Chelation and Heart Disease

Chelation Therapy

Dr. Rafael F Cruz MD is board certified in Chelation therapy by the American College for Advancement in Medicine (ACAM), the only national organization that teaches and certifies physicians and technicians in the Art and Science of Chelation therapy.
What is Chelation Therapy? Chelation Therapy is the “gold” standard scientific medical treatment for the detoxification and removal of toxic heavy metals, such as lead, cadmium, mercury, etc. This is a medical procedure, usually involving a series of intravenous infusions of a commonly used food chemical called Ethylene-Diamine-Tetraacetic Acid, or “EDTA” for short. You will see the term EDTA in the list of ingredients for most canned goods where it is used as an additive. EDTA Chelation Therapy treatments act to remove what are called “Toxic heavy metals” from the blood stream. These toxic metals can play a significant role in causing and contributing to human illness. In some cases, mercury or arsenic for example, other amino acid chelators may be more effective, such as DMPS and DMSA. The determination of which chelating agent to use (EDTA, DMPS, etc.) is made by which toxic metal is present, in what amount, the skill, training and expertise of the physician and availability of the chelators.

Toxic heavy metals interfere with many of the body’s enzyme systems. Enzymes run the biochemistry of life in your body: immune function, digestion, liver function, etc. Disturbances here can have far ranging effects on health, and reestablishing normal conditions in the blood via Chelation Therapy is a natural benefit to your health. Mercury, lead, cadmium, aluminum, and excessive amounts of iron can enhance the activity and the dangers of certain chemicals called free radicals. Free radicals are very much involved in processes that damage blood vessels throughout the body. Removing these metals with Chelation Therapy promotes a healthy circulatory system, immune system and a healthy heart.

EDTA Chelation Therapy has also been found to be clinically useful for the treatment of generalized vascular atherosclerosis and other degenerative diseases. The view that Chelation Therapy is useful for vascular and degenerative diseases is currently accepted by a minority of the medical community.1 Since the FDA package insert for EDTA does not “approve” the use of Chelation Therapy for these clinical indications, most physicians and government agencies, including the FDA, still consider the use of Chelation Therapy for vascular and/or degenerative diseases to be an “off label” use of an approved agent. As such, it remains classified as “investigational” or “experimental” by a majority of the scientific medical community. Despite this classification, however, the use of an FDA approved drug for any informed off label use is completely legal, medically accepted treatment. In fact, off label uses of approved drugs are supported by the FDA. In addition, there is mounting clinical evidence of effectiveness and growing academic acceptance of Chelation Therapy for vascular disease. For example, it has been published as an effective treatment in a current textbook of cardiovascular therapy.2 In addition, a number of published clinical and statistical studies appear to demonstrate clinical effectiveness for cardiovascular disease.3-8 Additional studies have questioned this, but upon further analysis the data gathered in the studies appears to support rather then refute clinical benefit for peripheral vascular disease.9,10
In addition, thanks to the impressive results and benefits on cardiovascular disease from the TACT study (Trial to Assess Chelation Therapy) the following mainstream journals are sharing the clear benefits of chelation in patients with cardiovascular disease and diabetesJAMA 2013;309:1241-50. Am Heart J 2014;168:37-44.e5. Circ Cardiovasc Qual Outcomes 2014;7:15-24.   Recognizing the weight of the TACT results, the American Heart Association and the American College of Cardiology upgraded edetate disodium chelation from a 3C to a 2B indication in their 2014 revision of the guidelines for the treatment of chronic ischemic heart disease.24 Patient-centered clinicians should recognize a new arrow to keep in their quivers for the high-risk diabetic patient.

One of the major reasons for the lack of general scientific acceptance of Chelation Therapy for the treatment of vascular and degenerative diseases is due to the fact that its mechanism of action has not been completely described. Interestingly, a similar situation exists for ECP Therapy, but this method has been FDA approved for certain vascular indications.. It is known that Chelating agents remove toxic minerals from the body, but the exact reason(s) for providing benefit in heart and generalized vascular disease remains to be proven. The currently suggested mechanisms include removal of toxic environmental heavy metals and subsequent reactivation of self-healing enzyme systems and other important metabolic reactions, a powerful anti-oxidant effect and an anti-platelet blood clot reversing effect. Any or all of these mechanisms may account for the clinical improvement usually seen after a course of Chelation Therapy has been administered. Recent scientific evidence has provided support for the toxic heavy metal theory. It now appears that levels of many of these environmental pollutants that were thought to be “safe” and “acceptable” to government and academic scientists have now been demonstrated to have disease producing and disease sustaining effects, as well as inhibiting normal self-healing reactions.11-15

Chelation Therapy is considered by a significant minority of physicians to be an alternative to more expensive, toxic and invasive “standard” therapies used to treat cardiovascular and other degenerative diseases. Coronary bypass surgery, peripheral vascular surgery and/or vascular angioplasty are in common clinical use today, despite the fact that none of these surgical procedures has been proven to be effective in double-blind, placebo-controlled scientific studies. Instead, the evidence for the effectiveness of these invasive procedures is entirely clinical, sometimes referred to scientifically as “anecdotal evidence.” A similar situation exists with Chelation Therapy, although blinded scientific studies have produced favorable, but conflicting results.4,9,10 In addition, Chelation Therapy is significantly more cost effective then the invasive procedures.16 Bypass surgery in the state of Nevada averaged approximately $80,000 for hospital care alone in 1996.16 Readmission rates after surgery averaged greater then 13% and significantly increased cost, risk and reduced quality of life.17 The total cost for the five most common vascular disease Diagnosis Related Groups or DRG’s (a Medicare diagnosis term) in the state of Nevada in 1996 was $247 million! This only includes the hospital cost, not physician fees and not follow-up care. In addition, there were 114 in hospital deaths associated with these five DRG’s. According to a 1997 survey conducted by the Nevada Association of Homeopathic Physicians it is estimated that if 85% of these patients were treated with Chelation Therapy the comparable cost would have been $37 million for the first year after diagnosis. The 85% figure is the approximate clinical response rate noted for Chelation Therapy.3,5,6 The estimated death rate for the chelation group was “possibly” 1 death, thus representing an overwhelming savings in both money and lives. In addition, it has been estimated that 50% of coronary angioplasties and up to 70% of coronary bypass surgeries are medically unnecessary or can be significantly delayed with proper medical, non-invasive therapy and life style changes.18 

ANTI-AGING EFFECTS 

A new and exciting application of Chelation Therapy is in the area of Anti-Aging Medicine. Presently accepted theories of molecular and cellular aging include the concept of toxic free radicals.19 These are highly reactive, toxic forms of oxygen and other chemical species that damage delicate membrane, enzyme and genetic structures. Strong scientific interest has been focused on the probable role of toxic environmental metals, such as lead, iron, cadmium, mercury and others in accelerating toxic free radical reactions. The end result is accelerated molecular and cellular aging.19 A good example of the age promoting properties of free radicals is the relationship to cigarette smoking and accelerated age-related skin wrinkling. By removing many heavy metal pollutants from the body Chelation Therapy reduces the oxidizing stress these environmental toxins produce when left unchecked by eliminating certain toxic heavy metals from the body and acting as a powerful antioxidant treatment. This results in improved circulation, lower cholesterol levels, greater energy and additional clinical benefits. The end result is a clinical rejuvenation of the heart, arteries, other organs and tissues. These effects are further enhanced when a healthy life-style, including exercise, diet, meditation and other methods are also included in an individualized anti-aging prescription.

SIDE EFFECTS: Although Chelation Therapy is generally far safer and less toxic then the standard surgical procedures for vascular circulatory diseases, it does have certain potential side effects. These are generally minor and may include discomfort at the infusion site, minor irritation of the vein used for infusion (superficial phlebitis), temporary lowering of blood calcium, fatigue, muscle cramps, transient dizziness, low blood sugar, temporarily increased bleeding tendency and rarely, allergic reaction. The primary concern, however, is for kidney toxicity. Although rare and easily detected by using serial blood testing to follow kidney function, kidney toxicity is actually related to the degree of heavy metal burden the patient has before beginning Chelation Therapy. Most patients actually end up with better kidney function after completing Chelation Therapy than before beginning. This is due to the removal of low levels of environmental toxic metals found within almost everyone living in modern society.

COST: The cost of Chelation Therapy varies with the type and the extent of the problem being treated. Generally, the more extensive the problem the greater the cost. For an average patient a series of 40 EDTA infusions are given. The cost of the actual therapy does NOT include the cost of laboratory before and during therapy to monitor kidney function, cholesterol level and toxic/nutritional mineral levels, nutritional supplements required during treatment because Chelation is so effective at internal cleansing, vascular treating before and after to evaluate the clinical effects of the treatment and periodic physician visits during the treatment to review laboratory, adjust therapy and provide individualized lifestyle modification counseling. In addition, intermittent maintenance therapy is generally recommended once a clinical response has been achieved. The length of maintenance treatments, usually performed once monthly, will be determined by the extent of disease and the ability of the individual to effect serious and permanent changes in unhealthful life style patterns. For specific information on cost please contact our office.

Due to the fact that Chelation Therapy is not currently approved for the treatment of vascular or degenerative diseases by the Federal Drug Administration (FDA), we regret that the charges for the treatment are NOT COVERED by MEDICARE™ and are usually NOT COVERED by PRIVATE INSURANCE. The testing to determine the need for and monitor the progress of therapy is also currently NOT COVERED by MEDICARE™ and may also be DENIED coverage by PRIVATE INSURANCE. Chelation Therapy is an “approved” treatment for certain types of heavy metal poisoning. Under these circumstances Chelation Therapy MAY be covered by insurance, depending on the specific language of the insurance contract.

For further information on the uses of Chelation Therapy, and whether this may be an appropriate treatment for you, please call our office at (812)913-4416.

SCHEDULING: Appointments for initial consultation may be scheduled with our office at (812)913-4416. Chelation Therapy is generally given twice weekly for the first 40 treatments. Maintenance treatments are usually given once monthly. Chelation Therapy is provided at 8:00 am or 3:00 pm daily Monday -Friday.  In order to assure space for the desired treatment time(s) prior scheduling is strongly recommended.

REFERENCES

  1. Halstead B. The Scientific Basis of Chelation Therapy. Golden Quill Publishers. Colton, CA.
  2. Rubin M, Magnesium EDTA Chelation in [Messerli F, editor] Cardiovascular Drug Therapy. WB Saunders, Philadelphia. 1996:1613-1617.
  3. Olszewer E, Carter JP. EDTA Chelation Therapy: A retrospective Study of 2,870 Patients. J Adv Med 1989;2:197-212.
  4. Olszewer E, Sabbag FC, Carter JP. A Pilot Double-Blind Study of Sodium-Magnesium EDTA in Peripheral Vascular Disease. J Nat Med Assoc 1990;82:173-177.
  5. Chappell LT, Stahl JP. The Correlation Between EDTA Chelation Therapy and Improvement in Cardiovascular function: A Meta-Analysis. J Adv Med 1993;6:139-169.
  6. Chappel LT, Sathl JP, Evans MA. EDTA Chelation Treatment for Vascular Disease: A Meta-Analysis Using Unpublished Data. J Adv Med 1994;7:131-142.
  7. Edwards DA, Ibarra M, Ilarina CI. Hibernation and Stunning of Arterial Myocytes: A NovelHypothesis. J Adv Med 1995;10:233-247.
  8. Edwards DA, Ibarra CI, Essad L. EDTA Chelation Therapy in Myocardial Stunning and Hibernation. J Adv Med 1997;10:233-247.
  9. van Rij AM, Solomon C, Packer SGD, Hopkins WG. Chelation Therapy for Intermittent Claudication: A Double-Blind, Randonized, Control Trial. Circulation 1994;90:1194-1199.
  10. Chappell LT Disputes Author’s Conclusions on Effectiveness of EDTA Chelation Therapy (Letter). Alternative Therapies 1996;2:16-18.
  11. Hu H, Aro A, Payton M, et al. The Relationship of Bone Lead to Hypertension. JAMA 1996;275:1171-1176.
  12. Kim R, Rotnitzky A, Sparrow D, et al. A Longitudinal Study of Low-Level Lead Exposure and Impairment of Renal Function. JAMA 1996;275:1177-1181.
  13. Salonan JT, Seppanen K, Nyysomen K, et al. Intake of Mercury From Fish, Lipid Peroxidation, and the Risk of Myocardial Infarction and Coronary, Cardiovascular, and Any Death in Eastern Finnish Men. Circulation 1996;91:645-655.
  14. S.E.P.A. PB-184650. Mercury Study report to Congress 1996;4:3-20-2-21.
  15. S.E.P.A. PB96-184692 Mercury Study Report to Congress. 1996;8.
  16. Carns DE, Dejan E, Yang W, et al. Personal Health Choices. Bureau of Health Planning and Statistics. Nevada State Health Division, Carson City, NV. 1997.
  17. Beggs VL, Birkemeyer NJ, Nugent WC, et al. Factors Related to Rehospitalization WithinThirty Days of Discharge After Coronary Artery Bypass Grafting. Best Practices Benchmarking in Healthcare 1996;1:180-186.
  18. Graboys T, et al. Results of a Second Opinion Trial Among Patients Recommended for Coronary Artery Angiography. JAMA 1992;268:2537-2540.
  19. Harmon D. Free Radical Theory of Aging: Increasing Functional Life Span. In [Zs.-Nagy I, Harmon D, Kitani K eds] Pharmacology of Aging Processes Methods of Assessment and Potential Interventions. NY Acad Sci 1994;717:-16.