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Diabetic polyneuropathy is a risk factor for decline of lower extremity strength in patients with type 2 diabetes.
Nomura, T, Ishiguro, T, Ohira, M, Ikeda, Y
Journal of diabetes investigation. 2018;(1):186-192
Abstract
AIMS/INTRODUCTION The present study elucidated the effect of diabetic polyneuropathy (DPN) on lower extremity strength in a wide age range of type 2 diabetes patients. MATERIALS AND METHODS Participants (n = 1,442) were divided into three age groups (30-49 years, 50-69 years and 70-87 years), and comparisons were made separately for each sex. Lower extremity strength was measured in terms of knee extension force (KEF) with a hand-held dynamometer. KEF was compared according to the presence or absence of DPN. Furthermore, the effect of DPN on KEF with other diabetic complications (diabetic retinopathy and diabetic nephropathy), diabetes status (diabetes duration and glycated hemoglobin) and habitual behavior (regular exercise, smoking and drinking behaviors) as explanatory variables was analyzed using multiple regression analysis in several models. RESULTS The frequency of DPN differed among age groups, ranging from 14.3 to 49.6%, and increasing with age. There was no significant difference in KEF between patients aged 30-49 years with and without DPN. However, among both men and women aged 50-69 years and 70-87 years, patients with DPN showed significantly diminished KEF (11.0-12.9% and 11.9-16.6%, respectively) compared with those without DPN (P < 0.01-0.001). In women aged 50-69 years and 70-87 years, and in men aged 50-69 years, DPN was a significant explanatory variable for KEF in all multiple regression analysis models. CONCLUSION DPN might reinforce a KEF decline in middle-aged and elderly type 2 diabetes patients.
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Reversal of Lower-Extremity Intermittent Claudication and Rest Pain by Hydration.
Fernández, S, Parodi, JC, Moscovich, F, Pulmari, C
Annals of vascular surgery. 2018;:1-7
Abstract
BACKGROUND Medical treatment of disabling intermittent claudication or critical limb-threatening ischemia causing rest pain often fails or has partial response. METHODS In this pilot study, 36 patients (12 females) affected by disabling intermittent claudication or rest pain of the lower extremities were exposed to a daily 3-L water intake for up to 6 weeks. Cutaneous foot temperature, ankle/brachial index, time and distance of claudication, and pain intensity were recorded before and at the completion of the hydration period. RESULTS Patients with a mean ± SE age of 71 ± 2 years (range, 40-86) had disabling claudication (less than 100 meters) for more than 5 months while 11% reported pain at rest. A 6-week water intake of more than 2,500 mL/24 hr was achieved in 35 of the 36 patients enrolled in the study. Increased water intake was associated with significant improvements in median ankle/brachial index (from 0.60 to 0.76; P < 0.0001) and skin temperature (first dorsal right toe, from 29.95°C to 30.0°C, P < 0.001). Time and distance to report claudication of supervised treadmill exercise improved from 1.25 to 6.25 min (P < 0.0001) and from 100 meters to 535 meters (P < 0.0001), respectively. CONCLUSIONS This study suggests that hydration attained by daily water consumption of more than 2.5 L has a robust impact on reducing the symptoms of disabling claudication and rest pain caused by peripheral vascular disease.
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Associations of office workers' objectively assessed occupational sitting, standing and stepping time with musculoskeletal symptoms.
Coenen, P, Healy, GN, Winkler, EAH, Dunstan, DW, Owen, N, Moodie, M, LaMontagne, AD, Eakin, EA, O'Sullivan, PB, Straker, LM
Ergonomics. 2018;(9):1187-1195
Abstract
We examined the association of musculoskeletal symptoms (MSS) with workplace sitting, standing and stepping time, as well as sitting and standing time accumulation (i.e. usual bout duration of these activities), measured objectively with the activPAL3 monitor. Using baseline data from the Stand Up Victoria trial (216 office workers, 14 workplaces), cross-sectional associations of occupational activities with self-reported MSS (low-back, upper and lower extremity symptoms in the last three months) were examined using probit regression, correcting for clustering and adjusting for confounders. Sitting bout duration was significantly (p < 0.05) associated, non-linearly, with MSS, such that those in the middle tertile displayed the highest prevalence of upper extremity symptoms. Other associations were non-significant but sometimes involved large differences in symptom prevalence (e.g. 38%) by activity. Though causation is unclear, these non-linear associations suggest that sitting and its alternatives (i.e. standing and stepping) interact with MSS and this should be considered when designing safe work systems. Practitioner summary: We studied associations of objectively assessed occupational activities with musculoskeletal symptoms in office workers. Workers who accumulated longer sitting bouts reported fewer upper extremity symptoms. Total activity duration was not significantly associated with musculoskeletal symptoms. We underline the importance of considering total volumes and patterns of activity time in musculoskeletal research.
