Publications by authors named "Joseph Mills"

190 Publications

Comment on: Beyond the Crossroads by DuBose et al.

Ann Surg 2020 Dec 22. Epub 2020 Dec 22.

*Division of Vascular Surgery, Christiana Care Health System, Newark, DE †Division of Vascular Surgery, Department of Surgery, University of Washington School of Medicine, WA ‡Department of Surgery, Michigan State University, Central Michigan University, MI §Division of Vascular Surgery, Department of Surgery, University of California San Francisco, CA ||Division of Vascular Surgery, Department of Surgery, Emory University, Atlanta, GA ¶Division of Vascular Surgery, National University of Singapore, Singapore #Division of Vascular Surgery, Department of Surgery, Jacobs School of Medicine & Biomed. Sciences, SUNY at Buffalo, Buffalo, NY **Section of Vascular Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO ††Division of Vascular Surgery, Department of Surgery, Baylor College of Medicine, Houston, TX ‡‡Division of Vascular Surgery, Penn State Heart and Vascular Institute, Penn State College of Medicine, Hershey, PA.

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http://dx.doi.org/10.1097/SLA.0000000000004664DOI Listing
December 2020

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

JAMA Netw Open 2020 11 2;3(11):e2020161. Epub 2020 Nov 2.

Keck School of Medicine, University of Southern California, Los Angeles.

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.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.20161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677765PMC
November 2020

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

J Vasc Surg 2020 Oct 15. Epub 2020 Oct 15.

Division of Vascular Surgery and Endovascular Therapy, Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston, Tex. Electronic address:

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.
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http://dx.doi.org/10.1016/j.jvs.2020.10.002DOI Listing
October 2020

A Novel Scoring System for Small Artery Disease and Medial Arterial Calcification Is Strongly Associated With Major Adverse Limb Events in Patients With Chronic Limb-Threatening Ischemia.

J Endovasc Ther 2020 Oct 15:1526602820966309. Epub 2020 Oct 15.

Division of Vascular and Endovascular Surgery, Baylor College of Medicine, Houston, TX, USA.

Purpose: To evaluate the roles of small artery disease (SAD) and medial arterial calcification (MAC) in patients with chronic limb-threatening ischemia (CLTI) and to identify any correlation between these factors and peripheral artery disease (PAD) or outcomes after treatment.

Materials And Methods: A retrospective review was conducted of 259 limbs with tissue loss among 223 CLTI patients (mean age 72.2±11.4 years; 194 men) having an angiographic foot vessel study, foot radiography, and at least 6 months of follow-up after intervention. SAD and MAC were quantified using a 3-level score (0=absent, 1=moderate, 2=severe) based on angiography for SAD and foot radiographs for MAC. The MAC score was validated and compared with the SAD score, evaluating their associations with PAD distribution and clinical outcomes.

Results: Based on the MAC score, the 259 limbs were classified as 55 group 0 (21.2%), 89 group 1 (34.4%), and 115 group 2 (44.4%). The SAD score stratified the 259 limbs as 67 group 0 (25.9%), 76 group 1 (29.3%), and 116 group 2 (44.8%). Interobserver reproducibility of the MAC score was high (correlation coefficient 0.96). Sensitivity and specificity of the MAC score in detecting SAD was 100% and 98.1%, respectively, in SAD groups 0 and 2 vs 99.1% and 92.7%, respectively, for SAD group 1. PAD was more proximal in MAC and SAD groups 0 and more distal in groups 1 and 2. Both MAC and SAD scores were able to predict clinical endpoints. Multivariable analysis demonstrated that the MAC score represents an independent risk factor for adverse limb events.

Conclusion: SAD and MAC must be considered expressions of the same obstructing disease, able to adversely impact the fate of CLTI patients. SAD and MAC scores are powerful prognostic indicators of major adverse limb events in CLTI patients.
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http://dx.doi.org/10.1177/1526602820966309DOI Listing
October 2020

Chronic Limb Threatening Ischaemia: Hits and Misses.

Eur J Vasc Endovasc Surg 2020 11 22;60(5):643-644. Epub 2020 Sep 22.

