The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

 
The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

 
The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

bjancin@mdedge.com

COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

bjancin@mdedge.com

COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

bjancin@mdedge.com

The recent death of “Black Panther” star Chadwick Boseman has resulted in colorectal cancer (CRC) screening guidelines receiving more attention. Mr. Boseman was diagnosed with Stage 3 CRC in 2016 and underwent treatment. He passed away 4 years later at the young age of 44.

Mr. Boseman’s death has highlighted two important concerns about current screening guidelines for CRC. These include racial disparities in patients with colon cancer and the fact that more younger patients are getting this disease.

There are at least three different sets of CRC screening recommendations from different trusted professional organizations that primary care physicians must decide how to follow. These organizations each published their guidelines indicating review of the best available evidence. On first glance there is discrepancy between these guidelines, but a closer look at them reveals they have a lot of similarities.

The U.S. Multi-Society Task Force of Colorectal Cancer (MSTF), which represents the American College of Gastroenterology, the American Gatroenterological Association, and the American Society for Gastrointestinal Endoscopy, is one of the organizations that offers guidelines. The MSTF recommends CRC screening for non-African American average risked persons at the age of 50 years (strong recommendation; moderate quality evidence). The first-tier options for this recommendation are to have a colonoscopy every 10 years or annual fecal immunochemial test. Additionally, the MSTF recommends beginning screening of African Americans at age 45 years (weak recommendation; very-low-quality evidence). This recommendation cites higher incidence rates, earlier mean age at onset, higher proportion of cancers before age 50 years and late-stage presentation. The MSTF indicates that the increased rate of CRC at an earlier age in African Americans is caused by a combination of biologic and societal factors, but do not point to what those are. This earlier screening is not backed by evidence that it in fact improves morbidity or mortality outcomes. The MSTF also address screening among high-risk individuals. Those with first degree relatives with CRC or advanced adenomas diagnosed before the age of 60 years should be screened beginning at age 40 years or 10 years younger than the age the relative was diagnosed, whichever comes first, according to the MSTF recommendations. These individuals should have a colonoscopy every 5 years, the MSTF says. Those with first degree relatives with CRC or advanced adenomas diagnosed at older than 60 years should have CRC beginning at 40 years, though with the same testing intervals as average-risk individuals.¹

The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP), however, endorse the guidelines set forth by the United States Preventive Services Task Force (USPSTF). These guidelines were published in 2016 in the JAMA and notably are currently under review. These guidelines recommend routine screening for those at average risk at the age of 50 years. In the publication of these guidelines, the increasing incidence of CRC in those under 50 was acknowledged. It is however stated that the modest benefit of earlier diagnosis made via screening is not better than the increased risk of increased lifetime colonoscopy.²

The publication specifically addresses the disparity among Black adults who have the highest incidence and mortality rates in comparison with other racial/ethnic groups. These guidelines specifically state that there are higher rates of colon cancer among black adults. They however clarify that they think it is because of decreased screening and treatment in this group. When compared with other groups and the screening and treatment is controlled for, there is no longer a difference. Lowering the age for starting screening, therefore, won’t help resolve the disparity because the higher cases in Black adults has resulted from not enough Black adults being screened at the recommended age of 50, according to the USPSTF recommendation statement. As such, rather than changing the age of screening for Black adults, this publication recommends efforts to ensure that screening, follow-up, and treatment are received.

The USPSTF specifically did not include adults with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC. They instead refer to other professional organizations for these recommendations.²

The American Cancer Society (ACS) also had a separate guideline published in CA: A Cancer Journal for Clinicians. It provides a qualified recommendation that CRC screening begin at age 45 years for those with average risk. The guideline also includes a strong recommendation for CRC screening beginning at age 50 years. The qualified recommendation for the younger age group is based on the incidence of colorectal cancer being similar between those aged 45-49 and those aged 50-54 years. The ACS also hypothesized that screening at an earlier age will decrease the disparity among population groups with a higher burden. Importantly, this updated guideline prioritized incidence reduction rather than mortality reduction. The ACS also stressed the need for a multipronged approach to mitigate barriers to CRC screening at the individual, provider, organizational, and policy levels. Similar to the USPSTF, the ACS did not address the screening of those with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC.³

In all of the publications discussing CRC screening guidelines, it is stressed that there is not sufficient uptake of any of these recommendations. Rather than conduct earlier screening, in my opinion, we should focus on programmatic ways to ensure that the existing screening recommendations are followed. This is a space in which we can help affect the disparity seen among population groups.

