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Scleroligation procedure proposed for gastroesophageal varices
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point:
Major finding: Scleroligation required 2.22 sessions on average, compared with 3.43 for endoscopic band ligation.
Data source: Single-center randomized trial of 120 patients.
Disclosures: No funding source was disclosed. The authors reported no financial disclosures.
AGA Clinical Practice Update: Endoscope reprocessing guidelines are an improvement
While the 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines are an improvement over the 2011 guidelines, some of its minor changes are unlikely to guarantee against prevention of future outbreaks, according to Susan Hutfless, PhD, and Anthony N. Kalloo, MD.*
“The prevention of future outbreaks is left to the manufacturers to modify their protocols and the endoscopy units to adopt the protocols rapidly,” the authors, both from Johns Hopkins University, Baltimore, wrote in a commentary about the 2016 guidelines, which contain 41 recommendations and were endorsed by the AGA. “If followed, the guidelines will make it possible to better track the source of future outbreaks if the tracking and monitoring suggested is performed.” They added that the current cleaning paradigm for duodenoscopes “is ineffective and these guidelines reflect changes to contain, rather than prevent, future outbreaks.”
Some of the specific changes to the 2016 guidelines include recommendation no. 5, which has been revised to recommend “strict adherence” to manufacturer guidance. “The expectation is that all personnel will remain up to date with the manufacturer guidelines and that there will be documentation of the training,” Dr. Hutfless and Dr. Kalloo wrote. The 2016 guidelines specifically state that a “single standard work process within one institution may be insufficient, given differences among manufacturers’ instructions and varied instrument designs.” However, Dr. Hutfless and Dr. Kalloo point out that “an individual or group of individuals may need to be identified to keep up with the FDA, CDC, manufacturer and professional societies in order to modify and implement the changes to the cleaning and training protocols and update the training of all individuals in the unit. It is unclear from the guidelines what the minimum time should be between change in recommendations and updated training.”
Recommendation no. 24 is new and includes a suggestion consistent with the 2015 FDA endoscope reprocessing communications. “Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist,” the guidelines state. “However, units should review and consider the feasibility and appropriateness for their practice of employing one or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard high level disinfection, or use of a liquid chemical germicide.” For their part, Dr. Hutfless and Dr. Kalloo pointed out the limitations of these additional modalities. For example, they wrote, “the per procedure culture surveillance modality suggested by the FDA is not cost-effective unless the unit’s transmission probability of carbapenem-resistant Enterobacteriaceae is 24% or greater. Sterilization with ethylene oxide is problematic because a unit that used this approach still encountered an endoscope with carbapenem-resistant Enterobacteriaceae detected by culture. This unit also incurred extra costs to purchase additional scopes due to the longer reprocessing time for sterilization and had a greater number of endoscopes with damage, although the damage was not directly attributable to sterilization” (Gastrointest Endosc. 2016 Aug;84:259-62).
In 2016, the FDA approved the first disposable colonoscope, a product that is expected to be available in the United States in early 2017. Dr. Hutfless and Dr. Kalloo ended their commentary by suggesting that a disposable endoscope with an elevator mechanism, though not currently available, could be a solution to several of the unresolved issues that were present in the 2003, 2011, and 2016 guidelines. “These unresolved issues include interval of storage after reprocessing, microbiologic surveillance, and endoscope durability and longevity,” they wrote. “If the outbreaks persist after the use of disposable endoscopes it is possible that it is some other product or procedure within the endoscopic procedure that is the source of the infectious transmission.”
*This story was update on Jan. 26, 2017.
While the 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines are an improvement over the 2011 guidelines, some of its minor changes are unlikely to guarantee against prevention of future outbreaks, according to Susan Hutfless, PhD, and Anthony N. Kalloo, MD.*
“The prevention of future outbreaks is left to the manufacturers to modify their protocols and the endoscopy units to adopt the protocols rapidly,” the authors, both from Johns Hopkins University, Baltimore, wrote in a commentary about the 2016 guidelines, which contain 41 recommendations and were endorsed by the AGA. “If followed, the guidelines will make it possible to better track the source of future outbreaks if the tracking and monitoring suggested is performed.” They added that the current cleaning paradigm for duodenoscopes “is ineffective and these guidelines reflect changes to contain, rather than prevent, future outbreaks.”
