MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

MASTER CLASS

Prepare for endometriosis excision surgery with a multidisciplinary approach

Iris Kerin Orbuch, MD

Director, Advanced Gynecologic Laparoscopy Center, Los Angeles and New York City.

Series introduction

Charles Miller, MD

Professor, Obstetrics and Gynecology, Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois.
 

As I gained more interest and expertise in the treatment of endometriosis, I became aware of several articles concluding that if a woman sought treatment for chronic pelvic pain with an internist, the diagnosis would be irritable bowel syndrome (IBS); with a urologist, it would be interstitial cystitis; and with a gynecologist, endometriosis. Moreover, there is an increased propensity for IBS and IC in patients with endometriosis. There also is an increased risk of small intestine bacterial overgrowth (SIBO), as noted by our guest author for this latest installment of the Master Class in Gynecologic Surgery, Iris Orbuch, MD.

Like our guest author, I have also noted increased risk of pelvic floor myalgia. Dr. Orbuch clearly outlines why this occurs. In fact, we can now understand why many patients have multiple pelvic pain–inducing issues compounding their pain secondary to endometriosis and leading to remodeling of the central nervous system. Therefore, it certainly makes sense to follow Dr. Orbuch’s recommendation for a multidisciplinary pre- and postsurgical approach “to downregulate the pain generators.”

Dr. Orbuch is a minimally invasive gynecologic surgeon in Los Angeles who specializes in the treatment of patients diagnosed with endometriosis. Dr. Orbuch serves on the Board of Directors of the Foundation of the American Association of Gynecologic Laparoscopists and has served as the chair of the AAGL’s Special Interest Group on Endometriosis and Reproductive Surgery. She is the coauthor of the book “Beating Endo —How to Reclaim Your Life From Endometriosis” (New York: HarperCollins; 2019). The book is written for patients but addresses many issues discussed in this installment of the Master Class in Gynecologic Surgery.

https://www.mdedge.com/obgyn/master-class
 

GYNECOLOGIC ONCOLOGY CONSULT

The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Katherine Tucker, MD

Assistant Professor of Gynecologic Oncology at the University of North Carolina at Chapel Hill.
 

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

https://www.mdedge.com/obgyn/gynecologic-oncology-consult

LATEST NEWS

Few women identify breast density as a breast cancer risk

Walter Alexander
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

CDC recommends universal hepatitis B screening of adults

Lucy Hicks
 

Adults should be tested for hepatitis B virus (HBV) at least once in their lifetime, according to updated guidelines from the Centers for Disease Control and Prevention.

This is the first update to HBV screening guidelines since 2008, the agency said.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is considered inefficient for providers to implement,” the authors write in the new guidance, published in the CDC’s Morbidity and Mortality Weekly Report. “Universal screening of adults for HBV infection is cost-effective, compared with risk-based screening and averts liver disease and death. Although a curative treatment is not yet available, early diagnosis and treatment of chronic HBV infections reduces the risk for cirrhosis, liver cancer, nd death.”

An estimated 580,000 to 2.4 million individuals are living with HBV infection in the United States, and two-thirds may be unaware they are infected, the agency said.

The virus spreads through contact with blood, semen, and other body fluids of an infected person.

The guidance now recommends using the triple panel (HBsAg, anti-HBs, total anti-HBc) for initial screening.

“It can help identify persons who have an active HBV infection and could be linked to care; have [a] resolved infection and might be susceptible to reactivation (for example, immunosuppressed persons); are susceptible and need vaccination; or are vaccinated,” the authors write.
 

Ectopic pregnancy risk and levonorgestrel-releasing IUD

Diana Swift
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
 

EPA seeks to limit ‘forever’ chemicals in U.S. drinking water

Lisa Nainggolan
 

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water.

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

https://www.mdedge.com /obgyn/latest-news

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Have you ever looked at the operating room (OR) trash bin at the end of a case and wondered if all that waste is necessary? Since I started my residency, not a day goes by that I have not asked myself this question.

In the mid-1990s, John Elkington introduced the concept of the triple bottom line—that is, people, planet, and profit—for implementation and measurement of sustainability in businesses.¹ The health care sector is no exception when it comes to the bottom line! However, “people” remain the priority. What is our role, as ObGyns, in protecting the “planet” while keeping the “people” safe?

According to the World Health Organization (WHO), climate change remains the single biggest health threat to humanity.² The health care system is both the victim and the culprit. Studies suggest that the health care system, second to the food industry, is the biggest contributor to waste production in the United States. This sector generates more than 6,000 metric tons of waste each day and nearly 4 million tons (3.6 million metric tons) of solid waste each year.³ The health care system is responsible for an estimated 8% to 10% of total greenhouse gas emissions in the United States; the US health care system alone contributes to more than one-fourth of the global health care carbon footprint. If it were a country, the US health care system would rank 13th among all countries in emissions.⁴In turn, pollution produced by the health sector negatively impacts population health, further burdening the health care system. According to 2013 study data, the annual health damage caused by health care pollution was comparable to that of the deaths caused by preventable medical error.⁴

Aside from the environmental aspects, hospital waste disposal is expensive; reducing this cost is a potential area of interest for institutions.

As ObGyns, what is our role in reducing our waste generation and carbon footprint while keeping patients safe?

Defining health care waste, and disposal considerations

The WHO defines health care waste as including “the waste generated by health-care establishments, research facilities, and laboratories” as well as waste from scattered sources such as home dialysis and insulin injections.⁵ Despite representing a relatively small physical area of hospitals, labor and delivery units combined with ORs account for approximately 70% of all hospital waste.³ Operating room waste consists of disposable surgical supplies, personal protective equipment, drapes, plastic wrappers, sterile blue wraps, glass, cardboard, packaging material, medications, fluids, and other materials (FIGURE 1).

Photo: Courtesy of Golnaz Namazi, MD

The WHO also notes that of all the waste generated by health care activities, about 85% is general, nonhazardous waste that is comparable to domestic waste.⁶ Hazardous waste is any material that poses a health risk, including potentially infectious materials, such as blood-soaked gauze, sharps, pharmaceuticals, or radioactive materials.⁶

Disposal of hazardous waste is expensiveand energy consuming as it is typically incinerated rather than disposed of in a landfill. This process produces substantial greenhouse gases, about 3 kg of carbon dioxide for every 1 kg of hazardous waste.⁷

Red bags are used for hazardous waste disposal, while clear bags are used for general waste. Operating rooms produce about two-thirds of the hospital red-bag waste.⁸ Waste segregation unfortunately is not accurate, and as much as 90% of OR general waste is improperly designated as hazardous waste.³ Drapes and uncontaminated, needleless syringes, for example, should be disposed of in clear bags, but often they are instead directed to the red-bag and sharps container (FIGURE 2).

