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Hydroxychloroquine + Azithromycin Therapy at a Higher Dose Improved Survival by Nearly 200% in Ventilated COVID Patients

AHA Publisher — Mon, 07 Jun 2021 07:00:14 +0000

Dr. Liji Thomas, MD via News-Medical – Treatment options have been limited in the ongoing coronavirus disease 2019 (COVID-19) pandemic. Earlier optimism regarding immunomodulatory drugs such as azithromycin (AZM) and hydroxychloroquine (HCQ) seemed to be undermined by results of large interventional trials. However, a fascinating new study posted to the medRxiv* preprint server (not peer-reviewed*), suggests that such disappointment may have been both premature and unwarranted, based on a re-analysis of over 250 patients on invasive mechanical ventilation (IMV) during the first two months of the pandemic. Using computational modeling, the use of weight-adjusted HCQ and AZM appears to be associated with a more than 100% increase in survival, without a clear correlation with ECG abnormalities. Study Details In this study, based on a subset of critically ill COVID-19 patients, consisting of patients who required intubation and IMV, data from the medical records were analyzed using several novel methods. This included not only the vital signs and laboratory values but the therapeutic methods. The study was carried out on patients at Saint Barnabas Medical Center, New Jersey, with just over 1% having been clinically diagnosed to have COVID-19. Of the 255 patients, almost 80% died during the study period. Seven patients were transferred to another hospital on the ventilator, mostly after day 40 of hospitalization. Parameters were broadly comparable between survivors and non-survivors, except that all patients with an active malignancy, dementia, chronic obstructive pulmonary disease, and stroke failed to survive. However, sex, race, presentation severity, and blood type had no association with survival chances. A pre-print version of the research paper is available on the medRxiv* server. A preprint is a version of a scholarly or scientific paper that precedes formal peer review and publication in a peer-reviewed scholarly or scientific journal. Laboratory Markers Laboratory markers of inflammation, such as Ferritin, D-dimer, Lactate Dehydrogenase (LDH), and C-reactive protein (CRP), were above average in almost every patient (96%). While all parameters, except the LDH, were equivalent in survivors and non-survivors, three patients had D-dimer values above 69,000 ng/mL. LDH values were higher in non-survivors by almost 30%. The increase in these parameters over time was characteristically steeper in patients who did not survive. Clinical Complications More than three in four non-survivors developed acute kidney injury (AKI), of which a tenth received renal replacement therapy (RRT). Of this latter group, a fifth survived. Almost 60% of patients were intubated within three days of hospitalization. The time to intubation did not predict survival, but intubation beyond day 15 was associated with survival in only 1 of 16 patients. More than 90% of the patients in this cohort had high blood glucose levels above 140 mg/dL, peak at >200 mg/dL, without corticosteroid therapy. Although none were known to be diabetics, most probably had impaired glucose tolerance before they acquired SARS-CoV-2. This prevalence is higher than in most other studies, probably because the researchers looked actively for hyperglycemia Obesity While half of the patients were obese, and 30% were overweight, the older patients were significantly heavier. That is, 74% of those above 60 were obese, vs 37% of those below this age. The mean body weight was approximately 90 kg, but unlike most antibiotic clinical trials, the range of body weight was extensive. The heaviest patient thus weighed approximately seven times more than the lightest. Notably, blood glucose levels or obesity did not predict a good clinical outcome. Therapeutic Drugs The chief therapeutic classes included steroids, tocilizumab, convalescent plasma, hydroxychloroquine, and azithromycin. Corticosteroids, when given at 6 mg or more, reduced the mortality risk 1.4 times. Meanwhile, the interleukin-6 receptor blocker) tocilizumab had two-fold lower mortality. Convalescent plasma (CP) was used only from week 4, in a fifth of the patients, mostly younger than those who did not receive it. The survival of the group which received CP was almost doubled from CP non-users. HCQ was used in 94% of patients within 48 hours of emergency room arrival, while >55% received 2,000-3,000 mg, cumulatively. Of this number, approximately 63% also received AZM. This combination fell out of favor over the study period based on external recommendations. Effect of HCQ/AZM on Mortality With every log increase in the cumulative dose of HCQ, the mortality rate fell by 1.12 times, such that at 3 g HCQ, survival