Limb- and Person-Level Risk Factors for Lower-Limb Amputation in the Prospective Seattle Diabetic Foot Study.

OBJECTIVE: Diabetes is the leading cause of nontraumatic lower-limb amputations in the U.S., but no research has prospectively examined associations between limb-specific measurements and amputation risk among patients without foot ulcer. We investigated amputation risk by limb in relation to the same limb- and person-level factors. RESEARCH DESIGN AND METHODS: We conducted a 22-year prospective study among 1,461 male patients with diabetes without foot ulcer (mean age 62.4 years), with 2,893 lower limbs among subjects recruited between 1990 and 2002 from one Department of Veterans Affairs general internal medicine clinic. The following information was collected: demographic, lifestyle, and diabetes characteristics; visual acuity; kidney function (estimated glomerular filtration rate [eGFR]); and lower-limb measurements including presence of Charcot deformity, sensory neuropathy by 10-g monofilament, dorsal foot transcutaneous oximetry (TcPO2) at 44°C, and ankle-brachial index (ABI). RESULTS: Over 25,735 limb-years, 136 amputations occurred. A multivariable Cox model identified multiple independent risk factors: sensory neuropathy (hazard ratio 3.09 [95% CI 2.02-4.74]), ABI ≤0.5 vs. >0.9 to <1.3 (3.98 [2.31-6.85]), ABI ≥1.3 vs. >0.9 to <1.3 (2.20 [1.18-4.09]), 1-SD decrease in eGFR (1.18 [1.00-1.38]), poor vision (1.70 [1.05-2.73]), body weight in 21.4-kg increments (0.78 [0.61-0.98]), and age >70 years vs. <57 years (0.13 [0.04-0.38]). Although TcPO2 was not significantly associated with amputation overall, TcPO2 <26 mmHg significantly predicted a higher risk in the ABI ≥1.3 category. CONCLUSIONS: Arterial disease and neuropathy emerged as the only limb-specific risk factors for amputation, but these and several person-level factors may be amenable to prevention or treatment interventions to potentially reduce diabetic amputation risk.

Developing a wound and skin care program.

The purpose of this article is to review the process used in a large Veterans Affairs facility to unite a group of diverse wound care specialists together into a coordinated program. Program development is an iterative, interactive process requiring continued recycling of efforts until projects are completed. The Program Development Cycle is presented as an example of intentional planning that has been divided into 4 phases: (1) identifying the agency culture, (2) engaging in targeted project development, (3) developing operational strategies, and (4) conducting follow-up analysis. Specific examples of developing a mission, program goals, and wound care champions are discussed. Discussion also incorporates suggestions for changing organizational culture, developing policies and procedures, using best practices and guidelines, creating a wound fair, and incorporating a skin bundle and the challenges of outcome assessment.

Diabetic foot ulcer incidence in relation to plantar pressure magnitude and measurement location.

AIMS: We prospectively examined the relationship between site-specific peak plantar pressure (PPP) and ulcer risk. Researchers have previously reported associations between diabetic foot ulcer and elevated plantar foot pressure, but the effect of location-specific pressures has not been studied. METHODS: Diabetic subjects (n=591) were enrolled from a single VA hospital. Five measurements of in-shoe plantar pressure were collected using F-Scan. Pressures were measured at 8 areas: heel, lateral midfoot, medial midfoot, first metatarsal, second through fourth metatarsal, fifth metatarsal, hallux, and other toes. The relationship between incident plantar foot ulcer and PPP or pressure-time integral (PTI) was assessed using Cox regression. RESULTS: During follow-up (2.4years), 47 subjects developed plantar ulcers (10 heel, 12 metatarsal, 19 hallux, 6 other). Overall mean PPP was higher for ulcer subjects (219 vs. 194kPa), but the relationship differed by site (the metatarsals with ulcers had higher pressure, while the opposite was true for the hallux and heel). A statistical analysis was not performed on the means, but hazard ratios from a Cox survival analysis were nonsignificant for PPP across all sites and when adjusted for location. However, when the metatarsals were considered separately, higher baseline PPP was significantly associated with greater ulcer risk; at other sites, this relationship was nonsignificant. Hazard ratios for all PTI data were nonsignificant. CONCLUSIONS: Location must be considered when assessing the relationship between PPP and plantar ulceration.

