An increasing number of comorbidities in patients with rheumatoid arthritis correlates with a lower likelihood of reaching treatment targets, according to an analysis conducted with a series of large real-world datasets and presented in a symposium sponsored by the Rheumatology Research Foundation.

When compared to those with the lowest burden of comorbidity in one of these analyses, those with the highest had a nearly 50% lower likelihood (odds ratio, 0.54; 95% confidence interval [CI], 0.34-0.85) of achieving low disease activity or remission, according to Bryant England, MD, PhD, assistant professor in the division of rheumatology at the University of Nebraska, Omaha.

“Patients with more comorbidities struggle to reach treatment targets,” Dr. England said. In the treatment of RA, “we typically focus only on the joints, but these data suggest we need to begin to think more holistically about managing these patients.”

Both the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR) endorse a treat-to-target management approach in RA guidelines, but only a proportion of patients reach their targets, according to Dr. England. In his series of analyses, Dr. England has been exploring the role of comorbidities as one of the contributing factors.

Looking for real-world data, Dr. England evaluated comorbidities in the Veterans Affairs Rheumatoid Arthritis Registry, which has a male predominant population, the National Databank for Rheumatic Diseases, which is female predominant, the Truven Health Analytics MarketScan Database, and the Rheumatology Informatics System for Effectiveness Registry (RISE).
 

Comorbidities accrue more quickly in RA patients

All of these real-world data support the premise that comorbidities are higher in patients with RA than in those without, and show that the burden of comorbidities rises more quickly in patients with RA. For example, the average number of comorbidities in the MarketScan database of recently diagnosed RA patients was 2.6. Five years later, the average doubled to more than 5. For those without RA, the average at the baseline evaluation was 1.6 and remained below 3 at 5 years.

For the burden of comorbidities in RA, Dr. England prefers the term “multimorbidity” because he believes it captures the interconnections of these chronic diseases, many of which trigger or exacerbate others. When he looked at health history 2 years before the RA diagnosis, multimorbidities were already somewhat higher, but he found that burden “takes off” in the peri-diagnostic period and climbs steeply thereafter.

“The data tell us that multimorbidity becomes more problematic throughout the RA disease course,” said Dr. England, who published some of these data only a few weeks prior to his presentation.

In one effort to evaluate how multimorbidity affects treatment choices and outcome, he selected patients with persistently active disease from the RISE registry, a group expected to be candidates for a treatment change or escalation. The data suggested patients with multimorbidity were less likely than were those without to receive a change of therapy in response to their active disease, but it also demonstrated that patients with multimorbidity were less likely to achieve remission or low disease activity even if the medications were changed.

Each comorbidity lowers odds of remission

When relative burden of comorbidities was assessed by RxRisk score, a validated medication-based measure of chronic disease that recognizes 46 categories of chronic conditions, there was about a 5% lower odds ratio for each RxRisk unit of increase in comorbidity. The relationship was consistent across various cohorts of patients evaluated, according to Dr. England.

When looking for patterns of comorbidities in these large datasets using machine learning, Dr. England reported that there were “striking” relationships between organ systems. This included a pattern of cardiometabolic multimorbidity, cardiopulmonary multimorbidity, and mental health and chronic pain multimorbidity. Surprisingly, the same patterns could be identified in those with or without RA, but the prevalence differed.

“RA was closely associated with all of these different multimorbidity patterns, but the odds of having these patterns were one- to threefold greater,” Dr. England reported.

“The multimorbidity pattern most closely associated with RA was mental health and chronic pain,” he added, noting that the same results were observed across the datasets evaluated.

The implication of this work is that multimorbidity exerts an adverse effect on the course of RA and might be an appropriate target of therapies to improve RA outcomes. Although Dr. England called for better tools to measure multimorbidity and consider how it can be addressed systematically in RA patients with the intention of improving RA control, he believes this is an important direction of research.

“What our data show is that we need to begin to think more holistically about these other diseases in RA patients,” he said.
 

