A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

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

A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

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

A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

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

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.

Key clinical point: Treatment regimen was a key factor in survival rates among adults with acute myeloid leukemia, and patients with high responsiveness of tumor cells in vitro showed stronger response to chemotherapy.

Major finding: Patients with high sensitivity to daunorubicin showed a good response to anthracycline‐based therapy; by contrast, patients who received daunorubicin during induction chemotherapy as part of standard clinical care, but who did not sensitivity to it, responded poorly to treatment,

Study details: The data come from a retrospective analysis of survival rates in 127 adults with acute myeloid leukemia.

Disclosures: The study was funded by the Russian Science Foundation and the Russian State Budget Project of ICBFM SB RAS. The researchers had no financial conflicts to disclose. 

Source: Kolesnikova MA et al. Cancer Rep. 2021 Mar 6. doi: 10.1002/cnr2.1362.

Key clinical point: Treatment regimen was a key factor in survival rates among adults with acute myeloid leukemia, and patients with high responsiveness of tumor cells in vitro showed stronger response to chemotherapy.

Major finding: Patients with high sensitivity to daunorubicin showed a good response to anthracycline‐based therapy; by contrast, patients who received daunorubicin during induction chemotherapy as part of standard clinical care, but who did not sensitivity to it, responded poorly to treatment,

Study details: The data come from a retrospective analysis of survival rates in 127 adults with acute myeloid leukemia.

Disclosures: The study was funded by the Russian Science Foundation and the Russian State Budget Project of ICBFM SB RAS. The researchers had no financial conflicts to disclose. 

Source: Kolesnikova MA et al. Cancer Rep. 2021 Mar 6. doi: 10.1002/cnr2.1362.

Key clinical point: Treatment regimen was a key factor in survival rates among adults with acute myeloid leukemia, and patients with high responsiveness of tumor cells in vitro showed stronger response to chemotherapy.

Major finding: Patients with high sensitivity to daunorubicin showed a good response to anthracycline‐based therapy; by contrast, patients who received daunorubicin during induction chemotherapy as part of standard clinical care, but who did not sensitivity to it, responded poorly to treatment,

Study details: The data come from a retrospective analysis of survival rates in 127 adults with acute myeloid leukemia.

Disclosures: The study was funded by the Russian Science Foundation and the Russian State Budget Project of ICBFM SB RAS. The researchers had no financial conflicts to disclose. 

Source: Kolesnikova MA et al. Cancer Rep. 2021 Mar 6. doi: 10.1002/cnr2.1362.

Black patients entering hospitals in the United States face significantly higher risk in several measures of patient safety compared with their White counterparts, a new report finds. One expert says these findings should be a call to action for hospitals and physicians.

The Urban Institute, which is funded in part by the Robert Wood Johnson Foundation, looked at differences in Black and White patient safety measures among adults receiving inpatient care in 26 states.

Care quality was measured by the rate of preventable adverse hospital patient safety events per 1,000 at-risk discharges using data from the Agency for Healthcare Research and Quality (AHRQ).

Researchers compared experience by race on 11 patient safety indicators – four related to general patient safety, and seven linked to risk of adverse events with surgical procedures.

Surgical risk differences significant

The gaps were widest surrounding surgical care. Black patients were 7.9 percentage points more likely to be in a hospital considered low quality across all surgical safety measures. They were 4.9 percentage points more likely to be admitted to a hospital considered low quality across all general safety indicators.

“If you’re a Black patient getting surgery – relative to a White patient – in my study, you were 25% less likely to be in a hospital that prevented hemorrhage during surgery; you were 26% less likely to be in a hospital that prevented postoperative respiratory failure; and you were more than 30% less likely to be in a hospital that is effective in preventing postoperative sepsis,” Anuj Gangopadhyaya, PhD, senior research associate at the Urban Institute, said in an interview.

According to the report, Black patients were also 31.9% less likely than were White patients to be admitted into hospitals considered high quality in preventing pressure ulcers and 22.8% less likely to be in a hospital good at preventing iatrogenic pneumothorax.

Dr. Gangopadhyaya said this may be the first study to compare the numbers after the inception of the Affordable Care Act. These data were collected in 2017, 3 years after the core elements of the ACA kicked in.

He said that although the ACA has done much to narrow the racial gap in terms of insurance coverage, it has not been effective in reducing the heightened safety risk to Black patients in the hospital.

‘Shocking, though not surprising’

Uché Blackstock, MD, founder and CEO of Advancing Health Equity in New York City, called the findings “shocking, though not surprising.”

Though these data were collected before COVID-19, the pandemic has exposed profound racial inequities, she noted.

She cited the example of Susan Moore, MD, a Black physician in Carmel, Ind., who died from COVID-19 at age 52 in December after experiencing what she said was systemic racism in her care.

“We saw in the death of Dr. Susan Moore that even having a formal education and being a physician is not protective for Black patients. These findings only reaffirm what we already know – that Black patients receive worse and lower-quality care than White patients,” Dr. Blackstock said in an interview.

“These findings are not a result of Black patients’ individual choices as is often suggested, but rather the results of a health care system that has devalued the lives of Black patients and inherently provides poorer quality of care to them.”

Dr. Blackstock said this report represents a call to action.

Health care institutions must, she said, “look inward at the intentional and critical antiracism work that must be done on provider, organizational, and systems levels by allocating the necessary resources, continuing to track disaggregated health metrics, and committing to structural change within health care systems.”

Resources instead of penalties?

Dr. Gangopadhyaya said the second phase of the research will compare safety outcomes between Black and White patients in the same hospital. Those results will shed more light on what’s driving the differences in risk on safety measures.

He acknowledged that, particularly in an emergency, there is little choice involved with which hospital a patient enters. Patients typically go to a hospital in their neighborhood. And it’s well established that ZIP codes can determine health care outcomes.

But he suspects the differences cannot be explained simply by socioeconomic factors.

He pointed out that previous research has found disparities among Black and White patients in the same neighborhoods.

In one part of this study, researchers narrowed the comparison to Black and White adults with Medicare coverage, with similar provider networks and reimbursement structure, to test whether insurance was playing a significant role.

“Even among that group, you still see the persistent differences in the safety risks driven by the hospitals patients are admitted to,” Dr. Gangopadhyaya said.

He suggests two policy approaches to address the gaps: Either find ways for high-quality hospitals to reach more people of color, or find out what’s keeping the low-quality hospitals from implementing the practices that are effective in high-quality hospitals.

Currently, the ACA has penalties in place when hospitals score low for specific safety risks, he noted, saying that approach doesn’t appear to be working.

“Perhaps instead of penalizing hospitals, we might want to consider providing resources to hospitals that help them better adopt the successful protocols in their high-quality counterparts,” he said.

Dr. Gangopadhyaya has disclosed no relevant financial relationships. Dr. Blackstock has disclosed no relevant financial relationships.

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

This article was updated 4/2/21.