Photo: Courtesy of Golnaz Namazi, MD

Recycling in the OR

Recycling has become an established practice in many health care facilities and ORs. Studies suggest that introducing recycling programs in ORs not only reduces carbon footprints but also reduces costs.³ One study reported that US academic medical centers consume 2 million lb ($15 million) each year of recoverable medical supplies.⁹

Single-stream recycling, a system in which all recyclable material—including plastics, paper, metal, and glass—are placed in a single bin without segregation at the collection site, has gained in popularity. Recycling can be implemented both in ORs and in other perioperative areas where regular trash bins are located.

In a study done at Oxford University Hospitals in the United Kingdom, introducing recycling bins in every OR, as well as in recovery and staff rest areas, helped improve waste segregation such that approximately 22% of OR waste was recycled.¹⁰ Studies show that recycling programs not only decrease the health care carbon footprint but also have a considerable financial impact. Albert and colleagues demonstrated that introducing a single-stream recycling program to a 9-OR day (or ambulatory) surgery center could redirect more than 4 tons of waste each month and saved thousands of dollars.¹¹

Despite continued improvement in recycling programs, the segregation process is still far from optimal. In a survey done at the Mayo Clinic by Azouz and colleagues, more than half of the staff reported being unclear about which OR items are recyclable and nearly half reported that lack of knowledge was the barrier to proper recycling.¹² That study also showed that after implementation of a recycling education program, costs decreased 10% relative to the same time period in prior years.¹²

Blue wraps. One example of recycling optimization is blue wraps, the polypropylene (No. 5 plastic) material used for wrapping surgical instruments. Blue wraps account for approximately 19% of OR waste and 5% of all hospital waste.¹¹ Blue wraps are not biodegradable and also are not widely recycled. In recent years, a resale market has emerged for blue wraps, as they can be used for production of other No. 5 plastic items.⁹ By reselling blue wraps, revenue can be generated by recycling a necessary packing material that would otherwise require payment for disposal.

Sterility considerations. While recycling in ORs may raise concern due to the absolute sterility required in procedural settings, technologic developments have been promising in advancing safe recycling to reduce carbon footprints and health care costs without compromising patients’ safety. Segregation of waste from recyclable packaging material prior to the case, as well as directing trash to the correct bin (regular vs red bin), is one example. Moreover, because about 80% of all OR waste is generated during the set up before the patient arrives in the OR, it is not contaminated and can be safely recycled.¹³

Continue to: Packaging material...

A substantial part of OR waste consists of packaging material; of all OR waste, 26% consists of plastics and 7%, paper and cartons.¹⁴ Increasing use of disposable or “single use” medical products in ORs, along with the intention to safeguard sterility, contributes significantly to the generation of medical waste in operating units. Containers, wraps and overwraps, cardboard, and plastic packaging are all composed of materials that when clean, can be recycled; however, these items often end up in the landfill (FIGURE 3).

Photo: Courtesy of Golnaz Namazi, MD

Although the segregation of packaging material to recycling versus regular trash versus red bin is of paramount importance, packaging design plays a significant role as well. In 2018, Boston Scientific introduced a new packaging design for ureteral stents that reduced plastic use in packaging by 120,000 lb each year.¹⁵ Despite the advances in the medical packaging industry to increase sustainability while safeguarding sterility for medical devices, there is still room for innovation in this area.

Reducing overage by judicious selection of surgical devices, instruments, and supplies

Overage is the term used to describe surgical inventory that is opened and prepared for surgery but ultimately not used and therefore discarded. Design of surgical carts and instrument and supply selection requires direct input from ObGyns. Opening only the needed instruments while ensuring ready availability of potentially needed supplies can significantly reduce OR waste generation as well as decrease chemical pollution generated by instrument sterilization. Decreasing OR overage reduces overall costs as well (FIGURE 4).

Photo: Courtesy of Golnaz Namazi, MD

In a pilot study at the University of Massachusetts, Albert and colleagues examined the sets of disposable items and instruments designated for common plastic and hand surgery procedures.¹¹ They identified the supplies and instruments that are routinely opened and wasted, based on surgeons’ interview responses, and redesigned the sets. Fifteen items were removed from disposable plastic surgery packs and 7 items from hand surgery packs. The authors reported saving thousands of dollars per year with these changes alone, as well as reducing waste.¹¹ This same concept easily could be implemented in obstetrics and gynecology. We must ask ourselves: Do we always need, for example, a complete dilation and curettage kit to place the uterine manipulator prior to a minimally invasive hysterectomy?

In another pilot study, Greenberg and colleagues investigated whether cesarean deliveries consistently could be performed in a safe manner with only 20 instruments in the surgical kit.¹⁶ Obstetricians rated the 20-instrument kit an 8.7 out of 10 for performing cesarean deliveries safely.¹⁶

In addition to instrument selection, surgeons have a role in other supply use and waste generation: for instance, opening multiple pairs of surgical gloves and surgical gowns in advance when most of them will not be used during the case. Furthermore, many ObGyn surgeons routinely change gloves or even gowns during gynecologic procedures when they go back and forth between the vaginal and abdominal fields. Is the perineum “dirty” after application of a surgical prep solution?

In an observational study, Shockley and colleagues investigated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy.¹⁷ They showed that in 98.9% of cultures, the overall bacterial concentrations did not exceed the threshold for infection. There was no bacterial growth from vaginal cultures, and the only samples with some bacterial growth belonged to the surgeon’s gloves after specimen extraction; about one-third of samples showed growth after specimen extraction, but only 1 sample had a bacterial load above the infectious threshold of 5,000 colony-forming units per mL. The authors therefore suggested that if a surgeon changes gloves, doing so after specimen extraction and before turning attention back to the abdomen for vaginal cuff closure may be most effective in reducing bacterial load.¹⁷

Surgical site infection contributes to medical cost and likely medical waste as well. For example, surgical site infection may require prolonged treatments, tests, and medical instruments. In severe cases with abscesses, treatment entails hospitalization with prolonged antibiotic therapy with or without procedures to drain the collections. Further research therefore is warranted to investigate safe and environmentally friendly practices.

Myriad products are introduced to the medical system each day, some of which replace conventional tools. For instance, low-density polyethylene, or LDPE, transfer sheet is advertised for lateral patient transfer from the OR table to the bed or stretcher. This No. 4–coded plastic, while recyclable, is routinely discarded as trash in ORs. One ergonomic study found that reusable slide boards are as effective for reducing friction and staff muscle activities and are noninferior to the plastic sheets.¹⁸

Steps to making an impact

Operating rooms and labor and delivery units are responsible for a large proportion of hospital waste, and therefore they are of paramount importance in reducing waste and carbon footprint at the individual and institutional level. Reduction of OR waste not only is environmentally conscious but also decreases cost. Steps as small as individual practices to as big as changing infrastructures can make an impact. For instance:

• redesigning surgical carts
• reformulating surgeon-specific supply lists
• raising awareness about surgical overage
• encouraging recycling through education and audit
• optimizing surgical waste segregation through educational posters.

