1. A Real-Time Blood Flow Measurement Device for Patients with Peripheral Artery Disease
- Author
-
Mahmood K. Razavi, D. Preston Flanigan, Tyler B. Rice, and Sean M. White
- Subjects
Male ,medicine.medical_specialty ,Light ,Arterial disease ,Critical Illness ,Diagnostic Techniques, Cardiovascular ,Pilot Projects ,Disease ,Severity of Illness Index ,030218 nuclear medicine & medical imaging ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Measurement device ,Ischemia ,Predictive Value of Tests ,Internal medicine ,medicine ,Humans ,Scattering, Radiation ,Ankle Brachial Index ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Prospective cohort study ,Aged ,Aged, 80 and over ,Receiver operating characteristic ,business.industry ,Area under the curve ,Reproducibility of Results ,Equipment Design ,Critical limb ischemia ,Blood flow ,Middle Aged ,body regions ,Cross-Sectional Studies ,Regional Blood Flow ,030220 oncology & carcinogenesis ,Cardiology ,Feasibility Studies ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Blood Flow Velocity - Abstract
Purpose To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD). Materials and Methods In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow–waveform score and compared vs ankle–brachial index (ABI), toe–brachial index (TBI), and clinical presentation of patients per Rutherford category (RC). Receiver operating characteristic curves were constructed to predict RC. Area under the curve (AUC), sensitivity, and specificity were compared among flow–waveform score, ABI, and TBI. Results Qualitatively, the FlowMet waveforms were analogous to Doppler velocity measurements, and degradation of waveform phasicity and amplitude were observed with increasing PAD severity. Quantitatively, the flow, waveform, and composite flow–waveform scores decreased significantly with decreasing TBI. In predicting RC ≥ 4, the flow–waveform score (AUC = 0.83) showed a linear decrease with worsening patient symptoms and power comparable to that of TBI (AUC = 0.82) and better than that of ABI (AUC = 0.71). Optimal sensitivity and specificity pairs were found to be 56%/83%, 72%/81%, and 89%/74% for ABI, TBI, and flow–waveform score, respectively. Conclusions The technology tested in this pilot study showed a high predictive value for diagnosis of critical limb ischemia. The device showed promise as a diagnostic tool capable of providing clinical feedback in real time.
- Published
- 2021