M. Alexander Otto

SAN FRANCISCO – Both sorafenib and transcatheter arterial chemoembolization/radiofrequency ablation can extend the lives of patients with infiltrative hepatocellular carcinoma, according to a retrospective review of 155 patients.

The radiologic-based therapy gave patients a median of 3 additional months of life; sorafenib (Nexavar) gave them a median of 4.5 months. The difference between treatments was not statistically significant.

Little research has been done on infiltrative hepatocellular carcinoma (HCC), including whether it responds to treatment. "Often [patients] are deemed not to be treatment candidates. I think we’ve shown that if you treat these patients, they have a significantly lengthened life. It’s not a huge difference, but it can be decent," said lead investigator Dr. Neil Mehta, a gastroenterology fellow at the University of California, San Francisco.

Perhaps 10% of hepatocellular carcinomas are infiltrative; these tumors are usually larger, with poor definition and vascular invasion.

"I think we’ve shown that if you treat these patients, they have a significantly lengthened life."

Just 30% of the 155 patients were treated for their tumors, including the 22 treated with transcatheter arterial chemoembolization/radiofrequency ablation (TACE/RFA) and the 11 treated with sorafenib.

These low treatment rates are not unusual. Patients might be too sick, or may opt out of treatment, Dr. Mehta said. Sometimes it’s thought that the tumor won’t respond, he added.

Treatment did appear to make a difference at UCSF, however. Eleven (50%) of the TACE/RFA patients were alive at 6 months and 4 (18%) were living at 12 months; their median survival was 6 months. Eight (73%) of the sorafenib patients were alive at 6 months, with 4 (36%) alive at 12 months; their median survival was 7.5 months. Only 17% of the untreated patients were alive at 6 months, and 2% at 12 months; their median survival was 3 months.

"Tumor-directed therapy confers a significant survival benefit even after adjusting for factors that may affect treatment eligibility," the researchers concluded. Treatment approaches in the study included liver resection, transplant, and other chemotherapy regimens.

Besides lack of treatment, predictors of death within 6 months were advanced liver disease (Child-Pugh class B or C), alpha-fetoprotein greater than 1,000 ng/mL, large tumor size, and female gender.

Patients ranged in age from 22 to 89 years, and almost 80% were men. Seventy-one percent had stage C disease in the BCLC (Barcelona Clinic Liver Cancer) classification system, whereas 23% had stage D disease, and the rest had stage A or B.

The baseline median alpha-fetoprotein was 347 ng/mL and the median MELD (Model for End-Stage Liver Disease) score was 13. The median maximal tumor diameter was 11.9 cm; 48% of patients had extrahepatic metastases, and 26% had biliary dilation. Hepatitis C was thought to be the cause of liver disease in well over half of patients, followed by hepatitis B, alcoholism, and fatty liver disease.

Dr. Mehta said he had no disclosures. Coauthor Dr. Nicholas Fidelman disclosed grant/research support from Bayer Inc., maker of sorafenib, and Nordion Inc., maker of TheraSphere, a radioembolization product for unresectable HCC.

SAN FRANCISCO – Both sorafenib and transcatheter arterial chemoembolization/radiofrequency ablation can extend the lives of patients with infiltrative hepatocellular carcinoma, according to a retrospective review of 155 patients.

The radiologic-based therapy gave patients a median of 3 additional months of life; sorafenib (Nexavar) gave them a median of 4.5 months. The difference between treatments was not statistically significant.

Little research has been done on infiltrative hepatocellular carcinoma (HCC), including whether it responds to treatment. "Often [patients] are deemed not to be treatment candidates. I think we’ve shown that if you treat these patients, they have a significantly lengthened life. It’s not a huge difference, but it can be decent," said lead investigator Dr. Neil Mehta, a gastroenterology fellow at the University of California, San Francisco.

Perhaps 10% of hepatocellular carcinomas are infiltrative; these tumors are usually larger, with poor definition and vascular invasion.

"I think we’ve shown that if you treat these patients, they have a significantly lengthened life."

Just 30% of the 155 patients were treated for their tumors, including the 22 treated with transcatheter arterial chemoembolization/radiofrequency ablation (TACE/RFA) and the 11 treated with sorafenib.

These low treatment rates are not unusual. Patients might be too sick, or may opt out of treatment, Dr. Mehta said. Sometimes it’s thought that the tumor won’t respond, he added.

Treatment did appear to make a difference at UCSF, however. Eleven (50%) of the TACE/RFA patients were alive at 6 months and 4 (18%) were living at 12 months; their median survival was 6 months. Eight (73%) of the sorafenib patients were alive at 6 months, with 4 (36%) alive at 12 months; their median survival was 7.5 months. Only 17% of the untreated patients were alive at 6 months, and 2% at 12 months; their median survival was 3 months.

"Tumor-directed therapy confers a significant survival benefit even after adjusting for factors that may affect treatment eligibility," the researchers concluded. Treatment approaches in the study included liver resection, transplant, and other chemotherapy regimens.

Besides lack of treatment, predictors of death within 6 months were advanced liver disease (Child-Pugh class B or C), alpha-fetoprotein greater than 1,000 ng/mL, large tumor size, and female gender.

Patients ranged in age from 22 to 89 years, and almost 80% were men. Seventy-one percent had stage C disease in the BCLC (Barcelona Clinic Liver Cancer) classification system, whereas 23% had stage D disease, and the rest had stage A or B.

The baseline median alpha-fetoprotein was 347 ng/mL and the median MELD (Model for End-Stage Liver Disease) score was 13. The median maximal tumor diameter was 11.9 cm; 48% of patients had extrahepatic metastases, and 26% had biliary dilation. Hepatitis C was thought to be the cause of liver disease in well over half of patients, followed by hepatitis B, alcoholism, and fatty liver disease.

Dr. Mehta said he had no disclosures. Coauthor Dr. Nicholas Fidelman disclosed grant/research support from Bayer Inc., maker of sorafenib, and Nordion Inc., maker of TheraSphere, a radioembolization product for unresectable HCC.

SAN FRANCISCO – Both sorafenib and transcatheter arterial chemoembolization/radiofrequency ablation can extend the lives of patients with infiltrative hepatocellular carcinoma, according to a retrospective review of 155 patients.

The radiologic-based therapy gave patients a median of 3 additional months of life; sorafenib (Nexavar) gave them a median of 4.5 months. The difference between treatments was not statistically significant.

Little research has been done on infiltrative hepatocellular carcinoma (HCC), including whether it responds to treatment. "Often [patients] are deemed not to be treatment candidates. I think we’ve shown that if you treat these patients, they have a significantly lengthened life. It’s not a huge difference, but it can be decent," said lead investigator Dr. Neil Mehta, a gastroenterology fellow at the University of California, San Francisco.

Perhaps 10% of hepatocellular carcinomas are infiltrative; these tumors are usually larger, with poor definition and vascular invasion.

"I think we’ve shown that if you treat these patients, they have a significantly lengthened life."

Just 30% of the 155 patients were treated for their tumors, including the 22 treated with transcatheter arterial chemoembolization/radiofrequency ablation (TACE/RFA) and the 11 treated with sorafenib.

These low treatment rates are not unusual. Patients might be too sick, or may opt out of treatment, Dr. Mehta said. Sometimes it’s thought that the tumor won’t respond, he added.

Treatment did appear to make a difference at UCSF, however. Eleven (50%) of the TACE/RFA patients were alive at 6 months and 4 (18%) were living at 12 months; their median survival was 6 months. Eight (73%) of the sorafenib patients were alive at 6 months, with 4 (36%) alive at 12 months; their median survival was 7.5 months. Only 17% of the untreated patients were alive at 6 months, and 2% at 12 months; their median survival was 3 months.

"Tumor-directed therapy confers a significant survival benefit even after adjusting for factors that may affect treatment eligibility," the researchers concluded. Treatment approaches in the study included liver resection, transplant, and other chemotherapy regimens.

Besides lack of treatment, predictors of death within 6 months were advanced liver disease (Child-Pugh class B or C), alpha-fetoprotein greater than 1,000 ng/mL, large tumor size, and female gender.

Patients ranged in age from 22 to 89 years, and almost 80% were men. Seventy-one percent had stage C disease in the BCLC (Barcelona Clinic Liver Cancer) classification system, whereas 23% had stage D disease, and the rest had stage A or B.

The baseline median alpha-fetoprotein was 347 ng/mL and the median MELD (Model for End-Stage Liver Disease) score was 13. The median maximal tumor diameter was 11.9 cm; 48% of patients had extrahepatic metastases, and 26% had biliary dilation. Hepatitis C was thought to be the cause of liver disease in well over half of patients, followed by hepatitis B, alcoholism, and fatty liver disease.

Dr. Mehta said he had no disclosures. Coauthor Dr. Nicholas Fidelman disclosed grant/research support from Bayer Inc., maker of sorafenib, and Nordion Inc., maker of TheraSphere, a radioembolization product for unresectable HCC.

SAN FRANCISCO – Nonalcoholic fatty liver disease is common in adolescent girls with polycystic ovaries, and its presence coincides with worse metabolic derangements, according to Australian researchers.

Because of that, it makes sense when doing an ultrasound study of women with polycystic ovary syndrome (PCOS) to check the liver, as well, for signs of nonalcoholic fatty liver disease (NAFLD), including increased echogenicity and bile duct or blood vessel blurring, said lead investigator Dr. Oyekoya Ayonrinde.

"If we see a girl or woman who has PCOS, we should look for the presence of fatty liver. It just adds maybe another 5 or 10 minutes to the [ultrasound] study," said Dr. Ayonrinde at the annual meeting of the American Association for the Study of Liver Diseases.

That’s important because PCOS, and perhaps even more so when combined with NAFLD, predisposes women to diabetes and cardiovascular disease, among other problems. The combination might also increase the risk of nonalcoholic steatohepatitis.

Dr. Ayonrinde, a clinical gastroenterology lecturer at the University of Western Australia in Perth, and his colleagues came to their conclusions after analyzing 244 girls aged 14-17 years in the Western Australian Pregnancy Cohort (Raine) Study, plus 578 girls and 592 boys, all 17 years old, in a separate NAFLD study. In all, 201 girls had both ovarian and liver ultrasounds, which were used to diagnose both PCOS and NAFLD.

In all, 43% of the girls with PCOS had concomitant NAFLD.

The researchers also found that suprailiac skinfold thickness (odds ratio, 1.16; 95% CI, 1.08-1.24; P less than .001) and the presence of PCOS (OR 3.87; 95% CI, 1.09-13.76; P = .04) were independent predictors of NAFLD in the Raine cohort; free testosterone levels were not predictors after obesity was controlled for.

Obesity in girls with PCOS coincided with a greater prevalence of NAFLD. Girls with both conditions had a mean suprailiac skin fold thickness of 29.6 mm; girls with PCOS alone had a mean thickness of 15.4 mm.

Girls with both conditions, compared to those with PCOS alone, also had higher serum leptin and triglyceride levels, lower serum adiponectin levels, higher body mass indexes, and more subcutaneous fat.

They "approach what we find in boys" with NAFLD, who tend to have more severe disease, Dr. Ayonrinde said.

Boys with NAFLD and girls with PCOS and NAFLD had similar body weights, waist circumferences, waist/hip ratios, body mass indexes, subcutaneous and visceral fat thicknesses, and glucose tolerance test results, as well as similar serum glucose, insulin, triglyceride, cholesterol, and adiponectin levels.

Dr. Ayonrinde said he has no disclosures. Coauthors disclosed research support from Hoffmann-La Roche and Merck – both of whom are developing NAFLD therapies – and other companies.

SAN FRANCISCO – Nonalcoholic fatty liver disease is common in adolescent girls with polycystic ovaries, and its presence coincides with worse metabolic derangements, according to Australian researchers.

Because of that, it makes sense when doing an ultrasound study of women with polycystic ovary syndrome (PCOS) to check the liver, as well, for signs of nonalcoholic fatty liver disease (NAFLD), including increased echogenicity and bile duct or blood vessel blurring, said lead investigator Dr. Oyekoya Ayonrinde.

"If we see a girl or woman who has PCOS, we should look for the presence of fatty liver. It just adds maybe another 5 or 10 minutes to the [ultrasound] study," said Dr. Ayonrinde at the annual meeting of the American Association for the Study of Liver Diseases.

That’s important because PCOS, and perhaps even more so when combined with NAFLD, predisposes women to diabetes and cardiovascular disease, among other problems. The combination might also increase the risk of nonalcoholic steatohepatitis.

Dr. Ayonrinde, a clinical gastroenterology lecturer at the University of Western Australia in Perth, and his colleagues came to their conclusions after analyzing 244 girls aged 14-17 years in the Western Australian Pregnancy Cohort (Raine) Study, plus 578 girls and 592 boys, all 17 years old, in a separate NAFLD study. In all, 201 girls had both ovarian and liver ultrasounds, which were used to diagnose both PCOS and NAFLD.

In all, 43% of the girls with PCOS had concomitant NAFLD.

The researchers also found that suprailiac skinfold thickness (odds ratio, 1.16; 95% CI, 1.08-1.24; P less than .001) and the presence of PCOS (OR 3.87; 95% CI, 1.09-13.76; P = .04) were independent predictors of NAFLD in the Raine cohort; free testosterone levels were not predictors after obesity was controlled for.

Obesity in girls with PCOS coincided with a greater prevalence of NAFLD. Girls with both conditions had a mean suprailiac skin fold thickness of 29.6 mm; girls with PCOS alone had a mean thickness of 15.4 mm.

Girls with both conditions, compared to those with PCOS alone, also had higher serum leptin and triglyceride levels, lower serum adiponectin levels, higher body mass indexes, and more subcutaneous fat.

They "approach what we find in boys" with NAFLD, who tend to have more severe disease, Dr. Ayonrinde said.

Boys with NAFLD and girls with PCOS and NAFLD had similar body weights, waist circumferences, waist/hip ratios, body mass indexes, subcutaneous and visceral fat thicknesses, and glucose tolerance test results, as well as similar serum glucose, insulin, triglyceride, cholesterol, and adiponectin levels.

Dr. Ayonrinde said he has no disclosures. Coauthors disclosed research support from Hoffmann-La Roche and Merck – both of whom are developing NAFLD therapies – and other companies.

SAN FRANCISCO – Nonalcoholic fatty liver disease is common in adolescent girls with polycystic ovaries, and its presence coincides with worse metabolic derangements, according to Australian researchers.

Because of that, it makes sense when doing an ultrasound study of women with polycystic ovary syndrome (PCOS) to check the liver, as well, for signs of nonalcoholic fatty liver disease (NAFLD), including increased echogenicity and bile duct or blood vessel blurring, said lead investigator Dr. Oyekoya Ayonrinde.

"If we see a girl or woman who has PCOS, we should look for the presence of fatty liver. It just adds maybe another 5 or 10 minutes to the [ultrasound] study," said Dr. Ayonrinde at the annual meeting of the American Association for the Study of Liver Diseases.

That’s important because PCOS, and perhaps even more so when combined with NAFLD, predisposes women to diabetes and cardiovascular disease, among other problems. The combination might also increase the risk of nonalcoholic steatohepatitis.

Dr. Ayonrinde, a clinical gastroenterology lecturer at the University of Western Australia in Perth, and his colleagues came to their conclusions after analyzing 244 girls aged 14-17 years in the Western Australian Pregnancy Cohort (Raine) Study, plus 578 girls and 592 boys, all 17 years old, in a separate NAFLD study. In all, 201 girls had both ovarian and liver ultrasounds, which were used to diagnose both PCOS and NAFLD.

In all, 43% of the girls with PCOS had concomitant NAFLD.

The researchers also found that suprailiac skinfold thickness (odds ratio, 1.16; 95% CI, 1.08-1.24; P less than .001) and the presence of PCOS (OR 3.87; 95% CI, 1.09-13.76; P = .04) were independent predictors of NAFLD in the Raine cohort; free testosterone levels were not predictors after obesity was controlled for.

Obesity in girls with PCOS coincided with a greater prevalence of NAFLD. Girls with both conditions had a mean suprailiac skin fold thickness of 29.6 mm; girls with PCOS alone had a mean thickness of 15.4 mm.

Girls with both conditions, compared to those with PCOS alone, also had higher serum leptin and triglyceride levels, lower serum adiponectin levels, higher body mass indexes, and more subcutaneous fat.

They "approach what we find in boys" with NAFLD, who tend to have more severe disease, Dr. Ayonrinde said.

Boys with NAFLD and girls with PCOS and NAFLD had similar body weights, waist circumferences, waist/hip ratios, body mass indexes, subcutaneous and visceral fat thicknesses, and glucose tolerance test results, as well as similar serum glucose, insulin, triglyceride, cholesterol, and adiponectin levels.

Dr. Ayonrinde said he has no disclosures. Coauthors disclosed research support from Hoffmann-La Roche and Merck – both of whom are developing NAFLD therapies – and other companies.

SAN FRANCISCO – Patients with primary sclerosing cholangitis may not benefit from cholecystectomy for small gallbladder polyps, based on a Mayo Clinic study.

Polyps smaller than 0.8 cm on ultrasound were benign in all cases studied, and surgical complications were common when 57 primary sclerosing cholangitis (PSC) patients had cholecystectomies at the Mayo Clinic in Rochester, Minn.

A baseline Child-Pugh score of 7 or greater was linked to increased risk of early postoperative complications.

"We have to be careful who we send for cholecystectomy for these very small lesions, given the morbidity associated with the procedure," said lead investigator Dr. John Eaton, chief medical resident in internal medicine at the Mayo Clinic.

"If you are looking at a [small] lesion and see something that’s concerning" – for instance, adjacent-wall thickening or arterial blood flow – "then it’s a case-by-case decision, [but it] needs to be made with this information in the background," he said at the annual meeting of the American Association for the Study of Liver Diseases.