Others support targeting of comorbidities

Vanessa L. Kronzer, MD, a rheumatology fellow at Mayo Clinic, Rochester, Minn., agreed. An author of a study that identified 11 comorbidities significantly associated with RA, either as conditions that predispose to RA or that commonly develop in patients with RA, Dr. Kronzer has drawn the same conclusion in regard to targeting comorbidities in the RA patient.

“Based on mounting evidence that multimorbidity is associated with RA and RA disease activity, taking a broader view of the patient as a whole and his or her comorbidities may help us to not only predict RA but also achieve over disease-specific goals,” Dr. Kronzer said in an interview.

“I suspect that certain comorbidities, perhaps depression as an example, may play a particularly strong role in perpetuating high RA disease activity,” she added. She considers this a ripe area of study for improving clinical strategies in RA.

“Finding out which ones [perpetuate RA] and targeting them could be a reasonable approach to moving forward,” Dr. Kronzer said.

Dr. England and Dr. Kronzer reported having no potential conflicts of interest.

An increasing number of comorbidities in patients with rheumatoid arthritis correlates with a lower likelihood of reaching treatment targets, according to an analysis conducted with a series of large real-world datasets and presented in a symposium sponsored by the Rheumatology Research Foundation.

When compared to those with the lowest burden of comorbidity in one of these analyses, those with the highest had a nearly 50% lower likelihood (odds ratio, 0.54; 95% confidence interval [CI], 0.34-0.85) of achieving low disease activity or remission, according to Bryant England, MD, PhD, assistant professor in the division of rheumatology at the University of Nebraska, Omaha.

“Patients with more comorbidities struggle to reach treatment targets,” Dr. England said. In the treatment of RA, “we typically focus only on the joints, but these data suggest we need to begin to think more holistically about managing these patients.”

Both the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR) endorse a treat-to-target management approach in RA guidelines, but only a proportion of patients reach their targets, according to Dr. England. In his series of analyses, Dr. England has been exploring the role of comorbidities as one of the contributing factors.

Looking for real-world data, Dr. England evaluated comorbidities in the Veterans Affairs Rheumatoid Arthritis Registry, which has a male predominant population, the National Databank for Rheumatic Diseases, which is female predominant, the Truven Health Analytics MarketScan Database, and the Rheumatology Informatics System for Effectiveness Registry (RISE).
 

Comorbidities accrue more quickly in RA patients

All of these real-world data support the premise that comorbidities are higher in patients with RA than in those without, and show that the burden of comorbidities rises more quickly in patients with RA. For example, the average number of comorbidities in the MarketScan database of recently diagnosed RA patients was 2.6. Five years later, the average doubled to more than 5. For those without RA, the average at the baseline evaluation was 1.6 and remained below 3 at 5 years.

For the burden of comorbidities in RA, Dr. England prefers the term “multimorbidity” because he believes it captures the interconnections of these chronic diseases, many of which trigger or exacerbate others. When he looked at health history 2 years before the RA diagnosis, multimorbidities were already somewhat higher, but he found that burden “takes off” in the peri-diagnostic period and climbs steeply thereafter.

“The data tell us that multimorbidity becomes more problematic throughout the RA disease course,” said Dr. England, who published some of these data only a few weeks prior to his presentation.

In one effort to evaluate how multimorbidity affects treatment choices and outcome, he selected patients with persistently active disease from the RISE registry, a group expected to be candidates for a treatment change or escalation. The data suggested patients with multimorbidity were less likely than were those without to receive a change of therapy in response to their active disease, but it also demonstrated that patients with multimorbidity were less likely to achieve remission or low disease activity even if the medications were changed.

Each comorbidity lowers odds of remission

When relative burden of comorbidities was assessed by RxRisk score, a validated medication-based measure of chronic disease that recognizes 46 categories of chronic conditions, there was about a 5% lower odds ratio for each RxRisk unit of increase in comorbidity. The relationship was consistent across various cohorts of patients evaluated, according to Dr. England.

When looking for patterns of comorbidities in these large datasets using machine learning, Dr. England reported that there were “striking” relationships between organ systems. This included a pattern of cardiometabolic multimorbidity, cardiopulmonary multimorbidity, and mental health and chronic pain multimorbidity. Surprisingly, the same patterns could be identified in those with or without RA, but the prevalence differed.

