Part 1 of this 4 part series appeared in FloridaMD October 2016 issue.
F. Soterogram Score…
The designer of the Soterogram realized that providing two diagnostic parameters would be complicated for physicians performing interpretation. For that reason, the Calf and Thigh Max Vm50 values were combined into a single score, referred to as the Soterogram Score. From extensive clinical studies with the Soterogram, weighting of the parameters was established which allowed combining. The Soterogram Score is given in ml. Soterogram Score is directly correlated with Local Systemic Arterial Compliance and within the theory of the Soterogram, correlates with generalized atherosclerosis. As will be described, the Soterogram Score is compared to a Predicted Soterogram Score. Interpretation will be further discussed below.
G. Predicted Soterogram Score:
In order to have a “standard” to compare the Soterogram Score taken in specific patients at specific points in time, a Predicted Soterogram Score was established. This was accomplished secondary to requirements of the FDA to obtain clearance for this technology. Over an extensive period of time and in four major United States Clinical Centers (Columbia University, Bowman Gray School of Medicine – Wake Forest University, Emory Medical School, and the University of Miami) and two European Clinical Centers (University of Leiden and University of Groningen), thousands of normal subjects were evaluated between the ages of 20 and 80 years of age. These subjects, to the degree possible, were free of cardiovascular risk factors, symptomatology, and pharmacy.
This means that Soteria Medical, LLC was able to create a Predicted (i.e. Normal or Standard) Soterogram Score which is simply Gender and Age based. This non-diseased group may be compared to the target patient’s Soterogram Score. The DEGREE to which the patient’s Soterogram Score differs from the Predicted Soterogram Score determines the patient’s level of arterial elasticity, physiologic atherosclerotic burden, and cardiovascular risk. The developer of the Soterogram believes the Predicted Soterogram Score is a rigorous standard. However, if the patient’s Soterogram Score is reduced by more than -35% of the Predicted Soterogram Score, moderate (not mild) generalized atherosclerosis is clearly suggested. If the patient’s Soterogram Score is reduced by more and -49% of the Predicted Soterogram Score, advanced or severe arterial atherosclerotic disease is suggested.
H. Actual Age:
Actual Age is given as the age of the patient at his or her last birthday.
I. Arterial Age:
Arterial Age is based on the patient’s demographics, risk factor profile, and Soterogram Score. If a patient is 35 years of age temporally and has an Arterial Age based on Soteria Data that suggests his or her arteries are 42 years old, this is a negative finding for the patient. In contrast, if a patient is 35 years of age temporally and his or her calculated Arterial Age is 30 years old, this is a positive finding for the patient.
Elasticity is reported as a Percentage (%). The Percentage is based entirely on the Soterogram Score and compared to normal subjects (i.e. without evidence of atherosclerosis), gender and aged matched. If the Elasticity is NEGATIVE, the Patient’s Arterial Wall Elasticity is locally and systemically (assumed) reduced secondary to atherosclerosis when compared to absolutely normal controls. An Elasticity of -35% is consistent with significant atherosclerosis. An Elasticity greater than -49% is consistent with advanced atherosclerosis and associated cardiovasular risk.
A positive Elasticity means that the subject’s Elasticity has exceeded the predicted levels in absolutely normal controls. Elasticity and Atherosclerotic Burden have proven to be the most important diagnostic criteria derived from the Soteria Cardiac Platform. Our data clearly suggests the following important point – reduced Elasticity and associated Atherosclerotic Burden clearly are consisitent with atherosclerotic disease and the patient should be treated accordingly unless other credible data is found to the contrary. Table 9 provides the suggested the cutpoints for Elasticity and Degree of Generalized Atherosclerosis.
K. Atherosclerotic Burden:
The FDA and the NIH required, to obtain clearance for routine use of this technology, Soteria Medical, LLC obtain data that correlated Atherosclerotic Burden with Soterogram Score. This data was obtained at the four United States Clinical Centers mentioned above.
