A systematic review of reported outcomes in people with lower limb chronic venous insufficiency of the deep veins.

OBJECTIVE: The prevalence of lower limb chronic venous insufficiency (CVI) of the deep veins is increasing and presents a significant burden to patients and health care services. To improve the evaluation of interventions it is necessary to standardise their reporting. The aim of this study was to perform a systematic review of the outcomes of interventions delivered to people with CVI of the deep veins as part of the development of a novel core outcome set (COS). METHODS: Following the Core Outcome Measures in Effectiveness Trials (COMET) framework for COS development, a systematic review was conducted to PRISMA guidance. The protocol was preregistered on PROSPERO (CRD42021236795). MEDLINE, Embase, Emcare, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews and Clinicaltrials.gov were searched from January 2018 to January 2021. Clinical trials and observational studies involving more than 20 participants, reporting outcomes for patients with CVI of the deep veins were eligible. Outcomes were extracted verbatim, condensed into agreed outcome terms and coded into domains using standard COMET taxonomy. Outcome reporting consistency, where outcomes were fully reported throughout the methods and results of their respective articles was also assessed. RESULTS: Some 103 studies were eligible. There were 1183 verbatim outcomes extracted, spanning 22 domains. No outcome was reported unanimously, with the most widely reported outcome of primary patency featuring in 51 articles (<50%). There was a predominant focus on reporting clinical outcomes (n = 963 [81%]), with treatment durability (n = 278 [23%]) and clinical severity (n = 108 [9%]) reported frequently. Life impact outcomes were relatively under-reported (n = 60 [5%]). Outcome reporting consistency was poor, with just 50% of outcomes reported fully. CONCLUSIONS: Outcome reporting in studies of people with CVI of the deep veins is currently heterogeneous. Life impact outcomes, which likely reflect patients' priorities are under-reported. This study provides the first step in the development of a COS for people with lower limb CVI of the deep veins.

Trans-iliac Bypass for Critical Limb Ischaemia with Groin Necrosis: A Case Report.

INTRODUCTION: Infections at the level of the groin involving native or prosthetic vessels are typically bypassed using the obturator canal. However, extensive wounds or infections, particularly those involving the medial compartment of the thigh, can preclude this approach. REPORT: A 66 year old male with diabetes mellitus presented after several previous revascularisations of the femoral artery with extensive necrosis of the groin and critical limb ischaemia with necrotic changes in the toes. An iliopopliteal bypass through the iliac wing was planned because of the extent of the infection. DISCUSSION: The post-operative course was uneventful with complete resolution of tissue loss at one year follow up.

Critical Appraisal of the Quality of Evidence Addressing the Diagnosis, Prognosis, and Management of Peripheral Artery Disease in Patients With Diabetic Foot Ulceration.

AIMS: There is a paucity of robust evidence on prevention and management of diabetic foot ulcers (DFUs) to inform treatment. This study appraises the current quality of the evidence addressing diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with DFUs using a newly devised 21 point scoring (TOPS) disease specific research appraisal tool published by the International Working Group on the Diabetic Foot (IWGDF) and European Wound Management Association. METHODS: The 2015 IWGDF guidance on diagnosis, prognosis, and management of PAD in patients with DFUs was used to identify studies pertaining to prevention and management. Two reviewers assessed these articles against TOPS, which examines study design, conduct, and outcome reporting. RESULTS: The overall median score was 8 (3-12/21). The median design total score was 2 (0-4/11). The median conduct total score was 2 (1-4/6). The median outcomes total score was 3 (1-4/4). There was improvement with time in overall total (Spearman Rho 0.39, p = .0005), design total (0.35, p = .0023), and outcomes total (0.35, p = .0002), but not conduct total (-0.03, p = .8132) scores. CONCLUSIONS: Although this analysis revealed an improvement over time in the overall calibre of studies, the present quality remains poor on which to inform the diagnosis, management, and prognosis of patients with PAD and diabetic foot ulceration.

Trends in hospital admissions and surgical procedures for degenerative lumbar spine disease in England: a 15-year time-series study.

