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1.
Medicine (Baltimore) ; 99(12): e19502, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32195951

RESUMO

BACKGROUND: Diabetic foot (DF) problems are common throughout the world, about one-fourth of them develop a foot ulcer and serious cases would suffer from amputation, which seriously affects the patient's work and life. Previous studies indicated that acupuncture as adjuvant therapy would be effective in treating DF. However, these studies have no consistent results. Therefore, the aim of our study was to explore the efficacy and safety of acupuncture as adjuvant therapy for DF. METHODS: The randomized controlled trials associated with acupuncture therapy (or as adjuvant therapy) for DF will be included. We will search 6 electronic databases relevant to health sciences, including PubMed, Embase, the Cochrane Library, the Chinese databases Sino-Med, CNKI, and WANFANG database. All searches were from databases inception to March 30, 2019. The primary outcomes are the total curative effective rate, and the hemodynamic parameter and adverse events will be deemed as secondary outcomes. The Stata15.1 software and Review Manager (RevMan 5.3; Cochrane Collaboration, Copenhagen, Denmark) will be used for analysis, to assess the bias risk, subgroup analysis, and data synthesis. RESULTS: In this systematic review and meta-analysis, we will synthesize the studies to assess the safety and efficacy of acupuncture as adjuvant therapy for DF. CONCLUSION: The summary of our study will clarify whether acupuncture as adjuvant therapy could be an efficient method for DF.


Assuntos
Terapia por Acupuntura/métodos , Pé Diabético/complicações , Pé Diabético/terapia , Úlcera do Pé/complicações , Amputação , Complicações do Diabetes/patologia , Diabetes Mellitus/epidemiologia , Pé Diabético/epidemiologia , Feminino , Humanos , Masculino , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
2.
Acta Chir Orthop Traumatol Cech ; 87(1): 52-57, 2020.
Artigo em Tcheco | MEDLINE | ID: mdl-32131972

RESUMO

Hemicorporectomy or translumbar amputation is an extensive surgical procedure consisting in removing the lower portion of the body. Thakur et al. found a total of 71 hemicorporectomies described in literature before 2017. In the form of a case study we present the case of our patient with terminal pelvic osteomyelitis, in whom hemicorporectomy was subsequently performed, namely from the spine surgery perspective. The man, 19 years old, was exposed to high-voltage electricity and fell down from a height of 4 meters. He suffered an instable comminuted fracture of T10 (AO A3.3.) with paraplegia (Frankel A) and multiple third-degree burns affecting 25% of his total body surface area. Subsequently, the patient underwent a total of 16 surgical procedures performed by medical experts in various specialties (orthopaedic surgery, general surgery, plastic surgery, urology, vascular surgery), but in spite of that the extensive pelvic osteomyelitis has not been successfully managed. At first, urine and stool diversion were performed. After 3 weeks, i.e. 18 months after the injury, the removal of the lower portion of the body was scheduled. The hemicorporectomy was divided into 4 stages. The surgery started by posterior transecting the spine at L4-L5 segment with nerve root and dural sac ligation and treating the bleeding venous plexus in the spinal canal. After turning the patient to the supine position, the second stage of the operation followed, consisting in transecting large vessels and harvesting a musculocutaneous flap from the right thigh. During the third stage of the surgery the separation of the L4-L5 motion segment was completed by the transaction of the anterior longitudinal ligament and m. psoas major, subsequently followed by the amputation of the lower portion of the body. During the last stage of the surgery, the wound was closed by musculocutaneous flap from the fight thigh with preserved a. femoralis. The patient was discharged to home in a generally good condition 127 days after the amputation of the lower portion of the body. Now, 1 year after the surgery, the patient enjoys good physical as well as mental health. Hemicorporectomy is an extensive surgical technique, which can despite multiple complications be offered to patients with otherwise unmanageable condition. Terminal pelvic osteomyelitis is currently the most frequent diagnostic indication and the resulting condition makes possible a long-term survival of the patient in a satisfactory condition. The spinal surgeon is an irreplaceable member of the multidisciplinary team performing the surgical procedure, the primary treatment of the spinal column considerably limits blood losses. Key words: hemicorporectomy, en bloc sacrectomy, terminal pelvic osteomyelitis, sacral tumors.


