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Vascular OnlineFirst, published on January 13, 2014 as doi:10.1177/1708538113516315

Original Article

A disease-specific activity score for Thromboangiitis obliterans

Vascular 0(0) 1–5 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1708538113516315 vas.sagepub.com

Bahare Fazeli1 and Hassan Ravari2

Abstract Introduction: The aim of this study was to find a disease-specific activity score for Thromboangiitis obliterans (TAO). Methods: About 173 admission records from 125 patients with TAO over the period 2005–2011 were evaluated. The outcome of the patients was categorized as saved-limb or limb-loss. The risk of limb loss associated with each clinical sign or symptom and complete blood count (CBC) data were then assessed. This risk assessment value was multiplied by 100 to obtain the percentage risk, which was then considered to be the risk score. The receiver operating characteristic (ROC) curve was used for demonstrating cut-offs for each score. The reliability of the risk score was evaluated using a split-half reliability test. The divergent validity of the risk score was tested using the Pearson correlation coefficient between the total scores of the patients with and without limb loss. Results: The maximum possible clinical and CBC scores were 221 and 180, respectively, giving a maximum total score of 401. The cut-offs for clinical, laboratory and total score were 115, 75 and 213, respectively. Conclusion: Further cohort studies for evaluating the efficacy of different treatments for limb salvage of TAO patients based on these score are suggested.

Keywords Thromboangiitis obliterans, Buerger’s disease, disease activity, vasculitis

Introduction The activity of vasculitis is usually measured using the Birmingham vasculitis score (BVAS), which aims to improve treatment and management of the disease.1 Although some researchers consider Thromboangiitis obliterans (TAO) to be a medium and small-sized vasculitis, in most vasculitis classifications, TAO is not included.2 To calculate the BVAS, multiple organs must be assessed, while in TAO, involvement of the visceral vasculature is rare3; on the other hand, some symptoms that get very high scores in BVAS, such as paraesthesia, are common in TAO sufferers in early stages of the disease.2 Therefore, the BVAS does not seem to be suitable for assessment of TAO activity. The aim of this study was to find a disease-specific activity score that can be used in treatment and management of TAO.

Methods To evaluate the activity of TAO, we first collated 320 admission records belonging to 253 patients with TAO (some patients had several admissions). From these 320 documents, 173 records were selected belonging to 125 patients who were admitted to Emamreza hospital

between 2005 and 2011. Documents that had missing information or belonged to patients who had lost both their limbs, along with those of patients with suspicious diagnoses of TAO, were excluded from the study. Documents from patients over the age of 50 were also excluded, due to the possibility that their current problem may be linked to Atherosclerosis Obliterans, not to TAO. Shionoya and Olin criteria3,4 were used for the diagnosis of patients included in the study. The data gathered from the documents were divided into clinical and complete blood count (CBC) data. Clinical signs and symptoms were categorized as cutaneous, vascular and nervous system symptoms based on BVAS (Table 1). The outcome for the patients was also categorized as saved-limb or limb loss (below knee amputation). The risk of limb loss associated with each sign or symptom was 1 Inflammation and Inflammatory Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran 2 Vascular & Endovascular Research Center, Emamreza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Corresponding author: Hassan Ravari, Vascular & Endovascular Research Center, Vascular Surgery Department, Emamreza Hospital, Emamreza Sqr, Mashhad, Iran. Email: [email protected]

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then assessed by dividing the number of patients with that particular sign or symptom whose outcome was limb loss by the total number patients who showed that sign or symptom. This risk assessment value was multiplied by 100 to obtain the risk percentage for each sign, which was then used as that sign’s individual score. Additionally, counts of white blood cells (WBC), red blood cells (RBC) and platelets (Plt) were evaluated in all patients for any possible difference between limb loss and saved-limb groups. Statistical Package for the Social Sciences (SPSS) version 16.0 was used for statistical analysis. The descriptive data are presented as mean  standard deviation (mean  SD). Normality of the data was assessed

using the Kolmogorov–Smirnov test. Independent samples t-tests were used to test for any differences in clinical, laboratory and total scores between saved-limb and limb loss groups. Split-half reliability tests were used for evaluating the reliability of the clinical, CBC and total scores. The Spearman–Brown equal length (SBeq) cut-off value was considered to be 0.5. The divergent validity of the risk score was evaluated using the Pearson correlation coefficient between the total scores of the patients with and without limb loss, with no correlation confirming divergent validity. The receiver operating characteristic (ROC) curve was used for determining the cut-off point for clinical, laboratory and total score of the patients with and without limb loss. P-values of less than 0.05 were considered significant, with a confidence interval of 95%.

Results Table 1. The prevalence of the clinical signs and symptoms of 125 patients suffering from TAO. Prevalence in total TAO patients (%)

Signs and symptoms Cutaneous

Vascular

Neural

Gangrene Multiple digit gangrene Ulcer Multiple digit ulcer Buerger’s coloura Claudicationb Rest painc Absent pulse Diminished pulse More than one limb pulse involvement Popliteal pulse involvement Thrombophlebitis migransd Upper limb involvement Paresthesia Circadian rhythmic burning pain Alodynia

78 33 80 36 98 89 65 78 75 72 48 66 52 86 94 93

a In two patients, the Buerger’s colour extended from the toes to the knees, and in one patient it extended up to ankle joint. b Among the patients who had claudication, 17% complained of burning pain instead of cramping after a distinct activity. c In two patients, although the gangrene was in one toe only, the burning pain was felt from the knee to the toes. In the rest of these patients, this burning pain was quite localized. d In two patients, the pain of thrombophlebitis migrans (TM) was burning in nature, and in one patient, as well as showing TM, the superficial veins were also tender along the lower limb. In addition, nine patients complained of migrant arthralgia in the ankle, carpometacarpal and tarsometatarsal joints, which had lasted about a month before the onset of the gangrene.

Of the 125 patients, only one was female. Twenty-two patients (17.6%) underwent below the knee amputation. The mean ages of the patients with and without limb loss were 45  1 and 40  2, respectively. The prevalence of clinical signs and symptoms are summarized in Table 1. Evaluation of the CBC was not included in the goals of the study at the outset. However, during the data analysis phase, we noted changes in the CBC of patients who underwent below knee amputation, including leucocytosis, anaemia or thrombocytosis. The CBC findings for these patients are summarized in Table 2. We also noticed that monocyte levels in 15% TAO patients were low (less than 4%). Notably, 39% of the patients had anaemia (haemoglobin (Hgb) 10,500) High polymorphonuclear cells (>75%) Low monocytes (

A disease-specific activity score for Thromboangiitis obliterans.

The aim of this study was to find a disease-specific activity score for Thromboangiitis obliterans (TAO)...
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