The Control Measure was Degree of Atherosclerotic Wall Disease of the Abdominal Aorta as determined by Research-Level MRI ($4.5 million magnet). This data was published in many journals, including the AHA’s Circulation. This article and others are available in PFD format from Soteria Medical, LLC, on request.
Our studies found that Atherosclerotic Burden was a direct function of arterial Elasticity. In order to link the Elasticity measurement and level of Generalized Atherosclerosis (Table 9) to arterial obstructive anatomy, commonly used clinically, the picture given in Fig. 8 is displayed in Soterogram reporting.
From a practical standpoint, as confirmed by independent studies, many adult subjects present with Mild Atherosclerotic Burden. The P-Day Study found that 40% of individuals in the age group of 30-34 years (Male and Female) had evidence of Type-4 Atherosclerotic Lesions in the arterial beds from the Distal Abdominal Aorta through the Femoropopliteal Arteries. This number was limited to 20% in the Male Left Anterior Descending Coronary Artery (LAD). Significant generalized disease should be expected if Atherosclerotic Burden is > 40% and advanced disease is suggested if the Atherosclerotic Burden is > 50%. Extensive P-Day Results are available from Soteria Medical, LLC in Booklet and PDF formats on request.
In closing this section, we will stress the following tenets:
(i) Early identification of atherosclerotic burden is essential in changing the trajectory of cardiovascular disease, including events.
(ii) If the Cardiovascular Trajectory mentioned above is to be changed, physicians must be very aggressive with individuals identified as having early and established atherosclerotic disease.
(iii) Currently, aggressive therapy is limited to precise examination and control of traditional cardiovascular risk factors. On balance, patients are often not well controlled and many patients require considerable effort to obtain adequate control of atherosclerotic risk factors.
1. Tobacco Use
Burning or chewing tobacco results in the production of various chemicals which are ingested directly into the oral compartments and pulmonary system of the individual performing the burning or chewing. From the pulmonary system, these chemicals via blood absorption are placed in contact with the arterial wall. The one cell thick lining, known as the endothelium, separating the flowing blood from the other components of the arterial wall is a complex structure with many important functions. The endothelium responds to the presence of chemicals. Some chemicals cause the endothelium to change the arterial diameter of the flow surface (i.e. lumen). Other chemicals cause the endothelium to release chemicals into the blood stream to stabilize physiologic parameters such as: flowrate, velocity, and pressure.
It has been clearly demonstrated, well beyond scientific contradiction, that the chemicals released by tobacco-use produce immensely negative affects in the endothelium and the arterial wall in general, and therefore, clearly promote atherosclerosis. Finally, while negatively affecting the arterial wall, these chemicals are also among the most carcenogenic and addictive known to science.
Your attention should be drawn immediately to three tenets:
First, there is absolutely NO doubt that ALL forms of tobacco use (Cigarettes, Cigars, Pipes, and Chewing) are EXTREMELY detrimental to the health of EVERYONE that uses tobacco. For decades, it has been proven to the satisfaction of all reasonable minds (i.e. those not addicted to tobacco and its subproducts) that tobacco use is the single most destructive force in the development of atherosclerosis and most malignant disease (i.e. Cancer). Consider Table 1. In individuals requiring surgery for peripheral vascular disease, 75% were either previous or current tobacco users. The next highest cardiovascular risk factor was hypertension, with a frequency of 42%. This means that hypertension has a frequency which is a clearly 33% less than tobacco use. The very common cardiovascular risk factors like diabetes, elevated blood lipids, and obesity are 50% less frequent in atherosclerosis than tobacco use. Please also consider the following fact. Tobacco use in the form of cigarette smoking was introduced to the United States via Europe after our soldiers fought in the World War I. Prior to World War I, Lung Cancer was a medical curiosity. In the early 1920’s, medical students would be summoned to autopsies that demonstrated lung cancer, and told, they may never see another case of this disease.
Unfortunately, with tobacco use in the United States, lung cancer is now responsible for 60% of ALL cancer deaths. The concept that individuals continue to use tobacco in any form is a testimony to the addictive nature of tobacco and the general lack of understanding and self-responsibility taken by individuals for their health and the health of their family members.
Second, tobacco use is extremely addictive! Studies have repeatedly shown that tobacco-use can be MORE addictive than alcohol, prescription drug abuse, and even hard drug addiction. In many United States Veterans Hospital studies, it has been shown that individuals, despite being told of their atherosclerotic disease, which required lower extremity amputation, did not cease tobacco use, on average, until they had experienced a major lower extremity amputation (above-knee or below-knee) and a minor amputation (digits or transmetatarsal).
Third, individuals addicted to tobacco constantly employ psychological deflection. This means, when told to stop smoking or chewing tobacco because it is extremely bad for their health, the individual deflects the suggestions and adopts the following positions: (i) the source of the recommendation is not credible or is overreacting to the situation, (ii) if the individual accepts some of the described facts, they are deflected by the belief that said results “do not apply to me”, and (iii) despite my addiction, I am really doing just fine. This is extremely dangerous because it places the addicted individual in a position where he or she is relying and therefore living on the short-end of a bell-shaped statistical curve where the odds of being right are less than 20%.
If deflection does not carry the day, and the individual at risk begins to think rationally, the individual must construct an Individual Plan to Terminate Tobacco Addition. No doubt, these plans may include various features, however, in the experience of the author, said Plan must have several characteristics to be successful:
A. Whereas the individual’s physician, spouse, children, friends, and co-workers may make a strong case for the individual to cease tobacco-use, in reality, the ONLY person that can complete the termination plan, is the individual. In other words, others can be supportive, but the individual at risk must be 100% committed to making the plan work.
B. It has been shown time-and-time-again that plans that are associated with gradual reduction in tobacco use simple do not work and should be avoided. They are generally costly and produce desparation for the individual when they fail. In other words, the cessation must be both immediate and complete.
C. Support by family and friends are needed. The individual must sit down and make a list of the “triggers” that promote tobacco use. They can be numerous. These triggers must be avoided at all cost.
This section is closed by stating that Tobacco Users decrease their life expectancy, on average, by 12 years. This means that for an average Cigarette Smoker, every time the individual finishes a pack of cigarettes, the User’s Life Expectancy is reduced by 6 hours. This is the reason, when applying for life insurance, Actuary Analysis generally requires only three questions be asked to estimate risk and life expectancy: (i) Gender, (ii) Age, and (iii) Tobacco Use Status.
The relational strength between Hypertension and Atherosclerosis, is only exceeded by the relational strength between Tobacco Use and Atherosclerosis. Hypertension is referred to by the American Heart Association as the “silent killer”, because Hypertension often is very often not accompanied by telltale symptoms.
Despite the fact that many effective antihypertensive medications are available by prescription, study after study, continue to find that Hypertension is often not properly identified, and when identified is poorly controlled. Most investigators believe these findings are caused by two factors: (i) physicians do not prescribe the correct combination of medications and rely on poor confirmation that the prescribed regiment is working and (ii) lack of responsibility and action on the part of the hypertensive patient.
Hypertension is directly linked to not only Atherosclerosis, but also aneurysmal arterial disease (i.e. arterial dilatation and rupture), cerebral hemorrhage, and kidney disease. For the record, there are individuals that are: (i) never hypertensive, (ii) hypertensive in response to specific stimuli, and (iii) hypertensive all the time.
This is a simplistic Booklet and therefore, by definition will not present complex ideas. Blood pressure is classically defined by two Pressure Levels in the body. These Pressure Levels are Systolic Pressure and Diastolic Pressure. Due to the fact that the Heart functions as a pulsatile pump, the blood pressure is constantly changing with time and related to pumping status. Systolic Pressure is defined as the highest pressure in the body (i.e. systemic circulation) for a specific cardiac cycle.
Diastolic Pressure is defined as the lowest pressure in the body for a specific cardiac cycle. The unit for Blood Pressure is mmHg (i.e. millimeters of mercury). The unit mmHg is a pressure measurement, exactly like the familiar PSI (pounds per square inch). In fact, One (1) PSI is equal to approximately 50 mmHg. An individual might have a Blood Pressure of 120 / 80. This means the Systolic Pressure is 120 mmHg and the Diastolic Pressure is 80 mmHg.
