Aspirin alone after transcatheter aortic valve implantation (TAVI) significantly reduced bleeding, compared with aspirin plus clopidogrel, without increasing thromboembolic events, in the latest results from the POPular TAVI study.

“Physicians can easily and safely reduce rate of bleeding by omitting clopidogrel after TAVI,” lead author, Jorn Brouwer, MD, St Antonius Hospital, Nieuwegein, the Netherlands, said.

“Aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulants and have not recently undergone coronary stenting,” he concluded.

Senior author, Jurriën ten Berg, MD, PhD, also from St Antonius Hospital, said in an interview: “I think we can say for TAVI patients, when it comes to antithrombotic therapy, less is definitely more.”

“This is a major change to clinical practice, with current guidelines recommending 3-6 months of dual antiplatelet therapy after a TAVI procedure,” he added. “We expected that these guidelines will change after our results.”

These latest results from POPular TAVI were presented at the virtual European Society of Cardiology Congress 2020 and simultaneously published online in The New England Journal of Medicine.

The trial was conducted in two cohorts of patients undergoing TAVI. The results from cohort B – in patients who were already taking an anticoagulant for another indication – were reported earlier this year and showed no benefit of adding clopidogrel and an increase in bleeding. Now the current results in cohort A – patients undergoing TAVI who do not have an established indication for long-term anticoagulation – show similar results, with aspirin alone preferred over aspirin plus clopidogrel.

Dr. ten Berg explained that the recommendation for dual antiplatelet therapy (DAPT) was adopted mainly because this has been shown to be beneficial in patients undergoing percutaneous coronary intervention (PCI) with stenting; it was thought the same benefits would be seen in TAVI, which also uses a stent-based delivery system.

“However, TAVI patients are a different population – they are generally much older than PCI patients, with an average age of 80 plus, and they have many more comorbidities, so they are much higher bleeding risk,” Dr. ten Berg explained. “In addition, the catheters used for TAVI are larger than those used for PCI, forcing the femoral route to be employed, and both of these factors increases bleeding risk.”

“We saw that, in the trial, patients on dual antiplatelet therapy had a much greater rate of major bleeding and the addition of clopidogrel did not reduce the risk of major thrombotic events,” such as stroke, myocardial infarction (MI), or cardiovascular (CV) death.

Given that the TAVI procedure is associated with an increase in stroke in the immediate few days after the procedure, it would seem logical that increased antiplatelet therapy would be beneficial in reducing this, Dr. ten Berg noted.

“But this is not what we are seeing,” he said. “The stroke incidence was similar in the two groups in POPular TAVI. This suggests that the strokes may not be platelet mediated. They might be caused by another mechanism, such as dislodgement of calcium from the valve or tissue from the aorta.”

For the current part of the study, 690 patients who were undergoing TAVI and did not have an indication for long-term anticoagulation were randomly assigned to receive aspirin alone or aspirin plus clopidogrel for 3 months.

The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non–procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as not procedure related.

Results showed that a bleeding event occurred in 15.1% of patients receiving aspirin alone and 26.6% of those receiving aspirin plus clopidogrel (risk ratio, 0.57; P = .001). Non–procedure-related bleeding occurred 15.1% of patients receiving aspirin alone vs 24.9% of those receiving aspirin plus clopidogrel (risk ratio, 0.61; P = .005). Major, life-threatening, or disabling bleeding occurred in 5.1% of the aspirin-alone group versus 10.8% of those in the aspirin plus clopidogrel group.

Two secondary outcomes included thromboembolic events. The secondary composite one endpoint of death from cardiovascular causes, non–procedure-related bleeding, stroke, or MI at 1 year occurred in 23.0% of those receiving aspirin alone and in 31.1% of those receiving aspirin plus clopidogrel (difference, −8.2 percentage points; P for noninferiority < .001; risk ratio, 0.74; P for superiority = .04).

The secondary composite two endpoint of death from cardiovascular causes, ischemic stroke, or MI at 1 year occurred in 9.7% of the aspirin-alone group versus 9.9% of the dual-antiplatelet group (difference, −0.2 percentage points; P for noninferiority = .004; risk ratio, 0.98; P for superiority = .93).

Dr. ten Berg pointed out that the trial was not strictly powered to look at thrombotic events, but he added: “There was no hint of an increase in the aspirin-alone group and there was quite a high event rate, so we should have seen something if it was there.”

The group has also performed a meta-analysis of these results, with some previous smaller studies also comparing aspirin and DAPT in TAVI which again showed no reduction in thrombotic events with dual-antiplatelet therapy.

Dr. ten Berg noted that the trial included all-comer TAVI patients. “The overall risk was quite a low [STS score, 2.5]. This is a reflection of the typical TAVI patient we are seeing but I would say our results apply to patients of all risk.”
 

Simplifies and clarifies

Discussant of the trial at the ESC Hotline session, Anna Sonia Petronio, MD, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, said, “This was an excellent and essential study that simplifies and clarifies aspects of TAVI treatment and needs to change the guidelines.”

“These results will have a large impact on clinical practice in this elderly population,” she said. But she added that more data are needed for younger patients and more complicated cases, such as valve-in-valve and bicuspid valves.

Commenting on the results, Robert Bonow, MD, Northwestern University, Chicago, said, “The optimal antithrombotic management of patients undergoing TAVI who do not otherwise have an indication for anticoagulation [such as atrial fibrillation] has been uncertain and debatable. Aspirin plus clopidogrel for 3-6 months has been the standard, based on the experience with coronary stents.”

“Thus, the current results of cohort A of the POPular TAVI trial showing significant reduction in bleeding events with aspirin alone compared to DAPT for 3 months, with no difference in ischemic events, are important observations,” he said. “It is noteworthy that most of the bleeding events occurred in the first 30 days.

“This is a relatively small randomized trial, so whether these results will be practice changing will depend on confirmation by additional studies, but it is reassuring to know that patients at higher risk for bleeding would appear to do well with low-dose aspirin alone after TAVI,” Dr. Bonow added.

“These results complete the circle in terms of antithrombotic therapy after TAVI,” commented Michael Reardon, MD, Houston Methodist DeBakey Heart & Vascular Institute, Texas.

“I would add two caveats: First is that most of the difference in the primary endpoint occurs in the first month and levels out between the groups after that,” Dr. Reardon said. “Second is that this does not address the issue of leaflet thickening and immobility.”

Ashish Pershad, MD, Banner – University Medicine Heart Institute, Phoenix, added: “This trial answers a very important question and shows dual-antiplatelet therapy is hazardous in TAVI patients. Clopidogrel is not needed.”

Dr. Pershad says he still wonders about patients who receive very small valves who may have a higher risk for valve-induced thrombosis. “While there were some of these patients in the trial, the numbers were small, so we need more data on this group,” he commented.

“But for bread-and-butter TAVI, aspirin alone is the best choice, and the previous results showed, for patients already taking oral anticoagulation, no additional antithrombotic therapy is required,” Dr. Pershad concluded. “This is a big deal and will change the way we treat patients.”

 The POPular trial was supported by the Netherlands Organization for Health Research and Development. Brouwer reports no disclosures.
 

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

Aspirin alone after transcatheter aortic valve implantation (TAVI) significantly reduced bleeding, compared with aspirin plus clopidogrel, without increasing thromboembolic events, in the latest results from the POPular TAVI study.

“Physicians can easily and safely reduce rate of bleeding by omitting clopidogrel after TAVI,” lead author, Jorn Brouwer, MD, St Antonius Hospital, Nieuwegein, the Netherlands, said.

“Aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulants and have not recently undergone coronary stenting,” he concluded.

Senior author, Jurriën ten Berg, MD, PhD, also from St Antonius Hospital, said in an interview: “I think we can say for TAVI patients, when it comes to antithrombotic therapy, less is definitely more.”

“This is a major change to clinical practice, with current guidelines recommending 3-6 months of dual antiplatelet therapy after a TAVI procedure,” he added. “We expected that these guidelines will change after our results.”

These latest results from POPular TAVI were presented at the virtual European Society of Cardiology Congress 2020 and simultaneously published online in The New England Journal of Medicine.

The trial was conducted in two cohorts of patients undergoing TAVI. The results from cohort B – in patients who were already taking an anticoagulant for another indication – were reported earlier this year and showed no benefit of adding clopidogrel and an increase in bleeding. Now the current results in cohort A – patients undergoing TAVI who do not have an established indication for long-term anticoagulation – show similar results, with aspirin alone preferred over aspirin plus clopidogrel.

Dr. ten Berg explained that the recommendation for dual antiplatelet therapy (DAPT) was adopted mainly because this has been shown to be beneficial in patients undergoing percutaneous coronary intervention (PCI) with stenting; it was thought the same benefits would be seen in TAVI, which also uses a stent-based delivery system.

“However, TAVI patients are a different population – they are generally much older than PCI patients, with an average age of 80 plus, and they have many more comorbidities, so they are much higher bleeding risk,” Dr. ten Berg explained. “In addition, the catheters used for TAVI are larger than those used for PCI, forcing the femoral route to be employed, and both of these factors increases bleeding risk.”

“We saw that, in the trial, patients on dual antiplatelet therapy had a much greater rate of major bleeding and the addition of clopidogrel did not reduce the risk of major thrombotic events,” such as stroke, myocardial infarction (MI), or cardiovascular (CV) death.

Given that the TAVI procedure is associated with an increase in stroke in the immediate few days after the procedure, it would seem logical that increased antiplatelet therapy would be beneficial in reducing this, Dr. ten Berg noted.

“But this is not what we are seeing,” he said. “The stroke incidence was similar in the two groups in POPular TAVI. This suggests that the strokes may not be platelet mediated. They might be caused by another mechanism, such as dislodgement of calcium from the valve or tissue from the aorta.”

For the current part of the study, 690 patients who were undergoing TAVI and did not have an indication for long-term anticoagulation were randomly assigned to receive aspirin alone or aspirin plus clopidogrel for 3 months.

The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non–procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as not procedure related.

Results showed that a bleeding event occurred in 15.1% of patients receiving aspirin alone and 26.6% of those receiving aspirin plus clopidogrel (risk ratio, 0.57; P = .001). Non–procedure-related bleeding occurred 15.1% of patients receiving aspirin alone vs 24.9% of those receiving aspirin plus clopidogrel (risk ratio, 0.61; P = .005). Major, life-threatening, or disabling bleeding occurred in 5.1% of the aspirin-alone group versus 10.8% of those in the aspirin plus clopidogrel group.

Two secondary outcomes included thromboembolic events. The secondary composite one endpoint of death from cardiovascular causes, non–procedure-related bleeding, stroke, or MI at 1 year occurred in 23.0% of those receiving aspirin alone and in 31.1% of those receiving aspirin plus clopidogrel (difference, −8.2 percentage points; P for noninferiority < .001; risk ratio, 0.74; P for superiority = .04).

