Mixed Topics

As of April 9, 2020, the Centers for Disease Control and Prevention (CDC) reported that 9,282 health care providers in the US had contracted COVID-19, and 27 had died of the virus.² Medscape reports the toll as much higher. Thousands more nurses, doctors, epidemiologists, social workers, physician assistants, dentists, pharmacists, and other health care workers from Italy, China, and dozens of other countries have died fighting this plague.³

The truth is no one knows how many health care workers are actually sick or even have died. State and federal governments have not been routinely and specifically tracking that data, making these already grim statistics likely a gross underestimation.⁴ While not all of these health care providers were exposed to COVID-19 in the line of duty, many were, and many more will be as the pandemic subsides in one epicenter only to erupt in another, and smolders for months until a vaccine quenches it.

Each of those lost lives of promise had a story of hard work and sacrifice to become a health care professional, of friends and family who loved and cared for them when ill, who need and grieve for them, now gone far too soon. Nor should we forget to mourn all of the administrative professionals, the line and support staff of health care facilities, who also perished fighting the pestilence. It is fitting then, that this second editorial in my pledge to write each month about COVID-19 until the pandemic ends, be about the duty to care and its limits.

The duty to care is among the most fundamental and ancient ethical obligations of health care providers. It is included even in modern codes of ethics like that of the American Medical Association and American Nurses Association. The obligation to not abandon patients is even more compelling for the Military Health System, Veterans Health Administration (VHA), and the US Public Health Service whose health care mission also is a public trust. The duty is rooted in the fiduciary nature of the health professions in which the interests of the patient should take priority over other considerations, including a risk to their own health and life. Prioritization though has exceptions. Physician and attorney David Orentlicher points out the unconditional obligation that bound physicians in the 14th century Black Death, or the 1918 Spanish influenza, now admits exceptions and qualifications.⁵

The exception that has become the object of greatest concern to health care workers is personal protective equipment (PPE). In modern public health ethics, health care systems and state and federal governments have a corresponding ethical obligation of reciprocity toward their employees whose work places them at elevated risk of harm—in this case, COVID-19 exposure. The principle of reciprocity encompasses the measures and materials that health care institutions need to provide to health care workers to reasonably minimize the risk of viral transmission. The reasonableness standard does not demand that there be zero risk. It does require that health care workers have adequate and appropriate PPE so that in fulfilling their duty to care they are not exposed to a disproportionate risk.

This last assertion has been the subject of controversy in the media and consternation on the part of health care professionals for several disconcerting reasons. First and foremost, a cascade failure on the part of government and industry has resulted in PPE being the scarcest health care resource in this pandemic.⁶ The shortage is as serious as that of the life-saving ventilators that are rightly at the center of most crisis standards resource allocation plans.⁷ Second, the guidance from the CDC and other authoritative sources continues to change. This is, in part, to adjust to the even more rapid pace of knowledge about the virus and its behavior and to adapt to the reality of insufficient PPE.⁸

Understandably, health care providers, especially those on the frontlines, may lose trust in the scientific experts and the leadership of their institutions, compounding the climate of moral distress in a public health crisis. Health care workers in the community, and even in federal service, have launched socially distanced protests and taken to social media to voice their concern and rally assistance.^9,10 In response, VHA Executive-in-Charge Richard Stone, MD, admitted that VHA does have a shortage of PPE in a Washington Post interview.¹¹ He outlined how the organization plans to address staff concerns. The article also reported only a 4% absentee rate of VHA staff as opposed to the 40% that plans predicted was possible. This demonstrates once more the dedication of VHA health care professionals and workers to fulfill their duty to care for veterans even amid fears about inadequate PPE.

In the epigraph, Albert Camus captures the uncertainty and fear that as humans all health care providers experience as they face the unpredictable but very real threat of COVID-19.¹ Camus expresses even more strongly the devotion to duty of health care providers to care for vulnerable ill patients in need despite the inherent threat in a highly transmissible and potentially deadly infection that is inextricably linked to that caring. Orentlicher wisely opines that the integrity of the health professions and their respected role in society benefit from a strong duty to care.⁵ The best way to promote that duty is to do all in our power to protect those who willingly brave the pestilence to treat, and hope and pray someday to cure COVID-19.

As of April 9, 2020, the Centers for Disease Control and Prevention (CDC) reported that 9,282 health care providers in the US had contracted COVID-19, and 27 had died of the virus.² Medscape reports the toll as much higher. Thousands more nurses, doctors, epidemiologists, social workers, physician assistants, dentists, pharmacists, and other health care workers from Italy, China, and dozens of other countries have died fighting this plague.³

The truth is no one knows how many health care workers are actually sick or even have died. State and federal governments have not been routinely and specifically tracking that data, making these already grim statistics likely a gross underestimation.⁴ While not all of these health care providers were exposed to COVID-19 in the line of duty, many were, and many more will be as the pandemic subsides in one epicenter only to erupt in another, and smolders for months until a vaccine quenches it.

Each of those lost lives of promise had a story of hard work and sacrifice to become a health care professional, of friends and family who loved and cared for them when ill, who need and grieve for them, now gone far too soon. Nor should we forget to mourn all of the administrative professionals, the line and support staff of health care facilities, who also perished fighting the pestilence. It is fitting then, that this second editorial in my pledge to write each month about COVID-19 until the pandemic ends, be about the duty to care and its limits.

The duty to care is among the most fundamental and ancient ethical obligations of health care providers. It is included even in modern codes of ethics like that of the American Medical Association and American Nurses Association. The obligation to not abandon patients is even more compelling for the Military Health System, Veterans Health Administration (VHA), and the US Public Health Service whose health care mission also is a public trust. The duty is rooted in the fiduciary nature of the health professions in which the interests of the patient should take priority over other considerations, including a risk to their own health and life. Prioritization though has exceptions. Physician and attorney David Orentlicher points out the unconditional obligation that bound physicians in the 14th century Black Death, or the 1918 Spanish influenza, now admits exceptions and qualifications.⁵

The exception that has become the object of greatest concern to health care workers is personal protective equipment (PPE). In modern public health ethics, health care systems and state and federal governments have a corresponding ethical obligation of reciprocity toward their employees whose work places them at elevated risk of harm—in this case, COVID-19 exposure. The principle of reciprocity encompasses the measures and materials that health care institutions need to provide to health care workers to reasonably minimize the risk of viral transmission. The reasonableness standard does not demand that there be zero risk. It does require that health care workers have adequate and appropriate PPE so that in fulfilling their duty to care they are not exposed to a disproportionate risk.

This last assertion has been the subject of controversy in the media and consternation on the part of health care professionals for several disconcerting reasons. First and foremost, a cascade failure on the part of government and industry has resulted in PPE being the scarcest health care resource in this pandemic.⁶ The shortage is as serious as that of the life-saving ventilators that are rightly at the center of most crisis standards resource allocation plans.⁷ Second, the guidance from the CDC and other authoritative sources continues to change. This is, in part, to adjust to the even more rapid pace of knowledge about the virus and its behavior and to adapt to the reality of insufficient PPE.⁸

Understandably, health care providers, especially those on the frontlines, may lose trust in the scientific experts and the leadership of their institutions, compounding the climate of moral distress in a public health crisis. Health care workers in the community, and even in federal service, have launched socially distanced protests and taken to social media to voice their concern and rally assistance.^9,10 In response, VHA Executive-in-Charge Richard Stone, MD, admitted that VHA does have a shortage of PPE in a Washington Post interview.¹¹ He outlined how the organization plans to address staff concerns. The article also reported only a 4% absentee rate of VHA staff as opposed to the 40% that plans predicted was possible. This demonstrates once more the dedication of VHA health care professionals and workers to fulfill their duty to care for veterans even amid fears about inadequate PPE.

In the epigraph, Albert Camus captures the uncertainty and fear that as humans all health care providers experience as they face the unpredictable but very real threat of COVID-19.¹ Camus expresses even more strongly the devotion to duty of health care providers to care for vulnerable ill patients in need despite the inherent threat in a highly transmissible and potentially deadly infection that is inextricably linked to that caring. Orentlicher wisely opines that the integrity of the health professions and their respected role in society benefit from a strong duty to care.⁵ The best way to promote that duty is to do all in our power to protect those who willingly brave the pestilence to treat, and hope and pray someday to cure COVID-19.

As of April 9, 2020, the Centers for Disease Control and Prevention (CDC) reported that 9,282 health care providers in the US had contracted COVID-19, and 27 had died of the virus.² Medscape reports the toll as much higher. Thousands more nurses, doctors, epidemiologists, social workers, physician assistants, dentists, pharmacists, and other health care workers from Italy, China, and dozens of other countries have died fighting this plague.³

The truth is no one knows how many health care workers are actually sick or even have died. State and federal governments have not been routinely and specifically tracking that data, making these already grim statistics likely a gross underestimation.⁴ While not all of these health care providers were exposed to COVID-19 in the line of duty, many were, and many more will be as the pandemic subsides in one epicenter only to erupt in another, and smolders for months until a vaccine quenches it.

Each of those lost lives of promise had a story of hard work and sacrifice to become a health care professional, of friends and family who loved and cared for them when ill, who need and grieve for them, now gone far too soon. Nor should we forget to mourn all of the administrative professionals, the line and support staff of health care facilities, who also perished fighting the pestilence. It is fitting then, that this second editorial in my pledge to write each month about COVID-19 until the pandemic ends, be about the duty to care and its limits.

The duty to care is among the most fundamental and ancient ethical obligations of health care providers. It is included even in modern codes of ethics like that of the American Medical Association and American Nurses Association. The obligation to not abandon patients is even more compelling for the Military Health System, Veterans Health Administration (VHA), and the US Public Health Service whose health care mission also is a public trust. The duty is rooted in the fiduciary nature of the health professions in which the interests of the patient should take priority over other considerations, including a risk to their own health and life. Prioritization though has exceptions. Physician and attorney David Orentlicher points out the unconditional obligation that bound physicians in the 14th century Black Death, or the 1918 Spanish influenza, now admits exceptions and qualifications.⁵

The exception that has become the object of greatest concern to health care workers is personal protective equipment (PPE). In modern public health ethics, health care systems and state and federal governments have a corresponding ethical obligation of reciprocity toward their employees whose work places them at elevated risk of harm—in this case, COVID-19 exposure. The principle of reciprocity encompasses the measures and materials that health care institutions need to provide to health care workers to reasonably minimize the risk of viral transmission. The reasonableness standard does not demand that there be zero risk. It does require that health care workers have adequate and appropriate PPE so that in fulfilling their duty to care they are not exposed to a disproportionate risk.

This last assertion has been the subject of controversy in the media and consternation on the part of health care professionals for several disconcerting reasons. First and foremost, a cascade failure on the part of government and industry has resulted in PPE being the scarcest health care resource in this pandemic.⁶ The shortage is as serious as that of the life-saving ventilators that are rightly at the center of most crisis standards resource allocation plans.⁷ Second, the guidance from the CDC and other authoritative sources continues to change. This is, in part, to adjust to the even more rapid pace of knowledge about the virus and its behavior and to adapt to the reality of insufficient PPE.⁸

Understandably, health care providers, especially those on the frontlines, may lose trust in the scientific experts and the leadership of their institutions, compounding the climate of moral distress in a public health crisis. Health care workers in the community, and even in federal service, have launched socially distanced protests and taken to social media to voice their concern and rally assistance.^9,10 In response, VHA Executive-in-Charge Richard Stone, MD, admitted that VHA does have a shortage of PPE in a Washington Post interview.¹¹ He outlined how the organization plans to address staff concerns. The article also reported only a 4% absentee rate of VHA staff as opposed to the 40% that plans predicted was possible. This demonstrates once more the dedication of VHA health care professionals and workers to fulfill their duty to care for veterans even amid fears about inadequate PPE.

In the epigraph, Albert Camus captures the uncertainty and fear that as humans all health care providers experience as they face the unpredictable but very real threat of COVID-19.¹ Camus expresses even more strongly the devotion to duty of health care providers to care for vulnerable ill patients in need despite the inherent threat in a highly transmissible and potentially deadly infection that is inextricably linked to that caring. Orentlicher wisely opines that the integrity of the health professions and their respected role in society benefit from a strong duty to care.⁵ The best way to promote that duty is to do all in our power to protect those who willingly brave the pestilence to treat, and hope and pray someday to cure COVID-19.

Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.

The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.

The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.

The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

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

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

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

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

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

The Diagnosis: Rumpel-Leede Phenomenon 

Rumpel-Leede (R-L) phenomenon describes the rare benign occurrence of dermal capillaries acutely rupturing following the administration of a tourniquetlike force on an extremity,¹ which manifests as asymptomatic petechiae and ecchymoses on a distal extremity, usually following noninvasive measurement of blood pressure.² Rumpel-Leede phenomenon represents an underrecognized entity that either is excluded or minimally referenced in most dermatology textbooks. The R-L sign initially was described in the early 1900s after it was observed that tourniquets applied to the arms of patients with scarlet fever would lead to the development of petechiae in that extremity.³ It later was elucidated that underlying vascular disease predisposes to dermal capillary fragility, a risk factor for R-L phenomenon to occur upon application of a tourniquet. Rumpel-Leede phenomenon has been noted in patients with diabetes mellitus, acute or chronic hypertension, and thrombocytopenia.⁴ In addition to being hypertensive and diabetic, our patient had been taking amlodipine and diltiazem. Calcium channel blockers have been linked to R-L phenomenon in case reports as well as in a study of calcium channel blockers inducing capillary fragility in vivo.⁵ Rumpel-Leede phenomenon also has been noted in patients with tightly fitting garments and infants carried in baby carriers.¹ 

The differential diagnosis for R-L phenomenon includes actinic purpura, small vessel vasculitis, disseminated intravascular coagulation (DIC), and deep vein thrombosis (DVT). Actinic purpura, also called solar purpura or senile purpura, represents the petechiae and ecchymoses that are associated with aging skin. It is thought to occur when DNA damage, UV-induced solar elastosis, and decreased lipids in the stratum corneum cause a weakened ability to contain red blood cell extravasation from capillaries.⁶ Due to the lack of history of trauma and clear association with the blood pressure cuff placement in our patient, a diagnosis of actinic purpura was unlikely. In small vessel vasculitis, patients classically present with nonblanching palpable purpura frequently distributed over the lower extremities. The isolation of the lesions to only the left arm lowered the suspicion for vasculitis. Cutaneous manifestations of DIC and other hypercoagulable states may include purpura, livedo reticularis, atrophie blanche, and in extreme cases purpura fulminans. Routine laboratory examination reveals thrombocytopenia, prolonged prothrombin time/partial thromboplastin time, and hemolytic anemia.⁷ Although our patient had the risk factors of recent infection and surgery, a hemoglobin level of 10.9 g/dL (reference range, 14.0-17.5 g/dL) and platelet count of 279,000/µL (reference range, 150,000-350,000/µL) excluded DIC as the probable diagnosis. Our patient was at an overall increased risk for DVT due to his prolonged hospital stay, increased age, and other factors. Despite these risk factors, the lack of pain or swelling made this diagnosis unlikely. Furthermore, our patient was heparinized throughout his hospital stay, and upper extremity DVT accounts for only 4% to 10% of the total DVT incidence.⁵ 

Although R-L phenomenon is a benign, self-limited condition, it may be necessary in some cases to rule out more serious underlying etiologies with investigative workup comprised of a complete blood cell count, coagulation profile, and basic metabolic panel. However, recognition of the R-L phenomenon in the right clinical context of localized petechiae or ecchymoses with a history of a tourniquetlike force may prevent an unnecessary and costly workup. Patients should be encouraged that R-L phenomenon will resolve over time with identification and correction of the tourniquetlike force. In this case, we recommended loosening of the sphygmomanometer cuff and alternating extremities to which the cuff was to be placed, which resulted in complete clearance of the petechiae and ecchymoses within 5 days.  