The most important screening test is the one that patients are willing to use. Primary care physicians can use any of these guidelines to have conversations with patients about risk and when to start screening. Although these guidelines may seem to be different from each other, each one includes strong recommendations with the same information.

Additional studies should be done to determine the benefits and harms of screening in patients with known risk factors such as obesity, cigarette smoking, diabetes, high consumption of alcohol, high consumption of red meat and processed food, inactivity, and low intake of dietary fiber, fruits, and vegetables. It is possible that the higher burden of disease among Black adults is related to societal factors leading to increased obesity and dietary habits that increase rates of CRC.

Primary care physicians would be better served by a tool that allows for risk stratification to help guide early screening for all patients. For certain patients, such a tool might result in them qualifying for screening that begins at a later age than the current guidelines recommend. Finally, primary care physicians must remember that these are just the guidelines for screening for CRC. They all specifically exclude patients experiencing any symptoms. As such, patients with unexplained bleeding, anemia, weight loss, and other symptoms should be evaluated fully, including being considered for colonoscopy to diagnose CRC. Primary care physicians should use these guidelines to screen their asymptomatic patients and should ensure that they provide evaluation of any of the symptoms of CRC.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is also program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on editorial advisory board of Family Practice News.

References

1. Rex DK et al. Gastrointest Endosc. 2017;86(1):18-33.

2. US Preventive Services Task Force. JAMA. 2016;315(23):2564-2575.

3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.

fpnews@mdedge.com

The recent death of “Black Panther” star Chadwick Boseman has resulted in colorectal cancer (CRC) screening guidelines receiving more attention. Mr. Boseman was diagnosed with Stage 3 CRC in 2016 and underwent treatment. He passed away 4 years later at the young age of 44.

Mr. Boseman’s death has highlighted two important concerns about current screening guidelines for CRC. These include racial disparities in patients with colon cancer and the fact that more younger patients are getting this disease.

There are at least three different sets of CRC screening recommendations from different trusted professional organizations that primary care physicians must decide how to follow. These organizations each published their guidelines indicating review of the best available evidence. On first glance there is discrepancy between these guidelines, but a closer look at them reveals they have a lot of similarities.

The U.S. Multi-Society Task Force of Colorectal Cancer (MSTF), which represents the American College of Gastroenterology, the American Gatroenterological Association, and the American Society for Gastrointestinal Endoscopy, is one of the organizations that offers guidelines. The MSTF recommends CRC screening for non-African American average risked persons at the age of 50 years (strong recommendation; moderate quality evidence). The first-tier options for this recommendation are to have a colonoscopy every 10 years or annual fecal immunochemial test. Additionally, the MSTF recommends beginning screening of African Americans at age 45 years (weak recommendation; very-low-quality evidence). This recommendation cites higher incidence rates, earlier mean age at onset, higher proportion of cancers before age 50 years and late-stage presentation. The MSTF indicates that the increased rate of CRC at an earlier age in African Americans is caused by a combination of biologic and societal factors, but do not point to what those are. This earlier screening is not backed by evidence that it in fact improves morbidity or mortality outcomes. The MSTF also address screening among high-risk individuals. Those with first degree relatives with CRC or advanced adenomas diagnosed before the age of 60 years should be screened beginning at age 40 years or 10 years younger than the age the relative was diagnosed, whichever comes first, according to the MSTF recommendations. These individuals should have a colonoscopy every 5 years, the MSTF says. Those with first degree relatives with CRC or advanced adenomas diagnosed at older than 60 years should have CRC beginning at 40 years, though with the same testing intervals as average-risk individuals.¹

The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP), however, endorse the guidelines set forth by the United States Preventive Services Task Force (USPSTF). These guidelines were published in 2016 in the JAMA and notably are currently under review. These guidelines recommend routine screening for those at average risk at the age of 50 years. In the publication of these guidelines, the increasing incidence of CRC in those under 50 was acknowledged. It is however stated that the modest benefit of earlier diagnosis made via screening is not better than the increased risk of increased lifetime colonoscopy.²