These are all simple steps that could significantly reduce waste and carbon footprint.

Bottom line

Although waste reduction is the responsibility of all health care providers, as leaders in their workplace physicians can serve as role models by implementing “green” practices in procedural units. Raising awareness and using a team approach is critical to succeed in our endeavors to move toward an environmentally friendly future. ●

Although rheumatoid arthritis (RA) is well understood to be associated with cigarette smoking as well as with a risk for interstitial lung disease (ILD), its association with airway diseases such as asthma and chronic obstructive pulmonary disease (COPD), and with allergic disorders such as atopic dermatitis and allergic rhinitis, is unknown. Kim and colleagues performed a cross-sectional study using information from the Korean National Health and Nutrition Examination Survey by 334 respondents with RA and over 13,000 respondents without RA and analyzed the association of RA with asthma and asthma-related comorbidities. The prevalence of asthma was higher in respondents with RA (7.5% vs 2.8%; P < .001), but the prevalence of other allergic disorders and COPD wassimilar between groups. This finding in a small group of respondents is not striking and its importance is unclear compared with other nonallergic pulmonary disorders. Inferring a mechanistic connection to T-helper (Th) 1- vs Th2 immunity would thus be premature.

Baker and colleagues examined the risk for RA-associated ILD in patients taking different therapies for RA, a topic of great interest due to the frequency of this complication as well as uncertainty regarding its association with medications, including anti-tumor necrosis factor (TNF) agents and methotrexate. Using a claims database, they performed a retrospective study of patients with RA without existing ILD who were treated with a biologic (b) or targeted synthetic disease-modifying antirheumatic drugs (DMARD; abatacept, adalimumab, rituximab, tocilizumab, and tofacitinib). In over 28,000 patients with RA, incidence ratios for ILD were > 1 for all bDMARD, while the incidence ratio for ILD with tofacitinib was 1.47. As the group of patients treated with tofacitinib was the smallest, the reliability of this result is uncertain and thus not strong enough to suggest a protective effect or preference for this medication in patients with known ILD. However, prospective studies looking at ILD in RA patients taking tofacitinib would be of interest.

Kristensen and colleagues also looked at risks associated with tofacitinib and anti-TNF agents, in particular cardiovascular disease, malignancy, and venous thromboembolism, using data from the open-label randomized ORAL Surveillance study, which looked at patients taking 5 mg or 10 mg tofacitinib twice daily, adalimumab, or etanercept. The 10 mg dose was reduced to 5 mg twice daily after it was found that rates of pulmonary embolism were higher in the group taking the higher dose. Age and smoking are also known to be risk factors for malignancy and cardiovascular disease in patients with RA, and these findings carried through in this analysis as well. Within the study, patients taking tofacitinib over age 65 who had ever smoked had a higher risk for cardiovascular events, myocardial infarction, malignancy, venous thromboembolism, and death compared with patients on anti-TNF therapy, while patients taking tofacitinib who were younger than 65 and had never smoked had a risk similar to those on anti-TNF therapy.The study confirms prior knowledge regarding the risks of tofacitinib in different patient populations, suggesting that caution should be used with this medication in older patients and those who smoke.

Although rheumatoid arthritis (RA) is well understood to be associated with cigarette smoking as well as with a risk for interstitial lung disease (ILD), its association with airway diseases such as asthma and chronic obstructive pulmonary disease (COPD), and with allergic disorders such as atopic dermatitis and allergic rhinitis, is unknown. Kim and colleagues performed a cross-sectional study using information from the Korean National Health and Nutrition Examination Survey by 334 respondents with RA and over 13,000 respondents without RA and analyzed the association of RA with asthma and asthma-related comorbidities. The prevalence of asthma was higher in respondents with RA (7.5% vs 2.8%; P < .001), but the prevalence of other allergic disorders and COPD wassimilar between groups. This finding in a small group of respondents is not striking and its importance is unclear compared with other nonallergic pulmonary disorders. Inferring a mechanistic connection to T-helper (Th) 1- vs Th2 immunity would thus be premature.

Baker and colleagues examined the risk for RA-associated ILD in patients taking different therapies for RA, a topic of great interest due to the frequency of this complication as well as uncertainty regarding its association with medications, including anti-tumor necrosis factor (TNF) agents and methotrexate. Using a claims database, they performed a retrospective study of patients with RA without existing ILD who were treated with a biologic (b) or targeted synthetic disease-modifying antirheumatic drugs (DMARD; abatacept, adalimumab, rituximab, tocilizumab, and tofacitinib). In over 28,000 patients with RA, incidence ratios for ILD were > 1 for all bDMARD, while the incidence ratio for ILD with tofacitinib was 1.47. As the group of patients treated with tofacitinib was the smallest, the reliability of this result is uncertain and thus not strong enough to suggest a protective effect or preference for this medication in patients with known ILD. However, prospective studies looking at ILD in RA patients taking tofacitinib would be of interest.

Kristensen and colleagues also looked at risks associated with tofacitinib and anti-TNF agents, in particular cardiovascular disease, malignancy, and venous thromboembolism, using data from the open-label randomized ORAL Surveillance study, which looked at patients taking 5 mg or 10 mg tofacitinib twice daily, adalimumab, or etanercept. The 10 mg dose was reduced to 5 mg twice daily after it was found that rates of pulmonary embolism were higher in the group taking the higher dose. Age and smoking are also known to be risk factors for malignancy and cardiovascular disease in patients with RA, and these findings carried through in this analysis as well. Within the study, patients taking tofacitinib over age 65 who had ever smoked had a higher risk for cardiovascular events, myocardial infarction, malignancy, venous thromboembolism, and death compared with patients on anti-TNF therapy, while patients taking tofacitinib who were younger than 65 and had never smoked had a risk similar to those on anti-TNF therapy.The study confirms prior knowledge regarding the risks of tofacitinib in different patient populations, suggesting that caution should be used with this medication in older patients and those who smoke.

Although rheumatoid arthritis (RA) is well understood to be associated with cigarette smoking as well as with a risk for interstitial lung disease (ILD), its association with airway diseases such as asthma and chronic obstructive pulmonary disease (COPD), and with allergic disorders such as atopic dermatitis and allergic rhinitis, is unknown. Kim and colleagues performed a cross-sectional study using information from the Korean National Health and Nutrition Examination Survey by 334 respondents with RA and over 13,000 respondents without RA and analyzed the association of RA with asthma and asthma-related comorbidities. The prevalence of asthma was higher in respondents with RA (7.5% vs 2.8%; P < .001), but the prevalence of other allergic disorders and COPD wassimilar between groups. This finding in a small group of respondents is not striking and its importance is unclear compared with other nonallergic pulmonary disorders. Inferring a mechanistic connection to T-helper (Th) 1- vs Th2 immunity would thus be premature.

Baker and colleagues examined the risk for RA-associated ILD in patients taking different therapies for RA, a topic of great interest due to the frequency of this complication as well as uncertainty regarding its association with medications, including anti-tumor necrosis factor (TNF) agents and methotrexate. Using a claims database, they performed a retrospective study of patients with RA without existing ILD who were treated with a biologic (b) or targeted synthetic disease-modifying antirheumatic drugs (DMARD; abatacept, adalimumab, rituximab, tocilizumab, and tofacitinib). In over 28,000 patients with RA, incidence ratios for ILD were > 1 for all bDMARD, while the incidence ratio for ILD with tofacitinib was 1.47. As the group of patients treated with tofacitinib was the smallest, the reliability of this result is uncertain and thus not strong enough to suggest a protective effect or preference for this medication in patients with known ILD. However, prospective studies looking at ILD in RA patients taking tofacitinib would be of interest.

Kristensen and colleagues also looked at risks associated with tofacitinib and anti-TNF agents, in particular cardiovascular disease, malignancy, and venous thromboembolism, using data from the open-label randomized ORAL Surveillance study, which looked at patients taking 5 mg or 10 mg tofacitinib twice daily, adalimumab, or etanercept. The 10 mg dose was reduced to 5 mg twice daily after it was found that rates of pulmonary embolism were higher in the group taking the higher dose. Age and smoking are also known to be risk factors for malignancy and cardiovascular disease in patients with RA, and these findings carried through in this analysis as well. Within the study, patients taking tofacitinib over age 65 who had ever smoked had a higher risk for cardiovascular events, myocardial infarction, malignancy, venous thromboembolism, and death compared with patients on anti-TNF therapy, while patients taking tofacitinib who were younger than 65 and had never smoked had a risk similar to those on anti-TNF therapy.The study confirms prior knowledge regarding the risks of tofacitinib in different patient populations, suggesting that caution should be used with this medication in older patients and those who smoke.

For years evidence has pointed to multiple health benefits associated with bariatric surgery, including improvements in diabetes, sleep apnea, and blood pressure. Now researchers are adding cutting cancer risk by more than half to the list.

A retrospective, observational study of patients with obesity at 47 U.S. health care organizations found that, over 10 years, 4% who had bariatric surgery developed certain cancers, compared with 8.9% of their peers who did not undergo such surgery.

“We did see a difference in breast cancer, colon cancer, liver cancer, and ovarian cancer incidence. ... with patients in the bariatric surgery group having lower incidence of these four types of cancers when compared to the nonsurgical control group,” said Vibhu Chittajallu, MD, lead author and a gastroenterology fellow at Case Western Reserve University and University Hospitals in Cleveland.

The obesity epidemic is “one of the most serious health challenges in the United States today,” Dr. Chittajallu added at an April 27 media briefing during which select research was previewed for the annual Digestive Disease Week®. Obesity has been associated with multiple serious illnesses, including type 2 diabetes, heart disease, and cancer.

Obesity is also common. The Centers for Disease Control and Prevention reports that nearly 42% of American adults have obesity, and rates continue to rise.

Dr. Chittajallu and colleagues used billing codes in a national database to identify 55,789 patients with obesity who underwent bariatric surgery (sleeve gastrectomy, gastric bypass, or gastric band procedures) and a control group of the same size who did not have surgery.

Investigators controlled for risk factors that contribute to cancer development, including smoking history, alcohol use, heart disease, and hormone therapies.

Key findings

In 10 years of follow-up, 2,206 patients who underwent bariatric surgery developed an obesity-associated cancer, compared with 4,960 patients who did not have bariatric surgery.

The bariatric surgery group had lower numbers of new cases for six types of cancers (Table 1).

‘Fascinating’ study but questions remain

The study is “fascinating,” said Loren Laine, MD, moderator of the media briefing. “Obesity is clearly associated with a number of different cancers, and that’s very important. So, it makes logical sense that if you lose weight, you will reduce that risk.”

Although investigators controlled for several known cancer risk factors, there are some they couldn’t control for because they were not included in the database, and there could be unknowns that also affected the results, noted Dr. Laine, who is professor of medicine (digestive diseases) and chief of digestive health at Yale University in New Haven, Conn.

“You have to be circumspect when you look at retrospective observational studies,” he added.

It would be helpful to know when most cancers developed over the 10 years, Dr. Laine said. Dr. Chittajallu responded that the research team did not include cancers that developed in the first year after bariatric surgery to minimize incidental findings, but he did not provide a timeline for the cancers that developed.

Another unanswered question, Dr. Laine said, is whether a dose-response relationship exists. If future research shows that the more weight a person loses, the more likely they are to have a reduction in cancer risk, “that would be fascinating,” he said. Also, it would be interesting to know if endoscopic interventions and weight-loss medications decrease cancer risks in people with obesity.

More research is needed to understand how bariatric surgery affects cancer risk, Dr. Chittajallu said. “But the significant findings from this study suggest it’s an exciting avenue for further study.”

DDW 2023 will be held May 6-9 in Chicago and virtually.

The study was independently supported. Dr. Chittajallu and Dr. Laine have reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

For years evidence has pointed to multiple health benefits associated with bariatric surgery, including improvements in diabetes, sleep apnea, and blood pressure. Now researchers are adding cutting cancer risk by more than half to the list.

A retrospective, observational study of patients with obesity at 47 U.S. health care organizations found that, over 10 years, 4% who had bariatric surgery developed certain cancers, compared with 8.9% of their peers who did not undergo such surgery.

“We did see a difference in breast cancer, colon cancer, liver cancer, and ovarian cancer incidence. ... with patients in the bariatric surgery group having lower incidence of these four types of cancers when compared to the nonsurgical control group,” said Vibhu Chittajallu, MD, lead author and a gastroenterology fellow at Case Western Reserve University and University Hospitals in Cleveland.

The obesity epidemic is “one of the most serious health challenges in the United States today,” Dr. Chittajallu added at an April 27 media briefing during which select research was previewed for the annual Digestive Disease Week®. Obesity has been associated with multiple serious illnesses, including type 2 diabetes, heart disease, and cancer.

Obesity is also common. The Centers for Disease Control and Prevention reports that nearly 42% of American adults have obesity, and rates continue to rise.

Dr. Chittajallu and colleagues used billing codes in a national database to identify 55,789 patients with obesity who underwent bariatric surgery (sleeve gastrectomy, gastric bypass, or gastric band procedures) and a control group of the same size who did not have surgery.

Investigators controlled for risk factors that contribute to cancer development, including smoking history, alcohol use, heart disease, and hormone therapies.

Key findings

In 10 years of follow-up, 2,206 patients who underwent bariatric surgery developed an obesity-associated cancer, compared with 4,960 patients who did not have bariatric surgery.

The bariatric surgery group had lower numbers of new cases for six types of cancers (Table 1).

