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RSV Vaccine Effective in Older Veterans, But Protection Declines Over Time
RSV Vaccine Effective in Older Veterans, But Protection Declines Over Time
TOPLINE:
A single dose of respiratory syncytial virus (RSV) vaccine provided protection against RSV illness and associated health care use in nearly 290,000 older US veterans over 2 respiratory illness seasons compared with unvaccinated individuals; however, protection declined over time, particularly among immunocompromised individuals.
METHODOLOGY:
- Researchers emulated a target trial to assess the long-term effectiveness of a single does of RSV vaccine, administered between September 2023 and March 2024, to prevent RSV infection and associated health care use among older US veterans.
- The primary outcome was any positive RSV test from 14 days after vaccination; secondary outcomes included RSV-associated emergency department or urgent care visits, hospitalizations, and ICU admissions.
- The median follow-up duration, measured from 14 days after vaccination, was 15.8 months, with a maximum of 19.0 months.
TAKEAWAY:
- The estimated vaccines effectiveness against RSV infection decreased from 82.5% (95% CI, 77.5%-86.9%) over 0 to 1 month to 59.4% (95% CI, 55.6%-63.5%) over 0 to 18 months of follow-up.
- Protection against RSV-associated emergency department and urgent care visits fell from 84.9% over 0 to 1 month to 60.6% over 0 to 18 months, and the estimated effectiveness against hospitalizations decreased from 88.9% to 57.3% over the same interval.
- The estimated effectiveness against RSV-associated ICU admissions reduced from 92.5% (95% CI, 61.1%-100%) over 0 to 1 month to 71.9% (95% CI, 42.8%-90.0%) over 0 to 18 months.
- Among immunocompromised individuals, protection against RSV infection showed the largest decline from 75.2% at 0 to 1 month to 39.7% over 18 months.
IN PRACTICE:
"Boosters may be needed, but for now, our efforts should be focused on saving lives and decreasing disease by encouraging vaccination of persons 75 years and older and those 60 years and older with underlying health issues," experts wrote in an accompanying editorial.
SOURCE:
The study was led by Kristina L. Bajema, MD, Veterans Affairs Portland Health Care System, Portland, Oregon. It was published online on November 24, 2025, in JAMA Internal Medicine.
LIMITATIONS:
RSV documentation may have been incomplete for veterans who sought care outside the Veterans Health Administration. The cohort was predominantly White men, limiting generalizability. Residual confounding could not be excluded. Estimates of long-term effectiveness should be interpreted cautiously because they reflect patients who remained in care and may differ from the original matched cohort.
DISCLOSURES:
The study was supported by the US Department of Veterans Affairs Cooperative Studies Program, US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, and FDA. Two authors reported receiving grants from the study funder and/or the Patient-Centered Outcomes Research Institute; one of these authors also reported co-ownership of van Breemen & Hynes, LLC, unrelated to the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A single dose of respiratory syncytial virus (RSV) vaccine provided protection against RSV illness and associated health care use in nearly 290,000 older US veterans over 2 respiratory illness seasons compared with unvaccinated individuals; however, protection declined over time, particularly among immunocompromised individuals.
METHODOLOGY:
- Researchers emulated a target trial to assess the long-term effectiveness of a single does of RSV vaccine, administered between September 2023 and March 2024, to prevent RSV infection and associated health care use among older US veterans.
- The primary outcome was any positive RSV test from 14 days after vaccination; secondary outcomes included RSV-associated emergency department or urgent care visits, hospitalizations, and ICU admissions.
- The median follow-up duration, measured from 14 days after vaccination, was 15.8 months, with a maximum of 19.0 months.
TAKEAWAY:
- The estimated vaccines effectiveness against RSV infection decreased from 82.5% (95% CI, 77.5%-86.9%) over 0 to 1 month to 59.4% (95% CI, 55.6%-63.5%) over 0 to 18 months of follow-up.
- Protection against RSV-associated emergency department and urgent care visits fell from 84.9% over 0 to 1 month to 60.6% over 0 to 18 months, and the estimated effectiveness against hospitalizations decreased from 88.9% to 57.3% over the same interval.
- The estimated effectiveness against RSV-associated ICU admissions reduced from 92.5% (95% CI, 61.1%-100%) over 0 to 1 month to 71.9% (95% CI, 42.8%-90.0%) over 0 to 18 months.
