BaleDoneen Method

The BaleDoneen Method is an evidence-based, comprehensive risk assessment and treatment protocol for patients designed to prevent cardiovascular disease, heart attack, and stroke, and for treatment designed to prevent disease progression and repeat heart attacks or strokes after one of these medical events. The method also aims to prevent or reduce the effects of type 2 diabetes, technically known as diabetes mellitus type 2.

Description
Based on published, peer-reviewed research, the BaleDoneen Method uses a genetically guided, precision medicine approach to preventing, detecting, and treating cardiovascular disease, the leading cause of death globally. The U.S. National Research Council and the National Institutes of Health support precision medicine, which uses genomic and epigenomic factors to enhance the clinical management of an individual patient.

The goal of the BaleDoneen Method is to find out if patients have plaque (disease) in their arteries and if so, to halt its progression with evidence-based therapies. The method uses imaging and laboratory tests to directly check each patient for signs of silent cardiovascular disease, including the presence of arterial plaque, as well as “red flags,” defined as factors that may indicate an increased risk for heart attacks, strokes, coronary artery disease, and type 2 diabetes. The initial assessment also includes genetic testing, which is used to identify patients with certain genetic variations that may increase risk for heart attacks and strokes, and to guide personalized treatments for these inherited risks.

The method was developed by Dr. Bradley Field Bale, M.D. and Dr. Amy Lynn Hubbard Doneen, DNP. Both doctors are currently clinical associate professors at Washington State University College of Medicine, clinical assistant professors in the School of Nursing at the Texas Tech University Health Science Center, and assistant professors at the University of Kentucky College of Dentistry.
Dr. Doneen is also the owner and medical director of the Heart Attack & Stroke Prevention Center in Spokane, Washington. Since 2004, Drs. Bale and Doneen have taught their method to hundreds of medical and dental providers in their continuing medical education (CME)/continuing education (CE) BaleDoneen Preceptorship Course, which is currently accredited by the American Academy of Family Physicians and Academy of General Dentistry for up to 17.5 prescribed credit hours.

Heart attack, stroke, and diabetes prevention
The BaleDoneen Method takes a holistic, comprehensive approach to the early detection, prevention, and treatment of arterial disease and its root causes. The method has six components:
* Education. Patients learn how heart attacks and strokes actually happen. A common misconception is that arterial disease is a plumbing problem, like grease clogging a kitchen sink, causing an artery to become so obstructed that flow of blood stops, resulting a heart attack or stroke. However, studies have revealed that these events occur when plaque inside the artery becomes inflamed and ruptures explosively, leading to the formation of a clot that blocks the flow of blood to the heart or brain. Most heart attacks occur in arteries that are minimally blocked by plaque, with the clot creating the rest of the obstruction.
* Disease. Early detection and treatment of arterial plaque is a key element of the BaleDoneen Method approach to prevention. Medically known as atherosclerosis, this condition often causes no symptoms until it becomes severe enough to cause a heart attack or stroke, depending on which arteries are affected, Testing for plaque includes a carotid intima-media thickness test, (CIMT), which measures blood flow through the arteries and the thickness of the arteries. Physician Dr. Jeff Emery wrote that the test “allows us to identify if you are at future risk for a heart attack or stroke.” The method also uses the coronary artery calcium score (CAC), a measurement of the amount of calcium in the walls of the arteries that supply the heart muscle, using a coronary CT calcium scan of the heart.
* Fire in the arteries. Chronic systemic inflammation, which the method calls “fire,” has been shown to be both a cause and important treatment target for cardiovascular event prevention. The method uses urine and blood tests to check inflammatory markers, such as a high-sensitivity C-reactive protein test (CRP) measuring CRP, a protein in found in blood that indicates inflammation throughout the body. In 2012, two groundbreaking genetic studies published in Lancet reported a cause-and-effect relationship between an inflammatory biomarker called interleukin-6 and the creation of arterial plaque. In 2017, results of the CANTOS trial published in the New England Journal of Medicine demonstrated that anti-inflammatory therapies reduce risk for heart attack, stroke, other cardiovascular events and cancer by up to 50%. This discovery was described as “a new era in preventive medicine” by study author Dr. Paul Ridker, who said, “For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk.
* Root causes. Similar to other protocols, the method tests for cholesterol levels, blood pressure, and diabetes, as well as factors not included in other current protocols, including systemic inflammation, vitamin D deficiency, insulin resistance, elevated levels of lipoprotein(a), and genetic risks, to identify potential root causes of arterial plaque.
* Optimal goals. Results of these tests are tied to considerations of lifestyle, diet, sleep disorders, stress levels, genetic factors, and dental care, and personalized treatment targets are set to reduce patients’ cardiovascular risk. In some cases, these goals exceed those set by standard care. A common protocol for blood pressure indicates that an adult male with a reading of 130/85 is not at risk for a heart attack if the patient is being treated for high blood pressure. However the American Heart Association, the National Heart, Lung and Blood Institute, and the BaleDoneen Method define safe levels as being below 120/80.
* Genetics. The initial evaluation with the BaleDoneen Method also includes genetic testing, with the results used both to identify patients with inherited risk for heart attacks and strokes and to guide personalized treatments of those risks, including a diet and exercise plan based on the patient’s DNA.
Differences from other current cardiovascular protocols
Conventional medical care traditionally has used risk assessment calculators, such as the Framingham Risk Score or Reynolds Risk Score, to identify which patients may benefit from primary prevention interventions, such as lifestyle modification and preventive medications. However, a recent systematic review of randomized clinical trials of these widely used scoring systems, which provide an estimate of future risk for cardiovascular events, found limited benefit in helping medical providers target high-risk patients for preventive cardiovascular care.
Unlike other current protocols for cardiovascular disease prevention, the BaleDoneen Method does not rely on risk factor analysis alone. Screening and diagnosis is based on using vascular imaging and other testing to find out if patients have plaque in their arteries since heart attacks and strokes can only occur in people with this disease. A 2015 study of more than 5,000 adults, published in Journal of the American College of Cardiology found that most initial cardiac events do not occur in patients considered at “high risk” based on risk factor scores. The study also stated that the accuracy of cardiovascular risk prediction was “significantly improved” if vascular imaging, such as ultrasound imaging or Coronary Artery Calcium score (CAC), was used. The BaleDoneen Method also uses the Coronary Artery Calcium score, which has been shown to be an independent marker of risk for cardiac events, cardiac mortality, and all-cause mortality.
In 2001, the CAFES-CAVE study, published in the journal Atheroscolerosis, demonstrated the dangers of not treating subclinical arterial disease in seemingly healthy, low-risk patients. About 10,000 asymptomatic patients without high cholesterol, high blood pressure, and diabetes were examined with CIMT and femoral artery ultrasound tests. Based on the results of this testing, patients were then divided into four categories: normal arteries (class 1), thickening of the arterial wall (class 2), plaque inside the artery wall only (class 3), and plaque that obstructed blood flow (class 4). During the next 10 years, the patients received no treatment and suffered rates of cardiovascular events of 0.1%, 8.6%, 39.8%, and 81.1% respectively.
Effectiveness
Two recent peer-reviewed studies have evaluated the effectiveness of the BaleDoneen Method. In a 2016 retrospective study published in Archives of Medical Science, researchers from the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease analyzed data from 324 patients who had received comprehensive cardiovascular risk reduction treatments that included lipid-lowering medications, lifestyle modification, and additional therapies for those with insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, and other cardiovascular risks. The following outcomes were reported during the first year of treatment with the BaleDoneen Method, compared to baseline:
* A 52.7% decrease in the size of plaque deposits in the carotid arteries
* A 31% drop in triglycerides
* A 25% drop in LDL (bad) cholesterol and 6% rise in HDL (good) cholesterol
* A 5% decrease in systolic blood pressure
These trends continued into the second year of treatment. An earlier study of 576 patients treated with the BaleDoneen Method, published in 2014 in the Journal of Cardiovascular Nursing, found striking improvements in CIMT measurements, plaque burden, and blood sugar over an eight-year period, as well as significant decreases in LDL cholesterol and inflammation, the two major factors that lead to atherosclerosis.
Oral-systemic effects and treatments
The BaleDoneen Method has been described by Rachel O’Connor, PA-S, and Jonathan B. Levine, D.M.D., as “bridging the gap between doctors and dentists” by identifying “a new, treatable cause of heart disease,” namely, oral-systemic inflammation sparked by dental bacteria from periodontal disease. Also known as gum disease, this chronic oral infection affects nearly half of adults over the age of 30 and can lead to tooth loss if untreated. In a 2016 meta-analysis of studies of more than 7,000 people, those with infected gums were 2.5 times more likely to suffer heart attacks. A 2012 scientific statement from the American Heart Association reported a strong, independent association between periodontal disease and cardiovascular events.
In a 2016 peer-reviewed paper published in the Postgraduate Medical Journal, Drs. Bale and Doneen offered the evidence-based conclusion that certain high-risk bacteria from periodontal disease are not just a risk factor but also a contributing cause of cardiovascular disease. Writing for Inside Dentistry magazine in 2017, Scott Trettenero, D.D.S., Arthur Molzan, D.D.S., and Thomas Roberts, D.D.S., PA, described the paper as “landmark” and “a paradigm shift in dentistry.” The paper reported that these oral bacteria often enter the bloodstream and pose a triple threat to arterial health known as “the atherosclerotic triad” that can lead to heart attacks and strokes.
Based on this research, the BaleDoneen Method recommends that patients be screened for periodontal disease and tested for high-risk oral bacteria using DNA saliva tests. Treatments for gum disease include nonsurgical periodontal therapy, a daily program of self-care to follow at home, prescription mouthwashes, dental trays with antibacterial gel, and in some cases, a short course of antibiotics. The method also strongly recommends significant attention to dental care to improve heart and circulatory system health, including brushing and flossing teeth twice a day.<ref name=Bale2014/>
For treatment of arterial disease, the method uses pharmaceuticals such as statins, baby aspirin (low-dose aspirin), renin-angiotensin-aldosterone system inhibitors (RAAS inhibitors), and other drugs that are common tools for most physicians, as well as vitamins, supplements, lifestyle modification, and a diet based on the patient’s DNA.<ref name=Bale2014/>

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