Major Limb Amputation Research Articles

1137 Perioperative Glycaemic Control in Patients Undergoing Major Lower Limb Amputation – How Can We Improve?

Abstract Aim Patients with diabetes undergoing major lower limb amputation (MLLA) have higher rates of unfavourable postoperative outcomes compared to those without diabetes. Inadequate glycaemic management can lead to an increase in wound healing problems, infections, increased length of hospital stay and higher mortality rates. Guidelines from the Vascular Society for Great Britain and Ireland recommend that all MLLA patients should have early input from the Diabetes team. Our study aimed to evaluate local practice in perioperative glycaemic control in MLLA patients at our unit. Method All patients who underwent MLLA between November 2021 and April 2022 were identified by reviewing theatre records. Patient records were reviewed to collect data on diagnosis of diabetes, diabetic medications, capillary blood glucose (CBG) levels on admission, preoperative HbA1c levels, and perioperative and post-operative glycaemic control. Results 33 MLLA were performed (17 AKA, 16 BKA), age range 41 to 85 (mean age 66), 20 male and 13 female patients. 25 patients (76%) were diabetic, 19 patients (58%) had a preoperative HbA1c recorded and all 33 patients had a CBG recorded on admission. 10 diabetic patients (40%) were found to have inappropriate management of their diabetic medication. 18 patients (55%) were identified as having poor glycaemic control on admission (HbA1c >48 or CBG >11.1). Of these, 12 (67%) were reviewed by the Diabetes team. Conclusions Surgical teams must be actively involved in the management of diabetes of their MLLA patients. Patients undergoing MLLA should have HbA1c checked on admission to help identify those who need review by the Diabetes team.

Decreasing national trends in diabetic complications hide regional differences: a prospective population-based study using health care registers in Finland

Objectives. To examine whether possibilities to improve care among patients with diabetes are reflected in the numbers of cardiovascular complications at national and regional level in Finland. Methods. The study population included all patients with diabetes in Finland since 1964. The incidences of first acute coronary syndrome, ischemic stroke and lower limb amputation were examined for the period from 2010 to 2017. The age- and sex-standardised incidence rates were calculated for the first events. Adjusted Poisson regression mixed models were used to calculate average annual trends and assess regional variation of incidences during the periods 2010 to 2013 and 2014 to 2017 in the university hospital districts (UHDs) and hospital districts (HDs). Results. The nationwide incidence of first acute coronary syndrome decreased among patients with diabetes by 2.7% (95% confidence interval 2.3%; 3.0%), ischemic stroke by 2.0% (1.5%; 2.4%) and major lower limb amputation by 4.6% (3.1%; 5.9%) annually. The sexes differed only in the decrease in acute coronary events. The annual decrease among males was 2.1% (1.6%; 2.6%) and among females was 3.4% (2.8%; 4.0%) (p = .001). Marked variation was observed among UHDs and HDs in the incidences of cardiovascular events and lower limb amputations in patients with diabetes. The variation in annual trends of diabetic complications was most pronounced in acute coronary syndrome among UHDs with an estimated variance of 0.0006 (p = .034). Conclusions. The decrease in the incidence of first cardiovascular events among patients with diabetes continued from 2010 to 2017 in Finland. However, the declining national incidence rates hide regional differences which should be a target for improvement.

Ten-year experience with use of cryopreserved allografts for redo infrapopliteal bypass.

The aim of this study is to report the early and late outcomes of cryopreserved saphenous vein (CSV) in redo infrainguinal bypass and to investigate possible predictors of primary patency loss. All patients who underwent a redo bypass for critical limb ischemia from January 2010 to December 2020 were reviewed. Early and late complications were analyzed and included. The endpoints of the study were all cause mortality, major limb amputation, and primary patency (PP). Data were collected from 95 patients. Among the entire cohort, 16 (16.8%) patients received a cryopreserved vessel bypass with anastomosis in the popliteal artery and 79 (83.2%) patients had cryopreserved vessel bypasses with distal anastomosis in tibial vessels. Median duration of follow-up was 73months; during this, period estimated survival at 5years was 80.5 ± 4% (95% CI, 78.0-91.2) and estimates of freedom from limb amputation was 90.3 ± 3.2% (95% CI, 87.3-98.1). Overall, the estimated primary patency of the bypass was 43.7 ± 6.7% (95% CI, 30.2-51.4). On multivariable analysis, intraprocedural tibial vessel angioplasty (HR = 2.3, p = 0.01), distal anastomosis in tibial vessels (HR = 3.6, p = 0.36), and the use of a composite graft (HR = 2.4, p = 0.01) were independently associated with loss of PP. The use of CSV in redo bypass is an effective strategy in salvaging threatened lower extremities and in preventing or delaying limb amputation. Our results confirm that further attempts at revascularization are generally appropriate, even in technically changing patients.