Some of the specific changes to the 2016 guidelines include recommendation no. 5, which has been revised to recommend “strict adherence” to manufacturer guidance. “The expectation is that all personnel will remain up to date with the manufacturer guidelines and that there will be documentation of the training,” Dr. Hutfless and Dr. Kalloo wrote. The 2016 guidelines specifically state that a “single standard work process within one institution may be insufficient, given differences among manufacturers’ instructions and varied instrument designs.” However, Dr. Hutfless and Dr. Kalloo point out that “an individual or group of individuals may need to be identified to keep up with the FDA, CDC, manufacturer and professional societies in order to modify and implement the changes to the cleaning and training protocols and update the training of all individuals in the unit. It is unclear from the guidelines what the minimum time should be between change in recommendations and updated training.”
Recommendation no. 24 is new and includes a suggestion consistent with the 2015 FDA endoscope reprocessing communications. “Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist,” the guidelines state. “However, units should review and consider the feasibility and appropriateness for their practice of employing one or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard high level disinfection, or use of a liquid chemical germicide.” For their part, Dr. Hutfless and Dr. Kalloo pointed out the limitations of these additional modalities. For example, they wrote, “the per procedure culture surveillance modality suggested by the FDA is not cost-effective unless the unit’s transmission probability of carbapenem-resistant Enterobacteriaceae is 24% or greater. Sterilization with ethylene oxide is problematic because a unit that used this approach still encountered an endoscope with carbapenem-resistant Enterobacteriaceae detected by culture. This unit also incurred extra costs to purchase additional scopes due to the longer reprocessing time for sterilization and had a greater number of endoscopes with damage, although the damage was not directly attributable to sterilization” (Gastrointest Endosc. 2016 Aug;84:259-62).
In 2016, the FDA approved the first disposable colonoscope, a product that is expected to be available in the United States in early 2017. Dr. Hutfless and Dr. Kalloo ended their commentary by suggesting that a disposable endoscope with an elevator mechanism, though not currently available, could be a solution to several of the unresolved issues that were present in the 2003, 2011, and 2016 guidelines. “These unresolved issues include interval of storage after reprocessing, microbiologic surveillance, and endoscope durability and longevity,” they wrote. “If the outbreaks persist after the use of disposable endoscopes it is possible that it is some other product or procedure within the endoscopic procedure that is the source of the infectious transmission.”
*This story was update on Jan. 26, 2017.
While the 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines are an improvement over the 2011 guidelines, some of its minor changes are unlikely to guarantee against prevention of future outbreaks, according to Susan Hutfless, PhD, and Anthony N. Kalloo, MD.*
“The prevention of future outbreaks is left to the manufacturers to modify their protocols and the endoscopy units to adopt the protocols rapidly,” the authors, both from Johns Hopkins University, Baltimore, wrote in a commentary about the 2016 guidelines, which contain 41 recommendations and were endorsed by the AGA. “If followed, the guidelines will make it possible to better track the source of future outbreaks if the tracking and monitoring suggested is performed.” They added that the current cleaning paradigm for duodenoscopes “is ineffective and these guidelines reflect changes to contain, rather than prevent, future outbreaks.”
Some of the specific changes to the 2016 guidelines include recommendation no. 5, which has been revised to recommend “strict adherence” to manufacturer guidance. “The expectation is that all personnel will remain up to date with the manufacturer guidelines and that there will be documentation of the training,” Dr. Hutfless and Dr. Kalloo wrote. The 2016 guidelines specifically state that a “single standard work process within one institution may be insufficient, given differences among manufacturers’ instructions and varied instrument designs.” However, Dr. Hutfless and Dr. Kalloo point out that “an individual or group of individuals may need to be identified to keep up with the FDA, CDC, manufacturer and professional societies in order to modify and implement the changes to the cleaning and training protocols and update the training of all individuals in the unit. It is unclear from the guidelines what the minimum time should be between change in recommendations and updated training.”
