Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.

OBJECTIVE: Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS: The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS: Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS: In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.

Contemporary Medical Management of Peripheral Arterial Disease.

PURPOSE: Peripheral arterial disease (PAD) is characterized by atherosclerotic arterial occlusive disease of the lower extremities and is associated with an increased risk of major adverse cardiovascular events (MACE) in addition to disabling clinical sequelae, including intermittent claudication and chronic limb-threatening ischemia (CLTI). Given the growing burden of disease, knowledge of modern practices to prevent MACE and major adverse limb events (MALE) is essential. This review article examines evidence for medical management of PAD and its associated risk factors, as well as wound prevention and care. METHODS: A thorough review of the literature was performed, with attention to evidence for the management of modifiable atherosclerotic risk factors, claudication symptoms, wound prevention, and wound care. RESULTS: Contemporary management of PAD requires a multi-faceted approach to care, with medical optimization of smoking, hypertension, hyperlipidemia, and diabetes mellitus. The use of supervised exercise therapy for intermittent claudication is highlighted. The anatomic disease patterns of smoking and diabetes mellitus are discussed further, and best practices for diabetic foot ulcer prevention, including offloading footwear, are described. Quality wound care is essential in this patient population and involves strategic use of debridement, wound-healing adjuncts, and skin substitutes, when appropriate. CONCLUSION: The objective of medical management of PAD is to reduce the risk of MACE and MALE. Atherosclerotic risk factor optimization, appropriate wound care, and management of diabetic foot ulcers, foot infections, gangrene, and chronic, non-healing wounds are critical components of PAD care. Interdisciplinary care is essential to coordinate care, leverage expertise, and improve outcomes.

Potential applications of artificial intelligence and machine learning on diagnosis, treatment, and outcome prediction to address health care disparities of chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is the most advanced form of peripheral artery disease. CLTI has an extremely poor prognosis and is associated with considerable risk of major amputation, cardiac morbidity, mortality, and poor quality of life. Early diagnosis and targeted treatment of CLTI is critical for improving patient's prognosis. However, this objective has proven elusive, time-consuming, and challenging due to existing health care disparities among patients. In this article, we reviewed how artificial intelligence (AI) and machine learning (ML) can be helpful to accurately diagnose, improve outcome prediction, and identify disparities in the treatment of CLTI. We demonstrate the importance of AI/ML approaches for management of these patients and how available data could be used for computer-guided interventions. Although AI/ML applications to mitigate health care disparities in CLTI are in their infancy, we also highlighted specific AI/ML methods that show potential for addressing health care disparities in CLTI.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Early experience with venous arterialization for limb salvage in no-option patients with chronic limb-threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is associated with adverse limb outcomes and increased mortality. However, a small subset of the CLTI population will have no feasible conventional methods of revascularization. In such cases, venous arterialization (VA) could provide an alternative for limb salvage. The objective of the present study was to review the outcomes of VA at our institution. METHODS: We performed a single-institution review of 41 patients who had been followed up prospectively and had undergone either superficial or deep VA. The data collected included patient demographics, comorbidities, VA technique (endovascular vs hybrid), and WIfI (wound, ischemia, and foot infection) limb staging. Data were collected at 1-month, 6-month, and 1-year intervals and included the following outcomes: patency, wound healing, major adverse limb events, major amputation, and death. Descriptive statistics were used for analysis. RESULTS: The study group included 41 patients who had undergone successful open hybrid superficial or deep endovascular VA; 21 (51.2%) had undergone a purely endovascular procedure and 20 (48.8%), hybrid VA. The WIfI clinical stage was as follows: stage 4, 33 (80.5%); stage 3, 6 (14.6%); and stage 2, 1 (2.4%). Of the 41 patients, 24 (58.5%) had completed follow-up at 6 months and 16 (39%) at 1 year. At 1 year, the VA primary patency was 28.6% (95% confidence interval [CI], 0.15%-0.43%), primary assisted patency was 44.3% (95% CI, 0.27%-0.60%), and secondary patency was 67% (95% CI, 0.49%-0.80%). The complete wound healing rate was 2.7% (n = 1) at 1 month, 62.5% (n = 15) at 6 months, and 18.8% (n = 3) at 1 year. Overall wound healing at 1 year was 46.3% (n = 19). The number of major adverse limb events at 1 year was 15 (36.5%) and included 8 reinterventions (19.5%) and 7 major amputations (17%). The number of deaths was zero (0%) at 1 month and four (19%) at 6 months. Two deaths (9.5%) were attributed to COVID-19 (coronavirus disease 2019). No further deaths had occurred within 1 year. The limb salvage survival probability at 1 year was 81%. CONCLUSIONS: These findings suggest that for a select subset of CLTI patients presenting with a high WIfI clinical limb stage and no viable options for conventional open or endovascular arterial revascularization, superficial and deep VA are feasible options to achieve limb salvage.

