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Vascular dysfunction is related to Endothelial Dysfunction which is associated with arterial stiffness, microcirculation disorders, and Peripheral Artery Disease (PAD).
Endothelial dysfunction is characterized by a reduction of the bioavailability of Nitric Oxide (NO), which upsets the balance between vasoconstriction and vasodilation, and initiates a number of processes that promote hypertension.
In addition, endothelial damage includes increased endothelial permeability, platelet aggregation, pro-inflammatory and pro-coagulatory states, and monocytes migration from the blood into the subendothelial intima and transformation into macrophages, which accumulate lipids to form the lipid core of atherosclerotic plaque and increase arterial stiffness.
Endothelial dysfunction can be caused by several conditions, including diabetes or metabolic syndrome, hypertension, smoking, and physical inactivity
The assessments of the autonomic nervous system, endothelial function, and Ankle-Brachial Index (ABI) are well-recognized tests to detect early complications in diabetic patients – diabetic neuropathy risk, cardiovascular risk, and peripheral artery disease. These assessments are recommended by the U.S. and International Medical Associations. Unfortunately, most of these assessments or exams are not routinely performed in daily clinical practice because of concerns about complex procedures, time consumption, and a high level of difficulty in reading and/or interpreting exam reports.
Our ANS testing medical device platform eliminates these concerns by offering an innovative medical device that provides physicians with new and easy to use tools that simplify complex procedures, significantly reduces the time required by technicians to perform the exams, and offers easy to read and interpret exam reports with clinical guidance support which is backed by studies and peer reviews. Lastly, our most recent innovation includes wireless transmission to increase patient and technician comfort.
Conventional medical exams blood lab tests, Doppler, EKG, blood pressure measurements, etc.) are commonly used to diagnose diseases, but these exam markers can be too narrowly used today in treatment management – e.g., Diabetes and high blood pressure. It is well understood that diabetes is a state marked by increased blood glucose levels, and the treatment is narrowly focused on reducing the blood lab test/s marker/s. The same narrow focus is true with Hypertension. High blood pressure treatment is focused on increasing blood flow. However, it’s not enough to focus on treatment that only reduces the disease diagnostic marker. Why? Because diabetes, high blood pressure, or vascular disease are complex chronic diseases that negatively affect homeostasis by damaging the body’s regulatory functions.
Homeostasis refers to stability, balance, or equilibrium within a cell or the body. It is an organism’s ability to keep a constant internal environment. Homeostasis is an important characteristic of living things. Keeping a stable internal environment requires constant adjustments as conditions change inside and outside the cell. The adjusting of systems within a cell is called homeostatic regulation. Because the internal and external environments of a cell are constantly changing, adjustments must be made continuously to stay at or near the setpoint (the normal level or range). Homeostasis can be thought of as a dynamic equilibrium rather than a constant, unchanging state.
When the autonomic nervous system (ANS) and endothelial functions are properly working, the patient is in good health and has a high potential for recovery.
When one of the regulation’s functions fails or is stressed beyond its genetic potential for different reasons - inadequate lifestyle, aging, weak genetics, then disease may occur.
Lab tests show the damage of the regulation functions when the disease is already onset. By assessing the regulation functions, we could have early detection of a future potential disease when the treatment options can delay or reverse a condition or disease.
The conventional exams cannot detect Cardiac Autonomic Neuropathy (CAN) or endothelial dysfunction symptoms, and patients suffering from these symptoms cannot be treated effectively.
When a disease is diagnosed, the treatment management should not only control the disease diagnosis marker but also restore or maintain the regulations’ functions: Autonomic nervous system and endothelial functions.
Therefore, the ANS and endothelial function must be assessed as part of any patient health assessment or treatment follow up along with the conventional exams.
Problems with the ANS can range from mild to life-threatening. Sometimes, only one part of the nervous system is affected. In other cases, the entire ANS is affected. Some conditions are temporary and can be reversed, while others are chronic and will continue to worsen over time. Diseases such as Diabetes or Parkinson’s Disease can cause irregularities with ANS. Problems with ANS regulation often involve organ failure, or the failure of the nerves to transmit a necessary signal.
