Among patients with American Joint Committee on Cancer IIIA early-stage melanoma metastases, the presence of sentinel node (SN) tumor deposits of 0.3 mm or higher is associated with a greater risk of disease progression, and these individuals may be well served by adjuvant systemic therapy. It suggests that those with smaller tumor deposits can be managed in a similar way to AJCC IB patients who are SN negative.

Those are the conclusions from a new prospective analysis of melanoma patients drawn from nine high-volume cancer centers in Australia, Europe, and North America. It was published online in the Journal of Clinical Oncology.

Classification of stage III melanoma is difficult since it comprises a heterogeneous group of patients with divergent prognoses. That complexity has resulted in four subcategories of stage III, ranging from high-risk primaries with synchronous nodal metastases (IIID) to patients with early-stage primary tumors with low burden at the SN (IIIA). The latter patients have excellent prognoses, with close to 90% 5-year survival. In fact, they have a better survival rate than some stage II patients with SN-negative, high-risk primary tumors (AJCC IIB-IIC).

Recent phase 3 trials have produced standardized protocols for treating stage III patients with intermediate to high risk (IIIB-IIID), but there is little evidence for the best approach to treat stage IIIA.

To fill that gap, the researchers examined data from 3,607 patients with low-risk primaries, defined as AJCC pT1b-pT2a. About 11.3% were AJCC IIIA and the rest were AJCC IB with no SN tumors: They served as a comparison group. The median follow-up was 34 months.

The researchers conducted a survival analysis that identified 0.3 mm as the optimal size to stratify outcomes. Among those with SN tumors 0.3 mm or higher, 5-year disease-specific survival was 80.3%. For those with smaller tumors, the rate was 94.1% (hazard ratio, 1.26; P < .0001). For distant metastasis-free survival the rates were 72.4% and 92.1% (HR, 1.27; P < .0001). Survival rates were similar between AJCC IB and low-risk AJCC IIIA patients.

The researchers found no differences between the AJCC IB patients and low-risk (< 0.3 mm) AJCC IIIA patients.

Other factors were associated with the presence of high-risk SN tumor size, including male sex (chi-squared, 4.97; df, 1; P = .034), and mitotic rates higher than 1/mm² (chi-squared, 4.92; df, 1; P = .035), although only mitotic rate remained a statistically significant risk factor after multivariate analysis (HR, 1.59; P = .050).

Where extracapsular spread was present, the median maximum tumor deposit size was 3.0 mm versus 0.5 mm in the absence of ECS (Kruskal-Wallis; F, 17.78; df, 1; P < .0001). High-risk nodal disease trended towards an association with N2a stage nodal metastases, compared with N1a stage disease (22.6% vs. 13.8%; chi-squared, 4.31; df, 1; P = .052).

The results of the study suggest that guidelines from the National Comprehensive Cancer Network and The National Institute for Health and Care Excellence could be missing up to one-third of patients with stage IIIA disease with high risk of distance recurrence or death, who may benefit from adjuvant systemic therapy. “We suggest that early-stage, AJCC IIIA patients with micrometastases of maximum tumor dimension [of at least] 0.3 mm should be considered for adjuvant systemic therapy or enrollment into a clinical trial, whereas patients with micrometastases of maximum tumor dimension less than 0.3 mm can be managed in a similar fashion to their SN-negative, AJCC IB counterparts,” the authors wrote.

Eight coauthors reported various conflicts of interest with pharmaceutical companies; the other coauthors reported no conflicts of interest.

Among patients with American Joint Committee on Cancer IIIA early-stage melanoma metastases, the presence of sentinel node (SN) tumor deposits of 0.3 mm or higher is associated with a greater risk of disease progression, and these individuals may be well served by adjuvant systemic therapy. It suggests that those with smaller tumor deposits can be managed in a similar way to AJCC IB patients who are SN negative.

Those are the conclusions from a new prospective analysis of melanoma patients drawn from nine high-volume cancer centers in Australia, Europe, and North America. It was published online in the Journal of Clinical Oncology.

Classification of stage III melanoma is difficult since it comprises a heterogeneous group of patients with divergent prognoses. That complexity has resulted in four subcategories of stage III, ranging from high-risk primaries with synchronous nodal metastases (IIID) to patients with early-stage primary tumors with low burden at the SN (IIIA). The latter patients have excellent prognoses, with close to 90% 5-year survival. In fact, they have a better survival rate than some stage II patients with SN-negative, high-risk primary tumors (AJCC IIB-IIC).

Recent phase 3 trials have produced standardized protocols for treating stage III patients with intermediate to high risk (IIIB-IIID), but there is little evidence for the best approach to treat stage IIIA.

To fill that gap, the researchers examined data from 3,607 patients with low-risk primaries, defined as AJCC pT1b-pT2a. About 11.3% were AJCC IIIA and the rest were AJCC IB with no SN tumors: They served as a comparison group. The median follow-up was 34 months.

The researchers conducted a survival analysis that identified 0.3 mm as the optimal size to stratify outcomes. Among those with SN tumors 0.3 mm or higher, 5-year disease-specific survival was 80.3%. For those with smaller tumors, the rate was 94.1% (hazard ratio, 1.26; P < .0001). For distant metastasis-free survival the rates were 72.4% and 92.1% (HR, 1.27; P < .0001). Survival rates were similar between AJCC IB and low-risk AJCC IIIA patients.

The researchers found no differences between the AJCC IB patients and low-risk (< 0.3 mm) AJCC IIIA patients.

Other factors were associated with the presence of high-risk SN tumor size, including male sex (chi-squared, 4.97; df, 1; P = .034), and mitotic rates higher than 1/mm² (chi-squared, 4.92; df, 1; P = .035), although only mitotic rate remained a statistically significant risk factor after multivariate analysis (HR, 1.59; P = .050).

Where extracapsular spread was present, the median maximum tumor deposit size was 3.0 mm versus 0.5 mm in the absence of ECS (Kruskal-Wallis; F, 17.78; df, 1; P < .0001). High-risk nodal disease trended towards an association with N2a stage nodal metastases, compared with N1a stage disease (22.6% vs. 13.8%; chi-squared, 4.31; df, 1; P = .052).

The results of the study suggest that guidelines from the National Comprehensive Cancer Network and The National Institute for Health and Care Excellence could be missing up to one-third of patients with stage IIIA disease with high risk of distance recurrence or death, who may benefit from adjuvant systemic therapy. “We suggest that early-stage, AJCC IIIA patients with micrometastases of maximum tumor dimension [of at least] 0.3 mm should be considered for adjuvant systemic therapy or enrollment into a clinical trial, whereas patients with micrometastases of maximum tumor dimension less than 0.3 mm can be managed in a similar fashion to their SN-negative, AJCC IB counterparts,” the authors wrote.

Eight coauthors reported various conflicts of interest with pharmaceutical companies; the other coauthors reported no conflicts of interest.

Among patients with American Joint Committee on Cancer IIIA early-stage melanoma metastases, the presence of sentinel node (SN) tumor deposits of 0.3 mm or higher is associated with a greater risk of disease progression, and these individuals may be well served by adjuvant systemic therapy. It suggests that those with smaller tumor deposits can be managed in a similar way to AJCC IB patients who are SN negative.

Those are the conclusions from a new prospective analysis of melanoma patients drawn from nine high-volume cancer centers in Australia, Europe, and North America. It was published online in the Journal of Clinical Oncology.

Classification of stage III melanoma is difficult since it comprises a heterogeneous group of patients with divergent prognoses. That complexity has resulted in four subcategories of stage III, ranging from high-risk primaries with synchronous nodal metastases (IIID) to patients with early-stage primary tumors with low burden at the SN (IIIA). The latter patients have excellent prognoses, with close to 90% 5-year survival. In fact, they have a better survival rate than some stage II patients with SN-negative, high-risk primary tumors (AJCC IIB-IIC).

Recent phase 3 trials have produced standardized protocols for treating stage III patients with intermediate to high risk (IIIB-IIID), but there is little evidence for the best approach to treat stage IIIA.

To fill that gap, the researchers examined data from 3,607 patients with low-risk primaries, defined as AJCC pT1b-pT2a. About 11.3% were AJCC IIIA and the rest were AJCC IB with no SN tumors: They served as a comparison group. The median follow-up was 34 months.

