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1.
Folia Med Cracov ; 63(2): 65-75, 2023 Jul 30.
Article in English | MEDLINE | ID: mdl-37903380

ABSTRACT

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.


Subject(s)
Quality of Life , Varicose Veins , Humans , Female , Poland , Pelvis , Varicose Veins/diagnosis , Linguistics , Surveys and Questionnaires
2.
Postepy Kardiol Interwencyjnej ; 19(2): 171-177, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37465629

ABSTRACT

Introduction: One of the most popular tests of the heart is the electrocardiogram (ECG). The physical basis of this study has been known for over 200 years. However, the way an ECG is performed and the interpretation of the obtained results have undergone considerable evolution over time. Aim: To analyze the ECG recordings regarding the QTc interval in patients taking calcium channel blockers. Material and methods: The publicly available PhysioNet signals database was used to analyze the effect of selected drugs on the heart rhythm and QTc interval. To automate the QTc assessment, the database was processed in MATLAB. First, QTc was assessed using four formulas; then the results were compared in terms of methodology and medications taken. Results: In the group of patients taking dihydropyridine blockers, the QTc interval assessed by the Bazett formula (mean: 478.87 ms; SD: 73.10) is longer than in patients taking non-dihydropyridine blockers (mean: 446.54 ms, SD: 88.07, p = 0.2123) and in patients not taking calcium channel blockers (mean: 436.33 ms, SD: 49.94, p = 0.0319). The same significant differences were obtained regardless of the QTc assessment method used. However, the QTc result obtained with the Bazett formula is significantly lower than in the case of using the other three formulas used for the presented analysis. Conclusions: Automatic ECG analysis is possible; however, it should be used carefully, considering the possibility of obtaining incorrect results. Taking calcium channel blockers may affect the QTc interval. QTc results significantly depend on the formula based on which we evaluate this parameter.

3.
Postepy Kardiol Interwencyjnej ; 18(2): 131-136, 2022 Jun.
Article in English | MEDLINE | ID: mdl-36051830

ABSTRACT

Introduction: Percutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel. Aim: The aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size. Material and methods: Based on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients' demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified. Results: A group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure. Conclusions: The occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up.

4.
Postepy Kardiol Interwencyjnej ; 18(2): 118-121, 2022 Jun.
Article in English | MEDLINE | ID: mdl-36051833

ABSTRACT

Introduction: Some patients with coronary heart disease are diagnosed with severe aortic stenosis. For further treatment, coronary angiography is performed in these patients. For intermediate lesions, obtaining coronary artery physiological data can facilitate clinical decision-making regarding revascularization. Aim: The study compared the physiological significance of coronary artery stenosis using the fractional flow reserve (FFR) method with instantaneous wave-free pressure ratio (iFR) and quantitative flow ratio (QFR) in patients qualified for aortic valve replacement. Material and methods: Data were collected on patients hospitalized in the years 2019-2020 at the 2nd Department of Cardiology, University Hospital in Krakow. Results: Twelve patients with severe aortic stenosis and borderline lesions in the coronary artery were qualified for physiological assessment. There were 6 women, whose mean age was 73.8 ±7.5 years. The mean left ventricular ejection fraction was 52 ±15%. The mean aortic valve area was 0.80 ±0.16 cm2. The left anterior descending artery was assessed in 12 from 13 cases (92%). In comparison to FFR, all iFR measurements were concordant with FFR. The total agreement between QFR and FFR/iFR assessment was 69%. Conclusions: Despite the controversy and uncertainty of some operators regarding the interpretation of the FFR test in patients with severe aortic stenosis, we obtained complete agreement of FFR with iFR assessment. This fact suggests that in patients with severe aortic stenosis the choice of an invasive method to assess the physiological significance of the stenosis in the coronary artery is not crucial - both iFR and FFR allow comparable results.

