About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

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

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

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

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

There’s abundant evidence linking higher alcohol intake levels to greater stroke risk and, separately, increasing risk for new-onset atrial fibrillation (AFib). Less settled is whether moderate to heavy drinking worsens the risk for stroke in patients already in AFib and whether giving up alcohol can attenuate that risk. A new observational study suggests the answer to both questions is yes.

The risk for ischemic stroke was only around 1% over about 5 years in a Korean nationwide cohort of almost 98,000 patients with new-onset AFib. About half the patients followed were nondrinkers, as they had been before the study, 13% became abstinent soon after their AFib diagnosis, and 36% were currently drinkers.

But stroke risk went up about 30% with “moderate” current alcohol intake, compared with no intake, and by more than 40% for current drinkers reporting “heavy” alcohol intake, researchers found in an adjusted analysis.

However, abstainers who had mild to moderate alcohol-intake levels before their AFib diagnosis “had a similar risk of ischemic stroke as nondrinkers,” write the authors, led by So-Ryoung Lee, MD, PhD, and colleagues, Seoul National University Hospital, Republic of Korea, in their report published June 7 in the European Heart Journal. In a secondary analysis, binge drinking was also independently associated with risk for ischemic stroke.

The findings suggest that “alcohol abstinence after the diagnosis of AFib could reduce the risk of ischemic stroke,” they conclude. “Lifestyle interventions, including attention to alcohol consumption, should be encouraged as part of a comprehensive approach in the management of patients with a new diagnosis of AFib” for lowering the risk for stroke and other clinical outcomes.

“These results are pretty comparable to those obtained in the more general population,” David Conen, MD, MPH, not connected to the analysis, told this news organization.

In the study’s population with new-onset AFib, there is an alcohol-dependent risk for stroke “that goes up with increasing alcohol intake, which is more or less similar to that found without atrial fibrillation in previous studies,” said Dr. Conen, from the Population Health Research Institute, McMaster University, Hamilton, Ont.

The study, “which overall I think is very well done,” he said, is noteworthy for also suggesting that binge drinking, which was scrutinized in a secondary analysis, appeared independently to worsen the risk for stroke in its AFib population.

Dr. Conen said the observed 1% overall risk for stroke was very similar to the rate he and his colleagues saw in a recent combined analysis of two European cohorts with AFib that was usually longer standing; the median was 3 years. That analysis, in contrast, showed no significant association between increasing levels of alcohol intake and risk for stroke or systemic embolism.

However, “our confidence limits did not exclude the possibility of a small to moderate association,” he said. Given that, and the current study from Korea, there might indeed be “a weak association between alcohol consumption and stroke” in patients with AFib.

“Their results are just more precise because of the larger sample size. That’s why they were able to show those associations,” said Dr. Conen, who was senior author on the earlier report, which covered a pooled analysis of 3,852 patients with AFib in the BEAT-AF and SWISS-AF cohort studies. It was published January 25 in CMAJ, with lead author Philipp Reddiess, MD, Cardiovascular Research Institute Basel, Switzerland.

The two published studies contrast in other ways that are worth noting and together suggest the stroke rate might have been 1% in both by chance, Dr. Conen said. “The populations were pretty different.”

In the earlier study, for example, the overwhelmingly European patients had more comorbidities and had been in AFib for much longer; their mean age was 71 years; and 84% were on oral anticoagulation (OAC).

In contrast, the Korean cohort averaged 61 years in age and only about 24% were taking oral anticoagulants. Given their distribution of CHA2DS2-VASc scores and mean score of 2.3, more than twice as many should have been on OAC, Dr. Conen speculated. “Even if you take into account that some patients may have contraindications, this is clearly an underanticoagulated population.”

The European cohort might have been “a little bit more representative because atrial fibrillation is a disease of the elderly,” Dr. Conen said, but “the Korean paper has the advantage of being a population-based study.”

It involved 97,869 patients from a Korean national data base who were newly diagnosed with AFib from 2010 to 2016. Of the total, 49,781 (51%) were continuously nondrinkers before and after their diagnosis; 12,789 (13%) abstained from alcohol only after their AFib diagnosis; and 35,299 (36%) were drinkers during the follow-up, either because they continued to drink or newly started after their diagnosis.

Of the cohort, 3,120 were diagnosed with new ischemic stroke over a follow-up of 310,926 person-years, for a rate of 1 per 100 person-years.

The adjusted hazard ratio (HR) for ischemic stroke over a 5-year follow-up, compared with nondrinkers, was:

• 1.127 (95% confidence interval, 1.003-1.266) among abstainers
• 1.280 (95% CI, 1.166-1.405) for current drinkers

The corresponding HR, compared with current drinkers, was:

• 0.781 (95% CI, 0.712-0.858) for nondrinkers
• 0.880 (95% CI, 0.782-0.990) among abstainers

No significant interactions with ischemic stroke risk were observed in groups by sex, age, CHA2DS2-VASc score, or smoking status. The risk rose consistently with current drinking levels.

