En un gran estudio reciente, los pacientes recuperados de COVID-19 tuvieron 35 por ciento más probabilidades de sufrir daños a largo plazo en los riñones o un deterioro de la función renal.Desde el principio de la pandemia, los médicos han descubierto que la gente que experimenta casos graves de COVID-19 a menudo tiene problemas renales y no solo el daño pulmonar característico de esta enfermedad.Ahora, un estudio muy grande señala que, después de que los pacientes se recuperan de la infección inicial, los problemas renales pueden durar meses y que en algunos pacientes las secuelas pueden originar una reducción considerable de la función renal.En este estudio, publicado el 1 de septiembre en la revista Journal of the American Society of Nephrology, se descubrió que cuanto más enfermos estuvieran los pacientes al principio, más probable era que sufrieran un daño renal prolongado.Pero incluso las personas que contraen el virus y presentan una infección menos grave podrían ser vulnerables.“De manera generalizada, en realidad vemos un mayor riesgo de que se presente una serie de eventos importantes vinculados con el riñón”, señaló F. Perry Wilson, nefrólogo y profesor adjunto de Medicina en la Universidad de Yale, quien no participó en el estudio. “Y lo que más me sorprendió es que estos perduraron”.Los riñones tienen una participación fundamental en el organismo para eliminar las toxinas y el exceso de líquido de la sangre, ayudar a mantener una presión arterial saludable y regular el equilibrio de electrolitos y de otras sustancias importantes. Cuando los riñones no funcionan bien o de manera eficiente, los líquidos se acumulan y provocan inflamación, presión sanguínea alta, debilidad en los huesos y otros problemas.El corazón, los pulmones, el sistema nervioso central y el sistema inmunitario pueden sufrir un deterioro. En la etapa terminal de la insuficiencia renal, quizás se necesite la diálisis o un trasplante de riñón. Esta enfermedad podría provocar la muerte.Este nuevo estudio, el cual se basó en los registros de los pacientes del sistema de salud del Departamento de Asuntos de los Veteranos, analizó la información de 89.216 personas que dieron positivo al coronavirus entre el 1 de marzo de 2020 y el 15 de marzo de 2021, así como la información de 1.637.467 personas que no tuvieron covid.Entre uno y seis meses después de haberse infectado, los sobrevivientes de covid tuvieron aproximadamente un 35 por ciento más de probabilidades de tener un daño renal o un deterioro considerable en la función renal que quienes no tuvieron covid, señaló Ziyad Al-Aly, director del servicio de investigación y desarrollo en el Sistema de Atención a la Salud de San Luis del Departamento de Asuntos de los Veteranos (VA, por su sigla en inglés) y autor sénior del estudio.“Las personas que han sobrevivido a los primeros 30 días de la covid están en riesgo de desarrollar insuficiencia renal”, mencionó Al-Aly, nefrólogo y profesor adjunto de Medicina en la Escuela de Medicina de la Universidad de Washington.Debido a que muchas personas que tienen una función renal disminuida no experimentan dolor ni otros síntomas, “lo que importa en realidad es que la gente sepa que existe un riesgo y que los médicos de los pacientes que tuvieron covid estén muy atentos a la función y a la insuficiencia renal”, explicó.Los dos grupos de pacientes del estudio diferían en que todos los miembros de un grupo se habían infectado con covid y los miembros del otro grupo podían haber tenido una variedad de otros padecimientos. Los especialistas advirtieron que las comparaciones tenían limitaciones.Los investigadores intentaron reducir al mínimo las diferencias a través de análisis detallados que ajustaron a partir de una larga lista de características demográficas, enfermedades preexistentes, uso de medicamentos y si las personas estaban en asilos.Otra limitación es que los pacientes en el estudio del VA eran en su mayoría varones blancos de una edad promedio de 68 años, así que no queda muy claro cuán generalizables son los resultados.Según los expertos, un aspecto sólido de la investigación es que contempla a más de 1,7 millones de pacientes con expedientes médicos electrónicos detallados, lo que la convierte en el estudio más grande hasta ahora sobre problemas renales vinculados a la covid.Aunque lo más probable es que los resultados no sean aplicables para todos los pacientes con covid, muestran que entre los participantes del estudio “existe una afectación muy notable a largo plazo para la salud renal de los sobrevivientes de COVID-19, sobre todo para quienes estuvieron muy enfermos durante la enfermedad aguda”, señaló C. John Sperati, nefrólogo y profesor adjunto de Medicina en la Universidad Johns Hopkins, quien no participó en el estudio.Otros investigadores han descubierto patrones parecidos, “así que este no es el único estudio que indica que estos eventos están ocurriendo después de una infección de COVID-19”, añadió.Sperati y otros especialistas han señalado que incluso si solo un pequeño porcentaje de los millones de sobrevivientes de COVID-19 en Estados Unidos desarrollasen problemas renales prolongados, el impacto para la atención sanitaria sería muy importante.Con el fin de evaluar la función renal, el equipo de investigación evaluó los niveles de creatinina, un producto de desecho que los riñones deben eliminar del cuerpo y también un indicador de la adecuada filtración de la sangre, el cual se denomina índice de filtración glomerular.Wilson explicó que, a lo largo de la vida, los adultos sanos poco a poco pierden la función renal a partir de los treinta y tantos o cuarenta y tantos años a razón de aproximadamente el uno por ciento o menos al año. Las enfermedades y las infecciones importantes pueden provocar una pérdida más significativa o permanente de esta función, la cual puede originar una insuficiencia renal crónica o una insuficiencia renal en etapa terminal.Según Al-Aly, en el nuevo estudio se descubrió que 4757 sobrevivientes de covid habían perdido al menos un 30 por ciento de la función renal en el año posterior a haber tenido la infección.Eso equivale a cerca de “30 años de deterioro en la función renal”, afirmó Wilson.En el estudio se descubrió que existía un 25 por ciento más de probabilidades de que los pacientes que tuvieron covid alcanzaran ese nivel de deterioro que las personas que no contrajeron la enfermedad.Un grupo más pequeño de sobrevivientes de covid presentó deterioro más acentuado. Pero había un 44 por ciento más de probabilidades de que los pacientes con covid perdieran al menos el 40 por ciento de la función renal y era un 62 por ciento más probable que perdieran al menos el 50 por ciento que los pacientes sin covid.Al-Aly informó que en 220 pacientes con covid se detectó insuficiencia renal en etapa terminal, la cual se presenta cuando se pierde al menos el 85 por ciento de la función renal. En el estudio se encontró que los sobrevivientes de covid tenían tres veces más probabilidades de recibir este diagnóstico que los pacientes sin covid.Al-Aly y sus colegas también investigaron un tipo de falla renal repentina llamada insuficiencia renal aguda, la cual otros estudios han encontrado en hasta la mitad de los pacientes hospitalizados con covid. Esta falla puede sanar sin provocar pérdida de la función renal a largo plazo.No obstante, en el estudio del veteranos, se descubrió que meses después de haber tenido la infección, 2812 sobrevivientes de covid sufrieron insuficiencia renal aguda, casi el doble que los pacientes sin covid, aseveró Al-Aly.Wilson señaló que los nuevos datos respaldaban los resultados de un estudio con 1612 pacientes que realizaron él y sus colegas en el cual descubrieron que los pacientes con covid que tenían insuficiencia renal aguda presentaron una función renal significativamente peor en los meses posteriores a su salida del hospital comparados con quienes presentaban daños renales agudos resultantes de otras enfermedades.En el nuevo estudio, los investigadores no compararon de manera directa a los sobrevivientes de covid con las personas infectadas por otros virus, como el de la influenza, lo cual dificultaba saber si “en realidad estás más enfermo que si hubieras tenido otra infección grave”, comentó Sperati.Sin embargo, en un estudio anterior realizado por el equipo de Al-Aly, en el que se analizaron muchos problemas de salud posteriores a la covid, incluidos los problemas renales, las personas hospitalizadas por COVID-19 tenían un riesgo significativamente mayor de desarrollar problemas de salud a largo plazo en prácticamente todas las categorías médicas, incluidas las afecciones cardiovasculares, metabólicas y gastrointestinales, que las personas hospitalizadas por la gripe.Todos los tipos de trastornos renales monitoreados en el nuevo estudio fueron mucho más frecuentes en los pacientes de covid que estuvieron más enfermos al principio, es decir, los que pasaron algún tiempo en cuidados intensivos o los que experimentaron una lesión renal aguda en el hospital.Las personas que estuvieron menos graves durante su hospitalización por covid tenían menos probabilidades de sufrir problemas renales persistentes, pero seguían siendo considerablemente más propensas que los pacientes que no habían tenido covid.“Las personas que corren mayor riesgo son las que realmente lo pasaron mal ya desde el inicio”, dijo Al-Aly. “Pero realmente, nadie se libra del riesgo”.El estudio también descubrió que incluso los pacientes de covid que nunca necesitaron hospitalización tenían un riesgo ligeramente mayor de sufrir problemas renales que la población general de pacientes del VA. Pero el riesgo parecía tan pequeño, dijo Sperati, que “no sé si confiaría” en esos resultados.Wilson observó que algunos pacientes de covid que no necesitaron hospitalización estaban, sin embargo, bastante enfermos y requirieron permanecer en cama durante días. Dijo que es posible que esos fueran los que desarrollaron una disfunción renal a largo plazo, en lugar de las personas en el extremo más leve del espectro de covid.Los médicos no saben por qué la covid puede provocar daño renal. Los expertos explicaron que es posible que los riñones sean especialmente sensibles al aumento de la inflamación o la activación del sistema inmunitario, o que los problemas de formación de coágulos sanguíneos que casi siempre se observan en los pacientes con covid alteren la función renal.Sperati dijo que los pacientes de covid en el hospital parecían tener mayor necesidad de diálisis, y más proteínas y sangre en la orina que los pacientes hospitalizados con otras enfermedades graves.“El coronavirus es probablemente un virus un poco más tóxico para los riñones”, dijo Wilson. “Creo que el síndrome por covid tiene algunos efectos adversos a largo plazo en el riñón”.Pam Belluck es una reportera de ciencia y salud cuyos galardones incluyen un Premio Pulitzer compartido en 2015 y el premio Nellie Bly a la mejor historia de primera plana. Es autora de Island Practice, un libro sobre un doctor peculiar. @PamBelluck