The Diagnosis: Rumpel-Leede Phenomenon 

Rumpel-Leede (R-L) phenomenon describes the rare benign occurrence of dermal capillaries acutely rupturing following the administration of a tourniquetlike force on an extremity,¹ which manifests as asymptomatic petechiae and ecchymoses on a distal extremity, usually following noninvasive measurement of blood pressure.² Rumpel-Leede phenomenon represents an underrecognized entity that either is excluded or minimally referenced in most dermatology textbooks. The R-L sign initially was described in the early 1900s after it was observed that tourniquets applied to the arms of patients with scarlet fever would lead to the development of petechiae in that extremity.³ It later was elucidated that underlying vascular disease predisposes to dermal capillary fragility, a risk factor for R-L phenomenon to occur upon application of a tourniquet. Rumpel-Leede phenomenon has been noted in patients with diabetes mellitus, acute or chronic hypertension, and thrombocytopenia.⁴ In addition to being hypertensive and diabetic, our patient had been taking amlodipine and diltiazem. Calcium channel blockers have been linked to R-L phenomenon in case reports as well as in a study of calcium channel blockers inducing capillary fragility in vivo.⁵ Rumpel-Leede phenomenon also has been noted in patients with tightly fitting garments and infants carried in baby carriers.¹ 

The differential diagnosis for R-L phenomenon includes actinic purpura, small vessel vasculitis, disseminated intravascular coagulation (DIC), and deep vein thrombosis (DVT). Actinic purpura, also called solar purpura or senile purpura, represents the petechiae and ecchymoses that are associated with aging skin. It is thought to occur when DNA damage, UV-induced solar elastosis, and decreased lipids in the stratum corneum cause a weakened ability to contain red blood cell extravasation from capillaries.⁶ Due to the lack of history of trauma and clear association with the blood pressure cuff placement in our patient, a diagnosis of actinic purpura was unlikely. In small vessel vasculitis, patients classically present with nonblanching palpable purpura frequently distributed over the lower extremities. The isolation of the lesions to only the left arm lowered the suspicion for vasculitis. Cutaneous manifestations of DIC and other hypercoagulable states may include purpura, livedo reticularis, atrophie blanche, and in extreme cases purpura fulminans. Routine laboratory examination reveals thrombocytopenia, prolonged prothrombin time/partial thromboplastin time, and hemolytic anemia.⁷ Although our patient had the risk factors of recent infection and surgery, a hemoglobin level of 10.9 g/dL (reference range, 14.0-17.5 g/dL) and platelet count of 279,000/µL (reference range, 150,000-350,000/µL) excluded DIC as the probable diagnosis. Our patient was at an overall increased risk for DVT due to his prolonged hospital stay, increased age, and other factors. Despite these risk factors, the lack of pain or swelling made this diagnosis unlikely. Furthermore, our patient was heparinized throughout his hospital stay, and upper extremity DVT accounts for only 4% to 10% of the total DVT incidence.⁵ 

Although R-L phenomenon is a benign, self-limited condition, it may be necessary in some cases to rule out more serious underlying etiologies with investigative workup comprised of a complete blood cell count, coagulation profile, and basic metabolic panel. However, recognition of the R-L phenomenon in the right clinical context of localized petechiae or ecchymoses with a history of a tourniquetlike force may prevent an unnecessary and costly workup. Patients should be encouraged that R-L phenomenon will resolve over time with identification and correction of the tourniquetlike force. In this case, we recommended loosening of the sphygmomanometer cuff and alternating extremities to which the cuff was to be placed, which resulted in complete clearance of the petechiae and ecchymoses within 5 days.  

The Diagnosis: Rumpel-Leede Phenomenon 

Rumpel-Leede (R-L) phenomenon describes the rare benign occurrence of dermal capillaries acutely rupturing following the administration of a tourniquetlike force on an extremity,¹ which manifests as asymptomatic petechiae and ecchymoses on a distal extremity, usually following noninvasive measurement of blood pressure.² Rumpel-Leede phenomenon represents an underrecognized entity that either is excluded or minimally referenced in most dermatology textbooks. The R-L sign initially was described in the early 1900s after it was observed that tourniquets applied to the arms of patients with scarlet fever would lead to the development of petechiae in that extremity.³ It later was elucidated that underlying vascular disease predisposes to dermal capillary fragility, a risk factor for R-L phenomenon to occur upon application of a tourniquet. Rumpel-Leede phenomenon has been noted in patients with diabetes mellitus, acute or chronic hypertension, and thrombocytopenia.⁴ In addition to being hypertensive and diabetic, our patient had been taking amlodipine and diltiazem. Calcium channel blockers have been linked to R-L phenomenon in case reports as well as in a study of calcium channel blockers inducing capillary fragility in vivo.⁵ Rumpel-Leede phenomenon also has been noted in patients with tightly fitting garments and infants carried in baby carriers.¹ 

The differential diagnosis for R-L phenomenon includes actinic purpura, small vessel vasculitis, disseminated intravascular coagulation (DIC), and deep vein thrombosis (DVT). Actinic purpura, also called solar purpura or senile purpura, represents the petechiae and ecchymoses that are associated with aging skin. It is thought to occur when DNA damage, UV-induced solar elastosis, and decreased lipids in the stratum corneum cause a weakened ability to contain red blood cell extravasation from capillaries.⁶ Due to the lack of history of trauma and clear association with the blood pressure cuff placement in our patient, a diagnosis of actinic purpura was unlikely. In small vessel vasculitis, patients classically present with nonblanching palpable purpura frequently distributed over the lower extremities. The isolation of the lesions to only the left arm lowered the suspicion for vasculitis. Cutaneous manifestations of DIC and other hypercoagulable states may include purpura, livedo reticularis, atrophie blanche, and in extreme cases purpura fulminans. Routine laboratory examination reveals thrombocytopenia, prolonged prothrombin time/partial thromboplastin time, and hemolytic anemia.⁷ Although our patient had the risk factors of recent infection and surgery, a hemoglobin level of 10.9 g/dL (reference range, 14.0-17.5 g/dL) and platelet count of 279,000/µL (reference range, 150,000-350,000/µL) excluded DIC as the probable diagnosis. Our patient was at an overall increased risk for DVT due to his prolonged hospital stay, increased age, and other factors. Despite these risk factors, the lack of pain or swelling made this diagnosis unlikely. Furthermore, our patient was heparinized throughout his hospital stay, and upper extremity DVT accounts for only 4% to 10% of the total DVT incidence.⁵ 

Although R-L phenomenon is a benign, self-limited condition, it may be necessary in some cases to rule out more serious underlying etiologies with investigative workup comprised of a complete blood cell count, coagulation profile, and basic metabolic panel. However, recognition of the R-L phenomenon in the right clinical context of localized petechiae or ecchymoses with a history of a tourniquetlike force may prevent an unnecessary and costly workup. Patients should be encouraged that R-L phenomenon will resolve over time with identification and correction of the tourniquetlike force. In this case, we recommended loosening of the sphygmomanometer cuff and alternating extremities to which the cuff was to be placed, which resulted in complete clearance of the petechiae and ecchymoses within 5 days.  

Four more studies of the relationship of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) with COVID-19 have been published in the past few days in top-tier peer-reviewed journals, and on the whole, the data are reassuring.

Three of the new studies were published in the New England Journal of Medicine on May 1, and one study was published in JAMA Cardiology on May 5.

Although all the studies are observational in design and have some confounding factors, overall, the results do not suggest that continued use of ACE inhibitors and ARBs causes harm. However, there are some contradictory findings in secondary analyses regarding possible differences in the effects of the two drug classes.

Providing commentary, John McMurray, MD, professor of medical cardiology at the University of Glasgow, said: “The overall picture seems to suggest no increase in risk of adverse outcomes in patients taking renin-angiotensin system [RAS] blockers ― but with lots of caveats: These are all observational rather than randomized studies, and there may be residual or unmeasured confounding.”
 

Was it ‘Much ado about nothing’?

Franz Messerli, MD, professor of medicine at the University of Bern (Switzerland), added: “Given this state of the art, I am inclined to consider RAS blockade and COVID-19 – despite all the hype in the news media – as much ado about nothing.”

But both Dr. McMurray and Dr. Messerli said they were intrigued about possible differences in the effects of ACE inhibitors and ARBs that some of the new results suggest.

In one study, a team led by Mandeep Mehra, MD, of Brigham and Women’s Hospital Heart and Vascular Center, Boston, analyzed data from 8,910 patients with COVID-19 admitted to 169 hospitals in Asia, Europe, and North America who had either died in the hospital (5.8%) or survived to hospital discharge (94.2%).

In multivariate logistic-regression analysis, age greater than 65 years, coronary artery disease, congestive heart failure, history of cardiac arrhythmia, chronic obstructive pulmonary disease, and current smoking were associated with an increased risk for in-hospital death. Female sex was associated with a decreased risk. Neither ACE inhibitors nor ARBs were associated with an increased risk for in-hospital death.

In fact, ACE inhibitors were associated with a significant reduction in mortality (odds ratio, 0.33), as were statins (OR, 0.35).

The authors, however, stressed that these observations about reduced mortality with ACE inhibitors and statins “should be considered with extreme caution.”

“Because our study was not a randomized, controlled trial, we cannot exclude the possibility of confounding. In addition, we examined relationships between many variables and in-hospital death, and no primary hypothesis was prespecified; these factors increased the probability of chance associations being found. Therefore, a cause-and-effect relationship between drug therapy and survival should not be inferred,” they wrote.

A secondary analysis that was restricted to patients with hypertension (those for whom an ACE inhibitor or an ARB would be indicated) also did not show harm.

A second study published in the New England Journal of Medicine had a case-control design. The authors, led by Giuseppe Mancia, MD, of the University of Milano-Bicocca (Italy), compared 6,272 patients with confirmed COVID-19 (case patients) with 30,759 control persons who were matched according to age, sex, and municipality of residence.

In a conditional logistic-regression multivariate analysis, neither ACE inhibitors nor ARBs were associated with the likelihood of SARS-CoV-2 infection.

“Thus, our results do not provide evidence of an independent relationship between renin angiotensin aldosterone blockers and the susceptibility to COVID-19 in humans,” the authors concluded.

In addition, a second analysis that compared patients who had severe or fatal infections with matched control persons did not show an association between ACE inhibitors or ARBs and severe disease.

In the third study published in the New England Journal of Medicine, a group led by Harmony R. Reynolds, MD, of New York University, analyzed data from the health records of 12,594 patients in the NYU Langone Health system who had been tested for COVID-19. They found 5,894 patients whose test results were positive. Of these patients, 1,002 had severe illness, which was defined as illness requiring admission to the ICU, need for mechanical ventilation, or death.

Using Bayesian analysis and propensity score matching, the researchers assessed the relation between previous treatment with five different classes of antihypertensive drugs (ACE inhibitors, ARBs, beta blockers, calcium blockers, and thiazide diuretics) and the likelihood of a positive or negative result on COVID-19 testing, as well as the likelihood of severe illness among patients who tested positive.

Results showed no positive association between any of the analyzed drug classes and either a positive test result or severe illness.

In an accompanying editorial, a group led by John A. Jarcho, MD, of Harvard Medical School, Boston, and deputy editor of the New England Journal of Medicine, wrote: “Taken together, these three studies do not provide evidence to support the hypothesis that ACE inhibitor or ARB use is associated with the risk of SARS-CoV-2 infection, the risk of severe COVID-19 among those infected, or the risk of in-hospital death among those with a positive test.

“Each of these studies has weaknesses inherent in observational data, but we find it reassuring that three studies in different populations and with different designs arrive at the consistent message that the continued use of ACE inhibitors and ARBs is unlikely to be harmful in patients with COVID-19. Several other smaller studies from China and the United Kingdom have come to the same conclusion,” the authors of the editorial stated.

In the study published in JAMA Cardiology, a group led by Neil Mehta, MBBS, of the Cleveland Clinic, Ohio, analyzed data on 18,472 patients who had been tested for COVID-19 between March 8 and April 12 in the Cleveland Clinic Health System in Ohio and Florida. Of these patients, 9.4% tested positive.

After overlap propensity score weighting for both ACE inhibitors and ARBs to take into account relevant comorbidities, there was no difference in risk for testing positive among patients taking an ACE inhibitor or an ARB in comparison with those not taking such medication.
 

Are there different effects between ACE inhibitors and ARBs?

A secondary exploratory analysis showed a higher likelihood of hospital admission among patients who tested positive and who were taking either ACE inhibitors (OR, 1.84) or ARBs (OR, 1.61), and there was a higher likelihood of ICU admission among patients who tested positive and who were taking an ACE inhibitor (OR 1.77), but no such difference was observed among those taking ARBs.

Coauthor Ankur Kalra, MD, of the Cleveland Clinic, said in an interview that results of the exploratory analysis fit with the hypothesis that the two drugs classes may have different effects in patients with COVID-19.

“Angiotensin II promotes vasoconstriction, inflammation, and fibrosis in the lungs, and ARBs block the effects of angiotensin II more effectively than ACE inhibitors. In addition, ACE inhibitors (but not ARBs) increase levels of bradykinin, which may be one factor leading to acute respiratory distress syndrome,” he noted.

“However, these results should only be considered exploratory, as there is inherent bias in observational data,” Dr. Kalra stressed.

In an accompanying editorial in JAMA Cardiology, a group led by Laine E. Thomas, PhD, of Duke Clinical Research Institute, Durham, North Carolina, said that the results of this secondary exploratory analysis are limited by a small number of patients and “are likely explained by confounding and should not be inferred as causal.”

The New England Journal of Medicine editorialists reached a similar conclusion regarding the lower mortality in COVID-19 patients who took ACE inhibitors in the study by Dr. Mehra and colleagues. They say this unexpected result “may be due to unmeasured confounding and, in the absence of a randomized trial, should not be regarded as evidence to prescribe these drugs in patients with COVID-19.”

Providing further comment, Dr. McMurray said: “Normally, I would not read too much into the different effects of ACE inhibitors and ARBs suggested in the Cleveland study because of the small numbers (about 28 ACE inhibitor–treated patients admitted to ICU) and the limited information about matching and/or adjustment for potential differences between groups.

“I could also argue that the comparison that would best answer the question about risk related to type of RAS blocker would be the direct comparison of people taking an ACE inhibitor with those taking an ARB (and that doesn’t look very different). The only thing that makes me a little cautious about completely dismissing the possibility of a difference between ACE inhibitor and ARB here is the suggestion of a similar trend in another large study from the VA [Veterans Affairs] system,” he added.

He also noted that speculation about there being mechanisms that involve different effects of the two drug classes on bradykinin and angiotensin II was “plausible but unproven.”

Dr. Messerli added: “Before turning the page, I would like to see an analysis comparing ACE inhibitors and ARBs, since experimentally, their effect on ACE2 (the receptor to which the virus binds) seems to differ. The study of Mehta et al in JAMA Cardiology may be the first clinical hint indicating that ARBs are more protective than ACEIs. However even here, the looming possibility of confounding cannot be excluded.”

Dr. Messerli also pointed to a hypothesis that suggests that direct viral infection of endothelial cells expressing ACE2 receptors may explain worse outcomes in patients with cardiovascular comorbidities, which provides a rationale for therapies to stabilize the endothelium, particularly with anti-inflammatory anticytokine drugs, ACE inhibitors, and statins.

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

Four more studies of the relationship of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) with COVID-19 have been published in the past few days in top-tier peer-reviewed journals, and on the whole, the data are reassuring.

Three of the new studies were published in the New England Journal of Medicine on May 1, and one study was published in JAMA Cardiology on May 5.

Although all the studies are observational in design and have some confounding factors, overall, the results do not suggest that continued use of ACE inhibitors and ARBs causes harm. However, there are some contradictory findings in secondary analyses regarding possible differences in the effects of the two drug classes.

Providing commentary, John McMurray, MD, professor of medical cardiology at the University of Glasgow, said: “The overall picture seems to suggest no increase in risk of adverse outcomes in patients taking renin-angiotensin system [RAS] blockers ― but with lots of caveats: These are all observational rather than randomized studies, and there may be residual or unmeasured confounding.”
 