- Among immunocompromised individuals, protection against RSV infection showed the largest decline from 75.2% at 0 to 1 month to 39.7% over 18 months.
IN PRACTICE:
"Boosters may be needed, but for now, our efforts should be focused on saving lives and decreasing disease by encouraging vaccination of persons 75 years and older and those 60 years and older with underlying health issues," experts wrote in an accompanying editorial.
SOURCE:
The study was led by Kristina L. Bajema, MD, Veterans Affairs Portland Health Care System, Portland, Oregon. It was published online on November 24, 2025, in JAMA Internal Medicine.
LIMITATIONS:
RSV documentation may have been incomplete for veterans who sought care outside the Veterans Health Administration. The cohort was predominantly White men, limiting generalizability. Residual confounding could not be excluded. Estimates of long-term effectiveness should be interpreted cautiously because they reflect patients who remained in care and may differ from the original matched cohort.
DISCLOSURES:
The study was supported by the US Department of Veterans Affairs Cooperative Studies Program, US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, and FDA. Two authors reported receiving grants from the study funder and/or the Patient-Centered Outcomes Research Institute; one of these authors also reported co-ownership of van Breemen & Hynes, LLC, unrelated to the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A single dose of respiratory syncytial virus (RSV) vaccine provided protection against RSV illness and associated health care use in nearly 290,000 older US veterans over 2 respiratory illness seasons compared with unvaccinated individuals; however, protection declined over time, particularly among immunocompromised individuals.
METHODOLOGY:
- Researchers emulated a target trial to assess the long-term effectiveness of a single does of RSV vaccine, administered between September 2023 and March 2024, to prevent RSV infection and associated health care use among older US veterans.
- The primary outcome was any positive RSV test from 14 days after vaccination; secondary outcomes included RSV-associated emergency department or urgent care visits, hospitalizations, and ICU admissions.
- The median follow-up duration, measured from 14 days after vaccination, was 15.8 months, with a maximum of 19.0 months.
TAKEAWAY:
- The estimated vaccines effectiveness against RSV infection decreased from 82.5% (95% CI, 77.5%-86.9%) over 0 to 1 month to 59.4% (95% CI, 55.6%-63.5%) over 0 to 18 months of follow-up.
- Protection against RSV-associated emergency department and urgent care visits fell from 84.9% over 0 to 1 month to 60.6% over 0 to 18 months, and the estimated effectiveness against hospitalizations decreased from 88.9% to 57.3% over the same interval.
- The estimated effectiveness against RSV-associated ICU admissions reduced from 92.5% (95% CI, 61.1%-100%) over 0 to 1 month to 71.9% (95% CI, 42.8%-90.0%) over 0 to 18 months.
- Among immunocompromised individuals, protection against RSV infection showed the largest decline from 75.2% at 0 to 1 month to 39.7% over 18 months.
IN PRACTICE:
"Boosters may be needed, but for now, our efforts should be focused on saving lives and decreasing disease by encouraging vaccination of persons 75 years and older and those 60 years and older with underlying health issues," experts wrote in an accompanying editorial.
SOURCE:
The study was led by Kristina L. Bajema, MD, Veterans Affairs Portland Health Care System, Portland, Oregon. It was published online on November 24, 2025, in JAMA Internal Medicine.
LIMITATIONS:
RSV documentation may have been incomplete for veterans who sought care outside the Veterans Health Administration. The cohort was predominantly White men, limiting generalizability. Residual confounding could not be excluded. Estimates of long-term effectiveness should be interpreted cautiously because they reflect patients who remained in care and may differ from the original matched cohort.
DISCLOSURES:
The study was supported by the US Department of Veterans Affairs Cooperative Studies Program, US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, and FDA. Two authors reported receiving grants from the study funder and/or the Patient-Centered Outcomes Research Institute; one of these authors also reported co-ownership of van Breemen & Hynes, LLC, unrelated to the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
RSV Vaccine Effective in Older Veterans, But Protection Declines Over Time
RSV Vaccine Effective in Older Veterans, But Protection Declines Over Time
Single-Incision Robotic Surgery Exhibits Safety, Feasibility in Colorectal Cases
Single-Incision Robotic Surgery Exhibits Safety, Feasibility in Colorectal Cases
TOPLINE: A novel single-incision robotic surgery technique for colorectal procedures demonstrated feasibility with 0% conversion to open surgery rate; only 1 case required additional ports. The technique achieved a 30-day all-severity morbidity rate of 20% and major morbidity of 6%.