The secondary composite two endpoint of death from cardiovascular causes, ischemic stroke, or MI at 1 year occurred in 9.7% of the aspirin-alone group versus 9.9% of the dual-antiplatelet group (difference, −0.2 percentage points; P for noninferiority = .004; risk ratio, 0.98; P for superiority = .93).

Dr. ten Berg pointed out that the trial was not strictly powered to look at thrombotic events, but he added: “There was no hint of an increase in the aspirin-alone group and there was quite a high event rate, so we should have seen something if it was there.”

The group has also performed a meta-analysis of these results, with some previous smaller studies also comparing aspirin and DAPT in TAVI which again showed no reduction in thrombotic events with dual-antiplatelet therapy.

Dr. ten Berg noted that the trial included all-comer TAVI patients. “The overall risk was quite a low [STS score, 2.5]. This is a reflection of the typical TAVI patient we are seeing but I would say our results apply to patients of all risk.”
 

Simplifies and clarifies

Discussant of the trial at the ESC Hotline session, Anna Sonia Petronio, MD, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, said, “This was an excellent and essential study that simplifies and clarifies aspects of TAVI treatment and needs to change the guidelines.”

“These results will have a large impact on clinical practice in this elderly population,” she said. But she added that more data are needed for younger patients and more complicated cases, such as valve-in-valve and bicuspid valves.

Commenting on the results, Robert Bonow, MD, Northwestern University, Chicago, said, “The optimal antithrombotic management of patients undergoing TAVI who do not otherwise have an indication for anticoagulation [such as atrial fibrillation] has been uncertain and debatable. Aspirin plus clopidogrel for 3-6 months has been the standard, based on the experience with coronary stents.”

“Thus, the current results of cohort A of the POPular TAVI trial showing significant reduction in bleeding events with aspirin alone compared to DAPT for 3 months, with no difference in ischemic events, are important observations,” he said. “It is noteworthy that most of the bleeding events occurred in the first 30 days.

“This is a relatively small randomized trial, so whether these results will be practice changing will depend on confirmation by additional studies, but it is reassuring to know that patients at higher risk for bleeding would appear to do well with low-dose aspirin alone after TAVI,” Dr. Bonow added.

“These results complete the circle in terms of antithrombotic therapy after TAVI,” commented Michael Reardon, MD, Houston Methodist DeBakey Heart & Vascular Institute, Texas.

“I would add two caveats: First is that most of the difference in the primary endpoint occurs in the first month and levels out between the groups after that,” Dr. Reardon said. “Second is that this does not address the issue of leaflet thickening and immobility.”

Ashish Pershad, MD, Banner – University Medicine Heart Institute, Phoenix, added: “This trial answers a very important question and shows dual-antiplatelet therapy is hazardous in TAVI patients. Clopidogrel is not needed.”

Dr. Pershad says he still wonders about patients who receive very small valves who may have a higher risk for valve-induced thrombosis. “While there were some of these patients in the trial, the numbers were small, so we need more data on this group,” he commented.

“But for bread-and-butter TAVI, aspirin alone is the best choice, and the previous results showed, for patients already taking oral anticoagulation, no additional antithrombotic therapy is required,” Dr. Pershad concluded. “This is a big deal and will change the way we treat patients.”

 The POPular trial was supported by the Netherlands Organization for Health Research and Development. Brouwer reports no disclosures.
 

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

Aspirin alone after transcatheter aortic valve implantation (TAVI) significantly reduced bleeding, compared with aspirin plus clopidogrel, without increasing thromboembolic events, in the latest results from the POPular TAVI study.

“Physicians can easily and safely reduce rate of bleeding by omitting clopidogrel after TAVI,” lead author, Jorn Brouwer, MD, St Antonius Hospital, Nieuwegein, the Netherlands, said.

“Aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulants and have not recently undergone coronary stenting,” he concluded.

Senior author, Jurriën ten Berg, MD, PhD, also from St Antonius Hospital, said in an interview: “I think we can say for TAVI patients, when it comes to antithrombotic therapy, less is definitely more.”

“This is a major change to clinical practice, with current guidelines recommending 3-6 months of dual antiplatelet therapy after a TAVI procedure,” he added. “We expected that these guidelines will change after our results.”

These latest results from POPular TAVI were presented at the virtual European Society of Cardiology Congress 2020 and simultaneously published online in The New England Journal of Medicine.

The trial was conducted in two cohorts of patients undergoing TAVI. The results from cohort B – in patients who were already taking an anticoagulant for another indication – were reported earlier this year and showed no benefit of adding clopidogrel and an increase in bleeding. Now the current results in cohort A – patients undergoing TAVI who do not have an established indication for long-term anticoagulation – show similar results, with aspirin alone preferred over aspirin plus clopidogrel.

Dr. ten Berg explained that the recommendation for dual antiplatelet therapy (DAPT) was adopted mainly because this has been shown to be beneficial in patients undergoing percutaneous coronary intervention (PCI) with stenting; it was thought the same benefits would be seen in TAVI, which also uses a stent-based delivery system.

“However, TAVI patients are a different population – they are generally much older than PCI patients, with an average age of 80 plus, and they have many more comorbidities, so they are much higher bleeding risk,” Dr. ten Berg explained. “In addition, the catheters used for TAVI are larger than those used for PCI, forcing the femoral route to be employed, and both of these factors increases bleeding risk.”

“We saw that, in the trial, patients on dual antiplatelet therapy had a much greater rate of major bleeding and the addition of clopidogrel did not reduce the risk of major thrombotic events,” such as stroke, myocardial infarction (MI), or cardiovascular (CV) death.

Given that the TAVI procedure is associated with an increase in stroke in the immediate few days after the procedure, it would seem logical that increased antiplatelet therapy would be beneficial in reducing this, Dr. ten Berg noted.

“But this is not what we are seeing,” he said. “The stroke incidence was similar in the two groups in POPular TAVI. This suggests that the strokes may not be platelet mediated. They might be caused by another mechanism, such as dislodgement of calcium from the valve or tissue from the aorta.”

For the current part of the study, 690 patients who were undergoing TAVI and did not have an indication for long-term anticoagulation were randomly assigned to receive aspirin alone or aspirin plus clopidogrel for 3 months.

The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non–procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as not procedure related.

Results showed that a bleeding event occurred in 15.1% of patients receiving aspirin alone and 26.6% of those receiving aspirin plus clopidogrel (risk ratio, 0.57; P = .001). Non–procedure-related bleeding occurred 15.1% of patients receiving aspirin alone vs 24.9% of those receiving aspirin plus clopidogrel (risk ratio, 0.61; P = .005). Major, life-threatening, or disabling bleeding occurred in 5.1% of the aspirin-alone group versus 10.8% of those in the aspirin plus clopidogrel group.

Two secondary outcomes included thromboembolic events. The secondary composite one endpoint of death from cardiovascular causes, non–procedure-related bleeding, stroke, or MI at 1 year occurred in 23.0% of those receiving aspirin alone and in 31.1% of those receiving aspirin plus clopidogrel (difference, −8.2 percentage points; P for noninferiority < .001; risk ratio, 0.74; P for superiority = .04).

The secondary composite two endpoint of death from cardiovascular causes, ischemic stroke, or MI at 1 year occurred in 9.7% of the aspirin-alone group versus 9.9% of the dual-antiplatelet group (difference, −0.2 percentage points; P for noninferiority = .004; risk ratio, 0.98; P for superiority = .93).

Dr. ten Berg pointed out that the trial was not strictly powered to look at thrombotic events, but he added: “There was no hint of an increase in the aspirin-alone group and there was quite a high event rate, so we should have seen something if it was there.”

The group has also performed a meta-analysis of these results, with some previous smaller studies also comparing aspirin and DAPT in TAVI which again showed no reduction in thrombotic events with dual-antiplatelet therapy.

Dr. ten Berg noted that the trial included all-comer TAVI patients. “The overall risk was quite a low [STS score, 2.5]. This is a reflection of the typical TAVI patient we are seeing but I would say our results apply to patients of all risk.”
 

Simplifies and clarifies

Discussant of the trial at the ESC Hotline session, Anna Sonia Petronio, MD, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, said, “This was an excellent and essential study that simplifies and clarifies aspects of TAVI treatment and needs to change the guidelines.”

“These results will have a large impact on clinical practice in this elderly population,” she said. But she added that more data are needed for younger patients and more complicated cases, such as valve-in-valve and bicuspid valves.

Commenting on the results, Robert Bonow, MD, Northwestern University, Chicago, said, “The optimal antithrombotic management of patients undergoing TAVI who do not otherwise have an indication for anticoagulation [such as atrial fibrillation] has been uncertain and debatable. Aspirin plus clopidogrel for 3-6 months has been the standard, based on the experience with coronary stents.”

“Thus, the current results of cohort A of the POPular TAVI trial showing significant reduction in bleeding events with aspirin alone compared to DAPT for 3 months, with no difference in ischemic events, are important observations,” he said. “It is noteworthy that most of the bleeding events occurred in the first 30 days.

“This is a relatively small randomized trial, so whether these results will be practice changing will depend on confirmation by additional studies, but it is reassuring to know that patients at higher risk for bleeding would appear to do well with low-dose aspirin alone after TAVI,” Dr. Bonow added.

“These results complete the circle in terms of antithrombotic therapy after TAVI,” commented Michael Reardon, MD, Houston Methodist DeBakey Heart & Vascular Institute, Texas.

“I would add two caveats: First is that most of the difference in the primary endpoint occurs in the first month and levels out between the groups after that,” Dr. Reardon said. “Second is that this does not address the issue of leaflet thickening and immobility.”

Ashish Pershad, MD, Banner – University Medicine Heart Institute, Phoenix, added: “This trial answers a very important question and shows dual-antiplatelet therapy is hazardous in TAVI patients. Clopidogrel is not needed.”

Dr. Pershad says he still wonders about patients who receive very small valves who may have a higher risk for valve-induced thrombosis. “While there were some of these patients in the trial, the numbers were small, so we need more data on this group,” he commented.

“But for bread-and-butter TAVI, aspirin alone is the best choice, and the previous results showed, for patients already taking oral anticoagulation, no additional antithrombotic therapy is required,” Dr. Pershad concluded. “This is a big deal and will change the way we treat patients.”

 The POPular trial was supported by the Netherlands Organization for Health Research and Development. Brouwer reports no disclosures.
 

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

The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.

Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.

This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
 

Results plant drug class firmly as HFrEF treatment

Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.

The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.

In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.

“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.

Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.

Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.

Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
 

EMPEROR-Reduced outcomes

The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.

The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.

The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).

