DEEP SCIENCE NEWS: BREAKING NEW 'MEDTECH' GROUND IN PAIN HEALING

By IPHA TechReview/Editorial Team: Lennard Gettz, Ed.D. | Robert L. Bard, MD | Leslie V. Montoya, MD |  Roberta Kline, MD   | Josh Schueller

In our ongoing journey to review and feature NON‐INVASIVE MEDICAL & HEALTH INNOVATIONS, IPHA‐NEWS editors recently met with founders of AVACEN® Medical‐husband and wife team CMO/Co‐founder Danielle Forsgren and Chief developer Thomas Muehlbauer. They presented at a Health & Wellness Conference in Miami in the summer of 2022 where they shared a most unique therapeutic design to address chronic and acute pain through the science of microcirculation.

HEALTHTECH REVIEW on AVACEN® MICROCIRCULATION THERAPY

Abbreviated from "Advanced VAscular Circulatory ENhancement", the origin of this groundbreaking innovation was sparked by a deeply personal mission from its founders. In 2008, Tom (Muehlbauer) committed to the research and development of a medical device that could help (and restore) Danielle's older sister who, for 25 years, had suffered the crippling symptoms of severe chronic MIGRAINES. "It was very important [to us] that we had a medical device that was non‐invasive, because my sister took many medications on a daily basis‐ and I actually saw her NOT getting better ‐ but instead, actually grow worse", said Danielle.

It is also noted that the development duo was inspired to target MIGRAINES as the foundation of their main work venture due to our existing HEADACHE and MIGRAINE epidemic (over 20.0% of women and 9.7% of men in America)[1]. At the time, Tom was working with a group of scientists at a major research University on human thermal regulation. He applied this understanding of biophysics to developing the AVACEN concept. 6 years later, the AVACEN device achieved FDA class II clearance to offer thermo therapy for aches, pain, strains, overall muscular relaxation and joint pain associated with arthritis. This gave them the official green light to promote AVACEN as a medical grade device for the countless pain sufferers in the U.S.. In addition, this unique concept has also shown, in a published peer reviewed pilot study [2],  significant Fibromyalgia pain reduction and functioning markers after 4 weeks of directed use.

THE SCIENCE: MECHANISM OF ACTION

With over 4,000 programmed microprocessor instructions and 17 US and International patents, the AVACEN device, uses heat and vacuum, to accomplish the noninvasive and safe infusion of heat into the circulatory system. The result is the dilating of micro vessels thereby increasing microcirculation. It does so by taking advantage of a unique arrangement of blood vessels called arteriovenous anastomosis (AVA’s) in the palm of the hand. "Tom found a unique way to engage the AVA's in the palm of your hand using a dry heat transfer pad and a vacuum", explains Danielle. "The vacuum keeps these AVAs distended, whereas without a vacuum your body would shut the heat transfer down using vasoconstriction. The continually warmed blood is then circulated naturally to all the organs and deep muscle tissues carrying with it an increased level of beneficial oxygen and nutrients. This is also believed to enhance enzyme function for those with low core body temperature, and increase microvascular circulation throughout the entire body. ’ Studies have shown that increased microcirculation can increase functional capillary density (FCD)‐‐ and that is the holy grail for longevity".

PHILOSOPHY:
CMO Danielle Forsgren expressed subscribing to a more EASTERN (and naturopathic/ osteopathic) than WESTERN medicine philosophy. This very framework led the strategy of a sustainable and non‐invasive design plan (ie. "... thermography vs. an x‐ray"). "Having my sister handed pill after pill after drug after patch‐ then a medically implanted box that went septic... we sought to do what we could to get her off of medication and give her a little bit of her life back. That was what Tom and I decided was most important."

INDUSTRY UPGRADES:

Over the years, AVACEN continues to UPGRADE their original design concept with various models to suit ongoing market demands. Their base models called the AVACEN®HOME™ and the HOME+ is a single button push device than accommodates 95% of hand sizes. After five years in development, this year the AVACEN PRO+ and AVACEN XL were launched‐ with color touch screen controls, audio and video applications and a fully integrative user‐interface with various languages including the Asian community. It also supports Bluetooth /WIFI /RFID and accommodates 99% of hand sizes. These newly launched models will be discussed at the conclusion of our HEALTH TECH REPORTER test drive.