Assuntos
Procedimentos Ortopédicos , Osteomielite , Procedimentos Cirúrgicos Reconstrutivos , Adulto , Amputação , Humanos , Masculino , Osteomielite/cirurgia , Pelve , Fraturas da Coluna Vertebral/complicações , Adulto Jovem
3.
Medicine (Baltimore) ; 99(11): e19489, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32176087

RESUMO

RATIONALE: Fibrous hamartoma of infancy (FHI) is a rare benign soft-tissue tumor in children with a triphasic organoid histologic appearance. PATIENT CONCERNS: We here report a case with the largest FHI published so far. A 13-month-old boy with a rapidly growing tumor 45 cm in length and 69.3 cm in circumference of the left lower extremity was identified immediately at birth. DIAGNOSES: The diagnosis was uncertain before the operation, although biopsy was conducted. The postoperation histological examination showed arranged spindle cells, adipose tissue, and nests of immature small cells embedded in a myxoid background, which is the characteristic triphasic histology of FHI. INTERVENTIONS: Under general anesthesia, hip and lower extremity amputation was performed. OUTCOMES: The patient was followed-up for 6 years and no signs of recurrence were found, suggesting a favorable prognosis, although a part of the residual tumor was present after the surgery. LESSONS: FHI exhibits pathological and clinical characteristics. However, differential diagnosis of FHI from other soft-tissue tumors before operation remains a challenge. Thus, sometimes, aggressive therapy for the treatment of FHI might be a good choice to get a satisfactory.


Assuntos
Hamartoma/diagnóstico por imagem , Perna (Membro) , Neoplasias de Tecidos Moles/diagnóstico por imagem , Tecido Adiposo/patologia , Amputação , Angiografia por Tomografia Computadorizada , Diagnóstico Diferencial , Hamartoma/patologia , Hamartoma/cirurgia , Humanos , Lactente , Imagem por Ressonância Magnética , Masculino , Neoplasias de Tecidos Moles/patologia , Neoplasias de Tecidos Moles/cirurgia
4.
Rev Med Suisse ; 16(682): 366-369, 2020 Feb 19.
Artigo em Francês | MEDLINE | ID: mdl-32073772

RESUMO

In 2010 the canton of Vaud has innovated by launching the Cantonal Diabetes Program (PcD) aimed at reducing the impact of diabetes on the population. The evaluation after 7 years shows that some clinical examinations are performed more regularly and lower limb amputations tend to decrease. The contributions and interprofessional collaborations resulting from the PcD provide concrete guidelines for the implementation of a more comprehensive strategy of prevention and management of non-communicable diseases. It should be developed according to a chronicity model integrating social vulnerability.


Assuntos
Diabetes Mellitus/prevenção & controle , Diabetes Mellitus/terapia , Doenças não Transmissíveis/prevenção & controle , Doenças não Transmissíveis/terapia , Saúde Pública/educação , Amputação/estatística & dados numéricos , Diabetes Mellitus/epidemiologia , Humanos , Doenças não Transmissíveis/epidemiologia , Suíça/epidemiologia
5.
Bone Joint J ; 102-B(2): 162-169, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32009427

RESUMO

AIMS: Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees. METHODS: A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed. RESULTS: There were 22 periprosthetic fractures; they occurred exclusively in the femur: two in the femoral neck, 14 intertrochanteric and six subtrochanteric, representing 4.2% of 518 osseointegration operations and 6.3% of 347 femoral implants. The vast majority (19/22, 86.4%) occurred within 2 cm of the proximal tip of the implant and after a fall. No fractures occurred spontaneously. Fixation most commonly involved dynamic hip screws (10) and reconstruction plates (9). No osseointegration implants required removal, the K-level was not reduced after fixation of the fracture in any patient, and all retained a K-level of ≥ 2. All fractures united, 21 out of 22 patients (95.5%) wear their osseointegration-mounted prosthetic limb longer daily than when using a socket, with 18 out of 22 (81.8%) reporting using it for ≥ 16 hours daily. Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046). No increased risk was identified for bilateral implants (p = 0.083), time from amputation to osseointegration (p = 0.974), age at osseointegration (p = 0.331), or bone density (g/cm2, p = 0.560; T-score, p = 0.247; Z-score, p = 0.312). CONCLUSION: The risks and sequelae of periprosthetic fracture after press-fit osseointegration for amputation should not deter patients or clinicians from considering this procedure. Females and heavier patients are likely to have an increased risk of fracture. Age, years since amputation, and bone density do not appear influential. Cite this article: Bone Joint J 2020;102-B(2):162-169.