In a study of veterans, Covid survivors were 35 percent more likely than other patients to have long-term kidney damage or declines in kidney function.Since the beginning of the pandemic, doctors have found that people who become very ill with Covid-19 often experience kidney problems, not just the lung impairments that are the hallmark of the illness.Now, a large study suggests that kidney issues can last for months after patients recover from the initial infection, and may lead to a serious lifelong reduction of kidney function in some patients.The study, published Wednesday in the Journal of the American Society of Nephrology, found that the sicker Covid patients were initially, the more likely they were to experience lingering kidney damage.But even people with less severe initial infections could be vulnerable.“You see really, across the board, a higher risk of a bunch of important kidney-associated events,” said Dr. F. Perry Wilson, a nephrologist and associate professor of medicine at Yale, who was not involved in the study. “And what was particularly striking to me was that these persisted.”Kidneys play a vital role in the body, clearing toxins and excess fluid from the blood, helping maintain a healthy blood pressure, and keeping a balance of electrolytes and other important substances. When the kidneys are not working properly or efficiently, fluids build up, leading to swelling, high blood pressure, weakened bones and other problems.The heart, lungs, central nervous system and immune system can become impaired. In end-stage kidney disease, dialysis or an organ transplant may become necessary. The condition can be fatal.The new study, based on records of patients in the Department of Veterans Affairs health system, analyzed data from 89,216 people who tested positive for the coronavirus between March 1, 2020, and March 15, 2021, as well as data from 1,637,467 people who were not Covid patients.Between one and six months after becoming infected, Covid survivors were about 35 percent more likely than non-Covid patients to have kidney damage or substantial declines in kidney function, said Dr. Ziyad Al-Aly, chief of the research and development service at the V.A. St. Louis Health Care System and senior author of the study.“People who have survived the first 30 days of Covid are at risk of developing kidney disease,” Dr. Al-Aly, a nephrologist, said.Because many people with reduced kidney function do not experience pain or other symptoms, “what’s really important is that people realize that the risk is there and that physicians caring for post-Covid patients really pay attention to kidney function and disease,” he said.The two sets of patients in the study differed, in that members of one group had all been infected with Covid and members of the other group may have had a variety of other health conditions. Experts cautioned that there were limitations to the comparisons.The researchers tried to minimize the differences with detailed analyses that adjusted for a long list of demographic characteristics, pre-existing health conditions, medication usage and whether people were in nursing homes.Another limitation is that patients in the V.A. study were largely male and white, with a median age of 68, so it is unclear how generalizable the results are.One strength of the research, experts said, is that it involves over 1.7 million patients with detailed electronic medical records, making it the largest study so far on Covid-related kidney problems.While the results most likely would not apply to all Covid patients, they show that for those in the study, “there’s a pretty notable impact on kidney health in survivors of Covid-19 over the long term, particularly those who were very sick during their acute illness,” said Dr. C. John Sperati, a nephrologist and associate professor of medicine at Johns Hopkins, who was not involved in the study.Other researchers have found similar patterns, “so this is not the only study suggesting that these events are transpiring after Covid-19 infection,” he added.He and other experts said that if even a small percentage of the millions of Covid survivors in the United States developed lasting kidney problems, the impact on health care would be great.To assess kidney function, the research team evaluated levels of creatinine, a waste product that kidneys are supposed to clear from the body, as well as a measure of how well the kidneys filter the blood called the estimated glomerular filtration rate.Healthy adults gradually lose kidney function over time, about 1 percent or less a year, starting in their 30s or 40s, Dr. Wilson said. Serious illnesses and infections can cause more profound or permanent loss of function that may lead to chronic kidney disease or end-stage kidney disease.The new study found that 4,757 Covid survivors had lost at least 30 percent of kidney function in the year after their infection, Dr. Al-Aly said.That is equivalent to roughly “30 years of kidney function decline,” Dr. Wilson said.Covid patients were 25 percent more likely to reach that level of decline than people who had not had the illness, the study found.Smaller numbers of Covid survivors had steeper declines. But Covid patients were 44 percent more likely than non-Covid patients to lose at least 40 percent of kidney function and 62 percent more likely to lose at least 50 percent.End-stage kidney disease, which occurs when at least 85 percent of kidney function is lost, was detected in 220 Covid patients, Dr. Al-Aly said. Covid survivors were nearly three times as likely to receive the diagnosis as patients without Covid, the study found.Dr. Al-Aly and his colleagues also looked at a type of sudden renal failure called acute kidney injury, which other studies have found in up to half of hospitalized Covid patients. The condition can heal without causing long-term loss of kidney function.But the V.A. study found that months after their infection, 2,812 Covid survivors suffered acute kidney injury, nearly twice the rate in non-Covid patients, Dr. Al-Aly said.Dr. Wilson said the new data supported results of a study of 1,612 patients that he and colleagues conducted that found that Covid patients with acute kidney injury had significantly worse kidney function in the months after leaving the hospital than people with acute kidney injuries from other medical conditions.In the new study, researchers did not directly compare Covid survivors with people infected with other viruses, like the flu, making it hard to know “are you really any sicker than if you just had another bad infection,” Dr. Sperati said.In a previous study by Dr. Al-Aly’s team, however, which looked at many post-Covid health issues, including kidney problems, people hospitalized with Covid-19 were at significantly greater risk of developing long-term health problems in virtually every medical category, including cardiovascular, metabolic and gastrointestinal conditions, than were people hospitalized with the flu.Every type of kidney impairment measured in the new study was much more common in Covid patients who were sicker initially — those in intensive care or who experienced acute kidney injury in the hospital.People who were less ill during their Covid hospitalization were less likely to have lingering kidney problems, but still considerably more likely than non-Covid patients.“People who are at highest risk are the people who really had it bad to start with,” Dr. Al-Aly said. “But really, no one is spared the risk.”The study also found that even Covid patients who never needed hospitalization had slightly higher risk of kidney trouble than the general V.A. patient population. But the risk seemed so small, Dr. Sperati said, that “I don’t know that I would hang my hat on” those results.Dr. Wilson noted that some Covid patients who did not need hospitalization were nonetheless quite ill, needing to stay in bed for days. He said it’s possible that those were the ones who developed long-term kidney dysfunction, rather than people at the mildest end of the Covid spectrum.Doctors are unsure why Covid can cause kidney damage. Kidneys might be especially sensitive to surges of inflammation or immune system activation, or blood-clotting problems often seen in Covid patients may disturb kidney function, experts said.Dr. Sperati said Covid patients in the hospital seemed to have greater need for dialysis, and more protein and blood in their urine, than patients hospitalized with other severe illnesses.“Covid is probably a little more of a kidney-toxic virus,” Dr. Wilson said. “I do think that the Covid syndrome has some long-term adverse effects on the kidney.”