The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m² among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m² in the placebo patients.

Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.

“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.

The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.

EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
 

[email protected]

SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.

The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.

Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.

This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
 

Results plant drug class firmly as HFrEF treatment

Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.

The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.

In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.

“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.

Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.

Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.

Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
 

EMPEROR-Reduced outcomes

The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.

The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.

The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).

The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m² among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m² in the placebo patients.

Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.

“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.

The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.

EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
 

[email protected]

SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.

The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.

Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.

This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
 

Results plant drug class firmly as HFrEF treatment

Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.

The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.

In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.

“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.

Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.

Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.

Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
 

EMPEROR-Reduced outcomes

The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.

The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.

The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).

The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m² among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m² in the placebo patients.

Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.

“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.

The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.

EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
 

[email protected]

SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.

Initiation of rhythm control with antiarrhythmic drugs and/or ablation in patients with early, recently diagnosed atrial fibrillation (AFib) led to a significantly lower risk of major adverse cardiovascular outcomes, compared with a rate-control strategy, during more than 5 years of follow-up in the large randomized EAST-AFNET 4 trial, Paulus Kirchhof, MD, said at the virtual annual congress of the European Society of Cardiology.

Previous trials of rate versus rhythm control in AFib, such as AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management), failed to show an advantage for rhythm over rate control in terms of clinical outcomes. Why was EAST-AFNET 4 different? Dr. Kirchhof offered two major reasons: The study incorporated AFib ablation as an option in the rhythm control strategy, and treatment started soon after diagnosis of the arrhythmia. Indeed, nearly 40% of patients had their first-ever AFib episode at the time of randomization, and the median time from diagnosis to randomization was just 36 days.

“Once you are in AFib for a few months, the atrium suffers severe damage, some of it irreversible, so it becomes more difficult to restore and maintain sinus rhythm when you wait longer,” explained Dr. Kirchhof, director of the department of cardiology at the University Heart and Vascular Center in Hamburg (Ger.) and professor of cardiovascular medicine at the University of Birmingham, England.

Also, epidemiologic studies show that the risk of cardiovascular complications is heightened in the first year following diagnosis of AFib. “So there’s a window of opportunity to prevent complications,” he added.

The impetus for conducting EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial ) was straightforward, according to the cardiologist: “The question of whether rhythm control is beneficial or not has been in the field for several decades. Most people, like me, always believed that maintaining sinus rhythm would help, but we didn’t have the data to show it.”
 

Early rhythm control shows sustained benefits

EAST-AFNET 4 was a prospective, open, blinded-outcome-assessement trial. It included 2,789 patients with early AFib and an average CHA₂DS₂-VASc score of 3.4 who were randomized at 135 sites in 11 European countries to early rhythm control or guideline-recommended rate control. At a median 5.1 years of follow-up, the primary outcome – a composite of cardiovascular death, stroke, acute coronary syndrome, or hospitalization for worsening heart failure – occurred at a pace of 3.9% per year in the rhythm control group and 5% per year with rate control. This translated to a statistically significant and clinically meaningful 21% relative risk reduction favoring early rhythm control.

The 28% reduction in cardiovascular death with rhythm control was statistically significant, as was the 35% reduction in stroke. However, the 19% reduction in heart failure hospitalizations and 17% decrease in hospitalizations for acute coronary syndrome were not.

The co–primary endpoint – the mean number of nights spent in the hospital per year, which served as a proxy for the cost of treatment to a health care system – didn’t differ between the two treatment arms, at roughly 5 nights per year.

The clinical benefit of early rhythm control was consistent across all 19 prespecified patient subgroups, including those who were asymptomatic and patients with or without heart failure.

Serious adverse events related to rhythm control therapy – most often drug-related bradycardia – occurred in 4.9% of patients over the course of 5.1 years, compared to a 1.4% serious event rate in patients assigned to rate control. Dr. Kirchhof called the roughly 1% per year serious event rate in the rhythm control group quite acceptable.

“To put that in perspective, the annualized rate of severe bleeds on oral anticoagulation – a very beneficial therapy used by more than 90% of participants at 2 years – is about 2%,” the cardiologist noted.

Only 8% of patients randomized to rhythm control received AFib ablation as initial therapy, consistent with current clinical practice. By 2 years, 19.4% of the rhythm control group had undergone AFib ablation. Also at that time, 15% of the rate control group was receiving rhythm control therapy to help manage AFib-related symptoms.

One of the big surprises in the study, he said, was that nearly three-quarters of patients in both groups were asymptomatic at 2 years.

“I think that shows how well we control symptoms, even without rhythm control,” he observed.
 

Results ‘move the field forward’

Dr. Kirchhof stressed that this was a trial of two different treatment strategies, and it’s not yet possible to single out any specific component of the rhythm control strategy as being responsible for the improved outcomes.

“I cannot tell you whether the outcome difference was due to AFib ablation or early treatment or the fact that we’re now better at using antiarrhythmic drugs than we were 20 years ago,” he said.

Asked if the EAST-AFNET 4 findings warrant more aggressive screening for AFib in order to detect and intervene early in the arrhythmia, Dr. Kirchhof replied with an unambiguous yes.

“My conclusion is that every patient with newly diagnosed AFib and a CHA₂DS₂-VASc score of 2 or more should not only receive anticoagulation and rate control, but should also be offered rhythm control therapy at the time of diagnosis, which also means that all of these people have to be seen by a cardiologist who has expertise in the domain of AFib management. It’s a big clinical challenge, but it leads to a 21% improvement in outcomes, and I think we have to do what’s best for our patients,” he said.

In an interview, Kalyanam Shivkumar, MD, PhD, called EAST-AFNET 4 “a very important study.”

“It moves the field forward, for sure. I think it will change clinical practice, and it should,” commented Dr. Shivkumar, who was not involved in the study.

“Now there are so many wearable technologies out there – the Apple Watch and others – which will enable rhythm abnormalities to be detected early on. This bodes well for the field,” said Dr. Shivkumar, who is editor-in-chief of JACC: Clinical Electrophysiology. He is also professor of medicine, radiology, and bioengineering at the University of California, Los Angeles, and director of the UCLA Cardiac Arrhythmia Center.

Dr. Kirchhof reported receiving research grants to conduct the EAST-AFNET 4 trial from the German Ministry of Education and Research, the German Center for Cardiovascular Research, the Atrial Fibrillation Network, the European Heart Rhythm Association, St. Jude Medical, Abbott, Sanofi, the German Heart Foundation, the European Union, the British Heart Foundation, and the Leducq Foundation.

Simultaneous with his presentation at ESC Congress 2020, the study results were published online at NEJM.org.
 

[email protected]

SOURCE: Kirchhof P. ESC Congress 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2019422.

Initiation of rhythm control with antiarrhythmic drugs and/or ablation in patients with early, recently diagnosed atrial fibrillation (AFib) led to a significantly lower risk of major adverse cardiovascular outcomes, compared with a rate-control strategy, during more than 5 years of follow-up in the large randomized EAST-AFNET 4 trial, Paulus Kirchhof, MD, said at the virtual annual congress of the European Society of Cardiology.

Previous trials of rate versus rhythm control in AFib, such as AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management), failed to show an advantage for rhythm over rate control in terms of clinical outcomes. Why was EAST-AFNET 4 different? Dr. Kirchhof offered two major reasons: The study incorporated AFib ablation as an option in the rhythm control strategy, and treatment started soon after diagnosis of the arrhythmia. Indeed, nearly 40% of patients had their first-ever AFib episode at the time of randomization, and the median time from diagnosis to randomization was just 36 days.

“Once you are in AFib for a few months, the atrium suffers severe damage, some of it irreversible, so it becomes more difficult to restore and maintain sinus rhythm when you wait longer,” explained Dr. Kirchhof, director of the department of cardiology at the University Heart and Vascular Center in Hamburg (Ger.) and professor of cardiovascular medicine at the University of Birmingham, England.

Also, epidemiologic studies show that the risk of cardiovascular complications is heightened in the first year following diagnosis of AFib. “So there’s a window of opportunity to prevent complications,” he added.

The impetus for conducting EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial ) was straightforward, according to the cardiologist: “The question of whether rhythm control is beneficial or not has been in the field for several decades. Most people, like me, always believed that maintaining sinus rhythm would help, but we didn’t have the data to show it.”
 

Early rhythm control shows sustained benefits

EAST-AFNET 4 was a prospective, open, blinded-outcome-assessement trial. It included 2,789 patients with early AFib and an average CHA₂DS₂-VASc score of 3.4 who were randomized at 135 sites in 11 European countries to early rhythm control or guideline-recommended rate control. At a median 5.1 years of follow-up, the primary outcome – a composite of cardiovascular death, stroke, acute coronary syndrome, or hospitalization for worsening heart failure – occurred at a pace of 3.9% per year in the rhythm control group and 5% per year with rate control. This translated to a statistically significant and clinically meaningful 21% relative risk reduction favoring early rhythm control.

The 28% reduction in cardiovascular death with rhythm control was statistically significant, as was the 35% reduction in stroke. However, the 19% reduction in heart failure hospitalizations and 17% decrease in hospitalizations for acute coronary syndrome were not.

The co–primary endpoint – the mean number of nights spent in the hospital per year, which served as a proxy for the cost of treatment to a health care system – didn’t differ between the two treatment arms, at roughly 5 nights per year.

The clinical benefit of early rhythm control was consistent across all 19 prespecified patient subgroups, including those who were asymptomatic and patients with or without heart failure.

Serious adverse events related to rhythm control therapy – most often drug-related bradycardia – occurred in 4.9% of patients over the course of 5.1 years, compared to a 1.4% serious event rate in patients assigned to rate control. Dr. Kirchhof called the roughly 1% per year serious event rate in the rhythm control group quite acceptable.

“To put that in perspective, the annualized rate of severe bleeds on oral anticoagulation – a very beneficial therapy used by more than 90% of participants at 2 years – is about 2%,” the cardiologist noted.

Only 8% of patients randomized to rhythm control received AFib ablation as initial therapy, consistent with current clinical practice. By 2 years, 19.4% of the rhythm control group had undergone AFib ablation. Also at that time, 15% of the rate control group was receiving rhythm control therapy to help manage AFib-related symptoms.

One of the big surprises in the study, he said, was that nearly three-quarters of patients in both groups were asymptomatic at 2 years.

“I think that shows how well we control symptoms, even without rhythm control,” he observed.
 

Results ‘move the field forward’

Dr. Kirchhof stressed that this was a trial of two different treatment strategies, and it’s not yet possible to single out any specific component of the rhythm control strategy as being responsible for the improved outcomes.

“I cannot tell you whether the outcome difference was due to AFib ablation or early treatment or the fact that we’re now better at using antiarrhythmic drugs than we were 20 years ago,” he said.

