ABSTRACT
Background: Lower extremity Peripheral artery disease (PAD) is caused by atherosclerosis, or Plaque buildup, that reduces the blood flow to the legs and feet. PAD affects approximately 230 million adults worldwide and is associated with an increased risk of coronary heart disease, stroke, and leg amputation. The first-line method for diagnosis of PAD is the Ankle Brachial Index (ABI), which is the ratio of ankle to brachial higher systolic pressure measured in ankles and arms. The Toe Brachial Index (TBI), which is the ratio of the toe systolic pressure to brachial higher systolic pressure measured in both arms, is considered to be an alternative to the ABI in screening for PAD. The ABI and TBI are measured on the right and left side, and the lower of these numbers is the patient’s overall ABI and TBI. Clinical studies and meta-analysis reviews have shown that the conventional ABI measurement, which uses a cuff, and handheld sphygmomanometer and continuous-wave Doppler tracings, provides an acceptable-to-high specificity level but low sensitivity when compared with vascular color Doppler ultrasound, and/or angiography methods. Another study has shown that the TBI measurement has greater sensitivity but lower specificity than the ABI when compared with vascular color Doppler ultrasound diagnostic based on waveforms. The aim of this clinical study was to evaluate the specificity and sensitivity of the VasoPad System comparing its results to the vascular color doppler ultrasound waveforms. Materials and Methods: The VasoPad System is an automated device using the pulse wave method to measure the arms and ankles dorsalis and tibial posterior artery blood pressures, the photoplethysmography second derivative (PTGSD) to estimate the toe systolic pressure, a patented photoplethysmography (PTG) index marker and volume plethysmography via cuffs during deflation. Vascular Color Doppler ultrasound can diagnose stenosis through the direct visualization of atherosclerosis or plaques and through waveform analysis. The vascular color Doppler ultrasound provides 3 waveform types. The type 1, triphasic waveform is normal blood flow and no atherosclerosis or plaque, the type 2, diphasic waveform is seen when there are atherosclerosis plaques, but normal blood flow, and the type 3, monophasic waveform reflects stenosis with diameter reduction > 50%. Results: The sum of the overall ABI and TBI VasoPad values, called Sum of Brachial Indices (SBI), gave a specificity of 88.89% and sensitivity of 100% for detecting vascular color Doppler ultrasound biphasic and monophasic waveforms versus triphasic waveforms with a cutoff ≤ 1.36 (P < 0.0001, area under the receiver operating characteristic(ROC) curve of 0.960). The average of the SBI to detect the Doppler waveform triphasic, biphasic and monophasic is respectively 1.57, 1.29 and 1.20. The toe PTG Index, returned a specificity of 83.3% and a sensitivity of 100% compared with vascular color Doppler ultrasound biphasic and monophasic waveforms versus triphasic waveforms with a cutoff ≤ 26 (P = 0.001 and AUC = 0.917). The average of the PTG index to detect the Doppler waveform triphasic, biphasic and monophasic is respectively 29, 21.5 and 20 Volt per second (V/s). Conclusion: The VasoPad was useful for detecting PAD, which is fully defined as having vessel stenosis > 50% (Doppler monophasic waveforms) but also early stage of atherosclerosis plaque of the lower extremities (Doppler biphasic waveforms). The VasoPad method provided a remarkable sensitivity of 100% and a specificity level similar to those of the conventional ABI test method compared with the vascular color Doppler ultrasound. In addition to being useful to screen and detect PAD, the VasoPad offers early detection of lower extremity atherosclerosis, with normal blood flow (Doppler biphasic waveforms), which could provide greater treatment options and thus reduce the overall number of lower extremity complications.