Department of Biomedical and Preclinical Sciences, GIGA Cardiovascular Sciences, University of Liège, Liège, Belgium. Electronic address:

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http://dx.doi.org/10.1016/j.ejvs.2020.08.029DOI Listing
November 2020

Nonculprit Lesion Severity and Outcome of Revascularization in Patients With STEMI and Multivessel Coronary Disease.

J Am Coll Cardiol 2020 09;76(11):1277-1286

Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: https://twitter.com/PHRIresearch.

Background: In the COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial, angiography-guided percutaneous coronary intervention (PCI) of nonculprit lesions with the aim of complete revascularization reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (MI) and multivessel coronary artery disease.

Objectives: The purpose of this study was to determine the effect of nonculprit-lesion stenosis severity measured by quantitative coronary angiography (QCA) on the benefit of complete revascularization.

Methods: Among 4,041 patients randomized in the COMPLETE trial, nonculprit lesion stenosis severity was measured using QCA in the angiographic core laboratory in 3,851 patients with 5,355 nonculprit lesions. In pre-specified analyses, the treatment effect in patients with QCA stenosis ≥60% versus <60% on the first coprimary outcome of CV death or new MI and the second co-primary outcome of CV death, new MI, or ischemia-driven revascularization was determined.

Results: The first coprimary outcome was reduced with complete revascularization in the 2,479 patients with QCA stenosis ≥60% (2.5%/year vs. 4.2%/year; hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.47 to 0.79), but not in the 1,372 patients with QCA stenosis <60% (3.0%/year vs. 2.9%/year; HR: 1.04; 95% CI: 0.72 to 1.50; interaction p = 0.02). The second coprimary outcome was reduced in patients with QCA stenosis ≥60% (2.9%/year vs. 6.9%/year; HR: 0.43; 95% CI: 0.34 to 0.54) to a greater extent than patients with QCA stenosis <60% (3.3%/year vs. 5.2%/year; HR: 0.65; 95% CI: 0.47 to 0.89; interaction p = 0.04).

Conclusions: Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with <60%, as determined by quantitative coronary angiography.
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http://dx.doi.org/10.1016/j.jacc.2020.07.034DOI Listing
September 2020

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

J Vasc Surg 2020 Sep 3. Epub 2020 Sep 3.

Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Tex. Electronic address:

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.
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http://dx.doi.org/10.1016/j.jvs.2020.08.127DOI Listing
September 2020

Outcomes after Endovascular Stent Placement for Long-Segment Superficial Femoral Artery Lesions.

Ann Vasc Surg 2021 Feb 3;71:298-307. Epub 2020 Sep 3.

Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine/Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX. Electronic address:

Background: Endovascular intervention is commonly pursued as first-line management of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare metal stents (BMS), covered stents (CS), and drug-eluting stents (DES) for long-segment SFA lesions remain uncertain.

Methods: A retrospective cohort study identified patients with symptomatic SFA lesions measuring at least 15 cm in length who successfully received an endovascular stent (BMS, CS, or DES). The outcomes were patency, patient presentation upon stent occlusion, amputation-free survival (AFS), and all-cause mortality. Proportional hazards regressions and a multinomial logistic regression model were used to control for significant confounders.

Results: A total of 226 procedures were analyzed (BMS: 95 [42%]; CS: 74 [33%]; DES: 57 [25%]). There were no significant differences among the 3 stent types with respect to age, prevalence of either diabetes or end-stage renal disease, or smoking history. The median length of the SFA lesion varied across the cohorts (BMS: 28 cm [interquartile range, IQR 20-30]; CS: 26 cm [IQR 20-30]; DES: 20 cm [IQR 16-25]; P = 0.002). The unadjusted primary patency of BMS at 12, 24, and 48 month following index stent placement was 57%, 47%, and 44%, respectively. This is compared to 62%, 49%, and 42% for CS, and 81%, 66%, and 53% for DES, respectively (log-rank P = 0.044). In adjusted models, however, there were no significant differences in primary patency among the stent types. Compared to CS however, DES was associated with improved primary-assisted patency (hazard ratio [HR] for patency loss: 0.35, P = 0.008) and secondary patency (HR: 0.32, P = 0.011). Across the entire follow-up period, stent occlusions occurred in 38 (40%) BMS cases, 42 (57%) CS, and 11 (19%) DES (P < 0.001). Of these, acute limb ischemia (ALI) occurred in 2 (5%) BMS cases, 14 (33%) CS, and 1 (9%) DES (P = 0.010). After adjustment, the relative risk of presenting with ALI as opposed to claudication was 27 times greater among patients re-presenting with occluded CS compared to BMS (P = 0.020). There were no significant differences in AFS or all-cause mortality across the 3 cohorts.