**Stay tuned for HEALTH TECH REPORTER'S CLINCAL TEST DRIVE OF THE AVACEN®PRO+

1) QuickStats: Percentage* of Adults Aged ≥18 Years Who Reported Having a Severe Headache or Migraine in the Past 3 Months,...National Health Interview Survey,US 2015 /2017 / 66(24);654 https://www.cdc.gov/mmwr/volumes/66/wr/mm6624a8.htm

2) Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)  https://clinicaltrials.gov/ct2/show/NCT01619579

3) "Avacen Review: Heat Therapy for Pain Relief"- https://painresource.com/chronic‐pain/AVACEN‐review‐heat‐therapy‐for‐pain‐relief/

Overview: The Science of Energy Healing By: Roberta Kline, MD Energetic healing has been practiced by many cultures and in many forms over the centuries. While mainstream medicine has embraced some forms of energetic modalities, by and large it has viewed most as “alternative” and “non-science based”. This is slowly changing as the science is catching up to be able to explain this ancient practice.  The term "energy medicine" has been in general use since the founding of the International Society for the Study of Subtle Energies and Energy Medicine in the 1980s.  Energy medicine often proposes that imbalances in the body's "energy field" result in illness, and that by re-balancing the body's energy-field health can be restored.[5] Some modalities are described to "bring balance to the body's overall wellness", while others bring claims of  addressing pain, detoxing, cell regeneration or improve overall energy.  ENERGY IS EVERYWHERE Everything is energy. Quantum physics has demonstrated that everything exists as a vibrational energy. Some forms of energy have a frequency low enough to make the object solid and therefore visible and physically tangible, such as concrete, trees, mountains, and the human body. Others, such as sound, light, heat and gravity are invisible – but they are no less real.  Every living thing requires energy to exist and function, and this comes in different forms. For example, in the human body are “energy generators” called the mitochondria. These tiny powerhouses in our cells convert fat, protein and glucose into ATP – the energy that fuels everything that is needed for us to be alive. (see review on the mitochondria). While the science behind how energy exists and is utilized for health and well-being is quite complex, efforts have been underway for more than 30 years to create a more approachable understanding. (See complete report)

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THE SITTING CULTURE: HIGH RISK OF DECLINE AND MORTALITY

INTRODUCTION

by: Robert L. Bard, MD

Amidst our global pandemic, keeping the doctor away means heeding his or her lifestyle advice on prevention, early detection and taking in their research on what it means to truly stay out of trouble.  Meanwhile, upon review of many Americans' health challenges and concerns, we assembled some of the most pertinent questions and concerns that weigh in on their decision making process.   

Months into a new year awakens great opportunities to invest in HEALTHY CHANGE in your lifestyle.  For the many Americans who live a sedentary lifestyle, most of us use time markers (like a new year) as a sensible time to re-dedicate to new challenges.  Losing weight is the number one goal each year for most people - and the undisputed culprit to a non-active lifestyle drives unhealthy choice-making into a situational life trap.  Meanwhile, other members of the community are situated with the inability to perform physical activities due to chronic pain or a debilitating disease (ie. spinal cord injury, traumatic brain injury or stoke sufferers).  

In an interview with Dr. Jonathan S. Kirschner, physiatrist at HSS (Hospital for Special Surgery),  we found his expertise, his thought process and his insight on certain health solutions to deliver remarkable value to us all- especially those affected in some way by the debilitating effects of the pandemic lifestyle.  

2022 LIFE EXTENSION REVIEW

Adapted from an interview with Dr. Jonathan Kirschner

During the COVID pandemic, I see two types of people; people who move less and those who move more.  Some people with more free time typically don't have to spend extra hours to commute.  Now, they've got that time for themselves (instead of commuting) working from their home office.  So that frees up more time for physical activity.  Upon revaluing life and lifestyle in general, some people have the time to commit to things like learning about the importance of health and actually take actionable steps.  Where people did not used to have time to join an exercise program, we now have the option (because of Covid) to watch exercise classes through Zoom and things like that.  

There's enough data pointing the sedentary lifestyle as the main culprit to a wide array of medical issues- not only musculoskeletal issues like back pain, herniated discs, neck pain, neck strain with everyone at the computer because of covid, but also the metabolic effects of sitting.  So if we’re not moving, we're at a high risk for gaining weight, developing diabetes and high blood pressure.  Those are some of the consequences of our modern lifestyle with all this technology and computers, whereas in the old days we had to forage for food.  We had to farm the food, lift bales of hay, walk to the water well and come back home.  We are not doing those things now.  