5.
Am J Cardiol ; 155: 23-31, 2021 09 15.
Article in English | MEDLINE | ID: mdl-34315572

ABSTRACT

Data on long-term neointimal healing and neoatherosclerosis progression after primary percutaneous coronary intervention (PCI) with implantation of everolimus-eluting bioresorbable vascular scaffold (BVS) (ABSORB BVS 1.0, Abbott Vascular) are limited. The mechanisms underlying very late scaffold failure remain to be further elucidated. This study sought to assess healing pattern and presence of neoatherosclerosis. This was a single-center, prospective, longitudinal study with serial optical coherence tomography (OCT) assessment at baseline, 12, 24 and 60 months after PCI performed in 12 patients presenting with ST-segment elevation myocardial infarction (STEMI). The median follow-up was 59 months. The diameter stenosis increased from 7.11 ± 4.99% at 1-year to 21.00 ± 11.31% at 5 years, (p = 0.03), whereas minimum lumen diameter remained stable throughout the follow-up period, as assessed by angiography. Minimum and mean lumen area declined over the 5-year follow-up by 1.00 ± 1.57 mm2 and 1.75 ± 0.87 mm2, respectively; a significant decrease in minimum and mean lumen area in the first two years, was followed by stable luminal dimensions between 2 and 5 years of follow-up. The lumen eccentricity (0.85 ± 0.03) and asymmetry (0.43 ± 0.10) indexes showed no change over 60-month follow-up. The incidence of atherosclerosis was high both in the in-scaffold (IS) and out-scaffold (OS) regions consisting of calcifications (IS = 100%, OS = 92%, p = 0.99), macrophages (IS = 92% and OS = 67%, p = 0.31), neovascularization (IS = 75%, OS = 50%, p = 0.40). In conclusion, serial OCT imaging up to 5 years after implantation of BVS in STEMI indicated complete scaffold resorption, stable lumen area following period of neointima growth in the first two years after PCI and high incidence of neoatherosclerosis.


Subject(s)
Absorbable Implants , Coronary Vessels/diagnostic imaging , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/diagnosis , Tissue Scaffolds , Tomography, Optical Coherence/methods , Coronary Angiography , Coronary Vessels/surgery , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , ST Elevation Myocardial Infarction/surgery , Time Factors , Treatment Outcome
7.
Radiol Case Rep ; 15(11): 2445-2448, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33005282

ABSTRACT

Juvenile idiopathic arthritis (JIA) is a group of childhood inflammatory arthropathies that affects multiple joints including the spine, particularly the cervical region. There is paucity of literature regarding JIA in the lumbosacral spine; the few published studies which discuss imaging findings in the lumbosacral spine only include cohorts of older children and adolescents. We present a 22-month-old boy with refusal to walk, in which plain radiographs and contrast-enhanced magnetic resonance imaging of the lumbosacral spine suggested a diagnosis of JIA.

8.
Int J Cardiol ; 312: 27-32, 2020 08 01.
Article in English | MEDLINE | ID: mdl-32315682

ABSTRACT

BACKGROUND: Peri-strut low intensity areas (PLIA) visualized by optical coherence tomography (OCT) have been related to neointimal proliferation and increased incidence of target lesion revascularization in stable coronary artery disease. The aim of this study was to determine the association between PLIA by OCT and the long-term vascular healing response after bioresorbable scaffold (BRS) implantation in the setting of ST-segment elevation myocardial infarction (STEMI). METHODS: This is a single-centre, longitudinal, cohort study with a serial: baseline, 1, 2 and 5 years OCT evaluation of neointimal response (lumen area and neoatherosclerosis) after percutaneous coronary intervention (PCI) with BRS Absorb™ 1.0 implantation in patients presenting with STEMI. PLIA was analyzed in every cross section and scored: 0-no PLIA; 1-PLIA < 1 quadrant; 2-PLIA ≥ 1 and <2 quadrants; 3-PLIA ≥ 2 and <3 quadrants; 4-PLIA in ≥3 quadrants. RESULTS: Of the 23 patients implanted BRS, 18 completed 2-year follow-up, whereas complete OCT data up to 5 years were available in 12 patients. Presence of PLIA was identified in 100% patients at 1 and 2 years, whereas at 5 years neither PLIA nor scaffold struts were visualized by OCT. Neoatherosclerosis was identified in 73,68% patients after 1 year and in all patients at 2 and 5 years. The mean PLIA score > 1 at 2 years was associated with greater percentage of minimum lumen area decrease after 2 years from index procedure. CONCLUSIONS: The extent of PLIA by OCT at 2 years after primary PCI with BRS was associated with lumen area decrease. Neoatherosclerosis formation was detected in all patients at 2 and 5 years. PLIA assessment could serve as an additive means to predict neointimal healing pattern after next generation BRS implantation.


