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1.
BMJ Open ; 11(9): e050833, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34475182

RESUMO

INTRODUCTION: Diabetic foot disease is a common condition globally and is over-represented in indigenous populations. The propensity for patients with diabetic foot disease to undergo minor or major limb amputation is a concern. Diabetic foot disease and lower limb amputation are debilitating for patients and have a substantial financial impact on health services. The purpose of this multicentre study is to prospectively report the presentation, management and outcomes of diabetic foot disease, to validate existing scoring systems and assess long term outcomes for these patients particularly in relation to major limb amputation. METHODS AND ANALYSIS: This is a multisite, international, prospective observational study, being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth Hospital, Australia. Consecutive participants with diabetic foot disease that meet inclusion criteria and agree to participate will be recruited from multidisciplinary team diabetic foot clinic, vascular clinic, dialysis and admission to hospital. Follow-up of participants will occur at 1, 3, 6 and 12 months. At recruitment and follow-up reviews, information about service details, demographic and clinical history, wound data and discharge information will be recorded. The primary outcomes are the time to wound healing, major amputation, overall mortality and amputation-free survival at 12 months. This study started in NZ in August 2020 and will commence in Australian sites in early 2021. ETHICS AND DISSEMINATION: New Zealand Central Health and Disability Ethics Committee (20/CEN/122), Waikato DHB Research Department (RDO020044), Quality Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (13928). Results will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000337875).


Assuntos
Diabetes Mellitus , Pé Diabético , Austrália/epidemiologia , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Nova Zelândia/epidemiologia , Estudos Observacionais como Assunto , Diálise Renal , Temefós
3.
Eur J Vasc Endovasc Surg ; 62(2): 233-240, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34024706

RESUMO

OBJECTIVE: Diabetic foot disease is a serious and common complication of diabetes mellitus. The aim of this study was to assess limb and patient factors associated with key clinical outcomes in diabetic patients with foot ulcers. METHODS: This was a prospective observational study of diabetic patients with foot wounds admitted to a major tertiary teaching hospital in South Australia or seen at associated multidisciplinary foot clinics between February 2017 and December 2018. Patient demographic and clinical data were collected, including limb status severity assessed by the WIfI system and grip strength. Participants were followed up for 12 months. The primary outcomes were major amputation, death, amputation free survival, and completion of healing of the index wound within one year. RESULTS: A total of 153 participants were recruited and outcome data were obtained for 152. Forty-two participants underwent revascularisation during the research period. Eighteen participants (11.8%) suffered major amputation of the index limb and 16 (10.5%) died during follow up. Complete wound healing was achieved in 106 (70%) participants. There was a statistically significant association between WIfI stage and major amputation (subdistribution hazard ratio [SHR] 2.75), mortality (hazard ratio [HR] 2.60), amputation free survival (odds ratio [OR] 0.32), and wound healing (SHR 0.69). There was also a statistically significant association between time to healing and grip strength (SHR 0.50), and previous amputations (major or minor) (SHR 0.57). CONCLUSION: This prospective study supports the ability of the WIfI classification system to predict one year key clinical outcomes in a diabetic population with foot ulcers. It also demonstrated that grip strength may be a useful predictor of wound healing.


Assuntos
Amputação/estatística & dados numéricos , Pé Diabético/fisiopatologia , Pé Diabético/cirurgia , Cicatrização , Idoso , Pé Diabético/classificação , Feminino , Força da Mão , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida
4.
Ann Vasc Surg ; 75: 430-444, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33838242

