Cardiology News

Patients with stable coronary artery disease and type 2 diabetes mellitus could benefit from a “plethora of newly available risk-reduction strategies,” but their “adoption into clinical practice has been slow” and inconsistent, prompting an expert panel organized by the American Heart Association to collate the range of treatment recommendations now applicable to this patient population in a scientific statement released on April 13.

“There are a number of things to consider when treating patients with stable coronary artery disease [CAD] and type 2 diabetes mellitus [T2DM], with new medications and trials and data emerging. It’s difficult to keep up with all of the complexities,” which was why the Association’s Councils on Lifestyle and Cardiometabolic Health and on Clinical Cardiology put together a writing group to summarize and prioritize the range of lifestyle, medical, and interventional options that now require consideration and potential use on patients managed in routine practice, explained Suzanne V. Arnold, MD, chair of the writing group, in an interview.

The new scientific statement (Circulation. 2020 Apr 13; doi: 10.1161/CIR.0000000000000766), aimed primarily at cardiologists but also intended to inform primary care physicians, endocrinologists, and all other clinicians who deal with these patients, pulls together “everything someone needs to think about if they care for patients with CAD and T2DM,” said Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston and vice chair of the statement-writing panel in an interview. “There is a lot to know,” he added.

The statement covers antithrombotic therapies; blood pressure control, with a discussion of both the appropriate pressure goal and the best drug types used to reach it; lipid management; glycemic control; lifestyle modification; weight management, including the role of bariatric surgery; and approaches to managing stable angina, both medically and with revascularization.

“The goal was to give clinicians a good sense of what new treatments they should consider” for these patients, said Dr. Bhatt, who is also director of interventional cardiovascular programs at Brigham and Women’s Hospital, also in Boston. Because of the tight associations between T2DM and cardiovascular disease in general including CAD, “cardiologists are increasingly involved in managing patients with T2DM,” he noted. The statement gives a comprehensive overview and critical assessment of the management of these patients as of the end of 2019 as a consensus from a panel of 11 experts .

The statement also stressed that “substantial portions of patients with T2DM and CAD, including those after an acute coronary syndrome, do not receive therapies with proven cardiovascular benefit, such as high-intensity statins, dual-antiplatelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, and glucose-lowering agents with proven cardiovascular benefits.

“These gaps in care highlight a critical opportunity for cardiovascular specialists to assume a more active role in the collaborative care of patients with T2DM and CAD,” the statement said. This includes “encouraging cardiologists to become more active in the selection of glucose-lowering medications” for these patients because it could “really move the needle,” said Dr. Arnold, a cardiologist with Saint Luke’s Health System in Kansas City, Mo. She was referring specifically to broader reliance on both the SGTL2 (sodium-glucose cotransporter 2) inhibitors and the GLP-1 (glucagonlike peptide-1) receptor agonists as top choices for controlling hyperglycemia. Based on recent evidence drugs in these two classes “could be considered first line for patients with T2DM and CAD, and would likely be preferred over metformin,” Dr. Arnold said in an interview. Although the statement identified the SGLT2 inhibitors as “the first drug class [for glycemic control] to show clear benefits on cardiovascular outcomes,” it does not explicitly label the class first-line and it also skirts that designation for the GLP-1 receptor agonist class, while noting that metformin “remains the drug most frequently recommended as first-line therapy in treatment guidelines.”

“I wouldn’t disagree with someone who said that SGLT2 inhibitors and GLP-1 receptor agonists are first line,” but prescribing patterns also depend on familiarity, cost, and access, noted Dr. Bhatt, which can all be issues with agents from these classes compared with metformin, a widely available generic with decades of use. “Metformin is safe and cheap, so we did not want to discount it,” said Dr. Arnold. Dr. Bhatt recently coauthored an editorial that gave an enthusiastic endorsement to using SGLT2 inhibitors in patients with diabetes (Cell Metab. 2019 Nov 5;30[5]:47-9).

Another notable feature of the statement is the potential it assigns to bariatric surgery as a management tool with documented safety and efficacy for improving cardiovascular risk factors. However, the statement also notes that randomized trials “have thus far been inadequately powered to assess cardiovascular events and mortality, although observational studies have consistently shown cardiovascular risk reduction with such procedures.” The statement continues that despite potential cardiovascular benefits “bariatric surgery remains underused among eligible patients,” and said that surgery performed as Roux-en-Y bypass or sleeve gastrectomy “may be another effective tool for cardiovascular risk reduction in the subset of patients with obesity,” particularly patients with a body mass index of at least 35 kg/m².

“While the percentage of patients who are optimal for bariatric surgery is not known, the most recent NHANES [National Health and Nutrition Examination Study] study showed that less than 0.5% of eligible patients underwent bariatric surgery,” Dr. Arnold noted. Bariatric surgery is “certainly not a recommendation for everyone, or even a majority of patients, but bariatric surgery should be on our radar,” for patients with CAD and T2DM, she said.

Right now, “few cardiologists think about bariatric surgery,” as a treatment option, but study results have shown that “in carefully selected patients treated by skilled surgeons at high-volume centers, patients will do better with bariatric surgery than with best medical therapy for improvements in multiple risk factors, including glycemic control,” Dr. Bhatt said in the interview. “It’s not first-line treatment, but it’s an option to consider,” he added, while also noting that bariatric surgery is most beneficial to patients relatively early in the course of T2DM, when its been in place for just a few years rather than a couple of decades.

