Early detection of
Peripheral Arterial Disease
Next generation non-invasive patient diagnostics within minutes.
The VitalScan Vascular+ is an innovative system combining cuff-based technology and pulse wave velocity for performing the ankle-brachial index (ABI) and TBI exam. The assessment assists in the diagnosis of peripheral arterial disease (PAD).
The VitalScan Vascular+ provides new technologies better to serve the needs of health care providers and patients.
This new technology significantly improves ankle and pressure determination and PAD assessment over traditional forms of oscillometer ankle pressure estimation.
The VitalScan Vascular+ has 4 blood pressure cuffs with options up to 8 cuffs with pulse volume recording (PVR) technology.
The system also includes one PPG Sp02 finger and two toe pressure sensors for an accurate TBI assessment.
An initial assessment is the most vital step in managing a patient's health.
The information collected during the VitalScan Vascular+ uses the arm and ankle cuffs, plus the finger and toe PPG sensors to disseminate into a wide range of measurements.
This data is then extrapolated into many indexes and further classifications, which include the following:
- Ankle/Brachial Index (ABI)
- Arterial Stiffness Index (ASI)
- Toe/Brachial Index (TBI)
- Ejection Elasticity Index (EEI)
- Dicrotic Elasticity Index (DEI)
- Dicrotic Dilation Index (DDI)
- Augmentation Index (AI)
Why Arterial Vascular Assessment Matters
Peripheral Artery Disease (PAD) is a dominant concern for physicians and is intrinsically linked to arterial health. PAD is the occlusion of arteries due to the buildup of fatty cholesterol deposits called plaque lining the interior of arteries. As plaque formation accumulates, the arteries narrow, stiffen, and decline functionality. Plaque reduces blood flow, usually to the legs, and, if left to worsen, can lead to tissue death or even amputation. Research estimates that eight to 12 million people are affected by PAD in both the U.S. and Europe. Like many other cardiovascular diseases, over three-quarters of the population that develops Peripheral Artery Disease (PAD) do not show symptoms. As a result, patients with PAD have an increased risk of stroke, heart attack, and ischemic attack. PAD patients are six times more likely to die from cardiovascular disease than healthy adults within ten years of being diagnosed.
VitalScan Vascular+ enables specialists to isolate issues, track problems and manage patient health using noninvasive oscillometer readings performed automatically and efficiently.
The information deduced from the VitalScan Vascular+ is invaluable for detecting risk factors and facilitating the identification of patients who may be at risk for cardiovascular events.
Studies have shown that the Arterial Stiffness Index (ASI) illustrates a strong correlation between the functioning and integrity of coronary arteries and atherosclerotic lesions. This connection is significant because atherosclerotic lesions are fatal but remain asymptomatic for decades. Over 60 million Americans carry these life-threatening issues; isolating high-risk individuals is most valuable.
The indices generated by the VitalScan Vascular+ provide essential patient insight into several existing and potential health risks. These cardiovascular issues include the following:
Diagnosis of Peripheral Artery Disease (PAD)
Peripheral Artery Disease (PAD) is a common manifestation of atherosclerotic vascular disease.
The arteries in the legs or arms become narrowed or blocked. PAD incidence increases with age and in the presence of known cardiovascular risk factors (e.g., smoking and diabetes). People with PAD are at an increased risk of heart attack, stroke, poor circulation, and leg pain.
VitalScan Vascular+ evaluates PAD using the Ankle Brachial Index (ABI). The ABI compares systolic blood pressure measured at the ankle with systolic blood pressure measured at the arm. A low ABI can be a strong PAD indicator and risk circulatory problems.
Arterial stiffness occurs as a consequence of biological aging and Arteriosclerosis. As a result, the arteries become thick and stiff, sometimes restricting blood flow to the organs and tissues.
Arterial stiffness is associated with an increased risk of cardiovascular events such as heart attack and stroke. However, depending on the cause, arterial stiffness may be treated and prevented. VitalScan Vascular+ evaluates Arterial Stiffness using Pulse Wave Velocity (PWV), Peripheral Augmentation index (AI), and Central Aortic Systolic Pressure (CASP).
