CHEST Physician

Fighting the novel coronavirus together with you. By Dr. J. Li. 
 
Comparative Safety and Effectiveness of Inhaled Corticosteroid and Long-Acting Beta2-AgonistCombinations in Patients With COPD.By Dr. T-U Chang, et al. 
 
The Evolving Landscape of e-Cigarettes: A Systematic Review of Recent Evidence. By Dr. J. Bozier, et al.

Fighting the novel coronavirus together with you. By Dr. J. Li. 
 
Comparative Safety and Effectiveness of Inhaled Corticosteroid and Long-Acting Beta2-AgonistCombinations in Patients With COPD.By Dr. T-U Chang, et al. 
 
The Evolving Landscape of e-Cigarettes: A Systematic Review of Recent Evidence. By Dr. J. Bozier, et al.

Fighting the novel coronavirus together with you. By Dr. J. Li. 
 
Comparative Safety and Effectiveness of Inhaled Corticosteroid and Long-Acting Beta2-AgonistCombinations in Patients With COPD.By Dr. T-U Chang, et al. 
 
The Evolving Landscape of e-Cigarettes: A Systematic Review of Recent Evidence. By Dr. J. Bozier, et al.

Interventional and Chest Diagnostic Procedures

3D printing and pulmonology

Recent advances in 3D printing has enabled physicians to apply this technology in medical education, procedural planning, tissue modeling, and implantable device manufacturing. This is especially true in the field of pulmonology. Advancements in 3D printing have made personalized airway stents a reality, both by 3D printing-assisted injection molding or direct 3D printing.

Airway stents have significantly evolved over the last half century. With use of silicone, bare metallic, and hybrid stents, pulmonologists have an ever-expanding option to address airway stenosis due to both benign and malignancy etiologies. Personalized airway stents hold the potential for advance customization, minimizing pressure points, and improving airflow dynamics to increase mucus clearance. In January 2020, the US Food and Drug Administration (FDA) cleared patient-specific airway stents developed by Dr. Thomas Gildea of Cleveland Clinic. The patient-specific silicone stents are created using CT scans and 3D visualization software to generate a 3D-printed mold that was subsequently used to inject with medical-grade silicone. Two years earlier, a Duke University startup known as restor3D created the first direct 3D printed airway stent using a compressible biocompatible material with properties similar to that of silicone. Both of these stents have been used in patients with promising response.

As we look into the future, the field of pulmonology will experience significant changes with more adoption of 3D printing (ie, additive manufacturing). We may soon be able to create personalized airway prosthesis of any type (stents, spigots, valves, tracheostomies, t-tubes) for the benefit of our patients.

Pediatric Chest Medicine

COVID-19: Pediatric story of a new pandemic

In December 2019, an outbreak of pneumonia identified to be caused by 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China, possibly originating from the local wet market selling many species of live animals. A novel member of enveloped RNA coronavirus was identified in samples of BAL fluid from a patient in Wuhan.

It has since rapidly spread globally to countries across six continents. As of early April, 1,286,409 cases have been reported worldwide with 337,933 cases (9,600 deaths) in the US (https://coronavirus.jhu.edu/map.html) with more cases and deaths every day. Most of these initial reports of COVID-19 (COronaVIrusDisease) in children are from China. Fever (60%) and cough (65%) were the most common symptoms. Procalcitonin elevation (80% and co-infection (80%) were prominent clinical findings. Consolidation with surrounding halo sign (50%) and ground-glass opacities (60%) on CT scan were typical radiologic findings. Almost all children recovered without needing intensive care support.

Increased IgM COVID-19 antibody levels observed in three neonates raise questions of potential in-utero transmission (Kimberlin et al. JAMA 2020 Mar 26. doi: 10.1001/jama.2020.4868). One study provided evidence for persistent fecal shedding and possibility of fecal-oral transmission (Xu et al. Nat Med 2020 Mar 13. doi: 10.1038/s41591-020-0817-4).

Initial reports show that children appear to be at similar risk of infection as adults, though less likely to have severe symptoms. Young children, particularly infants, are more vulnerable to infection (Dong et al. Pediatrics. 2020 Apr. doi: 10.1542/peds.2020-0702); (Bi et al. medRxiv 2020 Mar 27. doi: 10.1101/2020.03.03.20028423v3). Thus far, few deaths have been reported in the pediatric age group. Trials are being conducted on a war footing to find a cure and a vaccine.

Harish Rao, MD, MBBS

Steering Committee Member
 

Pulmonary Physiology, Function, and Rehabilitation

Controversies and the clinical value of lung volume measurements

Lung volumes are often measured by body plethysmography or gas dilution. Their clinic importance in decision making is unclear. Though measured differently, predicted sets obtained by plethysmography from Caucasian populations are often used for gas dilution measurements (Ruppel GL. Respir Care. 2012 Jan;57[1]:26). Recently the GLI felt lung volume data were insufficient to develop universal reference equations (Cooper B, et al. Breathe (Sheff). 2017 Sep;13[3]:e56-e64). ERS/ATS guidelines recommend adjusting Caucasian predicted values depending on race, without advising how to adjust the confidence limits. Their algorithms show if the VC is normal, lung volumes are unnecessary, though it is not unusual to see a normal VC with reduced TLC. Does this suggest the VC is more important than the TLC, even if lacking predicted volume equations for non-Caucasians? Because combined obstructive and restrictive abnormalities occur simultaneously, recommendations state severity of impairment be determined by the FEV1 percent of predicted rather than TLC (Pellegrino R, et al. Eur Respir J. 2005;26:948). The value of quantifying other volumes such as FRC and ERV in conditions such as obesity and musculoskeletal defects is also not clear. In obstruction, volumes can indicate air trapping or hyperinflation measuring RV and RV/TLC. Though cutoffs of <80% and >120% of predicted are often used, guidelines discourage this practice, recommending using predicted equations based on age, race, height, and sex, with statistical limits of normal (Ruppel GL. Respir Care. 2012 Jan;57(1):26).

Said A. Chaaban, MD

Steering Committee Member

Zachary Q. Morris, MD

NetWork Member
 

Pulmonary Vascular Disease

Pulmonary hypertension associated with atrial septal defect in adults: closing time?

Up to 10% of adults with atrial septal defects (ASDs) can develop pulmonary arterial hypertension (PAH) according to European Guidelines on pulmonary hypertension (PH) (Galie, et al. Eur Heart J. 2016;37[1]:67). If ASD closure is considered, they propose a pulmonary vascular resistance index (PVRi) <4 Wood units (WU) m² as a safe cutoff. Higher PVRi carries a higher operative risk, warranting evaluation in specialized PH centers.

American guidelines (Stout, et al. Circulation. 2019 Apr 2;139[14]:e698) recommend closure in symptomatic patients with a net shunt (Qp/Qs) of >1.5:1. Closure appears safe if pulmonary artery (PA) systolic pressure is <1/2 systemic blood pressure, and PVR / systemic vascular resistance is <0.3. They recommend specialized evaluation for higher pressures and to avoid closure once a net right to left shunt is present (Qp/Qs <1.0).

However, in severe cases, experienced centers have reported some success with a “treat-and-close” approach if post-therapy PVR reaches <6.5 WU (Bradley, et al. Int J Cardiol. 2019;291:127).

Finally, consider the following when evaluating ASD-associated PAH: 1. A thermodilution cardiac output method should not be used to calculate PVR/PVRi because of confounding recirculation from the intracardiac shunt (Kwan, et al. Clin Cardiol. 2019;42[3]:334). Qp is used instead and is calculated using Fick equation, requiring accurate oxygen saturation measurements. 2. Mixed venous saturation (MvO2) is needed to determine Qs, and PA saturation cannot be used as MvO2 surrogate. MvO2 must be calculated using superior and inferior vena cava saturations. 3. Some patients with idiopathic PAH may have a small coexisting ASD that is not responsible for the abnormal hemodynamics. Closing the ASD in those cases would be contraindicated. 4. Patients may have more than one type of coexistent congenital heart defect.

Francisco J. Soto, MD, MS, FCCP

Steering Committee Member

Interventional and Chest Diagnostic Procedures

3D printing and pulmonology

Recent advances in 3D printing has enabled physicians to apply this technology in medical education, procedural planning, tissue modeling, and implantable device manufacturing. This is especially true in the field of pulmonology. Advancements in 3D printing have made personalized airway stents a reality, both by 3D printing-assisted injection molding or direct 3D printing.

Airway stents have significantly evolved over the last half century. With use of silicone, bare metallic, and hybrid stents, pulmonologists have an ever-expanding option to address airway stenosis due to both benign and malignancy etiologies. Personalized airway stents hold the potential for advance customization, minimizing pressure points, and improving airflow dynamics to increase mucus clearance. In January 2020, the US Food and Drug Administration (FDA) cleared patient-specific airway stents developed by Dr. Thomas Gildea of Cleveland Clinic. The patient-specific silicone stents are created using CT scans and 3D visualization software to generate a 3D-printed mold that was subsequently used to inject with medical-grade silicone. Two years earlier, a Duke University startup known as restor3D created the first direct 3D printed airway stent using a compressible biocompatible material with properties similar to that of silicone. Both of these stents have been used in patients with promising response.

As we look into the future, the field of pulmonology will experience significant changes with more adoption of 3D printing (ie, additive manufacturing). We may soon be able to create personalized airway prosthesis of any type (stents, spigots, valves, tracheostomies, t-tubes) for the benefit of our patients.

Pediatric Chest Medicine

COVID-19: Pediatric story of a new pandemic

In December 2019, an outbreak of pneumonia identified to be caused by 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China, possibly originating from the local wet market selling many species of live animals. A novel member of enveloped RNA coronavirus was identified in samples of BAL fluid from a patient in Wuhan.

It has since rapidly spread globally to countries across six continents. As of early April, 1,286,409 cases have been reported worldwide with 337,933 cases (9,600 deaths) in the US (https://coronavirus.jhu.edu/map.html) with more cases and deaths every day. Most of these initial reports of COVID-19 (COronaVIrusDisease) in children are from China. Fever (60%) and cough (65%) were the most common symptoms. Procalcitonin elevation (80% and co-infection (80%) were prominent clinical findings. Consolidation with surrounding halo sign (50%) and ground-glass opacities (60%) on CT scan were typical radiologic findings. Almost all children recovered without needing intensive care support.

Increased IgM COVID-19 antibody levels observed in three neonates raise questions of potential in-utero transmission (Kimberlin et al. JAMA 2020 Mar 26. doi: 10.1001/jama.2020.4868). One study provided evidence for persistent fecal shedding and possibility of fecal-oral transmission (Xu et al. Nat Med 2020 Mar 13. doi: 10.1038/s41591-020-0817-4).

Initial reports show that children appear to be at similar risk of infection as adults, though less likely to have severe symptoms. Young children, particularly infants, are more vulnerable to infection (Dong et al. Pediatrics. 2020 Apr. doi: 10.1542/peds.2020-0702); (Bi et al. medRxiv 2020 Mar 27. doi: 10.1101/2020.03.03.20028423v3). Thus far, few deaths have been reported in the pediatric age group. Trials are being conducted on a war footing to find a cure and a vaccine.

Harish Rao, MD, MBBS

Steering Committee Member
 

Pulmonary Physiology, Function, and Rehabilitation

Controversies and the clinical value of lung volume measurements

Lung volumes are often measured by body plethysmography or gas dilution. Their clinic importance in decision making is unclear. Though measured differently, predicted sets obtained by plethysmography from Caucasian populations are often used for gas dilution measurements (Ruppel GL. Respir Care. 2012 Jan;57[1]:26). Recently the GLI felt lung volume data were insufficient to develop universal reference equations (Cooper B, et al. Breathe (Sheff). 2017 Sep;13[3]:e56-e64). ERS/ATS guidelines recommend adjusting Caucasian predicted values depending on race, without advising how to adjust the confidence limits. Their algorithms show if the VC is normal, lung volumes are unnecessary, though it is not unusual to see a normal VC with reduced TLC. Does this suggest the VC is more important than the TLC, even if lacking predicted volume equations for non-Caucasians? Because combined obstructive and restrictive abnormalities occur simultaneously, recommendations state severity of impairment be determined by the FEV1 percent of predicted rather than TLC (Pellegrino R, et al. Eur Respir J. 2005;26:948). The value of quantifying other volumes such as FRC and ERV in conditions such as obesity and musculoskeletal defects is also not clear. In obstruction, volumes can indicate air trapping or hyperinflation measuring RV and RV/TLC. Though cutoffs of <80% and >120% of predicted are often used, guidelines discourage this practice, recommending using predicted equations based on age, race, height, and sex, with statistical limits of normal (Ruppel GL. Respir Care. 2012 Jan;57(1):26).

Said A. Chaaban, MD

Steering Committee Member

Zachary Q. Morris, MD

NetWork Member
 

Pulmonary Vascular Disease

Pulmonary hypertension associated with atrial septal defect in adults: closing time?

Up to 10% of adults with atrial septal defects (ASDs) can develop pulmonary arterial hypertension (PAH) according to European Guidelines on pulmonary hypertension (PH) (Galie, et al. Eur Heart J. 2016;37[1]:67). If ASD closure is considered, they propose a pulmonary vascular resistance index (PVRi) <4 Wood units (WU) m² as a safe cutoff. Higher PVRi carries a higher operative risk, warranting evaluation in specialized PH centers.

American guidelines (Stout, et al. Circulation. 2019 Apr 2;139[14]:e698) recommend closure in symptomatic patients with a net shunt (Qp/Qs) of >1.5:1. Closure appears safe if pulmonary artery (PA) systolic pressure is <1/2 systemic blood pressure, and PVR / systemic vascular resistance is <0.3. They recommend specialized evaluation for higher pressures and to avoid closure once a net right to left shunt is present (Qp/Qs <1.0).

However, in severe cases, experienced centers have reported some success with a “treat-and-close” approach if post-therapy PVR reaches <6.5 WU (Bradley, et al. Int J Cardiol. 2019;291:127).

Finally, consider the following when evaluating ASD-associated PAH: 1. A thermodilution cardiac output method should not be used to calculate PVR/PVRi because of confounding recirculation from the intracardiac shunt (Kwan, et al. Clin Cardiol. 2019;42[3]:334). Qp is used instead and is calculated using Fick equation, requiring accurate oxygen saturation measurements. 2. Mixed venous saturation (MvO2) is needed to determine Qs, and PA saturation cannot be used as MvO2 surrogate. MvO2 must be calculated using superior and inferior vena cava saturations. 3. Some patients with idiopathic PAH may have a small coexisting ASD that is not responsible for the abnormal hemodynamics. Closing the ASD in those cases would be contraindicated. 4. Patients may have more than one type of coexistent congenital heart defect.