METHODOLOGY:
- Researchers conducted a retrospective review to report a unique, single-incision robotic surgery technique that uses a fascial wound protector device and multiport robotic surgical system in colorectal surgery.
- Analysis included 50 patients (60% women) with mean ages of 53.5 years and median BMI of 27.2 kg/m2.
- Study was performed at a single quaternary, urban, academic institution from December 2023 to April 2025.
- Patients aged ≥ 18 years with colorectal indications who underwent robotic single-incision surgery using a Da Vinci multiport robotic platform were included.
TAKEAWAY:
- Conversion to open surgery rate was 0%; 1 case required additional robotic ports.
- The 30-day all-severity morbidity rate was 20%; 30-day major morbidity was 6%.
- Pathologies treated included Crohn's disease (26%), diverticulitis (22%), colon cancer (16%), colostomy status (8%), and rectal cancer (4%).
- Successful procedures included right-sided colectomies (14%), left-sided colectomies (28%), total colectomy (4%), rectal resection (4%), small bowel procedures (22%), and ostomy creation/reversal (18%).
IN PRACTICE: "Our rSIS technique utilizing a multiport robotic system is safe and feasible across a wide spectrum of colorectal procedures," wrote the study authors.
LIMITATIONS: According to the authors, reproducible successful completion of surgeries using this technique may be challenging in populations requiring deep pelvic dissections, especially in narrow male pelvis cases, and in patients with very high BMI and significant intra-abdominal adipose tissue.
DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: A novel single-incision robotic surgery technique for colorectal procedures demonstrated feasibility with 0% conversion to open surgery rate; only 1 case required additional ports. The technique achieved a 30-day all-severity morbidity rate of 20% and major morbidity of 6%.
METHODOLOGY:
- Researchers conducted a retrospective review to report a unique, single-incision robotic surgery technique that uses a fascial wound protector device and multiport robotic surgical system in colorectal surgery.
- Analysis included 50 patients (60% women) with mean ages of 53.5 years and median BMI of 27.2 kg/m2.
- Study was performed at a single quaternary, urban, academic institution from December 2023 to April 2025.
- Patients aged ≥ 18 years with colorectal indications who underwent robotic single-incision surgery using a Da Vinci multiport robotic platform were included.
TAKEAWAY:
- Conversion to open surgery rate was 0%; 1 case required additional robotic ports.
- The 30-day all-severity morbidity rate was 20%; 30-day major morbidity was 6%.
- Pathologies treated included Crohn's disease (26%), diverticulitis (22%), colon cancer (16%), colostomy status (8%), and rectal cancer (4%).
- Successful procedures included right-sided colectomies (14%), left-sided colectomies (28%), total colectomy (4%), rectal resection (4%), small bowel procedures (22%), and ostomy creation/reversal (18%).
IN PRACTICE: "Our rSIS technique utilizing a multiport robotic system is safe and feasible across a wide spectrum of colorectal procedures," wrote the study authors.
LIMITATIONS: According to the authors, reproducible successful completion of surgeries using this technique may be challenging in populations requiring deep pelvic dissections, especially in narrow male pelvis cases, and in patients with very high BMI and significant intra-abdominal adipose tissue.
DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: A novel single-incision robotic surgery technique for colorectal procedures demonstrated feasibility with 0% conversion to open surgery rate; only 1 case required additional ports. The technique achieved a 30-day all-severity morbidity rate of 20% and major morbidity of 6%.
METHODOLOGY:
- Researchers conducted a retrospective review to report a unique, single-incision robotic surgery technique that uses a fascial wound protector device and multiport robotic surgical system in colorectal surgery.
- Analysis included 50 patients (60% women) with mean ages of 53.5 years and median BMI of 27.2 kg/m2.
- Study was performed at a single quaternary, urban, academic institution from December 2023 to April 2025.
- Patients aged ≥ 18 years with colorectal indications who underwent robotic single-incision surgery using a Da Vinci multiport robotic platform were included.
TAKEAWAY:
- Conversion to open surgery rate was 0%; 1 case required additional robotic ports.
- The 30-day all-severity morbidity rate was 20%; 30-day major morbidity was 6%.