The value of PVR waveforms measurement
VitalScan Vascular+ also records the arm and ankle pulse volume waveforms (PVR) which provide pictorial evidence to aid a clinician's diagnosis; this is of particular value in patients prone to arterial calcification, such as diabetics.
PVR analysis provides a second line of investigation that can highlight when this has occurred while also providing qualitative information about the arterial status of the limb.
The superior diagnostic capabilities of the VitalScan Vascular+ are highlighted in a recent clinical study: a patient's ABIs are found to be within the normal range. However, an inspection of the PVRs indicated moderate to severe PAD, suggesting that arterial calcification has caused artifactual elevation of the ABIs within the normal range. The patient was subsequently referred to a vascular surgeon; moderate to severe PAD was confirmed, and the patient, after that, underwent successful angioplasty.
PVR waveform applies pressure cuffs to the limb to detect the tiny fluctuations in limb volume that occur with each heartbeat. Since Doppler sensitivity may be diminished due to arterial calcification, PVR is usually the option for obtaining peripheral arterial waveforms from patients with noncompressible arteries, such as patients with diabetes and renal disease.
The arterial PPG probe is another modality used to detect small blood volume changes from the finger and toe. When used with a digit cuff, the PPG is quite useful for measuring the pressures of patients with noncompressible arteries. The TBI exam compares toe pressures to brachial pressures.
With the VitalScan Vascular+, the PPG probe can also obtain limb pressures for the supine ABI and segmental exams.
VitalScan Vascular+ also records Brachial-ankle pulse wave velocity (baPWV).
It is a method to estimate arterial stiffness, which reflects the stiffness of both the aorta and peripheral artery.
Pulse Wave Velocity (PWV) Analysis
VitalScan Vascular+ Pulse Wave Velocity (PWV) analysis is based on physiological phenomena, observable and measurable in the arterial elasticity and stiffness during blood circulation. During one heart systole, a specific blood volume is expelled. This propagates the arteries due to the reciprocal transformation between the kinetic energy of a segmented blood volume segment and the potential energy of a stretched segment of the resilient vascular wall. We can observe the changes in pressure, blood flow, velocity, and profile throughout the pulse wave. It can be used for the classification of artery elasticity.
The condition of the small and large arteries is key to the prevention and diagnosis of cardio-vascular-related illness. In particular, the stiffness and augmentation of the major arteries is a strong indication of potential health problems, including heart attacks, heart failure, sclerosis, and renal complications. PWV Analysis and arterial stiffness indexes (EEI, DDI, and DEI) suggest that clinicians begin appropriate treatment long before the symptoms or clinical signs appear.
Age and systolic pressure strongly correlate with PWV. However, the most critical factor contributing to the increase in PWV is age because of increased arterial stiffness caused by medial calcification and loss of elasticity. Therefore, pulse wave velocity measurement is proper in studying the effects of aging, vascular diseases, vaso-dilating, and vaso-constricting agents on arteries.
VitalScan Vascular+ Pulse Wave Velocity measurement is a convenient quantifying arterial stiffness and augmentation. PWV provides invaluable insight into cardiovascular health, management of disease progression, and monitoring the effects of medication, treatments, lifestyle, and dietary habits.
Peripheral Arterial Tone (PAT)
PAT (Peripheral Arterial Tone) technology measures arterial tone changes in peripheral arterial beds. This information collected gives specialists important insight into the autonomic nervous system and the cardiovascular system. PAT technology is a noninvasive measure currently used to detect heart disease, erectile dysfunction, and obstructive sleep apnea; however, it has also proven highly effective in detecting and monitoring other cardiovascular conditions.
PAT data imparts early-stage information; PAT technology is valuable in disease detection and follow-up, improving patient treatment and healthcare costs. In addition to detecting cardiovascular disease, the PAT system also presents the potential for improving the diagnosis and management of other medical conditions, including metabolic syndrome, diabetes, peripheral arterial disease, and many others.