‘Fascinating’ study but questions remain

The study is “fascinating,” said Loren Laine, MD, moderator of the media briefing. “Obesity is clearly associated with a number of different cancers, and that’s very important. So, it makes logical sense that if you lose weight, you will reduce that risk.”

Although investigators controlled for several known cancer risk factors, there are some they couldn’t control for because they were not included in the database, and there could be unknowns that also affected the results, noted Dr. Laine, who is professor of medicine (digestive diseases) and chief of digestive health at Yale University in New Haven, Conn.

“You have to be circumspect when you look at retrospective observational studies,” he added.

It would be helpful to know when most cancers developed over the 10 years, Dr. Laine said. Dr. Chittajallu responded that the research team did not include cancers that developed in the first year after bariatric surgery to minimize incidental findings, but he did not provide a timeline for the cancers that developed.

Another unanswered question, Dr. Laine said, is whether a dose-response relationship exists. If future research shows that the more weight a person loses, the more likely they are to have a reduction in cancer risk, “that would be fascinating,” he said. Also, it would be interesting to know if endoscopic interventions and weight-loss medications decrease cancer risks in people with obesity.

More research is needed to understand how bariatric surgery affects cancer risk, Dr. Chittajallu said. “But the significant findings from this study suggest it’s an exciting avenue for further study.”

DDW 2023 will be held May 6-9 in Chicago and virtually.

The study was independently supported. Dr. Chittajallu and Dr. Laine have reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

For years evidence has pointed to multiple health benefits associated with bariatric surgery, including improvements in diabetes, sleep apnea, and blood pressure. Now researchers are adding cutting cancer risk by more than half to the list.

A retrospective, observational study of patients with obesity at 47 U.S. health care organizations found that, over 10 years, 4% who had bariatric surgery developed certain cancers, compared with 8.9% of their peers who did not undergo such surgery.

“We did see a difference in breast cancer, colon cancer, liver cancer, and ovarian cancer incidence. ... with patients in the bariatric surgery group having lower incidence of these four types of cancers when compared to the nonsurgical control group,” said Vibhu Chittajallu, MD, lead author and a gastroenterology fellow at Case Western Reserve University and University Hospitals in Cleveland.

The obesity epidemic is “one of the most serious health challenges in the United States today,” Dr. Chittajallu added at an April 27 media briefing during which select research was previewed for the annual Digestive Disease Week®. Obesity has been associated with multiple serious illnesses, including type 2 diabetes, heart disease, and cancer.

Obesity is also common. The Centers for Disease Control and Prevention reports that nearly 42% of American adults have obesity, and rates continue to rise.

Dr. Chittajallu and colleagues used billing codes in a national database to identify 55,789 patients with obesity who underwent bariatric surgery (sleeve gastrectomy, gastric bypass, or gastric band procedures) and a control group of the same size who did not have surgery.

Investigators controlled for risk factors that contribute to cancer development, including smoking history, alcohol use, heart disease, and hormone therapies.

Key findings

In 10 years of follow-up, 2,206 patients who underwent bariatric surgery developed an obesity-associated cancer, compared with 4,960 patients who did not have bariatric surgery.

The bariatric surgery group had lower numbers of new cases for six types of cancers (Table 1).

‘Fascinating’ study but questions remain

The study is “fascinating,” said Loren Laine, MD, moderator of the media briefing. “Obesity is clearly associated with a number of different cancers, and that’s very important. So, it makes logical sense that if you lose weight, you will reduce that risk.”

Although investigators controlled for several known cancer risk factors, there are some they couldn’t control for because they were not included in the database, and there could be unknowns that also affected the results, noted Dr. Laine, who is professor of medicine (digestive diseases) and chief of digestive health at Yale University in New Haven, Conn.

“You have to be circumspect when you look at retrospective observational studies,” he added.

It would be helpful to know when most cancers developed over the 10 years, Dr. Laine said. Dr. Chittajallu responded that the research team did not include cancers that developed in the first year after bariatric surgery to minimize incidental findings, but he did not provide a timeline for the cancers that developed.

Another unanswered question, Dr. Laine said, is whether a dose-response relationship exists. If future research shows that the more weight a person loses, the more likely they are to have a reduction in cancer risk, “that would be fascinating,” he said. Also, it would be interesting to know if endoscopic interventions and weight-loss medications decrease cancer risks in people with obesity.

More research is needed to understand how bariatric surgery affects cancer risk, Dr. Chittajallu said. “But the significant findings from this study suggest it’s an exciting avenue for further study.”

DDW 2023 will be held May 6-9 in Chicago and virtually.

The study was independently supported. Dr. Chittajallu and Dr. Laine have reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.

The Society for Assisted Reproductive Technology, an affiliate of the American Society for Reproductive Medicine, maintains standards and provides resources and education to both professionals and patients. SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.

Fertility CARE

SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
 

Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?

Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.

University of Iowa

This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.

This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
 

Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”

A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.

In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.

This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
 

Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?

A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.

SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
 

Q: Have national success rates in the United States continued to rise or have they plateaued?

A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.

Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
 

Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?

A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.

A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
 

Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?

A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.

Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?

A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.

Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?

A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.

The Society for Assisted Reproductive Technology, an affiliate of the American Society for Reproductive Medicine, maintains standards and provides resources and education to both professionals and patients. SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.

Fertility CARE

SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
 

Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?

Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.

University of Iowa

This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.

This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
 

Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”

A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.

In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.

This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
 

Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?

A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.

SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
 

Q: Have national success rates in the United States continued to rise or have they plateaued?

A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.

Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
 

Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?

A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.

A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
 

Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?

A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.

Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?

A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.

Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?

A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.

The Society for Assisted Reproductive Technology, an affiliate of the American Society for Reproductive Medicine, maintains standards and provides resources and education to both professionals and patients. SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.

Fertility CARE

SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
 

Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?

Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.

University of Iowa

This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.

This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
 

Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”

A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.

In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.

This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
 

Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?

A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.

SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
 

Q: Have national success rates in the United States continued to rise or have they plateaued?

A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.

Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
 

Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?

A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.

A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
 

Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?

A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.

Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?

A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.

Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?

A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Understanding more about the gut microbiome and how it may affect the development and treatment of heart failure could lead to a more personalized approach to managing the condition, a new review article suggests.

ChrisChrisW/Getty Images

“The gut microbiome modulates heart failure pathophysiology, contributes to disease progression and therapeutic responses, and holds promise as a novel biomarker,” the authors note. “Interactions among the gut microbiome, diet, and medications offer potentially innovative modalities for management of patients with heart failure,” they add.

The review was published online in the Journal of the American College of Cardiology.

“Over the past years we have gathered more understanding about how important the gut microbiome is in relation to how our bodies function overall and even though the cardiovascular system and the heart itself may appear to be quite distant from the gut, we know the gut microbiome affects the cardiovascular system and the physiology of heart failure,” lead author Petra Mamic, MD, Stanford (Calif.) University, told this news organization.

