A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.

In Massachusetts, the rate of lung cancer screening in high-risk individuals is almost 25 times higher than that seen in Nevada, according to the American Lung Association.

That disparity might suggest that Massachusetts has an exceptionally high rate, but it’s only 12.3%. And that means Nevada’s rate is very low, which it is: Only 0.5% of those at high risk are getting screened with annual low-dose CT scans, the ALA said in its 2019 State of Lung Cancer report.

“[The low rate of screening] may be because of a lack of access or low awareness and knowledge among patients and providers. As rates vary tremendously between states, it is clear that more can be done to increase screening rates,” the ALA stated.

Nationally, the screening rate is 4.2% among those at high risk for lung cancer, but “if everyone currently eligible were screened, close to 48,000 lives could be saved,” the ALA noted in its report.

Six states other than Nevada are below the 2% mark: Arizona, California, New Mexico, Oklahoma, Texas, and Wyoming. Besides Massachusetts, the three other states above 10% are Kentucky, New Hampshire, and Vermont, according to data from the American College of Radiology’s Lung Cancer Screening Registry state-level comparison for 2018.

For individuals at high risk for lung cancer – those aged 55-80 years who have at least a 30 pack-year history and either still smoke or have quit within 15 years – “screening with annual low-dose CT scans can reduce the lung cancer death rate by up to 20% by detecting tumors at early stages when the cancer is more likely to be curable,” the ALA wrote.

[email protected]

In Massachusetts, the rate of lung cancer screening in high-risk individuals is almost 25 times higher than that seen in Nevada, according to the American Lung Association.

That disparity might suggest that Massachusetts has an exceptionally high rate, but it’s only 12.3%. And that means Nevada’s rate is very low, which it is: Only 0.5% of those at high risk are getting screened with annual low-dose CT scans, the ALA said in its 2019 State of Lung Cancer report.

“[The low rate of screening] may be because of a lack of access or low awareness and knowledge among patients and providers. As rates vary tremendously between states, it is clear that more can be done to increase screening rates,” the ALA stated.

Nationally, the screening rate is 4.2% among those at high risk for lung cancer, but “if everyone currently eligible were screened, close to 48,000 lives could be saved,” the ALA noted in its report.

Six states other than Nevada are below the 2% mark: Arizona, California, New Mexico, Oklahoma, Texas, and Wyoming. Besides Massachusetts, the three other states above 10% are Kentucky, New Hampshire, and Vermont, according to data from the American College of Radiology’s Lung Cancer Screening Registry state-level comparison for 2018.

For individuals at high risk for lung cancer – those aged 55-80 years who have at least a 30 pack-year history and either still smoke or have quit within 15 years – “screening with annual low-dose CT scans can reduce the lung cancer death rate by up to 20% by detecting tumors at early stages when the cancer is more likely to be curable,” the ALA wrote.

[email protected]

In Massachusetts, the rate of lung cancer screening in high-risk individuals is almost 25 times higher than that seen in Nevada, according to the American Lung Association.

That disparity might suggest that Massachusetts has an exceptionally high rate, but it’s only 12.3%. And that means Nevada’s rate is very low, which it is: Only 0.5% of those at high risk are getting screened with annual low-dose CT scans, the ALA said in its 2019 State of Lung Cancer report.

“[The low rate of screening] may be because of a lack of access or low awareness and knowledge among patients and providers. As rates vary tremendously between states, it is clear that more can be done to increase screening rates,” the ALA stated.

Nationally, the screening rate is 4.2% among those at high risk for lung cancer, but “if everyone currently eligible were screened, close to 48,000 lives could be saved,” the ALA noted in its report.

Six states other than Nevada are below the 2% mark: Arizona, California, New Mexico, Oklahoma, Texas, and Wyoming. Besides Massachusetts, the three other states above 10% are Kentucky, New Hampshire, and Vermont, according to data from the American College of Radiology’s Lung Cancer Screening Registry state-level comparison for 2018.

For individuals at high risk for lung cancer – those aged 55-80 years who have at least a 30 pack-year history and either still smoke or have quit within 15 years – “screening with annual low-dose CT scans can reduce the lung cancer death rate by up to 20% by detecting tumors at early stages when the cancer is more likely to be curable,” the ALA wrote.

[email protected]

A single-use duodenoscope may reduce the risk of postendoscopic infections while maintaining a high level of user satisfaction, based on a recent multicenter case series study.

At six tertiary referral centers in the United States, seven expert endoscopists performed more than 70 procedures with disposable scopes, ultimately reporting a median satisfaction score of 9 out of 10, according to lead author Venkataraman Muthusamy, MD, of UCLA Health in Los Angeles, and colleagues.

Writing for Clinical Gastroenterology and Hepatology, the investigators noted that duodenoscope-related infections represent a serious threat to public health, particularly when considered in the context of antibiotic resistance and the high number of endoscopic procedures performed annually.

“Solutions to the duodenoscope contamination problem remain elusive,” the investigators wrote. “Evidence-based interventions are important to guard against labor-intensive measures that are unfeasible, unaffordable, and potentially ineffective.”

According to the investigators, routine culture surveillance and field investigations following suspected duodenoscope-related infections may fail to detect culprit bacteria or shortcomings in equipment reprocessing; and even when performed correctly, standard reprocessing can be insufficient.

“Using current reprocessing techniques, improved compliance with reprocessing guidelines is not a definitive solution because reusable duodenoscope contamination may be present even after high-level disinfection or sterilization,” the investigators wrote, going on to cite Food and Drug Administration–reported contamination rates of 5.4% for high-concern organisms.

To determine if a single-use endoscope could overcome such risks, the investigators first conducted preclinical testing with animal laboratories and simulations, finding that a single-use duodenoscope was comparable with three reusable scope models. The present study, which included 73 patients with normal pancreaticobiliary anatomy, evaluated clinical feasibility, safety, and performance. The single-use duodenoscope was a first-generation device by Boston Scientific named EXALT Model D.

Of the 73 patients, 13 underwent roll-in maneuvers and 60 underwent endoscopic retrograde cholangiopancreatography (ERCP). The most common cause for ERCP was exchange or removal of biliary stent (55.0%), followed by evaluation of biliary defect or stricture (26.7%), then bile duct stone clearance (18.3%). The majority of ERCPs had an American Society for Gastrointestinal Endoscopy (ASGE) procedural complexity grade of 2 (43.3%) or 3 (43.3%), while a minority were graded 1 (11.7%) or, most severe, 4 (1.7%).

Two ERCPs required crossover to a reusable duodenoscope for completion. In the first instance, crossover was needed because dilation of a biliary stricture was unsuccessful, with the endoscopist reporting difficulties maneuvering the disposable scope, possibly because of shaft stiffness. In the second case, crossover was elected because cannulation was unsuccessful with standard access techniques; however, cannulation also was not possible with the reusable scope, necessitating an alternative approach.

According to the investigators, safety signals were comparable with standard practice. No serious, scope-related adverse events were reported. Serious adverse events of any kind were relatively uncommon; three patients developed post-ERCP pancreatitis within 7 days of ERCP, one developed a postsphincterotomy bleed, and one had worsening of a preexisting infection that required hospitalization.

As described above, the endoscopists reported a median overall satisfaction score of 9 out of 10. Specifically, 17 out of 23 scored ERCP maneuvers (73.9%) received a median 5 out of 5 performance rating. Out of 1,289 total ratings, almost all (98.1%) received a performance rating of at least 3 out of 5. Low-scoring performance characteristics (receiving at least one “1” rating), included elevator function; aspects of positioning; visualization; image quality, brightness, or appearance; and ease and ability of passing ancillary devices through the channel of the single-use duodenoscope and into the papilla.

