Treatment of Peripheral Arterial Occlusive Disease around the Globe: Malta

Introduction: Malta is a small island in the middle of the Mediterranean with a population of 514,564 inhabitants and is served by one public tertiary hospital, Mater Dei Hospital. The Vascular unit was set up in 2007. The aim of this review is to analyse the work related to peripheral arterial occlusive disease (PAOD) in Malta with an in-depth focus on amputations and revascularisation procedures since the introduction of the Vascular unit. Method: Various sources of data have been interrogated to address this subject. Population and prevalence data on obesity and type II diabetes mellitus from 2003 to 2019 was obtained from the National Statistics Office, the World Health Organization, and the International Diabetes Federation, respectively. The Maltese Vascular Register (MaltaVasc), and in-hospital reports from 2003 to 2019 was used to obtain data on revascularisation procedures, major amputations and minor amputation rates in Malta. Results: Malta has one of the highest rates of obesity in Europe. In 2015, the prevalence rate was 30.6%. Similarly, data from the International Diabetes Federation Atlas showed that the prevalence rate of T2DM among adults was 14% in 2017. There was a mean of 33 open/hybrid procedures per 100,000 population (28–38, 95% confidence interval) between 2005 and 2009 and a mean of 57 endovascular procedures per 100,000 population (46–68, 95% confidence interval) during the same time-period. From 2009 to 2019, there was a mean of 16 major amputations and 78 minor amputations per 100,000 population. Conclusion: A significant reduction in major amputation rates with an increase in minor amputation rates and revascularisation rates has been noted since the establishment of the vascular unit in Malta. During this period, there has been an increase in prevalence in obesity and T2DM together with an aging population.

Foot Revascularization Avoids Major Amputation in Persons with Diabetes and Ischaemic Foot Ulcers

The study aims to evaluate the effectiveness of foot revascularization in persons with diabetic foot ulcers (DFUs) and below-the-ankle (BTA) arterial disease. Consecutive patients referred for a new active ischaemic DFU requiring lower limb revascularization were considered. Among those, only patients with a BTA arterial disease were included. Revascularization procedures were retrospectively analysed: in the case of successful foot revascularization (recanalization of pedal artery, or plantar arteries or both) or not, patients were respectively divided in two groups, successful foot perfusion (SFP) and failed foot perfusion (FFP). Healing, minor and major amputation at 12 months of follow-up were evaluated and compared. Eighty patients (80) were included. The mean age was 70.5 ± 10.9 years, 55 (68.7%) were male, 72 (90%) were affected by type 2 diabetes with a mean duration of 22.7 ± 11.3 years. Overall 45 (56.2%) patients healed, 47 (58.7%) had minor amputation and 13 (16.2%) major amputation. Outcomes for SFP and FFP were respectively: healing (89.3 vs. 9.1%, p < 0.0001), minor amputation (44.7 vs. 78.8%, p = 0.0001), major amputation (2.1 vs. 36.3%, p < 0.0001). Failed foot revascularization resulted an independent predictor of non-healing, minor amputation, and major amputation. Foot revascularization is mandatory to achieve healing and avoid major amputation in persons with ischaemic DFU and BTA arterial disease.

Early and eighteen month clinical outcomes of first UK case of percutaneous deep vein arterialisation (pDVA) to treat “no option” chronic limb-threatening ischemia using the LimFlow system

Background Chronic limb-threatening ischaemia (CLTI) in cases where there are no further standard treatment options for limb salvage represents the most advanced stage of peripheral arterial disease. For these “no-option” CLTI patients, an experimental treatment of foot vein arterialisation (FVA) was first described in 1912, however, it was never widely adopted as outcomes varied significantly most likely due to the complexity of the surgical intervention and lack of standardisation. In recent years there have been significant developments in performing FVA fully percutaneously and standardising the procedure with the introduction of specific indications for patient selection, a dedicated set of devices and structured follow up. This case represents the first UK use of the dedicated LimFlow System as a standardised procedure to perform percutaneous deep vein arterialisation (pDVA) in a “no option” CLTI patient according to the latest treatment recommendations in the literature, with outcomes out to 18 months post-procedure. Case presentation We present the case of a 78 year old male diabetic patient with a history of contralateral below knee amputation who presented with ischaemic rest pain and dry gangrene involving his left heel and first and second toes. Following review by the lower limb multi-disciplinary team at our institution, the patient was deemed to have no surgical or endovascular treatment options, apart from major amputation, as there was no suitable target for either angioplasty or bypass. He was therefore referred as a candidate for percutaneous deep vein arterialisation (pDVA) with the LimFlow System (LimFlow SA, France). After screening of the patient according to the indications for use, the pDVA procedure was successfully performed resulting in complete resolution of ischaemic rest pain immediately following the procedure, and adequate revascularisation of the foot. Following the index procedure, the subject went on to have minor amputation of the first, second and third toes 2 months post initial procedure with further secondary angioplasty procedures to optimise the flow throughout the arterialised circuit up to 4 months after the initial procedure. He underwent elective completion transmetatarsal amputation at 13 months post index procedure. The surgical wounds post minor amputation and the heel wound showed continued healing, especially after secondary optimisation of the pDVA outflow, with tissue epithelialisation by 6 months and complete healing by 18 months after the index procedure. Conclusions This case report demonstrates the clinical outcomes of a technically-successful standardised pDVA procedure with the LimFlow system including both limb salvage and wound healing at 18 months. It also highlights the importance of close clinical and radiological surveillance post-index procedure and the requirement for re-interventions to optimise wound healing.