“We’ve also learnt that the microbiome is very personalized. It seems to be affected by a lot of intrinsic and as well as extrinsic factors. For cardiovascular diseases in particular, we always knew that diet and lifestyle were part of the environmental risk, and we now believe that the gut microbiome may be one of the factors that mediates that risk,” she said.

“Studies on the gut microbiome are difficult to do and we are right at the beginning of this type of research. But we have learned that the microbiome is altered or dysregulated in many diseases including many cardiovascular diseases, and many of the changes in the microbiome we see in different cardiovascular diseases seem to overlap,” she added.

Dr. Mamic explained that patients with heart failure have a microbiome that appears different and dysregulated, compared with the microbiome in healthy individuals.

“The difficulty is teasing out whether the microbiome changes are causing heart failure or if they are a consequence of the heart failure and all the medications and comorbidities associated with heart failure,” she commented.

Animal studies have shown that many microbial products, small molecules made by the microbiome, seem to affect how the heart recovers from injury, for example after a myocardial infarction, and how much the heart scars and hypertrophies after an injury, Dr. Mamic reported. These microbiome-derived small molecules can also affect blood pressure, which is dysregulated in heart failure.

Other products of the microbiome can be pro-inflammatory or anti-inflammatory, which can again affect the cardiovascular physiology and the heart, she noted.
 

High-fiber diet may be beneficial

One area of particular interest at present involves the role of short-chain fatty acids, which are a byproduct of microbes in the gut that digest fiber.

“These short chain fatty acids seem to have positive effects on the host physiology. They are anti-inflammatory; they lower blood pressure; and they seem to protect the heart from scarring and hypertrophy after injury. In heart failure, the gut microbes that make these short-chain fatty acids are significantly depleted,” Dr. Mamic explained.

They are an obvious focus of interest because these short-chain fatty acids are produced when gut bacteria break down dietary fiber, raising the possibility of beneficial effects from eating a high-fiber diet.

Another product of the gut microbiome of interest is trimethylamine N-oxide, formed when gut bacteria break down nutrients such as L-carnitine and phosphatidyl choline, nutrients abundant in foods of animal origin, especially red meat. This metabolite has proatherogenic and prothrombotic effects, and negatively affected cardiac remodeling in a mouse heart failure model, the review notes.

However, though it is too early to make specific dietary recommendations based on these findings, Dr. Mamic points out that a high-fiber diet is thought to be beneficial.

“Nutritional research is very hard to do and the data is limited, but as best as we can summarize things, we know that plant-based diets such as the Mediterranean and DASH diets seem to prevent some of the risk factors for the development of heart failure and seem to slow the progression of heart failure,” she added.

One of the major recommendations in these diets is a high intake of fiber, including whole foods, vegetables, fruits, legumes, and nuts, and less intake of processed food and red meat. “In general, I think everyone should eat like that, but I specifically recommend a plant-based diet with a high amount of fiber to my heart failure patients,” Dr. Mamic said.
 

Large variation in microbiome composition

The review also explores the idea of personalization of diet or specific treatments dependent on an individual’s gut microbiome composition.

Dr. Mamic explains: “When we look at the microbiome composition between individuals, it is very different. There is very little overlap between individuals, even in people who are related. It seems to be more to do with the environment – people who are living together are more likely to have similarities in their microbiome. We are still trying to understand what drives these differences.”

It is thought that these differences may affect the response to a specific diet or medication. Dr. Mamic gives the example of fiber. “Not all bacteria can digest the same types of fiber, so not everyone responds in the same way to a high-fiber diet. That’s probably because of differences in their microbiome.”

Another example is the response to the heart failure drug digoxin, which is metabolized by one particular strain of bacteria in the gut. The toxicity or effectiveness of digoxin seems to be influenced by levels of this bacterial strain, and this again can be influenced by diet, Dr. Mamic says.
 

Manipulating the microbiome as a therapeutic strategy

Microbiome-targeting therapies may also become part of future treatment strategies for many conditions, including heart failure, the review authors say.

Probiotics (foods and dietary supplements that contain live microbes) interact with the gut microbiota to alter host physiology beneficially. Certain probiotics may specifically modulate processes dysregulated in heart failure, as was suggested in a rodent heart failure model in which supplementation with Lactobacillus-containing and Bifidobacterium-containing probiotics resulted in markedly improved cardiac function, the authors report.

However, a randomized trial (GutHeart) of probiotic yeast Saccharomyces boulardii in patients with heart failure found no improvement in cardiac function, compared with standard care.

Commenting on this, Dr. Mamic suggested that a more specific approach may be needed.

“Some of our preliminary data have shown people who have heart failure have severely depleted Bifidobacteria,” Dr. Mamic said. These bacteria are commercially available as a probiotic, and the researchers are planning a study to give patients with heart failure these specific probiotics. “We are trying to find practical ways forward and to be guided by the data. These people have very little Bifidobacteria, and we know that probiotics seem to be accepted best by the host where there is a specific need for them, so this seems like a sensible approach.”

Dr. Mamic does not recommend that heart failure patients take general probiotic products at present, but she tells her patients about the study she is doing. “Probiotics are quite different from each other. It is a very unregulated market. A general probiotic product may not contain the specific bacteria needed.”
 

Include microbiome data in biobanks

The review calls for more research on the subject and a more systematic approach to collecting data on the microbiome.

“At present for medical research, blood samples are collected, stored, and analyzed routinely. I think we should also be collecting stool samples in the same way to analyze the microbiome,” Dr. Mamic suggests.

“If we can combine that with data from blood tests on various metabolites/cytokines and look at how the microbiome changes over time or with medication, or with diet, and how the host responds including clinically relevant data, that would be really important. Given how quickly the field is growing I would think there would be biobanks including the microbiome in a few years’ time.”

“We need to gather this data. We would be looking for which bacteria are there, what their functionality is, how it changes over time, with diet or medication, and even whether we can use the microbiome data to predict who will respond to a specific drug.”

Dr. Mamic believes that in the future, analysis of the microbiome could be a routine part of deciding what people eat for good health and to characterize patients for personalized therapies.

“It is clear that the microbiome can influence health, and a dysregulated microbiome negatively affects the host, but there is lot of work to do. We need to learn a lot more about it, but we shouldn’t miss the opportunity to do this,” she concluded.

Dr. Mamic reported no disclosures.

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

Understanding more about the gut microbiome and how it may affect the development and treatment of heart failure could lead to a more personalized approach to managing the condition, a new review article suggests.

ChrisChrisW/Getty Images

“The gut microbiome modulates heart failure pathophysiology, contributes to disease progression and therapeutic responses, and holds promise as a novel biomarker,” the authors note. “Interactions among the gut microbiome, diet, and medications offer potentially innovative modalities for management of patients with heart failure,” they add.

The review was published online in the Journal of the American College of Cardiology.

“Over the past years we have gathered more understanding about how important the gut microbiome is in relation to how our bodies function overall and even though the cardiovascular system and the heart itself may appear to be quite distant from the gut, we know the gut microbiome affects the cardiovascular system and the physiology of heart failure,” lead author Petra Mamic, MD, Stanford (Calif.) University, told this news organization.

“We’ve also learnt that the microbiome is very personalized. It seems to be affected by a lot of intrinsic and as well as extrinsic factors. For cardiovascular diseases in particular, we always knew that diet and lifestyle were part of the environmental risk, and we now believe that the gut microbiome may be one of the factors that mediates that risk,” she said.

“Studies on the gut microbiome are difficult to do and we are right at the beginning of this type of research. But we have learned that the microbiome is altered or dysregulated in many diseases including many cardiovascular diseases, and many of the changes in the microbiome we see in different cardiovascular diseases seem to overlap,” she added.

Dr. Mamic explained that patients with heart failure have a microbiome that appears different and dysregulated, compared with the microbiome in healthy individuals.

“The difficulty is teasing out whether the microbiome changes are causing heart failure or if they are a consequence of the heart failure and all the medications and comorbidities associated with heart failure,” she commented.

Animal studies have shown that many microbial products, small molecules made by the microbiome, seem to affect how the heart recovers from injury, for example after a myocardial infarction, and how much the heart scars and hypertrophies after an injury, Dr. Mamic reported. These microbiome-derived small molecules can also affect blood pressure, which is dysregulated in heart failure.

Other products of the microbiome can be pro-inflammatory or anti-inflammatory, which can again affect the cardiovascular physiology and the heart, she noted.
 

High-fiber diet may be beneficial

One area of particular interest at present involves the role of short-chain fatty acids, which are a byproduct of microbes in the gut that digest fiber.

“These short chain fatty acids seem to have positive effects on the host physiology. They are anti-inflammatory; they lower blood pressure; and they seem to protect the heart from scarring and hypertrophy after injury. In heart failure, the gut microbes that make these short-chain fatty acids are significantly depleted,” Dr. Mamic explained.

They are an obvious focus of interest because these short-chain fatty acids are produced when gut bacteria break down dietary fiber, raising the possibility of beneficial effects from eating a high-fiber diet.

Another product of the gut microbiome of interest is trimethylamine N-oxide, formed when gut bacteria break down nutrients such as L-carnitine and phosphatidyl choline, nutrients abundant in foods of animal origin, especially red meat. This metabolite has proatherogenic and prothrombotic effects, and negatively affected cardiac remodeling in a mouse heart failure model, the review notes.

However, though it is too early to make specific dietary recommendations based on these findings, Dr. Mamic points out that a high-fiber diet is thought to be beneficial.

“Nutritional research is very hard to do and the data is limited, but as best as we can summarize things, we know that plant-based diets such as the Mediterranean and DASH diets seem to prevent some of the risk factors for the development of heart failure and seem to slow the progression of heart failure,” she added.

One of the major recommendations in these diets is a high intake of fiber, including whole foods, vegetables, fruits, legumes, and nuts, and less intake of processed food and red meat. “In general, I think everyone should eat like that, but I specifically recommend a plant-based diet with a high amount of fiber to my heart failure patients,” Dr. Mamic said.
 

Large variation in microbiome composition

The review also explores the idea of personalization of diet or specific treatments dependent on an individual’s gut microbiome composition.

Dr. Mamic explains: “When we look at the microbiome composition between individuals, it is very different. There is very little overlap between individuals, even in people who are related. It seems to be more to do with the environment – people who are living together are more likely to have similarities in their microbiome. We are still trying to understand what drives these differences.”

It is thought that these differences may affect the response to a specific diet or medication. Dr. Mamic gives the example of fiber. “Not all bacteria can digest the same types of fiber, so not everyone responds in the same way to a high-fiber diet. That’s probably because of differences in their microbiome.”

Another example is the response to the heart failure drug digoxin, which is metabolized by one particular strain of bacteria in the gut. The toxicity or effectiveness of digoxin seems to be influenced by levels of this bacterial strain, and this again can be influenced by diet, Dr. Mamic says.
 

Manipulating the microbiome as a therapeutic strategy

Microbiome-targeting therapies may also become part of future treatment strategies for many conditions, including heart failure, the review authors say.

Probiotics (foods and dietary supplements that contain live microbes) interact with the gut microbiota to alter host physiology beneficially. Certain probiotics may specifically modulate processes dysregulated in heart failure, as was suggested in a rodent heart failure model in which supplementation with Lactobacillus-containing and Bifidobacterium-containing probiotics resulted in markedly improved cardiac function, the authors report.

However, a randomized trial (GutHeart) of probiotic yeast Saccharomyces boulardii in patients with heart failure found no improvement in cardiac function, compared with standard care.

Commenting on this, Dr. Mamic suggested that a more specific approach may be needed.

“Some of our preliminary data have shown people who have heart failure have severely depleted Bifidobacteria,” Dr. Mamic said. These bacteria are commercially available as a probiotic, and the researchers are planning a study to give patients with heart failure these specific probiotics. “We are trying to find practical ways forward and to be guided by the data. These people have very little Bifidobacteria, and we know that probiotics seem to be accepted best by the host where there is a specific need for them, so this seems like a sensible approach.”

Dr. Mamic does not recommend that heart failure patients take general probiotic products at present, but she tells her patients about the study she is doing. “Probiotics are quite different from each other. It is a very unregulated market. A general probiotic product may not contain the specific bacteria needed.”
 

Include microbiome data in biobanks

The review calls for more research on the subject and a more systematic approach to collecting data on the microbiome.

“At present for medical research, blood samples are collected, stored, and analyzed routinely. I think we should also be collecting stool samples in the same way to analyze the microbiome,” Dr. Mamic suggests.

“If we can combine that with data from blood tests on various metabolites/cytokines and look at how the microbiome changes over time or with medication, or with diet, and how the host responds including clinically relevant data, that would be really important. Given how quickly the field is growing I would think there would be biobanks including the microbiome in a few years’ time.”

“We need to gather this data. We would be looking for which bacteria are there, what their functionality is, how it changes over time, with diet or medication, and even whether we can use the microbiome data to predict who will respond to a specific drug.”

Dr. Mamic believes that in the future, analysis of the microbiome could be a routine part of deciding what people eat for good health and to characterize patients for personalized therapies.

“It is clear that the microbiome can influence health, and a dysregulated microbiome negatively affects the host, but there is lot of work to do. We need to learn a lot more about it, but we shouldn’t miss the opportunity to do this,” she concluded.

Dr. Mamic reported no disclosures.

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

Understanding more about the gut microbiome and how it may affect the development and treatment of heart failure could lead to a more personalized approach to managing the condition, a new review article suggests.