Analysis of a Machine Learning-Based Risk Stratification Scheme for Chronic Limb-Threatening Ischemia.

Importance: Valid risk stratification schemes are key to performing comparative effectiveness research; however, for chronic limb-threatening ischemia (CLTI), risk stratification schemes have limited efficacy. Improved, accurate, comprehensive, and reproducible risk stratification models for CLTI are needed. Objective: To evaluate the use of topic model cluster analysis to generate an accurate risk prediction model for CLTI. Design, Setting, and Participants: This multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft Engineering via Transfection (PREVENT) III clinical trial data assessed data from patients undergoing infrainguinal vein bypass for the treatment of ischemic rest pain or ischemic tissue loss. Original data were collected from January 1, 2001, to December 31, 2003, and were analyzed in September 2021. All patients had 1 year of follow-up. Exposures: Supervised topic model cluster analysis was applied to nested cohort data from the PREVENT III randomized clinical trial. Given a fixed number of clusters, the data were used to examine the probability that a patient belonged to each of the clusters and the distribution of the features within each cluster. Main Outcomes and Measures: The primary outcome was 1-year CLTI-free survival, a composite of survival with remission of ischemic rest pain, wound healing, and freedom from major lower-extremity amputation without recurrent CLTI. Results: Of the original 1404 patients, 166 were excluded because of a lack of sufficient feature and/or outcome data, leaving 1238 patients for analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 wounds were present in 543 patients (43.8%), with rest pain present in 645 (52.1%). Three distinct clusters were identified within the cohort (130 patients in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) for stage 2, and 29.6% (132 of 446 patients) for stage 3. Conclusions and Relevance: The topic model cluster analysis in this cohort study identified 3 distinct stages within CLTI. Findings suggest that CLTI-free survival is an end point that can be accurately and reproducibly quantified and may be used as a patient-centric outcome.

The Society for Vascular Surgery Objective Performance Goals for Critical Limb Ischemia are attainable in select patients with ischemic wounds managed with wound care alone.

BACKGROUND: To set therapeutic benchmarks, in 2009 the Society for Vascular Surgery defined objective performance goals (OPG) for treatment of patients with chronic limb threatening ischemia (CLTI) with either open surgical bypass or endovascular intervention. The goal of these OPGs are to set standards of care from a revascularization standpoint and to provide performance benchmarks for 1 year patency rates for new endovascular therapies. While OPGs are useful in this regard, a critical decision point in the treatment of patients with CLTI is determining when revascularization is necessary. There is little guidance in the comprehensive treatment of this patient population, especially in the nonoperative cohort. Guidelines are needed for the CLTI patient population as a whole and not just those revascularized, and our aim was to assess whether CLTI OPGs could be attained with nonoperative management alone. METHODS: Our cohort included patients with an incident diagnosis of CLTI (by hemodynamic and symptomatic criteria) at our institution from 2013-2017. The primary outcome measured was mortality. Secondary outcomes were limb loss and failure of amputation-free survival. Descriptive statistics were used to define the 2 groups - patients undergoing primary revascularization and patients undergoing primary wound management. The risk difference in outcomes between the 2 groups was estimated using collaborative-targeted maximum likelihood estimation. RESULTS: Our cohort included 349 incident CLTI patients; 60% male, 51% white, mean age 63 +/- 13 years, 20% Rutherford 4, and 80% Rutherford 5. Most patients (277, 79%) underwent primary revascularization, and 72 (21%) were treated with wound care alone. Demographics and presenting characteristics were similar between groups. Although the revascularized patients were more likely to have femoropopliteal disease (72% vs. 36%), both groups had a high rate of infrapopliteal disease (62% vs. 57%). Not surprisingly, the patients in the revascularization group were less likely to have congestive heart failure (34% vs. 42%), complicated diabetes (52% vs. 79%), obesity (19% vs. 33%), and end stage renal disease (14% vs. 28%). In the wound care group, 2-year outcomes were 65% survival, 51% amputation free survival, 19% major limb amputation, and 17% major adverse cardiac event. The wound care cohort had a 13% greater risk of death at 2 years; however, the risk of limb loss at 2 years was 12% less in the wound care cohort. CONCLUSIONS: A comprehensive set treatment goals and expected amputation free survival outcomes can guide revascularization, but also assure that appropriate outcomes are achieved for patients treated without revascularization. The 2-year outcomes achieved in this cohort provide an estimate of outcomes for nonrevascularized CLTI patients. Although multi-center or prospective studies are needed, we demonstrate that equal, even improved, limb salvage rates are possible.

