Monday, August 24, 2020

Which Corticosteroid is Best for SARS-CoV-2?

“Problem-solving leaders have one thing in common: a faith that there’s always a better way.” – Gerald M. Weinberg


DEXAMETHASONE VS. METHYLPREDNISOLONE
Produced by: Lennard M. Gettz & Dr. Robert L. Bard
Edited by: FLCCC Technical Team


August, 2020- the current status of the Coronavirus pandemic keeps up a healthy dose of conflicting global news headlines (ranging in levels of scientific validity) as far as potential treatment solutions and vaccines.  Countless research groups and clinical trials world-wide bear differing fruits, one closer to the end game than the next.



By June, the W.H.O. launched the headline “Preliminary results about dexamethasone use in treating critically ill COVID-19 patients” [5].  This was echoed immediately by countless European news sources with encouragement like “Dexamethasone to be the proven first life-saving drug”- forming a global cascade of targeted positivity and market demand from a world so desperate for a cure.


Publicly recognized by health agencies like the NIH who stated, “Patients with severe COVID-19 can develop a systemic inflammatory response that can lead to lung injury and multisystem organ dysfunction. It has been proposed that the potent anti-inflammatory effects of corticosteroids might prevent or mitigate these deleterious effects” [1]

A unique insight into this disease showed that the majority of patients initially present with an inflammatory reaction in the lungs called “organizing pneumonia,” which is the body’s reaction to injury and has been well known to be profoundly responsive to corticosteroid therapy. If the organizing pneumonia response is left untreated or presents as a rapidly progressive sub-type, a condition called Acute Respiratory Distress Syndrome (ARDS) follows.



STRATEGIC TREATMENT CHALLENGE FROM THE FIELD
Meanwhile, teams of American physicians like Dr. Pierre Kory, Pulmonary and Critical Care Specialist (Milwaukee, WI) and his team of front-line Covid care providers (the Front Line Covid-19 Critical Care Alliance) challenged Dexamethasone as the exalted panacea of the pandemic.  Dr. Kory’s team dedicated their life’s work to the research and treatment of infectious diseases in critical illness, and recently published a battle-tested and proven Hospital Treatment Protocol called MATH+,  a combination of medicines designed to counteract the injurious hyperinflammation, hypercoagulability, and hypoxemia in COVID-19 using synergistic actions. Their group strongly recommends a different corticosteroid called METHYLPREDNISOLONE.   Work done by members of the group, in particular, Dr. G. Umberto Meduri, one of the worlds experts on the use of corticosteroids in critical illness, discovered key findings establishing the rationale in support of the preferred use of Methylprednisolone, while also providing a wider scope of evidence supporting corticosteroid therapy for Covid-19 critical cases.


According to Dr. George P. Chrousos (Athens, Greece), leading international expert on glucocorticoids, he detailed conclusive evidence about  "homeostasis and the “surprise” of effective glucocorticoid therapy" in a recent medical report with Dr. G. Umberto Meduri (7/2020, Elsevier/Science Direct).  His summary included-- "...on the basis of our understanding of the pathophysiological mechanisms of critical disease, one can conclude that the onset of therapy with glucocorticoids and, possibly, other useful or potentially useful agents in severe COVID-19 must take place early, before the homeostatic mechanisms of the organism reach complete, irreversible exhaustion. ... It is questionable whether dexamethasone is more efficacious than other synthetic glucocorticoids when given in equivalent doses. One potential advantage is the almost complete lack of salt-retaining activity of this corticosteroid. As the pleiotropic actions of ascorbic acid, vitamin D, and thiamine include assisting glucocorticoids and mitochondria in the change of the homeostatic immune balance from proinflammatory to anti-inflammatory, it is best for the patients to have sufficient reserves of these rapidly depleted micronutrients. This treatment approach is incorporated into the MATH+ (methylprednisolone, thiamine, ascorbic acid, heparin) protocol (https://covid19criticalcare.com). [6]




BACKGROUND
Between March of 2013, and Dec of 2018, a research group in Spain conducted a multi-ICU randomized trial to treat ARDS to an estimated 250 patients. It resulted in higher ventilator-free days in the DEXAMETHASONE group than in the control group. By day 60, 21% of the patients in the Dexamethasone group and 36% of the patients in the control group had died. [2] This randomized controlled trial showed profound benefits to treating ARDS with Dexamethasone.

A more recent study between Jan-Feb of 2020 at the isolation ward of the Union Hospital of Huazhong University of Science and Technology in Wuhan, China reported much higher survival rates among the 84 patients with severe COVID-19 pneumonia that were treated with early, low-dose Methylprednisolone compared to those who did not receive such treatment. Because this is was an early observational study, it encouraged later and larger randomized controlled trials to confirm the findings and further study the mid- and long-term outcomes after discharge.

Other studies continued with varying patient numbers and severity of illness (ie. respiratory distress, elevated respiratory rates and significantly diminished oxygen saturation), all seeking comparative clinical outcomes of COVID-19 pneumonia patients with or without Methylprednisolone treatment. [3] This studies concluded that “early administration of methylprednisolone could reduce duration of mechanical ventilation and overall mortality in patients with established moderate-to-severe ARDS”.



COVID ARDS / PNEUMONIA:
Chinese cohort, ARDS, Wuhan – 84 ARDS patients, 46% mortality with MethylP, 62% if no MethylPrednisolone [7]

HR=.38 (62% reduction in death)

Other COVID Studies, all using MethylPrednisolone
1) HFHS Trial, Detroit, Fadr R- showed a 45% RR, with early MP compared to 29% with dexamethasone in Recovery Trial
2) French study - steroids reduced rate of intubation from 51% to 8.6% - massive
3) Glucocovid trial - 50% Risk reduction for NIV, INTUBATION/DEATH Iin all, it was less ICU, in young it was less death)
4) Canfolanieri Trial from Italy- mortality was reduced from was 23.3% to 7.2%- a 69% relative reisk reduction (RRR), compare this to Recovery trial which had an RRR of 29% if on MV and 20% if on oxygen.