“RA was closely associated with all of these different multimorbidity patterns, but the odds of having these patterns were one- to threefold greater,” Dr. England reported.

“The multimorbidity pattern most closely associated with RA was mental health and chronic pain,” he added, noting that the same results were observed across the datasets evaluated.

The implication of this work is that multimorbidity exerts an adverse effect on the course of RA and might be an appropriate target of therapies to improve RA outcomes. Although Dr. England called for better tools to measure multimorbidity and consider how it can be addressed systematically in RA patients with the intention of improving RA control, he believes this is an important direction of research.

“What our data show is that we need to begin to think more holistically about these other diseases in RA patients,” he said.
 

Others support targeting of comorbidities

Vanessa L. Kronzer, MD, a rheumatology fellow at Mayo Clinic, Rochester, Minn., agreed. An author of a study that identified 11 comorbidities significantly associated with RA, either as conditions that predispose to RA or that commonly develop in patients with RA, Dr. Kronzer has drawn the same conclusion in regard to targeting comorbidities in the RA patient.

“Based on mounting evidence that multimorbidity is associated with RA and RA disease activity, taking a broader view of the patient as a whole and his or her comorbidities may help us to not only predict RA but also achieve over disease-specific goals,” Dr. Kronzer said in an interview.

“I suspect that certain comorbidities, perhaps depression as an example, may play a particularly strong role in perpetuating high RA disease activity,” she added. She considers this a ripe area of study for improving clinical strategies in RA.

“Finding out which ones [perpetuate RA] and targeting them could be a reasonable approach to moving forward,” Dr. Kronzer said.

Dr. England and Dr. Kronzer reported having no potential conflicts of interest.

An increasing number of comorbidities in patients with rheumatoid arthritis correlates with a lower likelihood of reaching treatment targets, according to an analysis conducted with a series of large real-world datasets and presented in a symposium sponsored by the Rheumatology Research Foundation.

When compared to those with the lowest burden of comorbidity in one of these analyses, those with the highest had a nearly 50% lower likelihood (odds ratio, 0.54; 95% confidence interval [CI], 0.34-0.85) of achieving low disease activity or remission, according to Bryant England, MD, PhD, assistant professor in the division of rheumatology at the University of Nebraska, Omaha.

“Patients with more comorbidities struggle to reach treatment targets,” Dr. England said. In the treatment of RA, “we typically focus only on the joints, but these data suggest we need to begin to think more holistically about managing these patients.”

Both the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR) endorse a treat-to-target management approach in RA guidelines, but only a proportion of patients reach their targets, according to Dr. England. In his series of analyses, Dr. England has been exploring the role of comorbidities as one of the contributing factors.

Looking for real-world data, Dr. England evaluated comorbidities in the Veterans Affairs Rheumatoid Arthritis Registry, which has a male predominant population, the National Databank for Rheumatic Diseases, which is female predominant, the Truven Health Analytics MarketScan Database, and the Rheumatology Informatics System for Effectiveness Registry (RISE).
 

Comorbidities accrue more quickly in RA patients

All of these real-world data support the premise that comorbidities are higher in patients with RA than in those without, and show that the burden of comorbidities rises more quickly in patients with RA. For example, the average number of comorbidities in the MarketScan database of recently diagnosed RA patients was 2.6. Five years later, the average doubled to more than 5. For those without RA, the average at the baseline evaluation was 1.6 and remained below 3 at 5 years.

For the burden of comorbidities in RA, Dr. England prefers the term “multimorbidity” because he believes it captures the interconnections of these chronic diseases, many of which trigger or exacerbate others. When he looked at health history 2 years before the RA diagnosis, multimorbidities were already somewhat higher, but he found that burden “takes off” in the peri-diagnostic period and climbs steeply thereafter.

“The data tell us that multimorbidity becomes more problematic throughout the RA disease course,” said Dr. England, who published some of these data only a few weeks prior to his presentation.

