Liver Disease

The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).

HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.

Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.

The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.

Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.

Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.

The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).

To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.

The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).

Results of the CONFIRM trial were published in The New England Journal of Medicine.

“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.

“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.

The company plans to launch the product in the coming weeks.

The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

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

The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).

HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.

Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.

The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.

Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.

Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.

The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).

To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.

The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).

Results of the CONFIRM trial were published in The New England Journal of Medicine.

“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.

“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.

The company plans to launch the product in the coming weeks.

The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

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

The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).

HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.

Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.

The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.

Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.

Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.

The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).

To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.

The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).

Results of the CONFIRM trial were published in The New England Journal of Medicine.

“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.

“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.

The company plans to launch the product in the coming weeks.

The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

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

New liver stiffness (LS) thresholds offer accurate prediction of disease progression and clinical outcomes in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis, according to investigators.

These new LS thresholds are more reliable because they are based on high-quality prospective data drawn from four randomized controlled trials, reported lead author Rohit Loomba, MD, of the University of California, San Diego, and colleagues.

“Retrospective studies report that increasing baseline LS by VCTE [vibration-controlled transient elastography] is associated with the risk of disease progression in patients with NAFLD [non-alcoholic fatty liver disease], but prospective data in well-characterized NASH cohorts with biopsy-confirmed advanced fibrosis are limited,” the investigators wrote in Gut. “The optimal LS thresholds for prognostication of fibrosis progression and decompensation are unknown.”

Seeking clarity, Dr. Loomba and colleagues leveraged data from two phase 3 placebo-controlled trials for selonsertib and two phase 2b placebo-controlled trials for simtuzumab.

“While the studies were discontinued prematurely due to lack of efficacy, the prospectively collected data in these well-characterized participants with serial liver biopsies provides a unique opportunity to study the association between baseline LS by VCTE and disease progression,” the investigators wrote.

Across all four studies, bridging fibrosis (F3) was present in 664 participants, while 734 individuals had cirrhosis (F4). In the selonsertib studies, fibrosis was staged at baseline and week 48. The simtuzumab studies measured liver fibrosis at baseline and week 96. Out of the 664 participants with bridging fibrosis, 103 (16%) progressed to cirrhosis. Among the 734 patients with cirrhosis, 27 (4%) experienced liver-related events. Comparing these outcomes with LS data at baseline and throughout the study revealed optimal LS thresholds.

The best threshold for predicting progression from bridging fibrosis to cirrhosis was 16.6 kPa. According to the authors, the sensitivity, specificity, positive predictive value, and negative predictive value of this threshold for progression to cirrhosis were 58%, 76%, 31%, and 91%, respectively. Among patients at or above 16.6 kPa, 31% progressed to cirrhosis, compared with 9.1% of those under that threshold. Furthermore, individuals with a baseline LS at or above 16.6 kPa had nearly four times greater risk of developing cirrhosis (adjusted hazard ratio, 3.99; 95% CI, 2.66­-5.98; P < .0001).

For patients with cirrhosis at baseline, the optimal threshold for predicting liver-related events, such as ascites, hepatic encephalopathy, and portal hypertension–related GI bleeding, liver transplantation, or mortality, was 30.7 kPa. The sensitivity, specificity, PPV, and NPV of this threshold for liver-related events were 62%, 87%, 10%, and 99%, respectively, according to the authors. Patients with an LS above this mark were 10 times as likely to experience liver-related events (aHR, 10.13; 95% CI, 4.38-23.41; P < .0001).

Scott L. Friedman, MD, chief of the division of liver diseases and dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, New York, called the study “an important effort” that offers valuable insights for both researchers and practitioners.

“For clinical trials, [these thresholds] really allow for greater refinement or enrichment of patients who are suitable for enrollment in the trial because they’re at a higher risk of clinical problems that might be mitigated if the drug is effective,” Dr. Friedman said in an interview. “For clinical practice, it might indicate that the patient should either be fast tracked for a clinical trial or, more importantly, maybe needs to be referred for evaluation for a liver transplant. It may also indicate – although they didn’t look at it in this study – that there’s a need to begin or accelerate screening for liver cancer, which becomes an encroaching risk as the fibrosis advances to later stages.”

The study was funded by Gilead Sciences. The investigators disclosed additional relationships with Amgen, Eli Lilly, CohBar, and others. Dr. Friedman reported no relevant conflicts of interest.

New liver stiffness (LS) thresholds offer accurate prediction of disease progression and clinical outcomes in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis, according to investigators.

These new LS thresholds are more reliable because they are based on high-quality prospective data drawn from four randomized controlled trials, reported lead author Rohit Loomba, MD, of the University of California, San Diego, and colleagues.

“Retrospective studies report that increasing baseline LS by VCTE [vibration-controlled transient elastography] is associated with the risk of disease progression in patients with NAFLD [non-alcoholic fatty liver disease], but prospective data in well-characterized NASH cohorts with biopsy-confirmed advanced fibrosis are limited,” the investigators wrote in Gut. “The optimal LS thresholds for prognostication of fibrosis progression and decompensation are unknown.”

Seeking clarity, Dr. Loomba and colleagues leveraged data from two phase 3 placebo-controlled trials for selonsertib and two phase 2b placebo-controlled trials for simtuzumab.

“While the studies were discontinued prematurely due to lack of efficacy, the prospectively collected data in these well-characterized participants with serial liver biopsies provides a unique opportunity to study the association between baseline LS by VCTE and disease progression,” the investigators wrote.

Across all four studies, bridging fibrosis (F3) was present in 664 participants, while 734 individuals had cirrhosis (F4). In the selonsertib studies, fibrosis was staged at baseline and week 48. The simtuzumab studies measured liver fibrosis at baseline and week 96. Out of the 664 participants with bridging fibrosis, 103 (16%) progressed to cirrhosis. Among the 734 patients with cirrhosis, 27 (4%) experienced liver-related events. Comparing these outcomes with LS data at baseline and throughout the study revealed optimal LS thresholds.

The best threshold for predicting progression from bridging fibrosis to cirrhosis was 16.6 kPa. According to the authors, the sensitivity, specificity, positive predictive value, and negative predictive value of this threshold for progression to cirrhosis were 58%, 76%, 31%, and 91%, respectively. Among patients at or above 16.6 kPa, 31% progressed to cirrhosis, compared with 9.1% of those under that threshold. Furthermore, individuals with a baseline LS at or above 16.6 kPa had nearly four times greater risk of developing cirrhosis (adjusted hazard ratio, 3.99; 95% CI, 2.66­-5.98; P < .0001).

For patients with cirrhosis at baseline, the optimal threshold for predicting liver-related events, such as ascites, hepatic encephalopathy, and portal hypertension–related GI bleeding, liver transplantation, or mortality, was 30.7 kPa. The sensitivity, specificity, PPV, and NPV of this threshold for liver-related events were 62%, 87%, 10%, and 99%, respectively, according to the authors. Patients with an LS above this mark were 10 times as likely to experience liver-related events (aHR, 10.13; 95% CI, 4.38-23.41; P < .0001).

Scott L. Friedman, MD, chief of the division of liver diseases and dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, New York, called the study “an important effort” that offers valuable insights for both researchers and practitioners.

“For clinical trials, [these thresholds] really allow for greater refinement or enrichment of patients who are suitable for enrollment in the trial because they’re at a higher risk of clinical problems that might be mitigated if the drug is effective,” Dr. Friedman said in an interview. “For clinical practice, it might indicate that the patient should either be fast tracked for a clinical trial or, more importantly, maybe needs to be referred for evaluation for a liver transplant. It may also indicate – although they didn’t look at it in this study – that there’s a need to begin or accelerate screening for liver cancer, which becomes an encroaching risk as the fibrosis advances to later stages.”

The study was funded by Gilead Sciences. The investigators disclosed additional relationships with Amgen, Eli Lilly, CohBar, and others. Dr. Friedman reported no relevant conflicts of interest.

New liver stiffness (LS) thresholds offer accurate prediction of disease progression and clinical outcomes in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis, according to investigators.

These new LS thresholds are more reliable because they are based on high-quality prospective data drawn from four randomized controlled trials, reported lead author Rohit Loomba, MD, of the University of California, San Diego, and colleagues.

“Retrospective studies report that increasing baseline LS by VCTE [vibration-controlled transient elastography] is associated with the risk of disease progression in patients with NAFLD [non-alcoholic fatty liver disease], but prospective data in well-characterized NASH cohorts with biopsy-confirmed advanced fibrosis are limited,” the investigators wrote in Gut. “The optimal LS thresholds for prognostication of fibrosis progression and decompensation are unknown.”

Seeking clarity, Dr. Loomba and colleagues leveraged data from two phase 3 placebo-controlled trials for selonsertib and two phase 2b placebo-controlled trials for simtuzumab.

“While the studies were discontinued prematurely due to lack of efficacy, the prospectively collected data in these well-characterized participants with serial liver biopsies provides a unique opportunity to study the association between baseline LS by VCTE and disease progression,” the investigators wrote.

Across all four studies, bridging fibrosis (F3) was present in 664 participants, while 734 individuals had cirrhosis (F4). In the selonsertib studies, fibrosis was staged at baseline and week 48. The simtuzumab studies measured liver fibrosis at baseline and week 96. Out of the 664 participants with bridging fibrosis, 103 (16%) progressed to cirrhosis. Among the 734 patients with cirrhosis, 27 (4%) experienced liver-related events. Comparing these outcomes with LS data at baseline and throughout the study revealed optimal LS thresholds.