Black patients entering hospitals in the United States face significantly higher risk in several measures of patient safety compared with their White counterparts, a new report finds. One expert says these findings should be a call to action for hospitals and physicians.

The Urban Institute, which is funded in part by the Robert Wood Johnson Foundation, looked at differences in Black and White patient safety measures among adults receiving inpatient care in 26 states.

Care quality was measured by the rate of preventable adverse hospital patient safety events per 1,000 at-risk discharges using data from the Agency for Healthcare Research and Quality (AHRQ).

Researchers compared experience by race on 11 patient safety indicators – four related to general patient safety, and seven linked to risk of adverse events with surgical procedures.

Surgical risk differences significant

The gaps were widest surrounding surgical care. Black patients were 7.9 percentage points more likely to be in a hospital considered low quality across all surgical safety measures. They were 4.9 percentage points more likely to be admitted to a hospital considered low quality across all general safety indicators.

“If you’re a Black patient getting surgery – relative to a White patient – in my study, you were 25% less likely to be in a hospital that prevented hemorrhage during surgery; you were 26% less likely to be in a hospital that prevented postoperative respiratory failure; and you were more than 30% less likely to be in a hospital that is effective in preventing postoperative sepsis,” Anuj Gangopadhyaya, PhD, senior research associate at the Urban Institute, said in an interview.

According to the report, Black patients were also 31.9% less likely than were White patients to be admitted into hospitals considered high quality in preventing pressure ulcers and 22.8% less likely to be in a hospital good at preventing iatrogenic pneumothorax.

Dr. Gangopadhyaya said this may be the first study to compare the numbers after the inception of the Affordable Care Act. These data were collected in 2017, 3 years after the core elements of the ACA kicked in.

He said that although the ACA has done much to narrow the racial gap in terms of insurance coverage, it has not been effective in reducing the heightened safety risk to Black patients in the hospital.

‘Shocking, though not surprising’

Uché Blackstock, MD, founder and CEO of Advancing Health Equity in New York City, called the findings “shocking, though not surprising.”

Though these data were collected before COVID-19, the pandemic has exposed profound racial inequities, she noted.

She cited the example of Susan Moore, MD, a Black physician in Carmel, Ind., who died from COVID-19 at age 52 in December after experiencing what she said was systemic racism in her care.

“We saw in the death of Dr. Susan Moore that even having a formal education and being a physician is not protective for Black patients. These findings only reaffirm what we already know – that Black patients receive worse and lower-quality care than White patients,” Dr. Blackstock said in an interview.

“These findings are not a result of Black patients’ individual choices as is often suggested, but rather the results of a health care system that has devalued the lives of Black patients and inherently provides poorer quality of care to them.”

Dr. Blackstock said this report represents a call to action.

Health care institutions must, she said, “look inward at the intentional and critical antiracism work that must be done on provider, organizational, and systems levels by allocating the necessary resources, continuing to track disaggregated health metrics, and committing to structural change within health care systems.”

Resources instead of penalties?

Dr. Gangopadhyaya said the second phase of the research will compare safety outcomes between Black and White patients in the same hospital. Those results will shed more light on what’s driving the differences in risk on safety measures.

He acknowledged that, particularly in an emergency, there is little choice involved with which hospital a patient enters. Patients typically go to a hospital in their neighborhood. And it’s well established that ZIP codes can determine health care outcomes.

But he suspects the differences cannot be explained simply by socioeconomic factors.

He pointed out that previous research has found disparities among Black and White patients in the same neighborhoods.

In one part of this study, researchers narrowed the comparison to Black and White adults with Medicare coverage, with similar provider networks and reimbursement structure, to test whether insurance was playing a significant role.

“Even among that group, you still see the persistent differences in the safety risks driven by the hospitals patients are admitted to,” Dr. Gangopadhyaya said.

He suggests two policy approaches to address the gaps: Either find ways for high-quality hospitals to reach more people of color, or find out what’s keeping the low-quality hospitals from implementing the practices that are effective in high-quality hospitals.

Currently, the ACA has penalties in place when hospitals score low for specific safety risks, he noted, saying that approach doesn’t appear to be working.

“Perhaps instead of penalizing hospitals, we might want to consider providing resources to hospitals that help them better adopt the successful protocols in their high-quality counterparts,” he said.

Dr. Gangopadhyaya has disclosed no relevant financial relationships. Dr. Blackstock has disclosed no relevant financial relationships.

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

This article was updated 4/2/21.

Black patients entering hospitals in the United States face significantly higher risk in several measures of patient safety compared with their White counterparts, a new report finds. One expert says these findings should be a call to action for hospitals and physicians.

The Urban Institute, which is funded in part by the Robert Wood Johnson Foundation, looked at differences in Black and White patient safety measures among adults receiving inpatient care in 26 states.

Care quality was measured by the rate of preventable adverse hospital patient safety events per 1,000 at-risk discharges using data from the Agency for Healthcare Research and Quality (AHRQ).

Researchers compared experience by race on 11 patient safety indicators – four related to general patient safety, and seven linked to risk of adverse events with surgical procedures.

Surgical risk differences significant

The gaps were widest surrounding surgical care. Black patients were 7.9 percentage points more likely to be in a hospital considered low quality across all surgical safety measures. They were 4.9 percentage points more likely to be admitted to a hospital considered low quality across all general safety indicators.

“If you’re a Black patient getting surgery – relative to a White patient – in my study, you were 25% less likely to be in a hospital that prevented hemorrhage during surgery; you were 26% less likely to be in a hospital that prevented postoperative respiratory failure; and you were more than 30% less likely to be in a hospital that is effective in preventing postoperative sepsis,” Anuj Gangopadhyaya, PhD, senior research associate at the Urban Institute, said in an interview.

According to the report, Black patients were also 31.9% less likely than were White patients to be admitted into hospitals considered high quality in preventing pressure ulcers and 22.8% less likely to be in a hospital good at preventing iatrogenic pneumothorax.

Dr. Gangopadhyaya said this may be the first study to compare the numbers after the inception of the Affordable Care Act. These data were collected in 2017, 3 years after the core elements of the ACA kicked in.

He said that although the ACA has done much to narrow the racial gap in terms of insurance coverage, it has not been effective in reducing the heightened safety risk to Black patients in the hospital.

‘Shocking, though not surprising’

Uché Blackstock, MD, founder and CEO of Advancing Health Equity in New York City, called the findings “shocking, though not surprising.”

Though these data were collected before COVID-19, the pandemic has exposed profound racial inequities, she noted.

She cited the example of Susan Moore, MD, a Black physician in Carmel, Ind., who died from COVID-19 at age 52 in December after experiencing what she said was systemic racism in her care.

“We saw in the death of Dr. Susan Moore that even having a formal education and being a physician is not protective for Black patients. These findings only reaffirm what we already know – that Black patients receive worse and lower-quality care than White patients,” Dr. Blackstock said in an interview.

