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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Use of opioids, SSRIs linked to increased fracture risk in RA
SAN DIEGO – The use of selective serotonin reuptake inhibitors and opioids was associated with an increased osteoporotic fracture risk in patients with rheumatoid arthritis, results from an analysis of national data showed.
“Osteoporotic fractures are one of the important causes of disability, health-related costs, and mortality in RA, with substantially higher complication and mortality rates than the general population,” study author Gulsen Ozen, MD, said in an interview prior to the annual meeting of the American College of Rheumatology. “Given the burden of osteoporotic fractures and the suboptimal osteoporosis care, identifying the factors associated with fracture risk in RA patients is of paramount importance.”
During a median follow-up of nearly 6 years, 863 patients (7.8%) sustained osteoporotic fractures. Compared with patients who did not develop fractures, those who did were significantly older, had higher disease duration and activity, glucocorticoid use, comorbidity and FRAX, a fracture risk assessment tool, scores at baseline. After adjusting for sociodemographics, comorbidities, body mass index, fracture risk by FRAX, and RA severity measures, the researchers found a significant risk of osteoporotic fractures with use of opioids of any strength (weak agents, hazard ratio, 1.45; strong agents, HR, 1.79; P less than .001 for both), SSRI use (HR, 1.35; P = .003), and glucocorticoid use of 3 months or longer at a dose of at least 7.5 mg per day (HR, 1.74; P less than .05). Osteoporotic fracture risk increase started even after 1-30 days of opioid use (HR, 1.96; P less than .001), whereas SSRI-associated risk increase started after 3 months of use (HR, 1.42; P = .054). No significant association with fracture risk was observed with the use of other disease-modifying antirheumatic drugs, statins, antidepressants, proton pump inhibitors, NSAIDs, anticonvulsants, and antipsychotics.
“One of the first surprising findings was that almost 40% of the RA patients older than 40 years of age were at least once exposed to opioid analgesics,” said Dr. Ozen, who is a research fellow in the division of immunology and rheumatology at the medical center. “Another surprising finding was that even very short-term (1-30 days) use of opioids was associated with increased fracture risk.” She went on to note that careful and regular reviewing of patient medications “is an essential part of the RA patient care, as the use of medications not indicated anymore brings harm rather than a benefit. The most well-known example for this is glucocorticoid use. This is valid for all medications, too. Therefore, we hope that our findings provide more awareness about osteoporotic fractures and associated risk factors in RA patients.”
She acknowledged certain limitations of the study, including its observational design. “Additionally, fracture and the level of the trauma in our cohort were reported by patients,” she said. “Therefore, there might be some misclassification of fractures as osteoporotic fractures. Lastly, we did not have detailed data regarding fall risk, which might explain the associations we observed with opioids and potentially, SSRIs.”
Dr. Ozen reported having no disclosures.
SAN DIEGO – The use of selective serotonin reuptake inhibitors and opioids was associated with an increased osteoporotic fracture risk in patients with rheumatoid arthritis, results from an analysis of national data showed.
“Osteoporotic fractures are one of the important causes of disability, health-related costs, and mortality in RA, with substantially higher complication and mortality rates than the general population,” study author Gulsen Ozen, MD, said in an interview prior to the annual meeting of the American College of Rheumatology. “Given the burden of osteoporotic fractures and the suboptimal osteoporosis care, identifying the factors associated with fracture risk in RA patients is of paramount importance.”