NON-VIRAL ARDS:
1 Trial using DEXAMETHASONE (277 patients) -LANCET “DEXA-ARDS’ TRIAL (Villar 2020)
– increased MV-free days by 4.8
-duration of MV decreased by 5.3
- Number need to treat to save a life using absolute mortality difference = 8

4 Trials using METHYPREDNISONE (322 patients) (Meduri, 1998, 2007, Steinberg 2006, Rezk 2013)
– increased MV free days by 8.5
-duration of MV decreased by 10.1
- Number need to treat to save a life using absolute mortality difference = 5.3
5 Trials using HYDROCORTISONE (494 patients) (Confalonieri, 05, Annane, ’06, Sabry, ’11, Liu, ’12, REzk, 2013, Tongyoo, 2016

-increased MV free days by 4.0
-Number need to treat to save a life using absolute mortality difference = 9.7


CONCLUSION
From the viewpoint of treatment strategy, Dr. Kory and his colleagues offer their assessment based on active historical data of mortality and an evidence based review; “the number needed to treat (NNT) to save one life with a therapy is calculated by dividing the absolute risk reduction associated with the treatment into 100. So let's say 80% of patients die and you get it down to 60%, that's an absolute risk reduction of 20. And that means you only need to treat five patients to save one life. And so we tend to estimate the potency of a life-saving therapy using the NNT. The NNT to save a life in ARDS with Methylprednisolone is about five and the number needed to treat to save a life with Dexamethazone using the existing studies is about eight based on old ARDS studies and in COVID it appears much higher than 8. And so when we're trying to advocate for use of methylprednisone, we’re doing so due to the fact that many more real lives could be saved, given the large difference in the efficacy of the two drugs."

If you can treat five patients and save a life (with one drug), whereas it takes eight patients to save a life with another drug (within your first 10 patients of) using Dexamethazone, you may have missed the opportunity to save a couple of lives - hence we emphasize the need for Methylprednisolone.

Trials are still going on, some are randomized control trials and cohort trials using methylprednisolone, including a famous one that received early attention from Henry Ford health System in Detroit, MI, another recently came out of Italy and another one from France. Those trials using methylprednisolone showed much more dramatic benefits- showing a reduction in mortality by 70%!  That's a significant number as far as saving lives.

Another study published in May, 2020, based on work done by a company called Advaita Bioinformatics, Dr. Sorin Draghici led a team that reviewed the comprehensive genetic database which lists the pattern of activation of all the hundreds of genes that are activated in cells cultured with SARS-CoV-2 (the virus that causes COVID-19). Almost all the genes produced inflammatory mediators,protein, cytokines and chemokines.

Advaita then used their database of several thousand medicines in which they had catalogued  the patterns of “gene suppression” induced by the medicines, and then they tried to find the “best match” that counteracted the pattern of activation. They did this for different viruses including H1N1 and SARS-CoV-2. At the conclusion of an extensive analysis, they found that the medicine whose suppression pattern most closely matched the activation pattern of SARS-Co-V2 was METHYLPREDNISOLONE. And on this top 10 list of matches, DEXAMETHAZONE WAS 6th.  Furthermore, according to their report, the researchers repeatedly stated that they didn't think that Dexamethasone would work very well. Hence, this genomic analysis review strongly supported the use of Methylprednisolone over dexamethasone. [4]



EPILOGUE: 

BEDSIDE DETECTION WITH DOPPLER ULTRASOUND IMAGING

by: Dr. Robert L. Bard


In reviewing the genes activated by SARS-CoV-2, almost all were for inflammatory proteins / cytokines / chemokines. A study of the gene “suppression” activity of a large number of medications has suggested the one medicine that best neutralized activity of the virus was methyprednisone. A new screening approach that provides real time evidence of clinical effect is the use of 3D high resolution lung ultrasound on the pleural surface and Doppler flow imaging on the inflammatory vascular dilation and blood velocity.

Lung ultrasound relies on the images produced by artifacts: A-lines from normal pleura, B-lines from abnormal pleural-parenchymal disease and increased Doppler flow in consolidations that are pleural based.

Survivors are experiencing either new organ system disorders or complications of ventilator dependency and pulmonary fibrosis. CT and ultrasound are useful in the investigation of these disorders and useful in follow up of potentially chronic conditions.  While lung CT abnormalities attain greatest severity approximately 10 days after onset of symptoms and tend to reduce after 14 days during the absorption phase with patients achieving normal living ability by about 2 months after onset, CT findings may remain apparent. CT images in the early recovery phase show reduction of GGO and reduced consolidation but pulmonary fibrosis appears as fibrous shadows such as fibrous stripes, subpleural lines and traction bronchiectasis in multiple lung lobes. This finding has been documented previously in SARS patients discharged after treatment. One can follow up fibrosis with non radiation imaging such as chestwall elastography and diaphragmatic ultrasound to compare with clinical respiratory evaluation.