Foot ulcer risk and location in relation to prospective clinical assessment of foot shape and mobility among persons with diabetes.

AIMS: We assessed baseline clinical foot shape for 2939 feet of diabetic subjects who were monitored prospectively for foot ulceration. METHODS: Assessments included hammer/claw toes, hallux valgus, hallux limitus, prominent metatarsal heads, bony prominences, Charcot deformity, plantar callus, foot type, muscle atrophy, ankle and hallux mobility, and neuropathy. Risk factors were linked to ulcer occurrence and location via a Cox proportional hazards model. RESULTS: Hammer/claw toes (hazard ratio [HR] (95% confidence interval [CI])=1.43 (1.06, 1.94) p=0.02), marked hammer/claw toes (HR=1.77 (1.18, 2.66) p=0.006), bony prominences (HR=1.38 (1.02, 1.88), p=0.04), and foot type (Charcot or drop foot vs. neutrally aligned) (HR=2.34 (1.33, 4.10), p=0.003) were significant risk factors for ulceration adjusting for age, body mass index, insulin medication, ulcer history and amputation history. With adjustment for neuropathy only hammer/claw toes (HR=1.40 (1.03, 1.90), p=0.03) and foot type (HR=1.76 (1.04, 3.04), p=0.05) were significantly related to ulceration. However, there was no relationship between ulcer location and foot deformity. CONCLUSIONS: Certain foot deformities were predictive of ulceration, although there was no relationship between clinical foot deformity and ulcer location.

Laparoscopic adjustable gastric banding in an ambulatory surgery center.

BACKGROUND: In the management of morbid obesity by laparoscopic adjustable gastric banding (LAGB), careful patient preparation and attentive follow-up have been shown to produce the best long-term results. METHODS: Between November 2002 and August 2007, prospective data were collected on 2,411 consecutive patients, 84% of whom underwent LAGB at our freestanding outpatient surgery center, staffed by our dedicated multidisciplinary bariatric team. Outcomes reported include changes in mean body mass index (BMI), percentage excess body weight loss (%EBWL), and incidence of complications at 1 year, as well as the slippage rate up to 3 years. RESULTS: A total of 2,003 (83%) female and 409 (17%) male patients with a mean age of 44.1 years (range 15-76 yrs) and a BMI (mean +/- SD) of 45.7 +/- 7.9 kg/m2 (range 29.1-83.1 kg/m2) underwent LAGB. In 2,027 patients (84%), LAGB was performed as an outpatient procedure, with 1 (0.04%), conversion from a laparoscopic to an open procedure. The majority of operations were completed in less than 1 hour, using the pars flaccida technique. One-year weight loss data were available in 1,144 patients (47%). BMI decreased to 36.9 +/- 7.4 kg/m2 (-8.8). Mean %EBWL at 1 year (+/- 60 days) was 41.0% +/- 18.1% (range 0.7%-113.9%). Complications occurred in 241 of 2,411 (10%) patients. There was 1 death (0.04%). Cumulative slippage at 1, 2, and 3 years, respectively, was 0.4%, 2.4%, and 10%. There were 56 (2.3%) port-related problems, and 13 band explantations (0.54%). CONCLUSIONS: With extensive staff experience and patient preparation, LAGB can be performed safely as an outpatient procedure for select patients. Close follow-up is crucial in order to optimize LAGB outcomes for the long term.

