Abstract

Deep vein thrombosis (DVT) is a blood clot most commonly found in the leg, which can lead to fatal pulmonary embolism (PE). Compression ultrasound of the legs is the diagnostic gold standard, leading to a definitive diagnosis. However, many patients with possible symptoms are not found to have a DVT, resulting in long referral waiting times for patients and a large clinical burden for specialists. Thus, diagnosis at the point of care by non-specialists is desired. We collect images in a pre-clinical study and investigate a deep learning approach for the automatic interpretation of compression ultrasound images. Our method provides guidance for free-hand ultrasound and aids non-specialists in detecting DVT. We train a deep learning algorithm on ultrasound videos from 255 volunteers and evaluate on a sample size of 53 prospectively enrolled patients from an NHS DVT diagnostic clinic and 30 prospectively enrolled patients from a German DVT clinic. Algorithmic DVT diagnosis performance results in a sensitivity within a 95% CI range of (0.82, 0.94), specificity of (0.70, 0.82), a positive predictive value of (0.65, 0.89), and a negative predictive value of (0.99, 1.00) when compared to the clinical gold standard. To assess the potential benefits of this technology in healthcare we evaluate the entire clinical DVT decision algorithm and provide cost analysis when integrating our approach into diagnostic pathways for DVT. Our approach is estimated to generate a positive net monetary benefit at costs up to £72 to £175 per software-supported examination, assuming a willingness to pay of £20,000/QALY.

Highlights

  • Venous thromboembolism (VTE) is associated with a major global burden of disease

  • External Validation Set 1 (EVS1). 124 patients who presented to the Oxford Haemophilia and Thrombosis Centre, Oxford, UK, with symptoms suggestive of deep vein thrombosis (DVT) were approached for inclusion into this study

  • The recorded screen capture videos have been curated to a data set that is similar in nature to one as it would have been acquired with AutoDVT software guidance

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Summary

Introduction

Venous thromboembolism (VTE) is associated with a major global burden of disease. The incidence of VTE is 1–3 per 1000 individuals, rising to 2–7 per 1000 in individuals aged over 70 years, and 3–12 per 1000 in those over 80 years[1]. VTE, deep vein thrombosis (DVT) and pulmonary embolus (PE) are the leading cause of hospital-related disability-adjusted life years lost[2]. Using these estimates, and using the most conservative incidence figure, globally at least 7.7 million people will require investigation for VTE every year. An ageing population across many countries will lead to a greater health burden, in middle- and low-income countries where early death from infection is decreasing. DVT has a high level of morbidity. 30–50% of the surviving patients develop long-term symptoms in their affected leg (post-thrombotic syndrome)[5]

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