Assuntos
Amputação , Fraturas do Fêmur/cirurgia , Osseointegração , Fraturas Periprotéticas/cirurgia , Implantação de Prótese/efeitos adversos , Procedimentos Cirúrgicos Reconstrutivos/efeitos adversos , Amputação/reabilitação , Feminino , Fraturas do Fêmur/etiologia , Fêmur/lesões , Fêmur/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Fraturas Periprotéticas/etiologia , Falha de Prótese , Estudos Retrospectivos , Fatores de Risco
6.
Zhonghua Shao Shang Za Zhi ; 36(1): 9-13, 2020 Jan 20.
Artigo em Chinês | MEDLINE | ID: mdl-32023712

RESUMO

Cold injury is very damaging. This article summarizes the mechanism, types, and rehabilitation of cold injury, focusing on the degree and clinical treatment of frostbite. Frostbite can mainly cause damage of microcirculation and capillary structure, while burn injury can mainly cause damage of cutaneous tissues. Based on this, the key point of management of frostbite is to improve microcirculation and appropriate rewarming, while that of burn injury is wound repair. Up to date, the rate of amputation caused by frostbite is still high, and the rehabilitation for sequela caused by frostbite remains a big challenge in modern medicine. It is worth paying more attention to.


Assuntos
Queimaduras , Congelamento das Extremidades , Amputação , Humanos , Microcirculação , Reaquecimento
7.
Zhonghua Shao Shang Za Zhi ; 36(1): 64-66, 2020 Jan 20.
Artigo em Chinês | MEDLINE | ID: mdl-32023721

RESUMO

On 18th October 2018, a 49 years old man with right thigh proximal medial swelling and pain was received in the Department of Pathology, People's Hospital of Deyang of Sichuan Province. The patient had experienced amputation twice because of burn in right lower limb 46 years ago. Cicatricial squamous cell carcinoma metastasis in right thigh proximal medial was diagnosed by fine needle aspiration cytology in our hospital. The wound remained ulcered and unhealed after biopsy in a higher level hospital. The patient died in ten days after first chemotherapy which was required by the patient. This case suggests that clinician should perform pathological examination on burn patients with scar ulcer as soon as possible to avoid delay in treatment, which may cause carcinogenesis deterioration and metastasis.


Assuntos
Carcinoma de Células Escamosas , Cicatriz , Neoplasias Cutâneas , Amputação , Humanos , Masculino , Pessoa de Meia-Idade , Coxa da Perna
8.
Vasc Health Risk Manag ; 16: 57-66, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32103970

RESUMO

Background: High-risk patients with advanced peripheral artery disease (PAD), including critical limb ischemia (CLI), are often excluded from peripheral endovascular device intervention clinical trials, leading to difficulty in translating trial results into real-world practice. There is a need for prospectively assessed studies to evaluate peripheral endovascular device intervention outcomes in CLI patients. Methods: LIBERTY 360 is a prospective, observational, multi-center study designed to evaluate the procedural and long-term clinical outcomes of peripheral endovascular device intervention in real-world patients with symptomatic lower-extremity PAD. One thousand two hundred and four patients were enrolled and stratified based on Rutherford Classification (RC): RC2-3 (N=501), RC4-5 (N=603), and RC6 (N=100). For this sub-analysis, RC5 and RC6 patients (RC5-6; N=404) were pooled and 1-year outcomes were assessed. Results: Procedural complications rarely (1.7%) resulted in post-procedural hospitalization and 89.1% of RC5-6 patients were discharged to home. Considering the advanced disease state in RC5-6 patients, there was a high freedom from 1-year major adverse event rate of 65.5% (defined as target vessel revascularization, death to 30 days, and major target limb amputation). At 1 year, freedom from major amputation was 89.6%. Wounds identified at baseline on the target limb had completely healed in 172/243 (70.8%) of the RC5-6 subjects by 1 year. Additionally, the overall quality of life, as measured by VascuQoL, improved from baseline to 1 year. Conclusion: LIBERTY investigated real-world PAD patients with independent oversight of outcomes. This analysis of LIBERTY RC5-6 patients demonstrates that peripheral endovascular device intervention can be successful in CLI patients, with low rates of major amputation and improvement in wound healing and quality of life through 1-year follow-up.LIBERTY 360, https://clinicaltrials.gov/ct2/show/NCT01855412, ClinicalTrials.gov Identifier: NCT01855412.