The statement also notably included a “first-line” call out for icosapent ethyl (Vascepa), a novel agent approved in December 2019 for routine use in U.S. patients, including those with CAD and T2DM as long as their blood triglyceride level was at least 150 mg/dL. Dr. Bhatt, who led the REDUCE-IT study that was pivotal for proving the safety and efficacy of icosapent ethyl (N Engl J Med. 2019 Jan 3;380[1]:11-22), estimated that anywhere from 15% to as many as half the patients with CAD and T2DM might have a triglyceride level that would allow them to receive icosapent ethyl. One population-based study in Canada of nearly 200,000 people with atherosclerotic cardiovascular disease found a 25% prevalence of the triglyceride level needed to qualify to receive icosapent ethyl under current labeling, he noted (Eur Heart J. 2020 Jan 1;41[1]:86-94). However, the FDA label does not specify that triglycerides be measured when fasting, and a nonfasting level of about 150 mg/dL will likely appear for patients with fasting levels that fall as low as about 100 mg/dL, Dr. Bhatt said. He hoped that future studies will assess the efficacy of icosapent ethyl in patients with even lower triglyceride levels.

Other sections of the statement also recommend that clinicians: Target long-term dual-antiplatelet therapy to CAD and T2DM patients with additional high-risk markers such as prior MI, younger age, and tobacco use; prescribe a low-dose oral anticoagulant along with an antiplatelet drug such as aspirin for secondary-prevention patients; promote a blood pressure target of less than 140/90 mm Hg for all CAD and T2DM patients and apply a goal of less than 130/80 mm Hg in higher-risk patients such as blacks, Asians, and those with cerebrovascular disease; and reassure patients that “despite a modest increase in blood sugars, the risk-benefit ratio is clearly in favor of administering statins to people with T2DM and CAD.”

Dr. Arnold had no disclosures. Dr. Bhatt has been an adviser to Cardax, Cereno Scientific, Medscape Cardiology, PhaseBio; PLx Pharma, and Regado Biosciences, and he has received research funding from numerous companies including Amarin, the company that markets icosapent ethyl.

[email protected]

Patients with stable coronary artery disease and type 2 diabetes mellitus could benefit from a “plethora of newly available risk-reduction strategies,” but their “adoption into clinical practice has been slow” and inconsistent, prompting an expert panel organized by the American Heart Association to collate the range of treatment recommendations now applicable to this patient population in a scientific statement released on April 13.

“There are a number of things to consider when treating patients with stable coronary artery disease [CAD] and type 2 diabetes mellitus [T2DM], with new medications and trials and data emerging. It’s difficult to keep up with all of the complexities,” which was why the Association’s Councils on Lifestyle and Cardiometabolic Health and on Clinical Cardiology put together a writing group to summarize and prioritize the range of lifestyle, medical, and interventional options that now require consideration and potential use on patients managed in routine practice, explained Suzanne V. Arnold, MD, chair of the writing group, in an interview.

The new scientific statement (Circulation. 2020 Apr 13; doi: 10.1161/CIR.0000000000000766), aimed primarily at cardiologists but also intended to inform primary care physicians, endocrinologists, and all other clinicians who deal with these patients, pulls together “everything someone needs to think about if they care for patients with CAD and T2DM,” said Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston and vice chair of the statement-writing panel in an interview. “There is a lot to know,” he added.

The statement covers antithrombotic therapies; blood pressure control, with a discussion of both the appropriate pressure goal and the best drug types used to reach it; lipid management; glycemic control; lifestyle modification; weight management, including the role of bariatric surgery; and approaches to managing stable angina, both medically and with revascularization.

“The goal was to give clinicians a good sense of what new treatments they should consider” for these patients, said Dr. Bhatt, who is also director of interventional cardiovascular programs at Brigham and Women’s Hospital, also in Boston. Because of the tight associations between T2DM and cardiovascular disease in general including CAD, “cardiologists are increasingly involved in managing patients with T2DM,” he noted. The statement gives a comprehensive overview and critical assessment of the management of these patients as of the end of 2019 as a consensus from a panel of 11 experts .

The statement also stressed that “substantial portions of patients with T2DM and CAD, including those after an acute coronary syndrome, do not receive therapies with proven cardiovascular benefit, such as high-intensity statins, dual-antiplatelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, and glucose-lowering agents with proven cardiovascular benefits.

“These gaps in care highlight a critical opportunity for cardiovascular specialists to assume a more active role in the collaborative care of patients with T2DM and CAD,” the statement said. This includes “encouraging cardiologists to become more active in the selection of glucose-lowering medications” for these patients because it could “really move the needle,” said Dr. Arnold, a cardiologist with Saint Luke’s Health System in Kansas City, Mo. She was referring specifically to broader reliance on both the SGTL2 (sodium-glucose cotransporter 2) inhibitors and the GLP-1 (glucagonlike peptide-1) receptor agonists as top choices for controlling hyperglycemia. Based on recent evidence drugs in these two classes “could be considered first line for patients with T2DM and CAD, and would likely be preferred over metformin,” Dr. Arnold said in an interview. Although the statement identified the SGLT2 inhibitors as “the first drug class [for glycemic control] to show clear benefits on cardiovascular outcomes,” it does not explicitly label the class first-line and it also skirts that designation for the GLP-1 receptor agonist class, while noting that metformin “remains the drug most frequently recommended as first-line therapy in treatment guidelines.”