Coronary Artery Respiratory Assessment (CRA)
Coronary artery disease (CAD) occurs when the blood vessels that transport blood to the heart are narrowed and hardened due to plaque buildup (atherosclerosis). This narrowing compromises the flow of nutrient-rich, oxygenated blood to vital organs, leading to stroke, heart attack, and death. Unfortunately, coronary artery disease is the leading cause of death among American adults. Therefore, detection and treatment are at the forefront of relevance.
The photoplethysmograph (PPG) waveform has profound prognostic value for coronary artery disease. In addition, studies show that fluctuations measured in photoplethysmograph (PPG) amplitude are directly related to coronary artery disease (CAD) and present robust risk predictions.
Photoplethysmograph (PPG) is measured using a non-invasive, radiation-free platform. This proprietary test system was developed by VitalScan Vascular+ and utilized a biosensor finger probe to collect data. The patient is asked to perform a series of controlled breathing exercises. The coronary respiratory response (CRR) is derived from spectral analysis of the PPG signal during instructed breathing.
The PPG signal is automatically extracted and captured for processing. Using algorithms and analyzing software, a reading is produced which offers a timely and accurate diagnosis of Significant Coronary Artery Disease (S-CAD).
Recent clinical studies undertaken by the following authors have shown that ABI is effective at measuring ABIs in many patient groups:
Lewis, Hawkins, Barree, Cawley and Dayananda (2011) have shown on 295 limbs (55% diabetic):
- Good agreement between ABI and Doppler measurements.
- ABI measurement takes significantly less time than Doppler.
- The need to rest the patient is eliminated by the simultaneous cuff inflation of ABI.
- ABI has the potential to be used as a screening tool for PAD in primary care settings.
- ABI improves the whole patient experience.
- Minimal training is required due to its ease of use.
- Excellent correlation and good agreement between ABI and Doppler measurements.
- The time taken to perform the automatic ABI tests was significantly quicker than with Doppler.
- PVR waveforms showed good agreement with Doppler waveforms.
- Using an ABI cut off of 0.8, Sensitivity=82%, Specificity=97%, Accuracy=94%.
- Automated ABI reduces operator error, allows a less highly skilled clinician to perform the test, and enables pressures at the arms and ankles to be measured simultaneously which would consequently reduce the test time as patients would not need to be rested.
- Automated ABI systems based on oscillometric technology poorly correlate with Doppler ABI especially in the presence of moderate to severe PAD.
- ABI has been clinically validated over a range of ABIs from 0.4-1.4 and produces a PVR waveform from both ankles which is particularly useful when the ABI is >1.3.
- ABI is ideal for use in general practice for screening and diagnosing PAD and can be easily used by a practice nurse or healthcare assistant.
- The introduction of ABI into a new clinical pathway can reduce inappropriate referrals and lead to the prioritization of clinical services.
- The ABI opens up a new chapter in the ABI testing relating to patients "at risk" of developing PAD.
- 8% had an ABI > 1.3 suggesting possible arterial calcification. Of these, 10% had PAD as indicated by analysis of PVRs.
- PVR waveforms can be easily utilized as an adjunct to ABI measurements to identify patients who may benefit from further vascular assessment and intervention.
- ABI had excellent correlation and agreement against Ultrasound Duplex Scans.
- Overall accuracy of ABI ABI was 88% compared to Duplex.
- Overall accuracy of ABI using PVR waveforms increased to 95% when compared to Duplex Scans.
- Range of ABIs measured with ABI were 0.29 - 1.57.
- Doppler ABI measurements are infrequently and often incorrectly used (42% out of compliance with current ABI guidance).
- Lack of time and inadequate training have been identified as factors associated with this find.
The VitalScan Vascular+ system is a Class II medical device that is US FDA 510(K) cleared.
VitalScan Vascular+ testing procedure is covered by the most major insurance providers, under CPT code 93922 and 93923.
VitalScan Vascular+ testing procedure is covered by the most major insurance providers, under CPT code 93922 and 93923.