The best threshold for predicting progression from bridging fibrosis to cirrhosis was 16.6 kPa. According to the authors, the sensitivity, specificity, positive predictive value, and negative predictive value of this threshold for progression to cirrhosis were 58%, 76%, 31%, and 91%, respectively. Among patients at or above 16.6 kPa, 31% progressed to cirrhosis, compared with 9.1% of those under that threshold. Furthermore, individuals with a baseline LS at or above 16.6 kPa had nearly four times greater risk of developing cirrhosis (adjusted hazard ratio, 3.99; 95% CI, 2.66­-5.98; P < .0001).

For patients with cirrhosis at baseline, the optimal threshold for predicting liver-related events, such as ascites, hepatic encephalopathy, and portal hypertension–related GI bleeding, liver transplantation, or mortality, was 30.7 kPa. The sensitivity, specificity, PPV, and NPV of this threshold for liver-related events were 62%, 87%, 10%, and 99%, respectively, according to the authors. Patients with an LS above this mark were 10 times as likely to experience liver-related events (aHR, 10.13; 95% CI, 4.38-23.41; P < .0001).

Scott L. Friedman, MD, chief of the division of liver diseases and dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, New York, called the study “an important effort” that offers valuable insights for both researchers and practitioners.

“For clinical trials, [these thresholds] really allow for greater refinement or enrichment of patients who are suitable for enrollment in the trial because they’re at a higher risk of clinical problems that might be mitigated if the drug is effective,” Dr. Friedman said in an interview. “For clinical practice, it might indicate that the patient should either be fast tracked for a clinical trial or, more importantly, maybe needs to be referred for evaluation for a liver transplant. It may also indicate – although they didn’t look at it in this study – that there’s a need to begin or accelerate screening for liver cancer, which becomes an encroaching risk as the fibrosis advances to later stages.”

The study was funded by Gilead Sciences. The investigators disclosed additional relationships with Amgen, Eli Lilly, CohBar, and others. Dr. Friedman reported no relevant conflicts of interest.

Moving recycling bins and providing education to staff led to a reduction in the carbon footprint at a Portuguese hospital’s endoscopy unit, according to a study published in Gut.

“Sustainable endoscopy regarding waste handling was achievable and sustained over time, did not compromise productivity, and may be cost-effective for stakeholders,” wrote João A Cunha Neves, MD, MMSc, of Algarve University Hospital Centre in Portimão, Portugal, and his colleagues.

Stephen Barnes/iStock/Getty Images

Although other work has shown that several of the strategies for reducing endoscopic waste are ‘easy wins,’ the authors noted that “lack of awareness by most endoscopy staff regarding the expenses and correct categorisation of endoscopic waste is the primary barrier to recycling in many endoscopy units.”

The four-stage prospective study took place at the Portimão endoscopy unit of Algarve University Hospital Centre in Portugal. It began with a 4-week audit that involved weighing regulated medical waste (“material fully contaminated with blood or body fluids or containing infectious agents”) and landfill waste (nonrecyclable material that isn’t fully contaminated). The researchers excluded from the analysis all waste from sharps containers, pre- and postprocedure activities, and endoscope reprocessing.

The second stage was one week of medical, nursing, and auxiliary team education about handling waste, in part based on observations collected during the first stage. Each endoscopy generates an estimated 1.5 kg of plastic waste, but recycling bins often are not available for the 0.3 kg of waste that’s recyclable. During the second stage, recycling bins were placed in endoscopy rooms while regulated medical waste and landfill bins were moved elsewhere.

The final two stages involved weighing both types of waste 1 month after the training and then 4 months after the training. For their calculations, the researchers assumed that 1 kg of landfill waste equated to 1 kg of carbon dioxide and 1 kg of regulated medical waste equated to 3 kg of carbon dioxide.

At the third stage, mean total waste fell by 12.9%, albeit not statistically significantly (P = .16), while the 41.4% regulated medical waste reduction was significant (P = .01). Landfill waste had increased 12.3% and both paper (0 to 1.2 kg) and plastic (0 to 2.1 kg) recycling waste increased. Mean endoscopy load had not significantly changed (46.2 vs. 44.5). Overall carbon dioxide was reduced by 31.6%, from 109.7 kg of carbon dioxide to 74.9 kg (P = .018), equating to an annual decrease of 1,665.6 kg. At four months postintervention, these effects remained.

“In both assessment periods, total waste produced by diagnostic standard endoscopic procedures was similar, but both regulated medical waste and overall carbon footprint were reduced,” the authors reported.

In a four-question assessment of the intervention with staff, “the entire team agreed that the study did not interfere with the daily work routine and was helpful in raising awareness about waste sorting within the unit,” the authors reported. The staff “also acknowledged that recycling waste allowed for more sustainable activity within the endoscopy unit, and that the achievements of the study were to be maintained in the future.”
 

How feasible is change?

The authors noted that health care accounts for 4.4% of the world’s carbon footprint and that endoscopy is the third largest generator of hospital medical waste, primarily because of single-use consumables. However, 71% of that health care carbon footprint comes from supply chain issues, particularly transportation, John I. Allen, MD, MBA, a retired clinical professor of medicine at the University Michigan, Ann Arbor, said in an interview. “Facility emissions add 17% and heating/cooling add 12%,” he said. “So, the actual footprint of endoscopy is quite small.”

Reducing single-use equipment and disposables by a third is a small overall impact considering the “labor-intensive education and monitoring system,” said Dr. Allen, who was not involved in the study. “That said, this paper and numerous others remind us of small steps that we can take – mostly to raise awareness about new technologies and more sustainable processes that are available or should be studied – to help transition us from the current [terrible] state to a more climate-friendly style of practice and life.”

One of the study’s limitations was the lack of a cost-benefit or impact analysis, according to Dr. Allen. Climate policies claiming to have local impact can be problematic when they “ignore both externalities and the actual wider impact on gas or temperature mitigation,” he added.

But he noted that “many health care systems are already implementing new ways of working with temperature- and carbon-mitigation in mind,” such as his own institution’s pledge to become carbon-neutral within a year. One step on that path has included transitioning more than 30% of their clinic visits to virtual visits, “thus saving [literally] millions of miles in travel and altering our parking construction plans,” Dr. Allen said.

“Reduction in climate impact will come from new ways to manufacture endoscopes, less reliance on single-use equipment, and increasing use of materials that encourage recycling,” Dr. Allen said. “In order to achieve meaningful climate impact, we need research into what current regulations and processes are necessary to protect patients and staff from infection transmission while creating an environmentally favorable workflow.”
 

Where does making a difference begin?

Another limitation was simply the small size of the department itself, which limits how much impact the intervention can have, but the study also showed the feasibility of getting buy-in from a department to make meaningful changes, according to Bishr Omary, MD, PhD, professor of medicine at Rutgers University’s Robert Wood Johnson Medical School, Piscataway, N.J. He was not involved in the study.

“Culture is an important aspect of this, but that’s where education comes in,” Dr. Omary said in an interview. “Leadership has to try to encourage and incentivize different units, not just endoscopy, but other surgery, too. I think the most effective approach is going to be top-down, where hospitals and health systems buy into this.”

One challenge to that buy-in is that climate change has become political, said Linda Anh B. Nguyen, MD, clinical professor of medicine and vice chief of clinical operations in Stanford (Calif.) University’s division of gastroenterology and hepatology.

“There may be resistance to implementation by those who do not see the value of reducing waste,” Dr. Nguyen, who was not involved in this study, said in an interview. “Successful implementation requires a culture change and reducing the physical barriers to make waste reduction easier. Having an advocate for the program embedded within the endoscopy unit will help with implementation.”

One of the advantages of the intervention in this study, Dr. Nguyen said, was its relative ease of implementation.

“The next step would be identifying which of the items that go into landfill can be replaced with reusable products,” Dr. Nguyen added.

Dr. Omary pointed to Practice Greenhealth as an example of an organization working toward the goal of climate change mitigation through a wide range of initiatives, including ones he has written about. The responsibility for reducing carbon footprints should be shared among individuals, institutions, and systems, Dr. Omary said, adding that individuals’ travel, such as to medical meetings, is a major contributor to greenhouse gas emissions.

A forthcoming publication from the four major gastroenterology medical organizations will outline additional ways gastroenterology can address climate change mitigation, Dr. Omary noted.

Dr. Nguyen said that gastroenterologists, as well as the entire health care industry, have a responsibility to combat climate change through waste reduction and that it can be done without sacrificing individual patient safety.

“Climate change must be at the forefront of our priorities for present and future generations,” Dr. Nguyen said. “We need to leave this world better than when we entered.”

But much of that change must especially occur at levels far higher than individual physicians or institutions, Dr. Allen said.

“Major responsibility for altering gastroenterology practices in order to mitigate climate change must originate in regulatory agencies and the manufacturers of our equipment,” Dr. Allen said. “Regulations must be based on demonstrated positive impact that is cost-effective for practices and health care systems.”