WTP1.11 The impact of the Covid-19 pandemic on discharge practices following vascular surgery

Abstract Introduction Standard operating procedures and patient pathways in healthcare have been greatly influenced by the Covid-19 pandemic. The aim of this study is to understand the impact of changes in discharge practices by comparing hospital length of stay and rates of failed discharge in selected common vascular procedures in the pre-Covid-19 and post-Covid-19 periods. Methods A single consultant surgeon’s logbook at a major vascular hub was used to identify all patients who underwent common vascular procedures in the pre-Covid-19 period (January to December 2017), and post-Covid-19 period (January 2021 to August 2022). Basic demographic data was recorded, as well as post-operative length of stay (LOS), failed discharge rates (re-admission within 24-hours) and re-admission within 30-days of the index procedure. Results 65 cases were identified in the pre-Covid-19 period. 71 cases identified in the Post-covid-19 period. For each of the surgical procedures, patient demographics were comparable. There has been a reduction in the median post- operative LOS for each of the surgical procedures. Common femoral endarterectomy from 3-days to 2-days, femoral-popliteal bypass from 10-days to 5-days, major limb amputation from 29-days to 18-days, endovascular aneurysm repair from 4-days to 2-days and fenestrated endovascular aneurysm repair from 4-days to 2- days. There were no recorded failed discharges. There was no increase in re-admission at 30-days. Conclusion We have demonstrated a reduction in the median duration of hospital stay in the post-Covid-19 period, without an increase in any readmissions. Early mobilisation and a prompt discharge policy is thought to be relevant.

WTP1.10 Infra-malleolar bypass in patients with chronic limb threatening ischaemia

Abstract Introduction There is clinical equipoise surrounding the optimal strategy for revascularisation of infra-popliteal arterial disease. The BASIL-2 trial is attempting to address this. The trial has been designed to try and define whether a ‘vein bypass first’ or ‘best endovascular first’ strategy is superior. We have sought to explore the outcomes associated with ultra-distal bypass in a single Scottish Health Board. Methods This was a retrospective review of a single surgeon’s ultra-distal bypass practice over a 7 year period. Index cases were identified from a prospectively maintained logbook. Outcomes included were primary graft patency and amputation free survival. Results There were 22 procedures performed over the 7-year period of interest. Mean age of 66 years. 15/22 (68%) were diabetic. The dorsalis pedis was the most common arterial target (n=14). The primary graft patency at 3-years was 54%. During the follow-up period 50% of the patients had a major limb amputation. There was 1 death in the post-operative period prior to discharge. Discussion Primary patency and limb salvage at 3-years are acceptable, although they are less than that described in the contemporary literature. It is likely that this may a consequence of selection bias given the local prejudice for an endovascular ‘first strategy’.

WTP1.2 Quality of Life concerns in patients undergoing operations for diabetic foot disease during the COVID-19 pandemic

Abstract Aim To evaluate QOL of diabetic patients following diabetic foot surgeries during the Covid-19 pandemic. Method Single Centre retrospective data collected from hospital systems between 01/01/2021- 31/12/2021. 30 patients requiring surgery for diabetic foot disease identified and were called for QOL questionnaire, 23 participated. Results 56% (13/23) patients were <70 years. 52% (12/23) underwent major limb amputations. Pre-operatively, 54% (7/13) of the <70 years and 40% (4/10) >70 years had mainly physical concerns and 46% (6/13) <70 years and 60% (6/10) of >70 years emotional concerns. Post-operative concerns were divided into 7 groups. The commonest were the “ability to mobilise and loss of independence” 65% (15/23), “wound healing duration & worries about tissue healing” 48% (11/23) and “further hospitalisation or re-intervention” 43% (10/23). These were similar when divided by age groups. Additionally, feeling abandoned post discharge was frequently described. Conclusion QOL concerns in our diabetic population following foot operations highlighted important issues that need to be addressed. The majority voiced concerns regarding their loss of independence/mobility, fear of the wound site not healing and worry regarding the need for further re-intervention. This further highlights the need of patient education and support and enhancing service provision pre- and post –op.