During a median follow-up of nearly 6 years, 863 patients (7.8%) sustained osteoporotic fractures. Compared with patients who did not develop fractures, those who did were significantly older, had higher disease duration and activity, glucocorticoid use, comorbidity and FRAX, a fracture risk assessment tool, scores at baseline. After adjusting for sociodemographics, comorbidities, body mass index, fracture risk by FRAX, and RA severity measures, the researchers found a significant risk of osteoporotic fractures with use of opioids of any strength (weak agents, hazard ratio, 1.45; strong agents, HR, 1.79; P less than .001 for both), SSRI use (HR, 1.35; P = .003), and glucocorticoid use of 3 months or longer at a dose of at least 7.5 mg per day (HR, 1.74; P less than .05). Osteoporotic fracture risk increase started even after 1-30 days of opioid use (HR, 1.96; P less than .001), whereas SSRI-associated risk increase started after 3 months of use (HR, 1.42; P = .054). No significant association with fracture risk was observed with the use of other disease-modifying antirheumatic drugs, statins, antidepressants, proton pump inhibitors, NSAIDs, anticonvulsants, and antipsychotics.
“One of the first surprising findings was that almost 40% of the RA patients older than 40 years of age were at least once exposed to opioid analgesics,” said Dr. Ozen, who is a research fellow in the division of immunology and rheumatology at the medical center. “Another surprising finding was that even very short-term (1-30 days) use of opioids was associated with increased fracture risk.” She went on to note that careful and regular reviewing of patient medications “is an essential part of the RA patient care, as the use of medications not indicated anymore brings harm rather than a benefit. The most well-known example for this is glucocorticoid use. This is valid for all medications, too. Therefore, we hope that our findings provide more awareness about osteoporotic fractures and associated risk factors in RA patients.”
She acknowledged certain limitations of the study, including its observational design. “Additionally, fracture and the level of the trauma in our cohort were reported by patients,” she said. “Therefore, there might be some misclassification of fractures as osteoporotic fractures. Lastly, we did not have detailed data regarding fall risk, which might explain the associations we observed with opioids and potentially, SSRIs.”
Dr. Ozen reported having no disclosures.
SAN DIEGO – The use of selective serotonin reuptake inhibitors and opioids was associated with an increased osteoporotic fracture risk in patients with rheumatoid arthritis, results from an analysis of national data showed.
“Osteoporotic fractures are one of the important causes of disability, health-related costs, and mortality in RA, with substantially higher complication and mortality rates than the general population,” study author Gulsen Ozen, MD, said in an interview prior to the annual meeting of the American College of Rheumatology. “Given the burden of osteoporotic fractures and the suboptimal osteoporosis care, identifying the factors associated with fracture risk in RA patients is of paramount importance.”
During a median follow-up of nearly 6 years, 863 patients (7.8%) sustained osteoporotic fractures. Compared with patients who did not develop fractures, those who did were significantly older, had higher disease duration and activity, glucocorticoid use, comorbidity and FRAX, a fracture risk assessment tool, scores at baseline. After adjusting for sociodemographics, comorbidities, body mass index, fracture risk by FRAX, and RA severity measures, the researchers found a significant risk of osteoporotic fractures with use of opioids of any strength (weak agents, hazard ratio, 1.45; strong agents, HR, 1.79; P less than .001 for both), SSRI use (HR, 1.35; P = .003), and glucocorticoid use of 3 months or longer at a dose of at least 7.5 mg per day (HR, 1.74; P less than .05). Osteoporotic fracture risk increase started even after 1-30 days of opioid use (HR, 1.96; P less than .001), whereas SSRI-associated risk increase started after 3 months of use (HR, 1.42; P = .054). No significant association with fracture risk was observed with the use of other disease-modifying antirheumatic drugs, statins, antidepressants, proton pump inhibitors, NSAIDs, anticonvulsants, and antipsychotics.
“One of the first surprising findings was that almost 40% of the RA patients older than 40 years of age were at least once exposed to opioid analgesics,” said Dr. Ozen, who is a research fellow in the division of immunology and rheumatology at the medical center. “Another surprising finding was that even very short-term (1-30 days) use of opioids was associated with increased fracture risk.” She went on to note that careful and regular reviewing of patient medications “is an essential part of the RA patient care, as the use of medications not indicated anymore brings harm rather than a benefit. The most well-known example for this is glucocorticoid use. This is valid for all medications, too. Therefore, we hope that our findings provide more awareness about osteoporotic fractures and associated risk factors in RA patients.”
