Major Limb Amputation Research Articles

A framework for perioperative care in lower extremity major limb amputation: a consensus statement by the Enhanced Recovery After Surgery (ERAS) Society and Society for Vascular Surgery

The Society for Vascular Surgery elected an international, multidisciplinary panel of experts to review the literature and provide evidence-based suggestions for coordinated perioperative care for patients undergoing major limb amputation due to nonreconstructable chronic limb-threatening ischemia. Structured around the Enhanced Recovery After Surgery (ERAS) core elements, 33 suggestions were made and organized into preadmission, preoperative, intraoperative, and postoperative sections.

How timing and preexisting pain affect outcomes of TMR: a systematic review

Introduction: Targeted muscle reinnervation (TMR) is increasingly common in the care of major limb amputation to limit amputation-related pain. This review aims to elucidate how chronic pain states and length of delay prior to TMR affect its success and outcomes. Methods: Manuscripts were collected from three databases. Articles were first screened and excluded based on exclusion criteria. The remaining manuscripts were independently reviewed to determine inclusion. Article and patient demographics, as well as pain outcomes, were extracted. Data were analyzed based on pain condition, amputation vs. neuroma, and time from amputation/injury to surgery. Results: The literature search yielded 723 articles, with 41 meeting the inclusion criteria. Twenty-one articles included patients with residual limb pain (RLP) and phantom limb pain (PLP), including 14 on amputation and 6 on neuroma excision. Five articles included cancer-related amputation. Complex Regional Pain Syndrome (CRPS) was discussed in 3 articles, ischemia or infection in 2 articles, and neurofibromatosis 1 in 1 article. Twenty-two articles described TMR at the time of amputation. Conclusions: TMR is effective at preventing neuroma formation and limiting pain when performed at the time of amputation. Delayed patients had a greater improvement in RLP but less of an improvement in PLP, when assessed against immediate TMR patients who were compared to non-TMR standard amputees. In the presence of chronic pain states, such as CRPS, there is also improved analgesia. However, current clinical data are limited, indicating a need for further research into the use of TMR for chronic pain management.

Factors Influencing Outcomes of Diabetic Foot Management: Retrospective Study at Mwananyamala Regional Referral Hospital

Background: Diabetic foot ulcers (DFUs) contribute to significant morbidity and mortality worldwide, with the global prevalence of diabetes expected to rise to 12.2% by 2045, an increasing number of people are at risk for complications like DFUs, which affect 19% to 34% of diabetic patients. People with DFUs carry a 20% lifetime risk of limb amputation and mortality rate of 50% to 70%. In Tanzania DFUs account for 41.9% of major limb amputations and mortality rate of 54%. Methods: A retrospective observational study aimed to investigate the clinical factors, and treatment modalities that influence the management outcomes of diabetic foot among patients attending Mwananyamala Regional Referral Hospital (MRRH). The study reviewed existing patient records. Results: A total of 143 participants were enrolled in the study, of which 94 (65.73%) were female. The participants had a mean age of 57 ± 13.9 years. And approximately half (50.35%) were married. Nearly, all patients, 140 (97.90%), underwent surgical treatment, nearly half (41.96%) had DFU Wagner Class 3 while most of participants (69.93%) had hypertension. The mean hospital stay was 9.2 days. In binary logistic regression model output, marital status, level of education, working diagnosis, surgical management, patient progress and number of readmissions were identified as determinants of the outcome (P-value < 0.05). Conclusion: This study identified key factors influencing diabetic foot outcomes, including gender, marital status, co-morbidities and ulcer grade. These findings underscore the importance of early diagnosis, targeted interventions, and comprehensive management to improve patient outcomes.

