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PCSK9 inhibition cuts events in very-high-risk groups
Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.
In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.
These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.
Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.
The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.
Polyvascular disease
In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.
The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).
Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.
These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.
“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.
Prior CABG
Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.
Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.
The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.
“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.
Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.
SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.
These two secondary analyses of the ODYSSEY OUTCOMES trial are very important studies that reinforce the usefulness of PCSK9 inhibition in extremely high risk populations.
Although each study has limitations as acknowledged, it provides further evidence that should lead us to strongly consider the use of PCSK9 inhibitors in patients with a previous coronary artery bypass grafting (CABG) or a history of polyvascular disease.
The studies confirm that aggressive lipid-lowering therapy will benefit patients in those high-risk subsets. The significant reductions in mortality associated with lowering LDL cholesterol using alirocumab can no longer be ignored.
Economic analyses would be interesting, as the substantial reductions in major adverse cardiovascular events and all-cause deaths attributed to alirocumab would likely impact health care costs and society at large.
However, it is concerning that patients with prior CABG and those with a high atherosclerosis burden in multiple arterial territories were seemingly less well treated than acute coronary syndrome patients.
An LDL cholesterol level of at least 100 mg/dL was seen in upward of 40% of the high-risk participants at randomization, while 87% had high BP, 40% had diabetes, and 16% were current smokers.
A reasonable first step in the approach to patient care is for physicians to be less complacent and apply, with enthusiasm, secondary prevention guidelines in post-CABG and polyvascular disease patients to strive to eliminate smoking and to enforce lifestyle modifications with known benefits in atherosclerotic cardiovascular disease.
Jacques Genest, MD, and Alexandre M. Bélanger, MD, of McGill University, Montreal, and Mandeep S. Sidhu, MD, of Albany (N.Y.) Medical College made these comments in an accompanying editorial ( J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.016 ). The authors reported disclosures related to Sanofi, Amgen, Pfizer, Aegerion Pharmaceuticals, Valeant Pharmaceuticals, and others.
These two secondary analyses of the ODYSSEY OUTCOMES trial are very important studies that reinforce the usefulness of PCSK9 inhibition in extremely high risk populations.
Although each study has limitations as acknowledged, it provides further evidence that should lead us to strongly consider the use of PCSK9 inhibitors in patients with a previous coronary artery bypass grafting (CABG) or a history of polyvascular disease.
The studies confirm that aggressive lipid-lowering therapy will benefit patients in those high-risk subsets. The significant reductions in mortality associated with lowering LDL cholesterol using alirocumab can no longer be ignored.
Economic analyses would be interesting, as the substantial reductions in major adverse cardiovascular events and all-cause deaths attributed to alirocumab would likely impact health care costs and society at large.
However, it is concerning that patients with prior CABG and those with a high atherosclerosis burden in multiple arterial territories were seemingly less well treated than acute coronary syndrome patients.
An LDL cholesterol level of at least 100 mg/dL was seen in upward of 40% of the high-risk participants at randomization, while 87% had high BP, 40% had diabetes, and 16% were current smokers.
A reasonable first step in the approach to patient care is for physicians to be less complacent and apply, with enthusiasm, secondary prevention guidelines in post-CABG and polyvascular disease patients to strive to eliminate smoking and to enforce lifestyle modifications with known benefits in atherosclerotic cardiovascular disease.
Jacques Genest, MD, and Alexandre M. Bélanger, MD, of McGill University, Montreal, and Mandeep S. Sidhu, MD, of Albany (N.Y.) Medical College made these comments in an accompanying editorial ( J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.016 ). The authors reported disclosures related to Sanofi, Amgen, Pfizer, Aegerion Pharmaceuticals, Valeant Pharmaceuticals, and others.
These two secondary analyses of the ODYSSEY OUTCOMES trial are very important studies that reinforce the usefulness of PCSK9 inhibition in extremely high risk populations.
Although each study has limitations as acknowledged, it provides further evidence that should lead us to strongly consider the use of PCSK9 inhibitors in patients with a previous coronary artery bypass grafting (CABG) or a history of polyvascular disease.