odds rose by 2.5 times. When given together with AZM, the benefit was still more significant. Chances of survival increased further. Among those who received both > 3g HCQ and >1g AZM, almost half survived, compared to one in seven (16%) among patients who received one of these drugs at the same dosages. This means a 32% absolute difference in survival, or a relative improvement in survival odds of 200%, with the combination of HCQ/AZM at this dosage. This far exceeds the survival benefit cited in any study of any intervention so far. When HCQ/AZM was given at lower dosages, the risk of death was over three times higher relative to the above combination and dosage regimen. When the cohort was divided into patients who received >3g HCQ/>1g AZM and those who did not, overall, the absolute chances of survival were 23% higher for the first group. The 17% survival in the second group would have increased to 39% with the former treatment, predicted the researchers. This indicates that treatment with >3g HCQ/>1g AZM was associated with a more than 130% increase in survival rate compared to any other standard therapy. Weight-Adjusted Cumulative Dosage The researchers also found that when adjusted for weight, the cumulative dose would have a still greater effect. In fact, the average treatment effect (difference in mean survival, in this case) shows a steep increase between 40-50 mg/kg to peak at 46% for a dose of 82 mg/kg. Thus, patients receiving HCQ above 80 mg/kg of HCQ with >1g AZM had 14 times higher survival odds compared to those who did not. If HCQ dosage was fixed at >3g, the odds of survival were 7 times higher, or less than half of that achieved with the weight-adjusted cumulative dosage. “The fact that weight-adjusted cumulative dose has an even greater effect on survival than cumulative HCQ dose is strong confirmation of the causal relationship between this treatment and improvement in survival rate.” Age was another major factor since those older than 60 were five times more likely to succumb than younger patients. Hyperlipidemia was the single comorbidity linked to approximately four times higher odds of death. Interestingly, there was no correlation between the cumulative dose of HCQ (or AZM) and the occurrence of QTc prolongation. In fact, the QT interval began to fall during the period when the cumulative dose of HCQ increased. None of the patients showed torsades de pointes. What Are the Implications? These findings indicate that a steeply rising ferritin, D-dimer and LDH over time predict poor survival, the rate of rise being several times greater for non-survivors. This should be validated to help provide a better prognosis for COVID-19 patients. The extensive range of obesity among critically ill patients indicates that weight-adjusted dosage is critical in achieving the correct therapeutic levels. Moreover, AZM is an independent contributor to improved survival. Most importantly, this is the first clinical study to demonstrate the remarkable benefit of using cumulative doses of HCQ>3g/AZM>1g, compared to those not treated with this combination. Why did such a large effect miss observation? For one thing, HCQ produces its benefit by cumulative effects on the target cells, which is weight-dependent. The failure to treat patients with weight-adjusted doses leads to ineffective treatment and outcomes biased towards lighter patients. HCQ is both safe and tolerable at higher doses, as shown in studies of rheumatoid arthritis or lupus. Such high doses for such long durations have not been used to treat COVID-19. The earlier studies claiming prolongation of the QTc duration with HCQ in COVID-19 treatment are shown to be flawed. Indeed, available data suggests that this finding is due to the underlying illness itself. The investigators also point out: “On April 24, 2020, the FDA issued a warning about the possible effects of low HCQ on QTc interval (47). Since 2010, the FDA has approved over 150 clinical trials, which include HCQ treatment. The FDA did and does not require monitoring for cardiotoxicity. In each of these trials, the total HCQ dose and expected tissue levels are markedly higher than used or seen in Covid patients. This discrepancy lacks logic or explanation.” In this startling study, the investigators carefully re-examined the data, showing that among critically ill COVID-19 patients on IMV, less than 4% “walk out of hospital.” In contrast, the survival benefit of combined HCQ/AZM at a cumulative dosage of >80 mg/kg and >1g, respectively, is shown to be both clear and significant. The safety at such doses is obvious, since survival is increased by almost 130% in this very high-risk population. Moreover, it appears that AZM is an important component of this therapy in terms of mortality reduction. *Important Notice medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. To read the original article click here.

