Bedside Toe Pressures Measurements in a Department of Vascular Surgery: A Study of Diagnostic Accuracy

Abstract

Objective: In patients with peripheral arterial disease (PAD), measurements of distal blood pressure form the basis of assessing the severity of the disease along with symptoms and objective findings. The reliability and accuracy of a fully automated bedside device (SysToe) vs. strain gauge plethysmography (SGP) in patients with low toe pressures in a bedside setting in an outpatient clinic of vascular surgery were investigated.

Methods: This was a prospective, single blinded study carried out in compliance with the Standards of Reporting of Diagnostic Accuracy Studies. A total of 94 outpatients with symptomatic PAD in an outpatient vascular surgery clinic were included and had index measurements performed with the automated bedside device in a bedside setting by observers with no training in routine distal pressure measurements. SGP reference measurements were performed in a vascular laboratory.

Results: There was agreement between modalities regarding the diagnostic classification of chronic limb threatening ischaemia (CLTI) in 79/94 (84%) patients. For detection of CLTI, Cohen's kappa was 0.57 with a sensitivity of 94%, specificity of 82%, positive predictive value (PPV) 52%, and negative predictive value (NPV) 98%. On average, the automated bedside device underestimated the pressures, compared with the SGP. The mean difference between SGP and SysToe was 9 ± 16 mmHg for right limbs and 10 ± 16 mmHg for left limbs (p < .001).

Conclusion: The automated bedside device showed a high sensitivity and a high NPV for excluding CLTI. However, the low PPV may result in overdiagnosis. The automated bedside device may function as a screening tool identifying patients in need of further diagnostics with more accurate equipment, for example SGP.

Keywords: Bedside testing; Diagnostic test; Peripheral arterial disease; Toe brachial index.