Francisco J. Soto, MD, MS, FCCP

Steering Committee Member

Interventional and Chest Diagnostic Procedures

3D printing and pulmonology

Recent advances in 3D printing has enabled physicians to apply this technology in medical education, procedural planning, tissue modeling, and implantable device manufacturing. This is especially true in the field of pulmonology. Advancements in 3D printing have made personalized airway stents a reality, both by 3D printing-assisted injection molding or direct 3D printing.

Airway stents have significantly evolved over the last half century. With use of silicone, bare metallic, and hybrid stents, pulmonologists have an ever-expanding option to address airway stenosis due to both benign and malignancy etiologies. Personalized airway stents hold the potential for advance customization, minimizing pressure points, and improving airflow dynamics to increase mucus clearance. In January 2020, the US Food and Drug Administration (FDA) cleared patient-specific airway stents developed by Dr. Thomas Gildea of Cleveland Clinic. The patient-specific silicone stents are created using CT scans and 3D visualization software to generate a 3D-printed mold that was subsequently used to inject with medical-grade silicone. Two years earlier, a Duke University startup known as restor3D created the first direct 3D printed airway stent using a compressible biocompatible material with properties similar to that of silicone. Both of these stents have been used in patients with promising response.

As we look into the future, the field of pulmonology will experience significant changes with more adoption of 3D printing (ie, additive manufacturing). We may soon be able to create personalized airway prosthesis of any type (stents, spigots, valves, tracheostomies, t-tubes) for the benefit of our patients.

Pediatric Chest Medicine

COVID-19: Pediatric story of a new pandemic

In December 2019, an outbreak of pneumonia identified to be caused by 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China, possibly originating from the local wet market selling many species of live animals. A novel member of enveloped RNA coronavirus was identified in samples of BAL fluid from a patient in Wuhan.

It has since rapidly spread globally to countries across six continents. As of early April, 1,286,409 cases have been reported worldwide with 337,933 cases (9,600 deaths) in the US (https://coronavirus.jhu.edu/map.html) with more cases and deaths every day. Most of these initial reports of COVID-19 (COronaVIrusDisease) in children are from China. Fever (60%) and cough (65%) were the most common symptoms. Procalcitonin elevation (80% and co-infection (80%) were prominent clinical findings. Consolidation with surrounding halo sign (50%) and ground-glass opacities (60%) on CT scan were typical radiologic findings. Almost all children recovered without needing intensive care support.

Increased IgM COVID-19 antibody levels observed in three neonates raise questions of potential in-utero transmission (Kimberlin et al. JAMA 2020 Mar 26. doi: 10.1001/jama.2020.4868). One study provided evidence for persistent fecal shedding and possibility of fecal-oral transmission (Xu et al. Nat Med 2020 Mar 13. doi: 10.1038/s41591-020-0817-4).

Initial reports show that children appear to be at similar risk of infection as adults, though less likely to have severe symptoms. Young children, particularly infants, are more vulnerable to infection (Dong et al. Pediatrics. 2020 Apr. doi: 10.1542/peds.2020-0702); (Bi et al. medRxiv 2020 Mar 27. doi: 10.1101/2020.03.03.20028423v3). Thus far, few deaths have been reported in the pediatric age group. Trials are being conducted on a war footing to find a cure and a vaccine.

Harish Rao, MD, MBBS

Steering Committee Member
 

Pulmonary Physiology, Function, and Rehabilitation

Controversies and the clinical value of lung volume measurements

Lung volumes are often measured by body plethysmography or gas dilution. Their clinic importance in decision making is unclear. Though measured differently, predicted sets obtained by plethysmography from Caucasian populations are often used for gas dilution measurements (Ruppel GL. Respir Care. 2012 Jan;57[1]:26). Recently the GLI felt lung volume data were insufficient to develop universal reference equations (Cooper B, et al. Breathe (Sheff). 2017 Sep;13[3]:e56-e64). ERS/ATS guidelines recommend adjusting Caucasian predicted values depending on race, without advising how to adjust the confidence limits. Their algorithms show if the VC is normal, lung volumes are unnecessary, though it is not unusual to see a normal VC with reduced TLC. Does this suggest the VC is more important than the TLC, even if lacking predicted volume equations for non-Caucasians? Because combined obstructive and restrictive abnormalities occur simultaneously, recommendations state severity of impairment be determined by the FEV1 percent of predicted rather than TLC (Pellegrino R, et al. Eur Respir J. 2005;26:948). The value of quantifying other volumes such as FRC and ERV in conditions such as obesity and musculoskeletal defects is also not clear. In obstruction, volumes can indicate air trapping or hyperinflation measuring RV and RV/TLC. Though cutoffs of <80% and >120% of predicted are often used, guidelines discourage this practice, recommending using predicted equations based on age, race, height, and sex, with statistical limits of normal (Ruppel GL. Respir Care. 2012 Jan;57(1):26).

Said A. Chaaban, MD

Steering Committee Member

Zachary Q. Morris, MD

NetWork Member
 

Pulmonary Vascular Disease

Pulmonary hypertension associated with atrial septal defect in adults: closing time?

Up to 10% of adults with atrial septal defects (ASDs) can develop pulmonary arterial hypertension (PAH) according to European Guidelines on pulmonary hypertension (PH) (Galie, et al. Eur Heart J. 2016;37[1]:67). If ASD closure is considered, they propose a pulmonary vascular resistance index (PVRi) <4 Wood units (WU) m² as a safe cutoff. Higher PVRi carries a higher operative risk, warranting evaluation in specialized PH centers.

American guidelines (Stout, et al. Circulation. 2019 Apr 2;139[14]:e698) recommend closure in symptomatic patients with a net shunt (Qp/Qs) of >1.5:1. Closure appears safe if pulmonary artery (PA) systolic pressure is <1/2 systemic blood pressure, and PVR / systemic vascular resistance is <0.3. They recommend specialized evaluation for higher pressures and to avoid closure once a net right to left shunt is present (Qp/Qs <1.0).

However, in severe cases, experienced centers have reported some success with a “treat-and-close” approach if post-therapy PVR reaches <6.5 WU (Bradley, et al. Int J Cardiol. 2019;291:127).

Finally, consider the following when evaluating ASD-associated PAH: 1. A thermodilution cardiac output method should not be used to calculate PVR/PVRi because of confounding recirculation from the intracardiac shunt (Kwan, et al. Clin Cardiol. 2019;42[3]:334). Qp is used instead and is calculated using Fick equation, requiring accurate oxygen saturation measurements. 2. Mixed venous saturation (MvO2) is needed to determine Qs, and PA saturation cannot be used as MvO2 surrogate. MvO2 must be calculated using superior and inferior vena cava saturations. 3. Some patients with idiopathic PAH may have a small coexisting ASD that is not responsible for the abnormal hemodynamics. Closing the ASD in those cases would be contraindicated. 4. Patients may have more than one type of coexistent congenital heart defect.

Francisco J. Soto, MD, MS, FCCP

Steering Committee Member

CHEST 2019 marked the inaugural FISH Bowl competition for attendees. Inspired by Shark Tank, our kinder, gentler, yet still competitive and cutting-edge FISH Bowl (Furthering Innovation and Science for Health) featured CHEST members disrupting our beliefs about how clinical care and education are performed. As health-care providers, they presented innovative ideas pertaining to education and clinical disease for pulmonary, critical care, and sleep medicine. Six finalists were chosen from dozens of submissions, and three emerged winners. In this new Meet the FISH Bowl Finalists series, CHEST introduces you to many of them – including the People’s Choice Award winning team that includes Dr. Russ Acevedo, Wendy Fascia, and Jennifer Pedley.

Names: Russ Acevedo, MD, FCCP; Wendy Fascia MA, RRT; Jennifer Pedley, RRT

Institutional Affiliation: Crouse Health

Title: Crouse Lung PaRTners

Brief Summary of Submission: The goal of our program is to improve the quality of life for patients with COPD by establishing a primary life-long relationship with a respiratory therapist who ensures that they and their caretakers have a thorough understanding of the disease process, as well as the ability to carry out prescribed therapy, obtain resources, and reach out for help once they leave the hospital.

Once enrolled in the Lung Partners Program, patients receive an in-depth initial assessment and daily assessments by a team of specially trained, primary respiratory therapists who will screen them for health literacy, physical functionality, anxiety, depression, sleep disorders, nutrition, and medication management.

Clinical protocols are in place to allow for optimal treatment plans in an efficient timeframe and to assist in timely referral of patients to specialists for further assessment and follow-up.


1. What inspired your innovation? By maximizing the Respiratory Care department efficiency, this allowed for the ability of a primary respiratory care inpatient disease management program. This allows us to use our respiratory therapists to the full extent of their licensure.

2. Who do you think can benefit most from it, and why? We feel this will most benefit the patients, the respiratory therapists, and our physician partners. In the end, the major benefit is to decrease health-care fractionation.

3. What do you see as challenges to your innovation gaining widespread acceptance? How can they be overcome? To be successful, there needs to be very strong direction from the medical director. We do a poor job in training our fellows to be strong medical directors. Increasing attention to training our fellows in the science of respiratory care will help to overcome this challenge.

Getting the word out is also a challenge that can be overcome by increased exposure of our program like we are receiving from the Fish Bowl Competition and presentations at national meetings.

4. What impact has winning Fish Bowl 2019 had on your vision for the innovation? The positive feedback and networking from our winning has confirmed the value of our program. We have received many requests for our Lung Partner Handbook.

5. How do you think your success at Fish Bowl 2019 will continue to impact your career overall in the months and years to come? We would like to grow our involvement in state and national leadership. In all that we have learned in the development and implementation of Lung Partners, we can help support other local and national COPD initiatives.






 

CHEST 2019 marked the inaugural FISH Bowl competition for attendees. Inspired by Shark Tank, our kinder, gentler, yet still competitive and cutting-edge FISH Bowl (Furthering Innovation and Science for Health) featured CHEST members disrupting our beliefs about how clinical care and education are performed. As health-care providers, they presented innovative ideas pertaining to education and clinical disease for pulmonary, critical care, and sleep medicine. Six finalists were chosen from dozens of submissions, and three emerged winners. In this new Meet the FISH Bowl Finalists series, CHEST introduces you to many of them – including the People’s Choice Award winning team that includes Dr. Russ Acevedo, Wendy Fascia, and Jennifer Pedley.

Names: Russ Acevedo, MD, FCCP; Wendy Fascia MA, RRT; Jennifer Pedley, RRT

Institutional Affiliation: Crouse Health

Title: Crouse Lung PaRTners

Brief Summary of Submission: The goal of our program is to improve the quality of life for patients with COPD by establishing a primary life-long relationship with a respiratory therapist who ensures that they and their caretakers have a thorough understanding of the disease process, as well as the ability to carry out prescribed therapy, obtain resources, and reach out for help once they leave the hospital.

Once enrolled in the Lung Partners Program, patients receive an in-depth initial assessment and daily assessments by a team of specially trained, primary respiratory therapists who will screen them for health literacy, physical functionality, anxiety, depression, sleep disorders, nutrition, and medication management.

Clinical protocols are in place to allow for optimal treatment plans in an efficient timeframe and to assist in timely referral of patients to specialists for further assessment and follow-up.


1. What inspired your innovation? By maximizing the Respiratory Care department efficiency, this allowed for the ability of a primary respiratory care inpatient disease management program. This allows us to use our respiratory therapists to the full extent of their licensure.

2. Who do you think can benefit most from it, and why? We feel this will most benefit the patients, the respiratory therapists, and our physician partners. In the end, the major benefit is to decrease health-care fractionation.

3. What do you see as challenges to your innovation gaining widespread acceptance? How can they be overcome? To be successful, there needs to be very strong direction from the medical director. We do a poor job in training our fellows to be strong medical directors. Increasing attention to training our fellows in the science of respiratory care will help to overcome this challenge.

Getting the word out is also a challenge that can be overcome by increased exposure of our program like we are receiving from the Fish Bowl Competition and presentations at national meetings.

4. What impact has winning Fish Bowl 2019 had on your vision for the innovation? The positive feedback and networking from our winning has confirmed the value of our program. We have received many requests for our Lung Partner Handbook.

5. How do you think your success at Fish Bowl 2019 will continue to impact your career overall in the months and years to come? We would like to grow our involvement in state and national leadership. In all that we have learned in the development and implementation of Lung Partners, we can help support other local and national COPD initiatives.






 

CHEST 2019 marked the inaugural FISH Bowl competition for attendees. Inspired by Shark Tank, our kinder, gentler, yet still competitive and cutting-edge FISH Bowl (Furthering Innovation and Science for Health) featured CHEST members disrupting our beliefs about how clinical care and education are performed. As health-care providers, they presented innovative ideas pertaining to education and clinical disease for pulmonary, critical care, and sleep medicine. Six finalists were chosen from dozens of submissions, and three emerged winners. In this new Meet the FISH Bowl Finalists series, CHEST introduces you to many of them – including the People’s Choice Award winning team that includes Dr. Russ Acevedo, Wendy Fascia, and Jennifer Pedley.

Names: Russ Acevedo, MD, FCCP; Wendy Fascia MA, RRT; Jennifer Pedley, RRT

Institutional Affiliation: Crouse Health

Title: Crouse Lung PaRTners

Brief Summary of Submission: The goal of our program is to improve the quality of life for patients with COPD by establishing a primary life-long relationship with a respiratory therapist who ensures that they and their caretakers have a thorough understanding of the disease process, as well as the ability to carry out prescribed therapy, obtain resources, and reach out for help once they leave the hospital.

Once enrolled in the Lung Partners Program, patients receive an in-depth initial assessment and daily assessments by a team of specially trained, primary respiratory therapists who will screen them for health literacy, physical functionality, anxiety, depression, sleep disorders, nutrition, and medication management.

Clinical protocols are in place to allow for optimal treatment plans in an efficient timeframe and to assist in timely referral of patients to specialists for further assessment and follow-up.


1. What inspired your innovation? By maximizing the Respiratory Care department efficiency, this allowed for the ability of a primary respiratory care inpatient disease management program. This allows us to use our respiratory therapists to the full extent of their licensure.

2. Who do you think can benefit most from it, and why? We feel this will most benefit the patients, the respiratory therapists, and our physician partners. In the end, the major benefit is to decrease health-care fractionation.