Assuntos
Procedimentos Endovasculares/instrumentação , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Amputação , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Isquemia/diagnóstico , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Intervalo Livre de Progressão , Estudos Prospectivos , Recuperação de Função Fisiológica , Fatores de Tempo , Estados Unidos , Cicatrização
10.
Crit Care ; 24(1): 68, 2020 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-32102696

RESUMO

BACKGROUND: Pneumococcal infections remain the main cause of overwhelming post-splenectomy infections, and purpura fulminans may develop in almost 20% of patients with overwhelming post-splenectomy infection. We aimed at describing the impact of asplenia/hyposplenia on the clinical features and the outcomes of adult patients admitted to the intensive care unit (ICU) for pneumococcal purpura fulminans. METHODS: A 17-year national multicenter retrospective cohort study included adult patients admitted to 55 French ICUs for an infectious purpura fulminans from 2000 to 2016. Patients with pneumococcal purpura fulminans were analyzed according to the absence or presence of asplenia/hyposplenia. RESULTS: Among the 306 patients admitted to the ICU for purpura fulminans, 67 (22%) had a pneumococcal purpura fulminans, of whom 34 (51%) had asplenia (n = 29/34, 85%) or hyposplenia (n = 5/34, 15%) and 33 (49%) had eusplenia. The prevalence of pneumococcal purpura fulminans was seven times higher in asplenic/hyposplenic patients compared to eusplenic patients with purpura fulminans (n = 34/39, 87% vs. n = 33/267, 12%; p < 0.001). The median time interval between the occurrence of asplenia/hyposplenia and ICU admission was 20 [9-32] years. Pneumococcal vaccine coverage was 35% in asplenic/hyposplenic patients. Purpura was more frequently reported before ICU admission in asplenic/hyposplenic patients (n = 25/34, 73% vs. n = 13/33, 39%; p = 0.01). The rate of bacteremia did not differ between asplenic/hyposplenic and eusplenic patients (n = 31/34, 91% vs n = 27/33, 82%; p = 0.261). SAPS II (60 ± 14 vs. 60 ± 18; p = 0.244) and SOFA (13 [1-5] vs. 14 [1-4, 6]; p = 0.48) scores did not differ between asplenic/hyposplenic and eusplenic patients. There were no significant differences between asplenic/hyposplenic and eusplenic patients regarding the rate of limb amputation (n = 9/34, 26% vs. 15/33, 45%; p = 0.11) and hospital mortality (n = 20/34, 59% vs. n = 15/33, 45%; p = 0.27). CONCLUSIONS: Half of pneumococcal purpura fulminans episodes occurred in asplenic or hyposplenic patients. Pneumococcal vaccine coverage was reported in one third of asplenic/hyposplenic patients. Half of pneumococcal purpura fulminans episodes occurred more than 20 years after splenectomy. Outcomes of pneumococcal purpura fulminans did not show significant differences between patients with or without asplenia or hyposplenia, although the small number of patients included limited our power to detect potential differences between groups.


Assuntos
Infecções Pneumocócicas , Púrpura Fulminante , Esplenectomia , Adulto , Idoso , Amputação , Bacteriemia , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Admissão do Paciente , Infecções Pneumocócicas/etiologia , Púrpura Fulminante/etiologia , Estudos Retrospectivos , Esplenectomia/efeitos adversos , Streptococcus pneumoniae
11.
Bone Joint J ; 102-B(1): 55-63, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31888375

RESUMO

AIMS: The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. METHODS: In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years' follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. RESULTS: The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. CONCLUSION: Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required. Cite this article: Bone Joint J 2020;102-B(1):55-63.


Assuntos
Amputação/métodos , Prótese Ancorada no Osso , Fêmur/cirurgia , Adolescente , Adulto , Idoso , Amputação/instrumentação , Amputados/psicologia , Membros Artificiais , Feminino , Neoplasias Femorais/cirurgia , Fêmur/lesões , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Osseointegração/fisiologia , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Falha de Prótese , Adulto Jovem
12.
J Surg Oncol ; 121(4): 612-619, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31919856