ChrisChrisW/Getty Images

“The gut microbiome modulates heart failure pathophysiology, contributes to disease progression and therapeutic responses, and holds promise as a novel biomarker,” the authors note. “Interactions among the gut microbiome, diet, and medications offer potentially innovative modalities for management of patients with heart failure,” they add.

The review was published online in the Journal of the American College of Cardiology.

“Over the past years we have gathered more understanding about how important the gut microbiome is in relation to how our bodies function overall and even though the cardiovascular system and the heart itself may appear to be quite distant from the gut, we know the gut microbiome affects the cardiovascular system and the physiology of heart failure,” lead author Petra Mamic, MD, Stanford (Calif.) University, told this news organization.

“We’ve also learnt that the microbiome is very personalized. It seems to be affected by a lot of intrinsic and as well as extrinsic factors. For cardiovascular diseases in particular, we always knew that diet and lifestyle were part of the environmental risk, and we now believe that the gut microbiome may be one of the factors that mediates that risk,” she said.

“Studies on the gut microbiome are difficult to do and we are right at the beginning of this type of research. But we have learned that the microbiome is altered or dysregulated in many diseases including many cardiovascular diseases, and many of the changes in the microbiome we see in different cardiovascular diseases seem to overlap,” she added.

Dr. Mamic explained that patients with heart failure have a microbiome that appears different and dysregulated, compared with the microbiome in healthy individuals.

“The difficulty is teasing out whether the microbiome changes are causing heart failure or if they are a consequence of the heart failure and all the medications and comorbidities associated with heart failure,” she commented.

Animal studies have shown that many microbial products, small molecules made by the microbiome, seem to affect how the heart recovers from injury, for example after a myocardial infarction, and how much the heart scars and hypertrophies after an injury, Dr. Mamic reported. These microbiome-derived small molecules can also affect blood pressure, which is dysregulated in heart failure.

Other products of the microbiome can be pro-inflammatory or anti-inflammatory, which can again affect the cardiovascular physiology and the heart, she noted.
 

High-fiber diet may be beneficial

One area of particular interest at present involves the role of short-chain fatty acids, which are a byproduct of microbes in the gut that digest fiber.

“These short chain fatty acids seem to have positive effects on the host physiology. They are anti-inflammatory; they lower blood pressure; and they seem to protect the heart from scarring and hypertrophy after injury. In heart failure, the gut microbes that make these short-chain fatty acids are significantly depleted,” Dr. Mamic explained.

They are an obvious focus of interest because these short-chain fatty acids are produced when gut bacteria break down dietary fiber, raising the possibility of beneficial effects from eating a high-fiber diet.

Another product of the gut microbiome of interest is trimethylamine N-oxide, formed when gut bacteria break down nutrients such as L-carnitine and phosphatidyl choline, nutrients abundant in foods of animal origin, especially red meat. This metabolite has proatherogenic and prothrombotic effects, and negatively affected cardiac remodeling in a mouse heart failure model, the review notes.

However, though it is too early to make specific dietary recommendations based on these findings, Dr. Mamic points out that a high-fiber diet is thought to be beneficial.

“Nutritional research is very hard to do and the data is limited, but as best as we can summarize things, we know that plant-based diets such as the Mediterranean and DASH diets seem to prevent some of the risk factors for the development of heart failure and seem to slow the progression of heart failure,” she added.

One of the major recommendations in these diets is a high intake of fiber, including whole foods, vegetables, fruits, legumes, and nuts, and less intake of processed food and red meat. “In general, I think everyone should eat like that, but I specifically recommend a plant-based diet with a high amount of fiber to my heart failure patients,” Dr. Mamic said.
 

Large variation in microbiome composition

The review also explores the idea of personalization of diet or specific treatments dependent on an individual’s gut microbiome composition.

Dr. Mamic explains: “When we look at the microbiome composition between individuals, it is very different. There is very little overlap between individuals, even in people who are related. It seems to be more to do with the environment – people who are living together are more likely to have similarities in their microbiome. We are still trying to understand what drives these differences.”

It is thought that these differences may affect the response to a specific diet or medication. Dr. Mamic gives the example of fiber. “Not all bacteria can digest the same types of fiber, so not everyone responds in the same way to a high-fiber diet. That’s probably because of differences in their microbiome.”

Another example is the response to the heart failure drug digoxin, which is metabolized by one particular strain of bacteria in the gut. The toxicity or effectiveness of digoxin seems to be influenced by levels of this bacterial strain, and this again can be influenced by diet, Dr. Mamic says.
 

Manipulating the microbiome as a therapeutic strategy

Microbiome-targeting therapies may also become part of future treatment strategies for many conditions, including heart failure, the review authors say.

Probiotics (foods and dietary supplements that contain live microbes) interact with the gut microbiota to alter host physiology beneficially. Certain probiotics may specifically modulate processes dysregulated in heart failure, as was suggested in a rodent heart failure model in which supplementation with Lactobacillus-containing and Bifidobacterium-containing probiotics resulted in markedly improved cardiac function, the authors report.

However, a randomized trial (GutHeart) of probiotic yeast Saccharomyces boulardii in patients with heart failure found no improvement in cardiac function, compared with standard care.

Commenting on this, Dr. Mamic suggested that a more specific approach may be needed.

“Some of our preliminary data have shown people who have heart failure have severely depleted Bifidobacteria,” Dr. Mamic said. These bacteria are commercially available as a probiotic, and the researchers are planning a study to give patients with heart failure these specific probiotics. “We are trying to find practical ways forward and to be guided by the data. These people have very little Bifidobacteria, and we know that probiotics seem to be accepted best by the host where there is a specific need for them, so this seems like a sensible approach.”

Dr. Mamic does not recommend that heart failure patients take general probiotic products at present, but she tells her patients about the study she is doing. “Probiotics are quite different from each other. It is a very unregulated market. A general probiotic product may not contain the specific bacteria needed.”
 

Include microbiome data in biobanks

The review calls for more research on the subject and a more systematic approach to collecting data on the microbiome.

“At present for medical research, blood samples are collected, stored, and analyzed routinely. I think we should also be collecting stool samples in the same way to analyze the microbiome,” Dr. Mamic suggests.

“If we can combine that with data from blood tests on various metabolites/cytokines and look at how the microbiome changes over time or with medication, or with diet, and how the host responds including clinically relevant data, that would be really important. Given how quickly the field is growing I would think there would be biobanks including the microbiome in a few years’ time.”

“We need to gather this data. We would be looking for which bacteria are there, what their functionality is, how it changes over time, with diet or medication, and even whether we can use the microbiome data to predict who will respond to a specific drug.”

Dr. Mamic believes that in the future, analysis of the microbiome could be a routine part of deciding what people eat for good health and to characterize patients for personalized therapies.

“It is clear that the microbiome can influence health, and a dysregulated microbiome negatively affects the host, but there is lot of work to do. We need to learn a lot more about it, but we shouldn’t miss the opportunity to do this,” she concluded.

Dr. Mamic reported no disclosures.

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

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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