The overall stroke rate of 1% per year is “very low,” and “the absolute differences are small, even though there is a clear significant trend from nondrinking to drinking,” Dr. Conen said.

However, “the difference becomes more sizable when you compare heavy drinking to abstinence.”

Dr. Lee reports no conflicts of interest; disclosures for the other authors are in their report. Dr. Conen reports receiving speaker fees from Servier Canada; disclosures for the other authors are in their report.

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

There’s abundant evidence linking higher alcohol intake levels to greater stroke risk and, separately, increasing risk for new-onset atrial fibrillation (AFib). Less settled is whether moderate to heavy drinking worsens the risk for stroke in patients already in AFib and whether giving up alcohol can attenuate that risk. A new observational study suggests the answer to both questions is yes.

The risk for ischemic stroke was only around 1% over about 5 years in a Korean nationwide cohort of almost 98,000 patients with new-onset AFib. About half the patients followed were nondrinkers, as they had been before the study, 13% became abstinent soon after their AFib diagnosis, and 36% were currently drinkers.

But stroke risk went up about 30% with “moderate” current alcohol intake, compared with no intake, and by more than 40% for current drinkers reporting “heavy” alcohol intake, researchers found in an adjusted analysis.

However, abstainers who had mild to moderate alcohol-intake levels before their AFib diagnosis “had a similar risk of ischemic stroke as nondrinkers,” write the authors, led by So-Ryoung Lee, MD, PhD, and colleagues, Seoul National University Hospital, Republic of Korea, in their report published June 7 in the European Heart Journal. In a secondary analysis, binge drinking was also independently associated with risk for ischemic stroke.

The findings suggest that “alcohol abstinence after the diagnosis of AFib could reduce the risk of ischemic stroke,” they conclude. “Lifestyle interventions, including attention to alcohol consumption, should be encouraged as part of a comprehensive approach in the management of patients with a new diagnosis of AFib” for lowering the risk for stroke and other clinical outcomes.

“These results are pretty comparable to those obtained in the more general population,” David Conen, MD, MPH, not connected to the analysis, told this news organization.

In the study’s population with new-onset AFib, there is an alcohol-dependent risk for stroke “that goes up with increasing alcohol intake, which is more or less similar to that found without atrial fibrillation in previous studies,” said Dr. Conen, from the Population Health Research Institute, McMaster University, Hamilton, Ont.

The study, “which overall I think is very well done,” he said, is noteworthy for also suggesting that binge drinking, which was scrutinized in a secondary analysis, appeared independently to worsen the risk for stroke in its AFib population.

Dr. Conen said the observed 1% overall risk for stroke was very similar to the rate he and his colleagues saw in a recent combined analysis of two European cohorts with AFib that was usually longer standing; the median was 3 years. That analysis, in contrast, showed no significant association between increasing levels of alcohol intake and risk for stroke or systemic embolism.

However, “our confidence limits did not exclude the possibility of a small to moderate association,” he said. Given that, and the current study from Korea, there might indeed be “a weak association between alcohol consumption and stroke” in patients with AFib.

“Their results are just more precise because of the larger sample size. That’s why they were able to show those associations,” said Dr. Conen, who was senior author on the earlier report, which covered a pooled analysis of 3,852 patients with AFib in the BEAT-AF and SWISS-AF cohort studies. It was published January 25 in CMAJ, with lead author Philipp Reddiess, MD, Cardiovascular Research Institute Basel, Switzerland.

The two published studies contrast in other ways that are worth noting and together suggest the stroke rate might have been 1% in both by chance, Dr. Conen said. “The populations were pretty different.”

In the earlier study, for example, the overwhelmingly European patients had more comorbidities and had been in AFib for much longer; their mean age was 71 years; and 84% were on oral anticoagulation (OAC).

In contrast, the Korean cohort averaged 61 years in age and only about 24% were taking oral anticoagulants. Given their distribution of CHA2DS2-VASc scores and mean score of 2.3, more than twice as many should have been on OAC, Dr. Conen speculated. “Even if you take into account that some patients may have contraindications, this is clearly an underanticoagulated population.”

The European cohort might have been “a little bit more representative because atrial fibrillation is a disease of the elderly,” Dr. Conen said, but “the Korean paper has the advantage of being a population-based study.”

It involved 97,869 patients from a Korean national data base who were newly diagnosed with AFib from 2010 to 2016. Of the total, 49,781 (51%) were continuously nondrinkers before and after their diagnosis; 12,789 (13%) abstained from alcohol only after their AFib diagnosis; and 35,299 (36%) were drinkers during the follow-up, either because they continued to drink or newly started after their diagnosis.

Of the cohort, 3,120 were diagnosed with new ischemic stroke over a follow-up of 310,926 person-years, for a rate of 1 per 100 person-years.

The adjusted hazard ratio (HR) for ischemic stroke over a 5-year follow-up, compared with nondrinkers, was:

• 1.127 (95% confidence interval, 1.003-1.266) among abstainers
• 1.280 (95% CI, 1.166-1.405) for current drinkers

The corresponding HR, compared with current drinkers, was:

• 0.781 (95% CI, 0.712-0.858) for nondrinkers
• 0.880 (95% CI, 0.782-0.990) among abstainers

No significant interactions with ischemic stroke risk were observed in groups by sex, age, CHA2DS2-VASc score, or smoking status. The risk rose consistently with current drinking levels.