In one effort to evaluate how multimorbidity affects treatment choices and outcome, he selected patients with persistently active disease from the RISE registry, a group expected to be candidates for a treatment change or escalation. The data suggested patients with multimorbidity were less likely than were those without to receive a change of therapy in response to their active disease, but it also demonstrated that patients with multimorbidity were less likely to achieve remission or low disease activity even if the medications were changed.

Each comorbidity lowers odds of remission

When relative burden of comorbidities was assessed by RxRisk score, a validated medication-based measure of chronic disease that recognizes 46 categories of chronic conditions, there was about a 5% lower odds ratio for each RxRisk unit of increase in comorbidity. The relationship was consistent across various cohorts of patients evaluated, according to Dr. England.

When looking for patterns of comorbidities in these large datasets using machine learning, Dr. England reported that there were “striking” relationships between organ systems. This included a pattern of cardiometabolic multimorbidity, cardiopulmonary multimorbidity, and mental health and chronic pain multimorbidity. Surprisingly, the same patterns could be identified in those with or without RA, but the prevalence differed.

“RA was closely associated with all of these different multimorbidity patterns, but the odds of having these patterns were one- to threefold greater,” Dr. England reported.

“The multimorbidity pattern most closely associated with RA was mental health and chronic pain,” he added, noting that the same results were observed across the datasets evaluated.

The implication of this work is that multimorbidity exerts an adverse effect on the course of RA and might be an appropriate target of therapies to improve RA outcomes. Although Dr. England called for better tools to measure multimorbidity and consider how it can be addressed systematically in RA patients with the intention of improving RA control, he believes this is an important direction of research.

“What our data show is that we need to begin to think more holistically about these other diseases in RA patients,” he said.
 

Others support targeting of comorbidities

Vanessa L. Kronzer, MD, a rheumatology fellow at Mayo Clinic, Rochester, Minn., agreed. An author of a study that identified 11 comorbidities significantly associated with RA, either as conditions that predispose to RA or that commonly develop in patients with RA, Dr. Kronzer has drawn the same conclusion in regard to targeting comorbidities in the RA patient.

“Based on mounting evidence that multimorbidity is associated with RA and RA disease activity, taking a broader view of the patient as a whole and his or her comorbidities may help us to not only predict RA but also achieve over disease-specific goals,” Dr. Kronzer said in an interview.

“I suspect that certain comorbidities, perhaps depression as an example, may play a particularly strong role in perpetuating high RA disease activity,” she added. She considers this a ripe area of study for improving clinical strategies in RA.

“Finding out which ones [perpetuate RA] and targeting them could be a reasonable approach to moving forward,” Dr. Kronzer said.

Dr. England and Dr. Kronzer reported having no potential conflicts of interest.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

To go back to last week’s column, some of the best advice I ever got came from those early days when I was just starting my solo practice.

One of the family docs I met was a bit off the path. He was in a small medical building, maybe three to four offices total. It wasn’t rundown, but was obviously an older building, and not located near the hospital.

When I went in, it was clear he’d been there a while, and hadn’t bothered to redecorate at all (granted, in 2021, neither have I). The lobby reminded me more of my grandparents’ living room than a medical practice. I watched as the receptionist artfully ran through answering several lines, putting people on hold, and scheduling appointments, before she turned to me.

As soon as I started my spiel (“Hi, I’m a new neurologist in the area”) she got up and went to get the doctor. She said he always wanted to meet the new doctors who came in.

Dr. Charlie took me back to his office. His desk was covered with charts in no obvious order, and the bookcases with various journals. There was a feeling of comfortable, intentional, messiness.

He was 67 at the time, obviously still enjoying his work. He told me he’d been in solo practice since day 1, recommended it to all starting out (23 years later I’ll agree with that), and offered me this piece of advice:

“Treat your practice like you would your dog. Enjoy it, take care of it, and it will serve you well. But never, ever, let it be your master. If you do, you’ll be miserable. Raise it the right way and you’ll always be happy.”

After the brief meeting he walked me up front and I went on to the next office.

In the years to come I encountered him on and off rounding at the hospital or sending each other letters about a patient. He retired a few years later and died in 2007.

I still think about him. I’ve had one practice and owned several dogs during that time, and he was really right.

In solo practice I probably haven’t made as much money as I would have in a larger group. But I have more time to do as I wish, no one else to argue with me about a new direction for the practice, computer upgrades, or staff changes. I see, within the limits allowed by my overhead, as many or as few patients as I want. I can take vacations and days off. I have time to goof off with my staff and spend extra minutes with patients who need it. Medicine is a high-stress field, but at least I can keep the stress as low as possible.

On the flip side, I see the people he warned me about. New docs who come out with guns blazing, cramming their schedule as full as possible until they can’t possibly see more patients. Their staff gets overworked and has a high turnover. They themselves burn out quickly and either melt down or close down.

So I’ll pass the same advice to all others starting out. I still recommend solo practice. And treat your practice as you would your dog. Let it be your loyal friend, but never let it run your life.

As I say to my dogs every day, “you guys are awesome.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

To go back to last week’s column, some of the best advice I ever got came from those early days when I was just starting my solo practice.

One of the family docs I met was a bit off the path. He was in a small medical building, maybe three to four offices total. It wasn’t rundown, but was obviously an older building, and not located near the hospital.

When I went in, it was clear he’d been there a while, and hadn’t bothered to redecorate at all (granted, in 2021, neither have I). The lobby reminded me more of my grandparents’ living room than a medical practice. I watched as the receptionist artfully ran through answering several lines, putting people on hold, and scheduling appointments, before she turned to me.

As soon as I started my spiel (“Hi, I’m a new neurologist in the area”) she got up and went to get the doctor. She said he always wanted to meet the new doctors who came in.

Dr. Charlie took me back to his office. His desk was covered with charts in no obvious order, and the bookcases with various journals. There was a feeling of comfortable, intentional, messiness.

He was 67 at the time, obviously still enjoying his work. He told me he’d been in solo practice since day 1, recommended it to all starting out (23 years later I’ll agree with that), and offered me this piece of advice:

“Treat your practice like you would your dog. Enjoy it, take care of it, and it will serve you well. But never, ever, let it be your master. If you do, you’ll be miserable. Raise it the right way and you’ll always be happy.”

After the brief meeting he walked me up front and I went on to the next office.

In the years to come I encountered him on and off rounding at the hospital or sending each other letters about a patient. He retired a few years later and died in 2007.

I still think about him. I’ve had one practice and owned several dogs during that time, and he was really right.

In solo practice I probably haven’t made as much money as I would have in a larger group. But I have more time to do as I wish, no one else to argue with me about a new direction for the practice, computer upgrades, or staff changes. I see, within the limits allowed by my overhead, as many or as few patients as I want. I can take vacations and days off. I have time to goof off with my staff and spend extra minutes with patients who need it. Medicine is a high-stress field, but at least I can keep the stress as low as possible.

On the flip side, I see the people he warned me about. New docs who come out with guns blazing, cramming their schedule as full as possible until they can’t possibly see more patients. Their staff gets overworked and has a high turnover. They themselves burn out quickly and either melt down or close down.

So I’ll pass the same advice to all others starting out. I still recommend solo practice. And treat your practice as you would your dog. Let it be your loyal friend, but never let it run your life.

As I say to my dogs every day, “you guys are awesome.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

To go back to last week’s column, some of the best advice I ever got came from those early days when I was just starting my solo practice.

One of the family docs I met was a bit off the path. He was in a small medical building, maybe three to four offices total. It wasn’t rundown, but was obviously an older building, and not located near the hospital.

When I went in, it was clear he’d been there a while, and hadn’t bothered to redecorate at all (granted, in 2021, neither have I). The lobby reminded me more of my grandparents’ living room than a medical practice. I watched as the receptionist artfully ran through answering several lines, putting people on hold, and scheduling appointments, before she turned to me.

As soon as I started my spiel (“Hi, I’m a new neurologist in the area”) she got up and went to get the doctor. She said he always wanted to meet the new doctors who came in.

Dr. Charlie took me back to his office. His desk was covered with charts in no obvious order, and the bookcases with various journals. There was a feeling of comfortable, intentional, messiness.

