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
References
[1]
Meijer, W.T., et al. (1998) Peripheral Arterial Disease in the Elderly: The Rotterdam Study. Arteriosclerosis, Thrombosis, and Vascular Biology, 18, 185-192. https://doi.org/10.1161/01.ATV.18.2.185
[2]
Norman, P.E., Eikelboom, J.W. and Hankey, G.J. (2004) Peripheral Arterial Disease: Prognostic Significance and Prevention of Atherothrombotic Complications. Medical Journal of Australia, 181, 150-154. https://doi.org/10.5694/j.1326-5377.2004.tb06206.x
[3]
McDermott, M.M. (2015) Lower Extremity Manifestations of Peripheral Artery Disease: The Pathophysiologic and Functional Implications of Leg Ischemia. Circulation Research, 116, 1540-1550. https://doi.org/10.1161/CIRCRESAHA.114.303517
[4]
Hirsch, A.T., et al. (2001) Peripheral Arterial Disease Detection, Awareness, and Treatment in Primary Care. JAMA, 286, 1317-1324. https://doi.org/10.1001/jama.286.11.1317
[5]
Bonham, P.A. (2006) Get the Lead out: Noninvasive Assessment for Lower Extremity Arterial Disease Using Ankle Brachial Index and Toe Brachial Index Measurements. Journal of Wound, Ostomy and Continence Nursing, 33, 30-41. https://doi.org/10.1097/00152192-200601000-00004
[6]
Lijmer, J.G., Hunink, M.G., van den Dungen, J.J., Loonstra, J. and Smit, A.J. (1996) ROC Analysis of Noninvasive Tests for Peripheral Arterial Disease. Ultrasound in Medicine and Biology, 22, 391-398. https://doi.org/10.1016/0301-5629(96)00036-1
[7]
Høyer, C., Sandermann, J. and Petersen, L.J. (2013) Randomised Diagnostic Accuracy Study of a Fully Automated Portable Device for Diagnosing Peripheral Arterial Disease by Measuring the Toe-Brachial Index. European Journal of Vascular and Endovascular Surgery, 45, 57-64. https://doi.org/10.1016/j.ejvs.2012.09.022
[8]
Gerhard-Herman, M.D., et al. (2017) 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 135, e686-e725. https://doi.org/10.1161/CIR.0000000000000501
[9]
Norgren, L., et al. (2007) Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Journal of Vascular Surgery, 45, S5-S67. https://doi.org/10.1016/j.jvs.2006.12.037
[10]
Xu, D., et al. (2010) Sensitivity and Specificity of the Ankle-Brachial Index to Diagnose Peripheral Artery Disease: A Structured Review. Vascular Medicine, 15, 361-369. https://doi.org/10.1177/1358863X10378376
[11]
Aboyans, V., et al. (2012) Measurement and Interpretation of the Ankle-Brachial Index: A Scientific Statement from the American Heart Association. Circulation, 126, 2890-2909. https://doi.org/10.1161/CIR.0b013e318276fbcb
[12]
Niazi, K., Khan, T.H. and Easley, K.A. (2006) Diagnostic Utility of the Two Methods of Ankle Brachial Index in the Detection of Peripheral Arterial Disease of Lower Extremities. Catheterization and Cardiovascular Interventions, 68, 788-792. https://doi.org/10.1002/ccd.20906
[13]
Guo, X., et al. (2008) Sensitivity and Specificity of Ankle-Brachial Index for Detecting Angiographic Stenosis of Peripheral Arteries. Circulation Journal, 72, 605-610. https://doi.org/10.1253/circj.72.605
[14]
Tehan, P., et al. (2015) Sensitivity and Specificity of the Toe-Brachial Index for Detecting Peripheral Arterial Disease. Journal of Ultrasound in Medicine, 34, 1737-1743. https://doi.org/10.7863/ultra.15.14.09071
[15]
Fowkes, F.G., Housley, E., Macintyre, C.C., Prescott, R.J. and Ruckley, C.V. (1988) Variability of Ankle and Brachial Systolic Pressures in the Measurement of Atherosclerotic Peripheral Arterial Disease. Journal of Epidemiology & Community Health, 42, 128-133. https://doi.org/10.1136/jech.42.2.128
[16]
Sensier, Y., Bell, P.R.F. and London, N.J.M. (1998) The Ability of Qualitative Assessment of the Common Femoral Doppler Waveform to Screen for Significant Aortoiliac Disease. European Journal of Vascular and Endovascular Surgery, 15, 357-364. https://doi.org/10.1016/S1078-5884(98)80041-5
[17]
Hussain, S.T. (1997) Blood Flow Measurements in Lower Limb Arteries Using Duplex Ultrasound. Annals of the Royal College of Surgeons of England, 79, 323-330.