Was it ‘Much ado about nothing’?

Franz Messerli, MD, professor of medicine at the University of Bern (Switzerland), added: “Given this state of the art, I am inclined to consider RAS blockade and COVID-19 – despite all the hype in the news media – as much ado about nothing.”

But both Dr. McMurray and Dr. Messerli said they were intrigued about possible differences in the effects of ACE inhibitors and ARBs that some of the new results suggest.

In one study, a team led by Mandeep Mehra, MD, of Brigham and Women’s Hospital Heart and Vascular Center, Boston, analyzed data from 8,910 patients with COVID-19 admitted to 169 hospitals in Asia, Europe, and North America who had either died in the hospital (5.8%) or survived to hospital discharge (94.2%).

In multivariate logistic-regression analysis, age greater than 65 years, coronary artery disease, congestive heart failure, history of cardiac arrhythmia, chronic obstructive pulmonary disease, and current smoking were associated with an increased risk for in-hospital death. Female sex was associated with a decreased risk. Neither ACE inhibitors nor ARBs were associated with an increased risk for in-hospital death.

In fact, ACE inhibitors were associated with a significant reduction in mortality (odds ratio, 0.33), as were statins (OR, 0.35).

The authors, however, stressed that these observations about reduced mortality with ACE inhibitors and statins “should be considered with extreme caution.”

“Because our study was not a randomized, controlled trial, we cannot exclude the possibility of confounding. In addition, we examined relationships between many variables and in-hospital death, and no primary hypothesis was prespecified; these factors increased the probability of chance associations being found. Therefore, a cause-and-effect relationship between drug therapy and survival should not be inferred,” they wrote.

A secondary analysis that was restricted to patients with hypertension (those for whom an ACE inhibitor or an ARB would be indicated) also did not show harm.

A second study published in the New England Journal of Medicine had a case-control design. The authors, led by Giuseppe Mancia, MD, of the University of Milano-Bicocca (Italy), compared 6,272 patients with confirmed COVID-19 (case patients) with 30,759 control persons who were matched according to age, sex, and municipality of residence.

In a conditional logistic-regression multivariate analysis, neither ACE inhibitors nor ARBs were associated with the likelihood of SARS-CoV-2 infection.

“Thus, our results do not provide evidence of an independent relationship between renin angiotensin aldosterone blockers and the susceptibility to COVID-19 in humans,” the authors concluded.

In addition, a second analysis that compared patients who had severe or fatal infections with matched control persons did not show an association between ACE inhibitors or ARBs and severe disease.

In the third study published in the New England Journal of Medicine, a group led by Harmony R. Reynolds, MD, of New York University, analyzed data from the health records of 12,594 patients in the NYU Langone Health system who had been tested for COVID-19. They found 5,894 patients whose test results were positive. Of these patients, 1,002 had severe illness, which was defined as illness requiring admission to the ICU, need for mechanical ventilation, or death.

Using Bayesian analysis and propensity score matching, the researchers assessed the relation between previous treatment with five different classes of antihypertensive drugs (ACE inhibitors, ARBs, beta blockers, calcium blockers, and thiazide diuretics) and the likelihood of a positive or negative result on COVID-19 testing, as well as the likelihood of severe illness among patients who tested positive.

Results showed no positive association between any of the analyzed drug classes and either a positive test result or severe illness.

In an accompanying editorial, a group led by John A. Jarcho, MD, of Harvard Medical School, Boston, and deputy editor of the New England Journal of Medicine, wrote: “Taken together, these three studies do not provide evidence to support the hypothesis that ACE inhibitor or ARB use is associated with the risk of SARS-CoV-2 infection, the risk of severe COVID-19 among those infected, or the risk of in-hospital death among those with a positive test.

“Each of these studies has weaknesses inherent in observational data, but we find it reassuring that three studies in different populations and with different designs arrive at the consistent message that the continued use of ACE inhibitors and ARBs is unlikely to be harmful in patients with COVID-19. Several other smaller studies from China and the United Kingdom have come to the same conclusion,” the authors of the editorial stated.

In the study published in JAMA Cardiology, a group led by Neil Mehta, MBBS, of the Cleveland Clinic, Ohio, analyzed data on 18,472 patients who had been tested for COVID-19 between March 8 and April 12 in the Cleveland Clinic Health System in Ohio and Florida. Of these patients, 9.4% tested positive.

After overlap propensity score weighting for both ACE inhibitors and ARBs to take into account relevant comorbidities, there was no difference in risk for testing positive among patients taking an ACE inhibitor or an ARB in comparison with those not taking such medication.
 

Are there different effects between ACE inhibitors and ARBs?

A secondary exploratory analysis showed a higher likelihood of hospital admission among patients who tested positive and who were taking either ACE inhibitors (OR, 1.84) or ARBs (OR, 1.61), and there was a higher likelihood of ICU admission among patients who tested positive and who were taking an ACE inhibitor (OR 1.77), but no such difference was observed among those taking ARBs.

Coauthor Ankur Kalra, MD, of the Cleveland Clinic, said in an interview that results of the exploratory analysis fit with the hypothesis that the two drugs classes may have different effects in patients with COVID-19.

“Angiotensin II promotes vasoconstriction, inflammation, and fibrosis in the lungs, and ARBs block the effects of angiotensin II more effectively than ACE inhibitors. In addition, ACE inhibitors (but not ARBs) increase levels of bradykinin, which may be one factor leading to acute respiratory distress syndrome,” he noted.

“However, these results should only be considered exploratory, as there is inherent bias in observational data,” Dr. Kalra stressed.

In an accompanying editorial in JAMA Cardiology, a group led by Laine E. Thomas, PhD, of Duke Clinical Research Institute, Durham, North Carolina, said that the results of this secondary exploratory analysis are limited by a small number of patients and “are likely explained by confounding and should not be inferred as causal.”

The New England Journal of Medicine editorialists reached a similar conclusion regarding the lower mortality in COVID-19 patients who took ACE inhibitors in the study by Dr. Mehra and colleagues. They say this unexpected result “may be due to unmeasured confounding and, in the absence of a randomized trial, should not be regarded as evidence to prescribe these drugs in patients with COVID-19.”

Providing further comment, Dr. McMurray said: “Normally, I would not read too much into the different effects of ACE inhibitors and ARBs suggested in the Cleveland study because of the small numbers (about 28 ACE inhibitor–treated patients admitted to ICU) and the limited information about matching and/or adjustment for potential differences between groups.

“I could also argue that the comparison that would best answer the question about risk related to type of RAS blocker would be the direct comparison of people taking an ACE inhibitor with those taking an ARB (and that doesn’t look very different). The only thing that makes me a little cautious about completely dismissing the possibility of a difference between ACE inhibitor and ARB here is the suggestion of a similar trend in another large study from the VA [Veterans Affairs] system,” he added.

He also noted that speculation about there being mechanisms that involve different effects of the two drug classes on bradykinin and angiotensin II was “plausible but unproven.”

Dr. Messerli added: “Before turning the page, I would like to see an analysis comparing ACE inhibitors and ARBs, since experimentally, their effect on ACE2 (the receptor to which the virus binds) seems to differ. The study of Mehta et al in JAMA Cardiology may be the first clinical hint indicating that ARBs are more protective than ACEIs. However even here, the looming possibility of confounding cannot be excluded.”

Dr. Messerli also pointed to a hypothesis that suggests that direct viral infection of endothelial cells expressing ACE2 receptors may explain worse outcomes in patients with cardiovascular comorbidities, which provides a rationale for therapies to stabilize the endothelium, particularly with anti-inflammatory anticytokine drugs, ACE inhibitors, and statins.

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

Four more studies of the relationship of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) with COVID-19 have been published in the past few days in top-tier peer-reviewed journals, and on the whole, the data are reassuring.

Three of the new studies were published in the New England Journal of Medicine on May 1, and one study was published in JAMA Cardiology on May 5.

Although all the studies are observational in design and have some confounding factors, overall, the results do not suggest that continued use of ACE inhibitors and ARBs causes harm. However, there are some contradictory findings in secondary analyses regarding possible differences in the effects of the two drug classes.

Providing commentary, John McMurray, MD, professor of medical cardiology at the University of Glasgow, said: “The overall picture seems to suggest no increase in risk of adverse outcomes in patients taking renin-angiotensin system [RAS] blockers ― but with lots of caveats: These are all observational rather than randomized studies, and there may be residual or unmeasured confounding.”
 

Was it ‘Much ado about nothing’?

Franz Messerli, MD, professor of medicine at the University of Bern (Switzerland), added: “Given this state of the art, I am inclined to consider RAS blockade and COVID-19 – despite all the hype in the news media – as much ado about nothing.”

But both Dr. McMurray and Dr. Messerli said they were intrigued about possible differences in the effects of ACE inhibitors and ARBs that some of the new results suggest.

In one study, a team led by Mandeep Mehra, MD, of Brigham and Women’s Hospital Heart and Vascular Center, Boston, analyzed data from 8,910 patients with COVID-19 admitted to 169 hospitals in Asia, Europe, and North America who had either died in the hospital (5.8%) or survived to hospital discharge (94.2%).

In multivariate logistic-regression analysis, age greater than 65 years, coronary artery disease, congestive heart failure, history of cardiac arrhythmia, chronic obstructive pulmonary disease, and current smoking were associated with an increased risk for in-hospital death. Female sex was associated with a decreased risk. Neither ACE inhibitors nor ARBs were associated with an increased risk for in-hospital death.

In fact, ACE inhibitors were associated with a significant reduction in mortality (odds ratio, 0.33), as were statins (OR, 0.35).

The authors, however, stressed that these observations about reduced mortality with ACE inhibitors and statins “should be considered with extreme caution.”

“Because our study was not a randomized, controlled trial, we cannot exclude the possibility of confounding. In addition, we examined relationships between many variables and in-hospital death, and no primary hypothesis was prespecified; these factors increased the probability of chance associations being found. Therefore, a cause-and-effect relationship between drug therapy and survival should not be inferred,” they wrote.

A secondary analysis that was restricted to patients with hypertension (those for whom an ACE inhibitor or an ARB would be indicated) also did not show harm.

A second study published in the New England Journal of Medicine had a case-control design. The authors, led by Giuseppe Mancia, MD, of the University of Milano-Bicocca (Italy), compared 6,272 patients with confirmed COVID-19 (case patients) with 30,759 control persons who were matched according to age, sex, and municipality of residence.

In a conditional logistic-regression multivariate analysis, neither ACE inhibitors nor ARBs were associated with the likelihood of SARS-CoV-2 infection.

“Thus, our results do not provide evidence of an independent relationship between renin angiotensin aldosterone blockers and the susceptibility to COVID-19 in humans,” the authors concluded.

In addition, a second analysis that compared patients who had severe or fatal infections with matched control persons did not show an association between ACE inhibitors or ARBs and severe disease.

In the third study published in the New England Journal of Medicine, a group led by Harmony R. Reynolds, MD, of New York University, analyzed data from the health records of 12,594 patients in the NYU Langone Health system who had been tested for COVID-19. They found 5,894 patients whose test results were positive. Of these patients, 1,002 had severe illness, which was defined as illness requiring admission to the ICU, need for mechanical ventilation, or death.

Using Bayesian analysis and propensity score matching, the researchers assessed the relation between previous treatment with five different classes of antihypertensive drugs (ACE inhibitors, ARBs, beta blockers, calcium blockers, and thiazide diuretics) and the likelihood of a positive or negative result on COVID-19 testing, as well as the likelihood of severe illness among patients who tested positive.

Results showed no positive association between any of the analyzed drug classes and either a positive test result or severe illness.

In an accompanying editorial, a group led by John A. Jarcho, MD, of Harvard Medical School, Boston, and deputy editor of the New England Journal of Medicine, wrote: “Taken together, these three studies do not provide evidence to support the hypothesis that ACE inhibitor or ARB use is associated with the risk of SARS-CoV-2 infection, the risk of severe COVID-19 among those infected, or the risk of in-hospital death among those with a positive test.

“Each of these studies has weaknesses inherent in observational data, but we find it reassuring that three studies in different populations and with different designs arrive at the consistent message that the continued use of ACE inhibitors and ARBs is unlikely to be harmful in patients with COVID-19. Several other smaller studies from China and the United Kingdom have come to the same conclusion,” the authors of the editorial stated.

In the study published in JAMA Cardiology, a group led by Neil Mehta, MBBS, of the Cleveland Clinic, Ohio, analyzed data on 18,472 patients who had been tested for COVID-19 between March 8 and April 12 in the Cleveland Clinic Health System in Ohio and Florida. Of these patients, 9.4% tested positive.

After overlap propensity score weighting for both ACE inhibitors and ARBs to take into account relevant comorbidities, there was no difference in risk for testing positive among patients taking an ACE inhibitor or an ARB in comparison with those not taking such medication.
 

Are there different effects between ACE inhibitors and ARBs?

A secondary exploratory analysis showed a higher likelihood of hospital admission among patients who tested positive and who were taking either ACE inhibitors (OR, 1.84) or ARBs (OR, 1.61), and there was a higher likelihood of ICU admission among patients who tested positive and who were taking an ACE inhibitor (OR 1.77), but no such difference was observed among those taking ARBs.

Coauthor Ankur Kalra, MD, of the Cleveland Clinic, said in an interview that results of the exploratory analysis fit with the hypothesis that the two drugs classes may have different effects in patients with COVID-19.

“Angiotensin II promotes vasoconstriction, inflammation, and fibrosis in the lungs, and ARBs block the effects of angiotensin II more effectively than ACE inhibitors. In addition, ACE inhibitors (but not ARBs) increase levels of bradykinin, which may be one factor leading to acute respiratory distress syndrome,” he noted.

“However, these results should only be considered exploratory, as there is inherent bias in observational data,” Dr. Kalra stressed.

In an accompanying editorial in JAMA Cardiology, a group led by Laine E. Thomas, PhD, of Duke Clinical Research Institute, Durham, North Carolina, said that the results of this secondary exploratory analysis are limited by a small number of patients and “are likely explained by confounding and should not be inferred as causal.”

The New England Journal of Medicine editorialists reached a similar conclusion regarding the lower mortality in COVID-19 patients who took ACE inhibitors in the study by Dr. Mehra and colleagues. They say this unexpected result “may be due to unmeasured confounding and, in the absence of a randomized trial, should not be regarded as evidence to prescribe these drugs in patients with COVID-19.”

Providing further comment, Dr. McMurray said: “Normally, I would not read too much into the different effects of ACE inhibitors and ARBs suggested in the Cleveland study because of the small numbers (about 28 ACE inhibitor–treated patients admitted to ICU) and the limited information about matching and/or adjustment for potential differences between groups.

“I could also argue that the comparison that would best answer the question about risk related to type of RAS blocker would be the direct comparison of people taking an ACE inhibitor with those taking an ARB (and that doesn’t look very different). The only thing that makes me a little cautious about completely dismissing the possibility of a difference between ACE inhibitor and ARB here is the suggestion of a similar trend in another large study from the VA [Veterans Affairs] system,” he added.

He also noted that speculation about there being mechanisms that involve different effects of the two drug classes on bradykinin and angiotensin II was “plausible but unproven.”

Dr. Messerli added: “Before turning the page, I would like to see an analysis comparing ACE inhibitors and ARBs, since experimentally, their effect on ACE2 (the receptor to which the virus binds) seems to differ. The study of Mehta et al in JAMA Cardiology may be the first clinical hint indicating that ARBs are more protective than ACEIs. However even here, the looming possibility of confounding cannot be excluded.”

Dr. Messerli also pointed to a hypothesis that suggests that direct viral infection of endothelial cells expressing ACE2 receptors may explain worse outcomes in patients with cardiovascular comorbidities, which provides a rationale for therapies to stabilize the endothelium, particularly with anti-inflammatory anticytokine drugs, ACE inhibitors, and statins.