Peripheral Arterial Disease and the Pharmacist’s Role in Management

Purpose. Atherosclerosis of arteries in the legs leads to peripheral arterial disease (PAD), increasing the risk of future cardiovascular events. Worldwide prevalence estimates indicate >200 million people have PAD, but this is likely underestimated given the variability in symptoms and lack of awareness by patients and clinicians. Antiplatelet therapy is recommended to reduce cardiovascular risk, but anticoagulation therapy may also be beneficial. This narrative review examined scientific literature for the burden and medical management of PAD, including use of anticoagulants in this population, and provides perspectives on the role of pharmacists to improve outcomes of PAD. Summary. A variety of antiplatelet therapies has been studied in patients with PAD, and treatment is recommended for those with symptomatic disease. The use of dual antiplatelet therapy is limited to patients with symptomatic PAD after revascularization. Anticoagulation with warfarin in combination with antiplatelet therapy did not improve efficacy over antiplatelet therapy alone and increased bleeding. In contrast, the direct factor Xa inhibitor rivaroxaban, when used in combination with low-dose aspirin, has been shown to significantly reduce the risk of cardiovascular death, myocardial infarction (MI), or stroke by 28% in patients with PAD compared with aspirin alone. Similarly, in patients with PAD who have undergone revascularization, rivaroxaban plus aspirin reduced the risk of acute limb ischemia, major amputation, MI, stroke, or cardiovascular death by 15% versus aspirin alone. Major bleeding was significantly increased with rivaroxaban plus aspirin, but with no differences in fatal bleeding, nonfatal intracranial hemorrhage, or symptomatic bleeding into a critical organ between groups. Pharmacist-led interventions for patients with PAD include identifying at-risk patients through medication reviews and clinical assessments, education and monitoring use of prescription and over-the-counter medications, and appropriate counseling on lifestyle modifications. Conclusion. Rivaroxaban plus aspirin reduces the risk of major cardiovascular events, including major adverse limb events and amputation, in patients with PAD. Pharmacists can play an integral role in identifying, screening, and managing patients with PAD to achieve favorable outcomes.

Differential impact of missed initial wound clinic visit on 6-month wound healing by race/ethnicity among patients with chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is associated with significant morbidity, including major limb amputation, and mortality. Healing ischemic wounds is necessary to optimise vascular outcomes and can be facilitated by dedicated appointments at a wound clinic. This study aimed to estimate the association between successful wound care initiation and 6-month wound healing, with specific attention to differences by race/ethnicity. This retrospective study included 398 patients with CLTI and at least one ischaemic wound who scheduled an appointment at our wound clinic between January 2015 and July 2020. The exposure was the completion status of patients' first scheduled wound care appointment (complete/not complete) and the primary outcome was 6-month wound healing (healed/not healed). The analysis focused on how this association was modified by race/ethnicity. We used Aalen-Johansen estimators to produce cumulative incidence curves and calculated risk ratios within strata of race/ethnicity. The final adjustment set included age, revascularization, and initial wound size. Patients had a mean age of 67 ± 14 years, were 41% female, 46% non-White and had 517 total wounds. In the overall cohort, 70% of patients completed their first visit and 34% of wounds healed within 6-months. There was no significant difference in 6-month healing based on first visit completion status for White/non-Hispanic individuals (RR [95% CI] = 1.18 [0.91, 1.45]; p-value = 0.130), while non-White individuals were roughly 3 times more likely to heal their wounds if they completed their first appointment (RR [95% CI] = 2.89 [2.66, 3.11]; p-value < 0.001). In conclusion, non-White patients were approximately three times more likely to heal their wound in 6 months if they completed their first scheduled wound care appointment while White/non-Hispanic individuals' risk of healing was similar regardless of first visit completion status. Future efforts should focus on providing additional resources to ensure minority groups with wounds have the support they need to access and successfully initiate wound care.

