Major Limb Amputation Research Articles

The use of fetal bovine acellular dermal matrix in severe diabetic foot ulceration and threatened limbs with tissue loss the use of FBADM as an adjunct for complex wounds.

Foot ulceration associated with diabetic foot disease (DFD) and chronic limb-threatening ischaemia (CLTI) presents a complex clinical challenge and failure to heal the wound imposes a significant risk of major limb amputation (MLA). In attempt to accelerate wound healing rates and decrease MLA, tissue engineering research into bio-engineered scaffolds and skin substitutes has become a growing area of interest. Advanced wound therapies such as fetal bovine acellular dermal matrix (FBADM) may have success in the treatment of difficult to heal chronic foot ulcers. The FBADM traps and binds the patients' own epithelial cells to rebuild the dermis layer of the skin. Previous studies have suggested that wounds treated with FBADM had a faster healing rate than wounds managed with conventional dressings. However, these studies excluded foot wounds with chronic exposed bone or tendon, active infection, gangrene, or osteomyelitis and patients with uncontrolled blood glucose levels were excluded. The aim of this study was to assess the efficacy of FBADM for patients admitted to hospital acutely with severe foot ulceration secondary to DFD and CLTI. Between February 2020 and December 2021, inpatients admitted acutely at a single tertiary centre with a severe non-healing foot ulcer and had a wound suitable for application of a FBADM after primary debridement were included in the study. A severe non-healing foot wound was defined as a Society for Vascular Surgery Wound, Ischaemia, and foot Infection (WIfI) stage of 3 or 4. Participants were prospectively followed up at regular intervals at a multidisciplinary high-risk diabetic foot clinic until June 2022. The primary endpoint was time to wound closure. The secondary endpoints were number of applications of FBADM, readmission rate and amputation-free survival. There were 22 patients included in the study with a median age of 71 (50-87) years and 15 were male. Five patients had a WIfI stage of 3 and 17 had a WIfI score of 4. Overall, 14 patients required revascularisation procedures (6 open surgery,8 endovascular intervention). A total of 18 patients achieved complete wound healing with a median time to wound healing of 178 (28-397) days. Two patients underwent a MLA and two patients died prior to complete wound healing. The median length of stay was 16.5 (5-115) days, and 4 patients were readmitted to hospital within 12months. FBADM may be a useful adjunct in the acute setting of complex DFD and CLTI ulceration to assist with wound healing. Future comparative prospective studies are required to further validate these preliminary findings.

Kinematic analysis of impairments and compensatory motor behavior during prosthetic grasping in below-elbow amputees.

After a major upper limb amputation, the use of myoelectric prosthesis as assistive devices is possible. However, these prostheses remain quite difficult to control for grasping and manipulation of daily life objects. The aim of the present observational case study is to document the kinematics of grasping in a group of 10 below-elbow amputated patients fitted with a myoelectric prosthesis in order to describe and better understand their compensatory strategies. They performed a grasping to lift task toward 3 objects (a mug, a cylinder and a cone) placed at two distances within the reaching area in front of the patients. The kinematics of the trunk and upper-limb on the non-amputated and prosthetic sides were recorded with 3 electromagnetic Polhemus sensors placed on the hand, the forearm (or the corresponding site on the prosthesis) and the ipsilateral acromion. The 3D position of the elbow joint and the shoulder and elbow angles were calculated thanks to a preliminary calibration of the sensor position. We examined first the effect of side, distance and objects with non-parametric statistics. Prosthetic grasping was characterized by severe temporo-spatial impairments consistent with previous clinical or kinematic observations. The grasping phase was prolonged and the reaching and grasping components uncoupled. The 3D hand displacement was symmetrical in average, but with some differences according to the objects. Compensatory strategies involved the trunk and the proximal part of the upper-limb, as shown by a greater 3D displacement of the elbow for close target and a greater forward displacement of the acromion, particularly for far targets. The hand orientation at the time of grasping showed marked side differences with a more frontal azimuth, and a more "thumb-up" roll. The variation of hand orientation with the object on the prosthetic side, suggested that the lack of finger and wrist mobility imposed some adaptation of hand pose relative to the object. The detailed kinematic analysis allows more insight into the mechanisms of the compensatory strategies that could be due to both increased distal or proximal kinematic constraints. A better knowledge of those compensatory strategies is important for the prevention of musculoskeletal disorders and the development of innovative prosthetics.