The overall stroke rate of 1% per year is “very low,” and “the absolute differences are small, even though there is a clear significant trend from nondrinking to drinking,” Dr. Conen said.

However, “the difference becomes more sizable when you compare heavy drinking to abstinence.”

Dr. Lee reports no conflicts of interest; disclosures for the other authors are in their report. Dr. Conen reports receiving speaker fees from Servier Canada; disclosures for the other authors are in their report.

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

There’s abundant evidence linking higher alcohol intake levels to greater stroke risk and, separately, increasing risk for new-onset atrial fibrillation (AFib). Less settled is whether moderate to heavy drinking worsens the risk for stroke in patients already in AFib and whether giving up alcohol can attenuate that risk. A new observational study suggests the answer to both questions is yes.

The risk for ischemic stroke was only around 1% over about 5 years in a Korean nationwide cohort of almost 98,000 patients with new-onset AFib. About half the patients followed were nondrinkers, as they had been before the study, 13% became abstinent soon after their AFib diagnosis, and 36% were currently drinkers.

But stroke risk went up about 30% with “moderate” current alcohol intake, compared with no intake, and by more than 40% for current drinkers reporting “heavy” alcohol intake, researchers found in an adjusted analysis.

However, abstainers who had mild to moderate alcohol-intake levels before their AFib diagnosis “had a similar risk of ischemic stroke as nondrinkers,” write the authors, led by So-Ryoung Lee, MD, PhD, and colleagues, Seoul National University Hospital, Republic of Korea, in their report published June 7 in the European Heart Journal. In a secondary analysis, binge drinking was also independently associated with risk for ischemic stroke.

The findings suggest that “alcohol abstinence after the diagnosis of AFib could reduce the risk of ischemic stroke,” they conclude. “Lifestyle interventions, including attention to alcohol consumption, should be encouraged as part of a comprehensive approach in the management of patients with a new diagnosis of AFib” for lowering the risk for stroke and other clinical outcomes.

“These results are pretty comparable to those obtained in the more general population,” David Conen, MD, MPH, not connected to the analysis, told this news organization.

In the study’s population with new-onset AFib, there is an alcohol-dependent risk for stroke “that goes up with increasing alcohol intake, which is more or less similar to that found without atrial fibrillation in previous studies,” said Dr. Conen, from the Population Health Research Institute, McMaster University, Hamilton, Ont.

The study, “which overall I think is very well done,” he said, is noteworthy for also suggesting that binge drinking, which was scrutinized in a secondary analysis, appeared independently to worsen the risk for stroke in its AFib population.

Dr. Conen said the observed 1% overall risk for stroke was very similar to the rate he and his colleagues saw in a recent combined analysis of two European cohorts with AFib that was usually longer standing; the median was 3 years. That analysis, in contrast, showed no significant association between increasing levels of alcohol intake and risk for stroke or systemic embolism.

However, “our confidence limits did not exclude the possibility of a small to moderate association,” he said. Given that, and the current study from Korea, there might indeed be “a weak association between alcohol consumption and stroke” in patients with AFib.

“Their results are just more precise because of the larger sample size. That’s why they were able to show those associations,” said Dr. Conen, who was senior author on the earlier report, which covered a pooled analysis of 3,852 patients with AFib in the BEAT-AF and SWISS-AF cohort studies. It was published January 25 in CMAJ, with lead author Philipp Reddiess, MD, Cardiovascular Research Institute Basel, Switzerland.

The two published studies contrast in other ways that are worth noting and together suggest the stroke rate might have been 1% in both by chance, Dr. Conen said. “The populations were pretty different.”

In the earlier study, for example, the overwhelmingly European patients had more comorbidities and had been in AFib for much longer; their mean age was 71 years; and 84% were on oral anticoagulation (OAC).

In contrast, the Korean cohort averaged 61 years in age and only about 24% were taking oral anticoagulants. Given their distribution of CHA2DS2-VASc scores and mean score of 2.3, more than twice as many should have been on OAC, Dr. Conen speculated. “Even if you take into account that some patients may have contraindications, this is clearly an underanticoagulated population.”

The European cohort might have been “a little bit more representative because atrial fibrillation is a disease of the elderly,” Dr. Conen said, but “the Korean paper has the advantage of being a population-based study.”

It involved 97,869 patients from a Korean national data base who were newly diagnosed with AFib from 2010 to 2016. Of the total, 49,781 (51%) were continuously nondrinkers before and after their diagnosis; 12,789 (13%) abstained from alcohol only after their AFib diagnosis; and 35,299 (36%) were drinkers during the follow-up, either because they continued to drink or newly started after their diagnosis.

Of the cohort, 3,120 were diagnosed with new ischemic stroke over a follow-up of 310,926 person-years, for a rate of 1 per 100 person-years.