Targeted cell delivery of mesenchymal stem cell therapy for cardiovascular disease applications: a review of preclinical advancements.

Cardiovascular diseases (CVD) continue to be the leading cause of morbidity and mortality globally and claim the lives of over 17 million people annually. Current management of CVD includes risk factor modification and preventative strategies including dietary and lifestyle changes, smoking cessation, medical management of hypertension and cholesterol lipid levels, and even surgical revascularization procedures if needed. Although these strategies have shown therapeutic efficacy in reducing major adverse cardiovascular events such as heart attack, stroke, symptoms of chronic limb-threatening ischemia (CLTI), and major limb amputation significant compliance by patients and caregivers is required and off-target effects from systemic medications can still result in organ dysfunction. Stem cell therapy holds major potential for CVD applications but is limited by the low quantities of cells that are able to traffic to and engraft at diseased tissue sites. New preclinical investigations have been undertaken to modify mesenchymal stem cells (MSCs) to achieve targeted cell delivery after systemic administration. Although previous reviews have focused broadly on the modification of MSCs for numerous local or intracoronary administration strategies, here we review recent preclinical advances related to overcoming challenges imposed by the high velocity and dynamic flow of the circulatory system to specifically deliver MSCs to ischemic cardiac and peripheral tissue sites. Many of these technologies can also be applied for the targeted delivery of other types of therapeutic cells for treating various diseases.

Epidemiology of Limb Amputations and Prosthetic Use During COVID-19 Pandemic in the Netherlands

ObjectiveTo evaluate the trends in the incidence of major limb amputations and the prevalence of Dutch prosthetic users at the national level in The Netherlands between 2012 and 2021 (during the COVID-19 pandemic). Local hospitals in The Netherlands reported a doubling of major lower limb amputations during COVID-19, information about a change in the incidence of major upper limb amputations was not reported. We could not confirm this remarkable increase in major lower limb amputations in our institution, nor did we observe a change in the incidence of major upper limb amputations. We hypothesize that the COVID-19 pandemic had no effect on the number of major limb amputations. DesignObservational retrospective study analyzing national open-access databases of health insurance claims. SettingThe Dutch national opensource database www.opendisdata.nl was used to retrieve the incidence of limb amputations in the period 2012-2021, stratified by the level of amputation and the cause of amputation. The results were verified using the www.gipdatabank.nl databank. This period included 4 intervals of nationwide COVID-19 lockdowns. Participants60,848 patients who underwent limb amputations at the upper or lower extremity in the Netherlands from 2012 to 2021 (N=60,848) were included in this study. InterventionNot applicable. Main Outcome MeasuresUpper- and lower-limb amputation and prosthetic use. ResultsData were retrieved for a total of 60,848 patients in the Netherlands, who underwent 68,180 amputations of the upper and lower extremities at any level from 2012 to 2021, including 22,095 major amputations of the lower extremities. The ongoing trend of stable numbers of major lower-limb amputations from 2012 to 2019 continued in 2020 and 2021. The verification of these data at the level of prosthetic users confirmed that the annual trends were unchanged. ConclusionThe reported increased numbers of major lower-limb amputations during the COVID-19 pandemic in the Netherlands could not be confirmed using nationwide epidemiologic data.

Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis

PurposeTo summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).MethodsThe IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).ResultsKaplan–Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan–Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.ConclusionsIn this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population.Level of EvidenceLevel 3, Non-randomized controlled cohort/follow-up study

Association between statin-use and mobility and long-term survival after major lower limb amputation.