The best way to communicate all this is to not throw it out to the patient all at once; sometimes it’s better to make baby steps because it can be daunting.  If the patient has a lot of weight to lose, or for anyone who has not been exercising, you want to start engaging them in an exercise program. (See complete feature)

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WHAT? YOU NEVER HEARD OF KREBS CYCLE? (The  Science of Self Regeneration)

 Written By: Josh Schueller, PT

As a Physical Therapist and a patient analyst, I find myself constantly referencing course work from my college days to explain to patients how modern therapy actually works.  Today's patient has a hungry mind equipped to handle deeper explanations about how their therapies actually affect them.  Because of this, it behooves me to share content from my own medical texts to explain how the latest "invisible" therapeutic innovations work on them.   Such modern breakthroughs include: Stem Cell & PRP therapies, PEMF & Biofeedback technologies, Transcranial Stimulation, Laser Acupuncture, Neurostim therapeutics etc-- just to name a few. Meanwhile, I am equally impressed at our Google surfing community that can retain much of the same medical information my career was founded on.  Just the other day, a 21 year old patient with spinal cord injury actually started asking me how my neurostim device affects cellular regeneration and THE KREBS CYCLE.  So my presentation begins.

The Krebs’s Cycle is a multi-step chemical reaction that is the main source of energy for cells during Aerobic respiration.  Also called the TCA (TriCarboxylic Acid) Cycle or Citric Acid Cycle, the Krebs cycle occurs in eukaryotes (cells with a nucleus) in the matrix of the mitochondria and the cytosol of prokaryotes (no distinct nucleus).   In a living organism, the TCA cycle is a series of reactions in which oxidation of Acetic Acid/glucose provides energy for storage in phosphate bonds (ATP).  Fuel for this comes from lipids and carbohydrates, which produce Acetyl-CoA.  These reactions are the major source of energy in all living organisms.  Critical in the building blocks for synthesis of fatty acids, steroids, cholesterol, amino acids for building proteins and purines and pyrimidines used in the synthesis of DNA. The byproducts of the Krebs’s Cycle are 3 NADH, 1 FADHL, 1 GTP, and 2 CO2. (3)  The cycle runs twice for glucose and then the electron transport chain produces ATP. The electron transport chain is a series of reactions inside the cell whose purpose is the formation of ATP.  By studying the rates, by-products, enzymatic activity and qualities in the processes of metabolism the potential to draw conclusion about and investigate the efficiency of therapies.  Glucose into mitochondria to go through Krebs Cycle (NADH, FADHL, GTP, CO2 byproducts) electron transport chain into ATP (energy) Disorders of the Krebs Cycle such as 2-Oxoglutaric aciduria and fumarase deficiency affects mitochondrial function and maintenance.  This can cause developmental delays, severe neurologic problems in infants like mental retardation.  Clinical presentation of mitochondrial depletion syndrome is hypotonia, progressive dystonia, muscle atrophy and hearing impairments. (5)  (see full feature report)

 

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Ultra Low Frequency Therapy: Meet The H-WAVE

Tech Report by: Leslie Valle-Montoya, MD

For those who suffer from acute, intractable, and/or chronic pain, H-WAVE is an evidenced-based modality you can use at home, and one that has changed the lives of many.  I was first introduced to this microcurrent device as a healing modality for patients with some chronic illnesses and were tired of taking so many different medications to help speed up their recovery to wellness.  Pain was the one symptom on top of everyone’s list.  And without proper management of pain, healing and regeneration seem impossible to achieve. 

DRUG-FREE PAIN RELIEF & RECOVERY

MICROCURRENT is a technology that gently delivers electrical impulses at an extremely low frequency.  Every cell in our body is electrically active and in order to promote healing in our tissues and decrease inflammation at the same time, electrical impulses must be stimulated in order for our cells to communicate with each other and correct pathways of communication, detoxification, and ultimately pain relief.

Most who have suffered from chronic pain have been exposed or introduced to the use of electricity for pain reduction and healing, such as TENS devices.  But don’t confuse microcurrent technology with TENS – they are not the same. TENS stands for transcutaneous electrical nerve stimulation and they operate at high power to cause tetany and block the pain signal.  Blocking the pain may feel great at first but are only a temporary effect and it doesn’t address the root cause; inflammation.  

H-Wave technology is uniquely different from other electronic waveforms in that it helps facilitate a dynamic (no tetany) muscle contraction.  This muscle contraction is the primary physiologic catalyst to increase circulation and lymphatic drainage, and decrease inflammation. 