Dr. Anthony S. Fauci warned on Sunday that the coronavirus pandemic is now “going in the wrong direction” in the United States because too many Americans are still choosing not to get vaccinated.Asked on CNN’s “State of the Union” program about projections in recent statistical models that Covid-19 cases and deaths could surge in the coming months if vaccination rates don’t increase, Dr. Fauci said “it’s not going to be good.”With about half of Americans not yet vaccinated and the fast-spreading Delta variant circulating, Dr. Fauci and a range of current and former health officials expressed exasperation at the situation on Sunday and vigorously pressed the case that vaccination is the best and most effective way to stem the tide of Covid cases.“It is really a pandemic among the unvaccinated,” Dr. Fauci said, adding “It’s like you have two kinds of America. You have the very vulnerable unvaccinated part and you have the really relatively protected vaccinated part. If you are vaccinated, you are in a very different category than someone who is not vaccinated.”The situation is so dire that in recent days, even some Republican governors in low-vaccination states have been pointedly exhorting people to get a Covid vaccine.On Sunday on CNN, Gov. Asa Hutchinson of Arkansas said that, with the new school year on the horizon, “this is a pivotal moment in our race against the Covid virus,” adding that “what’s holding us back is a low vaccination rate.”Governor Hutchinson, a Republican, said he has been holding town halls recently, which he credited for a 40 percent increase in vaccination. Still he added that “certainly the resistance has hardened” among some people. “It’s simply false information,” he said. “It is myths.”On CBS’s “Face the Nation,” Dr. Jerome Adams, who was surgeon general in the Trump administration, also encouraged vaccination, casting the decision in patriotic terms. “Get vaccinated because it’s going to help every single American enjoy the freedoms that we want to return to,” he said.Dr. Adams said some people still have legitimate questions about getting vaccinated, including workers who worry post-vaccine side effects might cause them to miss a day of work or a paycheck. He predicted immunization rates would increase once the vaccines — currently available under emergency use authorization from the Food and Drug Administration — become fully licensed. That will likely prompt the military and some businesses to mandate vaccination for service members and employees, he said.In the meantime, Dr. Adams said the message should be “it is your choice, but choices come with consequences to you and other people,” including children not yet old enough for vaccination and people who are medically vulnerable..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Several current and former officials discussed whether recommendations or mandates for wearing masks should be reinstated.Dr. Fauci said the Biden administration is considering reissuing stronger mask-wearing guidelines. In May, the Centers for Disease Control and Prevention relaxed its guidance, saying that people who are fully vaccinated do not need to wear a mask in most indoor settings.Dr. Adams said “that guidance, quite frankly, has confused citizens, it’s frustrated businesses and public health officials who I continue to hear from, and it’s been, by any qualification, a failure.”He said the C.D.C. should state clearly that even people who are vaccinated should wear masks if they are in public, around people whose vaccination status is unclear or in a community where Covid cases are increasing. “The CDC needs to give those businesses, those health officials a little bit of cover by clarifying the guidance that they have out there,” Dr. Adams said.

The major medical center’s rejection of the new Alzheimer’s drug is one of the starkest signs of concern over its effectiveness.In a striking reflection of concern over the approval of the controversial new Alzheimer’s drug Aduhelm, the Cleveland Clinic said Wednesday evening that it would not administer it to patients.The clinic, one of the largest and most respected medical centers in the country, said in a statement that a panel of its experts had “reviewed all available scientific evidence on this medication,” which is also called aducanumab.“Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time,” the statement said.A spokeswoman for the clinic said that individual physicians there could prescribe Aduhelm to patients, but those patients would have to go elsewhere to receive the drug, which is administered as a monthly intravenous infusion.The stance by the major medical center is the latest fallout from the Food and Drug Administration’s approval of the drug on June 7, a decision that has also spurred congressional investigations.Many Alzheimer’s experts and other scientists have said that it is unclear that the drug works to help slow cognitive decline and that in the best-case scenario, the evidence suggested only a slight slowing while also showing that Aduhelm could cause brain swelling or brain bleeding.The F.D.A. recently approved Aduhelm despite scant evidence that it helps patients.Biogen, via Associated PressThe drug is also expensive. Biogen, the maker, has set its price at $56,000 a year.In a recent survey of nearly 200 neurologists and primary care doctors, most said they disagreed with the F.D.A. decision and did not plan to prescribe the drug to their patients.Last week, in response to growing criticism, Dr. Janet Woodcock, the acting F.D.A. commissioner, called for an independent federal investigation into the agency’s approval process, writing that “to the extent these concerns could undermine the public’s confidence in F.D.A.’s decision, I believe it is critical that the events at issue be reviewed by an independent body.”Two nearly identical clinical trials of Aduhelm were stopped early because an independent data monitoring committee concluded that the drug didn’t appear to be helping patients. A later analysis by Biogen found that participants receiving the high dose of the drug in one trial had experienced a very slight slowing of cognitive decline — 0.39 on an 18-point scale — but that participants in the other trial had not benefited at all.About 40 percent of trial participants developed brain bleeding or brain swelling, and while most of those cases were mild or manageable, about 6 percent of participants dropped out of the trials because of serious adverse effects from those conditions.After evaluating the data late last year, an F.D.A. advisory committee of outside experts strongly recommended against approval, and three of its members resigned in protest last month when the agency bucked the advisory committee’s advice. The American Geriatrics Society had also urged the agency not to approve the drug, saying it would be “premature given the lack of sufficient evidence.”Last week, in response to widespread criticism that it had approved Aduhelm for anyone with Alzheimer’s, the F.D.A. sharply narrowed the drug’s recommended use, saying it should be used only for people with mild memory or thinking problems because there was no data on Aduhelm’s use in later stages of Alzheimer’s.

Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.A new drug for the treatment of Alzheimer’s disease should be given to a much narrower group of patients than the federal approval permits, Alzheimer’s experts — including those who strongly supported approval of the medication — said on Monday.Since the Food and Drug Administration approved the controversial and expensive drug, Aduhelm, made by Biogen, this month, much discussion has focused on the fact that many scientists, and the F.D.A.’s own independent advisory committee, say the evidence does not convincingly show that the drug works.But another major issue has received less attention: which patients should receive the drug and what doctors should do to prescribe it responsibly and safely.The F.D.A. has so far imposed strikingly few limitations on Aduhelm, a monthly intravenous infusion that requires patients to have regular M.R.I. scans because the drug can cause swelling or hemorrhaging in the brain.While the only patients who received the drug during clinical trials were those with very mild Alzheimer’s or an even milder pre-Alzheimer’s impairment, the F.D.A.’s label for Aduhelm says simply that the drug is “for the treatment of Alzheimer’s disease.” Under “contraindications,” the term for health conditions or other characteristics that should prevent patients from taking a drug, the label says “None.”The broadness of the label has surprised and concerned even the biggest champions of the drug.“Oy,” said one enthusiastic supporter of Aduhelm’s approval, Dr. Stephen Salloway, describing his reaction “when I saw from the label that there are no contraindications.”Dr. Salloway, director of neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I., spoke on Monday in a forum sponsored by the Alzheimer’s Association, a large patient advocacy group that pushed for approval of the drug. He and the five other experts answering questions about the use of the drug emphasized that the use of Aduhelm should be limited to certain patients: those in early stages of the disease whose brains contain high levels of amyloid, a protein that clumps into plaques in people with Alzheimer’s disease.The panelists, who had varying opinions about whether Aduhelm should have been approved, agreed that the drug’s potential brain side effects must be monitored carefully and that doctors should disclose to interested patients that there are many unknowns about Aduhelm, including whether it can provide any benefit.Aduhelm was designed to slow the progression of memory and thinking problems in people with mild cognitive symptoms, but its approval has been contentious. A number of scientists objected because only one of two clinical trials showed any hint of benefit, and in that trial the high dose of the medication slowed cognitive decline only slightly — by about four months in an 18-month period.Dr. Salloway, a site principal investigator for trials of the drug, wasn’t paid for that work but has received research and consulting fees from Biogen. He said doctors should use the drug only for patients whose statuses match those in the clinical trials.“There’s no evidence that it could be beneficial for any other stage of Alzheimer’s,” he said.Mary Sano, director of the Mount Sinai Alzheimer’s Disease Research Center in New York City, said the criteria that she and other panelists outlined were “very important” and meant that “it’s going to be very restrictive and the ability to share this drug with a wide range of people will be significantly limited, at least at this time.”Treating people only with mild symptoms would mean that for dementia clinicians, “most of your people in your current practice are probably not eligible,” Dr. Sano said.In its decision, the F.D.A. acknowledged that there was not the level of evidence of benefit that the agency usually requires. As a result, it is making Aduhelm available under a program called accelerated approval, citing the drug’s ability to reduce levels of amyloid in the brain. But reducing amyloid is not the same thing as slowing symptoms of dementia. Many amyloid-reducing drugs have failed to slow decline in clinical trials, a history that makes some experts especially wary of placing confidence in Aduhelm based on the evidence produced so far.Given the agency’s emphasis on amyloid in its approval decision, and the fact that all of the clinical trial participants had to have high amyloid levels, experts have also been surprised that the F.D.A. label does not require patients to be screened for the protein. Doctors at the Alzheimer’s Association forum all said that high levels of amyloid, typically measured by PET scan or spinal tap, should be a condition of treatment.Several of the panelists said that, at least at the outset, relatively few doctors and clinics would have the ability to adequately diagnose, screen and treat patients.“This is not a simple medication to use,” said Dr. Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California and a co-author of an article that urged the F.D.A. to approve the drug. “I think that establishing the appropriate individuals for treatment, and monitoring treatment, requires knowledge and benefits from experience, and there are very few clinicians who have this experience.”The panelists devoted considerable discussion to the possibility of brain swelling and hemorrhages, which occurred in about 40 percent of participants who received the high dose in the two large clinical trials. Many cases were mild or asymptomatic, but Dr. Alireza Atri, director of the Banner Sun Health Research Institute in Phoenix and another co-author of the article supporting approval of the drug, said that it was possible that “one out of 200 or 300 individuals can have a serious side effect and need to be in a hospital.”Dr. Salloway said that it would be “more challenging” for doctors to safely monitor for brain side effects than it was within the strict standards of the clinical trials. He said that people should not be given the drug if they have had a macro-hemorrhage in the brain; more than five micro-hemorrhages; a significant stroke; or “unstable medical conditions that could interfere with treatment.”Dr. David S. Knopman, a clinical neurologist at the Mayo Clinic and a site principal investigator for one of the trials, who did not support approval, said people who were taking blood thinners should also be excluded.“We know that this treatment carries considerable risks,” said Suzanne Craft, co-director of the Roena B. Kulynych Center for Memory and Cognition Research at the Wake Forest University School of Medicine. And assessing how and whether it helps patients could be tricky, Dr. Craft and others said.It will be important to have comprehensive discussions with patients and families about “how to weigh the inconvenience and cost and risk against the possible benefit,” Dr. Aisen said.“Managing expectations is a huge challenge here,” he said, adding that “our expectation is a modest slowing of the rate of decline. It is impossible to determine on an individual patient level whether someone is benefiting or not.”

An analysis of health insurance records of almost 2 million coronavirus patients found new issues in nearly a quarter — including those whose Covid infection was mild or asymptomatic.Hundreds of thousands of Americans have sought medical care for post-Covid health problems that they had not been diagnosed with before becoming infected with the coronavirus, according to the largest study to date of long-term symptoms in Covid-19 patients.The study, tracking the health insurance records of nearly 2 million people in the United States who contracted the coronavirus last year, found that one month or more after their infection, almost one-quarter — 23 percent — of them sought medical treatment for new conditions.Those affected were all ages, including children. Their most common new health problems were pain, including in nerves and muscles; breathing difficulties; high cholesterol; malaise and fatigue; and high blood pressure. Other issues included intestinal symptoms; migraines; skin problems; heart abnormalities; sleep disorders; and mental health conditions like anxiety and depression.Post-Covid health problems were common even among people who had not gotten sick from the virus at all, the study found. While nearly half of patients who were hospitalized for Covid-19 experienced subsequent medical issues, so did 27 percent of people who had mild or moderate symptoms and 19 percent of people who said they were asymptomatic.“One thing that was surprising to us was the large percentage of asymptomatic patients that are in that category of long Covid,” said Robin Gelburd, president of FAIR Health, a nonprofit organization that conducted the study based on what it says is the nation’s largest database of private health insurance claims.More than half of the 1,959,982 patients whose records were evaluated reported no symptoms from their Covid infection. Forty percent had symptoms but didn’t require hospitalization, including 1 percent whose only symptom was loss of taste or smell; only 5 percent were hospitalized.Ms. Gelburd said the fact that asymptomatic people can have post-Covid symptoms is important to emphasize, so that patients and doctors can know to consider the possibility that some health issues may actually be aftereffects of the coronavirus. “There are some people who may not have even known they had Covid,” she said, “but if they continue to present with some of these conditions that are unusual for their health history, it may be worth some further investigation by the medical professional that they’re working with.”The report, which will be posted publicly on Tuesday morning on the organization’s website, analyzed records of people diagnosed with Covid-19 between February and December 2020, tracking them until February 2021. It found that 454,477 people consulted health providers for symptoms 30 days or more after their infection. FAIR Health said the analysis was evaluated by an independent academic reviewer but was not formally peer-reviewed.“The strength of this study is really its size and its ability to look across the range of disease severity in a diversity of age groups,” said Dr. Helen Chu, an associate professor of medicine and infectious diseases at the University of Washington School of Medicine, who was not involved in the report. “This is a hard study to do with that much data.”The report “drives home the point that long Covid can affect nearly every organ system,” said Dr. Ziyad Al-Aly, chief of the research and development service at the VA St. Louis Health Care System, who was not involved in the new study.“Some of these manifestations are chronic conditions that will last a lifetime and will forever scar some individuals and families,” added Dr. Al-Aly, who was an author of a large study published in April of lingering symptoms in Covid patients in the Department of Veterans Affairs health system.In the new study, the most common issue for which patients sought medical care was pain — including nerve inflammation and aches and pains associated with nerves and muscles — which was reported by more than 5 percent of patients or nearly 100,000 people, more than a fifth of those who reported post-Covid problems. Breathing difficulties, including shortness of breath, were experienced by 3.5 percent of post-Covid patients.Nearly 3 percent of patients sought treatment for symptoms that were labeled with diagnostic codes for malaise and fatigue, a far-reaching category that could include issues like brain fog and exhaustion that gets worse after physical or mental activity — effects that have been reported by many people with long Covid.Other new issues for patients, especially adults in their 40s and 50s, included high cholesterol, diagnosed in 3 percent of all post-Covid patients, and high blood pressure, diagnosed in 2.4 percent, the report said. Dr. Al-Aly said such health conditions, which have not been commonly considered aftereffects of the virus, make it “increasingly clear that post-Covid or long Covid has a metabolic signature marked by derangements in the metabolic machinery.”Relatively few deaths — 594 — occurred 30 days or more post-Covid, and most were among people who had been hospitalized for their coronavirus infection, the report found.The study, like many involving electronic records, only addressed some aspects of the post-Covid landscape. It did not say when patients’ symptoms arose or how long the problems persisted, and it did not evaluate exactly when after infection patients sought help from doctors, only that it was 30 days or more.The database included only people with private health insurance or Medicare Advantage, not those uninsured or covered by Medicare Parts A, B and D, Medicaid or other government health programs. Dr. Chu said people without insurance or with incomes low enough to qualify for Medicaid are often “more likely to have worse outcomes,” so the findings may understate the prevalence of some post-Covid health problems or may not represent the full picture.In addition, diagnostic codes in electronic records are “only as good as what is documented by the provider who saw the patient,” said Dr. Chu, a co-author of a smaller study of post-Covid symptoms among patients at the University of Washington.For example, neurological or cognitive issues like brain fog may be underreported because doctors may not find an appropriate diagnostic code or patients may not be seeking medical help for that specific issue, FAIR Health said.It’s also possible that some people classified as having asymptomatic Covid-19 infections developed symptoms after they tested positive. And some people who received their first diagnosis of a medical issue like hypertension or high cholesterol post-Covid might have previously had those issues but never sought or received treatment.Another limitation of the study is that it did not compare people who had Covid-19 with those who did not, making it unclear if rates of post-Covid symptoms were higher than in a more general population. Dr. Al-Aly’s study, which made such a comparison, found that between one and six months after becoming infected with the coronavirus, patients who’d had Covid had a 60 percent greater risk of death and a 20 percent greater chance of needing outpatient medical care than people who had not been infected.The FAIR Health report excluded patients with certain serious or chronic pre-existing conditions like cancer, kidney disease, H.I.V., liver disease and stroke because researchers said it would be difficult to separate their previous health status from post-Covid symptoms.The report did not explore connections between other pre-existing conditions patients had and their likelihood of developing post-Covid symptoms. But it said that people with intellectual disabilities or those with Alzheimer’s disease or dementia had a greater risk of dying 30 days or more after their infection.Overall, experts said, the report’s findings underscore the widespread and varied nature of post-Covid symptoms.“People with long Covid need multidisciplinary care,” said Dr. Al-Aly, “and our health systems should adapt to this reality and develop capacity to deal with these patients.”