RESUMO

BACKGROUND AND OBJECTIVES: We aimed to identify the overall survival (OS), surgical complications, survival of reconstruction, and functional outcome of patients who underwent extra-articular resection of the shoulder joint for primary bone sarcomas. The OS and local recurrence rates in patients who underwent an amputation were also evaluated for comparison. METHODS: Thirty-two patients treated between 1988 and 2017 were studied. The tumours were located in the humerus in 22 (69%) and scapula in 10 patients (31%). The resection types were Malawer type IV in 6 (19%), type V in 21 (66%), and type VI in 5 patients (15%). Reconstruction was performed with endoprosthesis in 23 patients (72%) while excision arthroplasty with the suspension of the humerus to the clavicle was performed in 9 patients (28%). Surgical margins were wide in 16, marginal in 8, intralesional in 3, and not available in 5 patients. During the study period, 40 patients underwent a forequarter amputation and 11 patients underwent a shoulder disarticulation. RESULTS: The 5-year OS for patients who underwent extra-articular resection of the shoulder joint was 42% which was not statistically different compared with that of patients who underwent amputation (5-year OS = 30%; P = .091). The 5-year survival of the reconstruction was 94%, similar for endoprosthesis and excision arthroplasty. Local recurrence and complications developed in 6 (19%) and 10 patients (31%), respectively. Failures of the reconstruction requiring revision surgery occurred in two patients (6%). Limb salvage was achieved in 30 patients (94%). The median Musculoskeletal Tumour Society functional score was 61% (interquartile range, 57%-70%) and was similar in the endoprosthesis and excision arthroplasty group. CONCLUSIONS: Extra-articular resection of the shoulder joint for bone sarcomas is an effective limb-salvage method. However, local recurrence remains a principal concern.


Assuntos
Neoplasias Ósseas/cirurgia , Salvamento de Membro/métodos , Osteossarcoma/cirurgia , Articulação do Ombro/cirurgia , Adolescente , Adulto , Amputação/efeitos adversos , Amputação/métodos , Amputação/mortalidade , Neoplasias Ósseas/mortalidade , Neoplasias Ósseas/patologia , Desarticulação/efeitos adversos , Desarticulação/métodos , Desarticulação/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Salvamento de Membro/efeitos adversos , Salvamento de Membro/mortalidade , Masculino , Pessoa de Meia-Idade , Osteossarcoma/mortalidade , Osteossarcoma/patologia , Próteses e Implantes , Procedimentos Cirúrgicos Reconstrutivos/efeitos adversos , Procedimentos Cirúrgicos Reconstrutivos/métodos , Procedimentos Cirúrgicos Reconstrutivos/mortalidade , Estudos Retrospectivos , Articulação do Ombro/patologia , Adulto Jovem
14.
BMC Infect Dis ; 20(1): 23, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31914940

RESUMO

BACKGROUND: The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. METHODS/DESIGN: This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years. DISCUSSION: VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. TRIAL REGISTRATION: Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529.


Assuntos
Amputação , Pé Diabético/tratamento farmacológico , Osteomielite/tratamento farmacológico , Rifampina/uso terapêutico , Veteranos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação/estatística & dados numéricos , Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Pé Diabético/complicações , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Método Duplo-Cego , Feminino , Pé/microbiologia , Pé/patologia , Pé/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Osteomielite/complicações , Osteomielite/epidemiologia , Osteomielite/cirurgia , Placebos , Estudos Prospectivos , Prevenção Secundária/métodos , Veteranos/estatística & dados numéricos , Adulto Jovem
15.
Vasa ; 49(2): 87-97, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31638459

RESUMO

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.


Assuntos
Amputação , Assistência à Saúde , Bases de Dados Factuais
16.
Angiology ; 71(3): 226-234, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31769315

RESUMO

For many years, the only pharmacological option for patients with critical limb ischemia (CLI) unsuitable for revascularization has been prostanoids; however, some recent guidelines have become very restrictive regarding their use. We review the available evidence on the use of prostanoids and analyze the guideline positions as well as the possible reasons for changes over time. In most placebo-controlled trials and meta-analyses, prostanoids showed a significant effect in improving rest pain, promoting ulcer healing and reducing major amputations. Results for iloprost were especially consistent. Different prostanoid drugs have different evidence of efficacy, thus using a generic term "prostanoids" is misleading. Unfortunately, the available evidence is often of low quality and probably not sufficient to support an extensive use of prostanoids in all patients, and further high-quality randomized trials are needed. Consequently, some recent guidelines do not recommend treatment with prostanoids in this setting. However, in our opinion, pending definitive evidence, patients with CLI who have a viable limb in whom revascularization is unfeasible or has a poor chance of success, without alternative to amputation, may benefit from treatment with iloprost, balancing harms and benefits in each case.