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Predictors of surgical site infection after open lower extremity revascularization.
Davis, FM, Sutzko, DC, Grey, SF, Mansour, MA, Jain, KM, Nypaver, TJ, Gaborek, G, Henke, PK
Journal of vascular surgery. 2017;(6):1769-1778.e3
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OBJECTIVE Surgical site infection (SSI) after open lower extremity bypass (LEB) is a serious complication leading to an increased rate of graft failure, hospital readmission, and health care costs. This study sought to identify predictors of SSI after LEB for arterial occlusive disease and also potential modifiable factors to improve outcomes. METHODS Data from a statewide cardiovascular consortium of 35 hospitals were used to obtain demographic, procedural, and hospital risk factors for patients undergoing elective or urgent open LEB between January 2012 and June 2015. Bivariate comparisons and targeted maximum likelihood estimation were used to identify independent risk factors of SSI. Adjusted odds ratios (ORs) were calculated for patient demographics, comorbidities, operative details, and hospital-level factors. RESULTS Our study population included 3033 patients who underwent 703 femoral-femoral bypasses, 1431 femoral-popliteal bypasses, and 899 femoral-distal vessel bypasses. An SSI was diagnosed in 320 patients (10.6%) ≤30 days after the index operation. Adjusted patient and procedural predictors of SSI included renal failure currently requiring dialysis (OR, 4.35; 95% confidence interval [CI], 3.45-5.47; P < .001), hypertension (OR, 4.29; 95% CI, 2.74-6.72; P < .001), body mass index ≥25 kg/m2 (OR, 1.78; 95% CI, 1.23-2.57; P = .002), procedural time >240 minutes (OR, 2.95; 95% CI, 1.89-4.62; P < .001), and iodine-only skin preparation (OR, 1.73; 95% CI, 1.02-2.91; P = .04). Hospital factors associated with increased SSI included hospital size <500 beds (OR, 2.22; 95% CI, 1.09-4.55; P = .028) and major teaching hospital (OR, 1.66; 95% CI, 1.07-2.58; P = .024). SSI resulted in increased risk of major amputation and surgical reoperation (P < .01), but did not affect 30-day mortality. CONCLUSIONS SSI after LEB is associated with an increase in rate of amputation and reoperation. Several patient, operative, and hospital-related risk factors that predict postoperative SSI were identified, suggesting that targeted improvements in perioperative care may decrease complications and improve vascular patient outcomes.
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Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.
Backes, M, Dingemans, SA, Dijkgraaf, MGW, van den Berg, HR, van Dijkman, B, Hoogendoorn, JM, Joosse, P, Ritchie, ED, Roerdink, WH, Schots, JPM, et al
JAMA. 2017;(24):2438-2445
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IMPORTANCE Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. OBJECTIVE To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. INTERVENTIONS A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). MAIN OUTCOMES AND MEASURES Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. RESULTS Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). CONCLUSIONS AND RELEVANCE Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02225821.
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Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON study.