Asked if the EAST-AFNET 4 findings warrant more aggressive screening for AFib in order to detect and intervene early in the arrhythmia, Dr. Kirchhof replied with an unambiguous yes.

“My conclusion is that every patient with newly diagnosed AFib and a CHA₂DS₂-VASc score of 2 or more should not only receive anticoagulation and rate control, but should also be offered rhythm control therapy at the time of diagnosis, which also means that all of these people have to be seen by a cardiologist who has expertise in the domain of AFib management. It’s a big clinical challenge, but it leads to a 21% improvement in outcomes, and I think we have to do what’s best for our patients,” he said.

In an interview, Kalyanam Shivkumar, MD, PhD, called EAST-AFNET 4 “a very important study.”

“It moves the field forward, for sure. I think it will change clinical practice, and it should,” commented Dr. Shivkumar, who was not involved in the study.

“Now there are so many wearable technologies out there – the Apple Watch and others – which will enable rhythm abnormalities to be detected early on. This bodes well for the field,” said Dr. Shivkumar, who is editor-in-chief of JACC: Clinical Electrophysiology. He is also professor of medicine, radiology, and bioengineering at the University of California, Los Angeles, and director of the UCLA Cardiac Arrhythmia Center.

Dr. Kirchhof reported receiving research grants to conduct the EAST-AFNET 4 trial from the German Ministry of Education and Research, the German Center for Cardiovascular Research, the Atrial Fibrillation Network, the European Heart Rhythm Association, St. Jude Medical, Abbott, Sanofi, the German Heart Foundation, the European Union, the British Heart Foundation, and the Leducq Foundation.

Simultaneous with his presentation at ESC Congress 2020, the study results were published online at NEJM.org.
 

[email protected]

SOURCE: Kirchhof P. ESC Congress 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2019422.

Initiation of rhythm control with antiarrhythmic drugs and/or ablation in patients with early, recently diagnosed atrial fibrillation (AFib) led to a significantly lower risk of major adverse cardiovascular outcomes, compared with a rate-control strategy, during more than 5 years of follow-up in the large randomized EAST-AFNET 4 trial, Paulus Kirchhof, MD, said at the virtual annual congress of the European Society of Cardiology.

Previous trials of rate versus rhythm control in AFib, such as AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management), failed to show an advantage for rhythm over rate control in terms of clinical outcomes. Why was EAST-AFNET 4 different? Dr. Kirchhof offered two major reasons: The study incorporated AFib ablation as an option in the rhythm control strategy, and treatment started soon after diagnosis of the arrhythmia. Indeed, nearly 40% of patients had their first-ever AFib episode at the time of randomization, and the median time from diagnosis to randomization was just 36 days.

“Once you are in AFib for a few months, the atrium suffers severe damage, some of it irreversible, so it becomes more difficult to restore and maintain sinus rhythm when you wait longer,” explained Dr. Kirchhof, director of the department of cardiology at the University Heart and Vascular Center in Hamburg (Ger.) and professor of cardiovascular medicine at the University of Birmingham, England.

Also, epidemiologic studies show that the risk of cardiovascular complications is heightened in the first year following diagnosis of AFib. “So there’s a window of opportunity to prevent complications,” he added.

The impetus for conducting EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial ) was straightforward, according to the cardiologist: “The question of whether rhythm control is beneficial or not has been in the field for several decades. Most people, like me, always believed that maintaining sinus rhythm would help, but we didn’t have the data to show it.”
 

Early rhythm control shows sustained benefits

EAST-AFNET 4 was a prospective, open, blinded-outcome-assessement trial. It included 2,789 patients with early AFib and an average CHA₂DS₂-VASc score of 3.4 who were randomized at 135 sites in 11 European countries to early rhythm control or guideline-recommended rate control. At a median 5.1 years of follow-up, the primary outcome – a composite of cardiovascular death, stroke, acute coronary syndrome, or hospitalization for worsening heart failure – occurred at a pace of 3.9% per year in the rhythm control group and 5% per year with rate control. This translated to a statistically significant and clinically meaningful 21% relative risk reduction favoring early rhythm control.

The 28% reduction in cardiovascular death with rhythm control was statistically significant, as was the 35% reduction in stroke. However, the 19% reduction in heart failure hospitalizations and 17% decrease in hospitalizations for acute coronary syndrome were not.

The co–primary endpoint – the mean number of nights spent in the hospital per year, which served as a proxy for the cost of treatment to a health care system – didn’t differ between the two treatment arms, at roughly 5 nights per year.

The clinical benefit of early rhythm control was consistent across all 19 prespecified patient subgroups, including those who were asymptomatic and patients with or without heart failure.

Serious adverse events related to rhythm control therapy – most often drug-related bradycardia – occurred in 4.9% of patients over the course of 5.1 years, compared to a 1.4% serious event rate in patients assigned to rate control. Dr. Kirchhof called the roughly 1% per year serious event rate in the rhythm control group quite acceptable.

“To put that in perspective, the annualized rate of severe bleeds on oral anticoagulation – a very beneficial therapy used by more than 90% of participants at 2 years – is about 2%,” the cardiologist noted.

Only 8% of patients randomized to rhythm control received AFib ablation as initial therapy, consistent with current clinical practice. By 2 years, 19.4% of the rhythm control group had undergone AFib ablation. Also at that time, 15% of the rate control group was receiving rhythm control therapy to help manage AFib-related symptoms.

One of the big surprises in the study, he said, was that nearly three-quarters of patients in both groups were asymptomatic at 2 years.

“I think that shows how well we control symptoms, even without rhythm control,” he observed.
 

Results ‘move the field forward’

Dr. Kirchhof stressed that this was a trial of two different treatment strategies, and it’s not yet possible to single out any specific component of the rhythm control strategy as being responsible for the improved outcomes.

“I cannot tell you whether the outcome difference was due to AFib ablation or early treatment or the fact that we’re now better at using antiarrhythmic drugs than we were 20 years ago,” he said.

Asked if the EAST-AFNET 4 findings warrant more aggressive screening for AFib in order to detect and intervene early in the arrhythmia, Dr. Kirchhof replied with an unambiguous yes.

“My conclusion is that every patient with newly diagnosed AFib and a CHA₂DS₂-VASc score of 2 or more should not only receive anticoagulation and rate control, but should also be offered rhythm control therapy at the time of diagnosis, which also means that all of these people have to be seen by a cardiologist who has expertise in the domain of AFib management. It’s a big clinical challenge, but it leads to a 21% improvement in outcomes, and I think we have to do what’s best for our patients,” he said.

In an interview, Kalyanam Shivkumar, MD, PhD, called EAST-AFNET 4 “a very important study.”

“It moves the field forward, for sure. I think it will change clinical practice, and it should,” commented Dr. Shivkumar, who was not involved in the study.

“Now there are so many wearable technologies out there – the Apple Watch and others – which will enable rhythm abnormalities to be detected early on. This bodes well for the field,” said Dr. Shivkumar, who is editor-in-chief of JACC: Clinical Electrophysiology. He is also professor of medicine, radiology, and bioengineering at the University of California, Los Angeles, and director of the UCLA Cardiac Arrhythmia Center.

Dr. Kirchhof reported receiving research grants to conduct the EAST-AFNET 4 trial from the German Ministry of Education and Research, the German Center for Cardiovascular Research, the Atrial Fibrillation Network, the European Heart Rhythm Association, St. Jude Medical, Abbott, Sanofi, the German Heart Foundation, the European Union, the British Heart Foundation, and the Leducq Foundation.

Simultaneous with his presentation at ESC Congress 2020, the study results were published online at NEJM.org.
 

[email protected]

SOURCE: Kirchhof P. ESC Congress 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2019422.

Children with medical complexity account for 30% of pediatric hospitalizations and half of all pediatric hospital costs.¹ They frequently experience long lengths of stay (LOS), which are associated with hospital-acquired infections, high costs, and family stress.

In this issue of the Journal of Hospital Medicine, Steuart and colleagues investigate one opportunity to decrease LOS in a subset of children with medical complexity by studying the impact of discharge before patients’ return to their respiratory baseline status.² They examined 632 hospitalizations in children with neurologic impairment who required increased respiratory support for acute respiratory infections. After adjustment for demographic characteristics, clinical complexity, and acute illness severity, there was no difference in the risk of 30-day hospital reutilization (ie, emergency department revisits and readmissions) when comparing the 30% of children discharged before returning to their respiratory baseline with the 70% discharged at baseline (reutilization rates of 32.8% and 31.8%, respectively).

Twenty-six percent required readmission. This rate is four times that reported for children overall, and higher than the rate for children with the top 10 chronic conditions (range, 6%-21%).³ It also exceeds the median 30-day risk-standardized readmission rates for adult conditions targeted by the Centers for Medicare & Medicaid Services (range, 12%-22%).⁴ The high readmission rate demonstrates the vulnerability of this population and their need for support in hospital-to-home transitions.

These results suggest important areas for future research. First, the findings need to be replicated by multicenter studies to better understand their generalizability. Second, we need more information about the respiratory support required at discharge, which was not captured in this study. For example, clinicians and families may be more comfortable with discharge for a patient who needs slightly higher levels of their baseline support rather than a new modality of respiratory support. Third, we need to better understand the home context of patients discharged before return to respiratory baseline. Lack of home nursing, in particular, has been associated with discharge delays and prolonged LOS in this population.

This study prompts reconsideration of discharge criteria for acute respiratory infections, which often include return to respiratory baseline. Discharge before respiratory baseline for healthy children with bronchiolitis who were discharged on home supplemental oxygen has been associated with shorter hospitalizations and lower costs without differences in reutilization.⁵ Steuart and colleagues demonstrate the potential of this approach in children with neurologic impairment. One key question remains: Which children are most appropriate for discharge before return to respiratory baseline? Family engagement in discussions of goals of hospitalization, self-efficacy, and discharge readiness are important.⁶ These conversations provide context that informs discharge decisions. If the patient is stable and both the medical team and family are comfortable with discharge before respiratory baseline, there may be opportunities to engage in shared decision-making around discharge criteria.

The vulnerability of this population, evidenced by their high rates of readmission, reinforces the importance of family engagement, understanding these children’s diverse needs, and further research to identify effective interventions to support safe transitions from hospital to home.

Children with medical complexity account for 30% of pediatric hospitalizations and half of all pediatric hospital costs.¹ They frequently experience long lengths of stay (LOS), which are associated with hospital-acquired infections, high costs, and family stress.