Cholecystectomies are currently recommended to remove gallbladder lesions – whatever the size – in PSC patients because they are at greater risk for gallbladder cancer. It hasn’t been clear, though, whether the surgery is necessary for small polyps, or whether patients encounter complications after cholecystectomy, Dr. Eaton said.

Almost 70% percent (39) of the subjects were men. The PSC was histologic stage I or II in about half (54%) of the total cohort (31 of 57 patients). Gallbladder lesions on ultrasound were the most common indications for surgery. People with prior liver transplants or history of cholangiocarcinoma were excluded from the study.

For the cholecystectomies, about half of the patients had a laparoscopic procedure. Seventeen patients (30%) had additional surgeries when their gallbladders were removed.

Only seven polyps were smaller than 0.8 cm on preoperative ultrasounds; all of these proved to be benign, most often granulomas or normal tissue. The smallest polyp with low-grade dysplasia was 0.8 cm, and the smallest adenocarcinoma was 1.2 cm. As expected, larger growths were more likely to be cancerous.

The 0.8-cm cut-off was 100% sensitive and 70% specific for gallbladder neoplasia; the area under the receiver operating characteristic curve (AUC) was 0.90. "It’s pretty strong" as a predictor, Dr. Eaton said.

A 1.20-cm cut-off was 100% sensitive and 79% specific for gallbladder cancer, with an AUC of 0.93.

Twenty-three patients (40%) had a complication within 6 weeks after surgery, some with more than one. Bile leaks were most common. One patient required a liver transplant. A baseline Child-Pugh score of 7 was 41% sensitive and 88% specific for early postoperative complications.

Regarding longer-term follow-up, 53 patients were followed for a total of 259 patient-years. The only baseline characteristic associated with death or transplant was a PSC stage of IV (hazard ratio, 8.10; 95% confidence interval, 1.27-161.18; P = .02).

The researchers concluded that "gallbladder polyps less than 0.8 cm [on ultrasound] can be observed in patients with PSC given the low probability of malignancy and [the] high morbidity associated with a cholecystectomy."

However, the study "in no way comments on the natural history or progression [of gallbladder polyps]. If we detect one of these small lesions, well then what happens? We really can’t comment on what we should do after that," for example, whether it should be frequent ultrasounds and watchful waiting or some other approach, Dr. Eaton said.

Dr. Eaton said he has no disclosures.

SAN FRANCISCO – Patients with primary sclerosing cholangitis may not benefit from cholecystectomy for small gallbladder polyps, based on a Mayo Clinic study.

Polyps smaller than 0.8 cm on ultrasound were benign in all cases studied, and surgical complications were common when 57 primary sclerosing cholangitis (PSC) patients had cholecystectomies at the Mayo Clinic in Rochester, Minn.

A baseline Child-Pugh score of 7 or greater was linked to increased risk of early postoperative complications.

"We have to be careful who we send for cholecystectomy for these very small lesions, given the morbidity associated with the procedure," said lead investigator Dr. John Eaton, chief medical resident in internal medicine at the Mayo Clinic.

"If you are looking at a [small] lesion and see something that’s concerning" – for instance, adjacent-wall thickening or arterial blood flow – "then it’s a case-by-case decision, [but it] needs to be made with this information in the background," he said at the annual meeting of the American Association for the Study of Liver Diseases.

Cholecystectomies are currently recommended to remove gallbladder lesions – whatever the size – in PSC patients because they are at greater risk for gallbladder cancer. It hasn’t been clear, though, whether the surgery is necessary for small polyps, or whether patients encounter complications after cholecystectomy, Dr. Eaton said.

Almost 70% percent (39) of the subjects were men. The PSC was histologic stage I or II in about half (54%) of the total cohort (31 of 57 patients). Gallbladder lesions on ultrasound were the most common indications for surgery. People with prior liver transplants or history of cholangiocarcinoma were excluded from the study.

For the cholecystectomies, about half of the patients had a laparoscopic procedure. Seventeen patients (30%) had additional surgeries when their gallbladders were removed.

Only seven polyps were smaller than 0.8 cm on preoperative ultrasounds; all of these proved to be benign, most often granulomas or normal tissue. The smallest polyp with low-grade dysplasia was 0.8 cm, and the smallest adenocarcinoma was 1.2 cm. As expected, larger growths were more likely to be cancerous.

The 0.8-cm cut-off was 100% sensitive and 70% specific for gallbladder neoplasia; the area under the receiver operating characteristic curve (AUC) was 0.90. "It’s pretty strong" as a predictor, Dr. Eaton said.

A 1.20-cm cut-off was 100% sensitive and 79% specific for gallbladder cancer, with an AUC of 0.93.

Twenty-three patients (40%) had a complication within 6 weeks after surgery, some with more than one. Bile leaks were most common. One patient required a liver transplant. A baseline Child-Pugh score of 7 was 41% sensitive and 88% specific for early postoperative complications.

Regarding longer-term follow-up, 53 patients were followed for a total of 259 patient-years. The only baseline characteristic associated with death or transplant was a PSC stage of IV (hazard ratio, 8.10; 95% confidence interval, 1.27-161.18; P = .02).

The researchers concluded that "gallbladder polyps less than 0.8 cm [on ultrasound] can be observed in patients with PSC given the low probability of malignancy and [the] high morbidity associated with a cholecystectomy."

However, the study "in no way comments on the natural history or progression [of gallbladder polyps]. If we detect one of these small lesions, well then what happens? We really can’t comment on what we should do after that," for example, whether it should be frequent ultrasounds and watchful waiting or some other approach, Dr. Eaton said.

Dr. Eaton said he has no disclosures.

SAN FRANCISCO – Patients with primary sclerosing cholangitis may not benefit from cholecystectomy for small gallbladder polyps, based on a Mayo Clinic study.

Polyps smaller than 0.8 cm on ultrasound were benign in all cases studied, and surgical complications were common when 57 primary sclerosing cholangitis (PSC) patients had cholecystectomies at the Mayo Clinic in Rochester, Minn.

A baseline Child-Pugh score of 7 or greater was linked to increased risk of early postoperative complications.

"We have to be careful who we send for cholecystectomy for these very small lesions, given the morbidity associated with the procedure," said lead investigator Dr. John Eaton, chief medical resident in internal medicine at the Mayo Clinic.

"If you are looking at a [small] lesion and see something that’s concerning" – for instance, adjacent-wall thickening or arterial blood flow – "then it’s a case-by-case decision, [but it] needs to be made with this information in the background," he said at the annual meeting of the American Association for the Study of Liver Diseases.

Cholecystectomies are currently recommended to remove gallbladder lesions – whatever the size – in PSC patients because they are at greater risk for gallbladder cancer. It hasn’t been clear, though, whether the surgery is necessary for small polyps, or whether patients encounter complications after cholecystectomy, Dr. Eaton said.

Almost 70% percent (39) of the subjects were men. The PSC was histologic stage I or II in about half (54%) of the total cohort (31 of 57 patients). Gallbladder lesions on ultrasound were the most common indications for surgery. People with prior liver transplants or history of cholangiocarcinoma were excluded from the study.

For the cholecystectomies, about half of the patients had a laparoscopic procedure. Seventeen patients (30%) had additional surgeries when their gallbladders were removed.

Only seven polyps were smaller than 0.8 cm on preoperative ultrasounds; all of these proved to be benign, most often granulomas or normal tissue. The smallest polyp with low-grade dysplasia was 0.8 cm, and the smallest adenocarcinoma was 1.2 cm. As expected, larger growths were more likely to be cancerous.

The 0.8-cm cut-off was 100% sensitive and 70% specific for gallbladder neoplasia; the area under the receiver operating characteristic curve (AUC) was 0.90. "It’s pretty strong" as a predictor, Dr. Eaton said.

A 1.20-cm cut-off was 100% sensitive and 79% specific for gallbladder cancer, with an AUC of 0.93.

Twenty-three patients (40%) had a complication within 6 weeks after surgery, some with more than one. Bile leaks were most common. One patient required a liver transplant. A baseline Child-Pugh score of 7 was 41% sensitive and 88% specific for early postoperative complications.

Regarding longer-term follow-up, 53 patients were followed for a total of 259 patient-years. The only baseline characteristic associated with death or transplant was a PSC stage of IV (hazard ratio, 8.10; 95% confidence interval, 1.27-161.18; P = .02).

The researchers concluded that "gallbladder polyps less than 0.8 cm [on ultrasound] can be observed in patients with PSC given the low probability of malignancy and [the] high morbidity associated with a cholecystectomy."

However, the study "in no way comments on the natural history or progression [of gallbladder polyps]. If we detect one of these small lesions, well then what happens? We really can’t comment on what we should do after that," for example, whether it should be frequent ultrasounds and watchful waiting or some other approach, Dr. Eaton said.

Dr. Eaton said he has no disclosures.

SAN FRANCISCO – Transesophageal echocardiogram does not cause bleeding in cirrhotic patients with small varices or with large varices that have been previously treated, according to Australian researchers at the annual meeting of the American Association for the Study of Liver Diseases.