Outpatient laparoscopic adjustable gastric banding in super-obese patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe and effective treatment for morbid obesity that is well suited to outpatient surgery. Super-obese patients (BMI > or = 50) are often viewed as higher risk patients, with their surgical procedures limited to hospital operating-rooms. We report our experience performing LAGB for super-obese patients in a freestanding ambulatory surgery center and describe the program elements that make this feasible and safe. METHODS: Database records containing 1,780 consecutive patients from program inception (November 2002 to November 2006) were searched for patients with a BMI >49.9 undergoing an outpatient LAGB and reviewed to identify complications. RESULTS: 320 super-obese patients underwent an outpatient LAGB. Mean preoperative weight was 155.2 kg (range 112.3-220.5 kg), and mean BMI was 55.4 kg/m2 (range 50.0-71.1 kg/m2). 53 patients (16.6%) had BMI >60. There were no deaths, significant cardiopulmonary complications, significant intraoperative bleeding, conversion to open laparotomy, or hospital admissions. 3 patients (0.1%) developed gastric edema causing transient obstruction, and 1 developed a delayed colon perforation from electrocautery incurred during adhesiolysis. No complication arose or was more difficult to manage as a result of the procedure being done on an outpatient basis. CONCLUSIONS: Outpatient LAGB can be safely performed in super-obese patients with a complication rate similar to lower BMI patients. Patient selection and preoperative preparation are essential to achieve excellent outcomes. The decision to offer an outpatient LAGB should rest on the overall physiological condition rather than BMI or weight alone.

Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study.

OBJECTIVE: The ability of readily available clinical information to predict the occurrence of diabetic foot ulcer has not been extensively studied. We conducted a prospective study of the individual and combined effects of commonly available clinical information in the prediction of diabetic foot ulcer occurrence. RESEARCH DESIGN AND METHODS: We followed 1,285 diabetic veterans without foot ulcer for this outcome with annual clinical evaluations and quarterly mailed questionnaires to identify foot problems. At baseline we assessed age; race; weight; current smoking; diabetes duration and treatment; HbA(1c) (A1C); visual acuity; history of laser photocoagulation treatment, foot ulcer, and amputation; foot shape; claudication; foot insensitivity to the 10-g monofilament; foot callus; pedal edema; hallux limitus; tinea pedis; and onychomycosis. Cox proportional hazards modeling was used with backwards stepwise elimination to develop a prediction model for the first foot ulcer occurrence after the baseline examination. RESULTS: At baseline, subjects were 62.4 years of age on average and 98% male. Mean follow-up duration was 3.38 years, during which time 216 foot ulcers occurred, for an incidence of 5.0/100 person-years. Significant predictors (P

Adjustable gastric banding in an ambulatory surgery center.

BACKGROUND: We report our early experience with 343 consecutive patients who underwent laparoscopic adjustable gastric banding (LAGB) as an outpatient procedure in a self-standing ambulatory surgery center. METHODS: Between Apr 2003 and Feb 2005, data was collected prospectively on 343 consecutive patients who underwent LAGB as an outpatient. RESULTS: There were 305 females (88.9%) and 38 males (11.1%), with mean age 43.5 years (+/-SD 9.9, range 19-67) and mean BMI 44.5 kg/m2 (+/-SD 6.1, range 32.7-62.7). Mean operating-room time was 52.9 (+/-16.3) minutes. 10 complications occurred in 9 patients (2.8%): 5 stoma occlusion, 3 port problems requiring port replacement, 1 superficial wound infection, and 1 colon perforation associated with adhesiolysis requiring band removal. 3 patients required admission to the hospital: 1 for nausea, 1 for observation after bloody nasogastric tube drainage, and 1 for dysphagia due to esophageal spasm. All 9 patients with complications recovered fully. 1-year weight loss data was available in 91 patients; mean percent excess weight lost (%EWL) at 1 year was 45.4% (+/-17.6). CONCLUSIONS: LAGB has become an appropriate outpatient procedure in select patients.

Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year.

BACKGROUND: The objective of this study was to determine the weight loss, changes in co-morbidities, medication usage and general health status at 1 year after laparoscopic adjustable gastric banding (LAGB). METHODS: Prospective data were obtained from all subjects undergoing LAGB. These measurements included a medical history and review of systems, medications, height and weight and the SF-36 general health survey. Patients were seen for band adjustments as needed throughout the year. At the 1-year follow-up visit, patients were weighed and interviewed about the status of their health conditions and their current medications, and the SF-36 was repeated. RESULTS: Between November 2002 and November 2003, 195 patients had LAGB. The majority of subjects were female (82.8%), married (65.1%), and white (94.9%). Complications occurred in 18 subjects (9.2%). These included 3 slipped bands (1.5%), 4 port problems (2.1%), 8 patients with temporary stoma occlusion (4.1%), 1 explantation (0.5%), and 1 mortality (0.5%). Mean BMI decreased from 45.8 kg/m2 (+/- 7.7) to 32.3 kg/m2 (+/- 7.0). Mean percent excess body weight lost was 45.7% (+/- 17.1) during the first year. Major improvements occurred in arthritis, asthma, depression, diabetes, gastro-esophageal reflux disease, hyperlipidemia, hypertension, joint and back pain, sleep apnea and stress incontinence. Medication usage declined remarkably. Quality of life (QoL) by the SF-36 showed highly significant improvements. CONCLUSIONS: At 1 year after LAGB, patients had experienced significant weight loss, resolution of comorbidities, decreases in medication usage, and improvements in QoL.

Empowerment and self-management after weight loss surgery.

The bariatric surgery health-care professional team are often frustrated and discouraged when patients are unwilling or unable to follow their advice to achieve ideal outcomes after obesity surgery. The acute care model that suffices for other types of surgery is inadequate after a surgery that requires chronic life-long behavioral changes. Practical interventions that facilitate collaborative relationships and foster patient-centered practices are the key to giving up feeling responsible for the choices that patients make, by being responsible to them, and achieving better outcomes.

Laparoscopic adjustable gastric banding: early experience in 400 consecutive patients in the USA.

BACKGROUND: Early experience with 400 consecutive patients who underwent laparoscopic adjustable gastric banding (LAGB) is reported. METHODS: From Nov 2002 to Aug 2004, prospective data were collected on 400 consecutive LAGB patients and evaluated retrospectively. RESULTS: There were 354 (88.5%) females and 46 males (11.5%), with mean age 43.6 years and mean BMI 46.2 kg/m2. For outpatients (freestanding ambulatory surgery center), mean OR time was 55.4 min in 208 patients (52%), compared to mean inpatient OR time of 70.5 min in 192 patients. Inpatients had a higher BMI (48.2 +/- 9.3 SD) than outpatients (43.9 +/- 5.7 SD) (P<0.0001). Complications occurred in 35 patients (8.8%). These consisted of 9 slipped bands (2.3%) that were surgically repositioned, 6 port problems (1.5%) that were successfully repaired, 17 patients with temporary stoma occlusion (4.3%) that spontaneously resolved, and 2 bowel perforations (0.5%) that required surgical repair and band removal. One patient died of pneumonia 2 weeks after an uneventful procedure. Average 1-year percent excess weight loss (%EWL) in 138 patients was 48.2%. Patients who had < or =50 kg initial excess weight (n=37, 27%) had a significantly higher %EWL (55.2%) at 1 year than patients who had >50 kg initial excess weight (P=0.0011). CONCLUSIONS: LAGB has been safe and effective thus far for the surgical treatment of morbid obesity, and can be performed as an outpatient in select patients.

Biomechanical differences among pes cavus, neutrally aligned, and pes planus feet in subjects with diabetes.

