Nearly half of U.S. adults — 121.5 million Americans — have some form of cardiovascular disease (CVD), a disorder that includes coronary heart disease, heart failure, stroke and high blood pressure. By 2035, it is estimated that 130 million people in the U.S. will have CVD, with the annual cost of their care projected to rise to $1.1 trillion from the current level of $351 billion. And tragically, CVD currently kills about 2,200 American men and women every day — one every 40 seconds.

What will it take to reduce these staggering statistics? “True healthcare reform will be realized only when we focus attention on disease prevention and not disease management,” former American Heart Association president Dr. Gordon Tomaselli has stated. A landmark new BaleDoneen paper proposes the first step toward that goal: reclassification of CVD risk assessment to identify the patients most likely to benefit from optimal preventive care to avoid heart attacks, strokes and other devastating complications of CVD. Here’s a closer look at the paper and key takeaways to help you protect and enhance your arterial health.

Current Screening Tools Can Miss Millions at Risk for Heart Attacks and Strokes

Up to 60 percent of people who die suddenly from cardiovascular (CV) causes were previously unaware that they had CVD. If it goes undetected and untreated, this disease often causes no symptoms until it becomes severe enough to trigger a heart attack, stroke or other catastrophic events. Published in the peer-reviewed journal Frontiers in Cardiovascular Medicine, the paper by Drs. Amy Doneen, Bradley Bale, David Vigerust and Pierre Leimgruber draws on the latest scientific evidence to argue that a new, more accurate approach to identifying at-risk patients before these events occur could help save lives.

Currently, the standard of care is to divide patients into two categories. People who have “proven” that they have CVD by having heart attacks or strokes are classified as “secondary prevention,” with the goal of treatment being to help these high-risk patients avoid repeat events. Everybody else is classified as “primary prevention.” Current guidelines recommend that medical providers check these patients for heart attack and stroke risk the same way they did when Bill Clinton was president — even though many studies have shown that the tool they use is dangerously unreliable.

This tool, called Framingham Risk Score (FRS), was introduced in the late 1990s. It estimates patients’ ten-year risk for having a heart attack or stroke based on such factors as their age, gender, cholesterol levels, blood pressure and smoking status. Many studies, however, show that most initial CV events do not occur in people deemed at high risk by this scoring system. For example, a study of 150,000 people hospitalized for heart attacks found that 50 percent of them had “normal” cholesterol and many had “optimal” levels. Yet, a version of this faulty scoring system is still recommended in 2019 guidelines issued by the AHA and American Academy of Cardiology (ACC).

A Three-Tiered Approach for Accurate Cardiovascular Risk Detection

Instead of a binary CV risk classification system of “have’s” and “have-not’s,” the paper argues for a comprehensive, individualized, three-tiered approach in which patients who have not yet suffered a CV event would be evaluated for the presence of arterial plaque (disease), using lab and imaging tests, such as a 15-minute ultrasound scan of the neck’s carotid arteries. The BaleDoneen Method also uses blood and urine tests to check for inflammation, the fire that can ignite heart attacks and strokes in people with arterial plaque. Finding out if patients harbor silent, potentially deadly plaque in their arteries is fundamental for accurate assessment of their true risk for CV events. The paper proposes using these three risk categories to guide treatment decisions:

  1. Primary prevention. In the absence of atherosclerotic plaque, the likelihood of a plaque rupture and subsequent MI or stroke is so low that the vast majority of these patients don’t need prescription medications. They could also be harmed by such commonly prescribed preventive therapies as low-dose daily aspirin, which can cause bleeding complications. Instead, the goal of treatment, such as personalized lifestyle modification to address potential risk factors, is to help the patient avoid forming plaque.
  2. Secondary prevention. We propose use of this term for patients who have plaque but have not yet experienced a CV event. Given the presence of plaque, especially in patients who also have chronic inflammation, the risk of a plaque rupture and subsequent CV events outweighs the potential harms of such medications as low-dose aspirin.
  3. Tertiary prevention. We propose this term to describe what the standard of care currently calls “secondary prevention,” i.e. patients who have already experienced one or more CV events.

Benefits of a Proven, Personalized Approach to Prevention

Redefining CV risk assessment from a binary system to our proposed three-tiered approach has several important advantages for patients who currently fall into the “primary prevention” category. By directly checking patients for plaque with safe, accurate and widely available FDA-approved lab and imaging tests, healthcare providers can find out which patients actually need treatment. Under the current system, patients who lack the traditional risk factors but have silent plaque in their arteries may miss out on potentially lifesaving treatments.

For example, as we recently reported, J.P. Moore thought he was in perfect health until he suffered a widow-maker heart attack on July 4, 2014, at age 42. He’s a physically fit nonsmoker with normal blood pressure and cholesterol levels, eats a healthy diet, and exercises twice a day. And when we plugged the numbers from his annual physical, performed one month before this near-fatal event, into the latest AHA/ACC risk scoring algorithm, it predicted that his likelihood of having a heart attack in the next decade was only 1.4 percent! Based on this result, he would not have qualified for preventive treatments that could have reduced his risk, such as low-dose aspirin and statin medications.

Conversely, early detection and treatment with the BaleDoneen Method has been shown in two recent peer-reviewed studies to quickly shrink and stabilize plaque depositions in people with CVD, helping them avoid heart attacks and strokes. One of these studies, published in Archives of Medical Science, found that during the first year of treatment, our precision-medicine approach to medical management led to a 52.7 decrease in the size of plaque deposits in the patients’ neck arteries (compared to baseline), helping them avoid heart attacks and strokes. It was also proven that our method eradicated lipid-rich arterial plaque (the most dangerous kind) in 100 percent of cases.

The study, which included 328 patients of the Heart Attack & Stroke Prevention Center in Spokane, Washington, who were tracked for five years, also demonstrated striking improvements in cholesterol levels, blood pressure and triglycerides. An earlier peer-reviewed study of 572 patients treated with the BaleDoneen Method found dramatic reductions in plaque deposits, blood sugar, cholesterol, blood pressure and inflammation over an eight-year period, further highlighting the benefits of early detection and treatment of plaque — before it becomes deadly.