The Upper Extremity Functional Scale for Prosthesis Users (UEFS-P): subscales for one and two-handed tasks

Purpose To develop a self-report measure of activity performance for upper limb prosthesis users that quantifies outcomes by level of amputation and prosthesis type. Materials and methods Telephone survey of 423 adults with major upper limb amputation (ULA) who used a prosthesis. Item generation, cognitive, and pilot testing were followed by field testing. Items were categorized as one- or two-handed. Factor and Rasch analyses evaluated unidimensionality, monotonicity, item fit, differential item functioning (DIF), and reliability. Test–retest reliability was evaluated with intraclass correlation coefficients (ICCs). Known group validity was assessed with ANOVAs. Results Respondents with unilateral ULA utilized prosthesis for 24% of unilateral and 38% of bilateral tasks. Those with bilateral ULA utilized prostheses for 64% of unilateral and 46% of bilateral tasks. Factor analyses identified a One-handed Task factor (CFI = 0.963, TLI = 0.950, and RMSEA = 0.064) and a Two-Handed Task factor (CFI = 0.958, TLI = 0.953, and RMSEA = 0.053). Response categories were collapsed to address monotonicity. After DIF adjustment, person reliability was 0.49 and 0.82 for One-handed and Two-handed Task scales, respectively, and ICCs were 0.88 and 0.91. Both scales differed by amputation level (p < 0.001). Conclusions The Upper Extremity Functional Scale for Prosthesis Users (UEFS-P) measure of upper limb function of prosthesis users has promising psychometric properties. Implications for rehabilitation Measurement of upper limb function in persons with amputation is challenging, given currently available measures which do not explicitly grade activity performance with a prosthesis. The Upper Extremity Functional Scale for Prosthesis Users (UEFS-P) builds upon the original Orthotics and Prosthetics User Survey (OPUS) UEFS Scale with modified instructions, a revised item set, response categories and scoring algorithm. The UEFS-P consists of two unidimensional scales, the One-handed Tasks scale and the Two-handed Tasks scale. The UEFS-P scales have clear advantages over existing self-report measures of upper limb function that ask about difficulty with performing functional activities without accounting for prosthesis use, and do not differentiate persons who use and do not use a prosthesis.

Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide.

Diabetic foot disease is a serious complication of diabetes mellitus. Patients with diabetes mellitus have a 25% lifetime risk for developing a foot ulcer, and between 14% and 24% of patients require a major or minor lower limb amputation due to severe gangrene. However, decisions concerning whether to amputate or whether to perform a major or minor lower limb amputation, and how best to determine the amputation plane remain unclear. To consolidate the current literature with expert opinion to make recommendations that will guide surgical amputation for patients with diabetic foot ulcers. A total of 23 experts experienced in surgical treatment of patients with diabetic foot ulcers formed an expert consensus panel, and presented the relevant evidence, discussed clinical experiences, and derived consensus statements on surgical amputation for patients with diabetic foot ulcers. Each statement was discussed and revised until a unanimous consensus was achieved. A total of 16 recommendations for surgical amputation for patients with diabetic foot ulcers were formulated. The experts believe that determination of the amputation plane should be comprehensively evaluated according to a patient's general health status, the degree of injury, and the severity of lower limb vasculopathy. The Wagner grading system and the severity of diabetic lower extremity artery disease are important criteria when determining the degree of amputation. The severity of both diabetic foot infection and systemic underlying diseases are important factors when considering appropriate treatment. Moreover, consideration should also be given to a patient's socioeconomic status. Given the complexities of treating the diabetic foot, relevant issues in which consensus could not be reached will be discussed and revised in future. This expert consensus could be used to guide doctors in clinical practice, and help patients with diabetic foot ulcers gain access to appropriate amputation treatment.

Management of diabetic ulcers of the dorsum of the foot and distal leg ulcers.