Persistent under-representation of female patients in United States trials of common vascular diseases from 2008 to 2020.

BACKGROUND: Women have been historically under-represented in vascular surgery and cardiovascular medicine trials. The rate and change in representation of women in trials of common vascular diseases over the last decade is not understood completely. METHODS: We used publicly available data from ClinicalTrials.gov to evaluate trials pertaining to carotid artery stenosis (CAS), peripheral arterial disease (PAD), thoracic and abdominal aortic aneurysms (TAA and AAA), and type B aortic dissections (TBAD) from 2008 to the present. We evaluated representation of women in these trials based on the participation-to-prevalence ratios (PPR), which are calculated by dividing the percentage of women among trial participants by the percentage of women in the disease population. Values of 0.8 to 1.2 reflect similar representation. RESULTS: The sex distribution was reported in all 97 trials, including 11 CAS trials, 68 PAD trials, 16 TAA/AAA trials, and 2 TBAD trials. The total number of participants in these trials was 41,622 and the median number of participants per trial was 150.5 (interquartile range [IQR], 50-252). The percentage of women in the disease population was 51.9% for CAS, 53.1% for PAD, 34.1% for TAA/AAA, and 30.9% for TBAD. Industry sources funded 76 of the trials (77.6%), and the Veterans Affairs Administration (n = 4 [4.1%]), unspecified university (n = 7 [7.1%]), and extramural sources (n = 11 [11.2%]) funded the remainder of the trials. The overall median PPR for all four diseases was 0.65 (IQR, 0.51-0.80). Women were under-represented for all four conditions studied (CAS, 0.73 [IQR, 0.62-0.96]; PAD, 0.65 [IQR, 0.53-0.77]; TAA/AAA, 0.59 [IQR, 0.38-1.20]; and TBAD, 0.74 [IQR, 0.65-0.84]). There was no significant difference in PPR among the diseases (P = .88). From 2008 to the present, there was no significant change in PPR values over time overall (r2 = 0.002; P = .70). When examined individually, PPR did not change significantly over time for any of the diseases studied (for each, r2 < 0.04; P > .45). The PPR did not vary significantly over time for any of the funding sources (for each, r2 < 0.85, P > .08). There was appropriate representation (PPR of 0.8-1.2) in a minority of trials for each disease except TBAD (CAS, 27.3%; PAD, 15.9%; TAA/AAA, 18.8%; and TBAD, 50%). Trials that were primarily funded from university sources had the highest median PPR (1.04; IQR, 0.21-1.27), followed by industry-funded (0.67; IQR, 0.54-0.81), and extramurally funded (0.60; IQR, 0.34-0.73). Studies funded by Veterans Affairs had the lowest PPR (0.02; IQR, 0.00-0.11; P = .004). CONCLUSIONS: Participation of women in US trials of common vascular diseases remains low and has not improved since 2008. Therefore, the generalizability of recent trial results to women with these vascular diseases remains unknown. An improved understanding of the underlying root causes for poor female trial participation, advocacy, and education are required to improve the generalizability of trial results for female vascular patients.

Gender, Racial and Ethnic Disparities in Iatrogenic Vascular Injuries among the Ten Most Frequent Surgical Procedures in the United States.