Recommendation no. 24 is new and includes a suggestion consistent with the 2015 FDA endoscope reprocessing communications. “Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist,” the guidelines state. “However, units should review and consider the feasibility and appropriateness for their practice of employing one or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard high level disinfection, or use of a liquid chemical germicide.” For their part, Dr. Hutfless and Dr. Kalloo pointed out the limitations of these additional modalities. For example, they wrote, “the per procedure culture surveillance modality suggested by the FDA is not cost-effective unless the unit’s transmission probability of carbapenem-resistant Enterobacteriaceae is 24% or greater. Sterilization with ethylene oxide is problematic because a unit that used this approach still encountered an endoscope with carbapenem-resistant Enterobacteriaceae detected by culture. This unit also incurred extra costs to purchase additional scopes due to the longer reprocessing time for sterilization and had a greater number of endoscopes with damage, although the damage was not directly attributable to sterilization” (Gastrointest Endosc. 2016 Aug;84:259-62).
In 2016, the FDA approved the first disposable colonoscope, a product that is expected to be available in the United States in early 2017. Dr. Hutfless and Dr. Kalloo ended their commentary by suggesting that a disposable endoscope with an elevator mechanism, though not currently available, could be a solution to several of the unresolved issues that were present in the 2003, 2011, and 2016 guidelines. “These unresolved issues include interval of storage after reprocessing, microbiologic surveillance, and endoscope durability and longevity,” they wrote. “If the outbreaks persist after the use of disposable endoscopes it is possible that it is some other product or procedure within the endoscopic procedure that is the source of the infectious transmission.”
*This story was update on Jan. 26, 2017.
FROM GASTROENTEROLOGY
Half of newly detected antimicrobial antibodies do not lead to PBC
Nearly half of newly detected antimitochondrial antibodies (AMAs) in clinical practice do not lead to a diagnosis of primary biliary cholangitis (PBC), according to a prospective study.
Geraldine Dahlqvist, MD, and her associates examined 720 patients whose AMA tests were registered during a 1-year census period. They were divided into groups according to whether they were newly diagnosed (275), were previously diagnosed (216), or had a nonestablished diagnosis (229) of PBC. Results showed the prevalence of AMA-positive patients without evidence of PBC was 16.1 per 100,000 inhabitants. It was four (all AMA-positive patients) to six (PBC patients) times higher in women than in men. The median age was 58 years, with the median AMA titer at 1:16. Normal serum alkaline phosphatases (ALP) were 74%, and were 1.5 times above the upper limit of normal in 13% of patients, while cirrhosis was found in 6%. Among the patients with normal ALP and no evidence of cirrhosis, the 5-year incidence rate of PBC was 16%.
It was noted that no patients died officially from PBC in this study. The 1-, 3-, and 5-year rates of survival were 95%, 90%, and 75% (95% CI, 63-87), respectively, compared with 90% in the control group.
“The younger age and lower autoantibody titer of these patients, together with the frequent mild abnormalities of their biochemical liver tests, supports a very early, presymptomatic precholestatic stage of the disease,” Dr. Dahlqvist, of Catholic University of Louvain (Belgium), and her colleagues noted. “The incidence of clinical manifestations of PBC seems, however, much lower than previously reported.”
Find the full story in Hepatology (doi: 10.1002/hep.28559).
Nearly half of newly detected antimitochondrial antibodies (AMAs) in clinical practice do not lead to a diagnosis of primary biliary cholangitis (PBC), according to a prospective study.
Geraldine Dahlqvist, MD, and her associates examined 720 patients whose AMA tests were registered during a 1-year census period. They were divided into groups according to whether they were newly diagnosed (275), were previously diagnosed (216), or had a nonestablished diagnosis (229) of PBC. Results showed the prevalence of AMA-positive patients without evidence of PBC was 16.1 per 100,000 inhabitants. It was four (all AMA-positive patients) to six (PBC patients) times higher in women than in men. The median age was 58 years, with the median AMA titer at 1:16. Normal serum alkaline phosphatases (ALP) were 74%, and were 1.5 times above the upper limit of normal in 13% of patients, while cirrhosis was found in 6%. Among the patients with normal ALP and no evidence of cirrhosis, the 5-year incidence rate of PBC was 16%.
