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Risk factors associated with amputation-free survival in patient with diabetic foot ulcers.
Won SH, Chung CY, Park MS, Lee T, Sung KH, Lee SY, Kim TG, Lee KM. Yonsei Med J. 2014 Sep 1;55(5):1373-8.
To determine the 1-year survival rate, 1-year amputation-free survival rate and the risk factors of amputation for patients with diabetic foot ulcers.
MATERIALS AND METHODS:
One hundred seventy-three patients with diabetic foot ulcers were included in our study. Mean patient age was 67.5 (range, 29 to 87, SD ±11.4) years. 74% of the patients were male. Time from study entry to amputation and time to death were evaluated separately as censored event times by Kaplan-Meier curves and log-rank tests. A multivariate Cox proportional hazards regression analysis was carried out for determining the risk factors of amputation.
The survival rate and amputation-free survival rate were 96.5% (n=167), 65.9% (n=114), respectively, over one year study period. Severity of ulcer was the strongest significant risk factor of amputation [hazard ratio (HR): 7.99; confidence interval (CI): 3.12 to 20.47]. Peripheral artery disease was also independent risk factor of amputation (HR: 2.64; CI: 1.52 to 4.59).
In assessing the prognosis of diabetic foot ulcers, clinicians should consider the severity of ulcer and presence of peripheral artery disease. Our study provides important insights into clinical practice and supplementary information for both physicians and patients
Aims Identifying individuals with diabetes at high risk of cardiovascular disease (CVD) remains challenging. We aimed to establish whether peripheral neuropathy (PN) is associated with incident CVD events and to what extent information on PN may improve risk prediction among individuals with type 2 diabetes.
Methods We obtained data for individuals with type 2 diabetes, and free of CVD, from a large primary care patient cohort. Incident CVD events were recorded during a 30-month follow-up period. Eligible individuals had complete ascertainment of cardiovascular risk factors and PN status at baseline. The association between PN and incident CVD events (non-fatal myocardial infarction, coronary revascularisation, congestive cardiac failure, transient ischaemic attack and stroke) was evaluated using Cox regression, adjusted for standard CVD risk factors. We assessed the predictive accuracy of models including conventional CVD risk factors with and without information on PN.
Results Among 13 043 eligible individuals, we recorded 407 deaths from any cause and 399 non-fatal CVD events. After adjustment for age, sex, ethnicity, systolic blood pressure, cholesterol, body mass index, HbA1c, smoking status and use of statin or antihypertensive medication, PN was associated with incident CVD events (HR 1.33; 95% CI 1.02 to 1.75, p=0.04). The addition of information on PN to a model based on standard CVD risk factors resulted in modest improvements in discrimination for CVD risk prediction and reclassified 6.9% of individuals into different risk categories.
Conclusions PN is associated with increased risk for a first cardiovascular event among individuals with diabetes.
A great deal of emphasis, clinical and financial, is placed on limb salvage efforts in diabetic patients suffering from lower extremity ulceration. This is because of the impression that amputation in such patients may be a proximal cause of death. While amputation is certainly a negative clinical outcome, it is not entirely clear that it causes death. In this systematic review, we examine the available literature to attempt to understand the role that the ulceration itself may play in mortality. In brief, we searched for human studies in OVID, CINAHL and the COCHRANE CENTRAL DATABASE from 1980 to 2013, looking for articles related to ulcer or wound of the foot, in patients with diabetes or peripheral vascular disease, and death. We looked for articles with 5 years of follow-up, or Kaplan-Meier estimates of 5-year mortality, and excluded reviews and letters. Articles were assessed for quality and potential bias using the Newcastle-Ottawa scale. We find that while the patient populations studied varied widely in terms of demographics and comorbidities, limiting generalisability, 5-year mortality rates after ulceration were around 40%. Risk factors for death commonly identified were increased age, male gender, peripheral vascular disease and renal disease.
Re: Mortality and diabetic foot related complications
HDL cholesterol as a predictor for the incidence of lower extremity amputation and wound-related death in patients with diabetic foot ulcers.
Ikura K, Hanai K, Shinjyo T, Uchigata Y Atherosclerosis. 2015 Feb 7;239(2):465-469.