A small study found that six months after hospitalization, most children with MIS-C did not have debilitating health issues. But some had lingering muscle weakness and emotional difficulties.Children who get sick from the rare but serious Covid-related inflammatory syndrome may surmount their most significant symptoms within six months, but they may still have muscle weakness and emotional difficulties at that time, a new small study suggests.Published in the journal Lancet Child and Adolescent Health on Monday, the study appears to be the first detailed look at the health status of children six months after they were hospitalized with the condition, called Multisystem Inflammatory Syndrome in Children. The syndrome typically emerges two weeks to six weeks after a Covid-19 infection that is often quite mild, and it can result in hospitalizations for children with severe symptoms involving the heart and several other organs.A major question has been whether children who survive MIS-C will end up with lasting organ damage or other health problems. The new study, of 46 children under 18 who were admitted to a London hospital for MIS-C (it has a different name and abbreviation, PIMS-TS, in Britain), suggests that many of the most serious problems can resolve with time.“To be honest, I think we all didn’t know what to expect,” said Dr. Justin Penner, a pediatric infectious disease physician at the hospital involved in the study, Great Ormond Street Hospital, known as GOSH. “We didn’t know which body systems would require assistance or become a problem one month, three months, six months down the line.”The children in the study were hospitalized between April 4 and Sept. 1, 2020, part of the first wave of the inflammatory syndrome. Many were quite sick. They all had systemic inflammation, and most had symptoms involving multiple organ systems, such as the heart, kidneys or circulatory system. Forty-five children had gastrointestinal symptoms, and 24 had neurological symptoms such as confusion, memory problems, hallucinations, headaches or problems with balance or muscle control.Sixteen of the children were placed on ventilators, 22 needed medication to help their hearts pump more effectively and 40 were treated with immunotherapies like intravenous immunoglobulin. All survived.Six months after they were discharged from the hospital, only one child still had systemic inflammation, just two children had heart abnormalities and six children had gastrointestinal symptoms. All but one child was able to resume school, either virtually or in person.Still, 18 of the children were experiencing muscle weakness and fatigue, scoring in the bottom 3 percent for their age and sex on the six-minute walking test, a standard test of endurance and aerobic capacity. And 15 children were experiencing emotional difficulties like anxiety or severe mood changes, according to questionnaires answered by either the parents or the children.In the United States, 3,742 young people age 20 and under have developed the syndrome, and 35 have died, according to the most recent data from the Centers for Disease Control and Prevention. A major study of long-term outcomes has already recruited 600 children and will follow them for five years, according to a leader of that effort, Dr. Jane Newburger, associate chief for academic affairs in the cardiology department at Boston Children’s Hospital.Dr. Newburger, who was not involved in the British report, called it a “small but important study” that “contributes new information to the knowledge gap about long-term effects of MIS-C.”She and the authors themselves noted that there were limitations to the findings because the children in the study were not compared with a control group of children without MIS-C or those with other illnesses. It is unclear, for example, if their emotional problems and muscle weakness were the result of the syndrome, the process of being hospitalized for an illness or other stressors during this time. “Mental health and physical conditioning have taken a hit in children and adolescents in general during the pandemic,” Dr. Newburger said.Dr. Srinivas Murthy, an associate professor of pediatrics at the University of British Columbia, who was not involved in the new study, said it might be difficult to tease out which residual problems were directly attributable to the syndrome and which might have resulted from any critical illness. He said the fact that some of the children still had trouble with muscle weakness and endurance could yield important lessons, because such issues can require a different kind of a care including “post-hospitalization rehabilitation opportunities.”In fact, Dr. Penner said, the team at Great Ormond Street Hospital has made changes in the treatment of children hospitalized with the syndrome since the fall, because it has recognized “how affected their muscles are at the onset and how profoundly fatigued and weakened these kids are.”In the hospital, for example, “often just transferring from the bed to the toilet is exceptionally difficult for these children,” he said.The hospital now has a more concerted focus on providing the children in-hospital physical therapy and work with musculoskeletal therapists, he said, and it sends them home with an individualized rehabilitation plan that is linked to an app.“We’ve also involved our occupational therapists, and we’ve developed a fatigue program that’s run once a month where the parents dial in for a group session,” Dr. Penner said. “I think the main message that we give them is to avoid this boom-and-bust cycle, where the kids try to do the things they used to do at full speed and then they kind of crash afterwards — as opposed to a gradual increase of activity back to their normal state.”The hospital’s team is continuing to follow the children’s health. One potential concern is whether kidney or gastrointestinal problems might emerge later, which can occur after other critical illnesses, the study’s authors wrote. The team also hopes to conduct neurocognitive evaluations and other neurological testing, Dr. Penner said.“We don’t know what the longer-term outcomes will be,” Dr. Penner said. But for now, he added, “being able to relay at least what we’ve seen so far to parents has really enabled us to alleviate some of their anxieties about this black box of unknowns with regard to this new condition.”