Salami-Tactics: when is it time for a major cut after multiple minor amputations?

Introduction Repetitive minor amputations carry the concomitant risks of multiple surgical procedures, major amputations have physical and economical major drawbacks. The aim of this study was to evaluate whether there is a distinct number of minor amputations predicting a major amputation in the same leg and to determine risk factors for major amputation in multiple minor amputations. Materials and methods A retrospective chart review including 429 patients with 534 index minor amputations between 07/1984 and 06/2019 was conducted. Patient demographics and clinical data including number and level of re-amputations were extracted from medical records and statistically analyzed. Results 290 legs (54.3%) had one or multiple re-amputations after index minor amputation. 89 (16.7%) legs needed major amputation during follow up. Major amputation was performed at a mean of 32.5 (range 0 – 275.2) months after index minor amputation. No particular re-amputation demonstrated statistically significant elevated odds ratio (a.) to be a major amputation compared to the preceding amputation and (b.) to lead to a major amputation at any point during follow up. Stepwise multivariate Cox regression analysis revealed minor re-amputation within 90 days (HR 3.8, 95% CI 2.0-7.3, p <0.001) as the only risk factor for major amputation if at least one re-amputation had to be performed. Conclusions There is no distinct number of prior minor amputations in one leg that would justify a major amputation on its own. If a re-amputation has to be done, the timepoint needs to be considered as re-amputations within 90 days carry a fourfold risk for major amputation. Level of evidence Retrospective comparative study (Level III).

Incidence of lower limb amputation in people with and without diabetes: a nationwide 5-year cohort study in Japan

IntroductionThis study was conducted to investigate the incidence and time trend of lower limb amputation (LLA) among people with and without diabetes.Research design and methodsThis retrospective population-based cohort study was based on the national claims data in Japan, comprising a total population of 150 million. Data of all individuals who had LLA from April 2013 to March 2018 were obtained. We analysed the sex-adjusted and age-adjusted annual LLA rate (every fiscal year) in people with and without diabetes for major and minor amputation. To test for time trend, Poisson regression models were fitted.ResultsIn the 5-year period, 30 187 major and 29 299 minor LLAs were performed in Japan. The sex-adjusted and age-adjusted incidence of major and minor LLAs was 9.5 (people with diabetes, 21.8 vs people without diabetes, 2.3, per 100 000 person-years) and 14.9 (people with diabetes, 28.4 vs people without diabetes, 1.9, per 100 000 person-years) times higher, respectively, in people with diabetes compared with those without. A significant decline in the annual major amputation rate was observed (p<0.05) and the annual minor amputation rate remained stable (p=0.63) when sex, age and people with and without diabetes were included as dependent variables.ConclusionsThis is the first report of the national statistics of LLAs in Japan. The incidence of major and minor LLAs was 10 and 15 times higher, respectively, in people with diabetes compared with those without. A significant decline in the major amputation rate was observed, and the annual minor amputation rate remained stable during the observation period. This information can help to create an effective national healthcare strategy for preventing limb amputations, which affect the quality of life of patients with diabetes and add to the national healthcare expenditure.

Racial, Rural, and Regional Disparities in Diabetes-Related Lower-Extremity Amputation Rates, 2009–2017

Objective <p>To examine <a>the racial/ethnic, rural-urban, and regional variations in the trends of diabetes-related lower extremity amputations (LEA) among hospitalized U.S. adults from 2009-2017</a>.</p> <p>Research Design and Methods </p> <p>We used the National Inpatient Sample (NIS) (2009-2017) to identify trends in LEA rates among those primarily hospitalized with diabetes in the United States. We conducted multivariable logistic regressions to identify individuals at risk of LEA based on their race/ethnicity, census region location (North, Midwest, South and West) and rurality of residence.</p> <p>Results</p> <p>From 2009 to 2017, the rates of minor LEAs increased across all racial/ethnic, rural/urban, and census region categories. <a>The increase in minor LEAs was driven by Native Americans (Annual Percent Change (APC)=7.1%, p < 0.001) and Asian/Pacific Islanders (APC=7.8%, p < 0.001). Residents of Non-Core </a>(APC=5.4%, p < 0.001) and Large Central Metropolitan areas (APC=5.5%, p < 0.001), experienced the highest increases over time in minor LEA rates. Whites, residents of the Midwest, Non-Core and Small Metropolitan areas experienced a significant increase in major LEAs. Regression findings showed that Native Americans and Hispanics were more likely to have a minor or major LEA, compared to Whites. The odds of a major LEA increased with rurality and was also higher among residents of the South, compared to those of the Northeast. A steep decline in major to minor amputation ratios was observed, especially among Native Americans.</p> <p> </p> <p>Conclusions </p> <p>Despite increased risk of diabetes-related lower limb amputations in underserved groups, our findings are promising when the major to minor amputation ratio is considered.</p>

