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Sally Pipes: Coronavirus lockdown — How many harmed by disruption to routine medical care?

With states in the initial stages of reopening their economies, early research seems to indicate that the stay-at-home orders may not have had as much impact on the spread of COVID-19 as the conventional wisdom held.

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We may be on the cusp of a different “mass casualty incident,” a group of over 600 doctors recently argued in an open letter to President Trump. The doctors assert that 150,000 patients have had cancer go undetected during the lockdown. Even more have foregone treatment for conditions that could lead to heart disease or stroke.

Sadly, these physicians may be right.

Suspensions of routine medical care and elective surgeries have harmed patients across the country. In the end, the lockdowns may result in more sickness and death from other causes than the pandemic itself.

Nearly half of Americans say the outbreak has forced them or someone in their household to delay care, according to a new Kaiser Family Foundation poll. Over 10 percent of those reporting delays said their or their family member’s condition worsened because of the delay.

In a few short months, stay-at-home orders have caused Americans to shun essential care. From February to March, the insurance company Cigna reported a 35 percent drop in claims for atrial fibrillation, an irregular heartbeat that can lead to blood clots, heart failure and stroke. The insurer also noted a 28 percent decrease in claims for epilepsy and seizure and a 13 percent decrease in claims for appendicitis.

In a recent study published in The New England Journal of Medicine, Kaiser Permanente reported a nearly 50 percent drop in heart attack admissions at its Northern California hospitals since March.

Of course, disease hasn’t taken a holiday while patients stay away from hospitals. In late May, Dr. Michael Apostolakos, chief medical officer of the University of Rochester Medical Center, told The New York Times that patients who do seek help often arrive in the late, painful stages of heart attacks and strokes. The hospital’s emergency room has reported a 50 percent drop in admissions.

Delaying trips to the hospital for urgent conditions can cost patients their lives. In Newark, N.J., the number of deaths declared on the scene by the city’s emergency medical services in April quadrupled compared to the previous year. Fewer than half of those pronouncements were directly attributable to COVID-19. That suggests that some Newark residents are waiting until they’re on death’s door to call for help.

Even patients receiving treatment for serious diseases have seen their care interrupted. Four in five cancer patients currently undergoing treatment report delays in health care, according to a recent survey from the American Cancer Society. Seventeen percent of patients reported delays in cancer therapies like chemotherapy and radiation.

Some states have been slow to lift restrictions on routine care. Michigan Gov. Gretchen Whitmer did not green-light the resumption of elective surgeries until May 29. In late May, the University of Michigan Health System had a backlog of about 12,000 such surgeries. New York Gov. Andrew Cuomo’s administration only gave the green light to all hospitals in Erie County – home to Buffalo – to resume elective surgeries last week.

Of course, simply permitting surgeries once again may not bring patients back. Nationwide, hospital visits through the first half of May were down 40 percent, compared to 2019. Even though most states’ stay-at-home orders had expired by then, states have still been discouraging people from venturing out.

Such discouragement can have deadly consequences. Even as they relax their stay-at-home orders, states must make sure that they don’t further obstruct patients from seeking the medical care they’ve postponed and need.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation at the comforts of your home.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

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An exclusive interview with Dr. Geoffrey Watson, MD: Diabetic patients and Covid-19

Dr. Watson interview D'OXYVA

About Dr. Geoffrey Watson

Watson Wellness Center in Oakland, CA

A native and resident of Oakland, California, Geoffrey Watson obtained a Bachelor of Science in Health Care Administration from the University of California at Davis and a medical degree from Vanderbilt University in Nashville, Tennessee. Dr. Watson completed two years of his medical residency at the Vanderbilt Medical Center with his final year of medical residency completed at the University of California Medical Center in San Francisco. In 1985, Dr. Watson started his medical career in Oakland as a specialist in the art of Internal Medicine working as a staff physician at the Arlington Medical Center alongside his father, Dr. James A. Watson.

Dr. Watson has a special interest in education and has earned the position of Director of Continuing Medical Education at Fairmont Hospital in San Leandro and Alameda County Medical Center of the East Bay. In 1992, as a Board Certified Internist, his love for teaching and medical education has earned him a position as Assistant Clinical Professor of Medicine at the U.C.S.F. Medical Center. Also in 1992, as the Co-Medical Director of the Arlington Medical Center, Dr. Watson became a key player in the Oakland community as a leader in managed care and positioned himself as a Founding Member of the Alta Bates Medical Associates. He developed medical groups, leading the way in managed care, and helped to organize a merger of prominent physicians resulting in a powerful African American Primary Care Group geared towards serving the needs of African Americans in the East Bay, including the development of preventive care programs focused in the areas of hypertension, asthma, diabetes, heart disease, substance abuse and weight control.

Dr. Watson has served as the Secretary for the Sinkler Miller Medical and the Golden State Medical Associations during 1994. In May, 1997, he was inaugurated into office as President of the Golden State Medical Association and served through 1998. From 1996 through 1997 he has been honored with serving as the President of the Sinkler Miller Medical Association of the East Bay. On March 1, 1997, Dr. Watson established a new medical facility, The James A. Watson Wellness Center, a legacy of his father, moving his practice to Pill Hill and continuing to provide high quality and sensitive care to patients by treating the physical, socioeconomic, spiritual and psychological ailments and employing medical and practical solutions with hopes of resulting in complete wellness.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

Those people who are at the highest risks of contracting COVID-19, are those over the age 65, have heart disease, liver disorders, diabetes and other underlying health issues. Because it effects the immune system and compromises the bodies natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worse case amputations.

2. How does Circularity’s D’OXYVA help patients with foot issues, potentially including COVID-19?

D’OXYVA®  (deoxyhemoglobin vasodilator) is validated to significantly improve macro-, and micro-circulation of blood flow and certain nerve activities in the body, which together are widely reported to form an effective non-invasive, pain-free solution option for many conditions. It provides accelerated and comprehensive wound care — plus infection protection — in a painless, affordable non-prescription solution available in a clinical setting, or in the comfort and privacy of your own home.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system. This improved dermal microcirculation leads, in turn, to enhanced wound healing.