The adjusted hazard ratio (HR) for ischemic stroke over a 5-year follow-up, compared with nondrinkers, was:

• 1.127 (95% confidence interval, 1.003-1.266) among abstainers
• 1.280 (95% CI, 1.166-1.405) for current drinkers

The corresponding HR, compared with current drinkers, was:

• 0.781 (95% CI, 0.712-0.858) for nondrinkers
• 0.880 (95% CI, 0.782-0.990) among abstainers

No significant interactions with ischemic stroke risk were observed in groups by sex, age, CHA2DS2-VASc score, or smoking status. The risk rose consistently with current drinking levels.

The overall stroke rate of 1% per year is “very low,” and “the absolute differences are small, even though there is a clear significant trend from nondrinking to drinking,” Dr. Conen said.

However, “the difference becomes more sizable when you compare heavy drinking to abstinence.”

Dr. Lee reports no conflicts of interest; disclosures for the other authors are in their report. Dr. Conen reports receiving speaker fees from Servier Canada; disclosures for the other authors are in their report.

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

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

It is safe for patients with migraine to receive any of the COVID-19 vaccines without concern about the vaccination interfering with their migraine medications or the medications reducing an immune response to the vaccine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Amy Gelfand, MD, director of pediatric headache at University of California, San Francisco, reviewed common concerns migraine patients or their clinicians might have related any of the three vaccines, starting with a review of how the vaccines work – by targeting the spike protein of the SARS-CoV-2 virus.

“The vaccines induce response to that protein, but only that protein, so there’s no reason to think they’re going to cause the body to produce neutralizing antibodies against any of our migraine therapeutics,” Dr. Gelfand said. She added that the phase 3 clinical trials included participants from a wide range of ages and comorbidities, so there were likely many people in the trials who have migraine, though no subgroup analyses have been performed for this group or are likely to be performed.

Common questions

The two treatments people have the most questions about concerning the COVID-19 vaccine are onabotulinumtoxinA and CGRP pathway monoclonal antibodies (mAbs), likely because both of these are injections, as is the vaccine, Dr. Gelfand said. First, she reminded attendees that onabotulinumtoxinA is not a dermal filler, since some reports following administration of the Moderna vaccine suggested that some people with dermal fillers had swelling in those areas after vaccination.

In addition, “there’s no reason to think the onabotulinumtoxinA would influence our body’s immune response to any vaccine, so there’s no need to retime the onabotulinumtoxinA injections around COVID-19 vaccine administration,” Dr. Gelfand said.

Regarding mAbs, she acknowledged that some white blood cells have CGRP receptors, which may have a pro- or anti-inflammatory role, but clinical trials of mAbs did not show any evidence of being immunosuppressive or myelosuppressive.

“The monoclonal antibodies themselves have undergone engineering so that they are just going after their one target,” Dr. Gelfand said. “They’re not going to be expected to bind to anything else outside of their targets, so I don’t think there’s anything there to make us retime the monoclonal antibody administration relative to the COVID-19 vaccine.”

She did note that patients who choose to get mAbs injections in their arm instead of their thigh or abdomen may want to receive it in the opposite arm than they one they have gotten or will get the vaccine in since the vaccine can cause discomfort.

The other common question patients may have is whether taking any NSAIDs or acetaminophen before getting the COVID-19 vaccine will reduce their immune response to the vaccination. This concern arises because of past evidence showing that some infants tended to have lower immunologic responses when they received acetaminophen after their primary vaccines’ series, but the clinical significance of those reduced responses is not clear since they still had strong responses. Further, this effect was not seen with booster shots, suggesting it’s an age-dependent effect.

During the clinical trials of the AstraZeneca vaccine, several sites gave prophylactic paracetamol without any apparent detrimental effect on antibody response, Dr. Gelfand said. Further, the mRNA and adenovirus-vectored vaccines appear to induce antibodies far above what many believe is needed for protection.

“Even if there were a slight decrease, it’s not clear that that would have any kind of clinical significance for that person in terms of their level of protection against COVID-19,” she said. “Bottom line, it’s fine for patients to use either of these after administration of the COVID-19 vaccine.” The Centers for Disease Control and Prevention doesn’t recommend it prophylactically beforehand, but it’s fine to take it for a fever, aches or headache after getting the vaccine.

Migraine or vaccine reaction?

Dr. Gelfand then addressed whether it should affect physicians’ headache differential if seeing a patient who recently received an adenovirus-vectored vaccine, such as the Johnson & Johnson or AstraZeneca vaccines. The question relates to the discovery of a very rare potential adverse event from these vaccines: cerebral venous sinus thrombosis (CVST) with thrombocytopenia and thromboses in other major vessels, together called thrombosis thrombocytopenia syndrome (TTS). No TTS cases have been reported following mRNA vaccines.

TTS’s mechanism appears similar to autoimmune heparin-induced thrombocytopenia, where the body produces platelet-activating antibodies. TTS currently has three diagnostic criteria: new-onset thrombocytopenia (<150,000/microliter) without evidence of platelet clumping, venous or arterial thrombosis, and absence of prior exposure to heparin.

So far, TTS has been limited only to the vaccines that use an adenovirus vector. One male clinical trial participant experienced CVST with thrombocytopenia in Johnson & Johnson phase 3 trials, and 12 cases out of approximately 8 million Johnson & Johnson doses were reported to the Vaccine Adverse Event Reporting System between March 2 and April 21, 2021. Three TTS more cases followed these, resulting in 15 TTS events per 8 million doses.

In terms of clinical features, all 15 cases were females under age 60, mostly white, and all 11 who were tested were positive for the heparin-platelet factor 4 antibody test. TTS occurred 6-15 days after vaccination for these cases, and all but one had a headache. Their platelet count was 9,000-127,000. None were pregnant or postpartum.

“For us, as headache clinicians, the epidemiology of TTS overlaps with the epidemiology of migraine – they’re happening to the same group of patients,” Dr. Gelfand said. Most of the cases occurred in women aged 30-39 years, while the estimated incidence in women aged 50 or older is 0.9 cases per million doses.

The CDC has proceeded with the Johnson & Johnson vaccine because a risk-benefit analysis revealed that use of the vaccine will result in fewer hospitalization and deaths from COVID-19, compared with adverse events from the vaccine, Dr. Gelfand explained. However, the CDC notes that “women younger than 50 years old should be made aware of a rare risk of blood clots with low platelets following vaccination and the availability of other COVID-19 vaccines where this risk has not been observed.”

For clinicians, the existence of TTS raises a question when patients with a history of migraine call after having received the Johnson & Johnson vaccine, Dr. Gelfand said: “How do we know if this is a spontaneous attack, if it’s a headache provoked by receiving the vaccine, or they have one of these rare cases of [TTS]?”

Three things help with this differential, she said: timing, epidemiology, and headache phenotype. Headache after a vaccine is very common, but it usually happens within the first couple of hours or days after the vaccine. By day 4 after vaccination, few people had headaches in the clinical trials. Since TTS requires production of antibodies, a headache within a few hours of vaccination should not raise concerns about TTS. It should be considered, however, for patients who experience a headache within a week or 2 after vaccination.

Then consider the epidemiology: If it’s a woman between ages 18 and49 calling, the risk is higher than if it’s a male over age 50. Then consider whether there are any unusual headache features, positionality, encephalopathy, or clinical features that could suggest clots in other parts of the body, such as abdominal pain, shortness of breath, or pain in the legs.

“At the end of the day, if it’s a person who’s in this epidemiological window and they’re calling a week or 2 out from the Johnson & Johnson vaccine, we may just need to work it up and see,” Dr. Gelfand said. Work-up involves a CBC, a platelet count to see if they’re thrombocytopenic, and perhaps imaging, preferentially using MRI/MRV over CT since it’s a younger population. Treatment for CVST with thrombocytopenia is a nonheparin anticoagulant, and platelet transfusion should not occur before consulting with hematology.

Continue to vaccinate

“The big take home is that we should continue to vaccinate patients with migraine and that your current therapies do not interfere with the vaccine working and that the vaccine does not interact with our therapies,” Brian D. Loftus, MD, BSChE, immediate past president of the Southern Headache Society and a neurologist at Bellaire (Pa.) Neurology, said of the presentation. He also felt it was helpful to know that NSAIDs likely have no impact on the vaccines’ effectiveness as well.

“The most important new information for me was that the median onset of the CSVT was 8 days post vaccine,” Dr. Loftus said. “Typically, postvaccine headache is seen much sooner, within 1-2 days, so this is a useful clinical feature to separate out who needs to closer follow-up and possible neuroimaging.”

Given the epidemiology of those most likely to have TTS, Dr. Loftus said he would advise his female patients younger than 60 to simply get the Pfizer or Moderna vaccine since they appear safer for this demographic.

Dr. Gelfand is editor of the journal Headache but has no industry disclosures. Her spouse has received clinical trial grant support from Genentech and honoraria for editorial work from Dynamed Plus. Dr. Loftus has received grants or fees from Teva, Amgen, Abbvie, and Biohaven.

It is safe for patients with migraine to receive any of the COVID-19 vaccines without concern about the vaccination interfering with their migraine medications or the medications reducing an immune response to the vaccine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Amy Gelfand, MD, director of pediatric headache at University of California, San Francisco, reviewed common concerns migraine patients or their clinicians might have related any of the three vaccines, starting with a review of how the vaccines work – by targeting the spike protein of the SARS-CoV-2 virus.

“The vaccines induce response to that protein, but only that protein, so there’s no reason to think they’re going to cause the body to produce neutralizing antibodies against any of our migraine therapeutics,” Dr. Gelfand said. She added that the phase 3 clinical trials included participants from a wide range of ages and comorbidities, so there were likely many people in the trials who have migraine, though no subgroup analyses have been performed for this group or are likely to be performed.

Common questions

The two treatments people have the most questions about concerning the COVID-19 vaccine are onabotulinumtoxinA and CGRP pathway monoclonal antibodies (mAbs), likely because both of these are injections, as is the vaccine, Dr. Gelfand said. First, she reminded attendees that onabotulinumtoxinA is not a dermal filler, since some reports following administration of the Moderna vaccine suggested that some people with dermal fillers had swelling in those areas after vaccination.

In addition, “there’s no reason to think the onabotulinumtoxinA would influence our body’s immune response to any vaccine, so there’s no need to retime the onabotulinumtoxinA injections around COVID-19 vaccine administration,” Dr. Gelfand said.

Regarding mAbs, she acknowledged that some white blood cells have CGRP receptors, which may have a pro- or anti-inflammatory role, but clinical trials of mAbs did not show any evidence of being immunosuppressive or myelosuppressive.

“The monoclonal antibodies themselves have undergone engineering so that they are just going after their one target,” Dr. Gelfand said. “They’re not going to be expected to bind to anything else outside of their targets, so I don’t think there’s anything there to make us retime the monoclonal antibody administration relative to the COVID-19 vaccine.”

She did note that patients who choose to get mAbs injections in their arm instead of their thigh or abdomen may want to receive it in the opposite arm than they one they have gotten or will get the vaccine in since the vaccine can cause discomfort.

The other common question patients may have is whether taking any NSAIDs or acetaminophen before getting the COVID-19 vaccine will reduce their immune response to the vaccination. This concern arises because of past evidence showing that some infants tended to have lower immunologic responses when they received acetaminophen after their primary vaccines’ series, but the clinical significance of those reduced responses is not clear since they still had strong responses. Further, this effect was not seen with booster shots, suggesting it’s an age-dependent effect.

During the clinical trials of the AstraZeneca vaccine, several sites gave prophylactic paracetamol without any apparent detrimental effect on antibody response, Dr. Gelfand said. Further, the mRNA and adenovirus-vectored vaccines appear to induce antibodies far above what many believe is needed for protection.

“Even if there were a slight decrease, it’s not clear that that would have any kind of clinical significance for that person in terms of their level of protection against COVID-19,” she said. “Bottom line, it’s fine for patients to use either of these after administration of the COVID-19 vaccine.” The Centers for Disease Control and Prevention doesn’t recommend it prophylactically beforehand, but it’s fine to take it for a fever, aches or headache after getting the vaccine.

Migraine or vaccine reaction?

Dr. Gelfand then addressed whether it should affect physicians’ headache differential if seeing a patient who recently received an adenovirus-vectored vaccine, such as the Johnson & Johnson or AstraZeneca vaccines. The question relates to the discovery of a very rare potential adverse event from these vaccines: cerebral venous sinus thrombosis (CVST) with thrombocytopenia and thromboses in other major vessels, together called thrombosis thrombocytopenia syndrome (TTS). No TTS cases have been reported following mRNA vaccines.

TTS’s mechanism appears similar to autoimmune heparin-induced thrombocytopenia, where the body produces platelet-activating antibodies. TTS currently has three diagnostic criteria: new-onset thrombocytopenia (<150,000/microliter) without evidence of platelet clumping, venous or arterial thrombosis, and absence of prior exposure to heparin.

So far, TTS has been limited only to the vaccines that use an adenovirus vector. One male clinical trial participant experienced CVST with thrombocytopenia in Johnson & Johnson phase 3 trials, and 12 cases out of approximately 8 million Johnson & Johnson doses were reported to the Vaccine Adverse Event Reporting System between March 2 and April 21, 2021. Three TTS more cases followed these, resulting in 15 TTS events per 8 million doses.

In terms of clinical features, all 15 cases were females under age 60, mostly white, and all 11 who were tested were positive for the heparin-platelet factor 4 antibody test. TTS occurred 6-15 days after vaccination for these cases, and all but one had a headache. Their platelet count was 9,000-127,000. None were pregnant or postpartum.

“For us, as headache clinicians, the epidemiology of TTS overlaps with the epidemiology of migraine – they’re happening to the same group of patients,” Dr. Gelfand said. Most of the cases occurred in women aged 30-39 years, while the estimated incidence in women aged 50 or older is 0.9 cases per million doses.

The CDC has proceeded with the Johnson & Johnson vaccine because a risk-benefit analysis revealed that use of the vaccine will result in fewer hospitalization and deaths from COVID-19, compared with adverse events from the vaccine, Dr. Gelfand explained. However, the CDC notes that “women younger than 50 years old should be made aware of a rare risk of blood clots with low platelets following vaccination and the availability of other COVID-19 vaccines where this risk has not been observed.”

For clinicians, the existence of TTS raises a question when patients with a history of migraine call after having received the Johnson & Johnson vaccine, Dr. Gelfand said: “How do we know if this is a spontaneous attack, if it’s a headache provoked by receiving the vaccine, or they have one of these rare cases of [TTS]?”

Three things help with this differential, she said: timing, epidemiology, and headache phenotype. Headache after a vaccine is very common, but it usually happens within the first couple of hours or days after the vaccine. By day 4 after vaccination, few people had headaches in the clinical trials. Since TTS requires production of antibodies, a headache within a few hours of vaccination should not raise concerns about TTS. It should be considered, however, for patients who experience a headache within a week or 2 after vaccination.

Then consider the epidemiology: If it’s a woman between ages 18 and49 calling, the risk is higher than if it’s a male over age 50. Then consider whether there are any unusual headache features, positionality, encephalopathy, or clinical features that could suggest clots in other parts of the body, such as abdominal pain, shortness of breath, or pain in the legs.

“At the end of the day, if it’s a person who’s in this epidemiological window and they’re calling a week or 2 out from the Johnson & Johnson vaccine, we may just need to work it up and see,” Dr. Gelfand said. Work-up involves a CBC, a platelet count to see if they’re thrombocytopenic, and perhaps imaging, preferentially using MRI/MRV over CT since it’s a younger population. Treatment for CVST with thrombocytopenia is a nonheparin anticoagulant, and platelet transfusion should not occur before consulting with hematology.

Continue to vaccinate

“The big take home is that we should continue to vaccinate patients with migraine and that your current therapies do not interfere with the vaccine working and that the vaccine does not interact with our therapies,” Brian D. Loftus, MD, BSChE, immediate past president of the Southern Headache Society and a neurologist at Bellaire (Pa.) Neurology, said of the presentation. He also felt it was helpful to know that NSAIDs likely have no impact on the vaccines’ effectiveness as well.

“The most important new information for me was that the median onset of the CSVT was 8 days post vaccine,” Dr. Loftus said. “Typically, postvaccine headache is seen much sooner, within 1-2 days, so this is a useful clinical feature to separate out who needs to closer follow-up and possible neuroimaging.”

Given the epidemiology of those most likely to have TTS, Dr. Loftus said he would advise his female patients younger than 60 to simply get the Pfizer or Moderna vaccine since they appear safer for this demographic.

Dr. Gelfand is editor of the journal Headache but has no industry disclosures. Her spouse has received clinical trial grant support from Genentech and honoraria for editorial work from Dynamed Plus. Dr. Loftus has received grants or fees from Teva, Amgen, Abbvie, and Biohaven.

It is safe for patients with migraine to receive any of the COVID-19 vaccines without concern about the vaccination interfering with their migraine medications or the medications reducing an immune response to the vaccine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Amy Gelfand, MD, director of pediatric headache at University of California, San Francisco, reviewed common concerns migraine patients or their clinicians might have related any of the three vaccines, starting with a review of how the vaccines work – by targeting the spike protein of the SARS-CoV-2 virus.

“The vaccines induce response to that protein, but only that protein, so there’s no reason to think they’re going to cause the body to produce neutralizing antibodies against any of our migraine therapeutics,” Dr. Gelfand said. She added that the phase 3 clinical trials included participants from a wide range of ages and comorbidities, so there were likely many people in the trials who have migraine, though no subgroup analyses have been performed for this group or are likely to be performed.

Common questions

The two treatments people have the most questions about concerning the COVID-19 vaccine are onabotulinumtoxinA and CGRP pathway monoclonal antibodies (mAbs), likely because both of these are injections, as is the vaccine, Dr. Gelfand said. First, she reminded attendees that onabotulinumtoxinA is not a dermal filler, since some reports following administration of the Moderna vaccine suggested that some people with dermal fillers had swelling in those areas after vaccination.

In addition, “there’s no reason to think the onabotulinumtoxinA would influence our body’s immune response to any vaccine, so there’s no need to retime the onabotulinumtoxinA injections around COVID-19 vaccine administration,” Dr. Gelfand said.

Regarding mAbs, she acknowledged that some white blood cells have CGRP receptors, which may have a pro- or anti-inflammatory role, but clinical trials of mAbs did not show any evidence of being immunosuppressive or myelosuppressive.

“The monoclonal antibodies themselves have undergone engineering so that they are just going after their one target,” Dr. Gelfand said. “They’re not going to be expected to bind to anything else outside of their targets, so I don’t think there’s anything there to make us retime the monoclonal antibody administration relative to the COVID-19 vaccine.”

She did note that patients who choose to get mAbs injections in their arm instead of their thigh or abdomen may want to receive it in the opposite arm than they one they have gotten or will get the vaccine in since the vaccine can cause discomfort.

The other common question patients may have is whether taking any NSAIDs or acetaminophen before getting the COVID-19 vaccine will reduce their immune response to the vaccination. This concern arises because of past evidence showing that some infants tended to have lower immunologic responses when they received acetaminophen after their primary vaccines’ series, but the clinical significance of those reduced responses is not clear since they still had strong responses. Further, this effect was not seen with booster shots, suggesting it’s an age-dependent effect.

During the clinical trials of the AstraZeneca vaccine, several sites gave prophylactic paracetamol without any apparent detrimental effect on antibody response, Dr. Gelfand said. Further, the mRNA and adenovirus-vectored vaccines appear to induce antibodies far above what many believe is needed for protection.

“Even if there were a slight decrease, it’s not clear that that would have any kind of clinical significance for that person in terms of their level of protection against COVID-19,” she said. “Bottom line, it’s fine for patients to use either of these after administration of the COVID-19 vaccine.” The Centers for Disease Control and Prevention doesn’t recommend it prophylactically beforehand, but it’s fine to take it for a fever, aches or headache after getting the vaccine.

Migraine or vaccine reaction?

Dr. Gelfand then addressed whether it should affect physicians’ headache differential if seeing a patient who recently received an adenovirus-vectored vaccine, such as the Johnson & Johnson or AstraZeneca vaccines. The question relates to the discovery of a very rare potential adverse event from these vaccines: cerebral venous sinus thrombosis (CVST) with thrombocytopenia and thromboses in other major vessels, together called thrombosis thrombocytopenia syndrome (TTS). No TTS cases have been reported following mRNA vaccines.

TTS’s mechanism appears similar to autoimmune heparin-induced thrombocytopenia, where the body produces platelet-activating antibodies. TTS currently has three diagnostic criteria: new-onset thrombocytopenia (<150,000/microliter) without evidence of platelet clumping, venous or arterial thrombosis, and absence of prior exposure to heparin.

So far, TTS has been limited only to the vaccines that use an adenovirus vector. One male clinical trial participant experienced CVST with thrombocytopenia in Johnson & Johnson phase 3 trials, and 12 cases out of approximately 8 million Johnson & Johnson doses were reported to the Vaccine Adverse Event Reporting System between March 2 and April 21, 2021. Three TTS more cases followed these, resulting in 15 TTS events per 8 million doses.

In terms of clinical features, all 15 cases were females under age 60, mostly white, and all 11 who were tested were positive for the heparin-platelet factor 4 antibody test. TTS occurred 6-15 days after vaccination for these cases, and all but one had a headache. Their platelet count was 9,000-127,000. None were pregnant or postpartum.

“For us, as headache clinicians, the epidemiology of TTS overlaps with the epidemiology of migraine – they’re happening to the same group of patients,” Dr. Gelfand said. Most of the cases occurred in women aged 30-39 years, while the estimated incidence in women aged 50 or older is 0.9 cases per million doses.

The CDC has proceeded with the Johnson & Johnson vaccine because a risk-benefit analysis revealed that use of the vaccine will result in fewer hospitalization and deaths from COVID-19, compared with adverse events from the vaccine, Dr. Gelfand explained. However, the CDC notes that “women younger than 50 years old should be made aware of a rare risk of blood clots with low platelets following vaccination and the availability of other COVID-19 vaccines where this risk has not been observed.”

For clinicians, the existence of TTS raises a question when patients with a history of migraine call after having received the Johnson & Johnson vaccine, Dr. Gelfand said: “How do we know if this is a spontaneous attack, if it’s a headache provoked by receiving the vaccine, or they have one of these rare cases of [TTS]?”

Three things help with this differential, she said: timing, epidemiology, and headache phenotype. Headache after a vaccine is very common, but it usually happens within the first couple of hours or days after the vaccine. By day 4 after vaccination, few people had headaches in the clinical trials. Since TTS requires production of antibodies, a headache within a few hours of vaccination should not raise concerns about TTS. It should be considered, however, for patients who experience a headache within a week or 2 after vaccination.

Then consider the epidemiology: If it’s a woman between ages 18 and49 calling, the risk is higher than if it’s a male over age 50. Then consider whether there are any unusual headache features, positionality, encephalopathy, or clinical features that could suggest clots in other parts of the body, such as abdominal pain, shortness of breath, or pain in the legs.

“At the end of the day, if it’s a person who’s in this epidemiological window and they’re calling a week or 2 out from the Johnson & Johnson vaccine, we may just need to work it up and see,” Dr. Gelfand said. Work-up involves a CBC, a platelet count to see if they’re thrombocytopenic, and perhaps imaging, preferentially using MRI/MRV over CT since it’s a younger population. Treatment for CVST with thrombocytopenia is a nonheparin anticoagulant, and platelet transfusion should not occur before consulting with hematology.

Continue to vaccinate

“The big take home is that we should continue to vaccinate patients with migraine and that your current therapies do not interfere with the vaccine working and that the vaccine does not interact with our therapies,” Brian D. Loftus, MD, BSChE, immediate past president of the Southern Headache Society and a neurologist at Bellaire (Pa.) Neurology, said of the presentation. He also felt it was helpful to know that NSAIDs likely have no impact on the vaccines’ effectiveness as well.

“The most important new information for me was that the median onset of the CSVT was 8 days post vaccine,” Dr. Loftus said. “Typically, postvaccine headache is seen much sooner, within 1-2 days, so this is a useful clinical feature to separate out who needs to closer follow-up and possible neuroimaging.”

Given the epidemiology of those most likely to have TTS, Dr. Loftus said he would advise his female patients younger than 60 to simply get the Pfizer or Moderna vaccine since they appear safer for this demographic.

Dr. Gelfand is editor of the journal Headache but has no industry disclosures. Her spouse has received clinical trial grant support from Genentech and honoraria for editorial work from Dynamed Plus. Dr. Loftus has received grants or fees from Teva, Amgen, Abbvie, and Biohaven.