The studies confirm that aggressive lipid-lowering therapy will benefit patients in those high-risk subsets. The significant reductions in mortality associated with lowering LDL cholesterol using alirocumab can no longer be ignored.
Economic analyses would be interesting, as the substantial reductions in major adverse cardiovascular events and all-cause deaths attributed to alirocumab would likely impact health care costs and society at large.
However, it is concerning that patients with prior CABG and those with a high atherosclerosis burden in multiple arterial territories were seemingly less well treated than acute coronary syndrome patients.
An LDL cholesterol level of at least 100 mg/dL was seen in upward of 40% of the high-risk participants at randomization, while 87% had high BP, 40% had diabetes, and 16% were current smokers.
A reasonable first step in the approach to patient care is for physicians to be less complacent and apply, with enthusiasm, secondary prevention guidelines in post-CABG and polyvascular disease patients to strive to eliminate smoking and to enforce lifestyle modifications with known benefits in atherosclerotic cardiovascular disease.
Jacques Genest, MD, and Alexandre M. Bélanger, MD, of McGill University, Montreal, and Mandeep S. Sidhu, MD, of Albany (N.Y.) Medical College made these comments in an accompanying editorial ( J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.016 ). The authors reported disclosures related to Sanofi, Amgen, Pfizer, Aegerion Pharmaceuticals, Valeant Pharmaceuticals, and others.
Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.
In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.
These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.
Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.
The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.
Polyvascular disease
In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.
The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).
Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.
These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.
“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.
Prior CABG
Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.
Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.
The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.
“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.
Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.
SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.
Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.
In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.
These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.
Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.
The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.
Polyvascular disease
In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.
The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).
Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.
These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.
“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.
Prior CABG
Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.
Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.
The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.
“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.
Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.
SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: The PCSK9 inhibitor alirocumab improved cardiovascular outcomes in very-high-risk populations, including patients with previous coronary artery bypass grafting and those with polyvascular disease.
Major findings: In one analysis, the absolute risk reductions in major adverse coronary events with alirocumab were 1.3% for no coronary artery bypass grafting, 0.9% for index CABG, and 6.4% for prior CABG. In another analysis, alirocumab treatment resulted in an ARR for major adverse coronary events of 1.4%, 1.9%, and 13.0% for patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease, respectively.
Study details: Prespecified analyses of patients with recent acute coronary syndrome and high atherogenic lipoproteins despite intensive statin treatment in the ODYSSEY OUTCOMES trial, which included 18,924 total participants.
Disclosures: Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.
Sources: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.
CPAP safety for infants with bronchiolitis on the general pediatrics floor
SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.
It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.
It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”
Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”
Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.
Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H2O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.
With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.
CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.
For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.
Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.
Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.
The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.
The presenters didn’t report any disclosures.
This article was updated 8/27/19.
SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.
It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.
It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”
Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”
Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.
Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H2O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.
With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.
CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.
For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.
Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.
Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.
The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.
The presenters didn’t report any disclosures.
This article was updated 8/27/19.
SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.
It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.
It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”
Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”
Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.
Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H2O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.
With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.
CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.
For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.
Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.
Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.
The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.
The presenters didn’t report any disclosures.
This article was updated 8/27/19.
EXPERT ANALYSIS FROM PHM 2019
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As always, use your SVS credentials to sign in and reach out to [email protected] with questions.
If you’re looking to have the best remote user experience on SVSConnect, download the Member Centric app. Don’t limit your time on the community to only when you have a desktop or laptop computer available. The app gives you easy access to the Open Forum, member directory and shared resources directly from your mobile device. You're able to download this from either Google Play or the App Store. Read how to download the app here.
As always, use your SVS credentials to sign in and reach out to [email protected] with questions.
If you’re looking to have the best remote user experience on SVSConnect, download the Member Centric app. Don’t limit your time on the community to only when you have a desktop or laptop computer available. The app gives you easy access to the Open Forum, member directory and shared resources directly from your mobile device. You're able to download this from either Google Play or the App Store. Read how to download the app here.
As always, use your SVS credentials to sign in and reach out to [email protected] with questions.
Apply for SVS Membership
The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].
The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].
The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].
Last call for VAM 2020 Proposals
The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].
The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].
The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].