“I wouldn’t disagree with someone who said that SGLT2 inhibitors and GLP-1 receptor agonists are first line,” but prescribing patterns also depend on familiarity, cost, and access, noted Dr. Bhatt, which can all be issues with agents from these classes compared with metformin, a widely available generic with decades of use. “Metformin is safe and cheap, so we did not want to discount it,” said Dr. Arnold. Dr. Bhatt recently coauthored an editorial that gave an enthusiastic endorsement to using SGLT2 inhibitors in patients with diabetes (Cell Metab. 2019 Nov 5;30[5]:47-9).

Another notable feature of the statement is the potential it assigns to bariatric surgery as a management tool with documented safety and efficacy for improving cardiovascular risk factors. However, the statement also notes that randomized trials “have thus far been inadequately powered to assess cardiovascular events and mortality, although observational studies have consistently shown cardiovascular risk reduction with such procedures.” The statement continues that despite potential cardiovascular benefits “bariatric surgery remains underused among eligible patients,” and said that surgery performed as Roux-en-Y bypass or sleeve gastrectomy “may be another effective tool for cardiovascular risk reduction in the subset of patients with obesity,” particularly patients with a body mass index of at least 35 kg/m².

“While the percentage of patients who are optimal for bariatric surgery is not known, the most recent NHANES [National Health and Nutrition Examination Study] study showed that less than 0.5% of eligible patients underwent bariatric surgery,” Dr. Arnold noted. Bariatric surgery is “certainly not a recommendation for everyone, or even a majority of patients, but bariatric surgery should be on our radar,” for patients with CAD and T2DM, she said.

Right now, “few cardiologists think about bariatric surgery,” as a treatment option, but study results have shown that “in carefully selected patients treated by skilled surgeons at high-volume centers, patients will do better with bariatric surgery than with best medical therapy for improvements in multiple risk factors, including glycemic control,” Dr. Bhatt said in the interview. “It’s not first-line treatment, but it’s an option to consider,” he added, while also noting that bariatric surgery is most beneficial to patients relatively early in the course of T2DM, when its been in place for just a few years rather than a couple of decades.

The statement also notably included a “first-line” call out for icosapent ethyl (Vascepa), a novel agent approved in December 2019 for routine use in U.S. patients, including those with CAD and T2DM as long as their blood triglyceride level was at least 150 mg/dL. Dr. Bhatt, who led the REDUCE-IT study that was pivotal for proving the safety and efficacy of icosapent ethyl (N Engl J Med. 2019 Jan 3;380[1]:11-22), estimated that anywhere from 15% to as many as half the patients with CAD and T2DM might have a triglyceride level that would allow them to receive icosapent ethyl. One population-based study in Canada of nearly 200,000 people with atherosclerotic cardiovascular disease found a 25% prevalence of the triglyceride level needed to qualify to receive icosapent ethyl under current labeling, he noted (Eur Heart J. 2020 Jan 1;41[1]:86-94). However, the FDA label does not specify that triglycerides be measured when fasting, and a nonfasting level of about 150 mg/dL will likely appear for patients with fasting levels that fall as low as about 100 mg/dL, Dr. Bhatt said. He hoped that future studies will assess the efficacy of icosapent ethyl in patients with even lower triglyceride levels.

Other sections of the statement also recommend that clinicians: Target long-term dual-antiplatelet therapy to CAD and T2DM patients with additional high-risk markers such as prior MI, younger age, and tobacco use; prescribe a low-dose oral anticoagulant along with an antiplatelet drug such as aspirin for secondary-prevention patients; promote a blood pressure target of less than 140/90 mm Hg for all CAD and T2DM patients and apply a goal of less than 130/80 mm Hg in higher-risk patients such as blacks, Asians, and those with cerebrovascular disease; and reassure patients that “despite a modest increase in blood sugars, the risk-benefit ratio is clearly in favor of administering statins to people with T2DM and CAD.”

Dr. Arnold had no disclosures. Dr. Bhatt has been an adviser to Cardax, Cereno Scientific, Medscape Cardiology, PhaseBio; PLx Pharma, and Regado Biosciences, and he has received research funding from numerous companies including Amarin, the company that markets icosapent ethyl.

[email protected]

Patients with stable coronary artery disease and type 2 diabetes mellitus could benefit from a “plethora of newly available risk-reduction strategies,” but their “adoption into clinical practice has been slow” and inconsistent, prompting an expert panel organized by the American Heart Association to collate the range of treatment recommendations now applicable to this patient population in a scientific statement released on April 13.

“There are a number of things to consider when treating patients with stable coronary artery disease [CAD] and type 2 diabetes mellitus [T2DM], with new medications and trials and data emerging. It’s difficult to keep up with all of the complexities,” which was why the Association’s Councils on Lifestyle and Cardiometabolic Health and on Clinical Cardiology put together a writing group to summarize and prioritize the range of lifestyle, medical, and interventional options that now require consideration and potential use on patients managed in routine practice, explained Suzanne V. Arnold, MD, chair of the writing group, in an interview.

The new scientific statement (Circulation. 2020 Apr 13; doi: 10.1161/CIR.0000000000000766), aimed primarily at cardiologists but also intended to inform primary care physicians, endocrinologists, and all other clinicians who deal with these patients, pulls together “everything someone needs to think about if they care for patients with CAD and T2DM,” said Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston and vice chair of the statement-writing panel in an interview. “There is a lot to know,” he added.

The statement covers antithrombotic therapies; blood pressure control, with a discussion of both the appropriate pressure goal and the best drug types used to reach it; lipid management; glycemic control; lifestyle modification; weight management, including the role of bariatric surgery; and approaches to managing stable angina, both medically and with revascularization.

“The goal was to give clinicians a good sense of what new treatments they should consider” for these patients, said Dr. Bhatt, who is also director of interventional cardiovascular programs at Brigham and Women’s Hospital, also in Boston. Because of the tight associations between T2DM and cardiovascular disease in general including CAD, “cardiologists are increasingly involved in managing patients with T2DM,” he noted. The statement gives a comprehensive overview and critical assessment of the management of these patients as of the end of 2019 as a consensus from a panel of 11 experts .

The statement also stressed that “substantial portions of patients with T2DM and CAD, including those after an acute coronary syndrome, do not receive therapies with proven cardiovascular benefit, such as high-intensity statins, dual-antiplatelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, and glucose-lowering agents with proven cardiovascular benefits.

“These gaps in care highlight a critical opportunity for cardiovascular specialists to assume a more active role in the collaborative care of patients with T2DM and CAD,” the statement said. This includes “encouraging cardiologists to become more active in the selection of glucose-lowering medications” for these patients because it could “really move the needle,” said Dr. Arnold, a cardiologist with Saint Luke’s Health System in Kansas City, Mo. She was referring specifically to broader reliance on both the SGTL2 (sodium-glucose cotransporter 2) inhibitors and the GLP-1 (glucagonlike peptide-1) receptor agonists as top choices for controlling hyperglycemia. Based on recent evidence drugs in these two classes “could be considered first line for patients with T2DM and CAD, and would likely be preferred over metformin,” Dr. Arnold said in an interview. Although the statement identified the SGLT2 inhibitors as “the first drug class [for glycemic control] to show clear benefits on cardiovascular outcomes,” it does not explicitly label the class first-line and it also skirts that designation for the GLP-1 receptor agonist class, while noting that metformin “remains the drug most frequently recommended as first-line therapy in treatment guidelines.”

“I wouldn’t disagree with someone who said that SGLT2 inhibitors and GLP-1 receptor agonists are first line,” but prescribing patterns also depend on familiarity, cost, and access, noted Dr. Bhatt, which can all be issues with agents from these classes compared with metformin, a widely available generic with decades of use. “Metformin is safe and cheap, so we did not want to discount it,” said Dr. Arnold. Dr. Bhatt recently coauthored an editorial that gave an enthusiastic endorsement to using SGLT2 inhibitors in patients with diabetes (Cell Metab. 2019 Nov 5;30[5]:47-9).

Another notable feature of the statement is the potential it assigns to bariatric surgery as a management tool with documented safety and efficacy for improving cardiovascular risk factors. However, the statement also notes that randomized trials “have thus far been inadequately powered to assess cardiovascular events and mortality, although observational studies have consistently shown cardiovascular risk reduction with such procedures.” The statement continues that despite potential cardiovascular benefits “bariatric surgery remains underused among eligible patients,” and said that surgery performed as Roux-en-Y bypass or sleeve gastrectomy “may be another effective tool for cardiovascular risk reduction in the subset of patients with obesity,” particularly patients with a body mass index of at least 35 kg/m².

“While the percentage of patients who are optimal for bariatric surgery is not known, the most recent NHANES [National Health and Nutrition Examination Study] study showed that less than 0.5% of eligible patients underwent bariatric surgery,” Dr. Arnold noted. Bariatric surgery is “certainly not a recommendation for everyone, or even a majority of patients, but bariatric surgery should be on our radar,” for patients with CAD and T2DM, she said.

Right now, “few cardiologists think about bariatric surgery,” as a treatment option, but study results have shown that “in carefully selected patients treated by skilled surgeons at high-volume centers, patients will do better with bariatric surgery than with best medical therapy for improvements in multiple risk factors, including glycemic control,” Dr. Bhatt said in the interview. “It’s not first-line treatment, but it’s an option to consider,” he added, while also noting that bariatric surgery is most beneficial to patients relatively early in the course of T2DM, when its been in place for just a few years rather than a couple of decades.

The statement also notably included a “first-line” call out for icosapent ethyl (Vascepa), a novel agent approved in December 2019 for routine use in U.S. patients, including those with CAD and T2DM as long as their blood triglyceride level was at least 150 mg/dL. Dr. Bhatt, who led the REDUCE-IT study that was pivotal for proving the safety and efficacy of icosapent ethyl (N Engl J Med. 2019 Jan 3;380[1]:11-22), estimated that anywhere from 15% to as many as half the patients with CAD and T2DM might have a triglyceride level that would allow them to receive icosapent ethyl. One population-based study in Canada of nearly 200,000 people with atherosclerotic cardiovascular disease found a 25% prevalence of the triglyceride level needed to qualify to receive icosapent ethyl under current labeling, he noted (Eur Heart J. 2020 Jan 1;41[1]:86-94). However, the FDA label does not specify that triglycerides be measured when fasting, and a nonfasting level of about 150 mg/dL will likely appear for patients with fasting levels that fall as low as about 100 mg/dL, Dr. Bhatt said. He hoped that future studies will assess the efficacy of icosapent ethyl in patients with even lower triglyceride levels.

Other sections of the statement also recommend that clinicians: Target long-term dual-antiplatelet therapy to CAD and T2DM patients with additional high-risk markers such as prior MI, younger age, and tobacco use; prescribe a low-dose oral anticoagulant along with an antiplatelet drug such as aspirin for secondary-prevention patients; promote a blood pressure target of less than 140/90 mm Hg for all CAD and T2DM patients and apply a goal of less than 130/80 mm Hg in higher-risk patients such as blacks, Asians, and those with cerebrovascular disease; and reassure patients that “despite a modest increase in blood sugars, the risk-benefit ratio is clearly in favor of administering statins to people with T2DM and CAD.”

Dr. Arnold had no disclosures. Dr. Bhatt has been an adviser to Cardax, Cereno Scientific, Medscape Cardiology, PhaseBio; PLx Pharma, and Regado Biosciences, and he has received research funding from numerous companies including Amarin, the company that markets icosapent ethyl.

[email protected]

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

[email protected]

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

[email protected]

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

[email protected]

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

[email protected]

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

[email protected]

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

[email protected]

The Centers for Disease Control and Prevention is releasing new guidance on return-to-work rules for critical workers exposed to a COVID-19 case, or a suspected case, replacing previous guidance to stay home for 14 days.

“One of the most important things we can do is keep our critical workforce working,” CDC Director Robert Redfield said at a White House briefing on April 8. “In certain circumstances they can go back to work,” he said.

Neither Redfield nor the other governmental officials specified what counts as an essential worker, although it has generally referred to food-service and health care workers.

They must take their temperature before work, wear a facial mask at all times and practice social distancing when at work, the new guidance says. They cannot share headsets or other objects used near the face.

Employers must take the worker’s temperature and assess each one for symptoms before work starts, sending a worker home if he or she is sick. Employers must increase the cleaning of frequently used surfaces, increase air exchange in the building and test the use of face masks to be sure they do not interfere with workflow.

Pressed on whether he would reopen the country at the end of the 30-day Stop the Spread effort on April 30 — since one model has revised the U.S. death toll down from 100,000-240,000 to 61,000 — President Donald Trump said meetings will take place soon to discuss the decision and that he will ‘’rely very heavily” on health experts.

“We know now for sure that the mitigation we have been doing is having a positive effect,” said Anthony Fauci, MD, a coronavirus task force member and director of the National Institute of Allergy and Infectious Diseases.
 

This article first appeared on WebMD.

The Centers for Disease Control and Prevention is releasing new guidance on return-to-work rules for critical workers exposed to a COVID-19 case, or a suspected case, replacing previous guidance to stay home for 14 days.

“One of the most important things we can do is keep our critical workforce working,” CDC Director Robert Redfield said at a White House briefing on April 8. “In certain circumstances they can go back to work,” he said.

Neither Redfield nor the other governmental officials specified what counts as an essential worker, although it has generally referred to food-service and health care workers.

They must take their temperature before work, wear a facial mask at all times and practice social distancing when at work, the new guidance says. They cannot share headsets or other objects used near the face.

Employers must take the worker’s temperature and assess each one for symptoms before work starts, sending a worker home if he or she is sick. Employers must increase the cleaning of frequently used surfaces, increase air exchange in the building and test the use of face masks to be sure they do not interfere with workflow.

Pressed on whether he would reopen the country at the end of the 30-day Stop the Spread effort on April 30 — since one model has revised the U.S. death toll down from 100,000-240,000 to 61,000 — President Donald Trump said meetings will take place soon to discuss the decision and that he will ‘’rely very heavily” on health experts.

“We know now for sure that the mitigation we have been doing is having a positive effect,” said Anthony Fauci, MD, a coronavirus task force member and director of the National Institute of Allergy and Infectious Diseases.
 

This article first appeared on WebMD.

The Centers for Disease Control and Prevention is releasing new guidance on return-to-work rules for critical workers exposed to a COVID-19 case, or a suspected case, replacing previous guidance to stay home for 14 days.

“One of the most important things we can do is keep our critical workforce working,” CDC Director Robert Redfield said at a White House briefing on April 8. “In certain circumstances they can go back to work,” he said.

Neither Redfield nor the other governmental officials specified what counts as an essential worker, although it has generally referred to food-service and health care workers.

They must take their temperature before work, wear a facial mask at all times and practice social distancing when at work, the new guidance says. They cannot share headsets or other objects used near the face.

Employers must take the worker’s temperature and assess each one for symptoms before work starts, sending a worker home if he or she is sick. Employers must increase the cleaning of frequently used surfaces, increase air exchange in the building and test the use of face masks to be sure they do not interfere with workflow.

Pressed on whether he would reopen the country at the end of the 30-day Stop the Spread effort on April 30 — since one model has revised the U.S. death toll down from 100,000-240,000 to 61,000 — President Donald Trump said meetings will take place soon to discuss the decision and that he will ‘’rely very heavily” on health experts.

“We know now for sure that the mitigation we have been doing is having a positive effect,” said Anthony Fauci, MD, a coronavirus task force member and director of the National Institute of Allergy and Infectious Diseases.
 

This article first appeared on WebMD.

Transcatheter aortic valve replacement (TAVR) continued to show superiority over surgical replacement in terms of the primary composite endpoint in low-surgical-risk patients at 2 years of follow-up in the landmark randomized PARTNER 3 trial, but the between-group differences favoring the transcatheter procedure in some key outcomes have narrowed considerably, Michael J. Mack, MD, reported in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

“On the basis of 1-year data, many physicians were counseling patients that TAVR outcomes were better than surgery. Now we see that the outcomes are roughly the same at 2 years,” said Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

PARTNER 3 randomized 1,000 patients with severe symptomatic aortic stenosis with a tricuspid valve and a very low mean Society of Thoracic Surgeons risk score of 1.9% to TAVR with the Sapien 3 valve or surgical aortic valve replacement (SAVR). The 1-year results presented at ACC 2019 caused a huge stir, with the primary composite outcome of death, stroke, or cardiovascular rehospitalization occurring in 8.5% of TAVR patients and 15.6% of the SAVR group, representing a 48% relative risk reduction and a resounding win for TAVR (N Engl J Med. 2019 May 2;380:1695-705). At 2 years, the difference in the composite outcome remained statistically significant, but the gap had closed: 11.5% with TAVR and 17.4% with SAVR for a 37% relative risk reduction.

Moreover, the between-group difference in stroke, which at 1 year was significantly in favor of TAVR at 1.2% versus 3.3%, was no longer significant at 2 years, with rates of 2.4% versus 3.6%. Nor was the difference in mortality significant: 2.4% with TAVR, 3.2% with SAVR.

What was a statistically significant between-group difference at 2 years – and an eye-catching one at that – involved the cumulative incidence of valve thrombosis confirmed by CT or echocardiography: 2.6% in the TAVR arm, compared with 0.7% with SAVR, with most of these unwanted events coming in year 2.

The good news was there was no echocardiographic evidence of deterioration in valve structure or function in either study arm at 2 years. The mean gradients and aortic valve areas remained unchanged in both arms between 1 and 2 years, as did the frequency of mild or moderate paravalvular leak. Prospective follow-up will continue annually out to 10 years.

“I think it’s way too early to expect to see a signal, but I think it’s somewhat comforting at this point that there’s no signal of early structural valve deterioration,” Dr. Mack said.

Discussant Howard C. Hermann, MD, commented: “I guess the biggest concern in looking at the data is the increase in stroke and valve thrombosis, both numerically and relative to SAVR, between years 1 and 2.”

Dr. Mack offered a note of reassurance regarding the valve thrombosis findings: The rates he presented were based upon the now-outdated second Valve Academic Research Consortium (VARC-2) definition, per study protocol. When he and his coinvestigators recalculated the valve thrombosis rates using the contemporary VARC-3 definition of valve deterioration and bioprosthetic valve failure, the incidence was very low and not significantly different in the two study arms, at roughly 1%.

Dr. Hermann, professor of medicine and director of the cardiac catheterization laboratories at the University of Pennsylvania, Philadelphia, had a question: As a clinician taking care of TAVR patients, what clinical or hemodynamic findings should prompt an imaging study looking for valve thrombus or deterioration that might prompt initiating oral anticoagulation?

“If there’s a change in hemodynamics, an increasing valve gradient, if there’s increasing paravalvular leak, or if there’s a change in symptoms, that should prompt an imaging study. Only with confirmation of valve thrombosis on an imaging study should anticoagulation be considered. Oral anticoagulation is not benign: Of the six clinical events associated with valve thrombosis in the study, two were related to anticoagulation,” Dr. Mack replied.

“Regarding whether patients should receive warfarin or a novel anticoagulant, I don’t think we have evidence that there’s benefit to anything other than warfarin at the current time,” he added.

Dr. Mack reported receiving research support from Edwards Lifesciences, the sponsor of PARTNER 3, as well as from Abbott, Gore, and Medtronic.

[email protected]

Transcatheter aortic valve replacement (TAVR) continued to show superiority over surgical replacement in terms of the primary composite endpoint in low-surgical-risk patients at 2 years of follow-up in the landmark randomized PARTNER 3 trial, but the between-group differences favoring the transcatheter procedure in some key outcomes have narrowed considerably, Michael J. Mack, MD, reported in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

“On the basis of 1-year data, many physicians were counseling patients that TAVR outcomes were better than surgery. Now we see that the outcomes are roughly the same at 2 years,” said Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

PARTNER 3 randomized 1,000 patients with severe symptomatic aortic stenosis with a tricuspid valve and a very low mean Society of Thoracic Surgeons risk score of 1.9% to TAVR with the Sapien 3 valve or surgical aortic valve replacement (SAVR). The 1-year results presented at ACC 2019 caused a huge stir, with the primary composite outcome of death, stroke, or cardiovascular rehospitalization occurring in 8.5% of TAVR patients and 15.6% of the SAVR group, representing a 48% relative risk reduction and a resounding win for TAVR (N Engl J Med. 2019 May 2;380:1695-705). At 2 years, the difference in the composite outcome remained statistically significant, but the gap had closed: 11.5% with TAVR and 17.4% with SAVR for a 37% relative risk reduction.

Moreover, the between-group difference in stroke, which at 1 year was significantly in favor of TAVR at 1.2% versus 3.3%, was no longer significant at 2 years, with rates of 2.4% versus 3.6%. Nor was the difference in mortality significant: 2.4% with TAVR, 3.2% with SAVR.

What was a statistically significant between-group difference at 2 years – and an eye-catching one at that – involved the cumulative incidence of valve thrombosis confirmed by CT or echocardiography: 2.6% in the TAVR arm, compared with 0.7% with SAVR, with most of these unwanted events coming in year 2.