Conclusions: For long-segment SFA lesions, DES is associated with improved primary-assisted and secondary patency over long-term follow-up. In the event of stent occlusion, CS is associated with an increased risk of ALI.
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http://dx.doi.org/10.1016/j.avsg.2020.08.124DOI Listing
February 2021

Impact of catheterization on shear-mediated arterial dilation in healthy young men.

Eur J Appl Physiol 2020 Nov 28;120(11):2525-2532. Epub 2020 Aug 28.

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, L3 3AF, UK.

Purpose: Animal studies have shown that endothelial denudation abolishes vasodilation in response to increased shear stress. Interestingly, shear-mediated dilation has been reported to be reduced, but not abolished, in coronary artery disease (CAD) patients following catheterization. However, it is not known whether this resulted from a priori endothelial dysfunction in this diseased population. In this study, we evaluated shear-mediated dilation following catheterization in healthy young men.

Methods: Twenty-six (age: 24.4 ± 3.8 years, BMI: 24.3 ± 2.8 kg m, VO: 50.5 ± 8.8 ml/kg/min) healthy males underwent unilateral transradial catheterization. Shear-mediated dilation of both radial arteries was measured using flow-mediated dilation (FMD) pre-, and 7 days post-catheterization.

Results: FMD was reduced in the catheterized arm [9.3 ± 4.1% to 4.3 ± 4.1% (P < 0.001)] post-catheterization, whereas no change was observed in the control arm [8.4 ± 3.8% to 7.3 ± 3.8% (P = 0.168)]. FMD was completely abolished in the catheterized arm in five participants. Baseline diameter (P = 0.001) and peak diameter during FMD (P = 0.035) were increased in the catheterized arm 7 days post-catheterization (baseline: 2.3 ± 0.3 to 2.6 ± 0.2 mm, P < 0.001, peak: 2.5 ± 0.3 to 2.7 ± 0.3 mm, P = 0.001), with no change in the control arm (baseline: 2.3 ± 0.3 to 2.3 ± 0.3 mm, P = 0.288, peak: 2.5 ± 0.3 to 2.5 ± 0.3 mm, P = 0.608).

Conclusion: This is the first study in young healthy individuals with intact a priori endothelial function to provide evidence of impaired shear-mediated dilation following catheterization. When combined with earlier studies in CAD patients, our data suggest the catheterization impairs artery function in humans.
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http://dx.doi.org/10.1007/s00421-020-04473-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7557491PMC
November 2020

Giant coronary collaterals: when nature does it better than the surgeon.

Coron Artery Dis 2020 Aug 19. Epub 2020 Aug 19.

Cardiac Catheter Laboratory, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.

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http://dx.doi.org/10.1097/MCA.0000000000000948DOI Listing
August 2020

The "Vascular Surgery COVID-19 Collaborative" (VASCC).

Eur J Vasc Endovasc Surg 2020 09 29;60(3):489-490. Epub 2020 Jul 29.

Division of Vascular and Endovascular Surgery, Cardiovascular Department, Trieste University Hospital ASUIGI, Trieste, Italy.

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http://dx.doi.org/10.1016/j.ejvs.2020.07.072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388790PMC
September 2020

Modern treatment of chronic limb-threatening ischemia requires a PLAN, clinical judgment, and shared decision making.

Authors:
Joseph L Mills

J Vasc Surg 2020 08;72(2):389-390

Baylor College of Medicine, Michael E. DeBakey Department of Surgery, Houston, Tex. Electronic address:

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http://dx.doi.org/10.1016/j.jvs.2020.01.055DOI Listing
August 2020

NCL Inhibition Exerts Antineoplastic Effects against Prostate Cancer Cells by Modulating Oncogenic MicroRNAs.