Tell us what you think of our Patient Education Materials
Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.
Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.
Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.
Insurance networks: Is it time to abandon them?
Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.
Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.
What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.
When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.
But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.
Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.
Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.
What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?
Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.
“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.
Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.
“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”
Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”
“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”
One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.
Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.
Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.
Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.
What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.
When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.
But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.
Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.
Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.
What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?
Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.
“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.
Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.
“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”
Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”
“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”
One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.
Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.
Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.
Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.
What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.
When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.
But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.
Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.
Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.
What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?
Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.
“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.
Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.
“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”
Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”
“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”
One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.
Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.
Pretreatment CT data may help predict immunotherapy benefit in ovarian cancer
Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.
Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.
“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.
The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.
“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.
The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.
In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.
However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.
Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).
These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.
More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.
“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.
The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.
SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.
Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.
Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.
“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.
The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.
“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.
The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.
In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.
However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.
Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).
These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.
More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.
“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.
The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.
SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.
Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.
Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.
“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.
The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.
“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.
The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.
In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.
However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.
Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).
These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.
More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.
“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.
The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.
SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.
FROM JCO PRECISION ONCOLOGY
Researchers win grants to study real-world cancer data
Three researchers have won CancerLinQ Discovery Research Support Grants from the American Society of Clinical Oncology, and two researchers have received a National Institutes of Health R21 grant.
Igor Astsaturov, MD, PhD, and Edna Cukierman, PhD, both of Fox Chase Cancer Center in Philadelphia, won the R21 grant. The pair will receive $432,410 over 2 years for their research on pancreatic cancer.
With their work, Dr. Astsaturov and Dr. Cukierman are “hoping to describe the structural and functional nature of cell-cell contact, or oncogenic synapses, associated with cancer-associated fibroblasts and pancreatic cells,” according to Fox Chase.
Three other researchers have won ASCO’s CancerLinQ Discovery Research Support Grants. The recipients will conduct projects using CancerLinQ, which collects and analyzes real-world data from cancer patients at practices across the United States.
Each 1-year grant covers the cost of a CancerLinQ Discovery data set and a meeting at ASCO headquarters. The grants also contribute to personnel and/or research expenses. The grants are funded by the ASCO Foundation’s Mission Endowment of Conquer Cancer.
With his CancerLinQ Discovery grant, Sadiq Rehmani, MD, of Icahn School of Medicine at Mount Sinai in New York, will study immunotherapy in older lung cancer patients with comorbidities.
Grant recipient Yasmin Karimi, MD, of Stanford (Calif.) University, will study how osteoclast inhibitors affect skeletal-related events and mortality in “real-world” patients with metastatic breast cancer and bone metastasis.
Grant recipient Vinayak Muralidhar, MD, of Brigham and Women’s Hospital and the radiation oncology program at Harvard Medical School, Boston, will study the use of androgen-deprivation therapy and hypofractionation in prostate cancer.
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
Three researchers have won CancerLinQ Discovery Research Support Grants from the American Society of Clinical Oncology, and two researchers have received a National Institutes of Health R21 grant.
Igor Astsaturov, MD, PhD, and Edna Cukierman, PhD, both of Fox Chase Cancer Center in Philadelphia, won the R21 grant. The pair will receive $432,410 over 2 years for their research on pancreatic cancer.
With their work, Dr. Astsaturov and Dr. Cukierman are “hoping to describe the structural and functional nature of cell-cell contact, or oncogenic synapses, associated with cancer-associated fibroblasts and pancreatic cells,” according to Fox Chase.
Three other researchers have won ASCO’s CancerLinQ Discovery Research Support Grants. The recipients will conduct projects using CancerLinQ, which collects and analyzes real-world data from cancer patients at practices across the United States.
Each 1-year grant covers the cost of a CancerLinQ Discovery data set and a meeting at ASCO headquarters. The grants also contribute to personnel and/or research expenses. The grants are funded by the ASCO Foundation’s Mission Endowment of Conquer Cancer.
With his CancerLinQ Discovery grant, Sadiq Rehmani, MD, of Icahn School of Medicine at Mount Sinai in New York, will study immunotherapy in older lung cancer patients with comorbidities.
Grant recipient Yasmin Karimi, MD, of Stanford (Calif.) University, will study how osteoclast inhibitors affect skeletal-related events and mortality in “real-world” patients with metastatic breast cancer and bone metastasis.
Grant recipient Vinayak Muralidhar, MD, of Brigham and Women’s Hospital and the radiation oncology program at Harvard Medical School, Boston, will study the use of androgen-deprivation therapy and hypofractionation in prostate cancer.
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
Three researchers have won CancerLinQ Discovery Research Support Grants from the American Society of Clinical Oncology, and two researchers have received a National Institutes of Health R21 grant.
Igor Astsaturov, MD, PhD, and Edna Cukierman, PhD, both of Fox Chase Cancer Center in Philadelphia, won the R21 grant. The pair will receive $432,410 over 2 years for their research on pancreatic cancer.
With their work, Dr. Astsaturov and Dr. Cukierman are “hoping to describe the structural and functional nature of cell-cell contact, or oncogenic synapses, associated with cancer-associated fibroblasts and pancreatic cells,” according to Fox Chase.
Three other researchers have won ASCO’s CancerLinQ Discovery Research Support Grants. The recipients will conduct projects using CancerLinQ, which collects and analyzes real-world data from cancer patients at practices across the United States.
Each 1-year grant covers the cost of a CancerLinQ Discovery data set and a meeting at ASCO headquarters. The grants also contribute to personnel and/or research expenses. The grants are funded by the ASCO Foundation’s Mission Endowment of Conquer Cancer.
With his CancerLinQ Discovery grant, Sadiq Rehmani, MD, of Icahn School of Medicine at Mount Sinai in New York, will study immunotherapy in older lung cancer patients with comorbidities.
Grant recipient Yasmin Karimi, MD, of Stanford (Calif.) University, will study how osteoclast inhibitors affect skeletal-related events and mortality in “real-world” patients with metastatic breast cancer and bone metastasis.
Grant recipient Vinayak Muralidhar, MD, of Brigham and Women’s Hospital and the radiation oncology program at Harvard Medical School, Boston, will study the use of androgen-deprivation therapy and hypofractionation in prostate cancer.
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
What is your diagnosis? - September 2019
Erosive protein-losing enteropathy secondary to disseminated histoplasmosis
This patient was treated with amphotericin B and transitioned to oral itraconazole with frequent blood level monitoring to ensure absorption. His symptoms improved gradually. Small-bowel enteroscopy 3 weeks after presentation showed a normal duodenum and healing, superficial ulcers in the proximal jejunum (Figure F, G). Blood albumin levels had recovered to 3.1 g/dL (normal, 3.5–5.0 g/dL).
Protein-losing enteropathy (PLE) is a rare syndrome characterized by loss of serum proteins in the gastrointestinal (GI) tract, resulting in significant hypoproteinemia and consequent edema.1 PLE can also result in ascites, pleural and pericardial effusions, and, in prolonged cases, malnutrition. There are a variety of causes of PLE that can be broadly grouped into erosive GI disorders, disorders of increased GI mucosal permeability, and disorders of increased interstitial pressure. The clinical presentation depends on the underlying etiology, but commonly includes generalized edema owing to hypoproteinemia and resulting reduced oncotic pressure. GI symptoms are not frequently observed. The initial step in evaluating a patient with symptoms concerning for PLE is to rule out more common causes of hypoproteinemia, such as renal or hepatic disease, and malnutrition. To confirm enteric protein loss, alpha 1-antitrypsin clearance with a 24-hour stool collection is commonly and reliably used. Treatment of PLE is centered on treating the underlying cause while monitoring and treating malnutrition, including micronutrient deficiencies.
Fungal infections are a rare cause of PLE, but important to recognize as a potential complication of tumor necrosis factor–therapy, because these medications are commonly used for a variety of autoimmune diseases.2 Although histoplasmosis is an uncommon cause of GI inflammation, disseminated histoplasmosis causing PLE has been previously reported.3 In our patient, Histoplasma capsulatum infection caused diffuse GI ulcers, which allowed protein loss in the GI tract (erosive PLE). Antifungal treatment resulted in healing of intestinal ulcers and correction of hypoalbuminemia, thereby confirming the diagnosis of PLE and obviating the need for a confirmatory alpha 1-antitrypsin clearance study.