“The new device provides an alternative to reusable duodenoscopes that may harbor residual contamination despite appropriately implemented reprocessing,” the investigators concluded.

They also pointed out that switching to disposable scopes would not completely put an end to postendoscopic infections.

“The single-use duodenoscope is a timely and innovative option to improve exogenous infection control, and must be used with awareness of the continued risk of endogenous infection, with standard infection control precautions and continued diligence in the use of existing reusable devices,” they wrote.

The study was funded by Boston Scientific. The investigators reported additional relationships with Medtronic, Ethicon/Torax, CapsoVision, and others.

SOURCE: Muthusamy V et al. Clin Gastroenterol Hepatol. 2019 Oct 11. doi: 10.1016/j.cgh.2019.10.052.

A single-use duodenoscope may reduce the risk of postendoscopic infections while maintaining a high level of user satisfaction, based on a recent multicenter case series study.

At six tertiary referral centers in the United States, seven expert endoscopists performed more than 70 procedures with disposable scopes, ultimately reporting a median satisfaction score of 9 out of 10, according to lead author Venkataraman Muthusamy, MD, of UCLA Health in Los Angeles, and colleagues.

Writing for Clinical Gastroenterology and Hepatology, the investigators noted that duodenoscope-related infections represent a serious threat to public health, particularly when considered in the context of antibiotic resistance and the high number of endoscopic procedures performed annually.

“Solutions to the duodenoscope contamination problem remain elusive,” the investigators wrote. “Evidence-based interventions are important to guard against labor-intensive measures that are unfeasible, unaffordable, and potentially ineffective.”

According to the investigators, routine culture surveillance and field investigations following suspected duodenoscope-related infections may fail to detect culprit bacteria or shortcomings in equipment reprocessing; and even when performed correctly, standard reprocessing can be insufficient.

“Using current reprocessing techniques, improved compliance with reprocessing guidelines is not a definitive solution because reusable duodenoscope contamination may be present even after high-level disinfection or sterilization,” the investigators wrote, going on to cite Food and Drug Administration–reported contamination rates of 5.4% for high-concern organisms.

To determine if a single-use endoscope could overcome such risks, the investigators first conducted preclinical testing with animal laboratories and simulations, finding that a single-use duodenoscope was comparable with three reusable scope models. The present study, which included 73 patients with normal pancreaticobiliary anatomy, evaluated clinical feasibility, safety, and performance. The single-use duodenoscope was a first-generation device by Boston Scientific named EXALT Model D.

Of the 73 patients, 13 underwent roll-in maneuvers and 60 underwent endoscopic retrograde cholangiopancreatography (ERCP). The most common cause for ERCP was exchange or removal of biliary stent (55.0%), followed by evaluation of biliary defect or stricture (26.7%), then bile duct stone clearance (18.3%). The majority of ERCPs had an American Society for Gastrointestinal Endoscopy (ASGE) procedural complexity grade of 2 (43.3%) or 3 (43.3%), while a minority were graded 1 (11.7%) or, most severe, 4 (1.7%).

Two ERCPs required crossover to a reusable duodenoscope for completion. In the first instance, crossover was needed because dilation of a biliary stricture was unsuccessful, with the endoscopist reporting difficulties maneuvering the disposable scope, possibly because of shaft stiffness. In the second case, crossover was elected because cannulation was unsuccessful with standard access techniques; however, cannulation also was not possible with the reusable scope, necessitating an alternative approach.

According to the investigators, safety signals were comparable with standard practice. No serious, scope-related adverse events were reported. Serious adverse events of any kind were relatively uncommon; three patients developed post-ERCP pancreatitis within 7 days of ERCP, one developed a postsphincterotomy bleed, and one had worsening of a preexisting infection that required hospitalization.

As described above, the endoscopists reported a median overall satisfaction score of 9 out of 10. Specifically, 17 out of 23 scored ERCP maneuvers (73.9%) received a median 5 out of 5 performance rating. Out of 1,289 total ratings, almost all (98.1%) received a performance rating of at least 3 out of 5. Low-scoring performance characteristics (receiving at least one “1” rating), included elevator function; aspects of positioning; visualization; image quality, brightness, or appearance; and ease and ability of passing ancillary devices through the channel of the single-use duodenoscope and into the papilla.

“The new device provides an alternative to reusable duodenoscopes that may harbor residual contamination despite appropriately implemented reprocessing,” the investigators concluded.

They also pointed out that switching to disposable scopes would not completely put an end to postendoscopic infections.

“The single-use duodenoscope is a timely and innovative option to improve exogenous infection control, and must be used with awareness of the continued risk of endogenous infection, with standard infection control precautions and continued diligence in the use of existing reusable devices,” they wrote.

The study was funded by Boston Scientific. The investigators reported additional relationships with Medtronic, Ethicon/Torax, CapsoVision, and others.

SOURCE: Muthusamy V et al. Clin Gastroenterol Hepatol. 2019 Oct 11. doi: 10.1016/j.cgh.2019.10.052.

A single-use duodenoscope may reduce the risk of postendoscopic infections while maintaining a high level of user satisfaction, based on a recent multicenter case series study.

At six tertiary referral centers in the United States, seven expert endoscopists performed more than 70 procedures with disposable scopes, ultimately reporting a median satisfaction score of 9 out of 10, according to lead author Venkataraman Muthusamy, MD, of UCLA Health in Los Angeles, and colleagues.

Writing for Clinical Gastroenterology and Hepatology, the investigators noted that duodenoscope-related infections represent a serious threat to public health, particularly when considered in the context of antibiotic resistance and the high number of endoscopic procedures performed annually.

“Solutions to the duodenoscope contamination problem remain elusive,” the investigators wrote. “Evidence-based interventions are important to guard against labor-intensive measures that are unfeasible, unaffordable, and potentially ineffective.”

According to the investigators, routine culture surveillance and field investigations following suspected duodenoscope-related infections may fail to detect culprit bacteria or shortcomings in equipment reprocessing; and even when performed correctly, standard reprocessing can be insufficient.

“Using current reprocessing techniques, improved compliance with reprocessing guidelines is not a definitive solution because reusable duodenoscope contamination may be present even after high-level disinfection or sterilization,” the investigators wrote, going on to cite Food and Drug Administration–reported contamination rates of 5.4% for high-concern organisms.

To determine if a single-use endoscope could overcome such risks, the investigators first conducted preclinical testing with animal laboratories and simulations, finding that a single-use duodenoscope was comparable with three reusable scope models. The present study, which included 73 patients with normal pancreaticobiliary anatomy, evaluated clinical feasibility, safety, and performance. The single-use duodenoscope was a first-generation device by Boston Scientific named EXALT Model D.

Of the 73 patients, 13 underwent roll-in maneuvers and 60 underwent endoscopic retrograde cholangiopancreatography (ERCP). The most common cause for ERCP was exchange or removal of biliary stent (55.0%), followed by evaluation of biliary defect or stricture (26.7%), then bile duct stone clearance (18.3%). The majority of ERCPs had an American Society for Gastrointestinal Endoscopy (ASGE) procedural complexity grade of 2 (43.3%) or 3 (43.3%), while a minority were graded 1 (11.7%) or, most severe, 4 (1.7%).

Two ERCPs required crossover to a reusable duodenoscope for completion. In the first instance, crossover was needed because dilation of a biliary stricture was unsuccessful, with the endoscopist reporting difficulties maneuvering the disposable scope, possibly because of shaft stiffness. In the second case, crossover was elected because cannulation was unsuccessful with standard access techniques; however, cannulation also was not possible with the reusable scope, necessitating an alternative approach.