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CDC Reveals Connection to Weight & COVID: 79% of Hospitalized Americans Were Obese, Overweight

AHA Publisher — Thu, 11 Mar 2021 08:00:58 +0000

Andrea Morris via CBN News – Shocking news was released from the CDC Monday revealing that a vast majority of people who have been hospitalized, placed on a ventilator, or died from COVID-19 were obese or overweight. The new study shows that nearly 150,000 people at 238 U.S. hospitals tested positive for COVID-19 from March to December last year. Of those patients, 28.3 percent were overweight and 50.8 percent were obese. Overweight is identified as having a body mass index (BMI) of 25 or more and those who are considered obese have a BMI of 30 or more. The CDC discovered that the risk for hospitalizations, ICU admissions, and death was at its lowest level for patients with a BMI under 25. And the possibility of developing a serious illness “sharply increased,” for those with a higher BMI, especially for people 65 and older. “As clinicians develop care plans for COVID-19 patients, they should consider the risk for severe outcomes in patients with higher BMIs, especially for those with severe obesity,” the agency wrote. And the CDC reports that 73.6 percent of adults aged 20 and older are considered overweight while 42.5 percent within that same age bracket are obese. The CDC added that “These results highlight the need to promote and support a healthy BMI, which might be especially important for populations disproportionately affected by obesity, particularly Hispanic or Latino and non-Hispanic black adults and persons from low-income households, which are populations who have a higher prevalence of obesity and are more likely to have worse outcomes from COVID-19 compared with other populations.” “As clinicians develop care plans for COVID-19 patients, they should consider the risk for severe outcomes in patients with higher BMI’s, especially for those with severe obesity,” the agency added. Meanwhile, the World Obesity Federation (WOF) reports that of the 2.5 million COVID-related deaths that were reported at the end of last month, 2.2 million were in countries where over half the population is deemed overweight. To read the original article click here. For more articles from CBN News click here.

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Genetic Mutations Predispose Individuals to Severe COVID-19

AHA Publisher — Mon, 27 Jul 2020 07:00:16 +0000

Rabound University Medical Center via EurekAlert – Current observations suggest that the coronavirus SARS-CoV-2 causes severe symptoms mainly in elderly patients with chronic disease. However when two pairs of previously healthy young brothers from two families required mechanical ventilation at the intensive care unit in rapid succession, doctors and researchers at Radboud University Medical Center were inclined to consider that genetic factors had a key role in compromising their immune system. Their research identified the gene TLR7 as an essential player in the immune response against SARS-CoV-2. A finding with potentially major consequences for understanding and possibly treatment of COVID-19. During the wave of COVID-19 patients that flooded Dutch hospitals in the first half of 2020, two young brothers became seriously ill with the SARS-CoV-2 virus and had to be mechanically ventilated in the ICU. One of them died from the consequences of the infection, the other recovered. The severe course of disease in otherwise healthy young brothers was a relatively rare occurrence, especially because the virus mainly affects the elderly. This observation triggered the curiosity of an attentive physician from the MUMC+ department of clinical genetics. She contacted her colleagues in Nijmegen who then investigated why these two young brothers were so severely affected. Genetic Factors “In such a case, you immediately wonder whether genetic factors could play a role,” says geneticist Alexander Hoischen. “Getting sick from an infection is always an interplay between – in this case – the virus and the human immune system. It may be a mere coincidence that two brothers from the same family become so severely ill. But it is also possible that an inborn error of the immune system has played an important role. We investigated this possibility, together with our multidisciplinary team at Radboudumc.” One X-Chromosome All genes (collectively called the exome) of both brothers were sequenced, after which the investigators combed through the data searching for a possible shared cause. Cas van der Made, PhD student and resident at the department of Internal Medicine: “We mainly looked at genes that play a role in the immune system. We know that several of these genes are located on the X-chromosome, and with two brother pairs affected X-chromosomal genes were most suspicious. Women carry two X-chromosomes, while men possess a Y-chromosome apart from the X. Therefore, men have only one copy of the X-chromosomal genes. In case men have a defect in such a gene, there is no second gene that can take over that role, as in women.” Gene Identification That search quickly revealed mutations in the gene encoding for the Toll-like receptor 7, TLR7 for short. There are multiple TLR-genes, which belong to a family of receptors with an important role in the recognition of pathogens (such as bacteria and viruses) and the activation of the immune system. Hoischen: “A few letters were missing in the genetic code of the TLR7 gene. As a result, the code cannot be read properly and hardly any TLR7 protein is produced. TLR7 function has so far never been associated with an inborn error of immunity. But unexpectedly we now have an indication that TLR7 is essential for protection from this coronavirus. So it seems that the virus can replicate undisturbed because the immune system does not get a message that the virus has invaded. Because TLR7, which must identify the intruder and subsequently activate the defense, is hardly present. That could be the reason for the severity of the disease in these brothers.” Additional Confirmation Then, quite unexpectedly, the doctors and researchers at Radboudumc come across another pair of brothers who have fallen seriously ill with COVID-19. Again, they are both under 35 years of age. Both of them were also in the ICU for mechanical ventilation. “Then the question of the role of genetics became even more obvious.” says Hoischen. “We also investigated the genetic code of these two brothers, again via the ‘rapid-clinical exome’ method. This time we saw no deletion, no loss of letters, but a single spelling mistake of one DNA-letter of the TRL7 gene. The effect on the gene is the same, however, because these brothers also do not make sufficient functional TLR7 protein. Suddenly we had four young people with a defect in the same gene, all of whom had fallen seriously ill from the SARS-CoV-2 virus.” Essential Role in the Defense Van der Made and colleagues have investigated the consequences of improper functioning of the TLR7 receptor. “Once activated, TLR7 triggers the production of so-called interferons, signaling proteins that are essential in the defense against virus infections,” says van der Made. “This immune response is perhaps all the more important in the fight against the SARS-CoV-2 virus, because we know from the literature that the virus has tricks to reduce the production of interferons by immune cells. When we mimic an infection with the coronavirus, we see that immune cells of the patients without properly functioning TLR7 hardly respond, and that minimal amounts of interferons are produced. These tests make it clear that the virus appears to have free rein in people without properly functioning TLR7 because it [the virus] is not recognized by the immune system.” Consequences “Due to the serious illness of four brothers in two families, so serious that it cost one of the young men his life, we have discovered this condition,” says Hoischen. “It seems to be a very specific abnormality, an immunodeficiency, which is mainly related to this coronavirus. None of the four men have previously suffered from immune-related diseases. It is the first time that we can connect a clinical phenomenon so strongly with TLR7.” “This discovery not only provides us with more insight into the fundamental workings of the immune system, but it may also have important consequences for the treatment of severely ill COVID-19 patients,” says Frank van de Veerdonk, immunologist and infectiologist. “The substance interferon can be given as a therapy. It is currently being investigated whether administering interferon in COVID-19 can indeed help.” To read the original article click here.

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Actual Mortality Rate of COVID-19-Affected Adults Is Less Than What Was Previously Reported

AHA Publisher — Wed, 10 Jun 2020 07:00:18 +0000

Wolters Kluwer Health via News-Medical Net – An online first study published in Critical Care Medicine indicates the actual mortality rate of adults with critical illness from COVID-19 is less than what was previously reported. Compared to earlier reports of a 50 percent mortality rate, the study finds that the mortality rate of critically ill patients who required mechanical ventilation was only 35.7 percent. About 60 percent of patients observed in the study survived to hospital discharge. The study observed patients 18 years and older from six COVID-19 designated intensive care units in three hospitals in Atlanta, Ga. from March to April 2020. The authors note that several considerations may have influenced the outcomes of the study including that all critically ill patients with COVID-19 in the hospital network were admitted to pre-existing ICUs that had adequate staffing ratios and equipment. An accompanying online first editorial examines the role of mainstream and social media in creating the narrative that intubation and mechanical ventilation were “the cause of suboptimal outcomes” for critically ill COVID-19 patients, without accounting for hospital staffing and equipment shortages. To read the original article click here.

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When Ventilators Don’t Help COVID-19 Patients, This Might

AHA Publisher — Sun, 26 Apr 2020 07:00:27 +0000

Michigan Medicine – University of Michigan via Newswise – Ventilators have gotten a lot of attention in the ongoing fight against COVID-19. But hundreds of hospitals around the world have another, less-publicized weapon that might help some of the most desperately ill patients survive when ventilators aren’t enough. It’s called ECMO. Newswise — Ventilators have gotten a lot of attention in the ongoing fight against COVID-19. But hundreds of hospitals around the world have another, less-publicized weapon that might help some of the most desperately ill patients survive when ventilators aren’t enough. Right now, hundreds of COVID-19 patients in intensive care worldwide are being kept alive using a life support technology called ECMO and the skills of specially trained teams of nurses, respiratory therapists, technicians and doctors. Meanwhile, experts are tracking in real time how well ECMO works in treating COVID-19. But early indications are that it could offer a last chance at life for a subset of the sickest COVID-19 patients: those who were relatively young and healthy before becoming infected with the novel coronavirus. Early evidence, based on a rapidly evolving international registry, shows that more than a third of critically ill COVID-19 patients who have completed ECMO treatment survived and left the hospital alive. Without ECMO, most would probably have died. With more time and data, it will be possible to see if ECMO saves as many people as it did during the H1N1 flu pandemic of 2009, when 60% of the patients critically ill enough to need ECMO were able to survive the viral infection. Replacement for Heart and Lungs Short for extracorporeal membrane oxygenation, ECMO involves a complex circuit of pumps, tubes, filters and monitors that must be operated by an expert team, to take over for both the heart and lungs. It channels the patient’s blood outside their body in order to add oxygen and remove waste before propelling it back to into the circulation system. Major medical centers, including the University of Michigan’s Michigan Medicine, have used ECMO for decades as a last-chance treatment for patients ranging from infants with heart malformations to adults with lung failure. Robert Bartlett, M.D., now an active emeritus professor of surgery at U-M, led the development of modern ECMO starting in the early 1980s, and has become known worldwide as the “grandfather of ECMO.” In the past decade, ECMO’s use has grown rapidly. More than 400 hospitals worldwide are listed in a registry of ECMO centers, up from about 120 centers 20 years ago. Additional hospitals have also added the capacity but are not yet part of the registry. Now, ECMO is being used in certain COVID-19 patients. But experts caution that patients must get evaluated by an ECMO center and transferred before their condition worsens too much. They should not have been on a ventilator more than seven days before starting ECMO, which means that they should be considered for ECMO soon after the decision to intubate them is made. Seven of the eight patients on ECMO at Michigan Medicine as of mid-April were COVID-19 patients, and most had transferred from hospitals in Detroit and its suburbs. “Despite the substantial resources required to care for patients on ECMO, we believe this is an appropriate strategy for selected patients that are otherwise at imminent risk of death,” says Jonathan Haft, M.D., medical director of U-M’s ECMO program. He adds that so far, the outcomes for ECMO patients treated by U-M’s team appear to be similar to outcomes from treating patients with other causes of acute respiratory failure. The U-M academic medical center treats more than 100 patients using ECMO every year, making its program among the largest in the country. The city where U-M is based, Ann Arbor, also serves as the headquarters of the Extracorporeal Life Support Organization, or ELSO, the international group that provides support and shared resources for ECMO care, and tracks and analyzes data to improve care. International Cooperation Through a massive and rapid effort by staff, ELSO has built a real-time dashboard of data on patients placed on ECMO for COVID-19 since March. As of April 21, it shows that more than 470 patients with suspected or confirmed cases of COVID-19 have been treated at the ECMO centers that are sharing their data. Most were men in their 40s and early 50s. Nearly half had obesity and one-fifth had diabetes. Most of those placed on ECMO for COVID-19 are still on the treatment, which can take weeks to allow the body to recover enough for the patient to function on their own. Every moment of that time, patients must be under the care of teams of trained nurses, respiratory therapists, technicians and physicians. In March, Bartlett and his colleagues created guidance for the use of the treatment in COVID-19, to help centers with existing ECMO capability understand when to devote resources to providing this level of care, and which patients to prioritize. They do not recommend that hospitals set up a new ECMO program in the middle of a pandemic. “If a patient is on a ventilator, and failing to respond, and they are relatively young with few comorbidities, that’s the time to think about ECMO,” says Bartlett. Sharing real-time data from ECMO centers around the world has been brought emerging data to frontline providers searching for information on ECMO and COVID-19, says Ryan Barbaro, M.D., M.S., the U-M pediatric intensivist who leads the ELSO Registry program. “We don’t know yet what the survival rate will be for ECMO-supported patients with this virus, but,” he says. “Sharing what we do know as the information is accumulated has been a valued resource for those considering ECMO support in patients with COVID-19.” Choosing Patients Carefully Lena Napolitano, M.D., co-directs the Surgical Intensive Care Unit where U-M’s adult ECMO patients are cared for, and is director of surgical critical care at Michigan Medicine. “ECMO centers provide an opportunity for patients to recover that not all institutions have, but it’s important to use this approach in the correct patient population,” she says. “It’s also important that centers without ECMO contact ECMO centers about evaluating COVID-19 acute respiratory distress syndrome patients for transfer as early as possible.” Michigan Medicine’s air ambulance service, Survival Flight, is equipped to provide ECMO in-flight, and its flight nurses are trained in critical care – making U-M’s helicopters flying intensive care units. Napolitano notes that in the face of a pandemic such as COVID-19, ECMO centers maybe limited not by how many ECMO circuits they have, but by how many trained staff they have available to provide the around-the-clock intensive care patients need. That’s what makes early consultation and timely transfer of appropriate patients so important, she says. Even if the patient does get transferred to an ECMO center, they may not be put on ECMO immediately, because ECMO centers may also offer additional types of advanced care. “If the patient has the full capacity to recover, the disease itself is recoverable,” she says. “In general, viral pneumonia has the best survival rate of all the indications for which we use ECMO, so it’s important we consider it in these patients too.” Even those with acute kidney injury and septic shock can recover from COVID-19, she adds. Napolitano emphasizes the critical role of nurses, respiratory therapists and physician trainees including residents and fellows in the tireless response to the current level of ECMO care for COVID-19 patients. Even medical students are playing a role, volunteering to keep families informed several times each day about how their loved ones are doing via phone when they cannot visit. Learning From This Experience Barbaro notes that even with seven ECMO patients at one time, U-M has one of the largest COVID-19 ECMO populations in the world. The median number of simultaneous cases at other hospitals is around three. About 100 of the centers that belong to ELSO say they have taken care of a COVID-19 patient using ECMO. Even as U-M and other hospitals provide ECMO care to COVID-19 patients, they’re taking care to ensure that circuits and staff are available for patients who need the technology for other types of care. The registry will help Bartlett, Barbaro and their colleagues gather enough data to publish findings soon, after the first hundred or so patients have completed their course of care. Even the patients who do not survive will provide valuable clues to help clinical teams in future. The COVID-19 data add to the data on more than 120,000 ECMO patients already in the registry. Meanwhile, past patients who owe their lives to ECMO continue to send messages to Bartlett. But he’s characteristically humble about this attention. “We’re just taking care of sick people, and we’ve figured out a way to help them live a little longer,” he says. To read the original article click here.

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Israel Fast-Tracks Ventilator Innovations for Covid-19 Care

AHA Publisher — Wed, 22 Apr 2020 07:00:51 +0000

Abigail Klein Leichman via Israel21c – In face of shortage, partnerships formed in the Startup Nation’s public, private and nonprofit sectors are finding fast and affordable alternatives. As soon as Israeli hospitals saw a possible shortage of ventilators for critical Covid-19 patients, the Startup Nation’s public, private and nonprofit sectors got busy finding fast and affordable alternatives. One of the coordinators of this task is Daniel Gold, the retired brigadier general who daringly began the Iron Dome missile defense project in defiance of the establishment in 2005. This time, as head of the Defense Ministry’s Directorate for Defense R&D (DDRD), Gold does not have to go behind anyone’s back. The DDRD enjoys full support in tackling this issue along with the ministry’s Directorate of Procurement and Production (DOPP). “Our defense industries have unparalleled capabilities — able to manufacture components quickly and in great quantities, whether it’s for weapon systems or ventilators. This eliminates our dependence on imports,” said Gold. “We are continuing in the race around the clock to translate the extraordinary tech capabilities of the defense establishment, to the fight against corona.” Everyone agrees the need is urgent. “Due to the shortage of ventilation machines, when medical staff face the impossible situation of deciding who to ventilate and who will be left to die, quick solutions for ventilation machines are direly necessary,” said Dr. Yoav Mintz, director of Hadassah Medical Center’s Center for Innovative Surgery. Portable Ventilators in Production The DDRD and DOPP converted an Israel Aerospace Industries (IAI) production facility to mass-produce portable turbine ventilators designed by Israeli medical device maker Inovytec. Inovytec’s Ventway Sparrow ventilators can be used in and out of the hospital. “The Ventway is suitable for chronic, life support-ventilation in COVID-19 patients,” the company says. IAI’s missile and space engineers are producing the lightweight, turbine-powered ventilators in cooperation with Inovytec. The Defense Ministry also is expanding ventilator production capacity through a collaboration between Israeli ventilator maker Flight Medical Innovations, electronic manufacturing company Baya Technologies and Rafael Advanced Defense Systems. Flight Medical’s Flight 60 compact mobile mechanical ventilator is suitable for all clinical situations. The company is now developing its Vento2ux series for use in ICUs. LifeCan One One made-in-Israel ventilator project is a partnership between an internationally known entity — defense electronics company Elbit Systems — and a new startup called LifeCan Medical. LifeCan’s emergency automatic ventilators are designed for non-hospital settings to support breathing in less severely ill patients. Projected to cost $2,000 a piece as opposed to tens of thousands for the type of ventilators used in intensive care units, LifeCan One ventilators were approved by the Health Ministry at the prototype stage and will be manufactured by Elbit starting next week at a rate of 500 per week. The initial goal is to produce 3,000 units to meet projected needs and help keep less critical patients from needing hospital care. Another made-in-Israel project is the result of a two-week collaborative effort spearheaded by Air Force Maj. David Alkaher. Among about 40 participating entities are the Israel Air Force electronics unit, IAI, Microsoft Israel, Rafael Advanced Defense Systems, robotics specialists, medical centers, national emergency network Magen David Adom and student robotics organization FIRST Israel. The first AmboVent emergency ventilator prototype was built within 48 hours by a high school robotics team. Mechanized to control respiration rate, volume and maximum peak pressure automatically, AmboVent is based on the Ambu Bag manual resuscitator that first responders use to restore normal breathing. An open-source plan released on GitHub on April 2 shows how the new device can be assembled quickly and cheaply using a 3D printer and off-the-shelf components such as sensors, car parts and a snowblower motor. Project coordinator Eitan Eliram, cofounder of Scout Innovation, reported that the specifications — translated from Hebrew into English, German, Italian, and Spanish by the Media Innovation Lab at IDC Herzliya — have been accessed by thousands of individuals and groups from countries including Iran, Egypt, South Africa, Guatemala, Italy and the United States. “We kept the design and every aspect of it very simple so it would be as easy as possible to replicate from everywhere,” he said. The device is being tested at medical centers. Eliram estimated that making each AmboVent will cost between $500 and $1,000. Sharing with the World “We’re making a lot of progress in ventilation, an area where we need new solutions because there is an extreme shortage all over the world,” said Dr. Eyal Zimlichman, chief medical officer and chief innovation officer at Sheba Medical Center and head of its ARC Innovation Center. Sheba is treating most of Israel’s Covid-19 patients. They use a wide assortment of new technologies, particularly in the field of contact-free care. Zimlichman said ARC has been working with partners including the IDF, DDRD and IAI. This week, Sheba received 100 hospital-grade ventilators that were made by converting BiPAP (Bilevel Positive Airway Pressure) noninvasive ventilation machines, a project done in collaboration with the IDF. Converted BiPAP ventilators “IAI will do mass production [of the converted BiPAP ventilators] in the future if there is a need,” Zimlichman tells ISRAEL21c. “We believe the world will be very interested in this idea. We will share it with partners across the world.” Zimlichman cautions, however, that Covid-19 seems to manifest itself in different ways, and ventilation is not warranted for all critical patients; in fact, in some patients ventilation may be more harmful than helpful. Nevertheless, hospitals want to be sure enough ventilators and associated technologies are available for patients who may benefit from them. IAI’s Aviation R&D group is developing a sterilization system for hospital ventilators as well as a ventilation “helmet” made from 3D-printed parts. The Israeli Navy’s R&D team is working with partners on producing advanced medical oxygen compression systems to aid in treating ventilated Covid-19 patients. Avi Dadon, Deputy Director General and head of DOPP, added: “We are proud of the full mobilization of Israeli industries for the national mission of manufacturing and supplying ventilators. The cooperation between defense, high-tech and medical industries is a real force multiplier.” Meanwhile, World Judo Champion Sagi Muki is auctioning personal memorabilia to purchase five ventilators for a hospital in his hometown of Netanya. To read the original article click here. For more articles from Israel21c click here.

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Cost-Effective Canopy Protects Health Workers from COVID Infection During Ventilation

AHA Publisher — Wed, 22 Apr 2020 07:00:07 +0000

European Lung Foundation via EurekAlert – Researchers have designed a cost-effective, constant flow plastic canopy system that can help to protect healthcare workers who are at risk of airborne coronavirus infection while delivering non-invasive ventilation or oxygen via high flow nasal canula (HFNC), according to a research letter published in the European Respiratory Journal. Ventilatory support with non-invasive ventilation or HFNC are often used to treat people with respiratory failure, a symptom of severe coronavirus disease, as they help patients with breathing difficulties to breathe by pushing pressured air into the lungs via a mask covering the mouth and/or nose. This can alleviate the need for in-demand invasive mechanical ventilators, but there are concerns about the increased risk of infection for healthcare workers who treat patients with non-invasive respiratory support. Professor Yochai Adir, from the Lady Davis Carmel Medical Center Pulmonary Division, Israel, led the research team. He explained: “The current crisis has resulted in a shortage of access to negative pressure facilities and invasive mechanical ventilators. This means we must adapt, so that we can continue to treat patients as best we can while protecting the health and safety of healthcare workers. “Non-invasive ventilation is one solution for this, but it may increase the risk of infection for healthcare workers, as virus particles can become airborne due to mask leakage, the speed and direction of the air flow, or from patient coughing. The constant flow canopy system that we designed and built addresses this risk, by eliminating healthcare workers’ exposure to this potentially dangerous situation.” The flexible plastic canopy forms an air chamber that covers the upper part of the patient’s body. The canopy is connected to a system containing a high-quality air filter that cleans the air, and an electrical fan that creates negative pressure, pulling the filtered air to the open air. The canopy system can be used to support up to four patients at a time. The researchers say the plastic used for the canopy design does not allow fluid or particles to pass through it and that it has been tested against international standards, which score effectiveness based on the number and size of airborne particles that pass through the material. Professor Adir said: “We installed this cost-effective system within our hospital and found it supports the delivery of non-invasive ventilatory support with minimal risk of infection for the medical staff. It enables alternatives to mechanical ventilation for patients with moderate to severe coronavirus infection, who may otherwise go untreated because of a shortage of equipment.” The researchers say the physical barrier between patients and medical staff created by the canopy could make administering treatment challenging, and the size of the canopy system can be difficult to install in small treatment rooms. Professor Leo Heunks is an expert in intensive care medicine from the European Respiratory Society and was not involved in the study. He said: “Critical care systems are facing unprecedented challenges because of the coronavirus pandemic, so it is vital that we come up with ways to alleviate the pressure on healthcare systems without compromising health worker safety. The design outlined in this research paper offers an interesting approach for treating patients who require breathing support, and importantly it has a clear focus on protecting the health of frontline medical staff.” To read the original article click here.

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How and Where to Allocate Stockpiled Ventilators During a Pandemic

AHA Publisher — Sat, 28 Mar 2020 07:00:26 +0000

Mary Ann Liebert, INC./Genetic Engineering News via EurekAlert – Key factors must be taken into account in determining the need for and allocation of scarce ventilators during a severe pandemic, especially one causing respiratory illness. New Rochelle, NY, March 20, 2020–Strategies to help state and local planners in allocating stockpiled ventilators to healthcare facilities, including pre-pandemic actions and actions to be taken during the pandemic, are detailed in a timely article published in Health Security, a peer-reviewed journal from by Mary Ann Liebert, Inc., publishers. Click here to read the full-text article free on the Health Security website. Lisa Koonin, Health Preparedness Partners, and colleagues from the Centers for Disease Control and Prevention (Atlanta, GA), coauthored the article entitled “Strategies to Inform Allocation of Stockpiled Ventilators to Healthcare Facilities During a Pandemic.” Prior to a pandemic, planners should determine existing inventories and facilities’ ability to make use of additional ventilators in the event of a public health emergency. This information needs to be updated at the time of a pandemic. Determining where to allocate stockpiled ventilators should be based on an assessment of need, the consideration of ethical principles discussed in the article, the ability of facilities to absorb additional ventilators, and the ability to ensure access to ventilators for vulnerable or high-risk populations. “Ventilators will be pivotal to saving countless lives in this COVID pandemic. Understanding CDC’s plans and recommendations for state and local planners around ventilator management in this kind of crisis will be key for helping them make decisions under very difficult conditions,” says Editor-in-Chief Thomas V. Inglesby, MD, Director, Johns Hopkins Center for Health Security, Baltimore, MD. To read the original article click here.

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