We examined whether HDL cholesterol levels are a predictor for an incidence of lower-extremity amputation (LEA) and wound-related death in patients with diabetic foot ulcers (DFUs).
RESEARCH DESIGN AND METHODS:
This was a single-center, observational, longitudinal historical cohort study of 163 Japanese ambulatory patients with DFUs, 45 woman and 118 men, with a mean (standard deviation) age of 62 (14) years. The primary composite endpoint was defined as the worst of the following outcomes for each individual; (1) minor amputation, defined as amputation below the ankle, (2) major amputation, defined as amputation above the ankle, and (3) wound-related death.
During the median follow-up period of 5.1 months, 67 patients (41.1%) reached the endpoint (43 minor amputations, 16 major amputations, and 8 wound-related deaths). In the univariate Cox proportional hazard model analysis, lower HDL cholesterol levels (mmol/L) were significantly associated with the incidence of the primary composite endpoint (hazard ratio 0.16 [95% CI 0.08-0.32], p < 0.001). In the multivariate Cox proportional hazard model analysis using a stepwise variable-selecting procedure, HDL cholesterol levels in addition to the presence of ankle brachial index <0.9 or ≥1.4 and serum albumin levels were selected as independent risk factors for the incidence of the endpoint (hazard ratio 0.30 [95% CI 0.14-0.63], p = 0.002). Similar results were obtained when HDL cholesterol levels were treated as a categorical variable (≥1.03 mmol/L or less).
HDL cholesterol levels might be a novel clinical predictor for the incidence of LEA and wound-related death in patients with DFUs.
Re: Mortality and diabetic foot related complications
Treatment for Diabetic Foot Ulcers Complicated by Major Cardiac Events
Shih-Yuan Hung, MD, Yu-Yao Huang, MD, PhD, Lung-An Hsu, MD, PhD, Chun-Chi Chen, MD, Hui-Mei Yang, RN, Jui-Hung Sun, MD, Cheng-Wei Lin, MD, Chih-Ching Wang, MD CJD; Articles in Press
Diabetic foot ulcer (DFU) is a major complication in patients with diabetes mellitus and the leading cause of non-traumatic amputation in adults. Patients with DFU are usually fragile due to chronic diabetic comorbidities; therefore, tedious debridement and intervention procedures may not be well tolerated in patients with DFU. This study aimed to identify a casual relationship between in-hospital complications and treatment for limb-threatening DFUs.
From 2009 to 2011, 1130 consecutive patients who were admitted to the Diabetic Foot Care Center in Chang Gung Medical Center were surveyed. Rates of in-hospital mortality or events that lead to transfer to the intensive care unit (ICU) for various severe complications were retrospectively analyzed.
Forty-seven patients (4.2%) experienced in-hospital complications (28 patients died). Major adverse cardiac events (MACE) (n=21, 44.7%) were the most common complications, followed by nosocomial infection (n=18, 38.3%). Previous myocardial infarction was a risk factor for MACE. The presentation of MACE was fulminant (eg, acute pulmonary edema, cardiogenic shock,cardiac arrest), and occurred within 10 days of admission or within 10 days following a major procedure in most cases. ST-T segment abnormality at rest was the most common presentation of electrocardiography for MACE.
MACE should be prevented during treatment for limb-threatening DFU in high-risk patients. Acute stress might have caused MACE during the first 10 days after admission or a major procedure.
Re: Mortality and diabetic foot related complications
Elevated costs and high one-year mortality in
patients with diabetic foot ulcers after surgery
Lise Nørregaard Søndergaard, Anette Bundgaard Christensen
, Anker Lund Vinding, Inge Lunding Kjær & Peter Larsen Dan Med J 62/4 April 2015
INTRODUCTION: In Denmark, approximately 300,000 patients
have a diabetes mellitus diagnosis. Recently published
guidelines emphasise that health-care professionals
who are in direct contact with citizens should be aware of
the importance of prevention and early detection of diabetic
foot ulcers. The objective of this study was to evaluate
the mortality, length of hospital stay and economic impact
on health care in patients with acute diabetic foot ulcers
who were hospitalised in the Department of Orthopaedic
Surgery, Aalborg University Hospital, Denmark.
METHODS: This was a prospective cohort study including all
patients admitted with a diagnosis of acute foot ulcer to the
Department of Orthopaedic Surgery, Aalborg, Denmark
from September 2011 to February 2012.
RESULTS: A total of 48 patients were referred for surgical
treatment of a diabetic foot ulcer. The average age on admission
was 64 years (35-87 years). The median length of
hospital stay was 17 days (3-150 days), and 14 patients
were readmitted within the first year. Within the first year
of enrolment, 13 patients died, corresponding to a 36%
mortality rate. Based on the Danish Diagnosis-Related
Groups rates, the median cost associated with a case in the
study population was 133,867 DKK.
CONCLUSION: Patients referred for surgical revision of diabetic
foot ulcers are often severely ill, and the condition is
associated with a high one-year mortality rate. Furthermore,
the cost of these cases is considerable. Preventive interventions,
early diagnosis and treatment and multidisciplinary
interventions – before and during hospitalisation
– should be implemented.
Diabetic foot ulcerations have been extensively reported as vascular complications of diabetes mellitus associated with a high degree of morbidity and mortality; in fact, some authors showed a higher prevalence of major, previous and new-onset, cardiovascular, and cerebrovascular events in diabetic patients with foot ulcers than in those without these complications. This is consistent with the fact that in diabetes there is a complex interplay of several variables with inflammatory metabolic disorders and their effect on the cardiovascular system that could explain previous reports of high morbidity and mortality rates in diabetic patients with amputations. Involvement of inflammatory markers such as IL-6 plasma levels and resistin in diabetic subjects confirmed the pathogenetic issue of the "adipovascular" axis that may contribute to cardiovascular risk in patients with type 2 diabetes. In patients with diabetic foot, this "adipovascular axis" expression in lower plasma levels of adiponectin and higher plasma levels of IL-6 could be linked to foot ulcers pathogenesis by microvascular and inflammatory mechanisms. The purpose of this review is to focus on the immune inflammatory features of DFS and its possible role as a marker of cardiovascular risk in diabetes patients.
Re: Mortality and diabetic foot related complications
Clinical characteristics and survival of patients with diabetes mellitus following non-traumatic lower extremity amputation.
Wiessman MP, Liberty IF, Segev RW, Katz T, Abu Tailakh M, Novack V. Isr Med Assoc J. 2015 Mar;17(3):145-9.
Diabetes mellitus-related lower extremity amputation is a major complication severely affecting patient survival and quality of life.
To analyze epidemiological and clinical trends in the incidence and survival of lower extremity amputations among diabetes patients.
We conducted a retrospective observational cohort study of 565 consecutive diabetes patients who underwent their first non-traumatic lower extremity amputation between January 2002 and December 2009.
Major amputations were performed in 316 (55.9%) patients: 142 above the knee (25.1%) and 174 below (30.8%); 249 (44.1%) had a minor amputation. The incidence rates of amputations decreased from 2.9 to 2.1 per 1000 diabetes patients. Kaplan-Meier survival analysis showed that first year mortality rates were lower among patients with minor amputations (31.7% vs. 39.6%, P = 0.569). First year mortality rates following below-knee amputation were somewhat lower than above-knee amputation (33.1 vs. 45.1%, respectively). Cox regression model of survival at 1 year after the procedure found that age (HR 1.06 per year, 95% CI 1.04-1.07, P < 0.001), above-knee amputation (HR 1.36, 95% CI 1.01-1.83, P = 0.045) and ischemic heart disease (HR 1.68, 95% CI 1.26-2.24, P < 0.001) significantly increased one year mortality risk.
In this population-based study the incidence rate of non-traumatic amputations in diabetes patients between January 2002 and December 2009 decreased slightly. However, one year mortality rates after the surgery did not decline and remained high, stressing the need for a multidisciplinary effort to prevent amputations in diabetes patients.
Previous studies conducted in Australian hospital settings suggest high variability in assessments, investigations, and management of diabetic foot infections and poor adherence to widely accessible evidence-based protocols and guidelines. Diabetic foot complications require a multidisciplinary approach and often involve both medical and surgical teams during inpatient care.
The aim of this clinical audit was to better understand the scope of diabetes-related foot complications, evaluate whether current assessment and management strategies are in line with best practice guidelines, and to formulate future models of care.
A retrospective review of patients was carried out between 12 July 2012 and 11 July 2013. Recorded assessments of inpatient care, including risk factors, surgery, length of stay, interdepartmental referrals, and antibiotic administration were reviewed.
There were 24 admissions in 12 months (total patients n=19). Fifty-eight per cent of patients were admitted to the medical ward. More than one-quarter had evidence of osteomyelitis. While one patient required intensive care unit (ICU) management, there was no inpatient mortality. Two patients experienced significant delay to undergo initial surgical intervention presumably because of failed medical treatment. Clinical data was recorded poorly, especially regarding neuropathy, HbA1c, and clinical examination findings. Twelve per cent of patients did not undergo any follow-up. The average length of stay was 12 days. One-half of the cohort was not evaluated by the endocrinology department.
This audit highlights the need for improved care for patients with diabetic foot complications and better coordination among the multidisciplinary teams involved.
Skin wounds are associated with significant morbidity and mortality. Data are, however, not readily available for benchmarking, to allow prognostic evaluation, and to suggest when involvement of wound-healing experts is indicated. We therefore conducted an observational cohort study to investigate wound healing and all-cause mortality associated with different types of skin wounds. Consecutive skin wound patients who received wound care by home-care nurses from January 2010 to December 2011 in a district in Eastern Denmark were included in this study. Patients were followed up until wound healing, death, or until the end of follow-up on December 2012. In total, 958 consecutive patients received wound care by home-care nurses, corresponding to a one-year prevalence of 1.2% of the total population in the district. During the study, wound healing was achieved in 511 (53.3%), whereas 90 (9.4%) died. During the first 3 weeks of therapy, healing was most likely to occur in surgical wounds (surgical vs. other wounds: adjusted hazard ratio [AHR] 2.21, 95% confidence interval 1.50–3.23), while from 3 weeks to 3 months of therapy, cancer wounds and pressure ulcers were least likely to heal (cancer vs. other wounds: AHR 0.12, 0.03– 0.50; pressure vs. other wounds: AHR 0.44, 0.27–0.74). Cancer wounds and pressure ulcers were further associated with a three times increased probability of mortality compared with other wounds (cancer vs. other wounds: AHR 3.19, 1.35–7.50; pressure vs. other wounds: AHR 2.91, 1.56–5.42). In summary, the wound type was found to be a significant predictor of healing and mortality with cancer wounds and pressure ulcers being associated with poor prognosis. This article is protected by copyright. All rights reserved.
Background: Mortality after amputation is known to be extremely high and is associated with a number of patient features. We wished to calculate this mortality after first-time lower-limb amputation and investigate whether any population or treatment factors are associated with worse mortality.
Objective: To follow up individuals after lower limb amputation and ascertain the mortality rate as well as population or treatment features associated with mortality.
Study design: A prospective cohort study.
Methods: Prospective lower-limb amputations over 1 year (N = 105) at a Regional Rehabilitation Centre were followed up for 3 years.
Results: After 3 years, 35 individuals in the cohort had died, representing a mortality of 33%. On initial univariate analysis, those who died were more likely to have diabetes mellitus (χ2 = 7.16, df = 1, p = 0.007) and less likely to have been fitted with a prosthesis (χ2 = 5.84, df = 1, p = 0.016). There was no association with age, gender, level of amputation, social isolation, significant medical co-morbidity other than diabetes or presence of mood disorders. A multi-variable logistic regression (backward step) confirmed that diabetes (odds ratio = 3.04, confidence intervals = 1.25–7.40, p = 0.014) and absence of prosthesis-fitting (odds ratio = 2.60, confidence interval = 1.16–6.25, p = 0.028) were independent predictors of mortality.
Conclusion: Mortality after amputation is extremely high and is increased in individuals with diabetes or in those who are not fitted with a prosthesis after amputation.
Clinical relevance The link between diabetes and mortality after amputation has been noted by others, but this is the first study to find an effect from prosthetic limb-wearing. This requires further investigation to ascertain why the wearing of a prosthetic limb, confers an independent survival benefit that is not related to the presence of medical co-morbidity.