In the months following patients with very minimal CT images, the clinical symptoms in some progress due to a chronic fibrotic response even as the imaging findings improve. This makes the pleural findings an important parameter and suggests initial and serial follow up with non invasive high resolution 3D ultrasound with elastographic scanning. The normal pleural thickness at 18 MHz linear transducer imaging is 0.3mm to 0.5mm and the normal pleural echo may be inhomogeneous due to the expected respiratory motion. Similarly, the expected A-lines  have the same features . A pathologically thickened pleura line is optimally imaged with a 3D 17 MHz linear probe or 18 MHz convex probe.  The diaphragmatic pleural interface is important since most of the pathology is found in this area which has some B-line activity in recumbent positions or in elderly patients so the pleural thickness is helpful in determining disease aggression. A thin pleural line with good respiratory excursion suggests healthy tissues.  Inflammatory or neoplastic hepatic or splenic disorder may cause attenuation of deep pleural echoes.


Doppler imaging of pleural based pneumonic consolidations shows increased blood flow in aggressive disease which decreases as the pneumonia improves or recedes from chestwall pleural contact. This novel approach is undergoing clinical study and has been used to differentiate benign from malignancy that is pleural based.

SUMMARY
Real time imaging of the pleural thickness is a surrogate marker for treatment effect. A pleural A-line that remains the same or reduces in thickness means pharmacologic drug effect is effective. Conversely a thickening line implies disease progression. Similarly, Doppler flow decreasing in a pleural based consolidation is a positive sign of clinical impact.



CONTRIBUTORS

ROBERT L. BARD, MD, PC, DABR, FASLMS
Advanced Imaging & Diagnostic Specialist
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 



PIERRE KORY, M.D., M.P.A.
Dr. Kory is Board Certified in Internal Medicine, Critical Care, and Pulmonary Medicine. He served as the Medical Director of the Trauma and Life Support Center at the University of Wisconsin where he was an Associate Professor and the Chief of the Critical Care Service. He is considered a pioneer and national/international expert in the field of Critical Care Ultrasound and is the senior editor of the widely read textbook “Point-of-Care Ultrasound” (winner of the President’s Choice Award for Medical Textbooks from the British Medical Association in 2015).  Most recently, Dr. Kory joined the emergency volunteer team during the early COVID-19 pandemic in NYC at Mount Sinai Beth Israel Medical Center. He is also a founding member of the Front Line COVID-19 Critical Working Group (flccc.net) composed of 5 critical care experts that devised the COVID-19 treatment protocol called MATH+. (www.covid19criticalcare.com/)



REFERENCES
1) Corticosteroids (Last Updated: July 30, 2020) Recommendations for Patients with COVID-19
2) Dexa randomized multi-unit test in Spain/ https://pubmed.ncbi.nlm.nih.gov/32043986/
3) A retrospective cohort study of methylprednisolone therapy in severe patients with COVID-19 pneumonia https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186116/
4) Wayne State spinoff Advaita Bioinformatics identifies generic drug shown to be effective against COVID-19 (Wayne State Univ) https://today.wayne.edu/news/2020/05/12/wayne-state-spinoff-advaita-bioinformatics-identifies-generic-drug-shown-to-be-effective-against-covid-19-37290
5) WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients https://www.who.int/news-room/detail/16-06-2020-who-welcomes-preliminary-results-about-dexamethasone-use-in-treating-critically-ill-covid-19-patients
6) Critical COVID-19 disease, homeostasis, and the “surprise” of effective glucocorticoid therapy - https://www.sciencedirect.com/science/article/pii/S1521661620307002
7) A retrospective cohort study of methylprednisolone therapy in severe patients with COVID-19 pneumonia  https://www.nature.com/articles/s41392-020-0158-2


Epilogue References:

7) Covid-19 Symposium-Italian Experience 2020   European Society of Radiology March 2020
8) Bard R 2021 IMAGE GUIDED TREATMENT OF COVID-19 LUNG DISEASE Springer(in press)




Other recent articles from:




"Does UV-C Carry the Promise of SAFE SANITIZING?" - July 22, 2020 - In our current health crisis, prevention terms like DISINFECTING, SANITIZING or ANTI-BACTERIAL treatments are part of our common reality. Historical tests of UVC light were performed by irradiating surfaces with bacteria. Modern developments have honed the science of deactivating viruses and their ability to transmit diseases when directly applying 222-254 nm of UVC light on airborne viruses and microbes. (See article)


Initially, there was a great deal of reluctance in accepting the belief that COVID-19 could be transmitted via airborne means.  To explain this, the Schlieren imaging technique by LaVision puts the debate to rest- by showing in real time how BREATH travels. See how vapors & droplets in your exhaled CO2 can deploy as you speak, cough, laugh or sneeze WITH and WITHOUT a mask. This video helps explain how viral contamination occurs. (See video)




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Monday, August 10, 2020

OVERREADING: How WIFI Changed the Face of Medicine

Introduction by: Dr. Robert L. Bard, MD, PC, DABR, FASLMS

In a recent case study with a Covid-Positive patient locked down at home, I partnered with an ultrasound manufacturer to donate use of their latest scanning model and remote access to their best virtual technical trainer to manage an at-home self-scanning scenario.  The patient had personal hand-held access to a high end ultrasound to monitor and screen for any possible symptoms with the complete remote guidance of the imaging tech and (me) the Radiologist/Overreader. Thanks to  today's teleconferencing tools and remote access to the device, the patient learned how to scan himself accurately and getting his proper cardiovascular readings was fast, easy and efficient.

This program was yet another proof that DIGITAL ULTRASOUND is the future of emergent diagnostics. What makes ultrasound a perfect device for this remote diagnostic paradigm is its ability to come in many PORTABLE models.  Also, ultrasound is fast responding, safe (radiation free), non-invasive and easy to learn with a trainer.   This is the perfect formula for satisfying the many critical care situations where the reality of distance can be addressed with technology.


THE DIAGNOSTIC OVERREADER: YOUR VIRTUAL RADIOLOGIST
The concept of REMOTE imaging has been around for decades. My practice has been involved with some of the most complex clinical trials and treatment partnerships with hospitals in Italy, Australia, Germany and other foreign lands, reviewing, investigating or confirming scans like MRI's, CT and Ultrasound.  To operate high-powered imaging technology is a craft in and of itself, but to READ what you see, then to dig deeper to 'play detective' and to drive the investigative process with accuracy and intuition is a solid contribution to any medical team.  

Click to see complete Remote Self-Screening Program
I have built a reputation of being the surgeon's "go-to second opinion".  To have an oversight partner, reviewing your scans and conclusions is accountability at its finest, and peace-of-mind of a second pair of expert eyes.

Thanks to the advancements of our web-based communication tools, overseas collaboration via electronic FILE-SHARING has been streamlined to empower and facilitate the world of patient care.  As with TELEMEDICINE (where a patient and physician's time and safety are better supported) the concept of installing a Radiological Overreader in any patient care facility is part of our next generation of unified medicine.


BENEFITS OF AN IMAGING OVERREADER PARTNERSHIP:
1) Installing an affordable value added service to any practice
2) A second opinion is PEACE OF MIND of all your scans from a certified Radiologist- adding new diagnostic support to your patients
3) Expands your ability to collaborate with other physicians as well as treating your patients remotely
4) Having advanced imaging analysis reduces the level of RISK by raising a level of validity and added confidence to all your medical reports relating to complex scans
5) As a virtual partnership, having an overreader is an affordable upgrade to your staff without the overhead

D2D: Doctor-to-Doctor is a common term in TeleMed Conferencing uniting physicians in active sites (Point of Care
activity with patient) + a remotely accessed medical radiologist placed on the scene via WIFI.


























...................................................................................................................................................................

OVERREADING IN CLINICAL TRIALS
Diagnostic Imaging in Remote Team Research Studies

From product testing to quality reviews of treatment solutions and medicines, proposed innovations undergo intensive assessment protocols to achieve the highest possible levels of quantitative data-gathering necessary- and to prove the EFFICACY of any product. To pass all the strict regulatory guidelines for public distribution, testing labs are the last line of defense for public health and safety by either confirming or rejecting manufacturers' claims. SAFETY is the other top consideration in product reviews- ensuring the low-to-zero level of risk from public use. Once a product in question has fulfilled the initial staging guidelines of testing, a means to confirm effectiveness and safety (on humans) is through CLNICAL TRIALS where a population of patients is monitored for any and all biochemical effects. Forms of scanning and detection include observational surveying, blood & skin testing, mechanical stress-testing, bio-simulations and the use of clinical imaging technologies (when applicable). Innovations like advanced ultrasound is a common option for repeat checking of any bodily responses. Today's sonograms are preferred by primary investigators for their fast, accurate and affordable data collecting. In addition, repeat use for tracking and monitoring is completely safe (non-radiation) for any patient.

 "Before & After" Studies
The most sensible and logical way to identify the results of any treatment is by tracking the body's response to it. Controlled testing must show the patient's condition PRE and POST effects, where true data-finding is collecting the necessary EVIDENCE of its claims. The investigator can pull a significant amount of data from this form of scan-testing: including stage-by-stage bodily response to future projections of possible side effects. Recording of any and all psysiological response means the researchers are counting on the patient's body to tell us what it is undergoing during the testing phase. To prevent mis-reading and erroneous reports, trials tend to work with a large number of test patients (commonly 50-100) and may also employ redundancies like undergoing multiple testing protocols for a second or even third opinion. To capture the benefits of a BEFORE AND AFTER review, Imaging is often used as a standard screening solution for the response of most of the major organs.




WHAT ARE B LINES? Expert ultrasound readers are trained to identify anomalies in organ performance. In the case of screening for possible Covid-related pathogen response, B-lines are often  sought after as a prime indicator of fluid in the lungs.  They can be visualized as hyperechoic vertical lines extending from the pleura to the edge of the ultrasound screen. These lines are sharply defined and laser-like and they typically do not fade as they progress down the screen. A few B-lines that move along with the sliding pleura can be seen in normal lung due to acoustic impedance differences between water and air. However, excessive B-lines are abnormal and are typically indicative of underlying lung pathology.
...................................................................................................................................................................

GOING PORTABLE: Fast Response for Field Demands
Once upon a time, ultrasound imaging device design were large and cumbersome, often the size of a refrigerator.  They were one-piece units with wheels to support in-hospital traveling.  But over time,  as the medical community took to the ultrasound as the reliable choice for quick, accurate scanning, so did the demand to scan patients out on the field.  From ambulances, cruise ships, commercial airlines and even the space program, the design of the ultrasound steered toward more PORTABLE, and HAND-HELD models.

The battery-powered, pocket-sized ultrasound machine became commercially available in the late 1990s where smaller and lighter devices with higher image quality such as those manufactured by GE Healthcare, Siemens and Philips dominated this portable market. These pocket-sized ultrasound machines allowed clinicians to have immediate visual correlation with physical examination findings. They also allow for quick and instant assessments, which are extremely important for emergency physicians. At a healthcare resource allocation level, they significantly reduce a patient’s waiting time and improve clinician’s workflow. Furthermore, the cost of pocket-sized ultrasound machines is much lower than that of standard ones. [3]

















A recent study from emergent care physicians and EMT's have called on the need for "pre-hospital imaging"- where the need for efficiency in applying "precious seconds" of focused care means everything. Portable scanners and handheld ultrasound devices are clearly expanding toward at-home  versions all the way to “battlefield” models called “the modern stethoscope”- today’s solution to fast, initial examinations and real-time response, timely suited for our current health crisis and beyond.