Cancers (Basel) 2020 Jul 10;12(7). Epub 2020 Jul 10.

Department of Cancer Biology and Genetics, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.

Prostate cancer (PCa) is the most frequently diagnosed cancer in men and second most common cause of cancer-related deaths in the United States. Androgen deprivation therapy (ADT) is only temporarily effective for advanced-stage PCa, as the disease inevitably progresses to castration-resistant prostate cancer (CRPC). The protein nucleolin (NCL) is overexpressed in several types of human tumors where it is also mislocalized to the cell surface. We previously reported the identification of a single-chain fragment variable (scFv) immuno-agent that is able to bind NCL on the surface of breast cancer cells and inhibit proliferation both in vitro and in vivo. In the present study, we evaluated whether NCL could be a valid therapeutic target for PCa, utilizing DU145, PC3 (CRPC), and LNCaP (androgen-sensitive) cell lines. First, we interrogated the publicly available databases and noted that higher NCL mRNA levels are associated with higher Gleason Scores as well as with recurrent and metastatic tumors. Then, using our anti-NCL scFv, we demonstrated that NCL is expressed on the surface of all three tested cell lines and that NCL inhibition results in reduced proliferation and migration. We also measured the inhibitory effect of NCL targeting on the biogenesis of oncogenic microRNAs such as miR-21, -221 and -222, which was cell context dependent. Taken together, our data provide evidence that NCL targeting inhibits the key hallmarks of malignancy in PCa cells and may provide a novel therapeutic option for patients with advanced-stage PCa.
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http://dx.doi.org/10.3390/cancers12071861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408652PMC
July 2020

Disparities in Physical Activity Levels in Patients with Peripheral Arterial Disease Across the Atlantic.

Eur J Vasc Endovasc Surg 2020 12 27;60(6):896. Epub 2020 Jun 27.

Division of Vascular and Endovascular Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.

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http://dx.doi.org/10.1016/j.ejvs.2020.05.040DOI Listing
December 2020

The impact of organized multidisciplinary care on limb salvage in patients with mild to moderate WIfI ischemia grades.

Authors:
Joseph L Mills

J Vasc Surg 2020 06;71(6):2081-2082

Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Tex.

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http://dx.doi.org/10.1016/j.jvs.2019.09.021DOI Listing
June 2020

Failure on a Vascular Surgery Board-American Board of Surgery Examination does not predict cardiovascular outcomes in the Society for Vascular Surgery Vascular Quality Initiative.

J Vasc Surg 2020 11 1;72(5):1753-1760. Epub 2020 Apr 1.

Division of Vascular Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah.

Objective: The Vascular Surgery Board of the American Board of Surgery (VSB-ABS) Qualifying and Certifying examinations are meant to assess qualifications to independently practice vascular surgery, but it is unclear whether examination performance correlates with clinical outcomes. We assessed this relationship using clinical outcomes data for VSB-ABS diplomates from the Society for Vascular Surgery Vascular Quality Initiative (SVS-VQI).

Methods: VSB-ABS examination performance for vascular surgeons participating in the SVS-VQI registry was characterized according to pass/fail status. Surgical experience was measured by number of years since completion of training. Examination performance and experience were compared with a composite clinical outcome (in-patient major adverse cardiac events or postoperative death [MACE+POD]) after arterial reconstructions (carotid stenting or endarterectomy, aortic aneurysm repair, open peripheral surgical bypasses) registered in the SVS-VQI. Multivariate mixed effects regression was performed adjusting for sex and surgery type, as well as clustering by surgeon and by hospital.