RESUMO

BACKGROUND: Risk assessment models must be continuously validated and updated to ensure that predictions remain valid. Here, the Endovascular Aneurysm Repair Risk Assessment Model, developed in 2008, is updated and improved. METHODS: We used prospectively collected data from Australian patients who underwent elective endovascular aneurysm repair between 2009 and 2013 (n = 695). Data were provided by treating surgeons and the National Death Index. Key outcomes were early and midterm survival, early complications (endoleak, operative, and graft-related) and late complications (endoleak and graft-related). Multinomial logistic regression determined which preoperative variables best predicted each outcome. Area under Receiver Operating Characteristic curve (AUROC), model P-value and internal validation statistics were used to select the best model. RESULTS: Ten preoperative variables were included in the modeling for 10 key outcomes. The most valid outcomes with AUROC>0.7 were 1- and 3-year survival, 30 and 90-day mortality, early and late endoleak (types I, III and IV) and type II endoleak (with an increase in sac size ≥5 mm). The 10 preoperative variables that contributed to outcome models were self-reported fitness, American Society of Anesthesiologists physical status score, history of stroke/transient ischemic attack, age, aneurysm angle, infrarenal neck length, white cell count, respiratory assessment, diabetes and statin therapy. Fitness alone statistically significantly predicted 30 and 90-day deaths better than any other preoperative variable; achieving high AUROCs (0.78 and 0.80), and high odds ratios (12.8 [95% CI: 1.5-110.4] and 18.1 [95% CI: 2.2-149]). CONCLUSIONS: An updated interactive predictive model of outcomes after endovascular aneurysm repair has been created. Many of the variables used in the 2008 model continued to be significant, however, new variables including fitness and respiratory assessment, improved the model. The new model uses variables routinely collected preoperatively, and hence can better support surgeon-patient discussions prior to operation. Informing patients of potential risks or likely outcomes following elective surgery can assist with preoperative shared decision-making.

5.
Wound Repair Regen ; 29(3): 460-465, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33657252

RESUMO

The accurate measurement of diabetic foot ulcer (DFU) wound size is essential as the rate of wound healing is a significant prognostic indicator of the likelihood of complete wound healing. Mobile phone photography is often used for surveillance and to aid in telemedicine consultations. However, there remains no accurate and objective measurement of wound size integrated into these photos. The NDKare mobile phone application has been developed to address this need and our study evaluates its accuracy and practicality for DFU wound size assessment. The NDKare mobile phone application was evaluated for its accuracy in two- (2D) and three-dimensional (3D) wound measurement. One hundred and fifteen diabetic foot wounds were assessed for wound surface area, depth and volume accuracy in comparison to Visitrak and the WoundVue camera. Thirty five wounds had two assessors with different mobiles phones utilizing both applications to assess the reproducibility of the measurements. The 2D surface area measurements by NDKare showed excellent concordance with Visitrak and WoundVue measurements (ICC: 0.991 [95% CI: 0.988, 0.993]) and between different users (ICC: 0.98 [95% CI: 0.96, 0.99)]. The 3D NDKare measurements had good agreement for depth and fair agreement for volume with the WoundVue camera. The NDKare phone application can consistently and accurately obtain 2D measurements of diabetic foot wounds with mobile phone photography. This is a quick and readily accessible tool which can be integrated into comprehensive diabetic wound care.

6.
Int J Cardiol ; 330: 200-206, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33581177

RESUMO

AIM: Imaging can help guide management in peripheral arterial disease (PAD) with symptoms refractory to medical treatment. However, there are no set guidelines to determine when physicians should seek further imaging in patients with PAD for the assessment of new, persistent or worsening symptoms. This study describes the rates and variability in non-invasive and invasive imaging for patients presenting to vascular specialty clinics for symptomatic PAD. METHODS: Patients (n=1,275) with a new PAD diagnosis or exacerbation of PAD symptoms were enrolled from 16 vascular clinics. Hierarchical logistic regression models were used to estimate the referral rates for 1) non-invasive and 2) invasive imaging tests, after adjusting for patient demographics, disease characteristics, PAQ summary score, PAD performance measures and country. Median Odds Ratios (MOR) were calculated to examine the variability across sites and providers. RESULTS: Mean ABI was 0.67 ± 0.19. There were 690 (54.1%) patients who had imaging, of which 62 (9.0%) had invasive imaging. Imaging rates ranged from 8.6% to 98.6% across sites. The MOR for use of imaging for site was 3.36 (p < 0.001) and provider 3.49 (p < 0.001). The variability was explained primarily by (R2 = 29%) country followed by patient-level factors, provider and lastly site (R2 = 17%, 14%, and 13%, respectively). CONCLUSION: There is wide variation in the use of imaging for patients presenting with new onset or recent exacerbations of their PAD. Country, followed by provider and site, were most strongly associated with this variability after adjusting for patient characteristics.