The aim of this study was to determine if there is an association between statin-use and prosthetic mobility and long-term survival in patients receiving rehabilitation after major amputation for lower limb arterial disease. A retrospective analysis of prospectively maintained data (2008-2020) from a centre for rehabilitation was performed. Patients were grouped by statin-use status and sub-grouped by the combination of statin and antithrombotic drugs (antiplatelets or anticoagulants). Outcomes were prosthetic mobility (SIGAM score, timed-up-go and 2-min walking distance) and long-term survival. Regression, Kaplan-Meier and Cox-proportional hazard analyses were performed to test associations adjusted to confounders. Of 771 patients, 499 (64.7%) were on a statin before amputation or prescribed a statin peri-operatively. Rate of statin-use was significantly lower among female (53.3%) compared to male (68.2%) patients, P < 0.001. Statin-use was associated with significantly better prosthetic independence (53.1% vs 44.1%, P = 0.017), timed-up-go (mean difference of 4 s, P = 0.04) and long-term survival HR 0.59 (0.48-0.72, P < 0.001). Significance persisted after adjusting for confounding factors and in subgroup analyses. The combination of statin with antiplatelet was associated with the most superior survival, HR 0.51 (0.40-0.65, P < 0.001). Sensitivity analysis (exclusion of non-users of prosthesis) showed that statin-use remained a significant indicator of longer survival, maximally when combined with antiplatelet use HR 0.52 (0.39-0.68, P < 0.001). Statin-use is associated with better mobility and long-term survival in rehabilitees after limb loss, particularly when used in combination with antiplatelets. Significantly lower rates of statin-use were observed in female patients. Further research is warranted on gender disparities in statin-use and causality in their association with improved mobility and survival.

Medial arterial calcification score is associated with increased risk of major limb amputation

ObjectiveThe pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. MethodsA multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. ResultsThere were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P = .001 and P = .044, respectively), and lower overall amputation-free survival (log-rank P = .008). ConclusionsPedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia.

Comparing the Safety and Feasibility of Endovascular Therapy via Transradial and Transfemoral Approaches in Patients with Aortoiliac Occlusive Disease: A Propensity Score-Matched Analysis of the Nationwide Registry.

Our objective was to evaluate the feasibility of performing endovascular therapy (EVT) for aortoiliac artery disease using transradial approach (TRA) as compared to transfemoral approach (TFA). We analyzed 9671 cases with symptomatic lower extremity artery disease due to aortoiliac occlusive disease (AIOD) treated using EVT from a Japanese Nationwide EVT Registry between January and December 2021. We compared the baseline characteristics, procedural information, and 30-day outcomes of patients who received EVT only via TRA (n=863 [16.9%]) and those only via TFA (n=4255 [83.1%]) by using propensity score (PS) matching, after excluding those who required regular dialysis, those who underwent hybrid surgeries, and those who received EVT through 2 or more approach sites. After matching, the final study population consisted of 862 matched patients with similar baseline characteristics in each group. Technical success rate was comparable between the 2 groups (99.3% vs. 99.3%, p>0.99). No significant differences were observed with respect to the composite of all-cause death within 48 hours after EVT and post-procedural complications within 30 days, including severe bleeding that required transfusion, revascularization procedures, urgent surgeries, cerebral infarction, and major limb amputation (0.2% vs. 0.7%, p=0.29). Transradial approach was associated with shorter operation time (85 vs. 90 minutes, p=0.016), but longer fluoroscopy time (26 vs. 20 minutes, p<0.001) and higher contrast agent volume (80 vs. 75 mL, p<0.001). After PS matching, TRA showed the comparable rates of successful EVT and 30-day complications in patients with AIOD compared to TFA. Transradial approach was found to be safe and be a viable alternative of TFA for the treatment of AIOD. The efficacy of transradial approach (TRA) is established in percutaneous coronary intervention; however, its safety and feasibility are unclear in endovascular therapy (EVT). We analyzed 9,671 cases with symptomatic aortoiliac occlusive disease treated using EVT from a Nationwide Registry to compare the 30-day outcomes of those who received EVT only via TRA (n = 863 [16.9%]and those only via TFA (n=4,255 [83.1%]) by using propensity score matching. Technical success rate (99.3% vs. 99.3%, p > 0.99) and 30-day complications (0.2% vs. 0.7%, p = 0.29) were comparable between the two groups. EVT via TRA could be performed safely.