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

SHM is entering an exciting new chapter in its history because we will soon see Dr. Eric Howell take the reins from Dr. Larry Wellikson as CEO, as we watch Dr. Danielle Scheurer assume the role of president from Dr. Chris Frost, and as a side note, I will try to fill Dr. Scheurer’s shoes as physician editor of The Hospitalist.

This changing of the guard of SHM’s leadership will take place amid the backdrop of an acrimonious presidential election and the emergence of a novel coronavirus that threatens to upend the typical routines of our social and professional lives.

Without a doubt, our leaders, whether national, regional, or local, will be at the helm during one of the most uncertain times in the history of modern health care. Will we see a U.S. President who is a proponent of supporting the Affordable Care Act? Will we see further erosion of Obamacare under a second term of President Trump? Will we see rural hospitals continue to close or shrink¹ as their margins get squeezed by skyrocketing denials for inpatient status in favor of observation or outpatient status?²

Forces that seem beyond our control threaten to drastically alter our professions and even our livelihoods. In the space of the few weeks during which I began and finished this piece, every day brought a whole new world of changes in my hospital, town, state, and country. No leader can predict the future with any semblance of certitude.

In the face of these swirling winds of uncertainty, what is clear is that maintaining our commitment as hospitalists to providing evidence-based, high-quality care to our patients while providing support to our colleagues in the health care industry will greatly benefit from collaborating effectively under the “big tent” philosophy of SHM. Over my career, I have benefited from great role models and colleagues as my career took me from primary care med-peds to the “new” field of hospital medicine as a med-peds hospitalist, to a leadership role in pediatric hospital medicine. I have also benefited from “learning opportunities,” as I have made my fair share of mistakes in efforts to improve systems of care. Nearly all of these mistakes share a common thread – not collaborating effectively with critical stakeholders, both within and outside of my institution.³ As this pandemic progresses, I am (and likely you are) witnessing your leaders succeed or fail based on their ability to collaborate across the institution.

As a field, we risk making similar errors by being too narrowly focused as we strive to improve the care of our patients. Recently, Dr. Russell Buhr and his colleagues at the University of California, Los Angeles, demonstrated that a majority of 30-day readmissions for chronic obstructive pulmonary disease (COPD) are due to non-COPD diagnoses.⁴ As we discharge our COPD patients, we may be satisfied that we’ve “tuned up” our patient’s COPD, but have we adequately arranged for appropriate ongoing care of their other medical problems? This requires an activity undertaken less and less these days in medicine – a conversation between hospitalists and outpatient medical providers. The coronavirus disease 2019 (COVID-19) pandemic has made this more challenging, but I can assure you that you can neither transmit nor catch the coronavirus from a phone call.

Perhaps we can learn from our hospitalist colleagues trained in family medicine. A recent study found that hospitalists in a team made up of family medicine–trained physicians in an academic health center achieved a 33% shorter length of stay for patients from the family medicine clinic, after adjustment for disease, demographics, and disease severity.⁵ The conclusion of the authors was that this was likely caused by greater familiarity with outpatient resources. I would conjecture that family medicine hospitalists were also more likely to have a conversation with a patient’s outpatient primary care provider (PCP).

Of course, I am the first to admit that chatting with a PCP is not as easy as it used to be – when we could bump into each other in the doctor’s lounge drinking coffee or in radiology while pulling x-ray films (remember those?) – and in the age of COVID-19, these interactions are even less likely. It can take considerable time and effort to get PCP colleagues on the phone unless you’re chummy enough to have their cell phone numbers. And time is a resource in short supply because most hospital medicine groups are understaffed – in the 2018 SHM State of Hospital Medicine (SoHM) Report, 66.4% of responding groups had open positions, with a median of 12% understaffing reported. The 2020 SoHM report is being compiled as we speak, but I suspect this situation will not have improved, and as the pandemic strikes, staffing models have been completely blown up.

To dig ourselves out of this staffing hole and still stay under (or not too over) budget, bringing more advanced practice providers (APP) into our groups/divisions will be needed. We must recognize, however, that APPs can’t just be hired rapidly and thrown into the schedule. As Tracy Cardin, ACNP-BC, SFHM, stated in her December 2019 blog post on the Hospital Leader website, leaders need to implement consistent onboarding, training, and support of APPs, just as they would for any other hospitalist in their group.⁶ Physician hospitalists need to develop and maintain proven competency in effectively interacting with APPs practicing at the top of their skills and productivity. No time has ever proven the need to allow APPs to practice at the top of their skills than the age of COVID-19.⁷

But if your “field” doesn’t even recognize you at all? That is the fate of many providers left behind by the field of pediatric hospital medicine. Over the past year, we have seen PHM attain a great achievement in its recognition as a board-certified subspecialty established by the American Board of Pediatrics (ABP), only to have the process beset by allegations of gender and maternal bias. While a groundswell of opposition from pediatric hospitalists triggered by the exclusion of applicants to the Practice Pathway to board certification led the ABP to remove the practice interruption criteria, other potential sources of gender and maternal bias remain.⁸

This does not even address pediatric hospitalists trained in family medicine who cannot be eligible for PHM board certification through experience or fellowship, med-peds trained pediatric hospitalists who cannot quality because of insufficient time spent on pediatric inpatient care, newborn hospitalists (who do not qualify), and APPs specialized in pediatric inpatient care. While it is completely understandable that the ABP cannot provide a certification pathway for all of these groups, this still leaves a gap for these providers when it comes to being in a professional community that supports their professional development, ongoing education, and training. Fortunately, leaders of the three societies that have significant numbers of pediatric hospitalists – SHM, American Academy of Pediatrics, and Academic Pediatric Association – are working to develop a PHM designation outside of the ABP board certification pathway that will extend the professional community to those left out of board certification.

As we move bravely into this new era of SHM, our clarion call is to collaborate whenever and wherever we can, with our practice administrators, APPs, outpatient providers, subspecialist providers, and patient/family advocates – pandemic or no pandemic. In fact, what this pandemic has shown us is that rapid cycle, fully 360-degree collaboration is the only way hospitalists and hospital leaders will weather the storms of changing reimbursement, pandemics, or politics. This will be our challenge for the next decade, to ensure that SHM collaboratively moves beyond the confines of the hospital ward.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. Frakt A. A Sense of Alarm as Rural Hospitals Keep Closing. The New York Times. 2018. https://www.nytimes.com/2018/10/29/upshot/a-sense-of-alarm-as-rural-hospitals-keep-closing.html. Accessed February 28, 2020.

2. Poonacha TK, Chamoun F. The burden of prior authorizations and denials in health care. Medpage Today’s KevinMD. 2019. https://www.kevinmd.com/blog/2019/12/the-burden-of-prior-authorizations-and-denials-in-health-care.html. Accessed February 28, 2020.

3. 10 reasons healthcare leaders fail and how to prevent them. Becker’s Hospital Review. 2015. https://www.beckershospitalreview.com/hospital-management-administration/10-reasons-healthcare-leaders-fail-and-how-to-prevent-them.html. Accessed March 15, 2020

4. Buhr RG et al. Comorbidity and thirty-day hospital readmission odds in chronic obstructive pulmonary disease: a comparison of the Charlson and Elixhauser comorbidity indices. BMC Health Serv Res. 2019;19:701.

5. Garrison GM et al. Family medicine patients have shorter length of stay when cared for on a family medicine inpatient service. J Prim Care Community Health. 2019. doi: 10.1177/2150132719840517.

6. Cardin T. Work the Program for NP/PAs, and the Program Will Work. The Hospital Leader: Official Blog of SHM. 2019. https://thehospitalleader.org/work-the-program-for-np-pas-and-the-program-will-work/

7. Mittman DE. More physician assistants are ready to help with COVID-19 – now governors must empower them. The Hill. 2020. https://thehill.com/opinion/healthcare/489985-more-physician-assistants-are-ready-to-help-with-covid-19-now-governors. Accessed March 31, 2020.

8. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019;14:630-2.

SHM is entering an exciting new chapter in its history because we will soon see Dr. Eric Howell take the reins from Dr. Larry Wellikson as CEO, as we watch Dr. Danielle Scheurer assume the role of president from Dr. Chris Frost, and as a side note, I will try to fill Dr. Scheurer’s shoes as physician editor of The Hospitalist.

This changing of the guard of SHM’s leadership will take place amid the backdrop of an acrimonious presidential election and the emergence of a novel coronavirus that threatens to upend the typical routines of our social and professional lives.

Without a doubt, our leaders, whether national, regional, or local, will be at the helm during one of the most uncertain times in the history of modern health care. Will we see a U.S. President who is a proponent of supporting the Affordable Care Act? Will we see further erosion of Obamacare under a second term of President Trump? Will we see rural hospitals continue to close or shrink¹ as their margins get squeezed by skyrocketing denials for inpatient status in favor of observation or outpatient status?²

Forces that seem beyond our control threaten to drastically alter our professions and even our livelihoods. In the space of the few weeks during which I began and finished this piece, every day brought a whole new world of changes in my hospital, town, state, and country. No leader can predict the future with any semblance of certitude.

In the face of these swirling winds of uncertainty, what is clear is that maintaining our commitment as hospitalists to providing evidence-based, high-quality care to our patients while providing support to our colleagues in the health care industry will greatly benefit from collaborating effectively under the “big tent” philosophy of SHM. Over my career, I have benefited from great role models and colleagues as my career took me from primary care med-peds to the “new” field of hospital medicine as a med-peds hospitalist, to a leadership role in pediatric hospital medicine. I have also benefited from “learning opportunities,” as I have made my fair share of mistakes in efforts to improve systems of care. Nearly all of these mistakes share a common thread – not collaborating effectively with critical stakeholders, both within and outside of my institution.³ As this pandemic progresses, I am (and likely you are) witnessing your leaders succeed or fail based on their ability to collaborate across the institution.

As a field, we risk making similar errors by being too narrowly focused as we strive to improve the care of our patients. Recently, Dr. Russell Buhr and his colleagues at the University of California, Los Angeles, demonstrated that a majority of 30-day readmissions for chronic obstructive pulmonary disease (COPD) are due to non-COPD diagnoses.⁴ As we discharge our COPD patients, we may be satisfied that we’ve “tuned up” our patient’s COPD, but have we adequately arranged for appropriate ongoing care of their other medical problems? This requires an activity undertaken less and less these days in medicine – a conversation between hospitalists and outpatient medical providers. The coronavirus disease 2019 (COVID-19) pandemic has made this more challenging, but I can assure you that you can neither transmit nor catch the coronavirus from a phone call.

Perhaps we can learn from our hospitalist colleagues trained in family medicine. A recent study found that hospitalists in a team made up of family medicine–trained physicians in an academic health center achieved a 33% shorter length of stay for patients from the family medicine clinic, after adjustment for disease, demographics, and disease severity.⁵ The conclusion of the authors was that this was likely caused by greater familiarity with outpatient resources. I would conjecture that family medicine hospitalists were also more likely to have a conversation with a patient’s outpatient primary care provider (PCP).

Of course, I am the first to admit that chatting with a PCP is not as easy as it used to be – when we could bump into each other in the doctor’s lounge drinking coffee or in radiology while pulling x-ray films (remember those?) – and in the age of COVID-19, these interactions are even less likely. It can take considerable time and effort to get PCP colleagues on the phone unless you’re chummy enough to have their cell phone numbers. And time is a resource in short supply because most hospital medicine groups are understaffed – in the 2018 SHM State of Hospital Medicine (SoHM) Report, 66.4% of responding groups had open positions, with a median of 12% understaffing reported. The 2020 SoHM report is being compiled as we speak, but I suspect this situation will not have improved, and as the pandemic strikes, staffing models have been completely blown up.

To dig ourselves out of this staffing hole and still stay under (or not too over) budget, bringing more advanced practice providers (APP) into our groups/divisions will be needed. We must recognize, however, that APPs can’t just be hired rapidly and thrown into the schedule. As Tracy Cardin, ACNP-BC, SFHM, stated in her December 2019 blog post on the Hospital Leader website, leaders need to implement consistent onboarding, training, and support of APPs, just as they would for any other hospitalist in their group.⁶ Physician hospitalists need to develop and maintain proven competency in effectively interacting with APPs practicing at the top of their skills and productivity. No time has ever proven the need to allow APPs to practice at the top of their skills than the age of COVID-19.⁷

But if your “field” doesn’t even recognize you at all? That is the fate of many providers left behind by the field of pediatric hospital medicine. Over the past year, we have seen PHM attain a great achievement in its recognition as a board-certified subspecialty established by the American Board of Pediatrics (ABP), only to have the process beset by allegations of gender and maternal bias. While a groundswell of opposition from pediatric hospitalists triggered by the exclusion of applicants to the Practice Pathway to board certification led the ABP to remove the practice interruption criteria, other potential sources of gender and maternal bias remain.⁸

This does not even address pediatric hospitalists trained in family medicine who cannot be eligible for PHM board certification through experience or fellowship, med-peds trained pediatric hospitalists who cannot quality because of insufficient time spent on pediatric inpatient care, newborn hospitalists (who do not qualify), and APPs specialized in pediatric inpatient care. While it is completely understandable that the ABP cannot provide a certification pathway for all of these groups, this still leaves a gap for these providers when it comes to being in a professional community that supports their professional development, ongoing education, and training. Fortunately, leaders of the three societies that have significant numbers of pediatric hospitalists – SHM, American Academy of Pediatrics, and Academic Pediatric Association – are working to develop a PHM designation outside of the ABP board certification pathway that will extend the professional community to those left out of board certification.

As we move bravely into this new era of SHM, our clarion call is to collaborate whenever and wherever we can, with our practice administrators, APPs, outpatient providers, subspecialist providers, and patient/family advocates – pandemic or no pandemic. In fact, what this pandemic has shown us is that rapid cycle, fully 360-degree collaboration is the only way hospitalists and hospital leaders will weather the storms of changing reimbursement, pandemics, or politics. This will be our challenge for the next decade, to ensure that SHM collaboratively moves beyond the confines of the hospital ward.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. Frakt A. A Sense of Alarm as Rural Hospitals Keep Closing. The New York Times. 2018. https://www.nytimes.com/2018/10/29/upshot/a-sense-of-alarm-as-rural-hospitals-keep-closing.html. Accessed February 28, 2020.

2. Poonacha TK, Chamoun F. The burden of prior authorizations and denials in health care. Medpage Today’s KevinMD. 2019. https://www.kevinmd.com/blog/2019/12/the-burden-of-prior-authorizations-and-denials-in-health-care.html. Accessed February 28, 2020.

3. 10 reasons healthcare leaders fail and how to prevent them. Becker’s Hospital Review. 2015. https://www.beckershospitalreview.com/hospital-management-administration/10-reasons-healthcare-leaders-fail-and-how-to-prevent-them.html. Accessed March 15, 2020

4. Buhr RG et al. Comorbidity and thirty-day hospital readmission odds in chronic obstructive pulmonary disease: a comparison of the Charlson and Elixhauser comorbidity indices. BMC Health Serv Res. 2019;19:701.

5. Garrison GM et al. Family medicine patients have shorter length of stay when cared for on a family medicine inpatient service. J Prim Care Community Health. 2019. doi: 10.1177/2150132719840517.

6. Cardin T. Work the Program for NP/PAs, and the Program Will Work. The Hospital Leader: Official Blog of SHM. 2019. https://thehospitalleader.org/work-the-program-for-np-pas-and-the-program-will-work/

7. Mittman DE. More physician assistants are ready to help with COVID-19 – now governors must empower them. The Hill. 2020. https://thehill.com/opinion/healthcare/489985-more-physician-assistants-are-ready-to-help-with-covid-19-now-governors. Accessed March 31, 2020.

8. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019;14:630-2.

SHM is entering an exciting new chapter in its history because we will soon see Dr. Eric Howell take the reins from Dr. Larry Wellikson as CEO, as we watch Dr. Danielle Scheurer assume the role of president from Dr. Chris Frost, and as a side note, I will try to fill Dr. Scheurer’s shoes as physician editor of The Hospitalist.

