PALO ALTO, November 19, 2018 –Leading cardiologists and cardiovascular researchers from SHAPE (Society for Heart Attack Prevention and Eradication www.shapesociety.org), a nonprofit grassroots organization dedicated to the mission of eradicating heart attacks by advocating early detection and treatment of Vulnerable Patients (heart attack victims before a heart attack strikes), issued a press release today following the release of the new national cholesterol guideline, calling it a step forward in personalizing preventive cardiology. Additionally, the SHAPE organization called out Dr. Steven Nissen for misrepresentation on the cost of coronary calcium testing in his interview with CNN.

“Over the past decade, I have worked closely with some of the world’s most distinguished leaders in cardiology who participated in the SHAPE Task Force, and I have felt their frustration that our country lacks a personalized approach in heart disease prevention guidelines. The new guideline from AHA/ ACC partially addresses that frustration and has been a long time coming.” said JoAnne Zawitoski, President and Chairwoman of SHAPE, who has volunteered with the organization since 2006 after losing her husband to a sudden heart attack at age 49.

Last weekend, November 10-12, during the 2018 Annual Scientific Sessions of American Heart Association in Chicago, thousands of heart doctors gathered to learn about news and updates in cardiology. During this event, the new guideline for treatment of high cholesterol and prevention of heart attacks was presented. One of the major advancements in the new guideline is the addition of coronary calcium scoring to personalize risk assessment and drug therapy.

“It is encouraging that coronary calcium scoring is now recommended when the decision about initiating statin therapy is uncertain,” Said Dr. David Maron, Clinical Professor of Medicine and Director of Preventive Cardiology at Stanford University School of Medicine, a volunteer SHAPE Scientific Advisory Board member.

It is noteworthy that all of SHAPE advisory doctors and board members are unpaid volunteers who have contributed an enormous amount of time and personal resources for the good cause of the organization.

Since 2006, the SHAPE Task Force, an international group of leading cardiovascular experts that created the SHAPE Guideline, has been working hard to persuade traditional heart organizations including American Heart Association (AHA) and American College of Cardiology (ACC) to adopt a more progressive approach to prevention particularly for early detection and treatment of Vulnerable Patients (individuals with a high risk of cardiac events in the near future). The new guideline issued by AHA and ACC last weekend is a major step forward in this direction and supports the SHAPE Task Force’s position that coronary artery calcium (CAC) scoring is useful for personalizing risk assessment. CAC is a measure of the amount of plaque in the coronary arteries—the source of heart attacks. Those with high coronary calcium but “normal” cholesterol are high risk. The so-called “normal” or “borderline” cholesterol is not normal for them and they need to receive intensive therapies. On the other hand, individuals with zero coronary calcium are very low risk. Despite borderline cholesterol they should not be subject to drug therapy. It’s an unnecessary cost and a burden on our healthcare system. These two key components of SHAPE guideline that were published in American Journal of Cardiology 2006 July 17;98(2A):2H-15H http://shapesociety.org/pdf/The-Scientific-Foundation-of-SHAPE-part-1-2-3.pdf , are finally adopted by the new AHA/ACC guideline.

“Now that the new guideline acknowledges a critical role for coronary artery calcium testing, SHAPE will work in unison with AHA and ACC to raise awareness among physicians and patients about the importance of CAC both for intensifying therapy in patients with a high calcium score and stopping unnecessary drug therapy in those with a zero calcium score,” said Dr. Morteza Naghavi, founder of SHAPE and Executive Chairman of the SHAPE Task Force. “Equally important, we need their help to secure coverage for CAC testing like we did in Texas with HB1290. If insurance companies do not cover CAC testing, physicians will not be able to fully adopt the new guideline, and patients will be underserved” added Dr. Naghavi.   

Many practicing physicians are still unaware of the value of coronary calcium scoring and have not yet incorporated it into their patient care.  Now that AHA and ACC have recognized the value of the SHAPE Guidelines, the challenges are public education and insurance reimbursement.

 “The American Heart Association and American College of Cardiology represent the best of the best in the fight against heart disease. We knew it was just a matter of time for them to recognize the importance of coronary calcium scoring which is the initial step in SHAPE Guidelines,” said Dr. PK Shah, Chair of Scientific Committee for the SHAPE Task Force and Director of Atherosclerosis Research at Cedars Sinai.“Despite this delightful news, until reimbursement and inadequate public education barriers are removed, we have a long way to go, and preventive cardiology will be far from personalized preventive care.” Dr. Shah added.

Although the new guideline validated an important role for coronary calcium scoring, it still falls short in being completely personalized as advocated by SHAPE.

“Unfortunately, for many decades treatment for prevention of heart attacks had been based on a patient’s “risk factors,” rather on the amount of coronary plaque, reflecting particular individual’s true risk. When countless healthy-looking individuals—including those with low risk factors– are victimized every year by a sudden heart attack, we knew that the status quo was not working and that it was time for a new approach.  The SHAPE Task Force has long advocated going beyond traditional risk factors, to measuring CAC for personalized risk assessment. It is gratifying to see the SHAPE approach finally being adopted,” said Dr. Daniel Berman, Professor of Medicine at UCLA and Director of Nuclear Cardiology at Cedars Sinai Hospital, on behalf of the SHAPE Task Force.

It has taken the cardiology establishment over a decade to incorporate noninvasive imaging of atherosclerosis in early detection and treatment of atherosclerotic cardiovascular disease. Now that this major step forward is taken, the next challenge is securing reimbursement and universal coverage by payers. The good news is that the cost of CAC has significantly come down from what it was over a decade ago. Today, in the majority of diagnostic centers, the charge for a CAC test is usually $100-$200. In fact, certain hospitals offer the test at a cost below $100. Given this fact, SHAPE’s doctors were disappointed by the CNN quote attributed to Dr. Steve Nissen, a long term CAC-opponent. In this report https://www.cnn.com/2018/11/10/health/cholesterol-guidelines-aha-bn/index.html titled “New guidelines offer a more personalized approach” CNN’s Jessica Ravitz @JRavitzCNN wrote:

 “Nissen offered just one criticism of the new recommendations: the suggestion that coronary artery calcium scores be used to help determine the need for cholesterol-lowering treatments in patients for whom the need isn’t clear. This score shows plaque buildup in arteries and is determined through a CT scan, which can cost between $800 and $1,000, he said.” 

Dr. Mathew Budoff, professor of medicine and director of preventive cardiology at Harbor UCLA, stated “Dr. Nissen is an eminent cardiologist with many accomplishments, but in this case he is doing patients a great disservice. If the quote was accurately stated, he clearly misguided CNN and its numerous readers. Hopefully, Dr. Nissen will correct the record and follow the facts when it comes to CAC cost.” he added.

SHAPE acknowledges the reports by Gina Kolata @ginakolata of New York Times that accurately stated the cost of CAC and the barriers in the way of its adoption. (https://www.nytimes.com/2015/10/06/health/heart-scan-can-fine-tune-risk-estimate-for-patients-considering-statins.html ) “The test is a CT scan that looks for calcium in coronary arteries, a signal that plaque is present. It used to be expensive — about $500 — but now typically costs between $75 and $100. Still, it is generally not covered by insurance and so is not often used to assess risk. The X-ray dose is about that of a mammogram.” Kolata wrote in October 2015.

“I must say that she did an absolutely outstanding job of educating the public, something that the established professional organizations had failed to do at the time.” said Dr. Naghavi, founder of SHAPE and Executive Chairman of the SHAPE Task Force.

Although coronary artery calcium is the best indicator available today for detection of the Vulnerable Patient, the SHAPE Task Force recognizes that existing tools, including coronary calcium scoring, fall short in accurately identifying the Vulnerable Patient. Most recently, SHAPE has proposed a major, multi-national collaborative project dubbed “Machine Learning Vulnerable Patient.” This project aims at utilizing certain forms of artificial intelligence in a unique subset of cases from various prospective “cohort studies” around the world to identify the biological signature of a near future heart attack.  Through this initiative, blood samples will be collected from blood banks of major cohorts in which apparently healthy people experienced a heart attack few days, weeks, or months after their blood draw and clinical exams. The in- depth investigation of this unique subset has the potential to provide researchers with new insight into what is happening in the days, weeks, and months prior to a heart attack, and will allow them to characterize related biological signals. Once the Vulnerable Patient is characterized, researchers will be able to conduct clinical trials to evaluate the effect of various therapeutic interventions on these individuals and develop new “short-range” treatment guidelines that do not exist today.

Currently, heart attacks are predicted using a 10-year risk prediction based on “risk factors” alone.  “Imagine if we tried to predict 10 years ago where and when Hurricanes Harvey and Irma would strike: our predictions would hardly be accurate. We know long term predictions of disasters in nature are ineffective. Similarly our traditional 10-year and life-time risk predictions do not work well because they do not trigger immediate preventive actions. Preventive cardiology needs a short-term predictor. An accurate 12 month forecast of who is likely to have a heart attack can be a game changer in cardiology. It can trigger aggressive life style modifications in patients and provide unprecedented opportunities for intensive therapies including new therapies that are not currently implemented. Overall there is a great potential to save many lives from sudden cardiac events, and it can be achieved with a small investment in Machine Learning Vulnerable Patient Project.

This topic was extensively discussed during SHAPE Symposia, held in conjunction with the past Annual Scientific Sessions of American Heart Associations. For details and viewing the presentations visit the following links:

The First Machine Learning Vulnerable Patient Symposium

http://shapesociety.org/the-first-machine-learning-heart-attack-forecast-symposium/

The Second Machine Learning Vulnerable Patient Symposium

http://shapesociety.org/the-second-machine-learning-heart-attack-forecast-symposium/

 

Machine Learning Outperforms ACC/AHA CVD Risk Calculator in MESA
Originally published 11 Nov 2018Journal of the American Heart Association. 2018;7:e009476

https://www.ahajournals.org/doi/full/10.1161/JAHA.118.009476 (Full-Text)

 

About SHAPE
The Society for Heart Attack Prevention and Eradication (SHAPE) is a non-profit organization that promotes education and research related to prevention, detection, and treatment of heart attacks. SHAPE is committed to raising public awareness about revolutionary discoveries that are opening exciting avenues to prevent heart attacks. SHAPE’s mission is to eradicate heart attacks in the 21st century. Additional information is available on the organization’s website at http://shapesociety.org or by calling 1-877-SHAPE11 or 713-529-4484.

About SHAPE Task Force:
The SHAPE Task Force, an international group of leading cardiovascular physicians and researchers, has created the SHAPE Guidelines, which educates physicians on how to identify asymptomatic atherosclerosis (hidden plaques) and implement proper therapies to prevent a future heart attack. According to the SHAPE Guidelines, men 45-75 and women 55-75 need to be tested for hidden plaques in coronary or carotid arteries. Individuals with high risk atherosclerosis (high plaque score) should be treated even if their cholesterol level is within statistical “normal range.” If they have plaques, the so-called normal is not normal for them. The higher the amount of plaque burden in the arteries the higher the risk and the more vulnerable to heart attack. SHAPE Guideline aims to identify the asymptomatic “Vulnerable Patient” and offer them intensive preventive therapy to prevent a future heart attack. Knowing one’s plaque score can be a matter of life and death. Additional information is available by calling 1-877-SHAPE11 or 713-529-4484. And Additional information is available at http://shapesociety.org
The SHAPE Task Force includes the following:
Morteza Naghavi, M.D. – Executive Chairman
PK Shah, M.D. – Chair of Scientific Board
Erling Falk, M.D., Ph.D. – Chief of Editorial Committee

SHAPE Task Force Members and Advisors (alphabetic order):

Arthur Agatston, M.D., Daniel Arking, Ph.D., Juan Badimon, Ph.D., Raymond Bahr, M.D., Daniel S. Berman, M.D., Matthew J. Budoff, M.D., Michael Blaha, M.D., Jay Cohn, M.D., Michael Davidson, M.D., Raimund Erbel, M.D., Erling Falk, M.D., Ph.D., Zahi Fayad, Ph.D., Sergio Fazio, MD, PhD, Steven B. Feinstein, M.D., Craig Hartley, Ph.D., Harvey S. Hecht, M.D., Howard Hodis, M.D., Ioannis Kakadiaris, Ph.D., Sanjay Kaul, M.D., M.P.H., Asher Kimchi. M.D., Wolfgang Koenig, M.D., Ph.D., Iftikhar J. Kullo, M.D., Daniel Lane, M.D., Ph.D., David Maron, M.D., Roxana Mehran, M.D., Ralph Metcalfe, Ph.D., Morteza Naghavi, M.D., Khurram Nasir, M.D., M.P.H., Tasneem Z. Naqvi, M.D., Jagat Narula, M.D., Paolo Raggi, M.D., George P. Rodgers, M.D., James HF Rudd, Ph.D., John A. Rumberger, PhD, M.D., Robert S. Schwartz, M.D., PK Shah, M.D., Leslee Shaw, Ph.D., David Spence, M.D., H. Robert Superko, M.D., Henrik Sillesen, M.D., Ph.D., Pierre-Jean Touboul, M.D. Nathan D. Wong, Ph.D.
http://shapesociety.org/scientific-advisory-board