Mohammedi, K, Woodward, M, Hirakawa, Y, Zoungas, S, Colagiuri, S, Hamet, P, Harrap, S, Poulter, N, Matthews, DR, Marre, M, et al
Cardiovascular diabetology. 2016;(1):129
Abstract
BACKGROUND Peripheral arterial disease (PAD) is known to be associated with high cardiovascular risk, but the individual impact of PAD presentations on risk of macrovascular and microvascular events has not been reliably compared in patients with type 2 diabetes. We aimed to evaluate the impact of major PAD, and its different presentations, on the 10-year risk of death, major macrovascular events, and major clinical microvascular events in these patients. METHODS Participants in the action in diabetes and vascular disease: PreterAx and DiamicroN modified-release controlled evaluation (ADVANCE) trial and the ADVANCE-ON post-trial study were followed for a median of 5.0 (in-trial), 5.4 (post-trial), and 9.9 (overall) years. Major PAD at baseline was subdivided into lower-extremity chronic ulceration or amputation secondary to vascular disease and history of peripheral revascularization by angioplasty or surgery. RESULTS Among 11,140 participants, 516 (4.6 %) had major PAD at baseline: 300 (2.7 %) had lower-extremity ulceration or amputation alone, 190 (1.7 %) had peripheral revascularization alone, and 26 (0.2 %) had both presentations. All-cause mortality, major macrovascular events, and major clinical microvascular events occurred in 2265 (20.3 %), 2166 (19.4 %), and 807 (7.2 %) participants, respectively. Compared to those without PAD, patients with major PAD had increased rates of all-cause mortality (HR 1.35, 95 % CI 1.15-1.60, p = 0.0004), and major macrovascular events (1.47 [1.23-1.75], p < 0.0001), after multiple adjustments for region of origin, cardiovascular risk factors and treatments, peripheral neuropathy markers, and randomized treatments. We have also observed a trend toward an association of baseline PAD with risk of major clinical microvascular events [1.31 (0.96-1.78), p = 0.09]. These associations were comparable for patients with a lower-extremity ulceration or amputation and for those with a history of peripheral revascularization. Furthermore, the risk of retinal photocoagulation or blindness, but not renal events, increased in patients with lower-extremity ulceration or amputation [1.53 (1.01-2.30), p = 0.04]. CONCLUSIONS Lower-extremity ulceration or amputation, and peripheral revascularization both increased the risks of death and cardiovascular events, but only lower-extremity ulceration or amputation increased the risk of severe retinopathy in patients with type 2 diabetes. Screening for major PAD and its management remain crucial for cardiovascular prevention in patients with type 2 diabetes (ClinicalTrials.gov number, NCT00949286).
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Predictors of major amputation despite patent bypass grafts.
Smith, AD, Hawkins, AT, Schaumeier, MJ, de Vos, MS, Conte, MS, Nguyen, LL
Journal of vascular surgery. 2016;(5):1279-88
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OBJECTIVE Despite patent vein bypass grafts, some patients with critical limb ischemia (CLI) receive major amputations. We analyzed the predictive factors leading to major amputation in the presence of patent lower extremity bypass (LEB) grafts. METHODS Data from the Project of Ex-Vivo vein graft Engineering via Transfection III (PREVENT III), a large prospective randomized trial of 1404 patients who underwent LEB with vein graft for CLI, were queried for outcomes. The primary outcome was major amputation with patent (PMA) LEB compared with patients with patent LEB who achieved limb salvage (PLS). The population excluded those who received amputation for occluded grafts. A Cox proportional hazard model identified independent predictors. RESULTS Of 1404 LEB patients, 162 (11.5%) had major amputation: 89 (6.3%) with patent and 73 (5.2%) with occluded LEB. For PMA, 21 of 89 (23.6%) developed critical stenosis and 11 of 21 (52.4%) were revised. For PLS, 460 of 1242 (37.0%) developed critical stenosis and 351 of 460 (76.3%) were revised. Predictive patient factors included having preoperative gangrene (vs rest pain; hazard ratio [HR], 3.504; 95% confidence interval [CI], 1.533-8.007; P = .0029), diabetes (HR, 1.800; 95% CI, 1.006-3.219; P = .0477), black (vs white) race (HR, 1.779; 