This changing of the guard of SHM’s leadership will take place amid the backdrop of an acrimonious presidential election and the emergence of a novel coronavirus that threatens to upend the typical routines of our social and professional lives.

Without a doubt, our leaders, whether national, regional, or local, will be at the helm during one of the most uncertain times in the history of modern health care. Will we see a U.S. President who is a proponent of supporting the Affordable Care Act? Will we see further erosion of Obamacare under a second term of President Trump? Will we see rural hospitals continue to close or shrink¹ as their margins get squeezed by skyrocketing denials for inpatient status in favor of observation or outpatient status?²

Forces that seem beyond our control threaten to drastically alter our professions and even our livelihoods. In the space of the few weeks during which I began and finished this piece, every day brought a whole new world of changes in my hospital, town, state, and country. No leader can predict the future with any semblance of certitude.

In the face of these swirling winds of uncertainty, what is clear is that maintaining our commitment as hospitalists to providing evidence-based, high-quality care to our patients while providing support to our colleagues in the health care industry will greatly benefit from collaborating effectively under the “big tent” philosophy of SHM. Over my career, I have benefited from great role models and colleagues as my career took me from primary care med-peds to the “new” field of hospital medicine as a med-peds hospitalist, to a leadership role in pediatric hospital medicine. I have also benefited from “learning opportunities,” as I have made my fair share of mistakes in efforts to improve systems of care. Nearly all of these mistakes share a common thread – not collaborating effectively with critical stakeholders, both within and outside of my institution.³ As this pandemic progresses, I am (and likely you are) witnessing your leaders succeed or fail based on their ability to collaborate across the institution.

As a field, we risk making similar errors by being too narrowly focused as we strive to improve the care of our patients. Recently, Dr. Russell Buhr and his colleagues at the University of California, Los Angeles, demonstrated that a majority of 30-day readmissions for chronic obstructive pulmonary disease (COPD) are due to non-COPD diagnoses.⁴ As we discharge our COPD patients, we may be satisfied that we’ve “tuned up” our patient’s COPD, but have we adequately arranged for appropriate ongoing care of their other medical problems? This requires an activity undertaken less and less these days in medicine – a conversation between hospitalists and outpatient medical providers. The coronavirus disease 2019 (COVID-19) pandemic has made this more challenging, but I can assure you that you can neither transmit nor catch the coronavirus from a phone call.

Perhaps we can learn from our hospitalist colleagues trained in family medicine. A recent study found that hospitalists in a team made up of family medicine–trained physicians in an academic health center achieved a 33% shorter length of stay for patients from the family medicine clinic, after adjustment for disease, demographics, and disease severity.⁵ The conclusion of the authors was that this was likely caused by greater familiarity with outpatient resources. I would conjecture that family medicine hospitalists were also more likely to have a conversation with a patient’s outpatient primary care provider (PCP).

Of course, I am the first to admit that chatting with a PCP is not as easy as it used to be – when we could bump into each other in the doctor’s lounge drinking coffee or in radiology while pulling x-ray films (remember those?) – and in the age of COVID-19, these interactions are even less likely. It can take considerable time and effort to get PCP colleagues on the phone unless you’re chummy enough to have their cell phone numbers. And time is a resource in short supply because most hospital medicine groups are understaffed – in the 2018 SHM State of Hospital Medicine (SoHM) Report, 66.4% of responding groups had open positions, with a median of 12% understaffing reported. The 2020 SoHM report is being compiled as we speak, but I suspect this situation will not have improved, and as the pandemic strikes, staffing models have been completely blown up.

To dig ourselves out of this staffing hole and still stay under (or not too over) budget, bringing more advanced practice providers (APP) into our groups/divisions will be needed. We must recognize, however, that APPs can’t just be hired rapidly and thrown into the schedule. As Tracy Cardin, ACNP-BC, SFHM, stated in her December 2019 blog post on the Hospital Leader website, leaders need to implement consistent onboarding, training, and support of APPs, just as they would for any other hospitalist in their group.⁶ Physician hospitalists need to develop and maintain proven competency in effectively interacting with APPs practicing at the top of their skills and productivity. No time has ever proven the need to allow APPs to practice at the top of their skills than the age of COVID-19.⁷

But if your “field” doesn’t even recognize you at all? That is the fate of many providers left behind by the field of pediatric hospital medicine. Over the past year, we have seen PHM attain a great achievement in its recognition as a board-certified subspecialty established by the American Board of Pediatrics (ABP), only to have the process beset by allegations of gender and maternal bias. While a groundswell of opposition from pediatric hospitalists triggered by the exclusion of applicants to the Practice Pathway to board certification led the ABP to remove the practice interruption criteria, other potential sources of gender and maternal bias remain.⁸

This does not even address pediatric hospitalists trained in family medicine who cannot be eligible for PHM board certification through experience or fellowship, med-peds trained pediatric hospitalists who cannot quality because of insufficient time spent on pediatric inpatient care, newborn hospitalists (who do not qualify), and APPs specialized in pediatric inpatient care. While it is completely understandable that the ABP cannot provide a certification pathway for all of these groups, this still leaves a gap for these providers when it comes to being in a professional community that supports their professional development, ongoing education, and training. Fortunately, leaders of the three societies that have significant numbers of pediatric hospitalists – SHM, American Academy of Pediatrics, and Academic Pediatric Association – are working to develop a PHM designation outside of the ABP board certification pathway that will extend the professional community to those left out of board certification.

As we move bravely into this new era of SHM, our clarion call is to collaborate whenever and wherever we can, with our practice administrators, APPs, outpatient providers, subspecialist providers, and patient/family advocates – pandemic or no pandemic. In fact, what this pandemic has shown us is that rapid cycle, fully 360-degree collaboration is the only way hospitalists and hospital leaders will weather the storms of changing reimbursement, pandemics, or politics. This will be our challenge for the next decade, to ensure that SHM collaboratively moves beyond the confines of the hospital ward.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. Frakt A. A Sense of Alarm as Rural Hospitals Keep Closing. The New York Times. 2018. https://www.nytimes.com/2018/10/29/upshot/a-sense-of-alarm-as-rural-hospitals-keep-closing.html. Accessed February 28, 2020.

2. Poonacha TK, Chamoun F. The burden of prior authorizations and denials in health care. Medpage Today’s KevinMD. 2019. https://www.kevinmd.com/blog/2019/12/the-burden-of-prior-authorizations-and-denials-in-health-care.html. Accessed February 28, 2020.

3. 10 reasons healthcare leaders fail and how to prevent them. Becker’s Hospital Review. 2015. https://www.beckershospitalreview.com/hospital-management-administration/10-reasons-healthcare-leaders-fail-and-how-to-prevent-them.html. Accessed March 15, 2020

4. Buhr RG et al. Comorbidity and thirty-day hospital readmission odds in chronic obstructive pulmonary disease: a comparison of the Charlson and Elixhauser comorbidity indices. BMC Health Serv Res. 2019;19:701.

5. Garrison GM et al. Family medicine patients have shorter length of stay when cared for on a family medicine inpatient service. J Prim Care Community Health. 2019. doi: 10.1177/2150132719840517.

6. Cardin T. Work the Program for NP/PAs, and the Program Will Work. The Hospital Leader: Official Blog of SHM. 2019. https://thehospitalleader.org/work-the-program-for-np-pas-and-the-program-will-work/

7. Mittman DE. More physician assistants are ready to help with COVID-19 – now governors must empower them. The Hill. 2020. https://thehill.com/opinion/healthcare/489985-more-physician-assistants-are-ready-to-help-with-covid-19-now-governors. Accessed March 31, 2020.

8. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019;14:630-2.

To the Editor:

Ongoing concern about the high costs of dermatology residency interviews has led to several cost-saving proposals, as presented by Hussain¹ in the Cutis article, “Reducing the Cost of Dermatology Residency Applications: An Applicant’s Perspective.” Additional strategies to reduce applicant costs include eliminating travel costs through video or telephone interviews, interviewing students who are visiting during their away rotation, and developing and implementing a mechanism to exempt students from participating in the Electronic Residency Application Service (ERAS) and the National Resident Matching Program (NRMP).² A potential mechanism for the latter suggestion could be a binding early decision program for dermatology residency. Binding early decision has been successfully employed by medical schools for many years.³ Under this model for dermatology residency, applicants may apply to 1 dermatology residency program by the early deadline and the program would have the option of accepting as many of the early-decision applicants as the number of residency positions in their program permits, allowing nonadmitted and nonparticipating applicants time to apply through the usual ERAS/NRMP cycle. There are several potential advantages to this model that would decrease the number of applicants applying to all the available dermatology residency programs each cycle.

First, because applicants would be limited to 1 application to participate in the early decision program, they must realistically consider the strength of their application and weigh their chances for acceptance to that program. Programs could facilitate the process by becoming more transparent about the type of applicants that have previously matched in their program.² If an early-decision applicant successfully matches, that applicant would be prohibited from applying to additional dermatology residency programs through ERAS and NRMP during that application cycle.

Second, early-decision actions by programs—probably by August 1, a time when most third-year medical students have completed their academic year—would be determined before ERAS releases applications to residency programs. This timeline would remove successful applicants in the early decision program from going to additional interviews and incurring the associated travel costs.

Third, early decision could be potentially beneficial to applicants who are tied to a specific geographic region for training and to programs with specific program needs, such as expertise in specific areas of dermatology research or areas of clinical need (eg, adding a dermatopathologist, plastic surgeon, internist, or a pediatrician to the residency program who now wants dermatology training) or other program needs.

Fourth, application costs could potentially be lower for early-decision applicants than through the present application process if participating institutions waived application fees. Applicants would still be responsible for submitting requested academic transcripts, letters of recommendation, and travel expenses if an on-site interview is requested by the program.

Finally, highly desirable applicants who are offered a position through early decision would result in more opportunities for other applicants to interview for the remaining available residency positions through ERAS/NRMP.

Downsides to early decision for dermatology residency include the inability of applicants to compare programs to one another through their personal experiences, such as prior rotations or interviews, and for programs to compare applicants though the interview process and away rotations. In addition, US Medical Licensing Examination Step 2 scores and Alpha Omega Alpha honor medical society status and other academic honors may not be available to programs to consider at the time of early decision. Cooperation would be needed with ERAS and NRMP to create an early decision program for dermatology residency.

One other potential consequence of the early match could involve instances of strained relationships between research fellows and their sponsoring institution or dermatology program. Research fellows often match at their research institution, and failing to early match could potentially sour the relationship between the applicant and the program, thus leading to a less productive year. However, many programs participating in an early match will probably have additional residency positions remaining in the traditional match that would be still available to the fellows.

The concept of an early-binding residency match process has the potential to save both time and money for programs and applicants. Although an early-match process would have many positive effects, there also would be inherent downsides that accompany such a system. Nonetheless, an early-match process in dermatology has the prospect of efficiently pairing applicants and programs that feel strongly about each other while simplifying the match process and reducing costs for all parties involved.

References

1. Hussain AN. Reducing the cost of dermatology residency applications: an applicant’s perspective. Cutis. 2019;104:352-353.

2. Weisert E, Phan M. Thoughts on reducing the cost for dermatology residency applications. DIG@UTMB blog. http://digutmb.blogspot.com/2019/12/thoughts-on-reducing-cost-for.html. Published December 23, 2019. Accessed April 17, 2020.

3. Early decision program. Association of American Medical Colleges website. https://students-residents.aamc.org/applying-medical-school/article/early-decision-program/. Accessed April 8, 2020.

Author’s Response

The early decision option for dermatology residency applications would be a welcomed addition to the process but may be complicated by 2 recent events: the coronavirus disease 2019 (COVID-19) pandemic and the change of US Medical Licensing Examination (USMLE) Step 1 score reporting to a pass/fail system.

The COVID-19 pandemic has caused remarkable economic distress and likely affects medical students more acutely given their high levels of debt. As Ryan and Wagner observed, one advantage of the early-decision option would be financial relief for certain students. If applicants successfully match during the early-decision phase, they will not need to apply to any additional dermatology programs and also can target their preliminary-year applications to the geographic region where they have already matched.

In addition, the COVID-19 pandemic may further reduce early applicants’ ability to visit programs in person. Various medical schools have curtailed away rotations, and programs may opt for virtual interviews in accordance with social distancing guidelines.¹ Thus, early applicants will have even fewer opportunities to compare programs before they must make a binding decision about their residency placement. Although away rotations and interview travel are some of the largest drivers of application cost,² reducing costs in this way might shortchange both students and programs.

Arguably, the change in USMLE Step 1 score reporting beginning in 2022 may impact residency selection for a longer period of time than the COVID-19 pandemic. Program directors cited USMLE Step 1 scores as one of the main factors determining which applicants may be invited to interview.³ The lack of numerical USMLE Step 1 scores may encourage programs to place more weight on other metrics such as USMLE Step 2 CK scores or Alpha Omega Alpha membership.⁴ However, as Ryan and Wagner point out, such metrics may not be available in time for early-decision applicants.

As such, future program directors will have precious little information to screen early-decision applicants and may need to conduct holistic application review. This would require increased time and manpower compared to screening based on traditional metrics but may lead to a better “fit” for an applicant with a residency.

In general, implementation of any early decision program would benefit dermatology applicants as a group by removing elite candidates from the applicant pool. According to National Resident Matching Program data, just 3% of dermatology applicants account for more than 12% of overall interviews.⁵ In other words, a small group of the strongest applicants receives a lion’s share of interviews, crowding out many other candidates. Removing these top-tier applicants likely would provide remaining applicants with a higher return on investment per application, and students may choose to save money by applying to fewer programs.

Adopting early-decision options within the dermatology match may be complicated given the COVID-19 pandemic and USMLE score changes but may spur positive changes in the process while also reducing the financial burden on applicants.

Aamir N. Hussain, MD, MAPP

From Northwell Health, Manhasset, New York.

The author reports no conflict of interest.

Correspondence: Aamir N. Hussain, MD, MAPP ([email protected]).

References

1. Coronavirus (COVID-19) and the VSLO program. Association of American Medical Colleges website. https://students-residents.aamc.org/attending-medical-school/article/coronavirus-covid-19-and-vslo-program/. Accessed April 17, 2020.

2. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.

3. National Resident Matching Program, Data Release and Research Committee. Results of the 2018 NRMP Program Director Survey. Washington, DC: National Resident Matching Program; 2018. https://www.nrmp.org/wp-content/uploads/2018/07/NRMP-2018-Program-Director-Survey-for-WWW.pdf. Published June 2018. Accessed April 17, 2020.

4. Crane MA, Chang HA, Azamfirei R. Medical education takes a step in the right direction: where does that leave students? [published online March 6, 2020]. JAMA. doi:10.1001/jama.2020.2950.

5. Lee AH, Young P, Liao R, et al. I dream of Gini: quantifying inequality in otolaryngology residency interviews. Laryngoscope. 2019;129:627-633.

To the Editor:

Ongoing concern about the high costs of dermatology residency interviews has led to several cost-saving proposals, as presented by Hussain¹ in the Cutis article, “Reducing the Cost of Dermatology Residency Applications: An Applicant’s Perspective.” Additional strategies to reduce applicant costs include eliminating travel costs through video or telephone interviews, interviewing students who are visiting during their away rotation, and developing and implementing a mechanism to exempt students from participating in the Electronic Residency Application Service (ERAS) and the National Resident Matching Program (NRMP).² A potential mechanism for the latter suggestion could be a binding early decision program for dermatology residency. Binding early decision has been successfully employed by medical schools for many years.³ Under this model for dermatology residency, applicants may apply to 1 dermatology residency program by the early deadline and the program would have the option of accepting as many of the early-decision applicants as the number of residency positions in their program permits, allowing nonadmitted and nonparticipating applicants time to apply through the usual ERAS/NRMP cycle. There are several potential advantages to this model that would decrease the number of applicants applying to all the available dermatology residency programs each cycle.