In this issue of the Journal of Hospital Medicine, Steuart and colleagues investigate one opportunity to decrease LOS in a subset of children with medical complexity by studying the impact of discharge before patients’ return to their respiratory baseline status.² They examined 632 hospitalizations in children with neurologic impairment who required increased respiratory support for acute respiratory infections. After adjustment for demographic characteristics, clinical complexity, and acute illness severity, there was no difference in the risk of 30-day hospital reutilization (ie, emergency department revisits and readmissions) when comparing the 30% of children discharged before returning to their respiratory baseline with the 70% discharged at baseline (reutilization rates of 32.8% and 31.8%, respectively).

Twenty-six percent required readmission. This rate is four times that reported for children overall, and higher than the rate for children with the top 10 chronic conditions (range, 6%-21%).³ It also exceeds the median 30-day risk-standardized readmission rates for adult conditions targeted by the Centers for Medicare & Medicaid Services (range, 12%-22%).⁴ The high readmission rate demonstrates the vulnerability of this population and their need for support in hospital-to-home transitions.

These results suggest important areas for future research. First, the findings need to be replicated by multicenter studies to better understand their generalizability. Second, we need more information about the respiratory support required at discharge, which was not captured in this study. For example, clinicians and families may be more comfortable with discharge for a patient who needs slightly higher levels of their baseline support rather than a new modality of respiratory support. Third, we need to better understand the home context of patients discharged before return to respiratory baseline. Lack of home nursing, in particular, has been associated with discharge delays and prolonged LOS in this population.

This study prompts reconsideration of discharge criteria for acute respiratory infections, which often include return to respiratory baseline. Discharge before respiratory baseline for healthy children with bronchiolitis who were discharged on home supplemental oxygen has been associated with shorter hospitalizations and lower costs without differences in reutilization.⁵ Steuart and colleagues demonstrate the potential of this approach in children with neurologic impairment. One key question remains: Which children are most appropriate for discharge before return to respiratory baseline? Family engagement in discussions of goals of hospitalization, self-efficacy, and discharge readiness are important.⁶ These conversations provide context that informs discharge decisions. If the patient is stable and both the medical team and family are comfortable with discharge before respiratory baseline, there may be opportunities to engage in shared decision-making around discharge criteria.

The vulnerability of this population, evidenced by their high rates of readmission, reinforces the importance of family engagement, understanding these children’s diverse needs, and further research to identify effective interventions to support safe transitions from hospital to home.

Children with medical complexity account for 30% of pediatric hospitalizations and half of all pediatric hospital costs.¹ They frequently experience long lengths of stay (LOS), which are associated with hospital-acquired infections, high costs, and family stress.

In this issue of the Journal of Hospital Medicine, Steuart and colleagues investigate one opportunity to decrease LOS in a subset of children with medical complexity by studying the impact of discharge before patients’ return to their respiratory baseline status.² They examined 632 hospitalizations in children with neurologic impairment who required increased respiratory support for acute respiratory infections. After adjustment for demographic characteristics, clinical complexity, and acute illness severity, there was no difference in the risk of 30-day hospital reutilization (ie, emergency department revisits and readmissions) when comparing the 30% of children discharged before returning to their respiratory baseline with the 70% discharged at baseline (reutilization rates of 32.8% and 31.8%, respectively).

Twenty-six percent required readmission. This rate is four times that reported for children overall, and higher than the rate for children with the top 10 chronic conditions (range, 6%-21%).³ It also exceeds the median 30-day risk-standardized readmission rates for adult conditions targeted by the Centers for Medicare & Medicaid Services (range, 12%-22%).⁴ The high readmission rate demonstrates the vulnerability of this population and their need for support in hospital-to-home transitions.

These results suggest important areas for future research. First, the findings need to be replicated by multicenter studies to better understand their generalizability. Second, we need more information about the respiratory support required at discharge, which was not captured in this study. For example, clinicians and families may be more comfortable with discharge for a patient who needs slightly higher levels of their baseline support rather than a new modality of respiratory support. Third, we need to better understand the home context of patients discharged before return to respiratory baseline. Lack of home nursing, in particular, has been associated with discharge delays and prolonged LOS in this population.

This study prompts reconsideration of discharge criteria for acute respiratory infections, which often include return to respiratory baseline. Discharge before respiratory baseline for healthy children with bronchiolitis who were discharged on home supplemental oxygen has been associated with shorter hospitalizations and lower costs without differences in reutilization.⁵ Steuart and colleagues demonstrate the potential of this approach in children with neurologic impairment. One key question remains: Which children are most appropriate for discharge before return to respiratory baseline? Family engagement in discussions of goals of hospitalization, self-efficacy, and discharge readiness are important.⁶ These conversations provide context that informs discharge decisions. If the patient is stable and both the medical team and family are comfortable with discharge before respiratory baseline, there may be opportunities to engage in shared decision-making around discharge criteria.

The vulnerability of this population, evidenced by their high rates of readmission, reinforces the importance of family engagement, understanding these children’s diverse needs, and further research to identify effective interventions to support safe transitions from hospital to home.

Despite concerted national efforts to decrease pediatric readmissions, recent data suggest that preventable and all-cause readmission rates of hospitalized children remain unchanged.¹ Because some readmissions may be caused by inadequate postdischarge follow-up, nurse (RN) home visits offer the prospect of addressing unresolved clinical issues after discharge and ameliorating patient and family concerns that may otherwise prompt re-presentation for acute care. Yet a recent trial of this approach, the Hospital to Home Outcomes (H2O) trial,² found the opposite to be true: participants receiving home nurse visits had higher reutilization rates than did participants in the control group. This raises interesting questions: Is it time to revisit postdischarge outreach as an intervention to reduce pediatric readmissions—and even pediatric readmissions altogether as an outcome metric?

In this issue of the Journal of Hospital Medicine, Riddle et al³ explored the perspectives of key stakeholders to understand the factors driving increased reutilization after postdischarge home visits in the H2O trial and obtained feedback for improving potential interventions. The investigators used a qualitative approach that consisted of telephone interviews with 33 parents who were enrolled in the H2O trial and in-person focus groups with 10 home care RNs involved in the trial, 12 hospital medicine physicians, and 7 primary care physicians (PCPs). Inductive thematic analysis was used to analyze responses to open-ended questions through a rigorous, iterative and multidisciplinary process. Key themes elicited from stakeholders included questions about the clinical appropriateness of reutilization episodes; the influence of insufficiently contextualized “red flag,” or warning sign, instructions given to parents in facilitating reutilization; the potential for hospital-employed home care nurses to inadvertently promote emergency department rather than PCP follow-up; and escalation of care exceeding that expected in a PCP office. Stakeholders suggested the intervention could be improved by enhancing postdischarge communication between home care RNs, hospital medicine physicians, and PCPs; tailoring home visits to specific clinical, patient, and family scenarios; and more clearly framing “red flags.”

We welcome the work of Riddle and colleagues in exposing the elements of home visits that may have led to increased utilization, and their proposed next steps to improve the intervention—enhancing contact with PCP offices and focusing interventions on specific populations—unquestionably have merit. We agree that this may be particularly true in children with medical complexity (a population that was excluded from this study), who have unique discharge needs and account for over half of pediatric readmissions.⁴ However, we suggest that the instinct to refine the design of the study intervention should be weighed against alternative possibilities: that postdischarge interventions are simply not effective in decreasing reutilization or, at the very least, that the findings of the H2O trial should not lead us to invest the resources required to further discern the efficacy of postdischarge interventions.

This counter-intuitive possibility is only compounded by the fact that reutilization rates were not improved in the study group’s H2O II trial, a follow-up study that focused on postdischarge nurse telephone calls as the intervention of interest⁵; and indeed, the results of these two, well-designed negative trials have been previously cited to propose postdischarge nurse contact as a potential target of deimplementation efforts.⁶ In the pediatric population, in which caregivers rather than patients themselves are generally responsible for seeking out care, postdischarge outreach may inevitably escalate concerning findings that will result in reutilization. Instead, perhaps the H2O study findings should prompt a broader exploration for alternative solutions to pediatric readmission reduction. One such solution could build on the finding by Riddle et al that stakeholders perceive ambiguity in whether discharging physicians, or rather PCPs, have ownership of clinical issues after discharge. Rather than asking visiting RNs to triangulate between inpatient and outpatient physicians, developing systems to directly integrate PCPs in the hospital discharge process for select patients—for instance, through leveraging the rapid expansion of telemedicine services during the COVID-19 crisis—may promote shared understanding of a patient’s illness trajectory and follow-up needs.

Importantly, the authors also noted that despite the findings of increased reutilization, parents who received home visits expressed their wishes to receive home visits in the future. While not a central finding of the study, this validates a hypothesis expressed in prior work by the H2O study group: “Hospital quality readmission metrics may not be well aligned with family desires for improved postdischarge transitions.”⁵ Given that efforts to reduce pediatric readmission have been largely unsuccessful and that readmission events are relatively uncommon in the general pediatric population,⁴ the parental wishes resonate with existing calls in the literature to consider looking beyond readmissions reduction in isolation as a quality metric. In contrast to the increasing presence of hospital reimbursement penalties among state Medicaid agencies for readmissions, a shift in focus toward outcome measures that are patient- and family-centered is imperative.^1,7 If home visits are not ultimately a solution to pediatric reutilization reduction, they may nonetheless still enable families to effectively manage the concerns that families endorse following discharge, including medication safety and social hardships.⁸

In summary, Riddle et al not only provided important context for the unexpected outcome of a well-designed randomized clinical trial but also provided a rich source of qualitative data that furthers our understanding of a child’s discharge home from the hospital through the perspective of multiple stakeholders. While the authors offer well-reasoned next steps in narrowing the intervention population of interest and enhancing connections of families with PCP care, it may be time to broadly revisit postdischarge interventions and outcomes to identify new approaches and redefine quality measures for hospital-to-home transitions of children and their families.

Despite concerted national efforts to decrease pediatric readmissions, recent data suggest that preventable and all-cause readmission rates of hospitalized children remain unchanged.¹ Because some readmissions may be caused by inadequate postdischarge follow-up, nurse (RN) home visits offer the prospect of addressing unresolved clinical issues after discharge and ameliorating patient and family concerns that may otherwise prompt re-presentation for acute care. Yet a recent trial of this approach, the Hospital to Home Outcomes (H2O) trial,² found the opposite to be true: participants receiving home nurse visits had higher reutilization rates than did participants in the control group. This raises interesting questions: Is it time to revisit postdischarge outreach as an intervention to reduce pediatric readmissions—and even pediatric readmissions altogether as an outcome metric?

In this issue of the Journal of Hospital Medicine, Riddle et al³ explored the perspectives of key stakeholders to understand the factors driving increased reutilization after postdischarge home visits in the H2O trial and obtained feedback for improving potential interventions. The investigators used a qualitative approach that consisted of telephone interviews with 33 parents who were enrolled in the H2O trial and in-person focus groups with 10 home care RNs involved in the trial, 12 hospital medicine physicians, and 7 primary care physicians (PCPs). Inductive thematic analysis was used to analyze responses to open-ended questions through a rigorous, iterative and multidisciplinary process. Key themes elicited from stakeholders included questions about the clinical appropriateness of reutilization episodes; the influence of insufficiently contextualized “red flag,” or warning sign, instructions given to parents in facilitating reutilization; the potential for hospital-employed home care nurses to inadvertently promote emergency department rather than PCP follow-up; and escalation of care exceeding that expected in a PCP office. Stakeholders suggested the intervention could be improved by enhancing postdischarge communication between home care RNs, hospital medicine physicians, and PCPs; tailoring home visits to specific clinical, patient, and family scenarios; and more clearly framing “red flags.”

We welcome the work of Riddle and colleagues in exposing the elements of home visits that may have led to increased utilization, and their proposed next steps to improve the intervention—enhancing contact with PCP offices and focusing interventions on specific populations—unquestionably have merit. We agree that this may be particularly true in children with medical complexity (a population that was excluded from this study), who have unique discharge needs and account for over half of pediatric readmissions.⁴ However, we suggest that the instinct to refine the design of the study intervention should be weighed against alternative possibilities: that postdischarge interventions are simply not effective in decreasing reutilization or, at the very least, that the findings of the H2O trial should not lead us to invest the resources required to further discern the efficacy of postdischarge interventions.

This counter-intuitive possibility is only compounded by the fact that reutilization rates were not improved in the study group’s H2O II trial, a follow-up study that focused on postdischarge nurse telephone calls as the intervention of interest⁵; and indeed, the results of these two, well-designed negative trials have been previously cited to propose postdischarge nurse contact as a potential target of deimplementation efforts.⁶ In the pediatric population, in which caregivers rather than patients themselves are generally responsible for seeking out care, postdischarge outreach may inevitably escalate concerning findings that will result in reutilization. Instead, perhaps the H2O study findings should prompt a broader exploration for alternative solutions to pediatric readmission reduction. One such solution could build on the finding by Riddle et al that stakeholders perceive ambiguity in whether discharging physicians, or rather PCPs, have ownership of clinical issues after discharge. Rather than asking visiting RNs to triangulate between inpatient and outpatient physicians, developing systems to directly integrate PCPs in the hospital discharge process for select patients—for instance, through leveraging the rapid expansion of telemedicine services during the COVID-19 crisis—may promote shared understanding of a patient’s illness trajectory and follow-up needs.

Importantly, the authors also noted that despite the findings of increased reutilization, parents who received home visits expressed their wishes to receive home visits in the future. While not a central finding of the study, this validates a hypothesis expressed in prior work by the H2O study group: “Hospital quality readmission metrics may not be well aligned with family desires for improved postdischarge transitions.”⁵ Given that efforts to reduce pediatric readmission have been largely unsuccessful and that readmission events are relatively uncommon in the general pediatric population,⁴ the parental wishes resonate with existing calls in the literature to consider looking beyond readmissions reduction in isolation as a quality metric. In contrast to the increasing presence of hospital reimbursement penalties among state Medicaid agencies for readmissions, a shift in focus toward outcome measures that are patient- and family-centered is imperative.^1,7 If home visits are not ultimately a solution to pediatric reutilization reduction, they may nonetheless still enable families to effectively manage the concerns that families endorse following discharge, including medication safety and social hardships.⁸

In summary, Riddle et al not only provided important context for the unexpected outcome of a well-designed randomized clinical trial but also provided a rich source of qualitative data that furthers our understanding of a child’s discharge home from the hospital through the perspective of multiple stakeholders. While the authors offer well-reasoned next steps in narrowing the intervention population of interest and enhancing connections of families with PCP care, it may be time to broadly revisit postdischarge interventions and outcomes to identify new approaches and redefine quality measures for hospital-to-home transitions of children and their families.

Despite concerted national efforts to decrease pediatric readmissions, recent data suggest that preventable and all-cause readmission rates of hospitalized children remain unchanged.¹ Because some readmissions may be caused by inadequate postdischarge follow-up, nurse (RN) home visits offer the prospect of addressing unresolved clinical issues after discharge and ameliorating patient and family concerns that may otherwise prompt re-presentation for acute care. Yet a recent trial of this approach, the Hospital to Home Outcomes (H2O) trial,² found the opposite to be true: participants receiving home nurse visits had higher reutilization rates than did participants in the control group. This raises interesting questions: Is it time to revisit postdischarge outreach as an intervention to reduce pediatric readmissions—and even pediatric readmissions altogether as an outcome metric?

In this issue of the Journal of Hospital Medicine, Riddle et al³ explored the perspectives of key stakeholders to understand the factors driving increased reutilization after postdischarge home visits in the H2O trial and obtained feedback for improving potential interventions. The investigators used a qualitative approach that consisted of telephone interviews with 33 parents who were enrolled in the H2O trial and in-person focus groups with 10 home care RNs involved in the trial, 12 hospital medicine physicians, and 7 primary care physicians (PCPs). Inductive thematic analysis was used to analyze responses to open-ended questions through a rigorous, iterative and multidisciplinary process. Key themes elicited from stakeholders included questions about the clinical appropriateness of reutilization episodes; the influence of insufficiently contextualized “red flag,” or warning sign, instructions given to parents in facilitating reutilization; the potential for hospital-employed home care nurses to inadvertently promote emergency department rather than PCP follow-up; and escalation of care exceeding that expected in a PCP office. Stakeholders suggested the intervention could be improved by enhancing postdischarge communication between home care RNs, hospital medicine physicians, and PCPs; tailoring home visits to specific clinical, patient, and family scenarios; and more clearly framing “red flags.”

We welcome the work of Riddle and colleagues in exposing the elements of home visits that may have led to increased utilization, and their proposed next steps to improve the intervention—enhancing contact with PCP offices and focusing interventions on specific populations—unquestionably have merit. We agree that this may be particularly true in children with medical complexity (a population that was excluded from this study), who have unique discharge needs and account for over half of pediatric readmissions.⁴ However, we suggest that the instinct to refine the design of the study intervention should be weighed against alternative possibilities: that postdischarge interventions are simply not effective in decreasing reutilization or, at the very least, that the findings of the H2O trial should not lead us to invest the resources required to further discern the efficacy of postdischarge interventions.

This counter-intuitive possibility is only compounded by the fact that reutilization rates were not improved in the study group’s H2O II trial, a follow-up study that focused on postdischarge nurse telephone calls as the intervention of interest⁵; and indeed, the results of these two, well-designed negative trials have been previously cited to propose postdischarge nurse contact as a potential target of deimplementation efforts.⁶ In the pediatric population, in which caregivers rather than patients themselves are generally responsible for seeking out care, postdischarge outreach may inevitably escalate concerning findings that will result in reutilization. Instead, perhaps the H2O study findings should prompt a broader exploration for alternative solutions to pediatric readmission reduction. One such solution could build on the finding by Riddle et al that stakeholders perceive ambiguity in whether discharging physicians, or rather PCPs, have ownership of clinical issues after discharge. Rather than asking visiting RNs to triangulate between inpatient and outpatient physicians, developing systems to directly integrate PCPs in the hospital discharge process for select patients—for instance, through leveraging the rapid expansion of telemedicine services during the COVID-19 crisis—may promote shared understanding of a patient’s illness trajectory and follow-up needs.

Importantly, the authors also noted that despite the findings of increased reutilization, parents who received home visits expressed their wishes to receive home visits in the future. While not a central finding of the study, this validates a hypothesis expressed in prior work by the H2O study group: “Hospital quality readmission metrics may not be well aligned with family desires for improved postdischarge transitions.”⁵ Given that efforts to reduce pediatric readmission have been largely unsuccessful and that readmission events are relatively uncommon in the general pediatric population,⁴ the parental wishes resonate with existing calls in the literature to consider looking beyond readmissions reduction in isolation as a quality metric. In contrast to the increasing presence of hospital reimbursement penalties among state Medicaid agencies for readmissions, a shift in focus toward outcome measures that are patient- and family-centered is imperative.^1,7 If home visits are not ultimately a solution to pediatric reutilization reduction, they may nonetheless still enable families to effectively manage the concerns that families endorse following discharge, including medication safety and social hardships.⁸

In summary, Riddle et al not only provided important context for the unexpected outcome of a well-designed randomized clinical trial but also provided a rich source of qualitative data that furthers our understanding of a child’s discharge home from the hospital through the perspective of multiple stakeholders. While the authors offer well-reasoned next steps in narrowing the intervention population of interest and enhancing connections of families with PCP care, it may be time to broadly revisit postdischarge interventions and outcomes to identify new approaches and redefine quality measures for hospital-to-home transitions of children and their families.

“Confidence comes from being prepared.”

—John Wooden

Hospital medicine is a field that requires a constant state of readiness and flexibility. With respect to patient care, constant preparedness is required because conditions change. This necessitates always having a backup plan, or Plan B. For example, your patient with a gastrointestinal (GI) bleed should have two large-bore intravenous (IV) catheters and packed red blood cells (RBCs) typed and crossed. If the patient becomes unstable, the response is not just doing more of the same (IV fluids and proton pump inhibitors); the focus shifts to your Plan B: call GI, transfuse blood, transfer the patient to the intensive care unit.

In contrast to clinical scenarios, there is often a lack of readiness to deal with rapid changes in workflow. Without a plan, efficiency decreases, stress levels rise, and both patients and providers alike suffer the consequences. Patients spending extended periods of time in the Emergency Department (ED) receive less timely services and often don’t benefit from the expertise that they would receive in inpatient units.¹ This is particularly true in an era in which many hospitals are experiencing higher overall volume and surges are more common.

Ideally, readiness should manifest as the ability to adapt to changes at the individual, hospitalist team, and leadership levels. Having a Plan B in the practice of hospital medicine is a focused exercise for anticipating future problems and addressing them prospectively. When thinking about a Plan B, the following are some steps to consider:

1. Identify Triggers. In the earlier example of the GI bleed, our triggers for Plan B would be a change in vitals or a brisk drop in hemoglobin. Regarding hospital workflow, the triggers might include low service or bed capacity or a decreased number of expected discharges for the day. Perhaps a high ED census or increased surgical volume will trigger your plan to handle the surge.

2. Define Your Response. At both an individual and service level, there are steps you might consider in your Plan B. On teaching services, this might mean prioritizing rounding on patients that you’re expecting to discharge so they’re able to leave the hospital sooner. For patients on observation status who are boarding in the ED for extended periods, there might be opportunities to safely discharge them with follow-up or even complete their work-up in the ED. There may be circumstances in which providers should exceed the usual service capacity and conditions in which it is truly unsafe to exceed that limit. If there are resources available to increase staffing, consider how to best utilize them.