The research did not use external funding, and the authors reported no financial disclosures or conflicts of interests. Dr. Allen has consulted for Topography Health, OSHI Health, and Lynxmd. Dr. Nguyen has consulted for Alnylam, Ardelyx, Eli Lilly, Evoke Pharma, Ironwood, Pendulum, Phathom, Neurogastx, Sanofi, and Takeda; has served on the advisory board of Gemelli Biotech; and has received grants from Bold Health and Vanda. Dr. Omary had no disclosures.

Moving recycling bins and providing education to staff led to a reduction in the carbon footprint at a Portuguese hospital’s endoscopy unit, according to a study published in Gut.

“Sustainable endoscopy regarding waste handling was achievable and sustained over time, did not compromise productivity, and may be cost-effective for stakeholders,” wrote João A Cunha Neves, MD, MMSc, of Algarve University Hospital Centre in Portimão, Portugal, and his colleagues.

Stephen Barnes/iStock/Getty Images

Although other work has shown that several of the strategies for reducing endoscopic waste are ‘easy wins,’ the authors noted that “lack of awareness by most endoscopy staff regarding the expenses and correct categorisation of endoscopic waste is the primary barrier to recycling in many endoscopy units.”

The four-stage prospective study took place at the Portimão endoscopy unit of Algarve University Hospital Centre in Portugal. It began with a 4-week audit that involved weighing regulated medical waste (“material fully contaminated with blood or body fluids or containing infectious agents”) and landfill waste (nonrecyclable material that isn’t fully contaminated). The researchers excluded from the analysis all waste from sharps containers, pre- and postprocedure activities, and endoscope reprocessing.

The second stage was one week of medical, nursing, and auxiliary team education about handling waste, in part based on observations collected during the first stage. Each endoscopy generates an estimated 1.5 kg of plastic waste, but recycling bins often are not available for the 0.3 kg of waste that’s recyclable. During the second stage, recycling bins were placed in endoscopy rooms while regulated medical waste and landfill bins were moved elsewhere.

The final two stages involved weighing both types of waste 1 month after the training and then 4 months after the training. For their calculations, the researchers assumed that 1 kg of landfill waste equated to 1 kg of carbon dioxide and 1 kg of regulated medical waste equated to 3 kg of carbon dioxide.

At the third stage, mean total waste fell by 12.9%, albeit not statistically significantly (P = .16), while the 41.4% regulated medical waste reduction was significant (P = .01). Landfill waste had increased 12.3% and both paper (0 to 1.2 kg) and plastic (0 to 2.1 kg) recycling waste increased. Mean endoscopy load had not significantly changed (46.2 vs. 44.5). Overall carbon dioxide was reduced by 31.6%, from 109.7 kg of carbon dioxide to 74.9 kg (P = .018), equating to an annual decrease of 1,665.6 kg. At four months postintervention, these effects remained.

“In both assessment periods, total waste produced by diagnostic standard endoscopic procedures was similar, but both regulated medical waste and overall carbon footprint were reduced,” the authors reported.

In a four-question assessment of the intervention with staff, “the entire team agreed that the study did not interfere with the daily work routine and was helpful in raising awareness about waste sorting within the unit,” the authors reported. The staff “also acknowledged that recycling waste allowed for more sustainable activity within the endoscopy unit, and that the achievements of the study were to be maintained in the future.”
 

How feasible is change?

The authors noted that health care accounts for 4.4% of the world’s carbon footprint and that endoscopy is the third largest generator of hospital medical waste, primarily because of single-use consumables. However, 71% of that health care carbon footprint comes from supply chain issues, particularly transportation, John I. Allen, MD, MBA, a retired clinical professor of medicine at the University Michigan, Ann Arbor, said in an interview. “Facility emissions add 17% and heating/cooling add 12%,” he said. “So, the actual footprint of endoscopy is quite small.”

Reducing single-use equipment and disposables by a third is a small overall impact considering the “labor-intensive education and monitoring system,” said Dr. Allen, who was not involved in the study. “That said, this paper and numerous others remind us of small steps that we can take – mostly to raise awareness about new technologies and more sustainable processes that are available or should be studied – to help transition us from the current [terrible] state to a more climate-friendly style of practice and life.”

One of the study’s limitations was the lack of a cost-benefit or impact analysis, according to Dr. Allen. Climate policies claiming to have local impact can be problematic when they “ignore both externalities and the actual wider impact on gas or temperature mitigation,” he added.

But he noted that “many health care systems are already implementing new ways of working with temperature- and carbon-mitigation in mind,” such as his own institution’s pledge to become carbon-neutral within a year. One step on that path has included transitioning more than 30% of their clinic visits to virtual visits, “thus saving [literally] millions of miles in travel and altering our parking construction plans,” Dr. Allen said.

“Reduction in climate impact will come from new ways to manufacture endoscopes, less reliance on single-use equipment, and increasing use of materials that encourage recycling,” Dr. Allen said. “In order to achieve meaningful climate impact, we need research into what current regulations and processes are necessary to protect patients and staff from infection transmission while creating an environmentally favorable workflow.”
 

Where does making a difference begin?

Another limitation was simply the small size of the department itself, which limits how much impact the intervention can have, but the study also showed the feasibility of getting buy-in from a department to make meaningful changes, according to Bishr Omary, MD, PhD, professor of medicine at Rutgers University’s Robert Wood Johnson Medical School, Piscataway, N.J. He was not involved in the study.

“Culture is an important aspect of this, but that’s where education comes in,” Dr. Omary said in an interview. “Leadership has to try to encourage and incentivize different units, not just endoscopy, but other surgery, too. I think the most effective approach is going to be top-down, where hospitals and health systems buy into this.”

One challenge to that buy-in is that climate change has become political, said Linda Anh B. Nguyen, MD, clinical professor of medicine and vice chief of clinical operations in Stanford (Calif.) University’s division of gastroenterology and hepatology.

“There may be resistance to implementation by those who do not see the value of reducing waste,” Dr. Nguyen, who was not involved in this study, said in an interview. “Successful implementation requires a culture change and reducing the physical barriers to make waste reduction easier. Having an advocate for the program embedded within the endoscopy unit will help with implementation.”

One of the advantages of the intervention in this study, Dr. Nguyen said, was its relative ease of implementation.

“The next step would be identifying which of the items that go into landfill can be replaced with reusable products,” Dr. Nguyen added.

Dr. Omary pointed to Practice Greenhealth as an example of an organization working toward the goal of climate change mitigation through a wide range of initiatives, including ones he has written about. The responsibility for reducing carbon footprints should be shared among individuals, institutions, and systems, Dr. Omary said, adding that individuals’ travel, such as to medical meetings, is a major contributor to greenhouse gas emissions.

A forthcoming publication from the four major gastroenterology medical organizations will outline additional ways gastroenterology can address climate change mitigation, Dr. Omary noted.

Dr. Nguyen said that gastroenterologists, as well as the entire health care industry, have a responsibility to combat climate change through waste reduction and that it can be done without sacrificing individual patient safety.

“Climate change must be at the forefront of our priorities for present and future generations,” Dr. Nguyen said. “We need to leave this world better than when we entered.”

But much of that change must especially occur at levels far higher than individual physicians or institutions, Dr. Allen said.

“Major responsibility for altering gastroenterology practices in order to mitigate climate change must originate in regulatory agencies and the manufacturers of our equipment,” Dr. Allen said. “Regulations must be based on demonstrated positive impact that is cost-effective for practices and health care systems.”

The research did not use external funding, and the authors reported no financial disclosures or conflicts of interests. Dr. Allen has consulted for Topography Health, OSHI Health, and Lynxmd. Dr. Nguyen has consulted for Alnylam, Ardelyx, Eli Lilly, Evoke Pharma, Ironwood, Pendulum, Phathom, Neurogastx, Sanofi, and Takeda; has served on the advisory board of Gemelli Biotech; and has received grants from Bold Health and Vanda. Dr. Omary had no disclosures.

Moving recycling bins and providing education to staff led to a reduction in the carbon footprint at a Portuguese hospital’s endoscopy unit, according to a study published in Gut.

“Sustainable endoscopy regarding waste handling was achievable and sustained over time, did not compromise productivity, and may be cost-effective for stakeholders,” wrote João A Cunha Neves, MD, MMSc, of Algarve University Hospital Centre in Portimão, Portugal, and his colleagues.

Stephen Barnes/iStock/Getty Images

Although other work has shown that several of the strategies for reducing endoscopic waste are ‘easy wins,’ the authors noted that “lack of awareness by most endoscopy staff regarding the expenses and correct categorisation of endoscopic waste is the primary barrier to recycling in many endoscopy units.”

The four-stage prospective study took place at the Portimão endoscopy unit of Algarve University Hospital Centre in Portugal. It began with a 4-week audit that involved weighing regulated medical waste (“material fully contaminated with blood or body fluids or containing infectious agents”) and landfill waste (nonrecyclable material that isn’t fully contaminated). The researchers excluded from the analysis all waste from sharps containers, pre- and postprocedure activities, and endoscope reprocessing.

The second stage was one week of medical, nursing, and auxiliary team education about handling waste, in part based on observations collected during the first stage. Each endoscopy generates an estimated 1.5 kg of plastic waste, but recycling bins often are not available for the 0.3 kg of waste that’s recyclable. During the second stage, recycling bins were placed in endoscopy rooms while regulated medical waste and landfill bins were moved elsewhere.