First, because applicants would be limited to 1 application to participate in the early decision program, they must realistically consider the strength of their application and weigh their chances for acceptance to that program. Programs could facilitate the process by becoming more transparent about the type of applicants that have previously matched in their program.² If an early-decision applicant successfully matches, that applicant would be prohibited from applying to additional dermatology residency programs through ERAS and NRMP during that application cycle.

Second, early-decision actions by programs—probably by August 1, a time when most third-year medical students have completed their academic year—would be determined before ERAS releases applications to residency programs. This timeline would remove successful applicants in the early decision program from going to additional interviews and incurring the associated travel costs.

Third, early decision could be potentially beneficial to applicants who are tied to a specific geographic region for training and to programs with specific program needs, such as expertise in specific areas of dermatology research or areas of clinical need (eg, adding a dermatopathologist, plastic surgeon, internist, or a pediatrician to the residency program who now wants dermatology training) or other program needs.

Fourth, application costs could potentially be lower for early-decision applicants than through the present application process if participating institutions waived application fees. Applicants would still be responsible for submitting requested academic transcripts, letters of recommendation, and travel expenses if an on-site interview is requested by the program.

Finally, highly desirable applicants who are offered a position through early decision would result in more opportunities for other applicants to interview for the remaining available residency positions through ERAS/NRMP.

Downsides to early decision for dermatology residency include the inability of applicants to compare programs to one another through their personal experiences, such as prior rotations or interviews, and for programs to compare applicants though the interview process and away rotations. In addition, US Medical Licensing Examination Step 2 scores and Alpha Omega Alpha honor medical society status and other academic honors may not be available to programs to consider at the time of early decision. Cooperation would be needed with ERAS and NRMP to create an early decision program for dermatology residency.

One other potential consequence of the early match could involve instances of strained relationships between research fellows and their sponsoring institution or dermatology program. Research fellows often match at their research institution, and failing to early match could potentially sour the relationship between the applicant and the program, thus leading to a less productive year. However, many programs participating in an early match will probably have additional residency positions remaining in the traditional match that would be still available to the fellows.

The concept of an early-binding residency match process has the potential to save both time and money for programs and applicants. Although an early-match process would have many positive effects, there also would be inherent downsides that accompany such a system. Nonetheless, an early-match process in dermatology has the prospect of efficiently pairing applicants and programs that feel strongly about each other while simplifying the match process and reducing costs for all parties involved.

References

1. Hussain AN. Reducing the cost of dermatology residency applications: an applicant’s perspective. Cutis. 2019;104:352-353.

2. Weisert E, Phan M. Thoughts on reducing the cost for dermatology residency applications. DIG@UTMB blog. http://digutmb.blogspot.com/2019/12/thoughts-on-reducing-cost-for.html. Published December 23, 2019. Accessed April 17, 2020.

3. Early decision program. Association of American Medical Colleges website. https://students-residents.aamc.org/applying-medical-school/article/early-decision-program/. Accessed April 8, 2020.

Author’s Response

The early decision option for dermatology residency applications would be a welcomed addition to the process but may be complicated by 2 recent events: the coronavirus disease 2019 (COVID-19) pandemic and the change of US Medical Licensing Examination (USMLE) Step 1 score reporting to a pass/fail system.

The COVID-19 pandemic has caused remarkable economic distress and likely affects medical students more acutely given their high levels of debt. As Ryan and Wagner observed, one advantage of the early-decision option would be financial relief for certain students. If applicants successfully match during the early-decision phase, they will not need to apply to any additional dermatology programs and also can target their preliminary-year applications to the geographic region where they have already matched.

In addition, the COVID-19 pandemic may further reduce early applicants’ ability to visit programs in person. Various medical schools have curtailed away rotations, and programs may opt for virtual interviews in accordance with social distancing guidelines.¹ Thus, early applicants will have even fewer opportunities to compare programs before they must make a binding decision about their residency placement. Although away rotations and interview travel are some of the largest drivers of application cost,² reducing costs in this way might shortchange both students and programs.

Arguably, the change in USMLE Step 1 score reporting beginning in 2022 may impact residency selection for a longer period of time than the COVID-19 pandemic. Program directors cited USMLE Step 1 scores as one of the main factors determining which applicants may be invited to interview.³ The lack of numerical USMLE Step 1 scores may encourage programs to place more weight on other metrics such as USMLE Step 2 CK scores or Alpha Omega Alpha membership.⁴ However, as Ryan and Wagner point out, such metrics may not be available in time for early-decision applicants.

As such, future program directors will have precious little information to screen early-decision applicants and may need to conduct holistic application review. This would require increased time and manpower compared to screening based on traditional metrics but may lead to a better “fit” for an applicant with a residency.

In general, implementation of any early decision program would benefit dermatology applicants as a group by removing elite candidates from the applicant pool. According to National Resident Matching Program data, just 3% of dermatology applicants account for more than 12% of overall interviews.⁵ In other words, a small group of the strongest applicants receives a lion’s share of interviews, crowding out many other candidates. Removing these top-tier applicants likely would provide remaining applicants with a higher return on investment per application, and students may choose to save money by applying to fewer programs.

Adopting early-decision options within the dermatology match may be complicated given the COVID-19 pandemic and USMLE score changes but may spur positive changes in the process while also reducing the financial burden on applicants.

Aamir N. Hussain, MD, MAPP

From Northwell Health, Manhasset, New York.

The author reports no conflict of interest.

Correspondence: Aamir N. Hussain, MD, MAPP ([email protected]).

References

1. Coronavirus (COVID-19) and the VSLO program. Association of American Medical Colleges website. https://students-residents.aamc.org/attending-medical-school/article/coronavirus-covid-19-and-vslo-program/. Accessed April 17, 2020.

2. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.

3. National Resident Matching Program, Data Release and Research Committee. Results of the 2018 NRMP Program Director Survey. Washington, DC: National Resident Matching Program; 2018. https://www.nrmp.org/wp-content/uploads/2018/07/NRMP-2018-Program-Director-Survey-for-WWW.pdf. Published June 2018. Accessed April 17, 2020.

4. Crane MA, Chang HA, Azamfirei R. Medical education takes a step in the right direction: where does that leave students? [published online March 6, 2020]. JAMA. doi:10.1001/jama.2020.2950.

5. Lee AH, Young P, Liao R, et al. I dream of Gini: quantifying inequality in otolaryngology residency interviews. Laryngoscope. 2019;129:627-633.

To the Editor:

Ongoing concern about the high costs of dermatology residency interviews has led to several cost-saving proposals, as presented by Hussain¹ in the Cutis article, “Reducing the Cost of Dermatology Residency Applications: An Applicant’s Perspective.” Additional strategies to reduce applicant costs include eliminating travel costs through video or telephone interviews, interviewing students who are visiting during their away rotation, and developing and implementing a mechanism to exempt students from participating in the Electronic Residency Application Service (ERAS) and the National Resident Matching Program (NRMP).² A potential mechanism for the latter suggestion could be a binding early decision program for dermatology residency. Binding early decision has been successfully employed by medical schools for many years.³ Under this model for dermatology residency, applicants may apply to 1 dermatology residency program by the early deadline and the program would have the option of accepting as many of the early-decision applicants as the number of residency positions in their program permits, allowing nonadmitted and nonparticipating applicants time to apply through the usual ERAS/NRMP cycle. There are several potential advantages to this model that would decrease the number of applicants applying to all the available dermatology residency programs each cycle.

First, because applicants would be limited to 1 application to participate in the early decision program, they must realistically consider the strength of their application and weigh their chances for acceptance to that program. Programs could facilitate the process by becoming more transparent about the type of applicants that have previously matched in their program.² If an early-decision applicant successfully matches, that applicant would be prohibited from applying to additional dermatology residency programs through ERAS and NRMP during that application cycle.

Second, early-decision actions by programs—probably by August 1, a time when most third-year medical students have completed their academic year—would be determined before ERAS releases applications to residency programs. This timeline would remove successful applicants in the early decision program from going to additional interviews and incurring the associated travel costs.

Third, early decision could be potentially beneficial to applicants who are tied to a specific geographic region for training and to programs with specific program needs, such as expertise in specific areas of dermatology research or areas of clinical need (eg, adding a dermatopathologist, plastic surgeon, internist, or a pediatrician to the residency program who now wants dermatology training) or other program needs.

Fourth, application costs could potentially be lower for early-decision applicants than through the present application process if participating institutions waived application fees. Applicants would still be responsible for submitting requested academic transcripts, letters of recommendation, and travel expenses if an on-site interview is requested by the program.

Finally, highly desirable applicants who are offered a position through early decision would result in more opportunities for other applicants to interview for the remaining available residency positions through ERAS/NRMP.

Downsides to early decision for dermatology residency include the inability of applicants to compare programs to one another through their personal experiences, such as prior rotations or interviews, and for programs to compare applicants though the interview process and away rotations. In addition, US Medical Licensing Examination Step 2 scores and Alpha Omega Alpha honor medical society status and other academic honors may not be available to programs to consider at the time of early decision. Cooperation would be needed with ERAS and NRMP to create an early decision program for dermatology residency.

One other potential consequence of the early match could involve instances of strained relationships between research fellows and their sponsoring institution or dermatology program. Research fellows often match at their research institution, and failing to early match could potentially sour the relationship between the applicant and the program, thus leading to a less productive year. However, many programs participating in an early match will probably have additional residency positions remaining in the traditional match that would be still available to the fellows.

The concept of an early-binding residency match process has the potential to save both time and money for programs and applicants. Although an early-match process would have many positive effects, there also would be inherent downsides that accompany such a system. Nonetheless, an early-match process in dermatology has the prospect of efficiently pairing applicants and programs that feel strongly about each other while simplifying the match process and reducing costs for all parties involved.

References

1. Hussain AN. Reducing the cost of dermatology residency applications: an applicant’s perspective. Cutis. 2019;104:352-353.

2. Weisert E, Phan M. Thoughts on reducing the cost for dermatology residency applications. DIG@UTMB blog. http://digutmb.blogspot.com/2019/12/thoughts-on-reducing-cost-for.html. Published December 23, 2019. Accessed April 17, 2020.

3. Early decision program. Association of American Medical Colleges website. https://students-residents.aamc.org/applying-medical-school/article/early-decision-program/. Accessed April 8, 2020.

Author’s Response

The early decision option for dermatology residency applications would be a welcomed addition to the process but may be complicated by 2 recent events: the coronavirus disease 2019 (COVID-19) pandemic and the change of US Medical Licensing Examination (USMLE) Step 1 score reporting to a pass/fail system.

The COVID-19 pandemic has caused remarkable economic distress and likely affects medical students more acutely given their high levels of debt. As Ryan and Wagner observed, one advantage of the early-decision option would be financial relief for certain students. If applicants successfully match during the early-decision phase, they will not need to apply to any additional dermatology programs and also can target their preliminary-year applications to the geographic region where they have already matched.

In addition, the COVID-19 pandemic may further reduce early applicants’ ability to visit programs in person. Various medical schools have curtailed away rotations, and programs may opt for virtual interviews in accordance with social distancing guidelines.¹ Thus, early applicants will have even fewer opportunities to compare programs before they must make a binding decision about their residency placement. Although away rotations and interview travel are some of the largest drivers of application cost,² reducing costs in this way might shortchange both students and programs.

Arguably, the change in USMLE Step 1 score reporting beginning in 2022 may impact residency selection for a longer period of time than the COVID-19 pandemic. Program directors cited USMLE Step 1 scores as one of the main factors determining which applicants may be invited to interview.³ The lack of numerical USMLE Step 1 scores may encourage programs to place more weight on other metrics such as USMLE Step 2 CK scores or Alpha Omega Alpha membership.⁴ However, as Ryan and Wagner point out, such metrics may not be available in time for early-decision applicants.

As such, future program directors will have precious little information to screen early-decision applicants and may need to conduct holistic application review. This would require increased time and manpower compared to screening based on traditional metrics but may lead to a better “fit” for an applicant with a residency.

In general, implementation of any early decision program would benefit dermatology applicants as a group by removing elite candidates from the applicant pool. According to National Resident Matching Program data, just 3% of dermatology applicants account for more than 12% of overall interviews.⁵ In other words, a small group of the strongest applicants receives a lion’s share of interviews, crowding out many other candidates. Removing these top-tier applicants likely would provide remaining applicants with a higher return on investment per application, and students may choose to save money by applying to fewer programs.

Adopting early-decision options within the dermatology match may be complicated given the COVID-19 pandemic and USMLE score changes but may spur positive changes in the process while also reducing the financial burden on applicants.

Aamir N. Hussain, MD, MAPP

From Northwell Health, Manhasset, New York.

The author reports no conflict of interest.

Correspondence: Aamir N. Hussain, MD, MAPP ([email protected]).

References

1. Coronavirus (COVID-19) and the VSLO program. Association of American Medical Colleges website. https://students-residents.aamc.org/attending-medical-school/article/coronavirus-covid-19-and-vslo-program/. Accessed April 17, 2020.

2. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.

3. National Resident Matching Program, Data Release and Research Committee. Results of the 2018 NRMP Program Director Survey. Washington, DC: National Resident Matching Program; 2018. https://www.nrmp.org/wp-content/uploads/2018/07/NRMP-2018-Program-Director-Survey-for-WWW.pdf. Published June 2018. Accessed April 17, 2020.

4. Crane MA, Chang HA, Azamfirei R. Medical education takes a step in the right direction: where does that leave students? [published online March 6, 2020]. JAMA. doi:10.1001/jama.2020.2950.

5. Lee AH, Young P, Liao R, et al. I dream of Gini: quantifying inequality in otolaryngology residency interviews. Laryngoscope. 2019;129:627-633.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.

The worldwide spread of SARS-CoV-2, the coronavirus that causes the syndrome designated COVID-19 by the World Health Organization (WHO), presents a challenge for emergency operative care in a global pandemic setting that is novel for modern surgical practice. The virulence of this new pathogen has raised concern for how to protect operating room (OR) staff and their environs in the event that an infected patient requires urgent surgical care. Because coronaviridae spread mainly through contact with contaminated respiratory droplets or aerosolized virion-containing particles, personal protective equipment (PPE) is vital to personnel involved in these cases, and proper utilization of these scarce resources poses an additional challenge. Establishment of a clear protocol that adheres to rigorous infection control measures while providing a safe system for intrafacility transport and operative care is an essential component of a successful surgical pandemic response.

The first case of COVID-19 disease identified in the US was diagnosed in Everett, Washington, on January 21, 2020.¹ In the succeeding months, the Seattle region became an early epicenter of the epidemic in the US, with Washington State becoming the first state to see in excess of 1,000 cases by mid-March 2020. As hospitalizations for COVID-19 increased, emergency surge preparations were enacted at medical centers across the region. Recommendations for how to manage infected patients evolved rapidly. Anticipating the need to provide surgical services during this pandemic, starting in early March 2020, the perioperative services staff at the US Department of Veterans Affairs (VA) Puget Sound Health Care System (PSHCS) convened to develop the protocol described here through a process of literature review, multidisciplinary discussion, and practical trial runs and drills. VAPSHCS is an urban academic medical center affiliated with the University of Washington, Seattle. The result of this collaboration is a detailed, step-by-step protocol that establishes the roles and responsibilities of the various personnel who intersect in the OR and recruits their teamwork to prevent environmental contamination and health care worker transmission of SARS-CoV-2.

The protocol is divided into discrete practice recommendations for the preoperative, intraoperative, and postoperative management of patients with confirmed or suspected COVID-19 infection, with a focus on maintaining Centers of Disease Control and Prevention-defined respiratory droplet and airborne precautions throughout the period of patient contact and mitigating infectious contamination of the operating suite.² It is acknowledged that no written protocol can encompass all the possible considerations that attend the vast diversity of surgical scenarios which can transpire in the operative setting. Patient acuity must sometimes mandate modifications to even the most thoroughly laid plans; for instance, the exsanguinating patient requiring emergent surgery for hemorrhage control will undoubtedly require an urgent appraisal of the relative risks and benefits of certain elements of the practices here described. Nevertheless, we believe that this protocol provides a useful framework for mitigating the infection and contamination risks of operative care in an epidemic environment, and should be readily adaptable to any facility that may perform surgery in patients infected with a high-risk contagious pathogen.

Preoperative Management 

In addition to introducing the risk of viral transmission, surgery in the patient with COVID-19 also imposes a large consumption of vital PPE, supplies and can become dangerously low in health care centers coping with an influx of infected patients. Early in the pandemic, to reduce exposure, conserve the medical workforce and lessen the resource strain on the overall health care infrastructure, the American College of Surgeons (ACS), American College of Gastroenterology, and other professional societies recommended cancellation of elective procedures, confining operations to urgent or emergent procedures for high-acuity diseases that would negatively impact morbidity or mortality if delayed.^3,4 In each case, physicians from the surgical and anesthesia services should discuss the rationale for the operation and secure agreement to commit resources to the endeavor prior to reserving the OR. These considerations should be shared with the patient prior to obtaining informed consent.

Preoperatively, the surgical team, consisting of surgeon, anesthesiologist, OR nurse, surgical technician, and assistants to the surgeon, anesthesiologist and nurse, convene for a preoperative “team huddle.” While assistants will aid in patient transport and supplying equipment to the team during the procedure, they should not be in the OR during the case, to minimize personnel exposure and PPE consumption. All members of the surgical team remove their personal effects, including wallets, phones, badges, and jewelry; any pagers are handed to other members of the care team for the duration of the surgery. During this preoperative team huddle, proper setup and accounting of the surgical equipment is confirmed, as well as the availability of all necessary anesthesia equipment and medications.

A specific OR with versatile characteristics was chosen to be the designated OR for procedures in patients with confirmed or suspected COVID-19. The COVID OR is on standby when no such cases are active, and it is not used for surgeries in noninfected patients. This is in accord with published recommendations of anesthesiologists who, throughout the COVID-19 epidemic in China, maintained designated ORs and anesthesia machines for only infected patients.⁵ Strong consideration should be given to performing procedures for which endotracheal intubation is not required in the patient’s own respiratory isolation room, rather than the OR to avoid room contamination and excessive use of PPE.^5,6

The availability of adequate PPE is confirmed during the preoperative team huddle. At a minimum, powered air purifying respirator devices (PAPRs) with hoods must be available for the anesthesia provider, surgeon and surgical technician, recognizing the Anesthesia Patient Safety Foundation (APSF) recommendation that these devices confer superior protection for those with the highest risk and most proximate exposure to the patient throughout the case.^7,8 An N95 respirator, at minimum, must be available for the circulating OR nurse. Patient condition, need for critical care transport, anesthetic plan (monitored anesthesia care or general anesthesia), and availability of negative pressure isolation rooms in the ward vs in the operating suite should help decide patient transport strategies and help determine the most suitable location to secure the airway. In case of an inadvertent tube disconnection, transporting intubated patients carries the risk of disseminating virus laden aerosols into the environment. Risks of pre-OR intubation should be balanced with the potential benefit of securing the airway prior to transport and decreased gross OR contamination with intubation in the operating suite. Airway manipulation and intubation are among the highest risk procedures for nosocomial transmission and performance of these procedures should utilize precautions described in current APSF recommendations.^3,9,10

For patients not requiring critical care transport, and when conditions favor intubation in the OR, patients should be transported in a gurney while wearing a surgical mask. Verification of the operative site, surgical plan, and other components of the WHO universal surgical safety checklist or time out are performed in the OR prior to induction of anesthesia, and a conscious patient can be an active participant.

If critical care transport is deemed necessary and/or a decision is made to intubate the patient outside the OR, preferably in a negative airflow respiratory isolation room, the perioperative team will confirm the availability of the following equipment needed for patient transport:

• Portable transport monitor;
• Video laryngoscope;
• Airway supplies and medications for induction of general anesthesia;
• Self-inflating bag-mask apparatus attached to an oxygen source;
• High-quality HMEF (heat and moisture exchanging filter) rated to remove at least 99.97% of airborne particles ≥ 0.3 microns to filter out viral particles attached to the expiratory outlet; and
• PPE including impermeable disposable gowns, gloves, and shoe covers.

While the surgical technician remains in the OR, the rest of the team will proceed to the patient’s location with these supplies, along with the necessary number of PAPRs and N95 respirators.

Intraoperative Management

Advance planning can help to ensure a safer intraoperative period when a COVID-19 patient is brought to the OR. Patient room airflow patterns and ventilation capacity should be considered when developing measures to prevent aerosol transmission of airborne infectious agents. Although negative pressure rooms are ideal for aerosol generating procedures such as intubation, most ORs are generally maintained at a positive pressure when compared with the surrounding areas. The feasibility of rapidly converting ORs into negative pressure rooms should be in facility planning for COVID-19; portable high-efficiency particulate air (HEPA) machines, for instance, can be set up to create negative pressure areas around the OR.¹³ We established a negative pressure anteroom outside our OR to be used for doffing and as an airlock, for use by staff who need to enter midcase or pass supplies or specimens into and out of the procedure room (Figure 2). By adding 2 portable HEPA filters and directing the HEPA-filtered exhaust into the OR ventilation return columns, we were able to establish negative pressure airflow in the OR (Figure 3).

The protocol was devised with the current pandemic-associated shortage of PPE taken into consideration. We decided to minimize staffing across disciplines by excluding all nonessential personal from entering the OR. This includes observers, researchers, and medical students. Residents and fellows may participate if their presence is deemed vital to the patient’s intraoperative care. To further prevent resource consumption, equipment in the designated COVID OR was reduced to essential elements such as the anesthesia machine, a minimized anesthesia drug cart and general supply cabinet, all of which were covered with disposable transparent covers (Figure 4).¹⁴ After transfer of the patient to the OR table, the patient stretcher is kept in the OR (space permitting) to minimize contamination of areas immediately outside the OR.

Postperative Management 

Similar to intubation, extubation poses a risk of generating aerosolization of infectious airborne microbes.¹⁰ It is helpful for OR personnel to be aware of the airflow pattern in their ORs, whether it is positive, negative, or neutral. As the PSHCS ORs were originally engineered as positive pressure rooms, we elected to have to postoperative patients with COVID-19 transported intubated to a reverse airflow or negative pressure room in the ICU. Extubation is performed when the intensive care team has determined the patient meets extubation criteria and has passed a spontaneous breathing trial. When a negative pressure room in the ICU is not available for recovery, extubation may be performed in the OR.

In that circumstance, the patient remains in the OR for 30 minutes after extubation to allow for turnover of air in the room prior to the doors opening for patient transport to the ICU.¹⁶ A surgical mask is placed over the patient’s oxygenating face mask to reduce droplet spread during transport. Patients who are not intubated for the anesthetic may be first recovered in the operating room or transported under droplet precautions directly back to a negative pressure isolation room.

Prior to transport, the patient’s gurney is thoroughly cleaned with Environmental Protection Agency-approved disinfectant wipes, and a clean sheet is placed over the patient’s body below the head.¹⁷ The front face shield of the surgeon’s and anesthesiologist’s PAPR hood should be wiped down with an alcohol-based disinfectant. Both health care providers don a clean disposable gown as an outer layer to minimize contamination by their used attire during transport. Once the patient is transported out of the OR, all disposable items are discarded. Reusable medical equipment are cleaned and disinfected according to a thorough application of local environmental services standard operating procedures.¹⁸ The surgeon and anesthesia providers aid in transporting the patient to the ICU, along with their outside OR assistants. All personnel remaining in the OR exit and doff their PPE according to the doffing protocol, which is similar to the donning protocol, utilizes a PPE partner tasked with providing instructions to the surgical team member step by step (Figure 5).

Conclusions

The outbreak of COVID-19 has resulted in an unprecedented modern health care crisis across the globe. Perioperative management of patients with COVID-19 pose unique challenges to all personnel working in the OR, where the risk of nosocomial transmission of infection is ever present. It is essential that hospitals consider their local resources, infrastructure and capabilities when devising policies to respond to the COVID-19 emergency. In all perioperative situations, meticulous attention should be given to both donning and doffing of PPE, crucial for the safety of everyone involved in the care of patients with COVID-19.

Our experience also highlighted the importance of treating a new protocol as an evolving document, which can be modified and improved through the conduct of training and simulation exercises with providers across disciplines (Figure 6). In gathering nurses, anesthesia staff, and surgeons to perform drills and simulate their roles in an imaginary scenario, we gained new insights, and made corrections and additions that ultimately generated the presently described process. Modifications to any protocol may be necessary depending on the unique circumstances of individual health care systems and hospitals, the characteristics of the patient population they cater to, and the resources and expertise they have available. As the pandemic continues, we are bound to learn more about the epidemiology and modes of transmission of SARS-CoV-2, which may demand further changes to our practice. It is crucial to remember that while emergency policies must be rapidly developed, they should be collaboratively improved and incorporate new knowledge when it becomes available. This is essential to ensure the ultimate protocol is useful, up-to-date, easy to follow and tailored to the unique local environment of each health care setting.

The worldwide spread of SARS-CoV-2, the coronavirus that causes the syndrome designated COVID-19 by the World Health Organization (WHO), presents a challenge for emergency operative care in a global pandemic setting that is novel for modern surgical practice. The virulence of this new pathogen has raised concern for how to protect operating room (OR) staff and their environs in the event that an infected patient requires urgent surgical care. Because coronaviridae spread mainly through contact with contaminated respiratory droplets or aerosolized virion-containing particles, personal protective equipment (PPE) is vital to personnel involved in these cases, and proper utilization of these scarce resources poses an additional challenge. Establishment of a clear protocol that adheres to rigorous infection control measures while providing a safe system for intrafacility transport and operative care is an essential component of a successful surgical pandemic response.

The first case of COVID-19 disease identified in the US was diagnosed in Everett, Washington, on January 21, 2020.¹ In the succeeding months, the Seattle region became an early epicenter of the epidemic in the US, with Washington State becoming the first state to see in excess of 1,000 cases by mid-March 2020. As hospitalizations for COVID-19 increased, emergency surge preparations were enacted at medical centers across the region. Recommendations for how to manage infected patients evolved rapidly. Anticipating the need to provide surgical services during this pandemic, starting in early March 2020, the perioperative services staff at the US Department of Veterans Affairs (VA) Puget Sound Health Care System (PSHCS) convened to develop the protocol described here through a process of literature review, multidisciplinary discussion, and practical trial runs and drills. VAPSHCS is an urban academic medical center affiliated with the University of Washington, Seattle. The result of this collaboration is a detailed, step-by-step protocol that establishes the roles and responsibilities of the various personnel who intersect in the OR and recruits their teamwork to prevent environmental contamination and health care worker transmission of SARS-CoV-2.

The protocol is divided into discrete practice recommendations for the preoperative, intraoperative, and postoperative management of patients with confirmed or suspected COVID-19 infection, with a focus on maintaining Centers of Disease Control and Prevention-defined respiratory droplet and airborne precautions throughout the period of patient contact and mitigating infectious contamination of the operating suite.² It is acknowledged that no written protocol can encompass all the possible considerations that attend the vast diversity of surgical scenarios which can transpire in the operative setting. Patient acuity must sometimes mandate modifications to even the most thoroughly laid plans; for instance, the exsanguinating patient requiring emergent surgery for hemorrhage control will undoubtedly require an urgent appraisal of the relative risks and benefits of certain elements of the practices here described. Nevertheless, we believe that this protocol provides a useful framework for mitigating the infection and contamination risks of operative care in an epidemic environment, and should be readily adaptable to any facility that may perform surgery in patients infected with a high-risk contagious pathogen.

Preoperative Management 

In addition to introducing the risk of viral transmission, surgery in the patient with COVID-19 also imposes a large consumption of vital PPE, supplies and can become dangerously low in health care centers coping with an influx of infected patients. Early in the pandemic, to reduce exposure, conserve the medical workforce and lessen the resource strain on the overall health care infrastructure, the American College of Surgeons (ACS), American College of Gastroenterology, and other professional societies recommended cancellation of elective procedures, confining operations to urgent or emergent procedures for high-acuity diseases that would negatively impact morbidity or mortality if delayed.^3,4 In each case, physicians from the surgical and anesthesia services should discuss the rationale for the operation and secure agreement to commit resources to the endeavor prior to reserving the OR. These considerations should be shared with the patient prior to obtaining informed consent.

Preoperatively, the surgical team, consisting of surgeon, anesthesiologist, OR nurse, surgical technician, and assistants to the surgeon, anesthesiologist and nurse, convene for a preoperative “team huddle.” While assistants will aid in patient transport and supplying equipment to the team during the procedure, they should not be in the OR during the case, to minimize personnel exposure and PPE consumption. All members of the surgical team remove their personal effects, including wallets, phones, badges, and jewelry; any pagers are handed to other members of the care team for the duration of the surgery. During this preoperative team huddle, proper setup and accounting of the surgical equipment is confirmed, as well as the availability of all necessary anesthesia equipment and medications.

A specific OR with versatile characteristics was chosen to be the designated OR for procedures in patients with confirmed or suspected COVID-19. The COVID OR is on standby when no such cases are active, and it is not used for surgeries in noninfected patients. This is in accord with published recommendations of anesthesiologists who, throughout the COVID-19 epidemic in China, maintained designated ORs and anesthesia machines for only infected patients.⁵ Strong consideration should be given to performing procedures for which endotracheal intubation is not required in the patient’s own respiratory isolation room, rather than the OR to avoid room contamination and excessive use of PPE.^5,6

The availability of adequate PPE is confirmed during the preoperative team huddle. At a minimum, powered air purifying respirator devices (PAPRs) with hoods must be available for the anesthesia provider, surgeon and surgical technician, recognizing the Anesthesia Patient Safety Foundation (APSF) recommendation that these devices confer superior protection for those with the highest risk and most proximate exposure to the patient throughout the case.^7,8 An N95 respirator, at minimum, must be available for the circulating OR nurse. Patient condition, need for critical care transport, anesthetic plan (monitored anesthesia care or general anesthesia), and availability of negative pressure isolation rooms in the ward vs in the operating suite should help decide patient transport strategies and help determine the most suitable location to secure the airway. In case of an inadvertent tube disconnection, transporting intubated patients carries the risk of disseminating virus laden aerosols into the environment. Risks of pre-OR intubation should be balanced with the potential benefit of securing the airway prior to transport and decreased gross OR contamination with intubation in the operating suite. Airway manipulation and intubation are among the highest risk procedures for nosocomial transmission and performance of these procedures should utilize precautions described in current APSF recommendations.^3,9,10

For patients not requiring critical care transport, and when conditions favor intubation in the OR, patients should be transported in a gurney while wearing a surgical mask. Verification of the operative site, surgical plan, and other components of the WHO universal surgical safety checklist or time out are performed in the OR prior to induction of anesthesia, and a conscious patient can be an active participant.

If critical care transport is deemed necessary and/or a decision is made to intubate the patient outside the OR, preferably in a negative airflow respiratory isolation room, the perioperative team will confirm the availability of the following equipment needed for patient transport:

• Portable transport monitor;
• Video laryngoscope;
• Airway supplies and medications for induction of general anesthesia;
• Self-inflating bag-mask apparatus attached to an oxygen source;
• High-quality HMEF (heat and moisture exchanging filter) rated to remove at least 99.97% of airborne particles ≥ 0.3 microns to filter out viral particles attached to the expiratory outlet; and
• PPE including impermeable disposable gowns, gloves, and shoe covers.

While the surgical technician remains in the OR, the rest of the team will proceed to the patient’s location with these supplies, along with the necessary number of PAPRs and N95 respirators.

Intraoperative Management

Advance planning can help to ensure a safer intraoperative period when a COVID-19 patient is brought to the OR. Patient room airflow patterns and ventilation capacity should be considered when developing measures to prevent aerosol transmission of airborne infectious agents. Although negative pressure rooms are ideal for aerosol generating procedures such as intubation, most ORs are generally maintained at a positive pressure when compared with the surrounding areas. The feasibility of rapidly converting ORs into negative pressure rooms should be in facility planning for COVID-19; portable high-efficiency particulate air (HEPA) machines, for instance, can be set up to create negative pressure areas around the OR.¹³ We established a negative pressure anteroom outside our OR to be used for doffing and as an airlock, for use by staff who need to enter midcase or pass supplies or specimens into and out of the procedure room (Figure 2). By adding 2 portable HEPA filters and directing the HEPA-filtered exhaust into the OR ventilation return columns, we were able to establish negative pressure airflow in the OR (Figure 3).

The protocol was devised with the current pandemic-associated shortage of PPE taken into consideration. We decided to minimize staffing across disciplines by excluding all nonessential personal from entering the OR. This includes observers, researchers, and medical students. Residents and fellows may participate if their presence is deemed vital to the patient’s intraoperative care. To further prevent resource consumption, equipment in the designated COVID OR was reduced to essential elements such as the anesthesia machine, a minimized anesthesia drug cart and general supply cabinet, all of which were covered with disposable transparent covers (Figure 4).¹⁴ After transfer of the patient to the OR table, the patient stretcher is kept in the OR (space permitting) to minimize contamination of areas immediately outside the OR.

Postperative Management 

Similar to intubation, extubation poses a risk of generating aerosolization of infectious airborne microbes.¹⁰ It is helpful for OR personnel to be aware of the airflow pattern in their ORs, whether it is positive, negative, or neutral. As the PSHCS ORs were originally engineered as positive pressure rooms, we elected to have to postoperative patients with COVID-19 transported intubated to a reverse airflow or negative pressure room in the ICU. Extubation is performed when the intensive care team has determined the patient meets extubation criteria and has passed a spontaneous breathing trial. When a negative pressure room in the ICU is not available for recovery, extubation may be performed in the OR.

In that circumstance, the patient remains in the OR for 30 minutes after extubation to allow for turnover of air in the room prior to the doors opening for patient transport to the ICU.¹⁶ A surgical mask is placed over the patient’s oxygenating face mask to reduce droplet spread during transport. Patients who are not intubated for the anesthetic may be first recovered in the operating room or transported under droplet precautions directly back to a negative pressure isolation room.

Prior to transport, the patient’s gurney is thoroughly cleaned with Environmental Protection Agency-approved disinfectant wipes, and a clean sheet is placed over the patient’s body below the head.¹⁷ The front face shield of the surgeon’s and anesthesiologist’s PAPR hood should be wiped down with an alcohol-based disinfectant. Both health care providers don a clean disposable gown as an outer layer to minimize contamination by their used attire during transport. Once the patient is transported out of the OR, all disposable items are discarded. Reusable medical equipment are cleaned and disinfected according to a thorough application of local environmental services standard operating procedures.¹⁸ The surgeon and anesthesia providers aid in transporting the patient to the ICU, along with their outside OR assistants. All personnel remaining in the OR exit and doff their PPE according to the doffing protocol, which is similar to the donning protocol, utilizes a PPE partner tasked with providing instructions to the surgical team member step by step (Figure 5).

Conclusions

The outbreak of COVID-19 has resulted in an unprecedented modern health care crisis across the globe. Perioperative management of patients with COVID-19 pose unique challenges to all personnel working in the OR, where the risk of nosocomial transmission of infection is ever present. It is essential that hospitals consider their local resources, infrastructure and capabilities when devising policies to respond to the COVID-19 emergency. In all perioperative situations, meticulous attention should be given to both donning and doffing of PPE, crucial for the safety of everyone involved in the care of patients with COVID-19.

Our experience also highlighted the importance of treating a new protocol as an evolving document, which can be modified and improved through the conduct of training and simulation exercises with providers across disciplines (Figure 6). In gathering nurses, anesthesia staff, and surgeons to perform drills and simulate their roles in an imaginary scenario, we gained new insights, and made corrections and additions that ultimately generated the presently described process. Modifications to any protocol may be necessary depending on the unique circumstances of individual health care systems and hospitals, the characteristics of the patient population they cater to, and the resources and expertise they have available. As the pandemic continues, we are bound to learn more about the epidemiology and modes of transmission of SARS-CoV-2, which may demand further changes to our practice. It is crucial to remember that while emergency policies must be rapidly developed, they should be collaboratively improved and incorporate new knowledge when it becomes available. This is essential to ensure the ultimate protocol is useful, up-to-date, easy to follow and tailored to the unique local environment of each health care setting.

The worldwide spread of SARS-CoV-2, the coronavirus that causes the syndrome designated COVID-19 by the World Health Organization (WHO), presents a challenge for emergency operative care in a global pandemic setting that is novel for modern surgical practice. The virulence of this new pathogen has raised concern for how to protect operating room (OR) staff and their environs in the event that an infected patient requires urgent surgical care. Because coronaviridae spread mainly through contact with contaminated respiratory droplets or aerosolized virion-containing particles, personal protective equipment (PPE) is vital to personnel involved in these cases, and proper utilization of these scarce resources poses an additional challenge. Establishment of a clear protocol that adheres to rigorous infection control measures while providing a safe system for intrafacility transport and operative care is an essential component of a successful surgical pandemic response.

The first case of COVID-19 disease identified in the US was diagnosed in Everett, Washington, on January 21, 2020.¹ In the succeeding months, the Seattle region became an early epicenter of the epidemic in the US, with Washington State becoming the first state to see in excess of 1,000 cases by mid-March 2020. As hospitalizations for COVID-19 increased, emergency surge preparations were enacted at medical centers across the region. Recommendations for how to manage infected patients evolved rapidly. Anticipating the need to provide surgical services during this pandemic, starting in early March 2020, the perioperative services staff at the US Department of Veterans Affairs (VA) Puget Sound Health Care System (PSHCS) convened to develop the protocol described here through a process of literature review, multidisciplinary discussion, and practical trial runs and drills. VAPSHCS is an urban academic medical center affiliated with the University of Washington, Seattle. The result of this collaboration is a detailed, step-by-step protocol that establishes the roles and responsibilities of the various personnel who intersect in the OR and recruits their teamwork to prevent environmental contamination and health care worker transmission of SARS-CoV-2.

The protocol is divided into discrete practice recommendations for the preoperative, intraoperative, and postoperative management of patients with confirmed or suspected COVID-19 infection, with a focus on maintaining Centers of Disease Control and Prevention-defined respiratory droplet and airborne precautions throughout the period of patient contact and mitigating infectious contamination of the operating suite.² It is acknowledged that no written protocol can encompass all the possible considerations that attend the vast diversity of surgical scenarios which can transpire in the operative setting. Patient acuity must sometimes mandate modifications to even the most thoroughly laid plans; for instance, the exsanguinating patient requiring emergent surgery for hemorrhage control will undoubtedly require an urgent appraisal of the relative risks and benefits of certain elements of the practices here described. Nevertheless, we believe that this protocol provides a useful framework for mitigating the infection and contamination risks of operative care in an epidemic environment, and should be readily adaptable to any facility that may perform surgery in patients infected with a high-risk contagious pathogen.

Preoperative Management 

In addition to introducing the risk of viral transmission, surgery in the patient with COVID-19 also imposes a large consumption of vital PPE, supplies and can become dangerously low in health care centers coping with an influx of infected patients. Early in the pandemic, to reduce exposure, conserve the medical workforce and lessen the resource strain on the overall health care infrastructure, the American College of Surgeons (ACS), American College of Gastroenterology, and other professional societies recommended cancellation of elective procedures, confining operations to urgent or emergent procedures for high-acuity diseases that would negatively impact morbidity or mortality if delayed.^3,4 In each case, physicians from the surgical and anesthesia services should discuss the rationale for the operation and secure agreement to commit resources to the endeavor prior to reserving the OR. These considerations should be shared with the patient prior to obtaining informed consent.

Preoperatively, the surgical team, consisting of surgeon, anesthesiologist, OR nurse, surgical technician, and assistants to the surgeon, anesthesiologist and nurse, convene for a preoperative “team huddle.” While assistants will aid in patient transport and supplying equipment to the team during the procedure, they should not be in the OR during the case, to minimize personnel exposure and PPE consumption. All members of the surgical team remove their personal effects, including wallets, phones, badges, and jewelry; any pagers are handed to other members of the care team for the duration of the surgery. During this preoperative team huddle, proper setup and accounting of the surgical equipment is confirmed, as well as the availability of all necessary anesthesia equipment and medications.

A specific OR with versatile characteristics was chosen to be the designated OR for procedures in patients with confirmed or suspected COVID-19. The COVID OR is on standby when no such cases are active, and it is not used for surgeries in noninfected patients. This is in accord with published recommendations of anesthesiologists who, throughout the COVID-19 epidemic in China, maintained designated ORs and anesthesia machines for only infected patients.⁵ Strong consideration should be given to performing procedures for which endotracheal intubation is not required in the patient’s own respiratory isolation room, rather than the OR to avoid room contamination and excessive use of PPE.^5,6

The availability of adequate PPE is confirmed during the preoperative team huddle. At a minimum, powered air purifying respirator devices (PAPRs) with hoods must be available for the anesthesia provider, surgeon and surgical technician, recognizing the Anesthesia Patient Safety Foundation (APSF) recommendation that these devices confer superior protection for those with the highest risk and most proximate exposure to the patient throughout the case.^7,8 An N95 respirator, at minimum, must be available for the circulating OR nurse. Patient condition, need for critical care transport, anesthetic plan (monitored anesthesia care or general anesthesia), and availability of negative pressure isolation rooms in the ward vs in the operating suite should help decide patient transport strategies and help determine the most suitable location to secure the airway. In case of an inadvertent tube disconnection, transporting intubated patients carries the risk of disseminating virus laden aerosols into the environment. Risks of pre-OR intubation should be balanced with the potential benefit of securing the airway prior to transport and decreased gross OR contamination with intubation in the operating suite. Airway manipulation and intubation are among the highest risk procedures for nosocomial transmission and performance of these procedures should utilize precautions described in current APSF recommendations.^3,9,10

For patients not requiring critical care transport, and when conditions favor intubation in the OR, patients should be transported in a gurney while wearing a surgical mask. Verification of the operative site, surgical plan, and other components of the WHO universal surgical safety checklist or time out are performed in the OR prior to induction of anesthesia, and a conscious patient can be an active participant.

If critical care transport is deemed necessary and/or a decision is made to intubate the patient outside the OR, preferably in a negative airflow respiratory isolation room, the perioperative team will confirm the availability of the following equipment needed for patient transport:

• Portable transport monitor;
• Video laryngoscope;
• Airway supplies and medications for induction of general anesthesia;
• Self-inflating bag-mask apparatus attached to an oxygen source;
• High-quality HMEF (heat and moisture exchanging filter) rated to remove at least 99.97% of airborne particles ≥ 0.3 microns to filter out viral particles attached to the expiratory outlet; and
• PPE including impermeable disposable gowns, gloves, and shoe covers.

While the surgical technician remains in the OR, the rest of the team will proceed to the patient’s location with these supplies, along with the necessary number of PAPRs and N95 respirators.

Intraoperative Management

Advance planning can help to ensure a safer intraoperative period when a COVID-19 patient is brought to the OR. Patient room airflow patterns and ventilation capacity should be considered when developing measures to prevent aerosol transmission of airborne infectious agents. Although negative pressure rooms are ideal for aerosol generating procedures such as intubation, most ORs are generally maintained at a positive pressure when compared with the surrounding areas. The feasibility of rapidly converting ORs into negative pressure rooms should be in facility planning for COVID-19; portable high-efficiency particulate air (HEPA) machines, for instance, can be set up to create negative pressure areas around the OR.¹³ We established a negative pressure anteroom outside our OR to be used for doffing and as an airlock, for use by staff who need to enter midcase or pass supplies or specimens into and out of the procedure room (Figure 2). By adding 2 portable HEPA filters and directing the HEPA-filtered exhaust into the OR ventilation return columns, we were able to establish negative pressure airflow in the OR (Figure 3).

The protocol was devised with the current pandemic-associated shortage of PPE taken into consideration. We decided to minimize staffing across disciplines by excluding all nonessential personal from entering the OR. This includes observers, researchers, and medical students. Residents and fellows may participate if their presence is deemed vital to the patient’s intraoperative care. To further prevent resource consumption, equipment in the designated COVID OR was reduced to essential elements such as the anesthesia machine, a minimized anesthesia drug cart and general supply cabinet, all of which were covered with disposable transparent covers (Figure 4).¹⁴ After transfer of the patient to the OR table, the patient stretcher is kept in the OR (space permitting) to minimize contamination of areas immediately outside the OR.

Postperative Management 

Similar to intubation, extubation poses a risk of generating aerosolization of infectious airborne microbes.¹⁰ It is helpful for OR personnel to be aware of the airflow pattern in their ORs, whether it is positive, negative, or neutral. As the PSHCS ORs were originally engineered as positive pressure rooms, we elected to have to postoperative patients with COVID-19 transported intubated to a reverse airflow or negative pressure room in the ICU. Extubation is performed when the intensive care team has determined the patient meets extubation criteria and has passed a spontaneous breathing trial. When a negative pressure room in the ICU is not available for recovery, extubation may be performed in the OR.

In that circumstance, the patient remains in the OR for 30 minutes after extubation to allow for turnover of air in the room prior to the doors opening for patient transport to the ICU.¹⁶ A surgical mask is placed over the patient’s oxygenating face mask to reduce droplet spread during transport. Patients who are not intubated for the anesthetic may be first recovered in the operating room or transported under droplet precautions directly back to a negative pressure isolation room.

Prior to transport, the patient’s gurney is thoroughly cleaned with Environmental Protection Agency-approved disinfectant wipes, and a clean sheet is placed over the patient’s body below the head.¹⁷ The front face shield of the surgeon’s and anesthesiologist’s PAPR hood should be wiped down with an alcohol-based disinfectant. Both health care providers don a clean disposable gown as an outer layer to minimize contamination by their used attire during transport. Once the patient is transported out of the OR, all disposable items are discarded. Reusable medical equipment are cleaned and disinfected according to a thorough application of local environmental services standard operating procedures.¹⁸ The surgeon and anesthesia providers aid in transporting the patient to the ICU, along with their outside OR assistants. All personnel remaining in the OR exit and doff their PPE according to the doffing protocol, which is similar to the donning protocol, utilizes a PPE partner tasked with providing instructions to the surgical team member step by step (Figure 5).

Conclusions

The outbreak of COVID-19 has resulted in an unprecedented modern health care crisis across the globe. Perioperative management of patients with COVID-19 pose unique challenges to all personnel working in the OR, where the risk of nosocomial transmission of infection is ever present. It is essential that hospitals consider their local resources, infrastructure and capabilities when devising policies to respond to the COVID-19 emergency. In all perioperative situations, meticulous attention should be given to both donning and doffing of PPE, crucial for the safety of everyone involved in the care of patients with COVID-19.

Our experience also highlighted the importance of treating a new protocol as an evolving document, which can be modified and improved through the conduct of training and simulation exercises with providers across disciplines (Figure 6). In gathering nurses, anesthesia staff, and surgeons to perform drills and simulate their roles in an imaginary scenario, we gained new insights, and made corrections and additions that ultimately generated the presently described process. Modifications to any protocol may be necessary depending on the unique circumstances of individual health care systems and hospitals, the characteristics of the patient population they cater to, and the resources and expertise they have available. As the pandemic continues, we are bound to learn more about the epidemiology and modes of transmission of SARS-CoV-2, which may demand further changes to our practice. It is crucial to remember that while emergency policies must be rapidly developed, they should be collaboratively improved and incorporate new knowledge when it becomes available. This is essential to ensure the ultimate protocol is useful, up-to-date, easy to follow and tailored to the unique local environment of each health care setting.

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]