He was 67 at the time, obviously still enjoying his work. He told me he’d been in solo practice since day 1, recommended it to all starting out (23 years later I’ll agree with that), and offered me this piece of advice:

“Treat your practice like you would your dog. Enjoy it, take care of it, and it will serve you well. But never, ever, let it be your master. If you do, you’ll be miserable. Raise it the right way and you’ll always be happy.”

After the brief meeting he walked me up front and I went on to the next office.

In the years to come I encountered him on and off rounding at the hospital or sending each other letters about a patient. He retired a few years later and died in 2007.

I still think about him. I’ve had one practice and owned several dogs during that time, and he was really right.

In solo practice I probably haven’t made as much money as I would have in a larger group. But I have more time to do as I wish, no one else to argue with me about a new direction for the practice, computer upgrades, or staff changes. I see, within the limits allowed by my overhead, as many or as few patients as I want. I can take vacations and days off. I have time to goof off with my staff and spend extra minutes with patients who need it. Medicine is a high-stress field, but at least I can keep the stress as low as possible.

On the flip side, I see the people he warned me about. New docs who come out with guns blazing, cramming their schedule as full as possible until they can’t possibly see more patients. Their staff gets overworked and has a high turnover. They themselves burn out quickly and either melt down or close down.

So I’ll pass the same advice to all others starting out. I still recommend solo practice. And treat your practice as you would your dog. Let it be your loyal friend, but never let it run your life.

As I say to my dogs every day, “you guys are awesome.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

Clinicians should not blindly accept a person’s self-diagnosis as transgender and desire to medically transition without closer inspection; rather, they should make a distinction between ‘acceptance’ and conducting an in-depth, respectful, and collaborative exploration of an individual’s claims about what they believe will best promote their well-being.

These are the conclusions of two experts in ethics and clinical psychology in an extended essay published in the Journal of Medical Ethics.

“It’s not about making life harder for people who wish to transition but about improving care for all people who identify as transgender,” lead author Alessandra Lemma, DClin Psych, visiting professor in the psychoanalysis unit at University College London, said in an interview.

She stressed that the argument is neither for nor against medical transitioning per se.

“It’s an invitation to think about how the medical and mental health care communities can best support anyone considering a transition, whether they eventually pursue that course of action or not. The provision of psychotherapy, irrespective of whether the individual medically transitions or not, makes for a better outcome either way,” said Dr. Lemma, who cares for adolescents as well as adults with gender dysphoria in her private practice in London.  
 

Reflective space has been eroded in gender identity services for the young

There has been an exponential increase in the number of adolescents who identify as transgender in Western countries in recent years. This news organization has covered the debate in detail, which has intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

This has “raised concern about how the laudable aims of gender affirmative care may be ushering children and young people too quickly into medical transitioning,” generally defined as treatment with puberty blockers in minors followed by cross-sex hormones to transition to the opposite sex, “leading subsequently to a wish to detransition with all the attendant physical and psychological complications,” wrote Dr. Lemma and her coauthor, Julian Savulescu, MD, professor of practical ethics, University of Oxford (England).

While the United Kingdom and other countries such as Finland have tightened regulations regarding the treatment of minors, “these medical interventions continue to be provided in many other countries,” they noted.

Such affirmative care has recently been interpreted by “influential sections of the transgender community” as forbidding “’questioning’ of any kind of the person’s stated gender and what will help them,” the essayists stated.

But Dr. Lemma noted that, for teenagers, this is typically a time to “try on” different identities and ways of presenting oneself to the world.

“All this requires a reflective space during the decision-making process, and this has been eroded in many gender identity services for young people especially, with a massive pressure on services.”

Family issues, trauma, and comorbid conditions can all influence people too, she noted, adding that what may be happening unconsciously may be driving the decision to modify the body.

“I cannot see that it would be harmful to anyone to have the opportunity to really think about what they are doing before making decisions about medical interventions,” she asserted.
 

Decision to transition must be judged to be autonomous

Dr. Lemma noted that even in those instances where medical transitioning, on balance, is the best option, it’s important to acknowledge that the process has a psychological impact.