Subject(s)
Drug-Eluting Stents , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Absorbable Implants , Cohort Studies , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , Humans , Neointima/diagnostic imaging , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/surgery , Tomography, Optical Coherence , Treatment Outcome
10.
J Vasc Surg Venous Lymphat Disord ; 7(6): 845-852.e2, 2019 11.
Article in English | MEDLINE | ID: mdl-31444091

ABSTRACT

OBJECTIVE: Pelvic venous incompetence or pelvic congestion syndrome (commonly referred to as pelvic venous disorder [PVD]) is increasingly diagnosed, especially in multiparous women. This may be either primary or secondary to pelvic venous outflow obstruction-left common iliac vein (LCIV) or left renal vein (LRV) stenosis. Intravascular ultrasound (IVUS) examination performed in the supine position is commonly used for diagnosis of LRV and LCIV stenosis; however, body position may affect the cross-sectional area (CSA) of both of these veins during IVUS. The aim of the study was to test the hypothesis that postural changes may significantly affect the CSA of the LRV and LCIV. METHODS: A single-arm, single-center cohort study of women suffering from PVD was performed at a tertiary hospital in Poland. It comprised consecutive patients with either pelvic vein reflux or suggestion of LCIV or LRV obstruction but no signs of deep venous thrombosis. IVUS examination of the iliac veins, inferior vena cava, and LRV was performed in the supine position. IVUS of the LRV and LCIV was performed also with a Valsalva maneuver and with patients lying on the left side and standing. A 60% CSA reduction was used as a cutoff value between significant and nonsignificant vein stenosis. RESULTS: A total of 41 women were examined. Significant stenosis of the LRV was seen in 22 patients (55%) supine but in only 4 (10%) patients studied when lying on the left side and in 27 (67.5%) patients studied while standing. Significant stenosis of the LCIV was seen in 26 supine patients (63.4%), in 8 lying on the left side (19.5%), and in 10 (24.4%) standing. CONCLUSIONS: Postural changes dramatically affect CSA of the LCIV and LRV and thus the degree of stenosis in women diagnosed with PVD. Stenosis found in patients while supine often disappears when the position is changed to lying on the left side or to standing. Therapeutic decisions based on assessment of CSA reduction in the supine position are likely to be inadequate.


Subject(s)
Iliac Vein/physiopathology , Patient Positioning , Pelvis/blood supply , Renal Veins/physiopathology , Standing Position , Supine Position , Ultrasonography, Interventional , Vascular Patency , Venous Insufficiency/physiopathology , Adult , Aged , Constriction, Pathologic , Female , Humans , Iliac Vein/diagnostic imaging , Middle Aged , Poland , Predictive Value of Tests , Prospective Studies , Regional Blood Flow , Renal Veins/diagnostic imaging , Severity of Illness Index , Valsalva Maneuver , Venous Insufficiency/diagnostic imaging , Young Adult
12.
Catheter Cardiovasc Interv ; 94(1): 149-156, 2019 Jul 01.
Article in English | MEDLINE | ID: mdl-30945420

ABSTRACT

OBJECTIVES: To assess feasibility, safety, angiographic, and clinical outcome of highly-calcific carotid stenosis (HCCS) endovascular management using CGuard™ dual-layer carotid stents. BACKGROUND: HCCS has been a challenge to carotid artery stenting (CAS) using conventional stents. CGuard combines a high-radial-force open-cell frame conformability with MicroNet sealing properties. METHODS: The PARADIGM study is prospectively assessing routine CGuard use in all-comer carotid revascularization patients; the focus of the present analysis is HCCS versus non-HCCS lesions. Angiographic HCCS (core laboratory evaluation) required calcific segment length to lesion length ≥2/3, minimal calcification thickness ≥3 mm, circularity (≥3 quadrants), and calcification severity grade ≥3 (carotid calcification severity scoring system [CCSS]; G0-G4). RESULTS: One hundred and one consecutive patients (51-86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non-HCCS); eight others (two HCCS) were treated surgically. CCSS evaluation was reproducible, with weighted kappa (95% CI) of 0.73 (0.58-0.88) and 0.83 (0.71-0.94) for inter- and intra-observer reproducibility respectively. HCCS postdilatation pressures were higher than those in non-HCCS; 22 (20-24) versus 20 (18-24) atm, p = .028; median (Q1-Q3). Angiography-optimized HCCS-CAS was feasible and free of contrast extravasation or clinical complications. Overall residual diameter stenosis was single-digit but it was higher in HCCS; 9 (4-17) versus 3 (1-7) %, p = .002. At 30 days and 12 months HCCS in-stent velocities were normal and there were no adverse clinical events. CONCLUSION: CGuard HCCS endovascular management was feasible and safe. A novel algorithm to grade carotid artery calcification severity was reproducible and applicable in clinical study setting. Larger HCCS series and longer-term follow-up are warranted.


Subject(s)
Carotid Stenosis/therapy , Endovascular Procedures/instrumentation , Stents , Stroke/prevention & control , Vascular Calcification/therapy , Aged , Aged, 80 and over , Angiography , Asymptomatic Diseases , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Endovascular Procedures/adverse effects , Feasibility Studies , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Risk Factors , Severity of Illness Index , Stroke/diagnostic imaging , Stroke/etiology , Time Factors , Treatment Outcome , Vascular Calcification/complications , Vascular Calcification/diagnostic imaging , Vascular Calcification/mortality
13.
Environ Res ; 172: 258-265, 2019 05.
Article in English | MEDLINE | ID: mdl-30822558

ABSTRACT

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.


Subject(s)
Air Pollution , Breath Tests , Carbon Monoxide , Tobacco Smoke Pollution , Adult , Carbon Monoxide/analysis , Cities , Cross-Sectional Studies , Humans , Poland , Smoking , Tobacco Smoke Pollution/analysis
14.
Pol Arch Intern Med ; 129(3): 167-174, 2019 03 29.
Article in English | MEDLINE | ID: mdl-30793704

ABSTRACT

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.


Subject(s)
Intermittent Claudication/psychology , Peripheral Arterial Disease/psychology , Quality of Life/psychology , Surveys and Questionnaires/standards , Female , Health Status Indicators , Humans , Male , Middle Aged , Poland , Psychometrics , Reproducibility of Results , Severity of Illness Index
15.
Kardiol Pol ; 77(1): 24-32, 2019.
Article in English | MEDLINE | ID: mdl-30338500

ABSTRACT

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.


Subject(s)
Endovascular Procedures , Ischemia/surgery , Tibial Arteries/surgery , Aged , Ankle Brachial Index , Female , Follow-Up Studies , Humans , Male , Middle Aged , Treatment Outcome
16.
Int J Environ Health Res ; 29(3): 290-300, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30375883

ABSTRACT

Carbon monoxide (CO) is an important component of tobacco smoke, but also environmental toxicity. This study analyzed possible correlation between exhaled CO level and oral health indicators in two geographically distributed populations during health-promoting public events organized for local communities in cities with high and low environmental pollution in Poland (907 patients). Self-reported, instructor-led, oral health questionnaire was developed to monitor current and previous mucosal lesion incidence. Exhaled CO correlated with subjects smoking status and environmental CO exposure: highest in smoking inhabitants of Krakow (12 ppm), with lower levels in smokers from Kozienice (6.5 ppm) and non-smokers from Krakow (6 ppm), and lowest for Kozienice non-smokers (2 ppm) (p < 0.001). After propensity score matching and adjustment for smoking status, demography and comorbidities odds ratio for mucosal lesion incidence was 1.46 (1.31-1.63), p < 0.001) per 1 ppm increase of exhaled CO level. This result might implicate a possible role of environmental pollution factors in oral health pathology.