OBJECTIVES: Low back pain (LBP), from degenerative lumbar spine disease, represents a significant burden on healthcare resources. Studies worldwide report trends attributable to their country's specific demographics and healthcare system. Considering England's specific medico-socioeconomic conditions, we investigate recent trends in hospital admissions and procedures for LBP, and discuss the implications for the allocation of healthcare resources. DESIGN: Retrospective cohort study using Hospital Episode Statistics data relating to degenerative lumbar spine disease in England, between 1999 and 2013. Regression models were used to analyse trends. OUTCOME MEASURES: Trends in the number of admissions and procedures for LBP, mean patient age, gender and length of stay. RESULTS: Hospital admissions and procedures have increased significantly over the study period, from 127.09 to 216.16 and from 24.5 to 48.83 per 100,000, respectively, (p<0.001). The increase was most marked in the oldest age groups with a 1.9 and 2.33-fold increase in admissions for patients aged 60-74 and ≥ 75 years, respectively, and a 2.8-fold increase in procedures for those aged ≥ 60 years. Trends in hospital admissions were characterised by a widening gender gap, increasing mean patient age, and decreasing mean hospital stay (p<0.001). Trends in procedures were characterised by a narrowing gender gap, increasing mean patient age (p=0.014) and decreasing mean hospital stay (p<0.001). Linear regression models estimate that each hospital admission translates to 0.27 procedures, per 100,000 (95% CI 0.25 to 0.30, r 0.99, p<0.001; r, Pearson's correlation coefficient). Hospital admissions are increasing at 3.5 times the rate of surgical procedures (regression gradient 7.63 vs 2.18 per 100,000/year). CONCLUSIONS: LBP represents a significant and increasing workload for hospitals in England. These trends demonstrate an increasing demand for specialists involved in the surgical and non-surgical management of this disease, and highlight the need for services capable of dealing with the increased comorbidity burden associated with an ageing patient group.

Research activity and the association with mortality.

INTRODUCTION: The aims of this study were to describe the key features of acute NHS Trusts with different levels of research activity and to investigate associations between research activity and clinical outcomes. METHODS: National Institute for Health Research (NIHR) Comprehensive Clinical Research Network (CCRN) funding and number of patients recruited to NIHR Clinical Research Network (CRN) portfolio studies for each NHS Trusts were used as markers of research activity. Patient-level data for adult non-elective admissions were extracted from the English Hospital Episode Statistics (2005-10). Risk-adjusted mortality associations between Trust structures, research activity and, clinical outcomes were investigated. RESULTS: Low mortality Trusts received greater levels of funding and recruited more patients adjusted for size of Trust (n = 35, 2,349 £/bed [95% CI 1,855-2,843], 5.9 patients/bed [2.7-9.0]) than Trusts with expected (n = 63, 1,110 £/bed, [864-1,357] p<0.0001, 2.6 patients/bed [1.7-3.5] p<0.0169) or, high (n = 42, 930 £/bed [683-1,177] p = 0.0001, 1.8 patients/bed [1.4-2.1] p<0.0005) mortality rates. The most research active Trusts were those with more doctors, nurses, critical care beds, operating theatres and, made greater use of radiology. Multifactorial analysis demonstrated better survival in the top funding and patient recruitment tertiles (lowest vs. highest (odds ratio & 95% CI: funding 1.050 [1.033-1.068] p<0.0001, recruitment 1.069 [1.052-1.086] p<0.0001), middle vs. highest (funding 1.040 [1.024-1.055] p<0.0001, recruitment 1.085 [1.070-1.100] p<0.0001). CONCLUSIONS: Research active Trusts appear to have key differences in composition than less research active Trusts. Research active Trusts had lower risk-adjusted mortality for acute admissions, which persisted after adjustment for staffing and other structural factors.

The importance of structures and processes in determining outcomes for abdominal aortic aneurysm repair: an international perspective.