“These findings are not a result of Black patients’ individual choices as is often suggested, but rather the results of a health care system that has devalued the lives of Black patients and inherently provides poorer quality of care to them.”

Dr. Blackstock said this report represents a call to action.

Health care institutions must, she said, “look inward at the intentional and critical antiracism work that must be done on provider, organizational, and systems levels by allocating the necessary resources, continuing to track disaggregated health metrics, and committing to structural change within health care systems.”

Resources instead of penalties?

Dr. Gangopadhyaya said the second phase of the research will compare safety outcomes between Black and White patients in the same hospital. Those results will shed more light on what’s driving the differences in risk on safety measures.

He acknowledged that, particularly in an emergency, there is little choice involved with which hospital a patient enters. Patients typically go to a hospital in their neighborhood. And it’s well established that ZIP codes can determine health care outcomes.

But he suspects the differences cannot be explained simply by socioeconomic factors.

He pointed out that previous research has found disparities among Black and White patients in the same neighborhoods.

In one part of this study, researchers narrowed the comparison to Black and White adults with Medicare coverage, with similar provider networks and reimbursement structure, to test whether insurance was playing a significant role.

“Even among that group, you still see the persistent differences in the safety risks driven by the hospitals patients are admitted to,” Dr. Gangopadhyaya said.

He suggests two policy approaches to address the gaps: Either find ways for high-quality hospitals to reach more people of color, or find out what’s keeping the low-quality hospitals from implementing the practices that are effective in high-quality hospitals.

Currently, the ACA has penalties in place when hospitals score low for specific safety risks, he noted, saying that approach doesn’t appear to be working.

“Perhaps instead of penalizing hospitals, we might want to consider providing resources to hospitals that help them better adopt the successful protocols in their high-quality counterparts,” he said.

Dr. Gangopadhyaya has disclosed no relevant financial relationships. Dr. Blackstock has disclosed no relevant financial relationships.

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

This article was updated 4/2/21.

Key clinical point: No significant differences were seen between urban and rural acute myeloid leukemia patients with regard to overall survival or progression to hematopoietic cell transplantation.

Major finding:  Overall survival at one year was 47.9% between the groups (45% for rural and 49% for urban). In addition, the proportions of patients with cytogenetic risk factors and who went on to hematopoietic cell transplantation (HCT) were not significantly different between the two groups.

Study details: The data come from a retrospective study of 163 acute myeloid leukemia patients diagnosed at a single center between September 2015 and December 2019, 42% of whom lived in a rural area at the time of diagnosis.

Disclosures: The study received no outside funding. Lead author Dr. Isaac had no financial conflicts to disclose. 

Source: Isaac KM et al. Cancer Rep 2021 Mar 9. doi: 10.1002/cnr2.1354.

Key clinical point: No significant differences were seen between urban and rural acute myeloid leukemia patients with regard to overall survival or progression to hematopoietic cell transplantation.

Major finding:  Overall survival at one year was 47.9% between the groups (45% for rural and 49% for urban). In addition, the proportions of patients with cytogenetic risk factors and who went on to hematopoietic cell transplantation (HCT) were not significantly different between the two groups.

Study details: The data come from a retrospective study of 163 acute myeloid leukemia patients diagnosed at a single center between September 2015 and December 2019, 42% of whom lived in a rural area at the time of diagnosis.

Disclosures: The study received no outside funding. Lead author Dr. Isaac had no financial conflicts to disclose. 

Source: Isaac KM et al. Cancer Rep 2021 Mar 9. doi: 10.1002/cnr2.1354.

Key clinical point: No significant differences were seen between urban and rural acute myeloid leukemia patients with regard to overall survival or progression to hematopoietic cell transplantation.

Major finding:  Overall survival at one year was 47.9% between the groups (45% for rural and 49% for urban). In addition, the proportions of patients with cytogenetic risk factors and who went on to hematopoietic cell transplantation (HCT) were not significantly different between the two groups.

Study details: The data come from a retrospective study of 163 acute myeloid leukemia patients diagnosed at a single center between September 2015 and December 2019, 42% of whom lived in a rural area at the time of diagnosis.

Disclosures: The study received no outside funding. Lead author Dr. Isaac had no financial conflicts to disclose. 

Source: Isaac KM et al. Cancer Rep 2021 Mar 9. doi: 10.1002/cnr2.1354.

Patients with vitiligo have faced significant impacts psychosocially and in many cases, profound losses of identity – and they’ve had only minimal success with treatment, according to participants who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

FG Trade/E+

The virtual meeting, held in March, was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.

Seemal Desai, MD, of the department of dermatology at the University of Texas, Dallas, who attended the meeting as an observer, said in a later interview that while “all skin diseases have a psychosocial component … vitiligo is a really unique one, because it really relates to the patient’s own identity.

“What I heard loud and clear from the FDA [leaders who ran and attended the meeting] is recognition that patients are suffering. They needed to hear about the emotional devastation of the disease and how it is a medical condition,” Dr. Desai said.

The meeting was the “first-ever vitiligo meeting at the FDA” and was a “historic moment for the vitiligo community,” he added.

The pigmentation disorder affects 1% of the world’s population. Nearly 50% have an onset before age 20, and onset before age 12 is common, Brenda Carr, MD, medical officer with the FDA’s Division of Dermatology and Dentistry in the Center for Drug Evaluation and Research, said in an introductory overview.

The only FDA-approved treatment for vitiligo is monobenzone cream, but this is indicated for final depigmentation in extensive vitiligo and is no longer marketed. Treatment options include corticosteroids, calcineurin inhibitors, vitamin D analogues, phototherapy, surgical treatments (tissue grafts and cellular grafts), and camouflage (make-up, tattoos, self-tanning products), Dr. Carr said.

Patients participated in one of two panels – one about the health effects and daily impacts of vitiligo and the other about treatments – or submitted input electronically. All patients were invited to answer poll questions and open-ended queries, including questions about how they would assess new treatments.

Several panel members who are Black shared series of photos that showed the evolution of defined white patches into widespread, generalized depigmentation. One man with skin of color who lives in the Netherlands said he has had vitiligo since the age of 12, but that when he became older, over a 4-year period, he was “transformed from a man of Indonesian roots to a totally white man.”

Experiencing only minimal benefit from treatment and the short-term effectiveness of treatments were the top two answers to a poll question asking participants about the most burdensome impacts of the medical products and interventions they have used. Difficulty in accessing treatment, concern about serious risks of treatment, and uncertainty about long-term effects of treatment were other frequently chosen answers.

Patients described the onerous nature of phototherapy (treatments repeated several times a week over long periods) and other treatments, and several described feeling that some physicians did not take the condition seriously or fully know of treatment options.

In her closing remarks, Kendall Marcus, MD, director of the Division of Dermatology and Dentistry at the FDA, acknowledged the input. “Some of you have had difficulty having your disease taken seriously by physicians who view it as a cosmetic condition and are reluctant to treat because they believe your expectations will not be met, that it will be an exercise in frustration,” she said.