3. What do you see as challenges to your innovation gaining widespread acceptance? How can they be overcome? To be successful, there needs to be very strong direction from the medical director. We do a poor job in training our fellows to be strong medical directors. Increasing attention to training our fellows in the science of respiratory care will help to overcome this challenge.

Getting the word out is also a challenge that can be overcome by increased exposure of our program like we are receiving from the Fish Bowl Competition and presentations at national meetings.

4. What impact has winning Fish Bowl 2019 had on your vision for the innovation? The positive feedback and networking from our winning has confirmed the value of our program. We have received many requests for our Lung Partner Handbook.

5. How do you think your success at Fish Bowl 2019 will continue to impact your career overall in the months and years to come? We would like to grow our involvement in state and national leadership. In all that we have learned in the development and implementation of Lung Partners, we can help support other local and national COPD initiatives.






 

Amid the COVID-19 pandemic, we are filled with gratitude because of the support you have provided the CHEST Foundation. Along with our sincere thanks, we wanted to share how your philanthropic dollars are being put to use fulfilling the urgent needs of our community during this crisis. Specifically, the CHEST Foundation is:

1. Continuing to provide reliable educational materials and resources that support our clinicians, their patients, and caregivers;

2. Actively working with manufacturers and vendors from around the globe to secure life-saving equipment for US hospitals; and

3. Partnering with other leading health-care organizations to increase our impact in vulnerable and at-risk communities.

These are just some of the ways the CHEST Foundation and CHEST are rallying to support the fight against COVID-19. To see more of what we are doing, and to keep an eye out for future resources, please visit us here: CHEST COVID-19 Website. We will continue to identify new ways in which we can support the efforts of our health-care providers and serve as a leading resource for patients, caregivers, and those we consider “at-risk, noninfected” populations.

Additionally, the CHEST Foundation’s redesigned website will be launching May 1! Be sure to visit us at chestfoundation.org to view and share our clinician-authored patient education guides with anyone who needs them.

Thank you for providing your generous support, which has allowed us to develop these much-needed resources. We would not be able to do it without you.

Amid the COVID-19 pandemic, we are filled with gratitude because of the support you have provided the CHEST Foundation. Along with our sincere thanks, we wanted to share how your philanthropic dollars are being put to use fulfilling the urgent needs of our community during this crisis. Specifically, the CHEST Foundation is:

1. Continuing to provide reliable educational materials and resources that support our clinicians, their patients, and caregivers;

2. Actively working with manufacturers and vendors from around the globe to secure life-saving equipment for US hospitals; and

3. Partnering with other leading health-care organizations to increase our impact in vulnerable and at-risk communities.

These are just some of the ways the CHEST Foundation and CHEST are rallying to support the fight against COVID-19. To see more of what we are doing, and to keep an eye out for future resources, please visit us here: CHEST COVID-19 Website. We will continue to identify new ways in which we can support the efforts of our health-care providers and serve as a leading resource for patients, caregivers, and those we consider “at-risk, noninfected” populations.

Additionally, the CHEST Foundation’s redesigned website will be launching May 1! Be sure to visit us at chestfoundation.org to view and share our clinician-authored patient education guides with anyone who needs them.

Thank you for providing your generous support, which has allowed us to develop these much-needed resources. We would not be able to do it without you.

Amid the COVID-19 pandemic, we are filled with gratitude because of the support you have provided the CHEST Foundation. Along with our sincere thanks, we wanted to share how your philanthropic dollars are being put to use fulfilling the urgent needs of our community during this crisis. Specifically, the CHEST Foundation is:

1. Continuing to provide reliable educational materials and resources that support our clinicians, their patients, and caregivers;

2. Actively working with manufacturers and vendors from around the globe to secure life-saving equipment for US hospitals; and

3. Partnering with other leading health-care organizations to increase our impact in vulnerable and at-risk communities.

These are just some of the ways the CHEST Foundation and CHEST are rallying to support the fight against COVID-19. To see more of what we are doing, and to keep an eye out for future resources, please visit us here: CHEST COVID-19 Website. We will continue to identify new ways in which we can support the efforts of our health-care providers and serve as a leading resource for patients, caregivers, and those we consider “at-risk, noninfected” populations.

Additionally, the CHEST Foundation’s redesigned website will be launching May 1! Be sure to visit us at chestfoundation.org to view and share our clinician-authored patient education guides with anyone who needs them.

Thank you for providing your generous support, which has allowed us to develop these much-needed resources. We would not be able to do it without you.

Many ICUs are very busy dealing with the pandemic these days, and a recent survey shows that clinicians in the ICU are feeling the stress.

They are worried about getting infected, and they are even more worried about infecting family members, according to the Society for Critical Care Medicine, which surveyed members of four professional organizations – the American Association of Critical-Care Nurses, American College of Chest Physicians, American Thoracic Society, and the SCCM – April 7-22, 2020.

Four items in the survey assessed respondents’ level of stress or concern on a scale of 1-10:

• Personal stress before the COVID-19 pandemic.
• Personal stress as a result of COVID-19 pandemic.
• Concern about personally being exposed to COVID-19.
• Concern about exposing family members to COVID-19.

Personal stress rose from a median of 3 before the pandemic to a current 8, a level that was equaled by personal concerns about being exposed and surpassed (10) by concerns about exposing family members, the SCCM reported in a blog post.

Most of the respondents “are taking special measures to limit the potential spread of the virus to their loved ones, including implementing a decontamination routine before interacting with families,” the SCCM wrote.

The most common strategy, employed by 72% of ICU clinicians, is changing clothes before/after work. Showering before joining family was mentioned by 64% of providers, followed by limiting contact until decontamination (57%) and using hand sanitizer before entering home (51%), the SCCM said.

More extreme measures included self-isolating within their homes (16%) and staying in alternative housing away from their families (12%), the SCCM said, based on data for 9,120 clinicians in the United States.

Most of the respondents (88%) reported having cared for a patient with confirmed or presumed COVID-19. Nurses made up the majority (91%) of the sample, which also included nurse practitioners and physician assistants (4.5%) and physicians (2.9%), as well as smaller numbers of respiratory therapists, pharmacists, and emergency medicine flight personnel.

The results of the survey “underline the personal sacrifices of critical care clinicians during the COVID-19 response and suggest the need to help them proactively manage stress,” the SCCM wrote.

[email protected]

Many ICUs are very busy dealing with the pandemic these days, and a recent survey shows that clinicians in the ICU are feeling the stress.

They are worried about getting infected, and they are even more worried about infecting family members, according to the Society for Critical Care Medicine, which surveyed members of four professional organizations – the American Association of Critical-Care Nurses, American College of Chest Physicians, American Thoracic Society, and the SCCM – April 7-22, 2020.

Four items in the survey assessed respondents’ level of stress or concern on a scale of 1-10:

• Personal stress before the COVID-19 pandemic.
• Personal stress as a result of COVID-19 pandemic.
• Concern about personally being exposed to COVID-19.
• Concern about exposing family members to COVID-19.

Personal stress rose from a median of 3 before the pandemic to a current 8, a level that was equaled by personal concerns about being exposed and surpassed (10) by concerns about exposing family members, the SCCM reported in a blog post.

Most of the respondents “are taking special measures to limit the potential spread of the virus to their loved ones, including implementing a decontamination routine before interacting with families,” the SCCM wrote.

The most common strategy, employed by 72% of ICU clinicians, is changing clothes before/after work. Showering before joining family was mentioned by 64% of providers, followed by limiting contact until decontamination (57%) and using hand sanitizer before entering home (51%), the SCCM said.

More extreme measures included self-isolating within their homes (16%) and staying in alternative housing away from their families (12%), the SCCM said, based on data for 9,120 clinicians in the United States.

Most of the respondents (88%) reported having cared for a patient with confirmed or presumed COVID-19. Nurses made up the majority (91%) of the sample, which also included nurse practitioners and physician assistants (4.5%) and physicians (2.9%), as well as smaller numbers of respiratory therapists, pharmacists, and emergency medicine flight personnel.

The results of the survey “underline the personal sacrifices of critical care clinicians during the COVID-19 response and suggest the need to help them proactively manage stress,” the SCCM wrote.

[email protected]

Many ICUs are very busy dealing with the pandemic these days, and a recent survey shows that clinicians in the ICU are feeling the stress.

They are worried about getting infected, and they are even more worried about infecting family members, according to the Society for Critical Care Medicine, which surveyed members of four professional organizations – the American Association of Critical-Care Nurses, American College of Chest Physicians, American Thoracic Society, and the SCCM – April 7-22, 2020.

Four items in the survey assessed respondents’ level of stress or concern on a scale of 1-10:

• Personal stress before the COVID-19 pandemic.
• Personal stress as a result of COVID-19 pandemic.
• Concern about personally being exposed to COVID-19.
• Concern about exposing family members to COVID-19.

Personal stress rose from a median of 3 before the pandemic to a current 8, a level that was equaled by personal concerns about being exposed and surpassed (10) by concerns about exposing family members, the SCCM reported in a blog post.

Most of the respondents “are taking special measures to limit the potential spread of the virus to their loved ones, including implementing a decontamination routine before interacting with families,” the SCCM wrote.

The most common strategy, employed by 72% of ICU clinicians, is changing clothes before/after work. Showering before joining family was mentioned by 64% of providers, followed by limiting contact until decontamination (57%) and using hand sanitizer before entering home (51%), the SCCM said.

More extreme measures included self-isolating within their homes (16%) and staying in alternative housing away from their families (12%), the SCCM said, based on data for 9,120 clinicians in the United States.

Most of the respondents (88%) reported having cared for a patient with confirmed or presumed COVID-19. Nurses made up the majority (91%) of the sample, which also included nurse practitioners and physician assistants (4.5%) and physicians (2.9%), as well as smaller numbers of respiratory therapists, pharmacists, and emergency medicine flight personnel.

The results of the survey “underline the personal sacrifices of critical care clinicians during the COVID-19 response and suggest the need to help them proactively manage stress,” the SCCM wrote.

[email protected]

After COVID-19 hit the Denver area, internist Jean Kutner, MD, and her clinical colleagues drastically reduced the number of patients they saw and kept a minimum number of people in the office. A small team sees patients who still require in-person visits on one side of the clinic; on the other side, another team conducts clinic-based telehealth visits. A rotating schedule allows for social distancing.

The rest of the practice’s physicians are home, conducting more virtual visits.

Dr. Kutner said she is looking forward to reopening her practice completely at some point. She said she realizes that the practice probably won’t be exactly the same as before.

“We have to embrace the fact that the way we practice medicine has fundamentally changed,” said Dr. Kutner, professor of medicine at the University of Colorado at Denver, Aurora, and incoming president of the Society of General Internal Medicine. She anticipates keeping many of these changes in place for the foreseeable future.

Nearly half of 2,600 primary care physicians who responded to a recent national survey said they were struggling to remain open during the crisis. Most have had to limit wellness/chronic-disease management visits, and nearly half reported that physicians or staff were out sick. Layoffs, furloughs, and reduced hours are commonplace; some practices were forced to shut down entirely.

Social distancing helps reduce the rates of hospitalizations and deaths. Now, many physicians are considering when and how to reopen their offices and ramp up to full capacity. But they’re also aware that it won’t be “business as usual” for quite some time.

For example, remote monitoring capabilities have reduced the need for in-person checks of vital signs, such as respiratory rate oxygenation, blood glucose levels, and heart rate. “We can’t go back,” she said.

Dr. Kutner sees the pandemic as an opportunity to innovate, to think about how primary practices can best utilize their resources, face-to-face time with patients, and when and how to best leverage virtual visits in a way that improves patient health. The goal, of course, is to meet the needs of the patients while keeping everyone safe.

Like many physicians in private practice, Dr. Kutner is concerned about revenue. She hopes the Centers for Medicare & Medicaid Services makes its temporary waivers permanent.
 

What you need to consider when planning to reopen your office

Physicians say their post-COVID-19 practices will look very different from their prepandemic practices. Many plan to maintain guidelines, such as those from the AAFP, long after the pandemic has peaked.

If you are starting to think about reopening, here are some major considerations.
 

1. Develop procedures and practices that will keep your patients and staff safe.

“When we return, the first thing we need to do is limit the number of patients in the waiting room,” said Clinton Coleman, MD, who practices internal medicine and nephrology in Teaneck, N.J. “No one is comfortable in a waiting room any longer,” said Dr. Coleman, chief of internal medicine at Holy Name Medical Center in Teaneck.

Careful planning is required to resume in-person care of patients requiring non-COVID-19 care, as well as all aspects of care, according to the CMS. Adequate staff, testing, supplies, and support services, such as pathology services, are just a few considerations. The CMS recommends that physicians “evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical/procedural care and high-complexity chronic disease management; however, select preventive services may also be highly necessary.”

The American Medical Association recently unveiled a checklist for reopening. One key recommendation was for practices to select a date for reopening the office, ideally preceded by a “soft” or incremental reopening to ensure that new procedures are working. The AMA also recommends opening incrementally, continuing telehealth while also inviting patients back into the office.
 

2. Figure out how to safely see patients, particularly in your waiting areas and common spaces.

Logistic factors, such as managing patient flow, will change. Waiting rooms will be emptier; in some locations, patients may be asked to wait in their cars until an exam room is available.

The AMA also suggests limiting nonpatient visitors by posting the practice’s policy at the entrance and on the practice’s website. If service calls for repairs are needed, have those visitors come outside of normal operating hours.

Commonly shared objects such magazines or toys in pediatric offices will likely disappear. Wipes, hand sanitizers, and the wearing of masks will become even more commonplace. Those who suspect they’re ill or who have respiratory symptoms may be relegated to specific “sick visit” appointment times or taken to designated exam rooms, which will be thoroughly sanitized between patients.
 

3. Prepare for routine screening of staff and other facility workers.

According to recent CMS guidelines, you and your staff will need to undergo routine screening, as will others who work in the facility (housekeeping, delivery personnel, and anyone else who enters the area). This may mean regularly stocking screening tests and setting guidelines for what to do if one of your staff tests positive.

You may need to hire temporary workers if your staff tests positive. The CDC recommends at the very least understanding the minimum staffing requirements to ensure good patient care and a safe work environment. Consider adjusting staff schedules and rotating clinical personnel to positions that support patient care activities. You may also want to look into cross-training your office staff so that they can fill in or help out with each other’s responsibilities if one or more persons are ill.

Dr. Kutner is on board with these changes. “We don’t want to get rid of social distancing right away, because it will give us a new spike in cases – how do we figure out patient flow while honoring that?”
 