She acknowledged certain limitations of the study, including its observational design. “Additionally, fracture and the level of the trauma in our cohort were reported by patients,” she said. “Therefore, there might be some misclassification of fractures as osteoporotic fractures. Lastly, we did not have detailed data regarding fall risk, which might explain the associations we observed with opioids and potentially, SSRIs.”
Dr. Ozen reported having no disclosures.
AT ACR 2017
Key clinical point: When managing with opioids, even in the short-term, clinicians should be aware of the fracture risk.
Major finding: In patients with RA, concomitant use of selective serotonin reuptake inhibitors was associated with an increased risk of osteoporotic fracture (HR, 1.35; P = .003), as was opioid use (HR, 1.45 and HR, 1.79) for weak and strong agents, respectively; P less than .001 for both).
Study details: An observational study of 11,049 patients from the National Data Bank for Rheumatic Diseases.
Disclosures: Dr. Ozen reported having no disclosures.
Low vitamin D levels linked to increased ESRD risk in SLE patients
SAN DIEGO – , results from a single-center cohort study showed.
“We had previously proved that vitamin D supplementation helped lupus activity,” lead study author Michelle Petri, MD, MPH, said in an interview in advance of the annual meeting of the American College of Rheumatology. “Now, we prove that it specifically helps renal activity as measured by the urine protein. By helping to reduce urine protein, it helps to prevent permanent renal damage and end-stage renal disease.”
The first measure of vitamin D typically occurred in late 2009 or 2010 for existing patients and at the first visit of new patients after that. The researchers categorized patients based on their first measure of vitamin D as less than 20 ng/mL or 20 ng/mL or higher. At the first visit when vitamin D was measured, 27.3% had levels of 25-hydroxyvitamin D less than 20 ng/mL. The mean age of patients was 47.3 years, 92% were female, 50% were white, and 41% were African American.
In the study, Dr. Petri and her associates used the Systemic Lupus International Collaborative Clinics/American College of Rheumatology Damage Index to calculate the risk of lifetime organ damage. After adjusting for age, gender, and ethnicity, low levels of vitamin D were significantly associated with increased risk of renal damage (RR, 1.66; P = .0206) and total organ damage (RR, 1.17; P = .0245), they found.
Skin damage was another concern, with an adjusted relative risk of 1.22, though it was not statistically significant (P = .3561). The investigators observed no association between low vitamin D and musculoskeletal damage, including osteoporotic fractures.
“There is a lot of interest in lupus right now, due to [singer Selena] Gomez’s kidney transplant for lupus nephritis,” said Dr. Petri, who also directs the Johns Hopkins Lupus Center. “So, I think there is interest in how to prevent the need for kidney transplant. Vitamin D helps kidney lupus – and we only need to achieve a level of 40 ng/mL, [which is] safe and easy to do.” She acknowledged the study’s single-center design as a limitation but underscored its large sample size as a strength.
The Hopkins Lupus Cohort is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Petri disclosed having received research support from Anthera, GlaxoSmithKline, EMD Serono, Eli Lilly, Bristol-Myers Squibb, Amgen, United Rheumatology, Global Academy, and Exagen.
SAN DIEGO – , results from a single-center cohort study showed.
“We had previously proved that vitamin D supplementation helped lupus activity,” lead study author Michelle Petri, MD, MPH, said in an interview in advance of the annual meeting of the American College of Rheumatology. “Now, we prove that it specifically helps renal activity as measured by the urine protein. By helping to reduce urine protein, it helps to prevent permanent renal damage and end-stage renal disease.”
The first measure of vitamin D typically occurred in late 2009 or 2010 for existing patients and at the first visit of new patients after that. The researchers categorized patients based on their first measure of vitamin D as less than 20 ng/mL or 20 ng/mL or higher. At the first visit when vitamin D was measured, 27.3% had levels of 25-hydroxyvitamin D less than 20 ng/mL. The mean age of patients was 47.3 years, 92% were female, 50% were white, and 41% were African American.
In the study, Dr. Petri and her associates used the Systemic Lupus International Collaborative Clinics/American College of Rheumatology Damage Index to calculate the risk of lifetime organ damage. After adjusting for age, gender, and ethnicity, low levels of vitamin D were significantly associated with increased risk of renal damage (RR, 1.66; P = .0206) and total organ damage (RR, 1.17; P = .0245), they found.
Skin damage was another concern, with an adjusted relative risk of 1.22, though it was not statistically significant (P = .3561). The investigators observed no association between low vitamin D and musculoskeletal damage, including osteoporotic fractures.
“There is a lot of interest in lupus right now, due to [singer Selena] Gomez’s kidney transplant for lupus nephritis,” said Dr. Petri, who also directs the Johns Hopkins Lupus Center. “So, I think there is interest in how to prevent the need for kidney transplant. Vitamin D helps kidney lupus – and we only need to achieve a level of 40 ng/mL, [which is] safe and easy to do.” She acknowledged the study’s single-center design as a limitation but underscored its large sample size as a strength.
The Hopkins Lupus Cohort is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Petri disclosed having received research support from Anthera, GlaxoSmithKline, EMD Serono, Eli Lilly, Bristol-Myers Squibb, Amgen, United Rheumatology, Global Academy, and Exagen.
SAN DIEGO – , results from a single-center cohort study showed.
“We had previously proved that vitamin D supplementation helped lupus activity,” lead study author Michelle Petri, MD, MPH, said in an interview in advance of the annual meeting of the American College of Rheumatology. “Now, we prove that it specifically helps renal activity as measured by the urine protein. By helping to reduce urine protein, it helps to prevent permanent renal damage and end-stage renal disease.”
The first measure of vitamin D typically occurred in late 2009 or 2010 for existing patients and at the first visit of new patients after that. The researchers categorized patients based on their first measure of vitamin D as less than 20 ng/mL or 20 ng/mL or higher. At the first visit when vitamin D was measured, 27.3% had levels of 25-hydroxyvitamin D less than 20 ng/mL. The mean age of patients was 47.3 years, 92% were female, 50% were white, and 41% were African American.
In the study, Dr. Petri and her associates used the Systemic Lupus International Collaborative Clinics/American College of Rheumatology Damage Index to calculate the risk of lifetime organ damage. After adjusting for age, gender, and ethnicity, low levels of vitamin D were significantly associated with increased risk of renal damage (RR, 1.66; P = .0206) and total organ damage (RR, 1.17; P = .0245), they found.
Skin damage was another concern, with an adjusted relative risk of 1.22, though it was not statistically significant (P = .3561). The investigators observed no association between low vitamin D and musculoskeletal damage, including osteoporotic fractures.
“There is a lot of interest in lupus right now, due to [singer Selena] Gomez’s kidney transplant for lupus nephritis,” said Dr. Petri, who also directs the Johns Hopkins Lupus Center. “So, I think there is interest in how to prevent the need for kidney transplant. Vitamin D helps kidney lupus – and we only need to achieve a level of 40 ng/mL, [which is] safe and easy to do.” She acknowledged the study’s single-center design as a limitation but underscored its large sample size as a strength.
The Hopkins Lupus Cohort is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Petri disclosed having received research support from Anthera, GlaxoSmithKline, EMD Serono, Eli Lilly, Bristol-Myers Squibb, Amgen, United Rheumatology, Global Academy, and Exagen.
AT ACR 2017
Key clinical point: Supplemental vitamin D should be part of the treatment plan for patients with systemic lupus erythematosus (SLE).
Major finding: SLE patients with low vitamin D levels face a significantly increased risk of renal damage (relatve risk, 1.66; P = .0206) and total organ damage (RR, 1.17; P = .0245).
Study details: A single-center cohort study of 1,392 patients with SLE.
Disclosures: The Hopkins Lupus Cohort is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Petri disclosed having received research support from Anthera, GlaxoSmithKline, EMD Serono, Eli Lilly, Bristol-Myers Squibb, Amgen, United Rheumatology, Global Academy, and Exagen.
Hiatal hernia repair more common at time of sleeve gastrectomy, compared with RYGB
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
AT THE ACS CLINICAL CONGRESS
Key clinical point: LSG patients are more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
Major finding: According to multivariate analysis, LSG patients were more likely to undergo concomitant HH repair (odds ratio, 2.14).
Study details: A retrospective analysis of 130,686 patients who underwent bariatric surgery in 2015.
Disclosures: Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
VIDEO: Biologic use during pregnancy had no impact on serious infection risks in infants
SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACR 2017
Key clinical point:
Major finding: Infections occurred in 4% of infants born to mothers with RA treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy.
Study details: An observational cohort study of 1,156 pregnant women with RA.
Disclosures: Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
VIDEO: Obesity linked to worse outcomes in axial spondyloarthropathy
SAN DIEGO – Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.
“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.
“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”
Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.
Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”
The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).
“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”
She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”
ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.
“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.
“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”
Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.
Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”
The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).
“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”
She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”
ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.
“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.
“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”
Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.
Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”
The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).
“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”
She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”
ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACR 2017
Key clinical point: Obese patients with axial spondyloarthropathy have worse disease outcomes.
Major finding: In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).
Study details: A cross-sectional study of 683 patients with axial spondyloarthropathy.
Disclosures: ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie Hopkins.
Type of headwear worn during surgery had no impact on SSI rates
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Surgeon preference should dictate choice of headwear in the OR.
Major finding: There was no significant difference in the rate of SSI, regardless of whether a skull cap or a bouffant cap was used during surgery.
Study details: Re-examination of a prospective, randomized non-inferiority trial of 1,543 patients, on the impact of hair removal on surgical site infection rates.
Disclosures: Dr. Kothari reporting having no relevant disclosures.
Strict OR attire policy had no impact on SSI rate
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Implementation of stringent operating room attire policies do not reduce rates superficial surgical site infections (SSIs).
Major finding: The researchers observed no significant differences preimplementation and postimplementation of OR attire policies in the rates of incisional SSI (0.97 vs. 0.96, respectively; P = .949), organ space SSI (1.20 vs 0.81; P = .115), and total SSIs (2.11 vs. 1.77; P = .321).
Study details: A study of 6,517 patients who underwent surgery at two tertiary care teaching hospitals.
Disclosures: The researchers reported having no financial disclosures.
DiaRem score predicts remission of type 2 diabetes after sleeve gastrectomy
SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.
Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.
The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.
Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.
“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”
The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.
SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.
Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.
The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.
Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.
“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”
The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.
SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.
Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.
The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.
Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.
“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”
The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: The DiaRem score is useful in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy.
Major finding: Results of the DiaRem scores indicated that 58% of patients achieved complete remission of type 2 diabetes.
Study details: A retrospective analysis of 162 patients who underwent laparoscopic sleeve gastrectomy.
Disclosures: Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.
Pre-injury statin use found to benefit survival following TBI
SAN DIEGO – Patients who were on statins prior to sustaining a traumatic brain injury doubled their survival rate over those who were not on the drugs in a retrospective analysis.
The study provides preliminary data that can help set a framework to conduct larger, randomized, controlled trials to further evaluate the role of statins, which have been shown in animal models to improve outcomes after traumatic brain injury (TBI).
In an effort to evaluate the effect of pre-injury statins on outcomes after TBI, Dr. Lokhandwala, a general surgery resident at the University of Arizona, Tucson, and his associates identified all patients aged 40 years and older from the Multiparameter Intelligent Monitoring in Intensive Care (MIMIC) III database with a diagnosis of TBI and ICU length of stay of greater than 24 hours. They divided patients into two groups: those who were on statins and those who were not. The primary outcome was in-hospital survival. Secondary outcomes measures were hospital length of stay and ICU length of stay.
Dr. Lokhandwala, who is also a commissioned officer with the U.S. Army Reserves, reported results from 918 patients with a TBI. Their mean age was 55 years, 76% were white, and 22% were on statins. The overall in-hospital survival rate was 78.6%, while the median Glasgow Coma Scale was 12. The median hospital length of stay and ICU length of stay were 9.1 and 7.2 days, respectively. The researchers observed that compared with patients who were not on statins, those on statin therapy had significantly higher rates of survival (88% vs. 68.4%; P less than .001). However, there was no difference in hospital or ICU length of stay between the two groups (P = .19 and P = .39, respectively). On regression analysis after controlling for confounding factors, statin use was found to be an independent predictor of survival (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P less than .001).
“Even though we isolated our patients to TBI, there could have been other causes of their mortality, like a pulmonary embolism or a myocardial infarction,” Dr. Lokhandwala said. “We need to conduct a randomized, controlled trial to follow these individuals and see what their actual mortality is and look at their psychosocial outcomes to see if there’s a long-term benefit to statins. Do these people have decreased incidence of PTSD or are they more functional? Is it easier for them to hold a job or develop social relationships? The impact of post-injury statin use could also be studied.”
He went on to note that many studies have shown that aggressive team-based rehabilitation can improve outcomes in TBI patients. “Would we be able to include statin use in such a program to see if statins further improve outcomes faster or are there individuals that don’t benefit as much?” Dr. Lokhandwala asked. “This study sets up a framework to show that there is a strong association, and take this further in a more structured trial to see if there is any potential for therapeutic use in TBI.”
Dr. Lokhandwala reported having no financial disclosures.
SAN DIEGO – Patients who were on statins prior to sustaining a traumatic brain injury doubled their survival rate over those who were not on the drugs in a retrospective analysis.
The study provides preliminary data that can help set a framework to conduct larger, randomized, controlled trials to further evaluate the role of statins, which have been shown in animal models to improve outcomes after traumatic brain injury (TBI).
In an effort to evaluate the effect of pre-injury statins on outcomes after TBI, Dr. Lokhandwala, a general surgery resident at the University of Arizona, Tucson, and his associates identified all patients aged 40 years and older from the Multiparameter Intelligent Monitoring in Intensive Care (MIMIC) III database with a diagnosis of TBI and ICU length of stay of greater than 24 hours. They divided patients into two groups: those who were on statins and those who were not. The primary outcome was in-hospital survival. Secondary outcomes measures were hospital length of stay and ICU length of stay.
Dr. Lokhandwala, who is also a commissioned officer with the U.S. Army Reserves, reported results from 918 patients with a TBI. Their mean age was 55 years, 76% were white, and 22% were on statins. The overall in-hospital survival rate was 78.6%, while the median Glasgow Coma Scale was 12. The median hospital length of stay and ICU length of stay were 9.1 and 7.2 days, respectively. The researchers observed that compared with patients who were not on statins, those on statin therapy had significantly higher rates of survival (88% vs. 68.4%; P less than .001). However, there was no difference in hospital or ICU length of stay between the two groups (P = .19 and P = .39, respectively). On regression analysis after controlling for confounding factors, statin use was found to be an independent predictor of survival (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P less than .001).
“Even though we isolated our patients to TBI, there could have been other causes of their mortality, like a pulmonary embolism or a myocardial infarction,” Dr. Lokhandwala said. “We need to conduct a randomized, controlled trial to follow these individuals and see what their actual mortality is and look at their psychosocial outcomes to see if there’s a long-term benefit to statins. Do these people have decreased incidence of PTSD or are they more functional? Is it easier for them to hold a job or develop social relationships? The impact of post-injury statin use could also be studied.”
He went on to note that many studies have shown that aggressive team-based rehabilitation can improve outcomes in TBI patients. “Would we be able to include statin use in such a program to see if statins further improve outcomes faster or are there individuals that don’t benefit as much?” Dr. Lokhandwala asked. “This study sets up a framework to show that there is a strong association, and take this further in a more structured trial to see if there is any potential for therapeutic use in TBI.”
Dr. Lokhandwala reported having no financial disclosures.
SAN DIEGO – Patients who were on statins prior to sustaining a traumatic brain injury doubled their survival rate over those who were not on the drugs in a retrospective analysis.
The study provides preliminary data that can help set a framework to conduct larger, randomized, controlled trials to further evaluate the role of statins, which have been shown in animal models to improve outcomes after traumatic brain injury (TBI).
In an effort to evaluate the effect of pre-injury statins on outcomes after TBI, Dr. Lokhandwala, a general surgery resident at the University of Arizona, Tucson, and his associates identified all patients aged 40 years and older from the Multiparameter Intelligent Monitoring in Intensive Care (MIMIC) III database with a diagnosis of TBI and ICU length of stay of greater than 24 hours. They divided patients into two groups: those who were on statins and those who were not. The primary outcome was in-hospital survival. Secondary outcomes measures were hospital length of stay and ICU length of stay.
Dr. Lokhandwala, who is also a commissioned officer with the U.S. Army Reserves, reported results from 918 patients with a TBI. Their mean age was 55 years, 76% were white, and 22% were on statins. The overall in-hospital survival rate was 78.6%, while the median Glasgow Coma Scale was 12. The median hospital length of stay and ICU length of stay were 9.1 and 7.2 days, respectively. The researchers observed that compared with patients who were not on statins, those on statin therapy had significantly higher rates of survival (88% vs. 68.4%; P less than .001). However, there was no difference in hospital or ICU length of stay between the two groups (P = .19 and P = .39, respectively). On regression analysis after controlling for confounding factors, statin use was found to be an independent predictor of survival (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P less than .001).
“Even though we isolated our patients to TBI, there could have been other causes of their mortality, like a pulmonary embolism or a myocardial infarction,” Dr. Lokhandwala said. “We need to conduct a randomized, controlled trial to follow these individuals and see what their actual mortality is and look at their psychosocial outcomes to see if there’s a long-term benefit to statins. Do these people have decreased incidence of PTSD or are they more functional? Is it easier for them to hold a job or develop social relationships? The impact of post-injury statin use could also be studied.”
He went on to note that many studies have shown that aggressive team-based rehabilitation can improve outcomes in TBI patients. “Would we be able to include statin use in such a program to see if statins further improve outcomes faster or are there individuals that don’t benefit as much?” Dr. Lokhandwala asked. “This study sets up a framework to show that there is a strong association, and take this further in a more structured trial to see if there is any potential for therapeutic use in TBI.”
Dr. Lokhandwala reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: After controlling for confounding factors, statin use was found to be an independent predictor of survival following traumatic brain injury (OR, 1.8; 95% CI, 1.5-2.2; P less than .001).
Study details: A retrospective analysis of 918 patients who sustained a TBI.
Disclosures: Dr. Lokhandwala reported having no financial disclosures.
Antibiotic exposure blunted metabolic improvement following vertical sleeve gastrectomy
SAN DIEGO – results from a mouse study demonstrated.
The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.
According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”
Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.
“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.
For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.
Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.
“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.
“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.
Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.
“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”
The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
SAN DIEGO – results from a mouse study demonstrated.
The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.
According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”
Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.
“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.
For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.
Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.
“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.
“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.
Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.
“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”
The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
SAN DIEGO – results from a mouse study demonstrated.
The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.
According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”
Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.
“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.
For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.
Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.
“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.
“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.
Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.
“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”
The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Postsurgical disruption of intestinal microbiota composition attenuates the metabolic efficacy of vertical sleeve gastrectomy.
Major finding: VSG mice exposed to antibiotics had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, compared with control mice.
Study details: A study of diet-induced obese mice that were randomized to VSG or sham surgery, with or without exposure to antibiotics.
Disclosures: The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.