Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

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

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

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

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

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

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

A new type of electrode made from sugar could help doctors and researchers more effectively monitor contractions during preterm labor, a condition that precedes almost half of preterm births and is the leading cause of U.S. neonatal deaths.

The sensors, developed by engineers at the McKelvey School of Engineering at Washington University, St. Louis, could help us understand why some patients experience preterm labor, improve medical interventions, and save lives. In the experiment, the researchers built an array of the new electrodes and successfully tested it on a pregnant person in a lab.

The goal is a home-monitoring belt that is comfortable enough for patients to wear and accurate enough to be clinically useful. Built off a framework of sugar and conductive polymers, the thin electrodes have a sponge-like quality that allows them to hold more gel than standard electrodes, measure for 3 hours instead of 1, and resist artifacts created by patient movement. When tested on a pregnant woman, the new electrodes picked up clean signals even when the patient moved, said electrical engineer and article co-author Chuan Wang, PhD.

There is current technology that exists to monitor and map contractions during early labor, but the tests require hundreds of wire electrodes. Patients must sit still for half an hour while the electrodes are applied, then remain immobile for the test itself, which has a high sensitivity to movement.

“It’s very uncomfortable. In the clinical setting, the recording typically lasts for 15 minutes to half an hour. During that time, doctors want the patient to be still,” said Dr. Wang. “If the patient has to move, it’s going to introduce some artifacts, which is going to ruin the imaging process.”

Dr. Wang and colleagues wanted to develop an inexpensive new electrode that would be more comfortable for patients to wear for longer periods of time, yet sensitive enough to detect electrical signals in the body during preterm labor.

To do this, they used sugar structures to create a pliable electrode with a spongy structure. The new electrodes have micropores that hold conductive gel, increasing the amount of electrified surface area touching the skin.

“With the porous structure, we are effectively increasing the area by many, many times,” Dr. Wang said. “Because all those voids also contact the skin, increasing the contact area can boost the strength of the signal.”

With conventional electrodes, the gel dries quickly on the flat surface, causing signal quality to plummet. But the new electrodes can be used for “many hours” before drying out, according to Dr. Wang.

Additionally, the soft material of the new electrode acts “like a buffer” that absorbs motion and prevents the electrode from sliding around, according to Dr. Wang. That means patients can move while wearing the spongy electrodes without disturbing the recording of electrical signals in the body.
 

From sugar cube to spongy electrode

To create the new electrode, the researchers began by molding sugar into an electrode-shaped template. The template was then dipped into a liquid polymer, which oozed in between the grains of sugar. Next, the template underwent oven curing, emerging as a solid yet spongy structure. Hot water was then applied to dissolve the sugar.

The sugar structure is useful here because of the negative space around the grains, which is filled by the polymer – and then because of the negative space left when the sugar dissolves.

“When the sugar grains are removed, that’s where the pores are located,” Dr. Wang explained.

The sponge surface was then converted from hydrophobic to hydrophilic, thanks to an oxygen plasma treatment. Next, the sponge was blanketed in a layer of conductive polymer – a liquid that Dr. Wang likens to black ink – transforming it into an electrode. (Without the oxygen plasma step, the sponge wouldn’t have absorbed the conductive material.) After another oven-curing session, the device was affixed with wires and ready to be used.

The researchers are continuing to refine the concept and hope to develop a wireless wearable device with many spongy electrodes that record signals simultaneously – and that patients can use at home.

In addition to monitoring maternal and fetal health during labor, the researchers say the belt-like device could be used for other types of imaging and diagnosis.

“Depending on the scenario, different signals can be recorded,” Dr. Wang said. “It could be an EMG for a pregnant woman, or an ECG for an athlete or a patient with chronic cardiovascular disease that needs monitoring.”

This work was funded by the Bill & Melinda Gates Foundation (INV-005417, INV-035476). The authors acknowledge the Washington University in St. Louis Institute of Materials Science and Engineering for the use of instruments and staff assistance.