Good blood circulation has many important health benefits. Among the most prominent is the optimal oxygenation of bodily tissues and organs, which allows for efficient functioning of the heart, lungs and muscles. Active blood circulation also improves the immune response against disease by allowing the better transportation of white blood cells throughout the body. Furthermore, proper blood circulation improves cellular detoxification, while waste removal becomes more efficient. Among its other health benefits, D’OXYVA has been also studied as a successful means of improving the autonomic nervous system.

4. What have clinical trials shown about how D’OXYVA helps patients, especially diabetics with foot problems?

Studies with D’OXYVA have shown increased oxygen concentration and lower carbon dioxide concentration in the blood just 30 minutes after treatment that can last over 60 minutes. Over two dozen studies demonstrated convincing results at clinics and at home with no adverse events.

Many treatments make bold online claims to help cure various conditions and restore you to health — pills, shots, creams, procedures, and devices. But only science-backed, one-of-a-kind D’OXYVA stands alone, delivering the remarkable physical, mental, and emotionally rejuvenating results.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

The heart is the engine that makes the body function. The foot though a far distance from the heart requires consistent blood flow. It requires open pathways. If those pathways are constricted, which is fairly normal occurrence with diabetic patients, those areas have a tendency to die off, because of the poor blood circulation. That is why it is key to some type of vasodilation to promote microcirculatory blood flow to supply adequate oxygenation the the feet. There by likely helping to prevent infections, ulcers and wounds.

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Why Use D'OXYVA?

Increasing demand for painless drug delivery, coupled with rising demand for self-administration of drugs, is anticipated to fuel market growth. D’OXYVA® (deoxyhemoglobin vasodilator) is the only fully non-invasive, non-irritating, non-opioid, and completely painless, over-the-skin delivery nerve stimulant and microcirculatory solution with over seven years of industry-leading research results.

D’OXYVA® has been demonstrating for years that it does not break the skin’s barrier, while it provides exceptional quality of life and health benefits quickly and affordably. In short, based on current leading neurology, immunology, microvascular, and cellular oxygenation science, D’OXYVA® is leading the field by:

Significantly lowering the risk of diabetes and cardiovascular complications.

Providing complete significant improvement of difficult wounds together with major pain relief and improved quality of life.

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How a New Advanced Health Solution Underpinned by Nobel-winning Science Can Protect You by Targeting Underlying Conditions

Covid-19 underlying medical conditions

Patients dealing with underlying health issues, including diabetes and chronic heart conditions, as well as COVID-19, may find fast and painless relief from an advanced solution.

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An easy-to-use , commercially-available device, D’OXYVA (deoxyhemoglobin vasodilator) by Circularity Healthcare, LLC, delivers transdermal ultra-purified medical gas directly to the blood stream and body tissues that are low in oxygen-rich blood flow.

The handheld, lightweight device – which promotes  the rest and digest functions of the autonomic nervous system  and the circulation of the blood in the smallest blood vessels, known as microcirculation – has demonstrated over years of studies and user feedback great efficacy in treating a number of health issues, including treating and closing so-called non-healing diabetic wounds.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers,” says Dr. Michael McGlamry, a podiatrist in Georgia.

He says the device helps increase oxygen-rich blood flow in the local microcirculatory system, leading to better blood perfusion and tissue oxygenation.

“Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to bring the blood to all the organs of the body,” says Dr. McGlamry.

Wound healing

Foot wounds are a significant concern for diabetics: 15% will develop a foot ulcer, and 14-24% of individuals with a foot ulcer, will need amputation.

Dr. Felix Sigal, a Los Angeles podiatrist, says this device is a game changer.

“Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation,” he says. “By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.”

The device was evaluated over eight years and three dozen human studies where zero adverse effects were reported. The CO₂ is approved by the FDA for anesthesia and oxygen therapy as a non-toxic, simple molecule under the Medical Gas Safety Act of 2012. It’s in the final phase of getting a combination device-drug approval.

“D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users,” says Dr. McGlamry.

Applications for COVID-19 patients

The device may help improved blood flow and tissue oxygenation for people with COVID-19 . Patients most at risk for the novel coronavirus include those over 65 who have heart disease, liver disorders, diabetes or other underlying health issues.

“Because it affects the immune system and compromises the body’s natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worst case amputations,” says Dr. Geoffrey Watson, who specializes in chronic care management in Oakland, California.

He says while the heart is a far distance from the foot, the foot relies on the heart for consistent blood flow, requiring open pathways. Often those pathways are constricted in diabetics, resulting in poor blood circulation

Dr. Watson says vasodilation is essential, “to promote microcirculatory blood flow to supply adequate oxygenation the feet, thereby likely helping to prevent infections, ulcers and wounds.”

Clinical Trial

Circularity Healthcare’s pivotal clinical trial — which involves the use of an FDA-approved drug in addition to IDE device D’OXYVA® (deoxyhemoglobin vasodilator), a non-toxic, non-invasive  transdermal drug delivery device — is poised to help the most at-risk coronavirus patients experiencing complications due to diabetes, poor circulation, hypertension, high blood pressure, and cardiovascular disease.

“Further studies are needed but this device has the potential to prevent symmetrical peripheral gangrene, a limb threatening complication of COVID-19,” says Dr. Sigal, who is helping conduct the D’OXYVA pivotal diabetic foot ulcer clinical trials.

This clinical trial represents the first biotech solution to improve a patient’s overall oxygen-rich blood flow.

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Why Use D'OXYVA?

Experts say D’OXYVA® can help patients find relief. Overwhelming medical data shows people with preexisting conditions, including diabetes may experience serious complications with COVID-19.