3. Engage Broadly and Proactively. It is very difficult to execute a Plan B (or frankly a Plan A) without buy-in from your stakeholders. This starts with the rank and file, those on your team who will actually execute the plan. The leadership of your department or division, the ED, and nursing will also likely need to provide input. If financial resources for flexing up staff are part of your plan, the hospital administration might need to weigh in. It is best to engage stakeholders early on rather than during a crisis.

4. Constant Assessment and Improvement. Going back to our example of our patient with a GI bleed, you’re constantly reevaluating your patient to determine if your Plan B is working. Similarly, you should collect data and reassess the effectiveness of your plan. There are likely opportunities to improve it.

There are no textbook chapters or medical school lectures to prepare hospitalists for these real-world crises. Yet failing to have a Plan B is to surrender a tremendous amount of personal control in the face of chaos, to jeopardize patient care, and to ultimately forgo the opportunity to achieve a level of mastery in a field predicated on readiness.

“Confidence comes from being prepared.”

—John Wooden

Hospital medicine is a field that requires a constant state of readiness and flexibility. With respect to patient care, constant preparedness is required because conditions change. This necessitates always having a backup plan, or Plan B. For example, your patient with a gastrointestinal (GI) bleed should have two large-bore intravenous (IV) catheters and packed red blood cells (RBCs) typed and crossed. If the patient becomes unstable, the response is not just doing more of the same (IV fluids and proton pump inhibitors); the focus shifts to your Plan B: call GI, transfuse blood, transfer the patient to the intensive care unit.

In contrast to clinical scenarios, there is often a lack of readiness to deal with rapid changes in workflow. Without a plan, efficiency decreases, stress levels rise, and both patients and providers alike suffer the consequences. Patients spending extended periods of time in the Emergency Department (ED) receive less timely services and often don’t benefit from the expertise that they would receive in inpatient units.¹ This is particularly true in an era in which many hospitals are experiencing higher overall volume and surges are more common.

Ideally, readiness should manifest as the ability to adapt to changes at the individual, hospitalist team, and leadership levels. Having a Plan B in the practice of hospital medicine is a focused exercise for anticipating future problems and addressing them prospectively. When thinking about a Plan B, the following are some steps to consider:

1. Identify Triggers. In the earlier example of the GI bleed, our triggers for Plan B would be a change in vitals or a brisk drop in hemoglobin. Regarding hospital workflow, the triggers might include low service or bed capacity or a decreased number of expected discharges for the day. Perhaps a high ED census or increased surgical volume will trigger your plan to handle the surge.

2. Define Your Response. At both an individual and service level, there are steps you might consider in your Plan B. On teaching services, this might mean prioritizing rounding on patients that you’re expecting to discharge so they’re able to leave the hospital sooner. For patients on observation status who are boarding in the ED for extended periods, there might be opportunities to safely discharge them with follow-up or even complete their work-up in the ED. There may be circumstances in which providers should exceed the usual service capacity and conditions in which it is truly unsafe to exceed that limit. If there are resources available to increase staffing, consider how to best utilize them.

3. Engage Broadly and Proactively. It is very difficult to execute a Plan B (or frankly a Plan A) without buy-in from your stakeholders. This starts with the rank and file, those on your team who will actually execute the plan. The leadership of your department or division, the ED, and nursing will also likely need to provide input. If financial resources for flexing up staff are part of your plan, the hospital administration might need to weigh in. It is best to engage stakeholders early on rather than during a crisis.

4. Constant Assessment and Improvement. Going back to our example of our patient with a GI bleed, you’re constantly reevaluating your patient to determine if your Plan B is working. Similarly, you should collect data and reassess the effectiveness of your plan. There are likely opportunities to improve it.

There are no textbook chapters or medical school lectures to prepare hospitalists for these real-world crises. Yet failing to have a Plan B is to surrender a tremendous amount of personal control in the face of chaos, to jeopardize patient care, and to ultimately forgo the opportunity to achieve a level of mastery in a field predicated on readiness.

“Confidence comes from being prepared.”

—John Wooden

Hospital medicine is a field that requires a constant state of readiness and flexibility. With respect to patient care, constant preparedness is required because conditions change. This necessitates always having a backup plan, or Plan B. For example, your patient with a gastrointestinal (GI) bleed should have two large-bore intravenous (IV) catheters and packed red blood cells (RBCs) typed and crossed. If the patient becomes unstable, the response is not just doing more of the same (IV fluids and proton pump inhibitors); the focus shifts to your Plan B: call GI, transfuse blood, transfer the patient to the intensive care unit.

In contrast to clinical scenarios, there is often a lack of readiness to deal with rapid changes in workflow. Without a plan, efficiency decreases, stress levels rise, and both patients and providers alike suffer the consequences. Patients spending extended periods of time in the Emergency Department (ED) receive less timely services and often don’t benefit from the expertise that they would receive in inpatient units.¹ This is particularly true in an era in which many hospitals are experiencing higher overall volume and surges are more common.

Ideally, readiness should manifest as the ability to adapt to changes at the individual, hospitalist team, and leadership levels. Having a Plan B in the practice of hospital medicine is a focused exercise for anticipating future problems and addressing them prospectively. When thinking about a Plan B, the following are some steps to consider:

1. Identify Triggers. In the earlier example of the GI bleed, our triggers for Plan B would be a change in vitals or a brisk drop in hemoglobin. Regarding hospital workflow, the triggers might include low service or bed capacity or a decreased number of expected discharges for the day. Perhaps a high ED census or increased surgical volume will trigger your plan to handle the surge.

2. Define Your Response. At both an individual and service level, there are steps you might consider in your Plan B. On teaching services, this might mean prioritizing rounding on patients that you’re expecting to discharge so they’re able to leave the hospital sooner. For patients on observation status who are boarding in the ED for extended periods, there might be opportunities to safely discharge them with follow-up or even complete their work-up in the ED. There may be circumstances in which providers should exceed the usual service capacity and conditions in which it is truly unsafe to exceed that limit. If there are resources available to increase staffing, consider how to best utilize them.

3. Engage Broadly and Proactively. It is very difficult to execute a Plan B (or frankly a Plan A) without buy-in from your stakeholders. This starts with the rank and file, those on your team who will actually execute the plan. The leadership of your department or division, the ED, and nursing will also likely need to provide input. If financial resources for flexing up staff are part of your plan, the hospital administration might need to weigh in. It is best to engage stakeholders early on rather than during a crisis.

4. Constant Assessment and Improvement. Going back to our example of our patient with a GI bleed, you’re constantly reevaluating your patient to determine if your Plan B is working. Similarly, you should collect data and reassess the effectiveness of your plan. There are likely opportunities to improve it.

There are no textbook chapters or medical school lectures to prepare hospitalists for these real-world crises. Yet failing to have a Plan B is to surrender a tremendous amount of personal control in the face of chaos, to jeopardize patient care, and to ultimately forgo the opportunity to achieve a level of mastery in a field predicated on readiness.

Last year we pledged to lead by example and improve representation within the Journal of Hospital Medicine community.¹ By emphasizing diversity, we expand the pool of faculty to whom leadership opportunities are available. A diverse team will put forth a broader range of ideas for consideration, spur greater innovation, and promote diversity in both published content and authorship, ensuring that the spectrum of content we publish reflects and benefits all patients to whom we provide care.

We write to share our progress, first reporting on gender equity. Currently, 45% of the journal leadership team are women, increased from 30% in 2018. In the past year, we also developed processes to collect peer reviewer and author demographic information through our manuscript management system. These processes helped us understand our baseline state.

Prior to developing these processes, we discussed our goals and potential approaches with Society of Hospital Medicine leaders; medical school deans of diversity, equity, and inclusion; department chairs in pediatrics and internal medicine; women, underrepresented minorities, and LGBTQ+ faculty; and trainees. We achieved consensus as a journal leadership team and implemented a new data collection system in July 2019. We focused on first and last authors given the importance of these positions for promotion and tenure. We requested that peer reviewers and authors provide demographic data, including gender (with nonbinary as an option), race, and ethnicity; “prefer not to answer” was a response option for each question. These data were not available during the manuscript decision process. Authors who did not submit information received up to three reminder emails from the Editor-in-Chief encouraging them to provide demographic information and stating the rationale for the request. We did not use gender identifying algorithms (eg, assignment of gender probability based on name) or visit professional websites; our intent was author self-identification.

We categorized Journal of Hospital Medicine article types as research, generally solicited, and generally unsolicited (Table). Among research articles, the proportion of women and men were similar with women accounting for 47% of first authors (vs 47% men) and 33% of last authors (vs 35% men) (Table). However, 27% of last authors left this field blank. Among solicited article types, there was an equal proportion of women and men for first but not for last authors. Among unsolicited article types, a smaller proportion of women accounted for first authors. While the proportion of women and men was equal among last authors, 45% left this field blank.

Collecting author demographics and reporting our data on gender represent an important first step for the journal. In the upcoming year, we will develop strategies to obtain more complete data and report our performance on race, ethnicity, and intersectionality, and continue deliberate efforts to improve equity within all areas of the journal, including reviewer, author, and editorial roles. We are committed to continue sharing our progress.

Last year we pledged to lead by example and improve representation within the Journal of Hospital Medicine community.¹ By emphasizing diversity, we expand the pool of faculty to whom leadership opportunities are available. A diverse team will put forth a broader range of ideas for consideration, spur greater innovation, and promote diversity in both published content and authorship, ensuring that the spectrum of content we publish reflects and benefits all patients to whom we provide care.

We write to share our progress, first reporting on gender equity. Currently, 45% of the journal leadership team are women, increased from 30% in 2018. In the past year, we also developed processes to collect peer reviewer and author demographic information through our manuscript management system. These processes helped us understand our baseline state.

Prior to developing these processes, we discussed our goals and potential approaches with Society of Hospital Medicine leaders; medical school deans of diversity, equity, and inclusion; department chairs in pediatrics and internal medicine; women, underrepresented minorities, and LGBTQ+ faculty; and trainees. We achieved consensus as a journal leadership team and implemented a new data collection system in July 2019. We focused on first and last authors given the importance of these positions for promotion and tenure. We requested that peer reviewers and authors provide demographic data, including gender (with nonbinary as an option), race, and ethnicity; “prefer not to answer” was a response option for each question. These data were not available during the manuscript decision process. Authors who did not submit information received up to three reminder emails from the Editor-in-Chief encouraging them to provide demographic information and stating the rationale for the request. We did not use gender identifying algorithms (eg, assignment of gender probability based on name) or visit professional websites; our intent was author self-identification.

We categorized Journal of Hospital Medicine article types as research, generally solicited, and generally unsolicited (Table). Among research articles, the proportion of women and men were similar with women accounting for 47% of first authors (vs 47% men) and 33% of last authors (vs 35% men) (Table). However, 27% of last authors left this field blank. Among solicited article types, there was an equal proportion of women and men for first but not for last authors. Among unsolicited article types, a smaller proportion of women accounted for first authors. While the proportion of women and men was equal among last authors, 45% left this field blank.

Collecting author demographics and reporting our data on gender represent an important first step for the journal. In the upcoming year, we will develop strategies to obtain more complete data and report our performance on race, ethnicity, and intersectionality, and continue deliberate efforts to improve equity within all areas of the journal, including reviewer, author, and editorial roles. We are committed to continue sharing our progress.

Last year we pledged to lead by example and improve representation within the Journal of Hospital Medicine community.¹ By emphasizing diversity, we expand the pool of faculty to whom leadership opportunities are available. A diverse team will put forth a broader range of ideas for consideration, spur greater innovation, and promote diversity in both published content and authorship, ensuring that the spectrum of content we publish reflects and benefits all patients to whom we provide care.

We write to share our progress, first reporting on gender equity. Currently, 45% of the journal leadership team are women, increased from 30% in 2018. In the past year, we also developed processes to collect peer reviewer and author demographic information through our manuscript management system. These processes helped us understand our baseline state.

Prior to developing these processes, we discussed our goals and potential approaches with Society of Hospital Medicine leaders; medical school deans of diversity, equity, and inclusion; department chairs in pediatrics and internal medicine; women, underrepresented minorities, and LGBTQ+ faculty; and trainees. We achieved consensus as a journal leadership team and implemented a new data collection system in July 2019. We focused on first and last authors given the importance of these positions for promotion and tenure. We requested that peer reviewers and authors provide demographic data, including gender (with nonbinary as an option), race, and ethnicity; “prefer not to answer” was a response option for each question. These data were not available during the manuscript decision process. Authors who did not submit information received up to three reminder emails from the Editor-in-Chief encouraging them to provide demographic information and stating the rationale for the request. We did not use gender identifying algorithms (eg, assignment of gender probability based on name) or visit professional websites; our intent was author self-identification.

We categorized Journal of Hospital Medicine article types as research, generally solicited, and generally unsolicited (Table). Among research articles, the proportion of women and men were similar with women accounting for 47% of first authors (vs 47% men) and 33% of last authors (vs 35% men) (Table). However, 27% of last authors left this field blank. Among solicited article types, there was an equal proportion of women and men for first but not for last authors. Among unsolicited article types, a smaller proportion of women accounted for first authors. While the proportion of women and men was equal among last authors, 45% left this field blank.

Collecting author demographics and reporting our data on gender represent an important first step for the journal. In the upcoming year, we will develop strategies to obtain more complete data and report our performance on race, ethnicity, and intersectionality, and continue deliberate efforts to improve equity within all areas of the journal, including reviewer, author, and editorial roles. We are committed to continue sharing our progress.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

In a Q&A session at HM20 Virtual, hosted by the Society of Hospital Medicine, Heather Nye, MD, PhD, SFHM, professor of medicine at the University of California, San Francisco, and David J. Alfandre, MD, MPH, associate professor of medicine at New York University Langone, discussed strategies to help hospitalists tend to their personal wellness during the COVID-19 pandemic.

The speakers described the complicated logistics and emotional and psychological strain that has come from working during the pandemic, while balancing home responsibilities and parenting. The session was an opportunity to humanize hospitalists’ experience as they straddle work and family.

Dr. Nye said she was still “warming up to personal wellness” because there have been so many other demands over the past several months, but that taking the time to go for walks – to bring on a feeling of health even more than the physical benefits – has been helpful. Even before the pandemic, she said, she brought a guitar to the office to take a few minutes for a hobby for which she can’t seem to find uninterrupted time at home.

“Bringing a little bit of yourself into your work life goes a long way for a lot of people,” she said.

Child care and odd hours always have been a challenge for hospitalists, the presenters said, and for those in academia, any “wiggle room” in the schedule is often taken up by education, administration, and research projects.

Dr. Alfandre said etching out time for yourself must be “a priority, or it won’t happen.” Doing so, he said, “feels indulgent but it’s not. It’s central to being able to do the kind of work you do when you’re at the hospital, at the office, and when you’re back home again.”

Dr. Nye observed that, while working from home on nonclinical work, “recognizing how little I got done was a big surprise,” and she had to “grow comfortable with that” and learn to live with the uncertainty about when that was going to change.

Both physicians described the emotional toll of worrying about their children if they have to continue distance learning.

Dr. Alfandre said that a shared Google calendar for his wife and him – with appointments, work obligations, children’s doctor’s appointments, recitals – has been helpful, removing the strain of having to remind each other. He said that there are skills used at work that hospitalists can use at home – such as not getting upset with a child for crying about a spilled drink – in the same way that a physician wouldn’t get upset with a patient concerned about a test.

“We empathize with our patients, and we empathize with our kids and what their experience is,” he said. Similarly, seeing family members crowd around a smartphone video call to check in with a COVID-19 patient can be a helpful reminder to appreciate going home to family at the end of the day.

When her children get upset that she has to go in to work, Dr. Nye said, it has been helpful to explain that her many patients are suffering and scared and need her help.

“I feel like sharing that part of our job [with] our kids helps them understand that there are very, very big problems out there – that they don’t have to know too much about and be frightened about – but [that knowledge] just gives them a little perspective.”

Dr. Nye and Dr. Alfandre said they had no financial conflicts of interest.

In a Q&A session at HM20 Virtual, hosted by the Society of Hospital Medicine, Heather Nye, MD, PhD, SFHM, professor of medicine at the University of California, San Francisco, and David J. Alfandre, MD, MPH, associate professor of medicine at New York University Langone, discussed strategies to help hospitalists tend to their personal wellness during the COVID-19 pandemic.

The speakers described the complicated logistics and emotional and psychological strain that has come from working during the pandemic, while balancing home responsibilities and parenting. The session was an opportunity to humanize hospitalists’ experience as they straddle work and family.

Dr. Nye said she was still “warming up to personal wellness” because there have been so many other demands over the past several months, but that taking the time to go for walks – to bring on a feeling of health even more than the physical benefits – has been helpful. Even before the pandemic, she said, she brought a guitar to the office to take a few minutes for a hobby for which she can’t seem to find uninterrupted time at home.

“Bringing a little bit of yourself into your work life goes a long way for a lot of people,” she said.

Child care and odd hours always have been a challenge for hospitalists, the presenters said, and for those in academia, any “wiggle room” in the schedule is often taken up by education, administration, and research projects.

Dr. Alfandre said etching out time for yourself must be “a priority, or it won’t happen.” Doing so, he said, “feels indulgent but it’s not. It’s central to being able to do the kind of work you do when you’re at the hospital, at the office, and when you’re back home again.”

Dr. Nye observed that, while working from home on nonclinical work, “recognizing how little I got done was a big surprise,” and she had to “grow comfortable with that” and learn to live with the uncertainty about when that was going to change.

Both physicians described the emotional toll of worrying about their children if they have to continue distance learning.

Dr. Alfandre said that a shared Google calendar for his wife and him – with appointments, work obligations, children’s doctor’s appointments, recitals – has been helpful, removing the strain of having to remind each other. He said that there are skills used at work that hospitalists can use at home – such as not getting upset with a child for crying about a spilled drink – in the same way that a physician wouldn’t get upset with a patient concerned about a test.

“We empathize with our patients, and we empathize with our kids and what their experience is,” he said. Similarly, seeing family members crowd around a smartphone video call to check in with a COVID-19 patient can be a helpful reminder to appreciate going home to family at the end of the day.

When her children get upset that she has to go in to work, Dr. Nye said, it has been helpful to explain that her many patients are suffering and scared and need her help.

“I feel like sharing that part of our job [with] our kids helps them understand that there are very, very big problems out there – that they don’t have to know too much about and be frightened about – but [that knowledge] just gives them a little perspective.”

Dr. Nye and Dr. Alfandre said they had no financial conflicts of interest.

In a Q&A session at HM20 Virtual, hosted by the Society of Hospital Medicine, Heather Nye, MD, PhD, SFHM, professor of medicine at the University of California, San Francisco, and David J. Alfandre, MD, MPH, associate professor of medicine at New York University Langone, discussed strategies to help hospitalists tend to their personal wellness during the COVID-19 pandemic.

The speakers described the complicated logistics and emotional and psychological strain that has come from working during the pandemic, while balancing home responsibilities and parenting. The session was an opportunity to humanize hospitalists’ experience as they straddle work and family.

Dr. Nye said she was still “warming up to personal wellness” because there have been so many other demands over the past several months, but that taking the time to go for walks – to bring on a feeling of health even more than the physical benefits – has been helpful. Even before the pandemic, she said, she brought a guitar to the office to take a few minutes for a hobby for which she can’t seem to find uninterrupted time at home.

“Bringing a little bit of yourself into your work life goes a long way for a lot of people,” she said.

Child care and odd hours always have been a challenge for hospitalists, the presenters said, and for those in academia, any “wiggle room” in the schedule is often taken up by education, administration, and research projects.

Dr. Alfandre said etching out time for yourself must be “a priority, or it won’t happen.” Doing so, he said, “feels indulgent but it’s not. It’s central to being able to do the kind of work you do when you’re at the hospital, at the office, and when you’re back home again.”

Dr. Nye observed that, while working from home on nonclinical work, “recognizing how little I got done was a big surprise,” and she had to “grow comfortable with that” and learn to live with the uncertainty about when that was going to change.

Both physicians described the emotional toll of worrying about their children if they have to continue distance learning.

Dr. Alfandre said that a shared Google calendar for his wife and him – with appointments, work obligations, children’s doctor’s appointments, recitals – has been helpful, removing the strain of having to remind each other. He said that there are skills used at work that hospitalists can use at home – such as not getting upset with a child for crying about a spilled drink – in the same way that a physician wouldn’t get upset with a patient concerned about a test.

“We empathize with our patients, and we empathize with our kids and what their experience is,” he said. Similarly, seeing family members crowd around a smartphone video call to check in with a COVID-19 patient can be a helpful reminder to appreciate going home to family at the end of the day.

When her children get upset that she has to go in to work, Dr. Nye said, it has been helpful to explain that her many patients are suffering and scared and need her help.

“I feel like sharing that part of our job [with] our kids helps them understand that there are very, very big problems out there – that they don’t have to know too much about and be frightened about – but [that knowledge] just gives them a little perspective.”

Dr. Nye and Dr. Alfandre said they had no financial conflicts of interest.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

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For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at [email protected].
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

SDI Productions/E+

For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at [email protected].
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

SDI Productions/E+

For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at [email protected].
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.