Robert J. Hinchliffe

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.

To evaluate the psychometric properties of three new condition-specific questionnaires designed to assess outcomes amongst patients under pre-operative surveillance for a small abdominal aortic aneurysm (AAA) or who have undergone aneurysm repair. These tools are the Aneurysm-Dependent Quality of Life measure (AneurysmDQoL), the Aneurysm Symptom Rating Questionnaire (AneurysmSRQ) and the Aneurysm Treatment Satisfaction Questionnaire (AneurysmTSQ). The questionnaires were sent to 297 patients with abdominal aortic aneurysm (AAA) or who had undergone AAA repair (using open or endovascular technique) sampled from five UK NHS Trusts. Exploratory Factor Analysis was used to examine factor structure together with reliability analysis. A subset of 65 patients completed the questionnaires a second time four months later. One hundred and ninety-seven patients (178 men; 18 women) provided data for analysis (69% response rate): mean age was 75 years (range 60–95). Nineteen were under pre-operative surveillance for AAA and 178 had undergone AAA repair (70 open repair; 104 endovascular repair; 4 uncertain). Exploratory Factor Analysis of the AneurysmDQoL and the AneurysmTSQ each demonstrated a one-factor structure. The AneurysmSRQ demonstrated a six-factor structure (emotional, weight loss, lower limb, cognitive, general malaise and gastrointestinal symptoms) and a one-factor composite symptom scale. All scales have clean factor structures: item loadings above 0.40, no cross-loadings, and no factors with fewer than three items. Internal consistency reliability was excellent (α = 0.869–0.959) and test-retest reliability good (Intraclass correlation coefficient = 0.70–0.88). The three new questionnaires have a clear structure and strong reliability and are now ready for use in clinical trials and routine practice, which will allow evaluation of responsiveness to change.

Introduction To evaluate the safety of percutaneous endovascular aortic repair and the relationship of access site characteristics to complications Materials and Methods All patients undergoing percutaneous TEVAR, EVAR and FEVAR procedures from January 2010 to May 2016 were retrospectively analysed for incidence of complications and their relationship to various access site characteristics like access artery size, degree of vessel calcification, skin to artery distance and sheath to artery ratio. Hemostasis occurring within 15 min after suture closure with or without manual compression was defined as primary hemostasis. Results 92 patients with 142 femoral access sites were included in the study. Median follow-up was 28.13 months (range 2.5 – 76.7 months, Mean 32.39, SD – 21.66 months). Introducer system size ranged from 12F to 25F. Primary haemostasis was achieved in 97.1 % (138/142) of the total femoral access sites. Four access sites (2.8 %) had to be closed surgically; in all 4 cases the introducer systems was ≥ 18F. Two of these access sites had been operated upon previously. Late complications including inguinal hematoma (n = 7), wound infection (n = 1), scrotal hematoma (n = 1), pseudoaneurysm (n = 4) and late bleeding (n = 4) occurred in 17 access sites (11.9 %), of which 13 were managed conservatively. On account of the low complication rate, no correlation between the evaluated variables and observed complications could be established. Conclusion Percutaneous endovascular aortic repair is feasible and safe irrespective of the size of the introducer sheath and the nature of aorto-iliac pathology. The technical success rate is high and the incidence of complications is low. Early complications are most often associated with sheath sizes ≥ 18 F. The majority of the late complications can be treated conservatively. Key points: Citation Format Zielsetzung Überprüfung der Sicherheit von perkutanen endovaskulären aortalen Prozeduren und des Einflusses von Zugangscharakteristika auf Komplikationen. Material und Methoden Alle Patienten, welche sich von Januar 2010 bis Mai 2016 einer perkutanen TEVAR, EVAR und FEVAR Prozedur unterzogen haben, wurden retrospektiv ausgewertet in Bezug auf die Komplikationshäufigkeiten unter Berücksichtigung der Zugangs-charakteristika wie Gefäßdurchmesser, Ausmaß vorhandener Gefäßverkalkungen, Abstand Hautoberfläche zum Zugangsgefäß sowie des Verhältnisses von Gefäßdurchmesser zum Einführbesteck. Hämostase mit oder ohne manuelle Kompression innerhalb von 15 Minuten nach Gefäßnahtverschluss wurde als primäre Hämostase definiert. Ergebnisse Insgesamt wurden 92 Patienten mit 142 femoralen Zugängen in die Studie eingeschlossen. Die Mediane Nachbeobachtungszeit betrug 28,13 Monaten (range 2,5 – 76,7 Monate; Mittel 32,39, SD 21,66 Monate). Die Größe des Einführsystems variierte zwischen 12 und 25F. Eine primäre Hämostase wurde in 97,1 % (138/142) der femoralen Zugänge erreicht; vier Zugänge (2,8 %) mussten chirurgisch verschlossen werden; bei allen 4 Zugängen waren die Einführbestecke ≥ 18F, zwei der vier Leisten waren voroperiert. Spätkomplikationen waren Leistenhämatome (n = 7), Wundinfekt (n = 1), Skrotalhämatom (n = 1), Pseudoaneurysmen (n = 4) sowie Nachblutungen (n = 4), diese wurden bei 17 Zugangswegen (11,9 %) beobachtet, wovon 13 rein konservativ behandelt werden konnten. Auf Grund der niedrigen Komplikationsrate ergaben sich keine Zusammenhänge zwischen den Zugangscharakteristika und den stattgehabten Komplikationen. Zusammenfassung Perkutane Stentgraftimplantationen sind unabhängig von der Größe des verwendeten Einführsystems und der vorliegenden Aortenpathologie sicher durchführbar. Es besteht eine hohe technische Erfolgsrate bei einer niedrigen Komplikationsrate. Ein Versagen des Nahtverschlusssystems ist häufiger bei verwendeten Einführsystemen ≥ 18F. Die Mehrzahl der Spätkomplikationen kann konservativ behandelt werden. Kernaussagen:

Zur optimalen Strategie bei Patienten mit Diabetes und kritischer Extremitätenischämie gibt es eine Vielzahl offene Fragen. Dazu zählt auch der natürliche Verlauf der Erkrankung, der sich aus ethischen Gründen nur schwer untersuchen lässt. Auch die optimale Art der Revaskularisierung, wenn die Indikation einmal gestellt ist, ist derzeit nicht gesichert; hier könnten laufende Studien wie BASIL-2 und auch BASIL-3 (die verschiedene endovaskuläre Strategien miteinander vergleicht) Informationen beitragen. Darüber hinaus sollten Studien grundsätzlich nicht nur die Gefäßdurchgängigkeit als Endpunkt untersuchen, da trotz offener Gefäße eine Amputation notwendig werden kann. Patienten-relevante Outcomes, wie Wundheilung, Funktionsfähigkeit und Vermeiden einer Amputation, müssen stärker berücksichtigt werden als bisher.

Scoring systems for diabetic foot ulcers may be used for clinical purposes, research or audit, to help assess disease severity, plan management, and even predict outcomes. While many have been validated in study populations, little is known about their interobserver reliability. This prospective study aimed to evaluate interobserver reliability of 3 scoring systems for diabetic foot ulceration. After sharp debridement, diabetic foot ulcers were classified by a multidisciplinary pool of trained observers, using the PEDIS (Perfusion, Extent, Depth, Infection, Sensation), SINBAD (Site, Ischemia, Neuropathy, Bacterial infection, Depth), and University of Texas (UT) wound classification systems. Interobserver reliability was assessed using intraclass correlations (0 = no agreement; 1 = complete agreement). Thirty-seven patients (78.4% male) were assessed by a pool of 12 observers. Single observer reliability was slight to moderate for all scoring systems (UT 0.53; SINBAD 0.44; PEDIS 0.23-0.42), but multiple observer reliability was almost perfect (UT 0.94; SINBAD 0.91; PEDIS 0.80-0.90). The worst agreement for single observers was when scoring infection (SINBAD 0.28; PEDIS 0.28), ischemia (SINBAD 0.26; PEDIS 0.23), or both (UT 0.25); however, this improved to almost perfect agreement for multiple observers (infection: 0.83; ischemia: 0.80-0.82; both: 0.81). These classification systems may be reliably used by multiple observers, for example, when conducting research and audit. However, they demonstrate only slight to moderate reliability when used by a single observer on an individual subject and may therefore be less helpful in the clinical setting, when documenting ulcer characteristics or communicating between colleagues.

Assessment of foot perfusion is a vital step in the management of patients with diabetic foot ulceration, in order to understand the risk of amputation and likelihood of wound healing. Underlying peripheral artery disease is a common finding in patients with foot ulceration and is associated with poor outcomes. Assessment of foot perfusion should therefore focus on identifying the presence of peripheral artery disease and to subsequently estimate the effect this may have on wound healing. Assessment of perfusion can be difficult because of the often complex, diffuse and distal nature of peripheral artery disease in patients with diabetes, as well as poor collateralisation and heavy vascular calcification. Conventional methods of assessing tissue perfusion in the peripheral circulation may be unreliable in patients with diabetes, and it may therefore be difficult to determine the extent to which poor perfusion contributes to foot ulceration. Anatomical data obtained on cross‐sectional imaging is important but must be combined with measurements of tissue perfusion (such as transcutaneous oxygen tension) in order to understand the global and regional perfusion deficit present in a patient with diabetic foot ulceration. Ankle‐brachial pressure index is routinely used to screen for peripheral artery disease, but its use in patients with diabetes is limited in the presence of neuropathy and medial arterial calcification. Toe pressure index may be more useful because of the relative sparing of pedal arteries from medial calcification but may not always be possible in patients with ulceration. Fluorescence angiography is a non‐invasive technique that can provide rapid quantitative information about regional tissue perfusion; capillaroscopy, iontophoresis and hyperspectral imaging may also be useful in assessing physiological perfusion but are not widely available.There may be a future role for specialized perfusion imaging of these patients, including magnetic resonance imaging techniques, single‐photon emission computed tomography and PET‐based molecular imaging; however, these novel techniques require further validation and are unlikely to become standard practice in the near future. Copyright © 2016 John Wiley & Sons, Ltd.

The management of peripheral arterial disease (PAD) in patients with diabetic foot ulceration (DFU) is complex and there is a lack of robust evidence to guide definitive treatment strategies. Due to the distinct differences in etiology, disease distribution and treatment outcomes patients with diabetes, PAD and foot ulceration should be considered separately from those without diabetes. There is no randomized trial data to compare angioplasty and surgical bypass for revascularization in patients with DFU and PAD and the decision of whether, and how, to revascularize should be taken by experienced surgeons, in a multidisciplinary setting. Revascularization is only part of a treatment regimen which includes aggressive management of infection, neuropathy, foot deformity and cardiovascular risk. The burden and challenge of DFU in the context of PAD is continuing to increase and new research studies should be targeted specifically towards this ever-expanding group of patients.