OBJECTIVE: Iatrogenic vascular injuries (IaVI's) appear to be increasing, with disparate prevalence across gender, race and ethnicity. We aim to assess the risk of IaVI's across these characteristics. METHODS: Using the Nationwide Inpatient Sample for the years 2008 to 2015, we identified rates of IaVI's among the top ten most frequently performed inpatient procedures in the United States. Joint point regression was employed to examine the trends in the rates of IaVI's. We also calculated the adjusted odds ratios for IaVI's using survey logistic regression. RESULTS: During the eight-year study period, a total of 29,877,180 procedures were performed (33.6% hip replacement, 14% knee arthroplasty, 11.2% cholecystectomy, 10.3% spinal fusion, 8.9% lysis of adhesions, 8% colorectal resection, 7.9% partial bone excision, 5% appendectomy, 0.6% percutaneous coronary angioplasty, 0.6% laminectomy). A total of 194,031 (0.65%) IaVI's were associated with these procedures. The incidence of IaVI's increased over time with an average annual percentage change (AAPC) of 4.2% (95% CI: 3.1, 5.4; P < 0.01). More females (105,747; 54.5%) than males (88,284; 45.5%) suffered IaVI's during their hospital admission (P < 0.01). Patients 70 years of age and older had the highest incidence of IaVI's (12,244,082; 34.3%; P ≤ 0.01). Among the ten index procedures, Non-Hispanic (NH) Whites underwent the highest proportion of procedures (14.1 procedures/100 hospitalizations; P < 0.01) and cholecystectomy was associated with the highest rate of IaVI's (19.4 per 1000 hospitalizations, P ≤ 0.01). Overall, patients from the lowest income quartile were least likely to suffer IaVI's (0.83 95% CI 0.79-0.88, P < 0.01) compared to the highest income quartile. All form of healthcare coverage increased the odds of IaVI's: Medicaid (1.07 95% CI 1.07-1.13, P < 0.01); Private insurance (1.35 95% CI 1.3-1.39, P < 0.01); Self-pay or no charge (1.45 95% CI 1.38-1.52, P < 0.01). IaVI's increased the odds of in-hospital mortality in all groups (1.25 95% CI 1.14-1.35, P < 0.01) and more pronounced in NH-Blacks (1.51 95% CI 1.15-1.99, P < 0.01). In the overall cohort, urban teaching hospitals observed the highest odds of in-hospital mortality (1.11 95% CI 1.07-1.15, P < 0.01). CONCLUSION: Between 2008 to 2015, IaVI's rates for the top ten most frequently performed inpatient procedures increased by 33.6% (4.2% annually; P < 0.01). The elderly, females, and Hispanics more frequently had hospitalizations complicated by IaVI's. Overall, IaVI's independently increased the adjusted odds of mortality by 25%. IaVI's were most fatal among Blacks, about 50% elevated risk of death compared to NH-Whites. These benchmarks will be critical to future efforts to reduce IaVI, and associated healthcare disparities.

Influence of the COVID-19 pandemic on the management of chronic limb-threatening ischemia.

The COVID-19 pandemic negatively impacted patients with conditions that are associated with significant morbidity, but might not be immediately life-threatening. Patients with chronic limb-threatening ischemia (CLTI) were affected by delays in care, potentially increasing major limb amputations. This study sought to review strategies employed, and limb salvage outcomes reported, during the COVID-19 pandemic. We performed a literature review of the electronic database PubMed from December 2019 to December 2020. Articles subjected to analysis must have had a specific CLTI group before the pandemic to compare to the pandemic group. Case reports, case series, and non-CLTI comparisons were excluded. The literature search yielded 55 articles for review, of which 6 articles met criteria for analysis. The main classifications used for disease stratification included Rutherford, Fontaine, and SVS WIfI (Wound, Ischemia, Foot Infection). Overall, a decrease in vascular clinical volume was reported, ranging from 29% to 54%. A higher major limb amputation rate (2.6% to 32.2%) during the pandemic surge was reported in 5 of 6 publications. Four of 6 studies also reported minor amputations; 3 of these demonstrated an increase in minor amputations (7% to 17.7%). The CLTI population is vulnerable and it appears that both minor and major amputation rates increased in this population during the pandemic. The limited data available in CLTI patients during the COVID-19 pandemic and use of different stratifications schemes in areas impacted to variable extents prevent recommendations for the best treatment strategy. Further data are required to improve strategies for treating this population to minimize negative outcomes.

Updates in Diabetic Wound Healing, Inflammation, and Scarring.

Diabetic patients can sustain wounds either as a sequelae of their disease process or postoperatively. Wound healing is a complex process that proceeds through phases of inflammation, proliferation, and remodeling. Diabetes results in several pathological changes that impair almost all of these healing processes. Diabetic wounds are often characterized by excessive inflammation and reduced angiogenesis. Due to these changes, diabetic patients are at a higher risk for postoperative wound healing complications. There is significant evidence in the literature that diabetic patients are at a higher risk for increased wound infections, wound dehiscence, and pathological scarring. Factors such as nutritional status and glycemic control also significantly influence diabetic wound outcomes. There are a variety of treatments available for addressing diabetic wounds.

Engaging patients and caregivers to establish priorities for the management of diabetic foot ulcers.

OBJECTIVE: Effective diabetic foot ulcer (DFU) care has been stymied by a lack of input from patients and caregivers, reducing treatment adherence and overall quality of care. Our objectives were to capture the patient and caregiver perspectives on experiencing a DFU and to improve prioritization of patient-centered outcomes. METHODS: A DFU-related stakeholder group was formed at an urban tertiary care center. Seven group meetings were held across 4 months, each lasting ∼1 hour. The meeting facilitator used semistructured questions to guide each discussion. The topics assessed the challenges of the current DFU care system and identified the outcomes most important to stakeholders. The meetings were audio recorded and transcribed. Directed and conventional content analyses were used to identify key themes. RESULTS: Six patients with diabetes (five with an active DFU), 3 family caregivers, and 1 Wound Clinic staff member participated in the stakeholder group meetings. The mean patient age was 61 years, four (67%) were women, five (83%) were either African American or Hispanic, and the mean hemoglobin A1c was 8.3%. Of the five patients with a DFU, three had previously required lower extremity endovascular treatment and four had undergone at least one minor foot amputation. Overall, stakeholders described how poor communication between medical personnel and patients made the DFU experience difficult. They felt overwhelmed by the complexity of DFU care and were persistently frustrated by inconsistent medical recommendations. Limited resources further exacerbated their frustrations and barriers to care. To improve DFU management, the stakeholders suggested a centralized healthcare delivery pathway with timely access to a coordinated, multidisciplinary DFU team. The clinical outcomes most valued by stakeholders were (1) avoiding amputation and (2) maintaining or improving health-related quality of life, which included independent mobility, pain control, and mental health. From these themes, we developed a conceptual model to inform DFU care pathways. CONCLUSIONS: Current DFU management lacks adequate care coordination. Multidisciplinary approaches tailored to the self-identified needs of patients and caregivers could improve adherence. Future DFU-related comparative effectiveness studies will benefit from direct stakeholder engagement and are required to evaluate the efficacy of incorporating patient-centered goals into the design of a multidisciplinary DFU care delivery system.

Safety and efficacy of an endovascular-first approach to acute limb ischemia.