“What matters is that in facing a major life-changing decision, an individual has the opportunity to understand the developmental and social experiences that drive their experience of gender dysphoria such that the decisions they make about medical transitioning can be said to be taken more autonomously,” she and Dr. Savulescu wrote.

And for those people who opt for full gender reassignment surgery, they are the first to say, “I don’t think I could have got through this as well as I have without psychological support,” Dr. Lemma remarked.

Ultimately, what’s important is to ensure the protection of those individuals whose needs will most likely not be met by medical transitioning, while not making it impossible for those who are suffering to get the care they need in order to transition, she concluded. 

Until 2016, Dr. Lemma was professor of psychological therapies at the Tavistock and Portman NHS Foundation Trust and Essex University. During that time she worked with adult transgender individuals at the Portman clinic but not at the Gender Identity Service at the Tavistock clinic. Currently, she works in private practice with transgender individuals at the Queen Anne Street Practice, London. Dr. Savulescu has reported no relevant financial relationships.

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

Clinicians should not blindly accept a person’s self-diagnosis as transgender and desire to medically transition without closer inspection; rather, they should make a distinction between ‘acceptance’ and conducting an in-depth, respectful, and collaborative exploration of an individual’s claims about what they believe will best promote their well-being.

These are the conclusions of two experts in ethics and clinical psychology in an extended essay published in the Journal of Medical Ethics.

“It’s not about making life harder for people who wish to transition but about improving care for all people who identify as transgender,” lead author Alessandra Lemma, DClin Psych, visiting professor in the psychoanalysis unit at University College London, said in an interview.

She stressed that the argument is neither for nor against medical transitioning per se.

“It’s an invitation to think about how the medical and mental health care communities can best support anyone considering a transition, whether they eventually pursue that course of action or not. The provision of psychotherapy, irrespective of whether the individual medically transitions or not, makes for a better outcome either way,” said Dr. Lemma, who cares for adolescents as well as adults with gender dysphoria in her private practice in London.  
 

Reflective space has been eroded in gender identity services for the young

There has been an exponential increase in the number of adolescents who identify as transgender in Western countries in recent years. This news organization has covered the debate in detail, which has intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

This has “raised concern about how the laudable aims of gender affirmative care may be ushering children and young people too quickly into medical transitioning,” generally defined as treatment with puberty blockers in minors followed by cross-sex hormones to transition to the opposite sex, “leading subsequently to a wish to detransition with all the attendant physical and psychological complications,” wrote Dr. Lemma and her coauthor, Julian Savulescu, MD, professor of practical ethics, University of Oxford (England).

While the United Kingdom and other countries such as Finland have tightened regulations regarding the treatment of minors, “these medical interventions continue to be provided in many other countries,” they noted.

Such affirmative care has recently been interpreted by “influential sections of the transgender community” as forbidding “’questioning’ of any kind of the person’s stated gender and what will help them,” the essayists stated.

But Dr. Lemma noted that, for teenagers, this is typically a time to “try on” different identities and ways of presenting oneself to the world.

“All this requires a reflective space during the decision-making process, and this has been eroded in many gender identity services for young people especially, with a massive pressure on services.”

Family issues, trauma, and comorbid conditions can all influence people too, she noted, adding that what may be happening unconsciously may be driving the decision to modify the body.

“I cannot see that it would be harmful to anyone to have the opportunity to really think about what they are doing before making decisions about medical interventions,” she asserted.
 

Decision to transition must be judged to be autonomous

Dr. Lemma noted that even in those instances where medical transitioning, on balance, is the best option, it’s important to acknowledge that the process has a psychological impact.

“What matters is that in facing a major life-changing decision, an individual has the opportunity to understand the developmental and social experiences that drive their experience of gender dysphoria such that the decisions they make about medical transitioning can be said to be taken more autonomously,” she and Dr. Savulescu wrote.

And for those people who opt for full gender reassignment surgery, they are the first to say, “I don’t think I could have got through this as well as I have without psychological support,” Dr. Lemma remarked.