Regarding the impacts of treatments that have been utilized, “some of the treatments make it impossible to do other activities such as work or care for yourself in other ways,” Dr. Marcus said. “Certainly that’s not the kind of treatment … that anybody wants to have.”

Dr. Desai, who utilizes an array of oral and topical treatments and phototherapies in his practice, said he was surprised and disheartened to hear the level of concern about side effects of treatment. Most of those who expressed concerns alluded to phototherapy. “I think light treatments are very safe and effective,” he said in the interview. “I might equate [such concerns] to the older PUVA [psoralen plus UVA ultraviolet light] therapy, but not so much the newer therapies.”

The FDA participants probed patients for their perspective on a meaningful level of repigmentation and an acceptable level of risk for any new hypothetical treatment. Specifically, they asked whether patients would use a new topical cream approved for vitiligo if the cream needed to be applied once a day, would have up to 50% efficacy in some people, and would have common side effects of redness and irritation at the application site, mild acne, and burning, as well as several rarer but more serious side effects.

Only 36% answered yes; 24% said no, and 40% answered maybe. Some patients said during the meeting that they had accepted their condition and were not pursuing any treatment. Others said they were very interested in treatment but only if the level of repigmentation were significantly higher than 50%. Some described their fear that positive treatment effects would be short term only.

Meri Izrail Kohen, who lives in France and has lost half of her skin’s pigmentation, said that treatment efficacy is “not only about how much recovery of pigment it allows, but how long the recovery will last.” Some treatments will work for some patients, she said, “but even in these cases when we stop the treatment, it will come back somehow.”

Lee Thomas, a TV anchor in Detroit, and a reporter and author of the book “Turning White,” described how he tried “every treatment he could afford” but stopped trying 10 years ago. A treatment in Germany “gave me 80% of my pigment back, but it has gone again,” he said. “I would love to have my face back again. I was born a Black child, and I’d like to die a Black man.”

Patients also spoke of their skin burning easily outdoors; skin sensitivity, itchiness, and burning with the spread of disease; treatment expenses and not being able to afford treatment; and worsening of their vitiligo with the stress of the pandemic. Parents expressed having fear that their children would develop vitiligo and experience bullying, isolation, or other emotional or psychosocial impacts that they had experienced; one described having an almost-paralyzing anxiety when he saw patchy white spots on his 20-month-old daughter (it was not diagnosed as vitiligo).

Calls for further advancement with home phototherapy – which Dr. Desai said is a growing market but not yet adequately covered by insurance plans – were also made, as were pleas for research on the root causes of the disease.

Patients clearly indicated “that they need more efficacious treatments, and more comprehensive treatments,” said Dr. Desai, who chairs the advisory committee of the Global Vitiligo Foundation. “It’s disappointing to me that patients come in with a not fully optimistic viewpoint, with a lot of anxiety and angst that treatments are not going to work. … But the Agency needs to hear that. This means that there haven’t been good treatments and we need more.”

The FDA will accept public comments until May 10, 2021, at which time comments will be compiled into a summary report. FDA officials assured patients that the report would be visible and circulated not only within the FDA but among drug companies, researchers, and other product developers.

Patients with vitiligo have faced significant impacts psychosocially and in many cases, profound losses of identity – and they’ve had only minimal success with treatment, according to participants who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

FG Trade/E+

The virtual meeting, held in March, was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.

Seemal Desai, MD, of the department of dermatology at the University of Texas, Dallas, who attended the meeting as an observer, said in a later interview that while “all skin diseases have a psychosocial component … vitiligo is a really unique one, because it really relates to the patient’s own identity.

“What I heard loud and clear from the FDA [leaders who ran and attended the meeting] is recognition that patients are suffering. They needed to hear about the emotional devastation of the disease and how it is a medical condition,” Dr. Desai said.

The meeting was the “first-ever vitiligo meeting at the FDA” and was a “historic moment for the vitiligo community,” he added.

The pigmentation disorder affects 1% of the world’s population. Nearly 50% have an onset before age 20, and onset before age 12 is common, Brenda Carr, MD, medical officer with the FDA’s Division of Dermatology and Dentistry in the Center for Drug Evaluation and Research, said in an introductory overview.

The only FDA-approved treatment for vitiligo is monobenzone cream, but this is indicated for final depigmentation in extensive vitiligo and is no longer marketed. Treatment options include corticosteroids, calcineurin inhibitors, vitamin D analogues, phototherapy, surgical treatments (tissue grafts and cellular grafts), and camouflage (make-up, tattoos, self-tanning products), Dr. Carr said.

Patients participated in one of two panels – one about the health effects and daily impacts of vitiligo and the other about treatments – or submitted input electronically. All patients were invited to answer poll questions and open-ended queries, including questions about how they would assess new treatments.

Several panel members who are Black shared series of photos that showed the evolution of defined white patches into widespread, generalized depigmentation. One man with skin of color who lives in the Netherlands said he has had vitiligo since the age of 12, but that when he became older, over a 4-year period, he was “transformed from a man of Indonesian roots to a totally white man.”

Experiencing only minimal benefit from treatment and the short-term effectiveness of treatments were the top two answers to a poll question asking participants about the most burdensome impacts of the medical products and interventions they have used. Difficulty in accessing treatment, concern about serious risks of treatment, and uncertainty about long-term effects of treatment were other frequently chosen answers.

Patients described the onerous nature of phototherapy (treatments repeated several times a week over long periods) and other treatments, and several described feeling that some physicians did not take the condition seriously or fully know of treatment options.

In her closing remarks, Kendall Marcus, MD, director of the Division of Dermatology and Dentistry at the FDA, acknowledged the input. “Some of you have had difficulty having your disease taken seriously by physicians who view it as a cosmetic condition and are reluctant to treat because they believe your expectations will not be met, that it will be an exercise in frustration,” she said.

Regarding the impacts of treatments that have been utilized, “some of the treatments make it impossible to do other activities such as work or care for yourself in other ways,” Dr. Marcus said. “Certainly that’s not the kind of treatment … that anybody wants to have.”

Dr. Desai, who utilizes an array of oral and topical treatments and phototherapies in his practice, said he was surprised and disheartened to hear the level of concern about side effects of treatment. Most of those who expressed concerns alluded to phototherapy. “I think light treatments are very safe and effective,” he said in the interview. “I might equate [such concerns] to the older PUVA [psoralen plus UVA ultraviolet light] therapy, but not so much the newer therapies.”

The FDA participants probed patients for their perspective on a meaningful level of repigmentation and an acceptable level of risk for any new hypothetical treatment. Specifically, they asked whether patients would use a new topical cream approved for vitiligo if the cream needed to be applied once a day, would have up to 50% efficacy in some people, and would have common side effects of redness and irritation at the application site, mild acne, and burning, as well as several rarer but more serious side effects.