Results: From 2003 to 2017, complete data were available for 776 vascular surgeons who performed 124,171 arterial reconstructions (carotid n = 56,650; aortic n = 34,764; peripheral n = 32,757) registered in the SVS-VQI. Patient characteristics associated with higher odds of MACE+POD were female sex (odds ratio [OR] 1.07; 95% confidence interval [CI], 1.03-1.12; P = .006) and advancing age (OR, 1.04; 95% CI, 1.03-1.04; P < .001). Of the 776 surgeons, 149 (17%) had failed at least one VSB-ABS examination (group F). The unadjusted primary composite outcome of MACE+POD was marginally higher after operations performed by surgeons who never failed an examination (group P; 7% vs 6%; P = .03). This difference seems to be driven by higher rates of postoperative congestive heart failure in the aortic and lower extremity bypass cohorts as well as more postoperative myocardial infarctions after lower extremity bypass by group P surgeons. Following multivariable analyses, examination pass status was not associated with MACE+POD (OR, 0.98; 95% CI, 0.89-1.50; P = .517). However, increasing surgical experience correlated with significantly lower odds of MACE+POD (2% lower odds/year of experience since training [OR, 0.98; 95% CI, 0.98-0.99; P < .001]).

Conclusions: VSB-ABS examination performance by SVS-VQI surgeons does not correlate with registry-reported mortality or cardiovascular complications. Increasing surgical experience is strongly associated with lower odds of cardiovascular morbidity and death.
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http://dx.doi.org/10.1016/j.jvs.2020.01.053DOI Listing
November 2020

Endovascular Therapy in an "All-Comers" Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery.

Ann Vasc Surg 2020 Aug 21;67:425-436. Epub 2020 Mar 21.

Division of Vascular Surgery and Endovascular Therapy, Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston TX.

Background: The aim of this study was to describe the applicability of the Society for Vascular Surgery (SVS) objective performance goals (OPGs) as a tool to evaluate results in the context of endovascular management of noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI).

Methods: Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were major amputation (AMP), major adverse limb events (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis.

Results: A total of 72 patients were included (OPGR = 58.3% vs. nOPGR = 41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR = 4.7%, nOPGR = 0%, P = 0.225, vs. SVS OPG<3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG>84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG>71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG>80%).

Conclusions: The SVS OPGs set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy endpoints proposed by the limited risk OPG panel.
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http://dx.doi.org/10.1016/j.avsg.2020.03.008DOI Listing
August 2020

Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study.

J Med Internet Res 2020 03 18;22(3):e15548. Epub 2020 Mar 18.

Population Health Research Institute, Hamilton, ON, Canada.

Background: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure.

Objective: As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively.

Methods: Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews.

Results: A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems.

Conclusions: User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.
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http://dx.doi.org/10.2196/15548DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113803PMC
March 2020

Diabetic foot ulcer classifications: A critical review.

Diabetes Metab Res Rev 2020 03;36 Suppl 1:e3272

Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.

Classification and scoring systems can help both clinical management and audit outcomes of routine care. The aim of this study was to assess published systems of diabetic foot ulcers (DFUs) to determine which should be recommended for a given clinical purpose. Published classifications had to have been validated in populations of > 75% people with diabetes and a foot ulcer. Each study was assessed for internal and external validity and reliability. Eight key factors associated with failure to heal were identified from large clinical series and each classification was scored on the number of these key factors included. Classifications were then arranged according to their proposed purpose into one or more of four groups: (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) aid clinical management decision making for an individual case, and (d) audit to compare outcome in different populations. Thirty-seven classification systems were identified of which 18 were excluded for not being validated in a population of >75% DFUs. The included 19 classifications had different purposes and were derived from different populations. Only six were developed in multicentre studies, just 13 were externally validated, and very few had evaluated reliability.Classifications varied in the number (4 - 30), and definition of individual items and the diagnostic tools required. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalization, limb amputation, mortality, and cost. Despite the limitations, there was sufficient evidence to make recommendations on the use of particular classifications for the indications listed above.
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http://dx.doi.org/10.1002/dmrr.3272DOI Listing
March 2020

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.

Diabetes Metab Res Rev 2020 03;36 Suppl 1:e3277

Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.