4. Develop a strategy for triaging and caring for a potential backlog of patients.

“Many of my partners are scared right now because they have no income except for emergencies,” said Andrew Gonzalez, MD, JD, MPH, a vascular surgeon and assistant professor of surgery at Indiana University, Indianapolis. Almost all nonemergency surgery has been put on hold.

“If we don’t operate, the practice makes no money,” he said. He thinks revenue will continue to be a problem as long as patients fear in-person consultations or undergoing surgery for nonacute problems such as hernias.

As restrictions ease, most physicians will face an enormous backlog of patients and will need to find new ways of triaging the most serious cases, he says. Telehealth will help, but Dr. Gonzalez predicts many of his colleagues will be working longer hours and on weekends to catch up. “Physicians are going to have to really think about ways of optimizing their time and workflow to be very efficient, because the backlog is going to prodigious.”
 

5. Anticipate changes in patient expectations.

This may entail your reconsidering tests and procedures you previously performed and considering developing new sources for some services, phasing some others out, and revising your current approach. It will most likely also mean that you make telemedicine and televisits a greater part of your practice.

Carolyn Kaloostian, MD, a family medicine and geriatric practitioner in Los Angeles, points to increased reliance on community agencies for conducting common office-based procedures, such as performing blood tests and taking ECGs and x-rays. “A lot of patients are using telemedicine or telephone visits and get the lab work or x-rays somewhere that’s less congested,” she said. To become sustainable, many of these changes will hinge on economics – whether and how they are reimbursed.

The pandemic will leave lasting effects in our health care delivery, according to Dr. Kaloostian. She is sure many of her colleagues’ and patients’ current experiences will be infused into future care. “I can’t say we’ll ever be back to normal, necessarily.”

Even if the CMS rolls back its telehealth waivers, some physicians, like Dr. Coleman, plan to continue using the technology extensively. He’s confident about the level of care he’s currently providing patients in his practice. It allows him to better manage many low-income patients who can’t access his office regularly. Not only does splitting his time between the clinic and telehealth allow him to be more available for more patients, he says it also empowers patients to take better care of themselves.
 

6. Consider a new way to conduct “check-in visits.”

One thing that will likely go by the wayside are “check-in” visits, or so-called “social visits,” those interval appointments that can just as easily be completed virtually. “Patients are going to ask why they need to drive 3 hours so you can tell them their incision looks fine from an operation you did 5 years ago,” Dr. Gonzalez said.

He’s concerned that some people will remain so fearful of the health care system that a formerly busy practice may see the pendulum swing in the opposite direction. If an aneurysm patient skips a visit, that person may also decide not to undergo a CT scan – and something preventable will be missed. “Not everybody has the option to stay away until they feel comfortable. They’re basically playing hot potato. And at some point, the music’s going to stop,” Dr. Gonzalez said.

The pandemic has prompted some very honest conversations with his patients about what truly needs to get done and what may be optional. “Everyone has now become a hyper-rational user of health care,” he said.
 

7. If you haven’t yet, consider becoming more involved with technology.

In addition to greater use of telehealth, Dr. Kaloostian, assistant professor of clinical family medicine at the University of Southern California, Los Angeles, foresees continued reliance upon technology such as smartphone apps that connect with a user’s smartwatch. This allows for more proactive, remote monitoring.

“For example, any time a patient is having recurrent nighttime trips to the bathroom, I’ll get pinged and know that,” she explained. It means she can reach out and ask about any changes before a fall occurs or a condition worsens. “It provides reassurance to the provider and to the patient that you’re doing all you can to keep an eye on them from afar.”
 

8. Update or reformulate your business plans.

Some physicians in smaller practices may have to temporarily or permanently rethink their situation. Those who have struggled or who have closed down and are considering reopening need to update their business plans. It may be safer economically to become part of a bigger group that is affiliated with an academic center or join a larger health care system that has more funds or resources.

In addition, Dr. Kaloostian suggests that primary care physicians become more flexible in the short term, perhaps working part time in an urgent care clinic or larger organization to gain additional sources of revenue until their own practice finances pick back up.

For offices that reopen, the AMA recommends contacting medical malpractice insurance carriers to check on possible liability concerns. Congress has provided certain protections for clinicians during this time, but malpractice carriers may have more information and may offer more coverage.

Dr. Coleman said a hybrid model of fewer in-person and more telehealth visits “will allow me to practice in a different way.” If the CMS reimposes prior restrictions, reimbursement may be affected initially, but that will likely change once insurers see the increased cost-effectiveness of this approach. Patients with minor complaints, those who need to have medications refilled, and patients with chronic diseases that need managing won’t have to deal with crowded waiting rooms, and it will help mitigate problems with infection control.

If there’s any upside to the pandemic, it’s an increase in attention given to advanced care planning, said Dr. Kutner. It’s something she hopes continues after everyone stops being in crisis mode. “We’re realizing how important it is to have these conversations and document people’s goals and values and code status,” she said.
 

Are offices likely to open soon?

An assumption that may or may not be valid is that a practice will remain viable and can return to former capacity. Prior to passage of the CARES Act on March 27, a survey from Kareo, a company in Irvine, California, that makes a technology platform for independent physician practices, found that 9% of respondents reported practice closures. Many more reported concern about potential closures as patient office visits plummet because of stay-at-home orders and other concerns.

By mid-April, a survey from the Primary Care Collaborative and the Larry A. Green Center found that 42% of practices had experienced layoffs and had furloughed staff. Most (85%) have seen dramatic decreases in patient volume.

“Reopening the economy or loosening physical distancing restrictions will be difficult when 20% of primary care practices predict closure within 4 weeks,” the survey concluded.

For the practices and the doctors who make it through this, we’re going to probably be better, stronger, and more efficient, Dr. Gonzalez predicts. This shock has uncovered a lot of weaknesses in the American health care system that doctors have known about and have been complaining about for a long time. It will take an open mind and lots of continued flexibility on the part of physicians, hospitals, health care systems, and the government for these changes to stick.
 

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

After COVID-19 hit the Denver area, internist Jean Kutner, MD, and her clinical colleagues drastically reduced the number of patients they saw and kept a minimum number of people in the office. A small team sees patients who still require in-person visits on one side of the clinic; on the other side, another team conducts clinic-based telehealth visits. A rotating schedule allows for social distancing.

The rest of the practice’s physicians are home, conducting more virtual visits.

Dr. Kutner said she is looking forward to reopening her practice completely at some point. She said she realizes that the practice probably won’t be exactly the same as before.

“We have to embrace the fact that the way we practice medicine has fundamentally changed,” said Dr. Kutner, professor of medicine at the University of Colorado at Denver, Aurora, and incoming president of the Society of General Internal Medicine. She anticipates keeping many of these changes in place for the foreseeable future.

Nearly half of 2,600 primary care physicians who responded to a recent national survey said they were struggling to remain open during the crisis. Most have had to limit wellness/chronic-disease management visits, and nearly half reported that physicians or staff were out sick. Layoffs, furloughs, and reduced hours are commonplace; some practices were forced to shut down entirely.

Social distancing helps reduce the rates of hospitalizations and deaths. Now, many physicians are considering when and how to reopen their offices and ramp up to full capacity. But they’re also aware that it won’t be “business as usual” for quite some time.

For example, remote monitoring capabilities have reduced the need for in-person checks of vital signs, such as respiratory rate oxygenation, blood glucose levels, and heart rate. “We can’t go back,” she said.

Dr. Kutner sees the pandemic as an opportunity to innovate, to think about how primary practices can best utilize their resources, face-to-face time with patients, and when and how to best leverage virtual visits in a way that improves patient health. The goal, of course, is to meet the needs of the patients while keeping everyone safe.

Like many physicians in private practice, Dr. Kutner is concerned about revenue. She hopes the Centers for Medicare & Medicaid Services makes its temporary waivers permanent.
 

What you need to consider when planning to reopen your office

Physicians say their post-COVID-19 practices will look very different from their prepandemic practices. Many plan to maintain guidelines, such as those from the AAFP, long after the pandemic has peaked.

If you are starting to think about reopening, here are some major considerations.
 

1. Develop procedures and practices that will keep your patients and staff safe.

“When we return, the first thing we need to do is limit the number of patients in the waiting room,” said Clinton Coleman, MD, who practices internal medicine and nephrology in Teaneck, N.J. “No one is comfortable in a waiting room any longer,” said Dr. Coleman, chief of internal medicine at Holy Name Medical Center in Teaneck.

Careful planning is required to resume in-person care of patients requiring non-COVID-19 care, as well as all aspects of care, according to the CMS. Adequate staff, testing, supplies, and support services, such as pathology services, are just a few considerations. The CMS recommends that physicians “evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical/procedural care and high-complexity chronic disease management; however, select preventive services may also be highly necessary.”

The American Medical Association recently unveiled a checklist for reopening. One key recommendation was for practices to select a date for reopening the office, ideally preceded by a “soft” or incremental reopening to ensure that new procedures are working. The AMA also recommends opening incrementally, continuing telehealth while also inviting patients back into the office.
 

2. Figure out how to safely see patients, particularly in your waiting areas and common spaces.

Logistic factors, such as managing patient flow, will change. Waiting rooms will be emptier; in some locations, patients may be asked to wait in their cars until an exam room is available.

The AMA also suggests limiting nonpatient visitors by posting the practice’s policy at the entrance and on the practice’s website. If service calls for repairs are needed, have those visitors come outside of normal operating hours.

Commonly shared objects such magazines or toys in pediatric offices will likely disappear. Wipes, hand sanitizers, and the wearing of masks will become even more commonplace. Those who suspect they’re ill or who have respiratory symptoms may be relegated to specific “sick visit” appointment times or taken to designated exam rooms, which will be thoroughly sanitized between patients.
 

3. Prepare for routine screening of staff and other facility workers.

According to recent CMS guidelines, you and your staff will need to undergo routine screening, as will others who work in the facility (housekeeping, delivery personnel, and anyone else who enters the area). This may mean regularly stocking screening tests and setting guidelines for what to do if one of your staff tests positive.

You may need to hire temporary workers if your staff tests positive. The CDC recommends at the very least understanding the minimum staffing requirements to ensure good patient care and a safe work environment. Consider adjusting staff schedules and rotating clinical personnel to positions that support patient care activities. You may also want to look into cross-training your office staff so that they can fill in or help out with each other’s responsibilities if one or more persons are ill.

Dr. Kutner is on board with these changes. “We don’t want to get rid of social distancing right away, because it will give us a new spike in cases – how do we figure out patient flow while honoring that?”
 

4. Develop a strategy for triaging and caring for a potential backlog of patients.

“Many of my partners are scared right now because they have no income except for emergencies,” said Andrew Gonzalez, MD, JD, MPH, a vascular surgeon and assistant professor of surgery at Indiana University, Indianapolis. Almost all nonemergency surgery has been put on hold.

“If we don’t operate, the practice makes no money,” he said. He thinks revenue will continue to be a problem as long as patients fear in-person consultations or undergoing surgery for nonacute problems such as hernias.

As restrictions ease, most physicians will face an enormous backlog of patients and will need to find new ways of triaging the most serious cases, he says. Telehealth will help, but Dr. Gonzalez predicts many of his colleagues will be working longer hours and on weekends to catch up. “Physicians are going to have to really think about ways of optimizing their time and workflow to be very efficient, because the backlog is going to prodigious.”
 

5. Anticipate changes in patient expectations.

This may entail your reconsidering tests and procedures you previously performed and considering developing new sources for some services, phasing some others out, and revising your current approach. It will most likely also mean that you make telemedicine and televisits a greater part of your practice.

Carolyn Kaloostian, MD, a family medicine and geriatric practitioner in Los Angeles, points to increased reliance on community agencies for conducting common office-based procedures, such as performing blood tests and taking ECGs and x-rays. “A lot of patients are using telemedicine or telephone visits and get the lab work or x-rays somewhere that’s less congested,” she said. To become sustainable, many of these changes will hinge on economics – whether and how they are reimbursed.

The pandemic will leave lasting effects in our health care delivery, according to Dr. Kaloostian. She is sure many of her colleagues’ and patients’ current experiences will be infused into future care. “I can’t say we’ll ever be back to normal, necessarily.”

Even if the CMS rolls back its telehealth waivers, some physicians, like Dr. Coleman, plan to continue using the technology extensively. He’s confident about the level of care he’s currently providing patients in his practice. It allows him to better manage many low-income patients who can’t access his office regularly. Not only does splitting his time between the clinic and telehealth allow him to be more available for more patients, he says it also empowers patients to take better care of themselves.
 

6. Consider a new way to conduct “check-in visits.”

One thing that will likely go by the wayside are “check-in” visits, or so-called “social visits,” those interval appointments that can just as easily be completed virtually. “Patients are going to ask why they need to drive 3 hours so you can tell them their incision looks fine from an operation you did 5 years ago,” Dr. Gonzalez said.

He’s concerned that some people will remain so fearful of the health care system that a formerly busy practice may see the pendulum swing in the opposite direction. If an aneurysm patient skips a visit, that person may also decide not to undergo a CT scan – and something preventable will be missed. “Not everybody has the option to stay away until they feel comfortable. They’re basically playing hot potato. And at some point, the music’s going to stop,” Dr. Gonzalez said.

The pandemic has prompted some very honest conversations with his patients about what truly needs to get done and what may be optional. “Everyone has now become a hyper-rational user of health care,” he said.
 

7. If you haven’t yet, consider becoming more involved with technology.

In addition to greater use of telehealth, Dr. Kaloostian, assistant professor of clinical family medicine at the University of Southern California, Los Angeles, foresees continued reliance upon technology such as smartphone apps that connect with a user’s smartwatch. This allows for more proactive, remote monitoring.

“For example, any time a patient is having recurrent nighttime trips to the bathroom, I’ll get pinged and know that,” she explained. It means she can reach out and ask about any changes before a fall occurs or a condition worsens. “It provides reassurance to the provider and to the patient that you’re doing all you can to keep an eye on them from afar.”
 

8. Update or reformulate your business plans.

Some physicians in smaller practices may have to temporarily or permanently rethink their situation. Those who have struggled or who have closed down and are considering reopening need to update their business plans. It may be safer economically to become part of a bigger group that is affiliated with an academic center or join a larger health care system that has more funds or resources.

In addition, Dr. Kaloostian suggests that primary care physicians become more flexible in the short term, perhaps working part time in an urgent care clinic or larger organization to gain additional sources of revenue until their own practice finances pick back up.

For offices that reopen, the AMA recommends contacting medical malpractice insurance carriers to check on possible liability concerns. Congress has provided certain protections for clinicians during this time, but malpractice carriers may have more information and may offer more coverage.

Dr. Coleman said a hybrid model of fewer in-person and more telehealth visits “will allow me to practice in a different way.” If the CMS reimposes prior restrictions, reimbursement may be affected initially, but that will likely change once insurers see the increased cost-effectiveness of this approach. Patients with minor complaints, those who need to have medications refilled, and patients with chronic diseases that need managing won’t have to deal with crowded waiting rooms, and it will help mitigate problems with infection control.

If there’s any upside to the pandemic, it’s an increase in attention given to advanced care planning, said Dr. Kutner. It’s something she hopes continues after everyone stops being in crisis mode. “We’re realizing how important it is to have these conversations and document people’s goals and values and code status,” she said.
 

Are offices likely to open soon?

An assumption that may or may not be valid is that a practice will remain viable and can return to former capacity. Prior to passage of the CARES Act on March 27, a survey from Kareo, a company in Irvine, California, that makes a technology platform for independent physician practices, found that 9% of respondents reported practice closures. Many more reported concern about potential closures as patient office visits plummet because of stay-at-home orders and other concerns.

By mid-April, a survey from the Primary Care Collaborative and the Larry A. Green Center found that 42% of practices had experienced layoffs and had furloughed staff. Most (85%) have seen dramatic decreases in patient volume.

“Reopening the economy or loosening physical distancing restrictions will be difficult when 20% of primary care practices predict closure within 4 weeks,” the survey concluded.

For the practices and the doctors who make it through this, we’re going to probably be better, stronger, and more efficient, Dr. Gonzalez predicts. This shock has uncovered a lot of weaknesses in the American health care system that doctors have known about and have been complaining about for a long time. It will take an open mind and lots of continued flexibility on the part of physicians, hospitals, health care systems, and the government for these changes to stick.
 

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

After COVID-19 hit the Denver area, internist Jean Kutner, MD, and her clinical colleagues drastically reduced the number of patients they saw and kept a minimum number of people in the office. A small team sees patients who still require in-person visits on one side of the clinic; on the other side, another team conducts clinic-based telehealth visits. A rotating schedule allows for social distancing.

The rest of the practice’s physicians are home, conducting more virtual visits.

Dr. Kutner said she is looking forward to reopening her practice completely at some point. She said she realizes that the practice probably won’t be exactly the same as before.

“We have to embrace the fact that the way we practice medicine has fundamentally changed,” said Dr. Kutner, professor of medicine at the University of Colorado at Denver, Aurora, and incoming president of the Society of General Internal Medicine. She anticipates keeping many of these changes in place for the foreseeable future.

Nearly half of 2,600 primary care physicians who responded to a recent national survey said they were struggling to remain open during the crisis. Most have had to limit wellness/chronic-disease management visits, and nearly half reported that physicians or staff were out sick. Layoffs, furloughs, and reduced hours are commonplace; some practices were forced to shut down entirely.

Social distancing helps reduce the rates of hospitalizations and deaths. Now, many physicians are considering when and how to reopen their offices and ramp up to full capacity. But they’re also aware that it won’t be “business as usual” for quite some time.

For example, remote monitoring capabilities have reduced the need for in-person checks of vital signs, such as respiratory rate oxygenation, blood glucose levels, and heart rate. “We can’t go back,” she said.

Dr. Kutner sees the pandemic as an opportunity to innovate, to think about how primary practices can best utilize their resources, face-to-face time with patients, and when and how to best leverage virtual visits in a way that improves patient health. The goal, of course, is to meet the needs of the patients while keeping everyone safe.

Like many physicians in private practice, Dr. Kutner is concerned about revenue. She hopes the Centers for Medicare & Medicaid Services makes its temporary waivers permanent.
 

What you need to consider when planning to reopen your office

Physicians say their post-COVID-19 practices will look very different from their prepandemic practices. Many plan to maintain guidelines, such as those from the AAFP, long after the pandemic has peaked.

If you are starting to think about reopening, here are some major considerations.
 

1. Develop procedures and practices that will keep your patients and staff safe.

“When we return, the first thing we need to do is limit the number of patients in the waiting room,” said Clinton Coleman, MD, who practices internal medicine and nephrology in Teaneck, N.J. “No one is comfortable in a waiting room any longer,” said Dr. Coleman, chief of internal medicine at Holy Name Medical Center in Teaneck.

Careful planning is required to resume in-person care of patients requiring non-COVID-19 care, as well as all aspects of care, according to the CMS. Adequate staff, testing, supplies, and support services, such as pathology services, are just a few considerations. The CMS recommends that physicians “evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical/procedural care and high-complexity chronic disease management; however, select preventive services may also be highly necessary.”

The American Medical Association recently unveiled a checklist for reopening. One key recommendation was for practices to select a date for reopening the office, ideally preceded by a “soft” or incremental reopening to ensure that new procedures are working. The AMA also recommends opening incrementally, continuing telehealth while also inviting patients back into the office.
 

2. Figure out how to safely see patients, particularly in your waiting areas and common spaces.

Logistic factors, such as managing patient flow, will change. Waiting rooms will be emptier; in some locations, patients may be asked to wait in their cars until an exam room is available.

The AMA also suggests limiting nonpatient visitors by posting the practice’s policy at the entrance and on the practice’s website. If service calls for repairs are needed, have those visitors come outside of normal operating hours.

Commonly shared objects such magazines or toys in pediatric offices will likely disappear. Wipes, hand sanitizers, and the wearing of masks will become even more commonplace. Those who suspect they’re ill or who have respiratory symptoms may be relegated to specific “sick visit” appointment times or taken to designated exam rooms, which will be thoroughly sanitized between patients.
 

3. Prepare for routine screening of staff and other facility workers.

According to recent CMS guidelines, you and your staff will need to undergo routine screening, as will others who work in the facility (housekeeping, delivery personnel, and anyone else who enters the area). This may mean regularly stocking screening tests and setting guidelines for what to do if one of your staff tests positive.

You may need to hire temporary workers if your staff tests positive. The CDC recommends at the very least understanding the minimum staffing requirements to ensure good patient care and a safe work environment. Consider adjusting staff schedules and rotating clinical personnel to positions that support patient care activities. You may also want to look into cross-training your office staff so that they can fill in or help out with each other’s responsibilities if one or more persons are ill.

Dr. Kutner is on board with these changes. “We don’t want to get rid of social distancing right away, because it will give us a new spike in cases – how do we figure out patient flow while honoring that?”
 

4. Develop a strategy for triaging and caring for a potential backlog of patients.

“Many of my partners are scared right now because they have no income except for emergencies,” said Andrew Gonzalez, MD, JD, MPH, a vascular surgeon and assistant professor of surgery at Indiana University, Indianapolis. Almost all nonemergency surgery has been put on hold.

“If we don’t operate, the practice makes no money,” he said. He thinks revenue will continue to be a problem as long as patients fear in-person consultations or undergoing surgery for nonacute problems such as hernias.

As restrictions ease, most physicians will face an enormous backlog of patients and will need to find new ways of triaging the most serious cases, he says. Telehealth will help, but Dr. Gonzalez predicts many of his colleagues will be working longer hours and on weekends to catch up. “Physicians are going to have to really think about ways of optimizing their time and workflow to be very efficient, because the backlog is going to prodigious.”
 

5. Anticipate changes in patient expectations.

This may entail your reconsidering tests and procedures you previously performed and considering developing new sources for some services, phasing some others out, and revising your current approach. It will most likely also mean that you make telemedicine and televisits a greater part of your practice.

Carolyn Kaloostian, MD, a family medicine and geriatric practitioner in Los Angeles, points to increased reliance on community agencies for conducting common office-based procedures, such as performing blood tests and taking ECGs and x-rays. “A lot of patients are using telemedicine or telephone visits and get the lab work or x-rays somewhere that’s less congested,” she said. To become sustainable, many of these changes will hinge on economics – whether and how they are reimbursed.

The pandemic will leave lasting effects in our health care delivery, according to Dr. Kaloostian. She is sure many of her colleagues’ and patients’ current experiences will be infused into future care. “I can’t say we’ll ever be back to normal, necessarily.”

Even if the CMS rolls back its telehealth waivers, some physicians, like Dr. Coleman, plan to continue using the technology extensively. He’s confident about the level of care he’s currently providing patients in his practice. It allows him to better manage many low-income patients who can’t access his office regularly. Not only does splitting his time between the clinic and telehealth allow him to be more available for more patients, he says it also empowers patients to take better care of themselves.
 

6. Consider a new way to conduct “check-in visits.”

One thing that will likely go by the wayside are “check-in” visits, or so-called “social visits,” those interval appointments that can just as easily be completed virtually. “Patients are going to ask why they need to drive 3 hours so you can tell them their incision looks fine from an operation you did 5 years ago,” Dr. Gonzalez said.

He’s concerned that some people will remain so fearful of the health care system that a formerly busy practice may see the pendulum swing in the opposite direction. If an aneurysm patient skips a visit, that person may also decide not to undergo a CT scan – and something preventable will be missed. “Not everybody has the option to stay away until they feel comfortable. They’re basically playing hot potato. And at some point, the music’s going to stop,” Dr. Gonzalez said.

The pandemic has prompted some very honest conversations with his patients about what truly needs to get done and what may be optional. “Everyone has now become a hyper-rational user of health care,” he said.
 

7. If you haven’t yet, consider becoming more involved with technology.

In addition to greater use of telehealth, Dr. Kaloostian, assistant professor of clinical family medicine at the University of Southern California, Los Angeles, foresees continued reliance upon technology such as smartphone apps that connect with a user’s smartwatch. This allows for more proactive, remote monitoring.

“For example, any time a patient is having recurrent nighttime trips to the bathroom, I’ll get pinged and know that,” she explained. It means she can reach out and ask about any changes before a fall occurs or a condition worsens. “It provides reassurance to the provider and to the patient that you’re doing all you can to keep an eye on them from afar.”
 

8. Update or reformulate your business plans.

Some physicians in smaller practices may have to temporarily or permanently rethink their situation. Those who have struggled or who have closed down and are considering reopening need to update their business plans. It may be safer economically to become part of a bigger group that is affiliated with an academic center or join a larger health care system that has more funds or resources.

In addition, Dr. Kaloostian suggests that primary care physicians become more flexible in the short term, perhaps working part time in an urgent care clinic or larger organization to gain additional sources of revenue until their own practice finances pick back up.

For offices that reopen, the AMA recommends contacting medical malpractice insurance carriers to check on possible liability concerns. Congress has provided certain protections for clinicians during this time, but malpractice carriers may have more information and may offer more coverage.

Dr. Coleman said a hybrid model of fewer in-person and more telehealth visits “will allow me to practice in a different way.” If the CMS reimposes prior restrictions, reimbursement may be affected initially, but that will likely change once insurers see the increased cost-effectiveness of this approach. Patients with minor complaints, those who need to have medications refilled, and patients with chronic diseases that need managing won’t have to deal with crowded waiting rooms, and it will help mitigate problems with infection control.

If there’s any upside to the pandemic, it’s an increase in attention given to advanced care planning, said Dr. Kutner. It’s something she hopes continues after everyone stops being in crisis mode. “We’re realizing how important it is to have these conversations and document people’s goals and values and code status,” she said.
 

Are offices likely to open soon?

An assumption that may or may not be valid is that a practice will remain viable and can return to former capacity. Prior to passage of the CARES Act on March 27, a survey from Kareo, a company in Irvine, California, that makes a technology platform for independent physician practices, found that 9% of respondents reported practice closures. Many more reported concern about potential closures as patient office visits plummet because of stay-at-home orders and other concerns.

By mid-April, a survey from the Primary Care Collaborative and the Larry A. Green Center found that 42% of practices had experienced layoffs and had furloughed staff. Most (85%) have seen dramatic decreases in patient volume.

“Reopening the economy or loosening physical distancing restrictions will be difficult when 20% of primary care practices predict closure within 4 weeks,” the survey concluded.

For the practices and the doctors who make it through this, we’re going to probably be better, stronger, and more efficient, Dr. Gonzalez predicts. This shock has uncovered a lot of weaknesses in the American health care system that doctors have known about and have been complaining about for a long time. It will take an open mind and lots of continued flexibility on the part of physicians, hospitals, health care systems, and the government for these changes to stick.
 

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

New guidance is available for managing inpatient hyperglycemia and diabetic ketoacidosis (DKA) in COVID-19 patients with diabetes using subcutaneous insulin.

“The glycemic management of many COVID-19–positive patients with diabetes is proving extremely complex, with huge fluctuations in glucose control and the need for very high doses of insulin,” says Diabetes UK’s National Diabetes Inpatient COVID Response Team.

“Intravenous infusion pumps, also required for inotropes, are at a premium and there may be the need to consider the use of subcutaneous or intramuscular insulin protocols,” they note.

Updated as of April 29, all of the information of the National Diabetes Inpatient COVID Response Team is available on the Diabetes UK website.

The new inpatient management graphic adds more detail to the previous “front-door” guidance, as reported by Medscape Medical News.

The document stressed that, as well as identifying patients with known diabetes, it is imperative that all newly admitted patients with COVID-19 are evaluated for diabetes, as the infection is known to cause new-onset diabetes.
 

Subcutaneous insulin dosing

The new graphic gives extensive details on subcutaneous insulin dosing in place of variable rate intravenous insulin when infusion pumps are not available, and when the patient has a glucose level above 12 mmol/L (216 mg/dL) but does not have DKA or hyperosmolar hyperglycemic state.

However, the advice is not intended for people with COVID-19 causing severe insulin resistance in the intensive care unit.

The other new guidance graphic on managing DKA or hyperosmolar state in people with COVID-19 using subcutaneous insulin is also intended for situations where intravenous infusion isn’t available.
 

Seek help from specialist diabetes team when needed

This is not to be used for mixed DKA/hyperosmolar state or for patients who are pregnant, have severe metabolic derangement, other significant comorbidity, or impaired consciousness, however.

For those situations, the advice is to seek help from a specialist diabetes team, says Diabetes UK.

Specialist teams will be available to answer diabetes queries, both by signposting to relevant existing local documents and also by providing patient-specific advice.

Indeed, NHS England recommends that such a team be available in every hospital, with a lead consultant designated each day to co-ordinate these services who must be free of other clinical duties when doing so. The role involves co-ordination of the whole service from the emergency department through to liaison with other specialties and managers.

Also newly updated is a page with extensive information for patients, including advice for staying at home, medication use, self-isolating, shielding, hospital and doctor appointments, need for urgent medical advice, and going to the hospital.

It also covers how coronavirus can affect people with diabetes, children and school, pregnancy, work situations, and tips for picking up prescriptions.

Another, shorter document with COVID-19 advice for patients has been posted by the JDRF and Beyond Type 1 Alliance.

It has also been endorsed by the American Diabetes Association, Harvard Medical School, and International Society for Pediatric and Adolescent Diabetes, in partnership with many other professional organizations, including the International Diabetes Federation, American Association of Clinical Endocrinologists, and Association of Diabetes Care & Education Specialists.

The shorter document covers topics such as personal hygiene, distancing, diabetes management, and seeking treatment, as well as links to other resources on what to do when health insurance is lost and legal rights.

This article first appeared on Medscape.com.

New guidance is available for managing inpatient hyperglycemia and diabetic ketoacidosis (DKA) in COVID-19 patients with diabetes using subcutaneous insulin.

“The glycemic management of many COVID-19–positive patients with diabetes is proving extremely complex, with huge fluctuations in glucose control and the need for very high doses of insulin,” says Diabetes UK’s National Diabetes Inpatient COVID Response Team.

“Intravenous infusion pumps, also required for inotropes, are at a premium and there may be the need to consider the use of subcutaneous or intramuscular insulin protocols,” they note.

Updated as of April 29, all of the information of the National Diabetes Inpatient COVID Response Team is available on the Diabetes UK website.

The new inpatient management graphic adds more detail to the previous “front-door” guidance, as reported by Medscape Medical News.

The document stressed that, as well as identifying patients with known diabetes, it is imperative that all newly admitted patients with COVID-19 are evaluated for diabetes, as the infection is known to cause new-onset diabetes.
 

Subcutaneous insulin dosing

The new graphic gives extensive details on subcutaneous insulin dosing in place of variable rate intravenous insulin when infusion pumps are not available, and when the patient has a glucose level above 12 mmol/L (216 mg/dL) but does not have DKA or hyperosmolar hyperglycemic state.

However, the advice is not intended for people with COVID-19 causing severe insulin resistance in the intensive care unit.

The other new guidance graphic on managing DKA or hyperosmolar state in people with COVID-19 using subcutaneous insulin is also intended for situations where intravenous infusion isn’t available.
 

Seek help from specialist diabetes team when needed

This is not to be used for mixed DKA/hyperosmolar state or for patients who are pregnant, have severe metabolic derangement, other significant comorbidity, or impaired consciousness, however.

For those situations, the advice is to seek help from a specialist diabetes team, says Diabetes UK.

Specialist teams will be available to answer diabetes queries, both by signposting to relevant existing local documents and also by providing patient-specific advice.

Indeed, NHS England recommends that such a team be available in every hospital, with a lead consultant designated each day to co-ordinate these services who must be free of other clinical duties when doing so. The role involves co-ordination of the whole service from the emergency department through to liaison with other specialties and managers.

Also newly updated is a page with extensive information for patients, including advice for staying at home, medication use, self-isolating, shielding, hospital and doctor appointments, need for urgent medical advice, and going to the hospital.

It also covers how coronavirus can affect people with diabetes, children and school, pregnancy, work situations, and tips for picking up prescriptions.

Another, shorter document with COVID-19 advice for patients has been posted by the JDRF and Beyond Type 1 Alliance.

It has also been endorsed by the American Diabetes Association, Harvard Medical School, and International Society for Pediatric and Adolescent Diabetes, in partnership with many other professional organizations, including the International Diabetes Federation, American Association of Clinical Endocrinologists, and Association of Diabetes Care & Education Specialists.

The shorter document covers topics such as personal hygiene, distancing, diabetes management, and seeking treatment, as well as links to other resources on what to do when health insurance is lost and legal rights.

This article first appeared on Medscape.com.

New guidance is available for managing inpatient hyperglycemia and diabetic ketoacidosis (DKA) in COVID-19 patients with diabetes using subcutaneous insulin.

“The glycemic management of many COVID-19–positive patients with diabetes is proving extremely complex, with huge fluctuations in glucose control and the need for very high doses of insulin,” says Diabetes UK’s National Diabetes Inpatient COVID Response Team.

“Intravenous infusion pumps, also required for inotropes, are at a premium and there may be the need to consider the use of subcutaneous or intramuscular insulin protocols,” they note.

Updated as of April 29, all of the information of the National Diabetes Inpatient COVID Response Team is available on the Diabetes UK website.

The new inpatient management graphic adds more detail to the previous “front-door” guidance, as reported by Medscape Medical News.

The document stressed that, as well as identifying patients with known diabetes, it is imperative that all newly admitted patients with COVID-19 are evaluated for diabetes, as the infection is known to cause new-onset diabetes.
 

Subcutaneous insulin dosing

The new graphic gives extensive details on subcutaneous insulin dosing in place of variable rate intravenous insulin when infusion pumps are not available, and when the patient has a glucose level above 12 mmol/L (216 mg/dL) but does not have DKA or hyperosmolar hyperglycemic state.

However, the advice is not intended for people with COVID-19 causing severe insulin resistance in the intensive care unit.

The other new guidance graphic on managing DKA or hyperosmolar state in people with COVID-19 using subcutaneous insulin is also intended for situations where intravenous infusion isn’t available.
 

Seek help from specialist diabetes team when needed

This is not to be used for mixed DKA/hyperosmolar state or for patients who are pregnant, have severe metabolic derangement, other significant comorbidity, or impaired consciousness, however.

For those situations, the advice is to seek help from a specialist diabetes team, says Diabetes UK.

Specialist teams will be available to answer diabetes queries, both by signposting to relevant existing local documents and also by providing patient-specific advice.

Indeed, NHS England recommends that such a team be available in every hospital, with a lead consultant designated each day to co-ordinate these services who must be free of other clinical duties when doing so. The role involves co-ordination of the whole service from the emergency department through to liaison with other specialties and managers.

Also newly updated is a page with extensive information for patients, including advice for staying at home, medication use, self-isolating, shielding, hospital and doctor appointments, need for urgent medical advice, and going to the hospital.

It also covers how coronavirus can affect people with diabetes, children and school, pregnancy, work situations, and tips for picking up prescriptions.

Another, shorter document with COVID-19 advice for patients has been posted by the JDRF and Beyond Type 1 Alliance.

It has also been endorsed by the American Diabetes Association, Harvard Medical School, and International Society for Pediatric and Adolescent Diabetes, in partnership with many other professional organizations, including the International Diabetes Federation, American Association of Clinical Endocrinologists, and Association of Diabetes Care & Education Specialists.

The shorter document covers topics such as personal hygiene, distancing, diabetes management, and seeking treatment, as well as links to other resources on what to do when health insurance is lost and legal rights.

This article first appeared on Medscape.com.

The American Heart Association (AHA) has awarded $1.2 million in grants to teams at 11 institutions to study COVID-19 effects on the cardiovascular and cerebrovascular systems. Work is set to start in June, with findings reported in as few as 6 months. The Cleveland Clinic will coordinate the efforts, collecting and disseminating the findings.

There were more than 750 research proposals in less than a month after the association announced its COVID-19 and Its Cardiovascular Impact Rapid Response Grant initiative.

“We were just blown away and so impressed to see this level of interest and commitment from the teams submitting such thorough proposals so quickly,” AHA President Robert Harrington, MD, chair of the department of medicine at Stanford (Calif.) University, said in a press statement. “There’s so much we don’t know about this unique coronavirus, and we continue to see emerging complications affecting both heart and brain health for which we desperately need answers and we need them quickly.”

The projects include the following:

• A Comprehensive Assessment of Arterial and Venous Thrombotic Complications in Patients with COVID-19, led by Columbia University, New York City.
• Repurposing Drugs for Treatment of Cardiomyopathy Caused by Coronavirus-2 (SARS-CoV-2), led by Brigham and Women’s Hospital and Harvard Medical School, Boston.
• Risk of Severe Morbidity and Mortality of Coronavirus Disease 2019 (COVID-19) Among Patients Taking Antihypertensive Medications, led by Kaiser Permanente Southern California.
• Deep Learning Using Chest Radiographs to Predict COVID-19 Cardiopulmonary Risk, led by Massachusetts General Hospital, Boston.
• Cardiovascular Outcomes and Biomarker Titrated Corticosteroid Dosing for SARS COV-2 (COVID-19): A Randomized Controlled Trial, led by the Mayo Clinic, Rochester Minn.
• Outcomes for Patients With Hypertension, Diabetes, and Heart Disease in the Coronavirus Pandemic: Impact of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers Treatment, led by Stanford University.
• Rapid COVID-19-on-A-Chip to Screen Competitive Targets for SARS-CoV-2 Spike Binding Sites, led by University of California, Los Angeles.
• COVID-19 Infection, African American Women and Cardiovascular Health, led by University of California, San Francisco.
• Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients with Clinically Important Myocardial Dysfunction, led by the University of Colorado, Aurora.
• The Role of the Platelet in Mediating Cardiovascular Disease in SARS-CoV-2 Infection, led by the University of Massachusetts, Worcester.
• Harnessing Glycomics to Understand Myocardial Injury in COVID-19, led by the University of Nebraska Medical Center, Omaha.

The AHA also awarded $800,000 for short-term projects to members of its new Health Technologies & Innovation Strategically Focused Research Network.

Cincinnati Children’s Hospital will assess the use of ejection fraction to triage COVID-19 patients; Johns Hopkins University, Baltimore, will assess smartphones for “virtual check-in” for stroke symptoms; Stanford will assess digital tracking of COVID-19 patients with cardiovascular complications; and the University of Michigan, Ann Arbor, will assess a system to track physiological and cardiovascular consequences of the infection.

[email protected]

The American Heart Association (AHA) has awarded $1.2 million in grants to teams at 11 institutions to study COVID-19 effects on the cardiovascular and cerebrovascular systems. Work is set to start in June, with findings reported in as few as 6 months. The Cleveland Clinic will coordinate the efforts, collecting and disseminating the findings.

There were more than 750 research proposals in less than a month after the association announced its COVID-19 and Its Cardiovascular Impact Rapid Response Grant initiative.

“We were just blown away and so impressed to see this level of interest and commitment from the teams submitting such thorough proposals so quickly,” AHA President Robert Harrington, MD, chair of the department of medicine at Stanford (Calif.) University, said in a press statement. “There’s so much we don’t know about this unique coronavirus, and we continue to see emerging complications affecting both heart and brain health for which we desperately need answers and we need them quickly.”

The projects include the following:

• A Comprehensive Assessment of Arterial and Venous Thrombotic Complications in Patients with COVID-19, led by Columbia University, New York City.
• Repurposing Drugs for Treatment of Cardiomyopathy Caused by Coronavirus-2 (SARS-CoV-2), led by Brigham and Women’s Hospital and Harvard Medical School, Boston.
• Risk of Severe Morbidity and Mortality of Coronavirus Disease 2019 (COVID-19) Among Patients Taking Antihypertensive Medications, led by Kaiser Permanente Southern California.
• Deep Learning Using Chest Radiographs to Predict COVID-19 Cardiopulmonary Risk, led by Massachusetts General Hospital, Boston.
• Cardiovascular Outcomes and Biomarker Titrated Corticosteroid Dosing for SARS COV-2 (COVID-19): A Randomized Controlled Trial, led by the Mayo Clinic, Rochester Minn.
• Outcomes for Patients With Hypertension, Diabetes, and Heart Disease in the Coronavirus Pandemic: Impact of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers Treatment, led by Stanford University.
• Rapid COVID-19-on-A-Chip to Screen Competitive Targets for SARS-CoV-2 Spike Binding Sites, led by University of California, Los Angeles.
• COVID-19 Infection, African American Women and Cardiovascular Health, led by University of California, San Francisco.
• Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients with Clinically Important Myocardial Dysfunction, led by the University of Colorado, Aurora.
• The Role of the Platelet in Mediating Cardiovascular Disease in SARS-CoV-2 Infection, led by the University of Massachusetts, Worcester.
• Harnessing Glycomics to Understand Myocardial Injury in COVID-19, led by the University of Nebraska Medical Center, Omaha.

The AHA also awarded $800,000 for short-term projects to members of its new Health Technologies & Innovation Strategically Focused Research Network.

Cincinnati Children’s Hospital will assess the use of ejection fraction to triage COVID-19 patients; Johns Hopkins University, Baltimore, will assess smartphones for “virtual check-in” for stroke symptoms; Stanford will assess digital tracking of COVID-19 patients with cardiovascular complications; and the University of Michigan, Ann Arbor, will assess a system to track physiological and cardiovascular consequences of the infection.

[email protected]

The American Heart Association (AHA) has awarded $1.2 million in grants to teams at 11 institutions to study COVID-19 effects on the cardiovascular and cerebrovascular systems. Work is set to start in June, with findings reported in as few as 6 months. The Cleveland Clinic will coordinate the efforts, collecting and disseminating the findings.

There were more than 750 research proposals in less than a month after the association announced its COVID-19 and Its Cardiovascular Impact Rapid Response Grant initiative.

“We were just blown away and so impressed to see this level of interest and commitment from the teams submitting such thorough proposals so quickly,” AHA President Robert Harrington, MD, chair of the department of medicine at Stanford (Calif.) University, said in a press statement. “There’s so much we don’t know about this unique coronavirus, and we continue to see emerging complications affecting both heart and brain health for which we desperately need answers and we need them quickly.”

The projects include the following:

• A Comprehensive Assessment of Arterial and Venous Thrombotic Complications in Patients with COVID-19, led by Columbia University, New York City.
• Repurposing Drugs for Treatment of Cardiomyopathy Caused by Coronavirus-2 (SARS-CoV-2), led by Brigham and Women’s Hospital and Harvard Medical School, Boston.
• Risk of Severe Morbidity and Mortality of Coronavirus Disease 2019 (COVID-19) Among Patients Taking Antihypertensive Medications, led by Kaiser Permanente Southern California.
• Deep Learning Using Chest Radiographs to Predict COVID-19 Cardiopulmonary Risk, led by Massachusetts General Hospital, Boston.
• Cardiovascular Outcomes and Biomarker Titrated Corticosteroid Dosing for SARS COV-2 (COVID-19): A Randomized Controlled Trial, led by the Mayo Clinic, Rochester Minn.
• Outcomes for Patients With Hypertension, Diabetes, and Heart Disease in the Coronavirus Pandemic: Impact of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers Treatment, led by Stanford University.
• Rapid COVID-19-on-A-Chip to Screen Competitive Targets for SARS-CoV-2 Spike Binding Sites, led by University of California, Los Angeles.
• COVID-19 Infection, African American Women and Cardiovascular Health, led by University of California, San Francisco.
• Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients with Clinically Important Myocardial Dysfunction, led by the University of Colorado, Aurora.
• The Role of the Platelet in Mediating Cardiovascular Disease in SARS-CoV-2 Infection, led by the University of Massachusetts, Worcester.
• Harnessing Glycomics to Understand Myocardial Injury in COVID-19, led by the University of Nebraska Medical Center, Omaha.

The AHA also awarded $800,000 for short-term projects to members of its new Health Technologies & Innovation Strategically Focused Research Network.

Cincinnati Children’s Hospital will assess the use of ejection fraction to triage COVID-19 patients; Johns Hopkins University, Baltimore, will assess smartphones for “virtual check-in” for stroke symptoms; Stanford will assess digital tracking of COVID-19 patients with cardiovascular complications; and the University of Michigan, Ann Arbor, will assess a system to track physiological and cardiovascular consequences of the infection.

[email protected]

Coronavirus disease 2019 (COVID-19) is a viral illness caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), currently causing a pandemic affecting many countries around the world, beginning in December 2019 and spreading rapidly on a global scale since. Globally, its burden has been increasing rapidly, with more than 1.2 million people testing positive for the illness and 123,000 people losing their lives, as per April 15th’s WHO COVID-19 Situation Report.¹ These numbers are increasing with each passing day. Clinically, SARS-CoV-2 has a highly variable course, ranging from mild disease manifested as a self-limited illness (seen in younger and healthier patients) to severe pneumonia/ARDS and multiorgan failure with intravascular coagulopathy.²

In this article, we intend to investigate and establish a comprehensive review of COVID-19–associated coagulopathy mechanisms, laboratory findings, and current management guidelines put forth by various societies globally. 
 

Mechanism of coagulopathy

COVID-19–associated coagulopathy has been shown to predispose to both arterial and venous thrombosis through excessive inflammation and hypoxia, leading to activation of the coagulation cascade and consumption of coagulation factors, resulting in microvascular thrombosis.³ Though the exact pathophysiology for the activation of this cascade is not known, the proposed mechanism has been: endothelial damage triggering platelet activation within the lung, leading to aggregation, thrombosis, and consumption of platelets in the lung.^2,5,6

Fox et al. noted similar coagulopathy findings of four deceased COVID-19 patients. Autopsy results concluded that the dominant process was diffuse alveolar damage, notable CD4+ aggregates around thrombosed small vessels, significant associated hemorrhage, and thrombotic microangiopathy restricted to the lungs. The proposed mechanism was the activation of megakaryocytes, possibly native to the lung, with platelet aggregation, formation of platelet-rich clots, and fibrin deposition playing a major role.⁴

It has been noted that diabetic patients are at an increased risk of vascular events and hypercoagulability with COVID-19.⁷ COVID-19 can also cause livedo reticularis and acrocyanosis because of the microthrombosis in the cutaneous vasculature secondary to underlying coagulopathy, as reported in a case report of two U.S. patients with COVID-19.⁸

Clinical and laboratory abnormalities

A recent study reported from Netherlands by Klok et al. analyzed 184 ICU patients with COVID-19 pneumonia and concluded that the cumulative incidence of acute pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke, MI, or systemic arterial embolism was 31% (95% confidence interval, 20%-41%). PE was the most frequent thrombotic complication and was noted in 81% of patients. Coagulopathy, defined as spontaneous prolongation of prothrombin time (PT) > 3s or activated partial thromboplastin time (aPTT) > 5s, was reported as an independent predictor of thrombotic complications.³

Hematologic abnormalities that were noted in COVID-19 coagulopathy include: decreased platelet counts, decreased fibrinogen levels, elevated PT/INR, elevated partial thromboplastin time (PTT), and elevated d-dimer.^9,10 In a retrospective analysis⁹ by Tang et al., 71.4% of nonsurvivors and 0.6% of survivors had met the criteria of disseminated intravascular coagulation (DIC) during their hospital stay. Nonsurvivors of COVID-19 had statistically significant elevation of d-dimer levels, FDP levels, PT, and aPTT, when compared to survivors (P < .05). The overall mortality in this study was reported as 11.5%.⁹ In addition, elevated ^d-dimer, fibrin and fibrinogen degradation product (FDP) levels and longer PT and aPTT were associated with poor prognosis.

Thus, d-dimer, PT, and platelet count should be measured in all patients who present with COVID-19 infection. We can also suggest that in patients with markedly elevated d-dimer (three- to fourfold increase), admission to hospital should be considered even in the absence of severe clinical symptoms.¹¹

COVID-19 coagulopathy management

In a retrospective study⁹ of 449 patients with severe COVID-19 from Wuhan, China, by Tang et al., 99 patients mainly received low-weight molecular heparin (LMWH) for 7 days or longer. No difference in 28-day mortality was noted between heparin users and nonusers (30.3% vs. 29.7%; P = .910). A lower 28-day mortality rate was noted in heparin patients with sepsis-induced coagulopathy score of ≥4.0 (40.0% vs. 64.2%; P = .029) or a d-dimer level greater than sixfold of upper limit of normal, compared with nonusers of heparin.¹²

Another small study of seven COVID-19 patients with acroischemia in China demonstrated that administering LMWH was successful at decreasing the d-dimer and fibrinogen degradation product levels but noted no significant improvement in clinical symptoms.¹³

Recently, the International Society of Thrombosis and Hemostasis and American Society of Hematology published recommendations and guidelines regarding the recognition and management of coagulopathy in COVID-19.¹¹ Prophylactic anticoagulation therapy with LMWH was recommended in all hospitalized patients with COVID-19, provided there was an absence of any contraindications (active bleeding, platelet count less than 25 x 10⁹/L and fibrinogen less than 0.5 g/dL). Anticoagulation with LMWH was associated with better prognosis in severe COVID-19 patients and in COVID-19 patients with markedly elevated d-dimer, as it also has anti-inflammatory effects.¹² This anti-inflammatory property of heparin has been documented in previous studies but the underlying mechanism is unknown and more research is required.^14,15

Despite coagulopathy being noticed with cases of COVID-19, bleeding has been a rare finding in COVID-19 infections. If bleeding is noted, recommendations were made to keep platelet levels greater than 50 x10⁹/L, fibrinogen less than 2.0 g/L, and INR [international normalized ratio] greater than 1.5.¹¹ Mechanical thromboprophylaxis should be used when pharmacologic thromboprophylaxis is contraindicated.¹⁶

COVID-19 patients with new diagnoses of venous thromboembolism (VTE) or atrial fibrillation should be prescribed therapeutic anticoagulation. Patients who are already on anticoagulation for VTE or atrial fibrillation should continue their therapy unless the platelet count is less than 30-50x10⁹/L or if the fibrinogen is less than 1.0 g/L.¹⁶

Conclusion

Coagulopathies associated with COVID-19 infections have been documented in several studies around the world, and it has been shown to be fatal in some cases. Despite documentation, the mechanism behind this coagulopathy is not well understood. Because of the potentially lethal complications associated with coagulopathies, early recognition and anticoagulation is imperative to improve clinical outcomes. These results are very preliminary: More studies are required to understand the role of anticoagulation and its effect on the morbidity and mortality associated with COVID-19–associated coagulopathy.

Dr. Yeruva is a board-certified hematologist/medical oncologist with WellSpan Health and clinical assistant professor of internal medicine, Penn State University, Hershey. Mr. Henderson is a third-year graduate-entry medical student at the Royal College of Surgeons in Ireland with interests in family medicine, dermatology, and tropical diseases. Dr. Al-Tawfiq is a consultant of internal medicine & infectious diseases, and the director of quality at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia, an adjunct associate professor of infectious diseases, molecular medicine and clinical pharmacology at Johns Hopkins University School of Medicine, and adjunct associate professor at Indiana University School of Medicine, Indianapolis. Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals.

References

1. World Health Organization. Coronavirus disease (COVID-2019) situation reports.

2. Lippi G et al. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020 Mar 13. 506:145-8. doi: 10.1016/j.cca.2020.03.022.

3. Klok FA et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Throm Res. 2020;18(4):844-7. doi: 10.1016/j.thromres.2020.04.013.

4. Fox S et al. Pulmonary and cardiac pathology in Covid-19: The first autopsy series from New Orleans. MedRxiv. 2020 Apr 10. doi: 10.1101/2020.04.06.20050575. 

5. Yang M et al. Thrombocytopenia in patients with severe acute respiratory syndrome (review). Hematology 2013 Sep 4. doi: 10.1080/1024533040002617.

6. Giannis D et al. Coagulation disorders in coronavirus infected patients: COVID-19, SARS-CoV-1, MERS-CoV and lessons from the past. J Clin Virol. 2020 June. doi: 10.1016/j.jcv.2020.104362. 

7. Guo W et al. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319. 

8.  Manalo IF et al. A dermatologic manifestation of COVID-19: Transient livedo reticularis. J Am Acad Dermat. 2020 Apr. doi: 10.1016/j.jaad.2020.04.018.

9. Tang N et al. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Feb 19. doi: 10.1111/jth.14768, 18: 844-847. 

10. Huang C et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

11. Thachil J et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 Mar 25. doi: 10.1111/JTH.14810. 

12. Tang N et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 Mar 27. doi: 10.1111/JTH.14817. 

13.  Zhang Y et al. Clinical and coagulation characteristics of 7 patients with critical COVID-2019 pneumonia and acro-ischemia. Zhonghua Xue Ye Xue Za Zhi. 2020 Mar 28. doi: 10.3760/cma.j.issn.0253-2727.2020.0006.

14. Poterucha TJ et al. More than an anticoagulant: Do heparins have direct anti-inflammatory effects? Thromb Haemost. 2017. doi: 10.1160/TH16-08-0620.

15. Mousavi S et al. Anti-inflammatory effects of heparin and its derivatives: A systematic review. Adv Pharmacol Pharm Sci. 2015 May 12. doi: 10.1155/2015/507151.

16. Kreuziger L et al. COVID-19 and VTE/anticoagulation: Frequently asked questions. American Society of Hematology. 2020 Apr 17.

Coronavirus disease 2019 (COVID-19) is a viral illness caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), currently causing a pandemic affecting many countries around the world, beginning in December 2019 and spreading rapidly on a global scale since. Globally, its burden has been increasing rapidly, with more than 1.2 million people testing positive for the illness and 123,000 people losing their lives, as per April 15th’s WHO COVID-19 Situation Report.¹ These numbers are increasing with each passing day. Clinically, SARS-CoV-2 has a highly variable course, ranging from mild disease manifested as a self-limited illness (seen in younger and healthier patients) to severe pneumonia/ARDS and multiorgan failure with intravascular coagulopathy.²

In this article, we intend to investigate and establish a comprehensive review of COVID-19–associated coagulopathy mechanisms, laboratory findings, and current management guidelines put forth by various societies globally. 
 

Mechanism of coagulopathy

COVID-19–associated coagulopathy has been shown to predispose to both arterial and venous thrombosis through excessive inflammation and hypoxia, leading to activation of the coagulation cascade and consumption of coagulation factors, resulting in microvascular thrombosis.³ Though the exact pathophysiology for the activation of this cascade is not known, the proposed mechanism has been: endothelial damage triggering platelet activation within the lung, leading to aggregation, thrombosis, and consumption of platelets in the lung.^2,5,6

Fox et al. noted similar coagulopathy findings of four deceased COVID-19 patients. Autopsy results concluded that the dominant process was diffuse alveolar damage, notable CD4+ aggregates around thrombosed small vessels, significant associated hemorrhage, and thrombotic microangiopathy restricted to the lungs. The proposed mechanism was the activation of megakaryocytes, possibly native to the lung, with platelet aggregation, formation of platelet-rich clots, and fibrin deposition playing a major role.⁴

It has been noted that diabetic patients are at an increased risk of vascular events and hypercoagulability with COVID-19.⁷ COVID-19 can also cause livedo reticularis and acrocyanosis because of the microthrombosis in the cutaneous vasculature secondary to underlying coagulopathy, as reported in a case report of two U.S. patients with COVID-19.⁸

Clinical and laboratory abnormalities

A recent study reported from Netherlands by Klok et al. analyzed 184 ICU patients with COVID-19 pneumonia and concluded that the cumulative incidence of acute pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke, MI, or systemic arterial embolism was 31% (95% confidence interval, 20%-41%). PE was the most frequent thrombotic complication and was noted in 81% of patients. Coagulopathy, defined as spontaneous prolongation of prothrombin time (PT) > 3s or activated partial thromboplastin time (aPTT) > 5s, was reported as an independent predictor of thrombotic complications.³

Hematologic abnormalities that were noted in COVID-19 coagulopathy include: decreased platelet counts, decreased fibrinogen levels, elevated PT/INR, elevated partial thromboplastin time (PTT), and elevated d-dimer.^9,10 In a retrospective analysis⁹ by Tang et al., 71.4% of nonsurvivors and 0.6% of survivors had met the criteria of disseminated intravascular coagulation (DIC) during their hospital stay. Nonsurvivors of COVID-19 had statistically significant elevation of d-dimer levels, FDP levels, PT, and aPTT, when compared to survivors (P < .05). The overall mortality in this study was reported as 11.5%.⁹ In addition, elevated ^d-dimer, fibrin and fibrinogen degradation product (FDP) levels and longer PT and aPTT were associated with poor prognosis.

Thus, d-dimer, PT, and platelet count should be measured in all patients who present with COVID-19 infection. We can also suggest that in patients with markedly elevated d-dimer (three- to fourfold increase), admission to hospital should be considered even in the absence of severe clinical symptoms.¹¹

COVID-19 coagulopathy management

In a retrospective study⁹ of 449 patients with severe COVID-19 from Wuhan, China, by Tang et al., 99 patients mainly received low-weight molecular heparin (LMWH) for 7 days or longer. No difference in 28-day mortality was noted between heparin users and nonusers (30.3% vs. 29.7%; P = .910). A lower 28-day mortality rate was noted in heparin patients with sepsis-induced coagulopathy score of ≥4.0 (40.0% vs. 64.2%; P = .029) or a d-dimer level greater than sixfold of upper limit of normal, compared with nonusers of heparin.¹²

Another small study of seven COVID-19 patients with acroischemia in China demonstrated that administering LMWH was successful at decreasing the d-dimer and fibrinogen degradation product levels but noted no significant improvement in clinical symptoms.¹³

Recently, the International Society of Thrombosis and Hemostasis and American Society of Hematology published recommendations and guidelines regarding the recognition and management of coagulopathy in COVID-19.¹¹ Prophylactic anticoagulation therapy with LMWH was recommended in all hospitalized patients with COVID-19, provided there was an absence of any contraindications (active bleeding, platelet count less than 25 x 10⁹/L and fibrinogen less than 0.5 g/dL). Anticoagulation with LMWH was associated with better prognosis in severe COVID-19 patients and in COVID-19 patients with markedly elevated d-dimer, as it also has anti-inflammatory effects.¹² This anti-inflammatory property of heparin has been documented in previous studies but the underlying mechanism is unknown and more research is required.^14,15

Despite coagulopathy being noticed with cases of COVID-19, bleeding has been a rare finding in COVID-19 infections. If bleeding is noted, recommendations were made to keep platelet levels greater than 50 x10⁹/L, fibrinogen less than 2.0 g/L, and INR [international normalized ratio] greater than 1.5.¹¹ Mechanical thromboprophylaxis should be used when pharmacologic thromboprophylaxis is contraindicated.¹⁶

COVID-19 patients with new diagnoses of venous thromboembolism (VTE) or atrial fibrillation should be prescribed therapeutic anticoagulation. Patients who are already on anticoagulation for VTE or atrial fibrillation should continue their therapy unless the platelet count is less than 30-50x10⁹/L or if the fibrinogen is less than 1.0 g/L.¹⁶

Conclusion

Coagulopathies associated with COVID-19 infections have been documented in several studies around the world, and it has been shown to be fatal in some cases. Despite documentation, the mechanism behind this coagulopathy is not well understood. Because of the potentially lethal complications associated with coagulopathies, early recognition and anticoagulation is imperative to improve clinical outcomes. These results are very preliminary: More studies are required to understand the role of anticoagulation and its effect on the morbidity and mortality associated with COVID-19–associated coagulopathy.

Dr. Yeruva is a board-certified hematologist/medical oncologist with WellSpan Health and clinical assistant professor of internal medicine, Penn State University, Hershey. Mr. Henderson is a third-year graduate-entry medical student at the Royal College of Surgeons in Ireland with interests in family medicine, dermatology, and tropical diseases. Dr. Al-Tawfiq is a consultant of internal medicine & infectious diseases, and the director of quality at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia, an adjunct associate professor of infectious diseases, molecular medicine and clinical pharmacology at Johns Hopkins University School of Medicine, and adjunct associate professor at Indiana University School of Medicine, Indianapolis. Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals.

References

1. World Health Organization. Coronavirus disease (COVID-2019) situation reports.

2. Lippi G et al. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020 Mar 13. 506:145-8. doi: 10.1016/j.cca.2020.03.022.

3. Klok FA et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Throm Res. 2020;18(4):844-7. doi: 10.1016/j.thromres.2020.04.013.

4. Fox S et al. Pulmonary and cardiac pathology in Covid-19: The first autopsy series from New Orleans. MedRxiv. 2020 Apr 10. doi: 10.1101/2020.04.06.20050575. 

5. Yang M et al. Thrombocytopenia in patients with severe acute respiratory syndrome (review). Hematology 2013 Sep 4. doi: 10.1080/1024533040002617.

6. Giannis D et al. Coagulation disorders in coronavirus infected patients: COVID-19, SARS-CoV-1, MERS-CoV and lessons from the past. J Clin Virol. 2020 June. doi: 10.1016/j.jcv.2020.104362. 

7. Guo W et al. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319. 

8.  Manalo IF et al. A dermatologic manifestation of COVID-19: Transient livedo reticularis. J Am Acad Dermat. 2020 Apr. doi: 10.1016/j.jaad.2020.04.018.

9. Tang N et al. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Feb 19. doi: 10.1111/jth.14768, 18: 844-847. 

10. Huang C et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

11. Thachil J et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 Mar 25. doi: 10.1111/JTH.14810. 

12. Tang N et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 Mar 27. doi: 10.1111/JTH.14817. 

13.  Zhang Y et al. Clinical and coagulation characteristics of 7 patients with critical COVID-2019 pneumonia and acro-ischemia. Zhonghua Xue Ye Xue Za Zhi. 2020 Mar 28. doi: 10.3760/cma.j.issn.0253-2727.2020.0006.

14. Poterucha TJ et al. More than an anticoagulant: Do heparins have direct anti-inflammatory effects? Thromb Haemost. 2017. doi: 10.1160/TH16-08-0620.

15. Mousavi S et al. Anti-inflammatory effects of heparin and its derivatives: A systematic review. Adv Pharmacol Pharm Sci. 2015 May 12. doi: 10.1155/2015/507151.

16. Kreuziger L et al. COVID-19 and VTE/anticoagulation: Frequently asked questions. American Society of Hematology. 2020 Apr 17.

Coronavirus disease 2019 (COVID-19) is a viral illness caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), currently causing a pandemic affecting many countries around the world, beginning in December 2019 and spreading rapidly on a global scale since. Globally, its burden has been increasing rapidly, with more than 1.2 million people testing positive for the illness and 123,000 people losing their lives, as per April 15th’s WHO COVID-19 Situation Report.¹ These numbers are increasing with each passing day. Clinically, SARS-CoV-2 has a highly variable course, ranging from mild disease manifested as a self-limited illness (seen in younger and healthier patients) to severe pneumonia/ARDS and multiorgan failure with intravascular coagulopathy.²

In this article, we intend to investigate and establish a comprehensive review of COVID-19–associated coagulopathy mechanisms, laboratory findings, and current management guidelines put forth by various societies globally. 
 

Mechanism of coagulopathy

COVID-19–associated coagulopathy has been shown to predispose to both arterial and venous thrombosis through excessive inflammation and hypoxia, leading to activation of the coagulation cascade and consumption of coagulation factors, resulting in microvascular thrombosis.³ Though the exact pathophysiology for the activation of this cascade is not known, the proposed mechanism has been: endothelial damage triggering platelet activation within the lung, leading to aggregation, thrombosis, and consumption of platelets in the lung.^2,5,6

Fox et al. noted similar coagulopathy findings of four deceased COVID-19 patients. Autopsy results concluded that the dominant process was diffuse alveolar damage, notable CD4+ aggregates around thrombosed small vessels, significant associated hemorrhage, and thrombotic microangiopathy restricted to the lungs. The proposed mechanism was the activation of megakaryocytes, possibly native to the lung, with platelet aggregation, formation of platelet-rich clots, and fibrin deposition playing a major role.⁴

It has been noted that diabetic patients are at an increased risk of vascular events and hypercoagulability with COVID-19.⁷ COVID-19 can also cause livedo reticularis and acrocyanosis because of the microthrombosis in the cutaneous vasculature secondary to underlying coagulopathy, as reported in a case report of two U.S. patients with COVID-19.⁸

Clinical and laboratory abnormalities

A recent study reported from Netherlands by Klok et al. analyzed 184 ICU patients with COVID-19 pneumonia and concluded that the cumulative incidence of acute pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke, MI, or systemic arterial embolism was 31% (95% confidence interval, 20%-41%). PE was the most frequent thrombotic complication and was noted in 81% of patients. Coagulopathy, defined as spontaneous prolongation of prothrombin time (PT) > 3s or activated partial thromboplastin time (aPTT) > 5s, was reported as an independent predictor of thrombotic complications.³

Hematologic abnormalities that were noted in COVID-19 coagulopathy include: decreased platelet counts, decreased fibrinogen levels, elevated PT/INR, elevated partial thromboplastin time (PTT), and elevated d-dimer.^9,10 In a retrospective analysis⁹ by Tang et al., 71.4% of nonsurvivors and 0.6% of survivors had met the criteria of disseminated intravascular coagulation (DIC) during their hospital stay. Nonsurvivors of COVID-19 had statistically significant elevation of d-dimer levels, FDP levels, PT, and aPTT, when compared to survivors (P < .05). The overall mortality in this study was reported as 11.5%.⁹ In addition, elevated ^d-dimer, fibrin and fibrinogen degradation product (FDP) levels and longer PT and aPTT were associated with poor prognosis.

Thus, d-dimer, PT, and platelet count should be measured in all patients who present with COVID-19 infection. We can also suggest that in patients with markedly elevated d-dimer (three- to fourfold increase), admission to hospital should be considered even in the absence of severe clinical symptoms.¹¹

COVID-19 coagulopathy management

In a retrospective study⁹ of 449 patients with severe COVID-19 from Wuhan, China, by Tang et al., 99 patients mainly received low-weight molecular heparin (LMWH) for 7 days or longer. No difference in 28-day mortality was noted between heparin users and nonusers (30.3% vs. 29.7%; P = .910). A lower 28-day mortality rate was noted in heparin patients with sepsis-induced coagulopathy score of ≥4.0 (40.0% vs. 64.2%; P = .029) or a d-dimer level greater than sixfold of upper limit of normal, compared with nonusers of heparin.¹²

Another small study of seven COVID-19 patients with acroischemia in China demonstrated that administering LMWH was successful at decreasing the d-dimer and fibrinogen degradation product levels but noted no significant improvement in clinical symptoms.¹³

Recently, the International Society of Thrombosis and Hemostasis and American Society of Hematology published recommendations and guidelines regarding the recognition and management of coagulopathy in COVID-19.¹¹ Prophylactic anticoagulation therapy with LMWH was recommended in all hospitalized patients with COVID-19, provided there was an absence of any contraindications (active bleeding, platelet count less than 25 x 10⁹/L and fibrinogen less than 0.5 g/dL). Anticoagulation with LMWH was associated with better prognosis in severe COVID-19 patients and in COVID-19 patients with markedly elevated d-dimer, as it also has anti-inflammatory effects.¹² This anti-inflammatory property of heparin has been documented in previous studies but the underlying mechanism is unknown and more research is required.^14,15

Despite coagulopathy being noticed with cases of COVID-19, bleeding has been a rare finding in COVID-19 infections. If bleeding is noted, recommendations were made to keep platelet levels greater than 50 x10⁹/L, fibrinogen less than 2.0 g/L, and INR [international normalized ratio] greater than 1.5.¹¹ Mechanical thromboprophylaxis should be used when pharmacologic thromboprophylaxis is contraindicated.¹⁶

COVID-19 patients with new diagnoses of venous thromboembolism (VTE) or atrial fibrillation should be prescribed therapeutic anticoagulation. Patients who are already on anticoagulation for VTE or atrial fibrillation should continue their therapy unless the platelet count is less than 30-50x10⁹/L or if the fibrinogen is less than 1.0 g/L.¹⁶

Conclusion

Coagulopathies associated with COVID-19 infections have been documented in several studies around the world, and it has been shown to be fatal in some cases. Despite documentation, the mechanism behind this coagulopathy is not well understood. Because of the potentially lethal complications associated with coagulopathies, early recognition and anticoagulation is imperative to improve clinical outcomes. These results are very preliminary: More studies are required to understand the role of anticoagulation and its effect on the morbidity and mortality associated with COVID-19–associated coagulopathy.

Dr. Yeruva is a board-certified hematologist/medical oncologist with WellSpan Health and clinical assistant professor of internal medicine, Penn State University, Hershey. Mr. Henderson is a third-year graduate-entry medical student at the Royal College of Surgeons in Ireland with interests in family medicine, dermatology, and tropical diseases. Dr. Al-Tawfiq is a consultant of internal medicine & infectious diseases, and the director of quality at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia, an adjunct associate professor of infectious diseases, molecular medicine and clinical pharmacology at Johns Hopkins University School of Medicine, and adjunct associate professor at Indiana University School of Medicine, Indianapolis. Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals.

References

1. World Health Organization. Coronavirus disease (COVID-2019) situation reports.

2. Lippi G et al. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020 Mar 13. 506:145-8. doi: 10.1016/j.cca.2020.03.022.

3. Klok FA et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Throm Res. 2020;18(4):844-7. doi: 10.1016/j.thromres.2020.04.013.

4. Fox S et al. Pulmonary and cardiac pathology in Covid-19: The first autopsy series from New Orleans. MedRxiv. 2020 Apr 10. doi: 10.1101/2020.04.06.20050575. 

5. Yang M et al. Thrombocytopenia in patients with severe acute respiratory syndrome (review). Hematology 2013 Sep 4. doi: 10.1080/1024533040002617.

6. Giannis D et al. Coagulation disorders in coronavirus infected patients: COVID-19, SARS-CoV-1, MERS-CoV and lessons from the past. J Clin Virol. 2020 June. doi: 10.1016/j.jcv.2020.104362. 

7. Guo W et al. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319. 

8.  Manalo IF et al. A dermatologic manifestation of COVID-19: Transient livedo reticularis. J Am Acad Dermat. 2020 Apr. doi: 10.1016/j.jaad.2020.04.018.

9. Tang N et al. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Feb 19. doi: 10.1111/jth.14768, 18: 844-847. 

10. Huang C et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

11. Thachil J et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 Mar 25. doi: 10.1111/JTH.14810. 

12. Tang N et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 Mar 27. doi: 10.1111/JTH.14817. 

13.  Zhang Y et al. Clinical and coagulation characteristics of 7 patients with critical COVID-2019 pneumonia and acro-ischemia. Zhonghua Xue Ye Xue Za Zhi. 2020 Mar 28. doi: 10.3760/cma.j.issn.0253-2727.2020.0006.

14. Poterucha TJ et al. More than an anticoagulant: Do heparins have direct anti-inflammatory effects? Thromb Haemost. 2017. doi: 10.1160/TH16-08-0620.

15. Mousavi S et al. Anti-inflammatory effects of heparin and its derivatives: A systematic review. Adv Pharmacol Pharm Sci. 2015 May 12. doi: 10.1155/2015/507151.

16. Kreuziger L et al. COVID-19 and VTE/anticoagulation: Frequently asked questions. American Society of Hematology. 2020 Apr 17.

The Food and Drug Administration has approved capmatinib (Tabrecta) to treat adults with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, as detected by an FDA-approved test.

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.

Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.

The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.

The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

The full prescribing information for capmatinib is available for download from the FDA website.

The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.

[email protected]

The Food and Drug Administration has approved capmatinib (Tabrecta) to treat adults with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, as detected by an FDA-approved test.

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.

Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.

The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.

The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

The full prescribing information for capmatinib is available for download from the FDA website.

The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.

[email protected]

The Food and Drug Administration has approved capmatinib (Tabrecta) to treat adults with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, as detected by an FDA-approved test.

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.

Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.

The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.

The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

The full prescribing information for capmatinib is available for download from the FDA website.

The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.

[email protected]