes in patients undergoing endovascular treatment of the peripheral arteries.

Involvement of CD8+ T cell subsets in early response to vascular injury in patients with peripheral artery disease in vivo.

AIMS: Adaptive immunity is critical in vascular remodelling following arterial injury. We hypothesized that acute changes in T cells at a percutaneous transluminal angioplasty (PTA) site could serve as an index of their potential interaction with the injured vascular wall. METHODS AND RESULTS: T cell subsets were characterised in 45 patients with Rutherford 3-4 peripheral artery disease (PAD) undergoing PTA. Direct angioplasty catheter blood sampling was performed before and immediately after the procedure. PTA was associated with an acute reduction of α/ß-TcR CD8+ T cells. Further characterisation revealed significant reduction in pro-atherosclerotic CD28nullCD57+ T cells, effector (CD45RA+CCR7-) and effector memory (CD45RA-CCR7-) cells, in addition to cells bearing activation (CD69, CD38) and tissue homing/adhesion markers (CD38, CCR5). CONCLUSIONS: The acute reduction observed here is likely due to the adhesion of cells to the injured vascular wall, suggesting that immunosenescent, activated effector CD8+ cells have a role in the early vascular injury immune response following PTA in PAD patients.

Myocardial injury after endovascular revascularization in critical limb ischemia predicts 1-year mortality: a prospective observational cohort study.

BACKGROUND: Patients with critical limb ischemia (CLI) are at increased risk of cardiovascular complications and mortality. To determine (1) incidence of myocardial injury following endovascular revascularization, and (2) relationship between myocardial injury with 1-year mortality and major adverse cardiovascular events (MACE; i.e., composite of myocardial infarction, stroke, and death). METHODS AND RESULTS: Single-center, prospective cohort study of CLI patients ≥ 45 years of age, who underwent endovascular revascularization with overnight hospitalization. High-sensitive troponins T (hsTnTs) were measured on admission, 3-6 h after endovascular revascularization and the subsequent morning. Myocardial injury after endovascular revascularization was defined as an hsTnT ≥ 14 ng/L with a relative increase ≥ 30% from the baseline value. We also evaluated other myocardial injury hsTnT thresholds (i.e., ≥ 30, ≥ 40, ≥ 60, and ≥ 80 ng/L). 239 consecutive patients (56% male, mean age 71.5 ± 10.1 years) were included; one patient was lost to follow-up. At 1 year, there were 34 deaths (14.2%), and 48 MACE (20.5%). Myocardial injury with the hsTnT threshold of 14 ng/L and relative increase by ≥ 30% from the baseline level occurred in 61 patients (25.5%). Myocardial injury was independently associated with 1-year mortality ([aHR], 2.44; 95% CI 1.18-5.06, for hsTnT ≥ 14 ng/L to aHR, 3.34; 95% CI 1.29-8.65 for hsTnT ≥ 80 ng/L). Myocardial injury was also independently associated with 1-year MACE ([AOR] 2.89; 95% CI 1.41-5.92 for hsTnT ≥ 14 ng/L to AOR, 6.69; 95% CI 2.17-20.68 for hsTnT ≥ 80 ng/L). 85.2% patients who had myocardial injury did not have ischemic clinical symptoms or electrocardiography changes. In sensitive analysis with exclusion of symptomatic patients that developed myocardial injury for the hsTnT ≥ 14 ng/L threshold, both the 1-year mortality (aHR: 2.19; CI 1.02-4.68; p = 0.04), and 1-year MACE (OR 2.25; CI 1.06-4.77; p = 0.036) remained significant. CONCLUSIONS: Myocardial injury is common following endovascular revascularization for CLI and associated with the risk of 1-year mortality and MACE.

Influence of air pollution on exhaled carbon monoxide levels in smokers and non-smokers. A prospective cross-sectional study.

BACKGROUND: The poor air quality and cigarette smoking are the most important reasons for increased carbon monoxide (CO) level in exhaled air. However, the influence of high air pollution concentration in big cities on the exhaled CO level has not been well studied yet. OBJECTIVES: To evaluate the impact of smoking habit and air pollution in the place of living on the level of CO in exhaled air. METHODS: Citizens from two large cities and one small town in Poland were asked to complete a survey disclosing their place of residence, education level, work status and smoking habits. Subsequently, the CO level in their exhaled air was measured. Air quality data, obtained from the Regional Inspectorates of Environmental Protection, revealed the differences in atmospheric CO concentration between locations. RESULTS: 1226 subjects were divided into 4 groups based on their declared smoking status and place of living. The average CO level in exhaled air was significantly higher in smokers than in non-smokers (p<0.0001) as well as in non-smokers from big cities than non-smokers from small ones (p<0.0001). Created model showed that non-smokers from big cities have odds ratio of 125.3 for exceeding CO cutoff level of 4ppm compared to non-smokers from small towns. CONCLUSIONS: The average CO level in exhaled air is significantly higher in smokers than non-smokers. Among non-smokers, the average exhaled CO level is significantly higher in big city than small town citizens. These results suggest that permanent exposure to an increased concentration of air pollution and cigarette smoking affect the level of exhaled CO.