The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non-invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15 380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive likelihood ratio (PLR) and negative likelihood ratio (NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) <0.9, which may be useful to suggest the presence of PAD (PLR 6.5) but an ABI value between 0.9 and 1.3 does not rule out PAD (NLR 0.31). A toe brachial index >0.75 makes the diagnosis of PAD less likely (NLR 0.14-0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation < 2% lower than finger saturation; PLR 17.23-30) or render PAD less likely (NLR 0.2-0.27). We found that the presence of triphasic tibial waveforms has the best performance value for excluding a diagnosis of PAD (NLR 0.09-0.28), but was evaluated in only two studies. In addition, we found that beside clinical examination (including palpation of foot pulses) cannot reliably exclude PAD (NLR 0.75), as evaluated in one study. Overall, the quality of data is generally poor and there is insufficient evidence to recommend one bedside test over another. While there have been six additional publications in the last 4 years that met our inclusion criteria, more robust evidence is required to achieve consensus on the most useful non-invasive bedside test to diagnose PAD.
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http://dx.doi.org/10.1002/dmrr.3277DOI Listing
March 2020

Guidelines on the classification of diabetic foot ulcers (IWGDF 2019).

Diabetes Metab Res Rev 2020 03;36 Suppl 1:e3273

Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, United Kingdom.

The International Working Group on the Diabetic Foot (IWGDF) has been publishing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This publication represents a new guideline addressing the use of classifications of diabetic foot ulcers in routine clinical practice and reviews those which have been published. We only consider systems of classification used for active diabetic foot ulcers and do not include those that might be used to define risk of future ulceration. The guidelines are based on a review of the available literature and on expert opinion leading to the identification of eight key factors judged to contribute most to clinical outcomes. Classifications are graded on the number of key factors included as well as on internal and external validation and the use for which a classification is intended. Key factors judged to contribute to the scoring of classifications are of three types: patient related (end-stage renal failure), limb-related (peripheral artery disease and loss of protective sensation), and ulcer-related (area, depth, site, single, or multiple and infection). Particular systems considered for each of the following five clinical situations: (a) communication among health professionals, (b) predicting the outcome of an individual ulcer, (c) as an aid to clinical decision-making for an individual case, (d) assessment of a wound, with/without infection, and peripheral artery disease (assessment of perfusion and potential benefit from revascularisation), and (d) audit of outcome in local, regional, or national populations. We recommend: (a) for communication among health professionals the use of the SINBAD system (that includes Site, Ischaemia, Neuropathy, Bacterial Infection and Depth); (b) no existing classification for predicting outcome of an individual ulcer; (c) the Infectious Diseases Society of America/IWGDF (IDSA/IWGDF) classification for assessment of infection; (d) the WIfI (Wound, Ischemia, and foot Infection) system for the assessment of perfusion and the likely benefit of revascularisation; and (e) the SINBAD classification for the audit of outcome of populations.
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http://dx.doi.org/10.1002/dmrr.3273DOI Listing
March 2020

Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: A systematic review.

Diabetes Metab Res Rev 2020 03;36 Suppl 1:e3278

Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.

Clinical outcomes of patients with diabetes, foot ulceration, and peripheral artery disease (PAD) are difficult to predict. The prediction of important clinical outcomes, such as wound healing and major amputation, would be a valuable tool to help guide management and target interventions for limb salvage. Despite the existence of a number of classification tools, no consensus exists as to the most useful bedside tests with which to predict outcome. We here present an updated systematic review from the International Working Group of the Diabetic Foot, comprising 15 studies published between 1980 and 2018 describing almost 6800 patients with diabetes and foot ulceration. Clinical examination findings as well as six non-invasive bedside tests were evaluated for their ability to predict wound healing and amputation. The most useful tests to inform on the probability of healing were skin perfusion pressure ≥ 40 mmHg, toe pressure ≥ 30 mmHg, or TcPO  ≥ 25 mmHg. With these thresholds, all of these tests increased the probability of healing by greater than 25% in at least one study. To predict major amputation, the most useful tests were ankle pressure < 50 mmHg, ABI < 0.5, toe pressure < 30 mmHg, and TcPO  < 25 mmHg, which increased the probability of major amputation by greater than 25%. These indicative values may be used as a guide when deciding which patients are at highest risk for poor outcomes and should therefore be evaluated for revascularization at an early stage. However, this should always be considered within the wider context of important co-existing factors such as infection, wound characteristics, and other comorbidities.
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http://dx.doi.org/10.1002/dmrr.3278DOI Listing
March 2020

Effectiveness of revascularisation of the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review.

Diabetes Metab Res Rev 2020 03;36 Suppl 1:e3279

Div. Endocrinology, MUMC+, CARIM and CAPHRI Institute, Maastricht, The Netherlands.