A small study found that six months after hospitalization, most children with MIS-C did not have debilitating health issues. But some had lingering muscle weakness and emotional difficulties.Children who get sick from the rare but serious Covid-related inflammatory syndrome may surmount their most significant symptoms within six months, but they may still have muscle weakness and emotional difficulties at that time, a new small study suggests.Published in the journal Lancet Child and Adolescent Health on Monday, the study appears to be the first detailed look at the health status of children six months after they were hospitalized with the condition, called Multisystem Inflammatory Syndrome in Children. The syndrome typically emerges two weeks to six weeks after a Covid-19 infection that is often quite mild, and it can result in hospitalizations for children with severe symptoms involving the heart and several other organs.A major question has been whether children who survive MIS-C will end up with lasting organ damage or other health problems. The new study, of 46 children under 18 who were admitted to a London hospital for MIS-C (it has a different name and abbreviation, PIMS-TS, in Britain), suggests that many of the most serious problems can resolve with time.“To be honest, I think we all didn’t know what to expect,” said Dr. Justin Penner, a pediatric infectious disease physician at the hospital involved in the study, Great Ormond Street Hospital, known as GOSH. “We didn’t know which body systems would require assistance or become a problem one month, three months, six months down the line.”The children in the study were hospitalized between April 4 and Sept. 1, 2020, part of the first wave of the inflammatory syndrome. Many were quite sick. They all had systemic inflammation, and most had symptoms involving multiple organ systems, such as the heart, kidneys or circulatory system. Forty-five children had gastrointestinal symptoms, and 24 had neurological symptoms such as confusion, memory problems, hallucinations, headaches or problems with balance or muscle control.Sixteen of the children were placed on ventilators, 22 needed medication to help their hearts pump more effectively and 40 were treated with immunotherapies like intravenous immunoglobulin. All survived.Six months after they were discharged from the hospital, only one child still had systemic inflammation, just two children had heart abnormalities and six children had gastrointestinal symptoms. All but one child was able to resume school, either virtually or in person.Still, 18 of the children were experiencing muscle weakness and fatigue, scoring in the bottom 3 percent for their age and sex on the six-minute walking test, a standard test of endurance and aerobic capacity. And 15 children were experiencing emotional difficulties like anxiety or severe mood changes, according to questionnaires answered by either the parents or the children.In the United States, 3,742 young people age 20 and under have developed the syndrome, and 35 have died, according to the most recent data from the Centers for Disease Control and Prevention. A major study of long-term outcomes has already recruited 600 children and will follow them for five years, according to a leader of that effort, Dr. Jane Newburger, associate chief for academic affairs in the cardiology department at Boston Children’s Hospital.Dr. Newburger, who was not involved in the British report, called it a “small but important study” that “contributes new information to the knowledge gap about long-term effects of MIS-C.”She and the authors themselves noted that there were limitations to the findings because the children in the study were not compared with a control group of children without MIS-C or those with other illnesses. It is unclear, for example, if their emotional problems and muscle weakness were the result of the syndrome, the process of being hospitalized for an illness or other stressors during this time. “Mental health and physical conditioning have taken a hit in children and adolescents in general during the pandemic,” Dr. Newburger said.Dr. Srinivas Murthy, an associate professor of pediatrics at the University of British Columbia, who was not involved in the new study, said it might be difficult to tease out which residual problems were directly attributable to the syndrome and which might have resulted from any critical illness. He said the fact that some of the children still had trouble with muscle weakness and endurance could yield important lessons, because such issues can require a different kind of a care including “post-hospitalization rehabilitation opportunities.”In fact, Dr. Penner said, the team at Great Ormond Street Hospital has made changes in the treatment of children hospitalized with the syndrome since the fall, because it has recognized “how affected their muscles are at the onset and how profoundly fatigued and weakened these kids are.”In the hospital, for example, “often just transferring from the bed to the toilet is exceptionally difficult for these children,” he said.The hospital now has a more concerted focus on providing the children in-hospital physical therapy and work with musculoskeletal therapists, he said, and it sends them home with an individualized rehabilitation plan that is linked to an app.“We’ve also involved our occupational therapists, and we’ve developed a fatigue program that’s run once a month where the parents dial in for a group session,” Dr. Penner said. “I think the main message that we give them is to avoid this boom-and-bust cycle, where the kids try to do the things they used to do at full speed and then they kind of crash afterwards — as opposed to a gradual increase of activity back to their normal state.”The hospital’s team is continuing to follow the children’s health. One potential concern is whether kidney or gastrointestinal problems might emerge later, which can occur after other critical illnesses, the study’s authors wrote. The team also hopes to conduct neurocognitive evaluations and other neurological testing, Dr. Penner said.“We don’t know what the longer-term outcomes will be,” Dr. Penner said. But for now, he added, “being able to relay at least what we’ve seen so far to parents has really enabled us to alleviate some of their anxieties about this black box of unknowns with regard to this new condition.”

El síndrome MIS-C puede afectar a los menores semanas después de infectarse con el coronavirus. Los expertos, tras publicarse el mayor estudio realizado en Estados Unidos sobre la afección, recomiendan a los pediatras estar atentos.Muchos niños y adolescentes que desarrollaron el misterioso síndrome inflamatorio que puede manifestarse varias semanas después de contraer el coronavirus nunca tuvieron los síntomas clásicos de COVID-19 al momento de su infección, según el estudio de casos más grande hasta ahora en Estados Unidos.El estudio, dirigido por investigadores de los Centros para el Control y la Prevención de Enfermedades (CDC, por su sigla en inglés), encontró que en más de 1000 casos en los que se disponía de información sobre si se habían enfermado por su COVID-19 inicial, el 75 por ciento de los pacientes no experimentaron tales síntomas. Sin embargo, de dos a cinco semanas después, se enfermaron lo suficiente como para ser hospitalizados por la afección, llamada síndrome inflamatorio multisistémico pediátrico (MIS-C, por su sigla en inglés), que puede afectar diversos órganos, especialmente el corazón.El estudio, publicado el 6 de abril en JAMA Pediatrics, afirmó que “se cree que la mayoría de las enfermedades MIS-C son el resultado de casos leves o asintomáticos de COVID-19” seguidos de una respuesta hiperinflamatoria que parece ocurrir cuando los cuerpos de los pacientes han producido su nivel máximo de anticuerpos contra el virus. Los expertos aún no saben por qué algunos jóvenes, y una cantidad menor de adultos, responden de esta manera.“Eso significa que los pediatras de atención primaria deben tener un alto índice de sospecha de esto porque la covid es muy frecuente en la sociedad y los niños a menudo tienen una enfermedad asintomática en su infección inicial de covid”, afirmó Jennifer Blumenthal, intensivista pediátrica y especialista en enfermedades infecciosas pediátricas del Hospital para Niños de Boston, quien no estuvo involucrada en el estudio.Los investigadores evaluaron 1733 de los 2090 casos del síndrome en personas de 20 años o menos que habían sido reportados a los CDC hasta enero.Los resultados muestran que, aunque el síndrome es poco común, puede ser grave. Los datos de los CDC solo incluyeron pacientes que fueron hospitalizados. Más del 90 por ciento de estas personas jóvenes experimentaron síntomas que involucraron al menos cuatro sistemas de órganos y el 58 por ciento necesitó tratamiento en unidades de cuidados intensivos.Muchos experimentaron problemas cardiacos importantes: más de la mitad desarrolló baja presión arterial, el 37 por ciento desarrolló choque cardiogénico y el 31 por ciento experimentó una disfunción cardiaca relacionada con la incapacidad del corazón para bombear de forma adecuada. El estudio afirmó que un porcentaje significativamente mayor de pacientes que no habían tenido síntomas de COVID-19 experimentaron estos problemas cardiacos, en comparación con aquellos que sí tuvieron síntomas iniciales de coronavirus. Un porcentaje mayor de pacientes que al principio fueron asintomáticos también terminaron en unidades de cuidados intensivos (UCI).“Incluso la gran mayoría de los niños con casos graves de MIS-C que estuvieron en la UCI, no tuvieron una enfermedad previa que pudieran reconocer”, afirmó Roberta DeBiasi, jefa del departamento de enfermedades infecciosas del Children’s National Hospital en Washington D. C., quien no participó en la investigación.El estudio proporcionó la imagen demográfica y geográfica más detallada del síndrome hasta la fecha. Alrededor del 34 por ciento de los pacientes eran negros y el 37 por ciento eran hispanos, lo que refleja la forma en que el coronavirus ha afectado desproporcionadamente a los miembros de esas comunidades. A medida que avanzaba la pandemia, escribieron los autores, aumentó la proporción de pacientes de raza blanca, que representaban el 20 por ciento de todos los casos. Las personas de origen asiático representaban poco más del uno por ciento de los pacientes.En general, casi el 58 por ciento de los pacientes eran hombres, pero la proporción no era la misma en todas las edades. En el grupo más joven —recién nacidos hasta los 4 años— el número de niños y niñas era prácticamente igual, y la proporción entre hombres y mujeres aumentaba en los grupos de mayor edad hasta que la proporción llegaba a más de dos en el grupo de 18 a 20 años.La gran mayoría de los pacientes (casi el 86 por ciento) eran menores de 15 años. El estudio reveló que los menores de 5 años tuvieron el menor riesgo de desarrollar complicaciones cardiacas graves y fueron menos propensos a necesitar cuidados intensivos. Los pacientes de 10 años o más tuvieron una probabilidad mucho mayor de desarrollar problemas como choque cardiogénico, presión arterial baja y miocarditis (inflamación del músculo cardiaco).“Creo que es parecido a lo que vimos con la covid, donde los niños mayores parecían tener enfermedades más graves”, dijo DeBiasi. “Y eso se debe a que lo que en realidad enferma a las personas de la covid es su aspecto inflamatorio, así que quizás estos niños mayores, por diversas razones, produjeron más inflamación en la covid inicial o en el MIS-C”.Aun así, un número significativo de los pacientes más jóvenes desarrollaron problemas cardiacos. En el grupo entre recién nacidos hasta niños de 4 años, el 36 por ciento tuvo baja presión arterial, 25 por ciento tuvo choque cardiogénico y el 44 por ciento recibió tratamiento en la UCI.Pacientes de todas las edades en el estudio experimentaron casi la misma incidencia de algunos de los problemas cardiacos menos comunes relacionados con el síndrome, como aneurismas coronarios y acumulación de líquido. Los niños de 14 años o menos fueron más propensos a tener sarpullido y enrojecimiento de los ojos, mientras que los mayores de 14 tuvieron mayores probabilidades de desarrollar dolor en el pecho, dificultad para respirar y tos. Cerca de dos tercios de todos los pacientes se vieron afectados por dolores abdominales y vómito.Se registraron 24 muertes, repartidas en todos los grupos de edad. No hubo información en el estudio sobre si los pacientes tenían afecciones médicas subyacentes, pero los médicos e investigadores informaron que las personas jóvenes con MIS-C por lo general estuvieron previamente sanas y tenían muchas más probabilidades de estar sanas que el número relativamente pequeño de jóvenes que padecieron enfermedades graves de las infecciones iniciales de covid.De los 1075 pacientes de los que se tenía información sobre la enfermedad de covid inicial, solo 265 mostraron síntomas en ese momento. Eran más propensos a ser mayores: su edad promedio fue de 11 años, mientras que la edad promedio de aquellos con infecciones de covid asintomáticas fue de 8. Sin embargo, eso podría deberse a que “los niños más pequeños no pueden expresar sus preocupaciones con la misma eficiencia”, aseguró Blumenthal, quien coescribió una editorial sobre el estudio.“En realidad no sabemos si en efecto hay menos sintomatología en la población muy joven”, concluyó.Tampoco están claras las razones que subyacen al hallazgo del estudio de que en la primera oleada de MIS-C, del 1 de marzo al 1 de julio de 2020, los jóvenes eran más propensos a algunas de las complicaciones cardíacas más graves. DeBiasi dijo que eso no coincidía con la experiencia de su hospital, donde “los niños estaban más enfermos en la segunda ola”.El estudio documentó dos oleadas de casos de MIS-C que siguieron a los aumentos de los casos generales de coronavirus durante un mes o más. “El tercer pico más reciente de la pandemia de COVID-19 parece estar conduciendo a otro pico de MIS-C que quizá implique a comunidades urbanas y rurales”, escribieron los autores.El estudio descubrió que la mayoría de los estados en los que la tasa de casos de MIS-C por población era más alta se encontraban en el noreste, donde se produjo el primer aumento de casos, y en el sur. Por el contrario, la mayoría de los estados con altas tasas de niños con COVID-19 por población, pero con bajas tasas de MIS-C, se encontraban en el Medio Oeste y el Oeste. Aunque la concentración de casos se extendió de las grandes ciudades a los pueblos más pequeños con el tiempo, no fue tan pronunciada como las tendencias generales de la pandemia, dijeron los autores.Blumenthal dijo que ese patrón geográfico podría reflejar que la “comprensión de las complicaciones de la enfermedad” no había alcanzado su prevalencia en las distintas regiones o que muchos estados con tasas más bajas de MIS-C tienen poblaciones menos diversas étnicamente. “También podría tratarse de algo relacionado con la propia covid, aunque no lo sabemos”, dijo. “En este momento, no sabemos nada sobre cómo las variantes afectan necesariamente a los niños”.El estudio representó solo los criterios más estrictos sobre MIS-C, al excluir unos 350 casos notificados que cumplían la definición del síndrome de los CDC pero tenían una prueba de anticuerpos negativa o presentaban principalmente síntomas respiratorios. DeBiasi dijo que también hay muchos casos probables de MIS-C que no se comunican a los CDC porque no cumplen todos los criterios oficiales.“Estos probables niños con MIS-C, en la vida real, son un montón de niños”, dijo. Además, aunque hasta ahora se ha centrado en los casos graves, “hay todo un grupo de niños que en realidad pueden tener MIS-C leve”.Si una comunidad ha experimentado un aumento reciente de coronavirus, entonces “solo porque el niño diga: ‘Nunca he tenido covid o mis padres nunca lo han tenido’, eso no significa que el niño que tienes delante no tenga MIS-C”, dijo DeBiasi. “Si tu ciudad tiene covid, prepárate”.Pam Belluck es una reportera de ciencia y salud cuyos galardones incluyen un Premio Pulitzer compartido en 2015 y el premio Nellie Bly a la mejor historia de primera plana. Es autora de Island Practice, un libro sobre un doctor peculiar. @PamBelluck

“I can’t do this anymore,” Sonia Sein told herself, her family and her doctor.For six years, she had endured a tube inserted in her windpipe, or trachea, to keep her alive, but her discomfort and distress were becoming more and more unbearable.Largely confined to her Bronx apartment, she needed home health aides and had to quit her career as a social worker for pregnant women. If she talked for over five minutes, she had to stop “because I couldn’t breathe.”The tube was necessary because her trachea — the airway leading to the lungs — had become damaged after she spent weeks on a ventilator for a severe asthma attack in 2014. She had subsequently undergone six major surgeries and more than 10 smaller procedures, but with all conventional approaches to address her condition exhausted, she made plans to have the tube removed and receive only palliative care. “I don’t want to live like this,” she concluded.Today, Ms. Sein, 56, dances and plays tag with her grandchildren and plans to resume working, possibly as an acupuncturist. She says she feels she has been given a “chance of being alive one more time.”Her transformation follows a groundbreaking experimental procedure she underwent in January: the first time, medical experts believe, a donor trachea has been successfully directly transplanted into another person.The 18-hour procedure, conceived and led by Dr. Eric M. Genden Sr., chairman of otolaryngology-head and neck surgery at Mount Sinai Health System in New York, is a milestone because — unlike kidneys, hearts and lungs — the trachea has defied decades of transplantation attempts.“It’s very exciting,” said Dr. G. Alexander Patterson, a professor of surgery at Washington University in St. Louis, who was not involved in the case.Thousands of people in the United States alone develop trachea problems each year from burns, birth defects, tumors and extended intubation on ventilators. The coronavirus pandemic will most likely create more cases because many Covid-19 patients have needed weeks on ventilators.Hundreds of Americans are estimated to die each year because techniques like stents, surgery or lasers cannot heal their damaged tracheas, and they suffocate when airways narrow dangerously or collapse.“There was nothing anybody could do for these patients,” said Dr. Genden, who became captivated by the problem in medical school 30 years ago after a patient with a tracheal tumor died. Guided by several mentors, he delved into research and animal experiments, developing a transplant approach.Because immunosuppressant drugs are required to prevent rejection of the transplant, cancer patients would be eligible only if free of cancer for five years, Dr. Genden said. For other cases, though, doctors say the approach seems promising.