Only 36% answered yes; 24% said no, and 40% answered maybe. Some patients said during the meeting that they had accepted their condition and were not pursuing any treatment. Others said they were very interested in treatment but only if the level of repigmentation were significantly higher than 50%. Some described their fear that positive treatment effects would be short term only.

Meri Izrail Kohen, who lives in France and has lost half of her skin’s pigmentation, said that treatment efficacy is “not only about how much recovery of pigment it allows, but how long the recovery will last.” Some treatments will work for some patients, she said, “but even in these cases when we stop the treatment, it will come back somehow.”

Lee Thomas, a TV anchor in Detroit, and a reporter and author of the book “Turning White,” described how he tried “every treatment he could afford” but stopped trying 10 years ago. A treatment in Germany “gave me 80% of my pigment back, but it has gone again,” he said. “I would love to have my face back again. I was born a Black child, and I’d like to die a Black man.”

Patients also spoke of their skin burning easily outdoors; skin sensitivity, itchiness, and burning with the spread of disease; treatment expenses and not being able to afford treatment; and worsening of their vitiligo with the stress of the pandemic. Parents expressed having fear that their children would develop vitiligo and experience bullying, isolation, or other emotional or psychosocial impacts that they had experienced; one described having an almost-paralyzing anxiety when he saw patchy white spots on his 20-month-old daughter (it was not diagnosed as vitiligo).

Calls for further advancement with home phototherapy – which Dr. Desai said is a growing market but not yet adequately covered by insurance plans – were also made, as were pleas for research on the root causes of the disease.

Patients clearly indicated “that they need more efficacious treatments, and more comprehensive treatments,” said Dr. Desai, who chairs the advisory committee of the Global Vitiligo Foundation. “It’s disappointing to me that patients come in with a not fully optimistic viewpoint, with a lot of anxiety and angst that treatments are not going to work. … But the Agency needs to hear that. This means that there haven’t been good treatments and we need more.”

The FDA will accept public comments until May 10, 2021, at which time comments will be compiled into a summary report. FDA officials assured patients that the report would be visible and circulated not only within the FDA but among drug companies, researchers, and other product developers.

Patients with vitiligo have faced significant impacts psychosocially and in many cases, profound losses of identity – and they’ve had only minimal success with treatment, according to participants who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

FG Trade/E+

The virtual meeting, held in March, was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.

Seemal Desai, MD, of the department of dermatology at the University of Texas, Dallas, who attended the meeting as an observer, said in a later interview that while “all skin diseases have a psychosocial component … vitiligo is a really unique one, because it really relates to the patient’s own identity.

“What I heard loud and clear from the FDA [leaders who ran and attended the meeting] is recognition that patients are suffering. They needed to hear about the emotional devastation of the disease and how it is a medical condition,” Dr. Desai said.

The meeting was the “first-ever vitiligo meeting at the FDA” and was a “historic moment for the vitiligo community,” he added.

The pigmentation disorder affects 1% of the world’s population. Nearly 50% have an onset before age 20, and onset before age 12 is common, Brenda Carr, MD, medical officer with the FDA’s Division of Dermatology and Dentistry in the Center for Drug Evaluation and Research, said in an introductory overview.

The only FDA-approved treatment for vitiligo is monobenzone cream, but this is indicated for final depigmentation in extensive vitiligo and is no longer marketed. Treatment options include corticosteroids, calcineurin inhibitors, vitamin D analogues, phototherapy, surgical treatments (tissue grafts and cellular grafts), and camouflage (make-up, tattoos, self-tanning products), Dr. Carr said.

Patients participated in one of two panels – one about the health effects and daily impacts of vitiligo and the other about treatments – or submitted input electronically. All patients were invited to answer poll questions and open-ended queries, including questions about how they would assess new treatments.

Several panel members who are Black shared series of photos that showed the evolution of defined white patches into widespread, generalized depigmentation. One man with skin of color who lives in the Netherlands said he has had vitiligo since the age of 12, but that when he became older, over a 4-year period, he was “transformed from a man of Indonesian roots to a totally white man.”

Experiencing only minimal benefit from treatment and the short-term effectiveness of treatments were the top two answers to a poll question asking participants about the most burdensome impacts of the medical products and interventions they have used. Difficulty in accessing treatment, concern about serious risks of treatment, and uncertainty about long-term effects of treatment were other frequently chosen answers.

Patients described the onerous nature of phototherapy (treatments repeated several times a week over long periods) and other treatments, and several described feeling that some physicians did not take the condition seriously or fully know of treatment options.

In her closing remarks, Kendall Marcus, MD, director of the Division of Dermatology and Dentistry at the FDA, acknowledged the input. “Some of you have had difficulty having your disease taken seriously by physicians who view it as a cosmetic condition and are reluctant to treat because they believe your expectations will not be met, that it will be an exercise in frustration,” she said.

Regarding the impacts of treatments that have been utilized, “some of the treatments make it impossible to do other activities such as work or care for yourself in other ways,” Dr. Marcus said. “Certainly that’s not the kind of treatment … that anybody wants to have.”

Dr. Desai, who utilizes an array of oral and topical treatments and phototherapies in his practice, said he was surprised and disheartened to hear the level of concern about side effects of treatment. Most of those who expressed concerns alluded to phototherapy. “I think light treatments are very safe and effective,” he said in the interview. “I might equate [such concerns] to the older PUVA [psoralen plus UVA ultraviolet light] therapy, but not so much the newer therapies.”

The FDA participants probed patients for their perspective on a meaningful level of repigmentation and an acceptable level of risk for any new hypothetical treatment. Specifically, they asked whether patients would use a new topical cream approved for vitiligo if the cream needed to be applied once a day, would have up to 50% efficacy in some people, and would have common side effects of redness and irritation at the application site, mild acne, and burning, as well as several rarer but more serious side effects.

Only 36% answered yes; 24% said no, and 40% answered maybe. Some patients said during the meeting that they had accepted their condition and were not pursuing any treatment. Others said they were very interested in treatment but only if the level of repigmentation were significantly higher than 50%. Some described their fear that positive treatment effects would be short term only.

Meri Izrail Kohen, who lives in France and has lost half of her skin’s pigmentation, said that treatment efficacy is “not only about how much recovery of pigment it allows, but how long the recovery will last.” Some treatments will work for some patients, she said, “but even in these cases when we stop the treatment, it will come back somehow.”

Lee Thomas, a TV anchor in Detroit, and a reporter and author of the book “Turning White,” described how he tried “every treatment he could afford” but stopped trying 10 years ago. A treatment in Germany “gave me 80% of my pigment back, but it has gone again,” he said. “I would love to have my face back again. I was born a Black child, and I’d like to die a Black man.”

Patients also spoke of their skin burning easily outdoors; skin sensitivity, itchiness, and burning with the spread of disease; treatment expenses and not being able to afford treatment; and worsening of their vitiligo with the stress of the pandemic. Parents expressed having fear that their children would develop vitiligo and experience bullying, isolation, or other emotional or psychosocial impacts that they had experienced; one described having an almost-paralyzing anxiety when he saw patchy white spots on his 20-month-old daughter (it was not diagnosed as vitiligo).

Calls for further advancement with home phototherapy – which Dr. Desai said is a growing market but not yet adequately covered by insurance plans – were also made, as were pleas for research on the root causes of the disease.

Patients clearly indicated “that they need more efficacious treatments, and more comprehensive treatments,” said Dr. Desai, who chairs the advisory committee of the Global Vitiligo Foundation. “It’s disappointing to me that patients come in with a not fully optimistic viewpoint, with a lot of anxiety and angst that treatments are not going to work. … But the Agency needs to hear that. This means that there haven’t been good treatments and we need more.”

The FDA will accept public comments until May 10, 2021, at which time comments will be compiled into a summary report. FDA officials assured patients that the report would be visible and circulated not only within the FDA but among drug companies, researchers, and other product developers.

To the Editor:

A 7-day-old full-term infant presented to the neonatal intensive care unit with poor feeding and altered consciousness. She was born at 39 weeks and 3 days to a gravida 1 mother with a pregnancy history complicated by maternal chorioamnionitis and gestational diabetes. During labor, nonreassuring fetal heart tones and arrest of labor prompted an uncomplicated cesarean delivery with normal Apgar scores at birth. The infant’s family history revealed only beta thalassemia minor in her father. At 5 to 7 days of life, the mother noted difficulty with feeding and poor latch along with lethargy and depressed consciousness in the infant.

Upon arrival to the neonatal intensive care unit, the infant was noted to have rhythmic lip-smacking behavior, intermittent nystagmus, mild hypotonia, and clonic movements of the left upper extremity. An electroencephalogram was markedly abnormal, capturing multiple seizures in the bilateral cortical hemispheres. She was loaded with phenobarbital with no further seizure activity. Brain magnetic resonance imaging revealed innumerable punctate foci of restricted diffusion with corresponding punctate hemorrhage within the frontal and parietal white matter, as well as cortical diffusion restriction within the occipital lobe, inferior temporal lobe, bilateral thalami, and corpus callosum (Figure 1). An exhaustive infectious workup also was completed and was unremarkable, though she was treated with broad-spectrum antimicrobials, including intravenous acyclovir.

Incontinentia pigmenti, also known as Bloch-Sulzberger syndrome, is a rare multisystem neuroectodermal disorder, primarily affecting the skin, central nervous system (CNS), and retinas. The disorder can be inherited in an X-linked dominant fashion and appears almost exclusively in women with typical in utero lethality seen in males. Most affected individuals have a sporadic, or de novo, mutation, which was likely the case in our patient given that her mother demonstrated no signs or symptoms.¹ The pathogenesis of disease is a defect at chromosome Xq28 that is a region encoding the nuclear factor–κB essential modulator, IKBKG. Absence or mutation of IKBKG in IP results in failure to activate nuclear factor–κB and leaves cells vulnerable to cytokine-mediated apoptosis, especially after exposure to tumor necrosis factor α.²

Clinical manifestations of IP are present at or soon after birth. The cutaneous findings of this disorder are classically described as a step-wise progression through 4 distinct stages: (1) a linear and/or whorled vesicular eruption predominantly on the extremities at birth or within the first few weeks of life; (2) thickened linear or whorled verrucous plaques; (3) hyperpigmented streaks and whorls that may or may not correspond with prior affected areas that may resolve by adolescence; and (4) hypopigmented, possibly atrophic plaques on the extremities that may persist lifelong. Importantly, not every patient will experience each of these stages. Overlap can occur, and the time course of each stage is highly variable. Other ectodermal manifestations include dental abnormalities such as small, misshaped, or missing teeth; alopecia; and nail abnormalities. Ocular abnormalities associated with IP primarily occur in the retina, including vascular occlusion, neovascularization, hemorrhages, foveal abnormalities, as well as exudative and tractional detachments.^3,4

It is crucial to recognize CNS anomalies in association with the cutaneous findings of IP, as CNS pathology can be severe with profound developmental implications. Central nervous system findings have been noted to correlate with the appearance of the vesicular stage of IP. A high index of suspicion is needed, as the disease can demonstrate progression within a short time.^5-8 The most frequent anomalies include seizures, motor impairment, intellectual disability, and microcephaly.^9,10 Some of the most commonly identified CNS lesions on imaging include necrosis or brain infarcts, atrophy, and lesions of the corpus callosum.⁷

The pathogenesis of observed CNS changes in IP is not well understood. There have been numerous proposals of a vascular mechanism, and a microangiopathic process appears to be most plausible. Mutations in IKBKG may result in interruption of signaling via vascular endothelial growth factor receptor 3 with a consequent impact on angiogenesis, supporting a vascular mechanism. Additionally, mutations in IKBKG lead to activation of eotaxin, an eosinophil-selective chemokine.⁹ Eotaxin activation results in eosinophilic degranulation that mediates the classic eosinophilic infiltrate seen in the classic skin histology of IP. Additionally, it has been shown that eotaxin is strongly expressed by endothelial cells in IP, and more abundant eosinophil degranulation may play a role in mediating vaso-occlusion.⁷ Other studies have found that the highest expression level of the IKBKG gene is in the CNS, potentially explaining the extensive imaging findings of hemorrhage and diffusion restriction in our patient. These features likely are attributable to apoptosis of cells possessing the mutated IKBKG gene.^9-11

To the Editor:

A 7-day-old full-term infant presented to the neonatal intensive care unit with poor feeding and altered consciousness. She was born at 39 weeks and 3 days to a gravida 1 mother with a pregnancy history complicated by maternal chorioamnionitis and gestational diabetes. During labor, nonreassuring fetal heart tones and arrest of labor prompted an uncomplicated cesarean delivery with normal Apgar scores at birth. The infant’s family history revealed only beta thalassemia minor in her father. At 5 to 7 days of life, the mother noted difficulty with feeding and poor latch along with lethargy and depressed consciousness in the infant.

Upon arrival to the neonatal intensive care unit, the infant was noted to have rhythmic lip-smacking behavior, intermittent nystagmus, mild hypotonia, and clonic movements of the left upper extremity. An electroencephalogram was markedly abnormal, capturing multiple seizures in the bilateral cortical hemispheres. She was loaded with phenobarbital with no further seizure activity. Brain magnetic resonance imaging revealed innumerable punctate foci of restricted diffusion with corresponding punctate hemorrhage within the frontal and parietal white matter, as well as cortical diffusion restriction within the occipital lobe, inferior temporal lobe, bilateral thalami, and corpus callosum (Figure 1). An exhaustive infectious workup also was completed and was unremarkable, though she was treated with broad-spectrum antimicrobials, including intravenous acyclovir.

Incontinentia pigmenti, also known as Bloch-Sulzberger syndrome, is a rare multisystem neuroectodermal disorder, primarily affecting the skin, central nervous system (CNS), and retinas. The disorder can be inherited in an X-linked dominant fashion and appears almost exclusively in women with typical in utero lethality seen in males. Most affected individuals have a sporadic, or de novo, mutation, which was likely the case in our patient given that her mother demonstrated no signs or symptoms.¹ The pathogenesis of disease is a defect at chromosome Xq28 that is a region encoding the nuclear factor–κB essential modulator, IKBKG. Absence or mutation of IKBKG in IP results in failure to activate nuclear factor–κB and leaves cells vulnerable to cytokine-mediated apoptosis, especially after exposure to tumor necrosis factor α.²

Clinical manifestations of IP are present at or soon after birth. The cutaneous findings of this disorder are classically described as a step-wise progression through 4 distinct stages: (1) a linear and/or whorled vesicular eruption predominantly on the extremities at birth or within the first few weeks of life; (2) thickened linear or whorled verrucous plaques; (3) hyperpigmented streaks and whorls that may or may not correspond with prior affected areas that may resolve by adolescence; and (4) hypopigmented, possibly atrophic plaques on the extremities that may persist lifelong. Importantly, not every patient will experience each of these stages. Overlap can occur, and the time course of each stage is highly variable. Other ectodermal manifestations include dental abnormalities such as small, misshaped, or missing teeth; alopecia; and nail abnormalities. Ocular abnormalities associated with IP primarily occur in the retina, including vascular occlusion, neovascularization, hemorrhages, foveal abnormalities, as well as exudative and tractional detachments.^3,4

It is crucial to recognize CNS anomalies in association with the cutaneous findings of IP, as CNS pathology can be severe with profound developmental implications. Central nervous system findings have been noted to correlate with the appearance of the vesicular stage of IP. A high index of suspicion is needed, as the disease can demonstrate progression within a short time.^5-8 The most frequent anomalies include seizures, motor impairment, intellectual disability, and microcephaly.^9,10 Some of the most commonly identified CNS lesions on imaging include necrosis or brain infarcts, atrophy, and lesions of the corpus callosum.⁷

The pathogenesis of observed CNS changes in IP is not well understood. There have been numerous proposals of a vascular mechanism, and a microangiopathic process appears to be most plausible. Mutations in IKBKG may result in interruption of signaling via vascular endothelial growth factor receptor 3 with a consequent impact on angiogenesis, supporting a vascular mechanism. Additionally, mutations in IKBKG lead to activation of eotaxin, an eosinophil-selective chemokine.⁹ Eotaxin activation results in eosinophilic degranulation that mediates the classic eosinophilic infiltrate seen in the classic skin histology of IP. Additionally, it has been shown that eotaxin is strongly expressed by endothelial cells in IP, and more abundant eosinophil degranulation may play a role in mediating vaso-occlusion.⁷ Other studies have found that the highest expression level of the IKBKG gene is in the CNS, potentially explaining the extensive imaging findings of hemorrhage and diffusion restriction in our patient. These features likely are attributable to apoptosis of cells possessing the mutated IKBKG gene.^9-11

To the Editor:

A 7-day-old full-term infant presented to the neonatal intensive care unit with poor feeding and altered consciousness. She was born at 39 weeks and 3 days to a gravida 1 mother with a pregnancy history complicated by maternal chorioamnionitis and gestational diabetes. During labor, nonreassuring fetal heart tones and arrest of labor prompted an uncomplicated cesarean delivery with normal Apgar scores at birth. The infant’s family history revealed only beta thalassemia minor in her father. At 5 to 7 days of life, the mother noted difficulty with feeding and poor latch along with lethargy and depressed consciousness in the infant.

Upon arrival to the neonatal intensive care unit, the infant was noted to have rhythmic lip-smacking behavior, intermittent nystagmus, mild hypotonia, and clonic movements of the left upper extremity. An electroencephalogram was markedly abnormal, capturing multiple seizures in the bilateral cortical hemispheres. She was loaded with phenobarbital with no further seizure activity. Brain magnetic resonance imaging revealed innumerable punctate foci of restricted diffusion with corresponding punctate hemorrhage within the frontal and parietal white matter, as well as cortical diffusion restriction within the occipital lobe, inferior temporal lobe, bilateral thalami, and corpus callosum (Figure 1). An exhaustive infectious workup also was completed and was unremarkable, though she was treated with broad-spectrum antimicrobials, including intravenous acyclovir.

Incontinentia pigmenti, also known as Bloch-Sulzberger syndrome, is a rare multisystem neuroectodermal disorder, primarily affecting the skin, central nervous system (CNS), and retinas. The disorder can be inherited in an X-linked dominant fashion and appears almost exclusively in women with typical in utero lethality seen in males. Most affected individuals have a sporadic, or de novo, mutation, which was likely the case in our patient given that her mother demonstrated no signs or symptoms.¹ The pathogenesis of disease is a defect at chromosome Xq28 that is a region encoding the nuclear factor–κB essential modulator, IKBKG. Absence or mutation of IKBKG in IP results in failure to activate nuclear factor–κB and leaves cells vulnerable to cytokine-mediated apoptosis, especially after exposure to tumor necrosis factor α.²

Clinical manifestations of IP are present at or soon after birth. The cutaneous findings of this disorder are classically described as a step-wise progression through 4 distinct stages: (1) a linear and/or whorled vesicular eruption predominantly on the extremities at birth or within the first few weeks of life; (2) thickened linear or whorled verrucous plaques; (3) hyperpigmented streaks and whorls that may or may not correspond with prior affected areas that may resolve by adolescence; and (4) hypopigmented, possibly atrophic plaques on the extremities that may persist lifelong. Importantly, not every patient will experience each of these stages. Overlap can occur, and the time course of each stage is highly variable. Other ectodermal manifestations include dental abnormalities such as small, misshaped, or missing teeth; alopecia; and nail abnormalities. Ocular abnormalities associated with IP primarily occur in the retina, including vascular occlusion, neovascularization, hemorrhages, foveal abnormalities, as well as exudative and tractional detachments.^3,4

It is crucial to recognize CNS anomalies in association with the cutaneous findings of IP, as CNS pathology can be severe with profound developmental implications. Central nervous system findings have been noted to correlate with the appearance of the vesicular stage of IP. A high index of suspicion is needed, as the disease can demonstrate progression within a short time.^5-8 The most frequent anomalies include seizures, motor impairment, intellectual disability, and microcephaly.^9,10 Some of the most commonly identified CNS lesions on imaging include necrosis or brain infarcts, atrophy, and lesions of the corpus callosum.⁷

The pathogenesis of observed CNS changes in IP is not well understood. There have been numerous proposals of a vascular mechanism, and a microangiopathic process appears to be most plausible. Mutations in IKBKG may result in interruption of signaling via vascular endothelial growth factor receptor 3 with a consequent impact on angiogenesis, supporting a vascular mechanism. Additionally, mutations in IKBKG lead to activation of eotaxin, an eosinophil-selective chemokine.⁹ Eotaxin activation results in eosinophilic degranulation that mediates the classic eosinophilic infiltrate seen in the classic skin histology of IP. Additionally, it has been shown that eotaxin is strongly expressed by endothelial cells in IP, and more abundant eosinophil degranulation may play a role in mediating vaso-occlusion.⁷ Other studies have found that the highest expression level of the IKBKG gene is in the CNS, potentially explaining the extensive imaging findings of hemorrhage and diffusion restriction in our patient. These features likely are attributable to apoptosis of cells possessing the mutated IKBKG gene.^9-11

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

Background: While PCI with drug-eluting stents has become more accepted as treatment for some patients with left main disease, long-term outcomes from randomized control trials comparing PCI with CABG have yet to be clearly established.