In patients with diabetes, foot ulceration and peripheral artery disease (PAD), it is often difficult to determine whether, when and how to revascularise the affected lower extremity. The presence of PAD is a major risk factor for non-healing and yet clinical outcomes of revascularisation are not necessarily related to technical success. The International Working Group of the Diabetic Foot updated systematic review on the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and PAD is comprised of 64 studies describing >13 000 patients. Amongst 60 case series and 4 non-randomised controlled studies, we summarised clinically relevant outcomes and found them to be broadly similar between patients treated with open vs endovascular therapy. Following endovascular revascularisation, the 1 year and 2 year limb salvage rates were 80% (IQR 78-82%) and 78% (IQR 75-83%), whereas open therapy was associated with rates of 85% (IQR 80-90%) at 1 year and 87% (IQR 85-88%) at 2 years, however these results were based on a varying combination of studies and cannot therefore be interpreted as cumulative. Overall, wound healing was achieved in a median of 60% of patients (IQR 50-69%) at 1 year in those treated by endovascular or surgical therapy, and the major amputation rate of endovascular vs open therapy was 2% vs 5% at 30 days, 10% vs 9% at 1 year and 13% vs 9% at 2 years. For both strategies, overall mortality was found to be high, with 2% (1-6%) perioperative (or 30 day) mortality, rising sharply to 13% (9-23%) at 1 year, 29% (19-48%) at 2 years and 47% (39-71%) at 5 years. Both the angiosome concept (revascularisation directly to the area of tissue loss via its main feeding artery) or indirect revascularisation through collaterals, appear to be equally effective strategies for restoring perfusion. Overall, the available data do not allow us to recommend one method of revascularisation over the other and more studies are required to determine the best revascularisation approach in diabetic foot ulceration.
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http://dx.doi.org/10.1002/dmrr.3279DOI Listing
March 2020

Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update).

Diabetes Metab Res Rev 2020 03 20;36 Suppl 1:e3276. Epub 2020 Jan 20.

Division of Endocrinology, MUMC+, CARIM and CAPHRI Institute, Maastricht, The Netherlands.

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with foot ulcers and diabetes and updates the previous IWGDF Guideline. Up to 50% of patients with diabetes and foot ulceration have concurrent PAD, which confers a significantly elevated risk of adverse limb events and cardiovascular disease. We know that the diagnosis, prognosis, and treatment of these patients are markedly different to patients with diabetes who do not have PAD and yet there are few good quality studies addressing this important subset of patients. We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to devise clinical questions and critically important outcomes in the patient-intervention-comparison-outcome (PICO) format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We here present the updated 2019 guidelines on diagnosis, prognosis, and management of PAD in patients with a foot ulcer and diabetes, and we suggest some key future topics of particular research interest.
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http://dx.doi.org/10.1002/dmrr.3276DOI Listing
March 2020

Exercise-induced vasodilation is not impaired following radial artery catheterization in coronary artery disease patients.

J Appl Physiol (1985) 2020 02 9;128(2):422-428. Epub 2020 Jan 9.

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.

Diagnosis and treatment for coronary artery disease (CAD) often involves angiography and/or percutaneous coronary intervention. However, the radial artery catheterization required during both procedures may result in acute artery dysfunction/damage. While exercise-based rehabilitation is recommended for CAD patients following catheterization, it is not known if there is a period when exercise may be detrimental due to catheter-induced damage. Animal studies have demonstrated exercise-induced paradoxical vasoconstriction postcatheterization. This study aimed to examine arterial responses to acute exercise following catheterization. Thirty-three CAD patients (65.8 ± 7.3 yr, 31.5 ± 6.3 kg/m, 82% men) undergoing transradial catheterization were assessed before and 1 wk postcatheterization. Radial artery (RA) diameter and shear rate were assessed during handgrip exercise (HE), in both the catheterized (CATH) and control (CON) arms. Endothelial function was also assessed via simultaneous bilateral radial flow-mediated dilation (FMD) at both time points. We found that the increase in RA diameter and shear stress in response to HE ( < 0.0001) was maintained postcatheterization in both the CATH and CON arms, whereas FMD following catheterization was impaired in the CATH [6.5 ± 3.3 to 4.7 ± 3.5% ( = 0.005)] but not in the CON [6.2 ± 2.6 to 6.4 ± 3.5% ( = 0.797)] limb. While endothelial dysfunction, assessed by FMD, was apparent 1 wk postcatheterization, the ability of the RA to dilate in response to exercise was not impaired. The impact of catheterization and consequent endothelial denudation on vascular dys/function in humans may therefore be stimulus specific, and a highly level of redundancy appears to exist that preserves exercise-mediated vasodilator responses. Despite depressed flow-mediated endothelium-dependent dilation following catheterization-induced damage, radial artery responses to handgrip exercise were preserved. This suggests that arterial responses to catheterization may be stimulus specific and that redundant mechanisms may compensate for vasodilator impairment during exercise. This has implications for exercise-based rehabilitation after catheterization.
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http://dx.doi.org/10.1152/japplphysiol.00695.2019DOI Listing
February 2020