D’OXYVA significantly helps people and their pets by gently and quickly spraying a patented and patent-pending ultra-purified, supersaturated solution on the skin surface to achieve major health benefits for well over 90% of users.

Experts call D’OXYVA a game-changer biotech. “Studies with D’OXYVA have shown unmatched results in noninvasive wound care,” Dr. Michael McGlamry. Anyone with an underlying condition should know this option is available.

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An interview with Dr. Michael McGlamry: Diabetic patients and Covid-19

Dr. McGlamry interview D'OXYVA

About Dr. Michael McGlamry

Forsyth Foot and Ankle Associates, Cumming, GA

Dr. McGlamry was born and raised in Atlanta. He graduated from Tucker High School in 1982, and earned a Bachelor of Science in Engineering with honors from The University of Florida. In 1991, he earned a Doctorate of Podiatric Medicine from The Penn. College of Podiatric Medicine/Temple University.

In 1991, he began his residency training in reconstructive surgery of the foot and leg at Northlake Regional Medical Center in Tucker. After completion, he started a practice in Gainesville, Fl where he practiced for 11 years.

Currently, he teaches at DeKalb Medical Center, with the residency program. He also teach on the post graduate level with the Podiatry Institute, and AO North America; both of which are renowned for their dedication to physicians’ education, and for the improvement of quality patient care.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

In the middle of a global pandemic, like the one we’re living, it is very important to be able to assess risks and try to diminish their effects. Cardiovascular disease is one of the most relevant and impactful; that is why improving blood flow and tissue oxygenation is so important for improving the health outcomes of a COVID-19 infection.

People with diabetes, especially those over 65 years of age, have been shown to be affected more often and with greater severity by coronavirus infection. Diabetic patients, particularly those with more longstanding and poorly controlled disease, suffer from diminished oxygen-rich blood in their microcirculation, which may be a major risk factor for why COVID is so deadly for them. Reports from Chinese authorities and from top American institutions, such as Harvard Medical School, show that underlying cardiovascular disease is associated with an increased risk of in-hospital death for patients hospitalized with COVID-19.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA® (deoxyhemoglobin vasodilator) is a groundbreaking noninvasive, painless transdermal delivery system based on widely established, groundbreaking, Nobel Prize-winning science and is shown to increase oxygen-rich blood flow in the local microcirculatory system, which in turn leads to better blood perfusion and tissue oxygenation. The increased peripheral perfusion plays a significant role in enhancing the wound healing process, which may lead to a reduction in the influence of preexisting conditions in cases of a coronavirus infection.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide (CO2), a naturally occurring nontoxic substance, which is delivered via the D’OXYVA noninvasive skin delivery system. The CO2 acts as a signaling agent for the body to help stimulate delivery of red blood cells loaded with fresh oxygen to the peripheral tissue. D’OXYVA’s over-the-skin route of administration has demonstrated a safer, more effective alternative route to inhalation — a routine CO2 delivery method in hospitals. Purified carbon dioxide is a nontoxic molecule and can be sold by Circularity over the counter (OTC) and online without the need for a prescription. Circularity’s products are manufactured in compliance with the highest standards.

Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to propel the blood to all the organs of the body.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Over two dozen studies have demonstrated convincing results at clinics and in homes with no adverse events. D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users. Studies of D’OXYVA have shown unmatched results in noninvasive wound care — particularly when all other approaches have failed. D’OXYVA provides an adjunct to accelerate comprehensive wound care programs and infection protection in a painless, affordable nonprescription solution that is available in a clinical setting or in the comfort and privacy of your own home.

In an ongoing multiyear, multicountry, multicenter randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA demonstrated hastened wound improvement and eventual wound closure in an average of 5 weeks**.

In addition, D’OXYVA eliminated pain and improved quality of life such as in regard to sleep, appetite, and mood in just a week in 100% of subjects.

No adverse events of any kind were reported during and for years after the studies.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

Microcirculation is often disregarded by diabetic patients, and I’d like to emphasize to them that microcirculation is important, especially in wound healing. In other words, microcirculation is the bridge between blood and single cells that supply oxygen and nutrients to human tissues, especially where it is needed the most. Without proper blood flow, their body will be prone to more complications, including the development of foot ulcers that could lead to amputation. Remember that having improved microcirculation and oxygenation promotes faster wound healing, promotes better performance, and enhances the renewal and replacement of damaged tissues.

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An interview with Dr. Felix Sigal: Diabetic patients and Covid-19

Dr. Felix Sigal D'OXYVA | Cardiovascular, Diabetes, Wound Care, Pain Relief

About Dr. Felix Sigal

Foot and Ankle Clinic, Los Angeles Podiatrist

Dr. Felix Sigal, DPM is a podiatry specialist in Los Angeles, CA. He graduated from California College of Podiatric Medicine and specializes in podiatry. He is the principal doctor at our clinic, graduated from California State University of Northridge and pursued his training at the California College of Podiatric Medicine, completing his residency at USC General Hospital. Throughout his training, Dr. Sigal expanded his interests in diabetic limb salvage and became one of the most distinguished specialists in the field. Dr. Sigal currently is on staff at both the St. Vincent Medical Center and the California Hospital Medical Center, where he focuses on wound care, diabetic limb salvage, as well as pursues his interest in clinical research to enable better treatment options for his patients. Dr. Sigal serves as a Principal Investigator on numerous clinical research studies in the field of diabetic complications, wound care and has contributed his expertise to the field of clinical research always searching for better treatment options to improve the lives of patients. Dr. Sigal is seeing patients in the Los Angeles and Lancaster offices.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

COVID-19 can infect people of all ages. However, two groups are at higher risk of developing severe complications secondary to COVID-19. These are older adults (over 60 years old) and individuals with underlying medical conditions such as obesity, cancer, diabetes, cardiovascular disease, and chronic respiratory disease. Because diabetic patients often have multiple comorbidities, such as obesity and cardiovascular disease, new data suggests that the death rate and hospitalization duration are four times higher for this subset of the population.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

Disseminated intravascular coagulation (DIC) is one of the severe complications related to COVID-19. This is a serious disorder in which the proteins that control blood clotting become overactive, which can result in symmetrical peripheral gangrene. The Circularity OTC device is a novel transdermal delivery system that can deliver carbon dioxide directly to body tissues low in oxygen. Further studies are needed, but this device has the potential to prevent symmetrical peripheral gangrene, a limb-threatening complication of COVID-19.