References
1. Umar SB, DiBaise JK. Protein-losing enteropathy: case illustrations and clinical review. Am J Gastroenterol. 2010;105:43-9.
2. Tsiodras S, Samonis G, Boumpas DT. et al. Fungal infections complicating tumor necrosis factor alpha blockade therapy. Mayo Clin Proc. 2008;83:181-94.
3. Kok J, Chen SC, Anderson L, et al. Protein-losing enteropathy and hypogammaglobulinaemia as first manifestations of disseminated histoplasmosis coincident with Nocardia infection. J Med Microbiol. 2010;59:610-3.
Erosive protein-losing enteropathy secondary to disseminated histoplasmosis
This patient was treated with amphotericin B and transitioned to oral itraconazole with frequent blood level monitoring to ensure absorption. His symptoms improved gradually. Small-bowel enteroscopy 3 weeks after presentation showed a normal duodenum and healing, superficial ulcers in the proximal jejunum (Figure F, G). Blood albumin levels had recovered to 3.1 g/dL (normal, 3.5–5.0 g/dL).
Protein-losing enteropathy (PLE) is a rare syndrome characterized by loss of serum proteins in the gastrointestinal (GI) tract, resulting in significant hypoproteinemia and consequent edema.1 PLE can also result in ascites, pleural and pericardial effusions, and, in prolonged cases, malnutrition. There are a variety of causes of PLE that can be broadly grouped into erosive GI disorders, disorders of increased GI mucosal permeability, and disorders of increased interstitial pressure. The clinical presentation depends on the underlying etiology, but commonly includes generalized edema owing to hypoproteinemia and resulting reduced oncotic pressure. GI symptoms are not frequently observed. The initial step in evaluating a patient with symptoms concerning for PLE is to rule out more common causes of hypoproteinemia, such as renal or hepatic disease, and malnutrition. To confirm enteric protein loss, alpha 1-antitrypsin clearance with a 24-hour stool collection is commonly and reliably used. Treatment of PLE is centered on treating the underlying cause while monitoring and treating malnutrition, including micronutrient deficiencies.
Fungal infections are a rare cause of PLE, but important to recognize as a potential complication of tumor necrosis factor–therapy, because these medications are commonly used for a variety of autoimmune diseases.2 Although histoplasmosis is an uncommon cause of GI inflammation, disseminated histoplasmosis causing PLE has been previously reported.3 In our patient, Histoplasma capsulatum infection caused diffuse GI ulcers, which allowed protein loss in the GI tract (erosive PLE). Antifungal treatment resulted in healing of intestinal ulcers and correction of hypoalbuminemia, thereby confirming the diagnosis of PLE and obviating the need for a confirmatory alpha 1-antitrypsin clearance study.
References
1. Umar SB, DiBaise JK. Protein-losing enteropathy: case illustrations and clinical review. Am J Gastroenterol. 2010;105:43-9.
2. Tsiodras S, Samonis G, Boumpas DT. et al. Fungal infections complicating tumor necrosis factor alpha blockade therapy. Mayo Clin Proc. 2008;83:181-94.
3. Kok J, Chen SC, Anderson L, et al. Protein-losing enteropathy and hypogammaglobulinaemia as first manifestations of disseminated histoplasmosis coincident with Nocardia infection. J Med Microbiol. 2010;59:610-3.
Erosive protein-losing enteropathy secondary to disseminated histoplasmosis
This patient was treated with amphotericin B and transitioned to oral itraconazole with frequent blood level monitoring to ensure absorption. His symptoms improved gradually. Small-bowel enteroscopy 3 weeks after presentation showed a normal duodenum and healing, superficial ulcers in the proximal jejunum (Figure F, G). Blood albumin levels had recovered to 3.1 g/dL (normal, 3.5–5.0 g/dL).