Leg Amputations Among Texans Remote From Experienced Surgical Care.

J Surg Res 2020 06 24;250:232-238. Epub 2019 Dec 24.

Section of Trauma and Acute Care Surgery, Department of Surgery, University of Chicago Medicine & Biological Sciences, Chicago, Illinois.

Background: Surgical outcomes may differ between low-volume and experienced hospitals. We sought to identify characteristics of remote patients-those living more than 50 miles from an experienced center-who underwent leg amputations for peripheral artery disease (PAD) and foot complications at low-volume and experienced hospitals and identify regions of Texas where such patients live.

Materials And Methods: Publicly available Texas hospitalization data from 2004 through 2009 were used to identify patients with PAD who underwent leg amputation for foot complications, including foot ulcers, foot infections, and gangrene. Geocoding was used to further identify a subset of remote patients and to estimate distances from zip code of residence to hospital in which care was received.

Results: Among all leg amputations, 850 (18.6%) were performed on patients classified as remote, and 3723 (81.4%) were performed on patients classified as nonremote. Compared with nonremote patients, remote patients were more often categorized as white and more frequently received Medicare and/or Medicaid. Of the subset of remote patients, those at low-volume hospitals were older, were less often categorized as Hispanic, more often had Medicaid coverage, were also more frequently admitted through the emergency department, and often had a foot infection compared with those at experienced centers. Geospatial analysis identified five concentrated geographic areas of remote patients who live more than 50 miles from an experienced center.

Conclusions: These findings suggest travel distance may at least influence, if not constrain, the choice of hospital for patients with PAD and foot complications. Efforts to decrease leg amputations among remote patients should be focused on five specific geographic areas of Texas.
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http://dx.doi.org/10.1016/j.jss.2019.09.074DOI Listing
June 2020

The patient presenting with chronic limb-threatening ischaemia. Does diabetes influence presentation, limb outcomes and survival?

Diabetes Metab Res Rev 2020 03 22;36 Suppl 1:e3242. Epub 2019 Dec 22.

Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, Texas.

Peripheral arterial disease (PAD) confers an elevated risk of major amputation and delayed wound healing in diabetic patients with foot ulcers. The major international vascular societies recently developed evidence-based guidelines for the assessment and management of patients with chronic limb-threatening ischaemia (CLTI). CLTI represents the cohort of diabetic and non-diabetic patients who have PAD which is of sufficient severity to delay wound healing and increase amputation risk. Diabetic patients with CLTI are more likely to present with tissue loss, infection and have less favourable anatomy for revascularization than those without diabetes. Although diabetes is not consistently reported as a strong independent risk factor for limb loss, major morbidity and mortality in CLTI patients, it is impossible in clinical practice to isolate diabetes from comorbidities, such as end-stage renal disease and coronary artery disease which occur more commonly in diabetic patients. Treatment of CLTI in the diabetic patient is complex and should involve a multi-disciplinary team to optimize outcomes. Clinicians should use an integrated approach to management based on patient risk assessment, an assessment of the severity of the foot pathology and a structured anatomical assessment of arterial disease as suggested by the Global Vascular Guidelines for CLTI.
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http://dx.doi.org/10.1002/dmrr.3242DOI Listing
March 2020