The researchers conducted a survival analysis that identified 0.3 mm as the optimal size to stratify outcomes. Among those with SN tumors 0.3 mm or higher, 5-year disease-specific survival was 80.3%. For those with smaller tumors, the rate was 94.1% (hazard ratio, 1.26; P < .0001). For distant metastasis-free survival the rates were 72.4% and 92.1% (HR, 1.27; P < .0001). Survival rates were similar between AJCC IB and low-risk AJCC IIIA patients.

The researchers found no differences between the AJCC IB patients and low-risk (< 0.3 mm) AJCC IIIA patients.

Other factors were associated with the presence of high-risk SN tumor size, including male sex (chi-squared, 4.97; df, 1; P = .034), and mitotic rates higher than 1/mm² (chi-squared, 4.92; df, 1; P = .035), although only mitotic rate remained a statistically significant risk factor after multivariate analysis (HR, 1.59; P = .050).

Where extracapsular spread was present, the median maximum tumor deposit size was 3.0 mm versus 0.5 mm in the absence of ECS (Kruskal-Wallis; F, 17.78; df, 1; P < .0001). High-risk nodal disease trended towards an association with N2a stage nodal metastases, compared with N1a stage disease (22.6% vs. 13.8%; chi-squared, 4.31; df, 1; P = .052).

The results of the study suggest that guidelines from the National Comprehensive Cancer Network and The National Institute for Health and Care Excellence could be missing up to one-third of patients with stage IIIA disease with high risk of distance recurrence or death, who may benefit from adjuvant systemic therapy. “We suggest that early-stage, AJCC IIIA patients with micrometastases of maximum tumor dimension [of at least] 0.3 mm should be considered for adjuvant systemic therapy or enrollment into a clinical trial, whereas patients with micrometastases of maximum tumor dimension less than 0.3 mm can be managed in a similar fashion to their SN-negative, AJCC IB counterparts,” the authors wrote.

Eight coauthors reported various conflicts of interest with pharmaceutical companies; the other coauthors reported no conflicts of interest.

Neoadjuvant immunotherapy for stage II-IV cutaneous squamous cell carcinoma (CSCC) led to a strong pathological complete response rate, according to results from a stage 2 clinical trial.

CSCC hasn’t received much attention from pharmaceutical companies, in part because it so often responds well to surgery or local therapy. Still, some patients develop more advanced cancer that requires surgery, often on exposed surfaces like the scalp, face, or neck. That can lead to cosmetic and functional impairment.

“Having witnessed the toxicity of treatments over time has really kind of kind of pushed me for a long time to seek better ways to treat this,” lead author Neil Gross, MD, said in an interview. Dr. Gross is director of clinical research in the department of head and neck surgery at the University of Texas MD Anderson Cancer Center, Houston. The study was presented at the annual meeting of the European Society for Medical Oncology and published simultaneously in the New England Journal of Medicine.

Dr. Gross and colleagues conducted a pilot study that examined neoadjuvant immunotherapy with cemiplimab (Libtayo, Regeneron). It received Food and Drug Administration approval in 2018 for metastatic cutaneous squamous cell carcinoma. The aim of the study was to determine how cells responded to the therapy and learn more about the biology, but the results turned heads. “We were surprised to learn just how well the patients responded, Over half of the patients had a complete pathologic response to treatment, and another 4 patients out of 20 had a near-complete pathological response. It prompted a multicenter trial to confirm whether or not what we’re seeing was real,” Dr. Gross said.

The new phase 2 study, conducted in 79 patients at centers in Australia, Germany, and the United States, was encouraging. “The results were very, very similar. About 63% overall had this really impressive pathologic response to treatment. And, it may even be an underestimation of the responses because there were several patients in the trial who responded so well that they refused surgery. Those patients were counted as nonresponders just to be most conservative,” Dr. Gross said.

“I think it will change practice. The results are just so dramatic that it’s hard to imagine it’s not going to influence how patients are treated,” he said.
 

Dramatic results and an attractive option

Among 79 patients in the new trial, the median age was 73 years, 85% were male, and 87% were White. About 91% of primary tumors were head and neck; 6% were stage II, 48% stage III, and 46% stage IV. All patients received four doses of 350 mg cemiplimab at 3-week intervals.

After a median follow-up of 9.7 months (range, 1.3-19.6 months), 51% achieved a pathological complete response (95% confidence interval, 39%-62%). The null hypothesis was that 25% would achieve a pathologic response. An additional 13% had a pathological major response (95% CI, 6%-22%). 25% did not achieve a pathological complete or pathological major response, which was defined as viable tumor cells representing at least 10% of the surgical specimen.

72% of patients experienced an adverse event considered by the investigator to be related to treatment, most commonly fatigue (28%), maculopapular rash (14%), and diarrhea (11%). 15% of patients experienced immune-related adverse events. 4% experienced a grade 3 immune-related adverse event.

Despite the encouraging results, more research needs to be done. One key question is the optimal number of treatments prior to surgery. The pilot study used two doses while the phase 2 study used four doses. Another is whether the surgical excision can be safely reduced after treatment to reduce morbidity, and still another is whether some patients can avoid radiation. “There are lots of unanswered questions that are really important to how this gets rolled out into clinical practice, but I do think that there’s no turning back. The results are so dramatic that it’s a very attractive option to patients and providers. We will have to figure out how to learn the best way to use this in practice while it’s being used,” Dr. Gross said.

Additional studies are in the planning phase, though the results are so encouraging that they might hinder future research. “Will patients be willing in the future to be randomized to the current standard of care, which would be upfront surgery and radiation for advanced disease? I don’t know. There’s a lot of thought being put into the best way to design these studies moving forward that are really advantageous to patients, but still answer these some of these fundamental questions,” Dr. Gross said.

He also noted that these studies looked at pathological responses, not overall survival or clinical outcomes. “We believe that these responses will be durable, but this has to be borne out as the data matures.”

The study was funded by Regeneron. Dr. Gross has consulted for DragonFly Therapeutics, Intuitive Surgical, Regeneron, and Sanofi/Genzyme. He has been on scientific advisory boards for PDS Biotechnology and Shattuck Labs.

Neoadjuvant immunotherapy for stage II-IV cutaneous squamous cell carcinoma (CSCC) led to a strong pathological complete response rate, according to results from a stage 2 clinical trial.

CSCC hasn’t received much attention from pharmaceutical companies, in part because it so often responds well to surgery or local therapy. Still, some patients develop more advanced cancer that requires surgery, often on exposed surfaces like the scalp, face, or neck. That can lead to cosmetic and functional impairment.

“Having witnessed the toxicity of treatments over time has really kind of kind of pushed me for a long time to seek better ways to treat this,” lead author Neil Gross, MD, said in an interview. Dr. Gross is director of clinical research in the department of head and neck surgery at the University of Texas MD Anderson Cancer Center, Houston. The study was presented at the annual meeting of the European Society for Medical Oncology and published simultaneously in the New England Journal of Medicine.

Dr. Gross and colleagues conducted a pilot study that examined neoadjuvant immunotherapy with cemiplimab (Libtayo, Regeneron). It received Food and Drug Administration approval in 2018 for metastatic cutaneous squamous cell carcinoma. The aim of the study was to determine how cells responded to the therapy and learn more about the biology, but the results turned heads. “We were surprised to learn just how well the patients responded, Over half of the patients had a complete pathologic response to treatment, and another 4 patients out of 20 had a near-complete pathological response. It prompted a multicenter trial to confirm whether or not what we’re seeing was real,” Dr. Gross said.

The new phase 2 study, conducted in 79 patients at centers in Australia, Germany, and the United States, was encouraging. “The results were very, very similar. About 63% overall had this really impressive pathologic response to treatment. And, it may even be an underestimation of the responses because there were several patients in the trial who responded so well that they refused surgery. Those patients were counted as nonresponders just to be most conservative,” Dr. Gross said.

“I think it will change practice. The results are just so dramatic that it’s hard to imagine it’s not going to influence how patients are treated,” he said.
 

Dramatic results and an attractive option

Among 79 patients in the new trial, the median age was 73 years, 85% were male, and 87% were White. About 91% of primary tumors were head and neck; 6% were stage II, 48% stage III, and 46% stage IV. All patients received four doses of 350 mg cemiplimab at 3-week intervals.

After a median follow-up of 9.7 months (range, 1.3-19.6 months), 51% achieved a pathological complete response (95% confidence interval, 39%-62%). The null hypothesis was that 25% would achieve a pathologic response. An additional 13% had a pathological major response (95% CI, 6%-22%). 25% did not achieve a pathological complete or pathological major response, which was defined as viable tumor cells representing at least 10% of the surgical specimen.

72% of patients experienced an adverse event considered by the investigator to be related to treatment, most commonly fatigue (28%), maculopapular rash (14%), and diarrhea (11%). 15% of patients experienced immune-related adverse events. 4% experienced a grade 3 immune-related adverse event.

Despite the encouraging results, more research needs to be done. One key question is the optimal number of treatments prior to surgery. The pilot study used two doses while the phase 2 study used four doses. Another is whether the surgical excision can be safely reduced after treatment to reduce morbidity, and still another is whether some patients can avoid radiation. “There are lots of unanswered questions that are really important to how this gets rolled out into clinical practice, but I do think that there’s no turning back. The results are so dramatic that it’s a very attractive option to patients and providers. We will have to figure out how to learn the best way to use this in practice while it’s being used,” Dr. Gross said.

Additional studies are in the planning phase, though the results are so encouraging that they might hinder future research. “Will patients be willing in the future to be randomized to the current standard of care, which would be upfront surgery and radiation for advanced disease? I don’t know. There’s a lot of thought being put into the best way to design these studies moving forward that are really advantageous to patients, but still answer these some of these fundamental questions,” Dr. Gross said.

He also noted that these studies looked at pathological responses, not overall survival or clinical outcomes. “We believe that these responses will be durable, but this has to be borne out as the data matures.”

The study was funded by Regeneron. Dr. Gross has consulted for DragonFly Therapeutics, Intuitive Surgical, Regeneron, and Sanofi/Genzyme. He has been on scientific advisory boards for PDS Biotechnology and Shattuck Labs.

Neoadjuvant immunotherapy for stage II-IV cutaneous squamous cell carcinoma (CSCC) led to a strong pathological complete response rate, according to results from a stage 2 clinical trial.

CSCC hasn’t received much attention from pharmaceutical companies, in part because it so often responds well to surgery or local therapy. Still, some patients develop more advanced cancer that requires surgery, often on exposed surfaces like the scalp, face, or neck. That can lead to cosmetic and functional impairment.

“Having witnessed the toxicity of treatments over time has really kind of kind of pushed me for a long time to seek better ways to treat this,” lead author Neil Gross, MD, said in an interview. Dr. Gross is director of clinical research in the department of head and neck surgery at the University of Texas MD Anderson Cancer Center, Houston. The study was presented at the annual meeting of the European Society for Medical Oncology and published simultaneously in the New England Journal of Medicine.

Dr. Gross and colleagues conducted a pilot study that examined neoadjuvant immunotherapy with cemiplimab (Libtayo, Regeneron). It received Food and Drug Administration approval in 2018 for metastatic cutaneous squamous cell carcinoma. The aim of the study was to determine how cells responded to the therapy and learn more about the biology, but the results turned heads. “We were surprised to learn just how well the patients responded, Over half of the patients had a complete pathologic response to treatment, and another 4 patients out of 20 had a near-complete pathological response. It prompted a multicenter trial to confirm whether or not what we’re seeing was real,” Dr. Gross said.

The new phase 2 study, conducted in 79 patients at centers in Australia, Germany, and the United States, was encouraging. “The results were very, very similar. About 63% overall had this really impressive pathologic response to treatment. And, it may even be an underestimation of the responses because there were several patients in the trial who responded so well that they refused surgery. Those patients were counted as nonresponders just to be most conservative,” Dr. Gross said.

“I think it will change practice. The results are just so dramatic that it’s hard to imagine it’s not going to influence how patients are treated,” he said.
 

Dramatic results and an attractive option

Among 79 patients in the new trial, the median age was 73 years, 85% were male, and 87% were White. About 91% of primary tumors were head and neck; 6% were stage II, 48% stage III, and 46% stage IV. All patients received four doses of 350 mg cemiplimab at 3-week intervals.

After a median follow-up of 9.7 months (range, 1.3-19.6 months), 51% achieved a pathological complete response (95% confidence interval, 39%-62%). The null hypothesis was that 25% would achieve a pathologic response. An additional 13% had a pathological major response (95% CI, 6%-22%). 25% did not achieve a pathological complete or pathological major response, which was defined as viable tumor cells representing at least 10% of the surgical specimen.

72% of patients experienced an adverse event considered by the investigator to be related to treatment, most commonly fatigue (28%), maculopapular rash (14%), and diarrhea (11%). 15% of patients experienced immune-related adverse events. 4% experienced a grade 3 immune-related adverse event.

Despite the encouraging results, more research needs to be done. One key question is the optimal number of treatments prior to surgery. The pilot study used two doses while the phase 2 study used four doses. Another is whether the surgical excision can be safely reduced after treatment to reduce morbidity, and still another is whether some patients can avoid radiation. “There are lots of unanswered questions that are really important to how this gets rolled out into clinical practice, but I do think that there’s no turning back. The results are so dramatic that it’s a very attractive option to patients and providers. We will have to figure out how to learn the best way to use this in practice while it’s being used,” Dr. Gross said.

Additional studies are in the planning phase, though the results are so encouraging that they might hinder future research. “Will patients be willing in the future to be randomized to the current standard of care, which would be upfront surgery and radiation for advanced disease? I don’t know. There’s a lot of thought being put into the best way to design these studies moving forward that are really advantageous to patients, but still answer these some of these fundamental questions,” Dr. Gross said.

He also noted that these studies looked at pathological responses, not overall survival or clinical outcomes. “We believe that these responses will be durable, but this has to be borne out as the data matures.”

The study was funded by Regeneron. Dr. Gross has consulted for DragonFly Therapeutics, Intuitive Surgical, Regeneron, and Sanofi/Genzyme. He has been on scientific advisory boards for PDS Biotechnology and Shattuck Labs.

Key clinical point: Offspring who were exposed in utero to any subtype of hypertensive disorders during pregnancy (HDP) were at an increased risk for higher blood pressure (BP) than those with no exposure.

Major finding: In utero exposure vs no exposure to HDP was associated with higher systolic BP (mean difference 2.46 mm Hg; 95% CI 1.88-3.03 mm Hg) in offspring. Higher systolic BP was also observed in offspring exposed vs not exposed in utero to HDP subtypes, including pregnancy-associated hypertension, preeclampsia, gestational hypertension, and chronic hypertension.

Study details: Findings are from a systematic review and meta-analysis of 24 cohort studies including 3839 offspring who were exposed to HDP in utero and 57,977 offspring from normotensive mothers.

Disclosures: This study was partly supported by Sichuan Science and Technology Program, China. The authors declared no conflicts of interest.

Source: Yu H et al. Association between hypertensive disorders during pregnancy and elevated blood pressure in offspring: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2022 (Sep 12). Doi: 10.1111/jch.14577

Key clinical point: Offspring who were exposed in utero to any subtype of hypertensive disorders during pregnancy (HDP) were at an increased risk for higher blood pressure (BP) than those with no exposure.

Major finding: In utero exposure vs no exposure to HDP was associated with higher systolic BP (mean difference 2.46 mm Hg; 95% CI 1.88-3.03 mm Hg) in offspring. Higher systolic BP was also observed in offspring exposed vs not exposed in utero to HDP subtypes, including pregnancy-associated hypertension, preeclampsia, gestational hypertension, and chronic hypertension.

Study details: Findings are from a systematic review and meta-analysis of 24 cohort studies including 3839 offspring who were exposed to HDP in utero and 57,977 offspring from normotensive mothers.

Disclosures: This study was partly supported by Sichuan Science and Technology Program, China. The authors declared no conflicts of interest.

Source: Yu H et al. Association between hypertensive disorders during pregnancy and elevated blood pressure in offspring: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2022 (Sep 12). Doi: 10.1111/jch.14577

Key clinical point: Offspring who were exposed in utero to any subtype of hypertensive disorders during pregnancy (HDP) were at an increased risk for higher blood pressure (BP) than those with no exposure.

Major finding: In utero exposure vs no exposure to HDP was associated with higher systolic BP (mean difference 2.46 mm Hg; 95% CI 1.88-3.03 mm Hg) in offspring. Higher systolic BP was also observed in offspring exposed vs not exposed in utero to HDP subtypes, including pregnancy-associated hypertension, preeclampsia, gestational hypertension, and chronic hypertension.