The publication specifically addresses the disparity among Black adults who have the highest incidence and mortality rates in comparison with other racial/ethnic groups. These guidelines specifically state that there are higher rates of colon cancer among black adults. They however clarify that they think it is because of decreased screening and treatment in this group. When compared with other groups and the screening and treatment is controlled for, there is no longer a difference. Lowering the age for starting screening, therefore, won’t help resolve the disparity because the higher cases in Black adults has resulted from not enough Black adults being screened at the recommended age of 50, according to the USPSTF recommendation statement. As such, rather than changing the age of screening for Black adults, this publication recommends efforts to ensure that screening, follow-up, and treatment are received.

The USPSTF specifically did not include adults with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC. They instead refer to other professional organizations for these recommendations.²

The American Cancer Society (ACS) also had a separate guideline published in CA: A Cancer Journal for Clinicians. It provides a qualified recommendation that CRC screening begin at age 45 years for those with average risk. The guideline also includes a strong recommendation for CRC screening beginning at age 50 years. The qualified recommendation for the younger age group is based on the incidence of colorectal cancer being similar between those aged 45-49 and those aged 50-54 years. The ACS also hypothesized that screening at an earlier age will decrease the disparity among population groups with a higher burden. Importantly, this updated guideline prioritized incidence reduction rather than mortality reduction. The ACS also stressed the need for a multipronged approach to mitigate barriers to CRC screening at the individual, provider, organizational, and policy levels. Similar to the USPSTF, the ACS did not address the screening of those with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC.³

In all of the publications discussing CRC screening guidelines, it is stressed that there is not sufficient uptake of any of these recommendations. Rather than conduct earlier screening, in my opinion, we should focus on programmatic ways to ensure that the existing screening recommendations are followed. This is a space in which we can help affect the disparity seen among population groups.

The most important screening test is the one that patients are willing to use. Primary care physicians can use any of these guidelines to have conversations with patients about risk and when to start screening. Although these guidelines may seem to be different from each other, each one includes strong recommendations with the same information.

Additional studies should be done to determine the benefits and harms of screening in patients with known risk factors such as obesity, cigarette smoking, diabetes, high consumption of alcohol, high consumption of red meat and processed food, inactivity, and low intake of dietary fiber, fruits, and vegetables. It is possible that the higher burden of disease among Black adults is related to societal factors leading to increased obesity and dietary habits that increase rates of CRC.

Primary care physicians would be better served by a tool that allows for risk stratification to help guide early screening for all patients. For certain patients, such a tool might result in them qualifying for screening that begins at a later age than the current guidelines recommend. Finally, primary care physicians must remember that these are just the guidelines for screening for CRC. They all specifically exclude patients experiencing any symptoms. As such, patients with unexplained bleeding, anemia, weight loss, and other symptoms should be evaluated fully, including being considered for colonoscopy to diagnose CRC. Primary care physicians should use these guidelines to screen their asymptomatic patients and should ensure that they provide evaluation of any of the symptoms of CRC.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is also program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on editorial advisory board of Family Practice News.

References

1. Rex DK et al. Gastrointest Endosc. 2017;86(1):18-33.

2. US Preventive Services Task Force. JAMA. 2016;315(23):2564-2575.

3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.

fpnews@mdedge.com

The recent death of “Black Panther” star Chadwick Boseman has resulted in colorectal cancer (CRC) screening guidelines receiving more attention. Mr. Boseman was diagnosed with Stage 3 CRC in 2016 and underwent treatment. He passed away 4 years later at the young age of 44.

Mr. Boseman’s death has highlighted two important concerns about current screening guidelines for CRC. These include racial disparities in patients with colon cancer and the fact that more younger patients are getting this disease.

There are at least three different sets of CRC screening recommendations from different trusted professional organizations that primary care physicians must decide how to follow. These organizations each published their guidelines indicating review of the best available evidence. On first glance there is discrepancy between these guidelines, but a closer look at them reveals they have a lot of similarities.

The U.S. Multi-Society Task Force of Colorectal Cancer (MSTF), which represents the American College of Gastroenterology, the American Gatroenterological Association, and the American Society for Gastrointestinal Endoscopy, is one of the organizations that offers guidelines. The MSTF recommends CRC screening for non-African American average risked persons at the age of 50 years (strong recommendation; moderate quality evidence). The first-tier options for this recommendation are to have a colonoscopy every 10 years or annual fecal immunochemial test. Additionally, the MSTF recommends beginning screening of African Americans at age 45 years (weak recommendation; very-low-quality evidence). This recommendation cites higher incidence rates, earlier mean age at onset, higher proportion of cancers before age 50 years and late-stage presentation. The MSTF indicates that the increased rate of CRC at an earlier age in African Americans is caused by a combination of biologic and societal factors, but do not point to what those are. This earlier screening is not backed by evidence that it in fact improves morbidity or mortality outcomes. The MSTF also address screening among high-risk individuals. Those with first degree relatives with CRC or advanced adenomas diagnosed before the age of 60 years should be screened beginning at age 40 years or 10 years younger than the age the relative was diagnosed, whichever comes first, according to the MSTF recommendations. These individuals should have a colonoscopy every 5 years, the MSTF says. Those with first degree relatives with CRC or advanced adenomas diagnosed at older than 60 years should have CRC beginning at 40 years, though with the same testing intervals as average-risk individuals.¹

The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP), however, endorse the guidelines set forth by the United States Preventive Services Task Force (USPSTF). These guidelines were published in 2016 in the JAMA and notably are currently under review. These guidelines recommend routine screening for those at average risk at the age of 50 years. In the publication of these guidelines, the increasing incidence of CRC in those under 50 was acknowledged. It is however stated that the modest benefit of earlier diagnosis made via screening is not better than the increased risk of increased lifetime colonoscopy.²

The publication specifically addresses the disparity among Black adults who have the highest incidence and mortality rates in comparison with other racial/ethnic groups. These guidelines specifically state that there are higher rates of colon cancer among black adults. They however clarify that they think it is because of decreased screening and treatment in this group. When compared with other groups and the screening and treatment is controlled for, there is no longer a difference. Lowering the age for starting screening, therefore, won’t help resolve the disparity because the higher cases in Black adults has resulted from not enough Black adults being screened at the recommended age of 50, according to the USPSTF recommendation statement. As such, rather than changing the age of screening for Black adults, this publication recommends efforts to ensure that screening, follow-up, and treatment are received.

The USPSTF specifically did not include adults with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC. They instead refer to other professional organizations for these recommendations.²

The American Cancer Society (ACS) also had a separate guideline published in CA: A Cancer Journal for Clinicians. It provides a qualified recommendation that CRC screening begin at age 45 years for those with average risk. The guideline also includes a strong recommendation for CRC screening beginning at age 50 years. The qualified recommendation for the younger age group is based on the incidence of colorectal cancer being similar between those aged 45-49 and those aged 50-54 years. The ACS also hypothesized that screening at an earlier age will decrease the disparity among population groups with a higher burden. Importantly, this updated guideline prioritized incidence reduction rather than mortality reduction. The ACS also stressed the need for a multipronged approach to mitigate barriers to CRC screening at the individual, provider, organizational, and policy levels. Similar to the USPSTF, the ACS did not address the screening of those with known disorders that have a genetic predisposition to CRC or those with a first degree relative with CRC.³

In all of the publications discussing CRC screening guidelines, it is stressed that there is not sufficient uptake of any of these recommendations. Rather than conduct earlier screening, in my opinion, we should focus on programmatic ways to ensure that the existing screening recommendations are followed. This is a space in which we can help affect the disparity seen among population groups.

The most important screening test is the one that patients are willing to use. Primary care physicians can use any of these guidelines to have conversations with patients about risk and when to start screening. Although these guidelines may seem to be different from each other, each one includes strong recommendations with the same information.

Additional studies should be done to determine the benefits and harms of screening in patients with known risk factors such as obesity, cigarette smoking, diabetes, high consumption of alcohol, high consumption of red meat and processed food, inactivity, and low intake of dietary fiber, fruits, and vegetables. It is possible that the higher burden of disease among Black adults is related to societal factors leading to increased obesity and dietary habits that increase rates of CRC.

Primary care physicians would be better served by a tool that allows for risk stratification to help guide early screening for all patients. For certain patients, such a tool might result in them qualifying for screening that begins at a later age than the current guidelines recommend. Finally, primary care physicians must remember that these are just the guidelines for screening for CRC. They all specifically exclude patients experiencing any symptoms. As such, patients with unexplained bleeding, anemia, weight loss, and other symptoms should be evaluated fully, including being considered for colonoscopy to diagnose CRC. Primary care physicians should use these guidelines to screen their asymptomatic patients and should ensure that they provide evaluation of any of the symptoms of CRC.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is also program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on editorial advisory board of Family Practice News.

References

1. Rex DK et al. Gastrointest Endosc. 2017;86(1):18-33.

2. US Preventive Services Task Force. JAMA. 2016;315(23):2564-2575.

3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.

fpnews@mdedge.com

Vidyard Video

Additional videos from SGS are available here, including these recent offerings:

• Laparoscopic management of bladder fibroids: Surgical tips and tricks
• Laparoscopic techniques for Essure device removal
• A clitoral cyst of 'epidermal' proportions

Vidyard Video

Additional videos from SGS are available here, including these recent offerings:

• Laparoscopic management of bladder fibroids: Surgical tips and tricks
• Laparoscopic techniques for Essure device removal
• A clitoral cyst of 'epidermal' proportions

Vidyard Video

Additional videos from SGS are available here, including these recent offerings:

• Laparoscopic management of bladder fibroids: Surgical tips and tricks
• Laparoscopic techniques for Essure device removal
• A clitoral cyst of 'epidermal' proportions

Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.

The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.

‘Striking’ findings suggest a future in personalized medicine

Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.

The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.

Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”

If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”

‘Rheumatologists are obliged to step up’

Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.

Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”

Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”

Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.

SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.

Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.

The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.

‘Striking’ findings suggest a future in personalized medicine

Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.

The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.

Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”

If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”

‘Rheumatologists are obliged to step up’

Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.

Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”

Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”

Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.

SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.

Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.

The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.

‘Striking’ findings suggest a future in personalized medicine

Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.

The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.

Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”

If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”

‘Rheumatologists are obliged to step up’

Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.

Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”

Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”

Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.

SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.

Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.

Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.

“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”

Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”

For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.

Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.

The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.

The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.

The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.

About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.

“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”

Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.

“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”

The authors reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.

Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.

Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.

“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”

Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”

For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.

Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.

The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.

The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.

The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.

About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.

“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”

Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.

“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”

The authors reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.

Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.

Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.

“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”

Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”

For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.

Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.

The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.

The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.

The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.

About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.

“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”

Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.

“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”

The authors reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.

Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.

“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”

The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.

Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.

The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.

After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”

The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.

In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.

Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).

“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”

The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
 

Similar activity levels in both groups

As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.

All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.

“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
 

Pulmonary rehabilitation

“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.

“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”

In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.

They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”

An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.

“People don’t necessarily do more just because they can,” he noted.

Dr. Howard has received consulting fees from Actelion.
 

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

Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.

“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”

The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.

Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.

The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.

After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”

The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.

In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.

Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).

“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”

The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
 

Similar activity levels in both groups

As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.

All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.

“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
 

Pulmonary rehabilitation

“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.

“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”

In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.

They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”

An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.

“People don’t necessarily do more just because they can,” he noted.

Dr. Howard has received consulting fees from Actelion.
 

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

Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.

“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”

The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.

Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.

The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.

After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”

The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.

In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.

Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).

“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”

The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
 

Similar activity levels in both groups

As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.

All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.

“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
 

Pulmonary rehabilitation

“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.

“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”

In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.

They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”

An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.

“People don’t necessarily do more just because they can,” he noted.

Dr. Howard has received consulting fees from Actelion.
 

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

The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.

In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.

The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”

A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. He reportedly died Oct. 15 due to complications from COVID-19. The newspaper report said he received a dose of the AZDI222 vaccine in late July. Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.

It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.

“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.

This article was translated and adapted from the Portuguese edition of Medscape.

The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.

In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.

The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”

A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. He reportedly died Oct. 15 due to complications from COVID-19. The newspaper report said he received a dose of the AZDI222 vaccine in late July. Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.

It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.

“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.

This article was translated and adapted from the Portuguese edition of Medscape.

The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.

In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.

The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”

A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. He reportedly died Oct. 15 due to complications from COVID-19. The newspaper report said he received a dose of the AZDI222 vaccine in late July. Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.

It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.

“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.

This article was translated and adapted from the Portuguese edition of Medscape.