[18]
Alberto, A.P., Butlin, M. and Walsh, A. (2010) Arterial Blood Pressure Measurement and Pulse Wave Analysis—Their Role in Enhancing Cardiovascular Assessment. Physiological Measurement, 31, R1-R47. https://doi.org/10.1088/0967-3334/31/1/R01
[19]
Shabani Varaki, E., Gargiulo, G.D., Penkala, S. and Breen, P.P. (2018) Peripheral Vascular Disease Assessment in the Lower Limb: A Review of Current and Emerging Non-Invasive Diagnostic Methods. BioMedical Engineering OnLine, 17, Article No. 61. https://doi.org/10.1186/s12938-018-0494-4
[20]
Gandhi, P., Rao, G. and Maarek, A. (2014) The Spectral Analysis of Photoplethysmography to Evaluate an Independent Cardiovascular Risk Factor. International Journal of General Medicine, 7, 539-547. https://doi.org/10.2147/IJGM.S70892
[21]
Fujita, D., Suzuki, A. and Ryu, K. (2019) PPG-Based Systolic Blood Pressure Estimation Method Using PLS and Level-Crossing Feature. Applied Sciences, 9, Article No. 304. https://doi.org/10.3390/app9020304
[22]
Spronk, S., den Hoed, P.T., de Jonge, L.C., van Dijk, L.C. and Pattynama, P.M. (2005) Value of the Duplex Waveform at the Common Femoral Artery for Diagnosing Obstructive Aortoiliac Disease. Journal of Vascular Surgery, 42, 236-242. https://doi.org/10.1016/j.jvs.2005.04.048
[23]
Kotval, P.S. (1989) Doppler Waveform Parvus and Tardus. A Sign of Proximal Flow Obstruction. Journal of Ultrasound in Medicine, 8, 435-440. https://doi.org/10.7863/jum.1989.8.8.435
[24]
Hwang, J.Y. (2017) Doppler Ultrasonography of the Lower Extremity Arteries: Anatomy and Scanning Guidelines. Ultrasonography, 36, 111-119. https://doi.org/10.14366/usg.16054
[25]
Norgren, L., et al. (2007) Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). European Journal of Vascular and Endovascular Surgery, 33, S1-S75. https://doi.org/10.1016/j.ejvs.2006.09.024
[26]
Mukherjee, D. and Eagle, K. (2010) The Importance of Early Diagnosis and Treatment in Peripheral Arterial Disease: Insights from the PARTNERS and REACH Registries. Current Vascular Pharmacology, 8, 293-300. https://doi.org/10.2174/157016110791112304
[27]
Suominen, V., Uurto, I., Saarinen, J., Venermo, M. and Salenius, J. (2010) PAD as a Risk Factor for Mortality among Patients with Elevated ABI—A Clinical Study. European Journal of Vascular and Endovascular Surgery, 39, 316-322. https://doi.org/10.1016/j.ejvs.2009.12.003
Bird, C.E., et al. (1999) Quantitative and Qualitative Progression of Peripheral Arterial Disease by Non-Invasive Testing. Vascular Medicine, 4, 15-21. https://doi.org/10.1177/1358836X9900400103
[30]
Lewis, J.E., et al. (2014) A Cross-Sectional Assessment to Detect Type 2 Diabetes with Endothelial and Autonomic Nervous System Markers Using a Novel System. Journal of Diabetes & Metabolic Disorders, 13, Article No. 118. https://doi.org/10.1186/s40200-014-0118-x
[31]
Maarek, A., Gandhi, P.G. and Rao, G.H.R. (2015) Identifying Autonomic Neuropathy and Endothelial Dysfunction in Type II Diabetic Patients. EC Neurology, 2, 63-78.