There were numerical differences in nonpowered secondary outcomes that may represent effects but should be interpreted cautiously: ischemia-driven revascularization (16.9% with PCI vs. 10% with CABG), transient ischemic attack plus stroke (3.3% with PCI vs. 5.2% with CABG), and death from any cause (3% with PCI vs. 9.9% with CABG). There was no significant difference in cardiovascular events, MI, or stroke.

One interesting limitation was that patients who had PCI were more commonly on dual-antiplatelet therapy and angiotensin converting–enzyme inhibitors, whereas CABG patients were more often on beta-blockers, diuretics, anticoagulants, and antiarrhythmics.

Bottom line: PCI and CABG treatments for left main disease have no significant difference in the composite outcome of death, stroke, or MI at 5 years.

Citation: Stone GW et al. Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med. 2019;381:1820-30.

Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: While PCI with drug-eluting stents has become more accepted as treatment for some patients with left main disease, long-term outcomes from randomized control trials comparing PCI with CABG have yet to be clearly established.

There were numerical differences in nonpowered secondary outcomes that may represent effects but should be interpreted cautiously: ischemia-driven revascularization (16.9% with PCI vs. 10% with CABG), transient ischemic attack plus stroke (3.3% with PCI vs. 5.2% with CABG), and death from any cause (3% with PCI vs. 9.9% with CABG). There was no significant difference in cardiovascular events, MI, or stroke.

One interesting limitation was that patients who had PCI were more commonly on dual-antiplatelet therapy and angiotensin converting–enzyme inhibitors, whereas CABG patients were more often on beta-blockers, diuretics, anticoagulants, and antiarrhythmics.

Bottom line: PCI and CABG treatments for left main disease have no significant difference in the composite outcome of death, stroke, or MI at 5 years.

Citation: Stone GW et al. Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med. 2019;381:1820-30.

Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: While PCI with drug-eluting stents has become more accepted as treatment for some patients with left main disease, long-term outcomes from randomized control trials comparing PCI with CABG have yet to be clearly established.

There were numerical differences in nonpowered secondary outcomes that may represent effects but should be interpreted cautiously: ischemia-driven revascularization (16.9% with PCI vs. 10% with CABG), transient ischemic attack plus stroke (3.3% with PCI vs. 5.2% with CABG), and death from any cause (3% with PCI vs. 9.9% with CABG). There was no significant difference in cardiovascular events, MI, or stroke.

One interesting limitation was that patients who had PCI were more commonly on dual-antiplatelet therapy and angiotensin converting–enzyme inhibitors, whereas CABG patients were more often on beta-blockers, diuretics, anticoagulants, and antiarrhythmics.

Bottom line: PCI and CABG treatments for left main disease have no significant difference in the composite outcome of death, stroke, or MI at 5 years.

Citation: Stone GW et al. Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med. 2019;381:1820-30.

Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Correct answer: B. Prednisone  

Rationale  
This is a case of Henoch-Schönlein purpura, which is a self-limited, systemic, nongranulomatous, autoimmune complex, small-vessel vasculitis with multiorgan involvement. It is characterized by a classic tetrad of nonthrombocytopenic palpable purpura, arthritis or arthralgias, gastrointestinal involvement, and renal involvement. GI involvement may mimic Crohn's disease, although the biopsies are usually diagnostic. Most cases are self-limiting, but oral steroids are indicated in patients with severe colicky abdominal pain; usually they're started as prednisone or methylprednisolone at 1-2 mg/kg per day for 1-2 weeks and then tapering to a stop in the next 1-2 weeks. Steroids may prevent major complications such as gastrointestinal bleeding or intussusception. Immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporine A, and mycophenolate mofetil) in combination with high-dose IV pulse steroids are recommended if there is no benefit from steroids alone.  
 
Reference  
Sohagia AB et al. Gastroenterol Res Pract. 2010. doi: 10.1155/2010/59764. 
 

Correct answer: B. Prednisone  

Rationale  
This is a case of Henoch-Schönlein purpura, which is a self-limited, systemic, nongranulomatous, autoimmune complex, small-vessel vasculitis with multiorgan involvement. It is characterized by a classic tetrad of nonthrombocytopenic palpable purpura, arthritis or arthralgias, gastrointestinal involvement, and renal involvement. GI involvement may mimic Crohn's disease, although the biopsies are usually diagnostic. Most cases are self-limiting, but oral steroids are indicated in patients with severe colicky abdominal pain; usually they're started as prednisone or methylprednisolone at 1-2 mg/kg per day for 1-2 weeks and then tapering to a stop in the next 1-2 weeks. Steroids may prevent major complications such as gastrointestinal bleeding or intussusception. Immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporine A, and mycophenolate mofetil) in combination with high-dose IV pulse steroids are recommended if there is no benefit from steroids alone.  
 
Reference  
Sohagia AB et al. Gastroenterol Res Pract. 2010. doi: 10.1155/2010/59764. 
 

Correct answer: B. Prednisone  

Rationale  
This is a case of Henoch-Schönlein purpura, which is a self-limited, systemic, nongranulomatous, autoimmune complex, small-vessel vasculitis with multiorgan involvement. It is characterized by a classic tetrad of nonthrombocytopenic palpable purpura, arthritis or arthralgias, gastrointestinal involvement, and renal involvement. GI involvement may mimic Crohn's disease, although the biopsies are usually diagnostic. Most cases are self-limiting, but oral steroids are indicated in patients with severe colicky abdominal pain; usually they're started as prednisone or methylprednisolone at 1-2 mg/kg per day for 1-2 weeks and then tapering to a stop in the next 1-2 weeks. Steroids may prevent major complications such as gastrointestinal bleeding or intussusception. Immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporine A, and mycophenolate mofetil) in combination with high-dose IV pulse steroids are recommended if there is no benefit from steroids alone.  
 
Reference  
Sohagia AB et al. Gastroenterol Res Pract. 2010. doi: 10.1155/2010/59764.