According to the investigators, safety signals were comparable with standard practice. No serious, scope-related adverse events were reported. Serious adverse events of any kind were relatively uncommon; three patients developed post-ERCP pancreatitis within 7 days of ERCP, one developed a postsphincterotomy bleed, and one had worsening of a preexisting infection that required hospitalization.

As described above, the endoscopists reported a median overall satisfaction score of 9 out of 10. Specifically, 17 out of 23 scored ERCP maneuvers (73.9%) received a median 5 out of 5 performance rating. Out of 1,289 total ratings, almost all (98.1%) received a performance rating of at least 3 out of 5. Low-scoring performance characteristics (receiving at least one “1” rating), included elevator function; aspects of positioning; visualization; image quality, brightness, or appearance; and ease and ability of passing ancillary devices through the channel of the single-use duodenoscope and into the papilla.

“The new device provides an alternative to reusable duodenoscopes that may harbor residual contamination despite appropriately implemented reprocessing,” the investigators concluded.

They also pointed out that switching to disposable scopes would not completely put an end to postendoscopic infections.

“The single-use duodenoscope is a timely and innovative option to improve exogenous infection control, and must be used with awareness of the continued risk of endogenous infection, with standard infection control precautions and continued diligence in the use of existing reusable devices,” they wrote.

The study was funded by Boston Scientific. The investigators reported additional relationships with Medtronic, Ethicon/Torax, CapsoVision, and others.

SOURCE: Muthusamy V et al. Clin Gastroenterol Hepatol. 2019 Oct 11. doi: 10.1016/j.cgh.2019.10.052.

PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.

Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.

“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”

The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.

“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”

“Almost never,” Dr. Weintraub responded.

REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.

The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.

An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”

The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.

Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.

Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.

SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
 

PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.

Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.

“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”

The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.

“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”

“Almost never,” Dr. Weintraub responded.

REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.

The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.

An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”

The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.

Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.

Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.

SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
 

PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.

Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.

“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”

The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.

“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”

“Almost never,” Dr. Weintraub responded.

REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.

The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.

An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”

The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.

Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.

Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.

SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
 

Nearly one in five adolescents and one in four young adults in the United States have prediabetes, with a higher prevalence among males, a study has found.

copyright Martynasfoto/Thinkstock

Linda J. Andes, PhD, from the Centers for Disease Control and Prevention and coauthors reported in JAMA Pediatrics their analysis of data from 2,606 adolescent (12-18 years) and 3,180 young adult (19-34 years) participants in the 2005-2016 National Health and Nutrition Examination Surveys.

This found that the percentage with prediabetes – defined as either impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or increased hemoglobin A_1c (HbA_1c) level – was 18% among adolescents and 24% among young adults.

The most common condition was IFG, which was seen in 11% of adolescents and 16% of young adults. The rate of IGT was 4% in adolescents and 6% of young adults, while elevated HbA_1c levels were seen in 5% of adolescents and 8% of young adults.

This information is important because “In adults, these three phenotypes increase the risk of developing type 2 diabetes as well as cardiovascular diseases,” Dr. Andes and coauthors wrote. “In 2011-2012, the overall prevalence of prediabetes among U.S. adults, defined as the presence of any of the three glucose metabolism dysregulation phenotypes, was 38% and it increased to about 50% in persons 65 years and older.”

Dr. Andes and associates noted that isolated IFG was the most common glucose dysregulation seen in both adolescents and young adults. “While individuals with IFG are at increased risk for type 2 diabetes, few primary prevention trials have included individuals selected for the presence of IFG and none have been conducted in adolescents with IFG or IGT to our knowledge.”

The study saw some key gender differences in prevalence. For example, the prevalence of IFG was significantly lower in adolescent girls than in boys (7% vs. 15%; P less than .001), and in young women, compared with young men (10% vs. 22%; P less than .001).

“These findings are consistent with those of other studies in adults; however, the underlying mechanisms for explaining this discrepancy are still unclear,” Dr. Andes and coauthors wrote.

Ethnicity also appeared to influence risk, with the prevalence of IFG significantly lower in non-Hispanic black adolescents, compared with Hispanic adolescents. However, increased HbA_1c levels were significantly more prevalent in non-Hispanic black adolescents, compared with Hispanic or non-Hispanic white adolescents.

“These findings highlight the need for additional studies on the long-term consequences and preventive strategies of abnormal glucose metabolism as measured by HbA_1c levels in adolescents and young adults, especially of minority racial/ethnic groups,” the authors wrote.

Adolescents with prediabetes had significantly higher systolic blood pressure, non-HDL cholesterol, waist-to-height ratio, higher body mass index, and lower insulin sensitivity, compared with those with normal glucose tolerance. Among young adults with prediabetes, there was significantly higher systolic blood pressure and non-HDL cholesterol, compared with individuals with normal glucose tolerance.

No funding or conflicts of interest were declared.

SOURCE: Andes LJ et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4498.

Nearly one in five adolescents and one in four young adults in the United States have prediabetes, with a higher prevalence among males, a study has found.

copyright Martynasfoto/Thinkstock

Linda J. Andes, PhD, from the Centers for Disease Control and Prevention and coauthors reported in JAMA Pediatrics their analysis of data from 2,606 adolescent (12-18 years) and 3,180 young adult (19-34 years) participants in the 2005-2016 National Health and Nutrition Examination Surveys.

This found that the percentage with prediabetes – defined as either impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or increased hemoglobin A_1c (HbA_1c) level – was 18% among adolescents and 24% among young adults.

The most common condition was IFG, which was seen in 11% of adolescents and 16% of young adults. The rate of IGT was 4% in adolescents and 6% of young adults, while elevated HbA_1c levels were seen in 5% of adolescents and 8% of young adults.

This information is important because “In adults, these three phenotypes increase the risk of developing type 2 diabetes as well as cardiovascular diseases,” Dr. Andes and coauthors wrote. “In 2011-2012, the overall prevalence of prediabetes among U.S. adults, defined as the presence of any of the three glucose metabolism dysregulation phenotypes, was 38% and it increased to about 50% in persons 65 years and older.”

Dr. Andes and associates noted that isolated IFG was the most common glucose dysregulation seen in both adolescents and young adults. “While individuals with IFG are at increased risk for type 2 diabetes, few primary prevention trials have included individuals selected for the presence of IFG and none have been conducted in adolescents with IFG or IGT to our knowledge.”

The study saw some key gender differences in prevalence. For example, the prevalence of IFG was significantly lower in adolescent girls than in boys (7% vs. 15%; P less than .001), and in young women, compared with young men (10% vs. 22%; P less than .001).

“These findings are consistent with those of other studies in adults; however, the underlying mechanisms for explaining this discrepancy are still unclear,” Dr. Andes and coauthors wrote.

Ethnicity also appeared to influence risk, with the prevalence of IFG significantly lower in non-Hispanic black adolescents, compared with Hispanic adolescents. However, increased HbA_1c levels were significantly more prevalent in non-Hispanic black adolescents, compared with Hispanic or non-Hispanic white adolescents.

“These findings highlight the need for additional studies on the long-term consequences and preventive strategies of abnormal glucose metabolism as measured by HbA_1c levels in adolescents and young adults, especially of minority racial/ethnic groups,” the authors wrote.

Adolescents with prediabetes had significantly higher systolic blood pressure, non-HDL cholesterol, waist-to-height ratio, higher body mass index, and lower insulin sensitivity, compared with those with normal glucose tolerance. Among young adults with prediabetes, there was significantly higher systolic blood pressure and non-HDL cholesterol, compared with individuals with normal glucose tolerance.