The good news was there was no echocardiographic evidence of deterioration in valve structure or function in either study arm at 2 years. The mean gradients and aortic valve areas remained unchanged in both arms between 1 and 2 years, as did the frequency of mild or moderate paravalvular leak. Prospective follow-up will continue annually out to 10 years.

“I think it’s way too early to expect to see a signal, but I think it’s somewhat comforting at this point that there’s no signal of early structural valve deterioration,” Dr. Mack said.

Discussant Howard C. Hermann, MD, commented: “I guess the biggest concern in looking at the data is the increase in stroke and valve thrombosis, both numerically and relative to SAVR, between years 1 and 2.”

Dr. Mack offered a note of reassurance regarding the valve thrombosis findings: The rates he presented were based upon the now-outdated second Valve Academic Research Consortium (VARC-2) definition, per study protocol. When he and his coinvestigators recalculated the valve thrombosis rates using the contemporary VARC-3 definition of valve deterioration and bioprosthetic valve failure, the incidence was very low and not significantly different in the two study arms, at roughly 1%.

Dr. Hermann, professor of medicine and director of the cardiac catheterization laboratories at the University of Pennsylvania, Philadelphia, had a question: As a clinician taking care of TAVR patients, what clinical or hemodynamic findings should prompt an imaging study looking for valve thrombus or deterioration that might prompt initiating oral anticoagulation?

“If there’s a change in hemodynamics, an increasing valve gradient, if there’s increasing paravalvular leak, or if there’s a change in symptoms, that should prompt an imaging study. Only with confirmation of valve thrombosis on an imaging study should anticoagulation be considered. Oral anticoagulation is not benign: Of the six clinical events associated with valve thrombosis in the study, two were related to anticoagulation,” Dr. Mack replied.

“Regarding whether patients should receive warfarin or a novel anticoagulant, I don’t think we have evidence that there’s benefit to anything other than warfarin at the current time,” he added.

Dr. Mack reported receiving research support from Edwards Lifesciences, the sponsor of PARTNER 3, as well as from Abbott, Gore, and Medtronic.

[email protected]

Transcatheter aortic valve replacement (TAVR) continued to show superiority over surgical replacement in terms of the primary composite endpoint in low-surgical-risk patients at 2 years of follow-up in the landmark randomized PARTNER 3 trial, but the between-group differences favoring the transcatheter procedure in some key outcomes have narrowed considerably, Michael J. Mack, MD, reported in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

“On the basis of 1-year data, many physicians were counseling patients that TAVR outcomes were better than surgery. Now we see that the outcomes are roughly the same at 2 years,” said Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

PARTNER 3 randomized 1,000 patients with severe symptomatic aortic stenosis with a tricuspid valve and a very low mean Society of Thoracic Surgeons risk score of 1.9% to TAVR with the Sapien 3 valve or surgical aortic valve replacement (SAVR). The 1-year results presented at ACC 2019 caused a huge stir, with the primary composite outcome of death, stroke, or cardiovascular rehospitalization occurring in 8.5% of TAVR patients and 15.6% of the SAVR group, representing a 48% relative risk reduction and a resounding win for TAVR (N Engl J Med. 2019 May 2;380:1695-705). At 2 years, the difference in the composite outcome remained statistically significant, but the gap had closed: 11.5% with TAVR and 17.4% with SAVR for a 37% relative risk reduction.

Moreover, the between-group difference in stroke, which at 1 year was significantly in favor of TAVR at 1.2% versus 3.3%, was no longer significant at 2 years, with rates of 2.4% versus 3.6%. Nor was the difference in mortality significant: 2.4% with TAVR, 3.2% with SAVR.

What was a statistically significant between-group difference at 2 years – and an eye-catching one at that – involved the cumulative incidence of valve thrombosis confirmed by CT or echocardiography: 2.6% in the TAVR arm, compared with 0.7% with SAVR, with most of these unwanted events coming in year 2.

The good news was there was no echocardiographic evidence of deterioration in valve structure or function in either study arm at 2 years. The mean gradients and aortic valve areas remained unchanged in both arms between 1 and 2 years, as did the frequency of mild or moderate paravalvular leak. Prospective follow-up will continue annually out to 10 years.

“I think it’s way too early to expect to see a signal, but I think it’s somewhat comforting at this point that there’s no signal of early structural valve deterioration,” Dr. Mack said.

Discussant Howard C. Hermann, MD, commented: “I guess the biggest concern in looking at the data is the increase in stroke and valve thrombosis, both numerically and relative to SAVR, between years 1 and 2.”

Dr. Mack offered a note of reassurance regarding the valve thrombosis findings: The rates he presented were based upon the now-outdated second Valve Academic Research Consortium (VARC-2) definition, per study protocol. When he and his coinvestigators recalculated the valve thrombosis rates using the contemporary VARC-3 definition of valve deterioration and bioprosthetic valve failure, the incidence was very low and not significantly different in the two study arms, at roughly 1%.

Dr. Hermann, professor of medicine and director of the cardiac catheterization laboratories at the University of Pennsylvania, Philadelphia, had a question: As a clinician taking care of TAVR patients, what clinical or hemodynamic findings should prompt an imaging study looking for valve thrombus or deterioration that might prompt initiating oral anticoagulation?

