User login
Non-Radical Surgery a Win-Win for Early Cervical Cancer
according to results of the GOG-278 trial.
In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.
Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.
He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”
GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.
The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.
Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.
Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.
In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.
He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
‘Impressive’ Data
Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”
She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.
Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.
The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.
Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.
A version of this article appeared on Medscape.com.
according to results of the GOG-278 trial.
In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.
Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.
He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”
GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.
The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.
Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.
Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.
In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.
He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
‘Impressive’ Data
Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”
She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.
Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.
The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.
Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.
A version of this article appeared on Medscape.com.
according to results of the GOG-278 trial.
In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.
Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.
He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”
GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.
The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.
Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.
Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.
In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.
He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
‘Impressive’ Data
Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”
She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.
Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.
The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.
Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.
A version of this article appeared on Medscape.com.
FROM SGO 2024
Web-Based Aid Educates Women on Tubal Sterilization
Although tubal sterilization is common, especially among those with lower income and education levels, misunderstandings persist about the reversibility of the procedure, and previous studies suggest that many pregnant individuals are not making well-informed decisions, wrote Sonya Borrero, MD, of the University of Pittsburgh, and colleagues.
In a study published in JAMA Network Open, the researchers randomized 350 pregnant individuals with Medicaid insurance to usual care or usual care plus a web-based decision aid in English or Spanish called MyDecision/MiDecisión that included written, audio, and video information about tubal sterilization. The tool also included an interactive table comparing tubal sterilization to other contraceptive options, exercises to clarify patients’ values, knowledge checks, and a final summary report.
The two primary outcomes were knowledge of tubal sterilization based on a 10-question true/false test and decisional conflict about contraceptive choices using the low-literacy Decision Conflict Scale. The participants ranged in age from 21 to 45 years, with a mean age of 29.7 years. Participants were randomized prior to 24 weeks’ gestation, and those in the intervention group completed the intervention immediately using a personal device or a university device in the clinical setting. Further assessments occurred by phone during the third trimester and at 3 months postpartum.
Participants in the decision aid group showed significantly greater knowledge of tubal sterilization compared with controls, with a mean of 76.5% correct responses to the knowledge questions, vs. 55.6% in the control group (P < .001). Decisional conflict scores also were significantly lower in the intervention group compared with controls (mean 12.7 vs. 18.7, P = .002).
The most dramatic knowledge gap related to permanence of tubal sterilization; 90.1% of participants in the intervention group answered correctly that the procedure is not easily reversible, compared to 39.3% of the controls. Similarly, 86.6% of the intervention group responded correctly that the tubes do not “come untied” spontaneously, vs. 33.7% of controls (P < .001 for both).
The findings were limited by several factors including the focus only on pregnant Medicaid patients, the presentation of the decision tool only at a point early in pregnancy, which may have been too soon for some participants to consider tubal sterilization, and a lack of data on long-term satisfaction or regret about tubal sterilization decisions, the researchers noted.
However, the knowledge differences between the intervention and control groups remained significant at the third trimester assessment, they said.
More research is needed in other populations and using other time points, but the current study results suggest that use of the MyDecision/MiDecisión tool in a real-world clinical setting at the actual time of decision-making could improve knowledge and inform patients’ choices, the researchers concluded. Improved patient education also could inform policy decisions about the potential elimination of the 30-day waiting period for sterilization procedures, they said.
The study was supported by the National Institute on Minority Health and Health Disparities. The researchers had no financial conflicts to disclose.
Although tubal sterilization is common, especially among those with lower income and education levels, misunderstandings persist about the reversibility of the procedure, and previous studies suggest that many pregnant individuals are not making well-informed decisions, wrote Sonya Borrero, MD, of the University of Pittsburgh, and colleagues.
In a study published in JAMA Network Open, the researchers randomized 350 pregnant individuals with Medicaid insurance to usual care or usual care plus a web-based decision aid in English or Spanish called MyDecision/MiDecisión that included written, audio, and video information about tubal sterilization. The tool also included an interactive table comparing tubal sterilization to other contraceptive options, exercises to clarify patients’ values, knowledge checks, and a final summary report.
The two primary outcomes were knowledge of tubal sterilization based on a 10-question true/false test and decisional conflict about contraceptive choices using the low-literacy Decision Conflict Scale. The participants ranged in age from 21 to 45 years, with a mean age of 29.7 years. Participants were randomized prior to 24 weeks’ gestation, and those in the intervention group completed the intervention immediately using a personal device or a university device in the clinical setting. Further assessments occurred by phone during the third trimester and at 3 months postpartum.
Participants in the decision aid group showed significantly greater knowledge of tubal sterilization compared with controls, with a mean of 76.5% correct responses to the knowledge questions, vs. 55.6% in the control group (P < .001). Decisional conflict scores also were significantly lower in the intervention group compared with controls (mean 12.7 vs. 18.7, P = .002).
The most dramatic knowledge gap related to permanence of tubal sterilization; 90.1% of participants in the intervention group answered correctly that the procedure is not easily reversible, compared to 39.3% of the controls. Similarly, 86.6% of the intervention group responded correctly that the tubes do not “come untied” spontaneously, vs. 33.7% of controls (P < .001 for both).
The findings were limited by several factors including the focus only on pregnant Medicaid patients, the presentation of the decision tool only at a point early in pregnancy, which may have been too soon for some participants to consider tubal sterilization, and a lack of data on long-term satisfaction or regret about tubal sterilization decisions, the researchers noted.
However, the knowledge differences between the intervention and control groups remained significant at the third trimester assessment, they said.
More research is needed in other populations and using other time points, but the current study results suggest that use of the MyDecision/MiDecisión tool in a real-world clinical setting at the actual time of decision-making could improve knowledge and inform patients’ choices, the researchers concluded. Improved patient education also could inform policy decisions about the potential elimination of the 30-day waiting period for sterilization procedures, they said.
The study was supported by the National Institute on Minority Health and Health Disparities. The researchers had no financial conflicts to disclose.
Although tubal sterilization is common, especially among those with lower income and education levels, misunderstandings persist about the reversibility of the procedure, and previous studies suggest that many pregnant individuals are not making well-informed decisions, wrote Sonya Borrero, MD, of the University of Pittsburgh, and colleagues.
In a study published in JAMA Network Open, the researchers randomized 350 pregnant individuals with Medicaid insurance to usual care or usual care plus a web-based decision aid in English or Spanish called MyDecision/MiDecisión that included written, audio, and video information about tubal sterilization. The tool also included an interactive table comparing tubal sterilization to other contraceptive options, exercises to clarify patients’ values, knowledge checks, and a final summary report.
The two primary outcomes were knowledge of tubal sterilization based on a 10-question true/false test and decisional conflict about contraceptive choices using the low-literacy Decision Conflict Scale. The participants ranged in age from 21 to 45 years, with a mean age of 29.7 years. Participants were randomized prior to 24 weeks’ gestation, and those in the intervention group completed the intervention immediately using a personal device or a university device in the clinical setting. Further assessments occurred by phone during the third trimester and at 3 months postpartum.
Participants in the decision aid group showed significantly greater knowledge of tubal sterilization compared with controls, with a mean of 76.5% correct responses to the knowledge questions, vs. 55.6% in the control group (P < .001). Decisional conflict scores also were significantly lower in the intervention group compared with controls (mean 12.7 vs. 18.7, P = .002).
The most dramatic knowledge gap related to permanence of tubal sterilization; 90.1% of participants in the intervention group answered correctly that the procedure is not easily reversible, compared to 39.3% of the controls. Similarly, 86.6% of the intervention group responded correctly that the tubes do not “come untied” spontaneously, vs. 33.7% of controls (P < .001 for both).
The findings were limited by several factors including the focus only on pregnant Medicaid patients, the presentation of the decision tool only at a point early in pregnancy, which may have been too soon for some participants to consider tubal sterilization, and a lack of data on long-term satisfaction or regret about tubal sterilization decisions, the researchers noted.
However, the knowledge differences between the intervention and control groups remained significant at the third trimester assessment, they said.
More research is needed in other populations and using other time points, but the current study results suggest that use of the MyDecision/MiDecisión tool in a real-world clinical setting at the actual time of decision-making could improve knowledge and inform patients’ choices, the researchers concluded. Improved patient education also could inform policy decisions about the potential elimination of the 30-day waiting period for sterilization procedures, they said.
The study was supported by the National Institute on Minority Health and Health Disparities. The researchers had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Bariatric surgery tied to less pregnancy weight gain
TOPLINE:
Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.
METHODOLOGY:
- Using Swedish national registers, researchers investigated the association of pregnancy weight gain with history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
- Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
- Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
- Time from surgery to conception was also assessed.
TAKEAWAY:
- Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
- The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
- Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.
IN PRACTICE:
“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.
SOURCE:
The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.
LIMITATIONS:
Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.
DISCLOSURES:
Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.
METHODOLOGY:
- Using Swedish national registers, researchers investigated the association of pregnancy weight gain with history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
- Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
- Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
- Time from surgery to conception was also assessed.
TAKEAWAY:
- Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
- The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
- Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.
IN PRACTICE:
“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.
SOURCE:
The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.
LIMITATIONS:
Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.
DISCLOSURES:
Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.
METHODOLOGY:
- Using Swedish national registers, researchers investigated the association of pregnancy weight gain with history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
- Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
- Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
- Time from surgery to conception was also assessed.
TAKEAWAY:
- Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
- The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
- Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.
IN PRACTICE:
“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.
SOURCE:
The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.
LIMITATIONS:
Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.
DISCLOSURES:
Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
Less is more for axillary surgery in early breast cancer
SAN ANTONIO — than do those who have more extensive surgery, according to findings from a large meta-analysis.
Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.
These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.
Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population.
To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.
In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain.
Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).
The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).
Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).
Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.
“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.
To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained.
These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).
Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.
However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).
This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview.
“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”
This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added.
Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”
The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.
No relevant financial relationships have been declared.
A version of this article appeared on Medscape.com.
SAN ANTONIO — than do those who have more extensive surgery, according to findings from a large meta-analysis.
Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.
These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.
Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population.
To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.
In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain.
Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).
The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).
Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).
Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.
“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.
To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained.
These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).
Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.
However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).
This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview.
“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”
This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added.
Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”
The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.
No relevant financial relationships have been declared.
A version of this article appeared on Medscape.com.
SAN ANTONIO — than do those who have more extensive surgery, according to findings from a large meta-analysis.
Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.
These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.
Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population.
To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.
In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain.
Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).
The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).
Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).
Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.
“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.
To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained.
These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).
Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.
However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).
This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview.
“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”
This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added.
Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”
The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.
No relevant financial relationships have been declared.
A version of this article appeared on Medscape.com.
FROM SABCS 2023
Hemorrhage-control device holds up in real-world review
Morbidity and mortality related to postpartum hemorrhage (PPH) are often preventable if caught early, but the persistent rise in PPH-associated morbidity illustrates the need for new and innovative treatments, wrote Dena Goffman, MD, of New York-Presbyterian/Columbia University Irving Medical Center, New York, and colleagues.
The device, known as the Jada System, was cleared by the Food and Drug Administration for management of abnormal postpartum uterine bleeding or postpartum hemorrhage (PPH) in August 2020 and showed safety and effectiveness in a registrational study of 106 patients, the researchers said.
In a postmarket registry medical record review known as RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the Jada System), the researchers examined data collected from Oct. 8, 2020, to March 31, 2022, at 16 centers in the United States. The findings were published in Obstetrics & Gynecology.
The study population included all individuals treated with an intrauterine vacuum-induced hemorrhage control device; of these, 530 were vaginal births and 270 were cesarean births. A total of 94.3% had uterine atony, alone or in conjunction with other causes of bleeding. The median maternal age was 30.3 years; approximately 60% and 53% of patients in the vaginal and cesarean groups were White, and approximately 43% and 49% of patients in the two groups, respectively, were nulliparous.
The median blood loss at the time of device insertion was 1,250 mL in vaginal births and 1,980 mL in cesarean births, and the median time from delivery of the placenta to device insertion was 31 minutes and 108 minutes in the two groups, respectively.
The primary endpoint was treatment success, defined as control of bleeding after device insertion, with no escalation of treatment or recurrence of bleeding after the initial bleeding control and device removal.
Treatment success was achieved in 92.5% of vaginal births and 83.7% of cesarean births, and in 95.8% and 88.2%, respectively, among patients with isolated uterine atony. The median insertion time was 3.1 hours for vaginal births and 4.6 hours for cesarean births.
The safety profile was similar to that in the registrational trial and adverse effects were those expected in patients with PPH, the researchers noted.
A total of 14 SAEs were reported in 13 patients with vaginal births, and 22 SAEs were reported in 21 patients with cesarean births. Of these, three were identified as possibly related to the device or procedure (two cases of endometritis in the vaginal birth group and one case of hemorrhagic shock in the cesarean group); no uterine perforations of deaths were reported during the study.
The study was limited by several factors including the use of data mainly from academic centers, which could limit generalizability, and by the use of a mix of estimated and quantitative reporting of blood loss, the researchers noted. Other limitations include the inability to make direct comparisons to other treatments for PPH.
However, the results confirm the safety and efficacy of the device in a real-world setting and support its use as an important new tool in the management of PPH and reducing maternal morbidity and mortality, they concluded.
Two companies were involved in the study; Alydia Health contributed to the concept, design, and analysis, and Organon contributed to data analysis and reviewed the manuscript.
Dr. Goffman disclosed research support from Organon and Alydia Health, as well as serving as a speaker for Haymarket and PRIME PPH education and for Laborie, participation in the Cooper Surgical Obstetrical Safety Council, and serving as an editor for UpToDate. Several coauthors disclosed relationships with multiple companies including Organon and Alydia Health.
Morbidity and mortality related to postpartum hemorrhage (PPH) are often preventable if caught early, but the persistent rise in PPH-associated morbidity illustrates the need for new and innovative treatments, wrote Dena Goffman, MD, of New York-Presbyterian/Columbia University Irving Medical Center, New York, and colleagues.
The device, known as the Jada System, was cleared by the Food and Drug Administration for management of abnormal postpartum uterine bleeding or postpartum hemorrhage (PPH) in August 2020 and showed safety and effectiveness in a registrational study of 106 patients, the researchers said.
In a postmarket registry medical record review known as RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the Jada System), the researchers examined data collected from Oct. 8, 2020, to March 31, 2022, at 16 centers in the United States. The findings were published in Obstetrics & Gynecology.
The study population included all individuals treated with an intrauterine vacuum-induced hemorrhage control device; of these, 530 were vaginal births and 270 were cesarean births. A total of 94.3% had uterine atony, alone or in conjunction with other causes of bleeding. The median maternal age was 30.3 years; approximately 60% and 53% of patients in the vaginal and cesarean groups were White, and approximately 43% and 49% of patients in the two groups, respectively, were nulliparous.
The median blood loss at the time of device insertion was 1,250 mL in vaginal births and 1,980 mL in cesarean births, and the median time from delivery of the placenta to device insertion was 31 minutes and 108 minutes in the two groups, respectively.
The primary endpoint was treatment success, defined as control of bleeding after device insertion, with no escalation of treatment or recurrence of bleeding after the initial bleeding control and device removal.
Treatment success was achieved in 92.5% of vaginal births and 83.7% of cesarean births, and in 95.8% and 88.2%, respectively, among patients with isolated uterine atony. The median insertion time was 3.1 hours for vaginal births and 4.6 hours for cesarean births.
The safety profile was similar to that in the registrational trial and adverse effects were those expected in patients with PPH, the researchers noted.
A total of 14 SAEs were reported in 13 patients with vaginal births, and 22 SAEs were reported in 21 patients with cesarean births. Of these, three were identified as possibly related to the device or procedure (two cases of endometritis in the vaginal birth group and one case of hemorrhagic shock in the cesarean group); no uterine perforations of deaths were reported during the study.
The study was limited by several factors including the use of data mainly from academic centers, which could limit generalizability, and by the use of a mix of estimated and quantitative reporting of blood loss, the researchers noted. Other limitations include the inability to make direct comparisons to other treatments for PPH.
However, the results confirm the safety and efficacy of the device in a real-world setting and support its use as an important new tool in the management of PPH and reducing maternal morbidity and mortality, they concluded.
Two companies were involved in the study; Alydia Health contributed to the concept, design, and analysis, and Organon contributed to data analysis and reviewed the manuscript.
Dr. Goffman disclosed research support from Organon and Alydia Health, as well as serving as a speaker for Haymarket and PRIME PPH education and for Laborie, participation in the Cooper Surgical Obstetrical Safety Council, and serving as an editor for UpToDate. Several coauthors disclosed relationships with multiple companies including Organon and Alydia Health.
Morbidity and mortality related to postpartum hemorrhage (PPH) are often preventable if caught early, but the persistent rise in PPH-associated morbidity illustrates the need for new and innovative treatments, wrote Dena Goffman, MD, of New York-Presbyterian/Columbia University Irving Medical Center, New York, and colleagues.
The device, known as the Jada System, was cleared by the Food and Drug Administration for management of abnormal postpartum uterine bleeding or postpartum hemorrhage (PPH) in August 2020 and showed safety and effectiveness in a registrational study of 106 patients, the researchers said.
In a postmarket registry medical record review known as RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the Jada System), the researchers examined data collected from Oct. 8, 2020, to March 31, 2022, at 16 centers in the United States. The findings were published in Obstetrics & Gynecology.
The study population included all individuals treated with an intrauterine vacuum-induced hemorrhage control device; of these, 530 were vaginal births and 270 were cesarean births. A total of 94.3% had uterine atony, alone or in conjunction with other causes of bleeding. The median maternal age was 30.3 years; approximately 60% and 53% of patients in the vaginal and cesarean groups were White, and approximately 43% and 49% of patients in the two groups, respectively, were nulliparous.
The median blood loss at the time of device insertion was 1,250 mL in vaginal births and 1,980 mL in cesarean births, and the median time from delivery of the placenta to device insertion was 31 minutes and 108 minutes in the two groups, respectively.
The primary endpoint was treatment success, defined as control of bleeding after device insertion, with no escalation of treatment or recurrence of bleeding after the initial bleeding control and device removal.
Treatment success was achieved in 92.5% of vaginal births and 83.7% of cesarean births, and in 95.8% and 88.2%, respectively, among patients with isolated uterine atony. The median insertion time was 3.1 hours for vaginal births and 4.6 hours for cesarean births.
The safety profile was similar to that in the registrational trial and adverse effects were those expected in patients with PPH, the researchers noted.
A total of 14 SAEs were reported in 13 patients with vaginal births, and 22 SAEs were reported in 21 patients with cesarean births. Of these, three were identified as possibly related to the device or procedure (two cases of endometritis in the vaginal birth group and one case of hemorrhagic shock in the cesarean group); no uterine perforations of deaths were reported during the study.
The study was limited by several factors including the use of data mainly from academic centers, which could limit generalizability, and by the use of a mix of estimated and quantitative reporting of blood loss, the researchers noted. Other limitations include the inability to make direct comparisons to other treatments for PPH.
However, the results confirm the safety and efficacy of the device in a real-world setting and support its use as an important new tool in the management of PPH and reducing maternal morbidity and mortality, they concluded.
Two companies were involved in the study; Alydia Health contributed to the concept, design, and analysis, and Organon contributed to data analysis and reviewed the manuscript.
Dr. Goffman disclosed research support from Organon and Alydia Health, as well as serving as a speaker for Haymarket and PRIME PPH education and for Laborie, participation in the Cooper Surgical Obstetrical Safety Council, and serving as an editor for UpToDate. Several coauthors disclosed relationships with multiple companies including Organon and Alydia Health.
FROM OBSTETRICS & GYNECOLOGY
Alternative antirejection regimen is efficacious in pediatric heart transplant
Study challenges everolimus boxed warning
according to the first phase 3 trial to compare antirejection strategies in the pediatric setting.
Even though MMF and tacrolimus have never been evaluated for pediatric cardiac transplant in a controlled trial, this combination is widely considered a standard based on adult data, said Christopher Almond, MD, a professor of pediatric cardiology at Stanford (Calif.) Medicine.
Everolimus has not been widely used in an antirejection regimen in children following heart transplant in part because of a boxed warning. The warning was added to labeling when this agent was associated with increased infection and increased mortality in adults if given within 3 months of transplant.
In this non-inferiority trial, called TEAMMATE, patients were randomized to the MMF-based or everolimus-based regimen 6 months after transplant.
Everolimus- vs. MMF-based antirejection
The study enrolled 210 children and adolescents 21 years of age or younger. The control arm treatment consisted of MMF (660 mg/m2 every 12 hours) plus standard dose of tacrolimus (initially 7-10 ng/mL followed at 6 months by 5-8 ng/mL).
In the experimental arm, patients received everolimus (3-8 ng/mL) plus a low dose of tacrolimus (initially 3-5 ng/mL followed at 6 months by 2.5-4.5 ng/mL).
The primary endpoint was score on the major adverse transplant event (MATE-6) tool. Based on gradations of severity, this assigns values for cardiac allograft vasculopathy (CAV), chronic kidney disease (CKD), acute cellular rejection (ACR), antibody-mediated rejection, infection, and posttransplant lymphoproliferative disorder (PTLD).
Thirty months after randomization, the MATE-6 scores were 1.96 in the everolimus group and 2.18 in the MMF group, which conferred the everolimus-based regimen with a numerical but not a significant advantage over the MMF-based regimen. For the goal of noninferiority, the everolimus regimen “met the prespecified safety criterion for success,” Dr. Almond said.
Numerical advantage for everolimus on efficacy
The primary efficacy endpoint was the MATE-3 score, which is limited to CAV, CKD, and ACR. Again, the mean score on this metric (0.93 vs. 1.25) was lower on the everolimus-based regimen but not significantly different.
Looking at specific events in the MATE-6 score, the everolimus-based regimen was associated with lower numerical rates of CAV and CKD, but a higher rate of PTLD, Dr. Almond reported.
On the MATE-3 efficacy analysis, the everolimus-based regimen was again associated with lower numerical rates of CAV and CKD but higher rates of ACR.
In terms of adverse events, including those involving the gastrointestinal tract, blood cells, proteinuria, and interstitial lung disease, most did not differ markedly even if many were numerically more common in the MMF-based arm. The exception was aphthous stomatitis, which was more common on everolimus (32% vs. 7%; P < .001). There were more discontinuations for an adverse event in the MMF arm (21% vs. 12%; P < .001).
Other differences included a lower proportion of patients in the everolimus arm with anti-HLA antibodies (17% vs. 30%; P < .05). Total cholesterol levels at the end of the study were lower but not significantly different in the MMF group, while the higher median glomerular filtration rate was higher on everolimus, and this did reach statistical significance (P < .05).
Infection rates overall were similar, but cytomegalovirus (CMV) infection was more common on the MMF-based regimen. The 30% lower rate of CMV infection in the everolimus proved to be potentially clinically meaningful when it was considered in the context of MATE-3. When these two endpoints were combined (MATE-3 and CMV infection as a prespecified secondary endpoint, the difference was statistically significant (P = .03) in favor of the everolimus-based regimen,
Study supports safety of everolimus regimen
The take-home message is that the everolimus-based regimen, which “is safe in children and young adults when initiated at 6 months after transplant,” can be considered as an alternative to MFF, Dr. Almond concluded.
However, one of the coauthors of the study, Joseph Rossano, MD, chief of the division of cardiology, Children’s Hospital of Philadelphia, suggested a stronger message.
“These data provide compelling reasons to consider initiation of the combination of everolimus and tacrolimus at 6 months post transplant in pediatric heart transplant recipients,” Dr. Rossano said.
Even though the everolimus-based regimen met the terms of noninferiority overall, patients who received this combination rather than the MMF-based regimen “were less likely to have the combined endpoints of vasculopathy, CKD, rejection and CMV infection. Additionally, they were less likely to make donor specific antibodies,” he said.
He also said that this study challenges the current boxed warning for everolimus. He pointed out that the warning, based on early use of everolimus in adults, does not appear to be an issue for children treated at 6 months.
Early mortality based on infection “was not observed in our study,” he said.
The AHA-invited discussant, Antonio G. Cabrera, MD, division chief of pediatric cardiology, University of Utah, Salt Lake City, drew the same conclusions. Based on the study, the everolimus-based regimen can only be described as noninferior to the MMF-based regimen, but Dr. Cabrera listed the same relative advantages as Dr. Rossano, including better kidney function.
Overall, either regimen might be more appealing based on several variables, but Dr. Cabrera said these data suggest everolimus-based treatment “should be considered” as one of two evidence-based options,
Dr. Almond reported no potential financial conflicts of interest. Dr. Rossano reports financial relationships with Abiomed, Bayer, Cytokinetics, Merck, and Myokardia. Dr. Cabrera reported no potential financial conflicts of interest.
Study challenges everolimus boxed warning
Study challenges everolimus boxed warning
according to the first phase 3 trial to compare antirejection strategies in the pediatric setting.
Even though MMF and tacrolimus have never been evaluated for pediatric cardiac transplant in a controlled trial, this combination is widely considered a standard based on adult data, said Christopher Almond, MD, a professor of pediatric cardiology at Stanford (Calif.) Medicine.
Everolimus has not been widely used in an antirejection regimen in children following heart transplant in part because of a boxed warning. The warning was added to labeling when this agent was associated with increased infection and increased mortality in adults if given within 3 months of transplant.
In this non-inferiority trial, called TEAMMATE, patients were randomized to the MMF-based or everolimus-based regimen 6 months after transplant.
Everolimus- vs. MMF-based antirejection
The study enrolled 210 children and adolescents 21 years of age or younger. The control arm treatment consisted of MMF (660 mg/m2 every 12 hours) plus standard dose of tacrolimus (initially 7-10 ng/mL followed at 6 months by 5-8 ng/mL).
In the experimental arm, patients received everolimus (3-8 ng/mL) plus a low dose of tacrolimus (initially 3-5 ng/mL followed at 6 months by 2.5-4.5 ng/mL).
The primary endpoint was score on the major adverse transplant event (MATE-6) tool. Based on gradations of severity, this assigns values for cardiac allograft vasculopathy (CAV), chronic kidney disease (CKD), acute cellular rejection (ACR), antibody-mediated rejection, infection, and posttransplant lymphoproliferative disorder (PTLD).
Thirty months after randomization, the MATE-6 scores were 1.96 in the everolimus group and 2.18 in the MMF group, which conferred the everolimus-based regimen with a numerical but not a significant advantage over the MMF-based regimen. For the goal of noninferiority, the everolimus regimen “met the prespecified safety criterion for success,” Dr. Almond said.
Numerical advantage for everolimus on efficacy
The primary efficacy endpoint was the MATE-3 score, which is limited to CAV, CKD, and ACR. Again, the mean score on this metric (0.93 vs. 1.25) was lower on the everolimus-based regimen but not significantly different.
Looking at specific events in the MATE-6 score, the everolimus-based regimen was associated with lower numerical rates of CAV and CKD, but a higher rate of PTLD, Dr. Almond reported.
On the MATE-3 efficacy analysis, the everolimus-based regimen was again associated with lower numerical rates of CAV and CKD but higher rates of ACR.
In terms of adverse events, including those involving the gastrointestinal tract, blood cells, proteinuria, and interstitial lung disease, most did not differ markedly even if many were numerically more common in the MMF-based arm. The exception was aphthous stomatitis, which was more common on everolimus (32% vs. 7%; P < .001). There were more discontinuations for an adverse event in the MMF arm (21% vs. 12%; P < .001).
Other differences included a lower proportion of patients in the everolimus arm with anti-HLA antibodies (17% vs. 30%; P < .05). Total cholesterol levels at the end of the study were lower but not significantly different in the MMF group, while the higher median glomerular filtration rate was higher on everolimus, and this did reach statistical significance (P < .05).
Infection rates overall were similar, but cytomegalovirus (CMV) infection was more common on the MMF-based regimen. The 30% lower rate of CMV infection in the everolimus proved to be potentially clinically meaningful when it was considered in the context of MATE-3. When these two endpoints were combined (MATE-3 and CMV infection as a prespecified secondary endpoint, the difference was statistically significant (P = .03) in favor of the everolimus-based regimen,
Study supports safety of everolimus regimen
The take-home message is that the everolimus-based regimen, which “is safe in children and young adults when initiated at 6 months after transplant,” can be considered as an alternative to MFF, Dr. Almond concluded.
However, one of the coauthors of the study, Joseph Rossano, MD, chief of the division of cardiology, Children’s Hospital of Philadelphia, suggested a stronger message.
“These data provide compelling reasons to consider initiation of the combination of everolimus and tacrolimus at 6 months post transplant in pediatric heart transplant recipients,” Dr. Rossano said.
Even though the everolimus-based regimen met the terms of noninferiority overall, patients who received this combination rather than the MMF-based regimen “were less likely to have the combined endpoints of vasculopathy, CKD, rejection and CMV infection. Additionally, they were less likely to make donor specific antibodies,” he said.
He also said that this study challenges the current boxed warning for everolimus. He pointed out that the warning, based on early use of everolimus in adults, does not appear to be an issue for children treated at 6 months.
Early mortality based on infection “was not observed in our study,” he said.
The AHA-invited discussant, Antonio G. Cabrera, MD, division chief of pediatric cardiology, University of Utah, Salt Lake City, drew the same conclusions. Based on the study, the everolimus-based regimen can only be described as noninferior to the MMF-based regimen, but Dr. Cabrera listed the same relative advantages as Dr. Rossano, including better kidney function.
Overall, either regimen might be more appealing based on several variables, but Dr. Cabrera said these data suggest everolimus-based treatment “should be considered” as one of two evidence-based options,
Dr. Almond reported no potential financial conflicts of interest. Dr. Rossano reports financial relationships with Abiomed, Bayer, Cytokinetics, Merck, and Myokardia. Dr. Cabrera reported no potential financial conflicts of interest.
according to the first phase 3 trial to compare antirejection strategies in the pediatric setting.
Even though MMF and tacrolimus have never been evaluated for pediatric cardiac transplant in a controlled trial, this combination is widely considered a standard based on adult data, said Christopher Almond, MD, a professor of pediatric cardiology at Stanford (Calif.) Medicine.
Everolimus has not been widely used in an antirejection regimen in children following heart transplant in part because of a boxed warning. The warning was added to labeling when this agent was associated with increased infection and increased mortality in adults if given within 3 months of transplant.
In this non-inferiority trial, called TEAMMATE, patients were randomized to the MMF-based or everolimus-based regimen 6 months after transplant.
Everolimus- vs. MMF-based antirejection
The study enrolled 210 children and adolescents 21 years of age or younger. The control arm treatment consisted of MMF (660 mg/m2 every 12 hours) plus standard dose of tacrolimus (initially 7-10 ng/mL followed at 6 months by 5-8 ng/mL).
In the experimental arm, patients received everolimus (3-8 ng/mL) plus a low dose of tacrolimus (initially 3-5 ng/mL followed at 6 months by 2.5-4.5 ng/mL).
The primary endpoint was score on the major adverse transplant event (MATE-6) tool. Based on gradations of severity, this assigns values for cardiac allograft vasculopathy (CAV), chronic kidney disease (CKD), acute cellular rejection (ACR), antibody-mediated rejection, infection, and posttransplant lymphoproliferative disorder (PTLD).
Thirty months after randomization, the MATE-6 scores were 1.96 in the everolimus group and 2.18 in the MMF group, which conferred the everolimus-based regimen with a numerical but not a significant advantage over the MMF-based regimen. For the goal of noninferiority, the everolimus regimen “met the prespecified safety criterion for success,” Dr. Almond said.
Numerical advantage for everolimus on efficacy
The primary efficacy endpoint was the MATE-3 score, which is limited to CAV, CKD, and ACR. Again, the mean score on this metric (0.93 vs. 1.25) was lower on the everolimus-based regimen but not significantly different.
Looking at specific events in the MATE-6 score, the everolimus-based regimen was associated with lower numerical rates of CAV and CKD, but a higher rate of PTLD, Dr. Almond reported.
On the MATE-3 efficacy analysis, the everolimus-based regimen was again associated with lower numerical rates of CAV and CKD but higher rates of ACR.
In terms of adverse events, including those involving the gastrointestinal tract, blood cells, proteinuria, and interstitial lung disease, most did not differ markedly even if many were numerically more common in the MMF-based arm. The exception was aphthous stomatitis, which was more common on everolimus (32% vs. 7%; P < .001). There were more discontinuations for an adverse event in the MMF arm (21% vs. 12%; P < .001).
Other differences included a lower proportion of patients in the everolimus arm with anti-HLA antibodies (17% vs. 30%; P < .05). Total cholesterol levels at the end of the study were lower but not significantly different in the MMF group, while the higher median glomerular filtration rate was higher on everolimus, and this did reach statistical significance (P < .05).
Infection rates overall were similar, but cytomegalovirus (CMV) infection was more common on the MMF-based regimen. The 30% lower rate of CMV infection in the everolimus proved to be potentially clinically meaningful when it was considered in the context of MATE-3. When these two endpoints were combined (MATE-3 and CMV infection as a prespecified secondary endpoint, the difference was statistically significant (P = .03) in favor of the everolimus-based regimen,
Study supports safety of everolimus regimen
The take-home message is that the everolimus-based regimen, which “is safe in children and young adults when initiated at 6 months after transplant,” can be considered as an alternative to MFF, Dr. Almond concluded.
However, one of the coauthors of the study, Joseph Rossano, MD, chief of the division of cardiology, Children’s Hospital of Philadelphia, suggested a stronger message.
“These data provide compelling reasons to consider initiation of the combination of everolimus and tacrolimus at 6 months post transplant in pediatric heart transplant recipients,” Dr. Rossano said.
Even though the everolimus-based regimen met the terms of noninferiority overall, patients who received this combination rather than the MMF-based regimen “were less likely to have the combined endpoints of vasculopathy, CKD, rejection and CMV infection. Additionally, they were less likely to make donor specific antibodies,” he said.
He also said that this study challenges the current boxed warning for everolimus. He pointed out that the warning, based on early use of everolimus in adults, does not appear to be an issue for children treated at 6 months.
Early mortality based on infection “was not observed in our study,” he said.
The AHA-invited discussant, Antonio G. Cabrera, MD, division chief of pediatric cardiology, University of Utah, Salt Lake City, drew the same conclusions. Based on the study, the everolimus-based regimen can only be described as noninferior to the MMF-based regimen, but Dr. Cabrera listed the same relative advantages as Dr. Rossano, including better kidney function.
Overall, either regimen might be more appealing based on several variables, but Dr. Cabrera said these data suggest everolimus-based treatment “should be considered” as one of two evidence-based options,
Dr. Almond reported no potential financial conflicts of interest. Dr. Rossano reports financial relationships with Abiomed, Bayer, Cytokinetics, Merck, and Myokardia. Dr. Cabrera reported no potential financial conflicts of interest.
FROM AHA 2023
Algorithm cuts time to incision in urgent cesarean deliveries
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Product Update
REVIEW
By James Greenberg, MD
Chief of Gynecology
Associate Professor, Harvard Medical School
Boston, Massachusetts
Guardenia: A “really great solution” for contained tissue extraction
The Guardenia Contained Extraction System, developed by Advanced Surgical Concepts (Wicklow, Ireland), offers a comprehensive approach to contained tissue extraction.
Background. Contained tissue extraction has been an integral part of laparoscopic procedures from at least the late 1980s and early 1990s. Bags of one sort or another are routinely used to remove from the abdomen all sorts of human tissues, including but not limited to ovaries, ectopic pregnancies, gallbladders, kidneys, spleens, and the list goes on. However, after the April 17, 2014, FDA Safety Communication discouraging the use of power morcellators with myomectomy or hysterectomy, the need for more robust contained tissue extraction systems has been ongoing, and there has yet to be a really good solution despite some innovative attempts.
Design/Functionality. Advanced Surgical Concepts’ Guardenia System is the latest attempt to provide a “really great solution” for surgeons to address my 3 “musts” for any system to gain traction in this niche.
- Must #1. An easy method for getting the device into the abdomen.
- Must #2. An easy method for getting the tissue into the bag.
- Must #3. An easy method for getting the tissue out of the body while still containing the cells within the system.
In my opinion based on my usage, Guardenia does a pretty good job addressing all my “musts.”
The Guardenia System is a sterile, single-use device with 3 main components—an introducer with a plunger that will fit through any standard 12-mm trocar, a polyurethane film bag supported by a nitinol ring, and an opening ring with expandable semi-rigid polyethylene “Guard Petals.” When I used it in the operating room to manually morcellate a 10-cm myoma through the umbilicus, I thought it was pretty spot on. Getting the bag into the abdomen is 100% intuitive but even has a nifty up-arrow built onto the tip to make sure the bag is opened in the proper direction. The bag material and the nitinol ring, in combination with the 17.5-cm opening ring, make the process of getting the specimen into the bag and exteriorized easier than any other system I have ever used. And, the opening ring with the Guard Petals yields a very large retraction area for the incision size while providing excellent protection to the surrounding tissues. Overall, Guardenia worked better than anything else I have previously used.
Innovation. Guardenia does not really introduce any fundamentally novel ideas, but it does combine a lot of standard technologies into a product whose sum is much larger than its parts. I would like to see it combined with an occlusive top piece to allow the retractor to be used for single-port laparoscopy as well, but that would just be the cherry on top.
Summary. I have been working on inventing a really good contained tissue extraction system for a long time, and I am a bit chagrined to see someone else outsmart me (low bar), but Advanced Surgical Concepts did, and I really like Guardenia. For pathology that is appropriate for contained morcellation, this device is definitely worth a try, and I suspect many surgeons will switch to it from whatever they are currently using.
FOR MORE INFORMATION, VISIT https://advancedsurgical.ie/guardenia-contained-extraction-system/
The views of the author are personal opinions and do not necessarily represent the views of
REVIEW
By James Greenberg, MD
Chief of Gynecology
Associate Professor, Harvard Medical School
Boston, Massachusetts
Guardenia: A “really great solution” for contained tissue extraction
The Guardenia Contained Extraction System, developed by Advanced Surgical Concepts (Wicklow, Ireland), offers a comprehensive approach to contained tissue extraction.
Background. Contained tissue extraction has been an integral part of laparoscopic procedures from at least the late 1980s and early 1990s. Bags of one sort or another are routinely used to remove from the abdomen all sorts of human tissues, including but not limited to ovaries, ectopic pregnancies, gallbladders, kidneys, spleens, and the list goes on. However, after the April 17, 2014, FDA Safety Communication discouraging the use of power morcellators with myomectomy or hysterectomy, the need for more robust contained tissue extraction systems has been ongoing, and there has yet to be a really good solution despite some innovative attempts.
Design/Functionality. Advanced Surgical Concepts’ Guardenia System is the latest attempt to provide a “really great solution” for surgeons to address my 3 “musts” for any system to gain traction in this niche.
- Must #1. An easy method for getting the device into the abdomen.
- Must #2. An easy method for getting the tissue into the bag.
- Must #3. An easy method for getting the tissue out of the body while still containing the cells within the system.
In my opinion based on my usage, Guardenia does a pretty good job addressing all my “musts.”
The Guardenia System is a sterile, single-use device with 3 main components—an introducer with a plunger that will fit through any standard 12-mm trocar, a polyurethane film bag supported by a nitinol ring, and an opening ring with expandable semi-rigid polyethylene “Guard Petals.” When I used it in the operating room to manually morcellate a 10-cm myoma through the umbilicus, I thought it was pretty spot on. Getting the bag into the abdomen is 100% intuitive but even has a nifty up-arrow built onto the tip to make sure the bag is opened in the proper direction. The bag material and the nitinol ring, in combination with the 17.5-cm opening ring, make the process of getting the specimen into the bag and exteriorized easier than any other system I have ever used. And, the opening ring with the Guard Petals yields a very large retraction area for the incision size while providing excellent protection to the surrounding tissues. Overall, Guardenia worked better than anything else I have previously used.
Innovation. Guardenia does not really introduce any fundamentally novel ideas, but it does combine a lot of standard technologies into a product whose sum is much larger than its parts. I would like to see it combined with an occlusive top piece to allow the retractor to be used for single-port laparoscopy as well, but that would just be the cherry on top.
Summary. I have been working on inventing a really good contained tissue extraction system for a long time, and I am a bit chagrined to see someone else outsmart me (low bar), but Advanced Surgical Concepts did, and I really like Guardenia. For pathology that is appropriate for contained morcellation, this device is definitely worth a try, and I suspect many surgeons will switch to it from whatever they are currently using.
FOR MORE INFORMATION, VISIT https://advancedsurgical.ie/guardenia-contained-extraction-system/
The views of the author are personal opinions and do not necessarily represent the views of
REVIEW
By James Greenberg, MD
Chief of Gynecology
Associate Professor, Harvard Medical School
Boston, Massachusetts
Guardenia: A “really great solution” for contained tissue extraction
The Guardenia Contained Extraction System, developed by Advanced Surgical Concepts (Wicklow, Ireland), offers a comprehensive approach to contained tissue extraction.
Background. Contained tissue extraction has been an integral part of laparoscopic procedures from at least the late 1980s and early 1990s. Bags of one sort or another are routinely used to remove from the abdomen all sorts of human tissues, including but not limited to ovaries, ectopic pregnancies, gallbladders, kidneys, spleens, and the list goes on. However, after the April 17, 2014, FDA Safety Communication discouraging the use of power morcellators with myomectomy or hysterectomy, the need for more robust contained tissue extraction systems has been ongoing, and there has yet to be a really good solution despite some innovative attempts.
Design/Functionality. Advanced Surgical Concepts’ Guardenia System is the latest attempt to provide a “really great solution” for surgeons to address my 3 “musts” for any system to gain traction in this niche.
- Must #1. An easy method for getting the device into the abdomen.
- Must #2. An easy method for getting the tissue into the bag.
- Must #3. An easy method for getting the tissue out of the body while still containing the cells within the system.
In my opinion based on my usage, Guardenia does a pretty good job addressing all my “musts.”
The Guardenia System is a sterile, single-use device with 3 main components—an introducer with a plunger that will fit through any standard 12-mm trocar, a polyurethane film bag supported by a nitinol ring, and an opening ring with expandable semi-rigid polyethylene “Guard Petals.” When I used it in the operating room to manually morcellate a 10-cm myoma through the umbilicus, I thought it was pretty spot on. Getting the bag into the abdomen is 100% intuitive but even has a nifty up-arrow built onto the tip to make sure the bag is opened in the proper direction. The bag material and the nitinol ring, in combination with the 17.5-cm opening ring, make the process of getting the specimen into the bag and exteriorized easier than any other system I have ever used. And, the opening ring with the Guard Petals yields a very large retraction area for the incision size while providing excellent protection to the surrounding tissues. Overall, Guardenia worked better than anything else I have previously used.
Innovation. Guardenia does not really introduce any fundamentally novel ideas, but it does combine a lot of standard technologies into a product whose sum is much larger than its parts. I would like to see it combined with an occlusive top piece to allow the retractor to be used for single-port laparoscopy as well, but that would just be the cherry on top.
Summary. I have been working on inventing a really good contained tissue extraction system for a long time, and I am a bit chagrined to see someone else outsmart me (low bar), but Advanced Surgical Concepts did, and I really like Guardenia. For pathology that is appropriate for contained morcellation, this device is definitely worth a try, and I suspect many surgeons will switch to it from whatever they are currently using.
FOR MORE INFORMATION, VISIT https://advancedsurgical.ie/guardenia-contained-extraction-system/
The views of the author are personal opinions and do not necessarily represent the views of
Surgery approach may improve survival in advanced ovarian cancer
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Minimally invasive surfactant shows some benefit in infants’ first 2 years
Results of the OPTIMIST follow-up study were published online in JAMA.
Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.
However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
Study spanned 11 countries
The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.
It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.
The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
No significant difference in deaths, NDD
Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).
Secondary respiratory outcomes were better in the MIST group:
- Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
- Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
- Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
- Reported use of inhaled relievers (beta2 agonists) was 23.9% in the MIST group versus 38.7% in controls.
The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021.
Important benefit for respiratory health
Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”
Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.
“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”
Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”
Therefore, the finding of benefit to respiratory health is particularly important, he said.
He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.
“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.
Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.
Results of the OPTIMIST follow-up study were published online in JAMA.
Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.
However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
Study spanned 11 countries
The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.
It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.
The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
No significant difference in deaths, NDD
Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).
Secondary respiratory outcomes were better in the MIST group:
- Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
- Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
- Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
- Reported use of inhaled relievers (beta2 agonists) was 23.9% in the MIST group versus 38.7% in controls.
The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021.
Important benefit for respiratory health
Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”
Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.
“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”
Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”
Therefore, the finding of benefit to respiratory health is particularly important, he said.
He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.
“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.
Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.
Results of the OPTIMIST follow-up study were published online in JAMA.
Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.
However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
Study spanned 11 countries
The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.
It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.
The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
No significant difference in deaths, NDD
Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).
Secondary respiratory outcomes were better in the MIST group:
- Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
- Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
- Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
- Reported use of inhaled relievers (beta2 agonists) was 23.9% in the MIST group versus 38.7% in controls.
The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021.
Important benefit for respiratory health
Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”
Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.
“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”
Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”
Therefore, the finding of benefit to respiratory health is particularly important, he said.
He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.
“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.
Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.
FROM JAMA