Sudomotor dysfunction testing may indicate to physicians a patient's peripheral nerve and cardiac sympathetic dysfunction. Neuropathy is a common complication in diabetes mellitus (DM), with 60%-70% of patients affected over their lifetime. Symptoms of neuropathy are more common than clinical neuropathy. Neuropathy may remain undetected, and progress over time leading to serious complications. The most common associated clinical condition is peripheral neuropathy, affecting the feet. Autonomic nerve involvement is common but probably the most undiagnosed. Low scores in the sudomotor may lead a medical provider to look at clinical neuropathy.
Current evidence suggests that endothelial function is an integrative marker of the net effects of damage from traditional and emerging risk factors on the arterial wall and its intrinsic capacity for repair. Endothelial dysfunction, detected as the presence of reduced vasodilating response to endothelial stimuli, has been observed to be associated with major cardiovascular risk factors, such as aging, hyperhomocysteinemia, post-menopause state, smoking, diabetes, hypercholesterolemia, and hypertension.
Insulin resistance is defined clinically as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization in an individual as much as it does in a normal population. Insulin resistance occurs as part of a cluster of cardiovascular metabolic abnormalities commonly referred to as "The Insulin Resistance Syndrome" or "The Metabolic Syndrome". This cluster of abnormalities may lead to the development of Type-2 diabetes, accelerated atherosclerosis, hypertension, or polycystic ovarian syndrome depending on the genetic background of the individual developing insulin resistance.
The specific factors that can cause this increased risk include obesity (particularly central), hyperglycemia, hypertension, insulin resistance, and dyslipoproteinemia. When patients have one or more risk factors and are physically inactive or smoke, the cardiometabolic risk is increased even more. Medical conditions that often share the above characteristics, such as type 2 diabetes, can also increase cardiometabolic risk. The primary focus of cardiometabolic risk treatment is the man agement of each high-risk factor, including dyslipoproteinemia, hypertension, and diabetes. The management of these subjects is based principally on lifestyle measures, but various antihypertensive, lipid-lowering, insulin-sensitizing, anti-obesity, and antiplatelet drugs could be helpful in reducing cardiometabolic risk.
A small fiber neuropathy occurs when damage to the peripheral nerves predominantly or entirely affects the small myelinated fibers or unmyelinated C fibers. The specific fiber types involved in this process include both small somatic and autonomic fibers. The sensory functions of these fibers include thermal perception and nociception. These fibers are involved in many autonomic and enteric functions.
High blood glucose levels over a Additional of years may cause a condition called autonomic neuropathy. This is damage to the nerves that control the regulation of involuntary function. When the nerve damage affects the heart, it is called cardiac autonomic neuropathy (CAN). CAN encompasses damage to the autonomic nerve fibers that innervate the heart and blood vessels, resulting in abnormalities in heart rate control, vascular dynamics, and the body's ability to adjust blood pressure. CAN is a significant cause of morbidity and mortality associated with a high risk of cardiac arrhythmias and sudden death.
The PTG CVD risk factor is the combined total of the other seven risk factors assessments. It takes into consideration the cardiovascular as well as the autonomic nervous system (ANS) measurements.
Identify the cause of symptoms: By assessing the Autonomic nerves and endothelial regulation, the TM-Flow medical device identifies the cause of symptoms, such as chronic pain, Headaches, tingling, or burning on the feet, claudication, and lower extremity pain after exercise. Frequently, physicians encounter patients who have a chronic disease or other comorbid conditions and symptoms. At times, differentiating vascular from neuropathic disorders can be difficult. It is imperative to distinguish between autonomic neuropathy and vascular disease because the treatments are quite different.
Target Hb1Ac: Since Cardiac Autonomic Neuropathy is recognized as a hypoglycemia risk factor, the results presented through our Cardiac autonomic assessment can be used as a marker to Target HbA1c.
Early detection of diabetes complications and Cardiovascular disease to manage diabetic treatments.
Early detection of atherosclerosis using the endothelial assessment.
Hypertension treatment management using the estimated Central Aortic systolic pressure.
Identify the main homeostatic regulations:The TM-Flow medical device should identify the patient potential to maintain a healthy condition or recovery potential; the cause of symptoms not found by using conventional diagnostic methods - including dizziness, fatigue, gastrointestinal disorders, exercise intolerance, heat intolerance, genitourinary disorders, hypoglycemia unawareness, and early detection of cardiometabolic risk and its complications.