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

A new type of electrode made from sugar could help doctors and researchers more effectively monitor contractions during preterm labor, a condition that precedes almost half of preterm births and is the leading cause of U.S. neonatal deaths.

The sensors, developed by engineers at the McKelvey School of Engineering at Washington University, St. Louis, could help us understand why some patients experience preterm labor, improve medical interventions, and save lives. In the experiment, the researchers built an array of the new electrodes and successfully tested it on a pregnant person in a lab.

The goal is a home-monitoring belt that is comfortable enough for patients to wear and accurate enough to be clinically useful. Built off a framework of sugar and conductive polymers, the thin electrodes have a sponge-like quality that allows them to hold more gel than standard electrodes, measure for 3 hours instead of 1, and resist artifacts created by patient movement. When tested on a pregnant woman, the new electrodes picked up clean signals even when the patient moved, said electrical engineer and article co-author Chuan Wang, PhD.

There is current technology that exists to monitor and map contractions during early labor, but the tests require hundreds of wire electrodes. Patients must sit still for half an hour while the electrodes are applied, then remain immobile for the test itself, which has a high sensitivity to movement.

“It’s very uncomfortable. In the clinical setting, the recording typically lasts for 15 minutes to half an hour. During that time, doctors want the patient to be still,” said Dr. Wang. “If the patient has to move, it’s going to introduce some artifacts, which is going to ruin the imaging process.”

Dr. Wang and colleagues wanted to develop an inexpensive new electrode that would be more comfortable for patients to wear for longer periods of time, yet sensitive enough to detect electrical signals in the body during preterm labor.

To do this, they used sugar structures to create a pliable electrode with a spongy structure. The new electrodes have micropores that hold conductive gel, increasing the amount of electrified surface area touching the skin.

“With the porous structure, we are effectively increasing the area by many, many times,” Dr. Wang said. “Because all those voids also contact the skin, increasing the contact area can boost the strength of the signal.”

With conventional electrodes, the gel dries quickly on the flat surface, causing signal quality to plummet. But the new electrodes can be used for “many hours” before drying out, according to Dr. Wang.

Additionally, the soft material of the new electrode acts “like a buffer” that absorbs motion and prevents the electrode from sliding around, according to Dr. Wang. That means patients can move while wearing the spongy electrodes without disturbing the recording of electrical signals in the body.
 

From sugar cube to spongy electrode

To create the new electrode, the researchers began by molding sugar into an electrode-shaped template. The template was then dipped into a liquid polymer, which oozed in between the grains of sugar. Next, the template underwent oven curing, emerging as a solid yet spongy structure. Hot water was then applied to dissolve the sugar.

The sugar structure is useful here because of the negative space around the grains, which is filled by the polymer – and then because of the negative space left when the sugar dissolves.

“When the sugar grains are removed, that’s where the pores are located,” Dr. Wang explained.

The sponge surface was then converted from hydrophobic to hydrophilic, thanks to an oxygen plasma treatment. Next, the sponge was blanketed in a layer of conductive polymer – a liquid that Dr. Wang likens to black ink – transforming it into an electrode. (Without the oxygen plasma step, the sponge wouldn’t have absorbed the conductive material.) After another oven-curing session, the device was affixed with wires and ready to be used.

The researchers are continuing to refine the concept and hope to develop a wireless wearable device with many spongy electrodes that record signals simultaneously – and that patients can use at home.

In addition to monitoring maternal and fetal health during labor, the researchers say the belt-like device could be used for other types of imaging and diagnosis.

“Depending on the scenario, different signals can be recorded,” Dr. Wang said. “It could be an EMG for a pregnant woman, or an ECG for an athlete or a patient with chronic cardiovascular disease that needs monitoring.”

This work was funded by the Bill & Melinda Gates Foundation (INV-005417, INV-035476). The authors acknowledge the Washington University in St. Louis Institute of Materials Science and Engineering for the use of instruments and staff assistance.

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

A new type of electrode made from sugar could help doctors and researchers more effectively monitor contractions during preterm labor, a condition that precedes almost half of preterm births and is the leading cause of U.S. neonatal deaths.

The sensors, developed by engineers at the McKelvey School of Engineering at Washington University, St. Louis, could help us understand why some patients experience preterm labor, improve medical interventions, and save lives. In the experiment, the researchers built an array of the new electrodes and successfully tested it on a pregnant person in a lab.

The goal is a home-monitoring belt that is comfortable enough for patients to wear and accurate enough to be clinically useful. Built off a framework of sugar and conductive polymers, the thin electrodes have a sponge-like quality that allows them to hold more gel than standard electrodes, measure for 3 hours instead of 1, and resist artifacts created by patient movement. When tested on a pregnant woman, the new electrodes picked up clean signals even when the patient moved, said electrical engineer and article co-author Chuan Wang, PhD.

There is current technology that exists to monitor and map contractions during early labor, but the tests require hundreds of wire electrodes. Patients must sit still for half an hour while the electrodes are applied, then remain immobile for the test itself, which has a high sensitivity to movement.

“It’s very uncomfortable. In the clinical setting, the recording typically lasts for 15 minutes to half an hour. During that time, doctors want the patient to be still,” said Dr. Wang. “If the patient has to move, it’s going to introduce some artifacts, which is going to ruin the imaging process.”

Dr. Wang and colleagues wanted to develop an inexpensive new electrode that would be more comfortable for patients to wear for longer periods of time, yet sensitive enough to detect electrical signals in the body during preterm labor.

To do this, they used sugar structures to create a pliable electrode with a spongy structure. The new electrodes have micropores that hold conductive gel, increasing the amount of electrified surface area touching the skin.

“With the porous structure, we are effectively increasing the area by many, many times,” Dr. Wang said. “Because all those voids also contact the skin, increasing the contact area can boost the strength of the signal.”

With conventional electrodes, the gel dries quickly on the flat surface, causing signal quality to plummet. But the new electrodes can be used for “many hours” before drying out, according to Dr. Wang.

Additionally, the soft material of the new electrode acts “like a buffer” that absorbs motion and prevents the electrode from sliding around, according to Dr. Wang. That means patients can move while wearing the spongy electrodes without disturbing the recording of electrical signals in the body.
 

From sugar cube to spongy electrode

To create the new electrode, the researchers began by molding sugar into an electrode-shaped template. The template was then dipped into a liquid polymer, which oozed in between the grains of sugar. Next, the template underwent oven curing, emerging as a solid yet spongy structure. Hot water was then applied to dissolve the sugar.

The sugar structure is useful here because of the negative space around the grains, which is filled by the polymer – and then because of the negative space left when the sugar dissolves.

“When the sugar grains are removed, that’s where the pores are located,” Dr. Wang explained.

The sponge surface was then converted from hydrophobic to hydrophilic, thanks to an oxygen plasma treatment. Next, the sponge was blanketed in a layer of conductive polymer – a liquid that Dr. Wang likens to black ink – transforming it into an electrode. (Without the oxygen plasma step, the sponge wouldn’t have absorbed the conductive material.) After another oven-curing session, the device was affixed with wires and ready to be used.

The researchers are continuing to refine the concept and hope to develop a wireless wearable device with many spongy electrodes that record signals simultaneously – and that patients can use at home.

In addition to monitoring maternal and fetal health during labor, the researchers say the belt-like device could be used for other types of imaging and diagnosis.

“Depending on the scenario, different signals can be recorded,” Dr. Wang said. “It could be an EMG for a pregnant woman, or an ECG for an athlete or a patient with chronic cardiovascular disease that needs monitoring.”

This work was funded by the Bill & Melinda Gates Foundation (INV-005417, INV-035476). The authors acknowledge the Washington University in St. Louis Institute of Materials Science and Engineering for the use of instruments and staff assistance.

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

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at ≥20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at ≥20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at ≥20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837

Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837

Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837