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Background: Globally, diabetes mellitus (DM) and peripheral artery disease (PAD) have an increasing incidence and a high prevalence and are both associated with high morbidity and complication rates, e.g., as chronic non-healing peripheral ulcers. Impaired macro- and microcirculation and peripheral neuropathy lead to an increased risk of foot ulcers and infections. These complications are difficult to treat, have a high risk of becoming chronic and often lead to lower limb amputation. The aim of this planned study was to investigate the potential effects of acupuncture on improving microcirculation in patients with Diabetic Foot Syndrome (DFS) and PAD. Materials and methods: In 18 patients with chronic non-healing peripheral ulcers and diagnosed DM or PAD, data on 8 microcirculatory parameters were collected simultaneously on intact skin close to the wound margin. Microcirculation was assessed using an O2C device combining laser Doppler shift and white light spectroscopy (LEA Medizintechnik GmbH, Giessen, Germany). Unilateral and bilateral acupuncture was performed on the connecting line between acupuncture points Stomach 14 and Stomach 15. Results: After unilateral acupuncture (ipsilateral to the wound side), a statistically significant improvement in 7 out of 8 microcirculatory parameters was demonstrated compared to baseline measurements before acupuncture. After bilateral acupuncture, there was an additional improvement and statistical significance in all parameters in both DFS and PAD patients. Discussion: These results show an improvement in the microcirculation and peripheral blood flow at the edges of the wound. As impaired micro- and macrocirculation is considered to be a critical prognostic factor for the healing of a peripheral lesion, the intervention could have a positive impact on the healing of (chronic) peripheral wounds.
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Background: The femoropopliteal artery (FPA) plays a central role in diagnosing and treating peripheral arterial disease (PAD). FPA lesions are the most frequent cause of intermittent claudication, and no other artery of the lower extremities is recanalised more frequently. Generally, ultrasound is the primary imaging tool in PAD, particularly FPA. With the development of high-frame-rate ultrasound technology in addition to traditional ultrasound modes, vector flow imaging (VFI) has provided deeper haemodynamic insights when used in the carotid artery. Here, we report the use of VFI at the FPA level in routine PAD examinations. Patients and methods: In this single-centre prospective study, we evaluated consecutive patients with PAD using B-mode imaging, colour Doppler, pulsed wave Doppler (PW) and vector flow. Hemodynamic parameters at predefined locations at the carotid artery and FPA were compared. Results: Qualitatively adequate VFI at all sites was possible in 76% of the patients with PAD. With decreasing volume flow from the common carotid artery to the internal carotid artery and from the common femoral artery via the superficial femoral artery to the popliteal artery, the correlation between VFI- and PW-derived-volume flow was high at every site. Based on different techniques, the VFI-derived values were significantly lower than the PW-derived values. The mean wall shear stress was significantly lower at all femoropopliteal sites than at the carotid sites, whereas the oscillatory shear index at the femoral site was higher than that at the carotid sites rather than at the popliteal location. Conclusions: Our findings suggest that vector flow data acquisition in the FPA is feasible in most patients with PAD. Therefore, with knowledge of the method and its limitations, VFI provides haemodynamic information beyond traditional ultrasound techniques and is a promising new tool for flow analysis in PAD.
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Artéria Femoral , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Estudos Prospectivos , Ultrassonografia/métodos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Carótida Primitiva/diagnóstico por imagem , Velocidade do Fluxo SanguíneoRESUMO
BACKGROUND/AIM: Vascular age (VA) is an emerging metric in preventive cardiovascular (CV) medicine. VA can be derived from morphological parameters such as carotid intima-media thickness (CIMT), or functional parameters such as pulse wave analysis (PWA), which celebrates its 100th birthday. This study aimed to investigate whether the results of both approaches are comparable. PATIENTS AND METHODS: On the occasion of the double 100th anniversary of PWA and the Mannheim Clinic, 100 volunteers underwent a) bilateral CIMT assessment using high-resolution ultrasound and b) oscillometric PWA at the brachial forearm site. The respective VAs were calculated using previously published equations. RESULTS: Median age of the participants was 53.6 years (range=39.8-62.6 years), and 56% were female. Median CIMT was 632.5 µm (range=548.8-730.0 µm). Median PWA-derived VA was 55.3 years (36.5-70.5 years). Different values were obtained for CIMT-derived VA, depending on the reference cohort used as calculation basis, ranging from median 43.7 (26.2-59.5 years) to median 64.0 years (43.5-82.1 years). In 46% of the participants divergent VAs were found, that is, the calculated age was higher according to one method and lower according to the other. Correlation analysis revealed a strong dependence of VA (both PWA- and CIMT-derived) and chronological age, as well as an increase in CV risk factors and the detection of plaques with age. CONCLUSION: Different approaches for estimating VA are not comparable and often produce contradictory results. The current methods and their validity must be critically assessed if they are not standardized.