95% CI, 1.051-3.011; P = .0321), baseline creatinine clearance <25 mL/min (vs >65 mL/min; HR, 1.759; 95% CI, 1.016-3.048; P = .0439), prior history of coronary artery bypass grafting (HR, 1.702; 95% CI, 1.080-2.683; P = .0221), and lower baseline activity quality of life score (HR, 1.401; 95% CI, 1.105-1.778; P = .0054). Postoperative wound factors included gangrenous changes (HR, 5.830; 95% CI, 1.647-20.635; P = .0063), surgical wound necrosis (HR, 5.319; 95% CI, 1.478-19.146; P = .0105), deep (vs superficial) wound infection (HR, 3.815; 95% CI, 1.220-11.927; P = .0213), and wound healing abnormally (HR, 3.754; 95% CI, 1.061-13.278; P = .0402). Associated postoperative consequences leading to PMA included having recurrent CLI symptoms (HR, 2.915; 95% CI, 1.816-4.681; P < .0001), a severe (vs mild) adverse event (HR, 2.751; 95% CI, 1.391-5.443; P = .0036), fewer percutaneous revisions (HR, 2.425; 95% CI, 1.573-3.740; P < .0001), discharge on low-molecular-weight heparin (HR, 2.087; 95% CI, 1.309-3.326; P = .0020), and decreasing days to critical stenosis/occlusion/revision/amputation (HR, 1.010; 95% CI, 1.007-1.012; P < .0001). CONCLUSIONS Whereas a patent vein graft is important to all vascular surgeons, additional factors should be considered in trying to attain limb salvage for patients with CLI. These factors include intervening surgically before CLI has progressed to a state of gangrene or limited activity and optimizing nutrition, diabetes control, cardiac conditions, and activity level. Revision offers hope for clinical improvement but may be delayed when there is no graft lesion identified. The absence of a graft lesion to revise may also portend amputation despite a patent graft because of nongraft-related factors such as infection. Finally, the experience of a severe (vs mild) adverse event may also result in limb loss despite a patent graft. Systematic efforts to reduce severe adverse events among patients may also lead to increased limb salvage.
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Lower-extremity amputation as a marker for renal and cardiovascular events and mortality in patients with long standing type 1 diabetes.
Mohammedi, K, Potier, L, Belhatem, N, Matallah, N, Hadjadj, S, Roussel, R, Marre, M, Velho, G
Cardiovascular diabetology. 2016;:5
Abstract
BACKGROUND We evaluated the risks of renal and cardiovascular complications, and mortality associated with lower extremity amputation (LEA) in patients with type 1 diabetes. METHODS We studied two cohorts of people with long standing type 1 diabetes: GENEDIAB (n = 456) and GENESIS (n = 611). Subsets of the cohorts (n = 260, n = 544) were followed for 9 and 5 years, respectively. Outcomes were the incidence of end stage renal disease (ESRD), myocardial infarction, stroke and mortality during follow-up. Analyses were performed in pooled cohorts. RESULTS The prevalence of LEA at baseline was 9.3 % (n = 99). A positive history of LEA was associated with the baseline prevalence of established (OR 4.50, 95 % CI 2.33-8.91, p < 0.0001) and advanced diabetic nephropathy (OR 5.50, 95 % CI 2.89-10.78, p < 0.0001), ESRD (OR 2.86, 95 % CI 1.43-5.50, p = 0.004), myocardial infarction (OR 3.25, 95 % CI 1.68-6.15, p = 0.0006) and stroke (OR 3.88, 95 % CI 1.67-8.72, p = 0.002, adjusted for sex, age, and cohort membership). A positive history of LEA at baseline was associated with the incidence during follow-up of ESRD (HR 2.69, 95 % CI 1.17-6.20, p = 0.02), and myocardial infarction (HR 3.53, 95 % CI 1.79-6.97, p = 0.0001). History of LEA was also associated with increased risk for all-cause (HR 3.55, 95 % CI 2.05-6.16, p < 0.0001), cardiovascular (HR 3.30, 95 % CI 1.36-8.02, p = 0.008), infectious disease (HR 5.18, 95 % CI 1.13-23.84, p = 0.03) and other-cause mortality (HR 2.81, 95 % CI 1.09-7.26, p = 0.03). History of LEA at baseline was associated with a 40 % reduction in the duration of survival in the subset of patients who died during follow-up. Population attributable risk of the history of LEA at baseline for total mortality during follow-up was 0.31. CONCLUSIONS Patients with LEA have a higher risk of ESRD, myocardial infarction and cardiovascular and non-cardiovascular mortality. Our results highlight the importance of LEA as a key-predictor for major vascular events and premature death in type 1 diabetic patients.
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Factors associated with surgical site infection after lower extremity bypass in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI).
Kalish, JA, Farber, A, Homa, K, Trinidad, M, Beck, A, Davies, MG, Kraiss, LW, Cronenwett, JL, ,
Journal of vascular surgery. 2014;(5):1238-1246
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BACKGROUND Surgical site infection (SSI) is a major source of morbidity after infrainguinal lower extremity bypass (LEB). This study examines processes of care associated with in-hospital SSI after LEB and identifies factors that could potentially be modified to improve outcomes. METHODS The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry (2003 to 2012) was queried to identify in-hospital SSI after 7908 consecutive LEB procedures performed by 365 surgeons at 91 academic and community hospitals in 45 states. Variables associated with SSI were identified using multivariable logistic regression and hierarchical clustering. Expected and observed SSI rates were calculated for each hospital. RESULTS The overall in-hospital SSI rate after LEB was 4.8%. Univariate analysis showed that obesity, dialysis, tissue loss, preoperative ankle-brachial index <0.35, distal target, vein graft conduit, continuous incision for vein harvest, transfusion >2 units of packed red blood cells, procedure time >220 minutes, and estimated blood loss >100 mL were associated with higher SSI rates, whereas chlorhexidine (compared with iodine) skin preparation was protective. Multivariable analysis showed independent predictors of SSI included ankle-brachial index <0.35 (odds ratio [OR], 1.53; 95% confidence interval [CI], 1.03-2.30, P < .04), transfusion >2 units (OR, 3.30; 95% CI, 2.17-5.02; P < .001), and procedure time >220 minutes (OR, 2.11; 95% CI, 1.05-4.23; P < .04). Chlorhexidine was protective against SSI (OR, 0.53; 95% CI, 0.35-0.79; P = .002). Stratified analyses based on the presence of tissue loss yielded similar results. Across VQI hospitals, observed SSI rates ranged from 0% to 30%, whereas expected SSI rates adjusted by the four independent predictors ranged from 0% to 7.2%. CONCLUSIONS In-hospital SSI after LEB varies substantially across VQI hospitals. Three modifiable processes of care (transfusion rate, procedure time, and type of skin preparation) were identified and may be used by hospitals to reduce SSI rates. This study demonstrates the value of the SVS VQI detailed shared clinical registry to identify improvement opportunities directly pertinent to providers that are not available in typical administrative data sets.
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Discomfort assessment in peripheral angiography: randomized clinical trial of Iodixanol 270 versus Ioversol 320 in diabetics with critical limb ischemia.
Palena, LM, Sacco, ZD, Brigato, C, Sultato, E, Barra, D, Candeo, A, Manzi, M
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2014;(6):1019-25
Abstract
OBJECTIVES To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media (CM) and the impact on diagnostic efficacy in diabetics with critical limb ischemia (CLI). BACKGROUND Arterial revascularization is a mainstay in patients with CLI. Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results, and it could vary related to the CM agents. METHODS One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective, double-blind, randomized, parallel-group clinical trial. Injection-associated discomfort was assessed by Visual Analogic Scale (VAS). Diagnostic efficacy and safety up to 1 week were evaluated. RESULTS The incidence of pain has been around 50% of the all population in study, with lesser incidence of pain (25.7% vs 74.3%; P < 0.0001) and of heat sensation (55.4% vs 85.1%; P < 0.0001), after Iodixanol than after Ioversol injection. Discomfort mean score, according to VAS assessment, was less in the Iodixanol group (8.1 ± 15.3) than in the Ioversol group (36.0 ± 29.7), after first injection (P < 0.001) and for all injections (P < 0.001). A significant difference was also observed in favor of Iodixanol (P < 0.001), respect to mean score of discomfort and heat sensation, assessed by the operators after all the CM injections. CONCLUSIONS Iodixanol caused less frequent and severe discomfort, characterized as pain and heat during intra-arterial administration compared with Ioversol. The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes.