Debunking Psoriasis Myths: Which Psoriasis Therapies Can Be Used in Pregnant Women?

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Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

  • Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
  • Anti–TNF-α agents can be used during the first half of pregnancy.
  • Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
  • If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
  • Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
  • Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
  • Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

References

FDA determinations for pregnant and nursing women. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy/fda-determinations. Accessed December 4, 2017.

Porter ML, Lockwood SJ, Kimball AB. Update on biologic safety for patients with psoriasis during pregnancy. Int J Womens Dermatol. 2017;3:21-25.

Psoriasis and pregnancy: treatment options, psoriatic arthritis, and genetics. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy. Accessed December 4, 2017.

Weinberg JM. Treating psoriasis in pregnant women. Cutis. 2015;96:80.

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Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

  • Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
  • Anti–TNF-α agents can be used during the first half of pregnancy.
  • Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
  • If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
  • Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
  • Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
  • Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

  • Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
  • Anti–TNF-α agents can be used during the first half of pregnancy.
  • Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
  • If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
  • Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
  • Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
  • Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

References

FDA determinations for pregnant and nursing women. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy/fda-determinations. Accessed December 4, 2017.

Porter ML, Lockwood SJ, Kimball AB. Update on biologic safety for patients with psoriasis during pregnancy. Int J Womens Dermatol. 2017;3:21-25.

Psoriasis and pregnancy: treatment options, psoriatic arthritis, and genetics. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy. Accessed December 4, 2017.

Weinberg JM. Treating psoriasis in pregnant women. Cutis. 2015;96:80.

References

FDA determinations for pregnant and nursing women. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy/fda-determinations. Accessed December 4, 2017.

Porter ML, Lockwood SJ, Kimball AB. Update on biologic safety for patients with psoriasis during pregnancy. Int J Womens Dermatol. 2017;3:21-25.

Psoriasis and pregnancy: treatment options, psoriatic arthritis, and genetics. National Psoriasis Foundation website. https://www.psoriasis.org/pregnancy. Accessed December 4, 2017.

Weinberg JM. Treating psoriasis in pregnant women. Cutis. 2015;96:80.

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Cosmetic Corner: Dermatologists Weigh in on Wet Skin Moisturizers

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To improve patient care and outcomes, leading dermatologists offered their recommendations on wet skin moisturizers. Consideration must be given to:

 

  • Eucerin In-Shower Body Lotion
    Beiersdorf
    “This product is inexpensive, hypoallergenic, and fragrance free.”—Gary Goldenberg, MD, New York, New York
     
  • Jergens Wet Skin Moisturizer With Refreshing Coconut Oil
    Kao USA Inc
    “I like how quickly the skin absorbs this product, and coconut oil is an excellent moisturizing ingredient. You simply apply to wet skin straight out of the shower or bath, and gently pat dry.”—Jeannette Graf, MD, Great Neck, New York
     
  • Olay Ultra Moisture In-Shower Body Lotion
    Procter & Gamble
    “This is a time-saving and nongreasy moisturizing product for patients who are noncompliant with regular moisturizers.”—Shari Lipner, MD, PhD, New York, New York

 

Cutis invites readers to send us their recommendations. Bar soaps, lip plumpers, and pigment correctors will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

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To improve patient care and outcomes, leading dermatologists offered their recommendations on wet skin moisturizers. Consideration must be given to:

 

  • Eucerin In-Shower Body Lotion
    Beiersdorf
    “This product is inexpensive, hypoallergenic, and fragrance free.”—Gary Goldenberg, MD, New York, New York
     
  • Jergens Wet Skin Moisturizer With Refreshing Coconut Oil
    Kao USA Inc
    “I like how quickly the skin absorbs this product, and coconut oil is an excellent moisturizing ingredient. You simply apply to wet skin straight out of the shower or bath, and gently pat dry.”—Jeannette Graf, MD, Great Neck, New York
     
  • Olay Ultra Moisture In-Shower Body Lotion
    Procter & Gamble
    “This is a time-saving and nongreasy moisturizing product for patients who are noncompliant with regular moisturizers.”—Shari Lipner, MD, PhD, New York, New York

 

Cutis invites readers to send us their recommendations. Bar soaps, lip plumpers, and pigment correctors will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on wet skin moisturizers. Consideration must be given to:

 

  • Eucerin In-Shower Body Lotion
    Beiersdorf
    “This product is inexpensive, hypoallergenic, and fragrance free.”—Gary Goldenberg, MD, New York, New York
     
  • Jergens Wet Skin Moisturizer With Refreshing Coconut Oil
    Kao USA Inc
    “I like how quickly the skin absorbs this product, and coconut oil is an excellent moisturizing ingredient. You simply apply to wet skin straight out of the shower or bath, and gently pat dry.”—Jeannette Graf, MD, Great Neck, New York
     
  • Olay Ultra Moisture In-Shower Body Lotion
    Procter & Gamble
    “This is a time-saving and nongreasy moisturizing product for patients who are noncompliant with regular moisturizers.”—Shari Lipner, MD, PhD, New York, New York

 

Cutis invites readers to send us their recommendations. Bar soaps, lip plumpers, and pigment correctors will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

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Adolescents with chronic health conditions often undervaccinated

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Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock
Teen male is shown receiving vaccination.
In this retrospective study in four pediatric primary care clinics serving a low-income minority population in New York, 3,989 adolescents aged 11-17 years who had one or more visits between Aug. 1, 2011, and Jun. 30, 2013, were evaluated. Of these adolescents, 27% had chronic medical conditions (CMCs), most commonly asthma (77%), mental retardation (7%), epilepsy (7%), autism spectrum disorder (4%), and congenital heart disease (4%).

Fewer adolescents with CMCs had received one more doses of HPV (81%), than did those without CMCs (85%; P less than .01). Fewer adolescents with epilepsy (63%), mental retardation (58%), cerebral palsy (54%), and autism spectrum disorder (46%) had started HPV vaccination, compared with those without each of these conditions (84%; all comparisons, P less than .001). No differences were seen for asthma or congenital heart disease, the investigators said.

More adolescents with CMCs had gotten their flu shot than did those without CMCs during the 2011-2012 season (67% vs. 50%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). More adolescents with asthma got their flu shot than did those without asthma during the 2011-2012 season (69% vs. 51%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). No differences were seen for the other common CMCs.

Nonetheless, the mean number of missed opportunities was significantly higher among unvaccinated adolescents with CMCs, compared with those without CMCs, for the first HPV vaccination, meningococcal vaccination, and influenza vaccination in both seasons measured (P less than .001 for all).

“Missed opportunities for the third HPV vaccine dose or Tdap did not differ by CMC status,” Dr. Hofstetter and her associates said.

Read more in the American Journal of Preventive Medicine (2017 Nov;53[5]:680-8).
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Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock
Teen male is shown receiving vaccination.
In this retrospective study in four pediatric primary care clinics serving a low-income minority population in New York, 3,989 adolescents aged 11-17 years who had one or more visits between Aug. 1, 2011, and Jun. 30, 2013, were evaluated. Of these adolescents, 27% had chronic medical conditions (CMCs), most commonly asthma (77%), mental retardation (7%), epilepsy (7%), autism spectrum disorder (4%), and congenital heart disease (4%).

Fewer adolescents with CMCs had received one more doses of HPV (81%), than did those without CMCs (85%; P less than .01). Fewer adolescents with epilepsy (63%), mental retardation (58%), cerebral palsy (54%), and autism spectrum disorder (46%) had started HPV vaccination, compared with those without each of these conditions (84%; all comparisons, P less than .001). No differences were seen for asthma or congenital heart disease, the investigators said.

More adolescents with CMCs had gotten their flu shot than did those without CMCs during the 2011-2012 season (67% vs. 50%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). More adolescents with asthma got their flu shot than did those without asthma during the 2011-2012 season (69% vs. 51%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). No differences were seen for the other common CMCs.

Nonetheless, the mean number of missed opportunities was significantly higher among unvaccinated adolescents with CMCs, compared with those without CMCs, for the first HPV vaccination, meningococcal vaccination, and influenza vaccination in both seasons measured (P less than .001 for all).

“Missed opportunities for the third HPV vaccine dose or Tdap did not differ by CMC status,” Dr. Hofstetter and her associates said.

Read more in the American Journal of Preventive Medicine (2017 Nov;53[5]:680-8).

 

Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock
Teen male is shown receiving vaccination.
In this retrospective study in four pediatric primary care clinics serving a low-income minority population in New York, 3,989 adolescents aged 11-17 years who had one or more visits between Aug. 1, 2011, and Jun. 30, 2013, were evaluated. Of these adolescents, 27% had chronic medical conditions (CMCs), most commonly asthma (77%), mental retardation (7%), epilepsy (7%), autism spectrum disorder (4%), and congenital heart disease (4%).

Fewer adolescents with CMCs had received one more doses of HPV (81%), than did those without CMCs (85%; P less than .01). Fewer adolescents with epilepsy (63%), mental retardation (58%), cerebral palsy (54%), and autism spectrum disorder (46%) had started HPV vaccination, compared with those without each of these conditions (84%; all comparisons, P less than .001). No differences were seen for asthma or congenital heart disease, the investigators said.

More adolescents with CMCs had gotten their flu shot than did those without CMCs during the 2011-2012 season (67% vs. 50%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). More adolescents with asthma got their flu shot than did those without asthma during the 2011-2012 season (69% vs. 51%; P less than .001) or during the 2012-2013 season (74% vs. 65%; P less than .001). No differences were seen for the other common CMCs.

Nonetheless, the mean number of missed opportunities was significantly higher among unvaccinated adolescents with CMCs, compared with those without CMCs, for the first HPV vaccination, meningococcal vaccination, and influenza vaccination in both seasons measured (P less than .001 for all).

“Missed opportunities for the third HPV vaccine dose or Tdap did not differ by CMC status,” Dr. Hofstetter and her associates said.

Read more in the American Journal of Preventive Medicine (2017 Nov;53[5]:680-8).
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FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE

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Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses

M. Patricia Rivera, MD, FCCP, comments on EBUS
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– Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.

In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).

Mitchel L. Zoler/Frontline Medical News
Dr. Nichole T. Tanner
“You have a 50/50 chance” of making a diagnosis using an ultrathin bronchoscope plus radial EBUS, said Nichole T. Tanner, MD, at the CHEST annual meeting. “I think you need to be thoughtful about how you use this technology,” said Dr. Tanner, a pulmonologist and critical care medicine physician at the Medical University of South Carolina in Charleston.

“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.

The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.

The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.

Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).

The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.

Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.

The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.

The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
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Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.

Dr. M. Patricia Rivera
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Body

Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.

Dr. M. Patricia Rivera
Body

Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.

Dr. M. Patricia Rivera
Title
M. Patricia Rivera, MD, FCCP, comments on EBUS
M. Patricia Rivera, MD, FCCP, comments on EBUS

 

– Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.

In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).

Mitchel L. Zoler/Frontline Medical News
Dr. Nichole T. Tanner
“You have a 50/50 chance” of making a diagnosis using an ultrathin bronchoscope plus radial EBUS, said Nichole T. Tanner, MD, at the CHEST annual meeting. “I think you need to be thoughtful about how you use this technology,” said Dr. Tanner, a pulmonologist and critical care medicine physician at the Medical University of South Carolina in Charleston.

“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.

The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.

The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.

Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).

The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.

Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.

The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.

The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.

 

– Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.

In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).

Mitchel L. Zoler/Frontline Medical News
Dr. Nichole T. Tanner
“You have a 50/50 chance” of making a diagnosis using an ultrathin bronchoscope plus radial EBUS, said Nichole T. Tanner, MD, at the CHEST annual meeting. “I think you need to be thoughtful about how you use this technology,” said Dr. Tanner, a pulmonologist and critical care medicine physician at the Medical University of South Carolina in Charleston.

“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.

The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.

The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.

Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).

The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.

Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.

The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.

The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
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Key clinical point: Ultrathin bronchoscopy plus radial EBUS is unreliable at determining whether a solid lung lesion is cancerous or benign.

Major finding: The diagnostic yield using ultrathin bronchoscopy with radial EBUS was 49%, while standard bronchoscopy had a 38% yield.

Data source: Multicenter, randomized study with 221 total patients and 197 evaluable patients.

Disclosures: The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.

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Treat Hypertension Even Earlier, Guidelines Say

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New guidelines from the American Heart Association and American College of Cardiology update blood pressure treatment levels for the first time in more than 10 years.

High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.

The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.

The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.

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New guidelines from the American Heart Association and American College of Cardiology update blood pressure treatment levels for the first time in more than 10 years.
New guidelines from the American Heart Association and American College of Cardiology update blood pressure treatment levels for the first time in more than 10 years.

High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.

The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.

The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.

High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.

The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.

The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.

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System helps predict RFS, OS in BCP-ALL

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Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.

The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.

The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.

On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).

Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.

The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.

Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.

“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”

“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”

The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”

And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.

The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.

The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.

Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.

“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.”

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Children’s Cancer Institute
Rosemary Sutton, PhD Photo courtesy of

Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.

The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.

The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.

On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).

Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.

The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.

Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.

“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”

“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”

The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”

And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.

The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.

The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.

Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.

“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.”

Children’s Cancer Institute
Rosemary Sutton, PhD Photo courtesy of

Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.

The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.

The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.

On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).

Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.

The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.

Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.

“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”

“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”

The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”

And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.

The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.

The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.

Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.

“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.”

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FDA approves use of heparin products

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The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.

This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.

These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.

Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.

This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.

The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).

Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.

Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.

“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.

“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”

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Thrombus

The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.

This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.

These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.

Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.

This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.

The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).

Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.

Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.

“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.

“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”

Image by Andre E.X. Brown
Thrombus

The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.

This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.

These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.

Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.

This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.

The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).

Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.

Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.

“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.

“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”

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Cell-free DNA kit receives CE-IVD mark

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Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.

The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.

The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.

The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.

Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.

The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.

Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.

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Blood sample collection

Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.

The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.

The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.

The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.

Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.

The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.

Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.

Photo by Juan D. Alfonso
Blood sample collection

Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.

The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.

The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.

The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.

Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.

The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.

Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.

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Continuous bedside monitoring improved safety of intracranial stereotactic EEG

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– After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.

Ted Bosworth/Frontline Medical News
Dr. Brad Kamitaki
Despite the improved safety observed with continuous monitoring, the program has not been maintained at Columbia because of cost concerns, Dr. Kamitaki added.

Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.

In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.

There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.

In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.

The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.

Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”

A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.

“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.

“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.

Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
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– After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.

Ted Bosworth/Frontline Medical News
Dr. Brad Kamitaki
Despite the improved safety observed with continuous monitoring, the program has not been maintained at Columbia because of cost concerns, Dr. Kamitaki added.

Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.

In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.

There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.

In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.

The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.

Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”

A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.

“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.

“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.

Dr. Kamitaki reported having no potential conflicts of interest related to this topic.

– After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.

Ted Bosworth/Frontline Medical News
Dr. Brad Kamitaki
Despite the improved safety observed with continuous monitoring, the program has not been maintained at Columbia because of cost concerns, Dr. Kamitaki added.

Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.

In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.

There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.

In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.

The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.

Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”

A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.

“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.

“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.

Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
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Key clinical point: Continuous monitoring of patients during intracranial stereotactic EEG was associated with a reduced risk of adverse events, compared with closed circuit video monitoring.

Major finding: The missed seizures and unintentional electrode removals that occurred without continuous bedside monitoring did not occur in the course of monitoring.

Data source: Retrospective study of 26 patients.

Disclosures: Dr. Kamitaki reported having no potential conflicts of interest related to this topic.

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Baylor sees first U.S. birth from uterine transplant recipient

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A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.

Dr. Giuliano Testa

“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.

With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”

“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”

In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.

However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.

The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.

Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.

Dr. Liza Johannesson

The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.

To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.

Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*

Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.

Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.

Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.

All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.

It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”

Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”

Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
 

*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.

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A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.

Dr. Giuliano Testa

“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.

With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”

“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”

In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.

However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.

The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.

Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.

Dr. Liza Johannesson

The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.

To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.

Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*

Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.

Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.

Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.

All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.

It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”

Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”

Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
 

*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.

[email protected]
On Twitter @karioakes

 

A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.

Dr. Giuliano Testa

“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.

With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”

“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”

In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.

However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.

The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.

Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.

Dr. Liza Johannesson

The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.

To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.

Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*

Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.

Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.

Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.

All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.

It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”

Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”

Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
 

*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.

[email protected]
On Twitter @karioakes

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