No funding or conflicts of interest were declared.

SOURCE: Andes LJ et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4498.

Nearly one in five adolescents and one in four young adults in the United States have prediabetes, with a higher prevalence among males, a study has found.

copyright Martynasfoto/Thinkstock

Linda J. Andes, PhD, from the Centers for Disease Control and Prevention and coauthors reported in JAMA Pediatrics their analysis of data from 2,606 adolescent (12-18 years) and 3,180 young adult (19-34 years) participants in the 2005-2016 National Health and Nutrition Examination Surveys.

This found that the percentage with prediabetes – defined as either impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or increased hemoglobin A_1c (HbA_1c) level – was 18% among adolescents and 24% among young adults.

The most common condition was IFG, which was seen in 11% of adolescents and 16% of young adults. The rate of IGT was 4% in adolescents and 6% of young adults, while elevated HbA_1c levels were seen in 5% of adolescents and 8% of young adults.

This information is important because “In adults, these three phenotypes increase the risk of developing type 2 diabetes as well as cardiovascular diseases,” Dr. Andes and coauthors wrote. “In 2011-2012, the overall prevalence of prediabetes among U.S. adults, defined as the presence of any of the three glucose metabolism dysregulation phenotypes, was 38% and it increased to about 50% in persons 65 years and older.”

Dr. Andes and associates noted that isolated IFG was the most common glucose dysregulation seen in both adolescents and young adults. “While individuals with IFG are at increased risk for type 2 diabetes, few primary prevention trials have included individuals selected for the presence of IFG and none have been conducted in adolescents with IFG or IGT to our knowledge.”

The study saw some key gender differences in prevalence. For example, the prevalence of IFG was significantly lower in adolescent girls than in boys (7% vs. 15%; P less than .001), and in young women, compared with young men (10% vs. 22%; P less than .001).

“These findings are consistent with those of other studies in adults; however, the underlying mechanisms for explaining this discrepancy are still unclear,” Dr. Andes and coauthors wrote.

Ethnicity also appeared to influence risk, with the prevalence of IFG significantly lower in non-Hispanic black adolescents, compared with Hispanic adolescents. However, increased HbA_1c levels were significantly more prevalent in non-Hispanic black adolescents, compared with Hispanic or non-Hispanic white adolescents.

“These findings highlight the need for additional studies on the long-term consequences and preventive strategies of abnormal glucose metabolism as measured by HbA_1c levels in adolescents and young adults, especially of minority racial/ethnic groups,” the authors wrote.

Adolescents with prediabetes had significantly higher systolic blood pressure, non-HDL cholesterol, waist-to-height ratio, higher body mass index, and lower insulin sensitivity, compared with those with normal glucose tolerance. Among young adults with prediabetes, there was significantly higher systolic blood pressure and non-HDL cholesterol, compared with individuals with normal glucose tolerance.

No funding or conflicts of interest were declared.

SOURCE: Andes LJ et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4498.

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

Individuals with autism spectrum disorder might be at significantly higher risk of bipolar disorder, anxiety, and depression, a new study suggests.

“This study supports the importance of early, ongoing surveillance, and targeted treatments to address the psychiatric needs of individuals with ASD,” wrote lead author Alexandra C. Kirsch, PhD, and associates. The report was published in JAMA Pediatrics.

Dr. Kirsch and associates reported the outcomes of a population-based cohort study involving 1,014 individuals with autism spectrum disorder and 2,028 age-and sex-matched controls without autism spectrum disorder. They found that individuals with autism spectrum disorder were more than nine times more likely to be diagnosed with bipolar disorder, 2.81 times more likely to be diagnosed with depression, and 3.45 times more likely to be diagnosed with anxiety, compared with controls.

“Significant psychosocial sequelae associated with having ASD, including difficulties developing and maintaining relationships, challenges succeeding academically and vocationally, and behaviors that can be problematic to manage, particularly increase risk for mood and anxiety symptoms in individuals with ASD,” wrote Dr. Kirsch of the department of psychiatry and psychology at the Mayo Clinic, Rochester, Minn., and associates. “Individuals with ASD also experience greater rates of other mental health challenges, including attention-deficit/hyperactivity disorder and substance abuse.”

Individuals with autism spectrum disorder who received a diagnosis of depression, anxiety, or bipolar disorder also were more likely to be diagnosed at a younger age than were those without autism. In the case of depression, the median age of diagnosis was 15.7 years, compared with 18.1 years among controls. For anxiety, the median age of diagnosis among individuals with autism spectrum disorder was 15.2 years, compared with 20.3 years for controls. For bipolar disorder, it was 20.3 years, compared with 27 years although the small number of individuals meant this was not statistically significant.

The authors suggested that the earlier age at diagnosis might reflect that individuals with autism spectrum disorder generally are monitored more closely, and are more likely to be connected to screening and diagnostic resources because of their original diagnosis.

The researchers also found that the increased risk of depression and anxiety was even higher among men with autism spectrum disorder, even though the cumulative incidence of these conditions was greater in women both with and without autism. In addition, the researchers noted that individuals with autism spectrum disorder were more likely to be diagnosed with multiple psychiatric conditions than were those without autism.

Dr. Kirsch and associates cited several limitations. One is that the population studied came from Olmsted County, Minn., which is wealthier and less diverse than the general population. Nevertheless, the results could help guide treatments for patients with ASD.

“Given the high rates of comorbidity, researchers and practitioners should develop tools that are specific to the unique needs of this population and effective medications and treatments for mood and anxiety concerns, which remain limited in this population,” they wrote.

The study was funded by grants from the National Institutes of Health and the U.S. Public Health Service. No conflicts of interest were disclosed.

SOURCE: Kirsch A et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4368.

Individuals with autism spectrum disorder might be at significantly higher risk of bipolar disorder, anxiety, and depression, a new study suggests.

“This study supports the importance of early, ongoing surveillance, and targeted treatments to address the psychiatric needs of individuals with ASD,” wrote lead author Alexandra C. Kirsch, PhD, and associates. The report was published in JAMA Pediatrics.

Dr. Kirsch and associates reported the outcomes of a population-based cohort study involving 1,014 individuals with autism spectrum disorder and 2,028 age-and sex-matched controls without autism spectrum disorder. They found that individuals with autism spectrum disorder were more than nine times more likely to be diagnosed with bipolar disorder, 2.81 times more likely to be diagnosed with depression, and 3.45 times more likely to be diagnosed with anxiety, compared with controls.

“Significant psychosocial sequelae associated with having ASD, including difficulties developing and maintaining relationships, challenges succeeding academically and vocationally, and behaviors that can be problematic to manage, particularly increase risk for mood and anxiety symptoms in individuals with ASD,” wrote Dr. Kirsch of the department of psychiatry and psychology at the Mayo Clinic, Rochester, Minn., and associates. “Individuals with ASD also experience greater rates of other mental health challenges, including attention-deficit/hyperactivity disorder and substance abuse.”

Individuals with autism spectrum disorder who received a diagnosis of depression, anxiety, or bipolar disorder also were more likely to be diagnosed at a younger age than were those without autism. In the case of depression, the median age of diagnosis was 15.7 years, compared with 18.1 years among controls. For anxiety, the median age of diagnosis among individuals with autism spectrum disorder was 15.2 years, compared with 20.3 years for controls. For bipolar disorder, it was 20.3 years, compared with 27 years although the small number of individuals meant this was not statistically significant.

The authors suggested that the earlier age at diagnosis might reflect that individuals with autism spectrum disorder generally are monitored more closely, and are more likely to be connected to screening and diagnostic resources because of their original diagnosis.

The researchers also found that the increased risk of depression and anxiety was even higher among men with autism spectrum disorder, even though the cumulative incidence of these conditions was greater in women both with and without autism. In addition, the researchers noted that individuals with autism spectrum disorder were more likely to be diagnosed with multiple psychiatric conditions than were those without autism.

Dr. Kirsch and associates cited several limitations. One is that the population studied came from Olmsted County, Minn., which is wealthier and less diverse than the general population. Nevertheless, the results could help guide treatments for patients with ASD.

“Given the high rates of comorbidity, researchers and practitioners should develop tools that are specific to the unique needs of this population and effective medications and treatments for mood and anxiety concerns, which remain limited in this population,” they wrote.

The study was funded by grants from the National Institutes of Health and the U.S. Public Health Service. No conflicts of interest were disclosed.

SOURCE: Kirsch A et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4368.

Individuals with autism spectrum disorder might be at significantly higher risk of bipolar disorder, anxiety, and depression, a new study suggests.

“This study supports the importance of early, ongoing surveillance, and targeted treatments to address the psychiatric needs of individuals with ASD,” wrote lead author Alexandra C. Kirsch, PhD, and associates. The report was published in JAMA Pediatrics.

Dr. Kirsch and associates reported the outcomes of a population-based cohort study involving 1,014 individuals with autism spectrum disorder and 2,028 age-and sex-matched controls without autism spectrum disorder. They found that individuals with autism spectrum disorder were more than nine times more likely to be diagnosed with bipolar disorder, 2.81 times more likely to be diagnosed with depression, and 3.45 times more likely to be diagnosed with anxiety, compared with controls.

“Significant psychosocial sequelae associated with having ASD, including difficulties developing and maintaining relationships, challenges succeeding academically and vocationally, and behaviors that can be problematic to manage, particularly increase risk for mood and anxiety symptoms in individuals with ASD,” wrote Dr. Kirsch of the department of psychiatry and psychology at the Mayo Clinic, Rochester, Minn., and associates. “Individuals with ASD also experience greater rates of other mental health challenges, including attention-deficit/hyperactivity disorder and substance abuse.”

Individuals with autism spectrum disorder who received a diagnosis of depression, anxiety, or bipolar disorder also were more likely to be diagnosed at a younger age than were those without autism. In the case of depression, the median age of diagnosis was 15.7 years, compared with 18.1 years among controls. For anxiety, the median age of diagnosis among individuals with autism spectrum disorder was 15.2 years, compared with 20.3 years for controls. For bipolar disorder, it was 20.3 years, compared with 27 years although the small number of individuals meant this was not statistically significant.

The authors suggested that the earlier age at diagnosis might reflect that individuals with autism spectrum disorder generally are monitored more closely, and are more likely to be connected to screening and diagnostic resources because of their original diagnosis.

The researchers also found that the increased risk of depression and anxiety was even higher among men with autism spectrum disorder, even though the cumulative incidence of these conditions was greater in women both with and without autism. In addition, the researchers noted that individuals with autism spectrum disorder were more likely to be diagnosed with multiple psychiatric conditions than were those without autism.

Dr. Kirsch and associates cited several limitations. One is that the population studied came from Olmsted County, Minn., which is wealthier and less diverse than the general population. Nevertheless, the results could help guide treatments for patients with ASD.

“Given the high rates of comorbidity, researchers and practitioners should develop tools that are specific to the unique needs of this population and effective medications and treatments for mood and anxiety concerns, which remain limited in this population,” they wrote.

The study was funded by grants from the National Institutes of Health and the U.S. Public Health Service. No conflicts of interest were disclosed.

SOURCE: Kirsch A et al. JAMA Pediatr. 2019 Dec 2. doi: 10.1001/jamapediatrics.2019.4368.

You have just safely delivered the baby who is quietly resting on her mother’s chest. You begin active management of the third stage of labor, administering oxytocin, performing uterine massage and applying controlled tension on the umbilical cord. There is no evidence of excess postpartum bleeding.

How long will you wait to deliver the placenta?

Active management of the third stage of labor

Most authorities recommend active management of the third stage of labor because active management reduces the risk of maternal hemorrhage >1,000 mL (relative risk [RR], 0.34), postpartum hemoglobin levels < 9 g/dL (RR, 0.50), and maternal blood transfusion (RR, 0.35) compared with expectant management.¹

The most important component of active management of the third stage of labor is the administration of a uterotonic after delivery of the newborn. In the United States, oxytocin is the uterotonic most often utilized for the active management of the third stage of labor. Authors of a recent randomized clinical trial reported that intravenous oxytocin is superior to intramuscular oxytocin for reducing postpartum blood loss (385 vs 445 mL), the frequency of blood loss greater than 1,000 mL (4.6% vs 8.1%), and the rate of maternal blood transfusion (1.5% vs 4.4%).²

In addition to administering oxytocin, the active management of the third stage often involves maneuvers to accelerate placental delivery, including the Crede and Brandt-Andrews maneuvers and controlled tension on the umbilical cord. The Crede maneuver, described in 1853, involves placing a hand on the abdominal wall near the uterine fundus and squeezing the uterine fundus between the thumb and fingers.^3,4

The Brandt-Andrews maneuver, described in 1933, involves placing a clamp on the umbilical cord close to the vulva.⁵ The clamp is used to apply judicious tension on the cord with one hand, while the other hand is placed on the mother’s abdomen with the palm and fingers overlying the junction between the uterine corpus and the lower segment. With judicious tension on the cord, the abdominal hand pushes the uterus upward toward the umbilicus. Placental separation is indicated when lengthening of the umbilical cord occurs. The Brandt-Andrews maneuver may be associated with fewer cases of uterine inversion than the Crede maneuver.^5-7

Of note, umbilical cord traction has not been demonstrated to reduce the need for blood transfusion or the incidence of postpartum hemorrhage (PPH) >1,000 mL, and it is commonly utilized by obstetricians and midwives.^8,9 Hence, in the third stage, the delivering clinician should routinely administer a uterotonic, but use of judicious tension on the cord can be deferred if the woman prefers a noninterventional approach to delivery.

Following a vaginal birth, when should the diagnosis of retained placenta be made?

The historic definition of retained placenta is nonexpulsion of the placenta 30 minutes after delivery of the newborn. However, many observational studies report that, when active management of the third stage is utilized, 90%, 95%, and 99% of placentas deliver by 9 minutes, 13 minutes, and 28 minutes, respectively.¹⁰ In addition, many observational studies report that the incidence of PPH increases significantly with longer intervals between birth of the newborn and delivery of the placenta. In one study the rate of blood loss >500 mL was 8.5% when the placenta delivered between 5 and 9 minutes and 35.1% when the placenta delivered ≥30 minutes following birth of the baby.¹⁰ In another observational study, compared with women delivering the placenta < 10 minutes after birth, women delivering the placenta ≥30 minutes after birth had a 3-fold increased risk of PPH.¹¹ Similar findings have been reported in other studies.^12-14

Continue to: Based on the association between a delay in delivery...

Based on the association between a delay in delivery of the placenta and an increased risk of PPH, some authorities recommend that, in term pregnancy, the diagnosis of retained placenta should be made at 20 minutes following birth and consideration should be given to removing the placenta at this time. For women with effective neuraxial anesthesia, manual removal of the placenta 20 minutes following birth may be the best decision for balancing the benefit of preventing PPH with the risk of unnecessary intervention. For women with no anesthesia, delaying manual removal of the placenta to 30 minutes or more following birth may permit more time for the placenta to deliver prior to performing an intervention that might cause pain, but the delay increases the risk of PPH.

Beware of placenta accreta spectrum disorder, and be ready to recognize and treat uterine inversion

---

The retained placenta may prevent the uterine muscle from effectively contracting around penetrating veins and arteries, thereby increasing the risk of postpartum hemorrhage. The placenta that has separated from the uterine wall but is trapped inside the uterine cavity can be removed easily with manual extraction. If the placenta is physiologically adherent to the uterine wall, a gentle sweeping motion with an intrauterine hand usually can separate the placenta from the uterus in preparation for manual extraction. However, if a placenta accreta spectrum disorder is contributing to a retained placenta, it may be difficult to separate the densely adherent portion of the uterus from the uterine wall. In the presence of placenta accreta spectrum disorder, vigorous attempts to remove the placenta may precipitate massive bleeding. In some cases, the acchoucheur/midwife may recognize the presence of a focal accreta and cease attempts to remove the placenta in order to organize the personnel and equipment needed to effectively treat a potential case of placenta accreta. In one study, when a placenta accreta was recognized or suspected, immediately ceasing attempts at manually removing the placenta resulted in better case outcomes than continued attempts to remove the placenta.¹

Uterine inversion may occur during an attempt to manually remove the placenta. There is universal agreement that once a uterine inversion is recognized it is critically important to immediately restore normal uterine anatomy to avoid massive hemorrhage and maternal shock. The initial management of uterine inversion includes:

• stopping oxytocin infusion
• initiating high volume fluid resuscitation
• considering a dose of a uterine relaxant, such as nitroglycerin or terbutaline
• preparing for blood product replacement.

In my experience, when uterine inversion is immediately recognized and successfully treated, blood product replacement is not usually necessary. However, if uterine inversion has not been immediately recognized or treated, massive hemorrhage and shock may occur.

Two approaches to the vaginal restoration of uterine anatomy involve using the tips of the fingers and palm of the hand to guide the wall of the uterus back to its normal position (FIGURE 1) or to forcefully use a fist to force the uterine wall back to its normal position (FIGURE 2). If these maneuvers are unsuccessful, a laparotomy may be necessary.

At laparotomy, the Huntington or Haultain procedures may help restore normal uterine anatomy. The Huntington procedure involves using clamps to apply symmetrical tension to the left and right round ligaments and/or uterine serosa to sequentially tease the uterus back to normal anatomy.^2,3 The Haultain procedure involves a vertical incision on the posterior wall of the uterus to release the uterine constriction ring that is preventing the return of the uterine fundus to its normal position (FIGURE 3).^4,5

References

1. Kayem G, Anselem O, Schmitz T, et al. Conservative versus radical management in cases of placenta accreta: a historical study. J Gynecol Obstet Biol Reprod (Paris). 2007;36:680-687.
2. Huntington JL. Acute inversion of the uterus. Boston Med Surg J. 1921;184:376-378.
3. Huntington JL, Irving FC, Kellogg FS. Abdominal reposition in acute inversion of the puerperal uterus. Am J Obstet Gynecol. 1928;15:34-40.
4. Haultain FW. Abdominal hysterotomy for chronic uterine inversion: a record of 3 cases. Proc Roy Soc Med. 1908;1:528-535.
5. Easterday CL, Reid DE. Inversion of the puerperal uterus managed by the Haultain technique; A case report. Am J Obstet Gynecol. 1959;78:1224-1226.

Manual extraction of the placenta

Prior to performing manual extraction of the placenta, a decision should be made regarding the approach to anesthesia and perioperative antibiotics. Manual extraction of the placenta is performed by placing one hand on the uterine fundus to stabilize the uterus and using the other hand to follow the umbilical cord into the uterine cavity. The intrauterine hand is used to separate the uterine-placental interface with a gentle sweeping motion. The placental mass is grasped and gently teased through the cervix and vagina. Inspection of the placenta to ensure complete removal is necessary.

An alternative to manual extraction of the placenta is the use of Bierer forceps and ultrasound guidance to tease the placenta through the cervical os. This technique involves the following steps¹⁵:

1. use ultrasound to locate the placenta

2. place a ring forceps on the anterior lip of the cervix

3. introduce the Bierer forcep into the uterus

4. use the forceps to grasp the placenta and pull it toward the vagina

5. stop frequently to re-grasp placental tissue that is deeper in the uterine cavity

6. once the placenta is extracted, examine the placenta to ensure complete removal.

Of note when manual extraction is used to deliver a retained placenta, randomized clinical trials report no benefit for the following interventions:

• perioperative antibiotics¹⁶
• nitroglycerin to relax the uterus¹⁷
• ultrasound to detect retained placental tissue.¹⁸

Best timing for manual extraction of the placenta

The timing for the diagnosis of retained placenta, and the risks and benefits of manual extraction would be best evaluated in a large, randomized clinical trial. However, based on observational studies, in a term pregnancy, the diagnosis of retained placenta is best made using a 20-minute interval. In women with effective neuraxial anesthesia, consideration should be given to manual removal of the placenta at that time.

You have just safely delivered the baby who is quietly resting on her mother’s chest. You begin active management of the third stage of labor, administering oxytocin, performing uterine massage and applying controlled tension on the umbilical cord. There is no evidence of excess postpartum bleeding.

How long will you wait to deliver the placenta?

Active management of the third stage of labor

Most authorities recommend active management of the third stage of labor because active management reduces the risk of maternal hemorrhage >1,000 mL (relative risk [RR], 0.34), postpartum hemoglobin levels < 9 g/dL (RR, 0.50), and maternal blood transfusion (RR, 0.35) compared with expectant management.¹

The most important component of active management of the third stage of labor is the administration of a uterotonic after delivery of the newborn. In the United States, oxytocin is the uterotonic most often utilized for the active management of the third stage of labor. Authors of a recent randomized clinical trial reported that intravenous oxytocin is superior to intramuscular oxytocin for reducing postpartum blood loss (385 vs 445 mL), the frequency of blood loss greater than 1,000 mL (4.6% vs 8.1%), and the rate of maternal blood transfusion (1.5% vs 4.4%).²

In addition to administering oxytocin, the active management of the third stage often involves maneuvers to accelerate placental delivery, including the Crede and Brandt-Andrews maneuvers and controlled tension on the umbilical cord. The Crede maneuver, described in 1853, involves placing a hand on the abdominal wall near the uterine fundus and squeezing the uterine fundus between the thumb and fingers.^3,4

The Brandt-Andrews maneuver, described in 1933, involves placing a clamp on the umbilical cord close to the vulva.⁵ The clamp is used to apply judicious tension on the cord with one hand, while the other hand is placed on the mother’s abdomen with the palm and fingers overlying the junction between the uterine corpus and the lower segment. With judicious tension on the cord, the abdominal hand pushes the uterus upward toward the umbilicus. Placental separation is indicated when lengthening of the umbilical cord occurs. The Brandt-Andrews maneuver may be associated with fewer cases of uterine inversion than the Crede maneuver.^5-7

Of note, umbilical cord traction has not been demonstrated to reduce the need for blood transfusion or the incidence of postpartum hemorrhage (PPH) >1,000 mL, and it is commonly utilized by obstetricians and midwives.^8,9 Hence, in the third stage, the delivering clinician should routinely administer a uterotonic, but use of judicious tension on the cord can be deferred if the woman prefers a noninterventional approach to delivery.

Following a vaginal birth, when should the diagnosis of retained placenta be made?

The historic definition of retained placenta is nonexpulsion of the placenta 30 minutes after delivery of the newborn. However, many observational studies report that, when active management of the third stage is utilized, 90%, 95%, and 99% of placentas deliver by 9 minutes, 13 minutes, and 28 minutes, respectively.¹⁰ In addition, many observational studies report that the incidence of PPH increases significantly with longer intervals between birth of the newborn and delivery of the placenta. In one study the rate of blood loss >500 mL was 8.5% when the placenta delivered between 5 and 9 minutes and 35.1% when the placenta delivered ≥30 minutes following birth of the baby.¹⁰ In another observational study, compared with women delivering the placenta < 10 minutes after birth, women delivering the placenta ≥30 minutes after birth had a 3-fold increased risk of PPH.¹¹ Similar findings have been reported in other studies.^12-14

Continue to: Based on the association between a delay in delivery...

Based on the association between a delay in delivery of the placenta and an increased risk of PPH, some authorities recommend that, in term pregnancy, the diagnosis of retained placenta should be made at 20 minutes following birth and consideration should be given to removing the placenta at this time. For women with effective neuraxial anesthesia, manual removal of the placenta 20 minutes following birth may be the best decision for balancing the benefit of preventing PPH with the risk of unnecessary intervention. For women with no anesthesia, delaying manual removal of the placenta to 30 minutes or more following birth may permit more time for the placenta to deliver prior to performing an intervention that might cause pain, but the delay increases the risk of PPH.

Beware of placenta accreta spectrum disorder, and be ready to recognize and treat uterine inversion

---

The retained placenta may prevent the uterine muscle from effectively contracting around penetrating veins and arteries, thereby increasing the risk of postpartum hemorrhage. The placenta that has separated from the uterine wall but is trapped inside the uterine cavity can be removed easily with manual extraction. If the placenta is physiologically adherent to the uterine wall, a gentle sweeping motion with an intrauterine hand usually can separate the placenta from the uterus in preparation for manual extraction. However, if a placenta accreta spectrum disorder is contributing to a retained placenta, it may be difficult to separate the densely adherent portion of the uterus from the uterine wall. In the presence of placenta accreta spectrum disorder, vigorous attempts to remove the placenta may precipitate massive bleeding. In some cases, the acchoucheur/midwife may recognize the presence of a focal accreta and cease attempts to remove the placenta in order to organize the personnel and equipment needed to effectively treat a potential case of placenta accreta. In one study, when a placenta accreta was recognized or suspected, immediately ceasing attempts at manually removing the placenta resulted in better case outcomes than continued attempts to remove the placenta.¹

Uterine inversion may occur during an attempt to manually remove the placenta. There is universal agreement that once a uterine inversion is recognized it is critically important to immediately restore normal uterine anatomy to avoid massive hemorrhage and maternal shock. The initial management of uterine inversion includes:

• stopping oxytocin infusion
• initiating high volume fluid resuscitation
• considering a dose of a uterine relaxant, such as nitroglycerin or terbutaline
• preparing for blood product replacement.

In my experience, when uterine inversion is immediately recognized and successfully treated, blood product replacement is not usually necessary. However, if uterine inversion has not been immediately recognized or treated, massive hemorrhage and shock may occur.

Two approaches to the vaginal restoration of uterine anatomy involve using the tips of the fingers and palm of the hand to guide the wall of the uterus back to its normal position (FIGURE 1) or to forcefully use a fist to force the uterine wall back to its normal position (FIGURE 2). If these maneuvers are unsuccessful, a laparotomy may be necessary.

At laparotomy, the Huntington or Haultain procedures may help restore normal uterine anatomy. The Huntington procedure involves using clamps to apply symmetrical tension to the left and right round ligaments and/or uterine serosa to sequentially tease the uterus back to normal anatomy.^2,3 The Haultain procedure involves a vertical incision on the posterior wall of the uterus to release the uterine constriction ring that is preventing the return of the uterine fundus to its normal position (FIGURE 3).^4,5

References

1. Kayem G, Anselem O, Schmitz T, et al. Conservative versus radical management in cases of placenta accreta: a historical study. J Gynecol Obstet Biol Reprod (Paris). 2007;36:680-687.
2. Huntington JL. Acute inversion of the uterus. Boston Med Surg J. 1921;184:376-378.
3. Huntington JL, Irving FC, Kellogg FS. Abdominal reposition in acute inversion of the puerperal uterus. Am J Obstet Gynecol. 1928;15:34-40.
4. Haultain FW. Abdominal hysterotomy for chronic uterine inversion: a record of 3 cases. Proc Roy Soc Med. 1908;1:528-535.
5. Easterday CL, Reid DE. Inversion of the puerperal uterus managed by the Haultain technique; A case report. Am J Obstet Gynecol. 1959;78:1224-1226.

Manual extraction of the placenta

Prior to performing manual extraction of the placenta, a decision should be made regarding the approach to anesthesia and perioperative antibiotics. Manual extraction of the placenta is performed by placing one hand on the uterine fundus to stabilize the uterus and using the other hand to follow the umbilical cord into the uterine cavity. The intrauterine hand is used to separate the uterine-placental interface with a gentle sweeping motion. The placental mass is grasped and gently teased through the cervix and vagina. Inspection of the placenta to ensure complete removal is necessary.

An alternative to manual extraction of the placenta is the use of Bierer forceps and ultrasound guidance to tease the placenta through the cervical os. This technique involves the following steps¹⁵:

1. use ultrasound to locate the placenta

2. place a ring forceps on the anterior lip of the cervix

3. introduce the Bierer forcep into the uterus

4. use the forceps to grasp the placenta and pull it toward the vagina

5. stop frequently to re-grasp placental tissue that is deeper in the uterine cavity

6. once the placenta is extracted, examine the placenta to ensure complete removal.

Of note when manual extraction is used to deliver a retained placenta, randomized clinical trials report no benefit for the following interventions:

• perioperative antibiotics¹⁶
• nitroglycerin to relax the uterus¹⁷
• ultrasound to detect retained placental tissue.¹⁸

Best timing for manual extraction of the placenta

The timing for the diagnosis of retained placenta, and the risks and benefits of manual extraction would be best evaluated in a large, randomized clinical trial. However, based on observational studies, in a term pregnancy, the diagnosis of retained placenta is best made using a 20-minute interval. In women with effective neuraxial anesthesia, consideration should be given to manual removal of the placenta at that time.

You have just safely delivered the baby who is quietly resting on her mother’s chest. You begin active management of the third stage of labor, administering oxytocin, performing uterine massage and applying controlled tension on the umbilical cord. There is no evidence of excess postpartum bleeding.

How long will you wait to deliver the placenta?

Active management of the third stage of labor

Most authorities recommend active management of the third stage of labor because active management reduces the risk of maternal hemorrhage >1,000 mL (relative risk [RR], 0.34), postpartum hemoglobin levels < 9 g/dL (RR, 0.50), and maternal blood transfusion (RR, 0.35) compared with expectant management.¹

The most important component of active management of the third stage of labor is the administration of a uterotonic after delivery of the newborn. In the United States, oxytocin is the uterotonic most often utilized for the active management of the third stage of labor. Authors of a recent randomized clinical trial reported that intravenous oxytocin is superior to intramuscular oxytocin for reducing postpartum blood loss (385 vs 445 mL), the frequency of blood loss greater than 1,000 mL (4.6% vs 8.1%), and the rate of maternal blood transfusion (1.5% vs 4.4%).²

In addition to administering oxytocin, the active management of the third stage often involves maneuvers to accelerate placental delivery, including the Crede and Brandt-Andrews maneuvers and controlled tension on the umbilical cord. The Crede maneuver, described in 1853, involves placing a hand on the abdominal wall near the uterine fundus and squeezing the uterine fundus between the thumb and fingers.^3,4

The Brandt-Andrews maneuver, described in 1933, involves placing a clamp on the umbilical cord close to the vulva.⁵ The clamp is used to apply judicious tension on the cord with one hand, while the other hand is placed on the mother’s abdomen with the palm and fingers overlying the junction between the uterine corpus and the lower segment. With judicious tension on the cord, the abdominal hand pushes the uterus upward toward the umbilicus. Placental separation is indicated when lengthening of the umbilical cord occurs. The Brandt-Andrews maneuver may be associated with fewer cases of uterine inversion than the Crede maneuver.^5-7

Of note, umbilical cord traction has not been demonstrated to reduce the need for blood transfusion or the incidence of postpartum hemorrhage (PPH) >1,000 mL, and it is commonly utilized by obstetricians and midwives.^8,9 Hence, in the third stage, the delivering clinician should routinely administer a uterotonic, but use of judicious tension on the cord can be deferred if the woman prefers a noninterventional approach to delivery.

Following a vaginal birth, when should the diagnosis of retained placenta be made?

The historic definition of retained placenta is nonexpulsion of the placenta 30 minutes after delivery of the newborn. However, many observational studies report that, when active management of the third stage is utilized, 90%, 95%, and 99% of placentas deliver by 9 minutes, 13 minutes, and 28 minutes, respectively.¹⁰ In addition, many observational studies report that the incidence of PPH increases significantly with longer intervals between birth of the newborn and delivery of the placenta. In one study the rate of blood loss >500 mL was 8.5% when the placenta delivered between 5 and 9 minutes and 35.1% when the placenta delivered ≥30 minutes following birth of the baby.¹⁰ In another observational study, compared with women delivering the placenta < 10 minutes after birth, women delivering the placenta ≥30 minutes after birth had a 3-fold increased risk of PPH.¹¹ Similar findings have been reported in other studies.^12-14

Continue to: Based on the association between a delay in delivery...

Based on the association between a delay in delivery of the placenta and an increased risk of PPH, some authorities recommend that, in term pregnancy, the diagnosis of retained placenta should be made at 20 minutes following birth and consideration should be given to removing the placenta at this time. For women with effective neuraxial anesthesia, manual removal of the placenta 20 minutes following birth may be the best decision for balancing the benefit of preventing PPH with the risk of unnecessary intervention. For women with no anesthesia, delaying manual removal of the placenta to 30 minutes or more following birth may permit more time for the placenta to deliver prior to performing an intervention that might cause pain, but the delay increases the risk of PPH.

Beware of placenta accreta spectrum disorder, and be ready to recognize and treat uterine inversion

---

The retained placenta may prevent the uterine muscle from effectively contracting around penetrating veins and arteries, thereby increasing the risk of postpartum hemorrhage. The placenta that has separated from the uterine wall but is trapped inside the uterine cavity can be removed easily with manual extraction. If the placenta is physiologically adherent to the uterine wall, a gentle sweeping motion with an intrauterine hand usually can separate the placenta from the uterus in preparation for manual extraction. However, if a placenta accreta spectrum disorder is contributing to a retained placenta, it may be difficult to separate the densely adherent portion of the uterus from the uterine wall. In the presence of placenta accreta spectrum disorder, vigorous attempts to remove the placenta may precipitate massive bleeding. In some cases, the acchoucheur/midwife may recognize the presence of a focal accreta and cease attempts to remove the placenta in order to organize the personnel and equipment needed to effectively treat a potential case of placenta accreta. In one study, when a placenta accreta was recognized or suspected, immediately ceasing attempts at manually removing the placenta resulted in better case outcomes than continued attempts to remove the placenta.¹

Uterine inversion may occur during an attempt to manually remove the placenta. There is universal agreement that once a uterine inversion is recognized it is critically important to immediately restore normal uterine anatomy to avoid massive hemorrhage and maternal shock. The initial management of uterine inversion includes:

• stopping oxytocin infusion
• initiating high volume fluid resuscitation
• considering a dose of a uterine relaxant, such as nitroglycerin or terbutaline
• preparing for blood product replacement.

In my experience, when uterine inversion is immediately recognized and successfully treated, blood product replacement is not usually necessary. However, if uterine inversion has not been immediately recognized or treated, massive hemorrhage and shock may occur.

Two approaches to the vaginal restoration of uterine anatomy involve using the tips of the fingers and palm of the hand to guide the wall of the uterus back to its normal position (FIGURE 1) or to forcefully use a fist to force the uterine wall back to its normal position (FIGURE 2). If these maneuvers are unsuccessful, a laparotomy may be necessary.

At laparotomy, the Huntington or Haultain procedures may help restore normal uterine anatomy. The Huntington procedure involves using clamps to apply symmetrical tension to the left and right round ligaments and/or uterine serosa to sequentially tease the uterus back to normal anatomy.^2,3 The Haultain procedure involves a vertical incision on the posterior wall of the uterus to release the uterine constriction ring that is preventing the return of the uterine fundus to its normal position (FIGURE 3).^4,5

References

1. Kayem G, Anselem O, Schmitz T, et al. Conservative versus radical management in cases of placenta accreta: a historical study. J Gynecol Obstet Biol Reprod (Paris). 2007;36:680-687.
2. Huntington JL. Acute inversion of the uterus. Boston Med Surg J. 1921;184:376-378.
3. Huntington JL, Irving FC, Kellogg FS. Abdominal reposition in acute inversion of the puerperal uterus. Am J Obstet Gynecol. 1928;15:34-40.
4. Haultain FW. Abdominal hysterotomy for chronic uterine inversion: a record of 3 cases. Proc Roy Soc Med. 1908;1:528-535.
5. Easterday CL, Reid DE. Inversion of the puerperal uterus managed by the Haultain technique; A case report. Am J Obstet Gynecol. 1959;78:1224-1226.

Manual extraction of the placenta

Prior to performing manual extraction of the placenta, a decision should be made regarding the approach to anesthesia and perioperative antibiotics. Manual extraction of the placenta is performed by placing one hand on the uterine fundus to stabilize the uterus and using the other hand to follow the umbilical cord into the uterine cavity. The intrauterine hand is used to separate the uterine-placental interface with a gentle sweeping motion. The placental mass is grasped and gently teased through the cervix and vagina. Inspection of the placenta to ensure complete removal is necessary.

An alternative to manual extraction of the placenta is the use of Bierer forceps and ultrasound guidance to tease the placenta through the cervical os. This technique involves the following steps¹⁵:

1. use ultrasound to locate the placenta

2. place a ring forceps on the anterior lip of the cervix

3. introduce the Bierer forcep into the uterus

4. use the forceps to grasp the placenta and pull it toward the vagina

5. stop frequently to re-grasp placental tissue that is deeper in the uterine cavity

6. once the placenta is extracted, examine the placenta to ensure complete removal.

Of note when manual extraction is used to deliver a retained placenta, randomized clinical trials report no benefit for the following interventions:

• perioperative antibiotics¹⁶
• nitroglycerin to relax the uterus¹⁷
• ultrasound to detect retained placental tissue.¹⁸

Best timing for manual extraction of the placenta

The timing for the diagnosis of retained placenta, and the risks and benefits of manual extraction would be best evaluated in a large, randomized clinical trial. However, based on observational studies, in a term pregnancy, the diagnosis of retained placenta is best made using a 20-minute interval. In women with effective neuraxial anesthesia, consideration should be given to manual removal of the placenta at that time.