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Placa Aterosclerótica , Rigidez Vascular , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Masculino , Fatores de Risco , Espessura Intima-Media Carotídea , Artérias Carótidas , Ultrassonografia , Análise de Onda de PulsoRESUMO
Background: In peripheral arterial disease (PAD) the femoropopliteal (FP) artery is the most frequently recanalized lower limb artery. Stent-based interventions change the biomechanical properties of FP arteries. However, no clinical tool for functional imaging is established for quantitative measurements in vivo. Four-dimensional-flow magnetic resonance imaging enables a detailed evaluation of the hemodynamics of the central and - more challenging - the peripheral arteries. The present study aimed to determine the feasibility of assessing pulse wave velocities (PWV) as a marker of vessel stiffness in PAD patients with multiple spot stents and to compare the values with age-matched subjects and young-adult healthy subjects. Patients and methods: Contrast-free 4D-flow MRI was performed in seven PAD patients with focally stented FP arteries, five age-matched subjects after exclusion of PAD, and five young, healthy adults. PWV values were calculated from flow curves by using the foot-to-foot method. Results: Four-D-flow MRI sequences offering high spatial and temporal resolution enables quantification of flow velocity measurements and estimation of PWVs. Assessment of segmental PWV as a surrogate of vascular stiffness in focally stented femoral arteries is feasible. PWV values across all groups were 15.6±5.2 m/s, 13.3±4.1 m/s, and 9.9±2.2 m/s in PAD patients, senior-aged volunteers, and young-adult volunteers respectively. PWV values in PAD patients were similar with those in the senior-aged volunteers group (15.6±5.2 vs. 13.3 ±4.1 years, p=0.43). However, when compared to the young-adult volunteers, PAD patients had a statistically significantly higher mean local PWV (15.6±5.2 m/s vs. 9.9±2.2 m/s, p<0.05). Conclusions: Calculating segmental PWV in the femoral arteries is feasible in PAD patients with focally stented FP arteries. PWV values in PAD patients were similar to those in senior-aged volunteers, both of which were higher than in young-adult volunteers.
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Análise de Onda de Pulso , Rigidez Vascular , Adulto , Idoso , Velocidade do Fluxo Sanguíneo , Artéria Femoral/diagnóstico por imagem , Humanos , Imageamento por Ressonância Magnética , StentsRESUMO
The term 'aortitis' comprises a heterogeneous spectrum of diseases, with varied etiology and clinical presentations, whose common characteristic is the inflammation of the aortic wall. Since aortitis can mimic almost all common cardiovascular disorders, its clinical recognition remains a challenge. Some cases of aortitis remain undetected for a long time and may be diagnosed after severe life-threatening complications have already arisen. The diagnosis of aortitis is based on the presence of homogeneous circumferential thickening of the aortic wall detected on aortic imaging, or typical histological features in combination with clinical findings and laboratory parameters. Management of aortitis is usually conservative (immunosuppressive drugs in noninfectious aortitis; antimicrobial drugs in infectious). However, if vascular complications such as aortic aneurysm, rupture, or steno-occlusive events appear, aortic surgery or endovascular therapy may be required. This review article summarizes the current knowledge regarding the etiology, clinical presentation, diagnosis, and treatment of inflammatory diseases of the aorta to promote better clinical management of these entities.
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Aortite , Aorta , Aortite/diagnóstico , Aortite/epidemiologia , Aortite/etiologia , Humanos , ImunossupressoresRESUMO
Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.
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Angioplastia com Balão , Doença Arterial Periférica , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Artéria Femoral/diagnóstico por imagem , Alemanha , Humanos , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Estudos Prospectivos , Stents , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND/AIM: Restenosis and stent fractures are well-characterised treatment failures following femoropopliteal (FP) stent-based interventions. We aimed to determine patterns of restenosis and fracture rates following focal stenting of FP arteries. PATIENTS AND METHODS: This retrospective study investigated angiographic patterns of restenosis and the occurrence of stent fractures following focal FP stenting with the multiple stent delivery system VascuFlex® Multi-LOC. RESULTS: We identified 10 patients with 10 (of 129) FP lesions (mean length 11.7±4.6 cm) and a total of 51 (of 646) Multi-LOC stents that underwent clinically driven target lesion revascularizations (TLR) after 11.5±9.2 months, due to symptomatic recurrence of stenosis. None of the Multi-LOC stents had fractured. No isolated in-stent restenosis (>50%) was observed. Median diameter lumen loss was significantly more pronounced at the inter-stent segments (27.0%) compared to in-stent segments (7.8%, p=0.023). CONCLUSION: No evidence of fracture or susceptibility to stent-related restenosis using Multi-LOC stents was observed. Focal FP stenting may be more effective when combined with strategies known to reduce restenosis in non-stented artery segments.
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Constrição Patológica/terapia , Reestenose Coronária/terapia , Artéria Femoral/fisiopatologia , Artéria Poplítea/fisiopatologia , Stents/efeitos adversos , Procedimentos Cirúrgicos Vasculares/instrumentação , Idoso , Constrição Patológica/patologia , Reestenose Coronária/etiologia , Reestenose Coronária/patologia , Feminino , Artéria Femoral/cirurgia , Seguimentos , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Procedimentos Cirúrgicos Vasculares/métodosRESUMO
Background: With growing prevalence, end-stage renal disease (ESRD) as well as critical limb ischemia (CLI) are both conditions associated with high morbidity and mortality rates. Patients and methods: A retrospective single-centre study provided data of a German interdisciplinary vascular centre. Seventy-seven consecutive haemodialysis (HD) inpatients (median age, 73.6 years) with 91 threatened limbs with Wound, Ischemia, and foot Infection (WIfI) clinical stage 3 or 4 were evaluated for in-hospital treatment of peripheral arterial disease, limb salvage rates, major amputation (MA)-free and overall survival. Results: The 1-year MA-free limb salvage rate was 82 %. On multivariate analysis, a higher WIfI clinical stage (hazard ratio [HR], 7.54; p = 0.008) indicated a higher risk of MA, while at least one-vessel run-off to the foot after revascularization of any kind was associated with a lower risk of MA (HR, 0.17; p = 0.001). In the composite endpoint analysis, the 1-year MA-free overall survival rate was 65 %. Patients with limbs in WIfI clinical stage 4 versus stage 3 carried a more than two-fold increased hazard of death or MA (HR, 2.63; p = 0.028), while revascularization was associated with reduced risk (HR, 0.40; p = 0.021). One-year overall survival (78 %) was not associated with WIfI stage or revascularization but was worse in patients with previous symptomatic coronary artery disease (HR, 3.25; p = 0.039). During long-term follow-up over 12 years, MA-free survival probability was significantly lower in the WIfI stage 4 versus WIfI stage 3 group (HR, 1.58; p = 0.048) without significant differences in overall survival (HR, 1.10; p = 0.696). Conclusions: Lower-extremity CLI with tissue loss in HD patients is associated with high morbidity and mortality rates. WIfI clinical stage was predictive of 1-year MA-free survival, while revascularization significantly reduced MA risk but did not influence overall survival.
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Infecção dos Ferimentos , Idoso , Amputação Cirúrgica , Humanos , Isquemia , Estimativa de Kaplan-Meier , Salvamento de Membro , Valor Preditivo dos Testes , Diálise Renal , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , CicatrizaçãoRESUMO
BACKGROUND: AAA is a disease affecting predominantly male patients ≥65 years and its dreaded complications such as rupture led to population-based screening programs as preventive measure. Nonetheless, the supposed prevalence may have been overestimated, so that targeted screening of high risk populations may be more effective. This study was performed to evaluate the prevalence of abdominal aortic aneurysm (AAA) of an inpatient high-risk cohort and to estimate the co-prevalence of lower extremity arterial aneurysms. METHODS: Participants: 566 male inpatients, ≥ 65 years of age, hospitalized for suspected or known cardiopulmonary disease. Primary and secondary outcome measures: Maximal infrarenal aortic diameters using abdominal ultrasound (leading edge to leading edge method). Upon detection of an AAA (diameter ≥ 30 mm), the lower extremity arteries were examined with regard to associated aneurysms. RESULTS: In 40 of 566 patients (7.1%) AAAs were detectable. Fourteen patients (2.5%) had a first diagnosis of AAA, none of which was large (> 55 mm), the remaining 26 patients were either already diagnosed (14 patients, 2.5%) or previously repaired (12 patients, 2.1%). The three most common main diagnoses at discharge were acute coronary syndrome (43.3%), congestive heart failure (32.2%), and chronic obstructive pulmonary disease (12%). The cohort showed a distinct cardiovascular risk profile comprising arterial hypertension (82.9%), diabetes mellitus (44.4%), and a history of smoking (57.6%). In multivariate analysis, three-vessel coronary artery disease (Odds ratio (OR): 4.5, 95% confidence interval (CI): 2.3-8.9, p < 0.0001) and history of smoking (OR: 3.7, CI: 1.6-8.6, p < 0.01) were positively associated with AAA, while diabetes mellitus (OR: 0.5, CI: 0.2-0.9, p = 0.0295) showed a negative association with AAA. Among the subjects with AAA, we found two large iliac and two large popliteal aneurysms. CONCLUSION: Ultrasound screening in male inpatients, hospitalized for suspected or known cardiopulmonary disease, revealed a high AAA prevalence in comparison to the present epidemiological screening programs. There was a moderate proportion of newly-screen detected AAA and additional screening of the lower extremity arteries yielded some associated aneurysms with indication for possible intervention.
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Aneurisma da Aorta Abdominal/epidemiologia , Cardiopatias/epidemiologia , Aneurisma Ilíaco/epidemiologia , Extremidade Inferior/irrigação sanguínea , Pneumopatias/epidemiologia , Admissão do Paciente , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Alemanha/epidemiologia , Cardiopatias/diagnóstico , Humanos , Aneurisma Ilíaco/diagnóstico por imagem , Pneumopatias/diagnóstico , Masculino , Artéria Poplítea/diagnóstico por imagem , Prevalência , Medição de Risco , Fatores de Risco , UltrassonografiaRESUMO
Background: The study aimed to evaluate the outcomes of percutaneous transluminal angioplasty (PTA) in lower-extremity peripheral artery disease (PAD) patients. Patients and methods: A multi-centre, observational study was performed with 32 German and Austrian centres contributing data to the PTA registry. Data of 1,781 patients with lower-leg and pelvic PAD who were suitable for endovascular PTA treatment were contributed from participating centres. Data from 1,533 patients are reported here (1,055 male and 478 female). This study did not have exclusion criteria. Quality of life (QOL) questionnaire (EQ-5D) scores, Rutherford classification, mortality, patency rate and details of major adverse cardiovascular events were collected at 6-, 12-, 18-, and 24-month follow ups. Results: PTA with/without stenting achieved 90.3 %, 86.5 %, 82.7 %, and 71.9 % technical success (recanalisation achieving ≥ 70 % patency, no evidence of embolisation, recoiling or dissection) in iliac, femoral, popliteal, and below-the-knee arteries, respectively. Procedural/postprocedural complications occurred in 142 (9.3 %, 1 death) and 74 (4.8 %) patients. QOL, mobility, self-care, activity, and pain/discomfort scores improved (p < 0.01), anxiety/depression was insignificantly improved. During follow-up, 409 (26.7 %) patients were hospitalised for PAD, 281 (18.3 %) required reintervention, and 145 (9.5 %) died or needed amputation (n = 49; 3.2 %). Multivariate analysis demonstrated poorer outcomes in patients with comorbidities. Conclusions: PTA with/without stenting is effective, safe, and widely applicable, with few complications. It improves QOL, but not anxiety/depression.
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Angioplastia com Balão , Doença Arterial Periférica , Feminino , Artéria Femoral , Seguimentos , Humanos , Masculino , Artéria Poplítea , Estudos Prospectivos , Qualidade de Vida , Stents , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
AIMS: The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel stent delivery system with six short stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibility of the VascuFlex® "Multi-LOC" stent delivery system, which enables spot stenting without changing the delivery system. METHODS AND RESULTS: After proof of concept in a porcine model and after European Conformity marking, first clinical experiences were gathered in 20 patients with severe intermittent claudication or critical limb ischemia. First-in-human data are presented. The study included 20 limbs that underwent femoropopliteal revascularization for claudication (n = 14) or critical limb ischemia (n = 6). "Multi-LOC" provisional spot stenting resulted in acute technical success in all lesions with resolution of flow-limiting dissection and elastic recoil after balloon dilatation of the femoropopliteal artery. There were no device-related complications. Follow-up examinations after 30 to 40 days revealed no major adverse events, and six months' results were encouraging. CONCLUSIONS: First clinical use of the novel Multiple Stent Delivery System (Multi-LOC) after balloon dilatation of the femoropopliteal artery was safe and feasible in this early study.
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INTRODUCTION: The purpose of this observational study is to report the 12-month clinical outcomes with the novel Multiple Stent Delivery System (MSDS) to treat complex femoropopliteal lesions. Previously, we reported the 6-month clinical outcomes of the all-comers LOCOMOTIVE study, which demonstrated the safety and efficacy of the MSDS with a favorable target lesion revascularization (TLR) rate of 5.3% and a 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. METHODS: The LOCOMOTIVE study (Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implant multiple stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. RESULTS: At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (p < 0.001) and the mean Rutherford class improved from 3.5 to 1.9 (p < 0.001). CONCLUSIONS: Over a 12-month post-procedural period, MSDS for focal provisional stenting of complex femoropopliteal lesions demonstrated a promising primary patency and freedom from TLR after 12 months. In addition, significant improvements were observed in symptom classification and hemodynamics.
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Artéria Femoral/fisiopatologia , Doença Arterial Periférica/terapia , Artéria Poplítea/fisiopatologia , Stents , Idoso , Feminino , Artéria Femoral/diagnóstico por imagem , Seguimentos , Humanos , Masculino , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Sistema de Registros , Tempo , Resultado do Tratamento , Ultrassonografia , Grau de Desobstrução VascularRESUMO
Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The first clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.
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Angioplastia com Balão/instrumentação , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Dispositivos de Acesso Vascular , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Vigilância de Produtos Comercializados , Estudos Prospectivos , Desenho de Prótese , Falha de Prótese , Recidiva , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: A new stent system was studied in a porcine model to evaluate its feasibility for spot-stenting of the femoropopliteal artery. MATERIALS AND METHODS: In a preliminary study in a single pig, handling and mechanical features of the novel multiple stent delivery system were tested. The Multi-LOC system demonstrated great feasibility regarding its pushability, trackability, and crossability. Excellent visibility of the individual stents allowed exact anatomically controlled implantation. In our main study, four to five short Multi-LOC stents (13 mm long) were implanted into the femoropopliteal arteries of six domestic pigs and long (60 to 100 mm) self-expandable nitinol stents were implanted into the same target vessel contralaterally to allow for intraindividual comparison. After four weeks survival under dual antiplatelet treatment, control angiography was performed. The animals were euthanized, stented vessels were explanted, and histologic sections were examined for the presence of neointimal formation. RESULTS: Multi-LOC stents demonstrated no occlusion of the femoropopliteal axis (0 vs. 1 occlusion distal to a control stent), no stent fractures (0 out of 26 vs. 2 out of 6 control stents), and lower percentage diameter stenosis (0.564 ± 0.056 vs. 0.712 ± 0.089; p = 0.008) and length of stenosis (19.715 ± 5.225 vs. 39.397 ± 11.182; p = 0.007) compared to a standard control stent, which was similar in total length to the multiple stented artery segment. Histological examination confirmed myointimal hyperplasia underlying in-stent stenosis. CONCLUSIONS: The multiple stent delivery system was studied in a porcine model, which demonstrated its feasibility. Preclinical experience revealed favourable results concerning stent fracture, restenosis, and patency of spot-stented femoropopliteal arteries.
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Procedimentos Endovasculares/instrumentação , Artéria Femoral , Artéria Poplítea , Stents , Dispositivos de Acesso Vascular , Grau de Desobstrução Vascular , Angiografia , Animais , Arteriopatias Oclusivas/etiologia , Arteriopatias Oclusivas/fisiopatologia , Procedimentos Endovasculares/efeitos adversos , Estudos de Viabilidade , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/patologia , Artéria Femoral/fisiopatologia , Modelos Animais , Inibidores da Agregação Plaquetária/uso terapêutico , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/patologia , Artéria Poplítea/fisiopatologia , Estudo de Prova de Conceito , Desenho de Prótese , Falha de Prótese , Sus scrofa , Fatores de TempoRESUMO
PURPOSE: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). METHODS: In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. RESULTS: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. CONCLUSION: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.
Assuntos
Ligas , Angioplastia com Balão/instrumentação , Procedimentos Endovasculares/instrumentação , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Estado Terminal , Progressão da Doença , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Europa (Continente) , Feminino , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico , Isquemia/mortalidade , Isquemia/fisiopatologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Recidiva , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
Most patients with peripheral arterial disease suffer from arteriosclerosis, the prevalence of which increases with age. In some of these patients, however, the ischemic symptoms are not caused by stenotic arteriosclerosis, but by large vessel giant cell arteritis (LV-GCA), a disease also predominantly affecting patients of the older generation. Identifying large vessel vasculitis is a challenge for all physicians caring for patients with peripheral artery disease. The results of invasive treatment such as bypass surgery and angioplasty of inflammatory vascular lesions differ fundamentally from those of patients with atherosclerosis. Duplex ultrasound is a widely available diagnostic method for examining patients with lower limb claudication and pathological ankle-/toe- brachial index or pulse volume recording with or without exercise. Knowledge of characteristic sonographic findings suspicious about large vessel vasculitis is essential for a differential diagnosis of vasculitis versus atherosclerosis. In addition to clinical and laboratory findings, further imaging techniques, e.g. contrast-enhanced computed tomography, magnetic resonance imaging or a combination of positron emission tomography and computed tomography (PET-CT) can provide information on further vessel involvement and inflammatory activity. The present study focuses on diagnostic imaging of LV-GCA in patients presenting with claudication, illustrated by a series of cases.
Assuntos
Diagnóstico por Imagem , Arterite de Células Gigantes/diagnóstico , Claudicação Intermitente/diagnóstico , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico , Vasculite/diagnóstico , Algoritmos , Procedimentos Clínicos , Diagnóstico Diferencial , Diagnóstico por Imagem/métodos , Arterite de Células Gigantes/complicações , Arterite de Células Gigantes/terapia , Humanos , Claudicação Intermitente/etiologia , Claudicação Intermitente/terapia , Imagem Multimodal , Doença Arterial Periférica/complicações , Doença Arterial Periférica/terapia , Valor Preditivo dos Testes , Prognóstico , Vasculite/complicações , Vasculite/terapia , Fluxo de TrabalhoRESUMO
BACKGROUND: Patients with neuroischemic diabetic foot syndrome (DFS) may need arterial revascularization, minor amputations, débridements as well as meticulous wound care. Unfortunately, postoperative outpatient care is frequently inadequate. This is especially true for Germany, where the in- and outpatient sectors are funded and managed separately, with poor communication between the two. Thus, many patients may be readmitted to the hospital following successful treatment and discharge. In an attempt to overcome these problems, we looked at whether an integrated case management (CM) system for outpatient care according to in-hospital standards might improve patients care and avoid readmissions. In addition we analyzed the length of hospital stay (LOS) as well as hospital costs. PATIENTS AND METHODS: In this retrospective cohort study patients with DFS, bypass surgery and foot surgery after implementation of the CM (study group; n = 376) were compared with a matched historic control group (HCG; n = 190) including the flat rate revenues (G-DRG K01B). Following a standardized assessment, integrated trans-sectoral CM care was offered to 116 patients (CMP). RESULTS: The proportion of patients who were readmitted to hospital was reduced in CMP compared to HCG (8.8 vs. 16.4 %; p < 0.01), with consequent reduction of case consolidations (9.7 % versus 17.8 %, p < 0.001). Although initially, the mean LOS was higher in the CMP patients, the reduction in readmissions meant that this integrated CM program improved the hospital's economic situation. CONCLUSIONS: A hospital-based integrated CM system significantly reduces the hospital readmissions in patients with neuroischemic DFS following bypass surgery, with lower hospital costs.
Assuntos
Assistência Ambulatorial/organização & administração , Administração de Caso/organização & administração , Prestação Integrada de Cuidados de Saúde/organização & administração , Diabetes Mellitus/terapia , Pé Diabético/cirurgia , Readmissão do Paciente , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/economia , Administração de Caso/economia , Distribuição de Qui-Quadrado , Redução de Custos , Análise Custo-Benefício , Prestação Integrada de Cuidados de Saúde/economia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/economia , Pé Diabético/diagnóstico , Pé Diabético/economia , Feminino , Alemanha , Custos Hospitalares , Humanos , Tempo de Internação , Masculino , Modelos Organizacionais , Readmissão do Paciente/economia , Estudos Retrospectivos , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/economiaAssuntos
Cardiologia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/cirurgia , Educação Médica Continuada , Sociedades Médicas , Especialidades Cirúrgicas , Procedimentos Cirúrgicos Vasculares , Cardiologia/educação , Cardiologia/normas , Cardiologia/tendências , Competência Clínica , Comorbidade , Educação Médica Continuada/normas , Educação Médica Continuada/tendências , Procedimentos Endovasculares/educação , Procedimentos Endovasculares/normas , Procedimentos Endovasculares/tendências , Alemanha/epidemiologia , Humanos , Comunicação Interdisciplinar , Sociedades Médicas/tendências , Especialidades Cirúrgicas/educação , Especialidades Cirúrgicas/normas , Especialidades Cirúrgicas/tendências , Padrão de Cuidado/normas , Padrão de Cuidado/tendências , Terminologia como Assunto , Procedimentos Cirúrgicos Vasculares/educação , Procedimentos Cirúrgicos Vasculares/normas , Procedimentos Cirúrgicos Vasculares/tendênciasRESUMO
BACKGROUND: Recommendations of clinical guidelines for the treatment of critical limb ischemia (CLI) are based on randomized controlled trials. Recent data from clinical practice are however lacking. Therefore a prospective observational study in patients with critical limb ischemia (CLI) in 3 hospitals with a specialized vascular medicine department was conducted to document the clinical course and outcome of patients with critical limb ischemia (CLI) in clinical practice. METHODS: 155 patients were stratified: 56 received endovascular intervention, 82 prostanoids and 17 antibiotic treatment. Patients with surgical revascularisation and primary amputation were excluded. All patients received structured wound treatment, analgesia and vascular risk factor treatment during hospital stay. RESULTS: Age 72.0+/-12.7 years, hospitalisation 23.2+/-20.3 days. 56.1% had Diabetes, 9.7% multiresistant staphylococcus aureus infection. 40% patients had rest pain, 60% ischemic tissue loss. At discharge 40.0% had no ulcers, 48.4% ongoing trophic alterations, 10.3% received major amputation and 4.5% had stable necrosis. After 18 month rate of major amputation was 6.3% (prostanoids), 14.5% (endovascular treatment; p=n.s. vs. prostanoids) and 26.7% (antibiotics; p=0.0323 vs. prostanoids). Major amputations were not different in logistic regression analyses adjusting for baseline characteristics. Wound healing and mortality rate was not different between groups (26.8, 25.0 and 23.5%). CONCLUSION: Structured therapy at specialized vascular centres in combination with interventional or conservative treatment is beneficial in patients with critical limb ischemia. Survival without amputation is higher than expected over 18 months.