Ultimately, what’s important is to ensure the protection of those individuals whose needs will most likely not be met by medical transitioning, while not making it impossible for those who are suffering to get the care they need in order to transition, she concluded. 

Until 2016, Dr. Lemma was professor of psychological therapies at the Tavistock and Portman NHS Foundation Trust and Essex University. During that time she worked with adult transgender individuals at the Portman clinic but not at the Gender Identity Service at the Tavistock clinic. Currently, she works in private practice with transgender individuals at the Queen Anne Street Practice, London. Dr. Savulescu has reported no relevant financial relationships.

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

Clinicians should not blindly accept a person’s self-diagnosis as transgender and desire to medically transition without closer inspection; rather, they should make a distinction between ‘acceptance’ and conducting an in-depth, respectful, and collaborative exploration of an individual’s claims about what they believe will best promote their well-being.

These are the conclusions of two experts in ethics and clinical psychology in an extended essay published in the Journal of Medical Ethics.

“It’s not about making life harder for people who wish to transition but about improving care for all people who identify as transgender,” lead author Alessandra Lemma, DClin Psych, visiting professor in the psychoanalysis unit at University College London, said in an interview.

She stressed that the argument is neither for nor against medical transitioning per se.

“It’s an invitation to think about how the medical and mental health care communities can best support anyone considering a transition, whether they eventually pursue that course of action or not. The provision of psychotherapy, irrespective of whether the individual medically transitions or not, makes for a better outcome either way,” said Dr. Lemma, who cares for adolescents as well as adults with gender dysphoria in her private practice in London.  
 

Reflective space has been eroded in gender identity services for the young

There has been an exponential increase in the number of adolescents who identify as transgender in Western countries in recent years. This news organization has covered the debate in detail, which has intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

This has “raised concern about how the laudable aims of gender affirmative care may be ushering children and young people too quickly into medical transitioning,” generally defined as treatment with puberty blockers in minors followed by cross-sex hormones to transition to the opposite sex, “leading subsequently to a wish to detransition with all the attendant physical and psychological complications,” wrote Dr. Lemma and her coauthor, Julian Savulescu, MD, professor of practical ethics, University of Oxford (England).

While the United Kingdom and other countries such as Finland have tightened regulations regarding the treatment of minors, “these medical interventions continue to be provided in many other countries,” they noted.

Such affirmative care has recently been interpreted by “influential sections of the transgender community” as forbidding “’questioning’ of any kind of the person’s stated gender and what will help them,” the essayists stated.

But Dr. Lemma noted that, for teenagers, this is typically a time to “try on” different identities and ways of presenting oneself to the world.

“All this requires a reflective space during the decision-making process, and this has been eroded in many gender identity services for young people especially, with a massive pressure on services.”

Family issues, trauma, and comorbid conditions can all influence people too, she noted, adding that what may be happening unconsciously may be driving the decision to modify the body.

“I cannot see that it would be harmful to anyone to have the opportunity to really think about what they are doing before making decisions about medical interventions,” she asserted.
 

Decision to transition must be judged to be autonomous

Dr. Lemma noted that even in those instances where medical transitioning, on balance, is the best option, it’s important to acknowledge that the process has a psychological impact.

“What matters is that in facing a major life-changing decision, an individual has the opportunity to understand the developmental and social experiences that drive their experience of gender dysphoria such that the decisions they make about medical transitioning can be said to be taken more autonomously,” she and Dr. Savulescu wrote.

And for those people who opt for full gender reassignment surgery, they are the first to say, “I don’t think I could have got through this as well as I have without psychological support,” Dr. Lemma remarked.

Ultimately, what’s important is to ensure the protection of those individuals whose needs will most likely not be met by medical transitioning, while not making it impossible for those who are suffering to get the care they need in order to transition, she concluded. 

Until 2016, Dr. Lemma was professor of psychological therapies at the Tavistock and Portman NHS Foundation Trust and Essex University. During that time she worked with adult transgender individuals at the Portman clinic but not at the Gender Identity Service at the Tavistock clinic. Currently, she works in private practice with transgender individuals at the Queen Anne Street Practice, London. Dr. Savulescu has reported no relevant financial relationships.

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

The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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