Revascularizations and limb outcomes of hospitalized patients with diabetic peripheral arterial disease in the contemporary era.

BACKGROUND: Concomitant diabetes mellitus and peripheral artery disease (PAD) is a complex disease process. This retrospective analysis of the National Inpatient Sample sought to understand trends in limb outcomes of this unique and prevalent cohort of patients. METHODS: The National Inpatient Sample was queried between 2003 and 2017 for hospitalizations of patients with both type 2 diabetes mellitus and PAD. Trends in hospitalizations, limb outcomes, vascular interventions, and costs were analyzed. RESULTS: There were 10,303,673 hospitalizations of patients with concomitant diabetes mellitus and PAD that were identified between 2003 and 2017. The prevalence of hospitalizations associated with this disease process increased from 1644 to 3228 per 100,000 hospitalizations, a 96.4% increase. This included an increase of 288 to 587 per 100,000 hospitalizations of patients aged 18 to 49 years old, which was accompanied by a 10.8% increase in minor amputations. Nontraumatic lower extremity amputations decreased overall. Black and Hispanic ethnicity were associated with an increased risk for amputation, along with Medicaid insurance and lower income quartile. Inpatient endovascular revascularization has increased over time with an associated decrease in open revascularization procedures. Amputation-related hospital costs significantly increased from $6.6 billion in 2003 to $14.8 billion in 2017. CONCLUSIONS: An alarming increase of disease prevalence, negative in-hospital limb outcomes, and costs are seen in the current era in this analysis of patients with concurrent diabetes and PAD.

Assessment of Tissue Viability Following Amputation Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green.

BACKGROUND: Patients with chronic limb threatening ischemia have a risk of undergoing a major amputation within 1 year of nearly 30% with a substantial risk of re-amputation since wound healing is often impaired. Quantitative assessment of regional tissue viability following amputation surgery can identify patients at risk for impaired wound healing. In quantification of regional tissue perfusion, near-infrared (NIR) fluorescence imaging using Indocyanine Green (ICG) seems promising. METHODS: This pilot study included adult patients undergoing lower extremity amputation surgery due to peripheral artery disease or diabetes mellitus. ICG NIR fluorescence imaging was performed within 5 days following amputation surgery using the Quest Spectrum PlatformⓇ. Following intravenous administration of ICG, the NIR fluorescence intensity of the amputation wound was recorded for 10 minutes. The NIR fluorescence intensity videos were analyzed and if a fluorescence deficit was observed, this region was marked as "low fluorescence." All other regions were marked as "normal fluorescence." RESULTS: Successful ICG NIR fluorescence imaging was performed in 10 patients undergoing a total of 15 amputations. No "low fluorescence" regions were observed in 11 out of 15 amputation wounds. In 10 out of these 11 amputations, no wound healing problems occurred during follow-up. Regions with "low fluorescence" were observed in 4 amputation wounds. Impaired wound healing corresponding to these regions was observed in all wounds and a re-amputation was necessary in 3 out of 4. When observing time-related parameters, regions with low fluorescence had a significantly longer time to maximum intensity (113 seconds vs. 32 seconds, P = 0.003) and a significantly lesser decline in outflow after five minutes (80.3% vs. 57.0%, P = 0.003). CONCLUSIONS: ICG NIR fluorescence imaging was able to predict postoperative skin necrosis in all four cases. Quantitative assessment of regional perfusion remains challenging due toinfluencing factors on the NIR fluorescence intensity signal, including camera angle, camera distance and ICG dosage. This was also observed in this study, contributing to a large variety in fluorescence intensity parameters among patients. To provide surgeons with reliable NIR fluorescence cut-off values for prediction of wound healing, prospective studies on the intra-operative use of this technique are required. The potential prediction of wound healing using ICG NIR fluorescence imaging will have a huge impact on patient mortality, morbidity as well as the burden of amputation surgery on health care.

Predictors of outcome in diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. METHODS: Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. RESULTS: A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P = .015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P = .033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P = .023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P = .014). CONCLUSIONS: Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group.

Early ABI Testing May Decrease Risk of Amputation for Patients With Lower Extremity Ulcers.

BACKGROUND: Patients with lower extremity wounds from diabetes mellitus or peripheral artery disease (PAD) have a risk of amputation as high as 25%. In patients with arterial disease, revascularization decreases the risk of amputation. We aimed to determine if the early assessment of arterial perfusion correlates with the risk of amputation. METHODS: We retrospectively reviewed patients referred to the vascular clinic over 18 months with Rutherford Grade 5 and 6 chronic limb-threatening ischemia to determine if patients had a pulse exam done at the time the wound was identified and when ankle brachial index (ABI) testing to evaluate perfusion was performed. Kaplan Meier analysis was used to determine if the timing of ABI testing affected the time to revascularization, wound healing, and risk of amputation. RESULTS: Ninety-three patients with lower extremity wounds were identified. Of these, 59 patients (63%) did not have a pulse exam performed by their primary care provider when the wound was identified. Patients were classified by when they underwent ankle brachial index testing to assess arterial perfusion. Twenty-four had early ABI (<30 days) testing, with the remaining 69 patients having late ABI testing. Patients in the early ABI group were more likely to have a pulse exam done by their PCP than those in the late group, 12 (50%) vs. 22 (32%), P = 0.03. Early ABI patients had a quicker time to vascular referral (13 days vs. 91 days, P < 0.001). Early ABI patients also had quicker times to wound healing than those in the late group (117 days vs. 287 days, P < 0.001). Finally, patients that underwent early ABI were less likely to require amputation (Fig. 1), although this did not reach statistical significance (P = 0.07). CONCLUSIONS: Early ABI testing expedites specialty referral and time to revascularization. It can decrease the time to wound healing. Larger cohort studies are needed to determine the overall effect of early ABI testing to decrease amputation rates.

Real-world barriers and safety of initiating sodium-glucose co-transporter 2 inhibitor treatment immediately following an acute cardiac event in people with diabetes.

In this real-world study, the main barriers for not initiating SGLT2 inhibitor therapy early after an acute cardiac event are prescribing criteria around glycated haemoglobin and renal function. Initiation of SGLT2 inhibitors near to, or at, hospital discharge following the cardiac event was not associated with 30-day diabetic ketoacidosis readmissions.

The Importance of Prognostic Nutritional Index in Predicting Acute Renal Failure After On-Pump Coronary Artery Bypass Operations in Patients with Insulin-Dependent Diabetes Mellitus.

BACKGROUND: After coronary artery bypass graft (CABG) operations, acute kidney injury (AKI) appears at 5-30% rates, and this rate increases even more in patients with diabetes mellitus (DM). Prognostic nutritional index (PNI) is known as a valuable parameter that affects cardiovascular surgery outcomes. In this current study, we aimed to investigate the importance of PNI value in predicting AKI after on-pump CABG operations in insulin-dependent diabetic patients. METHODS: A total of 254 consecutive patients with insulin- dependent diabetes who underwent on-pump CABG in our clinic between January 2016 and January 2020 retrospectively were included in this study. In the postoperative period, patients were registered as the renal failure group (Group 1), and those who did not develop renal failure were registered as Group 2. RESULTS: A total of 255 patients with DM were included in the study. There were 82 patients in Group 1 and 173 patients in Group 2. There was no difference between the groups, in terms of age, gender, smoking, and hyperlipidemia rates. Hypertension rate significantly was higher in Group 2 (P = .001). In multivariate logistic regression analysis, hypertension (OR: 1.226, 95% CI: 1.114-2.459, P = .026), need for inotropic support (OR: 1.128, 95% CI: 1.070-1.784, P = .033), increased blood product use (OR: 1.291, 95% CI: 1.112-2.156, P = .021) preoperative high creatinine (OR: 3.563, 95% CI: 2.497-5.559, P < .001), and PNI (OR: 1.327, 95% CI: 1.118-2.785, P = .012) were independent predictors of AKI. CONCLUSION: In our study, we determined PNI value as an independent predictor in predicting acute renal injury occurring after on-pump CABG operations in patients with insulin-dependent DM.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

Effect of umbilical cord blood stem cell transplantation on restenosis after endovascular interventional therapy for diabetic hindlimb vascular disease.

This study aimed to investigate the mechanism of human umbilical cord blood stem cell (HUCBSC) transplantation on restenosis after percutaneous transluminal angioplasty (PTA) for diabetic hindlimb vascular disease in rabbits. After successfully preparing a rabbit model of diabetic hindlimb vascular disease, 16 rabbits were randomly assigned to two groups. Of these, 8 rabbits received PTA surgery alone (PTA group), and the other 8 rabbits received PTA and HUCBSC (PTA+HUCBSC group) treatments. Five more healthy rabbits were set as healthy control (HC group). Samples were collected after 4 weeks of treatment. The expressions of regulator of calcineurin 1 (RCAN1) and calcineurin A (CnA) in the diseased artery were detected by immunofluorescence staining. The distribution of HUCBSCs was observed by pathological examination in transplanted artery, distal artery, and liver. Cytology experiments were applied to assess the levels of JAK and STAT3, and the migration and proliferation of human aortic vascular smooth muscle cells (HA-VSMC). In the rabbit model of diabetic vascular lesions in the hindlimbs, we found the stenosis of the femoral artery became more and more serious with time, and the expression level of PCNA positive cells was also gradually increased. The expression levels of RCAN1 and CnA in the PTA+HUCBSC group were significantly lower than those in PTA group. HUCBSC inhibited the migration and proliferation of HA-VSMC via JAK/STAT3 pathway. After HUCBSC local transplantation, HUCBSC had no distal tissue distribution. HUCBSC transplantation may prevent restenosis after PTA of diabetic hindlimb vascular disease through JAK/STAT3 pathway.

Evaluation of Clinical Outcomes Following Minor Amputations in Australia - An Important Consideration for Timing of Revascularisation.

BACKGROUND: Vascular patients with tissue loss requiring minor amputations could be an early sign of a terminal event. The long-term outcomes and timing of revascularisation for these patients are not well-studied. The aim of this study was to determine the clinical outcomes following minor amputations. Primary outcomes were functional status, limb loss, and mortality. Secondary outcomes compared immediate and delayed revascularisation. METHODS: A retrospective analysis of 200 vascular patients who required minor amputations at Austin Hospital, Melbourne was performed over 5 years. Demographics, details of revascularisation, functional status, and clinical outcomes such as recurrent tissue loss, limb loss and death were recorded. RESULTS: Of the entire cohort requiring minor amputations, 118 (59%) patients underwent revascularisation. 111 (94%) revascularisation procedures were performed within 90 days of minor amputation. Over all 5-year limb preservation was 89.9%. Patients who required revascularisation were not statistically significantly more at risk for limb loss at 5 years [13.6% vs. 6.6%; P=0.08]. Limb salvage at 1 year was not different between groups revascularized before and after amputation [89.5% vs. 90.9%; P=0.70]. Over all 5-year mortality rate was 50%. In the diabetic subset, those who had revascularisation after minor amputation had a greater 5-year mortality [67.9% vs. 50%; P=0.03]. A scoring system based on risk factors was developed but was not reliable based on the study data. CONCLUSIONS: The data from this study suggest that patients with diabetes who undergo revascularisation after minor amputation have worse outcomes than those revascularised prior to minor amputation. A predictive model applied at presentation could help detect high-risk patients but requires further work.

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review.

OBJECTIVE: Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes. METHODS: A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs. RESULTS: Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM. CONCLUSION: A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

Diabetes management during cardiac surgery in the UK: A survey.

AIM: To determine current practice regarding the diabetes management of people undergoing cardiac surgery in the UK. METHODS: We conducted an online survey of UK cardiothoracic surgeons. All cardiothoracic surgeons listed in the Society of Cardiothoracic Surgery membership directory were invited to participate. The survey, compiled using SurveyMonkey software, comprised 15 closed and open-ended questions about the management of people with diabetes pre- and peri-operatively. RESULTS: Sixty-two cardiothoracic surgeons from all 33 UK cardiac centres completed the survey. Of these, 44% responded that they routinely measure HbA1c preoperatively for all patients, 19% had an HbA1c threshold above which they would not operate and 21% currently undertake a point-of-care HbA1c measurement during the cardiothoracic outpatient visit. A total of 74% of respondents reported that it was 'easy' or 'very easy' to obtain a diabetes team review; diabetes nurse specialists were the members of the diabetes team working most closely with cardiac surgeons. Up to a third of the surgeons did not provide physical activity recommendations prior to admission and over 80% did not have a different preoperative or surgical diabetes protocol. Inconsistency in the responses within centres suggests that differences in practice may depend on individual surgeons rather than local policy. CONCLUSIONS: The study demonstrates there is only limited peri-operative management of diabetes in people undergoing cardiac surgery in the UK. There is an opportunity for greater involvement of the diabetes specialist team both before and during admission for surgery to improve outcomes. (Trial registration: ISRCTN10170306).

Five-year follow-up observation of interventional therapy for lower extremity vascular disease in type 2 diabetes and analysis of risk factors for restenosis.

BACKGROUND: The high incidence of type 2 diabetes, the low rate of compliance, and the complex mechanism of vascular disease caused by diabetes make its complications increase year by year. Our study aimed to investigate the clinical characteristics of lower extremity vascular diseases in type 2 diabetes and evaluate the long-term efficacy of vascular intervention for these diseases. METHODS: From 2007 to 2014, 362 patients who underwent vascular intervention in our hospital due to lower extremity vascular diseases in type 2 diabetes were followed up for 5 years and their clinical characteristics were analyzed in this retrospective study. RESULTS: Compared with those before treatment, the values of blood pressure, fasting blood glucose, glycated hemoglobin (HbA1c), total cholesterol (TC), triglyceride Ester (TG), and low density lipoprotein-cholesterol (LDL-C) of patients were significantly lower 5 years after intervention (P < 0.01). We found that the levels of fibrinogen, blood glucose, HbA1c, TC, TG, LDL-C, and small dense low-density lipoprotein (sdLDL) in the vascular restenosis group were significantly higher than those in the vascular patency group (P < 0.001), whereas the level of HDL-C in the vascular restenosis group was significantly lower compared with the vascular patency group. CONCLUSIONS: Vascular intervention can significantly improve a series of biochemical indicators in patients with lower extremity vascular diseases caused by type 2 diabetes. Postoperative restenosis may be related to hypertension, duration of diabetes, rate of inferior knee disease, fibrinogen, and sdLDL. Good survival and limb salvage were achieved in the patients in this series with interventions and medical treatment provided by endocrinologists.

Regional health care services and rates of lower extremity amputation related to diabetes and peripheral artery disease: an ecological study.

BACKGROUND: The care necessary to prevent amputation from diabetes and peripheral artery disease (PAD) remains disjointed in many jurisdictions. To help inform integrated regional care, this study explores the correlation between regional health care services and rates of lower extremity amputation. METHODS: This ecological study included 14 administrative health regions in Ontario, Canada. All diabetes- or PAD-related major (above ankle) amputations (Apr. 1, 2007, to Mar. 31, 2017) were identified among residents 40 years of age and older. For each region, age-and sex-adjusted amputation rates were calculated as well as per capita counts of key health providers (podiatrists and chiropodists, as well as surgeons) and health care utilization among study patients in the year before the first major amputation (physician visits, publicly funded podiatry visits, emergency department visits, hospital admissions, home care nursing, minor amputation, limb revascularization). RESULTS: A total of 11 658 patients with major amputation were identified (of whom 79.2% had diabetes and 96.5% had PAD). There was wide regional variation in amputation rates: 2.53 to 11.77 per 100 000 person-quarters. At a regional level, the proportion of study patients who received revascularization showed the strongest negative correlation with amputation rates. The regional proportion of study patients who saw a vascular surgeon showed the strongest negative correlation with amputation rates, relative to other health provider visits. Other measures of health care utilization among patients correlated poorly with regional amputation rates, as did the regional provider counts. The results were similar when we restricted the analysis to diabetes-related amputations. INTERPRETATION: Amputation rates related to diabetes and PAD vary widely across Ontario. Access to vascular assessment and revascularization must be integrated into regional amputation prevention efforts.

Sortilin levels correlate with major cardiovascular events of diabetic patients with peripheral artery disease following revascularization: a prospective study.

BACKGROUND: Peripheral artery disease (PAD) represents one of the most relevant vascular complications of type 2 diabetes mellitus (T2DM). Moreover, T2DM patients suffering from PAD have an increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Sortilin, a protein involved in apolipoproteins trafficking, is associated with lower limb PAD in T2DM patients. OBJECTIVE: To evaluate the relationship between baseline serum levels of sortilin, MACE and MALE occurrence after revascularization of T2DM patients with PAD and chronic limb-threatening ischemia (CLTI). RESEARCH DESIGN AND METHODS: We performed a prospective non-randomized study including 230 statin-free T2DM patients with PAD and CLTI. Sortilin levels were measured before the endovascular intervention and incident outcomes were assessed during a 12 month follow-up. RESULTS: Sortilin levels were significantly increased in individuals with more aggressive PAD (2.25 ± 0.51 ng/mL vs 1.44 ± 0.47 ng/mL, p < 0.001). During follow-up, 83 MACE and 116 MALE occurred. In patients, who then developed MACE and MALE, sortilin was higher. In particular, 2.46 ± 0.53 ng/mL vs 1.55 ± 0.42 ng/mL, p < 0.001 for MACE and 2.10 ± 0.54 ng/mL vs 1.65 ± 0.65 ng/mL, p < 0.001 for MALE. After adjusting for traditional atherosclerosis risk factors, the association between sortilin and vascular outcomes remained significant in a multivariate analysis. In our receiver operating characteristics (ROC) curve analysis using sortilin levels the prediction of MACE incidence improved (area under the curve [AUC] = 0.94) and MALE (AUC = 0.72). CONCLUSIONS: This study demonstrates that sortilin correlates with incidence of MACE and MALE after endovascular revascularization in a diabetic population with PAD and CLTI.

Serum discrimination and phenotype assessment of coronary artery disease patents with and without type 2 diabetes prior to coronary artery bypass graft surgery.

Diabetes Mellitus (DM) accelerates coronary artery disease (CAD) and atherosclerosis, the causes of most heart attacks. The biomolecules involved in these inter-related disease processes are not well understood. This study analyzes biomolecules in the sera of patients with CAD, with and without type (T) 2DM, who are about to undergo coronary artery bypass graft (CABG) surgery. The goal is to develop methodology to help identify and monitor CAD patients with and without T2DM, in order to better understand these phenotypes and to glean relationships through analysis of serum biomolecules. Aorta, fat, muscle, and vein tissues from CAD T2DM patients display diabetic-related histologic changes (e.g., lipid accumulation, fibrosis, loss of cellularity) when compared to non-diabetic CAD patients. The patient discriminatory methodology utilized is serum biomolecule mass profiling. This mass spectrometry (MS) approach is able to distinguish the sera of a group of CAD patients from controls (p value 10-15), with the CAD group containing both T2DM and non-diabetic patients. This result indicates the T2DM phenotype does not interfere appreciably with the CAD determination versus control individuals. Sera from a group of T2DM CAD patients however are distinguishable from non-T2DM CAD patients (p value 10-8), indicating it may be possible to examine the T2DM phenotype within the CAD disease state with this MS methodology. The same serum samples used in the CAD T2DM versus non-T2DM binary group comparison were subjected to MS/MS peptide structure analysis to help identify potential biochemical and phenotypic changes associated with CAD and T2DM. Such peptide/protein identifications could lead to improved understanding of underlying mechanisms, additional biomarkers for discriminating and monitoring these disease conditions, and potential therapeutic targets. Bioinformatics/systems biology analysis of the peptide/protein changes associated with CAD and T2DM suggested cell pathways/systems affected include atherosclerosis, DM, fibrosis, lipogenesis, loss of cellularity (apoptosis), and inflammation.

Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation.

OBJECTIVE: To identify timing, incidence, and risk factors for ipsilateral re-amputation within 12 months of first dysvascular amputation and to determine specific subgroups of patients at each amputation level that are at increased risk. METHODS: A retrospective cohort study evaluating 7187 patients with first unilateral transmetatarsal (TM), transtibial (TT), or transfemoral (TF) amputation secondary to diabetes and/or peripheral artery disease (PAD) were identified in the VA Surgical Quality Improvement Program database between 2004 and 2014. Re-amputation was defined as any subsequent ipsilateral soft tissue/bony revision or amputation to a higher level. Twenty-three potential pre-operative risk factors (and nine potential interactions) were identified. A backward stepwise Cox regression was used to identify risk factors. Incidence rates and hazard ratios (HR) with 95% confidence intervals (CI) were computed. RESULTS: The median time to highest level of re-amputation in the first year was 33 (interquartile range, 13-73) days. Risk of requiring at least one re-amputation was 41% (TM), 25% (TT), and 9% (TF). Risk factors associated with requiring re-amputation included chronic obstructive pulmonary disease, elevated white blood cell count, abnormal ankle brachial index (ABI), history of revascularisation, and alcohol misuse. TM patients who had diabetes only (HR 1.9; 95% CI 1.4-2.5), diabetes with an abnormal ankle brachial index (ABI) score (HR 2.4; 95% CI 1.8-3.2), and kidney failure (HR 1.7; 95% CI 1.3-2.1) were at the greatest risk of re-amputation. TT amputees who were smokers were also at an increased risk (HR 1.4; 95% CI 1.2-1.6). CONCLUSION: This research identified important risk factors for failure of primary healing and need for re-amputation at the TM and TT level. If considering a TM amputation, caution should be exercised in patients with diabetes, in particular those with an abnormal ABI and/or renal failure. At the TT level, caution should be exercised in those who smoke.

Rates and timing of subsequent amputation after initial minor amputation.

OBJECTIVE: Studies evaluating major amputation after initial minor amputation are few with rates of subsequent major amputation ranging from 14% to 35% with limited understanding of associated comorbidities and time to limb loss. The aim of this study is to determine the major amputation rates for patients who had already undergone an initial minor amputation and determine which factors are associated with the need for subsequent major amputation. METHODS: Using statewide data between 2005 and 2013, patients with peripheral artery disease (PAD), diabetes mellitus (DM), and combined PAD/DM who had a lower extremity ulcer and who had also undergone a minor amputation were identified. These patients were evaluated for the rate of subsequent major amputation and competing risk Cox proportional hazards modeling was used to study which factors were associated with the risk of subsequent limb loss. RESULTS: The cohort consisted of 11,597 patients (DM, n = 4254; PAD, n = 2142; PAD/DM, n = 5201) with lower extremity ulcers who underwent an initial minor amputation. The rate of any subsequent amputation was highest in patients with PAD/DM (23% vs DM = 17%, PAD = 17%; P = not statistically significant). The rate of subsequent minor amputation was 16% in the PAD/DM versus 15.2% in PAD and 12.2% in patients with DM (P < .001). Patients with PAD/DM had the highest rate of subsequent major amputation (6.3% vs DM = 5.2%, PAD = 2.1%; P < .001). There was no statistically significant difference in the median time to major amputation among the three groups (PAD/DM, 13 months; DM, 14 months; PAD, 8.6 months; P = NS). Patients who were revascularized before a repeat minor amputation had a decreased risk of a major amputation compared with those who were intervened on after a repeat minor amputation (hazard ratio, 0.002; 95% confidence interval, 0-0.22). Patients treated completely in the outpatient setting were also less likely to undergo subsequent major amputation (hazard ratio, 0.7; 95% confidence interval, 0.5-0.98) compared with those who required hospitalization or presented to the emergency room. CONCLUSIONS: Patients with ulcers and combined PAD and DM have a higher risk for secondary major and minor amputation than patients with either disease alone with half of the limb loss occurring at approximately 1 year after the initial minor amputation. Additionally, early diagnosis and appropriate referral may result in decreased limb loss for these patients.