A secondary effect I saw from the use of this device is the benefit of lymphokinetic action.  What I saw in the majority of the chronic immune patients was not only symptoms of pain but symptoms of toxic overloads.  Most patients were in so much pain that exercising for the benefit of lymph movement was not at the top of their to-do lists. Luckily, with the use of H-Wave, patients experienced increased blood flow from full-cycle muscle contraction providing the transportation to purge and rinse the tissues of metabolites, chemical irritants, and other toxic-fluid pressures.  

Unlike ice, compression, or medications, this microcurrent technology has been shown to produce key elements for pain management and recovery: 

• Increase blood flow

• Pain management

• Nitric oxide-dependent vasodilation

• Activates muscles to move waste through the lymphatic system for drainage

• Reducing chemo-induced or diabetic-induced neuropathy

• Reduce inflammation

• Increase post-op range of motion

The history of microcurrent therapy

Hippocrates ‘the father of Medicine’ takes us back to the beginning use of microcurrent treatment.  He would immerse his patients into barrels of water filled with electrical eels for medical applications including arthritis, cephalalgia, pain relief, and increased circulation. (1)

Sounds shocking, right?  I have found to use this same theory in a more sophisticated and elegant method for using the power of electricity in patients with neuropathy.  The Father of Medicine laid the groundwork for many more scientists to come. In the 1960s, Dr. Ronald Melzack and Dr. Patrick Wall, created the Gate Control Theory of pain mechanisms and management. The scientist proposed that the spinal transmission cells activate an action system in the brain that experiences and blocks pain impulses to the brain. (2).  And in the 1980s, physicians in Europe and the United States would first use microcurrent to stimulate bone repair in non-union fractures.

Other uses: Dentistry
By inhibiting the function of the Sodium Channel within the nerve and thereby creating an anesthetic/analgesic effect, H-Wave’s potent effect on pain relief gave its clearance by the FDA for use in dental anesthesia. 

SYNCHRONIZED IMAGING OF TREATMENT PROGRESS  A feature from HEALTH & HEALING 101  One program for athletic pain and injuries is designed by Dr. Robert Bard (clinical diagnostician) aligning with with physiatrists from the realm of functional medicine to explore and refine what he aims to propose to be the next stage of evolution for imaging. “Combining the functions of real-time monitoring of ultrasound with these regenerative stimulators, we are able to see their immediate effects on the body.  With enough stress testing, we have proven that we have 100% compatibility (and no signal disruption) between the ultrasound probes while scanning the areas under electronic treatment- or vice-versa.  This is great news because our tests are of the body’s biometric response on a micro level- and these treatment devices all have some complex magnetic signals and emitters that may conflict with sound waves”, states Dr. Bard.  On a separate interview, NFL Alumni Director of Wellness Challenge Mr. Russ Allen applauds Dr. Bard’s research initiative for athletic injuries and the use of non-invasive intervention to get players back on the field.  “I have been a major fan of this PEMF technology for over a decade”, said Mr. Allen. “Someday, I hope to see the thought of drugs, shots and surgery in the past tense. So much about conventional medicine (and sports medicine) need an upgrade… especially when we have so many of these innovations that clearly show proven and sustainable results.  Dr. Bard is definitely on the right side of science by validating through imaging and encouraging non-invasive care, where seeing is believing.”

Sports Medicine/ Athletes
In Sports, performance and recovery are crucial for athletes, the biggest impact is the downtown of recovery.  The use of microcurrent can now be easily incorporated into daily use especially when devices are handheld, portable, and manageable with the guidance of a professional practitioner.  With the help of microcurrent therapy, one can improve physical health, and advance in their competitive career while recovering and healing.  

In the 2000 NBA Championship, Kobe Bryant’s ankle injury was extensively treated by H-Wave.  Gary Vitti, Head Athletic Trainer, Los Angeles Lakers believed “H-Wave was a big factor in helping Kobe return to action to help clinch the NBA title for the Lakers”.

My Cases
Here I share a recent case with the use of H-Wave and my patient and his recovery. Better yet, I will share his testimonial with you.

H Wave Testimonial Kevin W. (Perth, Western Australia)

I have lived an active sporting life however in my sixties I developed a severe case of posterior tibial tendonitis that resulted in pain on the inner side of my right foot and ankle. As the condition worsened it developed into a problem called adult-acquired flatfoot deformity (AAFD) which was very painful and limited my mobility to the extent that I could not walk long distances or walk without a limp.

I consulted my surgeon who recommended I undertake Subtalar Arthrodesis or joint fusion of my right foot. This surgery involves joining the talus and calcaneum together as an effective way of decreasing pain and improving the function of the foot. A bone graft harvest was taken from my knee to use to assist screws in the talonavicular fusion. Subsequent to the operation I experienced significant pain in my foot that required opiate painkillers for remediation; an MRI scan revealed that only minimal fusion was evident.

I was introduced to the H Wave technology by a friend in Perth Western Australia whose elderly father in London had been using the device successfully to remediate chronic hip pain. Via Dr. Valle’s telehealth guidance, I acquired my own H-Wave and continued medical consultations for the best use of this device. 

After using the H-Wave over the past year, a recent MRI indicated that there had been talonavicular progression and healing without complication. I am nearly pain-free, no longer take strong painkillers and use the H-Wave almost daily to improve my mobility and sleep patterns.

I cannot thank Dr. Valle enough for her professional guidance and assistance with the use of the H-Wave. She has given her time generously being on standby at a day’s notice to take my video call from Perth to discuss treatment options.

 

Highlights

• Microcurrent therapy can improve cellular function (e.g. increase circulation, tissue repair, and remodeling)

• Microcurrent is a non-invasive method of introducing bioelectricity into the body

• Microcurrent therapy pre and post-op speeds up recovery time

• Applying microcurrent during a post-workout time in endurance athletes can reduce the level of muscle soreness after performing an exhaustive exercise

• Combats tissue congestion

• Facilitates faster mobility

• Drug-free treatment protocol with pain relief

LESLIE VALLE, MD - Founder of Biomed Life/ Santa Barbara Longevity Center
After medical school, Dr. Valle focused on managing chronic disease starting with its links to poor nutrition and then introducing them into the world of energy frequencies.  She explores and includes non-invasive modalities such as: frequency therapies (including biofeedback), PEMF, proper detoxification, nutritional guidance and binaural beats as needed. - visit: www.biomedlifesb.com

 

References:

Tsoucalas, G. and Sgantzos, M.  (2016).  Electric current to cure arthritis and cephalaea in ancient Greek medicine.  Mediterranean Journal of Rheumatology. 27 (4): 198-203

Katz, J. and Rosenbloon, B.  (2015).  The golden anniversary of Melzack and Wall’s gate control theory of pain:  Celebrating 50 years of pain research and management.  Pain Research and Management. doi: 10.1155/2015/865487

Early Detection: The Risk of Being "Too Young for a Mammogram"

A major concern is the presence of breast cancer in underserved communities, including those TOO YOUNG FOR A MAMMOGRAM.  Whereby the medical community touts the recommended (and legal/billable status) of getting a mammo scan should be between 40-50, what happens to the many women who do not fit this age criteria?  How would they even know to get checked without the support of their clinicians or an alarm from family history?

Decades into the battle against breast cancer, clinicians and the public are much more educated about EARLY DETECTION, PREVENTION and the current protocols and modalities available to save lives.  Recent headlines on DENSE BREAST and the advancements in ULTRASOUND SCANNING supports a major part of this battle.

UNDERSERVED AGE FOR EARLY DETECTION

By Dr. Robert L. Bard and Joe Cappello of AreYouDense.org

According to Breastcancer.org, "Where mammography is available, ultrasound should be seen as a supplemental test for women with dense breasts who do not meet high-risk criteria for screening [with] MRI and for high-risk women with dense breasts who are unable to tolerate MRI... but if mammography isn’t available, then ultrasound seems to be a good alternative for breast cancer screening."

Doppler Sonography offers clinical accuracy and access
to breast imaging evaluation (www.breastcancernyc.com)

A recent cohort study is underway under a partnership between Molloy College and AreYouDense.org  to publish new findings about low BMI patients and younger women about the presence of dense breast tissue.  This same review also covers the advantages of ultrasound use where mammography is not available.

Mammography is the current standard for breast cancer early detection for women 40 & older. Recent studies have shown nearly half of all women who get mammograms are found to have dense breasts, exposing this population to the risk that mammograms may miss potentially cancerous tumors concealed by dense breast tissue.  Dr. Cutter's initial concepts to target LOW BMI (bet 12-22% body fat) was personally inspired.  As an active TRIATHLETE, her own diagnosis sparked her survey and inquiry throughout the athletic community where she uncovered a significant trend that became the basis for this research. She wishes to target younger women, athletes and members of underserved communities. "Younger women may be more likely to have dense breasts... also I find athletes with LOWER BMI (body mass index) or those with  less body fat are more likely to have more dense breast tissue compared with women who are obese." (See complete feature article)

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VIEWPOINT 

WHAT ABOUT IF YOU'RE TOO YOUNG FOR A MAMMOGRAM?   I went to my doctor for a lump I felt in my breast and she gave me a response that set off red flags: "don't worry about it". Being a researcher involved in breast density and breast cancer, I knew that I had to take action; I was fortunate enough to have my breast ultrasound training with Dr. Robert Bard (cancer imaging specialist, NYC) upcoming in the next week. Dr. Bard showed me how to use the ultrasound to help me find two benign tumors in my breasts, and it was there that he reported that I have dense breasts. Had I not taken action in getting screened at the young age of 22, I would have never known that I should be getting screened via ultrasound every 6 months (because having dense breasts puts me at a higher risk for breast cancer), nor would I have known that I had benign breast tumors. 

- ALEXANDRA FIEDERLEIN, 22

Cancer Researcher/ Graduate- Molloy Univ.

NEWS FROM THE FIELD  Click to see NEWS The DENSE BREAST TISSUE / CANCER CONNECTION is a topic that has finally achieved proper recognition in our community. Thanks to organizations like The 'ARE YOU DENSE?' Foundation, awareness of this health concern has now shed light to the risk to 40+% of the national women's population whereby more clinicians are now recognizing the need to state a patient's dense breast status.  Research crusaders like  Dr. Noelle Cutter and research associate Alexandra Fiederlein from Molloy University are underway the 2022 National Survey of Dense Breast Studies by bringing ultrasound access to underserved members of the women's community.  In a recent episode of SPOTLIGHT ON AMERICA, Dr. Bard spoke as the clinical expert in the report "Millions of women have this breast cancer risk factors... why aren't they being informed?" -- TND REPORT/Spotlight on America is pressing to ensure women have access to a crucial health fact that could save their lives. According to the Centers for Disease Control and Prevention, 40% of women have dense breast tissue, which is a risk factor for cancer. The TND team first highlighted this issue in October 2021, and more than a year later, we expose how some women are still being left in the dark about their density, and federal health bodies are failing to make sure they’re informed.

2022 REVIEW ON WOMEN'S EARLY DETECTION STANDARDS 

Excerpt from the 2021 NYCRA Dense Breast Diagnostic Conference By: Dr. Roberta Kline

Breast cancer is still one of the most common cancers in women, and the leading cause of cancer mortality. While mammography is considered the standard imaging for early detection, it falls short for many – including those with dense breasts. Approximately 40% of women have dense breasts, which we now know is associated with an increased risk of breast cancer. On top of this increased risk, mammogram is less sensitive for early detection – up to 50% less for women with the highest breast density. [1] As a result many women are not diagnosed until they have a much later stage cancer – and a worse prognosis. [2]

The State of Connecticut passed legislation requiring notification of breast density in 2009, after having passed legislation requiring insurance coverage for ultrasound for dense breasts in 2005. As an ObGyn physician practicing in CT at the time, I remember the discussions with colleagues and patients around this issue although at the time there were no formal efforts to raise awareness or update guidelines from our national specialty organization, the American College of Obstetricians and Gynecologists (ACOG). 

PERSPECTIVE: PERSONAL FINDINGS BY A CLINICAL PROFESSIONAL

I was fortunate to have benefited personally from this effort when I had my first screening mammogram shortly after the law went into effect. The reading radiologist personally informed me of my high breast density immediately after the mammogram, and after recommending a breast ultrasound for further evaluation this was done right then and there. I walked away from my appointment feeling well informed, and any potential anxiety relieved by the prompt additional imaging and results. I also knew that I needed a different approach for my screenings going forward.

Between 2009 and 2019, 37 other states and D.C. passed legislation requiring notification of breast density, one of the last being my new home state of New Mexico. In 2019 a federal law was passed to require both clinician and patient reports contain plain language around the woman’s breast density, and to discuss with her provider. The FDA then created standard language that has now been implemented, requiring reporting on a woman’s individual breast density, and recommendation to discuss with her provider.

There is still much to be learned about what causes dense breasts and why women with dense breasts have an increased risk of breast cancer, and our ongoing study is one of many that are seeking to answer these questions at the molecular and genetic level. But the evidence that supplementing mammograms with other imaging modalities can increase the rate of early detection is substantial, and provides us with tools we can use right now to make a difference. [3,4]  Despite this progress, there are still significant hurdles in changing the standard of care. A recent experience with my routine breast cancer screening highlighted the ongoing challenges. When I had asked to schedule an ultrasound with my screening mammogram, I was informed that it was not done this way – I could only get a mammogram. After my mammogram, I had to wait to receive my letter in the mail approximately one week later to be able to take any additional steps. The interpretation included a description of breast density and recommended to discuss any additional care with my physician. 

When I called to schedule an ultrasound, I was told that since the radiologist did not recommend it in the report, I could not schedule it. I then had to speak with my primary care provider, educating her on dense breasts and why I needed an ultrasound. Luckily, she agreed to order one. While the radiology facility still questioned the order, eventually I was able to have this done. When the radiologist came in to discuss my results, she too was confused as to why I was having the ultrasound, and was not aware that this should be standard for women with dense breasts.

See 2022 Dense Breast Ultrasound Study

Fortunately all was fine, but had I not been a physician that was fully aware of this issue, I would very likely have had only a mammogram and walked away with a dangerously false sense of security. This experience highlighted for me how much still needed to be done more than 20 years after my first experience. Legislation is only part of the solution. Clinician education and public awareness are the keys to changing how the intention behind these laws gets translated into actual change in health care.

As I experienced, many clinicians are ill-informed about the nature of dense breasts, and options for adjunctive screening including ultrasound or MRI. This means that many of these reports end up being filed away with no further action being taken that could make a significant difference in early detection and saving lives.

EPILOGUE: CURRENT STANDARDS VS NEEDS

ACOG still officially does not recommend any further imaging for women with dense breasts on mammogram, despite the significant body of evidence suggesting that mammogram alone is insufficient and adjunctive imaging with ultrasound or MRI increases rate of early detection. [5] The U.S. Preventive Task Force [6]  does not recommend routine adjunctive imaging for screening women with dense breasts. This leaves many healthcare practitioners, from ObGyns to other primary care providers, unprepared to discuss this with their patients or provide sound recommendations. 

The American College of Radiologists, who also publishes the BIRADS standards for breast cancer screening, acknowledges awareness of breast density detection issues with mammography but stops short of recommending routine adjunctive imaging. Instead, they list ultrasound and MRI as “may be appropriate”. [7] We have enough evidence to know how to better serve women with dense breasts, and we can do better. Now we need to push for better education of all primary health care providers, including ObGyns, and continue to raise awareness for women around current knowledge and best practices. 

References

1) Gordon PB. The Impact of Dense Breasts on the Stage of Breast Cancer at Diagnosis: A Review and Options for Supplemental Screening. Curr Oncol. 2022 May 17;29(5):3595-3636.

2) Chiu, S.Y.H.; Duffy, S.; Yen, A.M.F.; Tabár, L.; Smith, R.A.; Chen, H.H. Effect of baseline breast density on breast cancer incidence, stage, mortality, and screening parameters: 25-Year follow-up of a Swedish mammographic screening. Cancer Epidemiol. Biomark. Prev. 2010, 19, 1219–1228

3) Harada-Shoji N, Suzuki A, Ishida T, Zheng YF, Narikawa-Shiono Y, Sato-Tadano A, Ohta R, Ohuchi N. Evaluation of Adjunctive Ultrasonography for Breast Cancer Detection Among Women Aged 40-49 Years With Varying Breast Density Undergoing Screening Mammography: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121505

4) Mann, R.M., Athanasiou, A., Baltzer, P.A.T. et al. Breast cancer screening in women with extremely dense breasts recommendations of the European Society of Breast Imaging (EUSOBI). Eur Radiol 32, 4036–4045 (2022).

5) Management of Women With Dense Breasts Diagnosed by Mammography. ACOG Committee Opinion. CO Number 625 March 2015

6) https://uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening

7) American College of Radiology ACR Appropriateness Criteria® Supplemental Breast Cancer Screening Based on Breast Density. 2021

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Feature: Diagnostic Tech Review/News:

TRACE4BDENSITY® − THE RADIOLOGISTS’ GUIDED ARTIFICIAL INTELLIGENCE TOOL FOR THE AUTOMATIC DENSITY CLASSIFICATION OF MAMMOGRAMS

One relevant challenge in using mammographic breast density as a driver to supplemental screening with manual or automatic ultrasound, MRI, contrast-enhanced mammography, or other new diagnostic methods is the suboptimal reproducibility of visual classification into the four ACR (Americal College of Radiation) BI-RADS® categories. This is an important problem, especially considering that the last BI-RADS® manual does not base the breast density classification on a pure semiquantitative assessment of the fibrogladular to fatty tissue ratio but takes into consideration the possibility of a masking effect of also limited areas of dense tissue that may obscure underlying cancers. Therefore, artificial intelligence (AI) methods are the best candidate to mimic the qualitative human reading aiming at reducing the risk of a delayed cancer diagnosis, providing an immediate breast density classification with a 100% reproducibility.