Clinical Effects of Tourniquet Use for Nontraumatic Major Lower Limb Amputation: A Two-Center Retrospective Cohort Study

To investigate the effect of tourniquet use on outcomes after major lower limb amputation (MLLA) due to peripheral arterial disease or complications from diabetes mellitus. In this 2-center retrospective observational study, vascular patients who underwent MLLA between January 1, 2016 and December 31, 2020 at 2 UK hospitals were identified using operating theater databases. Hospital databases were used to access medical records, operation notes, and laboratory reports. The use of a tourniquet in each MLLA was noted. The primary outcome was postoperative hemoglobin (Hb) drop (g/L). Secondary outcomes were units of allogeneic blood transfused perioperatively, 90-day revision rates, 90-day wound breakdown rates, surgical site infection (SSI) rates (at 30days), and 90-day mortality. A follow-up index (a measure of follow-up completeness) was calculated for all 30-day and 90-day outcomes. Four hundred seventy two patients underwent MLLA, of which 124 had a tourniquet applied. The median postoperative Hb drop was significantly lower in the tourniquet group compared to the nontourniquet group (13 [interquartile range 5-22] g/L vs. 20 [interquartile range 11-28] g/L; P ≤ 0.001). Thirty three point one percent (41) of tourniquet patients received a blood transfusion perioperatively, compared to 35.6% (124) of nontourniquet patients (P=0.82). Sixteen percent (76) of patients required surgical revision within 90days, with no significant difference between the tourniquet and nontourniquet group (20.2% tourniquet vs. 14.7% no tourniquet; P=0.15). SSI rates (12.0% tourniquet vs. 10.6% no tourniquet, P=0.66) and 90-day mortality (6.5% tourniquet vs. 10.1% no tourniquet; P=0.23) were similar. Multivariable regression demonstrated that tourniquet use was independently associated with a reduced hemoglobin drop (β=-4.671, 95% confidence interval -7.51 to -1.83, P ≤ 0.001) but was not associated with wound breakdown, revision surgery, or SSI. Hypertension, SSI, and below-knee amputation using the skew flap technique were all significant predictors of revision surgery. All follow-up indices were ≥ 0.97. Tourniquet use in MLLA was associated with a significantly lower fall in postoperative Hb without evidence of harm in terms of SSI, wound breakdown/revision rates, or mortality.

Effectiveness of incisional negative pressure wound therapy after major lower extremity amputation: a randomised controlled trial.

The aim was to study the effect of incisional negative pressure wound therapy (iNPWT) in wound healing compared with standard sterile gauze dressings after major lower extremity amputation in patients with peripheral arterial disease (PAD). This prospective, randomised controlled trial included 50 patients undergoing major lower extremity amputations for PAD. Patients were randomised into iNPWT and standard dressing groups. The patency of blood vessels at the level of the stump was ensured with or without revascularisation. The primary outcome was wound-related complications such as surgical site infection (SSI), wound dehiscence, seroma/haematoma formation or the need for revision amputation. The secondary outcome was the time taken for the eligibility of prosthesis placement. It was found that only 12% of the patients in the iNPWT group had SSI compared with 36% in the standard dressing group (p = 0.047). Rates of wound dehiscence, seroma/haematoma formation and revision amputation were decreased in the iNPWT group but this was not statistically significant (p > 0.05). There was a significant reduction in the time taken for eligibility of prosthesis placement in the iNPWT group (5.12 ± 1.53 vs 6.8 ± 1.95 weeks, p = 0.002). iNPWT is effective in reducing the incidence of SSI and the time taken for rehabilitation in patients undergoing major lower limb amputation due to PAD.

Direct Aortic Versus Supra-Aortic Arterial Cannulation During Surgery for Acute Type A Aortic Dissection.

