Major Amputation Rate Research Articles

Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) affects 200 million individuals worldwide. In the United States, certain demographic groups experience a disproportionately higher prevalence and clinical effect of PAD. The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society. Herein, we present an overview statement of the myriad variables that contribute to PAD disparities and conclude with a summary of potential novel solutions.

#4880 SUCCESSFUL LIMB SALVAGE IN A CHALLENGING PATIENT ON DIALYSIS BY IMPLANTATION OF AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS: A CASE REPORT

Abstract Background and Aims Peripheral arterial disease (PAD) is an extremely common condition in patients with End-Stage Renal Disease (ESRD) on dialysis. Concomitant comorbidity such as diabetes may be associated with complex vascular dysfunction, and ESRD itself is a recognized risk factor for PAD leading to non healing ulcers and lower limb amputation, which occurs in a high rate of patients [1]. Despite improvement in endovascular techniques for lower extremity revascularization, the incidence of limb salvage among dialysis patients remains poor. Furthermore, lower extremity amputation in these patients is associated with higher mortality rates [2], in addition to important social and economic implications. In this Case Report, an emergent therapy approach was applied aiming to limb salvage in a 74 years old female patient on hemodialysis suffering from lower extremity critical ischemia in diabetic foot infection, otherwise candidate for major amputation, after ineffective angioplasty and Negative Pressure Wound Therapy (NPWT). Method After surgical debridement of the ischemic lesion, an innovative therapeutic approach [3] was performed. It consisted in implantation, in the perilesional area of the affected lower limb, of a concentrate of autologous peripheral blood mononuclear cells (PBMNC) taken from 120 ml of peripheral blood of the patient, by using a selective filtration separation system. This procedure was managed in the operating room and was repeated three times at intervals of 15 days from each other. Since concomitant osteomyelitis occurs in the ischemical diabetic foot under treatment, it was managed with a 2-dose regimen of weekly Dalbavancin, reaching infection control. The patient was followed twice a week for 7 months for regular medications. Results After the treatment approach, the granulation tissue improved gradually, obtaining complete surgical wound healing. Since toes gangrene occurs, amputation of the toes was necessary, but limb rescue was successfully reached. Conclusion The autologous implantation of PBMNC resulted in limb salvage in this patient on dialysis affected by critical peripheral arterial disease in diabetic foot. This approach has not been described in literature among patients on dialysis, despite the higher mortality rate associated with lower limb amputation in these patients. It seems to be a very promising therapy, with the potential to modify the natural history of no-options critical limb with diabetes complications, in terms of major amputation and overall survival rates. After thorough validation, the reported management could be considered for similar cases.

Sex-based differences in outcomes after lower extremity bypass for chronic limb-threatening ischemia

Background and aimsLower extremity bypass surgery is an effective treatment option for patients with chronic limb-threatening ischemia (CLTI). Recent studies have suggested that sex-based differences may impact patient outcomes following lower extremity revascularization, however, results have been inconsistent. MethodsIn this multicenter analysis, we retrospectively identified all infrainguinal bypass procedures performed for CLTI from 2002 to 2021. Patients were separated into two groups based on sex. Primary outcomes were major limb amputation and reintervention for graft patency. ResultsOf 843 bypasses performed over the study period, 347 (41.2%) patients were female. Racial/ethnic distribution and medical comorbidities were similar across sex groups. Surgical indications and operative details were also similar between groups, including conduit type (49.9% autogenous), bypass target (65.4% infrageniculate), and concurrent endarterectomy (38.9%). Female and male patients had similar hospital length of stay (6 days [4-9] vs 6 days [4-9]), hospital readmission (25.6% vs 25.0%), and postoperative complications (p=NS each). Female patients had higher major amputation rates (10.1% vs 6.3%, p=0.04) after one year, whereas reintervention rates were similar between groups (26.2% vs 24.6%, p=NS). After accounting for patient factors, female sex (odds ratio [OR] 1.02 [1.00–1.04]), infrageniculate target (OR 1.02 [1.00–1.04]), and bypass for tissue loss (OR 1.02 [1.00–1.04]) were associated with major amputation after bypass (p<0.05 each). ConclusionsFemale sex is associated with a small but significant increase major amputation after lower extremity bypass surgery for CLTI, despite similar clinical presentation, medical comorbidities, and operative details. These data support the increasingly recognized sex disparities in peripheral arterial disease.