Diabetic foot ulceration of toes, forefoot and heel have been extensively studied; however, the dorsum of the foot and the distal leg have rarely been addressed. The objective of this study was to assess diabetic ulcers of the dorsum of the foot and of the distal leg (DUDFDLs) as primary sites, or extended lesions from other foot locations, with regard to possible causes, management and outcomes. This was a retrospective study conducted in Jabir Abu Eliz Diabetic Centre (JADC) in Khartoum from January 2018 to August 2019. All patients with a primary DUDFDL, or one extending from a plantar or heel ulcer, were included. A cohort of 102 patients with DUDFDLs were studied; 74 (72.5%) were male and 28 (27.5%) were female, with a male-to-female ratio of 2.6:1, and a mean age of 57±12 years. The ulcer was a primary DUDFDL in 38 patients and a secondary ulcer in 64 patients. The outcome in 38 patients with primary DUDFDL was healing without amputation in 26 cases (68.4%), amputation of toes in 12 cases (31.6%), and no major amputation or death. Of the 64 patients presenting with secondary DUDFDL extending from the plantar surface, there was extension to the dorsum of the foot through the forefoot ulcer in 54 patients and through the ankle joint to the distal leg in 10 patients. For the plantar ulcers extending to the dorsum, five cases healed without amputation (9.3%), minor amputation was necessary in 29 cases (53.7%), major amputation in 14 cases (25.9%) and six patients died (11.1%). For the distal leg ulcers with extension through the ankle joint, five healed without amputation and five required minor amputation. Primary DUDFDLs had a favourable outcome. Dorsum extension of diabetic foot ulcer from the plantar aspect of the foot carries a high risk for major limb amputation and death.

Evaluation of global limb anatomic staging system for patients with chronic limb-threatening ischemia treated with autogenous bypass grafts.

We evaluated the relationship of the global limb anatomic staging system (GLASS) stage with the clinical outcomes for patients with chronic limb-threatening ischemia (CLTI) who had undergone distal bypass with vein grafting. We performed a single-center, retrospective analysis of patients with CLTI who had undergone distal bypass with vein grafting from January 2012 to December 2019. The primary end point was freedom from CLTI, including amputation-free survival, complete wound healing, and no ischemic rest pain. The secondary end points included a composite outcome of recurrence (patients who had achieved freedom from CLTI but had developed a new wound or ischemic rest pain), major limb amputation, amputation free-survival, overall survival, major adverse limb events, limb-based patency, and primary and secondary patency rates. A total of 190 patients had undergone 211 distal bypasses with a median follow-up of 30months. Of these patients, 80% had had diabetes or end-stage renal disease requiring dialysis. Most patients (63%) had experienced major or extensive tissue loss (WIfI [wound, ischemia, foot infection] wound class ≥2), and more than one half of these had had some degree of infection of the foot. A severe anatomic pattern (GLASS stage III) was predominant, with a prevalence of 78%. No significant differences were found between GLASS stage I and II and GLASS stage III groups for all the outcomes analyzed. Approximately 80% of the 211 revascularized limbs were free of CLTI at 12months after treatment. At 4years of follow-up, we observed that 25% of the patients had had CLTI recurrence, 83% were free from major amputation, and 61% were free from major adverse limb events. Limb-based patency, primary patency, and secondary patency were 79%, 80%, and 93% at 1year and 64%, 65%, and 81% at 4years, respectively. The GLASS stage was not related to patency or the clinical outcomes after distal bypass with vein grafting. Distal open revascularization resulted in excellent rates of freedom from CLTI with low rates of CLTI recurrence, two key time-integrated outcomes of clinical disease severity for patients with CLTI.

Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease

BackgroundEndovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS). ObjectivesThe purpose of this study was to compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials. MethodsPatient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE). ResultsThe primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months. ConclusionsIn a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis vs BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments.

A Modified Scapular-Parascapular Flap Design for Optimal Coverage of the Residual Limb.

Large soft tissue defects associated with major limb amputation pose a challenge to the reconstructive surgeon due to the 3-dimensional contour of the residual limb and the need to withstand the unnatural shear forces imparted by prosthetic sockets. Fasciocutaneous flaps based on the circumflex scapular system have proven useful for residual limb coverage due to the durability of the tissue provided, the absence of functional morbidity, and the ease of reelevation. A modified, bilobed flap design that incorporates large Burrow triangles into each limb serves to leverage the perforasome anatomy of the posterior trunk to provide maximal 3-dimensional coverage and favorable flap geometry while also facilitating donor site closure. A retrospective medical record review was performed for all patients who underwent reconstruction of a residual limb after major amputation using the modified, bilobed scapular-parascapular free flap design at Walter Reed National Military Medical Center between 2018 and 2021. A computer-based application was used to calculate flap area and dimensions based on photographs of preoperative and intraoperative markings. Six patients with varying amputation levels (2 transtibial, 1 transfemoral, 1 hip-disarticulation, 1 hemipelvectomy, 1 transradial) underwent soft tissue coverage using the modified flap design. Mean flap area was 318.4 cm 2 with 51.1 cm 2 attributable to the modified design. This represents a 16% increase over a conventional bilobed design. There were no partial or complete flap failures. The modified scapular-parascapular flap design enables harvest of a larger and more versatile fasciocutaneous flap with geometry that is well suited for coverage of the residual limb.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

PurposeThis study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).Materials and MethodsThe EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.ResultsKaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34).ConclusionsPrimary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

Comparing the Benefit of Duplex Ultrasound Surveillance Following Both Infrainguinal Bypass Surgery and Stenting for Femoro-Popliteal Disease

Duplex ultrasound surveillance (DUS) is commonly used following infrainguinal vein bypass. The role of DUS following endovascular revascularisation is as yet unclear. This study focuses on the role of DUS in a contemporary group of patients undergoing infrainguinal bypass or stent insertion. All patients undergoing either an infrainguinal vein graft bypass or stent insertion into the femoro-popliteal segment (November 2014 - January 2017) were identified. Patients were followed up for 2years. Data on entry into DUS, pre-operative characteristics, adjunctive pharmacotherapy and reintervention were collated. The primary outcomes were major lower limb amputation and mortality at 2years post revascularisation. One hundred and thirty-five patients underwent infrainguinal vein bypass and 100 patients underwent stent insertion. 107 patients in the bypass cohort and 58 patients in the stent cohort entered DUS. For the bypass cohort, entering DUS was associated with a lower mortality rate (P = .003) but was not associated with an improvement in amputation rates. The odds ratio of major amputation or mortality was greater in the no surveillance group (4.58, 95% CI: 1.855 - 11.364). In the stent cohort, DUS was not associated with a significant improvement in either major amputation or death (odds ratio 2.13 (95% CI 0.903 - 5.051; P = .081). DUS was associated with improved survival rates in patients undergoing lower limb bypass but had no benefit in those patients undergoing stent insertion. The role of DUS following stent insertion in the femoropopliteal segment needs to be better defined.

EP-474 An audit of cardiovascular risk modification in patients undergoing major limb amputation for the complications of peripheral atherosclerotic arterial disease and diabetes mellitus

Abstract Introduction The 5-year mortality for patients with peripheral atherosclerotic arterial disease is significant. Major adverse cardiovascular events are common – 16% of patients will have an event within 1-year of the diagnosis. Patients who present requiring major limb amputation represent a group where cardiovascular complications are significant – we have audited how risk is modified for this group at the point of discharge from hospital following treatment. Methods This was a retrospective review of patients admitted for major limb amputation. Specific variables of interest were the prescription of an antiplatelet agent (or oral anticoagulant) and a statin at the time of discharge from hospital. This was defined from immediate discharge letters. Results During the period of interest there were 282 major limb amputations performed and 235 patients were discharged from hospital. Most patients had peripheral atherosclerotic arterial disease (68%). A diagnosis of diabetes was mellitus was also common (52%). In this group of patients many had previous major adverse cardiovascular events – myocardial infarct 21%, angina 16% and previous stroke 18%. At the time of discharge on 80% of patients were prescribed an antiplatelet agent (or anticoagulant) and only 82% of patients had been prescribed a statin. Discussion Pharmacological management of cardiovascular risk in this high-risk group should be improved. At the point of admission a comprehensive assessment of cardiovascular risk should be made and modifiable risk factors addressed.

TH4.6 Is major limb amputation the most appropriate means of palliation for patients with non-reconstructable arterial disease?

Abstract Introduction Major limb amputation (MLA) is the highest risk lower limb surgical procedure performed in the United Kingdom with reported in hospital mortality 9.1%. For patients with non-reconstructable arterial disease it offers palliation of symptoms. The primary aim of the current work was to define if surgical palliation with major limb amputation is being offered to patients who may have been best managed medically Methods Retrospective review of major limb amputations (March 2019 to October 2021). Historical datasets have also been scrutinised (2008–2010). Specific variables of interest included the annual number of major limb amputations, mortality on the index admission and place of discharge. Results A complete dataset was available for 282 patients during the Covid period. Patient demographics were as anticipated - 206 (73%) male, mean age 63-years (range 23 to 90-years). Peripheral arterial disease (190) and diabetes mellitus (149) were common. The number of major limb amputations was comparable with the historical series. In-hospital mortality was 7% (n=20). The median duration of admission for patients who survived was 26-days and 38% of patients were limb-fitted (which was also comparable with historical data). Most patients (71%) were discharged to their own home. Conclusion The outcomes described are better than the comparable local historical and national data both in terms of in-hospital mortality and place of discharge. These data imply that we make the correct decision about MLA more often than we don't.

TH1.14 Major limb amputation during the Covid-19 pandemic – Have we seen a change in practice?

IntroductionThere have been significant changes in the delivery of health care as a consequence of the Covid-19 pandemic. Standard operating procedures have been re-defined to minimise harm from the reduction in access to services, whilst at the same time protecting hospitals (and in particular critical care units) from admissions.We have explored major limb amputation (MLA) practice and compared this with a historical series.MethodsRetrospective review of major limb amputations (March 2019 to October 2021). Historical datasets have also been scrutinised (2008–2010). Specific variables of interest included the annual number of major limb amputations, primary versus secondary amputation and ratio of transtibial (TTA) to transfemoral (TFA) amputations.ResultsA complete dataset was available for 282 patients during the Covid period. Patient demographics were as anticipated - 206 (73%) male, mean age 63-years (range 23 to 90-years). Peripheral arterial disease (190) and diabetes mellitus (149) were common. These demographics were comparable to the historical data. The annual number of MLA has not changed over the Covid period. The ratio of primary to secondary MLA was 1:1.3 in the historical series and 1:1 during the Covid period. The ratio of TTA to TFA was 3:1.8 in the historical series and 2:1 during the Covid period.ConclusionThe trends suggest that practice has not changed significantly during the Covid period. There has been a slight change in the ratio of transtibial to transfemoral amputation, which may reflect patients presenting with later stage disease.

SP5.2.1 Intra-muscular interposition of nerve endings to minimise neuropathic and residual pain in lower limb amputations

Abstract Introduction A major cause of morbidity in lower limb amputees is phantom limb pain (PLP) and residual limb pain (RLP). This study aimed to determine if surgical interposition of nerve endings into adjacent muscle bellies at the time of major lower limb amputation can decrease the incidence and severity of PLP and RLP. Methods Data was retrospectively collected from January 2015 to January 2021, including eight patients that underwent nerve interposition (NI) and 36 that received standard treatment. Primary outcomes included the 11-point Numerical Rating Scale (NRS) for pain severity, and Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity, behaviour, and interference. Secondary outcome included Neuro-QoL Lower Extremity Function assessing mobility. Cumulative scores were transformed to standardised t scores. Results Across all primary and secondary outcomes, NI patients had lower PLP and RLP. Mean ‘worst pain’ was 2 out of 10 for RLP in the NI group, compared to 3.58 in the control group (p=0.045). Mean PROMIS t scores were lower for NI cohort for both RLP (pain intensity [41.2 vs 48.1;p=0.035]; pain interference [44.9 vs 46.3;p=0.260]; pain behaviour [44.4 vs 50.8;p=0.039], and PLP (pain intensity [50.8 vs 58.5;p=0.029]; pain interference [49.1 vs 54.0;p=0.009]; pain behaviour [53.4 vs 55.6;p=0.061]). Mean Neuro-QoL t score was lower in NI cohort (45.4 vs 41.9;p=0.03). Conclusion Surgical interposition of nerve endings during lower limb amputation is a simple yet effective way of minimising PLP and RLP, improving patients’ subsequent quality of life. Additional comparisons with targeted muscle reinnervation should be performed to determine the optimal treatment option.

Incisional negative pressure wound therapy to reduce surgical-site infections in major limb amputations: a meta-analysis

PurposeIncisional negative pressure wound therapy (iNPWT) has shown effectiveness in the treatment of high-risk surgical wounds. Especially patients with diabetes-induced peripheral arterial disease undergoing major limb amputation have a high intrinsic risk for post-surgical wound infections. While normal gauze wound dressings do not cause stimulation of microvasculature, iNPWT might improve wound healing and reduce wound complications. The purpose of this study was to systematically review the literature for rates of wound complications and readmissions, as well as post-surgical 30-day mortality.MethodsWe conducted a systematic review searching the Cochrane, PubMed, and Ovid databases. Inclusion criteria were the modified Coleman methodology Score >60, non-traumatic major limb amputation, and adult patients. Traumatic amputations and animal studies were excluded. Relevant articles were reviewed independently by referring to the title and abstract. In a meta-analysis, we compared 3 studies and 457 patients.ResultsA significantly overall lower rate of postoperative complications is associated with usage of iNPWT (odds ratio (OR) = 0.52; 95% CI: 0.30–0.89; P = 0.02). There was no significant improvement for 30-day mortality, when iNPWT was used (OR= 081; 95% CI: 0.46 – 1.45; P = 0.48). Nevertheless, we did not note a significant difference in the readmission rate or revision surgery between the two groups.ConclusionOverall, the usage of iNPWT may reduce the risk of postoperative wound complications in major lower limb amputations but does not improve 30-day mortality rates significantly. However, to anticipate surgical-site infection, iNPWT has shown effectiveness and thus should be used whenever applicable.

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

PurposeData on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB.ResultsMean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan–Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%–80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%–77.3%] and 81.9% [95% CI: 69.7%–89.6%] (log-rank p = 0.074), respectively.ConclusionsThe results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. ClinicalTrials.gov identifier: NCT01609296.Level of Evidence.Level 3, Cohort Study.

The Application of Digital Frailty Screening to Triage Nonhealing and Complex Wounds.

We investigated the association between the complexity of diabetic foot ulcers (DFUs) and frailty. Individuals (n = 38) with Grade 2 Wagner DFU were classified into 3 groups based on the Society for Vascular Surgery risk-stratification for major limb amputation as Stage 1 at very low risk (n = 19), Stage 2 at low risk (n = 9), and Stage 3 to 4 at moderate-to-high risk (n = 10) of major limb amputation. Frailty status was objectively assessed using a validated digital frailty meter (FM). The FM works by quantifying weakness, slowness, rigidity, and exhaustion over a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of frailty. Skin perfusion pressure (SPP), albumin, and tissue oxygenation level (SatO2) were also measured. One-way analysis of variance (ANOVA) was used to identify group effect for wound complexity. Pearson's correlation coefficient was used to assess the associations with frailty and clinical endpoints. Frailty index was higher in Stage 3 and 4 as compared to Stage 1 (d = 1.4, P < .01) and Stage 2 (d = 1.2, P < .01). Among assessed frailty phenotypes, exhaustion was correlated with SPP (r = -0.63, P < .01) and albumin (r = -0.5, P < .01). Digital biomarkers of frailty may predict complexity of DFU and thus triage individuals who can be treated more simply in their primary clinic versus higher risk patients who require prompt referral to multidisciplinary, more complex care.

Impact of Timing of Targeted Muscle Reinnervation on Pain and Opioid Intake Following Major Limb Amputation.

Targeted muscle reinnervation (TMR) has been shown to play an important role in managing neuromas. However, the impact of the timing of TMR on pain visual analogue scale (VAS) scores or patient opioid use has not been thoroughly explored. We hypothesized that TMR performed acutely would lead to lower VAS scores and decreased opioid intake. Prospectively collected data from an amputation registry at a single institution were utilized to identify patients who underwent TMR. Acute TMR was defined as TMR performed within 1 month of the major limb amputation. Primary outcomes included VAS pain scores and patient-reported opioid consumption. In all, 25 patients (26 limbs) were identified in the acute group, and 18 patients (18 limbs) were identified in the delayed group. At intermediate follow-up (between 4 and 8 months postoperatively) and at final follow-up, the average pain VAS score in the delayed TMR group was significantly higher than that in the acute group (5.2 vs. 1.9 at intermediate P = .01 and 6.2 vs. 1.9 at final P = .002). In all, 84% of the amputees overall were not consuming opioid medications at the time of final follow-up (79% acute, 88% delayed, P = .72). There were no statistically significant differences in opioid consumption between the acute and delayed group at intermediate follow-up (P = .35) or at final follow-up (P = .68). TMR is an effective procedure to reduce pain following major limb amputation. Patients with TMR performed acutely had significantly lower VAS pain scores at both intermediate and final follow-up than patients with TMR performed in a delayed setting. Therapeutic II.

Major Extremity Amputation: The Koforidua Experience

Background: Major extremity amputation is a relatively common surgical procedure but there is a paucity of local data concerning such an important part of surgical practice. This study was undertaken to unearth the demographics, the common indications, levels, revision and mortality rates of major extremity amputation in a large orthopaedic facility in Ghana.Methods: A retrospective study of 94 consecutive patients with 95 major limb amputations between September 2010 to August 2013 was conducted and the results analysed.Results: Overall, the commonest indication for amputation was trauma which was responsible for 44(46.3%) cases. Of the 95 amputations, 81(85.3%) were lower limb amputations with below knee amputations accounting for 45(47.3%) cases. The age group 21 – 40years had the highest number of amputations with 38(40%) and the commonest cause in this age group was trauma. Average duration of hospitalization was 32 days with 8 patients (8.4%) requiring re-amputation. Six patients (6.4%) died.Conclusion: Major limb amputation is drastically life altering especially in third world countries where livelihoods may depend on the ability to perform manual tasks and opportunities for changes in career paths/gainful rehabilitation do not abound. If traumaticconditions are prevented and expeditiously dealt with and chronic diseases like diabetes are carefully managed, there will be a significant reduction in limb loss following trauma or diabetic foot syndrome.

The Impact of Clinical Follow-Up After Revascularization on the Outcomes of Patients with Chronic Limb Threatening Ischemia

Guidelines for optimal follow-up for patients undergoing lower extremity revascularization (LER) for peripheral arterial disease recommend multiple visits with imaging during the first year followed by yearly monitoring thereafter. Critical limb-threatening ischemia (CLTI) patients are at a greater risk for mortality and limb amputation than claudicants and thus necessitate closer monitoring. The goal of this article is to study the effects of compliance with follow-up after revascularization for patients with CLTI on major amputation rates and mortality. A single-center retrospective chart review of consecutive patients undergoing LER for CLTI was performed. Patients were stratified based on compliance with follow-up to compliant or noncompliant cohorts. Patient characteristics, reinterventions, and perioperative and long-term outcomes were compared between the 2 groups. There were 356 patients undergoing LER and 61% (N=218) were compliant. There was no significant difference in baseline characteristics between the 2 groups. Noncompliant patients were more likely to undergo endovascular interventions compared to compliant patients (92.8% vs. 79.4%, P=0.03). There was no difference in perioperative outcomes between the 2 groups with overall 30-day mortality of 0.6%. After mean follow-up of 2.7years, compliant patients had greater ipsilateral reintervention rates (49.1% vs. 34.1%, P=0.005) and overall reintervention rates (61% vs. 44.2%, P=0.002) compared to noncompliant patients. There was no significant difference in mortality or ipsilateral major amputations between the 2 groups. Patients who were compliant with follow-up after LER for CLTI underwent more reinterventions with no difference in mortality or major limb amputation. Further research regarding the threshold for reintervention and the optimal schedule for follow-up in patients with CLTI is needed.