Various medical organizations, including the American Heart Association, publish from time to time, “guidelines for blood pressure”. In December 2013, the 2014 Evidenced-Based Guidelines for the Management of High Blood Pressure in Adults was released by “the Panel Members Appointed to the Eighth Joint National Committee (JNC 8)”. This group had initially been sponsored by the National Heart, Lung, and Blood Institute (NHLBI) to write the guidelines based on an evidence-review sponsored by the NHLBI. Included in the Appendix of this document (Section 15) is the entire Hypertension Guideline File (Appendix 1), in Electronic Format. The following information in this section is taken/didacted from the referenced Guideline.
Currently, the consensus is that if individuals consistently have Blood Pressure (taken at the Brachial Artery Level – upper arm) at or below 140 / 90, significant elevation in Blood Pressure is not present. The Blood Pressure measurement of 120 / 80 is considered the “classical norm”. Table 2 is important and provides suggested BP Goals and suggested Drug Treatment / Monitoring.
Diabetes is another disease that has reached what is described as epidemic proportions in the United States and many locations in the developed world. It is estimated that in the United States, in only a few years, approximately 10% of the adult population will be Type 2 Diabetics. Further, the American Heart Association (AHA) and the National Institutes of Health (NIH) via recent study panels and published guidelines have equated for cardiovascular risk, the presence of Type 2 Diabetes with Documented Coronary Artery Disease. These positions clarify the importance of Diabetes which includes: (i) understanding, (ii) diagnosis, (iii) prediabetes, (iv) glycemic targets, (v) prevention, and (vi) diabetic management. The American Diabetes Association (ADA), this year (2016) published a comprehensive Diabetes Guideline. This entire file is found as Appendix 2 and 2A (Electronic Format). Table 3 given below is a summary of these guidelines and should be helpful in understanding and treating diabetes.
Jeffrey K. Raines and Zoraida Catherine Navarro
Professor Jeffrey K. Raines was responsible for the Soteria Cardiac Platform including its design and module development. After attending Harvard Medical School and training in the Surgery Department of Massachusetts General Hospital, Dr. Raines received a PhD in Engineering from MIT. His thesis title was Diagnosis and Analysis of Arteriosclerosis in the Lower Limbs from the Arterial Pressure Pulse; this work outlined the construction and testing of a new medical device called the Pulse Volume Recorder (“PVR”). This device was built and distributed by Life Sciences, Inc. and became a central device in the diagnosis of peripheral vascular disease and in the development of vascular diagnostic laboratories around the world. Dr. Raines was Chief of Research at the University of Miami Department of Surgery until his retirement in 2004 and Director of the Miami Vein Center from 2004 to 2010. Dr. Raines has developed Soteria’s technology over a period of 43 years and now that it has FDA clearance, he looks forward to expanding the use of the Platform worldwide. Dr. Raines is Emeritus Professor of Surgery at Harvard Medical School and the University of Miami. Dr. Raines is a Senior Member of the Society of Vascular Surgery, was elected to American College of Cardiology in 1975 and the Harvard Surgical Society in 2006. Dr. Raines lives in Homestead, Florida with Glo, his wife of many years; they have four children and five grandchildren.
Zoraida Catherine Navarro, MD practices at the Vein Center of the Palm Beaches and Navarro Dermatology Skin & Vein Care. Dr. Navarro earned a B.S. from MIT and medical degrees from Boston University School of Medicine and later, the University of Miami School of Medicine. As a member of the Palm Beach County Medical Society, she helped establish the Women Physicians Medical Society. In 1986, after a year as Director of Medicine for the Wellington Regional Medical Center, Dr. Navarro established the Vein Center of the Palm Beaches in West Palm Beach, an internal medicine solo practice with specialties in varicose vein sclerotherapy, skin care, and holistic approaches.