In this study we evaluated the impact of direct aortic cannulation versus innominate/subclavian/axillary artery cannulation on the outcome after surgery for type A aortic dissection. The outcomes of patients included in a multicenter European registry (ERTAAD) who underwent surgery for acute type A aortic dissection with direct aortic cannulation versus those with innominate/subclavian/axillary artery cannulation, i.e. supra-aortic arterial cannulation, were compared using propensity score matched analysis. Out of 3902 consecutive patients included in the registry, 2478 (63.5%) patients were eligible for this analysis. Direct aortic cannulation was performed in 627 (25.3%) patients, while supra-aortic arterial cannulation in 1851 (74.7%) patients. Propensity score matching yielded 614 pairs of patients. Among them, patients who underwent surgery for TAAD with direct aortic cannulation had significantly decreased in-hospital mortality (12.7% vs. 18.1%, p = 0.009) compared to those who had supra-aortic arterial cannulation. Furthermore, direct aortic cannulation was associated with decreased postoperative rates of paraparesis/paraplegia (2.0 vs. 6.0%, p < 0.0001), mesenteric ischemia (1.8 vs. 5.1%, p = 0.002), sepsis (7.0 vs. 14.2%, p < 0.0001), heart failure (11.2 vs. 15.2%, p = 0.043), and major lower limb amputation (0 vs. 1.0%, p = 0.031). Direct aortic cannulation showed a trend toward decreased risk of postoperative dialysis (10.1 vs. 13.7%, p = 0.051). This multicenter cohort study showed that direct aortic cannulation compared to supra-aortic arterial cannulation is associated with a significant reduction of the risk of in-hospital mortality after surgery for acute type A aortic dissection. ClinicalTrials.gov Identifier: NCT04831073.

Drug-Coated Balloon for the Treatment of Long-Segment Femoropopliteal Artery Disease: Pooled Analysis from the BIOLUX P-III SPAIN and BIOLUX P-III All-Comers Registry Long Lesion Subgroup

PurposeTo investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population. Material and MethodsData from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee. ResultsA total of 159 patients, of whom 32.7% had critical limb ischemia, were included in the Passeo-18 Lux long lesion cohort. The mean lesion length was 248.5 mm ± 71.6, and the majority were occluded (54.1%), calcified (87.4%), and of type TASC C (49.1%) or TASC D (50.9%). Freedom from MAEs was 90.6% (95% CI, 84.6–94.3) at 6 months and 83.9% (95% CI, 76.7–89.0) at 12 months. fCD-TLR was 84.4% (95% CI, 77.3–89.5) at 12 months. Freedom from target limb major amputation was 98.6% (95% CI, 94.6–99.7), and all-cause mortality was 5.3% (95% CI, 2.7–10.4) at 12 months. There were no device- or procedure-related deaths or amputations up to the 12-month follow-up. ConclusionPasseo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.

Chronic Limb-Threatening Ischemia in Patients with Type 2 Diabetes: Revascularization Index as a Predictor for Primary Endovascular Intervention Outcome.

Chronic limb-threatening ischemia in patients with diabetes is associated with a high risk of adverse outcomes. The associated co-morbidities, the heterogeneity of foot presentation and the distribution of atherosclerotic lesions led to the emergence of multiple revascularization strategies and scoring systems to improve management outcomes. This study aimed to introduce a new index, the revascularization index (RI), and to assess its predictive value for the outcomes of primary endovascular intervention in patients with type 2 diabetes presenting with chronic limb-threatening ischemia. A retrospective electronic medical records review was conducted for patients with type 2 diabetes presenting with chronic limb-threatening ischemia managed at King Abdullah University Hospital by primary endovascular interventions between January 2014 and August 2019. The RI was analyzed for its predictive value for the treatment outcomes. A total of 187 patients were included in this study, with a major lower limb amputation rate of 19.3%. The performance of the RI was excellent in predicting secondary revascularization (AUC = 0.80, 95% CI: 0.73-0.86, p-value < 0.001), good to predict major amputation (AUC = 0.76, 95% CI: 0.67-0.85, p-value = 0.047), and poor in predicting death (AUC = 0.46, 95% CI: 0.40-0.55, p-value = 0.398). RI of <1.21 was significantly associated with a higher risk of major lower limb amputation (HR = 5.8, 95% CI: 1.25-26.97, p-value < 0.025), and RI of < 1.3 was associated with a higher risk for secondary revascularization. The RI can be used to predict major adverse lower limb events (MALE). It might be used as a guide for the extent of endovascular interventions for diabetic chronic limb-threatening ischemia with multi-level outflow atherosclerotic disease.

Long-Term Patient Outcomes After Femoropopliteal Peripheral Vascular Intervention in Patients With Intermittent Claudication

BackgroundIn patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates. ObjectivesThe aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC. MethodsFrom 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression. ResultsThe 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only. ConclusionsIC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation.