Clinical

Holiday travel season is right around the corner, but coronavirus cases have already started to climb. But a new automated texting system could relieve pressure on emergency departments and reduce mortality rates if there were an uptick in COVID-19 this winter.

COVID Watch, a text message–based remote monitoring program developed by the University of Pennsylvania Health System, was associated with a 68% reduction in the risk of death, compared with those who received usual care. This was the main finding of a paper published in the Annals of Internal Medicine.

The investigators also determined that patients who enrolled in the program were more likely to seek care in the ED and when they did, they came in on average 2 days sooner than those who received usual care.

“When our clinical team designed COVID Watch the goal was to facilitate hospital care for patients who require it, while supporting access to care for patients who can safely remain at home,” study author M. Kit Delgado, MD, MS, an assistant professor of emergency medicine and epidemiology at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

Researchers had initially hoped COVID Watch would relieve pressure on EDs, Dr. Delgado said.
 

Significantly lower mortality seen among COVID Watch group

For the study, Dr. Delgado and colleagues enrolled 3,488 patients in COVID Watch and 4,377 in the usual care group to compare outcomes at 30 and 60 days.

“We didn’t include patients who were diagnosed with COVID in the ER or hospital, so this is a lower-risk cohort of patients who test positive in outpatient settings,” Dr. Delgado noted. “Outpatients who received usual care and COVID Watch both had relatively low mortality, but it was significantly lower in those who were in COVID Watch.”

The researchers found that 3 patients in the COVID Watch group died within 30 days of their enrollment, compared with 12 in the control group. At 60 days after enrollment, 5 people within COVID Watch died, compared with 16 not using the system. More than one-third of the deaths in the usual care group occurred outside the hospital, compared with zero deaths among those in COVID Watch.
 

More than half of program participants were Black or Latino

The messaging system also reduced mortality rates among “all major racial and ethnic subgroups,” the researchers said, with more than 50% of the patients enrolled in COVID Watch having been Black or Latino.

“This is important because Black and Hispanic communities have experienced higher exposure and infection rates, decreased access to care, and have had higher mortality rates,” Dr. Delgado said. “Therefore, the results imply that this type of program could play a role in decreasing disparities in COVID outcomes if scaled more broadly.”
 

Outside expert: COVID Watch bring new approach to digital health monitoring

The study not only highlights the efficacy and sustainment of the COVID Watch program, but it sheds light on the possibility of using text message monitoring systems on other chronic disease conditions, said Jamie Faro, PhD, who was not involved in the study.

“It brings a new approach to health monitoring using digital means, which may lessen the burden on health care providers and be more cost effective than usual care approaches,” said Dr. Faro, who is assistant professor at the department of population and quantitative health sciences at the University of Massachusetts, Worcester. “Text messaging, which is used by over 80% of Americans, can allow us to reach a large percentage of the population for remote health care monitoring.”

Researchers of the current study said the findings “reveal a model for outpatient health system management of patients with COVID-19 and possibly other conditions where the early detection of clinical declines is critical.” Dr. Faro said that COVID Watch can have a measurable impact on an outcome that is truly life or death. However, it would be critical to understand how to reach those who either “were not offered or refused to take part in the program.”

The authors of the paper and Dr. Faro had no disclosures.

Holiday travel season is right around the corner, but coronavirus cases have already started to climb. But a new automated texting system could relieve pressure on emergency departments and reduce mortality rates if there were an uptick in COVID-19 this winter.

COVID Watch, a text message–based remote monitoring program developed by the University of Pennsylvania Health System, was associated with a 68% reduction in the risk of death, compared with those who received usual care. This was the main finding of a paper published in the Annals of Internal Medicine.

The investigators also determined that patients who enrolled in the program were more likely to seek care in the ED and when they did, they came in on average 2 days sooner than those who received usual care.

“When our clinical team designed COVID Watch the goal was to facilitate hospital care for patients who require it, while supporting access to care for patients who can safely remain at home,” study author M. Kit Delgado, MD, MS, an assistant professor of emergency medicine and epidemiology at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

Researchers had initially hoped COVID Watch would relieve pressure on EDs, Dr. Delgado said.
 

Significantly lower mortality seen among COVID Watch group

For the study, Dr. Delgado and colleagues enrolled 3,488 patients in COVID Watch and 4,377 in the usual care group to compare outcomes at 30 and 60 days.

“We didn’t include patients who were diagnosed with COVID in the ER or hospital, so this is a lower-risk cohort of patients who test positive in outpatient settings,” Dr. Delgado noted. “Outpatients who received usual care and COVID Watch both had relatively low mortality, but it was significantly lower in those who were in COVID Watch.”

The researchers found that 3 patients in the COVID Watch group died within 30 days of their enrollment, compared with 12 in the control group. At 60 days after enrollment, 5 people within COVID Watch died, compared with 16 not using the system. More than one-third of the deaths in the usual care group occurred outside the hospital, compared with zero deaths among those in COVID Watch.
 

More than half of program participants were Black or Latino

The messaging system also reduced mortality rates among “all major racial and ethnic subgroups,” the researchers said, with more than 50% of the patients enrolled in COVID Watch having been Black or Latino.

“This is important because Black and Hispanic communities have experienced higher exposure and infection rates, decreased access to care, and have had higher mortality rates,” Dr. Delgado said. “Therefore, the results imply that this type of program could play a role in decreasing disparities in COVID outcomes if scaled more broadly.”
 

Outside expert: COVID Watch bring new approach to digital health monitoring

The study not only highlights the efficacy and sustainment of the COVID Watch program, but it sheds light on the possibility of using text message monitoring systems on other chronic disease conditions, said Jamie Faro, PhD, who was not involved in the study.

“It brings a new approach to health monitoring using digital means, which may lessen the burden on health care providers and be more cost effective than usual care approaches,” said Dr. Faro, who is assistant professor at the department of population and quantitative health sciences at the University of Massachusetts, Worcester. “Text messaging, which is used by over 80% of Americans, can allow us to reach a large percentage of the population for remote health care monitoring.”

Researchers of the current study said the findings “reveal a model for outpatient health system management of patients with COVID-19 and possibly other conditions where the early detection of clinical declines is critical.” Dr. Faro said that COVID Watch can have a measurable impact on an outcome that is truly life or death. However, it would be critical to understand how to reach those who either “were not offered or refused to take part in the program.”

The authors of the paper and Dr. Faro had no disclosures.

Holiday travel season is right around the corner, but coronavirus cases have already started to climb. But a new automated texting system could relieve pressure on emergency departments and reduce mortality rates if there were an uptick in COVID-19 this winter.

COVID Watch, a text message–based remote monitoring program developed by the University of Pennsylvania Health System, was associated with a 68% reduction in the risk of death, compared with those who received usual care. This was the main finding of a paper published in the Annals of Internal Medicine.

The investigators also determined that patients who enrolled in the program were more likely to seek care in the ED and when they did, they came in on average 2 days sooner than those who received usual care.

“When our clinical team designed COVID Watch the goal was to facilitate hospital care for patients who require it, while supporting access to care for patients who can safely remain at home,” study author M. Kit Delgado, MD, MS, an assistant professor of emergency medicine and epidemiology at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

Researchers had initially hoped COVID Watch would relieve pressure on EDs, Dr. Delgado said.
 

Significantly lower mortality seen among COVID Watch group

For the study, Dr. Delgado and colleagues enrolled 3,488 patients in COVID Watch and 4,377 in the usual care group to compare outcomes at 30 and 60 days.

“We didn’t include patients who were diagnosed with COVID in the ER or hospital, so this is a lower-risk cohort of patients who test positive in outpatient settings,” Dr. Delgado noted. “Outpatients who received usual care and COVID Watch both had relatively low mortality, but it was significantly lower in those who were in COVID Watch.”

The researchers found that 3 patients in the COVID Watch group died within 30 days of their enrollment, compared with 12 in the control group. At 60 days after enrollment, 5 people within COVID Watch died, compared with 16 not using the system. More than one-third of the deaths in the usual care group occurred outside the hospital, compared with zero deaths among those in COVID Watch.
 

More than half of program participants were Black or Latino

The messaging system also reduced mortality rates among “all major racial and ethnic subgroups,” the researchers said, with more than 50% of the patients enrolled in COVID Watch having been Black or Latino.

“This is important because Black and Hispanic communities have experienced higher exposure and infection rates, decreased access to care, and have had higher mortality rates,” Dr. Delgado said. “Therefore, the results imply that this type of program could play a role in decreasing disparities in COVID outcomes if scaled more broadly.”
 

Outside expert: COVID Watch bring new approach to digital health monitoring

The study not only highlights the efficacy and sustainment of the COVID Watch program, but it sheds light on the possibility of using text message monitoring systems on other chronic disease conditions, said Jamie Faro, PhD, who was not involved in the study.

“It brings a new approach to health monitoring using digital means, which may lessen the burden on health care providers and be more cost effective than usual care approaches,” said Dr. Faro, who is assistant professor at the department of population and quantitative health sciences at the University of Massachusetts, Worcester. “Text messaging, which is used by over 80% of Americans, can allow us to reach a large percentage of the population for remote health care monitoring.”

Researchers of the current study said the findings “reveal a model for outpatient health system management of patients with COVID-19 and possibly other conditions where the early detection of clinical declines is critical.” Dr. Faro said that COVID Watch can have a measurable impact on an outcome that is truly life or death. However, it would be critical to understand how to reach those who either “were not offered or refused to take part in the program.”

The authors of the paper and Dr. Faro had no disclosures.

Background: Despite advances in AFib management, up to 5% of patients will have a major complication each year. Current guidelines favor rate control based on prior studies that did not show mortality benefit with rhythm control. By expanding the rhythm strategy to include catheter ablation in early AFib, this trial re-examines if implementing rhythm control leads to improved clinical outcomes. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

Background: Despite advances in AFib management, up to 5% of patients will have a major complication each year. Current guidelines favor rate control based on prior studies that did not show mortality benefit with rhythm control. By expanding the rhythm strategy to include catheter ablation in early AFib, this trial re-examines if implementing rhythm control leads to improved clinical outcomes. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

Background: Despite advances in AFib management, up to 5% of patients will have a major complication each year. Current guidelines favor rate control based on prior studies that did not show mortality benefit with rhythm control. By expanding the rhythm strategy to include catheter ablation in early AFib, this trial re-examines if implementing rhythm control leads to improved clinical outcomes. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

Main results from the landmark EMPEROR-Preserved trial, reported in August, established for the first time that treatment with a drug, the sodium-glucose cotransporter 2 inhibitor empagliflozin, could clearly benefit patients with heart failure with preserved ejection fraction (HFpEF).

The only caveat was that EMPEROR-Preserved enrolled patients with a left ventricular ejection fraction of at least 41%, while “true” HFpEF means patients with heart failure and an LVEF of at least 50%, according to recent definitions. About one-third of the 5,988 patients enrolled in EMPEROR-Preserved had an LVEF of 41%-49%, heart failure with mildly reduced ejection fraction.

Secondary analysis from the EMPEROR-Preserved trial has now resolved this ambiguity by showing that, among the 4,005 patients (67%) enrolled in the trial with an LVEF of at least 50%, treatment with empagliflozin (Jardiance) reduced the study’s primary endpoint – cardiovascular death or first hospitalization for heart failure – by a significant 17%, relative to patients who received placebo, dismissing any doubt about the relevance of the overall finding to the subgroup of patients with unmitigated HFpEF.

“This is the first large-scale trial to document meaningful and significant improvements associated with drug therapy in patients with ‘true’ HFpEF,” Stefan D. Anker, MD, said in presenting the results at the American Heart Association scientific sessions.

Streamlining heart failure treatment

The demonstration that empagliflozin is an effective – and safe – treatment for patients with HFpEF not only provides a new treatment for a disorder that until now had no evidence-based intervention, but also streamlines the management approach for treating patients with heart failure with an agent from empagliflozin’s class, the SGLT2 inhibitors, commented Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs at Ascension St. Vincent Heart Center in Indianapolis.

That’s because empagliflozin has shown significant and consistent benefit across essentially the full range of LVEFs seen in patients with heart failure based on its performance in EMPEROR-Preserved as well as in a mirror-image trial, EMPEROR-Reduced, run in patients with heart failure with reduced ejection fraction.

“Clinicians do not need to stop and assess LVEF with echocardiography or other imaging before they decide on how to treat heart failure patients” with an SGLT2 inhibitor, noted Dr. Walsh, a designated discussant for the report. “Clinicians who are busy can now refer less to LVEF than to the patient’s phenotype.”
 

Treatment prevents hospitalization for heart failure

The more-detailed data reported by Dr. Anker also strengthened the case that the benefit from empagliflozin in patients with an LVEF of at least 50% mostly came from a reduction in hospitalizations for heart failure (HHF), which dropped following start of empagliflozin treatment by a relative 22%, compared with placebo for first HHF, a significant decline, and by a relative 17% for total HHF, a reduction that missed significance in this secondary analysis. The other half of the primary endpoint, cardiovascular death, declined by a nonsignificant 11% with empagliflozin treatment, compared with placebo in patients with clear-cut HFpEF.

The significant reduction in first HHF is, by itself, sufficient reason to use empagliflozin (or possibly a different SGLT2 inhibitor) in patients with HFpEF, maintained Clyde W. Yancy, MD, professor and chief of cardiology at Northwestern Medicine in Chicago.

“Attenuated HHF is a meaningful outcome,” stressed Dr. Yancy, also a discussant for the study. “This is the first time we’ve had evidence supporting that we can change the natural history of patients with HFpEF. While we still need to find interventions that save lives, we cannot overlook that this treatment can improve morbidity, and we cannot overlook that patient quality of life is better.”
 

Further benefits in patients with an LVEF of at least 50%

Dr. Anker, professor of cardiology and metabolism at Charité Medical University in Berlin, also reported results from several other analyses that further defined the effect of empagliflozin on clinical outcomes of patients with “true” HFpEF:

• The impact of empagliflozin, compared with placebo, for reducing both the study’s combined, primary outcome as well as total HHF was statistically consistent across all strata of LVEF, from 50% to greater than 70%. However, both outcome measures also showed a puzzling loss of benefit among patients with an LVEF of 65%-69%. In prior reports, a researcher on the EMPEROR-Preserved team, Milton Packer, MD, speculated that some patients in this LVEF stratum might not actually have had heart failure but instead had a different disorder that mimicked heart failure in clinical presentation, such as atrial fibrillation.
• Patients’ quality of life as measured by the Kansas City Cardiomyopathy Questionnaire showed a consistent benefit from empagliflozin treatment, compared with placebo, both in patients with an LVEF of at least 50% as well as in those with an LVEF of 41%-49%. In both subgroups the adjusted mean difference from placebo was significant and about 1.5 points.
• Patients showed a significant improvement in average New York Heart Association functional class while on treatment, and a strong trend toward less deterioration in functional class while on treatment.
• Deterioration of renal function on treatment slowed by an average 1.24 mL/min per 1.73 m² per year in patients on empagliflozin, compared with placebo, in the subgroup with an LVEF of at least 50%.

Dr. Anker also reported the primary outcome and component results for the subgroup of patients with a baseline LVEF of 41%-49%. These patients had what looked like a “bigger magnitude” of effect from treatment, he noted, showing a significant 29% relative decline in the primary endpoint, compared with placebo-treated patients, and a significant 42% relative drop in first HHF and a significant 43% relative decline in total HHF, compared with placebo.

The primary analysis from EMPEROR-Preserved, which included all 5,988 randomized patients with heart failure and an LVEF of 41% or greater, showed a significant reduction in the combined, primary endpoint with empagliflozin treatment of 21%, compared with control patients during a median follow-up of about 26 months. The absolute rate reduction of the combined primary endpoint was 3.3% during 26-months’ follow-up. Statistical tests have shown no heterogeneity of this effect by diabetes status (49% of patients had diabetes), nor by renal function down to an estimated glomerular filtration rate at entry as low as 20 mL/min per 1.73 m².

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and Lilly, the two companies that market empagliflozin (Jardiance). Dr. Anker has been a consultant to Boehringer Ingelheim as well as to Abbott Vascular, Bayer, Brahms, Cardiac Dimensions, Cordio, Novartis, Servier, and Vifor. Dr. Walsh and Dr. Yancy had no disclosures.

mzoler@mdedge.com

Main results from the landmark EMPEROR-Preserved trial, reported in August, established for the first time that treatment with a drug, the sodium-glucose cotransporter 2 inhibitor empagliflozin, could clearly benefit patients with heart failure with preserved ejection fraction (HFpEF).

The only caveat was that EMPEROR-Preserved enrolled patients with a left ventricular ejection fraction of at least 41%, while “true” HFpEF means patients with heart failure and an LVEF of at least 50%, according to recent definitions. About one-third of the 5,988 patients enrolled in EMPEROR-Preserved had an LVEF of 41%-49%, heart failure with mildly reduced ejection fraction.

Secondary analysis from the EMPEROR-Preserved trial has now resolved this ambiguity by showing that, among the 4,005 patients (67%) enrolled in the trial with an LVEF of at least 50%, treatment with empagliflozin (Jardiance) reduced the study’s primary endpoint – cardiovascular death or first hospitalization for heart failure – by a significant 17%, relative to patients who received placebo, dismissing any doubt about the relevance of the overall finding to the subgroup of patients with unmitigated HFpEF.

“This is the first large-scale trial to document meaningful and significant improvements associated with drug therapy in patients with ‘true’ HFpEF,” Stefan D. Anker, MD, said in presenting the results at the American Heart Association scientific sessions.

Streamlining heart failure treatment

The demonstration that empagliflozin is an effective – and safe – treatment for patients with HFpEF not only provides a new treatment for a disorder that until now had no evidence-based intervention, but also streamlines the management approach for treating patients with heart failure with an agent from empagliflozin’s class, the SGLT2 inhibitors, commented Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs at Ascension St. Vincent Heart Center in Indianapolis.

That’s because empagliflozin has shown significant and consistent benefit across essentially the full range of LVEFs seen in patients with heart failure based on its performance in EMPEROR-Preserved as well as in a mirror-image trial, EMPEROR-Reduced, run in patients with heart failure with reduced ejection fraction.

“Clinicians do not need to stop and assess LVEF with echocardiography or other imaging before they decide on how to treat heart failure patients” with an SGLT2 inhibitor, noted Dr. Walsh, a designated discussant for the report. “Clinicians who are busy can now refer less to LVEF than to the patient’s phenotype.”
 

Treatment prevents hospitalization for heart failure

The more-detailed data reported by Dr. Anker also strengthened the case that the benefit from empagliflozin in patients with an LVEF of at least 50% mostly came from a reduction in hospitalizations for heart failure (HHF), which dropped following start of empagliflozin treatment by a relative 22%, compared with placebo for first HHF, a significant decline, and by a relative 17% for total HHF, a reduction that missed significance in this secondary analysis. The other half of the primary endpoint, cardiovascular death, declined by a nonsignificant 11% with empagliflozin treatment, compared with placebo in patients with clear-cut HFpEF.

The significant reduction in first HHF is, by itself, sufficient reason to use empagliflozin (or possibly a different SGLT2 inhibitor) in patients with HFpEF, maintained Clyde W. Yancy, MD, professor and chief of cardiology at Northwestern Medicine in Chicago.

“Attenuated HHF is a meaningful outcome,” stressed Dr. Yancy, also a discussant for the study. “This is the first time we’ve had evidence supporting that we can change the natural history of patients with HFpEF. While we still need to find interventions that save lives, we cannot overlook that this treatment can improve morbidity, and we cannot overlook that patient quality of life is better.”
 

Further benefits in patients with an LVEF of at least 50%

Dr. Anker, professor of cardiology and metabolism at Charité Medical University in Berlin, also reported results from several other analyses that further defined the effect of empagliflozin on clinical outcomes of patients with “true” HFpEF:

• The impact of empagliflozin, compared with placebo, for reducing both the study’s combined, primary outcome as well as total HHF was statistically consistent across all strata of LVEF, from 50% to greater than 70%. However, both outcome measures also showed a puzzling loss of benefit among patients with an LVEF of 65%-69%. In prior reports, a researcher on the EMPEROR-Preserved team, Milton Packer, MD, speculated that some patients in this LVEF stratum might not actually have had heart failure but instead had a different disorder that mimicked heart failure in clinical presentation, such as atrial fibrillation.
• Patients’ quality of life as measured by the Kansas City Cardiomyopathy Questionnaire showed a consistent benefit from empagliflozin treatment, compared with placebo, both in patients with an LVEF of at least 50% as well as in those with an LVEF of 41%-49%. In both subgroups the adjusted mean difference from placebo was significant and about 1.5 points.
• Patients showed a significant improvement in average New York Heart Association functional class while on treatment, and a strong trend toward less deterioration in functional class while on treatment.
• Deterioration of renal function on treatment slowed by an average 1.24 mL/min per 1.73 m² per year in patients on empagliflozin, compared with placebo, in the subgroup with an LVEF of at least 50%.

Dr. Anker also reported the primary outcome and component results for the subgroup of patients with a baseline LVEF of 41%-49%. These patients had what looked like a “bigger magnitude” of effect from treatment, he noted, showing a significant 29% relative decline in the primary endpoint, compared with placebo-treated patients, and a significant 42% relative drop in first HHF and a significant 43% relative decline in total HHF, compared with placebo.

The primary analysis from EMPEROR-Preserved, which included all 5,988 randomized patients with heart failure and an LVEF of 41% or greater, showed a significant reduction in the combined, primary endpoint with empagliflozin treatment of 21%, compared with control patients during a median follow-up of about 26 months. The absolute rate reduction of the combined primary endpoint was 3.3% during 26-months’ follow-up. Statistical tests have shown no heterogeneity of this effect by diabetes status (49% of patients had diabetes), nor by renal function down to an estimated glomerular filtration rate at entry as low as 20 mL/min per 1.73 m².

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and Lilly, the two companies that market empagliflozin (Jardiance). Dr. Anker has been a consultant to Boehringer Ingelheim as well as to Abbott Vascular, Bayer, Brahms, Cardiac Dimensions, Cordio, Novartis, Servier, and Vifor. Dr. Walsh and Dr. Yancy had no disclosures.

mzoler@mdedge.com

Main results from the landmark EMPEROR-Preserved trial, reported in August, established for the first time that treatment with a drug, the sodium-glucose cotransporter 2 inhibitor empagliflozin, could clearly benefit patients with heart failure with preserved ejection fraction (HFpEF).

The only caveat was that EMPEROR-Preserved enrolled patients with a left ventricular ejection fraction of at least 41%, while “true” HFpEF means patients with heart failure and an LVEF of at least 50%, according to recent definitions. About one-third of the 5,988 patients enrolled in EMPEROR-Preserved had an LVEF of 41%-49%, heart failure with mildly reduced ejection fraction.

Secondary analysis from the EMPEROR-Preserved trial has now resolved this ambiguity by showing that, among the 4,005 patients (67%) enrolled in the trial with an LVEF of at least 50%, treatment with empagliflozin (Jardiance) reduced the study’s primary endpoint – cardiovascular death or first hospitalization for heart failure – by a significant 17%, relative to patients who received placebo, dismissing any doubt about the relevance of the overall finding to the subgroup of patients with unmitigated HFpEF.

“This is the first large-scale trial to document meaningful and significant improvements associated with drug therapy in patients with ‘true’ HFpEF,” Stefan D. Anker, MD, said in presenting the results at the American Heart Association scientific sessions.

Streamlining heart failure treatment

The demonstration that empagliflozin is an effective – and safe – treatment for patients with HFpEF not only provides a new treatment for a disorder that until now had no evidence-based intervention, but also streamlines the management approach for treating patients with heart failure with an agent from empagliflozin’s class, the SGLT2 inhibitors, commented Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs at Ascension St. Vincent Heart Center in Indianapolis.

That’s because empagliflozin has shown significant and consistent benefit across essentially the full range of LVEFs seen in patients with heart failure based on its performance in EMPEROR-Preserved as well as in a mirror-image trial, EMPEROR-Reduced, run in patients with heart failure with reduced ejection fraction.

“Clinicians do not need to stop and assess LVEF with echocardiography or other imaging before they decide on how to treat heart failure patients” with an SGLT2 inhibitor, noted Dr. Walsh, a designated discussant for the report. “Clinicians who are busy can now refer less to LVEF than to the patient’s phenotype.”
 

Treatment prevents hospitalization for heart failure

The more-detailed data reported by Dr. Anker also strengthened the case that the benefit from empagliflozin in patients with an LVEF of at least 50% mostly came from a reduction in hospitalizations for heart failure (HHF), which dropped following start of empagliflozin treatment by a relative 22%, compared with placebo for first HHF, a significant decline, and by a relative 17% for total HHF, a reduction that missed significance in this secondary analysis. The other half of the primary endpoint, cardiovascular death, declined by a nonsignificant 11% with empagliflozin treatment, compared with placebo in patients with clear-cut HFpEF.

The significant reduction in first HHF is, by itself, sufficient reason to use empagliflozin (or possibly a different SGLT2 inhibitor) in patients with HFpEF, maintained Clyde W. Yancy, MD, professor and chief of cardiology at Northwestern Medicine in Chicago.

“Attenuated HHF is a meaningful outcome,” stressed Dr. Yancy, also a discussant for the study. “This is the first time we’ve had evidence supporting that we can change the natural history of patients with HFpEF. While we still need to find interventions that save lives, we cannot overlook that this treatment can improve morbidity, and we cannot overlook that patient quality of life is better.”
 

Further benefits in patients with an LVEF of at least 50%

Dr. Anker, professor of cardiology and metabolism at Charité Medical University in Berlin, also reported results from several other analyses that further defined the effect of empagliflozin on clinical outcomes of patients with “true” HFpEF:

• The impact of empagliflozin, compared with placebo, for reducing both the study’s combined, primary outcome as well as total HHF was statistically consistent across all strata of LVEF, from 50% to greater than 70%. However, both outcome measures also showed a puzzling loss of benefit among patients with an LVEF of 65%-69%. In prior reports, a researcher on the EMPEROR-Preserved team, Milton Packer, MD, speculated that some patients in this LVEF stratum might not actually have had heart failure but instead had a different disorder that mimicked heart failure in clinical presentation, such as atrial fibrillation.
• Patients’ quality of life as measured by the Kansas City Cardiomyopathy Questionnaire showed a consistent benefit from empagliflozin treatment, compared with placebo, both in patients with an LVEF of at least 50% as well as in those with an LVEF of 41%-49%. In both subgroups the adjusted mean difference from placebo was significant and about 1.5 points.
• Patients showed a significant improvement in average New York Heart Association functional class while on treatment, and a strong trend toward less deterioration in functional class while on treatment.
• Deterioration of renal function on treatment slowed by an average 1.24 mL/min per 1.73 m² per year in patients on empagliflozin, compared with placebo, in the subgroup with an LVEF of at least 50%.

Dr. Anker also reported the primary outcome and component results for the subgroup of patients with a baseline LVEF of 41%-49%. These patients had what looked like a “bigger magnitude” of effect from treatment, he noted, showing a significant 29% relative decline in the primary endpoint, compared with placebo-treated patients, and a significant 42% relative drop in first HHF and a significant 43% relative decline in total HHF, compared with placebo.

The primary analysis from EMPEROR-Preserved, which included all 5,988 randomized patients with heart failure and an LVEF of 41% or greater, showed a significant reduction in the combined, primary endpoint with empagliflozin treatment of 21%, compared with control patients during a median follow-up of about 26 months. The absolute rate reduction of the combined primary endpoint was 3.3% during 26-months’ follow-up. Statistical tests have shown no heterogeneity of this effect by diabetes status (49% of patients had diabetes), nor by renal function down to an estimated glomerular filtration rate at entry as low as 20 mL/min per 1.73 m².

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and Lilly, the two companies that market empagliflozin (Jardiance). Dr. Anker has been a consultant to Boehringer Ingelheim as well as to Abbott Vascular, Bayer, Brahms, Cardiac Dimensions, Cordio, Novartis, Servier, and Vifor. Dr. Walsh and Dr. Yancy had no disclosures.

mzoler@mdedge.com

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.
 

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.
 

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.
 

A high dose of the purified form of eicosapentaenoic acid, icosapent ethyl (Vascepa, Amarin), failed to significantly reduce hospitalizations or death in patients infected with COVID-19 in the PREPARE-IT 2 study.

The study did, however, show a favorable trend, with a 16% reduction in the primary endpoint of death or an indication for hospitalization. All secondary endpoints were also numerically reduced, but none reached statistical significance.

The product was also well tolerated over the 28 days of the study period, even though a new high-loading dose was used, with no increase in atrial fibrillation or bleeding or other adverse events versus placebo, although there was a slightly higher rate of discontinuation.

The trial was presented at the American Heart Association scientific sessions on Nov. 15 by Rafael Díaz, MD, director of Estudios Clínicos Latinoamérica in Rosario, Argentina.

“Larger, randomized trials powered for a relative risk reduction of around 15% with icosapent ethyl are needed to establish whether or not this product may have a role in the management of COVID-positive outpatients,” Dr. Diaz concluded.
 

‘Intriguing signals’

Commenting on the study, Manesh Patel, MD, chief of the division of cardiology and codirector of the Heart Center at Duke University, Durham, N.C., and chair of the Scientific Sessions scientific program, said that: “Certainly there are some intriguing signals.”

“I think the trend is valuable, but do we need a larger trial to confirm a benefit? I will leave that to the clinical community to decide,” Dr. Patel added. “But it is hard to power a trial to get that answer, and the world of COVID has changed since this trial started with vaccines now available and new therapeutics coming. So, there’s going to be a competing landscape.”

Discussing the trial at an AHA news briefing, Erin Michos, MD, associate professor of medicine within the division of cardiology at Johns Hopkins University, Baltimore, said: “Results showed that everything trended in the right direction, but did not reach statistical significance largely because there were fewer events than anticipated. COVID hospitalizations are going down because of the broad adoption of vaccines, which meant that this study didn’t quite meet its endpoint.”

But, she added: “Reassuringly, even with the higher loading dose, there was no increased risk of [atrial fibrillation] when used for just 28 days, and no increased risk in bleeding, so there was very good safety.”

“We need a larger trial to really definitely show whether icosapent ethyl can or cannot help COVID-positive outpatients, but I think a better prevention strategy would be the broad adoption of vaccinations globally,” Dr. Michos concluded.
 

‘A pretty big ask’

Donald Lloyd-Jones, MD, AHA president and designated discussant at the late-breaking science session, congratulated the investigators on conducting “a very nice pragmatic trial in the midst of the COVID pandemic.”

Dr. Lloyd-Jones concluded that the broad range of potentially beneficial actions of icosapent ethyl – including antitriglyceride, anti-inflammatory, antioxidant, and antithrombotic effects – leads to the possibility of it helping in COVID, but he added that “this is a pretty big ask for a fish oil supplement given short term.”

Presenting the study, Dr. Diaz noted that there are limited options for the outpatient treatment of patients with COVID-19 infection, and it is believed that inflammation plays a major role in worsening the severity of the infection.

He pointed out that previous data support a potential role of omega-3 fatty acids in reducing inflammation and infection, and that icosapent ethyl has shown a reduction in major cardiovascular events in the REDUCE-IT trial, with the mechanism thought to involve anti-inflammatory effects.

In the first trial to investigate the role of icosapent ethyl in COVID-19, PREPARE-IT, the product did not prevent uninfected individuals at risk from COVID from becoming infected with the virus, but there was no increase in side effects versus placebo with use over a 60-day period.

A small study last year in 100 COVID-positive patients showed icosapent ethyl reduced C-reactive protein, an inflammatory marker, and also improved symptoms.

PREPARE-IT 2, a pragmatic web-based trial, was conducted to investigate whether icosapent ethyl in nonhospitalized patients with a positive diagnosis of COVID-19 could reduce hospitalization rates and complications.

The trial enrolled 2,052 patients (mean age, 50 years), of whom 1,010 were allocated to the active group and 1,042 to the placebo group. Inclusion criteria included individuals aged 40 years or older with a confirmed COVID-19 diagnosis and no more than 7 days from the onset of symptoms and without a clear indication for hospitalization.

Patients who were allocated to the active arm received icosapent ethyl at a dose of 8 g (four capsules every 12 hours, morning and evening) for the first 3 days, followed by 4 g (two capsules every 12 hours) thereafter (days 4-28).

The primary outcome, COVID-19–related hospitalization (indication for hospitalization or hospitalization) or death at 28 days, occurred in 11.16% of the active group and 13.69% of the placebo group, giving a hazard ratio of 0.84 (95% confidence interval, 0.65-1.08; P = .166)

Secondary outcomes showed similar positive trends, but none were significant. These included: death or still hospitalized at 28 days (HR, 0.74), major events (MI, stroke, death; HR, 0.38), and total mortality (HR, 0.52).

In terms of safety, there was no significant difference in total adverse events between the two groups (16.5% in the active group vs. 14.8% in the placebo group). The most common adverse effects were constipation (2.7%), diarrhea (7.2%), and nausea (4%), but these were not significantly different from placebo. There were, however, more discontinuations in the active group (7% vs. 4%).

Dr. Diaz pointed out that the PREPARE-IT 2 trial was started in May 2020, when there wasn’t much known about the COVID-19 condition, and there were no vaccines or treatments, so hospitalization rates were high.

“We were hoping to see a 25%-30% reduction in hospitalizations with icosapent ethyl, and the trial was powered for that sort of reduction, but today we know we can expect a more modest reduction of about 15%,” Dr. Diaz concluded. “But to show that, we need a much larger trial with 8,000 or 9,000 patients, and that will be much more difficult to conduct.”

The PREPARE-IT 2 study was funded by Amarin. Dr. Diaz has received grants from Dalcor, Amarin, PHRI, and Lepetit.

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

A high dose of the purified form of eicosapentaenoic acid, icosapent ethyl (Vascepa, Amarin), failed to significantly reduce hospitalizations or death in patients infected with COVID-19 in the PREPARE-IT 2 study.

The study did, however, show a favorable trend, with a 16% reduction in the primary endpoint of death or an indication for hospitalization. All secondary endpoints were also numerically reduced, but none reached statistical significance.

The product was also well tolerated over the 28 days of the study period, even though a new high-loading dose was used, with no increase in atrial fibrillation or bleeding or other adverse events versus placebo, although there was a slightly higher rate of discontinuation.

The trial was presented at the American Heart Association scientific sessions on Nov. 15 by Rafael Díaz, MD, director of Estudios Clínicos Latinoamérica in Rosario, Argentina.

“Larger, randomized trials powered for a relative risk reduction of around 15% with icosapent ethyl are needed to establish whether or not this product may have a role in the management of COVID-positive outpatients,” Dr. Diaz concluded.
 

‘Intriguing signals’

Commenting on the study, Manesh Patel, MD, chief of the division of cardiology and codirector of the Heart Center at Duke University, Durham, N.C., and chair of the Scientific Sessions scientific program, said that: “Certainly there are some intriguing signals.”

“I think the trend is valuable, but do we need a larger trial to confirm a benefit? I will leave that to the clinical community to decide,” Dr. Patel added. “But it is hard to power a trial to get that answer, and the world of COVID has changed since this trial started with vaccines now available and new therapeutics coming. So, there’s going to be a competing landscape.”

Discussing the trial at an AHA news briefing, Erin Michos, MD, associate professor of medicine within the division of cardiology at Johns Hopkins University, Baltimore, said: “Results showed that everything trended in the right direction, but did not reach statistical significance largely because there were fewer events than anticipated. COVID hospitalizations are going down because of the broad adoption of vaccines, which meant that this study didn’t quite meet its endpoint.”

But, she added: “Reassuringly, even with the higher loading dose, there was no increased risk of [atrial fibrillation] when used for just 28 days, and no increased risk in bleeding, so there was very good safety.”

“We need a larger trial to really definitely show whether icosapent ethyl can or cannot help COVID-positive outpatients, but I think a better prevention strategy would be the broad adoption of vaccinations globally,” Dr. Michos concluded.
 

‘A pretty big ask’

Donald Lloyd-Jones, MD, AHA president and designated discussant at the late-breaking science session, congratulated the investigators on conducting “a very nice pragmatic trial in the midst of the COVID pandemic.”

Dr. Lloyd-Jones concluded that the broad range of potentially beneficial actions of icosapent ethyl – including antitriglyceride, anti-inflammatory, antioxidant, and antithrombotic effects – leads to the possibility of it helping in COVID, but he added that “this is a pretty big ask for a fish oil supplement given short term.”

Presenting the study, Dr. Diaz noted that there are limited options for the outpatient treatment of patients with COVID-19 infection, and it is believed that inflammation plays a major role in worsening the severity of the infection.

He pointed out that previous data support a potential role of omega-3 fatty acids in reducing inflammation and infection, and that icosapent ethyl has shown a reduction in major cardiovascular events in the REDUCE-IT trial, with the mechanism thought to involve anti-inflammatory effects.

In the first trial to investigate the role of icosapent ethyl in COVID-19, PREPARE-IT, the product did not prevent uninfected individuals at risk from COVID from becoming infected with the virus, but there was no increase in side effects versus placebo with use over a 60-day period.

A small study last year in 100 COVID-positive patients showed icosapent ethyl reduced C-reactive protein, an inflammatory marker, and also improved symptoms.

PREPARE-IT 2, a pragmatic web-based trial, was conducted to investigate whether icosapent ethyl in nonhospitalized patients with a positive diagnosis of COVID-19 could reduce hospitalization rates and complications.

The trial enrolled 2,052 patients (mean age, 50 years), of whom 1,010 were allocated to the active group and 1,042 to the placebo group. Inclusion criteria included individuals aged 40 years or older with a confirmed COVID-19 diagnosis and no more than 7 days from the onset of symptoms and without a clear indication for hospitalization.

Patients who were allocated to the active arm received icosapent ethyl at a dose of 8 g (four capsules every 12 hours, morning and evening) for the first 3 days, followed by 4 g (two capsules every 12 hours) thereafter (days 4-28).

The primary outcome, COVID-19–related hospitalization (indication for hospitalization or hospitalization) or death at 28 days, occurred in 11.16% of the active group and 13.69% of the placebo group, giving a hazard ratio of 0.84 (95% confidence interval, 0.65-1.08; P = .166)

Secondary outcomes showed similar positive trends, but none were significant. These included: death or still hospitalized at 28 days (HR, 0.74), major events (MI, stroke, death; HR, 0.38), and total mortality (HR, 0.52).

In terms of safety, there was no significant difference in total adverse events between the two groups (16.5% in the active group vs. 14.8% in the placebo group). The most common adverse effects were constipation (2.7%), diarrhea (7.2%), and nausea (4%), but these were not significantly different from placebo. There were, however, more discontinuations in the active group (7% vs. 4%).

Dr. Diaz pointed out that the PREPARE-IT 2 trial was started in May 2020, when there wasn’t much known about the COVID-19 condition, and there were no vaccines or treatments, so hospitalization rates were high.

“We were hoping to see a 25%-30% reduction in hospitalizations with icosapent ethyl, and the trial was powered for that sort of reduction, but today we know we can expect a more modest reduction of about 15%,” Dr. Diaz concluded. “But to show that, we need a much larger trial with 8,000 or 9,000 patients, and that will be much more difficult to conduct.”

The PREPARE-IT 2 study was funded by Amarin. Dr. Diaz has received grants from Dalcor, Amarin, PHRI, and Lepetit.

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

A high dose of the purified form of eicosapentaenoic acid, icosapent ethyl (Vascepa, Amarin), failed to significantly reduce hospitalizations or death in patients infected with COVID-19 in the PREPARE-IT 2 study.

The study did, however, show a favorable trend, with a 16% reduction in the primary endpoint of death or an indication for hospitalization. All secondary endpoints were also numerically reduced, but none reached statistical significance.

The product was also well tolerated over the 28 days of the study period, even though a new high-loading dose was used, with no increase in atrial fibrillation or bleeding or other adverse events versus placebo, although there was a slightly higher rate of discontinuation.

The trial was presented at the American Heart Association scientific sessions on Nov. 15 by Rafael Díaz, MD, director of Estudios Clínicos Latinoamérica in Rosario, Argentina.

“Larger, randomized trials powered for a relative risk reduction of around 15% with icosapent ethyl are needed to establish whether or not this product may have a role in the management of COVID-positive outpatients,” Dr. Diaz concluded.
 

‘Intriguing signals’

Commenting on the study, Manesh Patel, MD, chief of the division of cardiology and codirector of the Heart Center at Duke University, Durham, N.C., and chair of the Scientific Sessions scientific program, said that: “Certainly there are some intriguing signals.”

“I think the trend is valuable, but do we need a larger trial to confirm a benefit? I will leave that to the clinical community to decide,” Dr. Patel added. “But it is hard to power a trial to get that answer, and the world of COVID has changed since this trial started with vaccines now available and new therapeutics coming. So, there’s going to be a competing landscape.”

Discussing the trial at an AHA news briefing, Erin Michos, MD, associate professor of medicine within the division of cardiology at Johns Hopkins University, Baltimore, said: “Results showed that everything trended in the right direction, but did not reach statistical significance largely because there were fewer events than anticipated. COVID hospitalizations are going down because of the broad adoption of vaccines, which meant that this study didn’t quite meet its endpoint.”

But, she added: “Reassuringly, even with the higher loading dose, there was no increased risk of [atrial fibrillation] when used for just 28 days, and no increased risk in bleeding, so there was very good safety.”

“We need a larger trial to really definitely show whether icosapent ethyl can or cannot help COVID-positive outpatients, but I think a better prevention strategy would be the broad adoption of vaccinations globally,” Dr. Michos concluded.
 

‘A pretty big ask’

Donald Lloyd-Jones, MD, AHA president and designated discussant at the late-breaking science session, congratulated the investigators on conducting “a very nice pragmatic trial in the midst of the COVID pandemic.”

Dr. Lloyd-Jones concluded that the broad range of potentially beneficial actions of icosapent ethyl – including antitriglyceride, anti-inflammatory, antioxidant, and antithrombotic effects – leads to the possibility of it helping in COVID, but he added that “this is a pretty big ask for a fish oil supplement given short term.”

Presenting the study, Dr. Diaz noted that there are limited options for the outpatient treatment of patients with COVID-19 infection, and it is believed that inflammation plays a major role in worsening the severity of the infection.

He pointed out that previous data support a potential role of omega-3 fatty acids in reducing inflammation and infection, and that icosapent ethyl has shown a reduction in major cardiovascular events in the REDUCE-IT trial, with the mechanism thought to involve anti-inflammatory effects.

In the first trial to investigate the role of icosapent ethyl in COVID-19, PREPARE-IT, the product did not prevent uninfected individuals at risk from COVID from becoming infected with the virus, but there was no increase in side effects versus placebo with use over a 60-day period.

A small study last year in 100 COVID-positive patients showed icosapent ethyl reduced C-reactive protein, an inflammatory marker, and also improved symptoms.

PREPARE-IT 2, a pragmatic web-based trial, was conducted to investigate whether icosapent ethyl in nonhospitalized patients with a positive diagnosis of COVID-19 could reduce hospitalization rates and complications.

The trial enrolled 2,052 patients (mean age, 50 years), of whom 1,010 were allocated to the active group and 1,042 to the placebo group. Inclusion criteria included individuals aged 40 years or older with a confirmed COVID-19 diagnosis and no more than 7 days from the onset of symptoms and without a clear indication for hospitalization.

Patients who were allocated to the active arm received icosapent ethyl at a dose of 8 g (four capsules every 12 hours, morning and evening) for the first 3 days, followed by 4 g (two capsules every 12 hours) thereafter (days 4-28).

The primary outcome, COVID-19–related hospitalization (indication for hospitalization or hospitalization) or death at 28 days, occurred in 11.16% of the active group and 13.69% of the placebo group, giving a hazard ratio of 0.84 (95% confidence interval, 0.65-1.08; P = .166)

Secondary outcomes showed similar positive trends, but none were significant. These included: death or still hospitalized at 28 days (HR, 0.74), major events (MI, stroke, death; HR, 0.38), and total mortality (HR, 0.52).

In terms of safety, there was no significant difference in total adverse events between the two groups (16.5% in the active group vs. 14.8% in the placebo group). The most common adverse effects were constipation (2.7%), diarrhea (7.2%), and nausea (4%), but these were not significantly different from placebo. There were, however, more discontinuations in the active group (7% vs. 4%).

Dr. Diaz pointed out that the PREPARE-IT 2 trial was started in May 2020, when there wasn’t much known about the COVID-19 condition, and there were no vaccines or treatments, so hospitalization rates were high.

“We were hoping to see a 25%-30% reduction in hospitalizations with icosapent ethyl, and the trial was powered for that sort of reduction, but today we know we can expect a more modest reduction of about 15%,” Dr. Diaz concluded. “But to show that, we need a much larger trial with 8,000 or 9,000 patients, and that will be much more difficult to conduct.”

The PREPARE-IT 2 study was funded by Amarin. Dr. Diaz has received grants from Dalcor, Amarin, PHRI, and Lepetit.

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

Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE. 

Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.

When provided at the bedside of patients hospitalized for heart failure, an electronic health record (EHR) alert with prognostic information did not improve outcomes or appear to have any impact on what treatments were offered.

There was no signal that the EHR prognostic alerts, which identified the 12-month risk of mortality, had any impact on any of a variety of clinical-decision-making metrics or on any of the primary or secondary outcomes, according to Tariq Ahmad, MD, who reported results of the randomized REVEAL-HF trial, presented at the American Heart Association scientific sessions.

“These results call into question the hypothesis that accurate prognostic information alone will lead to better clinical decision-making,” said Dr. Ahmad, medical director of the Heart Transplant and Mechanical Circulatory Support Program at Yale University, New Haven, Conn., and principal investigator of REVEAL-HF.

He acknowledged that the possibility that many clinicians pay little or no attention to EHR alert might have played a role in the negative results.

At four participating Yale-affiliated clinical centers, all patients hospitalized for acute heart failure were randomized as long as they were over the age of 18, had an N-terminal pro-brain natriuretic peptide (NT-proBNP) level above 500 pg/mL, and had been placed on IV diuretics within 24 hours of admission. In the experimental arm, the provider at the time of entering orders received an EHR alert with an estimate of the risk of all-cause mortality at 12 months. There was no such alert for patients managed in the control arm.
 

Twelve-month mortality estimates calculated

The all-cause mortality risk was calculated on a sizeable list of variables that included laboratory results, such as cell counts, and patient characteristics, such as weight and age. The risk estimate was displayed along with a five-category color-coded bar to provide context for the risk in the spectrum of very low, low, medium, high, and very high likelihood of death within 12 months.

The 1,590 patients randomized to the experimental arm and the 1,534 patients randomized to the usual care arm did not differ significantly in any baseline characteristics. The median age was about 77 years, the mean left ventricular ejection fraction (LVEF) was 55%. About 29% had an LVEF below 40%, about 40% had chronic kidney disease, and about 30% had chronic obstructive pulmonary disease (COPD).

The composite primary outcome of all-cause mortality or rehospitalization within 12 months was reached by 38.9% and 39.3% (P = 0.82) of the intervention and control arms, respectively. The components of the primary outcome were also nearly identical, as was inpatient mortality (8.4% vs. 8.8%; P = 0.72).

There were no significant differences in any of the secondary outcomes, which included rates of 30-day rehospitalizations, discharge on guideline-recommended heart failure therapies, implantation of a cardioverter defibrillator, use of a left ventricular assist device, or heart transplant.

The proportion of patients referred for palliative care was almost identical in the very low, low, and medium risk groups. In the high (23.4 vs. 15.6; P = 0.19) and very high (50% vs. 40%; P = 0.92) groups, there were numerically more referrals in the group randomized to usual care, but these rates did not reach significance.
 

No differences seen in discharge meds

There was essentially no difference between groups in the rates at which patients were discharged on beta-blockers, renin-angiotensin system inhibitors, sodium-glucose co-transporter type 2 (SGLT2) inhibitors, or mineralocorticoid antagonists.

When prespecified subgroups, such as those older than age 75 years relative to those younger, males relative to females, Black versus White participants, patients with reduced ejection fraction (HFrEF) relative to preserved ejection fraction (HFpEF), and intensive care unit versus non-ICU patients, were compared, there were no indications that the EHR alert improved outcomes.

Invited discussant Harriette G. C. Van Spall, MD, director of digital health and virtual care and associate professor of cardiology at McMaster University, Hamilton, Ont., did not dispute the conclusions, but she pointed out several potential explanations for the neutral result.

Not least, nearly 75% of those enrolled had low risk or very low risk for adverse outcomes within 1 year, so the opportunity to show a reduction in events, including all-cause mortality, was limited.

“This was largely a HFpEF population, for which there are no treatments for which a risk score would change therapy,” she said.
 

EHR alert efficacy questioned

There is considerable evidence that risk prediction tools “are common but underutilized in HF,” Dr. Van Spall added. She noted that many clinicians find alerts in the EHR more annoying than informative, and it remains unknown what proportion of clinicians pay attention to them, particularly in the absence of evidence that they lead to meaningful improvements in care over their own clinical judgment.

Dr. Ahmad agreed.

“I think that we need to study these alerts in a clinical trial format,” he said. Acknowledging that alerts have been poorly received by many clinicians, Dr. Ahmad said that trials to validate the impact of any specific alert are needed to improve their credibility. If a positive impact cannot be shown, he said the alert should be eliminated, leaving only the alerts with proven clinical value.

Dr. Ahmad reported financial relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Cytokinetics, Novartis, and Relypsa. Dr. Van Spall reports no potential conflicts of interest.

When provided at the bedside of patients hospitalized for heart failure, an electronic health record (EHR) alert with prognostic information did not improve outcomes or appear to have any impact on what treatments were offered.

There was no signal that the EHR prognostic alerts, which identified the 12-month risk of mortality, had any impact on any of a variety of clinical-decision-making metrics or on any of the primary or secondary outcomes, according to Tariq Ahmad, MD, who reported results of the randomized REVEAL-HF trial, presented at the American Heart Association scientific sessions.

“These results call into question the hypothesis that accurate prognostic information alone will lead to better clinical decision-making,” said Dr. Ahmad, medical director of the Heart Transplant and Mechanical Circulatory Support Program at Yale University, New Haven, Conn., and principal investigator of REVEAL-HF.

He acknowledged that the possibility that many clinicians pay little or no attention to EHR alert might have played a role in the negative results.

At four participating Yale-affiliated clinical centers, all patients hospitalized for acute heart failure were randomized as long as they were over the age of 18, had an N-terminal pro-brain natriuretic peptide (NT-proBNP) level above 500 pg/mL, and had been placed on IV diuretics within 24 hours of admission. In the experimental arm, the provider at the time of entering orders received an EHR alert with an estimate of the risk of all-cause mortality at 12 months. There was no such alert for patients managed in the control arm.
 

Twelve-month mortality estimates calculated

The all-cause mortality risk was calculated on a sizeable list of variables that included laboratory results, such as cell counts, and patient characteristics, such as weight and age. The risk estimate was displayed along with a five-category color-coded bar to provide context for the risk in the spectrum of very low, low, medium, high, and very high likelihood of death within 12 months.

The 1,590 patients randomized to the experimental arm and the 1,534 patients randomized to the usual care arm did not differ significantly in any baseline characteristics. The median age was about 77 years, the mean left ventricular ejection fraction (LVEF) was 55%. About 29% had an LVEF below 40%, about 40% had chronic kidney disease, and about 30% had chronic obstructive pulmonary disease (COPD).

The composite primary outcome of all-cause mortality or rehospitalization within 12 months was reached by 38.9% and 39.3% (P = 0.82) of the intervention and control arms, respectively. The components of the primary outcome were also nearly identical, as was inpatient mortality (8.4% vs. 8.8%; P = 0.72).

There were no significant differences in any of the secondary outcomes, which included rates of 30-day rehospitalizations, discharge on guideline-recommended heart failure therapies, implantation of a cardioverter defibrillator, use of a left ventricular assist device, or heart transplant.

The proportion of patients referred for palliative care was almost identical in the very low, low, and medium risk groups. In the high (23.4 vs. 15.6; P = 0.19) and very high (50% vs. 40%; P = 0.92) groups, there were numerically more referrals in the group randomized to usual care, but these rates did not reach significance.
 

No differences seen in discharge meds

There was essentially no difference between groups in the rates at which patients were discharged on beta-blockers, renin-angiotensin system inhibitors, sodium-glucose co-transporter type 2 (SGLT2) inhibitors, or mineralocorticoid antagonists.

When prespecified subgroups, such as those older than age 75 years relative to those younger, males relative to females, Black versus White participants, patients with reduced ejection fraction (HFrEF) relative to preserved ejection fraction (HFpEF), and intensive care unit versus non-ICU patients, were compared, there were no indications that the EHR alert improved outcomes.

Invited discussant Harriette G. C. Van Spall, MD, director of digital health and virtual care and associate professor of cardiology at McMaster University, Hamilton, Ont., did not dispute the conclusions, but she pointed out several potential explanations for the neutral result.

Not least, nearly 75% of those enrolled had low risk or very low risk for adverse outcomes within 1 year, so the opportunity to show a reduction in events, including all-cause mortality, was limited.

“This was largely a HFpEF population, for which there are no treatments for which a risk score would change therapy,” she said.
 

EHR alert efficacy questioned

There is considerable evidence that risk prediction tools “are common but underutilized in HF,” Dr. Van Spall added. She noted that many clinicians find alerts in the EHR more annoying than informative, and it remains unknown what proportion of clinicians pay attention to them, particularly in the absence of evidence that they lead to meaningful improvements in care over their own clinical judgment.

Dr. Ahmad agreed.

“I think that we need to study these alerts in a clinical trial format,” he said. Acknowledging that alerts have been poorly received by many clinicians, Dr. Ahmad said that trials to validate the impact of any specific alert are needed to improve their credibility. If a positive impact cannot be shown, he said the alert should be eliminated, leaving only the alerts with proven clinical value.

Dr. Ahmad reported financial relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Cytokinetics, Novartis, and Relypsa. Dr. Van Spall reports no potential conflicts of interest.

When provided at the bedside of patients hospitalized for heart failure, an electronic health record (EHR) alert with prognostic information did not improve outcomes or appear to have any impact on what treatments were offered.

There was no signal that the EHR prognostic alerts, which identified the 12-month risk of mortality, had any impact on any of a variety of clinical-decision-making metrics or on any of the primary or secondary outcomes, according to Tariq Ahmad, MD, who reported results of the randomized REVEAL-HF trial, presented at the American Heart Association scientific sessions.

“These results call into question the hypothesis that accurate prognostic information alone will lead to better clinical decision-making,” said Dr. Ahmad, medical director of the Heart Transplant and Mechanical Circulatory Support Program at Yale University, New Haven, Conn., and principal investigator of REVEAL-HF.

He acknowledged that the possibility that many clinicians pay little or no attention to EHR alert might have played a role in the negative results.

At four participating Yale-affiliated clinical centers, all patients hospitalized for acute heart failure were randomized as long as they were over the age of 18, had an N-terminal pro-brain natriuretic peptide (NT-proBNP) level above 500 pg/mL, and had been placed on IV diuretics within 24 hours of admission. In the experimental arm, the provider at the time of entering orders received an EHR alert with an estimate of the risk of all-cause mortality at 12 months. There was no such alert for patients managed in the control arm.
 

Twelve-month mortality estimates calculated

The all-cause mortality risk was calculated on a sizeable list of variables that included laboratory results, such as cell counts, and patient characteristics, such as weight and age. The risk estimate was displayed along with a five-category color-coded bar to provide context for the risk in the spectrum of very low, low, medium, high, and very high likelihood of death within 12 months.

The 1,590 patients randomized to the experimental arm and the 1,534 patients randomized to the usual care arm did not differ significantly in any baseline characteristics. The median age was about 77 years, the mean left ventricular ejection fraction (LVEF) was 55%. About 29% had an LVEF below 40%, about 40% had chronic kidney disease, and about 30% had chronic obstructive pulmonary disease (COPD).

The composite primary outcome of all-cause mortality or rehospitalization within 12 months was reached by 38.9% and 39.3% (P = 0.82) of the intervention and control arms, respectively. The components of the primary outcome were also nearly identical, as was inpatient mortality (8.4% vs. 8.8%; P = 0.72).

There were no significant differences in any of the secondary outcomes, which included rates of 30-day rehospitalizations, discharge on guideline-recommended heart failure therapies, implantation of a cardioverter defibrillator, use of a left ventricular assist device, or heart transplant.

The proportion of patients referred for palliative care was almost identical in the very low, low, and medium risk groups. In the high (23.4 vs. 15.6; P = 0.19) and very high (50% vs. 40%; P = 0.92) groups, there were numerically more referrals in the group randomized to usual care, but these rates did not reach significance.
 

No differences seen in discharge meds

There was essentially no difference between groups in the rates at which patients were discharged on beta-blockers, renin-angiotensin system inhibitors, sodium-glucose co-transporter type 2 (SGLT2) inhibitors, or mineralocorticoid antagonists.

When prespecified subgroups, such as those older than age 75 years relative to those younger, males relative to females, Black versus White participants, patients with reduced ejection fraction (HFrEF) relative to preserved ejection fraction (HFpEF), and intensive care unit versus non-ICU patients, were compared, there were no indications that the EHR alert improved outcomes.

Invited discussant Harriette G. C. Van Spall, MD, director of digital health and virtual care and associate professor of cardiology at McMaster University, Hamilton, Ont., did not dispute the conclusions, but she pointed out several potential explanations for the neutral result.

Not least, nearly 75% of those enrolled had low risk or very low risk for adverse outcomes within 1 year, so the opportunity to show a reduction in events, including all-cause mortality, was limited.

“This was largely a HFpEF population, for which there are no treatments for which a risk score would change therapy,” she said.
 

EHR alert efficacy questioned

There is considerable evidence that risk prediction tools “are common but underutilized in HF,” Dr. Van Spall added. She noted that many clinicians find alerts in the EHR more annoying than informative, and it remains unknown what proportion of clinicians pay attention to them, particularly in the absence of evidence that they lead to meaningful improvements in care over their own clinical judgment.

Dr. Ahmad agreed.

“I think that we need to study these alerts in a clinical trial format,” he said. Acknowledging that alerts have been poorly received by many clinicians, Dr. Ahmad said that trials to validate the impact of any specific alert are needed to improve their credibility. If a positive impact cannot be shown, he said the alert should be eliminated, leaving only the alerts with proven clinical value.

Dr. Ahmad reported financial relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Cytokinetics, Novartis, and Relypsa. Dr. Van Spall reports no potential conflicts of interest.

Background: Although troponin is the preferred biomarker to indicate acute myocardial infarction, little is known about the implications of elevated troponin in the absence of plaque rupture.

Dr. Bhasin is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.

Background: Although troponin is the preferred biomarker to indicate acute myocardial infarction, little is known about the implications of elevated troponin in the absence of plaque rupture.

Dr. Bhasin is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.

Background: Although troponin is the preferred biomarker to indicate acute myocardial infarction, little is known about the implications of elevated troponin in the absence of plaque rupture.

Dr. Bhasin is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.

The proportion of hypertensive patients with blood pressure control fell substantially in the United States during the COVID-19 pandemic, if the data from 24 health systems is representative of national trends.

GlobalStock/Getty Images

The decline in blood pressure control corresponded with – and might be explained by – a parallel decline in follow-up visits for uncontrolled hypertension from the same data source, according to Alanna M. Chamberlain, PhD, associate professor of epidemiology in the division of quantitative health sciences, Mayo Clinic, Rochester, Minn.

If the data are representative, a wave of cardiovascular (CV) events might be coming.

The study, called BP Track, collated electronic medical data on almost 1.8 million patients with hypertension from 2017 through 2020. Up until the end of 2019 and prior to the pandemic, slightly less than 60% of these patients had blood pressure control, defined as less than 140/90 mm Hg.

While the pre-COVID control rates were already “suboptimal,” a decline began almost immediately when the full force of the COVID-19 pandemic began in March of 2020, said Dr. Chamberlain in reporting the BP Track results at the American Heart Association scientific sessions.

When graphed from the start of the pandemic until the end of 2020, the proportion under control fell 7.2% to a level just above 50%. For the more rigorous target of less than 130/80 mm Hg, the proportion fell 4.6% over the same period of time, leaving only about 25% at that level of control.

Repeat visits for BP control rebounded

The proportion of patients with a repeat office visit within 4 weeks of a diagnosis of uncontrolled hypertension fell even more steeply, reaching a nadir at about the middle of 2020, but it was followed by a partial recovery. The rate was 5% lower by the end of 2020, relative to the prepandemic rate (31.7% vs. 36.7%), but that was 5% higher than the nadir.

A similar phenomenon was observed with several other metrics. For example, there was a steep, immediate fall correlating with the onset of the pandemic in the proportion of patients who achieved at least a 10–mm Hg reduction or a BP under 140/90 mm Hg when treated for hypertension. Again, the nadir in this proportion was reached in about mid-2020 followed by a partial recovery. By the end of 2020, 5.9% fewer patients were achieving 10–mm Hg or better improvement in BP control when treated relative to the prepandemic level (23.8% vs. 29.7%), but this level was almost 10% higher than the nadir.

Data based on electronic medical records

The nearly 1.8 million patient records evaluated in the BP Track study were drawn from the 24 centers participating in the PCORnet Blood Pressure Control Laboratory Surveillance System. Nationally distributed, 18 of the 24 systems were academically affiliated.

When stratified by race, the proportion of Asians meeting the definition of BP control prior to the pandemic was about 5% higher than the overall average, and the proportion in Blacks was more than 5% lower. Whites had rates of blood pressure control very near the average. The relative declines in BP and the proportion of patients with uncontrolled blood pressure who had a repeat visit within 4 weeks during the pandemic were generally parallel across racial groups.

The implications of these data and the role of the COVID-19 pandemic on blood pressure control are “concerning,” according to Adam Bress, PharmD, department of population health sciences, University of Utah, Salt Lake City.

Citing a study published in 2020 that suggested blood pressure control rates in the United States were already declining before the COVID-19 pandemic, he said the COVID-19 epidemic appears to be exacerbating an existing problem. He expressed particular concern for populations who already have low rates of control, such as African Americans.

“The impact of COVID-19 is likely to be disproportionately greater for underserved and minoritized patients,” said Dr. Bress, who was the lead author of a recent article on this specific topic.

The implication of BP Track is that a wave of cardiovascular events will be coming if the data are nationally representative.

“A recent meta-analysis shows that each 5–mm Hg reduction in blood pressure is associated with age-related reductions in CV events,” Dr. Bress said. For those 55 years of age or older, he said the risk reduction is about 10%. Given that the inverse is almost certainly true, he expects diminishing blood pressure control, whether COVID-19-related or not, to translate into increased CV events.

However, there is no guarantee that the BP Track data are representative of the U.S. population, cautioned Eugene Yang, MD, professor in the division of cardiology, University of Washington, Seattle. Even though a large group of patients was included, they were largely drawn from academic centers.

Nevertheless, Dr. Yang, who chairs the Hypertension Working Group of the American College of Cardiology’s Prevention of Cardiovascular Disease Council, acknowledged that the implications are “scary.”

If the data are representative, “this type of reduction in blood pressure control would be expected to have a significant impact on morbidity and mortality, but we also have to think of all the variables that were not tracked and might add to risk,” he said. He named such risk factors as weight gain, diminished exercise, and increased alcohol consumption, which have been cited by others as being exacerbated by the pandemic.

If these lead to more cardiovascular events on a population basis, the timing of these events would be expected to be age dependent.

“If you look at the patients included in this study, about 50% were 65 years of age or older. In a population like this you would expect to see an increase in events sooner rather than later,” said Dr. Wang.

In other words, if the trial is representative, a wave of cardiovascular events might be seen in the most vulnerable patients “within the next few years,” Dr. Yang speculated.

Dr. Chamberlain reports a research grant from EpidStrategies. Dr. Bress and Dr. Yang report no potential financial conflicts of interest.

The proportion of hypertensive patients with blood pressure control fell substantially in the United States during the COVID-19 pandemic, if the data from 24 health systems is representative of national trends.

GlobalStock/Getty Images

The decline in blood pressure control corresponded with – and might be explained by – a parallel decline in follow-up visits for uncontrolled hypertension from the same data source, according to Alanna M. Chamberlain, PhD, associate professor of epidemiology in the division of quantitative health sciences, Mayo Clinic, Rochester, Minn.

If the data are representative, a wave of cardiovascular (CV) events might be coming.

The study, called BP Track, collated electronic medical data on almost 1.8 million patients with hypertension from 2017 through 2020. Up until the end of 2019 and prior to the pandemic, slightly less than 60% of these patients had blood pressure control, defined as less than 140/90 mm Hg.

While the pre-COVID control rates were already “suboptimal,” a decline began almost immediately when the full force of the COVID-19 pandemic began in March of 2020, said Dr. Chamberlain in reporting the BP Track results at the American Heart Association scientific sessions.

When graphed from the start of the pandemic until the end of 2020, the proportion under control fell 7.2% to a level just above 50%. For the more rigorous target of less than 130/80 mm Hg, the proportion fell 4.6% over the same period of time, leaving only about 25% at that level of control.

Repeat visits for BP control rebounded

The proportion of patients with a repeat office visit within 4 weeks of a diagnosis of uncontrolled hypertension fell even more steeply, reaching a nadir at about the middle of 2020, but it was followed by a partial recovery. The rate was 5% lower by the end of 2020, relative to the prepandemic rate (31.7% vs. 36.7%), but that was 5% higher than the nadir.

A similar phenomenon was observed with several other metrics. For example, there was a steep, immediate fall correlating with the onset of the pandemic in the proportion of patients who achieved at least a 10–mm Hg reduction or a BP under 140/90 mm Hg when treated for hypertension. Again, the nadir in this proportion was reached in about mid-2020 followed by a partial recovery. By the end of 2020, 5.9% fewer patients were achieving 10–mm Hg or better improvement in BP control when treated relative to the prepandemic level (23.8% vs. 29.7%), but this level was almost 10% higher than the nadir.

Data based on electronic medical records

The nearly 1.8 million patient records evaluated in the BP Track study were drawn from the 24 centers participating in the PCORnet Blood Pressure Control Laboratory Surveillance System. Nationally distributed, 18 of the 24 systems were academically affiliated.

When stratified by race, the proportion of Asians meeting the definition of BP control prior to the pandemic was about 5% higher than the overall average, and the proportion in Blacks was more than 5% lower. Whites had rates of blood pressure control very near the average. The relative declines in BP and the proportion of patients with uncontrolled blood pressure who had a repeat visit within 4 weeks during the pandemic were generally parallel across racial groups.

The implications of these data and the role of the COVID-19 pandemic on blood pressure control are “concerning,” according to Adam Bress, PharmD, department of population health sciences, University of Utah, Salt Lake City.

Citing a study published in 2020 that suggested blood pressure control rates in the United States were already declining before the COVID-19 pandemic, he said the COVID-19 epidemic appears to be exacerbating an existing problem. He expressed particular concern for populations who already have low rates of control, such as African Americans.

“The impact of COVID-19 is likely to be disproportionately greater for underserved and minoritized patients,” said Dr. Bress, who was the lead author of a recent article on this specific topic.

The implication of BP Track is that a wave of cardiovascular events will be coming if the data are nationally representative.

“A recent meta-analysis shows that each 5–mm Hg reduction in blood pressure is associated with age-related reductions in CV events,” Dr. Bress said. For those 55 years of age or older, he said the risk reduction is about 10%. Given that the inverse is almost certainly true, he expects diminishing blood pressure control, whether COVID-19-related or not, to translate into increased CV events.

However, there is no guarantee that the BP Track data are representative of the U.S. population, cautioned Eugene Yang, MD, professor in the division of cardiology, University of Washington, Seattle. Even though a large group of patients was included, they were largely drawn from academic centers.

Nevertheless, Dr. Yang, who chairs the Hypertension Working Group of the American College of Cardiology’s Prevention of Cardiovascular Disease Council, acknowledged that the implications are “scary.”

If the data are representative, “this type of reduction in blood pressure control would be expected to have a significant impact on morbidity and mortality, but we also have to think of all the variables that were not tracked and might add to risk,” he said. He named such risk factors as weight gain, diminished exercise, and increased alcohol consumption, which have been cited by others as being exacerbated by the pandemic.

If these lead to more cardiovascular events on a population basis, the timing of these events would be expected to be age dependent.

“If you look at the patients included in this study, about 50% were 65 years of age or older. In a population like this you would expect to see an increase in events sooner rather than later,” said Dr. Wang.

In other words, if the trial is representative, a wave of cardiovascular events might be seen in the most vulnerable patients “within the next few years,” Dr. Yang speculated.

Dr. Chamberlain reports a research grant from EpidStrategies. Dr. Bress and Dr. Yang report no potential financial conflicts of interest.

The proportion of hypertensive patients with blood pressure control fell substantially in the United States during the COVID-19 pandemic, if the data from 24 health systems is representative of national trends.

GlobalStock/Getty Images

The decline in blood pressure control corresponded with – and might be explained by – a parallel decline in follow-up visits for uncontrolled hypertension from the same data source, according to Alanna M. Chamberlain, PhD, associate professor of epidemiology in the division of quantitative health sciences, Mayo Clinic, Rochester, Minn.

If the data are representative, a wave of cardiovascular (CV) events might be coming.

The study, called BP Track, collated electronic medical data on almost 1.8 million patients with hypertension from 2017 through 2020. Up until the end of 2019 and prior to the pandemic, slightly less than 60% of these patients had blood pressure control, defined as less than 140/90 mm Hg.

While the pre-COVID control rates were already “suboptimal,” a decline began almost immediately when the full force of the COVID-19 pandemic began in March of 2020, said Dr. Chamberlain in reporting the BP Track results at the American Heart Association scientific sessions.

When graphed from the start of the pandemic until the end of 2020, the proportion under control fell 7.2% to a level just above 50%. For the more rigorous target of less than 130/80 mm Hg, the proportion fell 4.6% over the same period of time, leaving only about 25% at that level of control.

Repeat visits for BP control rebounded

The proportion of patients with a repeat office visit within 4 weeks of a diagnosis of uncontrolled hypertension fell even more steeply, reaching a nadir at about the middle of 2020, but it was followed by a partial recovery. The rate was 5% lower by the end of 2020, relative to the prepandemic rate (31.7% vs. 36.7%), but that was 5% higher than the nadir.

A similar phenomenon was observed with several other metrics. For example, there was a steep, immediate fall correlating with the onset of the pandemic in the proportion of patients who achieved at least a 10–mm Hg reduction or a BP under 140/90 mm Hg when treated for hypertension. Again, the nadir in this proportion was reached in about mid-2020 followed by a partial recovery. By the end of 2020, 5.9% fewer patients were achieving 10–mm Hg or better improvement in BP control when treated relative to the prepandemic level (23.8% vs. 29.7%), but this level was almost 10% higher than the nadir.

Data based on electronic medical records

The nearly 1.8 million patient records evaluated in the BP Track study were drawn from the 24 centers participating in the PCORnet Blood Pressure Control Laboratory Surveillance System. Nationally distributed, 18 of the 24 systems were academically affiliated.

When stratified by race, the proportion of Asians meeting the definition of BP control prior to the pandemic was about 5% higher than the overall average, and the proportion in Blacks was more than 5% lower. Whites had rates of blood pressure control very near the average. The relative declines in BP and the proportion of patients with uncontrolled blood pressure who had a repeat visit within 4 weeks during the pandemic were generally parallel across racial groups.

The implications of these data and the role of the COVID-19 pandemic on blood pressure control are “concerning,” according to Adam Bress, PharmD, department of population health sciences, University of Utah, Salt Lake City.

Citing a study published in 2020 that suggested blood pressure control rates in the United States were already declining before the COVID-19 pandemic, he said the COVID-19 epidemic appears to be exacerbating an existing problem. He expressed particular concern for populations who already have low rates of control, such as African Americans.

“The impact of COVID-19 is likely to be disproportionately greater for underserved and minoritized patients,” said Dr. Bress, who was the lead author of a recent article on this specific topic.

The implication of BP Track is that a wave of cardiovascular events will be coming if the data are nationally representative.

“A recent meta-analysis shows that each 5–mm Hg reduction in blood pressure is associated with age-related reductions in CV events,” Dr. Bress said. For those 55 years of age or older, he said the risk reduction is about 10%. Given that the inverse is almost certainly true, he expects diminishing blood pressure control, whether COVID-19-related or not, to translate into increased CV events.

However, there is no guarantee that the BP Track data are representative of the U.S. population, cautioned Eugene Yang, MD, professor in the division of cardiology, University of Washington, Seattle. Even though a large group of patients was included, they were largely drawn from academic centers.

Nevertheless, Dr. Yang, who chairs the Hypertension Working Group of the American College of Cardiology’s Prevention of Cardiovascular Disease Council, acknowledged that the implications are “scary.”

If the data are representative, “this type of reduction in blood pressure control would be expected to have a significant impact on morbidity and mortality, but we also have to think of all the variables that were not tracked and might add to risk,” he said. He named such risk factors as weight gain, diminished exercise, and increased alcohol consumption, which have been cited by others as being exacerbated by the pandemic.

If these lead to more cardiovascular events on a population basis, the timing of these events would be expected to be age dependent.

“If you look at the patients included in this study, about 50% were 65 years of age or older. In a population like this you would expect to see an increase in events sooner rather than later,” said Dr. Wang.

In other words, if the trial is representative, a wave of cardiovascular events might be seen in the most vulnerable patients “within the next few years,” Dr. Yang speculated.

Dr. Chamberlain reports a research grant from EpidStrategies. Dr. Bress and Dr. Yang report no potential financial conflicts of interest.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.