Preoperative sepsis is a predictive factor for 30-day mortality after major lower limb amputation among patients with arteriosclerosis obliterans and diabetes.

BACKGROUND: While many patients with lower limb ischemia also have severe infections, few studies have investigated whether the presence of preoperative sepsis affects patient prognosis following lower limb amputation (LLA). Therefore, we investigated the factors (including sepsis as defined in SEPSIS-3) that contribute to the acute mortality rate in patients who underwent LLA due to arteriosclerosis obliterans (ASO) or diabetes mellitus (DM). METHODS: In this retrospective, single-center, 10-year chart review study, 122 adult patients who underwent LLA due to ASO and/or DM were identified from 56,438 surgery cases. Patient characteristics, including co-morbidities, surgical conditions, the presence/absence of sepsis, and acute physiological condition after surgery, were investigated in patients who died within 30 days of LLA and those who survived. Univariate analysis between groups was performed using the chi-square test. Comparisons of age and American Society of Anesthesiologists-Physical Status classification between groups were performed using the Mann-Whitney U test. Risk factors for 30-day mortality after LLA were examined using stepwise logistic regression (backward elimination). Statistical results were considered significant at P < 0.05. RESULTS: Eight cases of mortality (6.6%) were found; we identified the causes as sepsis, myocardial infarction, fatal arrhythmia, and mesenteric artery occlusive disease in 5 (62.5%), 1 (12.5%), 1 (12.5%), and 1 (12.5%) cases, respectively. Using univariate analysis, we identified that age (≥74), delirium, sepsis, intensive care unit admission, non-DM (ASO only), hemodialysis, and acute kidney injury were significantly higher in the mortality group. In logistic regression analysis, non-DM (odds ratio [OR]: 35.2, 95% confidence interval [CI]: 2.8-432) and sepsis (OR: 80.7, 95% CI: 6.7-959) were potential risk factors for 30-day mortality. CONCLUSIONS: This study suggests that cases resulting in amputation due to ASO pathology alone might have poor prognosis and that preoperative sepsis can increase perioperative mortality; hence, the decision to amputate must be considered before the development of sepsis.

Biodegradable polymer drug-eluting stent vs. contemporary durable polymer drug-eluting stents in patients with diabetes: a meta-analysis of randomized controlled trials.

AIMS: The biodegradable polymer drug-eluting stents (BP-DES) offer controlled drug elution and complete degradation of the polymer over time, eventually lowering the risk for chronic inflammation and neoatherosclerosis, which can be particularly helpful in patients with diabetes. While BP-DES and durable polymer drug-eluting stents (DP-DES) have demonstrated comparable efficacy in all-comers population, their efficacy and safety in patients with diabetes remains uncertain. METHODS AND RESULTS: Electronic databases were systematically searched for randomized controlled trials (RCTs) comparing BP-DES with contemporary DP-DES in patients with diabetes. Study investigators were contacted to obtain additional data. The primary outcome was efficacy in terms of target-vessel revascularization (TVR) and target-lesion revascularization (TLR). We also evaluated the following safety outcomes separately: all-cause mortality, cardiac mortality, myocardial infarction (MI), and definite or probable stent thrombosis. Eleven RCTs including 5190 diabetic patients were included. At the longest available follow-up (mean 2.7 years), there was no significant difference in TLR [relative risk (RR): 1.02, 95% confidence interval (CI): 0.85-1.24; P = 0.80] or TVR (RR: 1.04, 95% CI: 0.81-1.34; P = 0.76). Safety outcomes of all-cause mortality, cardiac mortality, and MI were similar between the two groups. Stent thrombosis rates were also similar between BP-DES and DP-DES groups (1.66% vs. 1.83%; RR: 0.84, 95% CI: 0.54-1.31; P = 0.45). The heterogeneity was low and fixed-effect model yielded similar results. Meta-regression analysis showed no relationship between insulin requiring diabetes and difference in TLR or stent thrombosis between BP-DES and DP-DES. CONCLUSION: Overall, BP-DESs have similar safety and efficacy profiles compared to contemporary DP-DES in patients with diabetes.