“It’s very significant,” said Dr. Pierre Delaere, a professor of head and neck surgery at University Hospital Gasthuisberg in Belgium, a trachea specialist not involved in the case. Still, noting that previous attempts didn’t show documented success, he cautioned that longer-term results were needed before the technique should be embraced, adding, “Let’s see how it works and how you can do it in more patients.”The apparent success of Ms. Sein’s operation is also notable because the trachea field has been rocked for years by a sensational scandal.Ms. Sein speaking with Dr. Eric M. Genden Sr., left, who developed the pioneering procedure, and Dr. Sander S. Florman, director of Mount Sinai’s Transplantation Institute.Sarah Blesener for The New York TimesThat drama began about a decade ago when Dr. Paolo Macchiarini, working at Sweden’s famed Karolinska Institute, garnered headlines and accolades for replacing damaged tracheas with plastic tubes seeded with patients’ stem cells that he cultivated in devices called bioreactors. The transplants, performed on patients from the United States and other countries, were heralded as inaugurating a regenerative medicine revolution.But of 20 patients, including children, most ultimately died, and scientists said Dr. Macchiarini misrepresented data and exaggerated his technique’s effectiveness.A Swedish filmmaker’s investigative documentary raised further questions, as did a Vanity Fair article detailing how the beguiling surgeon became romantically involved with an NBC producer working on a feature about him and apparently conned her into believing he was divorced and would marry her in a ceremony officiated by the pope and attended by the Clintons, Obamas, John Legend and Elton John.The Karolinska Institute, alleging scientific misconduct, dismissed Dr. Macchiarini, who has long denied wrongdoing. Journals retracted several of his studies. In 2019, an Italian court said he had forged documents and abused his position, charges unrelated to his trachea work. In September, a Swedish prosecutor indicted him on aggravated assault charges related to three trachea transplants. The case is pending.Dr. Genden said Dr. Macchiarini’s rise and fall profoundly affected his own path.“Here’s this handsome Italian surgeon at the finest institution in the world, the Karolinska, and he’s everything I’m not: He’s got a beautiful head of hair, he drives a motorcycle, he’s got an accent, he’s incredibly charismatic and dynamic,” Dr. Genden said. “He says, ‘I’ve created this bioreactor and it’s stem cells and it makes tracheas.’ And it’s huge.”Dr. Genden said that when he and colleagues questioned Dr. Macchiarini at a conference early on, “in his bigger-than-life way he says, ‘This is ridiculous, you don’t know what you’re talking about, it functions beautifully.’”Dr. Genden thought his work had “become obsolete, so you basically shut down the lab,” he said. “You can’t justify doing experimental surgery and immunosuppression when you see something else that looks perfect, so you realize, wow, we’re out of business.”As Dr. Macchiarini’s work drew criticism, Dr. Genden revived his idea, but was uncertain about trying it. The scandal meant “there’s an amazing amount of scrutiny,” he said. “We’re going to show up and say, ‘As a student, I had this idea on the back of a napkin and now we’re ready to go’ — and if it fails, the patient dies and it becomes yet another example of some surgeon who thought he could solve a problem and he’s created, instead, just the opposite.”There was another reason to be daunted too: historical assumptions that tracheas weren’t transplantable.“The trachea has been characterized as a simple tube, but it’s very complex,” Dr. Delaere said. About 11 centimeters (4⅓ inches) long, one side curves like a halfpipe, composed of cartilage rings and ligaments. The other side is flat and mobile to move air to the lungs.Video by Mount Sinai HospitalAny replacement trachea must be rigid or “it’ll collapse like a straw in a McDonald’s milkshake,” Dr. Genden said. It must be lined with cilia, hairlike projections “like shag carpeting” that move and clean the air we breathe in, he said. And it needs a blood supply to connect to the patient’s vascular system.Other trachea replacement attempts include transplanting part of a donor’s frozen, preserved aorta, the body’s main artery, and fabricating tracheas from patients’ own chest muscles and rib cartilage.“Some of them have been successful, but they’re cumbersome in different ways and they’re not a trachea,” Dr. Patterson said. “It’s kind of a marginal substitute, and many patients need further interventions to maintain their airways.”Dr. Delaere developed another innovative method, performed on nine patients so far: implanting a section of donor trachea in a patient’s forearm for weeks until it develops blood vessels and can replace part of the patient’s trachea. An advantage is that immunosuppressants are necessary only for several months, he said.But, he added, “It’s an indirect technique.” It takes time and can replace only the trachea’s halfpipe side, “so it’s not a complete tube.”Dr. Genden said some scientists told him “‘You’re out of your mind’” because trying a transplant would risk his reputation. But when Dr. Sander S. Florman, director of Mount Sinai’s Transplantation Institute, and LiveOnNY, a nonprofit organ donation organization, agreed to collaborate, his wife, Audrey, encouraged him.“My wife was the one who said, ‘If you truly believe that people are dying from this and that you could maybe make a difference, you can’t just fold up and go home,’” he said.The “secret sauce” in his approach, he said, is transplanting not just the donor trachea but also its attached esophagus (food tube), thyroid gland and thyroid arteries. That meant the donor trachea was accompanied by a blood supply that Dr. Genden connected to Ms. Sein’s blood vessels.Guided by a high-powered microscope, he used surgical thread half the diameter of a human hair. He opened and cleaned out the donor’s esophagus, laying it against Ms. Sein’s esophagus.“That was a very smart idea to help maintain the fragile blood supply of the airway by leaving the esophagus in place behind it,” Dr. Patterson said.Dr. Genden also transplanted the cricoid, cartilage cuffing the trachea, supplanting Ms. Sein’s completely destroyed cricoid. The nine-centimeter transplant replaced all but two centimeters of her trachea.The donor was a young man (identifying details are being withheld to protect privacy). The different gender was important, allowing Dr. Genden to use chromosomal analysis to detect whether Ms. Sein’s cells populated the new trachea. As of late March, 6.5 percent of cells in the donor trachea were hers, with the proportion increasing, he said.He hopes the immunosuppressant drugs, which can create health risks, can be reduced or even stopped “if the entire graft becomes filled with Sonia’s cells.”Ms. Sein’s trachea before, left, and her new transplanted trachea.Mount SinaiFor Ms. Sein, the procedure was a long-sought dream. In 2017, after another hospital said everything possible had been tried, she felt desperate.“I thought, ‘If they do a transplant for everything, they should do a transplant for trachea,’” she recalled. “I Googled ‘trachea transplant’ and Dr. Genden popped up. So I called and called till I got an appointment.”Dr. Genden said Ms. Sein beseeched him for the transplant, saying, “‘You need to do this for me or I’m going to end my life.’”After realizing other treatment methods wouldn’t help, he concluded that Ms. Sein had a “logical, thoughtful” grasp of transplantation’s risks and of her health condition. He understood how difficult her life had become.At night, when she connected her tracheal tube to a ventilator, “the alarm kept going off to let people know that I stopped breathing,” said Ms. Sein, who hated causing her family concern.Because mucus would clog her tube, “she was constantly suctioning, constantly worried about her airway, and it becomes overwhelming,” Dr. Genden said, like being held down in a swimming pool. “You start to panic because you can’t breathe.”By early 2020, ethical approvals were in place, but the coronavirus pandemic held things up. By this year, Dr. Genden said, her condition had deteriorated so that “if we delay further, it’s not going to work out.”On Jan. 12, Dr. Genden got a call: An appropriate donor had died. The next morning, with the donor and Ms. Sein in adjacent rooms, a team of over 50 medical personnel assembled.“I had a brave face, but I was scared,” Ms. Sein said. She considered backing out.“You got this?” she asked Dr. Genden.“He said ‘yeah,’ so I said ‘Let’s go for it.’”After extracting the donor’s organs, “you go next door and you open up Sonia and you remove the diseased trachea, and there is no going back,” Dr. Genden said. “It’s like when you get on a rocket ship.”At times, he felt “in a dreamlike state,” he said. When the blood vessels were finally connected, the donor trachea began bleeding. “This thing came to life,” Dr. Genden marveled, “and we were like, ‘Holy smokes, we’ve done it.’”Photographs document Ms. Sein’s trachea transformation: Her old windpipe looks raw and red, her new one smooth as porcelain.“I can breathe,” she was amazed to discover. “I could feel it in my lungs.”After several weeks in recovery, she is home. She visits Mount Sinai weekly for blood work. Dr. Genden examines the new trachea by inserting a scope in a hole he left in her neck, which he’ll eventually close.Recently, Ms. Sein, covering the hole with her hand to speak, enthused about having the energy to cook sesame chicken for the first time and how she aims to visit relatives in Puerto Rico. Next month, she will turn 57.“We would have been planning my funeral,” she said, “but now we’re planning a birthday party.”