Frequently Asked Questions and

Answers on ENDOTECT™

(click on the links below to get answers)

• What is Endothelium and what is the Endothelial Function (EF) test?

  • The Endothelium is the inner layer of any artery or a vein in the body. In the artery, it releases many chemical and bio-chemical substances (according to the different needs) that help to control various physiological functions related to the cardiovascular and the circulatory systems. In addition to its many other functions, it protects the arteries from plaque and thrombus formation and as a result, provides protection from narrowing of the inner diameter of the artery and/or its occlusion. Maintaining and/or restoring normal endothelial function at all stages of the development of cardiovascular disease has been shown by research to result in a very low probability for a cardiovascular event, such as heart attack and stroke. This is evidenced by more than 110 studies including 10 from the highest quality journals in the field, such as Circulation. Endothelial function can be easily assessed by non-invasive devices like ultrasound and a few newer devices, including Cardiatec's device the Endotect, that were especially developed for this purpose.

• Is the significance of Endothelial Function based on sufficient studies?

  • It is based on thousands of studies  in many professional reviewed papers and the number increases every year. These studies were carried out in cardiac vessels as well as peripheral vessels such as the brachial artery in the arm.  The brachial artery is the peripheral artery most studied regarding this issue and is also the site for measurement by our device. These studies also cover a wide range of patient population and sub-group and cover all the different stages of cardiovascular disease (CVD).

• What is the difference between Endothelial Function measurement and other known tests like EKG (with and without stress), nuclear or other imagining device tests

  • Endothelial dysfunction is the earliest stage of the onset of the atherosclerotic process and can be detected before any structural change appears in the artery.  This stage cannot be detected by any other kind of imaging or any other existing devices not specifically designed for this purpose.  Endothelial Dysfunction (ED) is common to all CVD risk factors (known and unknown) and for this reason is now recognized as the common physiological pathway for all CVD risk factors.

• Is keeping the risk factors in normal range (such as blood pressure, glucose, fatty acids and cholesterols) not sufficient to treat cardiovascular disease?

  • Cardiovascular disease as often manifested by unexpected sudden heart attack and stroke makes it the number 1 killer in the developed countries. This fact indicates that there exists a large therapeutic and diagnostic gap between what is needed in the diagnostic area and the real results of all of the current preventative and curative treatments.  Reduction of the incidence of CVD includes firstly prevention (people that still do not have cardiovascular disease), and secondly protection (patient with known CVD risk or who have already suffered a CV event).  The reason for most of the CV event occurrences seems to be associated with the lack of efficient criterion to monitor the "real" efficacy of prescribed drugs and other treatments on the reduction of CVD risk.  It should be noted that about 40% of cardiac events are associated with sudden cardiac death.  This very sad fact emphasizes even more the crucial need to find an efficient means of helping to reduce to a minimum such events.  Incorporation of appropriate monitoring of the treatment is an ideal means to help to cope with this problem. It should also be noted that the same solution is relevant also for stroke occurrence.

• Is it really possible to close this gap?

  • Monitoring the status of a patient’s Endothelial function can help not only to know if Endothelial function is normal, (indicating very low risk for for a CV event), but also to monitor the efficacy of drugs and other treatments (e.g. change of life style, supplements, exercise) and all other known factors that improve Endothelial function.  The ability, through our device, to monitor EF status will substantially assist the patient and physician to keep the cardiovascular system in a healthy condition.  Maintaining the endothelium in normal range, or restoring its functioning, is considered the best criterion for assessing the efficacy of most preventing cardiovascular treatment,  since it is a universal test and is relevant for all CVD risk factors.  In addition EF status now can be easily, quickly and non-invasively monitored.

• Are there more explanations and data to support this concept?

  • The following examples illustrate the concept:

  • There are patients who, for example, have a cholesterol level of 250, and yet have normal EF. Current opinion is that such a patient has a very low CVD risk and that cholesterol need not be treated.   On the other hand, patients who have cholesterol level of 180, but suffers from ED, should be treated with statins (drugs used to reduce bad cholesterol level) in order to restore the EF.