In a retrospective case series, 75 patients with varices had undergone 78 transesophageal echocardiograms (TEEs), most of which were done to rule out endocarditis or to monitor hemodynamic stability during liver transplantation. A total of 62 patients (83%) had esophageal varices, and 19 (25%) had gastric varices.

About half of the esophageal varices were larger than 5 mm, sometimes with red whale marks, spurting, or other endoscopic stigmata. In a few cases, the varices filled up more than half of the esophageal lumen. Large varices were treated before TEE, usually by banding or transjugular intrahepatic portosystemic shunt.

Twenty-two percent (14) of the esophageal varices and 33% (6) of the gastric varices were treated before TEE. The rest were deemed too small to need treatment.

None of the patients bled from the TEE procedure, which was done in one case just a week after banding, but in most cases was done several months later, said investigator and gastroenterologist Lucy Lim.

It’s an important finding because the theoretical bleeding risk means that "there’s still a lot of controversy" about whether TEEs are safe in patients with varices. Cardiologists – who most often do the procedure – sometimes "outright refuse if there are even small varices. They are the ones we need to convince," said Dr. Lim of the gastroenterology and liver transplant unit at the Austin Hospital in Melbourne.

Almost 70% (52) of the patients were men (average age, 54 years). The majority had Childs-Pugh A cirrhosis; the rest had Childs-Pugh B. The cirrhosis was attributed to hepatitis C or alcohol consumption in most cases. Varices are a common complication of cirrhosis-induced portal vein hypertension.

A smaller 2009 case series also found that TEEs were safe in patients with varices (J. Am. Soc. Echocardiogr. 2009;22:396-400). A comprehensive review of the issue was published in 2010 (J. Am. Soc. Echocardiogr. 2010;23:1115-27).

Dr. Lim said she had no relevant financial disclosures.

SAN FRANCISCO – Transesophageal echocardiogram does not cause bleeding in cirrhotic patients with small varices or with large varices that have been previously treated, according to Australian researchers at the annual meeting of the American Association for the Study of Liver Diseases.

In a retrospective case series, 75 patients with varices had undergone 78 transesophageal echocardiograms (TEEs), most of which were done to rule out endocarditis or to monitor hemodynamic stability during liver transplantation. A total of 62 patients (83%) had esophageal varices, and 19 (25%) had gastric varices.

About half of the esophageal varices were larger than 5 mm, sometimes with red whale marks, spurting, or other endoscopic stigmata. In a few cases, the varices filled up more than half of the esophageal lumen. Large varices were treated before TEE, usually by banding or transjugular intrahepatic portosystemic shunt.

Twenty-two percent (14) of the esophageal varices and 33% (6) of the gastric varices were treated before TEE. The rest were deemed too small to need treatment.

None of the patients bled from the TEE procedure, which was done in one case just a week after banding, but in most cases was done several months later, said investigator and gastroenterologist Lucy Lim.

It’s an important finding because the theoretical bleeding risk means that "there’s still a lot of controversy" about whether TEEs are safe in patients with varices. Cardiologists – who most often do the procedure – sometimes "outright refuse if there are even small varices. They are the ones we need to convince," said Dr. Lim of the gastroenterology and liver transplant unit at the Austin Hospital in Melbourne.

Almost 70% (52) of the patients were men (average age, 54 years). The majority had Childs-Pugh A cirrhosis; the rest had Childs-Pugh B. The cirrhosis was attributed to hepatitis C or alcohol consumption in most cases. Varices are a common complication of cirrhosis-induced portal vein hypertension.

A smaller 2009 case series also found that TEEs were safe in patients with varices (J. Am. Soc. Echocardiogr. 2009;22:396-400). A comprehensive review of the issue was published in 2010 (J. Am. Soc. Echocardiogr. 2010;23:1115-27).

Dr. Lim said she had no relevant financial disclosures.

SAN FRANCISCO – Transesophageal echocardiogram does not cause bleeding in cirrhotic patients with small varices or with large varices that have been previously treated, according to Australian researchers at the annual meeting of the American Association for the Study of Liver Diseases.

In a retrospective case series, 75 patients with varices had undergone 78 transesophageal echocardiograms (TEEs), most of which were done to rule out endocarditis or to monitor hemodynamic stability during liver transplantation. A total of 62 patients (83%) had esophageal varices, and 19 (25%) had gastric varices.

About half of the esophageal varices were larger than 5 mm, sometimes with red whale marks, spurting, or other endoscopic stigmata. In a few cases, the varices filled up more than half of the esophageal lumen. Large varices were treated before TEE, usually by banding or transjugular intrahepatic portosystemic shunt.

Twenty-two percent (14) of the esophageal varices and 33% (6) of the gastric varices were treated before TEE. The rest were deemed too small to need treatment.

None of the patients bled from the TEE procedure, which was done in one case just a week after banding, but in most cases was done several months later, said investigator and gastroenterologist Lucy Lim.

It’s an important finding because the theoretical bleeding risk means that "there’s still a lot of controversy" about whether TEEs are safe in patients with varices. Cardiologists – who most often do the procedure – sometimes "outright refuse if there are even small varices. They are the ones we need to convince," said Dr. Lim of the gastroenterology and liver transplant unit at the Austin Hospital in Melbourne.

Almost 70% (52) of the patients were men (average age, 54 years). The majority had Childs-Pugh A cirrhosis; the rest had Childs-Pugh B. The cirrhosis was attributed to hepatitis C or alcohol consumption in most cases. Varices are a common complication of cirrhosis-induced portal vein hypertension.

A smaller 2009 case series also found that TEEs were safe in patients with varices (J. Am. Soc. Echocardiogr. 2009;22:396-400). A comprehensive review of the issue was published in 2010 (J. Am. Soc. Echocardiogr. 2010;23:1115-27).

Dr. Lim said she had no relevant financial disclosures.

SAN FRANCISCO – Radiofrequency ablation appears to work as well as surgical resection for treating early-stage hepatocellular carcinomas, based on a randomized trial of 168 patients.

Researchers at Southwest Hospital in Chongqing, China, compared radiofrequency ablation (RFA) with surgical resection; there were 84 patients in each group. Each patient had either one or two tumors that were less than 4 cm in diameter.

In the surgical resection group, 81 patients (96%) were alive at 1 year, 74 (88%) at 2 years, and 63 (75%) at 3 years. In the RFA group, 78 (93%) were alive at 1 year, 70 (83%) at 2 years, and 57 (68%) at 3 years. The differences between groups were not statistically significant (P = .3).

Results for tumor recurrence were similar: 27 (32%) of the surgery patients had tumor recurrence within 3 years, compared with 35 (42%) of the RFA patients. Again, this difference was not statistically significant.

For treatment of one or two liver tumors less than 4 cm, "RFA provided the same overall and recurrence-free survival rates as surgical resection [and] has the advantages of minimal invasiveness and a low occurrence of complications," said lead investigator Dr. Ma Kuansheng of the hospital’s hepatobiliary surgery department. Also, costs are lower with RFA, he added.

The study findings could help settle the debate about which technique is better for treating early liver cancer. "There are always arguments [about whether] you should just cut it out, [or] try [RFA]. I think this study basically shows that there is no difference, so you should decide what’s the most economic way of dealing with this," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases, at the association’s annual meeting.

In the United States, both treatment approaches are available. However, surgery can be especially difficult in patients with cirrhosis. "Because their livers are all scarred, it’s very difficult to resect them," said Dr. Liang, also chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Almost 10% of the RFA patients developed complications during the procedure, including two patients with hemorrhage. In contrast, complications occurred in over 20% of surgery patients, including two with hemorrhage that required emergency laparotomy, and one with a liver abscess.

RFA took an average of 41 minutes, and had a mean blood loss of 21 mL. Surgery took 141 minutes on average, and blood loss was a mean of 375 mL; many patients needed transfusions. Length of hospital stay was about 1 week for RFA patients vs. just over 2 weeks for surgery patients.

Eight RFA patients had residual tumor that was missed during the procedure: six with tumor under the liver capsule, one with tumor next to the gallbladder, and one with tumor adjacent to the portal vein trunk. Analysis both with and without those patients did not significantly affect 3-year survival outcomes.

Most of the patients in both arms were men, with a mean age of about 50 years. A total of 85% had blood markers of hepatitis, most often hepatitis B surface antigen. There were no statistically significant baseline differences in alanine aminotransferase; alpha-fetoprotein; tumor size, number, or grade; or other characteristics.

The findings come at a time when liver cancer is on the rise, "mostly because of viral hepatitis," Dr. Liang noted. "The best treatment for liver cancer is liver transplantation. You get a very high cure rate if you transplant early enough, but, obviously, not everybody can be transplanted. There are resource issues," he said.

Dr. Kuansheng and Dr. Liang said they have no financial disclosures.

SAN FRANCISCO – Radiofrequency ablation appears to work as well as surgical resection for treating early-stage hepatocellular carcinomas, based on a randomized trial of 168 patients.

Researchers at Southwest Hospital in Chongqing, China, compared radiofrequency ablation (RFA) with surgical resection; there were 84 patients in each group. Each patient had either one or two tumors that were less than 4 cm in diameter.