Assuntos
Doença Arterial Periférica , Diagnóstico por Imagem , Humanos , Modelos Logísticos , Razão de Chances , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/epidemiologia , Encaminhamento e Consulta
7.
Eur Heart J ; 2021 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-33624819

RESUMO

AIMS: Peripheral artery disease (PAD) revascularization can be performed by either endovascular or open surgical approach. Despite increasing use of endovascular revascularization, it is still uncertain which strategy yields better long-term outcomes. METHODS AND RESULTS: This retrospective cohort study evaluated patients hospitalized with PAD in Australia and New Zealand who underwent either endovascular or surgical revascularization between 2008 and 2015, and compared procedures using a propensity score-matched analysis. Hybrid interventions were excluded. The primary endpoint was mortality or major adverse limb events (MALE), defined as a composite endpoint of acute limb ischaemia, urgent surgical or endovascular reintervention, or major amputation, up to 8 years post-hospitalization using time-to-event analyses 75 189 patients fulfilled eligibility (15 239 surgery and 59 950 endovascular), from whom 14 339 matched pairs (mean ± SD age 71 ± 12 years, 73% male) with good covariate balance were identified. Endovascular revascularization was associated with an increase in combined MALE or mortality [hazard ratio (HR) 1.13, 95% confidence interval (CI): 1.09-1.17, P < 0.001]. There was a similar risk of MALE (HR 1.04, 95% CI: 0.99-1.10, P = 0.15), and all-cause urgent rehospitalizations (HR 1.01, 95% CI: 0.98-1.04, P = 0.57), but higher mortality (HR 1.16, 95% CI: 1.11-1.21, P < 0.001) when endovascular repair was compared to surgery. In subgroup analysis, these findings were consistent for both claudication and chronic limb-threatening ischaemia presentations. CONCLUSION: Although the long-term risk of MALE was comparable for both approaches, enduring advantages of surgical revascularization included lower long-term mortality. This is at odds with some prior PAD studies and highlights contention in this space.

8.
J Vasc Surg ; 73(1): 69-80, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32442605

RESUMO

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.


Assuntos
Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Procedimentos Endovasculares/métodos , Stents , Idoso , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico , Aneurisma da Aorta Abdominal/mortalidade , Aortografia/métodos , Causas de Morte/tendências , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
9.
Adv Wound Care (New Rochelle) ; 10(7): 370-380, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33176621

RESUMO

Significance: Prolonged inflammation and impaired angiogenesis are the two principal factors that prevent successful wound healing, which is exacerbated in people with diabetes. There is a significant need for new wound healing treatments that target both these factors simultaneously. This review discusses the emerging evidence that high-density lipoproteins (HDL) have pleiotropic wound healing benefits. Recent Advances: Numerous in vitro and in vivo studies have demonstrated the anti-inflammatory and proangiogenic effects of HDL. In endothelial cells, HDL mediate these effects through interaction with the scavenger receptor SR-BI, which activates the PI3K/Akt pathway, causing a decrease in inflammatory protein production and an increase in proangiogenic growth factors. In macrophages, HDL inhibit inflammation through suppression of the nuclear factor kappa B activation pathway. This review details the molecular disturbances that cause impaired wound healing in diabetes with a particular focus on inflammation and angiogenesis and the pathways in which HDL provide benefit. Critical Issues: Diabetic foot ulcers (DFUs) impose a major public health challenge worldwide. It is estimated that 20% patients with DFUs require amputation, which is accompanied by a significant social and economic burden. To date, there are no therapeutic agents with pleiotropic effects that actively improve wound healing, highlighting a therapeutic void for this complex disease.

10.
Adv Wound Care (New Rochelle) ; 9(11): 623-631, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33095125

RESUMO

Objective: The initial wound measurement and regular monitoring of diabetic foot ulcers (DFU) is critical to assess treatment response. There is no standardized, universally accepted, quick, reliable, and quantitative assessment method to characterize DFU. To address this need, a novel topographic imaging system has been developed. Our study aims at assessing the reliability and practicality of the WoundVue® camera technology in the assessment of DFU. Approach: The WoundVue system is a prototype device. It consists of two infrared cameras and an infrared projector, and it is able to produce a three-dimensional (3D) reconstruction of the wound structure. Fifty-seven diabetic foot wounds from patients seen in a multidisciplinary foot clinic were photographed from two different angles and distances by using the WoundVue camera. Wound area, volume, and maximum depth were measured for assessment of reliability. Thirty-one of these wounds also had area calculated by using the established Visitrak™ system, and a correlation between the area obtained by using both systems was assessed. Results: WoundVue images analysis showed excellent agreement for area (intraclass correlation coefficient [ICC]: 0.995), volume (ICC: 0.988), and maximum depth (ICC: 0.984). Good agreement was found for area measurement by using the WoundVue camera and Visitrak system (ICC: 0.842). The average percentage differences between measures obtained by using the WoundVue from different angles for assessment of different sizes and shapes of wounds were 2.9% (95% confidence interval [CI]: 0.3-5.4), 12.9% (95% CI: 9.6-35.7), and 6.2% (95% CI: 2.3-14.7) for area, maximum depth, and volume, respectively. Innovation: This is the first human trial evaluating this novel 3D wound measurement device. Conclusion: The WoundVue system is capable of recreating a 3D model of DFU and produces consistent data. Digital images are ideal for monitoring wounds over time, and the WoundVue camera has the potential to be a valuable adjunct in diabetic foot wound care.

11.
JAMA Cardiol ; 5(12): 1374-1381, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32845283

RESUMO

Importance: Currently there is no drug therapy for abdominal aortic aneurysm (AAA). Objective: To test the efficacy of the angiotensin receptor blocker telmisartan in slowing AAA growth in the Telmisartan in the Management of Abdominal Aortic Aneurysm (TEDY) trial. Design, Setting, and Participants: A randomized, double-blind, placebo-controlled trial recruited participants between September 6, 2011, and October 5, 2016, to evaluate the efficacy of telmisartan treatment in patients with AAA. Participants with 35- to 49-mm AAAs recruited from Australia, the Netherlands, and the US were randomized 1:1 to receive telmisartan, 40 mg, or identical placebo. Analyses were conducted according to intention-to-treat principles. Final follow-up was conducted on October 11, 2018, and data analysis was performed between June and November 2019. Intervention: Telmisartan, 40 mg, or identical placebo. Main Outcomes and Measures: The primary outcome of the difference in AAA growth, assessed on core imaging laboratory-read ultrasonographic scanning, was tested with linear mixed-effects models. Other outcomes included effects on blood pressure, computed tomographic (CT)-measured AAA diameter and volume, time to AAA-related events (AAA repair or mortality due to AAA rupture), and health-related quality of life. Results: Of 300 intended participants, 210 were enrolled and randomized to receive telmisartan (n = 107) or placebo (n = 103). Of patients included in the intention-to-treat analysis (telmisartan: n = 106, placebo: n = 101), 183 were men (88%); mean (SD) age was 73.5 (7.9) years. At 1 year, participants receiving telmisartan had mean lower systolic (8.9; 95% CI, 4.1-13.8 mm Hg; P < .001) and diastolic (7.0; 4.3-9.8 mm Hg; P < .001) blood pressure levels compared with participants receiving placebo. A total of 188 participants (91%) received at least 2 ultrasonographic scans and 133 participants (64%) had at least 2 CT scans. There was no significant difference in ultrasonographic-assessed AAA growth rates among those assigned telmisartan (1.68 mm/y) or placebo (1.78 mm/y): mean difference, -0.11 mm/y (95% CI, -0.60 to 0.38 mm/y; P = .66). Telmisartan had no significant effects on AAA growth assessed by CT-measured AAA diameter (mean difference, -0.01 mm/y; 95% CI, -0.02 to 0.01 mm/y; P = .23) or volume (mean difference, -0.02 cm3/y; 95% CI, -0.04 to 0.00 cm3/y; P = .11), AAA-related events (relative risk, 1.35; 95% CI, 0.54-3.35; P = .52), or health-related quality of life (mean difference in physical component score at 24 months, 0.4; 95% CI, 0.4-0.4; P = .80). Hypotensive symptoms (eg, syncope) were twice as common among participants receiving telmisartan compared with placebo (28 [26%] vs 13 [13%]; P = .02), but overall adverse event rates were otherwise similar for both groups. Conclusions and Relevance: This underpowered study did not show a treatment effect for telmisartan on small AAA growth. Future trials will need to ensure adequate sample size and duration of follow-up. Trial Registrations: anzctr.org.au Identifier: ACTRN12611000931976; ClinicalTrials.gov Identifier: NCT01683084.

12.
Int J Mol Sci ; 21(16)2020 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-32764293

RESUMO

Pericytes are peri-vascular mural cells which have an important role in the homeostatic regulation of inflammatory and angiogenic processes. Flightless I (Flii) is a cytoskeletal protein involved in regulating cellular functions, but its involvement in pericyte activities during wound healing is unknown. Exacerbated inflammation and reduced angiogenesis are hallmarks of impaired diabetic healing responses, and strategies aimed at regulating these processes are vital for improving healing outcomes. To determine the effect of altering Flii expression on pericyte function, in vitro and in vivo studies were performed to assess the effect on healing, inflammation and angiogenesis in diabetic wounds. Here, we demonstrated that human diabetic wounds display upregulated expression of the Flii protein in conjunction with a depletion in the number of platelet derived growth factor receptor ß (PDGFRß) +/ neural glial antigen 2 (NG2) + pericytes present in the dermis. Human pericytes were found to be positive for Flii and attenuating its expression in vitro through siRNA knockdown led to enhanced proliferation, migration and angiogenic functions. Genetic knockdown of Flii in a streptozotocin-induced murine model of diabetes led to increased numbers of pericytes within the wound. This was associated with dampened inflammation, an increased rate of angiogenic repair and improved wound healing. Our findings show that Flii expression directly impacts pericyte functions, including proliferation, motility and angiogenic responses. This suggests that Flii regulation of pericyte function may be in part responsible for the changes in pericyte-related processes observed in diabetic wounds.


Assuntos
Diabetes Mellitus/genética , Pé Diabético/genética , Inflamação/genética , Proteínas dos Microfilamentos/genética , Transativadores/genética , Cicatrização/genética , Animais , Proliferação de Células/genética , Proteínas do Citoesqueleto/genética , Complicações do Diabetes/genética , Complicações do Diabetes/patologia , Diabetes Mellitus/terapia , Pé Diabético/complicações , Pé Diabético/patologia , Humanos , Inflamação/complicações , Inflamação/patologia , Inflamação/terapia , Camundongos , Pericitos/metabolismo , Pericitos/patologia
13.
BMC Microbiol ; 20(1): 204, 2020 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-32646376

RESUMO

BACKGROUND: Diabetic foot ulcer (DFU) is a serious complication of diabetes mellitus. Antibiotic-resistant Staphylococcus aureus is frequently isolated from DFU infections. Bacteriophages (phages) represent an alternative or adjunct treatment to antibiotic therapy. Here we describe the efficacy of AB-SA01, a cocktail of three S. aureus Myoviridae phages, made to current good manufacturing practice (cGMP) standards, and which has undergone two phase I clinical trials, in treatment of multidrug-resistant (MDR) S. aureus infections. RESULTS: Wounds of saline-treated mice showed no healing, but expanded and became inflamed, ulcerated, and suppurating. In contrast, AB-SA01 treatment decreased the bacterial load with efficacy similar or superior to vancomycin treatment. At the end of the treatment period, there was a significant decrease (p < 0.001) in bacterial load and wound size in infected phage- and vancomycin-treated groups compared with infected saline-treated mice. In phage-treated mice, wound healing was seen similar to vancomycin treatment. No mortality was recorded associated with infections, and post-mortem examinations did not show any evident pathological lesions other than the skin wounds. No adverse effects related to the application of phages were observed. CONCLUSION: Topical application of phage cocktail AB-SA01 is effective, as shown by bacterial load reduction and wound closure, in the treatment of diabetic wound infections caused by MDR S. aureus. Our results suggest that topical phage cocktail treatment may be effective in treating antibiotic-resistant S. aureus DFU infections.

15.
PLoS One ; 15(4): e0231095, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32348306

RESUMO

INTRODUCTION: Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting. We aimed to evaluate the long-term (104 week) efficacy following a standard course of inpatient-initiated varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone. METHODS: Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals, were randomised to receive either 12-weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling, (n = 196) or Quitline-counselling alone, (n = 196), with continuous abstinence from smoking assessed at 104 weeks. RESULTS: A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011. The proportion of participants who remained continuously abstinent (intention-to-treat) at 104 weeks were significantly greater in the varenicline tartrate plus counselling arm (29.2% n = 56) compared to counselling alone (18.8% n = 36; p = 0.02; odds ratio 1.78; 95%CI 1.10 to 2.86, p = 0.02). Twenty-two deaths occurred during the 104 week study (n = 10 for varenicline tartrate plus counselling and n = 12 for Quitline-counselling alone). All of these participants had known or developed underlying co-morbidities. CONCLUSIONS: This is the first study to examine the efficacy and safety of varenicline tartrate over 104 weeks within any setting. Varenicline tartrate plus Quitline-counselling was found to be an effective opportunistic treatment when initiated for inpatient smokers who had been admitted with tobacco-related disease.


Assuntos
Abandono do Hábito de Fumar/métodos , Fumar/tratamento farmacológico , Fumar Tabaco/tratamento farmacológico , Vareniclina/administração & dosagem , Adulto , Idoso , Feminino , Humanos , Pacientes Internados , Masculino , Pessoa de Meia-Idade , Agonistas Nicotínicos/administração & dosagem , Pacientes Ambulatoriais , Fumar/epidemiologia , Fumar/psicologia , Tabaco/efeitos adversos , Fumar Tabaco/epidemiologia , Fumar Tabaco/psicologia , Resultado do Tratamento
16.
Diabetes Metab Res Rev ; 36 Suppl 1: e3279, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32176439

RESUMO

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.


Assuntos
Diabetes Mellitus/fisiopatologia , Pé Diabético/terapia , Procedimentos Endovasculares/métodos , Pé/irrigação sanguínea , Pé/cirurgia , Doença Arterial Periférica/complicações , Pé Diabético/etiologia , Humanos
17.
Diabetes Metab Res Rev ; 36 Suppl 1: e3278, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32176442

RESUMO

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 TcPO2  ≥ 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 TcPO2  < 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.


Assuntos
Amputação/métodos , Biomarcadores/análise , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/diagnóstico , Procedimentos Endovasculares/métodos , Cicatrização , Pé Diabético/etiologia , Pé Diabético/terapia , Humanos , Prognóstico , Terapias em Estudo
18.
Diabetes Metab Res Rev ; 36 Suppl 1: e3277, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32176448

RESUMO

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.


Assuntos
Diabetes Mellitus/fisiopatologia , Pé Diabético/complicações , Doença Arterial Periférica/diagnóstico , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Pé Diabético/epidemiologia , Humanos , Doença Arterial Periférica/etiologia , Prognóstico
19.
J Psychosom Res ; 131: 109963, 2020 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-32065970

RESUMO

OBJECTIVES: To document the prevalence and patient profiles of mental health concerns in patients with peripheral artery disease (PAD) seen in the vascular specialty setting. METHODS: In a cohort of 1275 patients presenting to 16 specialty clinics with new or worsening claudication, symptoms of depression, anxiety, and stress were quantified in 957 patients. The Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder scale-2 (GAD-2), and Perceived Stress Scale-4 (PSS-4) were assessed for mental health concerns at the initial PAD work-up and repeated 12 months later. PHQ-8 ≥ 10, GAD-2 ≥ 3 and PSS-4 ≥ 6 were considered significant for depression, anxiety and stress respectively. Patient characteristics were compared in groups divided by presence of 0, 1, 2 or all 3 mental health concerns. RESULTS: On the initial office visit, 336/957 (35%) of patients had high levels of at least one of the three mental health concerns. At both baseline and 12 months, high levels of perceived stress were most often reported (28.7% and 17.5% respectively), followed by symptoms of depression (14.1% and 8.9%) and then anxiety (8.3% and 5.7%). Patients with mental health concerns were more often female, younger, had more financial strain, less social support, and worse perceived health status. CONCLUSIONS: Mental health concerns, particularly stress, are highly prevalent in patients with PAD, especially upon first presenting with new or worsening symptoms. The role of stress and how it may impede successful PAD management and impact subsequent outcomes warrants further investigation.

20.
Diabetes Metab Res Rev ; 36 Suppl 1: e3276, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31958217

RESUMO

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.


Assuntos
Diabetes Mellitus/fisiopatologia , Pé Diabético/complicações , Medicina Baseada em Evidências , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/terapia , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Pé Diabético/epidemiologia , Gerenciamento Clínico , Humanos , Doença Arterial Periférica/etiologia , Prognóstico , Revisões Sistemáticas como Assunto
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