  • There are risk factors such as mental stress (depression, anxiety, hostility and others) and genetics that cause CVD but cannot not be directly measured (they do not have bio-markers except ED). The persistence of these factors and non treatment of endothelial dysfunction can result in early patient death, even when all the other common CVD risk factors are still in the normal range.
  • The effect of body infections and smoking cannot be directly measured, but the resulting endothelial dysfunction can now be detected.  The presence of multiple CVD risk factors that are only modestly increased above normal range (like in metabolic syndrome) can highly increase the risk of a CV event.  Current treatment protocols that focus on the level of each risk actor individually would not require that risk factor to be treated.  However when the deterioration of the endothelial function is taken into account, this would justify treatment of the risk factors and treatment to restore of the EF.  Monitoring of the progress of restoring endothelial function will help in finding the most effective drug for that patient to be used for each risk factor (hypertension, cholesterol, diabetes and others) and how aggressively treatment should be pursued.   It should also be noted that there are treatments unrelated to CVD risk factors that can restore the endothelial function, for example, in smokers.

• Is restoration of endothelial function always possible?

  • Yes, endothelial functioning can be retorted to normal and be maintained.  Restoration of endothelial function is possible during all stages of CVD including even heart failure for which there are special drugs and devices that improves endothelial function. Maintaining normal endothelial function also means minimizing the probability for re-occlusion (restenosis) after coronary bypass surgery and balloon angioplasty (stent). It also minimizes the possibility for CV event in CVD patients undergoing surgery not related to CV disease. The most importantly, it minimizes the probability for sudden cardiac death occurrence. It should also be noted that normal endothelial function also minimizes stroke events and appearance of dementia and Alzheimer in the elderly.

• Why is our device needed if there are already other devices for EF non-invasive measurement?

  • Other devices are costly, time consuming, some subject to significant operator and reading errors, others with results that are very sensitive to uncontrolled ambient factors.  These devices measure only one physiological parameter related to EF. Our device is accurate, reliable, fast, simple to use, and inexpensive.  It is uniquely based on measuring two parameters that act concomitantly which increases accuracy.  It measures endothelial function in large arteries whose size is similar to the coronary arteries.  This makes the Endotect relevant to a much larger target population than competing devices.  Ultrasound measurement, currently a de-facto gold standard, is not accepted for use in routine in-clinic patient tests because of it cost, high variability, and susceptibility to operator errors. Other devices monitors endothelial functioning in small peripheral arteries – where there are many uncontrollable factors that reduce accuracy and cause a large rate of false negatives.

• What are the recommended conditions under which a non-invasive endothelial function test is carried out (including the Cardiatec device)?

  • The test is carried out following 8 hours fasting (water permitted) usually at rest in supine position and at room temperature under quiet conditions. The test is similar to blood pressure measurement but lasts for longer time (10-15 min).  It can be repeated following a 30 minute of rest.

• Can use of supplements and other substances not included in conventional routine therapy improve endothelial function?

  • Based on large number of studies, there are many substances that can improve endothelial function but generally are not encouraged by the medical community.  A good example is Omega 3 that improves endothelial function and recently after long trials was declared by the American and European Heart Associations as a cardiovascular life-saving drug. Other examples of supplements that have been shown to have a positive effect on restoring and maintaining endothelial functioning include:

  • Falvonoid compounds that have high antioxidant properties and also improve endothelial function.  Some known examples are, dark chocolate, red wine, green and red and black tea and purple grape juice.
  • CoQ10 for the general population and Vitamin C for smokers (both strong anti-oxidants).  
  • Niacin elevates the good cholesterol (HDL) level.  About 4 companies are now carrying out studies tto develop drugs that will improve its efficacy.  
  • L-arginine
  • Magnesium

• Is measurement of the Endothelial Function accepted by the medical community?

  • The need for a cost-effective, reliable, simple, EF measurement device is already accepted by many of the leading cardiologists.  Some of them have already defined the desired technical properties of such device.  Our device meets these criteria: safe, noninvasive, reproducible results, repeatable, low-cost and standardization between users and sites.  

• Is the device cost effective?

  • The huge cost of medical care to the payers and to the economy at large of of cardiovascular disease indicate that any device which can be shown to reduce CVD risk, and cost-effectiveness, will become not only reimbursable, but its routine use will also be mandated. Cost-effective (and preferably low cost) CVD prevention is recognized by the medical community and HMOs as the most effective way to reduce CVD events and their costly after-effects. Detecting and monitoring endothelial function is an excellent method to meet this goal.

 

 

 

 

 

 

 

 

 

 

Falvonoid compounds includes a large group of water-soluble plant pigments that are beneficial to health.  Flavonoids are polyphenols and have antioxidant, anti-inflammatory, and antiviral properties.  They also help to maintain the health of small blood vessels and connective tissue, and some are under study as possible treatments of cancer.  Also called bioflavonoids.