Predictive Ability of the Pedal Medial Arterial Calcification Score for Major Adverse Limb Events Among Patients with Chronic Limb-Threatening Ischemia

ObjectivePedal medial arterial calcification (pMAC) is a potential predictor of major adverse limb events (MALE) among patients with critical limb-threatening ischemia (CLTI). This study aims to validate the prognostic value of the pMAC score in predicting major lower limb amputation (MLLA) and need for re-do revascularisation. MethodsA single centre study involving 196 patients diagnosed with CLTI, reviewed between 2012 and 2022. Patients’ pMAC scores were obtained through X-ray assessments. Correlations between pMAC scores and the incidence of MALE and re-do revascularisation, were analysed. A power analysis using G* Power 3 software determined a needed sample size of 157 participants. Statistical analysis employed SPSS 26, utilising descriptive statistics, Chi Square, Mann-Whitney, Kaplan-Meier with log-rank test, and Cox regression for predictor identification. ResultsThe cohort was predominantly male (79.1%) and diabetic (59.2%). Re-do revascularisation need was 15.3%, increasing with pMAC scores: 3.3% (low), 24.5% (medium), and 50% (high) (p<0.001). MLLA frequency also rose with pMAC scores: 6.7%, 27.5%, and 50% respectively (p<0.001). Higher pMAC scores correlated with a higher incidence of MALE (p=0.029). Multivariate analysis showed medium pMAC (HR 4.159, p=0.002), high pMAC (HR 7.366, p=0.015), and GLASS stage 3 (HR 3.529, p=0.011) as independent MLLA predictors. Re-do revascularisation predictors included female sex (HR 2.106, p=0.063), Black race (HR 64.498, p=0.001), medium pMAC (HR 6.812, p=0.002), high pMAC (HR 11.455, p=0.008), and GLASS stage 3 (HR 2.899, p=0.037). ConclusionThe pMAC score effectively predicts MALE in CLTI patients and enhances risk stratification. Using both, pMAC scores and GLASS stages enhances predictive accuracy, identifying patients at higher risk for MLLA, Informing clinical decision-making and therapeutic strategies.

Outcomes among Patients with End-Stage Kidney Disease and Chronic Limb-Threatening Ischemia: A Population-based Cohort Study.

To understand mortality and secondary outcomes in patients with both end-stage kidney disease (ESKD) and chronic limb-threatening ischemia (CLTI) after no procedural treatment, primary amputation, endovascular treatment, and open surgery. ESKD and CLTI commonly cooccur and limited prior work has demonstrated poor outcomes including one-year survival despite treatment. We conducted a retrospective national cohort study of United States Renal Data System data from January 1, 2016 to December 31, 2019 to determine mortality, major postoperative complications, and other outcomes. We performed an exploratory analysis comparing two-year survival by treatment using propensity matching. Of 1,876,652 records with a CLTI diagnosis, we identified 3,908 patients with ESKD and an incident CLTI diagnosis. Mean age at CLTI diagnosis was 65.7 years and 2,405 (61.5%) were male. 2,696 (69.0%) had no procedural treatment, 609 (15.6%) had major limb amputation, 439 (11.2%) had endovascular treatment, and 164 (4.2%) had open surgery. There was 44.9% mortality at one year, along with 41.8% major postoperative complications and 52.6% readmissions at 90 days. Comparing two-year survival, we found no differences between the amputation and endovascular cohorts (P=0.08) and between endovascular and open (P=.06). There was superior two-year survival in the open surgery cohort compared to the amputation cohort (P=0.002). Patients living with both ESKD and CLTI experience poor outcomes irrespective of treatment. Exploratory analyses demonstrated that two-year survival among the three principal procedural treatments was similar except for superior survival among patients undergoing open therapy compared to primary amputation.

National Trends and Outcomes of Pedal Bypass Surgery

ObjectiveThe technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers. MethodsAll patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, <2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, >4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ2 or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention. ResultsA total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680). ConclusionsThe utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation.

Improving the provision of emotional support for patients following major lower limb amputation

Major lower limb amputation (MLLA) is a lifesaving but life-altering surgical procedure. Psychological distress is common and typically heightened in the acute postoperative period. Despite the negative impact that poor...

What to expect following targeted muscle reinnervation/regenerative peripheral nerve interface: Pain outcomes in an amputee population

Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI) have shown promise in improving and/or preventing neuropathic pain and reducing narcotic use in amputees. However, anecdotally, some patients experience an increase in pain in the first few months post-operatively. This study explored the pain trajectory of 22 upper and lower extremity amputees following their TMR and/or RPNI procedure in their first post-operative year, with a focus on the patterns of recovery the first few months. Our study found an overall decrease in the amount of pain and pain medication use at various time points post-operatively. Of note, several individuals had an increase in pain or required an increase in pain medications in the first three months. Different outcomes for patients who underwent primary versus secondary surgery were seen, which has been observed in other studies. Further prospective studies are warranted to evaluate these trends in pain after TMR or RPNI surgery in individuals with major limb amputations.

Outpatient Rehabilitation Utilization After Major Limb Loss in Adults Receiving Care in the Military Health System From 2001 to 2017

ObjectiveTo investigate exposures associated with outpatient rehabilitation encounters among Military Health System (MHS) beneficiaries with major limb loss. DesignRetrospective, cohort study. SettingAmerican military treatment facilities and civilian health care facilities that accept TRICARE benefits. ParticipantsAdult MHS beneficiaries with major limb amputation(s) acquired between January 2001 and September 2017 (N=5161). InterventionsNot applicable. Main Outcome MeasuresThis exploratory analysis investigated associations between outpatient rehabilitation care and demographic and amputation characteristics in MHS beneficiaries with major limb loss. ResultsMost beneficiaries were aged 55-64 (36%), male (73%) and retirees/dependents (60%) with enlisted sponsor rank (88%) and single limb loss (89%). The active/reserve beneficiaries were younger, majority male, and more likely to be diagnosed with incident behavioral health conditions. Unadjusted negative binomial regression models revealed increased rates of outpatient rehabilitation encounters in active-duty service members (ADSMs) than in retirees/dependents (rate ratio, 10.02; 95% confidence interval, 9.30-10.80). The rate ratios for sex, sponsor rank, limb(s) lost, incident behavioral health condition, incident traumatic brain injury, incident posttraumatic stress disorder, and outpatient care setting were attenuated after stratification by beneficiary category. Enlisted ADSMs had increased rates of outpatient rehabilitation encounter days compared with officers, whereas retirees/dependents with enlisted sponsors had decreased than those with officer sponsors. ADSMs who accessed outpatient care in direct and private care settings demonstrated high rates of outpatient rehabilitation encounters compared with those who only sought care from private care settings (rate ratio, 4.60; 95% confidence interval, 2.95-6.81). ConclusionsThis study suggests that MHS beneficiaries with major limb loss use outpatient rehabilitation services differently, based on active/reserve duty or retiree/dependent status. This study is the first of its kind to quantify outpatient rehabilitation utilization for military beneficiaries with all-cause major limb loss and may inform MHS policymakers on the rehabilitation needs for combat- and noncombat-related amputee populations.

Below-knee amputation with an ultrasonic scalpel: evaluation of early postoperative clinical outcomes.

Despite the development of microscopic reconstructive techniques for lower limb salvage, major limb amputation is still required for critical, unsalvageable lower leg wounds, with steadily increasing estimates of major limb amputations. In this study, the authors highlight a surgical technique for below-knee (BK) amputation using an ultrasonic scalpel, and evaluate its safety and effectiveness compared with the conventional method of using surgical blades. A retrospective chart review was conducted at the Department of Plastic and Reconstructive Surgery, St. Vincent's Hospital, Republic of Korea, on patients who underwent BK amputation between October 2012 and January 2021. Patients were assigned to two groups: amputation using classical methods, such as surgical blades and electrocautery (group A); and amputation using an ultrasonic scalpel (group B). Numerous perioperative factors, such as operation time, intraoperative blood loss, postoperative complications and recovery time were examined. The present study adhered to the STROBE guidelines. A total of 41 patients (16 in group A and 25 in group B) were included in this study. Operation time was significantly shorter in group B (p=0.001) and intraoperative blood loss was lower (p=0.011). Wound healing time did not vary between groups. In this study, the use of an ultrasonic scalpel for lower limb amputation was effective in reducing operation time and blood loss, which may be helpful in improving outcomes for patients with comorbidities.

Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial

ObjectiveFemale patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular vs best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. MethodsIn a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb-threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared with all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. ResultsAmong 1830 patients, females were significantly underrepresented, comprising only 28% (n = 519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared with males: females were more likely to have rest pain alone (72% vs 60%; P < .0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%; P = .01). Females were less likely to have an adequate single-segment greater saphenous vein (SSGSV) available (82% vs 89%; P = .01). Controlled for baseline clinical factors, at 1 year, females had significantly lower rates of major limb amputation compared with males (hazard ratio [HR], 0.70; P = .023), which drove better amputation- and MALE-free survival rates. All-cause death at 1 year was not statistically different between sexes (11.8% vs 11.2%; P = .286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared with endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared with females undergoing open surgical bypass (24.8% vs 10.5%; P < .001). ConclusionsDespite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all-female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at 1 year compared with male patients. These findings suggest that in treating female patients with CLTI considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex.

Characteristics of Individuals Admitted to Vascular Surgery Service for a Major Lower Limb Amputation From 2017 to 2021 With Present on Admission Pressure Injuries.

The purpose of this study was to describe characteristics of persons admitted from 2017 to 2021 with peripheral arterial disease (PAD) who required a below knee amputation (BKA) or above knee amputation (AKA), including present on admission pressure injuries (POA-PIs). Descriptive, cross-sectional retrospective research design. The sample comprised 196 patients who underwent a total of 258 major lower limb amputations. A majority (65.9 %n=170) underwent BKAs and 88 (34.1 %) underwent AKAs. Coronary artery disease was present in 107 (54.6 %) and 143 (73.0%) had diabetes mellitus. The study site was a 670-bed level 1 trauma center in the Southeastern United States. A retrospective chart review of patients undergoing major lower limb amputations using CPT codes 27880 BKA, and 27590 AKA was completed. Variables extracted included age, sex, race, and comorbid conditions such as smoking, cardiovascular disease, diabetes mellitus, end stage renal disease requiring dialysis, and POA-PI. Descriptive statistics (frequencies, percentages, and means) were used to describe the sample. There were 25 (12.8%) individuals with POA-PI compared with 171 (87.2%) who did not have POA-PI. None of the reviewed significantly differed when patients with or without POA-PI were compared. Age was closest to statistical significance (P=.052). In addition, analysis revealed that 73% (n=143) of individuals had diabetes mellitus in addition to having PAD. Approximately 13% of a group of patients with PAD had POA-PI when admitted to hospital for major limb amputation. Analysis of multiple factors found that none significantly differed between patients with or without POA-PI. Age came nearest to statistical significance and we hypothesize that older age may increase the risk for POA-PI; additional research in samples with greater power to detect this effect are needed. Findings also indicate that diabetes mellitus is a common risk factor for major lower limb amputation. It is important to educate staff/patients/caregivers on the importance of PI prevention especially in the elderly vascular population who are at risk for undergoing major lower limb amputations.

Innovations in Gritti-Stokes Amputation: A Focused Analysis of Immobile Patient Outcomes.

Background Major lower limb amputation is a surgical operation performed for different reasons, including life-threatening infection, ischemia, trauma, and tumors. This study aims to investigate the viability of Gritti-Stokes amputation as a suitable alternative for individuals with impaired mobility and peripheral vascular disease. Patients and methods This was a descriptive, retrospective, and observational study. All patients who met the criteria and underwent Gritti-Stokes amputation were included. The study had a duration of one year, commencing in December 2022 and concluding in December 2023. The data was processed using statistical software (SPSS, version 21; IBM Corp., Armonk, NY, US). Results Twenty-four patients were included. Concerning the complications, 16 patients (66.7%) did not experience any complications, while 7 patients (29.2%) had stump infections. Three of them ultimately required more extensive amputation. A phantom limb was observed in a single patient, accounting for a mere 4.2% of the total. Total of 21 patients, 87.5% reported great stability and lever motion when transitioning from bed to chair, as well as vice versa. Furthermore, wound healing was observed in 21 individuals (87.5%), encompassing both primary and secondary wound healing. Conclusion The Gritti-Stokes amputation provides patients with excellent stability and lever function to facilitate movement. The Gritti-Stokes amputation is a suitableoption for immobile and high-risk patients.

Peripheral Nerve Blocks as a Predictor of Nerve Reconstruction Success After Major Limb Amputation.

Postamputation pain is a spectrum of debilitating sensations that impacts millions of people in the United States. While the development of postamputation pain, including phantom limb pain (PLP), is multifactorial, it has been associated with disorganized axonal sprouting, resulting in a neuroma and subsequent central nervous system changes. Nerve reconstruction surgeries, such as regenerative peripheral nerve interface (RPNI) and targeted muscle reinnervation (TMR), provide transected nerve fibers with proper target organs for reinnervationand have been shown to significantly reduce PLP. This case series aims to describe perioperative peripheral nerve blocks as a diagnostic tool for identifying patients who would benefit from RPNI or TMR. We conducted a retrospective search of patients who underwent major extremity amputation and who received a diagnostic peripheral nerve block before undergoing reconstructive nerve surgery (TMR and/or RPNI). Six patients (58-80 years old) with below-knee amputations (BKA) were examined. All patients experienced a reduction in postamputation pain (PAP), specifically PLP, after a diagnostic peripheral nerve block (PNB). The average time between amputation and revision surgery was approximately two years (Mean: 22.35 months). Following surgical intervention, all patientsreported a reduction in PLP episodes after nerve reconstruction surgery. Two patients no longer reported PLP.Ambulation rates also improved following revision (50% vs 83%). PNBs can be used as an effective diagnostic tool to identify patients that will significantly benefit from amputation revisions with TMR or RPNI.

ThP8.1 - Long-Term Impact of COVID-19 related disruption of NHS Elective services on Emergency Major Lower Limb Amputations

Abstract Background The COVID-19 pandemic has affected the healthcare systems worldwide since the dawn of 2020. In March 2020, the United Kingdom government announced the first national lockdown which severely disturbed all NHS healthcare elective services. Our aim is to assess the long-term impact of COVID-19 related disruption of NHS elective services on emergency major lower limb amputations. Method Patients' data for emergency major lower limb amputations (MLLA) for critical limbthreatening ischemia and diabetic foot infections performed at Aberdeen Royal Infirmary was collected through Trakcare® and divided into the control pre-pandemic group (April 2018 to March 2020) and the pandemic group (April 2020 to March 2022). The statistical analysis was conducted using the IBM SPSS software [v28.0.1.1 (14)]. Results A total of 358 patients underwent MLLA and 206 (57.5%) of these had diabetes mellitus. There was a 17% increase in the number of urgent referrals and every one in five of these finally underwent an amputation. There was an increase in the absolute number of Above- and Below-Knee amputations. There was a statistically significant increase by 33% in emergency MLLAs during the pandemic period (p-value &amp;lt;0.05). A total of 165 postoperative deaths up to December 2022 were recorded with 30-day mortality rate of 7.26% (n=26). Conclusion NHS vascular management groups should update themselves with evolving technologies to optimise the care provided during future unprecedented times. Furthermore, more effective measures should also be implemented to avoid delayed presentations, which can potentially lead to higher rates of major limb amputations.

Prospective Multi-Center Longitudinal Study to Validate Accuracy of the Global Anatomic Staging System (GLASS) Score in Predicting Major Acute Limb Events in Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention: The PROMOTE-GLASS Study Protocol.

Developed by the Global Vascular Guidelines committee, the Global Limb Anatomic Staging System (GLASS) is an angiographic scoring system used for quantifying infrainguinal disease extent and predicting treatment success with endovascular techniques (EVT). Currently, no other risk prediction model is available for patients with chronic limb threatening ischemia (CLTI) undergoing EVT. GLASS' validation and adoption outside academic institutions for research are limited. Thus, this longitudinal multicenter prospective study aims to examine GLASS' validity and reliability in predicting major acute limb events and overall survival (OS) in patients with CLTI undergoing EVT. This prospective, international, multicenter, observational study will include patients with CLTI undergoing EVT (PROMOTE-GLASS) (ClinicalTrials.gov; ID: NCT06186544) identified through routine clinical referrals and emergency visits to vascular units in participating centers. Only patients who are referred for EVT will be recruited. The primary outcomes are immediate technical success, immediate technical failure, and 1-year limb base patency. The secondary outcomes are major adverse limb events, major lower limb amputation, and OS in patients presenting with CLTI who undergo EVT up to 1 year after the procedure. Clinical and imaging data will be analyzed at the end of follow-up to validate risk prediction. This protocol outlines our approach for identifying cases, GLASS score calculation, outcome measures assessment, and a statistical analysis plan. PROMOTE-GLASS holds significant implications and can potentially revolutionize clinical decision-making by assisting clinicians in identifying patients who are likely to benefit from EVT. Ultimately, reduce the need for more invasive procedures and improve patient outcomes. Furthermore, PROMOTE-GLASS can provide useful information, including patient selection, for future randomized controlled trials (RCTs) investigating EVT for CLTI. PROMOTE-GLASS anticipated implications on the vascular community are rooted in its potential to improve patient care, inform future research, and address limitations in existing literature regarding CLTI treatment outcomes.

Race and the treatment of in-stent restenosis of the femoral-popliteal artery with paclitaxel drug-coated balloon angioplasty

ObjectiveThe aim of this study was to report the impact of race on paclitaxel drug-coated balloon (DCB) angioplasty for the treatment of femoral-popliteal artery in-stent restenosis (ISR). MethodsA prospective, non-randomized, post-market study of a paclitaxel DCB for the treatment of ISR of femoral-popliteal artery was conducted at 43 sites within the Vascular Quality Initiative (December 2016-January 2020). The primary endpoint was freedom from target lesion revascularization (F-TLR) through 12 months. Secondary endpoints included freedom from target vessel revascularization (F-TVR), freedom from major limb amputation, and survival. In this sub-analysis, the results were stratified by self-identified Black vs White race. ResultsBlack patients (n = 63) had a lower mean age (64.3 ± 9.7 vs 68.2 ± 9.7 years; P = .006) and were more often female (57.1% vs 37.0%; P = .004) compared with White patients (n = 219). Most patients had claudication (80.9%), with Black patients presenting with a higher rate of ischemic rest pain (30.2% vs 16.0%; P = .012). By Kaplan-Meier estimates, F-TLR was 91.3% vs 89.1% (log-rank P = .63) and 66.4% vs 74.0% (log-rank P = .41) at 12 and 24 months for Black vs White race. F-TVR was 87.8% vs 87.6% (log-rank P = .96) and 61.3% vs 70.6% (log-rank P = .29) at 12 and 24 months for Black vs White race. Freedom from major target limb amputation was 100.0% vs 99.5% (log-rank P = .59) and 100.0% vs 99.0% (log-rank P = .45) at 12 and 24 months for Black vs White race. Survival was 93.7% vs 95.9% (log-rank P = .47) and 84.1% vs 91.3% (log-rank P = .11) at 12 and 24 months for Black vs White race. In multivariable analysis, no significant predictors were identified for TLR or TVR through 24- months. Dialysis (hazard ratio [HR], 27.69; 95% confidence interval [CI], 10.35-74.09; P < .001), coronary disease (HR, 2.80; 95% CI, 1.29-6.06; P = .009), and lesion length (HR, 1.04; 95% CI, 1.02-1.07; P = .001) were associated with increased mortality through 24 months. Race was not significantly associated with TLR, TVR, or mortality. ConclusionsIn this sub-analysis of a Vascular Quality Initiative-based study, the treatment of femoral-popliteal ISR with paclitaxel angioplasty was equally safe and effective for Black and White races. The trend in reduced survival for patients of Black race at 2 years requires longer observation in a larger study.

Patients with dementia or frailty undergoing major limb amputation have poor outcomes

ObjectiveMajor lower limb amputation is a disfiguring operation associated with impaired mobility and high near-term mortality. Informed decision-making regarding amputation requires outcomes data. Despite the co-occurrence of both chronic limb-threatening ischemia (CLTI) and Alzheimer’s disease and related dementias (ADRD), there is sparse data on the outcomes of major limb amputation in this population and the impact of frailty. We sought to determine mortality, complications, readmissions, revisions, intensive interventions (eg, cardiopulmonary resuscitation), and other outcomes after amputation for CLTI in patients living with ADRD looking at the modifying effects of frailty. MethodsWe examined Medicare fee-for-service claims data from January 1, 2016, to December 31, 2020. Patients with CLTI undergoing amputation at or proximal to the ankle were included. Along with demographic information, dementia status, and comorbid conditions, we measured frailty using a claims-based frailty index. We dichotomized dementia and frailty (pre-frail/robust = “non-frail” vs moderate/severe frailty = “frail”) to create four groups: non-frail/non-ADRD, frail/non-ADRD, non-frail/ADRD, and frail/ADRD. We used linear and logistic regression via generalized estimating equations in addition to performing selected outcomes analyses with death as a competing risk to understand the association between dementia status, frailty status, and 1-year mortality as our primary outcome in addition to the postoperative outcomes outlined above. ResultsAmong 46,930 patients undergoing major limb amputation, 11,465 (24.4%) had ADRD and 24,790 (52.8%) had frailty. Overall, 55.9% of amputations were below-knee. Selected outcomes among frail/ADRD patients undergoing amputation (n = 10,153) were: 55.3% 1-year mortality 29.6% readmissions at 30 days, and 32.3% amputation revision/reoperation within 1 year. Of all four groups, those in the frail/ADRD had the worst outcomes only for 1-year mortality. ConclusionsFirst, patients with ADRD or moderate/severe frailty suffer an array of very poor outcomes after major limb amputation for CLTI, including high mortality, readmissions, revision, and risks of discharge to higher levels of care. Second, there is a complex relationship between outcome severity and ADRD/frailty status. Specifically, frailty is more often than ADRD associated with the poorest results for any given outcome. These data provide important outcomes data to help align decision-making with health care values and goals.

Tourniquet Use in Major Lower Limb Amputation: Useful or Harmful?

Tourniquet Use in Major Lower Limb Amputation: Useful or Harmful?

Reamputation Rate, Mortality, and the Incidence of Risk Factors for Ipsilateral Reamputation Among Patients with Dysvascular Major Lower Limb Amputation

A major lower-limb amputation (LLA) for dysvascular disease carries the risk of disturbed wound healing necessitating reamputation at a higher level. A reamputation causes a delay in prosthetic fitting and recovery of walking ability. The combination of a prolonged open wound and inability to walk can worsen of the physical and psychological situation. Prevention of reamputation seems therefore important. This study aims to identify risk factors for reamputation, and to evaluate a possible altered mortality rate after a dysvascular major LLA. These issues are crucial for shared decision-making prior to surgery. Retrospective study investigating a Dutch regional cohort of patients with a dysvascular below-knee, through-knee, or above-knee LLA. 516 Dysvascular major LLAs were included (2014-2018). One hundred reamputations were performed within 1 year after initial amputation (19.4%). Risk factors for ipsilateral reamputation were diabetes mellitus, lipid-lowering drugs usage, and lower level of amputation (respectively P = < 0.01, 0.037, and < 0.01). The 30-day mortality rates were 1% and 12% for the reamputation group and the non-reamputation group respectively (P = < 0.01). The 1-year mortality rates were 23% and 27% for the reamputation group and the non-reamputation group respectively (P = 0.423). Ipsilateral reamputation within one year after initial amputation is common. Several risk factors for reamputation were identified. The 30-day and 1-year mortality rate is high, but not significantly different after one year. A clinical decision tool for dysvascular patients needs to be developed to improve shared decision-making, reduce reamputation rates, and improve survival.