The second-generation anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alcensa) topped chemotherapy in crizotinib-pretreated ALK+ non–small cell lung cancer (NSCLC), according to results from the phase 3 ALUR trial.

Median investigator-assessed progression-free survival was 9.6 months with alectinib and 1.4 months with chemotherapy (hazard ratio, 0.15; P less than .001), reported Silvia Novello, MD, PhD, of University of Turin (Italy) and her associates. Among patients with measurable central nervous system disease, the rate of CNS objective response was significantly higher for alectinib (54%) versus chemotherapy (0%; P less than .001), Dr. Novello and her associates reported in Annals of Oncology.

The multicenter, open-label ALUR trial was the first to directly compare alectinib with standard chemotherapy in patients with ALK-rearranged NSCLC that previously had been treated with both platinum-based chemotherapy and crizotinib. In all, 107 patients were randomly assigned on a 2:1 basis to receive either alectinib (600 mg twice daily) or chemotherapy (clinician’s choice of pemetrexed 500 mg/m² or docetaxel 75 mg/m² every 3 weeks).

A blinded independent review committee calculated median progression-free survival (PFS) times that were 2.5 months shorter for alectinib and 0.2 months longer for chemotherapy. Consequently, the hazard ratio for PFS was somewhat attenuated at 0.32 but remained highly significant (95% confidence interval, 0.17-0.59). “[Median] PFS with alectinib in ALUR has exceeded that observed with [second-line] ceritinib” during the ASCEND-5 study, the researchers wrote. In ASCEND-5, median independent review committee–assessed PFS time was 5.4 months, which is 1.7 months shorter than that for alectinib in ALUR. In each study, chemotherapy yielded a median PFS time of 1.6 months, which facilitated intertrial comparisons, they wrote.

Rates of all-grade and serious adverse events were similar between arms in ALUR. Alectinib therapy caused no fatal adverse events, while chemotherapy was associated with one fatality deemed unrelated to treatment. Alectinib was more likely to produce constipation, dyspnea, and hyperbilirubinemia, while chemotherapy was more likely to cause nausea, alopecia, neutropenia, diarrhea, pruritus, stomatitis, and bacterial pneumonia. Although patients stayed on alectinib a median of 14 weeks longer than on chemotherapy, they were less likely to stop alectinib (6%) than chemotherapy (9%) for adverse events.

Dr. Novello disclosed personal fees from Roche, which markets alectinib. Eleven coinvestigators also disclosed employment, stock ownership, or other financial ties to Roche.

SOURCE: Novello S et al. Ann Oncol. 2018 Apr 14. doi: 10.1093/annonc/mdy121.

The second-generation anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alcensa) topped chemotherapy in crizotinib-pretreated ALK+ non–small cell lung cancer (NSCLC), according to results from the phase 3 ALUR trial.

Median investigator-assessed progression-free survival was 9.6 months with alectinib and 1.4 months with chemotherapy (hazard ratio, 0.15; P less than .001), reported Silvia Novello, MD, PhD, of University of Turin (Italy) and her associates. Among patients with measurable central nervous system disease, the rate of CNS objective response was significantly higher for alectinib (54%) versus chemotherapy (0%; P less than .001), Dr. Novello and her associates reported in Annals of Oncology.

The multicenter, open-label ALUR trial was the first to directly compare alectinib with standard chemotherapy in patients with ALK-rearranged NSCLC that previously had been treated with both platinum-based chemotherapy and crizotinib. In all, 107 patients were randomly assigned on a 2:1 basis to receive either alectinib (600 mg twice daily) or chemotherapy (clinician’s choice of pemetrexed 500 mg/m² or docetaxel 75 mg/m² every 3 weeks).

A blinded independent review committee calculated median progression-free survival (PFS) times that were 2.5 months shorter for alectinib and 0.2 months longer for chemotherapy. Consequently, the hazard ratio for PFS was somewhat attenuated at 0.32 but remained highly significant (95% confidence interval, 0.17-0.59). “[Median] PFS with alectinib in ALUR has exceeded that observed with [second-line] ceritinib” during the ASCEND-5 study, the researchers wrote. In ASCEND-5, median independent review committee–assessed PFS time was 5.4 months, which is 1.7 months shorter than that for alectinib in ALUR. In each study, chemotherapy yielded a median PFS time of 1.6 months, which facilitated intertrial comparisons, they wrote.

Rates of all-grade and serious adverse events were similar between arms in ALUR. Alectinib therapy caused no fatal adverse events, while chemotherapy was associated with one fatality deemed unrelated to treatment. Alectinib was more likely to produce constipation, dyspnea, and hyperbilirubinemia, while chemotherapy was more likely to cause nausea, alopecia, neutropenia, diarrhea, pruritus, stomatitis, and bacterial pneumonia. Although patients stayed on alectinib a median of 14 weeks longer than on chemotherapy, they were less likely to stop alectinib (6%) than chemotherapy (9%) for adverse events.

Dr. Novello disclosed personal fees from Roche, which markets alectinib. Eleven coinvestigators also disclosed employment, stock ownership, or other financial ties to Roche.

SOURCE: Novello S et al. Ann Oncol. 2018 Apr 14. doi: 10.1093/annonc/mdy121.

The second-generation anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alcensa) topped chemotherapy in crizotinib-pretreated ALK+ non–small cell lung cancer (NSCLC), according to results from the phase 3 ALUR trial.

Median investigator-assessed progression-free survival was 9.6 months with alectinib and 1.4 months with chemotherapy (hazard ratio, 0.15; P less than .001), reported Silvia Novello, MD, PhD, of University of Turin (Italy) and her associates. Among patients with measurable central nervous system disease, the rate of CNS objective response was significantly higher for alectinib (54%) versus chemotherapy (0%; P less than .001), Dr. Novello and her associates reported in Annals of Oncology.

The multicenter, open-label ALUR trial was the first to directly compare alectinib with standard chemotherapy in patients with ALK-rearranged NSCLC that previously had been treated with both platinum-based chemotherapy and crizotinib. In all, 107 patients were randomly assigned on a 2:1 basis to receive either alectinib (600 mg twice daily) or chemotherapy (clinician’s choice of pemetrexed 500 mg/m² or docetaxel 75 mg/m² every 3 weeks).

A blinded independent review committee calculated median progression-free survival (PFS) times that were 2.5 months shorter for alectinib and 0.2 months longer for chemotherapy. Consequently, the hazard ratio for PFS was somewhat attenuated at 0.32 but remained highly significant (95% confidence interval, 0.17-0.59). “[Median] PFS with alectinib in ALUR has exceeded that observed with [second-line] ceritinib” during the ASCEND-5 study, the researchers wrote. In ASCEND-5, median independent review committee–assessed PFS time was 5.4 months, which is 1.7 months shorter than that for alectinib in ALUR. In each study, chemotherapy yielded a median PFS time of 1.6 months, which facilitated intertrial comparisons, they wrote.

Rates of all-grade and serious adverse events were similar between arms in ALUR. Alectinib therapy caused no fatal adverse events, while chemotherapy was associated with one fatality deemed unrelated to treatment. Alectinib was more likely to produce constipation, dyspnea, and hyperbilirubinemia, while chemotherapy was more likely to cause nausea, alopecia, neutropenia, diarrhea, pruritus, stomatitis, and bacterial pneumonia. Although patients stayed on alectinib a median of 14 weeks longer than on chemotherapy, they were less likely to stop alectinib (6%) than chemotherapy (9%) for adverse events.

Dr. Novello disclosed personal fees from Roche, which markets alectinib. Eleven coinvestigators also disclosed employment, stock ownership, or other financial ties to Roche.

SOURCE: Novello S et al. Ann Oncol. 2018 Apr 14. doi: 10.1093/annonc/mdy121.

WASHINGTON – People with autism spectrum disorder face a double whammy on suicide risk: They have cognitive, social, and emotional behaviors that increase their vulnerability to suicide, but they also often find it difficult to communicate their depression and suicidality and so may often go unrecognized as suicidal. Or if they are identified, conventional prevention interventions might be less effective.

To try to address this, clinicians are trying to develop a suicide screening questionnaire that is better geared for use on people with autism spectrum disorder (ASD), Jacqueline Wynn, PhD said at the annual conference of the American Association of Suicidology.

Mitchel L. Zoler/MDedge News

“The point is that we need better measures in the ASQ,” said John P. Ackerman, PhD, a clinical psychologist and suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children’s. “There is a misperception that because people with autism don’t express their emotions and can’t always access the words they don’t have suicide ideation. They do,” he declared in an interview.

People with ASD have high rates of depression and anxiety, decreased inhibitory control and emotional regulation, rigidity or thought, and difficulty asking for help or accepting help. Youth with ASD undergo psychiatric hospitalization more than 10-fold more often than similarly aged youth without a psychiatric diagnosis, Dr. Ackerman noted. In one recent study of 374 adults with Asperger’s syndrome, two-thirds reported having suicidal ideation and one-third self-reported a planned or attempted suicide (Lancet Psychiatry. 2014 Jul;1[2]:142-7).

The risks that people with ASD have for depression and suicide contrasts with the way clinicians currently address this issue. “There are many gaps” in suicide-risk assessment and prevention interventions aimed at people with ASD, he said. For example, a depression symptom checklist that asks whether someone is withdrawn or feeling disconnected focuses on commonplace characteristics among people with ASD.

Mitchel L. Zoler/MDedge News

[email protected]

WASHINGTON – People with autism spectrum disorder face a double whammy on suicide risk: They have cognitive, social, and emotional behaviors that increase their vulnerability to suicide, but they also often find it difficult to communicate their depression and suicidality and so may often go unrecognized as suicidal. Or if they are identified, conventional prevention interventions might be less effective.

To try to address this, clinicians are trying to develop a suicide screening questionnaire that is better geared for use on people with autism spectrum disorder (ASD), Jacqueline Wynn, PhD said at the annual conference of the American Association of Suicidology.

Mitchel L. Zoler/MDedge News

“The point is that we need better measures in the ASQ,” said John P. Ackerman, PhD, a clinical psychologist and suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children’s. “There is a misperception that because people with autism don’t express their emotions and can’t always access the words they don’t have suicide ideation. They do,” he declared in an interview.

People with ASD have high rates of depression and anxiety, decreased inhibitory control and emotional regulation, rigidity or thought, and difficulty asking for help or accepting help. Youth with ASD undergo psychiatric hospitalization more than 10-fold more often than similarly aged youth without a psychiatric diagnosis, Dr. Ackerman noted. In one recent study of 374 adults with Asperger’s syndrome, two-thirds reported having suicidal ideation and one-third self-reported a planned or attempted suicide (Lancet Psychiatry. 2014 Jul;1[2]:142-7).

The risks that people with ASD have for depression and suicide contrasts with the way clinicians currently address this issue. “There are many gaps” in suicide-risk assessment and prevention interventions aimed at people with ASD, he said. For example, a depression symptom checklist that asks whether someone is withdrawn or feeling disconnected focuses on commonplace characteristics among people with ASD.

Mitchel L. Zoler/MDedge News

[email protected]

WASHINGTON – People with autism spectrum disorder face a double whammy on suicide risk: They have cognitive, social, and emotional behaviors that increase their vulnerability to suicide, but they also often find it difficult to communicate their depression and suicidality and so may often go unrecognized as suicidal. Or if they are identified, conventional prevention interventions might be less effective.

To try to address this, clinicians are trying to develop a suicide screening questionnaire that is better geared for use on people with autism spectrum disorder (ASD), Jacqueline Wynn, PhD said at the annual conference of the American Association of Suicidology.

Mitchel L. Zoler/MDedge News

“The point is that we need better measures in the ASQ,” said John P. Ackerman, PhD, a clinical psychologist and suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children’s. “There is a misperception that because people with autism don’t express their emotions and can’t always access the words they don’t have suicide ideation. They do,” he declared in an interview.

People with ASD have high rates of depression and anxiety, decreased inhibitory control and emotional regulation, rigidity or thought, and difficulty asking for help or accepting help. Youth with ASD undergo psychiatric hospitalization more than 10-fold more often than similarly aged youth without a psychiatric diagnosis, Dr. Ackerman noted. In one recent study of 374 adults with Asperger’s syndrome, two-thirds reported having suicidal ideation and one-third self-reported a planned or attempted suicide (Lancet Psychiatry. 2014 Jul;1[2]:142-7).

The risks that people with ASD have for depression and suicide contrasts with the way clinicians currently address this issue. “There are many gaps” in suicide-risk assessment and prevention interventions aimed at people with ASD, he said. For example, a depression symptom checklist that asks whether someone is withdrawn or feeling disconnected focuses on commonplace characteristics among people with ASD.

Mitchel L. Zoler/MDedge News

[email protected]

The Centers for Medicare & Medicaid Services wants physician input on developing direct provider contracting models to cover Medicare beneficiaries.

Under a direct provider contracting (DPC) arrangement, Medicare could pay physicians or physician groups a monthly fee to deliver a specific set of services to beneficiaries, who would gain greater access to the physicians. The physicians would be accountable for those Medicare patients’ costs and care quality.

zimmytws/gettyimages

CMS is looking at how to incorporate this concept into the Medicare ranks. On April 23, CMS issued a request for information (RFI) seeking input across a wide range of topics, including provider/state participation, beneficiary participation, payment, general model design, program integrity and beneficiary protection, and how such models would fit within the existing accountable care organization framework.

The RFI offered one possible vision on how a direct provider contracting model could work.

“Under a primary care–focused DPC model, CMS could enter into arrangements with primary care practices under which CMS would pay these participating practices a fixed per beneficiary per month (PBPM) payment to cover the primary care services the practice would be expected to furnish under the model, which may include office visits, certain office-based procedures, and other non–visit-based services covered under the physician fee schedule, and flexibility in how otherwise billable services are delivered,” the RFI states.

Physicians could also earn performance bonuses, depending on how the DPC is structured, through “performance-based incentives for total cost of care and quality.”

CMS noted it also “could test ways to reduce administrative burden though innovative changes to claims submission processes for services included in the PBPM payment under these models.”

The direct provider contracting idea grew out of a previous RFI issued in 2017 by CMS’s Center for Medicare and Medicaid Innovation to collect ideas on new ways to deliver patient-centered care. The agency released the more than 1,000 comments received from that request on the same day it issued the RFI on direct provider contracting.

In those comments, a number of physician groups offered support for a direct-contracting approach.

For example, the American Academy of Family Physicians wrote that it “sees continued growth and interest in family physicians adopting this practice model in all settings types, including rural and underserved communities.” And the AAFP suggested that the innovation center should work with DPC organizations to learn more about them.

The American College of Physicians reiterated its previous position that it “supports physician and patient choice of practice and delivery models that are accessible, ethical, and viable and that strengthen the patient-physician relationship.” But the ACP raised a number of issues that could impede access to care or result in lower quality care.

The American Medical Association offered support for “testing of models in which physicians have the ability to deliver more or different services to patients who need them and to be paid more for doing so.”

The AMA suggested that some of the models to be tested include allowing patients to contract directly with physicians, with Medicare paying its fee schedule rates and patients paying the difference; allowing patients to receive their care from DPC practices and get reimbursed by Medicare; or allowing “physicians to define a team of providers who will provide all of the treatment needed for an acute condition or management of a chronic condition, and then allowing patients who select the team to receive all of the services related to their condition from the team in return for a single predefined cost-sharing amount.”

Comments on the RFI are due May 25.

[email protected]

The Centers for Medicare & Medicaid Services wants physician input on developing direct provider contracting models to cover Medicare beneficiaries.

Under a direct provider contracting (DPC) arrangement, Medicare could pay physicians or physician groups a monthly fee to deliver a specific set of services to beneficiaries, who would gain greater access to the physicians. The physicians would be accountable for those Medicare patients’ costs and care quality.

zimmytws/gettyimages

CMS is looking at how to incorporate this concept into the Medicare ranks. On April 23, CMS issued a request for information (RFI) seeking input across a wide range of topics, including provider/state participation, beneficiary participation, payment, general model design, program integrity and beneficiary protection, and how such models would fit within the existing accountable care organization framework.

The RFI offered one possible vision on how a direct provider contracting model could work.

“Under a primary care–focused DPC model, CMS could enter into arrangements with primary care practices under which CMS would pay these participating practices a fixed per beneficiary per month (PBPM) payment to cover the primary care services the practice would be expected to furnish under the model, which may include office visits, certain office-based procedures, and other non–visit-based services covered under the physician fee schedule, and flexibility in how otherwise billable services are delivered,” the RFI states.

Physicians could also earn performance bonuses, depending on how the DPC is structured, through “performance-based incentives for total cost of care and quality.”

CMS noted it also “could test ways to reduce administrative burden though innovative changes to claims submission processes for services included in the PBPM payment under these models.”

The direct provider contracting idea grew out of a previous RFI issued in 2017 by CMS’s Center for Medicare and Medicaid Innovation to collect ideas on new ways to deliver patient-centered care. The agency released the more than 1,000 comments received from that request on the same day it issued the RFI on direct provider contracting.

In those comments, a number of physician groups offered support for a direct-contracting approach.

For example, the American Academy of Family Physicians wrote that it “sees continued growth and interest in family physicians adopting this practice model in all settings types, including rural and underserved communities.” And the AAFP suggested that the innovation center should work with DPC organizations to learn more about them.

The American College of Physicians reiterated its previous position that it “supports physician and patient choice of practice and delivery models that are accessible, ethical, and viable and that strengthen the patient-physician relationship.” But the ACP raised a number of issues that could impede access to care or result in lower quality care.

The American Medical Association offered support for “testing of models in which physicians have the ability to deliver more or different services to patients who need them and to be paid more for doing so.”

The AMA suggested that some of the models to be tested include allowing patients to contract directly with physicians, with Medicare paying its fee schedule rates and patients paying the difference; allowing patients to receive their care from DPC practices and get reimbursed by Medicare; or allowing “physicians to define a team of providers who will provide all of the treatment needed for an acute condition or management of a chronic condition, and then allowing patients who select the team to receive all of the services related to their condition from the team in return for a single predefined cost-sharing amount.”

Comments on the RFI are due May 25.

[email protected]

The Centers for Medicare & Medicaid Services wants physician input on developing direct provider contracting models to cover Medicare beneficiaries.

Under a direct provider contracting (DPC) arrangement, Medicare could pay physicians or physician groups a monthly fee to deliver a specific set of services to beneficiaries, who would gain greater access to the physicians. The physicians would be accountable for those Medicare patients’ costs and care quality.

zimmytws/gettyimages

CMS is looking at how to incorporate this concept into the Medicare ranks. On April 23, CMS issued a request for information (RFI) seeking input across a wide range of topics, including provider/state participation, beneficiary participation, payment, general model design, program integrity and beneficiary protection, and how such models would fit within the existing accountable care organization framework.

The RFI offered one possible vision on how a direct provider contracting model could work.

“Under a primary care–focused DPC model, CMS could enter into arrangements with primary care practices under which CMS would pay these participating practices a fixed per beneficiary per month (PBPM) payment to cover the primary care services the practice would be expected to furnish under the model, which may include office visits, certain office-based procedures, and other non–visit-based services covered under the physician fee schedule, and flexibility in how otherwise billable services are delivered,” the RFI states.

Physicians could also earn performance bonuses, depending on how the DPC is structured, through “performance-based incentives for total cost of care and quality.”

CMS noted it also “could test ways to reduce administrative burden though innovative changes to claims submission processes for services included in the PBPM payment under these models.”

The direct provider contracting idea grew out of a previous RFI issued in 2017 by CMS’s Center for Medicare and Medicaid Innovation to collect ideas on new ways to deliver patient-centered care. The agency released the more than 1,000 comments received from that request on the same day it issued the RFI on direct provider contracting.

In those comments, a number of physician groups offered support for a direct-contracting approach.

For example, the American Academy of Family Physicians wrote that it “sees continued growth and interest in family physicians adopting this practice model in all settings types, including rural and underserved communities.” And the AAFP suggested that the innovation center should work with DPC organizations to learn more about them.

The American College of Physicians reiterated its previous position that it “supports physician and patient choice of practice and delivery models that are accessible, ethical, and viable and that strengthen the patient-physician relationship.” But the ACP raised a number of issues that could impede access to care or result in lower quality care.

The American Medical Association offered support for “testing of models in which physicians have the ability to deliver more or different services to patients who need them and to be paid more for doing so.”

The AMA suggested that some of the models to be tested include allowing patients to contract directly with physicians, with Medicare paying its fee schedule rates and patients paying the difference; allowing patients to receive their care from DPC practices and get reimbursed by Medicare; or allowing “physicians to define a team of providers who will provide all of the treatment needed for an acute condition or management of a chronic condition, and then allowing patients who select the team to receive all of the services related to their condition from the team in return for a single predefined cost-sharing amount.”

Comments on the RFI are due May 25.

[email protected]

Liquid nicotine for e-cigarettes poses a poisoning risk for young children, said Preethi Govindarajan of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, and his associates.

Since January 2015, pediatric exposures to liquid nicotine have decreased, which may be attributable to legislation requiring child-resistant packaging for liquid nicotine containers and also greater public awareness of the risks associated with e-cigarette products, they noted.

Carpe89/ThinkStock

[email protected]

SOURCE: Govindarajan P et al. Pediatrics. 2018;141(5):e20173361.

Liquid nicotine for e-cigarettes poses a poisoning risk for young children, said Preethi Govindarajan of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, and his associates.

Since January 2015, pediatric exposures to liquid nicotine have decreased, which may be attributable to legislation requiring child-resistant packaging for liquid nicotine containers and also greater public awareness of the risks associated with e-cigarette products, they noted.

Carpe89/ThinkStock

[email protected]

SOURCE: Govindarajan P et al. Pediatrics. 2018;141(5):e20173361.

Liquid nicotine for e-cigarettes poses a poisoning risk for young children, said Preethi Govindarajan of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, and his associates.

Since January 2015, pediatric exposures to liquid nicotine have decreased, which may be attributable to legislation requiring child-resistant packaging for liquid nicotine containers and also greater public awareness of the risks associated with e-cigarette products, they noted.

Carpe89/ThinkStock

[email protected]

SOURCE: Govindarajan P et al. Pediatrics. 2018;141(5):e20173361.

LIVERPOOL, ENGLAND – Osteoarthritis is associated with an increased risk in mortality, but three factors – inactivity, low mood, and cognitive ability – could be important targets to reduce this risk, according to the results of a study presented at the World Congress on Osteoarthritis.

“There’s recently been increasing interest in whether osteoarthritis (OA) is associated with mortality as the literature has failed to find a consistent link,” said Simran Parmar, a third-year medical student at Keele University, Newcastle-Under-Lyme, U.K.

Sara Freeman/MDedge News

SOURCE: Parmar S et al. Osteoarthritis Cartilage. 2018;26(1):S14-15.

LIVERPOOL, ENGLAND – Osteoarthritis is associated with an increased risk in mortality, but three factors – inactivity, low mood, and cognitive ability – could be important targets to reduce this risk, according to the results of a study presented at the World Congress on Osteoarthritis.

“There’s recently been increasing interest in whether osteoarthritis (OA) is associated with mortality as the literature has failed to find a consistent link,” said Simran Parmar, a third-year medical student at Keele University, Newcastle-Under-Lyme, U.K.

Sara Freeman/MDedge News

SOURCE: Parmar S et al. Osteoarthritis Cartilage. 2018;26(1):S14-15.

LIVERPOOL, ENGLAND – Osteoarthritis is associated with an increased risk in mortality, but three factors – inactivity, low mood, and cognitive ability – could be important targets to reduce this risk, according to the results of a study presented at the World Congress on Osteoarthritis.

“There’s recently been increasing interest in whether osteoarthritis (OA) is associated with mortality as the literature has failed to find a consistent link,” said Simran Parmar, a third-year medical student at Keele University, Newcastle-Under-Lyme, U.K.

Sara Freeman/MDedge News

SOURCE: Parmar S et al. Osteoarthritis Cartilage. 2018;26(1):S14-15.

By Umberto G. Rossi, MD, Paolo Rigamonti, MD, and Maurizio Cariati, MD

Intraluminal gallbladder arterial hemorrhage as a complication of arteriosclerosis and anticoagulant therapy
This radiologic sign on multiphasic contrast-enhanced multidetector computed tomography with axial images (Figure A-C), coronal multiplanar reconstruction (Figure D) and coronal volume rendering technique were indicative for active hemorrhage of gallbladder wall. During the urgent surgical treatment, there was confirmation of that distended gallbladder. Postoperatively, opening of the gallbladder revealed in its lumen the presence of bile mixed with dishomogeneous blood clots. Pathologic evaluation demonstrated arteriosclerosis of the cystic artery, with a pseudoaneurysmatic tear of one of its collateral branches with focal surround inflammatory tissue of gallbladder wall. The postoperative course was uneventful, and the patient was discharged on day 8.
Hemorrhage from the gallbladder is not a frequent event.1 The etiologies for hemorrhage of the gallbladder are trauma, neoplasms, inflammation of the wall with gallstones, aneurysms, varicose veins with portal hypertension, arteriosclerosis, and coagulopathy. However, isolated gallbladder arterial hemorrhage owing to anticoagulation therapy has been reported rarely. This pathologic state can be detected by contrast-enhanced ultrasound, contrast-enhanced computed tomography, and digital subtraction angiography.2,3
 
References
1. Hudson, P.B., Johnson, P.P. Hemorrhage from the gall bladder. N Engl J Med. 1946;234:438-41.
2. Krudy, A.G., Doppman, J.L., Bissonette, M.B., et al. Hemobilia: computed tomographic diagnosis. Radiology. 1983;148:785-9.
3. Pandya, R., O'Malley, C. Hemorrhagic cholecystitis as a complication of anticoagulant therapy: role of CT in its diagnosis. Abdom Imaging. 2008;33:652-3.

By Umberto G. Rossi, MD, Paolo Rigamonti, MD, and Maurizio Cariati, MD

Intraluminal gallbladder arterial hemorrhage as a complication of arteriosclerosis and anticoagulant therapy
This radiologic sign on multiphasic contrast-enhanced multidetector computed tomography with axial images (Figure A-C), coronal multiplanar reconstruction (Figure D) and coronal volume rendering technique were indicative for active hemorrhage of gallbladder wall. During the urgent surgical treatment, there was confirmation of that distended gallbladder. Postoperatively, opening of the gallbladder revealed in its lumen the presence of bile mixed with dishomogeneous blood clots. Pathologic evaluation demonstrated arteriosclerosis of the cystic artery, with a pseudoaneurysmatic tear of one of its collateral branches with focal surround inflammatory tissue of gallbladder wall. The postoperative course was uneventful, and the patient was discharged on day 8.
Hemorrhage from the gallbladder is not a frequent event.1 The etiologies for hemorrhage of the gallbladder are trauma, neoplasms, inflammation of the wall with gallstones, aneurysms, varicose veins with portal hypertension, arteriosclerosis, and coagulopathy. However, isolated gallbladder arterial hemorrhage owing to anticoagulation therapy has been reported rarely. This pathologic state can be detected by contrast-enhanced ultrasound, contrast-enhanced computed tomography, and digital subtraction angiography.2,3
 
References
1. Hudson, P.B., Johnson, P.P. Hemorrhage from the gall bladder. N Engl J Med. 1946;234:438-41.
2. Krudy, A.G., Doppman, J.L., Bissonette, M.B., et al. Hemobilia: computed tomographic diagnosis. Radiology. 1983;148:785-9.
3. Pandya, R., O'Malley, C. Hemorrhagic cholecystitis as a complication of anticoagulant therapy: role of CT in its diagnosis. Abdom Imaging. 2008;33:652-3.

By Umberto G. Rossi, MD, Paolo Rigamonti, MD, and Maurizio Cariati, MD

Intraluminal gallbladder arterial hemorrhage as a complication of arteriosclerosis and anticoagulant therapy
This radiologic sign on multiphasic contrast-enhanced multidetector computed tomography with axial images (Figure A-C), coronal multiplanar reconstruction (Figure D) and coronal volume rendering technique were indicative for active hemorrhage of gallbladder wall. During the urgent surgical treatment, there was confirmation of that distended gallbladder. Postoperatively, opening of the gallbladder revealed in its lumen the presence of bile mixed with dishomogeneous blood clots. Pathologic evaluation demonstrated arteriosclerosis of the cystic artery, with a pseudoaneurysmatic tear of one of its collateral branches with focal surround inflammatory tissue of gallbladder wall. The postoperative course was uneventful, and the patient was discharged on day 8.
Hemorrhage from the gallbladder is not a frequent event.1 The etiologies for hemorrhage of the gallbladder are trauma, neoplasms, inflammation of the wall with gallstones, aneurysms, varicose veins with portal hypertension, arteriosclerosis, and coagulopathy. However, isolated gallbladder arterial hemorrhage owing to anticoagulation therapy has been reported rarely. This pathologic state can be detected by contrast-enhanced ultrasound, contrast-enhanced computed tomography, and digital subtraction angiography.2,3
 
References
1. Hudson, P.B., Johnson, P.P. Hemorrhage from the gall bladder. N Engl J Med. 1946;234:438-41.
2. Krudy, A.G., Doppman, J.L., Bissonette, M.B., et al. Hemobilia: computed tomographic diagnosis. Radiology. 1983;148:785-9.
3. Pandya, R., O'Malley, C. Hemorrhagic cholecystitis as a complication of anticoagulant therapy: role of CT in its diagnosis. Abdom Imaging. 2008;33:652-3.

WASHINGTON – Medicare Advantage claims data will soon be available for health researchers, Centers for Medicare & Medicaid Services Administrator Seema Verma announced.

Gregory Twachtman/MDedge News

“We recognize that the Medicare Advantage data are not perfect, but we have determined that the quality of the available data is adequate enough to support research,” Ms. Verma told attendees April 26 at an annual conference on health data and innovation.
 

CMS is starting with the Medicare managed care plans’ encounter data from 2015, and Ms. Verma said the data will be updated annually.

In addition, she announced that in 2019 CMS will make Medicaid and Children’s Health Insurance Program data available. That will give researchers access to data from another 70 million patients.

Ms. Verma noted that the Medicaid population includes a range of people, including people with disabilities, pregnant women, children, and low-income adults. Those low-income adults “often experience multiple health issues and face challenges managing their care,” Ms. Verma noted. “Our hope is that these data will be used for critical research on this vulnerable population.”

CMS also will look to the health information technology developer community to create open application program interface tools “to modernize how we share data with our partners,” she said. That push is part of the overall MyHealthEData initiative to improve patient access to their health data and become more informed about their own health care.

“Who knows what knowledge, treatments, and cures are hidden in the reams of CMS data?” Ms. Verma said. “Help us use it securely. After all, this is knowledge that could change the life of a patient or the trajectory of a health care system.”

[email protected]

WASHINGTON – Medicare Advantage claims data will soon be available for health researchers, Centers for Medicare & Medicaid Services Administrator Seema Verma announced.

Gregory Twachtman/MDedge News

“We recognize that the Medicare Advantage data are not perfect, but we have determined that the quality of the available data is adequate enough to support research,” Ms. Verma told attendees April 26 at an annual conference on health data and innovation.
 

CMS is starting with the Medicare managed care plans’ encounter data from 2015, and Ms. Verma said the data will be updated annually.

In addition, she announced that in 2019 CMS will make Medicaid and Children’s Health Insurance Program data available. That will give researchers access to data from another 70 million patients.

Ms. Verma noted that the Medicaid population includes a range of people, including people with disabilities, pregnant women, children, and low-income adults. Those low-income adults “often experience multiple health issues and face challenges managing their care,” Ms. Verma noted. “Our hope is that these data will be used for critical research on this vulnerable population.”

CMS also will look to the health information technology developer community to create open application program interface tools “to modernize how we share data with our partners,” she said. That push is part of the overall MyHealthEData initiative to improve patient access to their health data and become more informed about their own health care.

“Who knows what knowledge, treatments, and cures are hidden in the reams of CMS data?” Ms. Verma said. “Help us use it securely. After all, this is knowledge that could change the life of a patient or the trajectory of a health care system.”

[email protected]

WASHINGTON – Medicare Advantage claims data will soon be available for health researchers, Centers for Medicare & Medicaid Services Administrator Seema Verma announced.

Gregory Twachtman/MDedge News

“We recognize that the Medicare Advantage data are not perfect, but we have determined that the quality of the available data is adequate enough to support research,” Ms. Verma told attendees April 26 at an annual conference on health data and innovation.
 

CMS is starting with the Medicare managed care plans’ encounter data from 2015, and Ms. Verma said the data will be updated annually.

In addition, she announced that in 2019 CMS will make Medicaid and Children’s Health Insurance Program data available. That will give researchers access to data from another 70 million patients.

Ms. Verma noted that the Medicaid population includes a range of people, including people with disabilities, pregnant women, children, and low-income adults. Those low-income adults “often experience multiple health issues and face challenges managing their care,” Ms. Verma noted. “Our hope is that these data will be used for critical research on this vulnerable population.”

CMS also will look to the health information technology developer community to create open application program interface tools “to modernize how we share data with our partners,” she said. That push is part of the overall MyHealthEData initiative to improve patient access to their health data and become more informed about their own health care.

“Who knows what knowledge, treatments, and cures are hidden in the reams of CMS data?” Ms. Verma said. “Help us use it securely. After all, this is knowledge that could change the life of a patient or the trajectory of a health care system.”

[email protected]

Correct Answer: B
 
Rationale
This patient has a neuroendocrine tumor (e.g., carcinoid). These tumors are derived from enterochromaffin-like cells and appear as nests or ribbons of endocrine cells. There are three types of carcinoids. Type 1 is the most common and has a benign course. Type 1 neuroendocrine tumors can be multifocal, well-differentiated and associated with type A chronic atrophic gastritis. Small tumors can be treated with endoscopic resection. Type 2 lesions tend to be multifocal and associated with Zollinger-Ellison syndrome (ZES) and multiple endocrine neoplasia 1 (MEN1). Up to 30% of type 2 tumors present with lymph node metastases. Type 3 gastric carcinoids are not associated with hypergastrinemia and have poor prognosis. Type 3 gastric carcinoids should be managed with surgery.
 
References
1. ASGE Standards of Practice Committee, Evans JA, Chandrasekhara V, et al. The role of endoscopy in the management of premalignant and malignant conditions of the stomach. Gastrointest Endosc. 2015;82(1):1-8.
2. Shaib YH, Rugge M, Graham DY, et al. Management of gastric polyps: an endoscopy-based approach. Clin Gastroenterol Hepatol. 2013;11(11):1374-84.
 

Correct Answer: B
 
Rationale
This patient has a neuroendocrine tumor (e.g., carcinoid). These tumors are derived from enterochromaffin-like cells and appear as nests or ribbons of endocrine cells. There are three types of carcinoids. Type 1 is the most common and has a benign course. Type 1 neuroendocrine tumors can be multifocal, well-differentiated and associated with type A chronic atrophic gastritis. Small tumors can be treated with endoscopic resection. Type 2 lesions tend to be multifocal and associated with Zollinger-Ellison syndrome (ZES) and multiple endocrine neoplasia 1 (MEN1). Up to 30% of type 2 tumors present with lymph node metastases. Type 3 gastric carcinoids are not associated with hypergastrinemia and have poor prognosis. Type 3 gastric carcinoids should be managed with surgery.
 
References
1. ASGE Standards of Practice Committee, Evans JA, Chandrasekhara V, et al. The role of endoscopy in the management of premalignant and malignant conditions of the stomach. Gastrointest Endosc. 2015;82(1):1-8.
2. Shaib YH, Rugge M, Graham DY, et al. Management of gastric polyps: an endoscopy-based approach. Clin Gastroenterol Hepatol. 2013;11(11):1374-84.
 

Correct Answer: B
 
Rationale
This patient has a neuroendocrine tumor (e.g., carcinoid). These tumors are derived from enterochromaffin-like cells and appear as nests or ribbons of endocrine cells. There are three types of carcinoids. Type 1 is the most common and has a benign course. Type 1 neuroendocrine tumors can be multifocal, well-differentiated and associated with type A chronic atrophic gastritis. Small tumors can be treated with endoscopic resection. Type 2 lesions tend to be multifocal and associated with Zollinger-Ellison syndrome (ZES) and multiple endocrine neoplasia 1 (MEN1). Up to 30% of type 2 tumors present with lymph node metastases. Type 3 gastric carcinoids are not associated with hypergastrinemia and have poor prognosis. Type 3 gastric carcinoids should be managed with surgery.
 
References
1. ASGE Standards of Practice Committee, Evans JA, Chandrasekhara V, et al. The role of endoscopy in the management of premalignant and malignant conditions of the stomach. Gastrointest Endosc. 2015;82(1):1-8.
2. Shaib YH, Rugge M, Graham DY, et al. Management of gastric polyps: an endoscopy-based approach. Clin Gastroenterol Hepatol. 2013;11(11):1374-84.
 

 Correct Answer: C
 
Rationale
In a population study of U.S. veterans infected with hepatitis C (n = 110,484), a Cox proportional hazards model was used to determine risk of developing cirrhosis and hepatocellular carcinoma for genotypes 1-4, after adjusting for age, period of service, race, gender, human immunodeficiency virus (HIV) infection, alcohol use, diabetes, body mass index, and antiviral treatment. Despite genotype 3 patients being younger, their risk of developing cirrhosis was highest with hazard ratio = 1.30 (1.22, 1.39), compared to genotype 1 (reference, HR 1.0), genotype 2 with HR = 0.68 (0.64, 0.73), and genotype 4 with HR = 0.94 (0.78, 1.14). Likewise, the risk of development of hepatocellular carcinoma was highest for genotype 3 HCV with HR = 1.80 (1.60, 2.03), compared to a genotype 2 (HR = 0.55, 0.47, 0.63), and genotype 4 (0.99, 0.68, 1.45).  
It is speculated that the hepatic steatosis that is a direct result of genotype 3 HCV may contribute to the accelerated progression to cirrhosis and HCC, but this has not been proven and was not evaluated in this Veteran Affairs study.
 
Reference
1. Kanwal F, Kramer JR, Ilyas J, et al. HCV genotype 3 is associated with an increased risk of cirrhosis and hepatocellular cancer in a national sample of U.S. veterans with HCV. Hepatology. 2014;60(1):98-105.

 Correct Answer: C
 
Rationale
In a population study of U.S. veterans infected with hepatitis C (n = 110,484), a Cox proportional hazards model was used to determine risk of developing cirrhosis and hepatocellular carcinoma for genotypes 1-4, after adjusting for age, period of service, race, gender, human immunodeficiency virus (HIV) infection, alcohol use, diabetes, body mass index, and antiviral treatment. Despite genotype 3 patients being younger, their risk of developing cirrhosis was highest with hazard ratio = 1.30 (1.22, 1.39), compared to genotype 1 (reference, HR 1.0), genotype 2 with HR = 0.68 (0.64, 0.73), and genotype 4 with HR = 0.94 (0.78, 1.14). Likewise, the risk of development of hepatocellular carcinoma was highest for genotype 3 HCV with HR = 1.80 (1.60, 2.03), compared to a genotype 2 (HR = 0.55, 0.47, 0.63), and genotype 4 (0.99, 0.68, 1.45).  
It is speculated that the hepatic steatosis that is a direct result of genotype 3 HCV may contribute to the accelerated progression to cirrhosis and HCC, but this has not been proven and was not evaluated in this Veteran Affairs study.
 
Reference
1. Kanwal F, Kramer JR, Ilyas J, et al. HCV genotype 3 is associated with an increased risk of cirrhosis and hepatocellular cancer in a national sample of U.S. veterans with HCV. Hepatology. 2014;60(1):98-105.

 Correct Answer: C
 
Rationale
In a population study of U.S. veterans infected with hepatitis C (n = 110,484), a Cox proportional hazards model was used to determine risk of developing cirrhosis and hepatocellular carcinoma for genotypes 1-4, after adjusting for age, period of service, race, gender, human immunodeficiency virus (HIV) infection, alcohol use, diabetes, body mass index, and antiviral treatment. Despite genotype 3 patients being younger, their risk of developing cirrhosis was highest with hazard ratio = 1.30 (1.22, 1.39), compared to genotype 1 (reference, HR 1.0), genotype 2 with HR = 0.68 (0.64, 0.73), and genotype 4 with HR = 0.94 (0.78, 1.14). Likewise, the risk of development of hepatocellular carcinoma was highest for genotype 3 HCV with HR = 1.80 (1.60, 2.03), compared to a genotype 2 (HR = 0.55, 0.47, 0.63), and genotype 4 (0.99, 0.68, 1.45).  
It is speculated that the hepatic steatosis that is a direct result of genotype 3 HCV may contribute to the accelerated progression to cirrhosis and HCC, but this has not been proven and was not evaluated in this Veteran Affairs study.
 
Reference
1. Kanwal F, Kramer JR, Ilyas J, et al. HCV genotype 3 is associated with an increased risk of cirrhosis and hepatocellular cancer in a national sample of U.S. veterans with HCV. Hepatology. 2014;60(1):98-105.

Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.

Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.

Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.