MDedge Cardiology

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

A version of this article first appeared on WebMD.com.

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

A version of this article first appeared on WebMD.com.

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

A version of this article first appeared on WebMD.com.

People who report regularly eating oily fish had a significantly reduced risk for developing type 2 diabetes in a prospective, observational study of nearly 400,000 UK residents.

Dmitriy Danilchenko/Shutterstock

The results also show a significant, but weaker, positive link between regular use of fish oil supplements and a drop in the incidence of type 2 diabetes, Qibin Qi, PhD, and colleagues wrote in a report published in Diabetes Care. Their analysis failed to show a significant link between consumption of non-oily fish and type 2 diabetes onset.

The study is notable for being “the largest so far” to examine the link between fish consumption and type 2 diabetes incidence, and the first to establish a clear, significant association between regularly eating oily fish and a drop in the incidence of diabetes, said Dr. Qi, an epidemiologist at Albert Einstein College of Medicine in New York.

“At present, it is prudent to recommend fresh oily fish as a part of a healthy dietary pattern instead of fish oil supplements for diabetes prevention,” said Dr. Qi and coauthors.

The study included just over 392,000 adults without type 2 diabetes or cardiovascular disease at baseline enrolled in the UK Biobank. Median follow-up was just over 10 years, during which 7,262 participants developed diabetes.

Participants who ate either one, or two or more, servings of oily fish weekly each had a significant 22% lower rate of incident type 2 diabetes than that of those who ate no oily fish, after adjustment for multiple confounders. Those who reported regularly taking a fish oil supplement had a significant 9% lower incidence of type 2 diabetes than that of those who didn’t.
 

Evidence growing to add oily fish to diet to prevent type 2 diabetes

“Many current dietary guidelines recommend consumption of two servings of fish, preferably oily, per week, primarily based on cardiovascular benefits,” Dr. Qi said in an interview.

“No prior statements recommended oily fish for prevention of type 2 diabetes,” he explained, adding: “Our findings support future recommendations, but the evidence is not strong enough to make a [formal] recommendation now. We need evidence from clinical trials.”

Jason Wu, PhD, an epidemiologist at the University of New South Wales in Sydney, Australia, who specializes in this field but was not involved with the current study, said it “is a very well-conducted study, and certainly generates important new evidence supporting the potential benefits of regular consumption of oily fish.”

But he agrees that the evidence remains too preliminary for any official recommendations on eating oily fish for preventing the development of type 2 diabetes, including targeting advice to high-risk subgroups such as those with prediabetes or people who are obese.

Before any groups make recommendations, “we need to thoroughly review all the literature in this space to appraise the overall body of evidence,” Dr. Wu noted in an interview.
 

Oily fish: Solid evidence for prevention of CVD events

In contrast, the case for including oily fish in the diet to prevent CVD events seems settled. In 2018, a panel assembled by the American Heart Association to address the issue released a statement that concluded: “Current scientific evidence strongly supports the recommendation that seafood be an integral component of a heart-healthy dietary pattern.” It added that “a large body of evidence supports the recommendation to consume nonfried seafood, especially species higher in long-chain n-3 fatty acids, one to two times per week for cardiovascular benefits, including reduced risk of cardiac death, coronary heart disease, and ischemic stroke.”

The statement highlighted that “cold-water oily fish such as salmon, anchovies, herring, mackerel (Atlantic and Pacific), tuna (bluefin and albacore), and sardines have the highest levels” of long-chain n-3 fatty acids, notably eicosapentaenoic acid and docosahexaenoic acid, also collectively known as omega-3 fatty acids.

These fish types were among the oily fishes tallied in the UK Biobank data used by Dr. Qi and colleagues.

The case for fish oil supplements for preventing CVD events is much rockier, as summarized in a 2019 editorial, with some studies reporting no discernible effect while others indicate efficacy.

A second commentary from December 2020 highlighted how results from the REDUCE-IT trial showed clear benefit for preventing CVD using a highly purified form of fish oil, icosapent ethyl (Vascepa, Amarin). However, findings from two other recent reports, the STRENGTH and OMENI studies, failed to show CVD benefits from more conventional fish oil formulations.
 

Composite CVD and diabetes prevention effects?

The new findings by Dr. Qi and colleagues “highlight the need to specifically test the effect of fish oil supplements on glucose metabolism in people who cannot or choose not to regularly eat oily fish,” said Dr. Wu, a researcher at the George Institute for Global Health in Newtown, Australia.

“If eventually there is really strong evidence that fish, fish oil, or both have independent effects on both CVD and type 2 diabetes” it would be reasonable to integrate both outcomes into a single, composite, efficacy endpoint for the purpose of future studies, he added.

Dr. Qi agreed on both points. “A randomized, controlled trial of fish oil on type 2 diabetes as a primary outcome is needed. Most existing data are based on secondary analyses in the randomized trials for CVD,” he explained.

But, he added, “our results suggest a potential beneficial effect from fish oil supplements,” which implies that these may be “better than nothing” for people who can’t add oily fish to their regular diet.

The means by which fish and fish oil might slow or stop progression to type 2 diabetes remains uncertain.

The mechanisms for preventing both diabetes and CVD events may overlap, Dr. Qi noted, such as anti-inflammatory effects and improved insulin sensitivity, both of which have been observed in animal studies.

Evidence is “still lacking from human studies,” he explained, but if such mechanisms were at play, Dr. Wu said that would “add biologic plausibility” to a possible causal link between oily fish consumption and diabetes prevention. 

“But we can’t assume that omega-3 fatty acids alone will have the same effect as oily fish, which obviously contains many other components.”

The study received no commercial funding. Dr. Qi and Dr. Wu have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

People who report regularly eating oily fish had a significantly reduced risk for developing type 2 diabetes in a prospective, observational study of nearly 400,000 UK residents.

Dmitriy Danilchenko/Shutterstock

The results also show a significant, but weaker, positive link between regular use of fish oil supplements and a drop in the incidence of type 2 diabetes, Qibin Qi, PhD, and colleagues wrote in a report published in Diabetes Care. Their analysis failed to show a significant link between consumption of non-oily fish and type 2 diabetes onset.

The study is notable for being “the largest so far” to examine the link between fish consumption and type 2 diabetes incidence, and the first to establish a clear, significant association between regularly eating oily fish and a drop in the incidence of diabetes, said Dr. Qi, an epidemiologist at Albert Einstein College of Medicine in New York.

“At present, it is prudent to recommend fresh oily fish as a part of a healthy dietary pattern instead of fish oil supplements for diabetes prevention,” said Dr. Qi and coauthors.

The study included just over 392,000 adults without type 2 diabetes or cardiovascular disease at baseline enrolled in the UK Biobank. Median follow-up was just over 10 years, during which 7,262 participants developed diabetes.

Participants who ate either one, or two or more, servings of oily fish weekly each had a significant 22% lower rate of incident type 2 diabetes than that of those who ate no oily fish, after adjustment for multiple confounders. Those who reported regularly taking a fish oil supplement had a significant 9% lower incidence of type 2 diabetes than that of those who didn’t.
 

Evidence growing to add oily fish to diet to prevent type 2 diabetes

“Many current dietary guidelines recommend consumption of two servings of fish, preferably oily, per week, primarily based on cardiovascular benefits,” Dr. Qi said in an interview.

“No prior statements recommended oily fish for prevention of type 2 diabetes,” he explained, adding: “Our findings support future recommendations, but the evidence is not strong enough to make a [formal] recommendation now. We need evidence from clinical trials.”

Jason Wu, PhD, an epidemiologist at the University of New South Wales in Sydney, Australia, who specializes in this field but was not involved with the current study, said it “is a very well-conducted study, and certainly generates important new evidence supporting the potential benefits of regular consumption of oily fish.”

But he agrees that the evidence remains too preliminary for any official recommendations on eating oily fish for preventing the development of type 2 diabetes, including targeting advice to high-risk subgroups such as those with prediabetes or people who are obese.

Before any groups make recommendations, “we need to thoroughly review all the literature in this space to appraise the overall body of evidence,” Dr. Wu noted in an interview.
 

Oily fish: Solid evidence for prevention of CVD events

In contrast, the case for including oily fish in the diet to prevent CVD events seems settled. In 2018, a panel assembled by the American Heart Association to address the issue released a statement that concluded: “Current scientific evidence strongly supports the recommendation that seafood be an integral component of a heart-healthy dietary pattern.” It added that “a large body of evidence supports the recommendation to consume nonfried seafood, especially species higher in long-chain n-3 fatty acids, one to two times per week for cardiovascular benefits, including reduced risk of cardiac death, coronary heart disease, and ischemic stroke.”

The statement highlighted that “cold-water oily fish such as salmon, anchovies, herring, mackerel (Atlantic and Pacific), tuna (bluefin and albacore), and sardines have the highest levels” of long-chain n-3 fatty acids, notably eicosapentaenoic acid and docosahexaenoic acid, also collectively known as omega-3 fatty acids.

These fish types were among the oily fishes tallied in the UK Biobank data used by Dr. Qi and colleagues.

The case for fish oil supplements for preventing CVD events is much rockier, as summarized in a 2019 editorial, with some studies reporting no discernible effect while others indicate efficacy.

A second commentary from December 2020 highlighted how results from the REDUCE-IT trial showed clear benefit for preventing CVD using a highly purified form of fish oil, icosapent ethyl (Vascepa, Amarin). However, findings from two other recent reports, the STRENGTH and OMENI studies, failed to show CVD benefits from more conventional fish oil formulations.
 

Composite CVD and diabetes prevention effects?

The new findings by Dr. Qi and colleagues “highlight the need to specifically test the effect of fish oil supplements on glucose metabolism in people who cannot or choose not to regularly eat oily fish,” said Dr. Wu, a researcher at the George Institute for Global Health in Newtown, Australia.

“If eventually there is really strong evidence that fish, fish oil, or both have independent effects on both CVD and type 2 diabetes” it would be reasonable to integrate both outcomes into a single, composite, efficacy endpoint for the purpose of future studies, he added.

Dr. Qi agreed on both points. “A randomized, controlled trial of fish oil on type 2 diabetes as a primary outcome is needed. Most existing data are based on secondary analyses in the randomized trials for CVD,” he explained.

But, he added, “our results suggest a potential beneficial effect from fish oil supplements,” which implies that these may be “better than nothing” for people who can’t add oily fish to their regular diet.

The means by which fish and fish oil might slow or stop progression to type 2 diabetes remains uncertain.

The mechanisms for preventing both diabetes and CVD events may overlap, Dr. Qi noted, such as anti-inflammatory effects and improved insulin sensitivity, both of which have been observed in animal studies.

Evidence is “still lacking from human studies,” he explained, but if such mechanisms were at play, Dr. Wu said that would “add biologic plausibility” to a possible causal link between oily fish consumption and diabetes prevention. 

“But we can’t assume that omega-3 fatty acids alone will have the same effect as oily fish, which obviously contains many other components.”

The study received no commercial funding. Dr. Qi and Dr. Wu have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

People who report regularly eating oily fish had a significantly reduced risk for developing type 2 diabetes in a prospective, observational study of nearly 400,000 UK residents.

Dmitriy Danilchenko/Shutterstock

The results also show a significant, but weaker, positive link between regular use of fish oil supplements and a drop in the incidence of type 2 diabetes, Qibin Qi, PhD, and colleagues wrote in a report published in Diabetes Care. Their analysis failed to show a significant link between consumption of non-oily fish and type 2 diabetes onset.

The study is notable for being “the largest so far” to examine the link between fish consumption and type 2 diabetes incidence, and the first to establish a clear, significant association between regularly eating oily fish and a drop in the incidence of diabetes, said Dr. Qi, an epidemiologist at Albert Einstein College of Medicine in New York.

“At present, it is prudent to recommend fresh oily fish as a part of a healthy dietary pattern instead of fish oil supplements for diabetes prevention,” said Dr. Qi and coauthors.

The study included just over 392,000 adults without type 2 diabetes or cardiovascular disease at baseline enrolled in the UK Biobank. Median follow-up was just over 10 years, during which 7,262 participants developed diabetes.

Participants who ate either one, or two or more, servings of oily fish weekly each had a significant 22% lower rate of incident type 2 diabetes than that of those who ate no oily fish, after adjustment for multiple confounders. Those who reported regularly taking a fish oil supplement had a significant 9% lower incidence of type 2 diabetes than that of those who didn’t.
 

Evidence growing to add oily fish to diet to prevent type 2 diabetes

“Many current dietary guidelines recommend consumption of two servings of fish, preferably oily, per week, primarily based on cardiovascular benefits,” Dr. Qi said in an interview.

“No prior statements recommended oily fish for prevention of type 2 diabetes,” he explained, adding: “Our findings support future recommendations, but the evidence is not strong enough to make a [formal] recommendation now. We need evidence from clinical trials.”

Jason Wu, PhD, an epidemiologist at the University of New South Wales in Sydney, Australia, who specializes in this field but was not involved with the current study, said it “is a very well-conducted study, and certainly generates important new evidence supporting the potential benefits of regular consumption of oily fish.”

But he agrees that the evidence remains too preliminary for any official recommendations on eating oily fish for preventing the development of type 2 diabetes, including targeting advice to high-risk subgroups such as those with prediabetes or people who are obese.

Before any groups make recommendations, “we need to thoroughly review all the literature in this space to appraise the overall body of evidence,” Dr. Wu noted in an interview.
 

Oily fish: Solid evidence for prevention of CVD events

In contrast, the case for including oily fish in the diet to prevent CVD events seems settled. In 2018, a panel assembled by the American Heart Association to address the issue released a statement that concluded: “Current scientific evidence strongly supports the recommendation that seafood be an integral component of a heart-healthy dietary pattern.” It added that “a large body of evidence supports the recommendation to consume nonfried seafood, especially species higher in long-chain n-3 fatty acids, one to two times per week for cardiovascular benefits, including reduced risk of cardiac death, coronary heart disease, and ischemic stroke.”

The statement highlighted that “cold-water oily fish such as salmon, anchovies, herring, mackerel (Atlantic and Pacific), tuna (bluefin and albacore), and sardines have the highest levels” of long-chain n-3 fatty acids, notably eicosapentaenoic acid and docosahexaenoic acid, also collectively known as omega-3 fatty acids.

These fish types were among the oily fishes tallied in the UK Biobank data used by Dr. Qi and colleagues.

The case for fish oil supplements for preventing CVD events is much rockier, as summarized in a 2019 editorial, with some studies reporting no discernible effect while others indicate efficacy.

A second commentary from December 2020 highlighted how results from the REDUCE-IT trial showed clear benefit for preventing CVD using a highly purified form of fish oil, icosapent ethyl (Vascepa, Amarin). However, findings from two other recent reports, the STRENGTH and OMENI studies, failed to show CVD benefits from more conventional fish oil formulations.
 

Composite CVD and diabetes prevention effects?

The new findings by Dr. Qi and colleagues “highlight the need to specifically test the effect of fish oil supplements on glucose metabolism in people who cannot or choose not to regularly eat oily fish,” said Dr. Wu, a researcher at the George Institute for Global Health in Newtown, Australia.

“If eventually there is really strong evidence that fish, fish oil, or both have independent effects on both CVD and type 2 diabetes” it would be reasonable to integrate both outcomes into a single, composite, efficacy endpoint for the purpose of future studies, he added.

Dr. Qi agreed on both points. “A randomized, controlled trial of fish oil on type 2 diabetes as a primary outcome is needed. Most existing data are based on secondary analyses in the randomized trials for CVD,” he explained.

But, he added, “our results suggest a potential beneficial effect from fish oil supplements,” which implies that these may be “better than nothing” for people who can’t add oily fish to their regular diet.

The means by which fish and fish oil might slow or stop progression to type 2 diabetes remains uncertain.

The mechanisms for preventing both diabetes and CVD events may overlap, Dr. Qi noted, such as anti-inflammatory effects and improved insulin sensitivity, both of which have been observed in animal studies.

Evidence is “still lacking from human studies,” he explained, but if such mechanisms were at play, Dr. Wu said that would “add biologic plausibility” to a possible causal link between oily fish consumption and diabetes prevention. 

“But we can’t assume that omega-3 fatty acids alone will have the same effect as oily fish, which obviously contains many other components.”

The study received no commercial funding. Dr. Qi and Dr. Wu have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The final numbers won’t look much different, but the 2021 Match results will be unlike any before. As of mid-January, only 16 more institutions were confirmed to be participating in Match Day this year, resulting in about 800 more positions, said Donna Lamb, president and CEO of the National Resident Matching Program (NRMP). The Electronic Residency Application Service reported about 50,000 individual applicant submissions, a slight increase from prior years.

The stats may be similar, but the current residency application cycle may lead to wildly different results after the pandemic forced interviews to be conducted virtually and caused the cancellation of most away clinical rotations. Troy Amen, a fifth-year MD-MBA student at Harvard Medical School, Boston, and copresident of his student class, says the lack of on-campus, in-person experiences means students feel more in the dark than ever. The same is true for institutions. “The programs are also suffering because now they don’t know which students are a good ‘cultural fit’ for them,” he said.

Standing out has always been a concern for prospective residents, but Mr. Amen says fears are even higher this year. “[Institutions are] struggling to vet out 850 applicants, and they have no connection to us.”

Organizations have scrambled to keep the process as fair and informative as possible. “Everyone is trying to do the right thing here,” said Alison J. Whelan, MD, chief academic officer of the Association of American Medical Colleges (AAMC). She says that although the process has significantly changed, the heart of it remains the same. “The bottom line is directors really want to fill their intern class, and schools and students really want to match.”

Since the NRMP was established in 1952, it has never had to contend with a pandemic of this scale. The unprecedented circumstances have led to some much-feared and some unexpected changes, like top candidates “stealing” interview slots, “swag bags” sent to entice residents, beefed-up online profiles, as well as “Zoom fatigue,” a spike in home-field advantage for institutions, and massive anxiety for those students staking their future to a city they may have never seen in person.
 

What was lost and what was gained

“It’s really hard to get a real feel for the program when you’ve not been there in person,” said Christopher Smith, MD, director of the internal medicine residency program at Beth Israel Deaconess Medical Center in Boston. Dr. Smith recalled interviewing for residencies 25 years ago. His wife, a teacher, took time off to travel with him.

“She would ‘interview the town’ while I interviewed the program, and we compared notes at night,” he said. Because of COVID-19-related travel restrictions, just physically seeing the city in which they may live for years wasn’t an option for many. “I have a lot of sympathy for students applying right now,” Dr. Smith said.

For the residency class of 2021, the first shoe really dropped last March, when the AAMC issued guidance strongly recommending that programs pause clinical rotations away from their home schools. As established doctors know well, and as graduating medical students confirmed, these rotations are crucial to understanding a program’s culture and gaining experience that can boost candidacy. “I’m applying to orthopedic surgery, where away rotations are the gold standard for impressing attendees and residents at institutions away from home,” said Mr. Amen.

The pandemic completely cut off that key source of information to determine the right fit. It also meant applicants couldn’t have as diverse a portfolio of recommendation letters, something many worry may be detrimental to their soon-to-be-released Match rankings.

Unlike the loss of away rotations, the forced shift from in-person to virtual interviews had some meaningful benefits. Students no longer incurred expenses for airline flights, hotel rooms, and rental cars. Many organizations and programs have been trying for years to figure out how to lower the financial burden of interviews to make the process more equitable for those at economic or other disadvantage.

“The equity piece of this is huge – decreasing barriers and leveling the field a little bit is a really huge advantage,” said Kate Shaw, MD, residency program director and associate chair of education for the obstetrics and gynecology program at Stanford (Calif.) University. In some ways, this latest change is an extension of a strategy Dr. Shaw and others had already begun implementing.

“Over the last 5 to 10 years, we’ve been working to address the implicit bias in the application process, so we’ve gone to a holistic review of applicants, where we don’t have score cutoffs. We look at the whole person,” she said. “And we did that in an effort to increase diversity and equity.” Dr. Shaw and others hope that the accidental positive changes from COVID restrictions may be intentionally preserved long after the pandemic ends.
 

Home-field advantage vs. swag bags

Many medical students applying to residencies this year say they have given greater weight to their home programs than they might have without the pandemic. “I didn’t get a sense of anyone’s culture other than my home institution,” said Alex Skidmore, a fourth-year medical student at Washington University in St. Louis. “I definitely am ranking Wash-U higher.”

The desire to emphasize the known quality of a student’s home institution isn’t surprising to program directors. Dr. Shaw said she thinks this year’s Match could well end with a higher percentage of students matching either in their home programs or in programs close to loved ones. “The value of being close to family has come up in our conversations, where students are considering the right program for them but also the other life factors,” she said.

To overcome this home-field advantage, many programs have beefed up their websites, including providing video tours of their facilities. They also “upped their social media game” and encouraged residents to create online groups for prospective residents to share information about programs and life outside of work. Some residents even offered video tours of their personal apartments to applicants.

Without in-person access to facilities and staff, a program’s online presence became a deciding factor, applicants said. “If you have a bad website, it’s like having a dirty building to interview applicants in,” Mr. Skidmore said. For many prospective residents, an institution’s Internet presence was a “make or break” factor. “It’s the only thing I saw for many programs, and when we are doing the amount of research we are doing remotely, when I saw a program with a bad website, it made me not like the program as much,” he said.

Some programs, hoping to woo candidates as well as to provide them with more insight into what they and their cities have to offer, sent “swag bags” to candidates. These included things like gift cards for food delivery and offerings from local businesses. Washington University’s pediatrics residency program sent gooey butter cakes – a St. Louis staple – along with other treats from small businesses and copies of magazines that showcased the city’s dining and entertainment scene.

Other programs, even those at the same medical institution, felt quite strongly that those types of packages shouldn’t be sent. “We interviewed almost 500 applicants, so there was no way we could have afforded that,” said Dominique Cosco, MD, director of Washington University’s internal medicine residency program. “Our normal recruitment budget is almost $100,000 in a normal year, and that got cut because of COVID. For us, it was thinking about allocations of resources.”
 

Interview slot theft and zoom fatigue

Remote interviewing also meant that applicants could accept more interviews, something that raised a big concern. Without expenses or travel time, would top-tier candidates take more interviews than normal and thus take limited interview spots from other qualified candidates? Maybe so, says the AAMC’s Dr. Whelan.

“We didn’t have systematic data, but we heard from enough schools and programs ... that students who were maybe not the top-top ranked students in the class but in every way solid were receiving fewer interviews than previous years,” Dr. Whelan said. This is despite guidance that recommended programs add interview slots to serve as a counterbalance.

Some students say they accepted more interview slots in the beginning of the interview season, partly because they could, and partly because some thought of early interviews as “practice” for later interviews. However, as video interviews piled up, some of them described feeling “Zoom fatigue” and said they later canceled interviews with programs they didn’t anticipate joining.
 

More SOAP, less clarity

As for what comes next, the NRMP is preparing for a longer-than-normal Supplemental Offer and Acceptance Program (SOAP) than in years past. SOAP usually offers three rounds of matches after the initial Match Day; Ms. Lamb said things are different this year.

“SOAP will be the same number of days, but we’ve added an additional round on Thursday afternoon,” she said. Will it be unnecessary or not enough? Nobody knows. “How big SOAP actually is going to be is one of the things that we really don’t have a sense of right now and probably aren’t going to have a sense of until the Match.”

Uncertainty is the name of the game. More than any other Match before, programs and applicants won’t know how results from this pandemic year stack up for a few months at the very least. “I really want to see what this looks like on the other side,” Dr. Smith said. “Are applicants happy with the way it looks when they come here? Do they feel like they matched with the right place?”

Whether this unprecedented year will be remembered more for positive changes moving forward, including more flexibility on remote interviews, or for less-informed decisions that result in dissatisfied participants is also unclear.

“I think after the Match is over, we’ll be talking to everyone to get more perspective on what people who are applying now would tell the next class, and how programs can adjust,” said Kathy Diemer, MD, assistant dean for career counseling at Washington University. At the very least, those who are involved in this year after year can start thinking about what the future should look like.

“We’re going to need to do some kind of debriefing after this is over, both program directors and our students as well, so we can determine how to move forward next year and beyond.”

A version of this article first appeared on Medscape.com.

The final numbers won’t look much different, but the 2021 Match results will be unlike any before. As of mid-January, only 16 more institutions were confirmed to be participating in Match Day this year, resulting in about 800 more positions, said Donna Lamb, president and CEO of the National Resident Matching Program (NRMP). The Electronic Residency Application Service reported about 50,000 individual applicant submissions, a slight increase from prior years.

The stats may be similar, but the current residency application cycle may lead to wildly different results after the pandemic forced interviews to be conducted virtually and caused the cancellation of most away clinical rotations. Troy Amen, a fifth-year MD-MBA student at Harvard Medical School, Boston, and copresident of his student class, says the lack of on-campus, in-person experiences means students feel more in the dark than ever. The same is true for institutions. “The programs are also suffering because now they don’t know which students are a good ‘cultural fit’ for them,” he said.

Standing out has always been a concern for prospective residents, but Mr. Amen says fears are even higher this year. “[Institutions are] struggling to vet out 850 applicants, and they have no connection to us.”

Organizations have scrambled to keep the process as fair and informative as possible. “Everyone is trying to do the right thing here,” said Alison J. Whelan, MD, chief academic officer of the Association of American Medical Colleges (AAMC). She says that although the process has significantly changed, the heart of it remains the same. “The bottom line is directors really want to fill their intern class, and schools and students really want to match.”

Since the NRMP was established in 1952, it has never had to contend with a pandemic of this scale. The unprecedented circumstances have led to some much-feared and some unexpected changes, like top candidates “stealing” interview slots, “swag bags” sent to entice residents, beefed-up online profiles, as well as “Zoom fatigue,” a spike in home-field advantage for institutions, and massive anxiety for those students staking their future to a city they may have never seen in person.
 

What was lost and what was gained

“It’s really hard to get a real feel for the program when you’ve not been there in person,” said Christopher Smith, MD, director of the internal medicine residency program at Beth Israel Deaconess Medical Center in Boston. Dr. Smith recalled interviewing for residencies 25 years ago. His wife, a teacher, took time off to travel with him.

“She would ‘interview the town’ while I interviewed the program, and we compared notes at night,” he said. Because of COVID-19-related travel restrictions, just physically seeing the city in which they may live for years wasn’t an option for many. “I have a lot of sympathy for students applying right now,” Dr. Smith said.

For the residency class of 2021, the first shoe really dropped last March, when the AAMC issued guidance strongly recommending that programs pause clinical rotations away from their home schools. As established doctors know well, and as graduating medical students confirmed, these rotations are crucial to understanding a program’s culture and gaining experience that can boost candidacy. “I’m applying to orthopedic surgery, where away rotations are the gold standard for impressing attendees and residents at institutions away from home,” said Mr. Amen.

The pandemic completely cut off that key source of information to determine the right fit. It also meant applicants couldn’t have as diverse a portfolio of recommendation letters, something many worry may be detrimental to their soon-to-be-released Match rankings.

Unlike the loss of away rotations, the forced shift from in-person to virtual interviews had some meaningful benefits. Students no longer incurred expenses for airline flights, hotel rooms, and rental cars. Many organizations and programs have been trying for years to figure out how to lower the financial burden of interviews to make the process more equitable for those at economic or other disadvantage.

“The equity piece of this is huge – decreasing barriers and leveling the field a little bit is a really huge advantage,” said Kate Shaw, MD, residency program director and associate chair of education for the obstetrics and gynecology program at Stanford (Calif.) University. In some ways, this latest change is an extension of a strategy Dr. Shaw and others had already begun implementing.

“Over the last 5 to 10 years, we’ve been working to address the implicit bias in the application process, so we’ve gone to a holistic review of applicants, where we don’t have score cutoffs. We look at the whole person,” she said. “And we did that in an effort to increase diversity and equity.” Dr. Shaw and others hope that the accidental positive changes from COVID restrictions may be intentionally preserved long after the pandemic ends.
 

Home-field advantage vs. swag bags

Many medical students applying to residencies this year say they have given greater weight to their home programs than they might have without the pandemic. “I didn’t get a sense of anyone’s culture other than my home institution,” said Alex Skidmore, a fourth-year medical student at Washington University in St. Louis. “I definitely am ranking Wash-U higher.”

The desire to emphasize the known quality of a student’s home institution isn’t surprising to program directors. Dr. Shaw said she thinks this year’s Match could well end with a higher percentage of students matching either in their home programs or in programs close to loved ones. “The value of being close to family has come up in our conversations, where students are considering the right program for them but also the other life factors,” she said.

To overcome this home-field advantage, many programs have beefed up their websites, including providing video tours of their facilities. They also “upped their social media game” and encouraged residents to create online groups for prospective residents to share information about programs and life outside of work. Some residents even offered video tours of their personal apartments to applicants.

Without in-person access to facilities and staff, a program’s online presence became a deciding factor, applicants said. “If you have a bad website, it’s like having a dirty building to interview applicants in,” Mr. Skidmore said. For many prospective residents, an institution’s Internet presence was a “make or break” factor. “It’s the only thing I saw for many programs, and when we are doing the amount of research we are doing remotely, when I saw a program with a bad website, it made me not like the program as much,” he said.

Some programs, hoping to woo candidates as well as to provide them with more insight into what they and their cities have to offer, sent “swag bags” to candidates. These included things like gift cards for food delivery and offerings from local businesses. Washington University’s pediatrics residency program sent gooey butter cakes – a St. Louis staple – along with other treats from small businesses and copies of magazines that showcased the city’s dining and entertainment scene.

Other programs, even those at the same medical institution, felt quite strongly that those types of packages shouldn’t be sent. “We interviewed almost 500 applicants, so there was no way we could have afforded that,” said Dominique Cosco, MD, director of Washington University’s internal medicine residency program. “Our normal recruitment budget is almost $100,000 in a normal year, and that got cut because of COVID. For us, it was thinking about allocations of resources.”
 

Interview slot theft and zoom fatigue

Remote interviewing also meant that applicants could accept more interviews, something that raised a big concern. Without expenses or travel time, would top-tier candidates take more interviews than normal and thus take limited interview spots from other qualified candidates? Maybe so, says the AAMC’s Dr. Whelan.

“We didn’t have systematic data, but we heard from enough schools and programs ... that students who were maybe not the top-top ranked students in the class but in every way solid were receiving fewer interviews than previous years,” Dr. Whelan said. This is despite guidance that recommended programs add interview slots to serve as a counterbalance.

Some students say they accepted more interview slots in the beginning of the interview season, partly because they could, and partly because some thought of early interviews as “practice” for later interviews. However, as video interviews piled up, some of them described feeling “Zoom fatigue” and said they later canceled interviews with programs they didn’t anticipate joining.
 

More SOAP, less clarity

As for what comes next, the NRMP is preparing for a longer-than-normal Supplemental Offer and Acceptance Program (SOAP) than in years past. SOAP usually offers three rounds of matches after the initial Match Day; Ms. Lamb said things are different this year.

“SOAP will be the same number of days, but we’ve added an additional round on Thursday afternoon,” she said. Will it be unnecessary or not enough? Nobody knows. “How big SOAP actually is going to be is one of the things that we really don’t have a sense of right now and probably aren’t going to have a sense of until the Match.”

Uncertainty is the name of the game. More than any other Match before, programs and applicants won’t know how results from this pandemic year stack up for a few months at the very least. “I really want to see what this looks like on the other side,” Dr. Smith said. “Are applicants happy with the way it looks when they come here? Do they feel like they matched with the right place?”

Whether this unprecedented year will be remembered more for positive changes moving forward, including more flexibility on remote interviews, or for less-informed decisions that result in dissatisfied participants is also unclear.

“I think after the Match is over, we’ll be talking to everyone to get more perspective on what people who are applying now would tell the next class, and how programs can adjust,” said Kathy Diemer, MD, assistant dean for career counseling at Washington University. At the very least, those who are involved in this year after year can start thinking about what the future should look like.

“We’re going to need to do some kind of debriefing after this is over, both program directors and our students as well, so we can determine how to move forward next year and beyond.”

A version of this article first appeared on Medscape.com.

The final numbers won’t look much different, but the 2021 Match results will be unlike any before. As of mid-January, only 16 more institutions were confirmed to be participating in Match Day this year, resulting in about 800 more positions, said Donna Lamb, president and CEO of the National Resident Matching Program (NRMP). The Electronic Residency Application Service reported about 50,000 individual applicant submissions, a slight increase from prior years.

The stats may be similar, but the current residency application cycle may lead to wildly different results after the pandemic forced interviews to be conducted virtually and caused the cancellation of most away clinical rotations. Troy Amen, a fifth-year MD-MBA student at Harvard Medical School, Boston, and copresident of his student class, says the lack of on-campus, in-person experiences means students feel more in the dark than ever. The same is true for institutions. “The programs are also suffering because now they don’t know which students are a good ‘cultural fit’ for them,” he said.

Standing out has always been a concern for prospective residents, but Mr. Amen says fears are even higher this year. “[Institutions are] struggling to vet out 850 applicants, and they have no connection to us.”

Organizations have scrambled to keep the process as fair and informative as possible. “Everyone is trying to do the right thing here,” said Alison J. Whelan, MD, chief academic officer of the Association of American Medical Colleges (AAMC). She says that although the process has significantly changed, the heart of it remains the same. “The bottom line is directors really want to fill their intern class, and schools and students really want to match.”

Since the NRMP was established in 1952, it has never had to contend with a pandemic of this scale. The unprecedented circumstances have led to some much-feared and some unexpected changes, like top candidates “stealing” interview slots, “swag bags” sent to entice residents, beefed-up online profiles, as well as “Zoom fatigue,” a spike in home-field advantage for institutions, and massive anxiety for those students staking their future to a city they may have never seen in person.
 

What was lost and what was gained

“It’s really hard to get a real feel for the program when you’ve not been there in person,” said Christopher Smith, MD, director of the internal medicine residency program at Beth Israel Deaconess Medical Center in Boston. Dr. Smith recalled interviewing for residencies 25 years ago. His wife, a teacher, took time off to travel with him.

“She would ‘interview the town’ while I interviewed the program, and we compared notes at night,” he said. Because of COVID-19-related travel restrictions, just physically seeing the city in which they may live for years wasn’t an option for many. “I have a lot of sympathy for students applying right now,” Dr. Smith said.

For the residency class of 2021, the first shoe really dropped last March, when the AAMC issued guidance strongly recommending that programs pause clinical rotations away from their home schools. As established doctors know well, and as graduating medical students confirmed, these rotations are crucial to understanding a program’s culture and gaining experience that can boost candidacy. “I’m applying to orthopedic surgery, where away rotations are the gold standard for impressing attendees and residents at institutions away from home,” said Mr. Amen.

The pandemic completely cut off that key source of information to determine the right fit. It also meant applicants couldn’t have as diverse a portfolio of recommendation letters, something many worry may be detrimental to their soon-to-be-released Match rankings.

Unlike the loss of away rotations, the forced shift from in-person to virtual interviews had some meaningful benefits. Students no longer incurred expenses for airline flights, hotel rooms, and rental cars. Many organizations and programs have been trying for years to figure out how to lower the financial burden of interviews to make the process more equitable for those at economic or other disadvantage.

“The equity piece of this is huge – decreasing barriers and leveling the field a little bit is a really huge advantage,” said Kate Shaw, MD, residency program director and associate chair of education for the obstetrics and gynecology program at Stanford (Calif.) University. In some ways, this latest change is an extension of a strategy Dr. Shaw and others had already begun implementing.