The purpose of this study was to quantify differences in joint range of motion, foot deformity, and foot morphology among pes cavus, neutrally aligned, pes planus rigid, and pes planus flexible feet. A cohort of 1047 veterans with diabetes (contributing 2047 feet) was enrolled in a prospective study of diabetic ulcer risk factors (the Seattle Diabetic Foot Study). Significant differences between foot types were found. Pes cavus feet had an increased percentage of prominent metatarsal heads, bony prominences, and hammer/claw toes (p < .0001), as well as significantly increased amounts of hallux dorsiflexion and decreased amounts of hallux plantarflexion (p < .0001) with a total range of motion equal to the other foot types (p = .3). Neutrally aligned feet had a lower percentage of intrinsic muscle atrophy, bony prominences, and hammer/claw toes (p < .0001). Pes planus feet had an increased lateral talometatarsal angle (p < .0001) and an increased second metatarsal length. These data demonstrate structural differences between foot types in a population with diabetes.

Prospective study of autonomic neuropathy as a predictor of mortality in patients with diabetes.

OBJECTIVE: The objective of this study is to evaluate whether autonomic neuropathy predicts short term all-cause mortality in an elderly cohort of veteran patients with diabetes. RESEARCH DESIGN AND METHODS: All of the diabetic patients receiving primary care at one VA medical center were eligible for participation, between 1990 and 1997. One thousand and fifteen patients were identified, of whom 14% declined to participate, so that a total of 843 diabetic patients were enrolled. Autonomic neuropathy was evaluated by heart rate response to timed deep breathing. One hundred and fifty one patients have died since the onset of the study. RESULTS: Mean follow-up was 42.4 months. Subjects who died had greater diabetes duration compared with survivors (13.1 vs. 11.4 years, P=0.04) but were comparable with regards to type of diabetes and mean glycosylated hemoglobin level. The Cox proportional hazards analysis, adjusting for age, smoking status, creatinine, pack-years of cigarettes smoked, diabetes duration, race, history of ischemic heart disease and hypertension showed that those patients with the lowest quintile of heart rate variability had a significantly increased risk of mortality (hazard ratio=1.49, 95% confidence limits 1.01-2.19). CONCLUSIONS: This study supports the hypothesis that decreased heart rate variability is an independent risk factor for mortality in diabetic patients followed in a primary care setting.

Relationship of medial arterial calcinosis to autonomic neuropathy and adverse outcomes in a diabetic veteran population.

STATEMENT OF THE PROBLEM: Medial arterial calcinosis (MAC) is associated with neuropathy, amputation, and mortality through an unknown mechanism. We hypothesized that MAC was a marker of autonomic neuropathy rather than a risk factor and that the outcomes were due to autonomic neuropathy. METHODS: All subjects in an ongoing prospective study of diabetic foot conditions in a diabetic veteran cohort who received a foot radiograph between 11/7/90 and 11/5/93 were included. Autonomic neuropathy measured as either heart rate variability with timed respiration or postural hypotension. A logistic model predicted the presence of MAC at baseline and Cox proportional models assessed the relative contribution of autonomic neuropathy and traditional risk factors for the outcomes of ulceration, amputation, and death. RESULTS: MAC was identified in 181 subjects, no MAC in 253 subjects, and 39 were excluded due to disagreement between observers. Both measures of autonomic neuropathy were independent predictors of MAC at baseline, even after adjustment for vibration sensation loss in a logistic model. MAC was associated with an increased risk for ulceration (hazards ratio, HR: 2.1, 95% confidence intervals, CI, 1.4-3.1), amputation (HR 3.3, 95% CI 1.5-7.4), and mortality (HR 1.6, 95% CI 1.1-2.2). The addition of either autonomic measure of neuropathy did not change the MAC HR or significantly improved the fit of the model. CONCLUSIONS: Our hypothesis that the excess mortality, amputation, and ulceration in persons with MAC could be explained by autonomic neuropathy measured as postural hypotension or heart rate variability with measured respiration was not supported.