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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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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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Ankle brachial index values, leg symptoms, and functional performance among community-dwelling older men and women in the lifestyle interventions and independence for elders study.
McDermott, MM, Applegate, WB, Bonds, DE, Buford, TW, Church, T, Espeland, MA, Gill, TM, Guralnik, JM, Haskell, W, Lovato, LC, et al
Journal of the American Heart Association. 2013;(6):e000257
Abstract
BACKGROUND The prevalence and significance of low normal and abnormal ankle brachial index (ABI) values in a community-dwelling population of sedentary, older individuals is unknown. We describe the prevalence of categories of definite peripheral artery disease (PAD), borderline ABI, low normal ABI, and no PAD and their association with lower-extremity functional performance in the LIFE Study population. METHODS AND RESULTS Participants age 70 to 89 in the LIFE Study underwent baseline measurement of the ABI, 400-m walk, and 4-m walking velocity. Participants were classified as follows: definite PAD (ABI <0.90), borderline PAD (ABI 0.90 to 0.99), low normal ABI (ABI 1.00 to 1.09), and no PAD (ABI 1.10 to 1.40). Of 1566 participants, 220 (14%) had definite PAD, 250 (16%) had borderline PAD, 509 (33%) had low normal ABI, and 587 (37%) had no PAD. Among those with definite PAD, 65% were asymptomatic. Adjusting for age, sex, race, body mass index, smoking, and comorbidities, lower ABI was associated with longer mean 400-m walk time: (definite PAD=533 seconds; borderline PAD=514 seconds; low normal ABI=503 seconds; and no PAD=498 seconds [P<0.001]). Among asymptomatic participants with and without PAD, lower ABI values were also associated with longer 400-m walk time (P<0.001) and slower walking velocity (P=0.042). CONCLUSION Among older community-dwelling men and women, 14% had PAD and 49% had borderline or low normal ABI values. Lower ABI values were associated with greater functional impairment, suggesting that lower extremity atherosclerosis may be a common preventable cause of functional limitations in older people. CLINICAL TRIAL REGISTRATION URL http://clinicaltrials.gov/ Unique identifier: NCT01072500.
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Controlled reperfusion using a simplified perfusion system preserves function after acute and persistent limb ischemia: a preliminary study.
Wilhelm, MP, Schlensak, C, Hoh, A, Knipping, L, Mangold, G, Dallmeier Rojas, D, Beyersdorf, F
Journal of vascular surgery. 2005;(4):690-4
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OBJECTIVE Reperfusion of the limb after acute and persistent ischemia is associated with high rates of morbidity and mortality despite complete revascularization. Although reperfusion is a prerequisite for maintaining limb function, it may in itself cause further injury. There is experimental evidence that modification of the initial reperfusion modalities can minimize this reperfusion injury. We hypothesized that controlled reperfusion using a simple blood bag perfusion system reduces reperfusion injury and facilitates the return of normal function. METHODS Fifteen consecutive patients (mean age, 80.5 +/- 5.0 years) with severe, acute lower-limb ischemia were allocated to two treatment arms in this prospective, controlled observational study. Group I (n = 8) underwent surgical embolectomy alone, and group II (n = 7) underwent surgical embolectomy plus controlled reperfusion using a simplified perfusion system. Indication for controlled reperfusion was made by the responsible surgeon. Controlled reperfusion consisted of a 30-minute infusion of a crystalloid reperfusion solution that was mixed with oxygenated blood (the blood:reperfusion solution ratio was 6:1) distal to the occlusion. Duration of ischemia, postoperative amputation rate, motor function of the ischemic limb, and pre- and postoperative serum creatine kinase levels were assessed. RESULTS The duration of ischemia was 10.7 +/- 1.1 hours in group I and 19 +/- 5.2 hours in group II (P < .05). The site of the arterial occlusion was the iliac artery in nine patients and the common femoral artery in six patients. Full recovery was achieved in six of seven patients in group II and in only two of eight patients in group I (P < .05). There were three in-hospital deaths in group I, and two patients underwent major amputations. No in-hospital deaths or major amputations occurred in group II. CONCLUSION The results from this preliminary study strongly suggest the hypothesis that the results of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion. To prove our preliminary findings, a large randomized, prospective, controlled, multicenter trial, the Controlled Reperfusion of the Acutely Ischemic Limb trial (CRAIL-Trial) is currently being conducted to prove our preliminary findings.