“Over the last 5 to 10 years, we’ve been working to address the implicit bias in the application process, so we’ve gone to a holistic review of applicants, where we don’t have score cutoffs. We look at the whole person,” she said. “And we did that in an effort to increase diversity and equity.” Dr. Shaw and others hope that the accidental positive changes from COVID restrictions may be intentionally preserved long after the pandemic ends.
 

Home-field advantage vs. swag bags

Many medical students applying to residencies this year say they have given greater weight to their home programs than they might have without the pandemic. “I didn’t get a sense of anyone’s culture other than my home institution,” said Alex Skidmore, a fourth-year medical student at Washington University in St. Louis. “I definitely am ranking Wash-U higher.”

The desire to emphasize the known quality of a student’s home institution isn’t surprising to program directors. Dr. Shaw said she thinks this year’s Match could well end with a higher percentage of students matching either in their home programs or in programs close to loved ones. “The value of being close to family has come up in our conversations, where students are considering the right program for them but also the other life factors,” she said.

To overcome this home-field advantage, many programs have beefed up their websites, including providing video tours of their facilities. They also “upped their social media game” and encouraged residents to create online groups for prospective residents to share information about programs and life outside of work. Some residents even offered video tours of their personal apartments to applicants.

Without in-person access to facilities and staff, a program’s online presence became a deciding factor, applicants said. “If you have a bad website, it’s like having a dirty building to interview applicants in,” Mr. Skidmore said. For many prospective residents, an institution’s Internet presence was a “make or break” factor. “It’s the only thing I saw for many programs, and when we are doing the amount of research we are doing remotely, when I saw a program with a bad website, it made me not like the program as much,” he said.

Some programs, hoping to woo candidates as well as to provide them with more insight into what they and their cities have to offer, sent “swag bags” to candidates. These included things like gift cards for food delivery and offerings from local businesses. Washington University’s pediatrics residency program sent gooey butter cakes – a St. Louis staple – along with other treats from small businesses and copies of magazines that showcased the city’s dining and entertainment scene.

Other programs, even those at the same medical institution, felt quite strongly that those types of packages shouldn’t be sent. “We interviewed almost 500 applicants, so there was no way we could have afforded that,” said Dominique Cosco, MD, director of Washington University’s internal medicine residency program. “Our normal recruitment budget is almost $100,000 in a normal year, and that got cut because of COVID. For us, it was thinking about allocations of resources.”
 

Interview slot theft and zoom fatigue

Remote interviewing also meant that applicants could accept more interviews, something that raised a big concern. Without expenses or travel time, would top-tier candidates take more interviews than normal and thus take limited interview spots from other qualified candidates? Maybe so, says the AAMC’s Dr. Whelan.

“We didn’t have systematic data, but we heard from enough schools and programs ... that students who were maybe not the top-top ranked students in the class but in every way solid were receiving fewer interviews than previous years,” Dr. Whelan said. This is despite guidance that recommended programs add interview slots to serve as a counterbalance.

Some students say they accepted more interview slots in the beginning of the interview season, partly because they could, and partly because some thought of early interviews as “practice” for later interviews. However, as video interviews piled up, some of them described feeling “Zoom fatigue” and said they later canceled interviews with programs they didn’t anticipate joining.
 

More SOAP, less clarity

As for what comes next, the NRMP is preparing for a longer-than-normal Supplemental Offer and Acceptance Program (SOAP) than in years past. SOAP usually offers three rounds of matches after the initial Match Day; Ms. Lamb said things are different this year.

“SOAP will be the same number of days, but we’ve added an additional round on Thursday afternoon,” she said. Will it be unnecessary or not enough? Nobody knows. “How big SOAP actually is going to be is one of the things that we really don’t have a sense of right now and probably aren’t going to have a sense of until the Match.”

Uncertainty is the name of the game. More than any other Match before, programs and applicants won’t know how results from this pandemic year stack up for a few months at the very least. “I really want to see what this looks like on the other side,” Dr. Smith said. “Are applicants happy with the way it looks when they come here? Do they feel like they matched with the right place?”

Whether this unprecedented year will be remembered more for positive changes moving forward, including more flexibility on remote interviews, or for less-informed decisions that result in dissatisfied participants is also unclear.

“I think after the Match is over, we’ll be talking to everyone to get more perspective on what people who are applying now would tell the next class, and how programs can adjust,” said Kathy Diemer, MD, assistant dean for career counseling at Washington University. At the very least, those who are involved in this year after year can start thinking about what the future should look like.

“We’re going to need to do some kind of debriefing after this is over, both program directors and our students as well, so we can determine how to move forward next year and beyond.”

A version of this article first appeared on Medscape.com.

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

Autopsies on patients who died from COVID-19 are providing important clues on how to treat the disease. In an analysis of 40 hearts from COVID-19 patients who died early in the pandemic, myocyte necrosis was seen in 14 hearts, or 35%.

In the majority of these hearts, pathologists found both small areas of focal necrosis and cardiac thrombi, most of which were microthrombi in myocardial capillaries, arterioles, and small muscular cells.

In an interview, senior author Aloke V. Finn, MD, CVPath Institute, Gaithersburg, Md., stressed the importance of understanding what they saw, but also what they didn’t see.

“What we saw in the majority of patients with myocardial injury were these small areas of infarct and microthrombi in small vessels. What we didn’t see was any evidence of myocarditis and or huge infarcts in, like, the LAD artery,” he said.

“What we’re seeing here is not clinically detectable. ... There is no test that will tell you there are microthrombi and no imaging tests that will show these focal areas of necrosis, but that doesn’t mean it’s not there,” he added.

The finding of myocyte necrosis in about one-third of samples is consistent with another study that showed that 30%-40% of patients hospitalized with COVID-19 have elevated troponins, noted Dr. Finn. The investigators were unable to obtain troponin levels on their patients, which could limit the clinical translation of myocardial necrosis detected at autopsy.

Dr. Finn and colleagues, including first author Dario Pellegrini, MD, from Ospedale Papa Giovanni XXIII in Bergamo, Italy, published their findings online in Circulation on Jan. 22, 2020.

The report is a follow-up to another just published by Dr. Finn’s group in the Journal of the American College of Cardiology, which showed that myocarditis is a very rare finding in COVID-19 autopsies.

Only three of 14 individuals (21.4%) with evidence of myocyte necrosis showed evidence of acute MI, which Dr. Finn and colleagues define as an area of necrosis at least 1 cm² in size. The remaining 11 (78.6%) had only discrete areas of myocyte necrosis (>20 necrotic myocytes with an area of ≥0.05 mm², but <1 cm²).

“This makes sense when we saw what type of thrombus there was in these cases; it wasn’t thrombus in major epicardial vessels but microthombi in small vessels,” said Dr. Finn.

In those with necrosis, cardiac thrombi were present in 11 of 14 (78.6%) cases, with 2 of 14 (14.2%) having epicardial coronary artery thrombi and 0 of 14 (64.3%) having microthrombi in myocardial capillaries, arterioles, and small muscular arteries.

