General Surgery

BOSTON – For patients with nonalcoholic fatty liver disease (NAFLD), leaner may really be meaner, according to a recent French study involving more than 100,000 individuals of the general population.

NAFLD was uncommon among participants with normal bodyweight, but when NAFLD was present, lean patients had almost twice the risk of advanced fibrosis as that of overweight and obese patients, reported principal author Lawrence Serfaty, MD, chief of the department of hepatology at Strasbourg (France) University, who conducted the project with colleagues at the French public research organization, Inserm.

“Normally, NAFLD and [nonalcoholic steatohepatitis (NASH)] are part of metabolic syndrome,” Dr. Serfaty said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “But there are some patients with no metabolic risk factors who are lean and who may have NAFLD.”

To determine the prevalence and characteristics of these patients, the investigators drew data from the CONSTANCES cohort, which is composed of 118,664 members of the general public in France. After excluding those who withdrew consent, had a history of other liver diseases, or reported an excess of alcohol consumption (more than 20 g/day), the analyzed dataset included 102,344 subjects. Among these participants, NAFLD and advanced fibrosis were diagnosed with the Fatty Liver Index (FLI) and the Forns Index (FI), respectively, in which an FLI score greater than 60 indicated NAFLD and an FI score greater than 6.9 indicated advanced fibrosis.

Participants were sorted into three weight categories by body mass index: lean (BMI less than 25 kg/m²), overweight (BMI 25-30), or obese (BMI more than 30). In addition, a variety of other health measures were recorded, including presence of metabolic risk factors, such as diabetes or metabolic syndrome, and elevated alanine transaminase (ALT).

Analysis showed that the prevalence of NAFLD in the general population was 18.2%. Of those diagnosed with NAFLD, 2.6% had advanced fibrosis. As expected, Dr. Serfaty said, NAFLD was much less common among those who were of normal bodyweight, with lean patients accounting for only 1.9% of NAFLD diagnoses. However, when NAFLD was diagnosed in lean patients, it was more often severe. Among lean patients with NAFLD, 4.5% had advanced fibrosis, compared with 2.4% of overweight patients and 2.3% of obese patients.

Dr. Serfaty noted that lean patients with NAFLD tended to have fewer metabolic risk factors, but most had at least one. Lifestyle factors were likely to blame, he said, because lean patients with NAFLD were relatively heavy users of tobacco and alcohol, compared with obese or overweight patients. Cardiovascular disease was also more common among lean patients with NAFLD.

“There are probably other factors [that are different, such as] genetic factors, the microbiome, and maybe the immune system,” Dr. Serfaty said.

While drivers of NAFLD among lean patients remain to be clarified, Dr. Serfaty highlighted the importance of recognizing this unique patient population, and if encountered, not discounting the severity of disease based on a lack of other metabolic risk factors.

“It is very important to know that these patients exist because it is very difficult to identify these patients,” Dr. Serfaty said. “If you have a lean patient with NAFLD, normally you [might] say, it’s not very severe for this patient because he’s lean; but no, [that’s not correct], because maybe he has more advanced fibrosis. So you have to go through and check with other noninvasive markers to be sure that this patient does not have advanced fibrosis.”

Concerning the difficulty of identifying such patients in the first place, Dr. Serfaty suggested that elevated ALT may be the most reliable red flag because this laboratory abnormality occurred in more than half of the lean patients diagnosed with NAFLD, despite no excessive alcohol consumption or prior hepatitis. The investigators disclosed relationships with Gilead, AbbVie, Echosens, and others.

SOURCE: Serfaty L et al. The Liver Meeting 2019, Abstract 1188.

BOSTON – For patients with nonalcoholic fatty liver disease (NAFLD), leaner may really be meaner, according to a recent French study involving more than 100,000 individuals of the general population.

NAFLD was uncommon among participants with normal bodyweight, but when NAFLD was present, lean patients had almost twice the risk of advanced fibrosis as that of overweight and obese patients, reported principal author Lawrence Serfaty, MD, chief of the department of hepatology at Strasbourg (France) University, who conducted the project with colleagues at the French public research organization, Inserm.

“Normally, NAFLD and [nonalcoholic steatohepatitis (NASH)] are part of metabolic syndrome,” Dr. Serfaty said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “But there are some patients with no metabolic risk factors who are lean and who may have NAFLD.”

To determine the prevalence and characteristics of these patients, the investigators drew data from the CONSTANCES cohort, which is composed of 118,664 members of the general public in France. After excluding those who withdrew consent, had a history of other liver diseases, or reported an excess of alcohol consumption (more than 20 g/day), the analyzed dataset included 102,344 subjects. Among these participants, NAFLD and advanced fibrosis were diagnosed with the Fatty Liver Index (FLI) and the Forns Index (FI), respectively, in which an FLI score greater than 60 indicated NAFLD and an FI score greater than 6.9 indicated advanced fibrosis.

Participants were sorted into three weight categories by body mass index: lean (BMI less than 25 kg/m²), overweight (BMI 25-30), or obese (BMI more than 30). In addition, a variety of other health measures were recorded, including presence of metabolic risk factors, such as diabetes or metabolic syndrome, and elevated alanine transaminase (ALT).

Analysis showed that the prevalence of NAFLD in the general population was 18.2%. Of those diagnosed with NAFLD, 2.6% had advanced fibrosis. As expected, Dr. Serfaty said, NAFLD was much less common among those who were of normal bodyweight, with lean patients accounting for only 1.9% of NAFLD diagnoses. However, when NAFLD was diagnosed in lean patients, it was more often severe. Among lean patients with NAFLD, 4.5% had advanced fibrosis, compared with 2.4% of overweight patients and 2.3% of obese patients.

Dr. Serfaty noted that lean patients with NAFLD tended to have fewer metabolic risk factors, but most had at least one. Lifestyle factors were likely to blame, he said, because lean patients with NAFLD were relatively heavy users of tobacco and alcohol, compared with obese or overweight patients. Cardiovascular disease was also more common among lean patients with NAFLD.

“There are probably other factors [that are different, such as] genetic factors, the microbiome, and maybe the immune system,” Dr. Serfaty said.

While drivers of NAFLD among lean patients remain to be clarified, Dr. Serfaty highlighted the importance of recognizing this unique patient population, and if encountered, not discounting the severity of disease based on a lack of other metabolic risk factors.

“It is very important to know that these patients exist because it is very difficult to identify these patients,” Dr. Serfaty said. “If you have a lean patient with NAFLD, normally you [might] say, it’s not very severe for this patient because he’s lean; but no, [that’s not correct], because maybe he has more advanced fibrosis. So you have to go through and check with other noninvasive markers to be sure that this patient does not have advanced fibrosis.”

Concerning the difficulty of identifying such patients in the first place, Dr. Serfaty suggested that elevated ALT may be the most reliable red flag because this laboratory abnormality occurred in more than half of the lean patients diagnosed with NAFLD, despite no excessive alcohol consumption or prior hepatitis. The investigators disclosed relationships with Gilead, AbbVie, Echosens, and others.

SOURCE: Serfaty L et al. The Liver Meeting 2019, Abstract 1188.

BOSTON – For patients with nonalcoholic fatty liver disease (NAFLD), leaner may really be meaner, according to a recent French study involving more than 100,000 individuals of the general population.

NAFLD was uncommon among participants with normal bodyweight, but when NAFLD was present, lean patients had almost twice the risk of advanced fibrosis as that of overweight and obese patients, reported principal author Lawrence Serfaty, MD, chief of the department of hepatology at Strasbourg (France) University, who conducted the project with colleagues at the French public research organization, Inserm.

“Normally, NAFLD and [nonalcoholic steatohepatitis (NASH)] are part of metabolic syndrome,” Dr. Serfaty said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “But there are some patients with no metabolic risk factors who are lean and who may have NAFLD.”

To determine the prevalence and characteristics of these patients, the investigators drew data from the CONSTANCES cohort, which is composed of 118,664 members of the general public in France. After excluding those who withdrew consent, had a history of other liver diseases, or reported an excess of alcohol consumption (more than 20 g/day), the analyzed dataset included 102,344 subjects. Among these participants, NAFLD and advanced fibrosis were diagnosed with the Fatty Liver Index (FLI) and the Forns Index (FI), respectively, in which an FLI score greater than 60 indicated NAFLD and an FI score greater than 6.9 indicated advanced fibrosis.

Participants were sorted into three weight categories by body mass index: lean (BMI less than 25 kg/m²), overweight (BMI 25-30), or obese (BMI more than 30). In addition, a variety of other health measures were recorded, including presence of metabolic risk factors, such as diabetes or metabolic syndrome, and elevated alanine transaminase (ALT).

Analysis showed that the prevalence of NAFLD in the general population was 18.2%. Of those diagnosed with NAFLD, 2.6% had advanced fibrosis. As expected, Dr. Serfaty said, NAFLD was much less common among those who were of normal bodyweight, with lean patients accounting for only 1.9% of NAFLD diagnoses. However, when NAFLD was diagnosed in lean patients, it was more often severe. Among lean patients with NAFLD, 4.5% had advanced fibrosis, compared with 2.4% of overweight patients and 2.3% of obese patients.

Dr. Serfaty noted that lean patients with NAFLD tended to have fewer metabolic risk factors, but most had at least one. Lifestyle factors were likely to blame, he said, because lean patients with NAFLD were relatively heavy users of tobacco and alcohol, compared with obese or overweight patients. Cardiovascular disease was also more common among lean patients with NAFLD.

“There are probably other factors [that are different, such as] genetic factors, the microbiome, and maybe the immune system,” Dr. Serfaty said.

While drivers of NAFLD among lean patients remain to be clarified, Dr. Serfaty highlighted the importance of recognizing this unique patient population, and if encountered, not discounting the severity of disease based on a lack of other metabolic risk factors.

“It is very important to know that these patients exist because it is very difficult to identify these patients,” Dr. Serfaty said. “If you have a lean patient with NAFLD, normally you [might] say, it’s not very severe for this patient because he’s lean; but no, [that’s not correct], because maybe he has more advanced fibrosis. So you have to go through and check with other noninvasive markers to be sure that this patient does not have advanced fibrosis.”

Concerning the difficulty of identifying such patients in the first place, Dr. Serfaty suggested that elevated ALT may be the most reliable red flag because this laboratory abnormality occurred in more than half of the lean patients diagnosed with NAFLD, despite no excessive alcohol consumption or prior hepatitis. The investigators disclosed relationships with Gilead, AbbVie, Echosens, and others.

SOURCE: Serfaty L et al. The Liver Meeting 2019, Abstract 1188.

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

For patients with advanced cirrhosis and acute variceal bleeding, early treatment with transjugular intrahepatic portosystemic shunt (TIPS) appears to improve transplantation-free survival, according to investigators.

Early TIPS “should therefore be preferred to the current standard of care,” reported lead author Yong Lv, MD, of the Fourth Military Medical University in Xi’an, China, and colleagues, referring to standard pharmaceutical and endoscopic therapy.

“[The current standard] approach has improved patient outcomes,” the investigators wrote in the Lancet Gastroenterology & Hepatology. “However, up to 10%-20% of patients still experience treatment failure, requiring further intensive management. In such patients, [TIPS] is successful in achieving hemostasis in 90%-100% of patients. However, 6-week mortality remains high [35%-55%]. This is probably because the severity of the underlying liver disease has worsened and additional organ dysfunction may have occurred after several failed endoscopic therapy attempts.”

Previous studies have explored earlier intervention with TIPS; however, according to the investigators, these trials were inconclusive for various reasons. For example, uncovered stents and an out-of-date control therapy were employed in a trial by Monescillo et al., while a study by Garcia-Pagan et al. lacked a primary survival endpoint and has been criticized for selection bias. “Thus, whether early TIPS confers a survival benefit in a broader population remains to be assessed,” the investigators wrote.

To this end, the investigators screened 373 patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding. Of these, 132 were eligible for inclusion based on age, disease severity, willingness to participate, comorbidities, and other factors. Patients were randomized 2:1 to receive either early TIPS or standard therapy. Within 12 hours of hospital admission for the initial bleeding episode, all patients received vasoactive drugs or endoscopic band ligation and prophylactic antibiotics. Control patients continued vasoactive drugs for up to 5 days, followed by propranolol, which was titrated to reduce resting heart rate by 25% but not less than 55 beats per minute. Elective endoscopic band ligation was performed within 1-2 weeks of initial endoscopic treatment, then approximately every 2 weeks until variceal eradication, and additionally if varices reappeared. TIPS was allowed as rescue therapy. In contrast, patients in the TIPS group underwent the procedure with conscious sedation and local anesthesia within 72 hours of diagnostic endoscopy, followed by approximately 1 week of antibiotics and vasoactive drugs. TIPS revision with angioplasty or another stent placement was performed in the event of shunt dysfunction or reemergence of portal hypertensive complications. The final dataset contained 127 patients, as 3 were excluded after randomization because of exclusionary diagnoses, 1 withdrew consent, and 1 died before TIPS placement.

The primary endpoint was transplantation-free survival. The secondary endpoints were new or worsening ascites based on ultrasound score or sustained ascites necessitating paracentesis, failure to control bleeding or rebleeding, overt hepatic encephalopathy, other complications of portal hypertension, and adverse events.

After a median follow-up of 24 months, data analysis showed a survival benefit associated with early TIPS based on multiple measures. Out of 84 patients in the TIPS group, 15 (18%) died during follow-up, compared with 15 (33%) in the control group. Actuarial transplantation-free survival was also better with TIPS instead of standard therapy at 6 weeks (99% vs. 84%), 1 year (86% vs. 73%), and 2 years (79% vs. 64%). The hazard ratio for transplantation-free survival was 0.50 in favor of TIPS (P = .04). These survival advantages were maintained regardless of hepatitis B virus status or Child-Pugh/Model for End-Stage Liver Disease score.

Similarly to transplantation-free survival, patients treated with TIPS were more likely to be free of uncontrolled bleeding or rebleeding at 1 year (89% vs. 66%) and 2 years (86% vs. 57%). The associated hazard ratio for this outcome favored early TIPS (HR, 0.26; P less than .0001), and univariate and multivariate analysis confirmed an independent protective role. In further support of superiority over standard therapy, patients treated with TIPS were more likely than those in the control group to be free of new or worsening ascites at 1 year (89% vs. 57%) and 2 years (81% vs. 54%).

No significant intergroup differences were found for rates of overt hepatic encephalopathy, hepatic hydrothorax, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, serious adverse events, or nonserious adverse events. At 1 and 3 months, patients in the TIPS group had a slight increase of median bilirubin concentrations and median international normalized ratio; however, these values normalized after 6 months. A similar temporal pattern was observed in early TIPS patients with regard to median Model for End-Stage Liver Disease score.

“[The transplantation-free survival benefit of early TIPS] was probably related to better control of factors contributing to death, such as failure to control bleeding or rebleeding or new or worsening ascites, without increasing the frequency and severity of overt hepatic encephalopathy and other adverse events,” the investigators concluded. “This study provides direct evidence and greater confidence in the recommendations of current guidelines that early TIPS should be performed in high-risk patients without contraindications.

“Future studies addressing whether early TIPS can be equally recommended in Child-Pugh B and C patients are warranted,” the investigators added.

The study was funded by the National Key Technology R&D Program, Boost Program of Xijing Hospital, Optimized Overall Project of Shaanxi Province, and National Natural Science Foundation of China. The investigators reported no conflicts of interest.

SOURCE: Lv Y et al. Lancet Gastroenterol Hepatol. 2019 May 29. doi: 10.1016/S2468-1253(19)30090-1.

For patients with advanced cirrhosis and acute variceal bleeding, early treatment with transjugular intrahepatic portosystemic shunt (TIPS) appears to improve transplantation-free survival, according to investigators.

Early TIPS “should therefore be preferred to the current standard of care,” reported lead author Yong Lv, MD, of the Fourth Military Medical University in Xi’an, China, and colleagues, referring to standard pharmaceutical and endoscopic therapy.

“[The current standard] approach has improved patient outcomes,” the investigators wrote in the Lancet Gastroenterology & Hepatology. “However, up to 10%-20% of patients still experience treatment failure, requiring further intensive management. In such patients, [TIPS] is successful in achieving hemostasis in 90%-100% of patients. However, 6-week mortality remains high [35%-55%]. This is probably because the severity of the underlying liver disease has worsened and additional organ dysfunction may have occurred after several failed endoscopic therapy attempts.”

Previous studies have explored earlier intervention with TIPS; however, according to the investigators, these trials were inconclusive for various reasons. For example, uncovered stents and an out-of-date control therapy were employed in a trial by Monescillo et al., while a study by Garcia-Pagan et al. lacked a primary survival endpoint and has been criticized for selection bias. “Thus, whether early TIPS confers a survival benefit in a broader population remains to be assessed,” the investigators wrote.

To this end, the investigators screened 373 patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding. Of these, 132 were eligible for inclusion based on age, disease severity, willingness to participate, comorbidities, and other factors. Patients were randomized 2:1 to receive either early TIPS or standard therapy. Within 12 hours of hospital admission for the initial bleeding episode, all patients received vasoactive drugs or endoscopic band ligation and prophylactic antibiotics. Control patients continued vasoactive drugs for up to 5 days, followed by propranolol, which was titrated to reduce resting heart rate by 25% but not less than 55 beats per minute. Elective endoscopic band ligation was performed within 1-2 weeks of initial endoscopic treatment, then approximately every 2 weeks until variceal eradication, and additionally if varices reappeared. TIPS was allowed as rescue therapy. In contrast, patients in the TIPS group underwent the procedure with conscious sedation and local anesthesia within 72 hours of diagnostic endoscopy, followed by approximately 1 week of antibiotics and vasoactive drugs. TIPS revision with angioplasty or another stent placement was performed in the event of shunt dysfunction or reemergence of portal hypertensive complications. The final dataset contained 127 patients, as 3 were excluded after randomization because of exclusionary diagnoses, 1 withdrew consent, and 1 died before TIPS placement.

The primary endpoint was transplantation-free survival. The secondary endpoints were new or worsening ascites based on ultrasound score or sustained ascites necessitating paracentesis, failure to control bleeding or rebleeding, overt hepatic encephalopathy, other complications of portal hypertension, and adverse events.

After a median follow-up of 24 months, data analysis showed a survival benefit associated with early TIPS based on multiple measures. Out of 84 patients in the TIPS group, 15 (18%) died during follow-up, compared with 15 (33%) in the control group. Actuarial transplantation-free survival was also better with TIPS instead of standard therapy at 6 weeks (99% vs. 84%), 1 year (86% vs. 73%), and 2 years (79% vs. 64%). The hazard ratio for transplantation-free survival was 0.50 in favor of TIPS (P = .04). These survival advantages were maintained regardless of hepatitis B virus status or Child-Pugh/Model for End-Stage Liver Disease score.

Similarly to transplantation-free survival, patients treated with TIPS were more likely to be free of uncontrolled bleeding or rebleeding at 1 year (89% vs. 66%) and 2 years (86% vs. 57%). The associated hazard ratio for this outcome favored early TIPS (HR, 0.26; P less than .0001), and univariate and multivariate analysis confirmed an independent protective role. In further support of superiority over standard therapy, patients treated with TIPS were more likely than those in the control group to be free of new or worsening ascites at 1 year (89% vs. 57%) and 2 years (81% vs. 54%).

No significant intergroup differences were found for rates of overt hepatic encephalopathy, hepatic hydrothorax, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, serious adverse events, or nonserious adverse events. At 1 and 3 months, patients in the TIPS group had a slight increase of median bilirubin concentrations and median international normalized ratio; however, these values normalized after 6 months. A similar temporal pattern was observed in early TIPS patients with regard to median Model for End-Stage Liver Disease score.

“[The transplantation-free survival benefit of early TIPS] was probably related to better control of factors contributing to death, such as failure to control bleeding or rebleeding or new or worsening ascites, without increasing the frequency and severity of overt hepatic encephalopathy and other adverse events,” the investigators concluded. “This study provides direct evidence and greater confidence in the recommendations of current guidelines that early TIPS should be performed in high-risk patients without contraindications.

“Future studies addressing whether early TIPS can be equally recommended in Child-Pugh B and C patients are warranted,” the investigators added.

The study was funded by the National Key Technology R&D Program, Boost Program of Xijing Hospital, Optimized Overall Project of Shaanxi Province, and National Natural Science Foundation of China. The investigators reported no conflicts of interest.

SOURCE: Lv Y et al. Lancet Gastroenterol Hepatol. 2019 May 29. doi: 10.1016/S2468-1253(19)30090-1.

For patients with advanced cirrhosis and acute variceal bleeding, early treatment with transjugular intrahepatic portosystemic shunt (TIPS) appears to improve transplantation-free survival, according to investigators.

Early TIPS “should therefore be preferred to the current standard of care,” reported lead author Yong Lv, MD, of the Fourth Military Medical University in Xi’an, China, and colleagues, referring to standard pharmaceutical and endoscopic therapy.

“[The current standard] approach has improved patient outcomes,” the investigators wrote in the Lancet Gastroenterology & Hepatology. “However, up to 10%-20% of patients still experience treatment failure, requiring further intensive management. In such patients, [TIPS] is successful in achieving hemostasis in 90%-100% of patients. However, 6-week mortality remains high [35%-55%]. This is probably because the severity of the underlying liver disease has worsened and additional organ dysfunction may have occurred after several failed endoscopic therapy attempts.”

Previous studies have explored earlier intervention with TIPS; however, according to the investigators, these trials were inconclusive for various reasons. For example, uncovered stents and an out-of-date control therapy were employed in a trial by Monescillo et al., while a study by Garcia-Pagan et al. lacked a primary survival endpoint and has been criticized for selection bias. “Thus, whether early TIPS confers a survival benefit in a broader population remains to be assessed,” the investigators wrote.

To this end, the investigators screened 373 patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding. Of these, 132 were eligible for inclusion based on age, disease severity, willingness to participate, comorbidities, and other factors. Patients were randomized 2:1 to receive either early TIPS or standard therapy. Within 12 hours of hospital admission for the initial bleeding episode, all patients received vasoactive drugs or endoscopic band ligation and prophylactic antibiotics. Control patients continued vasoactive drugs for up to 5 days, followed by propranolol, which was titrated to reduce resting heart rate by 25% but not less than 55 beats per minute. Elective endoscopic band ligation was performed within 1-2 weeks of initial endoscopic treatment, then approximately every 2 weeks until variceal eradication, and additionally if varices reappeared. TIPS was allowed as rescue therapy. In contrast, patients in the TIPS group underwent the procedure with conscious sedation and local anesthesia within 72 hours of diagnostic endoscopy, followed by approximately 1 week of antibiotics and vasoactive drugs. TIPS revision with angioplasty or another stent placement was performed in the event of shunt dysfunction or reemergence of portal hypertensive complications. The final dataset contained 127 patients, as 3 were excluded after randomization because of exclusionary diagnoses, 1 withdrew consent, and 1 died before TIPS placement.

The primary endpoint was transplantation-free survival. The secondary endpoints were new or worsening ascites based on ultrasound score or sustained ascites necessitating paracentesis, failure to control bleeding or rebleeding, overt hepatic encephalopathy, other complications of portal hypertension, and adverse events.

After a median follow-up of 24 months, data analysis showed a survival benefit associated with early TIPS based on multiple measures. Out of 84 patients in the TIPS group, 15 (18%) died during follow-up, compared with 15 (33%) in the control group. Actuarial transplantation-free survival was also better with TIPS instead of standard therapy at 6 weeks (99% vs. 84%), 1 year (86% vs. 73%), and 2 years (79% vs. 64%). The hazard ratio for transplantation-free survival was 0.50 in favor of TIPS (P = .04). These survival advantages were maintained regardless of hepatitis B virus status or Child-Pugh/Model for End-Stage Liver Disease score.

Similarly to transplantation-free survival, patients treated with TIPS were more likely to be free of uncontrolled bleeding or rebleeding at 1 year (89% vs. 66%) and 2 years (86% vs. 57%). The associated hazard ratio for this outcome favored early TIPS (HR, 0.26; P less than .0001), and univariate and multivariate analysis confirmed an independent protective role. In further support of superiority over standard therapy, patients treated with TIPS were more likely than those in the control group to be free of new or worsening ascites at 1 year (89% vs. 57%) and 2 years (81% vs. 54%).

No significant intergroup differences were found for rates of overt hepatic encephalopathy, hepatic hydrothorax, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, serious adverse events, or nonserious adverse events. At 1 and 3 months, patients in the TIPS group had a slight increase of median bilirubin concentrations and median international normalized ratio; however, these values normalized after 6 months. A similar temporal pattern was observed in early TIPS patients with regard to median Model for End-Stage Liver Disease score.

“[The transplantation-free survival benefit of early TIPS] was probably related to better control of factors contributing to death, such as failure to control bleeding or rebleeding or new or worsening ascites, without increasing the frequency and severity of overt hepatic encephalopathy and other adverse events,” the investigators concluded. “This study provides direct evidence and greater confidence in the recommendations of current guidelines that early TIPS should be performed in high-risk patients without contraindications.

“Future studies addressing whether early TIPS can be equally recommended in Child-Pugh B and C patients are warranted,” the investigators added.

The study was funded by the National Key Technology R&D Program, Boost Program of Xijing Hospital, Optimized Overall Project of Shaanxi Province, and National Natural Science Foundation of China. The investigators reported no conflicts of interest.

SOURCE: Lv Y et al. Lancet Gastroenterol Hepatol. 2019 May 29. doi: 10.1016/S2468-1253(19)30090-1.

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

[email protected]

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

[email protected]

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

[email protected]

SAN DIEGO – Waiting to perform cholecystectomy after mild biliary pancreatitis was associated with an increased risk of recurrent biliary events in a recent study. In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.

Dmitrii Kotin/Thinkstock.com

Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.

Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.

To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.

The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.

A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m². A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.

Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).

The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.

The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.

Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.

The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.

Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.

However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.

Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.

“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Ullah M. et al. DDW 2019, Abstract 24.

SAN DIEGO – Waiting to perform cholecystectomy after mild biliary pancreatitis was associated with an increased risk of recurrent biliary events in a recent study. In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.

Dmitrii Kotin/Thinkstock.com

Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.

Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.

To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.

The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.

A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m². A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.

Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).

The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.

The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.

Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.

The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.

Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.

However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.

Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.

“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Ullah M. et al. DDW 2019, Abstract 24.

SAN DIEGO – Waiting to perform cholecystectomy after mild biliary pancreatitis was associated with an increased risk of recurrent biliary events in a recent study. In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.

Dmitrii Kotin/Thinkstock.com

Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.

Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.

To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.

The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.

A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m². A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.

Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).

The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.

The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.

Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.

The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.

Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.

However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.

Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.

“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Ullah M. et al. DDW 2019, Abstract 24.

Patients who undergo appendectomy face an increased risk of Parkinson’s disease, especially those aged 18-64 years, results from a large population-based study demonstrated.

“One of the factors that’s seen in the brains of patients with Parkinson’s disease is accumulation of an abnormal protein known as alpha-synuclein,” one of the study authors, Gregory S. Cooper, MD, said during a media briefing in advance of the annual Digestive Disease Week. “It’s released by damaged nerve cells in the brain. Not only is alpha-synuclein found in the brain of patients with Parkinson’s disease; it’s also found in the GI tract. It’s thought that its accumulation in the GI tract occurs prior to the development of its accumulation in the brain.”

This has prompted scientists around the world to evaluate the GI tract, including the appendix, for evidence about the pathophysiology and onset of Parkinson’s disease, said Dr. Cooper, professor of medicine, oncology, and population and quantitative health sciences at Case Western Reserve University, Cleveland. “It’s thought that, potentially, in the presence of inflammation, [molecules] of this protein are released from damaged nerves in the gut and then are transported to the brain, where they accumulate,” he said. “Or, it could be that the appendix is a storage place for this protein and gets released at the time of appendectomy.”

To investigate if appendectomy increases the risk of Parkinson’s disease, Dr. Cooper and colleagues drew from the Explorys database, which contains EHRs from 26 integrated U.S. health care systems. They limited their search to patients who underwent appendectomies and those who were diagnosed with Parkinson’s disease based on Systematized Nomenclature of Medicine–Clinical Terms. The researchers chose a washout period of 6 months to the development of Parkinson’s disease after appendectomy, and compared the prevalence of Parkinson’s disease in the general population to those with appendectomies.

Of the 62,218,050 records in the database, Dr. Cooper and colleagues identified 488,190 patients who underwent appendectomies. In all, 4,470 cases of Parkinson’s disease were observed in patients with appendectomies, and 177,230 cases of Parkinson’s disease in patients without appendectomies. The overall relative risk of developing Parkinson’s disease in patients after appendectomies was 3.19 (95% confidence interval, 3.10-3.28; P less than .0001), compared with those who did not undergo the procedure. The relative risk was higher in patients aged 18-64 years (RR, 4.27; 95% CI, 3.99-4.57; P less than .0001), compared with those 65 years and older (RR, 2.20; 95% CI, 2.13-2.27; P less than .0001). “We know that Parkinson’s disease is more common in the elderly,” Dr. Cooper said. “But at virtually all ages, the prevalence of Parkinson’s disease was higher in patients who had an appendectomy, compared to those without an appendectomy.”

The overall relative risk of developing Parkinson’s disease in patients after appendectomies was slightly higher in females (RR, 3.86; 95% CI, 3.71-4.02; P less than .0001), compared with males (RR, 2.67; 95% CI, 2.56-2.79; P less than .0001). The researchers also observed a similar effect of appendectomy by race. The overall relative risk of developing Parkinson’s disease in patients after appendectomy was slightly higher in African Americans (RR, 3.11; 95% CI, 2.69-3.58; P less than .0001), compared with Asians (RR, 2.73; 95% CI, 2.19-3.41; P less than .0001), and whites (RR, 2.55; 95% CI, 2.48-2.63; P less than .0001).

“If these data get borne out, it may question the role of doing a discretionary appendectomy in a patient who’s having surgery for another reason,” Dr. Cooper said. “Our research does show a clear relationship between appendectomy and Parkinson’s disease. However, at this point, it’s only an association. As a next step, we’d like to conduct additional research to confirm this connection and better understand the mechanisms involved.”

He pointed out that, because of the nature of the Explorys database, he and his colleagues were unable to determine the length of time following appendectomy to the development of Parkinson’s disease.

The study’s lead author was Mohammed Z. Sheriff, MD, also of Case Western Reserve University, Cleveland. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Sheriff MZ et al. DDW 2019, Abstract 739.

Patients who undergo appendectomy face an increased risk of Parkinson’s disease, especially those aged 18-64 years, results from a large population-based study demonstrated.

“One of the factors that’s seen in the brains of patients with Parkinson’s disease is accumulation of an abnormal protein known as alpha-synuclein,” one of the study authors, Gregory S. Cooper, MD, said during a media briefing in advance of the annual Digestive Disease Week. “It’s released by damaged nerve cells in the brain. Not only is alpha-synuclein found in the brain of patients with Parkinson’s disease; it’s also found in the GI tract. It’s thought that its accumulation in the GI tract occurs prior to the development of its accumulation in the brain.”

This has prompted scientists around the world to evaluate the GI tract, including the appendix, for evidence about the pathophysiology and onset of Parkinson’s disease, said Dr. Cooper, professor of medicine, oncology, and population and quantitative health sciences at Case Western Reserve University, Cleveland. “It’s thought that, potentially, in the presence of inflammation, [molecules] of this protein are released from damaged nerves in the gut and then are transported to the brain, where they accumulate,” he said. “Or, it could be that the appendix is a storage place for this protein and gets released at the time of appendectomy.”

To investigate if appendectomy increases the risk of Parkinson’s disease, Dr. Cooper and colleagues drew from the Explorys database, which contains EHRs from 26 integrated U.S. health care systems. They limited their search to patients who underwent appendectomies and those who were diagnosed with Parkinson’s disease based on Systematized Nomenclature of Medicine–Clinical Terms. The researchers chose a washout period of 6 months to the development of Parkinson’s disease after appendectomy, and compared the prevalence of Parkinson’s disease in the general population to those with appendectomies.

Of the 62,218,050 records in the database, Dr. Cooper and colleagues identified 488,190 patients who underwent appendectomies. In all, 4,470 cases of Parkinson’s disease were observed in patients with appendectomies, and 177,230 cases of Parkinson’s disease in patients without appendectomies. The overall relative risk of developing Parkinson’s disease in patients after appendectomies was 3.19 (95% confidence interval, 3.10-3.28; P less than .0001), compared with those who did not undergo the procedure. The relative risk was higher in patients aged 18-64 years (RR, 4.27; 95% CI, 3.99-4.57; P less than .0001), compared with those 65 years and older (RR, 2.20; 95% CI, 2.13-2.27; P less than .0001). “We know that Parkinson’s disease is more common in the elderly,” Dr. Cooper said. “But at virtually all ages, the prevalence of Parkinson’s disease was higher in patients who had an appendectomy, compared to those without an appendectomy.”

The overall relative risk of developing Parkinson’s disease in patients after appendectomies was slightly higher in females (RR, 3.86; 95% CI, 3.71-4.02; P less than .0001), compared with males (RR, 2.67; 95% CI, 2.56-2.79; P less than .0001). The researchers also observed a similar effect of appendectomy by race. The overall relative risk of developing Parkinson’s disease in patients after appendectomy was slightly higher in African Americans (RR, 3.11; 95% CI, 2.69-3.58; P less than .0001), compared with Asians (RR, 2.73; 95% CI, 2.19-3.41; P less than .0001), and whites (RR, 2.55; 95% CI, 2.48-2.63; P less than .0001).

“If these data get borne out, it may question the role of doing a discretionary appendectomy in a patient who’s having surgery for another reason,” Dr. Cooper said. “Our research does show a clear relationship between appendectomy and Parkinson’s disease. However, at this point, it’s only an association. As a next step, we’d like to conduct additional research to confirm this connection and better understand the mechanisms involved.”

He pointed out that, because of the nature of the Explorys database, he and his colleagues were unable to determine the length of time following appendectomy to the development of Parkinson’s disease.

The study’s lead author was Mohammed Z. Sheriff, MD, also of Case Western Reserve University, Cleveland. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Sheriff MZ et al. DDW 2019, Abstract 739.

Patients who undergo appendectomy face an increased risk of Parkinson’s disease, especially those aged 18-64 years, results from a large population-based study demonstrated.

“One of the factors that’s seen in the brains of patients with Parkinson’s disease is accumulation of an abnormal protein known as alpha-synuclein,” one of the study authors, Gregory S. Cooper, MD, said during a media briefing in advance of the annual Digestive Disease Week. “It’s released by damaged nerve cells in the brain. Not only is alpha-synuclein found in the brain of patients with Parkinson’s disease; it’s also found in the GI tract. It’s thought that its accumulation in the GI tract occurs prior to the development of its accumulation in the brain.”

This has prompted scientists around the world to evaluate the GI tract, including the appendix, for evidence about the pathophysiology and onset of Parkinson’s disease, said Dr. Cooper, professor of medicine, oncology, and population and quantitative health sciences at Case Western Reserve University, Cleveland. “It’s thought that, potentially, in the presence of inflammation, [molecules] of this protein are released from damaged nerves in the gut and then are transported to the brain, where they accumulate,” he said. “Or, it could be that the appendix is a storage place for this protein and gets released at the time of appendectomy.”

To investigate if appendectomy increases the risk of Parkinson’s disease, Dr. Cooper and colleagues drew from the Explorys database, which contains EHRs from 26 integrated U.S. health care systems. They limited their search to patients who underwent appendectomies and those who were diagnosed with Parkinson’s disease based on Systematized Nomenclature of Medicine–Clinical Terms. The researchers chose a washout period of 6 months to the development of Parkinson’s disease after appendectomy, and compared the prevalence of Parkinson’s disease in the general population to those with appendectomies.

Of the 62,218,050 records in the database, Dr. Cooper and colleagues identified 488,190 patients who underwent appendectomies. In all, 4,470 cases of Parkinson’s disease were observed in patients with appendectomies, and 177,230 cases of Parkinson’s disease in patients without appendectomies. The overall relative risk of developing Parkinson’s disease in patients after appendectomies was 3.19 (95% confidence interval, 3.10-3.28; P less than .0001), compared with those who did not undergo the procedure. The relative risk was higher in patients aged 18-64 years (RR, 4.27; 95% CI, 3.99-4.57; P less than .0001), compared with those 65 years and older (RR, 2.20; 95% CI, 2.13-2.27; P less than .0001). “We know that Parkinson’s disease is more common in the elderly,” Dr. Cooper said. “But at virtually all ages, the prevalence of Parkinson’s disease was higher in patients who had an appendectomy, compared to those without an appendectomy.”

The overall relative risk of developing Parkinson’s disease in patients after appendectomies was slightly higher in females (RR, 3.86; 95% CI, 3.71-4.02; P less than .0001), compared with males (RR, 2.67; 95% CI, 2.56-2.79; P less than .0001). The researchers also observed a similar effect of appendectomy by race. The overall relative risk of developing Parkinson’s disease in patients after appendectomy was slightly higher in African Americans (RR, 3.11; 95% CI, 2.69-3.58; P less than .0001), compared with Asians (RR, 2.73; 95% CI, 2.19-3.41; P less than .0001), and whites (RR, 2.55; 95% CI, 2.48-2.63; P less than .0001).

“If these data get borne out, it may question the role of doing a discretionary appendectomy in a patient who’s having surgery for another reason,” Dr. Cooper said. “Our research does show a clear relationship between appendectomy and Parkinson’s disease. However, at this point, it’s only an association. As a next step, we’d like to conduct additional research to confirm this connection and better understand the mechanisms involved.”

He pointed out that, because of the nature of the Explorys database, he and his colleagues were unable to determine the length of time following appendectomy to the development of Parkinson’s disease.

The study’s lead author was Mohammed Z. Sheriff, MD, also of Case Western Reserve University, Cleveland. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Sheriff MZ et al. DDW 2019, Abstract 739.

PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.

The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.

A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.

Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.

While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.

Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.

To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.

Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.

Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.

One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.

Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.

SOURCE: Chan F et al. AAN 2019. P1.3-001.

PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.

The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.

A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.

Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.

While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.

Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.

To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.

Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.

Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.

One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.

Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.

SOURCE: Chan F et al. AAN 2019. P1.3-001.

PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.

The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.

A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.

Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.

While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.

Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.

To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.

Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.

Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.

One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.

Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.

SOURCE: Chan F et al. AAN 2019. P1.3-001.

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

BALTIMORE – Patients who take benzodiazepines for anxiety and have laparoscopic Nissen fundoplication for gastroesophageal reflux disease achieve similar outcomes as other patients, but also have much lower rates of postop satisfaction, according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.

DAJ/Thinkstock

Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.

The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.

However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.

“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”

Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.

Dr. Holcomb had no relevant financial disclosures.

SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.

BALTIMORE – Patients who take benzodiazepines for anxiety and have laparoscopic Nissen fundoplication for gastroesophageal reflux disease achieve similar outcomes as other patients, but also have much lower rates of postop satisfaction, according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.

DAJ/Thinkstock

Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.

The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.

However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.

“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”

Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.

Dr. Holcomb had no relevant financial disclosures.

SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.

BALTIMORE – Patients who take benzodiazepines for anxiety and have laparoscopic Nissen fundoplication for gastroesophageal reflux disease achieve similar outcomes as other patients, but also have much lower rates of postop satisfaction, according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.

DAJ/Thinkstock

Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.

The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.

However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.

“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”

Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.

Dr. Holcomb had no relevant financial disclosures.

SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.