Outcomes of a multidisciplinary Diabetic Foot Day Unit

ObjectiveTo analyse the main characteristics of patients and the health outcomes obtained and to evaluate the impact of peripheral artery disease (PAD) in patients treated in our multidisciplinary Diabetic Foot Unit. Research design and methodsObservational prospective study. 273 patients from two different populations (with and without PAD – classified according to the presence of distal pulses) treated over a 14-month period in the multidisciplinary Diabetic Foot Unit were included. The data on patient characteristics and outcomes were analysed for the purpose of comparison. For the inference study, a comparison of medians with the non-parametric test for independent samples for the quantitative variables and a χ2 test for the comparison of proportions in qualitative variables were performed. ResultsPatients with PAD ulcers were older (60 (54–67) vs. 64 (75–81), p=0.000) and had a higher macrovascular burden (8.1% vs. 29% for ischaemic heart disease history, p=0.000; 6.7% vs. 18.1% for cerebrovascular disease history, p=0.004). Their Texas Score was higher (p=0.000) and their major amputation rate was higher (1.4% vs. 12.3%, p=0.001). They had less background of previous ulcers (52.6% vs. 26.8%, p=0.000), their episode duration was shorter (4 (0–10) vs. 0 (0–3) weeks, p=0.000), and their proportional need for antibiotic therapy was lower (64.4% vs. 51.4%, p=0.03). ConclusionsThe differences found between ulcers with and without vascular involvement support the need for a different approach and for the inclusion of vascular surgeons on the team. The multidisciplinary care model for diabetic foot patients could be effective and improve health outcomes.

Outcomes of Aortobifemoral Bypass Based on Configuration of the Proximal Anastomosis

Aortobifemoral bypass (ABF) remains an important treatment modality in the revascularization of aortoiliac occlusive disease. Despite ABF being performed for decades, questions remain regarding the preferred technique for the proximal anastomosis, specifically whether an end-to-end (EE) or an end-to-side (ES) configuration is superior. The goal of this study was to compare the outcomes of ABF based on proximal configuration. We queried the Vascular Quality Initiative (VQI) registry for ABF procedures performed between 2009 and 2020. Univariate and multivariate logistic regression analyses were used to compare peri-operative and 1-year outcomes between EE and ES configurations. Of the 6782 patients (median (interquartile range) age, 60.0 (54-66 years) who underwent ABF, 3524 (52%) had an EE proximal anastomosis and 3258 (48%) had an ES proximal anastomosis. Post-operatively, the ES cohort had a higher frequency of extubation in the operating room (80.3% vs 77.4%; p<0.01), lower change in renal function (8.8% vs 11.5%; p <0.01), and lower use of vasopressors (15.6% vs 19.1%; p<0.01), but higher rates of unanticipated return to the operating room (10.2% vs 8.7%; p=0.037) compared with the EE configuration. At 1-year follow up, the ES cohort had a significantly lower primary graft patency rate (87.5% vs 90.2%; p<0.01) and higher rates of graft revision (4.8% vs 3.1%; p<0.01), and claudication symptoms (11.6% vs 9.9%; p<0.01). The ES configuration was significantly associated with a higher rate of 1-year major limb amputations in univariate (1.6% vs 0.9%; p<0.01) and multivariate (OR, 1.95, CI, 1.18-3.23, p=<0.01) analyses. While the ES cohort seemed to have less physiologic insult immediately post-operatively, the EE configuration appeared to have improved 1-year outcomes. To our knowledge, this study is one of the largest population-based studies comparing the outcomes of the proximal anastomotic configurations. Longer-term follow-up is needed to determine which configuration is optimal.

The Use and Impact of Cilostazol on Patients Undergoing Peripheral Vascular Interventions