Annual procedural mortality reports have become mandatory for vascular surgery in England, reflecting a more widespread appetite for transparency and accountability across the National Health Service (NHS) [BMJ 2013;346:f854]. The outcomes of abdominal aortic aneurysm (AAA) repair, in particular, have attracted considerable commentary: from 1999 to 2006, postoperative mortality was higher in England than in many other countries (7.9 vs. 1.9-4.5%) [European Society for Vascular Surgery. 2nd Vascunet Report. 2008]. This stimulated considerable service reconfiguration (centralization), quality improvement initiatives, the uptake of endovascular technology, and the examination of institution-level mortality data [http://www.vascularsociety.org.uk/library/quality-improvement.html], which resulted in a fall in elective AAA mortality to 1.8% by 2012 [http://www.hqip.org.uk/assets/NCAPOP-Library/NCAPOP-2013-2014/Outcomes-after-Elective-Repair-of-Infra-renal-Abdominal-Aortic-Aneurysm.pdf (February 2015)]. Despite improvements at a national level, the outcomes of AAA repair vary considerably between different hospitals in the NHS [Circ Cardiovasc Qual Outcomes 2014;7:131-141], analogous to interprovider variation that has been reported across a range of emergency medical and surgical conditions [BMC Health Serv Res 2014;14:270]. This suggests that underlying institution structures and processes contribute independently to patients' outcomes. There is also considerable evidence that the outcomes of AAA repair vary in different healthcare systems, both in the elective European Society for Vascular Surgery, 2008 and emergency settings. A consideration of the role of structures and processes in influencing outcomes for AAA repair can be conducted across different institutions or even different healthcare systems. This can help identify which factors are consistently associated with the best outcomes, informing efforts to better organize and deliver services for patients requiring vascular surgery.

Acute limb ischaemia due to focal brachial artery aneurysms complicating brachiocephalic arteriovenous fistula ligation: two recent case reports.

INTRODUCTION: True brachial artery aneurysms are rare, typically occurring secondary to trauma. In this report, we describe two recent cases of patients who presented acutely with upper limb ischaemia due to brachial artery aneurysms. Both patients presented many years after brachiocephalic arteriovenous (AV) fistula ligation in the ipsilateral limb. REPORT: Two male patients, aged 60 and 63 years, respectively, were seen acutely with symptoms of upper limb ischaemia. They had both undergone ligation of AV fistulae many years earlier having received functioning transplants. Subsequently, both patients were found to have true brachial artery aneurysms, which were bypassed in both instances using great saphenous vein grafts. DISCUSSION: Patients undergoing ligation of AV fistulae should receive interval surveillance imaging to detect potential aneurysmal dilatation of upper limb vessels. Little is known about the incidence of aneurysm formation after AV fistula ligation; given the increasing number of patients undergoing dialysis, and hence the burgeoning number of patients who may receive transplants, it is important that upper limb ischaemia is pre-empted by appropriate follow-up.

Infrainguinal angioplasty with drug-eluting stents and balloons.

OBJECTIVE: The objective of this study was to provide a systematic review and meta-analysis of outcomes of infrainguinal angioplasty with drug-eluting stent (DES) or balloon (DEB). METHODS: The EMBASE, MEDLINE, and Cochrane databases and the Current Controlled Trials register were systematically interrogated for articles reporting results of infrainguinal angioplasty with DESs or DEBs. Clinical and angiographic end points were included. RESULTS: The review included 26 studies that reported on 2407 limbs; 11 were prospective randomized controlled trials. Infrapopliteal angioplasty with DEB was reported in 109 limbs (claudication, 19; critical limb ischemia [CLI], 90) (limb salvage in CLI, 95.6%; target lesion revascularization [TLR], 17.3%; mortality, 16%; mean follow-up, 12.3 months). Infrapopliteal angioplasty with DES was reported in 882 limbs (claudication, 160; CLI, 590; unclear severity, 132) (limb salvage in CLI, 97.4%, TLR, 10.8%; mortality, 17%; mean follow-up, 22.9 months). Femoropopliteal angioplasty with DES was reported in 1174 limbs (claudication, 301; CLI, 58; unclear severity, 815) (limb salvage in CLI, 89.6%; TLR, 17.3%; mortality, 3%; mean follow-up, 10.6 months). Femoropopliteal angioplasty with DEB was reported in 242 limbs (claudication, 182; CLI, 12; unclear severity, 48) (TLR, 10.6%; mortality, 2%; mean follow-up, 11 months). Meta-analysis of studies comparing DEB with standard balloon angioplasty demonstrated a result in favor of DEBs for preventing binary primary restenosis (odds ratio [OR], 0.27; P = .005) and TLR (OR, 0.17; P = .001). The meta-analysis comparing DESs with bare-metal stents demonstrated a result in favor of DES with regard to preventing TLR (OR, 0.15; P = .001) and binary primary restenosis (OR, 0.23; P = .001). Drug-eluting technology did not prevent more deaths or amputations. CONCLUSIONS: Early angiographic data suggest that drug-eluting devices prevent restenosis in the short term, but there is as yet no evidence of an increase in limb salvage rates or a reduction in mortality. Further large randomized controlled trials with a focus on clinical outcomes and longer follow-up are needed.

Mortality from ruptured abdominal aortic aneurysms: clinical lessons from a comparison of outcomes in England and the USA.

BACKGROUND: The outcome of patients with ruptured abdominal aortic aneurysm (rAAA) varies by country. Study of practice differences might allow the formulation of pathways to improve care. METHODS: We compared data from the Hospital Episode Statistics for England and the Nationwide Inpatient Sample for the USA for patients admitted to hospital with rAAA from 2005 to 2010. Primary outcomes were in-hospital mortality, mortality after intervention, and decision to follow non-corrective treatment. In-hospital mortality and the rate of non-corrective treatment were analysed by binary logistic regression for each health-care system, after adjustment for age, sex, year, and Charlson comorbidity index. FINDINGS: The study included 11,799 patients with rAAA in England and 23,838 patients with rAAA in the USA. In-hospital mortality was lower in the USA than in England (53·05% [95% CI 51·26-54·85] vs 65·90%; p<0·0001). Intervention (open or endovascular repair) was offered to a greater proportion of cases in the USA than in England (19,174 [80·43%] vs 6897 [58·45%]; p<0·0001) and endovascular repair was more common in the USA than in England (4003 [20·88%] vs 589 [8·54%]; p<0·0001). Postintervention mortality was similar in both countries (41·77% for England and 41·65% for USA). These observations persisted in age-matched and sex-matched comparisons. In both countries, reduced mortality was associated with increased use of endovascular repair, increased hospital caseload (volume) for rAAA, high hospital bed capacity, hospitals with teaching status, and admission on a weekday. INTERPRETATION: In-hospital survival from rAAA, intervention rates, and uptake of endovascular repair are lower in England than in the USA. In England and the USA, the lowest mortality for rAAA was seen in teaching hospitals with larger bed capacities and doing a greater proportion of cases with endovascular repair. These common factors suggest strategies for improving outcomes for patients with rAAA. FUNDING: None.

Retrograde aortic dissection after thoracic endovascular aortic repair.

OBJECTIVE: To provide data regarding the etiology and timing of retrograde type A aortic dissection (RTAD) after thoracic endovascular aortic repair (TEVAR). METHODS: Details of patients who had RTAD after TEVAR were obtained from the MOTHER Registry supplemented by data from a systematic review of the literature. Univariate analysis and binary logistic regression analysis of patient or technical factors was performed. RESULTS: In MOTHER, RTAD developed in 16 of the 1010 patients (1.6%). Binary logistic regression demonstrated that an indication of TEVAR for aortic dissection (acute P = 0.000212; chronic P = 0.006) and device oversizing (OR 1.14 per 1% increase in oversizing above 9%, P < 0.0001) were significantly more frequent in patients with RTAD. Data from the systematic review was pooled with MOTHER data and demonstrated that RTAD occurred in 1.7% (168/9894). Most of RTAD occurred in the immediate postoperative (58%) period and was associated with a high mortality rate (33.6%). The odds ratio of RTAD for an acute aortic dissection was 10.0 (CI: 4.7-21.9) and 3.4 (CI: 1.3-8.8) for chronic aortic dissection. The incidence of RTAD was not significantly different for endografts with proximal bare stent (2.8%) or nonbare stent (1.9%) (P = 0.1298). CONCLUSIONS: Although RTAD after TEVAR is an uncommon complication, it has a high mortality rate. RTAD is significantly more frequent in patients treated for acute and chronic type B dissection, and when the endograft is significantly oversized. The proximal endograft configuration was not associated with any difference in the incidence of RTAD.

Systematic review of screening investigations for peripheral arterial disease in patients with diabetes mellitus.

Diabetes-related foot complications are a major cause of amputation. The presence of peripheral arterial disease (PAD) identifies those at increased risk of ulceration, failure to heal an ulcer, and amputation. This systematic review assesses the ability of noninvasive screening tests to detect PAD in patients with diabetes mellitus. A database search was performed using the OVIDSP Web site, from 1946 to June 30, 2012 (MEDLINE®), and from 1974 to June 30, 2012 (EMBASE), to identify studies assessing the utility of screening tests in detecting PAD or predicting clinical outcomes in patients with diabetes mellitus. Thirteen studies were identified that reported sensitivity and specificity data on screening tests. No single screening test was reliable in identifying or excluding peripheral arterial disease in patients with diabetes. Although the evidence base is limited, transcutaneous oxygen measurements appear to be predictive of ulcer or surgical wound healing. The diagnosis of PAD (and the decision to revascularize) in patients with diabetes is unreliable using screening tests. Therefore, all patients with diabetes-related foot ulceration should be assessed by a multidisciplinary diabetes foot team that has access to a vascular specialist. A low threshold for noninvasive diagnostic imaging seems appropriate in patients with diabetes-related foot ulceration.

Single-port laparoscopic subtotal gastrectomy with DIα lymphadenectomy.

BACKGROUND: "Conventional multiport" laparoscopic gastrectomy for early stage gastric cancer is an increasingly frequently performed procedure. The authors describe their experience of the first reported single-port laparoscopic subtotal gastrectomy in an 88-year-old lady with early antral gastric adenocarcinoma. METHOD: Single-port laparoscopic subtotal gastrectomy with D1α lymphadenectomy was successfully performed using a transumbilical multichannel single port. Straight and flexible tipped laparoscopes were used to obtain off-axis views of the operative field. A flexible tipped stapler and curved instruments were used to reconstruct the Polya-type gastrojejunostomy. The procedure was performed without compromising standard, oncological principles. RESULTS: Specimen histology revealed moderately to poorly differentiated adenocarcinoma infiltrating the submucosa. Proximal and distal resection margins were tumor free. Furthermore, 41 tumor-free lymph nodes were harvested. The patient was discharged on postoperative day 6. CONCLUSIONS: Single-port gastrectomy for cancer is technically and oncologically feasible when performed by experienced minimally invasive surgical oncologists with extensive experience of benign single-port laparoscopic procedures. The advantages to the patient in terms of cosmesis and shorter hospital stay are clear. However, further studies are required to assess this technique when treating gastric and other malignancies.

Impairment of autonomic reactivity is a feature of heart failure whether or not the left ventricular ejection fraction is normal.

BACKGROUND: Autonomic dysfunction (AD) is associated with morbidity and mortality in patients with systolic heart failure (SHF). The extent of AD when LV ejection fraction is preserved (HF-NEF), is unclear. Our objectives were: 1) quantitative assessment of autonomic function in SHF and HF-NEF; and 2) exploration of relationships among AD, symptoms and cardiac function. METHODS: This was an observational study of patients newly referred from primary care with a heart failure diagnosis; 21 SHF, 20 HF-NEF patients and 21 normal subjects were recruited. All subjects underwent clinical evaluation, 6-minute walk test (6 MWT), Minnesota Questionnaire (MLWHFQ) and echocardiography. Autonomic assessment included haemodynamic responses to standing, deep breathing and handgrip. Concomitant blood pressure variability (BPV) and heart rate variability (HRV) parameters were also derived. RESULTS: There were significant differences in all haemodynamic responses between SHF, HF-NEF and normal. Log transformed (ln) low frequency spectral component of BPV was lower in SHF (4.1 ± 0.3) than HF-NEF (4.2 ± 0.4) and normal (4.4 ± 0.1; p=0.001 SHF vs HF-NEF and vs normal). Ln LF/HF was greater in normal than HF-NEF and SHF (1.5 ± 0.7 vs 0.9 ± 1.0 vs 0.6 ± 0.6; p=0.003). Autonomic modulations correlated negatively with severity of heart failure. CONCLUSIONS: Autonomic responses in heart failure were blunted and the attenuation of responses correlated strongly with symptomatic and functional markers of disease severity. Autonomic dysfunction is a feature of the heart failure syndrome but is not dependent on ejection fraction.