DeepTrace Technologies SRL  (http://www.deeptracetech.com/), the multi-awarded university spinoff of the IUSS School of Pavia, Italy, developed an AI software for automatic breast density classification using a deep learning approach, i.e., supervised convolutional neural networks: TRACE4BDensity®. The system was trained using the majority breast density category determined by seven board-certified radiologists who independently visually assessed 760 mediolateral oblique images. The model showed an accuracy of 89.3% in distinguishing BI-RADS a or b (nondense breasts) versus c or d (dense breasts) categories, with an agreement of 90.4% and a reliability of 0.807 (Cohen κ) compared with human readers. The clinical study that used TRACE4BDensity has been published in Radiology Artificial Intelligence 2022[1] and recently presented at the European Congress of Radiology in Vienna on July 16, 2022.

From A to D: examples of human readers (HR)–artificial intelligence (AI) agreement. TRACE4BDensity showed a 89.3% agreement and a reliability of 0.807 (Cohen κ) with human readings for the differention of dense breasts (category c or d) versus nondense breasts (category a or b). Radiol Artif Intell 2022 (doi/10.1148/ryai.210199). 

The software can be directly applied to the PACS of radiology centers providing the breast density category in a few seconds with 100% reproducibility, allowing breast radiologists to overcome the limitations of human reading that unfortunately may give different answers to the crucial question: Are you dense? In addition, this approach can be considered more fitting with the aim of avoiding delayed cancer diagnoses than methods purely based on quantitative assessment of fibroglandular and fatty breast tissue that may underestimate the masking effect of localized high- density areas. Such an accurate tool, proposing a standardized density classification, represents a valid help in the decision-making process and in proposing a more personalized breast cancer screening. «TRACE4BDensity can help us to provide advice to women with dense breasts about the possibility of having, after a negative mammogram, additional screening with ultrasound, MRI, or contrast-enhanced mammography − explains Professor Francesco Sardanelli, head of the Diagnostic Imaging Service at the IRCCS Policlinico San Donato, coordinator of the Gruppo San Donato Breast Imaging Joint Research Unit, and full professor at the University of Milan, principal investigator of the study − This software, therefore, proves useful for radiologists as well as for women and patients». 

References:

1) Development and Validation of an AI-driven Mammographic Breast Density Classification Tool Based on Radiologist Consensus, https://pubs.rsna.org/doi/10.1148/ryai.210199

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CONTRIBUTORS:

DR. ROBERT L. BARD has paved the way for the diagnostic study of various cancers both clinically and academically. He runs an active NYC practice (Bard Diagnostic Imaging) using the latest in digital Imaging technology which has been also used to help guide biopsies and, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered Sonograms, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. His commitment to lead the community of cancer imaging and diagnostic experts has led to the establishment of the "Get Checked Now!" campaign.

JOSEPH J. CAPPELLO married Nancy Marcucci, in 1974 and the story began.  Joe is the co-founder and executive director of Are You Dense, and Are You Dense Advocacy- in January of 2019 after Nancy’s passing from treatment related bone marrow cancer (MDS). His passion is to continue Nancy’s legacy by pursuing the goal that they set in 2004; that not one woman would die from a late stage breast cancer due to dense breast tissue. In 2009, Joe and Nancy championed the first in the nation breast density inform law in the State of Connecticut (and now, 36 States have breast density legislation).

ROBERTA KLINE, MD (Educational Dir. /Women's Diagnostic Group) is a board-certified ObGyn physician, Integrative Personalized Medicine expert, consultant, author, and educator whose mission is to change how we approach health and deliver healthcare. She helped to create the Integrative & Functional Medicine program for a family practice residency, has consulted with Sodexo to implement the first personalized nutrition menu for healthcare facilities, and serves as Education Director for several organizations including the Women’s Diagnostic Health Network, Mommies on a Mission. 

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