Cilostazol is used for the treatment of intermittent claudication. The impact of cilostazol on the outcomes of peripheral vascular interventions (PVIs) remains controversial. This study assesses the use and impact of cilostazol on patients undergoing PVI for peripheral arterial disease (PAD). The Vascular Quality Initiative (VQI) database files for PVI were reviewed. Patients who underwent PVI for PAD were included and divided based on the use of cilostazol preoperatively. After propensity matching for patient demographics and comorbidities, the short-term and long-term outcomes of the two groups were compared. A total of 183,661 patients underwent PVI procedures, and 6.5% (n = 12,014) of them were on cilostazol preoperatively. PVI was performed for claudication in 62% (n = 6174) on cilostazol. Patients that received cilostazol were more likely to be White (77% vs 75%; P < .001) and smokers (84% vs 77%; P < .001). They were more likely to undergo balloon angioplasty (39% vs 31%; P < .001) and less likely to have diabetes mellitus (50% vs 56%; P < .001), congestive heart failure (14% vs 22%; P < .001), and prior amputation (10% vs 19%; P < .001) compared with patients who did not receive cilostazol. After 3:1 propensity matching, there were 37,304 patients included in the analysis. Patients receiving cilostazol had significantly higher incidence of dissection (3.3% vs 2.6%; P = .007) with but were more likely to be discharged home (95% vs 94%; P < .001). Patients on cilostazol had lower rates of long-term mortality (10% vs 12%; P = .003). There were no significant differences in rates of major amputation, reintervention, major adverse limb events, or patency rates after PVI (Table). Amputation-free survival rates were significantly higher for patients on cilostazol, after 4 years of follow-up (90% vs 88%; P = .03) (Fig). Cilostazol is underutilized in the VQI database and seems to be associated with improved amputation-free survival. Cilostazol therapy should be considered in all patients with PAD who can tolerate it prior to PVI.TableCharacteristics and outcomes of patients treated with PVI with and without cilostazol after propensity matchingCharacteristicsNo cilostazol, n = 27,978Cilostazol, n = 9326P-valueaSMDDemographics Age, years68 ± 1068 ± 100.015 Female sex10,108 (36)3446 (37)0.017 Race0.059White21,857 (78)7054 (76)African American4231 (15)1581 (17)Other1890 (6.8)691 (7.4) Hispanic1611 (5.8)675 (7.2) Body mass index, kg/m228.2 ± 6.128.1 ± 6 Living status0.016Nursing home/homeless492 (1.8)184 (2.0) Function0.043Independent21,987 (79)7165 (77)Assisted5248 (19)1885 (20)Non-ambulatory743 (2.7)276 (3.0)Comorbidities Hypertension25,127 (90)8433 (90)0.03 Diabetes14,279 (51)4856 (52)0.021 Smoking23,136 (83)7623 (82)0.025 Chronic obstructive pulmonary disease7489 (27)2595 (28)0.024 Congestive heart failure3764 (13)1321 (14)0.021 Cardiovascular disease4000 (14)1132 (12) Coronary artery disease9792 (35)3396 (36)0.03 Coronary artery bypass graft5464 (20)1979 (21)<.001 Percutaneous coronary intervention7195 (26)2475 (27).11 Renal status0.034Chronic kidney disease21,203 (76)6937 (74)End-stage renal disease1210 (4.3)411 (4.4) Prior lower-extremity revascularization15,927 (57)5408 (58)0.021 Prior amputation2926 (10)1054 (11).022 Prior coronary artery stenting/carotid endarterectomy2465 (8.8)852 (9.1).3 Prior aneurysm894 (3.2)190 (2.0)<.001Medications Angiotensin-converting enzyme inhibitor15,563 (56)5481 (59)<.001 Aspirin20,786 (74)7387 (79)<.001 Statin21,593 (77)7837 (84)<.001 P2Y12 inhibitors13,409 (48)4964 (53)<.001 Anticoagulation5163 (18)1441 (15)<.001Procedural characteristics Indication0.008Claudication17,384 (62)5833 (63)Chronic limb-threatening ischemia10,594 (38)3493 (37) Urgency0.055Elective25,485 (91)8344 (89)Urgent/emergent2493 (8.9)982 (11) Fluoroscopy time, minutes14 (8-22)15 (9-24)<.001OutcomesNo cilostazol, n = 16,619bCilostazol, n = 5435b Periprocedural outcomesTechnical success15,461 (95)5105 (95).9Thrombosis99 (0.6)28 (0.5).5Dissection428 (2.6)177 (3.3).007Hematoma349 (2.1)121 (2.2).6 Surgical length of stay, days2.2 ± 15.41.6 ± 7.1.052 Systemic complicationsCardiac169 (1.0)48 (0.9).4Myocardial infarction54 (0.3)13 (0.2).3Pulmonary48 (0.3)16 (0.3)>.9Renal85 (0.5)23 (0.4).4Infection13 (<0.1)3 (<0.1).8 30-day mortality122 (0.7)28 (0.5).088 Discharge status<.001Home15,537 (94)5165 (95)Rehab unit447 (2.7)104 (1.9)Others609 (3.7)157 (2.9)Long-term outcomes Follow-up time, days393 ± 183396 ± 174.2 Reintervention1971 (16)641 (15).3 Secondary patency8675 (90)3042 (91).4 Major amputation571 (4.5)166 (3.8).059 Major adverse limb events2415 (19)780 (18).13 Mortality1928 (12)550 (10).003SMD, Standardized mean differences for variables used in propensity-matching.Data are expressed as median (interquartile range), number (%), or mean ± standard deviation.Boldface P values indicates statistically significant difference for P < .05 and SMD >0.1.aWilcoxon rank sum test; Pearson χ- test.bSample numbers changed due to loss to follow-up. 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Impact of Dual Eligibility on Surgical Outcomes After Lower Extremity Bypass or Peripheral Vascular Intervention