BACKGROUND: The optimal techniques to manage acute limb ischemia (ALI) remain unclear. Previous reports have suggested that the decreased morbidity and mortality of endovascular approaches are mitigated by the limited technical success rates relative to open or hybrid approaches for ALI. However, these data failed to include newer technologies that might improve the technical success rates. We, therefore, sought to describe the current outcomes for an endovascular-first approach to ALI. METHODS: We performed a single-center, single-arm, retrospective cohort study of consecutive patients with ALI from 2015 to 2018. Technical success, limb salvage, survival, patency, and length of stay were quantified using Kaplan-Meier (KM) analysis. Cox regression analysis was used to identify the predictors of amputation-free survival. RESULTS: During the 3 years, 60 consecutive patients (39 men [65%]; median age, 65 years) presented with ALI. The Rutherford class was I in 15 patients (25%), IIa in 23 (38%), IIb in 13 (22%), and III in 9 patients (15%). Of the 60 patients, 34 had a history of previous failed ipsilateral revascularization (56%), including open bypass for 8 (13%), endovascular for 8 (13%), and both open and endovascular intervention for 18 (30%). The endovascular-first approach procedures included catheter-directed thrombolysis only (n = 19; 3%), catheter-directed thrombolysis plus aspiration and/or rheolytic thrombectomy (n = 19; 32%), and aspiration and/or rheolytic thrombectomy (n = 16; 26%). Six patients (10%) underwent covered stent placement only. The underlying occlusive process was most often thrombosis of a previous bypass graft or stent in 32 patients (53%), followed by native vessel thrombosis in 15 (25%). ALI had resulted from embolism in 13 patients (21.7%), including 2 (3%) with embolization to occlude a previous bypass graft or stent. Technical success was achieved in 58 patients (97%), with open conversion required in two patients (3%). At 30 days postoperatively, 52 patients (87%) survived, and 53 (88%) had successful limb salvage. Five patients (8%) had required four-compartment fasciotomy. No major hemorrhagic complications developed. The median length of stay overall and in the intensive care unit was 9 days (interquartile range, 4-14 days) and 2 days (interquartile range, 1-5 days), respectively. At 1 year, the KM estimates were as follows: amputation-free survival, 58% ± 0.08%; limb salvage, 74.3% ± 0.07%; and survival, 73.3% ± 0.07%. The 1-year KM estimates for primary and secondary patency were 39.4% ± 0.08% and 78.2% ± 0.07%, respectively. On multivariable Cox regression analysis, only age independently predicted for death and/or amputation at the last follow-up (hazard ratio, 1.06; 95% confidence interval, 1.01-1.10; P = .01). CONCLUSIONS: The current endovascular approaches to ALI have high technical success rates. Survival, limb salvage, perioperative complications, and length of stay were similar to those from previous reports of historical open cohorts. Further prospective, appropriately powered, multicenter cohort studies are warranted to evaluate the efficacy of endovascular vs open approaches to ALI.

Association Between Wearable Device-Based Measures of Physical Frailty and Major Adverse Events Following Lower Extremity Revascularization.

Importance: Physical frailty is a key risk factor associated with higher rates of major adverse events (MAEs) after surgery. Assessing physical frailty is often challenging among patients with chronic limb-threatening ischemia (CLTI) who are often unable to perform gait-based assessments because of the presence of plantar wounds. Objective: To test a frailty meter (FM) that does not rely on gait to determine the risk of occurrence of MAEs after revascularization for patients with CLTI. Design, Setting, and Participants: This cohort study included 184 consecutively recruited patients with CLTI at 2 tertiary care centers. After 32 individuals were excluded, 152 participants were included in the study. Data collection was conducted between May 2018 and June 2019. Exposures: Physical frailty measurement within 1 week before limb revascularization and incidence of MAEs for as long as 1 month after surgery. Main Outcomes and Measures: The FM works by quantifying weakness, slowness, rigidity, and exhaustion during a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. The FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of physical frailty. Results: Of 152 eligible participants (mean [SD] age, 67.0 [11.8] years; 59 [38.8%] women), 119 (78.2%) were unable to perform the gait test, while all could perform the FM test. Overall, 53 (34.9%), 58 (38.1%), and 41 (27.0%) were classified as robust (FI <0.20), prefrail (FI ≥0.20 to <0.35), or frail (FI ≥0.35), respectively. Within 30 days after surgery, 24 (15.7%) developed MAEs, either major adverse cardiovascular events (MACE; 8 [5.2%]) or major adverse limb events (MALE; 16 [10.5%]). Baseline demographic characteristics were not significantly different between frailty groups. In contrast, the FI was approximately 30% higher in the group that developed MAEs (mean [SD] score, 0.36 [0.14]) than those who were MAE free (mean [SD] score, 0.26 [0.13]; P = .001), with observed MAE rates of 4 patients (7.5%), 7 patients (12.1%), and 13 patients (31.7%) in the robust, prefrail and frail groups, respectively (P = .004). The FI distinguished individuals who developed MACE and MALE from those who were MAE free (MACE: mean [SD] FI score, 0.38 [0.16]; P = .03; MALE: mean [SD] FI score, 0.35 [0.13]; P = .004) after adjusting by body mass index. Conclusions and Relevance: In this cohort study, measuring physical frailty using a wrist-worn sensor during a short upper extremity test was a practical method for stratifying the risk of MAEs following revascularization for CLTI when the administration of gait-based tests is often challenging.