Study details: Findings are from a systematic review and meta-analysis of 24 cohort studies including 3839 offspring who were exposed to HDP in utero and 57,977 offspring from normotensive mothers.

Disclosures: This study was partly supported by Sichuan Science and Technology Program, China. The authors declared no conflicts of interest.

Source: Yu H et al. Association between hypertensive disorders during pregnancy and elevated blood pressure in offspring: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2022 (Sep 12). Doi: 10.1111/jch.14577

Key clinical point: The risk for brachial plexus strain, injury, or tear can be minimized with prompt identification of shoulder dystocia (SD) accompanied by cessation of axial fetal head traction, while accurate obstetrical maneuvers can avoid permanent obstetric brachial palsy (OBP) or cerebral morbidity.

Major finding: SD was mostly unilateral anterior, with only 0.9% of cases diagnosed as the more difficult bilateral SD and 2% as recurrent SD. The majority (87.4%) of SD cases were managed by McRobert’s maneuver; the other management procedures included Barnum’s procedure (7.9%), Wood’s maneuver (3.9%), and Menticoglou procedure (0.4%). Only 7.5% of newborns were diagnosed with transient form of Duchenne Erb obstetrics brachioparesis (OBP), none with permanent OBP, and only 1 with cerebral morbidity.

Study details: This retrospective study analyzed the data of 45,687 singleton deliveries (vaginal deliveries, 78.9%; cesarean sections, 21.1%). Overall, 0.7% of vaginally delivered neonates had fetal SD.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Habek D et al. Obstetrics injuries during shoulder dystocia in a tertiary perinatal center. Eur J Obstet Gynecol Reprod Biol. 2022;278:33-37 (Sep 10). Doi: 10.1016/j.ejogrb.2022.09.009

Key clinical point: The risk for brachial plexus strain, injury, or tear can be minimized with prompt identification of shoulder dystocia (SD) accompanied by cessation of axial fetal head traction, while accurate obstetrical maneuvers can avoid permanent obstetric brachial palsy (OBP) or cerebral morbidity.

Major finding: SD was mostly unilateral anterior, with only 0.9% of cases diagnosed as the more difficult bilateral SD and 2% as recurrent SD. The majority (87.4%) of SD cases were managed by McRobert’s maneuver; the other management procedures included Barnum’s procedure (7.9%), Wood’s maneuver (3.9%), and Menticoglou procedure (0.4%). Only 7.5% of newborns were diagnosed with transient form of Duchenne Erb obstetrics brachioparesis (OBP), none with permanent OBP, and only 1 with cerebral morbidity.

Study details: This retrospective study analyzed the data of 45,687 singleton deliveries (vaginal deliveries, 78.9%; cesarean sections, 21.1%). Overall, 0.7% of vaginally delivered neonates had fetal SD.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Habek D et al. Obstetrics injuries during shoulder dystocia in a tertiary perinatal center. Eur J Obstet Gynecol Reprod Biol. 2022;278:33-37 (Sep 10). Doi: 10.1016/j.ejogrb.2022.09.009

Key clinical point: The risk for brachial plexus strain, injury, or tear can be minimized with prompt identification of shoulder dystocia (SD) accompanied by cessation of axial fetal head traction, while accurate obstetrical maneuvers can avoid permanent obstetric brachial palsy (OBP) or cerebral morbidity.

Major finding: SD was mostly unilateral anterior, with only 0.9% of cases diagnosed as the more difficult bilateral SD and 2% as recurrent SD. The majority (87.4%) of SD cases were managed by McRobert’s maneuver; the other management procedures included Barnum’s procedure (7.9%), Wood’s maneuver (3.9%), and Menticoglou procedure (0.4%). Only 7.5% of newborns were diagnosed with transient form of Duchenne Erb obstetrics brachioparesis (OBP), none with permanent OBP, and only 1 with cerebral morbidity.

Study details: This retrospective study analyzed the data of 45,687 singleton deliveries (vaginal deliveries, 78.9%; cesarean sections, 21.1%). Overall, 0.7% of vaginally delivered neonates had fetal SD.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Habek D et al. Obstetrics injuries during shoulder dystocia in a tertiary perinatal center. Eur J Obstet Gynecol Reprod Biol. 2022;278:33-37 (Sep 10). Doi: 10.1016/j.ejogrb.2022.09.009

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888