Assuntos
Iloprosta/farmacologia , Isquemia/tratamento farmacológico , Dor/tratamento farmacológico , Prostaglandinas/farmacologia , Alprostadil/uso terapêutico , Amputação/métodos , Humanos , Resultado do Tratamento , Vasodilatadores/uso terapêutico
17.
J Trauma Acute Care Surg ; 88(2): 197-206, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31804418

RESUMO

BACKGROUND: Traumatic popliteal arterial injury (TPAI) is associated with a risk of both limb loss and long-term morbidity due to prolonged ischemia and the often-associated musculoskeletal injuries. Long-term functional outcome following this injury has not been adequately studied. We evaluated patients with TPAI to determine if there was an improvement in functional outcome over time. We hypothesized that both the initial severity of ischemia and the associated injuries limited the ability of patients to improve functional outcome. METHODS: Patients with TPAI for 20 years were identified. All patients had at least a 2-year follow-up. Functional outcomes were measured using the Boston University Activity Measure for Post-Acute Care to assess basic mobility (BM) and daily activity (DA). Multiple linear regression, adjusted for age, severity of injury and shock, operative complexity, associated injuries, ischemic time, and length of follow-up were used to identify predictors of functional outcome after TPAI. RESULTS: A total of 214 patients were identified: 123 penetrating (57%) and 91 blunt (43%). Overall mortality was 1.9% (all in-hospital), and amputation occurred in 10%. Of the 210 survivors, follow-up was obtained in 145 patients (69%). Median follow-up was 9.2 years (interquartile range, 5.7-15.7 years). Mean Activity Measure for Post-Acute Care scores for BM and DA were 78 and 75, respectively, both signifying mild impairment (normal, >84). Multiple linear regression failed to identify increasing length of follow-up as a predictor of improved functional outcomes. Only age, lower extremity fracture, and ischemic time were identified as predictors of decreased BM and DA. CONCLUSION: Increasing age, lower extremity fracture, and prolonged ischemic time worsened long-term functional outcomes. Functional outcome did not improve over time, suggesting that maximal recovery may be achieved within the first 2 years postinjury. Thus, early and effective revascularization remains the only potentially modifiable risk factor for improving functional outcomes following TPAI. LEVEL OF EVIDENCE: Prognostic, level III.


Assuntos
Amputação/estatística & dados numéricos , Procedimentos Endovasculares , Isquemia/cirurgia , Traumatismos da Perna/cirurgia , Extremidade Inferior/irrigação sanguínea , Atividades Cotidianas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Isquemia/etiologia , Isquemia/mortalidade , Traumatismos da Perna/complicações , Traumatismos da Perna/mortalidade , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/lesões , Artéria Poplítea/cirurgia , Prognóstico , Sobreviventes/estatística & dados numéricos , Resultado do Tratamento , Adulto Jovem
18.
Vasa ; 49(2): 121-127, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31808379

RESUMO

Background: Patients with chronic critical limb-threatening ischemia (CLTI) are at high risk of amputation and death. Despite the general recommendation for revascularization in CTLI in the guidelines, the underlying evidence for such a recommendation is limited. The aim of our study was to assess the outcome of patients with CLTI depending on the use of revascularization in a retrospective real-world cohort. Patients and methods: Administrative data of the largest German Health insurance (BARMER GEK) were provided for all patients that were hospitalized for the treatment of CLTI Rutherford category (RF) 5 and 6 between 2009 and 2011. Patients were followed-up until December 31st, 2012 for limb amputation and death in relation to whether patients did (Rx +) or did not have (Rx -) revascularization during index-hospitalization. Results: We identified 15,314 patients with CLTI at RF5 (n = 6,908 (45.1%)) and RF6 (n = 8,406 (54.9%)), thereof 7,651 (50.0%) underwent revascularization (Rx +) and 7,663 (50.0%) were treated conservatively (Rx -). During follow-up (mean 647 days; 95% CI 640-654 days) limb amputation (46.5% Rx- vs. 40.6% Rx+, P < 0.001) and overall mortality (48.2% Rx- vs. 42.6% Rx+, P < 0.001) were significantly lower in the subgroup Rx+. Conclusions: In a real-world setting, only half of CLTI were revascularized during the in-hospital treatment. Though, revascularization was associated with significantly better observed short- and long-term outcome. These data do not allow causal conclusion due to lack of data on the underlying reason for applied or withheld revascularization and therefore may involve a relevant selection bias.


Assuntos
Procedimentos Endovasculares , Isquemia , Amputação , Humanos , Salvamento de Membro , Doença Arterial Periférica , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
Vasa ; 49(1): 63-71, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31483747

RESUMO

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.


Assuntos
Infecção dos Ferimentos , Idoso , Amputação , 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 , Cicatrização
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