Racial, Rural, and Regional Disparities in Diabetes-Related Lower-Extremity Amputation Rates, 2009–2017

Objective <p>To examine <a>the racial/ethnic, rural-urban, and regional variations in the trends of diabetes-related lower extremity amputations (LEA) among hospitalized U.S. adults from 2009-2017</a>.</p> <p>Research Design and Methods </p> <p>We used the National Inpatient Sample (NIS) (2009-2017) to identify trends in LEA rates among those primarily hospitalized with diabetes in the United States. We conducted multivariable logistic regressions to identify individuals at risk of LEA based on their race/ethnicity, census region location (North, Midwest, South and West) and rurality of residence.</p> <p>Results</p> <p>From 2009 to 2017, the rates of minor LEAs increased across all racial/ethnic, rural/urban, and census region categories. <a>The increase in minor LEAs was driven by Native Americans (Annual Percent Change (APC)=7.1%, p < 0.001) and Asian/Pacific Islanders (APC=7.8%, p < 0.001). Residents of Non-Core </a>(APC=5.4%, p < 0.001) and Large Central Metropolitan areas (APC=5.5%, p < 0.001), experienced the highest increases over time in minor LEA rates. Whites, residents of the Midwest, Non-Core and Small Metropolitan areas experienced a significant increase in major LEAs. Regression findings showed that Native Americans and Hispanics were more likely to have a minor or major LEA, compared to Whites. The odds of a major LEA increased with rurality and was also higher among residents of the South, compared to those of the Northeast. A steep decline in major to minor amputation ratios was observed, especially among Native Americans.</p> <p> </p> <p>Conclusions </p> <p>Despite increased risk of diabetes-related lower limb amputations in underserved groups, our findings are promising when the major to minor amputation ratio is considered.</p>

Early and Eighteen Month Clinical Outcomes of First UK Case of Percutaneous Deep Vein Arterialisation (pDVA) to Treat “No Option” Chronic Limb-Threatening Ischemia Using the Limflow System

Background: Chronic limb-threatening ischaemia (CLTI) in cases where there are no further standard treatment options for limb salvage represents the most advanced stage of peripheral arterial disease. This case represents the first UK use of the LimFlow System to perform percutaneous deep vein arterialisation (pDVA) in a “no option” CLTI patient, with outcomes out to 18 months post-procedure.Case Presentation: We present the case of a 78 year old male diabetic patient with a history of contralateral below knee amputation who presented with ischaemic rest pain and dry gangrene involving his left heel and first and second toes. Following review by the lower limb multi-disciplinary team at our institution, the patient was deemed to have no surgical or endovascular treatment options, apart from major amputation, as there was no viable target for angioplasty or bypass. He was therefore referred as a candidate for percutaneous deep vein arterialisation (pDVA) with the LimFlow System (LimFlow SA, France). After screening of the patient according to the indications for use, the pDVA procedure was successfully performed resulting in complete resolution of ischaemic rest pain immediately following the procedure, and adequate revascularisation of the foot. The subject went on to have minor amputation of the first, second and third toes 2 months post initial procedure with further secondary angioplasty procedures to optimise the flow throughout the arterialised circuit up to 4 months after the initial procedure. He underwent elective completion transmetatarsal amputation at 13 months post index procedure. The surgical wounds post minor amputation and the heel wound showed continued healing progress, especially after secondary optimisation of the pDVA outflow, with tissue epithelialisation by 6 months and complete healing by 18 months post index procedure.Conclusions: This case report demonstrates the clinical outcomes of a technically-successful LimFlow pDVA including both limb salvage and wound healing at 18 months.

Diabetic foot ulcer management in a multidisciplinary foot centre: one-year healing, amputation and mortality rate

Objective: To describe the rates of healing, major amputation and mortality after 12 months in patients with a new diabetic foot ulcer (DFU) and their care in a French diabetic foot service (DFS). Method: A prospective single-centre study including patients from March 2009 to December 2010. The length of time to healing, minor amputation, major amputation and mortality rate after inclusion were analysed using the Kaplan–Meier method. Results: Some 347 patients were included (3% lost to follow-up), with a median follow-up (IQR) of 19 (12–24) months. The mean (SD) age was 65±12 years, 68% were male, and the median duration of the ulcer was 49 (19–120) days. Complications of the DFU were ischaemia (70%), infection (55%) and osteomyelitis (47%). Of the patients, 50% were inpatients in the DFS at inclusion (median duration of hospitalisation 26 (15–41) days). The rate of healing at one year was 67% (95% confidence interval (CI): 61–72); of major amputation 10% (95% CI: 7–17); of minor amputation 19% (95% CI: 14–25), and the death rate was 9% (95% CI: 7–13). Using an adjusted hazard ratio, the predictive factors of healing were perfusion and the area of the wound. The risk factors for a major amputation were active smoking and osteomyelitis. The risk factors for mortality were perfusion and age. Conclusion: This study confirms the need to treat DFUs rapidly, in a multidisciplinary DFS.