“If there’s a change in hemodynamics, an increasing valve gradient, if there’s increasing paravalvular leak, or if there’s a change in symptoms, that should prompt an imaging study. Only with confirmation of valve thrombosis on an imaging study should anticoagulation be considered. Oral anticoagulation is not benign: Of the six clinical events associated with valve thrombosis in the study, two were related to anticoagulation,” Dr. Mack replied.

“Regarding whether patients should receive warfarin or a novel anticoagulant, I don’t think we have evidence that there’s benefit to anything other than warfarin at the current time,” he added.

Dr. Mack reported receiving research support from Edwards Lifesciences, the sponsor of PARTNER 3, as well as from Abbott, Gore, and Medtronic.

[email protected]

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

The American Lung Association has launched a $25 million initiative to end COVID-19 and defend against future respiratory virus pandemics.

The goals of the COVID-19 Action Initiative will be to expand the ALA’s respiratory research program, improve public health measures, and create an advanced network to prevent future respiratory virus pandemics. In cooperation with the public and private sectors, the initiative will promote research collaboration and develop new vaccines, diagnostic tests, and therapies. The initiative will take advantage of the ALA’s current research network and will also fund respiratory virus research. It also will fund education and advocacy to support public health measures against current and future respiratory viruses.

The COVID-19 Action Initiative will fund respiratory virus research through three main activities. It will expand COVID-19 research within the current clinical trials of the Airways Clinical Research Center (ACRC) Network. Second, it will fund coronavirus awards and grants for preventive research, vaccines, antivirals, and efforts to promote preparedness for future outbreaks. Third, it will provide ACRC pilot grants to evaluate the effect of COVID-19 on patients with chronic lung disease.

“More than 36 million people in the U.S. suffer from lung disease, which places them at higher risk for experiencing complications of COVID-19, making it even more critical that we urgently work on reducing its impact,” said Harold Wimmer, president and CEO of the ALA, in a press release.

The ALA has $8 million available and earmarked for the initiative. The association plans to raise additional funds during the next 3 years by reaching out to corporate partners, public health entities, and individuals. “With the help of our staff and volunteers, and with the support and donations of generous Americans, we can stand together and face the challenges to lung health of today and tomorrow,” said Mr. Wimmer in a press briefing.
 

[email protected]

The American Lung Association has launched a $25 million initiative to end COVID-19 and defend against future respiratory virus pandemics.

The goals of the COVID-19 Action Initiative will be to expand the ALA’s respiratory research program, improve public health measures, and create an advanced network to prevent future respiratory virus pandemics. In cooperation with the public and private sectors, the initiative will promote research collaboration and develop new vaccines, diagnostic tests, and therapies. The initiative will take advantage of the ALA’s current research network and will also fund respiratory virus research. It also will fund education and advocacy to support public health measures against current and future respiratory viruses.

The COVID-19 Action Initiative will fund respiratory virus research through three main activities. It will expand COVID-19 research within the current clinical trials of the Airways Clinical Research Center (ACRC) Network. Second, it will fund coronavirus awards and grants for preventive research, vaccines, antivirals, and efforts to promote preparedness for future outbreaks. Third, it will provide ACRC pilot grants to evaluate the effect of COVID-19 on patients with chronic lung disease.

“More than 36 million people in the U.S. suffer from lung disease, which places them at higher risk for experiencing complications of COVID-19, making it even more critical that we urgently work on reducing its impact,” said Harold Wimmer, president and CEO of the ALA, in a press release.

The ALA has $8 million available and earmarked for the initiative. The association plans to raise additional funds during the next 3 years by reaching out to corporate partners, public health entities, and individuals. “With the help of our staff and volunteers, and with the support and donations of generous Americans, we can stand together and face the challenges to lung health of today and tomorrow,” said Mr. Wimmer in a press briefing.
 

[email protected]

The American Lung Association has launched a $25 million initiative to end COVID-19 and defend against future respiratory virus pandemics.

The goals of the COVID-19 Action Initiative will be to expand the ALA’s respiratory research program, improve public health measures, and create an advanced network to prevent future respiratory virus pandemics. In cooperation with the public and private sectors, the initiative will promote research collaboration and develop new vaccines, diagnostic tests, and therapies. The initiative will take advantage of the ALA’s current research network and will also fund respiratory virus research. It also will fund education and advocacy to support public health measures against current and future respiratory viruses.

The COVID-19 Action Initiative will fund respiratory virus research through three main activities. It will expand COVID-19 research within the current clinical trials of the Airways Clinical Research Center (ACRC) Network. Second, it will fund coronavirus awards and grants for preventive research, vaccines, antivirals, and efforts to promote preparedness for future outbreaks. Third, it will provide ACRC pilot grants to evaluate the effect of COVID-19 on patients with chronic lung disease.

“More than 36 million people in the U.S. suffer from lung disease, which places them at higher risk for experiencing complications of COVID-19, making it even more critical that we urgently work on reducing its impact,” said Harold Wimmer, president and CEO of the ALA, in a press release.

The ALA has $8 million available and earmarked for the initiative. The association plans to raise additional funds during the next 3 years by reaching out to corporate partners, public health entities, and individuals. “With the help of our staff and volunteers, and with the support and donations of generous Americans, we can stand together and face the challenges to lung health of today and tomorrow,” said Mr. Wimmer in a press briefing.
 

[email protected]

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

[email protected]

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

[email protected]

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

[email protected]

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.