3. Tell us about CO2, microcirculation, and its effects on the body.

Inadequate wound healing in chronic wounds is secondary to poor blood perfusion at the level of the wound and surrounding tissues, defined as local hypoxia. Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation. By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Among patients with diabetes, 15% develop a foot ulcer, and 12-24% of individuals with a foot ulcer require amputation. The average cost of treatment ranges from $16,500 for patients without severely impaired circulation to about $63,000 for patients undergoing an amputation. Capillary microcirculation to foot skin has shown signs of significant impairment in diabetic patients when metabolic control is poor, resulting in poor healing rates for ulcers and worsening of diabetic peripheral neuropathy. The preliminary studies of the Circularity OTC medical device have shown increased oxygenation to tissue, resulting in improved wound healing.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

During the COVID-19 pandemic, it has become even more imperative for diabetic patients to avoid hospitalization from foot complications. To prevent foot complications, diabetic patients must continue to control their diabetes, look at their feet on a daily basis, and become comfortable with using telemedicine to communicate their medical needs to their physicians. During their daily exam, diabetics should look for blisters, minor injuries, sores, and any other abnormal changes to their feet. By following these simple steps, they can reduce the risk of foot complications and amputations.

Want to stay updated and be the first to know when we release new articles like this? Join our newsletter today and get the first dibs to new content and exclusive discounts!

FEATURED

Blog Posts

physician-recommended, easy to use daily

Why Use D'OXYVA?

Increasing demand for painless drug delivery, coupled with rising demand for self-administration of drugs, is anticipated to fuel market growth. D’OXYVA® (deoxyhemoglobin vasodilator) is the only fully non-invasive, non-irritating, non-opioid, and completely painless, over-the-skin delivery nerve stimulant and microcirculatory solution with over seven years of industry-leading research results.

D’OXYVA® has been demonstrating for years that it does not break the skin’s barrier, while it provides exceptional quality of life and health benefits quickly and affordably. In short, based on current leading neurology, immunology, microvascular, and cellular oxygenation science, D’OXYVA® is leading the field by:

Significantly lowering the risk of diabetes and cardiovascular complications.

Providing complete significant improvement of difficult wounds together with major pain relief and improved quality of life.

Reduce unwanted doctor visits, recommended and ranked top by experts!

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A mutant coronavirus has emerged, even more contagious than the original, study says

D'OXYVA COVID-19 Clinical Trial

Scientists have identified a new strain of the coronavirus that has become dominant worldwide and appears to be more contagious than the versions that spread in the early days of the COVID-19 pandemic, according to a new study led by scientists at Los Alamos National Laboratory.

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The new strain appeared in February in Europe, migrated quickly to the East Coast of the United States and has been the dominant strain across the world since mid-March, the scientists wrote.

In addition to spreading faster, it may make people vulnerable to a second infection after a first bout with the disease, the report warned.

The 33-page report was posted Thursday on BioRxiv, a website that researchers use to share their work before it is peer reviewed, an effort to speed up collaborations with scientists working on COVID-19 vaccines or treatments. That research has been largely based on the genetic sequence of earlier strains and might not be effective against the new one.

The mutation identified in the new report affects the now infamous spikes on the exterior of the coronavirus, which allow it to enter human respiratory cells. The report’s authors said they felt an “urgent need for an early warning” so that vaccines and drugs under development around the world will be effective against the mutated strain.

Wherever the new strain appeared, it quickly infected far more people than the earlier strains that came out of Wuhan, China, and within weeks it was the only strain that was prevalent in some nations, according to the report. The new strain’s dominance over its predecessors demonstrates that it is more infectious, according to the report, though exactly why is not yet known.

The coronavirus, known to scientists as SARS-CoV-2, has infected more than 3.5 million people around the world and caused more than 250,000 COVID-19 deaths since its discovery late last year.

The report was based on a computational analysis of more than 6,000 coronavirus sequences from around the world, collected by the Global Initiative for Sharing All Influenza Data, a public-private organization in Germany. Time and again, the analysis found the new version was transitioning to become dominant.

The Los Alamos team, assisted by scientists at Duke University and the University of Sheffield in England, identified 14 mutations. Those mutations occurred among the nearly 30,000 base pairs of RNA that other scientists say make up the coronavirus’s genome. The report authors focused on a mutation called D614G, which is responsible for the change in the virus’ spikes.

“The story is worrying, as we see a mutated form of the virus very rapidly emerging, and over the month of March becoming the dominant pandemic form,” study leader Bette Korber, a computational biologist at Los Alamos, wrote on her Facebook page. “When viruses with this mutation enter a population, they rapidly begin to take over the local epidemic, thus they are more transmissible.”

While the Los Alamos report is highly technical and dispassionate, Korber expressed some deep personal feelings about the implications of the finding in her Facebook post.

“This is hard news,” wrote Korber, “but please don’t only be disheartened by it. Our team at LANL was able to document this mutation and its impact on transmission only because of a massive global effort of clinical people and experimental groups, who make new sequences of the virus (SARS-CoV-2) in their local communities available as quickly as they possibly can.”

Korber, a graduate of Cal State Long Beach who went on to earn a PhD in chemistry at Caltech, joined the lab in 1990 and focused much of her work on an HIV vaccine. In 2004, she won the Ernest Orlando Lawrence Award, the U.S. Department of Energy’s highest recognition for scientific achievement. She contributed a portion of the financial prize to help establish an orphanage for young AIDS victims in South Africa.