Dual eligibility for Medicare and Medicaid is more common among Black and lower socioeconomic status patients than traditional Medicare and has been associated with worse health outcomes. Given that peripheral artery disease (PAD) disproportionately affects this underserved population, we sought to assess the impact of dual eligibility on surgical outcomes after lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for PAD. A retrospective analysis was conducted of all LEB and PVI procedures between 2010 and 2018 with Medicare-match data in the VQI-VISION (Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network) database. The sample was restricted to first-record LEB or PVI procedures in fee-for-service beneficiaries over the age of 65 who were either covered by traditional Medicare alone or were dually eligible for Medicare and Medicaid. The two groups were compared with identify baseline demographic differences. Inverse probability weighting with Cox regression was used to determine adjusted associations with death, major amputation, and amputation-free survival (AFS), for which, the time to major amputation was calculated with death as a competing risk. Of 46,032 patients in our sample, 12,872 (28.0%) were dually eligible for Medicare and Medicaid, whereas 33,160 (72.0%) had traditional Medicare only. Similar proportions of dually eligible and traditional Medicare patients underwent LEB (18.5%) and PVI (81.5%) for PAD. Before inverse probability weighting, dually eligible patients were more likely than traditional Medicare patients to be female (48.0% vs 37.9%, P < .00001), Black (25.1% vs 10.0%, P < .00001), and have lower median household income ($50,885 vs $60,306, P < .0001). On unadjusted analysis, rates of long-term mortality (42.3% vs 35.1%, P < .0001) and major amputation (19.4% vs 10.7%, P < .0001) were higher in the dually eligible cohort. After inverse probability weighting, dually eligible patients had a higher hazard of death relative to traditional Medicare patients after LEB or PVI for PAD (hazard ratio [HR]: 1.39 [95% confidence interval (CI): 1.34-1.45], P < .0001) as well as a higher hazard of major amputation (HR: 1.27 [95% CI: 1.19-1.36], P < .0001). On Fine-Gray analysis of AFS, dually eligible patients were found to have a 21% higher hazard of amputation or death (HR: 1.21 [95% CI: 1.14-1.27], P < .0001) (Fig). Findings were similar when LEB and PVI were analyzed separately. Compared with traditional Medicare, dual eligibility was associated with higher hazards of death and major amputation and lower AFS after LEB or PVI for PAD. This suggests possible deficiencies in insurance coverage or coordination for dually eligible patients with PAD, requiring further investigation.

Comparative Outcomes of Peripheral Vascular Intervention in Patients on Chronic Anticoagulation With Factor Xa Inhibitors and Vitamin K Antagonists

Comparative Outcomes of Peripheral Vascular Intervention in Patients on Chronic Anticoagulation With Factor Xa Inhibitors and Vitamin K Antagonists

Outcomes after minor lower limb amputation for peripheral arterial disease and diabetes: population-based cohort study.

Patients with diabetes and peripheral arterial disease are at increased risk of minor amputation. The aim of study was to assess the rate of re-amputations and death after an initial minor amputation, and to identify associated risk factors. Data on all patients aged 40 years and over with diabetes and/or peripheral arterial disease, who underwent minor amputation between January 2014 and December 2018, were extracted from Hospital Episode Statistics. Patients who had bilateral index procedures or an amputation in the 3 years before the study were excluded. Primary outcomes were ipsilateral major amputation and death after the index minor amputation. Secondary outcomes were ipsilateral minor re-amputations, and contralateral minor and major amputations. In this study of 22 118 patients, 16 808 (76.0 per cent) were men and 18 473 (83.5 per cent) had diabetes. At 1 year after minor amputation, the estimated ipsilateral major amputation rate was 10.7 (95 per cent c.i. 10.3 to 11.1) per cent. Factors associated with a higher risk of ipsilateral major amputation included male sex, severe frailty, diagnosis of gangrene, emergency admission, foot amputation (compared with toe amputation), and previous or concurrent revascularization. The estimated mortality rate was 17.2 (16.7 to 17.7) per cent at 1 year and 49.4 (48.6 to 50.1) per cent at 5 years after minor amputation. Older age, severe frailty, comorbidity, gangrene, and emergency admission were associated with a significantly higher mortality risk. Minor amputations were associated with a high risk of major amputation and death. One in 10 patients had an ipsilateral major amputation within the first year after minor amputation and half had died by 5 years.

Lower Extremity Amputation Rates in People With Diabetes Mellitus: A Retrospective Population Based Cohort Study in Zwolle Region, The Netherlands

Lower extremity amputations are a major complication of diabetes mellitus (DM). In a previous Dutch study, the incident rate of major amputations was 89.2 per 100 000 person years. The primary aim of this study was to describe the lower extremity amputation rates in people with DM in the Zwolle region, where preventive and curative footcare is organised according to the guidelines of the International Working Group of the Diabetic Foot (IWGDF). The secondary aim was to evaluate outcomes and underlying characteristics of these people. This was a retrospective regional population based cohort study. Data from all people with DM treated in primary and secondary care, living in the region Zwolle were collected. All amputations in the period 2017 to 2019 were analysed. Comparisons were made between those with and without an amputation. In the analysis 5 915 people with DM were included, with a mean age of 67.8 (IQR 57.9, 75.9) years. Of those people, 47% were women and the median HbA1c was 53 (IQR 47, 62) mmol/mol. Over the three year study period 68 amputations were performed in 59 people: 46 minor, 22 major. This translated into an average annual crude amputation incidence rate of non-traumatic major and minor amputations of 41.5 and 86.9 per 100 000 person years among people with diabetes. Compared with those not undergoing amputations, those who underwent an amputation were more often men, older, mainly had T2DM, were treated in secondary care, had higher diastolic blood pressure, worse diabetic footcare profile, longer DM duration and higher HbA1c. At the end of the follow up, 111 people died: 96 (1.6%) without and 15 (25.4%) with amputations (p < .001). This retrospective study provides detailed insight into the rate of amputations in Dutch people with diabetes in the region Zwolle. Compared with previous Dutch estimates, these data suggest a considerable decrease in the major amputation incidence rate.

The Impact of Implementing a Diabetic Limb-Preservation Program on Amputation Outcomes at an Academic Institution in a Majority-Minority State.

Background. Diabetic foot osteomyelitis may precede major limb amputations and lengthy hospital admission. These complications impact patients' morbidity and mortality. Healthcare institutions with dedicated limb-preservation teams realize reduced amputation rates and improved quality of care. This study evaluates the outcomes following the implementation of a rigorous diabetic limb-preservation program at an academic institution. Methods. Patients with diabetes admitted for osteomyelitis occurring below the knee were identified by ICD-10 codes and included for retrospective review. The number and type of amputations, bone biopsies, revascularizations, and hospital length of stay (LOS) were evaluated. Outcomes were compared using the high-low (Hi-Lo) amputation ratio for the 24 months preceding and the 24 months after the integration of a diabetic limb-preservation service. Results. The authors identified and included 337 patients admitted for diabetic foot osteomyelitis. In the 24-month period prior to program implementation, 140 patients were evaluated. In the 24-month period after program implementation, 197 patients were evaluated. The overall amputation rate decreased from 67.1% (n = 94) to 59.9% (n = 118) (P = .214). Major limb amputation rates significantly decreased from 32.9% (n = 46) to 12.7% (n = 25) (P = .001). Minor amputation rates significantly increased from 34.2% (n = 48) to 47.2% (n = 93) (P = .024). The Hi-Lo amputation ratio decreased from 0.96 to 0.27 (P < .001). The rate of obtaining bone biopsies increased from 32.1% (n = 45) to 72.1% (P < .001). The rate of revascularization increased from 10.7% (n = 15) to 15.2% (n = 30) (P = .299). Average hospital LOS decreased significantly from 11.6 days to 9.8 days (P = .044). Conclusion. After the implementation of a limb-preservation team, there was a precipitous drop in major limb amputations in favor of minor amputations. The average hospital LOS decreased. These findings demonstrated improved clinical care and outcomes in patients with lower extremity osteomyelitis and reinforce the importance of a diabetic foot-preservation service within healthcare institutions.

The Impact of Pre-Operative Anaemia on One Year Amputation Free Survival and Re-Admissions in Patients Undergoing Vascular Surgery for Peripheral Arterial Disease: a National Vascular Registry Study

Anaemia is common among patients undergoing surgery, but its association with post-operative outcomes in patients with peripheral arterial disease (PAD) is unclear. The aim of this observational population based study was to examine the association between pre-operative anaemia and one year outcomes after surgical revascularisation for PAD. This study used data from the National Vascular Registry, linked with an administrative database (Hospital Episode Statistics), to identify patients who underwent open surgical lower limb revascularisation for PAD in English NHS hospitals between January 2016 and December 2019. The primary outcome was one year amputation free survival. Secondary outcomes were one year re-admission rate, 30 day re-intervention rate, 30 day ipsilateral major amputation rate and 30 day death. Flexible parametric survival analysis and generalised linear regression were performed to assess the effect of anaemia on one year outcomes. The analysis included 13 641 patients, 57.9% of whom had no anaemia, 23.8% mild, and 18.3% moderate or severe anaemia. At one year follow up, 80.6% of patients were alive and amputation free. The risk of one year amputation or death was elevated in patients with mild anaemia (adjusted HR 1.3; 95% CI 1.15 - 1.41) and moderate or severe anaemia (aHR 1.5; 1.33 - 1.67). Patients with moderate or severe anaemia experienced more re-admissions over one year (adjusted IRR 1.31; 1.26 - 1.37) and had higher odds of 30 day re-interventions (aOR 1.22; 1.04 - 1.45), 30 day ipsilateral major amputation (aOR 1.53; 1.17 - 2.01), and 30 day death (aOR 1.39; 1.03 - 1.88) compared with patients with no anaemia. Pre-operative anaemia is associated with lower one year amputation free survival and higher one year re-admission rates following surgical revascularisation in patients with PAD. Research is required to evaluate whether interventions to correct anaemia improve outcomes after lower limb revascularisation.

Quantifying the incidence of lower limb amputation in people with and without diabetes in Wales between 2008–2018

BackgroundThere is variance in the incidence of lower extremity amputation across and within countries including within the UK. National data shows up to a fourfold variance in the amputation rate throughout the regions of England and differences in amputation incidence have been reported in Scotland and Ireland. Lower extremity amputation rate has yet to be documented within Wales. The aim of this cohort study was to examine trends in diabetes and non-diabetes related lower extremity amputation incidence within the Welsh population and to examine the influence of diabetes on the relative risk of amputation. Materials and MethodsAll first-time amputations between 2008-2018 were extracted from SAIL, a repository of all routine medical data of residents of Wales. People with diabetes were identified using an algorithm utilising data from several clinical and non-clinical sources. Crude and direct age and sex adjusted incidences were estimated over time. ResultsOver the period 3505 major amputations and 4335 minor amputations occurred. The diabetes population greater than 17 years of age increased by 29.4% from 143,595 in 2008 to 206,818 in 2018. There was a statistically significant rate reduction in major amputation in both populations. In the diabetes population the number of major amputations reduced from 6.9 [5.5–8.5]/10 000 person years (PY) in 2008 to 4.9 [5.4–6.2]/10 000 PY in 2018. However, for major amputation, the risk of incident amputation in people with diabetes was 7.3 fold higher [7.1–7.5] than those without diabetes. The relative risk of minor amputation for those with diabetes was higher at 11.9 [11.8 –1.01]. There was no reduction in this risk over the period. ConclusionThis study found that rates of major amputation decreased over the study period but the risk of amputation for persons with diabetes remained substantial. As the population with diabetes increases so do crude rates of amputation, providing a substantial financial and societal cost to the Welsh Population.

Enterococci in Diabetic Foot Infections: Prevalence, Clinical Characteristics, and Outcomes.

Diabetic foot infections (DFIs) are frequently polymicrobial, yet the relevance of each isolated pathogen, remains ill-defined. Specifically, the prevalence and pathogenicity of enterococcal DFIs and the impact of targeted antienterococcal treatment remain elusive. We collected demographic, clinical, and outcome-related data on patients admitted with DFIs to the Hadassah Medical Center diabetic foot unit between 2014 and 2019. The primary outcome was a composite of in-hospital death or major amputation. Secondary outcomes included any amputation, major amputation, length of stay (LOS), and 1-year major amputation or mortality rate. Enterococci were isolated in 35% of 537 eligible DFI case patients, who were notable for a higher prevalence of peripheral vascular disease, increased levels of C-reactive protein, and higher Wagner scores. Infection in enterococci-positive individuals was mostly polymicrobial (96.8% vs 61.0% in non-enterococci-infected patients; P < .001). Enterococci-infected patients were more likely to undergo amputation (72.3% vs 50.1%; P < .001) and had longer hospital stays (median LOS, 22.5 vs 17 days; P < .001), but the primary end point of major amputation or in-hospital death did not differ between groups (25.5% vs 21.0%; P = .26). Appropriate antienterococcal antibiotics were used in 78.1% of enterococci-infected patients and, compared with results in untreated patients, were associated with a trend toward a lower rate of major amputations (20.4% vs 34.1%; P = .06) but longer hospitalization (median LOS, 24 vs 18 days; P = .07). Enterococci are common in DFIs and associated with higher rates of amputation and longer hospitalization. A reduction in major amputation rates with appropriate enterococci treatment is suggested retrospectively, meriting validation by future prospective studies.

DIONYSIUS trial: “Does increasing oxygen nurture your symptomatic ischaemic ulcer sufficiently?” Study protocol for an international multicentre randomised trial

IntroductionDiabetic foot ulcers (DFUs) are a major complication of diabetes and often associated with peripheral arterial occlusive disease. Current available evidence shows hyperbaric oxygen therapy (HBOT) can reduce the risk...

Racial Disparities in Treatment Indications and Outcomes for Limb Ischemia

Studies suggest that the Affordable Care Act (ACA) of 2014 has improved access to vascular care and vascular outcomes among patients suffering from peripheral arterial disease (PAD). We sought to examine the racial disparities that exist in patients with PAD who have undergone lower extremity bypass (LEB) or a peripheral vascular intervention (PVI) using the Vascular Quality initiative (VQI) database. The VQI infrainguinal and PVI datasets were queried for patients receiving elective and urgent LEB or PVI between 2016, 2years after ACA implementation, and in 2021. Patients undergoing interventions urgently/emergently or for aneurysm were excluded. The primary outcome was major adverse limb event (MALE-defined as any vascular reintervention or above-ankle amputation) free survival at 1year. Standard statistical methods were utilized as appropriate. A total of 17,455 LEB and 87,475 PVIs were included in this analysis. Black persons present at a younger age when compared to non-Hispanic White persons (NHW) and are more likely to have diabetes, hypertension, end-stage renal disease (ESRD), and higher rates of prior amputation. Black persons are more likely to present with chronic limb-threatening ischemia (CLTI) rather than claudication, and in a more urgent setting. Postoperative outcomes show higher rates of major amputations among racial minorities, specifically Black persons for both LEB (1.8% vs. 0.8% P<0.001) and PVI (20.8% vs. 16.8% P<0.001). Black persons are at higher risk of 1-year MALE for LEB (36.7% vs. 29.9% P<0.001) and PVI (31.0% vs. 21.7%; P<0.001). Even after adjusting for confounding variables, Black persons have a higher risk of 1-year MALE for LEB, with an adjusted hazard ratio (aHR) of 1.15 (95% CI [1.05-1.26], P=0.003) and PVI (aHR 1.18 95% CI [1.12-1.24], P<0.001). Other major determinates of 1-year MALE on multivariate Cox regression included CLTI (LEB aHR 1.57 95% CI [1.43-1.72], P<0.001; PVI aHR 2.29 95% CI [2.20-2.39], P<0.001) and history of prior amputation (LEB aHR 1.35 95% CI [1.17-1.56], P<0.001; PVI aHR 1.5 95% CI [1.4-1.6], P<0.001). Compared to NHW persons, Black persons present with more advanced vascular disease regardless of the operative indication. Black persons are also at significantly higher risk of 1-year MALE. Despite some advances in more accessible care through the ACA of 2014, our observations suggest that Black persons still have significantly worse outcomes due to variety of variables that need further investigation.

Long-Term Outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique in Patients With Aorto-Iliac Occlusive Disease.

The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.

Management of Critical Limb Ischemia Prognostic Factors

Introduction: Critical limb ischemia (CLI) represents the most severe form of Peripheral artery disease (PAD). Its prevalence is estimated to be between 0.5% and 2.3% of the population over 40 years old. Despite its importance, epidemiological studies on CLI remain patchy. In Morocco, few studies have been carried out on this subject, and we have no epidemiological data on the morbimortality of chronic critical ischemia of the lower limbs on a national scale. Objective: The objective of our study was to evaluate the results of surgical treatment of critical limb ischemia and to identify the factors associated with the medium-term evolution. Methods: We conducted a retrospective cohort study of all patients admitted to the vascular surgery department of the Hassan II University Hospital for the management of critical ischemia of the lower limbs, who underwent revascularization surgery between 01/01/2013 and 31/12/2019. Patients who underwent a major amputation of the affected limb and those for whom the revascularization procedure was a revision were subsequently excluded. The follow-up period was 2 years and the events of major interest were the occurrence of a major limb amputation and 30-day mortality. Results: The cohort included 232 patients with critical ischemia. The mean age was 62 years with a clear male predominance of 84.5%. The most common comorbidities were diabetes (65.8%), active smoking (42.5%), and hypertension (31.2%). The majority of patients (62%) benefited from endovascular procedures. The primary technical success was 94.1%, the major amputation rate was 19.7%, and the 30-day mortality was 4.3%. In multivariate analysis, factors independently associated with a high postoperative complication rate were preoperative hyperglycemia, concomitant ischemic heart disease, female sex, young age, and intensive care unit stay. Conclusion: Our study highlights several risk factors for the occurrence of postoperative complications of CLI. These results .....

The management of patients with popliteal artery aneurysms presenting with acute limb ischemia

ObjectiveEndovascular popliteal artery aneurysm (PAA) repair has acceptable outcomes compared with open repair for elective therapy. Endovascular repair for urgent PAA causing acute limb ischemia (ALI) has not been well-studied. This project compares outcomes of urgent endovascular and open repair of PAA with ALI. MethodsThe Vascular Quality Initiative database for peripheral vascular interventions (PVIs) and infrainguinal bypass were reviewed for PAAs with ALI from 2010 to 2021. Only patients entered as having symptoms of ALI in the PVI module and ALI as indication in the infrainguinal bypass module were included. In addition, patients undergoing elective treatment were excluded and the sample analyzed was restricted to patients undergoing urgent and emergent open and endovascular repair. Patient demographics and comorbidities as well as procedural details were compared between the two groups. Perioperative complications up to 30 days were compared as well as long-term outcomes including major amputation and mortality at 1 year. ResultsUrgent PAA repair for ALI constituted 10.5% (n = 571) of all PAAs. Most urgent repairs were open (80.6%; n = 460) with 19.4% (n = 111) endovascular. The proportion of endovascular repair significantly increased from 16.7% in 2010 to 85.7% in 2021. Patients undergoing endovascular repair were older (71.2 ± 12.5 vs 68.0 ± 11.8; P = .011) than patients undergoing open repair. They were also more likely to have coronary artery disease (32.4% vs 21.7%; P = .006). Open PAA repair was associated with more bleeding complications (20.8% vs 2.7%; P < .001), longer postoperative length of stay (8.1 ± 9.3 days vs 4.9 ± 5.6 days; P < .001), and less likelihood of discharge to home (64.9% vs 70.3%; P = .051). Perioperative major amputation rate was 7.5% with no difference between the two treatment strategies up to 1 year. However, patients receiving endovascular repair had higher inpatient (1.1% vs 0%; P < .001), 30-day (6.3% vs 0.4%; P < .001), and 1-year (16.5% vs 8.4%; P = .02) mortality. Multivariable regression analysis suggested that endovascular repair was possibly associated with increased 30-day mortality, but not 1-year mortality. ConclusionsEndovascular PAA has exponentially increased from 2010 to 2021. Endovascular repair is associated with decreased complications and hospital length of stay. The increased perioperative mortality seen in this group is likely due to selection bias.

Lack of patient-centered evaluation of outcomes in intermittent claudication literature

BackgroundPeripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. MethodsA comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). ResultsTwenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. ConclusionsIC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.