- Pathologies treated included Crohn's disease (26%), diverticulitis (22%), colon cancer (16%), colostomy status (8%), and rectal cancer (4%).
- Successful procedures included right-sided colectomies (14%), left-sided colectomies (28%), total colectomy (4%), rectal resection (4%), small bowel procedures (22%), and ostomy creation/reversal (18%).
IN PRACTICE: "Our rSIS technique utilizing a multiport robotic system is safe and feasible across a wide spectrum of colorectal procedures," wrote the study authors.
LIMITATIONS: According to the authors, reproducible successful completion of surgeries using this technique may be challenging in populations requiring deep pelvic dissections, especially in narrow male pelvis cases, and in patients with very high BMI and significant intra-abdominal adipose tissue.
DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Single-Incision Robotic Surgery Exhibits Safety, Feasibility in Colorectal Cases
Single-Incision Robotic Surgery Exhibits Safety, Feasibility in Colorectal Cases
Beta-Blockers May Reduce Mortality in Patients with Gastric Varices
, according to investigators.
In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.
“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”
To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.
Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.
Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.
The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.
In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.
Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.
Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.
“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”
Moon and colleagues went on to call for additional research.
“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”
Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.
, according to investigators.
In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.
“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”
To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.
Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.
Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.
The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.
In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.
Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.
Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.
“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”
Moon and colleagues went on to call for additional research.
“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”
Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.
, according to investigators.
In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.
“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”
To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.
Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.
Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.
The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.
In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.
Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.
Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.
“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”
Moon and colleagues went on to call for additional research.
“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”
Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.
FROM GASTRO HEP ADVANCES
UK Approves Targeted Therapy for Cervical Cancer
UK Approves Targeted Therapy for Cervical Cancer
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.
The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.
How the Treatment Works
Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.
It is administered as a 30-minute intravenous infusion once every 3 weeks.
What Trials Showed
The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.
In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.
Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.
Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.
Safety and Tolerability
Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.
Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).
Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.
The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.
A version of this article first appeared on Medscape.com.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.
The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.
How the Treatment Works
Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.
It is administered as a 30-minute intravenous infusion once every 3 weeks.
What Trials Showed
The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.
In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.
Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.
Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.
Safety and Tolerability
Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.
Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).
Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.
The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.
A version of this article first appeared on Medscape.com.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.
The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.
How the Treatment Works
Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.
It is administered as a 30-minute intravenous infusion once every 3 weeks.
What Trials Showed
The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.
In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.
Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.
Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.
Safety and Tolerability
Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.
Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).
Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.
The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.
A version of this article first appeared on Medscape.com.
UK Approves Targeted Therapy for Cervical Cancer
UK Approves Targeted Therapy for Cervical Cancer
FDA OKs Blood-Based Test to Help Diagnose Prostate Cancer
FDA OKs Blood-Based Test to Help Diagnose Prostate Cancer
The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.
IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.
Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.
IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.
The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.
The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.
The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: aotto@mdedge.com.
A version of this article first appeared on Medscape.com.
The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.
IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.
Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.
IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.
The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.
The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.
The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: aotto@mdedge.com.
A version of this article first appeared on Medscape.com.
The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.
IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.
Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.
IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.
The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.
The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.
The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: aotto@mdedge.com.
A version of this article first appeared on Medscape.com.
FDA OKs Blood-Based Test to Help Diagnose Prostate Cancer
FDA OKs Blood-Based Test to Help Diagnose Prostate Cancer
Expert Advice for Difficult GERD Cases
PHOENIX – , said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.
“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.
For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
Advanced pH Testing Options
Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.
“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.
“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”
In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.
Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.
Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.
Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
Assessing pH Testing Results
After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.
Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.
But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.
Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.
Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
Challenges in the Clinic
One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.
He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.
But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.
One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News.
“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”
Lynch and Kingsley disclosed no financial conflicts of interest.
A version of this article appeared on Medscape.com .
PHOENIX – , said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.
“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.
For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
Advanced pH Testing Options
Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.
“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.
“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”
In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.
Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.
Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.
Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
Assessing pH Testing Results
After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.
Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.
But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.
Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.
Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
Challenges in the Clinic
One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.
He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.
But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.
One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News.
“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”
Lynch and Kingsley disclosed no financial conflicts of interest.
A version of this article appeared on Medscape.com .
PHOENIX – , said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.
“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.
For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
Advanced pH Testing Options
Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.
“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.
“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”
In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.
Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.
Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.
Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
Assessing pH Testing Results
After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.
Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.
But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.
Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.
Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
Challenges in the Clinic
One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.
He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.
But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.
One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News.
“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”
Lynch and Kingsley disclosed no financial conflicts of interest.
A version of this article appeared on Medscape.com .
FROM ACG 2025
GI Side Effects of Immune Checkpoint Inhibitors Linked to Colon Adenoma Risk
PHOENIX — — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.
“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.
ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.
Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.
However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.
With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.
All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.
The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.
Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.
They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.
Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.
Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).
However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).
Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).
Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.
And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.
Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.
“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.
Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
Findings Raise Questions of Surveillance
Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”
“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.
Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.
“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.
The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”
“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.
Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”
Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.
A version of this article appeared on Medscape.com.
PHOENIX — — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.
“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.
ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.
Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.
However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.
With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.
All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.
The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.
Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.
They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.
Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.
Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).
However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).
Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).
Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.
And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.
Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.
“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.
Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
Findings Raise Questions of Surveillance
Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”
“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.
Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.
“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.
The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”
“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.
Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”
Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.
A version of this article appeared on Medscape.com.
PHOENIX — — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.
“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.
ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.
Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.
However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.
With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.
All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.
The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.
Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.
They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.
Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.
Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).
However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).
Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).
Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.
And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.
Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.
“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.
Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
Findings Raise Questions of Surveillance
Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”
“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.
Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.
“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.
The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”
“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.
Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”
Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.
A version of this article appeared on Medscape.com.
FROM ACG 2025
Higher Epilepsy Mortality in Posttraumatic Cases, VA Study Finds
The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data.
Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues.
Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.
“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”
How Common is PTE?
PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”
PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy.
Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”
Methodology and Findings
Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).
Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.
Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.
After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion
is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote.
However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).
“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”
Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said.
Perspective on Findings
Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said.
As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said
In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”
Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”
Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”
He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.
The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures.
Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.
The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data.
Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues.
Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.
“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”
How Common is PTE?
PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”
PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy.
Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”
Methodology and Findings
Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).
Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.
Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.
After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion
is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote.
However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).
“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”
Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said.
Perspective on Findings
Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said.
As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said
In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”
Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”
Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”
He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.
The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures.
Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.
The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data.
Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues.
Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.
“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”
How Common is PTE?
PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”
PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy.
Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”
Methodology and Findings
Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).
Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.
Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.
After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion
is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote.
However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).
“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”
Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said.
Perspective on Findings
Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said.
As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said
In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”
Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”
Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”
He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.
The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures.
Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.
Journal Highlights: July-November 2025
Endoscopy
Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.
Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.
Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.
Esophagus
Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.
Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.
Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.
Stomach
Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.
Colon
Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.
Liver
Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.
Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.
Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.
IBD
Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.
Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.
Disorders of Gut-Brain Interaction
Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030.
Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.
Misc
Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Endoscopy
Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.
Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.
Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.
Esophagus
Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.
Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.
Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.
Stomach
Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.
Colon
Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.
Liver
Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.
Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.
Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.
IBD
Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.
Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.
Disorders of Gut-Brain Interaction
Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030.
Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.
Misc
Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Endoscopy
Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.
Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.
Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.
Esophagus
Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.
Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.
Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.
Stomach
Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.
Colon
Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.
Liver
Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.
Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.
Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.
IBD
Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.
Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.
Disorders of Gut-Brain Interaction
Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030.
Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.
Misc
Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Office-Based Endoscopy Model Offers Way Forward for Outpatient GI
After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.
Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.
“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.
During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.
Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.
“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
Considering Financial Shifts
Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.
When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.
“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”
The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.
In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.
“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.
The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.
“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
Regaining Autonomy and Time
Beyond the financial dynamics, , Kosinski and colleagues wrote.
Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.
Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.
“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.
“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”
Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.
At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.
“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”
Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
A version of this article appeared on Medscape.com.
After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.
Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.
“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.
During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.
Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.
“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
Considering Financial Shifts
Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.
When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.
“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”
The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.
In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.
“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.
The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.
“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
Regaining Autonomy and Time
Beyond the financial dynamics, , Kosinski and colleagues wrote.
Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.
Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.
“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.
“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”
Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.
At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.
“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”
Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
A version of this article appeared on Medscape.com.
After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.
Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.
“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.
During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.
Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.
“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
Considering Financial Shifts
Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.
When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.
“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”
The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.
In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.
“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.
The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.
“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
Regaining Autonomy and Time
Beyond the financial dynamics, , Kosinski and colleagues wrote.
Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.
Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.
“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.
“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”
Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.
At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.
“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”
Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY