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Background: Telemedicine is increasingly used in several fields of healthcare, including vascular medicine. This study aimed to investigate the views of experts and propose clinical practice recommendations on the possible applications of telemedicine in vascular medicine. Methods: A clinical guidance group proposed a set of 67 clinical practice recommendations based on the synthesis of current evidence and expert opinion. The Telemedicine Vascular Medicine Working Group included 32 experts from Europe evaluating the appropriateness of each clinical practice recommendation based on published RAND/UCLA methodology in two rounds. Results: In the first round, 60.9% of clinical practice recommendations were rated as appropriate, 35.9% as uncertain, and 3.1% as inappropriate. The strongest agreement (a median value of 10) was reached on statements regarding the usefulness of telemedicine during the 2019 coronavirus disease (COVID-19) pandemic, its usefulness for geographical areas that are difficult to access, and the superiority of video calls compared to phone calls only. The lowest degree of agreement (a median value of 2) was reported on statements regarding the utility of telemedicine being limited to the COVID-19 pandemic and regarding the applicability of teleconsultation in the diagnosis and management of abdominal aortic aneurysm. In the second round, 11 statements were re-evaluated to reduce variability. Conclusions: This study highlights the levels of agreement and the points that raise concern on the use of telemedicine in vascular medicine. It emphasizes the need for further clarification on various issues, including infrastructure, logistics, and legislation.
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Socio-economic determinants of health (SDoH) include various nonmedical factors in the socio-economic sphere with a potentially significant impact on health outcomes. Their effects manifest through several mediators/moderators (behavioral characteristics, physical environment, psychosocial circumstances, access to care, and biological factors). Various critical covariates (age, gender/sex, race/ethnicity, culture/acculturation, and disability status) also interact. Analyzing the effects of these factors is challenging due to their enormous complexity. Although the significance of SDoH for cardiovascular diseases is well documented, research regarding their impact on peripheral artery disease (PAD) occurrence and care is less well documented. This narrative review explores to what extent SDoH are multifaceted in PAD and how they are associated with its occurrence and care. Additionally, methodological issues that may hamper this effort are addressed. Finally, the most important question, whether this association may contribute to reasonable interventions aimed at SDoH, is analyzed. This endeavor requires attention to the social context, a whole systems approach, multilevel-thinking, and a broader alliance that reaches out to more stakeholders outside the medical sphere. More research is needed to justify the power in this concept to improve PAD-related outcomes like lower extremity amputations. At the present time, some evidence, reasonable consideration, and intuitive reasoning support the implementation of various interventions in SDoH in this field.
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Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/epidemiología , Enfermedad Arterial Periférica/terapia , Amputación Quirúrgica , Etnicidad , Factores SocioeconómicosRESUMEN
BACKGROUND: In the hypertensive population, the peripheral arterial disease (PAD) is considered one of the target organ damages. Ankle Brachial Index (ABI) measurement represents the widely accepted clinical method that may objectively detect the presence of PAD. The study aimed to assess how PAD revealed by ABI predicts mortality in patients with hypertension. METHODS: In the follow-up time (5 years period) of the Hungarian ERV Study, a large scale, multicenter observational study, recruiting hypertensive subjects between 50-75 years, the association of PAD with the survival time was analysed. Several multivariate, interval-censored survival models were developed to assess this association. RESULTS: Among the 21892 enrolled hypertensive patients, the prevalence of PAD (ABI≤0.9) was 14.4%. The crude death rate was 5.44% (1190 cases) over the available observational period. In multivariate models male sex, myocardial infarction in patients' history, diabetes, renal failure, PAD and cardiovascular risk (SCORE risk) were significantly associated with mortality. Lower ABI showed a continuous, close to linear association with worse survival. PAD was predictive for mortality risk in all SCORE patient groups. CONCLUSIONS: Low ABI is a strong predictor of mortality in hypertensive patients between the age 50-75, even after adjustment for several potential confounders. The association is linear, with no apparent cut-off, suggesting that ABI should be handled as a continuous variable. The detection of PAD in hypertensives may contribute to the determination of total cardiovascular risk in hypertensive population.
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Hipertensión , Infarto del Miocardio , Enfermedad Arterial Periférica , Humanos , Masculino , Persona de Mediana Edad , Anciano , Índice Tobillo Braquial/métodos , Estudios de Seguimiento , Hipertensión/diagnóstico , Hipertensión/epidemiología , Hipertensión/complicaciones , Factores de RiesgoRESUMEN
OBJECTIVE: Assessment of variations in the use of lower extremity open vascular surgical procedures (LEOPEN) and lower extremity endovascular procedures (LEENDO) across small geographic areas in Hungary from 2013 to 2017. Introduction of a new metric giving a rough estimate of unwarranted clinical variation in revascularisation practice. METHODS: Spatial variation (at local administrative unit level) of referral for LEOPEN and LEENDO was evaluated through a retrospective analysis using healthcare administrative data of all beneficiaries in Hungary. The same assessment was performed for percutaneous coronary intervention in acute myocardial infarction (PCIAMI). The latter was considered a reasonable comparator (similar at risk population, well organised, guideline driven patient pathways, small room for referral discretion). Consequently, the ratio of spatial variations of LEOPEN and LEENDO to PCIAMI (as a reference) are thought to reflect unwarranted clinical variation. RESULTS: A total of 109 882 procedures were identified in the database (LEOPEN, LEENDO, PCIAMI) affecting 85 083 patients. While estimates of spatial variations for LEOPEN and LEENDO turned out to be high (systematic component of variation [SCV] 0.09 and 0.21, respectively), PCIAMI showed a low SCV value of 0.02. Consequently, the ratios of SCVs were SCV/SCVref = 4.67 (LEOPEN) and SCV/SCVref = 10.3 (LEENDO), indicating high levels of unwarranted clinical variation. CONCLUSION: The analysis showed that patients living in different locations of Hungary face very different odds of having lower extremity revascularisation procedures (open or endovascular). This spatial variation is thought to be related mainly to the failure in vascular service organisation. The newly introduced numerical estimate of unwarranted clinical variation may support within, and also between, system comparisons.
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Procedimientos Endovasculares , Infarto del Miocardio , Enfermedad Arterial Periférica , Amputación Quirúrgica , Procedimientos Endovasculares/efectos adversos , Humanos , Hungría , Extremidad Inferior/irrigación sanguínea , Infarto del Miocardio/cirugía , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/epidemiología , Enfermedad Arterial Periférica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares/métodosAsunto(s)
Cardiología , Curriculum , Educación de Postgrado en Medicina , Europa (Continente) , Humanos , EspecializaciónRESUMEN
Background: Lower limb major amputations represent a substantial public health burden in Hungary, where previous research revealed markedly high rates with significant spatial variations. Therefore, we aimed to assess to what extent healthcare and socio-economic factors in the local environment explain the regional disparity. Patients and methods: In a retrospective cohort analysis, based on the healthcare administrative data of the Hungarian population, lower limb major amputations were identified from 1st of January 2017 to 31st of December 2019. The permanent residence of the amputees on the local administrative level (197 geographic units) was used to identify potential healthcare (outpatient care, revascularisation activity) and socio-economic (educational attainment, local infrastructure and services, income and employment) determinants of amputations. Spatial effects were modelled using the spatial Durbin error regression model. Results: 10,209 patients underwent 11,649 lower limb major amputations in the observational period. In our spatial analysis, outpatient care was not associated with local amputation rates. However, revascularisation activity in a geographic unit entailed an increased rate of amputations, while revascularisations in the neighbouring areas were associated with a lower rate of amputations, resulting in an overall neutral effect (ß=-0.002, 95% CI: -0.05 - 0.04, p=0.96). The local socio-economic environment had a significant direct inverse association with amputations (ß=-7.45, 95% CI: -10.50 - -4.42, p<0.0001) . Our spatial model showed better performance than the traditional statistical modelling (ordinary least squares regression), explaining 37% of the variation in amputations rates. Conclusions: Regional environmental factors explain a substantial portion of spatial disparities in amputation practice. While the socio-economic environment shows a significant inverse relationship with the regional amputation rates, the impact of the local healthcare-related factors (outpatient care, revascularisation activity) is not straightforward. Unravelling the impact of the location on amputation practice requires complex spatial modelling, which may guide efficient healthcare policy decisions.
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Amputación Quirúrgica , Extremidad Inferior , Geografía , Humanos , Hungría/epidemiología , Extremidad Inferior/cirugía , Estudios Retrospectivos , Análisis EspacialRESUMEN
Összefoglaló. A népesség öregedése, a meghatározó cardiovascularis rizikótényezok - mint a cukorbetegség - egyre nagyobb arányú elofordulása, a csökkeno akut cardiovascularis halálozás az alsó végtagi veroérszukület növekvo megjelenésével jár. Ezzel együtt szaporodnak a beavatkozást igénylo, jelentos életminoség-romlást, illetve végtag-veszélyeztetettséget okozó, súlyosabb esetek. Ilyenkor az alsó végtagi revascularisatio szüksége merül fel, ami az utóbbi évtizedben az endovascularis beavatkozások számának növekedéséhez vezetett. A beavatkozások technikai sikere mellett újabb szukületek, elzáródások veszélyével kell számolni. Ennek hátterében az atherosclerosis progressziója mellett a beavatkozáshoz kötheto, kontrollált érfalsérülés indukálta vascularis remodelling (neointima-hyperplasia), valamint thromboticus tényezok állnak. Az ér-nyitvamaradás hosszú távú biztosításának feltétele a fenti folyamatok megelozésére alkalmazott optimális gyógyszeres kezelés. Ennek biztosítása elengedhetetlen a beavatkozást megelozoen, periprocedurálisan, majd az érintett betegkör hosszú távú gondozása során. A gyógyszeres terápiás lehetoségek közül az antithromboticus, antikoaguláns terápiának kiemelt jelentosége van. Az ezen hatású gyógyszerek alkalmazását igen nehézzé teszi (i) a thromboticus elzáródás kiújulása és a potenciális vérzés közötti dinamikusan változó egyensúly bizonytalansága, (ii) az egyéb társbetegségek kapcsán felmerülo terápiás szempontok egyideju érvényesítése, valamint (iii) a napi ellátásban támpontot adó tudományos bizonyítékok relatív hiánya. Az összefoglaló tanulmány a fenti gyógyszerterápiás terület legújabb eredményeit kísérli meg elemezni. Orv Hetil. 2022; 163(3): 98-108. Summary. The aging of the population, the increasing prevalence of important risk factors of atherosclerosis, like diabetes, and the declining mortality of acute cardiovascular conditions lead to increased peripheral arterial disease incidence. At the same time, cases showing a severe decline in quality of life or danger of limb loss get more prevalent that demands vascular interventions. In such cases, revascularization is recommended, and consequently, in the last decade, an expansion in endovascular procedures can be seen. Considering these procedures, besides a technical success, the risk of new stenosis or occlusion may be imminent. This may be accounted for the progression of atherosclerosis and the controlled vascular injury caused by the procedure itself that induces vascular remodeling (neointima hyperplasia) and thrombotic hyperactivity. The long-term vascular patency is closely associated with the success of an optimal medical treatment strategy. Its effect is considered essential prior to the endovascular procedure, perioperatively, and in the phase of long-term follow-up of the affected patients. In this scenario, antithrombotic and anticoagulant therapy regimes bear particular relevance. The use of this kind of drugs is challenged by (i) the uncertainty of dynamic changes of balance between the thrombotic reocclusion and the risk of bleeding, (ii) the interplay of treatment strategy related to concomitant diseases, (iii) the relative lack of high-level scientific pieces of evidence guiding daily routine. The narrative review makes an effort to provide new findings and an analysis of this therapeutic field. Orv Hetil. 2022; 163(3): 98-108.
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Procedimientos Endovasculares , Fibrinolíticos , Anticoagulantes , Humanos , Extremidad Inferior , Calidad de VidaRESUMEN
Thirty years after the transition period, starting from 1989, Central and Eastern European countries (CEECs), representing one-fifth of the entire European population, share many historical, societal, political, economic, and cultural characteristics. Although accumulating data on coronary heart diseases and cerebrovascular diseases support these observations, in the case of peripheral arterial disease, data are scarce. The present review attempts to summarise the shreds of data that may highlight a divide in this field between CEECs and Western European countries. Disparities in risk factors and peripheral vascular care across Europe seem to be tangible and can be seen as a signal of existing differences. Improvements in research and development and the collection and cross-border share of scientific data are essential to initiate and facilitate convergence in this field.
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Even today thromboangiitis obliterans has disease features that remain misunderstood or underappreciated. The epidemiology, etiology and pathophysiology of the disease are still unclear. Biomarkers and disease activity markers are lacking, thus clinical assessment is difficult. We are still struggling to establish unique diagnostic, staging and treatment criteria. This is an academic-collaborative effort to describe the pathophysiology, the clinical manifestations, the diagnostic approach, and the challenges of management of patients with TAO. A systematic search for relevant studies dating from 1900 to the end of 2020 was performed on the PubMed, SCOPUS, and Science Direct databases. Given the intriguing nature of presentation of TAO, its management, to some extent is not only different in different regions of the world but also varies within the same region. Following this project, we discovered ambiguity, overlap and lack of clear-cut criteria for management of TAO. An international group of experts however came to one conclusion. They all agree that management of TAO needs a call for action for a renewed global look with multi-center studies, to update the geographical distribution of the disease and to establish a unique set of diagnostic criteria and a consensus-based guideline for best treatment based on current evidence.
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Cardiología , Tromboangitis Obliterante , Humanos , Tromboangitis Obliterante/diagnóstico , Tromboangitis Obliterante/epidemiología , Tromboangitis Obliterante/terapiaRESUMEN
Összefoglaló. A tudomány jelenlegi állása szerint - csoportok összehasonlítására épülo matematikai-statisztikai eszközökkel - a leginkább hatékonynak és hatásosnak vélt kezelési módszerek szisztematikus elemzése mentén, a bizonyítékokon alapuló irányelveken nyugvó gyógyító munkát tekintjük követendonek. A nyaki veroérszukület ellátása esetén az utóbbi években elkészült mind a hazai, mind az európai irányelv, mindemellett a társszakmák irányelveiben is megjelentek kezelési javaslatok. Közleményünkben összehasonlítottuk a témában publikált magyar, angol, német és olasz nyelvu, valamint az európai társaságok által kiadott irányelveket. Az irányelvek alapelveikben hasonlóak, formailag és tartalmilag azonban jelentos (idonként egymásnak ellentmondani látszó) különbségeket találhatunk. Az ellentmondások három leggyakoribb oka: 1) az egyes irányelvek által kituzött célok különbözosége, 2) az aszimptomatikus és szimptomatikus betegcsoport definíciói, valamint 3) az eltéro evidenciaszintek. Az irányelvek összevetése alapján a tünetes, szignifikáns nyaki veroérszukületek sebészi ellátása evidenciának tekintheto. A szimptomatikus nyaki veroérszukület a definíció szerint ellenoldali cerebralis ischaemia okozta, tranziens vagy definitív plegia, paresis, aphasia és az azonos oldali arteria centralis retinae embolisatiója miatti amaurosis fugax. A tünetmentes nyaki veroérszukületek ellátása tekintetében az európai és a nemzeti irányelvek nem azonosak, ezen esetek terápiás döntése egyéni mérlegelést igényel. Tünetmentes, 70%-os stenosis esetén vascularteam-konzílium javasolt. Orv Hetil. 2020; 161(51): 2139-2145. Summary. The correct practice is the one that is proven to be the most effective based on systematic statistical analyses of different treatment methods, and is applied according to evidence-based principles. In recent years, not only has the European Society of Vascular Surgery created a guideline about the management of supra-aortic steno-occlusive disease, but some nations' vascular surgical societies and related disciplines have also developed their own guidance. In this paper, the guidelines by the European societies on the clinical care of patients with carotid artery luminal narrowing is compared to national guidelines published in Hungarian, English, German, and Italian. Although the fundamental points of the guidelines are similar, there are some important differences among them both in presentation and in content; as a result, they sometimes appear to be contradictory. The three main sources of inconsistency are the various goals, the discrepancy in the definition of symptomatic and asymptomatic carotid artery stenosis, and the bias arising from the use of distinct evidence levels. A comparison of guidelines suggests that the treatment of symptomatic significant carotid artery stenosis with surgery can be considered evidence. Symptomatic carotid artery stenosis is defined as transient or definite plegia, paresis, aphasia due to cerebral ischemia, and monocular blindness caused by embolism in the central retinal artery. However, in the case of asymptomatic 70% or greater carotid artery stenosis, the guidelines are quite heterogeneous, and these patients require individual consideration and a vascular team decision is recommended. Orv Hetil. 2020; 161(51): 2139-2145.
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Estenosis Carotídea , Guías de Práctica Clínica como Asunto , Europa (Continente) , Humanos , HungríaRESUMEN
INTRODUCTION: Intermittent claudication has a significant negative impact on the patients' quality of life. Revascularization procedures and noninvasive medical therapies can improve walking capacity. Cilostazol has IA recommendation for the treatment of intermittent claudication. AIM: The aim of this study was to evaluate the effect of a three-month cilostazol treatment on the health-related quality of life and on the lower-limb functional capacity in diabetic (DM) and non-diabetic patients (NDM) with intermittent claudication in the clinical practice. METHOD: The study was a multicenter, non-interventional trial; 812 patients with peripheral artery disease (Fontaine II stage, mean age: 67.17 years, male/female: 58.25/41.75%, 318 diabetics) were enrolled, who received cilostazol (50 or 100 mg twice a day) for 3 months. The quality of life was evaluated with the EQ-5D-3L questionnaire, the functional capacity with the WELCH questionnaire. Walking distances, ankle-brachial index were measured at baseline and after 3 months. RESULTS: Upon conclusion of the study, the EQ-5D index improved both in non-diabetic and diabetic patients (baseline: NDM -0.45 ± 0.22, DM -0.48 ± 0.23, 3rd month: -0,24 ± 0.18, -0,27 ± 0.19; respectively; p<0.0001) and there was a significant increase in the WELCH score as well (baseline: NDM 20 ± 14, DM 18 ± 14; 3rd month: 33 ± 19, 29 ± 16, respectively; p<0.0001). Both pain-free and maximal walking distance increased by 59.2% (median: 50.0%), 46.58 (median: 40.51%) in NDM and 42.85% (median: 43.33%), 41.61% (median: 34.68%) in DM patients, respectively (p<0.001). CONCLUSIONS: Three months of cilostazol treatment improved the quality of life and lower-limb functional capacity in diabetic and non-diabetic claudicant patients. The WELCH questionnaire is a useful tool in clinical practice for the evaluation of intermittent claudication treatment. Orv Hetil. 2020; 161(38): 1637-1645.
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Cilostazol/uso terapéutico , Diabetes Mellitus/fisiopatología , Claudicación Intermitente/tratamiento farmacológico , Enfermedad Arterial Periférica/complicaciones , Calidad de Vida/psicología , Tetrazoles/uso terapéutico , Vasodilatadores/uso terapéutico , Anciano , Estudios de Casos y Controles , Complicaciones de la Diabetes , Femenino , Humanos , Claudicación Intermitente/psicología , Extremidad Inferior/fisiopatología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/tratamiento farmacológico , Resultado del Tratamiento , CaminataRESUMEN
COVID-19 is also manifested with hypercoagulability, pulmonary intravascular coagulation, microangiopathy, and venous thromboembolism (VTE) or arterial thrombosis. Predisposing risk factors to severe COVID-19 are male sex, underlying cardiovascular disease, or cardiovascular risk factors including noncontrolled diabetes mellitus or arterial hypertension, obesity, and advanced age. The VAS-European Independent Foundation in Angiology/Vascular Medicine draws attention to patients with vascular disease (VD) and presents an integral strategy for the management of patients with VD or cardiovascular risk factors (VD-CVR) and COVID-19. VAS recommends (1) a COVID-19-oriented primary health care network for patients with VD-CVR for identification of patients with VD-CVR in the community and patients' education for disease symptoms, use of eHealth technology, adherence to the antithrombotic and vascular regulating treatments, and (2) close medical follow-up for efficacious control of VD progression and prompt application of physical and social distancing measures in case of new epidemic waves. For patients with VD-CVR who receive home treatment for COVID-19, VAS recommends assessment for (1) disease worsening risk and prioritized hospitalization of those at high risk and (2) VTE risk assessment and thromboprophylaxis with rivaroxaban, betrixaban, or low-molecular-weight heparin (LMWH) for those at high risk. For hospitalized patients with VD-CVR and COVID-19, VAS recommends (1) routine thromboprophylaxis with weight-adjusted intermediate doses of LMWH (unless contraindication); (2) LMWH as the drug of choice over unfractionated heparin or direct oral anticoagulants for the treatment of VTE or hypercoagulability; (3) careful evaluation of the risk for disease worsening and prompt application of targeted antiviral or convalescence treatments; (4) monitoring of D-dimer for optimization of the antithrombotic treatment; and (5) evaluation of the risk of VTE before hospital discharge using the IMPROVE-D-dimer score and prolonged post-discharge thromboprophylaxis with rivaroxaban, betrixaban, or LMWH.
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COVID-19/diagnóstico , Cardiología , Enfermedades Cardiovasculares/diagnóstico , SARS-CoV-2/fisiología , Anticoagulantes/uso terapéutico , COVID-19/epidemiología , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/epidemiología , Europa (Continente) , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Inflamación , Guías de Práctica Clínica como Asunto , Factores de Riesgo , Rivaroxabán/uso terapéutico , Sociedades Médicas , Trombofilia , Trombosis , Tratamiento Farmacológico de COVID-19RESUMEN
Background: The incidence of lower limb major amputations is an important healthcare quality indicator, as it reflects all efforts aimed to prevent limb loss. Analysis of within-country regional variations in incidence may reveal the sources of disparities in care. Materials and methods: Based on the data of the Hungarian healthcare beneficiary population from 2004 to 2016, the incidence of lower limb major amputations and its spatial variations was determined regionally on four levels of geographic resolution. Variability and autocorrelation were quantified on different resolutions. Results: A total of 56,468 lower limb major amputation procedures were identified in 49,528 patients over the observation period. Marked regional variations were detected at all geographic scale levels. In the case of county-level and local administrative level, the systematic component of variation was 0.03 and 0.09, respectively. Only half of the variation at local administrative level was explained by county. Conclusions: Lower limb major amputations show marked regional variations on the different geographic levels of resolution. The more granular the assessment, the higher the regional variation was. Assumingly, this observation is partially a mathematical necessity but may also be related to the different characteristics of care at a given level of spatial aggregation. The decomposition of the variance of amputation rates indicates that the potential explanatory factors contributing to spatial variability are multiple and may be interpreted on different levels of geographic resolution. Addressing the unwarranted variations and resolving the issues that contribute to high lower limb major amputation rates needs further explorative analysis.
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Amputación Quirúrgica , Extremidad Inferior , Atención a la Salud , Humanos , Hungría/epidemiología , Incidencia , Extremidad Inferior/cirugíaRESUMEN
According to the nomenclature of the Chapel Hill Consensus Conference, giant-cell arteritis and Takayasu's arteritis belong to the group of large-vessel vasculitis. Recognition of these diseases is primarily based on the clinical assessment and the use of various vascular imaging modalities. With regard to the latter one, significant technological advances have been observed in recent years, which allow not only to make a diagnosis but also to evaluate the extent of the disease and the degree of vascular inflammation. In addition, subsequent complications of vascular inflammation can be examined. Ultrasound, computed tomography, magnetic resonance imaging, and positron-emission tomography represent imaging modalities that are essential for recognizing affected patients and planning effective treatment and follow-up. The review of this topic may be of interest to a number of medical specialties that are potentially involved in the care of these patients. Orv Hetil. 2020; 161(23): 939-950.
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Arteritis de Células Gigantes/diagnóstico por imagen , Arteritis de Takayasu/diagnóstico por imagen , Fluorodesoxiglucosa F18 , Humanos , Tomografía de Emisión de PositronesRESUMEN
Background: Symptomatic peripheral arterial disease (intermittent claudication) is a major cause of disability and mobility loss in older men and women and thus has a significant negative impact on the patients' quality of life. Both surgical and endovascular revascularization procedures and noninvasive medical therapies, such as supervised training and drug treatment, can improve walking capacity. Cilostazol is the only drug having a class I (level of evidence A) recommendation for the treatment of intermittent claudication (IC). The aim of this study was to evaluate the effect of three-month cilostazol treatment on the health-related quality of life and on the lower limb functional capacity in patients with IC in the clinical practice. Patients and methods: The study was a multicenter, non-interventional trial, performed in Hungary in 2018. 812 PAD patients (Fontaine II stage, mean age: 67.17 years, male/female: 58.25/41.75 %) were enrolled, who received cilostazol (50 or 100 mg b.i.d.) for 3 months. 802 patients completed the study. Quality of life was evaluated with the EQ-5D-3L questionnaire functional capacity with the WELCH (Walking Estimated-Limitation Calculated by History) questionnaire. Pain-free and maximal walking distance, ankle-brachial index (ABI) were measured at baseline and after 3-month treatment. Results: Upon conclusion of the study, the EQ-5D-3L index improved (baseline: -0.46 ± 0.22, 3rd month: -0.26 ± 0.18; p < 0.0001) and there was a significant increase in the WELCH score as well (19 ± 14, 31 ± 18; respectively, p < 0.0001). Both pain-free and maximal walking distance improved significantly by 54.52 % (median: 53.85 %) and 42.5 % (median: 34.68 %); respectively (p < 0.001). Adverse events occurred in 10 patients, 1 patient stopped cilostazol treatment because of side effects. Conclusions: Three months cilostazol treatment significantly improved quality of life and lower limb functional capacity in patients with intermittent claudication. The WELCH questionnaire is a useful tool for the evaluation of intermittent claudication treatment in the clinical practice.
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Calidad de Vida , Anciano , Cilostazol , Femenino , Humanos , Claudicación Intermitente , Extremidad Inferior , Masculino , Tetrazoles , CaminataRESUMEN
OBJECTIVE: The aim of this study was to assess the long term trends of lower limb amputation and revascularisation in Hungary over 14 years. METHODS: This was a retrospective cohort study that included all patients who underwent lower limb amputation or revascularisation over a 14 year period (2004-2017) in Hungary. Inpatient administrative data claims covering the entire beneficiary population were incorporated. Lower limb amputations (both minor and major) and revascularisation procedures (both open and endovascular) were identified in the claims files. Incidence rates were calculated and time trends were assessed via a generalised additive model. RESULTS: From 2004 to 2017, a total of 121 351 lower limb amputations (61 154 minor; 60 197 major) and 149 355 revascularisation procedures (89 243 open; 60 112 endovascular) were detected in 140 581 patients. The number of minor amputations decreased moderately in the last few years of the study period, while major amputations showed a slight decline (15%) beginning after 2013, which was more marked (22%) following adjustment for age. While the crude incidence of open vascular surgery procedures decreased by 31% (from 74.5/105 to 51.4/105), endovascular procedures showed growth by 79% (from 33.7/105 to 60.4/105) over the whole observation period. CONCLUSION: Observed amputation and revascularisation trends in Hungary are similar to the international experience. The major difference is a more than one decade lag in the starting point of the decline of amputations and in the move towards endovascular procedures. The number of amputations is more than twofold higher and the number of revascularisations is close to half that reported internationally. This comprehensive report of two vascular care performance indicators reveals an east/west vascular health divide in Europe and indicates the need to improve amputation prevention.
Asunto(s)
Amputación Quirúrgica/tendencias , Procedimientos Endovasculares/tendencias , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/cirugía , Pautas de la Práctica en Medicina/tendencias , Cirujanos/tendencias , Procedimientos Quirúrgicos Vasculares/tendencias , Anciano , Femenino , Humanos , Hungría/epidemiología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/epidemiología , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Although more and more data on lower limb amputations are becoming available by leveraging the widening access to health care administrative databases, the applicability of these data for public health decisions is still limited. Problems can be traced back to methodological issues, how data are generated and to conceptual issues, namely, how data are interpreted in a multidimensional environment. The present review summarised all of the steps from converting the claims data of administrative databases into the analytical data and reviewed the wide array of sources of potential biases in the analysis of such data. The origins of uncertainty of administrative data analysis include uncontrolled confounding due to a lack of clinical data, the left- and right-censored nature of data collection, the non-standardized diagnosis/procedure-based data extraction methods (i.e., numerator/denominator problems) and additional methodological problems associated with temporal and spatial analyses. The existence of these methodological challenges in the administrative data-based analysis should not deter the analysts from using these data as a powerful tool in the armamentarium of clinical research. However, it must be done with caution and a thorough understanding and respect of the methodological limitations. In addition to this requirement, there is a profound need for pursuing further research on methodology and widening the search for other indicators (structural, process or outcome) that allow a deeper insight how the quality of vascular care may be assessed. Effective research using administrative data is based on strong collaboration in three domains, namely expertise in claims data handling and processing, the clinical field, and statistical analysis. The final interpretations of results and the countermeasures on the level of vascular care ought to be grounded on the integrity of research, open discussions and institutionalized mechanisms of science arbitration and honest brokering.