Contributors & Technical Advisors

ROBERT L. BARD, MD, PC, DABR, FASLMS
Advanced Imaging & Diagnostic Specialist
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 


PIERRE KORY, M.D., M.P.A.
Dr. Kory is Board Certified in Internal Medicine, Critical Care, and Pulmonary Medicine. He served as the Medical Director of the Trauma and Life Support Center at the University of Wisconsin where he was an Associate Professor and the Chief of the Critical Care Service. He is considered a pioneer and national/international expert in the field of Critical Care Ultrasound and is the senior editor of the widely read textbook “Point-of-Care Ultrasound” (winner of the President’s Choice Award for Medical Textbooks from the British Medical Association in 2015).  Most recently, Dr. Kory joined the emergency volunteer team during the early COVID-19 pandemic in NYC at Mount Sinai Beth Israel Medical Center. He is also a founding member of the Front Line COVID-19 Critical Working Group (flccc.net) composed of 5 critical care experts that devised the COVID-19 treatment protocol called MATH+. (www.covid19criticalcare.com/)


MICHAEL THURY, RDCS, RVT, FASE
Michael is the current Global Product Manager for Terason Ultrasound (Burlington, MA). Commercially he has spent the last 19 years training physicians, clinicians and distribution partners around the world on the uses and benefits of ultrasound. He has been recognized numerous times for outstanding clinical and sales excellence both at Terason and GE Healthcare. Michael holds a AAS in Cardiovascular Technology from Southeast Technical College and is a South Dakota native. https://www.terason.com/

Thursday, August 6, 2020

PPE & Safety Supply Drive for Covid Responders & New Hot Spots


FOR IMMEDIATE RELEASE:
Safety & Prevention Initiatives + Philanthropic Support for the Front Lines: Meet the Advocacy for Professional Safety (NYC) 

July 25, 2020- Diagnostic Science Director of the First Responders Health Resource Dr. Robert L. Bard and medical publisher Lennard M. Gettz officially launched "The Advocacy for Professional Safety" (APS)- a volunteer backed Coronavirus prevention support project for the health care community. APS’ public educational mission promotes all current safety measures for patients and professional caregivers in healthcare facilities. APS also conducts a major humanitarian drive to collect and bring donated PPE to Covid front lines in the U.S.




APS is comprised of volunteer physicians, educators, writers and other professional care-givers who publish all safety protocols to keep viral transmission and contamination down in patient care areas.  APS launched its “Suggested Safety Guidelines in Patient Care Facilities” program in March of this year (at the height of NYC’s pandemic cases).  This project was directed toward the many local practices and hospitals due to their cluster of immuno-compromised and potentially contaminated traffic. Social media greatly aided in APS wide support from physicians in the northeast as they underwent their state re-opening from the Coronavirus shut-down.

SUPPORTING THE FRONT LINES
Their Safety Guidelines to medical offices expanded to educational videos and webinars to health groups about in-office safety. APS also acquired PREVENTION101.ORG, a health publication featuring current technologies, treatment updates, standardized safety initiatives and new trends in medical diagnostics. “I’ve always felt that there are many areas in patient care that could use an upgrade... this pandemic made us re-evaluate (just about) every part of our work process for better safety, risk prevention and cost efficiency. From modern air disinfecting innovations like the use of UV-C light, to TeleMedicine to portable hand-held ultrasound devices ... it's all about saving lives!"- says Dr. Bard.

Recognizing the current increase in U.S. figures of 4.6M cases and 155K+ deaths, the APS initiatives continue their public safety drive and uniting with healthcare providers to instill vigilance in prevention measures.  Medical professionals began adapting APS' suggested safety guidelines, and many joined to collaborate and share their safety measures to include in the list of “sensible prevention measures”.  The core is based on early postings by the CDC, NIOSH and NIST in pursuit of restoring public confidence in patient care- reducing/removing the risk of infection. “... this pandemic has awakened many changes in the way we do just about anything, and thinking SAFETY is a big part of that!", states Dr. Stephen Chagares, Breast Cancer Surgeon (NJ). "Meanwhile, I’m equally proud of supporting our health responders in the growing hot spots across the country… with our PPE drive.  This is making great use of social media and our many friends in the safety industry!”
Months into the pandemic, the APS Alliance expanded to include all safety resources like Covid-19 testing labs, sanitizing product manufacturers and medical suppliers including one of its’ first PPE supply partners, Jayson Dauphinee, president of the American Health Supply Co. who regularly donated a significant portion of their inventory of respirator masks and surgical gowns to  Covid treatment units in New York, and (now) other new hot-spots of the US.  Dr. Bard mirrors this philanthropic footprint by leading a PPE donation drive by partnering with other domestic distributors and safety equipment manufacturers, aligning target hospitals in the hardest hit states.

In response to the recent hot spots in 12+ states like Florida, Arizona and Texas, APS shares all useful and encouraging information including current press briefings by Governor Andrew Cuomo about the status of NYS’ continued drop in recent cases and mortality rates. "We are inspired by the many dedicated leaders whose commendable tracking and enforcing of New York's case control have helped bring us away from being the epicenter – and keeping us that way with prevention! We hope to share this level of self-leadership with everyone as a key to surviving this virus," says Cheri Ambrose, Male Breast Cancer Coalition.

THE JUNE SPIKE OF HOUSTON 
According to the Texas Medical Center data, COVID-19 cases escalated from 267 in week 10 (5/31) to 962 in week 13 (6/21). Dr. Joseph Varon, Chief of Clinical Care at the United Memorial Medical Center in Houston, TX.  Works at the Covid Unit of one of America's latest CoronaVirus epicenters. "I've had the worst 48 hours of the last 84 days. I have received more patients over the last two weeks than in the last 10 weeks [totaled]. As the state opened up, people get crazy‐‐ this includes Memorial Day weekend and last week's protest and mass gatherings. Out of all this, my ward is getting a flood of patients. I have tested more than 55,000 people for Covid in the Houston metropolitan area‐‐ and out of those 55,000, 10.5% are Covid positive. And these numbers in Texas are still going up." Dr Varon’s unit is just one of many hospitals in the U.S. who are close to (or currently) at capacity with patients as New York was during the early months of 2020. APS’ supply drive aims to send his hospital their first delivery of donations.

For complete information on the Advocacy for Professional Safety, visit: www.Prevention101.org. Media contact: editor.prevention101@gmail.com / Grace Davi- 631.920.5757

Wednesday, July 22, 2020

DOES UV-C HOLD THE PROMISE OF SAFE SANITIZING?

"My disease has played a very great role for my whole development… I was of course interested to know what benefit the sun really gave. During my work towards this goal I encountered several effects of light-- I then devised the treatment of small-pox in red light (1893) and further the treatment of lupus (1895)."-  Niels Ryberg Finsen


Written by: Cheri Ambrose  /   Introduction by: Dr. Robert L. Bard

In our current health crisis, prevention terms like DISINFECTING, SANITIZING or ANTI-BACTERIAL treatments are part of our common reality. Until recently, noxious "bio-killing" chemicals in atomized /spray form has been the most widely available choice on the market. With proper repeated use, fogging, spraying or ionizing chemistries in our living space are the popular option in contaminant prevention, but public concerns about the many possible physiological side effects of atomizing toxins into our air supply call for new alternatives.

Per-room disinfecting UV-C "Robot" (Skytron)
A sustainable upgrade in sanitizing was developed through the use of UV-C light. The CDC recognizes this innovation as one of the 'best disinfecting practices'. Ultraviolet germicidal irradiation (or UVGI) is the use of ultraviolet (UV) energy (electromagnetic radiation with a wavelength shorter than that of visible light) to kill or inactivate viral, bacterial, and fungal species. The UV spectrum is commonly divided into UV-A (wavelengths of 400 nm to 315 nm), UV-B (315 nm to 280 nm), and UV-C (280 nm to 200 nm). The entire UV spectrum can kill or inactivate many microorganisms, but UV-C energy provides the most germicidal effect, with 265 nm being the optimum wavelength. [1]

"VIRAL INACTIVATION": INSIGHTS FROM THE INDUSTRY
(From an interview with Skytron technology)
The earlier studies on the germicidal efficacy of far UVC light were performed exposing bacteria irradiated on a surface or in suspension. Modern developments have since honed the science of deactivating viruses and their ability to contaminate and transmit diseases with proven success when directly applying 222-254nm of UVC light on airborne viruses and microbes. [4]

On a recent interview, UVC expert Michael Czechowskyj of Skytron, a leading domestic manufacturer of infection prevention technologies presents valuable insight on the effectiveness of light disinfectants and the recent market expansion of UVC devices and installations. He discussed its ease-of-use and integrative friendliness of how a UVC device can take over the age-old spraying solutions.

"Today's UVC lamps are fully automated with complete safety features in place. You literally plug it in, start it up and leave the room to go about your day. Once the machine is done, it's perfectly safe that you can enter immediately. Not all sprayers and foggers can let you do that. And under the wait period, especially with ozone foggers, there's no ongoing chemicals that you're spraying or ongoing chemicals to buy either. Another difference is the coverage; with spray sanitizers, the sprayer can often MISS areas, or not spray enough solution in a specific area that needs it. This manual process of spraying leaves so much room for error and uncertainty. Irradiating a room with a UVC system does it all for you. It calculates the treatment time, intensity and because it's light, it gets into all the nooks and crannies to ensure a complete application."


HOW DOES IT WORK?
UV-C devices and lamps uses light wavelengths of around 254 nanometers, which denatures the DNA of the microbe. It creates a Thymine Dimer Pair, which prevents them from replicating. So it essentially does not kill the virus. It prevents it from reproducing, which means it prevents it from being infectious. Within a century of its existence, UV-C technology has maintained a constant design using the 254nm setup with a low pressure mercury amalgam bulb. The latest technology change was the bulb, where we eliminated ozone production. They have a special covering on them, which means that blocks the certain nanometers of light that produces ozone because ozone can be detrimental to humans as well.

Our devices all have a predetermined endpoint- much like filling a bucket of water.  Based on our research and lab studies, our machines identify when to turn itself off once it hits that mark of disinfecting the room. On a safety aspect, its 'dose' or application cycle is contingent upon the exact size of that room. There will be a faint, minor smell (most likely caused by irradiating the many particulates in the air) after the room and we call it "the new smell of clean".

'C. DIFF' TESTED- TOP MARKS IN "KILLING" AIRBORNE VIRUSES
There’s been very few studies done on the SARS COVID-19 virus. Most studies are done on surrogate pathogens. Corona viruses is recognized as a lipid based envelope virus and is fairly easy to kill. As with washing your hands, soap and water alone does a good job of killing this virus. We've also used a lot of similar studies on other types of CoronaViruses like MERS and SARS 14 COVID. Our devices are also calibrated for C-Diff (a spore producing bacteria known to cause a range if disorders from diarrhea to life-threatening inflammation of the colon- a bacteria that is very hard to kill, inactivate or sterilize). It is this lab standard that fosters the health industry's confidence in UVC technology's ability to inactivate the coronavirus.

Our industry undergoes strict efficacy studies with third party labs (to ensure the validity of the data) which is what are our end points were based on. Because of the nature of disinfecting, it's important to gain the confidence of the end user like a hospital- where we try to find more visualization for our clients. Something like a dosimeter color changing device (a device used to measure an absorbed dose of ionizing radiation) lets the director of a medical facility identify the right end point that they're looking for- and to make sure that they know the treatment is working properly.

RECENT APPLICATIONS
Facilitating health and safety protocols in this pandemic, UV-C disinfecting has been made available in smaller and larger applications. There's a smaller device that will disinfect masks in about six minutes. We defer to a lot of what the CDC has done with decontaminating N-95's. We know that not all UVC is created the same-- different bulbs, UVC output, wattage etc. And so, you know, we're real careful to make sure that we're keeping the clinicians as safe as possible and giving the people the information. When disinfecting an entire room, we use something called "dose assurance technology". This feature constantly reads the UVC field in real time; it reads the UVC that's being put out by the lamps and the UVC that is being reflected. We calibrated to a predetermined dose, that when they get to that end point, the machines then shut off knowing they've done their job well - within a specified time vs. ray intensity.

For additional information on UV-C technology or SKYTRON, visit www.skytron.com or contact Mr. Czechowskyj directly at mczechowskyj@skytron.com.



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Images courtesy of www.freshaireuv.com

In 2006, the U.S. Environmental Protection Agency approved a test plan for Biological Inactivation Efficiency by HVAC In-Duct Ultraviolet Light Air Cleaners. (1) The tests were conducted using three organisms, two bacteria (Bacillus atrophaeus and Serratia marcescens) and one bacterial virus (MS2).  These organisms were selected because their sizes, shapes and susceptibility to UV inactivation make them reasonable surrogates for biological warfare agents (BWAs). Generally, vegetative bacteria are readily killed and bacterial spores are more difficult. To model use in a VAC system, RTI used a test duct designed for testing filtration and inactivation efficiencies of aerosol, bioaerosol, and chemical challenges.  The bioaerosol inactivation efficiencies calculated for the three organisms were 9% for B. atrophaeus, 99.96% for S. marcescens and 75% for MS2. The irradiance was measured as 1190 W/cm2 at 161 cm(63 in.) upstream from the lamps with an airflow of 0.93 m3/sec (1970 cfm). The system had four lamps that were burned in for 100 hours prior to measurements.

UV lamps have been used to inactivate airborne microorganisms for many years. Much of the early work was directed at the control of very infectious microorganisms (particularly Mycobacterium tuberculosis, the causative agent of tuberculosis), often in medical facilities. Wavelengths within the short wave, or C band of UV light (UVC), were found to be the most effective germicidal light wavelengths. UVC usually is generated by use of UVC fluorescent lamps. These lamps use electrical discharge through low-pressure mercury vapor enclosed in a glass tube that transmits UVC light (primarily at the mercury wavelength of 253.7 nm). Because this wavelength has been found to be about the optimum for killing microorganisms, UVC from mercury lamps also is referred to as UVG to indicate that it is germicidal. UVG has been shown to inactivate viruses, mycoplasma, bacteria, and fungi when used appropriately.

Due to the recent pandemic, companies developing this technology are (now) on the fast track to advance UVC installations for a wide range of professional and commercial environments.  Specific testing is currently underway as to the efficacy against SARS-CoV-2 (the virus that causes COVID-19) but historically, systems like those developed by Fresh-Aire UV have been tested and proven effective against pathogens that require even greater UVC dosages.  "Every microorganism requires a specific UVC dosage for inactivation including the novel coronavirus. UV disinfection has been employed for decades in water treatment; these microwatt values have been used for reference to gauge UVC efficiency against a large cross-section of microorganisms. UV disinfection systems for room, surface & HVAC are (also) an ideal proactive measure to complement filtration", stated Aaron Engel, VP of Business Development at Fresh-Aire UV. 
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HISTORY
Niels Ryberg Finsen (1860-1904) was the first to employ UV rays in treating disease. He was awarded the Nobel Prize for Medicine in 1903 for his invention of the Finsen curative lamp, which was used successfully through the 1950s. [01]  Updates in the technology for commercial use evolved as UV-C germicidal lamps in the 1930's and have been primarily used in healthcare facilities. UVGI is highly recognized for addressing airborne microbial disease prevention (including influenza and tuberculosis). UVC is proven to prevent airborne transmission by deactivating airborne pathogens, but public use has been curtailed due to its potential to cause cancers and cataracts upon direct contact. [02]

The history of UVGI air disinfection has been one of promise, disappointment, and rebirth. Investigations of the bactericidal effect of sunlight in the late 19th century planted the seed of air disinfection by UV radiation. First to nurture this seed was Richard L. Riley and his mentor William F. Wells, who both discovered the spread of airborne infection by droplet nuclei and demonstrated the ability of UVGI to prevent such spread. With the enduring research of Riley and others, and an increase in tuberculosis (TB) during the 1980s, interest in UVGI was revitalized. With modern concerns regarding multi- and extensive drug-resistant TB, bioterrorism, influenza pandemics, and severe acute respiratory syndrome, interest in UVGI continues to grow. Research is ongoing, and there is much evidence on the efficacy of UVGI and the proper way to use it, though the technology has yet to fully mature.  [3]

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Epilogue: Straight Answers from the CDC
In our commitment to publish helpful information about innovative solutions, we rely on top health  authorities to provide us with unbiased clarity and technical standards. We inquired about how UV-C Disinfecting technology truly ranked as the future solution to defeating viruses and transmitted diseases. Steve Martin, PhD, an engineer in NIOSH’s Respiratory Health Division provided us with these valuable statements:

Q: Does the CDC see UV-C Disinfecting as the next trend- evolving from chemical spray sanitizing?
A: No.  CDC understands that germicidal UV technologies, including patient room terminal cleaning devices (sometimes called UV robots), can provide enhanced surface disinfection over the use of chemical disinfectants alone. However, UV technologies, as they currently exist, will never replace manual chemical cleaning in healthcare spaces.  While UV can be very efficient at inactivating pathogens on surfaces, UV-C energy cannot substantially penetrate blood and other bodily fluids, or through other simple spills and splashes that occur in the course of patient care, even those that have dried and left residues. Thus, healthcare surfaces need to first be thoroughly cleaned to remove gross contamination before the UV energy can directly impact the surfaces and provide the most disinfection benefit. Then, UV systems that are properly applied can effectively inactivate many of the pathogens that manual cleaning may have left behind.

Q: From an original post on 2016, CDC warned about potential OZONE output from UV.  It has been evident that companies have since been addressing the testing, preventing and validating of ozone output.  Does CDC have enough data on this upgrade?
A: Concerns about UV lamps producing ozone have existed for decades and there have not been any significant “upgrades” since 2016.  There are some UV-C lamps designed specifically to produce ozone.  Ozone-producing lamps generally do not use an internal coating on the glass (or quartz) tube so UV energy at wavelengths below 200 nm (predominantly 185 nm) is emitted from the lamp. These wavelengths are responsible for ozone production.  There is a separate group of UV-C lamps designed specifically not to produce ozone.  This group is the low-pressure mercury vapor lamps used for germicidal ultraviolet (GUV) applications.  GUV lamps have interior coatings to block UV energy at wavelengths below 200 nm from escaping the tube, so ozone is not created. Unfortunately, ozone-producing lamps and GUV lamps of the same type and size can often be powered using the same electrical connectors and electronic drivers (ballasts).  So, it is critical for the end user to choose the proper lamp for their application.  If they choose a typical GUV lamp for a germicidal application, then ozone is not a concern.  If an end user unknowingly chooses an ozone-producing lamp that happens to fit properly into their GUV device, then ozone exposures will happen. CDC always recommends that end users communicate with the UV device manufacturer or a reputable UV system designer when purchasing replacement UV lamps.


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CONTRIBUTORS

ROBERT L. BARD, MD, PC, DABR, FASLMS
Advanced Imaging & Diagnostic Specialist
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 

PIERRE KORY, M.D., M.P.A.
Dr. Kory is Board Certified in Internal Medicine, Critical Care, and Pulmonary Medicine. He served as the Medical Director of the Trauma and Life Support Center at the University of Wisconsin where he was an Associate Professor and the Chief of the Critical Care Service. He is considered a pioneer and national/international expert in the field of Critical Care Ultrasound and is the senior editor of the widely read textbook “Point-of-Care Ultrasound” (winner of the President’s Choice Award for Medical Textbooks from the British Medical Association in 2015).  Most recently, Dr. Kory joined the emergency volunteer team during the early COVID-19 pandemic in NYC at Mount Sinai Beth Israel Medical Center. He is also a founding member of the Front Line COVID-19 Critical Working Group (flccc.net) composed of 5 critical care experts that devised the COVID-19 treatment protocol called MATH+. (www.covid19criticalcare.com/)



MICHAEL CZECHOWSKYJ MSN, RN
Taking care of patients at the bedside is where Mike Czechowskyj started his nursing career.  After caring for patients in the Progressive Care and Burn ICU, he advanced into different leadership positions at Spectrum Health.  There he helped educate new staff, build new programs and advanced nursing practice.  He then joined the Spectrum Health Innovations team where he worked with local businesses, health systems, and universities to create new medical devices that would help patients and healthcare providers.  This led him to one of their partners, Skytron, where Michael now provides leadership for the Infection Prevention team. www.skytron.com


AARON ENGEL
Mr Engel is Vice-President of Business Development for Fresh-Aire UV, a global leader in UV disinfection technologies. Aaron has 20 years experience in the design, manufacturing and marketing of UV disinfection systems for domestic and international applications including those for residential, commercial and healthcare. Aaron has worked on projects with various groups & associations including the definitive study on UV inactivation of airborne bioterrorism agents sponsored by RTI, the United States EPA & US National Homeland Security. Aaron is frequent guest speaker and lecturer and contributes to publications on IAQ technologies and UV disinfection. Aaron is a member on various ASHRAE committees including TC2.9 Ultraviolet Air and Surface Treatment and the Programs Chair for TC2.9.  www.freshaireuv.com


2) Disinfection and Sterilization Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
3) US National Library of Medicine National Institutes of Health: The History of Ultraviolet Germicidal Irradiation for Air Disinfection  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2789813/
4) Far-UVC light: A new tool to control the spread of airborne-mediated microbial diseases

©Copyright Intermedia Worx Inc./Prevention 101. All Rights Reserved.

Sunday, July 19, 2020

Chest Ultrasound- Smart Uses in identifying Respiratory Issues







“When conducting lung ultrasound scanning, you look for signs of B-LINES. The more B lines you have equals a bad lung ultrasound score – indicating a high risk of deterioration. For any treatment protocol, if a patient whose lung ultrasound scan was getting worse, I might want to start escalating my therapy.” – Dr. Philippe Kory, MATH+