The report contains regional breakdowns of when the new strain of virus first emerged and how long it took to become dominant.

Italy was one of the first countries to see the new virus in the last week of February, almost at the same time that the original strain appeared. Washington was among the first states to get hit with the original strain in late February, but by March 15 the mutated strain dominated. New York was hit by the original virus around March 15, but within days the mutant strain took over. The team did not report results for California.

Scientists at major organizations working on a vaccine or drugs have told The Times that they are pinning their hopes on initial evidence that the virus is stable and not likely to mutate the way influenza virus does, requiring a new vaccine every year. The Los Alamos report could upend that assumption.

If the pandemic fails to wane seasonally as the weather warms, the study warns, the virus could undergo further mutations even as research organizations prepare the first medical treatments and vaccines. Without getting on top of the risk now, the effectiveness of vaccines could be limited. Some of the compounds in development are supposed to latch onto the spike or interrupt its action. If they were designed based on the original version of the spike, they might not be effective against the new coronavirus strain, the study’s authors warned.

“We cannot afford to be blindsided as we move vaccines and antibodies into clinical testing,” Korber wrote on Facebook. “Please be encouraged by knowing the global scientific community is on this, and we are cooperating with each other in ways I have never seen … in my 30 years as a scientist.”

David Montefiori, a Duke University scientist who worked on the report said it is the first to document a mutation in the coronavirus that appears to make it more infectious.

Although the researchers don’t yet know the details about how the mutated spike behaves inside the body, it’s clearly doing something that gives it an evolutionary advantage over its predecessor and is fueling its rapid spread. One scientist called it a “classic case of Darwinian evolution.”

“D614G is increasing in frequency at an alarming rate, indicating a fitness advantage relative to the original Wuhan strain that enables more rapid spread,” the study said.

Still unknown is whether this mutant virus could account for regional variations in how hard COVID-19 is hitting different parts of the world.

In the United States, doctors had begun to independently question whether new strains of the virus could account for the differences in how it has infected, sickened and killed people, said Alan Wu, a UC San Francisco professor who runs the clinical chemistry and toxicology laboratories at San Francisco General Hospital.

Medical experts have speculated in recent weeks that they were seeing at least two strains of the virus in the U.S., one prevalent on the East Coast and another on the West Coast, according to Wu.

“We are looking to identify the mutation,” he said, noting that his hospital has had only a few deaths out of the hundreds of cases it has treated, which is “quite a different story than we are hearing from New York.”

The Los Alamos study does not indicate that the new version of the virus is more lethal than the original. People infected with the mutated strain appear to have higher viral loads. But the study’s authors from the University of Sheffield found that among a local sample of 447 patients, hospitalization rates were about the same for people infected with either virus version.

Even if the new strain is no more dangerous than the others, it could still complicate efforts to bring the pandemic under control. That would be an issue if the mutation makes the virus so different from earlier strains that people who have immunity to them would not be immune to the new version.

If that is indeed the case, it could make “individuals susceptible to a second infection,” the study authors wrote.

It’s possible that the mutation changes the spike in some way that helps the virus evade the immune system, said Montefiori, who has worked on an HIV vaccine for 30 years. “It is hypothetical. We are looking at it very hard.”

HOW D’OXYVA CAN HELP?

D’OXYVA® is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation. It reverses* the dangers of septic shock by providing your body armor against infection.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

Reduce unwanted doctor visits, recommended and ranked top by experts!

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Detecting Sepsis Early

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Estimates suggest that more than 30 million people worldwide are affected by sepsis each year, with up to six million of these dying from the condition. While vulnerable populations such as the very young, elderly, pregnant women and immunocompromised people are most at risk, sepsis can strike anyone suffering from an infection. Rapid and accurate detection of sepsis is critical to help limit the extent of tissue and organ dysfunction and damage that sepsis can cause.

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We recently spoke to Elena Sukhacheva, Director Medical and Scientific Affairs at Beckman Coulter, to learn about some of the challenges of diagnosing sepsis early, and how measuring Monocyte Distribution Width can be used as a sepsis biomarker to aid the process.

Anna MacDonald (AM): Why is early detection of sepsis so critical?

Elena Sukhacheva (ES): Sepsis is one of the most deadly and costly medical conditions physicians and hospitals must face. In fact, statistics show that sepsis is the third leading cause of death in the U.S.1. Mortality rates for sepsis is extremely high – approximately 25-30%—with more individuals dying of sepsis than prostate cancer, breast cancer, and HIV combined 2,3. Hospitalizations due to sepsis cost the healthcare system more than any other condition in the U.S.,4 with a total annual cost greater than 24 billion dollars5.

According to data from the Healthcare Cost and Utilisation Project (HCUP), there was an increase both in the number of cases of sepsis, and the costs associated with sepsis between 2000 and 20097. With sepsis as their primary diagnosis, the mean length of a patient’s hospital stay was close to nine days in 2009, with an average cost per entire stay at $18,500 7.

Early detection of sepsis is critical, as a delay in antibiotic treatment has been documented to result in increased mortality, with a 7.6% increase in death for patients with severe sepsis and septic shock every hour antibiotic administration is delayed8. Therefore, the earlier sepsis is recognized and the earlier the treatment starts, the better the outcome for the patient and the lower the cost that can be expected to be borne by the healthcare system.

AM: What are some of the challenges of rapidly diagnosing sepsis?

ES: The main challenge of timely diagnosis is that sepsis may manifest in dramatically different ways. Sepsis may affect anyone. For example, a young patient acquiring an infection from an appendectomy, for whom a dysregulated immune response leads to organ failure and death, or a patient undergoing aggressive cancer treatments, whose immune system is unable to fight infection due to immunosuppression. In both cases, the diagnosis would be “sepsis”, but symptoms in these two patients might look very different.

It is also important to mention that most (two-thirds) of patients diagnosed with sepsis enter the healthcare system through A&E9. Therefore, it is very important to ensure that efficient sepsis detection practices are used at this entry point. Symptoms are not always clear, so in practice, clinicians only order a test for sepsis when symptoms become clearer in the patient and they are more obviously septic. This delay in the diagnosis and treatment for patients with ambiguous presentation often results in a worse outcome10.

AM: How is sepsis currently diagnosed? What are the limitations of these methods and markers? 


ES: 
Before we talk about diagnosing sepsis, let’s define what sepsis is. As you may know, for many years we had the so-called sepsis-2 definition, which was introduced in 199214. That definition of sepsis was based on the presence of at least 2 SIRS criteria (systemic inflammatory response syndrome) and either a clinically suspected or proven infection. In 2016, a new definition was established for sepsis, and today, sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection15. Deaths from sepsis result, not from the infection itself, but from dysregulated immunity and organ dysfunction, which makes it impossible to efficiently fight against the infection.

Practically speaking, clinicians may use SIRS criteria (if they are still using sepsis-2) or the SOFA score (sequential organ failure assessment, if they use the sepsis-3 definition) to diagnose sepsis. Additionally, laboratory tests are used to test for infection and help confirm a suspicion of sepsis; for example by measuring the patient’s WBC (white blood cell) count, Procalcitonin, C-Reactive Protein, Interleukin-6 or presepsin levels, or culturing body fluids such as blood or urine for infectious organisms. While positive cultures may be diagnostic of infection, none of these tests can definitively confirm a diagnosis of sepsis, so clinicians must rely on all the clinical and laboratory information available together to diagnose sepsis.

Additionally, it is important to note that not all tests are routinely performed for all patients, but only ordered when a clinician suspects infection or sepsis. Therefore, diagnosing sepsis early is very challenging, because symptoms may not be obvious and clear at the time at which the patient presents at the hospital.

AM: Can you tell us more about the Early Sepsis Indicator?

ES: The Early Sepsis Indicator is the only FDA-cleared hematologic biomarker that is available to be automatically reported as part of a complete blood count (CBC) with differential test for adults entering through the A&E or emergency department. The new sepsis biomarker is available exclusively on the Beckman Coulter hematology analyzer, DxH 900. The parameter, Monocyte Distribution Width (MDW), is based on morphological changes in monocytes in response to infection. Since the Early Sepsis Indicator is included as part of a CBC-Diff analysis, it does not require additional blood to be drawn or a special order, and it is automatically reported for all adult patients.

Two scientific papers have already demonstrated the analytical performance of the Early Sepsis Indicator. The first results about early sepsis detection in ED with Monocyte Distribution Width were published in the journal, Chest in 201719. This study, which was conducted by Ohio State University, demonstrated that an elevated MDW value was able to discriminate sepsis from non-sepsis (according to sepsis-2 criteria) with a Receiver-Operator Curve Area Under the Curve (AUC) of 0.79, 77% sensitivity and 73% specificity. The study also analyzed the performance of the WBC count and the combination of WBC and MDW. When MDW and WBC values were combined, they produced an AUC of 0.89, which was significantly higher than the AUC for each individual parameter [WBC AUC was 0.74].

Another study published in Critical Care Medicine included more than 2,100 consecutive adult emergency-department patients, and was conducted in three U.S. University Hospitals. This clinical trial confirmed the discriminatory capacity of MDW alone, and MDW with WBC20.

AM: What role do monocytes play in the development of sepsis? What are the benefits of using Monocyte Distribution Width as a sepsis biomarker?

ES: Monocytes are cells of the innate immune system. They are closely involved in two key events in sepsis pathogenesis, the cytokine storm and sepsis-induced immunosuppression.

Three main cytokines that contribute to a cytokine storm are Tumor Necrosis Factor-alpha, Interleukin 1-beta and Interleukin-6. They are produced mainly by monocytes and macrophages. Interestingly, one monocyte subtype, the so-called “classic” monocytes, are able to further differentiate into macrophages in response to infection and contribute to cytokine production. IL-1 beta is the main initiator of the cascade of cytokines, TNF-a and IL-6 induce production of acute phase proteins and activate other immune cells. Production of these inflammatory cytokines and mediators by monocytes/macrophages contribute to the efficient growth control and dissemination of invading pathogens. However, excessive and uncontrolled production of these inflammatory cytokines and mediators may lead to serious systemic complications including microcirculatory dysfunction, liver and kidney damage, and septic shock with high mortality rates.

The second main factor contributing to the high mortality rate of patients diagnosed with sepsis is sepsis-induced immunosuppression. Immunosuppression of innate immunity in sepsis will manifest as chronic inflammation, decreased pro-inflammatory cytokine production, increased anti-inflammatory cytokine production, reduced phagocytosis, and contracted antigen presentation.

If we look at monocytes, these cells in septic patients can be very heterogeneous. Recent research has demonstrated that monocytes in the course of sepsis can be polarised from a pro-inflammatory state to an immunosuppressive state21. We hypothesize that this increased functional heterogeneity of monocytes in sepsis probably results in increased morphological variability, which is measured as MDW. An MDW value above the FDA-cleared cut off indicates an increased probability that the patient has sepsis or will develop sepsis within 12 hours of the ED encounter.

The benefits of using the Early Sepsis Indicator include that it is reported automatically with a CBC-Diff analysis, results of which are very quickly returned to the physician; The test takes less than a minute, it requires no extra blood to be drawn, and there is no need to order the test, making it a powerful and convenient tool that clinicians can use to alert them that a patient may have sepsis or develop sepsis within 12 hours of presentation at A&E. Taken together with the WBC count, which is also part of a CBC-Diff analysis, along with other laboratory findings and clinical information, the Early Sepsis Indicator provides a qualitative assessment of sepsis risk from a single whole-blood venous sample22.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory solution that has been clinically tested to significantly improve microcirculation.

D’OXYVA works to prevent sepsis, and resulting septic shock, using life-restoring molecule carbon dioxide (CO₂) and gentle vapor dissolved across the skin in a fast, painless, handheld  5-minute application — performed either in a clinical setting or in the comfort and privacy of your own home.

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Cause of sepsis-induced lung injury

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

A KAIST research team succeeded in visualizing pulmonary microcirculation and circulating cells in vivo with a custom-built 3D intravital lung microscopic imaging system. They found a type of leukocyte called neutrophils aggregate inside the capillaries during sepsis-induced acute lung injury (ALI), leading to disturbances and dead space in blood microcirculation. According to the researchers, this phenomenon is responsible for tissue hypoxia causing lung damage in the sepsis model, and mitigating neutrophils improves microcirculation as well as hypoxia.

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According to the researchers, this phenomenon is responsible for tissue hypoxia causing lung damage in the sepsis model, and mitigating neutrophils improves microcirculation as well as hypoxia.

The lungs are responsible for exchanging oxygen with carbon dioxide gases during the breathing process, providing an essential function for sustaining life. This gas exchange occurs in the alveoli, each surrounded by many capillaries containing the circulating red blood cells.

Researchers have been making efforts to observe microcirculation in alveoli, but it has been technically challenging to capture high-resolution images of capillaries and red blood cells inside the lungs that are in constant breathing motion.

Professor Pilhan Kim from the Graduate School of Medical Science and Engineering and his team developed an ultra-fast laser scanning confocal microscope and an imaging chamber that could minimize the movement of a lung while preserving its respiratory state. They used this technology to successfully capture red blood cell circulation inside the capillaries of animal models with sepsis.

During the process, they found that hypoxia was induced by the increase of dead space inside the lungs of a sepsis model, a space where red blood cells do not circulate. This phenomenon is due to the neutrophils aggregating and trapping inside the capillaries and the arterioles. It was also shown that trapped neutrophils damage the lung tissue in the sepsis model by inhibiting microcirculation as well as releasing reactive oxygen species.

Further studies showed that the aggregated neutrophils inside pulmonary vessels exhibit a higher expression of the Mac-1 receptor (CD11b/CD18), which is a receptor involved in intercellular adhesion, compared to the neutrophils that normally circulate. Additionally, they confirmed that Mac-1 inhibitors can improve inhibited microcirculation, ameliorate hypoxia, while reducing pulmonary edema in the sepsis model.

Their high-resolution 3D intravital microscope technology allows the real-time imaging of living cells inside the lungs. This work is expected to be used in research on various lung diseases, including sepsis.

The research team’s pulmonary circulation imaging and precise analytical techniques will be used as the base technology for developing new diagnostic technologies, evaluating new therapeutic agents for various diseases related to microcirculation.

Professor Kim said, “In the ALI model, the inhibition of pulmonary microcirculation occurs due to neutrophils. By controlling this effect and improving microcirculation, it is possible to eliminate hypoxia and pulmonary edema — a new, effective strategy for treating patients with sepsis.”

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory solution that has been clinically tested to significantly improve microcirculation.

D’OXYVA works to prevent sepsis, and resulting septic shock, using life-restoring molecule carbon dioxide (CO₂) and gentle vapor dissolved across the skin in a fast, painless, handheld  5-minute application — performed either in a clinical setting or in the comfort and privacy of your own home.

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The Microcirculation in Sepsis

Deterioration of the Microcirculation in Diabetes

Sepsis is a leading cause of mortality in critically ill patients. The pathophysiology of sepsis involves a highly complex and integrated response, including the activation of various cell types, inflammatory mediators, and the haemostatic system.

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Recent evidence suggests an emerging role of the microcirculation in sepsis, necessitating a shift in our locus away Irom the macrohaemodynamics to ill icrohaemodynanmics in a septic patient. This review article provides a brief overview of the microcirculation, its assessment techniques, and specific therapies to resuscitate the microhaemodynamics.

Introduction

Sepsis and its progression to severe sepsis, septic shock and multiple organ dysfunction syndrome is a major cause of ICU admissions and mortality. Severe sepsis and septic shock may be characterized by a derangement in global cardiac indices typically leading to low peripheral resistance, which the body tries to compensate for by increasing the cardiac output. However, despite this increase in cardiac output, the tissues are unable to utilize oxygen as evidenced by the high lactate levels, deranged acid-base balance, and increased gastric carbon dioxide level. The presence of tissue hypoxia despite adequate systemic oxygen transport has been blamed on altered microhaemodynamics as well as in mitochondrial dysfunction during sepsis. However, the relative contributions of disturbed microcirculation and impaired mitochondrial function for sepsis related tissue dysoxia are still debatable. The present review aims to highlight the former cause of tissue hypoxia in sepsis i.e., involvement of the microcirculation. It moves from recapitulating relevant anatomy of microcirculation, to its current role in pathophysiology of sepsis, optimization during sepsis and lastly the modalities for its assessment.

Microcirculatory perfusion as an endpoint

Much of the research pertaining to resuscitation during sepsis has focused on restoring the macrodynamics of circulation such as blood pressure, oxygen delivery and oxygen extraction ratio. The pathologic shunting occurring in the microcirculation is not depicted by systemic haemodynamic derived and oxygen derived variables. The difference between macrocirculation and microcirculation was recognized very early on when it was pointed that changes in total peripheral resistance could not provide information regarding local vascular resistance changes since “dilation in one vascular bed may be accompanied by constriction elsewhere”. Also, the cause of alterations in the macrohaemodynamics lies in the microcirculation e.g., the decrease in systemic vascular resistance and hypotension result from arteriolar vasodilatation and hypovolemia from capillary leak. Thus, it needs to be answered whether resuscitating the microcirculation rather than the macrocirculation will finally answer the quest for improving survival in sepsis.

There is previous evidence that resuscitating the macrohaemodynamics is not always associated with improved microhaemodynamics, organ function, or survival. A study by LeDoux and colleagues observed the effect of norepinephrine on global haemodynamic parameters and measures of tissue oxygenation during septic shock. While the mean blood pressure increased from 65 to 85 mmHg along with expected increase in heart rate and cardiac index (p<0.05), there was no improvement in organ function or tissue oxygenation as evidenced by decrease in urine output, no change in capillary red blood cell velocity, fall in capillary blood flow and increase in gastric pCO2. The authors thus concluded that resuscitation of mean blood pressure or cardiac output alone in septic shock is inadequate. Microcirculatory independence from arterial blood pressure in septic shock has also been proven using direct imaging of microcirculation,. DeBacker et al reported a significant decrease in vessel density and proportion of small perfused vessels in septic patients, the alterations being more severe in non-survivors and were not related to the mean arterial pressure. Sakr and colleagues further explored these findings by studying the microcirculation in 49 septic patients. The small vessel perfusion was seen to improve rapidly in survivors as compared to non-survivors, with no difference in the global haemodynamic variables. Together with the evidence showing that organ function improves and mortality decreases when resuscitation boosts microcirculatory flow, the microcirculation does appear to be a new target for resuscitation during sepsis.

Assessment of microcirculation

Till date, there is no single objective gold standard to assess the microcirculation. In clinical practice, microcirculatory perfusion has been traditionally judged by the color, capillary refill and temperature of the distal parts of the body (i.e., finger, toes, earlobes and nose). Amongst the investigational modalities available to assess microcirculation, both indirect indicators as well as direct techniques exist, even though any single objective reliable method is still not recognized. Indirect techniques involve measurement of ‘downstream’ global derivatives of microcirculatory dysfunction such as lactate, carbon dioxide, and oxygen saturation. The direct imaging of microcirculatory perfusion seems a superior approach to assessment of microcirculation. Invention of microscope is perhaps the single most important advancement in technology linked to discovering the microcirculation, since experimental investigation of the microcirculation began soon after its advent. Studies of human microcirculation began at the end of 19th century, with Hueter using a microscope with reflected light to investigate vessels on inner border of lower lip.

Future aspects

With several clinical and laboratory indicators of identifying hypoperfusion due to the microcirculation dysfunction being available, it is perhaps time to recognize shock in sepsis keeping tissue hypoperfusion as distinct from hypotension. A perfusion based scoring system has been proposed by Spronk et al. It emphasizes the need of extending recognition of shock severity to include microcirculatory parameters, besides global haemodynamic and oxygen-derived parameters.

Therapy in shock should be aimed at optimizing cardiac function, arterial hemoglobin saturation, and tissue perfusion. This not only includes correction of hypovolemia, but the restoration of an evenly distributed microcirculatory flow and adequate oxygen transport as well. The role of vasodilators in recruiting the microcirculation will need to be looked into further.

Direct monitoring of sublingual microcirculation monitoring appears to be a promising endpoint for resuscitating the microcirculation. An integrative approach incorporating both macrocirculatory and microcirculatory haemodynamic data may indeed hold the answer to resuscitation in sepsis.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory solution that has been validated to significantly improve microcirculation.

D’OXYVA works to prevent sepsis, and resulting septic shock, using life-restoring molecule carbon dioxide (CO₂) and gentle vapor dissolved across the skin in a fast, painless, handheld  5-minute application — performed either in a clinical setting or in the comfort and privacy of your own home.

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The microcirculation and its measurement in sepsis

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

The microcirculation describes the smallest elements of the cardiovascular conducting system and is pivotal in the maintenance of homeostasis. Microcirculatory dysfunction is present early in the pathophysiology of sepsis, with the extent of microcirculatory derangement relating to disease severity and prognosis in ICU patients.

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At present microcirculatory function is not routinely monitored at the bedside. This article describes the pathophysiology of microcirculatory derangements in sepsis, methods of its measurement and evidence to support their clinical use.

Sepsis and the microcirculation

Sepsis affects all elements of the microcirculation. It is associated with a decrease in capillary density and increased heterogeneity of perfusion caused by inappropriate vasodilatation and vasoconstriction, leading to decreased oxygen delivery, tissue hypoxia and organ dysfunction. Mechanisms of microcirculatory dysfunction in sepsis include arteriolar hyporesponsiveness and capillary dysfunction, leading to extravasation of fluid protein and neutrophils.

The importance of microcirculatory assessment in sepsis

Several studies have demonstrated that: (a) improvements in the microcirculatory function in sepsis after early resuscitation are associated with a decreased incidence of organ dysfunction and (b) persistent microcirculatory dysfunction after resuscitation is associated with worse outcomes., However, the microcirculation is difficult to monitor in practice and so current resuscitation goals rely on the monitoring and restoration of macro-haemodynamic values (such as systemic arterial pressure, cardiac output, heart rate), along with restoration of organ perfusion (inferred from normalization of serum lactate and ScVO2). Moreover, restoration of macro-haemodynamic variables such as arterial pressure, especially with vasoactive agents such as noradrenaline, does not guarantee improvements in microcirculatory flow; in fact, noradrenaline can inhibit microcirculatory function irrespective of the presence of hypotension.

Summary

Microcirculatory derangement is common in patients with sepsis and cannot necessarily be predicted from macro-haemodynamic values. Improvement in macro-haemodynamic values in the critically ill does not imply improvement in microcirculatory flow and patients whose microcirculation fails to improve following resuscitation are at increased risk of mortality. Detection of microcirculatory dysfunction may aid diagnosis and risk stratification in patients with sepsis; restoration of the function of the microcirculation may be a useful therapeutic target for resuscitation but further data are needed.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory solution that has been clinically tested to significantly improve microcirculation.

D’OXYVA works to prevent sepsis, and resulting septic shock, using life-restoring molecule carbon dioxide (CO₂) and gentle vapor dissolved across the skin in a fast, painless, handheld  5-minute application — performed either in a clinical setting or in the comfort and privacy of your own home.