The final two stages involved weighing both types of waste 1 month after the training and then 4 months after the training. For their calculations, the researchers assumed that 1 kg of landfill waste equated to 1 kg of carbon dioxide and 1 kg of regulated medical waste equated to 3 kg of carbon dioxide.

At the third stage, mean total waste fell by 12.9%, albeit not statistically significantly (P = .16), while the 41.4% regulated medical waste reduction was significant (P = .01). Landfill waste had increased 12.3% and both paper (0 to 1.2 kg) and plastic (0 to 2.1 kg) recycling waste increased. Mean endoscopy load had not significantly changed (46.2 vs. 44.5). Overall carbon dioxide was reduced by 31.6%, from 109.7 kg of carbon dioxide to 74.9 kg (P = .018), equating to an annual decrease of 1,665.6 kg. At four months postintervention, these effects remained.

“In both assessment periods, total waste produced by diagnostic standard endoscopic procedures was similar, but both regulated medical waste and overall carbon footprint were reduced,” the authors reported.

In a four-question assessment of the intervention with staff, “the entire team agreed that the study did not interfere with the daily work routine and was helpful in raising awareness about waste sorting within the unit,” the authors reported. The staff “also acknowledged that recycling waste allowed for more sustainable activity within the endoscopy unit, and that the achievements of the study were to be maintained in the future.”
 

How feasible is change?

The authors noted that health care accounts for 4.4% of the world’s carbon footprint and that endoscopy is the third largest generator of hospital medical waste, primarily because of single-use consumables. However, 71% of that health care carbon footprint comes from supply chain issues, particularly transportation, John I. Allen, MD, MBA, a retired clinical professor of medicine at the University Michigan, Ann Arbor, said in an interview. “Facility emissions add 17% and heating/cooling add 12%,” he said. “So, the actual footprint of endoscopy is quite small.”

Reducing single-use equipment and disposables by a third is a small overall impact considering the “labor-intensive education and monitoring system,” said Dr. Allen, who was not involved in the study. “That said, this paper and numerous others remind us of small steps that we can take – mostly to raise awareness about new technologies and more sustainable processes that are available or should be studied – to help transition us from the current [terrible] state to a more climate-friendly style of practice and life.”

One of the study’s limitations was the lack of a cost-benefit or impact analysis, according to Dr. Allen. Climate policies claiming to have local impact can be problematic when they “ignore both externalities and the actual wider impact on gas or temperature mitigation,” he added.

But he noted that “many health care systems are already implementing new ways of working with temperature- and carbon-mitigation in mind,” such as his own institution’s pledge to become carbon-neutral within a year. One step on that path has included transitioning more than 30% of their clinic visits to virtual visits, “thus saving [literally] millions of miles in travel and altering our parking construction plans,” Dr. Allen said.

“Reduction in climate impact will come from new ways to manufacture endoscopes, less reliance on single-use equipment, and increasing use of materials that encourage recycling,” Dr. Allen said. “In order to achieve meaningful climate impact, we need research into what current regulations and processes are necessary to protect patients and staff from infection transmission while creating an environmentally favorable workflow.”
 

Where does making a difference begin?

Another limitation was simply the small size of the department itself, which limits how much impact the intervention can have, but the study also showed the feasibility of getting buy-in from a department to make meaningful changes, according to Bishr Omary, MD, PhD, professor of medicine at Rutgers University’s Robert Wood Johnson Medical School, Piscataway, N.J. He was not involved in the study.

“Culture is an important aspect of this, but that’s where education comes in,” Dr. Omary said in an interview. “Leadership has to try to encourage and incentivize different units, not just endoscopy, but other surgery, too. I think the most effective approach is going to be top-down, where hospitals and health systems buy into this.”

One challenge to that buy-in is that climate change has become political, said Linda Anh B. Nguyen, MD, clinical professor of medicine and vice chief of clinical operations in Stanford (Calif.) University’s division of gastroenterology and hepatology.

“There may be resistance to implementation by those who do not see the value of reducing waste,” Dr. Nguyen, who was not involved in this study, said in an interview. “Successful implementation requires a culture change and reducing the physical barriers to make waste reduction easier. Having an advocate for the program embedded within the endoscopy unit will help with implementation.”

One of the advantages of the intervention in this study, Dr. Nguyen said, was its relative ease of implementation.

“The next step would be identifying which of the items that go into landfill can be replaced with reusable products,” Dr. Nguyen added.

Dr. Omary pointed to Practice Greenhealth as an example of an organization working toward the goal of climate change mitigation through a wide range of initiatives, including ones he has written about. The responsibility for reducing carbon footprints should be shared among individuals, institutions, and systems, Dr. Omary said, adding that individuals’ travel, such as to medical meetings, is a major contributor to greenhouse gas emissions.

A forthcoming publication from the four major gastroenterology medical organizations will outline additional ways gastroenterology can address climate change mitigation, Dr. Omary noted.

Dr. Nguyen said that gastroenterologists, as well as the entire health care industry, have a responsibility to combat climate change through waste reduction and that it can be done without sacrificing individual patient safety.

“Climate change must be at the forefront of our priorities for present and future generations,” Dr. Nguyen said. “We need to leave this world better than when we entered.”

But much of that change must especially occur at levels far higher than individual physicians or institutions, Dr. Allen said.

“Major responsibility for altering gastroenterology practices in order to mitigate climate change must originate in regulatory agencies and the manufacturers of our equipment,” Dr. Allen said. “Regulations must be based on demonstrated positive impact that is cost-effective for practices and health care systems.”

The research did not use external funding, and the authors reported no financial disclosures or conflicts of interests. Dr. Allen has consulted for Topography Health, OSHI Health, and Lynxmd. Dr. Nguyen has consulted for Alnylam, Ardelyx, Eli Lilly, Evoke Pharma, Ironwood, Pendulum, Phathom, Neurogastx, Sanofi, and Takeda; has served on the advisory board of Gemelli Biotech; and has received grants from Bold Health and Vanda. Dr. Omary had no disclosures.

There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

Since the first issue of GI & Hepatology News was published 15 years ago, the field of hepatology has undergone a tremendous transformation.

In the late 2000s, we witnessed revolutionary discoveries and advances in our understanding and management of chronic hepatitis C. Who knew that when IL-28B was first described in 2009, providing a genetic basis for patients’ response to interferon-based therapies, its impact would also be so swiftly supplanted by the introduction of direct acting antivirals a few years later? The pipeline for HCV treatment was feverish for several years, which resulted in a complete transformation of HCV treatment from a long, exhausting, side-effect filled course to a simple 8-to-12-week regimen. Furthermore, we now have established protocols for organ transplantation for patients without active HCV infection to receive HCV-positive organs due to the effectiveness of treatments for HCV. This kind of progress in our field demonstrates how awe-inspiring medical advances can be and how fortunate we are to have witnessed and lived this progress in such a short period of time.

Dr. Jou is associate professor of medicine, division of gastroenterology and hepatology, School of Medicine Fellowship program director, Medicine, Division of Gastroenterology and Hepatology, School of Medicine, Oregon Health and Science University, Portland. She reported no relevant financial conflicts of interest.

Since the first issue of GI & Hepatology News was published 15 years ago, the field of hepatology has undergone a tremendous transformation.

In the late 2000s, we witnessed revolutionary discoveries and advances in our understanding and management of chronic hepatitis C. Who knew that when IL-28B was first described in 2009, providing a genetic basis for patients’ response to interferon-based therapies, its impact would also be so swiftly supplanted by the introduction of direct acting antivirals a few years later? The pipeline for HCV treatment was feverish for several years, which resulted in a complete transformation of HCV treatment from a long, exhausting, side-effect filled course to a simple 8-to-12-week regimen. Furthermore, we now have established protocols for organ transplantation for patients without active HCV infection to receive HCV-positive organs due to the effectiveness of treatments for HCV. This kind of progress in our field demonstrates how awe-inspiring medical advances can be and how fortunate we are to have witnessed and lived this progress in such a short period of time.

Dr. Jou is associate professor of medicine, division of gastroenterology and hepatology, School of Medicine Fellowship program director, Medicine, Division of Gastroenterology and Hepatology, School of Medicine, Oregon Health and Science University, Portland. She reported no relevant financial conflicts of interest.

Since the first issue of GI & Hepatology News was published 15 years ago, the field of hepatology has undergone a tremendous transformation.

In the late 2000s, we witnessed revolutionary discoveries and advances in our understanding and management of chronic hepatitis C. Who knew that when IL-28B was first described in 2009, providing a genetic basis for patients’ response to interferon-based therapies, its impact would also be so swiftly supplanted by the introduction of direct acting antivirals a few years later? The pipeline for HCV treatment was feverish for several years, which resulted in a complete transformation of HCV treatment from a long, exhausting, side-effect filled course to a simple 8-to-12-week regimen. Furthermore, we now have established protocols for organ transplantation for patients without active HCV infection to receive HCV-positive organs due to the effectiveness of treatments for HCV. This kind of progress in our field demonstrates how awe-inspiring medical advances can be and how fortunate we are to have witnessed and lived this progress in such a short period of time.

Dr. Jou is associate professor of medicine, division of gastroenterology and hepatology, School of Medicine Fellowship program director, Medicine, Division of Gastroenterology and Hepatology, School of Medicine, Oregon Health and Science University, Portland. She reported no relevant financial conflicts of interest.

People are more likely to die of alcohol-associated liver disease (ALD) when there are fewer gastroenterologists in their state, researchers say.

The finding raises questions about steps that policymakers could take to increase the number of gastroenterologists and spread them more evenly around the United States.

“We found that there’s a fivefold difference in density of gastroenterologists through different states,” said Brian P. Lee, MD, MAS, an assistant professor of clinical medicine at the University of Southern California, Los Angeles.

Dr. Lee and colleagues published their findings in Clinical Gastroenterology and Hepatology.

ALD is becoming more common, and it is killing more people. Research among veterans has linked visits to gastroenterologists to a lower risk for death from liver disease.

To see whether that correlation applies more broadly, Dr. Lee and colleagues compared multiple datasets. One from the U.S. Health Resources & Service Administration provided the number of gastroenterologists per 100,000 population. The other from the U.S. Centers for Disease Control and Prevention provided ALD-related deaths per 1,000,000 adults for each state and the District of Columbia.

The researchers adjusted for many variables that could affect the relationship between the availability of gastroenterologists and deaths related to ALD, including the age distribution of the population in each state, the gender balance, race and ethnicity, binge drinking, household income, obesity, and the proportion of rural residents.

They found that for every additional gastroenterologist, there is almost one fewer ALD-related death each year per 100,000 population (9.0 [95% confidence interval, 1.3-16.7] fewer ALD-related deaths per 1,000,000 population for each additional gastroenterologist per 100,000 population).

The strength of the association appeared to plateau when there were at least 7.5 gastroenterologists per 100,000 people.

From these findings, the researchers calculated that as many as 40% of deaths from ALD nationwide could be prevented by providing more gastroenterologists in the places where they are lacking.

The mean number of gastroenterologists per 100,000 people in the United States was 4.6, and the annual ALD-related death rate was 85.6 per 1,000,000 people.

The Atlantic states had the greatest concentration of gastroenterologists and the lowest ALD-related mortality, whereas the Mountain states had the lowest concentration of gastroenterologists and the highest ALD-related mortality.

The lowest mortality related to ALD was in New Jersey, Maryland, and Hawaii, with 52 per 1,000,000 people, and the highest was in Wyoming, with 289.
 

Study shines spotlight on general GI care

Access to liver transplants did not make a statistically significant difference in mortality from ALD.

“It makes you realize that transplant will only be accessible for really just a small fraction of the population who needs it,” Dr. Lee told this news organization.

General gastroenterologic care appears to make a bigger difference in saving patients’ lives. “Are they getting endoscopy for bleeding from varices?” Dr. Lee asked. “Are they getting appropriate antibiotics prescribed to prevent bacterial infection of ascites?”

The concentration of primary care physicians did not reduce mortality from ALD, and neither did the concentration of substance use, behavioral disorder, and mental health counselors.

Previous research has shown that substance abuse therapy is effective. But many people do not want to undertake it, or they face barriers of transportation, language, or insurance, said Dr. Lee.

“I have many patients whose insurance will provide them access to medical visits to me but will not to substance-use rehab, for example,” he said.

To see whether the effect was more generally due to the concentration of medical specialists, the researchers examined the state-level density of ophthalmologists and dermatologists. They found no significant difference in ALD-related mortality.

The finding builds on reports by the American Gastroenterological Association and the American Association for the Study of Liver Diseases that the number of gastroenterologists has not kept up with the U.S. population nor the burden of digestive diseases, and that predicts a critical shortage in the future.
 

Overcoming barriers to care for liver disease

The overall supply of gastroenterologists could be increased by reducing the educational requirements and increasing the funding for fellowships, said Dr. Lee.

“We have to have a better understanding as to the barriers to gastroenterology practice in certain areas, then interventions to address those barriers and also incentives to attract gastroenterologists to those areas,” Dr. Lee said.

The study underscores the importance of access to gastroenterological care, said George Cholankeril, MD, assistant professor of medicine at Baylor College of Medicine, Houston, who was not involved in the study. That urgency has only grown as ALD has spiraled up with the COVID-19 pandemic, he said.

“Anyone in clinical practice right now will be able to say that there’s been a clear rising tide of patients with alcohol-related liver disease,” he told this news organization. “There’s an urgent need to address this and provide the necessary resources.”

Prevention remains essential, Dr. Cholankeril said.

Gastroenterologists and primary care physicians can help stem the tide of ALD by screening their patients for the disease through a tool like AUDIT (Alcohol Use Disorders Identification Test), he said. They can then refer patients to substance abuse treatment centers or to psychologists and psychiatrists.

Dr. Lee and Dr. Cholankeril report no relevant financial relationships.

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

People are more likely to die of alcohol-associated liver disease (ALD) when there are fewer gastroenterologists in their state, researchers say.

The finding raises questions about steps that policymakers could take to increase the number of gastroenterologists and spread them more evenly around the United States.

“We found that there’s a fivefold difference in density of gastroenterologists through different states,” said Brian P. Lee, MD, MAS, an assistant professor of clinical medicine at the University of Southern California, Los Angeles.

Dr. Lee and colleagues published their findings in Clinical Gastroenterology and Hepatology.

ALD is becoming more common, and it is killing more people. Research among veterans has linked visits to gastroenterologists to a lower risk for death from liver disease.

To see whether that correlation applies more broadly, Dr. Lee and colleagues compared multiple datasets. One from the U.S. Health Resources & Service Administration provided the number of gastroenterologists per 100,000 population. The other from the U.S. Centers for Disease Control and Prevention provided ALD-related deaths per 1,000,000 adults for each state and the District of Columbia.

The researchers adjusted for many variables that could affect the relationship between the availability of gastroenterologists and deaths related to ALD, including the age distribution of the population in each state, the gender balance, race and ethnicity, binge drinking, household income, obesity, and the proportion of rural residents.

They found that for every additional gastroenterologist, there is almost one fewer ALD-related death each year per 100,000 population (9.0 [95% confidence interval, 1.3-16.7] fewer ALD-related deaths per 1,000,000 population for each additional gastroenterologist per 100,000 population).

The strength of the association appeared to plateau when there were at least 7.5 gastroenterologists per 100,000 people.

From these findings, the researchers calculated that as many as 40% of deaths from ALD nationwide could be prevented by providing more gastroenterologists in the places where they are lacking.

The mean number of gastroenterologists per 100,000 people in the United States was 4.6, and the annual ALD-related death rate was 85.6 per 1,000,000 people.

The Atlantic states had the greatest concentration of gastroenterologists and the lowest ALD-related mortality, whereas the Mountain states had the lowest concentration of gastroenterologists and the highest ALD-related mortality.

The lowest mortality related to ALD was in New Jersey, Maryland, and Hawaii, with 52 per 1,000,000 people, and the highest was in Wyoming, with 289.
 

Study shines spotlight on general GI care

Access to liver transplants did not make a statistically significant difference in mortality from ALD.

“It makes you realize that transplant will only be accessible for really just a small fraction of the population who needs it,” Dr. Lee told this news organization.

General gastroenterologic care appears to make a bigger difference in saving patients’ lives. “Are they getting endoscopy for bleeding from varices?” Dr. Lee asked. “Are they getting appropriate antibiotics prescribed to prevent bacterial infection of ascites?”

The concentration of primary care physicians did not reduce mortality from ALD, and neither did the concentration of substance use, behavioral disorder, and mental health counselors.

Previous research has shown that substance abuse therapy is effective. But many people do not want to undertake it, or they face barriers of transportation, language, or insurance, said Dr. Lee.

“I have many patients whose insurance will provide them access to medical visits to me but will not to substance-use rehab, for example,” he said.

To see whether the effect was more generally due to the concentration of medical specialists, the researchers examined the state-level density of ophthalmologists and dermatologists. They found no significant difference in ALD-related mortality.

The finding builds on reports by the American Gastroenterological Association and the American Association for the Study of Liver Diseases that the number of gastroenterologists has not kept up with the U.S. population nor the burden of digestive diseases, and that predicts a critical shortage in the future.
 

Overcoming barriers to care for liver disease

The overall supply of gastroenterologists could be increased by reducing the educational requirements and increasing the funding for fellowships, said Dr. Lee.

“We have to have a better understanding as to the barriers to gastroenterology practice in certain areas, then interventions to address those barriers and also incentives to attract gastroenterologists to those areas,” Dr. Lee said.

The study underscores the importance of access to gastroenterological care, said George Cholankeril, MD, assistant professor of medicine at Baylor College of Medicine, Houston, who was not involved in the study. That urgency has only grown as ALD has spiraled up with the COVID-19 pandemic, he said.

“Anyone in clinical practice right now will be able to say that there’s been a clear rising tide of patients with alcohol-related liver disease,” he told this news organization. “There’s an urgent need to address this and provide the necessary resources.”

Prevention remains essential, Dr. Cholankeril said.

Gastroenterologists and primary care physicians can help stem the tide of ALD by screening their patients for the disease through a tool like AUDIT (Alcohol Use Disorders Identification Test), he said. They can then refer patients to substance abuse treatment centers or to psychologists and psychiatrists.

Dr. Lee and Dr. Cholankeril report no relevant financial relationships.

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

People are more likely to die of alcohol-associated liver disease (ALD) when there are fewer gastroenterologists in their state, researchers say.

The finding raises questions about steps that policymakers could take to increase the number of gastroenterologists and spread them more evenly around the United States.

“We found that there’s a fivefold difference in density of gastroenterologists through different states,” said Brian P. Lee, MD, MAS, an assistant professor of clinical medicine at the University of Southern California, Los Angeles.

Dr. Lee and colleagues published their findings in Clinical Gastroenterology and Hepatology.

ALD is becoming more common, and it is killing more people. Research among veterans has linked visits to gastroenterologists to a lower risk for death from liver disease.

To see whether that correlation applies more broadly, Dr. Lee and colleagues compared multiple datasets. One from the U.S. Health Resources & Service Administration provided the number of gastroenterologists per 100,000 population. The other from the U.S. Centers for Disease Control and Prevention provided ALD-related deaths per 1,000,000 adults for each state and the District of Columbia.

The researchers adjusted for many variables that could affect the relationship between the availability of gastroenterologists and deaths related to ALD, including the age distribution of the population in each state, the gender balance, race and ethnicity, binge drinking, household income, obesity, and the proportion of rural residents.

They found that for every additional gastroenterologist, there is almost one fewer ALD-related death each year per 100,000 population (9.0 [95% confidence interval, 1.3-16.7] fewer ALD-related deaths per 1,000,000 population for each additional gastroenterologist per 100,000 population).

The strength of the association appeared to plateau when there were at least 7.5 gastroenterologists per 100,000 people.

From these findings, the researchers calculated that as many as 40% of deaths from ALD nationwide could be prevented by providing more gastroenterologists in the places where they are lacking.

The mean number of gastroenterologists per 100,000 people in the United States was 4.6, and the annual ALD-related death rate was 85.6 per 1,000,000 people.

The Atlantic states had the greatest concentration of gastroenterologists and the lowest ALD-related mortality, whereas the Mountain states had the lowest concentration of gastroenterologists and the highest ALD-related mortality.

The lowest mortality related to ALD was in New Jersey, Maryland, and Hawaii, with 52 per 1,000,000 people, and the highest was in Wyoming, with 289.
 

Study shines spotlight on general GI care

Access to liver transplants did not make a statistically significant difference in mortality from ALD.

“It makes you realize that transplant will only be accessible for really just a small fraction of the population who needs it,” Dr. Lee told this news organization.

General gastroenterologic care appears to make a bigger difference in saving patients’ lives. “Are they getting endoscopy for bleeding from varices?” Dr. Lee asked. “Are they getting appropriate antibiotics prescribed to prevent bacterial infection of ascites?”

The concentration of primary care physicians did not reduce mortality from ALD, and neither did the concentration of substance use, behavioral disorder, and mental health counselors.

Previous research has shown that substance abuse therapy is effective. But many people do not want to undertake it, or they face barriers of transportation, language, or insurance, said Dr. Lee.

“I have many patients whose insurance will provide them access to medical visits to me but will not to substance-use rehab, for example,” he said.

To see whether the effect was more generally due to the concentration of medical specialists, the researchers examined the state-level density of ophthalmologists and dermatologists. They found no significant difference in ALD-related mortality.

The finding builds on reports by the American Gastroenterological Association and the American Association for the Study of Liver Diseases that the number of gastroenterologists has not kept up with the U.S. population nor the burden of digestive diseases, and that predicts a critical shortage in the future.
 

Overcoming barriers to care for liver disease

The overall supply of gastroenterologists could be increased by reducing the educational requirements and increasing the funding for fellowships, said Dr. Lee.

“We have to have a better understanding as to the barriers to gastroenterology practice in certain areas, then interventions to address those barriers and also incentives to attract gastroenterologists to those areas,” Dr. Lee said.

The study underscores the importance of access to gastroenterological care, said George Cholankeril, MD, assistant professor of medicine at Baylor College of Medicine, Houston, who was not involved in the study. That urgency has only grown as ALD has spiraled up with the COVID-19 pandemic, he said.

“Anyone in clinical practice right now will be able to say that there’s been a clear rising tide of patients with alcohol-related liver disease,” he told this news organization. “There’s an urgent need to address this and provide the necessary resources.”

Prevention remains essential, Dr. Cholankeril said.

Gastroenterologists and primary care physicians can help stem the tide of ALD by screening their patients for the disease through a tool like AUDIT (Alcohol Use Disorders Identification Test), he said. They can then refer patients to substance abuse treatment centers or to psychologists and psychiatrists.

Dr. Lee and Dr. Cholankeril report no relevant financial relationships.

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

Rare gene variants are associated with a reduced risk for multiple types of liver disease, including cirrhosis, researchers say.

People with certain variants in the gene CIDEB are one-third less likely to develop any sort of liver disease, according to Aris Baras, MD, a senior vice president at Regeneron, and colleagues.

“The unprecedented protective effect that these CIDEB genetic variants have against liver disease provides us with one of our most exciting targets and potential therapeutic approaches for a notoriously hard-to-treat disease where there are currently no approved treatments,” said Dr. Baras in a press release.

Dr. Baras and colleagues published the finding in The New England Journal of Medicine.

The finding follows on a similar discovery about a common variant in the gene HSD17B13. Treatments targeting this gene are being tested in clinical trials.

To search for more such genes, the researchers analyzed human exomes – the part of the genome that codes for proteins – to look for associations between gene variants and liver function.

The researchers used exome sequencing on 542,904 people from the UK Biobank, the Geisinger Health System MyCode cohort, and other datasets.

They found that coding variants in APOB, ABCB4, SLC30A10, and TM6SF2 were associated with increased aminotransferase levels and an increased risk for liver disease.

But variants in CIDEB were associated with decreased levels of alanine aminotransferase, a biomarker of hepatocellular injury. And they were associated with a decreased risk for liver disease of any cause (odds ratio per allele, 0.67; 95% confidence interval, 0.57-0.79).

The CIDEB variants were present in only 0.7% of the persons in the study.

Zeroing in on various kinds of liver disease, the researchers found that the CIDEB variants were associated with a reduced risk for alcoholic liver disease, nonalcoholic liver disease, any liver cirrhosis, alcoholic liver cirrhosis, nonalcoholic liver cirrhosis, and viral hepatitis.

In 3,599 patients who had undergone bariatric surgery, variants in CIDEB were associated with a reduced nonalcoholic fatty liver disease activity score of –0.98 beta per allele in score units, where scores range from 0-8, with a higher score indicating more severe disease.

In patients for whom MRI data were available, those with rare coding variants in CIDEB had lower proportions of liver fat. However, percentage of liver fat did not fully explain the reduced risk for liver disease.

Pursuing another line of investigation, the researchers found that they could prevent the buildup of large lipid droplets in oleic acid-treated human hepatoma cell lines by silencing the CIDEB gene using small interfering RNA.

The association was particularly strong among people with higher body mass indices and type 2 diabetes.

The associations with the rare protective CIDEB variants were consistent across ancestries, but people of non-European ancestry, who might be disproportionately affected by liver disease, were underrepresented in the database, the researchers note.

The study was supported by Regeneron Pharmaceuticals, which also employed several of the researchers.

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

Rare gene variants are associated with a reduced risk for multiple types of liver disease, including cirrhosis, researchers say.

People with certain variants in the gene CIDEB are one-third less likely to develop any sort of liver disease, according to Aris Baras, MD, a senior vice president at Regeneron, and colleagues.

“The unprecedented protective effect that these CIDEB genetic variants have against liver disease provides us with one of our most exciting targets and potential therapeutic approaches for a notoriously hard-to-treat disease where there are currently no approved treatments,” said Dr. Baras in a press release.

Dr. Baras and colleagues published the finding in The New England Journal of Medicine.

The finding follows on a similar discovery about a common variant in the gene HSD17B13. Treatments targeting this gene are being tested in clinical trials.

To search for more such genes, the researchers analyzed human exomes – the part of the genome that codes for proteins – to look for associations between gene variants and liver function.

The researchers used exome sequencing on 542,904 people from the UK Biobank, the Geisinger Health System MyCode cohort, and other datasets.

They found that coding variants in APOB, ABCB4, SLC30A10, and TM6SF2 were associated with increased aminotransferase levels and an increased risk for liver disease.

But variants in CIDEB were associated with decreased levels of alanine aminotransferase, a biomarker of hepatocellular injury. And they were associated with a decreased risk for liver disease of any cause (odds ratio per allele, 0.67; 95% confidence interval, 0.57-0.79).

The CIDEB variants were present in only 0.7% of the persons in the study.

Zeroing in on various kinds of liver disease, the researchers found that the CIDEB variants were associated with a reduced risk for alcoholic liver disease, nonalcoholic liver disease, any liver cirrhosis, alcoholic liver cirrhosis, nonalcoholic liver cirrhosis, and viral hepatitis.

In 3,599 patients who had undergone bariatric surgery, variants in CIDEB were associated with a reduced nonalcoholic fatty liver disease activity score of –0.98 beta per allele in score units, where scores range from 0-8, with a higher score indicating more severe disease.

In patients for whom MRI data were available, those with rare coding variants in CIDEB had lower proportions of liver fat. However, percentage of liver fat did not fully explain the reduced risk for liver disease.

Pursuing another line of investigation, the researchers found that they could prevent the buildup of large lipid droplets in oleic acid-treated human hepatoma cell lines by silencing the CIDEB gene using small interfering RNA.

The association was particularly strong among people with higher body mass indices and type 2 diabetes.

The associations with the rare protective CIDEB variants were consistent across ancestries, but people of non-European ancestry, who might be disproportionately affected by liver disease, were underrepresented in the database, the researchers note.

The study was supported by Regeneron Pharmaceuticals, which also employed several of the researchers.

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

Rare gene variants are associated with a reduced risk for multiple types of liver disease, including cirrhosis, researchers say.

People with certain variants in the gene CIDEB are one-third less likely to develop any sort of liver disease, according to Aris Baras, MD, a senior vice president at Regeneron, and colleagues.

“The unprecedented protective effect that these CIDEB genetic variants have against liver disease provides us with one of our most exciting targets and potential therapeutic approaches for a notoriously hard-to-treat disease where there are currently no approved treatments,” said Dr. Baras in a press release.

Dr. Baras and colleagues published the finding in The New England Journal of Medicine.

The finding follows on a similar discovery about a common variant in the gene HSD17B13. Treatments targeting this gene are being tested in clinical trials.

To search for more such genes, the researchers analyzed human exomes – the part of the genome that codes for proteins – to look for associations between gene variants and liver function.

The researchers used exome sequencing on 542,904 people from the UK Biobank, the Geisinger Health System MyCode cohort, and other datasets.

They found that coding variants in APOB, ABCB4, SLC30A10, and TM6SF2 were associated with increased aminotransferase levels and an increased risk for liver disease.

But variants in CIDEB were associated with decreased levels of alanine aminotransferase, a biomarker of hepatocellular injury. And they were associated with a decreased risk for liver disease of any cause (odds ratio per allele, 0.67; 95% confidence interval, 0.57-0.79).

The CIDEB variants were present in only 0.7% of the persons in the study.

Zeroing in on various kinds of liver disease, the researchers found that the CIDEB variants were associated with a reduced risk for alcoholic liver disease, nonalcoholic liver disease, any liver cirrhosis, alcoholic liver cirrhosis, nonalcoholic liver cirrhosis, and viral hepatitis.

In 3,599 patients who had undergone bariatric surgery, variants in CIDEB were associated with a reduced nonalcoholic fatty liver disease activity score of –0.98 beta per allele in score units, where scores range from 0-8, with a higher score indicating more severe disease.

In patients for whom MRI data were available, those with rare coding variants in CIDEB had lower proportions of liver fat. However, percentage of liver fat did not fully explain the reduced risk for liver disease.

Pursuing another line of investigation, the researchers found that they could prevent the buildup of large lipid droplets in oleic acid-treated human hepatoma cell lines by silencing the CIDEB gene using small interfering RNA.

The association was particularly strong among people with higher body mass indices and type 2 diabetes.

The associations with the rare protective CIDEB variants were consistent across ancestries, but people of non-European ancestry, who might be disproportionately affected by liver disease, were underrepresented in the database, the researchers note.

The study was supported by Regeneron Pharmaceuticals, which also employed several of the researchers.

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

Factors operating at the community level may help explain disparities in rates of hepatocellular carcinoma (HCC) across Texas.

Researchers found that the risk for HCC is higher in neighborhoods characterized by minority populations, socioeconomic disadvantage, and blue-collar workers from specific industries.

However, these relationships are not uniform across the state, report researchers from Baylor College of Medicine, Houston.

“HCC is a serious health concern in Texas, and our foundational work is a step forward to better prevent this deadly disease,” study investigator Hashem El-Serag, MD, PhD, said in a news release.

The study was published online in Clinical Gastroenterology and Hepatology.

HCC is the most common type of liver cancer in the United States, and Texas has the highest rate of HCC. Yet, within Texas, incidence rates vary by race, ethnicity, and geographic location.

The Baylor team examined these disparities at the neighborhood level, with a focus on measures of social determinants of health and the industries where most neighborhood residents work.

They identified 11,547 Texas residents diagnosed with HCC between 2011 and 2015, at a mean age of 63 years. Roughly three-quarters were men, and 44% were non-Hispanic White, 14% non-Hispanic Black, 37% Hispanic, and 5% other.

The researchers used demographics, socioeconomic status, and employment provided by the U.S. Census Bureau to characterize the neighborhoods where these people lived when they were diagnosed with HCC.

Among their key findings, the risk for HCC among African American and Hispanic residents was highest in West Texas, South Texas, and the panhandle. However, some factors, like age and socioeconomic status, were not affected by location.

Across the entire state, however, people older than 60 years and those of low socioeconomic status had a higher relative risk for HCC.

Two areas of employment – construction and service occupations – also stood out as being associated with a higher risk for HCC, whereas employment in agriculture was associated with lower risk.

The authors caution that the ecological nature of the study precludes any firm conclusions regarding a causal link between working in these industries and HCC.

“Further research, including longitudinal studies, [is] needed to clarify the roles of specific occupations in HCC risk,” corresponding author Abiodun Oluyomi, PhD, said in the news release.

“Our findings validate factors previously associated with HCC, and our geographic analysis shows areas of Texas where specific intervention strategies may be most relevant,” Dr. Oluyomi added.

This research was supported by the Cancer Prevention & Research Institute of Texas. The authors have no relevant disclosures.

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

Factors operating at the community level may help explain disparities in rates of hepatocellular carcinoma (HCC) across Texas.

Researchers found that the risk for HCC is higher in neighborhoods characterized by minority populations, socioeconomic disadvantage, and blue-collar workers from specific industries.

However, these relationships are not uniform across the state, report researchers from Baylor College of Medicine, Houston.

“HCC is a serious health concern in Texas, and our foundational work is a step forward to better prevent this deadly disease,” study investigator Hashem El-Serag, MD, PhD, said in a news release.

The study was published online in Clinical Gastroenterology and Hepatology.

HCC is the most common type of liver cancer in the United States, and Texas has the highest rate of HCC. Yet, within Texas, incidence rates vary by race, ethnicity, and geographic location.

The Baylor team examined these disparities at the neighborhood level, with a focus on measures of social determinants of health and the industries where most neighborhood residents work.

They identified 11,547 Texas residents diagnosed with HCC between 2011 and 2015, at a mean age of 63 years. Roughly three-quarters were men, and 44% were non-Hispanic White, 14% non-Hispanic Black, 37% Hispanic, and 5% other.

The researchers used demographics, socioeconomic status, and employment provided by the U.S. Census Bureau to characterize the neighborhoods where these people lived when they were diagnosed with HCC.

Among their key findings, the risk for HCC among African American and Hispanic residents was highest in West Texas, South Texas, and the panhandle. However, some factors, like age and socioeconomic status, were not affected by location.

Across the entire state, however, people older than 60 years and those of low socioeconomic status had a higher relative risk for HCC.

Two areas of employment – construction and service occupations – also stood out as being associated with a higher risk for HCC, whereas employment in agriculture was associated with lower risk.

The authors caution that the ecological nature of the study precludes any firm conclusions regarding a causal link between working in these industries and HCC.

“Further research, including longitudinal studies, [is] needed to clarify the roles of specific occupations in HCC risk,” corresponding author Abiodun Oluyomi, PhD, said in the news release.

“Our findings validate factors previously associated with HCC, and our geographic analysis shows areas of Texas where specific intervention strategies may be most relevant,” Dr. Oluyomi added.

This research was supported by the Cancer Prevention & Research Institute of Texas. The authors have no relevant disclosures.

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

Factors operating at the community level may help explain disparities in rates of hepatocellular carcinoma (HCC) across Texas.

Researchers found that the risk for HCC is higher in neighborhoods characterized by minority populations, socioeconomic disadvantage, and blue-collar workers from specific industries.

However, these relationships are not uniform across the state, report researchers from Baylor College of Medicine, Houston.

“HCC is a serious health concern in Texas, and our foundational work is a step forward to better prevent this deadly disease,” study investigator Hashem El-Serag, MD, PhD, said in a news release.

The study was published online in Clinical Gastroenterology and Hepatology.

HCC is the most common type of liver cancer in the United States, and Texas has the highest rate of HCC. Yet, within Texas, incidence rates vary by race, ethnicity, and geographic location.

The Baylor team examined these disparities at the neighborhood level, with a focus on measures of social determinants of health and the industries where most neighborhood residents work.

They identified 11,547 Texas residents diagnosed with HCC between 2011 and 2015, at a mean age of 63 years. Roughly three-quarters were men, and 44% were non-Hispanic White, 14% non-Hispanic Black, 37% Hispanic, and 5% other.

The researchers used demographics, socioeconomic status, and employment provided by the U.S. Census Bureau to characterize the neighborhoods where these people lived when they were diagnosed with HCC.

Among their key findings, the risk for HCC among African American and Hispanic residents was highest in West Texas, South Texas, and the panhandle. However, some factors, like age and socioeconomic status, were not affected by location.

Across the entire state, however, people older than 60 years and those of low socioeconomic status had a higher relative risk for HCC.

Two areas of employment – construction and service occupations – also stood out as being associated with a higher risk for HCC, whereas employment in agriculture was associated with lower risk.

The authors caution that the ecological nature of the study precludes any firm conclusions regarding a causal link between working in these industries and HCC.

“Further research, including longitudinal studies, [is] needed to clarify the roles of specific occupations in HCC risk,” corresponding author Abiodun Oluyomi, PhD, said in the news release.

“Our findings validate factors previously associated with HCC, and our geographic analysis shows areas of Texas where specific intervention strategies may be most relevant,” Dr. Oluyomi added.

This research was supported by the Cancer Prevention & Research Institute of Texas. The authors have no relevant disclosures.

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

A reduction in portal hepatic pressure gradient (PPG) soon after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) greater than 60% was associated with improved ascites control at 6 weeks in a study published in Hepatology.

“The probability of ascites resolution is much higher if PPG reduction exceeded 60% of PPG before TIPS,” wrote the researchers, led by co–first authors Alexander Queck, MD, a postdoctoral researcher in the department of internal medicine at University Hospital Frankfurt (Germany) and Goethe University Frankfurt, and Louise Schwierz, MD, of the department of internal medicine in the University Hospital Bonn (Germany). “This study suggests that, even in patients with uncomplicated TIPS insertion, a short-term follow-up 6 weeks after TIPS should be scheduled to be able to predict their course of disease.”

Alexander Raths/Fotolia

The authors investigated the decrease of PPG in a single-center, retrospective analysis of 341 patients with liver cirrhosis undergoing TIPS insertion for recurrent or refractory ascites between March 1994 and July 2015. During each procedure, portal and inferior vena cava pressures were invasively measured and correlated with patients’ outcomes and ascites progression over time. In 241 patients, or 71%, chronic alcohol consumption was the reason for cirrhosis development, followed by 13% with chronic viral hepatitis (n = 43). Median survival after TIPS insertion was 102 weeks, and 19 patients received liver transplants over time.

Median portal pressure before TIPS placement was 28 mm Hg, which decreased to a median of 21 mm Hg after TIPS. Median PPG levels were 19 mm Hg before TIPS and 8 mm Hg immediately after TIPS placement.

At the time of TIPS placement, 65 patients, or 19%, had hepatic encephalopathy, and nine had severe hepatic encephalopathy. Six weeks after TIPS, two had episodes of hepatic encephalopathy.

After 6 weeks, ascites significantly improved through TIPS insertion. About 47% had a complete resolution of ascites at 6 weeks, whereas 29% had ascites detectable only by ultrasound and 24% of patients still needed large-volume paracentesis. There was an association between extent of PPG reduction and ascites resolution: Median PPG reduction was 55% of initial PPG in patients with persistence of severe ascites, 58% in patients with ascites detected by ultrasound, and 65% in patients with complete resolution of ascites at 6 weeks after TIPS.

Ascites resolved in 54% of patients with higher PPG reduction (60% or above), compared with 39% of patients with lower PPG reduction (below 60%). Ascites that was detected by ultrasound in another 27% of patients with higher PPG reduction, compared with 31% of patients with lower PPG reduction. In addition, persistent severe ascites was seen in 19% of patients with higher PPG reduction, compared with 30% of patients with lower PPG reduction.

The authors also noted the importance of timing follow-up evaluation: They noted that post-TIPS follow-up is a frequent question and not yet standardized; in this study, they found that, with follow-up at 6 weeks, they could “clearly stratify the course post TIPS” and this could “detect patients at high risk of unstable course of disease.”

PPG reduction of more than 60% after TIPS correlated with resolution of severe ascites 6 weeks after TIPS, the study authors concluded.

A reduction in portal hepatic pressure gradient (PPG) soon after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) greater than 60% was associated with improved ascites control at 6 weeks in a study published in Hepatology.

“The probability of ascites resolution is much higher if PPG reduction exceeded 60% of PPG before TIPS,” wrote the researchers, led by co–first authors Alexander Queck, MD, a postdoctoral researcher in the department of internal medicine at University Hospital Frankfurt (Germany) and Goethe University Frankfurt, and Louise Schwierz, MD, of the department of internal medicine in the University Hospital Bonn (Germany). “This study suggests that, even in patients with uncomplicated TIPS insertion, a short-term follow-up 6 weeks after TIPS should be scheduled to be able to predict their course of disease.”

Alexander Raths/Fotolia

The authors investigated the decrease of PPG in a single-center, retrospective analysis of 341 patients with liver cirrhosis undergoing TIPS insertion for recurrent or refractory ascites between March 1994 and July 2015. During each procedure, portal and inferior vena cava pressures were invasively measured and correlated with patients’ outcomes and ascites progression over time. In 241 patients, or 71%, chronic alcohol consumption was the reason for cirrhosis development, followed by 13% with chronic viral hepatitis (n = 43). Median survival after TIPS insertion was 102 weeks, and 19 patients received liver transplants over time.

Median portal pressure before TIPS placement was 28 mm Hg, which decreased to a median of 21 mm Hg after TIPS. Median PPG levels were 19 mm Hg before TIPS and 8 mm Hg immediately after TIPS placement.

At the time of TIPS placement, 65 patients, or 19%, had hepatic encephalopathy, and nine had severe hepatic encephalopathy. Six weeks after TIPS, two had episodes of hepatic encephalopathy.

After 6 weeks, ascites significantly improved through TIPS insertion. About 47% had a complete resolution of ascites at 6 weeks, whereas 29% had ascites detectable only by ultrasound and 24% of patients still needed large-volume paracentesis. There was an association between extent of PPG reduction and ascites resolution: Median PPG reduction was 55% of initial PPG in patients with persistence of severe ascites, 58% in patients with ascites detected by ultrasound, and 65% in patients with complete resolution of ascites at 6 weeks after TIPS.

Ascites resolved in 54% of patients with higher PPG reduction (60% or above), compared with 39% of patients with lower PPG reduction (below 60%). Ascites that was detected by ultrasound in another 27% of patients with higher PPG reduction, compared with 31% of patients with lower PPG reduction. In addition, persistent severe ascites was seen in 19% of patients with higher PPG reduction, compared with 30% of patients with lower PPG reduction.

The authors also noted the importance of timing follow-up evaluation: They noted that post-TIPS follow-up is a frequent question and not yet standardized; in this study, they found that, with follow-up at 6 weeks, they could “clearly stratify the course post TIPS” and this could “detect patients at high risk of unstable course of disease.”

PPG reduction of more than 60% after TIPS correlated with resolution of severe ascites 6 weeks after TIPS, the study authors concluded.

A reduction in portal hepatic pressure gradient (PPG) soon after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) greater than 60% was associated with improved ascites control at 6 weeks in a study published in Hepatology.

“The probability of ascites resolution is much higher if PPG reduction exceeded 60% of PPG before TIPS,” wrote the researchers, led by co–first authors Alexander Queck, MD, a postdoctoral researcher in the department of internal medicine at University Hospital Frankfurt (Germany) and Goethe University Frankfurt, and Louise Schwierz, MD, of the department of internal medicine in the University Hospital Bonn (Germany). “This study suggests that, even in patients with uncomplicated TIPS insertion, a short-term follow-up 6 weeks after TIPS should be scheduled to be able to predict their course of disease.”

Alexander Raths/Fotolia

The authors investigated the decrease of PPG in a single-center, retrospective analysis of 341 patients with liver cirrhosis undergoing TIPS insertion for recurrent or refractory ascites between March 1994 and July 2015. During each procedure, portal and inferior vena cava pressures were invasively measured and correlated with patients’ outcomes and ascites progression over time. In 241 patients, or 71%, chronic alcohol consumption was the reason for cirrhosis development, followed by 13% with chronic viral hepatitis (n = 43). Median survival after TIPS insertion was 102 weeks, and 19 patients received liver transplants over time.

Median portal pressure before TIPS placement was 28 mm Hg, which decreased to a median of 21 mm Hg after TIPS. Median PPG levels were 19 mm Hg before TIPS and 8 mm Hg immediately after TIPS placement.

At the time of TIPS placement, 65 patients, or 19%, had hepatic encephalopathy, and nine had severe hepatic encephalopathy. Six weeks after TIPS, two had episodes of hepatic encephalopathy.

After 6 weeks, ascites significantly improved through TIPS insertion. About 47% had a complete resolution of ascites at 6 weeks, whereas 29% had ascites detectable only by ultrasound and 24% of patients still needed large-volume paracentesis. There was an association between extent of PPG reduction and ascites resolution: Median PPG reduction was 55% of initial PPG in patients with persistence of severe ascites, 58% in patients with ascites detected by ultrasound, and 65% in patients with complete resolution of ascites at 6 weeks after TIPS.

Ascites resolved in 54% of patients with higher PPG reduction (60% or above), compared with 39% of patients with lower PPG reduction (below 60%). Ascites that was detected by ultrasound in another 27% of patients with higher PPG reduction, compared with 31% of patients with lower PPG reduction. In addition, persistent severe ascites was seen in 19% of patients with higher PPG reduction, compared with 30% of patients with lower PPG reduction.

The authors also noted the importance of timing follow-up evaluation: They noted that post-TIPS follow-up is a frequent question and not yet standardized; in this study, they found that, with follow-up at 6 weeks, they could “clearly stratify the course post TIPS” and this could “detect patients at high risk of unstable course of disease.”

PPG reduction of more than 60% after TIPS correlated with resolution of severe ascites 6 weeks after TIPS, the study authors concluded.