With our comprehensive and instructional ANS test reports, you will have access to credible testing criteria (based on validated medical markers). These criteria establish the medical necessity for over 21 validated additional tests for continued and accurate patient diagnosis!
|PTGTP, PTGVLFI, IR||ICD -10||ABI &/or Doppler||Additional|
|PTGTP, PTGVLFI, IR||R73.9 or E11.9||NA||Testing to Determine Insuilan Resistance and Glucose Tolerance Testing and/or A1C|
|PTGTP, PTGVLFI, IR (if any 2 are elevated)||R73.03||NA||Testing to Determine Insuilan Resistance and Glucose Tolerance Testing and/or A1C|
|ESRNO, ESR L and/or PEAK C||G60.3 or .8, .9 or G62.9 or G90.09||NA||Small Fiber Neuropathy Testing and If Peak C is elevated Nerve Conduction Studies or Potentially CT W/Contrast and/or Ultrasound|
|Column 2 and ESRNO and/or ESR L||E11.42 or G60.3||NA||Small Fiber Neuropathy Testing|
|Column 2 combined with PEAK C||E11.49||NA||Testing to Determine Insuilan Resistance and Glucose Tolerance Testing and/or A1C + Nerve Conduction Studies|
|PEAK C||NA||NA||If Nerve Damage Nerve Conduction Studies. In Rare Cases where Hypohidrosis or Hyperhidrosis are Identified Then Thermoregulatory Sweat Tests and/or Lab Tests|
|Column 1 Plus PTG Type||E11.59||ABI & Doppler||Testing to Determine Insuilan Resistance and Glucose Tolerance Testing and/or A1C Plus Noninvasive Vasculare Studies and Possibly CT, CT W/Contrast, Ultrasound or MRI|
|PTG CVD||I25.10 or IF With Angina Pectors I25.119||ABI & Doppler||Noninvasive Vascular Studies and Possibly CT, CT W/Contrast, Ultrasound or MRI|
|RMSSD and/or pNN50||R00.0||ABI & Dopler, Stress |
Test Advanced ECG
|Additonal Stress Testing, Advance ECG|
|Pre-Diabetes||R73.9||NA||A1C 5.7%–6.4%, Fasting plasma glucose 100–125 mg/dL (impaired fasting glucose), 2-hour post 75 g oral glucose challenge 140–199 mg/dL (impaired glucose tolerance)|
|Diabetes||E11.9||NA||A1C 5.7%–6.4%, Fasting plasma glucose 100–125 mg/dL (impaired fasting glucose), 2-hour post 75 g oral glucose challenge 140–199 mg/dL (impaired glucose tolerance)|
|Small Fiber Neuropathy||NA||NA||NCS , EMG to rule out large fiber peripheral neuropathies, which can cause similar symptoms|
|Perpheral & Distal Perpheral Neuropathy||G60.3, G60.8, G60.9, G90.09||NA||NCS, CT, MRI, Ultrasound|
|Nerve Damage||NA||NA||NCS, EMG|
|Peripheral Artery Disease (PAD or PVD)||I73.89, I73.9||NA||Ultrasound, Angiography, Blood Tests|
|Atherosclerotic heart disease of native coronary artery with unstable angina pectoris||I25.10 or IF With Angina Pectors I25.119||ABI & Doppler||Angiography, Stess Test, CT, Ultrasound|
|Abnormal Rate Variabilty||R00.0||ABI & Doppler||ECG, Photoplethysmography|
|Heart Electrical Stability||R00.0||ABI & Doppler||Advanced ECG, Electrophysiology (EP) Study|
|Heart Rhythm Stability||R00.0||ABI & Doppler||Holter Monitor, Transtelephonic Monitor, Treadmill Testing, Tilt-table Test, Electrophysiologic testing (EP study), Esophageal Electrophysiologic Procedure|
|Atherosclerosis||70.209||ABI & Doppler||Angiogram (Arteriogram), Cholesterol Tests, Chest X-ray, CT ,ECG or EKG), Exercise Stress Test|
|Complex Regional Pain Syndrome 1||G90.50, G.511, G90.512, G90.113, G90.521, G90.522, G90.523, G90.59||NA||Bone Scan, Sweat Production Tests, X-Ray, MRI|