Federal Register - June 21, 2021

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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations hospitalized patients 32% required ICU
care, 72% of the ICU patients and 60%
of the non-ICU patients reported fatigue a mean of 48 days after discharge Halpin et al., July 27, 2020.
Breathlessness was also common, affecting 65.6% of ICU patients and 42.6% of non-ICU patients.
In a New York City study, of the 638
COVID19 patients who required dialysis for AKI while hospitalized, only 108 survived. Of those 108, 33 still needed dialysis at discharge Ng et al., September 19, 2020. A study of Chinese patients reported that 11% of 333
hospitalized patients with COVID19
pneumonia developed AKI Pei et al., June, 2020. Only half 45.7%
experienced complete recovery of kidney function with a median follow up of 12 days. A similar study in Spain also found only half 45.72%
experienced complete recovery with a median follow up of 11 days Procaccini et al., February 14, 2021. A Hong Kong study provided a longer follow-up period including 30 and 90 days after the initial AKI event. At 7, 30, and 90
days after the initial AKI event, recovery was observed in 84.6, 87.3% and 92.1%, respectively Teoh et al., 2021. A study in New York City found that 77.1% of patients with AKI experienced complete recovery during the follow up period, excluding those who died or were sent to hospice Charytan et al., January 25, 2021. While 88% of these AKI cases were in March and April with a final follow-up date of August 25, it is uncertain how long it took for recovery to occur.
Long-term cardiovascular effects also appear to be common after SARSCoV
2 infections, even among those who did not require hospital care. A German study evaluated the presence of myocardial injury in 100 patients a median of 71 days after COVID19
diagnosis Puntmann et al., July 27, 2020. While only a third 33% of study participants required hospitalization, cardiovascular magnetic resonance CMR imaging was abnormal in 78%. In the U.S., a study of COVID19 cases in college athletes, of whom 16 of 54 30%
were asymptomatic, identified abnormal findings in 27 56.3% of the 48 athletes who completed both imaging studies, with 39.5% consistent with resolving pericardial inflammation Brito et al., November 4, 2020. A small number remained symptomatic with fatigue and shortness of breath at 5 weeks and were referred to cardiac rehabilitation Lowry, November 12, 2020.
A database for clinicians in the UK to report COVID19 patients with neurological complications revealed that 62% of the initial 125 patients
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enrolled presented with a cerebrovascular event including ischemic strokes and intracerebral hemorrhages Varatharaj et al., June 25, 2020. A UK study comparing COVID
19 ischemic stroke and intracerebral cases with similar non-COVID19 cases found a fatality rate of 19.8% for COVID19 patients in comparison to a fatality rate of 6.9% for non-COVID19
patients Perry et al., 2021. As discussed above, PICS, involving prolonged impairments in cognition, physical health, and/or mental health, may also occur. Other neurologic diagnoses, including encephalopathy, Guillain-Barre syndrome, and a range of other less-common diagnoses, may cause morbidity that persists during recovery Elkind et al., April 9, 2021;
Sharifian-Dorche et al., August 7, 2020.
A recent autopsy study of brain tissue from 18 COVID19 patients reported the presence of small blood vessel inflammation and damage in multiple different brain areas Lee et al., February 4, 2021. Persistent abnormalities in brain imaging have also been reported in patients after discharge Lu et al., August 3, 2020. A study of 509
hospitalized patients in the Chicago area early in the pandemic reported that a third had encephalopathy, resulting in symptoms such as confusion or decreased levels of consciousness Liotta et al., October 5, 2020.
Encephalopathy was associated with worse functional outcomes at discharge only 32% were able to handle their own affairs without assistance and higher deaths in the 30 days postdischarge.
COVID19 also impacts mental health, both as a result of the toll of living and working through such a disruptive pandemic, but also because of actual medical impacts the virus might have on the brain itself. As de Erausquin et al., January 5, 2021 notes, SARSCoV2 is a suspected neurotropic virus and neurotropic respiratory viruses have long been known to result in chronic brain pathology including emerging cognitive decline and dementia, movement disorders, and psychotic illness. Because brain inflammation accompanies the most common neurodegenerative disorders and may contribute to major psychiatric disorders, the neurological and psychiatric sequelae of COVID-19 need to be carefully tracked. An international consortium guided by WHO is attempting to determine these long-term neurodegenerative consequences more definitively, with follow up studies ending in 2022 de Erausquin et al., January 5, 2021.

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In the short term, a number of studies have already demonstrated the potential mental health effects caused by COVID
19. In the UK database mentioned above, 21 of 125 COVID19 patients had new psychiatric diagnoses, including 10
who became psychotic and others with dementia-like symptoms or depression Varatharaj et al., June 25, 2020. An Italian study screened 402 adults with COVID19 for psychiatric symptoms with clinical interviews and self-report questionnaires at one month follow-up after hospital treatment for COVID19.
Patients rated in the psychopathological range as follows: 28% for post-traumatic stress disorder PTSD, 31% for depression, 42% for anxiety, 20% for obsessive-compulsive symptoms, and 40% for insomnia. Overall, 56% scored in the pathological range in at least one clinical dimension Mazza et al., July 30, 2020. The TriNetX analytics network was used to capture deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States Taquet et al., November 9, 2020. Of those patients, 62,354
adults were diagnosed with COVID19
between January 20 and August 1, 2020.
Within 14 to 90 days after being diagnosed with COVID19, 5.8% of those patients received a first recorded diagnosis of psychiatric illness, which was measured as significantly greater than psychiatric onset incidence during the same time period after diagnoses of other medical issues including influenza 2.8%, other respiratory diseases 3.4%, skin infections 3.3%, cholelithiasis 3.2%, urolithiasis 2.5%, and fractures 2.5%. At the NIAID Workshop on Post-Acute Sequelae of COVID19, medical personnel discussed their experiences treating COVID19 patients in the Johns Hopkins Post-Acute COVID19 Team PACT Clinic. Among 49 patients in the Clinic, more than 50% had some form of cognitive impairment 3 months after acute illness Parker, December 3, 2020.
Both ICU and non-ICU patients were affected, but impairment was more pronounced in ICU survivors Parker, December 3, 2020. The medical personnel also reported mental health impairments among patients treated at the PACT Clinic.
The studies and evidence discussed above give some indication of the many serious long-term health effects COVID
19 patients might experience, including respiratory, cardiovascular, neurological, and psychiatric complications. However, the full extent of the long-term health consequences of COVID19 is unknown because the
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Federal Register - June 21, 2021

TítuloFederal Register

PaísEstados Unidos de América

Fecha21/06/2021

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Nro. de ediciones7798

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