Further supporting the role of COVID-19–related hypercoagulability as the cause of myocardial injury in many patients, the investigators noted that the incidence of severe coronary artery disease (defined as >75% cross sectional narrowing) did not differ significantly between those with and without necrosis.
 

COVID-19 vs. non–COVID-19 thrombi

Going one step further, Dr. Finn’s team compared cardiac microthrombi from their COVID-19–positive autopsy cases with intramyocardial thromboemboli from COVID-19 cases. They also compared the samples with aspirated thrombi obtained during primary percutaneous coronary intervention from uninfected and COVID-19–infected patients presenting with ST-segment elevation MI (STEMI).

The autopsy-obtained microthrombi had significantly more fibrin and terminal complement C5b-9 immunostaining than intramyocardial thromboemboli from COVID-19–negative subjects and than aspirated thrombi from either COVID-positive or COVID-negative STEMI patients.

“Basically, what we’re seeing in these thrombi is evidence of an immune-mediated reaction,” said Dr. Finn, explaining that complement C5b-9 is an innate immune system protein that circulates in the blood in response to any kind of activation of the immune system. “It is nonspecific but can also lead to coagulation problems,” he said.
 

Anticoagulation, yes, but dose unclear

These findings clearly support the use of anticoagulation in hospitalized COVID patients, said Jeffrey Weitz, MD, director of the Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, Ont. But the details of how much anticoagulation, what kind, and for whom are still a moving target.

“I think what we can say at this point is that these autopsy findings fit with previous studies that have shown microthrombi in the lungs and thrombi in the legs and gut, and support the notion that these patients should receive prophylactic doses of anticoagulants if they’re sick enough to be hospitalized,” said Dr. Weitz.

“But it’s not as simple as to say that this study shows clots form in the heart of COVID patients and therefore more anticoagulation is going to be better than less anticoagulation,” he said in an interview.

Recent top-line findings from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – show that full-dose anticoagulation was beneficial in moderately ill patients hospitalized for COVID-19 and reduced the need for mechanical ventilation.

Moderately ill patients are those not in intensive care and who did not require organ support, such as mechanical ventilation, at the time of enrollment.

However, the same group reported findings in December that showed that routine use of full-dose anticoagulation when started in the ICU in critically ill patients was not beneficial and possibly harmful.

Dr. Weitz was only a little bit surprised by this finding of potential harm in the sickest patients. “I figured everybody should get prophylaxis but I wasn’t sure that everybody should get intensified anticoagulant. But my assumption was that if anybody is going to benefit from it, it would be the ICU patients.”

It was notable, said Dr. Weitz, that levels of D-dimer, a fibrin degradation product, were not associated with outcomes. “So, it doesn’t seem to be that patients with evidence of more clotting are more likely to benefit, which might indicate that it’s not the anticoagulant effect of the heparin that’s helping, but maybe the anti-inflammatory effect. At this point, we just don’t know.”

All three studies have paused enrollment of the critically ill subgroup, but are continuing to enroll patients with moderate illness and expect to publish results in the coming months, according to previous coverage from this news organization.

The study was funded by CVPath, a nonprofit institute that receives funding from a number of different industry entities. Dr. Finn and Dr. Weitz reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Autopsies on patients who died from COVID-19 are providing important clues on how to treat the disease. In an analysis of 40 hearts from COVID-19 patients who died early in the pandemic, myocyte necrosis was seen in 14 hearts, or 35%.

In the majority of these hearts, pathologists found both small areas of focal necrosis and cardiac thrombi, most of which were microthrombi in myocardial capillaries, arterioles, and small muscular cells.

In an interview, senior author Aloke V. Finn, MD, CVPath Institute, Gaithersburg, Md., stressed the importance of understanding what they saw, but also what they didn’t see.

“What we saw in the majority of patients with myocardial injury were these small areas of infarct and microthrombi in small vessels. What we didn’t see was any evidence of myocarditis and or huge infarcts in, like, the LAD artery,” he said.

“What we’re seeing here is not clinically detectable. ... There is no test that will tell you there are microthrombi and no imaging tests that will show these focal areas of necrosis, but that doesn’t mean it’s not there,” he added.

The finding of myocyte necrosis in about one-third of samples is consistent with another study that showed that 30%-40% of patients hospitalized with COVID-19 have elevated troponins, noted Dr. Finn. The investigators were unable to obtain troponin levels on their patients, which could limit the clinical translation of myocardial necrosis detected at autopsy.

Dr. Finn and colleagues, including first author Dario Pellegrini, MD, from Ospedale Papa Giovanni XXIII in Bergamo, Italy, published their findings online in Circulation on Jan. 22, 2020.

The report is a follow-up to another just published by Dr. Finn’s group in the Journal of the American College of Cardiology, which showed that myocarditis is a very rare finding in COVID-19 autopsies.

Only three of 14 individuals (21.4%) with evidence of myocyte necrosis showed evidence of acute MI, which Dr. Finn and colleagues define as an area of necrosis at least 1 cm² in size. The remaining 11 (78.6%) had only discrete areas of myocyte necrosis (>20 necrotic myocytes with an area of ≥0.05 mm², but <1 cm²).

“This makes sense when we saw what type of thrombus there was in these cases; it wasn’t thrombus in major epicardial vessels but microthombi in small vessels,” said Dr. Finn.

In those with necrosis, cardiac thrombi were present in 11 of 14 (78.6%) cases, with 2 of 14 (14.2%) having epicardial coronary artery thrombi and 0 of 14 (64.3%) having microthrombi in myocardial capillaries, arterioles, and small muscular arteries.

Further supporting the role of COVID-19–related hypercoagulability as the cause of myocardial injury in many patients, the investigators noted that the incidence of severe coronary artery disease (defined as >75% cross sectional narrowing) did not differ significantly between those with and without necrosis.
 

COVID-19 vs. non–COVID-19 thrombi

Going one step further, Dr. Finn’s team compared cardiac microthrombi from their COVID-19–positive autopsy cases with intramyocardial thromboemboli from COVID-19 cases. They also compared the samples with aspirated thrombi obtained during primary percutaneous coronary intervention from uninfected and COVID-19–infected patients presenting with ST-segment elevation MI (STEMI).

The autopsy-obtained microthrombi had significantly more fibrin and terminal complement C5b-9 immunostaining than intramyocardial thromboemboli from COVID-19–negative subjects and than aspirated thrombi from either COVID-positive or COVID-negative STEMI patients.

“Basically, what we’re seeing in these thrombi is evidence of an immune-mediated reaction,” said Dr. Finn, explaining that complement C5b-9 is an innate immune system protein that circulates in the blood in response to any kind of activation of the immune system. “It is nonspecific but can also lead to coagulation problems,” he said.
 

Anticoagulation, yes, but dose unclear

These findings clearly support the use of anticoagulation in hospitalized COVID patients, said Jeffrey Weitz, MD, director of the Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, Ont. But the details of how much anticoagulation, what kind, and for whom are still a moving target.

“I think what we can say at this point is that these autopsy findings fit with previous studies that have shown microthrombi in the lungs and thrombi in the legs and gut, and support the notion that these patients should receive prophylactic doses of anticoagulants if they’re sick enough to be hospitalized,” said Dr. Weitz.

“But it’s not as simple as to say that this study shows clots form in the heart of COVID patients and therefore more anticoagulation is going to be better than less anticoagulation,” he said in an interview.

Recent top-line findings from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – show that full-dose anticoagulation was beneficial in moderately ill patients hospitalized for COVID-19 and reduced the need for mechanical ventilation.

Moderately ill patients are those not in intensive care and who did not require organ support, such as mechanical ventilation, at the time of enrollment.

However, the same group reported findings in December that showed that routine use of full-dose anticoagulation when started in the ICU in critically ill patients was not beneficial and possibly harmful.

Dr. Weitz was only a little bit surprised by this finding of potential harm in the sickest patients. “I figured everybody should get prophylaxis but I wasn’t sure that everybody should get intensified anticoagulant. But my assumption was that if anybody is going to benefit from it, it would be the ICU patients.”

It was notable, said Dr. Weitz, that levels of D-dimer, a fibrin degradation product, were not associated with outcomes. “So, it doesn’t seem to be that patients with evidence of more clotting are more likely to benefit, which might indicate that it’s not the anticoagulant effect of the heparin that’s helping, but maybe the anti-inflammatory effect. At this point, we just don’t know.”

All three studies have paused enrollment of the critically ill subgroup, but are continuing to enroll patients with moderate illness and expect to publish results in the coming months, according to previous coverage from this news organization.

The study was funded by CVPath, a nonprofit institute that receives funding from a number of different industry entities. Dr. Finn and Dr. Weitz reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Autopsies on patients who died from COVID-19 are providing important clues on how to treat the disease. In an analysis of 40 hearts from COVID-19 patients who died early in the pandemic, myocyte necrosis was seen in 14 hearts, or 35%.

In the majority of these hearts, pathologists found both small areas of focal necrosis and cardiac thrombi, most of which were microthrombi in myocardial capillaries, arterioles, and small muscular cells.

In an interview, senior author Aloke V. Finn, MD, CVPath Institute, Gaithersburg, Md., stressed the importance of understanding what they saw, but also what they didn’t see.

“What we saw in the majority of patients with myocardial injury were these small areas of infarct and microthrombi in small vessels. What we didn’t see was any evidence of myocarditis and or huge infarcts in, like, the LAD artery,” he said.

“What we’re seeing here is not clinically detectable. ... There is no test that will tell you there are microthrombi and no imaging tests that will show these focal areas of necrosis, but that doesn’t mean it’s not there,” he added.

The finding of myocyte necrosis in about one-third of samples is consistent with another study that showed that 30%-40% of patients hospitalized with COVID-19 have elevated troponins, noted Dr. Finn. The investigators were unable to obtain troponin levels on their patients, which could limit the clinical translation of myocardial necrosis detected at autopsy.

Dr. Finn and colleagues, including first author Dario Pellegrini, MD, from Ospedale Papa Giovanni XXIII in Bergamo, Italy, published their findings online in Circulation on Jan. 22, 2020.

The report is a follow-up to another just published by Dr. Finn’s group in the Journal of the American College of Cardiology, which showed that myocarditis is a very rare finding in COVID-19 autopsies.

Only three of 14 individuals (21.4%) with evidence of myocyte necrosis showed evidence of acute MI, which Dr. Finn and colleagues define as an area of necrosis at least 1 cm² in size. The remaining 11 (78.6%) had only discrete areas of myocyte necrosis (>20 necrotic myocytes with an area of ≥0.05 mm², but <1 cm²).

“This makes sense when we saw what type of thrombus there was in these cases; it wasn’t thrombus in major epicardial vessels but microthombi in small vessels,” said Dr. Finn.

In those with necrosis, cardiac thrombi were present in 11 of 14 (78.6%) cases, with 2 of 14 (14.2%) having epicardial coronary artery thrombi and 0 of 14 (64.3%) having microthrombi in myocardial capillaries, arterioles, and small muscular arteries.

Further supporting the role of COVID-19–related hypercoagulability as the cause of myocardial injury in many patients, the investigators noted that the incidence of severe coronary artery disease (defined as >75% cross sectional narrowing) did not differ significantly between those with and without necrosis.
 

COVID-19 vs. non–COVID-19 thrombi

Going one step further, Dr. Finn’s team compared cardiac microthrombi from their COVID-19–positive autopsy cases with intramyocardial thromboemboli from COVID-19 cases. They also compared the samples with aspirated thrombi obtained during primary percutaneous coronary intervention from uninfected and COVID-19–infected patients presenting with ST-segment elevation MI (STEMI).

The autopsy-obtained microthrombi had significantly more fibrin and terminal complement C5b-9 immunostaining than intramyocardial thromboemboli from COVID-19–negative subjects and than aspirated thrombi from either COVID-positive or COVID-negative STEMI patients.

“Basically, what we’re seeing in these thrombi is evidence of an immune-mediated reaction,” said Dr. Finn, explaining that complement C5b-9 is an innate immune system protein that circulates in the blood in response to any kind of activation of the immune system. “It is nonspecific but can also lead to coagulation problems,” he said.
 

Anticoagulation, yes, but dose unclear

These findings clearly support the use of anticoagulation in hospitalized COVID patients, said Jeffrey Weitz, MD, director of the Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, Ont. But the details of how much anticoagulation, what kind, and for whom are still a moving target.

“I think what we can say at this point is that these autopsy findings fit with previous studies that have shown microthrombi in the lungs and thrombi in the legs and gut, and support the notion that these patients should receive prophylactic doses of anticoagulants if they’re sick enough to be hospitalized,” said Dr. Weitz.

“But it’s not as simple as to say that this study shows clots form in the heart of COVID patients and therefore more anticoagulation is going to be better than less anticoagulation,” he said in an interview.

Recent top-line findings from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – show that full-dose anticoagulation was beneficial in moderately ill patients hospitalized for COVID-19 and reduced the need for mechanical ventilation.

Moderately ill patients are those not in intensive care and who did not require organ support, such as mechanical ventilation, at the time of enrollment.

However, the same group reported findings in December that showed that routine use of full-dose anticoagulation when started in the ICU in critically ill patients was not beneficial and possibly harmful.

Dr. Weitz was only a little bit surprised by this finding of potential harm in the sickest patients. “I figured everybody should get prophylaxis but I wasn’t sure that everybody should get intensified anticoagulant. But my assumption was that if anybody is going to benefit from it, it would be the ICU patients.”

It was notable, said Dr. Weitz, that levels of D-dimer, a fibrin degradation product, were not associated with outcomes. “So, it doesn’t seem to be that patients with evidence of more clotting are more likely to benefit, which might indicate that it’s not the anticoagulant effect of the heparin that’s helping, but maybe the anti-inflammatory effect. At this point, we just don’t know.”

All three studies have paused enrollment of the critically ill subgroup, but are continuing to enroll patients with moderate illness and expect to publish results in the coming months, according to previous coverage from this news organization.

The study was funded by CVPath, a nonprofit institute that receives funding from a number of different industry entities. Dr. Finn and Dr. Weitz reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

A version of this article first appeared on Medscape.com.

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

A version of this article first appeared on Medscape.com.

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

A version of this article first appeared on Medscape.com.

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

A version of this article first appeared on Medscape.com.

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

A version of this article first appeared on Medscape.com.

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

A version of this article first appeared on Medscape.com.

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.