Subject(s)
Carbon Monoxide/analysis , Mouth Diseases/epidemiology , Mouth Mucosa/pathology , Adult , Air Pollution , Comorbidity , Exhalation , Female , Humans , Incidence , Male , Middle Aged , Odds Ratio , Poland , Smoking/epidemiology , Surveys and Questionnaires , Young Adult
17.
Cardiol J ; 25(4): 521-529, 2018.
Article in English | MEDLINE | ID: mdl-30211929

ABSTRACT

BACKGROUND: The REGENT-VSEL trial demonstrated a neutral effect of transendocardial injection of autologous bone marrow (BM)-derived CD133+ in regard to myocardial ischemia. The current sub-analysis of the REGENT VSEL trial aims to assess the effect stem cell therapy has on quality of life (QoL) in patients with refractory angina. METHODS: Thirty-one patients (63.0 ± 6.4 years, 70% male) with recurrent CCS II-IV angina, despite optimal medical therapy, enrolled in the REGENT-VSEL single center, randomized, double-blinded, and placebo-controlled trial. Of the 31 patients, 16 individuals were randomly assigned to the active stem cell group and 15 individuals were randomly assigned to the placebo group on a 1:1 basis. The inducibility of ischemia, (≥ one myocardial segment) was confirmed for each patient using Tc-99m SPECT. QoL was measured using the Seattle Angina Questionnaire. Each patient completed the questionnaire prior to treatment and at the time of their outpatient follow-up visits at 1, 4, 6, and 12 months after cell/placebo treatment. RESULTS: The main finding of the REGENT-VSEL trial sub-analysis was that transendocardial injection of autologous BM-derived CD133+ stem cells in patients with chronic refractory angina did not show significant improvement in QoL in comparison to the control group. Moreover, there was no significant difference between cell therapy and placebo in a number of patients showing improvement of at least 1 Canadian Cardiovascular Society class during the follow-up period. CONCLUSIONS: Intra-myocardial delivery of autologous CD133+ stem cells is safe and feasible but does not show a significant improvement in the QoL or angina pectoris symptoms in patients with chronic myocardial ischemia.


Subject(s)
AC133 Antigen/immunology , Angina Pectoris/therapy , Bone Marrow Cells/immunology , Bone Marrow Transplantation/methods , Quality of Life , Ventricular Function, Left/physiology , Angina Pectoris/physiopathology , Bone Marrow Cells/cytology , Double-Blind Method , Endocardium , Female , Humans , Injections , Male , Middle Aged , Surveys and Questionnaires , Transplantation, Autologous , Treatment Outcome
18.
Clin Immunol ; 194: 26-33, 2018 09.
Article in English | MEDLINE | ID: mdl-29936303

ABSTRACT

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.


Subject(s)
CD8-Positive T-Lymphocytes/immunology , Peripheral Arterial Disease/immunology , T-Lymphocyte Subsets/immunology , Vascular System Injuries/immunology , Aged , Antigens, CD/immunology , Female , Humans , Immunologic Memory/immunology , Leukocyte Common Antigens/immunology , Male , Receptors, Antigen, T-Cell, alpha-beta/immunology
20.
Clin Res Cardiol ; 107(4): 319-328, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29177795

ABSTRACT

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.


Subject(s)
Endovascular Procedures/adverse effects , Heart Diseases/mortality , Ischemia/therapy , Peripheral Arterial Disease/therapy , Aged , Aged, 80 and over , Biomarkers/blood , Critical Illness , Female , Heart Diseases/diagnosis , Heart Diseases/physiopathology , Humans , Incidence , Ischemia/diagnosis , Ischemia/mortality , Ischemia/physiopathology , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/physiopathology , Poland/epidemiology , Prevalence , Prospective Studies , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Stroke/physiopathology , Time Factors , Treatment Outcome , Troponin T/blood
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