It was noted that no patients died officially from PBC in this study. The 1-, 3-, and 5-year rates of survival were 95%, 90%, and 75% (95% CI, 63-87), respectively, compared with 90% in the control group.
“The younger age and lower autoantibody titer of these patients, together with the frequent mild abnormalities of their biochemical liver tests, supports a very early, presymptomatic precholestatic stage of the disease,” Dr. Dahlqvist, of Catholic University of Louvain (Belgium), and her colleagues noted. “The incidence of clinical manifestations of PBC seems, however, much lower than previously reported.”
Find the full story in Hepatology (doi: 10.1002/hep.28559).
Nearly half of newly detected antimitochondrial antibodies (AMAs) in clinical practice do not lead to a diagnosis of primary biliary cholangitis (PBC), according to a prospective study.
Geraldine Dahlqvist, MD, and her associates examined 720 patients whose AMA tests were registered during a 1-year census period. They were divided into groups according to whether they were newly diagnosed (275), were previously diagnosed (216), or had a nonestablished diagnosis (229) of PBC. Results showed the prevalence of AMA-positive patients without evidence of PBC was 16.1 per 100,000 inhabitants. It was four (all AMA-positive patients) to six (PBC patients) times higher in women than in men. The median age was 58 years, with the median AMA titer at 1:16. Normal serum alkaline phosphatases (ALP) were 74%, and were 1.5 times above the upper limit of normal in 13% of patients, while cirrhosis was found in 6%. Among the patients with normal ALP and no evidence of cirrhosis, the 5-year incidence rate of PBC was 16%.
It was noted that no patients died officially from PBC in this study. The 1-, 3-, and 5-year rates of survival were 95%, 90%, and 75% (95% CI, 63-87), respectively, compared with 90% in the control group.
“The younger age and lower autoantibody titer of these patients, together with the frequent mild abnormalities of their biochemical liver tests, supports a very early, presymptomatic precholestatic stage of the disease,” Dr. Dahlqvist, of Catholic University of Louvain (Belgium), and her colleagues noted. “The incidence of clinical manifestations of PBC seems, however, much lower than previously reported.”
Find the full story in Hepatology (doi: 10.1002/hep.28559).
FROM HEPATOLOGY
Endoscopy during pregnancy increases risk of preterm, SGA birth
Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).
“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).
Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.
To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.
The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.
“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.
The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).
Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.
“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”
Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”
The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.
The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.
Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).
“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).
Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.
To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.
The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.
“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.
The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).
Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.
“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”
Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”
The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.
The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.
Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).
“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).
Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.
To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.
The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.
“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.
The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).
Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.
“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”
Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”
The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.
The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.
FROM GASTROENTEROLOGY
Key clinical point:
Major finding: The adjusted relative risk of preterm birth was 1.54 (95% CI, 1.36-1.75) and was 1.30 (95% CI, 1.07-1.57) for SGA.
Data source: A population-based cohort study of 3,052 pregnancies in Sweden exposed to endoscopy from 1992 through 2011.
Disclosures: The study was funded by the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. The authors did not report any relevant financial disclosures.
Insurance-mandated diet pre–bariatric surgery deemed harmful
NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.
“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.
“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.
“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
Key clinical point:
Major finding: At follow-up 2 years after bariatric surgery, patients who were required by their insurance company to participate in a physician-supervised preoperative diet program had an adjusted mean 25% weight loss, a significantly worse outcome than the mean 33% weight loss among patients with no such requirement.
Data source: This was a retrospective analysis of 284 patients in a prospectively collected university bariatric surgery database.
Disclosures: The study presenter reported having no relevant financial interests.
Unless it is diagnosed, obesity won’t be treated
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
AT OBESITY WEEK 2016
Key clinical point:
Major finding: Only 48% of a large group of patients with a BMI of 30 kg/m2 or higher had a formal diagnosis of obesity in their medical record.
Data source: This was a cross-sectional study of the electronic health records of nearly 325,000 active patients in the Cleveland Clinic database, 41.5% of whom had a BMI of 30 kg/m2 or higher.
Disclosures: The study was funded by Novo Nordisk.
What referring physicians need to know about bariatric surgery success rates
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
OBESITY WEEK 2016
Key clinical point:
Major finding: Patients who underwent bariatric surgery when their BMI was 40 kg/m2 or below were 13.3-fold more likely to have a BMI below 30 kg/m2 1 year later.
Data source: A study of 1-year outcomes in nearly 20,000 patients in the Michigan Bariatric Surgery Collaborative database.
Disclosures: The study presenter reported receiving research funding from Blue Cross Blue Shield of Michigan.
Mild, moderate hypertriglyceridemia raises pancreatitis risk
Mild to moderate hypertriglyceridemia, not just severe hypertriglyceridemia, is associated with increased risk of acute pancreatitis, according to a report published in JAMA Internal Medicine.
Severe hypertriglyceridemia is a recognized risk factor for acute pancreatitis, but “there is no consensus on a clear threshold above which triglycerides” raise that risk. The American College of Gastroenterology and The Endocrine Society state that levels over 1,000 mg/dL should be considered a risk factor, while the European Society of Cardiology and the European Atherosclerosis Society set the cutoff at 885 mg/dL, said Simon B. Pedersen, MD, of the department of clinical biochemistry, Herlev and Gentofte Hospital, Copenhagen University, Denmark, and his associates.
To examine whether lower triglyceride levels also put patients at risk for acute pancreatitis, the investigators analyzed data from two large prospective longitudinal studies of the general Danish population. They included 116,550 consecutive men and women who provided nonfasting triglyceride measurements and were followed for a median of 6.7 years. During that time, 434 of these participants developed acute pancreatitis.
The risk of developing acute pancreatitis increased with increasing triglyceride levels starting at the mildly elevated level of only 177 mg/dL. Compared with normal triglyceride levels of less than 89 mg/dL, the risk increased with a hazard ratio (HR) of 1.6 at 89-176 mg/dL, an HR of 2.3 at 177-265 mg/dL, an HR of 2.9 at 266-353 mg/dL, an HR of 3.9 at 354-442 mg/dL, and an HR of 8.7 at 443 mg/dL or above, Dr. Pedersen and his associates said (JAMA Intern. Med. 2016;176:1834-42).
This linear association persisted after the data were adjusted to account for potential confounders such as patient age, sex, body mass index, smoking status, alcohol intake, and education level, as well as the presence or absence of hypertension, diabetes, alcohol use, gallstone disease, and statin therapy.
This study was supported by the Herlev and Gentofte Hospital and Copenhagen University Hospital. Dr. Pedersen reported having no relevant financial disclosures; one of his associates reported ties to AstraZeneca, Merck, Omthera, Ionis, and Kowa.
Mild to moderate hypertriglyceridemia, not just severe hypertriglyceridemia, is associated with increased risk of acute pancreatitis, according to a report published in JAMA Internal Medicine.
Severe hypertriglyceridemia is a recognized risk factor for acute pancreatitis, but “there is no consensus on a clear threshold above which triglycerides” raise that risk. The American College of Gastroenterology and The Endocrine Society state that levels over 1,000 mg/dL should be considered a risk factor, while the European Society of Cardiology and the European Atherosclerosis Society set the cutoff at 885 mg/dL, said Simon B. Pedersen, MD, of the department of clinical biochemistry, Herlev and Gentofte Hospital, Copenhagen University, Denmark, and his associates.
To examine whether lower triglyceride levels also put patients at risk for acute pancreatitis, the investigators analyzed data from two large prospective longitudinal studies of the general Danish population. They included 116,550 consecutive men and women who provided nonfasting triglyceride measurements and were followed for a median of 6.7 years. During that time, 434 of these participants developed acute pancreatitis.
The risk of developing acute pancreatitis increased with increasing triglyceride levels starting at the mildly elevated level of only 177 mg/dL. Compared with normal triglyceride levels of less than 89 mg/dL, the risk increased with a hazard ratio (HR) of 1.6 at 89-176 mg/dL, an HR of 2.3 at 177-265 mg/dL, an HR of 2.9 at 266-353 mg/dL, an HR of 3.9 at 354-442 mg/dL, and an HR of 8.7 at 443 mg/dL or above, Dr. Pedersen and his associates said (JAMA Intern. Med. 2016;176:1834-42).
This linear association persisted after the data were adjusted to account for potential confounders such as patient age, sex, body mass index, smoking status, alcohol intake, and education level, as well as the presence or absence of hypertension, diabetes, alcohol use, gallstone disease, and statin therapy.
This study was supported by the Herlev and Gentofte Hospital and Copenhagen University Hospital. Dr. Pedersen reported having no relevant financial disclosures; one of his associates reported ties to AstraZeneca, Merck, Omthera, Ionis, and Kowa.
Mild to moderate hypertriglyceridemia, not just severe hypertriglyceridemia, is associated with increased risk of acute pancreatitis, according to a report published in JAMA Internal Medicine.
Severe hypertriglyceridemia is a recognized risk factor for acute pancreatitis, but “there is no consensus on a clear threshold above which triglycerides” raise that risk. The American College of Gastroenterology and The Endocrine Society state that levels over 1,000 mg/dL should be considered a risk factor, while the European Society of Cardiology and the European Atherosclerosis Society set the cutoff at 885 mg/dL, said Simon B. Pedersen, MD, of the department of clinical biochemistry, Herlev and Gentofte Hospital, Copenhagen University, Denmark, and his associates.
To examine whether lower triglyceride levels also put patients at risk for acute pancreatitis, the investigators analyzed data from two large prospective longitudinal studies of the general Danish population. They included 116,550 consecutive men and women who provided nonfasting triglyceride measurements and were followed for a median of 6.7 years. During that time, 434 of these participants developed acute pancreatitis.
The risk of developing acute pancreatitis increased with increasing triglyceride levels starting at the mildly elevated level of only 177 mg/dL. Compared with normal triglyceride levels of less than 89 mg/dL, the risk increased with a hazard ratio (HR) of 1.6 at 89-176 mg/dL, an HR of 2.3 at 177-265 mg/dL, an HR of 2.9 at 266-353 mg/dL, an HR of 3.9 at 354-442 mg/dL, and an HR of 8.7 at 443 mg/dL or above, Dr. Pedersen and his associates said (JAMA Intern. Med. 2016;176:1834-42).
This linear association persisted after the data were adjusted to account for potential confounders such as patient age, sex, body mass index, smoking status, alcohol intake, and education level, as well as the presence or absence of hypertension, diabetes, alcohol use, gallstone disease, and statin therapy.
This study was supported by the Herlev and Gentofte Hospital and Copenhagen University Hospital. Dr. Pedersen reported having no relevant financial disclosures; one of his associates reported ties to AstraZeneca, Merck, Omthera, Ionis, and Kowa.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Mild to moderate hypertriglyceridemia is associated with increased risk of acute pancreatitis.
Major finding: Compared with normal triglyceride levels of less than 89 mg/dL, the risk for acute pancreatitis increased with a hazard ratio (HR) of 1.6 at 89-176 mg/dL, an HR of 2.3 at 177-265 mg/dL, an HR of 2.9 at 266-353 mg/dL, an HR of 3.9 at 354-442 mg/dL, and an HR of 8.7 at 443 mg/dL or above.
Data source: A prospective, longitudinal cohort study involving 116,550 adults followed for 6.7 years.
Disclosures: This study was supported by the Herlev and Gentofte Hospital and Copenhagen University Hospital. Dr. Pedersen reported having no relevant financial disclosures; one of his associates reported ties to AstraZeneca, Merck, Omthera, Ionis, and Kowa.
Study shows NJ tube and PEG-J on par for enteral nutrition, but each has complications
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively).
Data source: A retrospective review of 242 patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015.
Disclosures: Dr. Roch reported having no financial disclosures.
Thyroid disease does not affect primary biliary cholangitis complications
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
Key clinical point:
Major finding: 150 of 921 PBC patients had TD (16.3%), but there was no correlation between PBC patients who had TD and their histologic stage either at diagnosis, hepatic decompensation events, occurrence of hepatocelluler carcinoma, or liver transplantation rates.
Data source: Prospective study of 921 PBC patients in Padua and Barcelona from 1975 to 2015.
Disclosures: No funding source was disclosed; authors reported no relevant financial disclosures.