Protein-losing enteropathy (PLE) is a rare syndrome characterized by loss of serum proteins in the gastrointestinal (GI) tract, resulting in significant hypoproteinemia and consequent edema.1 PLE can also result in ascites, pleural and pericardial effusions, and, in prolonged cases, malnutrition. There are a variety of causes of PLE that can be broadly grouped into erosive GI disorders, disorders of increased GI mucosal permeability, and disorders of increased interstitial pressure. The clinical presentation depends on the underlying etiology, but commonly includes generalized edema owing to hypoproteinemia and resulting reduced oncotic pressure. GI symptoms are not frequently observed. The initial step in evaluating a patient with symptoms concerning for PLE is to rule out more common causes of hypoproteinemia, such as renal or hepatic disease, and malnutrition. To confirm enteric protein loss, alpha 1-antitrypsin clearance with a 24-hour stool collection is commonly and reliably used. Treatment of PLE is centered on treating the underlying cause while monitoring and treating malnutrition, including micronutrient deficiencies.
Fungal infections are a rare cause of PLE, but important to recognize as a potential complication of tumor necrosis factor–therapy, because these medications are commonly used for a variety of autoimmune diseases.2 Although histoplasmosis is an uncommon cause of GI inflammation, disseminated histoplasmosis causing PLE has been previously reported.3 In our patient, Histoplasma capsulatum infection caused diffuse GI ulcers, which allowed protein loss in the GI tract (erosive PLE). Antifungal treatment resulted in healing of intestinal ulcers and correction of hypoalbuminemia, thereby confirming the diagnosis of PLE and obviating the need for a confirmatory alpha 1-antitrypsin clearance study.
References
1. Umar SB, DiBaise JK. Protein-losing enteropathy: case illustrations and clinical review. Am J Gastroenterol. 2010;105:43-9.
2. Tsiodras S, Samonis G, Boumpas DT. et al. Fungal infections complicating tumor necrosis factor alpha blockade therapy. Mayo Clin Proc. 2008;83:181-94.
3. Kok J, Chen SC, Anderson L, et al. Protein-losing enteropathy and hypogammaglobulinaemia as first manifestations of disseminated histoplasmosis coincident with Nocardia infection. J Med Microbiol. 2010;59:610-3.
A 34-year-old man with a medical history of psoriasis, on adalimumab, presented with a 2-week history of progressively worsening abdominal pain, nausea, vomiting, melenic diarrhea, subjective fevers, and generalized weakness. One week into the illness, he developed progressive bilateral extremity and scrotal swelling.
His vital signs included a temperature of 36.8°C, heart rate of 104 beats per minute, respiratory rate of 18 breaths per minute, and a blood pressure of 114/71 mm Hg. The physical examination was notable for a well-nourished appearance, diffuse abdominal tenderness to palpation without distension, organomegaly, or rigidity, and pitting lower extremity edema.
Laboratory evaluation showed hemoglobin 10.3 g/dL (normal, 13.5–17.5 g/dL), leukocytes 10 × 109/L (normal, 3.5–10.5 × 109/L), platelets 212 × 109/L (normal, 150–450 × 109/L), sodium 131 mmol/L (normal, 135–145 mmol/L), creatinine 1 mg/dL (normal, 0.8–1.3 mg/dL), albumin 1.8 g/dL (normal, 3.5–5.0 g/dL), and C-reactive protein 53 mg/L (normal, less than 8 mg/L). Liver chemistries were all normal.
Urinalysis was unremarkable with normal urine protein levels. The enteric pathogen panel by polymerase chain reaction was negative. Computed tomography (CT) of the abdomen and pelvis showed marked circumferential wall thickening with mural enhancement of multiple loops of jejunum (Figure A).
Small-bowel enteroscopy showed diffuse erosions in the entire duodenum and many oozing superficial ulcers with edematous and erythematous mucosa in the proximal jejunum (Figures B, C).
CT scan of the chest showed right lower lobe consolidation associated with a large right pleural effusion, and mediastinal, bilateral, hilar and abdominal lymphadenopathy (Figure D). Endobronchial ultrasound-guided transbronchial biopsy of lymph nodes was positive for oval-shaped organisms exhibiting narrow-based budding on GMS stain (Figure E).
Based on the clinical scenario and images, what is the most likely diagnosis?