In the surgical resection group, 81 patients (96%) were alive at 1 year, 74 (88%) at 2 years, and 63 (75%) at 3 years. In the RFA group, 78 (93%) were alive at 1 year, 70 (83%) at 2 years, and 57 (68%) at 3 years. The differences between groups were not statistically significant (P = .3).

Results for tumor recurrence were similar: 27 (32%) of the surgery patients had tumor recurrence within 3 years, compared with 35 (42%) of the RFA patients. Again, this difference was not statistically significant.

For treatment of one or two liver tumors less than 4 cm, "RFA provided the same overall and recurrence-free survival rates as surgical resection [and] has the advantages of minimal invasiveness and a low occurrence of complications," said lead investigator Dr. Ma Kuansheng of the hospital’s hepatobiliary surgery department. Also, costs are lower with RFA, he added.

The study findings could help settle the debate about which technique is better for treating early liver cancer. "There are always arguments [about whether] you should just cut it out, [or] try [RFA]. I think this study basically shows that there is no difference, so you should decide what’s the most economic way of dealing with this," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases, at the association’s annual meeting.

In the United States, both treatment approaches are available. However, surgery can be especially difficult in patients with cirrhosis. "Because their livers are all scarred, it’s very difficult to resect them," said Dr. Liang, also chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Almost 10% of the RFA patients developed complications during the procedure, including two patients with hemorrhage. In contrast, complications occurred in over 20% of surgery patients, including two with hemorrhage that required emergency laparotomy, and one with a liver abscess.

RFA took an average of 41 minutes, and had a mean blood loss of 21 mL. Surgery took 141 minutes on average, and blood loss was a mean of 375 mL; many patients needed transfusions. Length of hospital stay was about 1 week for RFA patients vs. just over 2 weeks for surgery patients.

Eight RFA patients had residual tumor that was missed during the procedure: six with tumor under the liver capsule, one with tumor next to the gallbladder, and one with tumor adjacent to the portal vein trunk. Analysis both with and without those patients did not significantly affect 3-year survival outcomes.

Most of the patients in both arms were men, with a mean age of about 50 years. A total of 85% had blood markers of hepatitis, most often hepatitis B surface antigen. There were no statistically significant baseline differences in alanine aminotransferase; alpha-fetoprotein; tumor size, number, or grade; or other characteristics.

The findings come at a time when liver cancer is on the rise, "mostly because of viral hepatitis," Dr. Liang noted. "The best treatment for liver cancer is liver transplantation. You get a very high cure rate if you transplant early enough, but, obviously, not everybody can be transplanted. There are resource issues," he said.

Dr. Kuansheng and Dr. Liang said they have no financial disclosures.

SAN FRANCISCO – Radiofrequency ablation appears to work as well as surgical resection for treating early-stage hepatocellular carcinomas, based on a randomized trial of 168 patients.

Researchers at Southwest Hospital in Chongqing, China, compared radiofrequency ablation (RFA) with surgical resection; there were 84 patients in each group. Each patient had either one or two tumors that were less than 4 cm in diameter.

In the surgical resection group, 81 patients (96%) were alive at 1 year, 74 (88%) at 2 years, and 63 (75%) at 3 years. In the RFA group, 78 (93%) were alive at 1 year, 70 (83%) at 2 years, and 57 (68%) at 3 years. The differences between groups were not statistically significant (P = .3).

Results for tumor recurrence were similar: 27 (32%) of the surgery patients had tumor recurrence within 3 years, compared with 35 (42%) of the RFA patients. Again, this difference was not statistically significant.

For treatment of one or two liver tumors less than 4 cm, "RFA provided the same overall and recurrence-free survival rates as surgical resection [and] has the advantages of minimal invasiveness and a low occurrence of complications," said lead investigator Dr. Ma Kuansheng of the hospital’s hepatobiliary surgery department. Also, costs are lower with RFA, he added.

The study findings could help settle the debate about which technique is better for treating early liver cancer. "There are always arguments [about whether] you should just cut it out, [or] try [RFA]. I think this study basically shows that there is no difference, so you should decide what’s the most economic way of dealing with this," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases, at the association’s annual meeting.

In the United States, both treatment approaches are available. However, surgery can be especially difficult in patients with cirrhosis. "Because their livers are all scarred, it’s very difficult to resect them," said Dr. Liang, also chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Almost 10% of the RFA patients developed complications during the procedure, including two patients with hemorrhage. In contrast, complications occurred in over 20% of surgery patients, including two with hemorrhage that required emergency laparotomy, and one with a liver abscess.

RFA took an average of 41 minutes, and had a mean blood loss of 21 mL. Surgery took 141 minutes on average, and blood loss was a mean of 375 mL; many patients needed transfusions. Length of hospital stay was about 1 week for RFA patients vs. just over 2 weeks for surgery patients.

Eight RFA patients had residual tumor that was missed during the procedure: six with tumor under the liver capsule, one with tumor next to the gallbladder, and one with tumor adjacent to the portal vein trunk. Analysis both with and without those patients did not significantly affect 3-year survival outcomes.

Most of the patients in both arms were men, with a mean age of about 50 years. A total of 85% had blood markers of hepatitis, most often hepatitis B surface antigen. There were no statistically significant baseline differences in alanine aminotransferase; alpha-fetoprotein; tumor size, number, or grade; or other characteristics.

The findings come at a time when liver cancer is on the rise, "mostly because of viral hepatitis," Dr. Liang noted. "The best treatment for liver cancer is liver transplantation. You get a very high cure rate if you transplant early enough, but, obviously, not everybody can be transplanted. There are resource issues," he said.

Dr. Kuansheng and Dr. Liang said they have no financial disclosures.

SAN FRANCISCO – The anticoagulant enoxaparin appears to prevent portal vein thrombosis in patients with advanced cirrhosis, based on a small Italian study presented at the annual meeting of the American Association for the Study of Liver Diseases.

In this trial, 6 of 36 patients (17%) randomized to placebo developed partial or complete portal vein thrombosis (PVT) within a year, whereas none of the 34 patients (0%) randomized to 4,000 IU daily of the low-molecular-weight heparin developed PVT.

The analysis indicated that enoxaparin had a significant protective effect (HR 0.218; 95% CI, 0.048-0.994, P = .049) in these patients with advanced cirrhosis.

At enrollment, none of the patients had PVT. The treatment and placebo groups had no significant differences in terms of biochemical or demographic factors at the outset of the trial, which was the first to prospectively investigate whether anticoagulation prevents PVT.

At the meeting, lead investigator Dr. Erica Villa, professor of gastroenterology at the University of Modena and Reggio Emilia in Modena, Italy, said that the results need to be confirmed in larger studies.

All of the subjects had cirrhosis classified as Child-Pugh B7 to C10. The mean age in both groups was 57 years, and the mean MELD (Model for End-Stage Liver Disease) score was approximately 14. Men made up more than 60% of both arms.

Enoxaparin appeared to provide significant protection against decompensation – defined as new-onset ascites, hepatic encephalopathy, or variceal bleeding – and death. Four enoxaparin patients (12%) decompensated during treatment, whereas 22 (61%) in the placebo arm decompensated. The difference persisted even after treatment with enoxaparin ended at 12 months.

Similarly, although 10 patients died in the enoxaparin group – 4 from sepsis, 2 from progressive liver failure, 3 from hepatocellular carcinoma, and 1 from variceal bleeding – 16 died in the placebo group. These deaths were due to sepsis in seven patients, progressive liver failure in another seven, hepatocellular carcinoma in one, and variceal bleeding in one.

There were no hemorrhagic or other treatment-related adverse events in the enoxaparin group, although asymptomatic thrombocytopenia led to the withdrawal of one patient 3 months into the trial. Three enoxaparin patients had liver transplants while on the drug, and Dr. Villa noted that they did not need extra blood transfusions.

Dr. Villa said she had no disclosures. She said the study was funded internally, and not by a company that makes enoxaparin.

SAN FRANCISCO – The anticoagulant enoxaparin appears to prevent portal vein thrombosis in patients with advanced cirrhosis, based on a small Italian study presented at the annual meeting of the American Association for the Study of Liver Diseases.

In this trial, 6 of 36 patients (17%) randomized to placebo developed partial or complete portal vein thrombosis (PVT) within a year, whereas none of the 34 patients (0%) randomized to 4,000 IU daily of the low-molecular-weight heparin developed PVT.

The analysis indicated that enoxaparin had a significant protective effect (HR 0.218; 95% CI, 0.048-0.994, P = .049) in these patients with advanced cirrhosis.

At enrollment, none of the patients had PVT. The treatment and placebo groups had no significant differences in terms of biochemical or demographic factors at the outset of the trial, which was the first to prospectively investigate whether anticoagulation prevents PVT.

At the meeting, lead investigator Dr. Erica Villa, professor of gastroenterology at the University of Modena and Reggio Emilia in Modena, Italy, said that the results need to be confirmed in larger studies.

All of the subjects had cirrhosis classified as Child-Pugh B7 to C10. The mean age in both groups was 57 years, and the mean MELD (Model for End-Stage Liver Disease) score was approximately 14. Men made up more than 60% of both arms.

Enoxaparin appeared to provide significant protection against decompensation – defined as new-onset ascites, hepatic encephalopathy, or variceal bleeding – and death. Four enoxaparin patients (12%) decompensated during treatment, whereas 22 (61%) in the placebo arm decompensated. The difference persisted even after treatment with enoxaparin ended at 12 months.

Similarly, although 10 patients died in the enoxaparin group – 4 from sepsis, 2 from progressive liver failure, 3 from hepatocellular carcinoma, and 1 from variceal bleeding – 16 died in the placebo group. These deaths were due to sepsis in seven patients, progressive liver failure in another seven, hepatocellular carcinoma in one, and variceal bleeding in one.

There were no hemorrhagic or other treatment-related adverse events in the enoxaparin group, although asymptomatic thrombocytopenia led to the withdrawal of one patient 3 months into the trial. Three enoxaparin patients had liver transplants while on the drug, and Dr. Villa noted that they did not need extra blood transfusions.

Dr. Villa said she had no disclosures. She said the study was funded internally, and not by a company that makes enoxaparin.

SAN FRANCISCO – The anticoagulant enoxaparin appears to prevent portal vein thrombosis in patients with advanced cirrhosis, based on a small Italian study presented at the annual meeting of the American Association for the Study of Liver Diseases.

In this trial, 6 of 36 patients (17%) randomized to placebo developed partial or complete portal vein thrombosis (PVT) within a year, whereas none of the 34 patients (0%) randomized to 4,000 IU daily of the low-molecular-weight heparin developed PVT.

The analysis indicated that enoxaparin had a significant protective effect (HR 0.218; 95% CI, 0.048-0.994, P = .049) in these patients with advanced cirrhosis.

At enrollment, none of the patients had PVT. The treatment and placebo groups had no significant differences in terms of biochemical or demographic factors at the outset of the trial, which was the first to prospectively investigate whether anticoagulation prevents PVT.

At the meeting, lead investigator Dr. Erica Villa, professor of gastroenterology at the University of Modena and Reggio Emilia in Modena, Italy, said that the results need to be confirmed in larger studies.

All of the subjects had cirrhosis classified as Child-Pugh B7 to C10. The mean age in both groups was 57 years, and the mean MELD (Model for End-Stage Liver Disease) score was approximately 14. Men made up more than 60% of both arms.

Enoxaparin appeared to provide significant protection against decompensation – defined as new-onset ascites, hepatic encephalopathy, or variceal bleeding – and death. Four enoxaparin patients (12%) decompensated during treatment, whereas 22 (61%) in the placebo arm decompensated. The difference persisted even after treatment with enoxaparin ended at 12 months.

Similarly, although 10 patients died in the enoxaparin group – 4 from sepsis, 2 from progressive liver failure, 3 from hepatocellular carcinoma, and 1 from variceal bleeding – 16 died in the placebo group. These deaths were due to sepsis in seven patients, progressive liver failure in another seven, hepatocellular carcinoma in one, and variceal bleeding in one.

There were no hemorrhagic or other treatment-related adverse events in the enoxaparin group, although asymptomatic thrombocytopenia led to the withdrawal of one patient 3 months into the trial. Three enoxaparin patients had liver transplants while on the drug, and Dr. Villa noted that they did not need extra blood transfusions.

Dr. Villa said she had no disclosures. She said the study was funded internally, and not by a company that makes enoxaparin.

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.

SAN FRANCISCO – Telaprevir is unlikely to be cost-effective as a first-line agent in treatment-naive genotype 1 hepatitis C patients with the CC interleukin 28B polymorphism, according to economic modeling of previously published data.

That’s because most of them don’t need telaprevir; about two-thirds will have a sustained virologic response (SVR) – essentially a cure – with standard pegylated interferon alfa/ribavirin therapy. It makes more economic sense to try that approach first, keeping telaprevir (Incivek) in reserve for patients who relapse or fail to respond, said lead investigator Dr. Ziad Gellad of Duke University, Durham, N.C.

SVR rates with that approach are about 90%, the same as if telaprevir was used right from the start. "The same proportion of the population will be cured whether you use telaprevir upfront or whether you use it as rescue. Maybe it’s worth reconsidering whether everyone needs these expensive drugs," Dr. Gellad said.

Of course, patients might not want to endure a 48-week or longer interferon/ribavirin regimen when adding telaprevir from the start may shorten treatment to 24 weeks, and it’s unclear at this point if insurers would ask them to do so. "Everybody is still working through those [payment] issues" following telaprevir’s May 2011 Food and Drug Administration approval, Dr. Gellad said.

Current labeling indicates that the drug can be used combination with interferon and ribavirin for both HCV treatment-naive patients and those who’ve failed initial dual therapy, suggesting a role as either a first- or second-line agent. Labeling also notes that the CC IL28B genotype – as opposed to the CT or TT genotypes – strongly predicts response to dual therapy.

There are commercially available screening blood tests for the polymorphism. The patent on the technology is shared by Duke, Merck, and Duke scientists who discovered it. It’s mostly academic hepatologists who screen for the polymorphism at present, said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases.

Although the study results support the test’s utility, Dr. Gellad, who has no ownership rights to the patent, cautioned that the "use of IL28 screening is still unclear. It may be that there are other pretreatment predictors that will also be helpful, or it may be, as many have argued, that on-treatment response is the best predictor [of outcome], rendering IL28 testing obsolete. This is still a matter of debate."

Dr. Gellad and his colleagues compared previously published SVR rates, and their associated costs, for three regimens. The first, standard 48 weeks of interferon and ribavirin, cost $54,931 and gave patients an estimated 19.38 quality-adjusted life years (QALYS). Interferon/ribavirin for 24 weeks – in individuals with rapid virologic responses – cost $46,785 and gave patients 19.26 QALYS. Modeling included re-treating nonresponders and relapsers with a 48-week telaprevir-inclusive regimen.

In the third strategy, individuals got 12 weeks of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin, again based on their virologic responses. The approach cost $68,788 and gave people 19.34 QALYS.

With all three approaches leading to SVRs in about 90% of patients and just over 19 QALYS, paying more for the same ultimate result makes little economic sense, the researchers concluded.

The study "is very important," said Dr. Liang, also chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

"With dwindling resources, we need to figure out whether a particular treatment is more cost effective than others. We are all very excited about the approval of [direct-acting antivirals like telaprevir] that clearly enhance treatment response, but perhaps not one size fits all. Maybe this could be a way for us to save some money," he said.

Dr. Gellad and his colleagues will continue to study the issue, and plan to include boceprevir (Victrelis) – another direct-acting HCV antiviral approved in May – to their modeling. "The story will get more interesting," he said.

Dr. Gellad is a consultant to and gets grant support from Merck, maker of boceprevir. He said that the company was not involved in the study.

SAN FRANCISCO – When cancer patients have hepatitis B virus, prophylaxis to prevent its reactivation during chemotherapy lowers their mortality, but screening for the virus remains uncommon, said researchers from M.D. Anderson Cancer Center in Houston.

Just 17% (1,787) of 10,729 patients who started chemotherapy there during a 3-year study were screened beforehand for hepatitis B virus (HBV), despite recommendations to do so from the Centers for Disease Control and Prevention and other groups.

Of those screened, 151 (8%) proved to be positive for hepatitis B surface antigen (HBsAg) and/or antibody to hepatitis B core antigen (anti-HBc). In all, 34 of them (23%) reactivated during chemotherapy. Most were being treated for hematologic malignancies.

Among the nine patients whose hepatitis B reactivated despite prophylaxis – in most cases with lamivudine (Epivir) – two patients (22%) died. Among the 11 who were treated with antivirals only after reactivation, 8 (72%) died. And of the 14 who were not treated with antivirals for their reactivation, 10 (71%) died.

M.D. Anderson probably isn’t the only institution failing to follow the HBV screening and prophylaxis recommendations, and physicians may be unaware of the guidelines, said lead investigator Dr. Jessica Hwang at the annual meeting of the American Association for the Study of Liver Diseases.

There’s also been – at least until now – a lack of large studies supporting the practice of screening and prophylaxis for HBV before chemotherapy. The evidence gap has led to debate about the merits of the approach, said Dr. Hwang, assistant professor in the department of general internal medicine at M.D. Anderson.

Now the study findings address this gap, showing that "preventable reactivation does occur. Prophylactic antivirals [can] dramatically reduce mortality in cancer patients with hepatitis B infection. You need to prophylax them before chemotherapy," Dr. Hwang said.

At least one observer agreed. It’s "a very simple solution to prevent potentially life-threatening complications" from the virus, said Dr. T. Jake Liang, president of the American Association for the Study of Liver Diseases and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Patients in the study were more likely to be screened if they were male, treated with rituximab (Rituxan), had hematologic cancers, or had at least one HBV risk factor. The risk factors include injection drug use, living with a person who has chronic hepatitis B, and hemodialysis, among others.

Patients were more likely to screen positive for HBV if they had a risk factor, or if they were male, Asian, or black.

The study also found that reactivators tended to be slightly younger – 47 years on average – than HBV-positive patients who did not reactivate; their mean age was 54.

Dr. Liang said he has no disclosures. Dr. Hwang disclosed grant support form Bristol-Myers Squibb, maker of the anti-HBV drug entecavir (Baraclude). The company funded the study, together with the National Cancer Institute and the American Cancer Society.

SAN FRANCISCO – When cancer patients have hepatitis B virus, prophylaxis to prevent its reactivation during chemotherapy lowers their mortality, but screening for the virus remains uncommon, said researchers from M.D. Anderson Cancer Center in Houston.

Just 17% (1,787) of 10,729 patients who started chemotherapy there during a 3-year study were screened beforehand for hepatitis B virus (HBV), despite recommendations to do so from the Centers for Disease Control and Prevention and other groups.

Of those screened, 151 (8%) proved to be positive for hepatitis B surface antigen (HBsAg) and/or antibody to hepatitis B core antigen (anti-HBc). In all, 34 of them (23%) reactivated during chemotherapy. Most were being treated for hematologic malignancies.

Among the nine patients whose hepatitis B reactivated despite prophylaxis – in most cases with lamivudine (Epivir) – two patients (22%) died. Among the 11 who were treated with antivirals only after reactivation, 8 (72%) died. And of the 14 who were not treated with antivirals for their reactivation, 10 (71%) died.

M.D. Anderson probably isn’t the only institution failing to follow the HBV screening and prophylaxis recommendations, and physicians may be unaware of the guidelines, said lead investigator Dr. Jessica Hwang at the annual meeting of the American Association for the Study of Liver Diseases.

There’s also been – at least until now – a lack of large studies supporting the practice of screening and prophylaxis for HBV before chemotherapy. The evidence gap has led to debate about the merits of the approach, said Dr. Hwang, assistant professor in the department of general internal medicine at M.D. Anderson.

Now the study findings address this gap, showing that "preventable reactivation does occur. Prophylactic antivirals [can] dramatically reduce mortality in cancer patients with hepatitis B infection. You need to prophylax them before chemotherapy," Dr. Hwang said.

At least one observer agreed. It’s "a very simple solution to prevent potentially life-threatening complications" from the virus, said Dr. T. Jake Liang, president of the American Association for the Study of Liver Diseases and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Patients in the study were more likely to be screened if they were male, treated with rituximab (Rituxan), had hematologic cancers, or had at least one HBV risk factor. The risk factors include injection drug use, living with a person who has chronic hepatitis B, and hemodialysis, among others.

Patients were more likely to screen positive for HBV if they had a risk factor, or if they were male, Asian, or black.

The study also found that reactivators tended to be slightly younger – 47 years on average – than HBV-positive patients who did not reactivate; their mean age was 54.

Dr. Liang said he has no disclosures. Dr. Hwang disclosed grant support form Bristol-Myers Squibb, maker of the anti-HBV drug entecavir (Baraclude). The company funded the study, together with the National Cancer Institute and the American Cancer Society.

SAN FRANCISCO – When cancer patients have hepatitis B virus, prophylaxis to prevent its reactivation during chemotherapy lowers their mortality, but screening for the virus remains uncommon, said researchers from M.D. Anderson Cancer Center in Houston.

Just 17% (1,787) of 10,729 patients who started chemotherapy there during a 3-year study were screened beforehand for hepatitis B virus (HBV), despite recommendations to do so from the Centers for Disease Control and Prevention and other groups.

Of those screened, 151 (8%) proved to be positive for hepatitis B surface antigen (HBsAg) and/or antibody to hepatitis B core antigen (anti-HBc). In all, 34 of them (23%) reactivated during chemotherapy. Most were being treated for hematologic malignancies.

Among the nine patients whose hepatitis B reactivated despite prophylaxis – in most cases with lamivudine (Epivir) – two patients (22%) died. Among the 11 who were treated with antivirals only after reactivation, 8 (72%) died. And of the 14 who were not treated with antivirals for their reactivation, 10 (71%) died.

M.D. Anderson probably isn’t the only institution failing to follow the HBV screening and prophylaxis recommendations, and physicians may be unaware of the guidelines, said lead investigator Dr. Jessica Hwang at the annual meeting of the American Association for the Study of Liver Diseases.

There’s also been – at least until now – a lack of large studies supporting the practice of screening and prophylaxis for HBV before chemotherapy. The evidence gap has led to debate about the merits of the approach, said Dr. Hwang, assistant professor in the department of general internal medicine at M.D. Anderson.

Now the study findings address this gap, showing that "preventable reactivation does occur. Prophylactic antivirals [can] dramatically reduce mortality in cancer patients with hepatitis B infection. You need to prophylax them before chemotherapy," Dr. Hwang said.

At least one observer agreed. It’s "a very simple solution to prevent potentially life-threatening complications" from the virus, said Dr. T. Jake Liang, president of the American Association for the Study of Liver Diseases and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

Patients in the study were more likely to be screened if they were male, treated with rituximab (Rituxan), had hematologic cancers, or had at least one HBV risk factor. The risk factors include injection drug use, living with a person who has chronic hepatitis B, and hemodialysis, among others.

Patients were more likely to screen positive for HBV if they had a risk factor, or if they were male, Asian, or black.

The study also found that reactivators tended to be slightly younger – 47 years on average – than HBV-positive patients who did not reactivate; their mean age was 54.

Dr. Liang said he has no disclosures. Dr. Hwang disclosed grant support form Bristol-Myers Squibb, maker of the anti-HBV drug entecavir (Baraclude). The company funded the study, together with the National Cancer Institute and the American Cancer Society.

SAN FRANCISCO – Nonalcoholic steatohepatitis patients may need a more thorough cardiovascular workup before liver transplantation, according to a study presented at the annual meeting of the American Association for Liver Diseases.

Standard pretransplant cardiac screening results were similar for 115 nonalcoholic steatohepatitis (NASH) and 127 alcohol-induced cirrhosis patients. Most patients had received transthoracic echocardiograms, and many had had other tests, including dobutamine stress echocardiograms, cardiac catheterizations, and ECGs.

The Revised Cardiac Risk Index, a common heart screen for noncardiac surgeries that focuses mostly on ischemia, predicted cardiac events in 6.6% of both groups.

The rate of cardiac events was higher in the NASH group; 26% had significant cardiac events within a year of surgery, two-thirds of those within a month. Cardiac arrests and arrhythmias – some fatal – were the most common events in the NASH group. Meanwhile, about 8% of the alcoholic-cirrhosis patients had cardiac events during their first postop year.

The inaccuracy of the screening of NASH patients illustrates the need for better methods of identifying cardiac risks prior to liver transplants, said investigator Dr. Lisa VanWagner, a first-year fellow in gastroenterology and hepatology at Northwestern University, Chicago.

"Current algorithms are designed to predict MI and plaque rupture. We tend to overutilize dobutamine stress echoes and other noninvasive stress tests to look for ischemic heart disease," she said.

In addition to atherosclerosis, NASH patients may have low systemic resistance, chronotropic incompetence, and other problems that a too-narrow focus on ischemia might miss. The cardiac arrests and arrhythmias noted in the study may not have been "related to plaque rupture. We really need to better risk-stratify these patients," said Dr. VanWagner, who noted she hopes to develop a liver-transplant specific cardiac risk index.

Tricuspid regurgitation might have predictive value, she said, as well as pulmonary hypertension and prolonged QTc interval, although the latter two did not differ significantly between the two groups before transplant.

Indeed, there were just two statistical differences; left ventricular hypertrophy was slightly more common in alcoholic-cirrhosis patients (20% vs. 15%), and that group was more likely than the NASH group to have clean coronary arteries on left heart catheterization (20% vs. 14%).

The mean age in the NASH group was 58 years, and 45% of NASH patients were women. The mean age in the alcoholic-cirrhosis group was 53 years, and 18% of patients were women. Mean MELD (Model for End-Stage Liver Disease) scores were about 25 for members of both groups.

NASH patients were more likely to be obese, dyslipidemic, and hypertensive. But even after controlling for those factors, as well as for smoking and prior history of coronary artery disease, NASH patients were still more likely to have an adverse cardiovascular event within a year of transplant (odds ratio, 2.69; 95% confidence interval, 1.32-6.34).

Most patients in both groups were alive at 1 year, but only 4% were alive in the NASH group at 10 years, compared with 18% in the alcoholic-cirrhosis group.

Before surgery, about 50% of NASH patients were on a beta-blocker, and 10% on a statin, although more than half had statin indications.

Dr. VanWagner said she has no disclosures.

SAN FRANCISCO – Nonalcoholic steatohepatitis patients may need a more thorough cardiovascular workup before liver transplantation, according to a study presented at the annual meeting of the American Association for Liver Diseases.

Standard pretransplant cardiac screening results were similar for 115 nonalcoholic steatohepatitis (NASH) and 127 alcohol-induced cirrhosis patients. Most patients had received transthoracic echocardiograms, and many had had other tests, including dobutamine stress echocardiograms, cardiac catheterizations, and ECGs.

The Revised Cardiac Risk Index, a common heart screen for noncardiac surgeries that focuses mostly on ischemia, predicted cardiac events in 6.6% of both groups.

The rate of cardiac events was higher in the NASH group; 26% had significant cardiac events within a year of surgery, two-thirds of those within a month. Cardiac arrests and arrhythmias – some fatal – were the most common events in the NASH group. Meanwhile, about 8% of the alcoholic-cirrhosis patients had cardiac events during their first postop year.

The inaccuracy of the screening of NASH patients illustrates the need for better methods of identifying cardiac risks prior to liver transplants, said investigator Dr. Lisa VanWagner, a first-year fellow in gastroenterology and hepatology at Northwestern University, Chicago.

"Current algorithms are designed to predict MI and plaque rupture. We tend to overutilize dobutamine stress echoes and other noninvasive stress tests to look for ischemic heart disease," she said.

In addition to atherosclerosis, NASH patients may have low systemic resistance, chronotropic incompetence, and other problems that a too-narrow focus on ischemia might miss. The cardiac arrests and arrhythmias noted in the study may not have been "related to plaque rupture. We really need to better risk-stratify these patients," said Dr. VanWagner, who noted she hopes to develop a liver-transplant specific cardiac risk index.

Tricuspid regurgitation might have predictive value, she said, as well as pulmonary hypertension and prolonged QTc interval, although the latter two did not differ significantly between the two groups before transplant.

Indeed, there were just two statistical differences; left ventricular hypertrophy was slightly more common in alcoholic-cirrhosis patients (20% vs. 15%), and that group was more likely than the NASH group to have clean coronary arteries on left heart catheterization (20% vs. 14%).

The mean age in the NASH group was 58 years, and 45% of NASH patients were women. The mean age in the alcoholic-cirrhosis group was 53 years, and 18% of patients were women. Mean MELD (Model for End-Stage Liver Disease) scores were about 25 for members of both groups.

NASH patients were more likely to be obese, dyslipidemic, and hypertensive. But even after controlling for those factors, as well as for smoking and prior history of coronary artery disease, NASH patients were still more likely to have an adverse cardiovascular event within a year of transplant (odds ratio, 2.69; 95% confidence interval, 1.32-6.34).

Most patients in both groups were alive at 1 year, but only 4% were alive in the NASH group at 10 years, compared with 18% in the alcoholic-cirrhosis group.

Before surgery, about 50% of NASH patients were on a beta-blocker, and 10% on a statin, although more than half had statin indications.

Dr. VanWagner said she has no disclosures.

SAN FRANCISCO – Nonalcoholic steatohepatitis patients may need a more thorough cardiovascular workup before liver transplantation, according to a study presented at the annual meeting of the American Association for Liver Diseases.

Standard pretransplant cardiac screening results were similar for 115 nonalcoholic steatohepatitis (NASH) and 127 alcohol-induced cirrhosis patients. Most patients had received transthoracic echocardiograms, and many had had other tests, including dobutamine stress echocardiograms, cardiac catheterizations, and ECGs.

The Revised Cardiac Risk Index, a common heart screen for noncardiac surgeries that focuses mostly on ischemia, predicted cardiac events in 6.6% of both groups.

The rate of cardiac events was higher in the NASH group; 26% had significant cardiac events within a year of surgery, two-thirds of those within a month. Cardiac arrests and arrhythmias – some fatal – were the most common events in the NASH group. Meanwhile, about 8% of the alcoholic-cirrhosis patients had cardiac events during their first postop year.

The inaccuracy of the screening of NASH patients illustrates the need for better methods of identifying cardiac risks prior to liver transplants, said investigator Dr. Lisa VanWagner, a first-year fellow in gastroenterology and hepatology at Northwestern University, Chicago.

"Current algorithms are designed to predict MI and plaque rupture. We tend to overutilize dobutamine stress echoes and other noninvasive stress tests to look for ischemic heart disease," she said.

In addition to atherosclerosis, NASH patients may have low systemic resistance, chronotropic incompetence, and other problems that a too-narrow focus on ischemia might miss. The cardiac arrests and arrhythmias noted in the study may not have been "related to plaque rupture. We really need to better risk-stratify these patients," said Dr. VanWagner, who noted she hopes to develop a liver-transplant specific cardiac risk index.

Tricuspid regurgitation might have predictive value, she said, as well as pulmonary hypertension and prolonged QTc interval, although the latter two did not differ significantly between the two groups before transplant.

Indeed, there were just two statistical differences; left ventricular hypertrophy was slightly more common in alcoholic-cirrhosis patients (20% vs. 15%), and that group was more likely than the NASH group to have clean coronary arteries on left heart catheterization (20% vs. 14%).

The mean age in the NASH group was 58 years, and 45% of NASH patients were women. The mean age in the alcoholic-cirrhosis group was 53 years, and 18% of patients were women. Mean MELD (Model for End-Stage Liver Disease) scores were about 25 for members of both groups.

NASH patients were more likely to be obese, dyslipidemic, and hypertensive. But even after controlling for those factors, as well as for smoking and prior history of coronary artery disease, NASH patients were still more likely to have an adverse cardiovascular event within a year of transplant (odds ratio, 2.69; 95% confidence interval, 1.32-6.34).

Most patients in both groups were alive at 1 year, but only 4% were alive in the NASH group at 10 years, compared with 18% in the alcoholic-cirrhosis group.

Before surgery, about 50% of NASH patients were on a beta-blocker, and 10% on a statin, although more than half had statin indications.

Dr. VanWagner said she has no disclosures.

SAN FRANCISCO – When it comes to practice transformation, starting from scratch can be better than reinventing the wheel.

At least it was in Texas, when six federally qualified health organizations implemented a novel, collaborative program to treat depressed patients.

Compared with the clinics with no preexisting mental health services, those that already had something in place had a harder time meeting follow-up, treatment, and symptom improvement targets in the first few months.

"They had difficulty thinking about treating people differently. People fell through the cracks," said the lead investigator in an evaluation of the project, Dr. Amy M. Bauer of the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

In short, "reengineering the airplane in midflight" can be tricky, she said, an important lesson at a time when collaborative care models are gaining traction in the United States.

University of Washington researchers developed the model and helped implement it in Texas. One aspect of the model that makes it novel is that it is population based; instead of focusing on individuals, participants, once they’re enrolled, are entered into a Web-based registry and followed as a group by care managers.

The registry makes it possible to help track patients’ clinical progress, as well as their visit history and prescribed medications. Care managers asked patients about their use of medications and used this information to inform treatment and intensify treatment when indicated. If patients do not follow up, care managers give them a call and address the reasons. However, there was no mechanism to independently verify whether patients were actually using medications as they reported.

"Organizations that already have a very established mental health system are going to have to think carefully about ... how they are going to work on changing it."

The care managers also coordinate patients’ care with primary care doctors who write prescriptions and adjust medications as needed. The whole operation is overseen at each clinic by a psychiatrist who reviews treatment plans, consults on difficult cases, and supervises the care managers, but generally doesn’t see patients directly. "The registry and proactive outreach are elements of the collaborative care model that aim to improve treatment engagement and enhance treatment retention," she said in an interview.

It’s "very different from the traditional model where you have a small group of people and if they stop coming, they’re off your case load," Dr. Bauer said.

The clinics treated 2,821 adult patients from 2006 to 2009; the mean age of patients was around 45, and more than 80% or so were women.

Overall, the clinics did well. After almost a year and a half, 70% or more of enrolled patients had either dropped their Patient Health Questionnaire depression scores (PHQ-9) by 50%, or had scores of 5 or less, indicating remission.

The quickest improvements tended to be at several rural health centers in the Rio Grande Valley. They started with no mental health services at all; "primary care doctors [there] felt really glad to have anything in place," Dr. Bauer said. Six months into the project, 60% or more of patients at the clinics starting from scratch met the improvement targets.

Clinics with at least some preexisting mental health services, however, lagged behind. One had a well-established system that treated depressed patients the old-fashioned way: 1 hour of therapy, no outreach, no clinical coordination, no population-based care.

Improvement rates ranged from about 30% to 60% at the clinics that tried to make existing services fit the new model. The results were significant, and differences between clinic populations were factored into the analysis.

Care got bogged down and remained fragmented in some cases. Patients got lost in a shuffle between primary care, care mangers, and the older mental health program. There were buy-in problems, too; some primary care providers didn’t think it was their role to manage mental health conditions.

The findings suggest "that organizations that already have a very established mental health system are going to have to think carefully about the existing culture of care and how they are going to work on changing it," Dr. Bauer said.

Even with the early problems in some clinics, however, the evaluation revealed that the program "got people into treatment and on medication. No site is so underresourced that it can’t implement a collaborative care model. In the real world, you can do remarkably well when implementing this model," she said.

Dr. Bauer said she had no relevant financial disclosures. The demonstration project was funded by the Hogg Foundation for Mental Health.

SAN FRANCISCO – When it comes to practice transformation, starting from scratch can be better than reinventing the wheel.

At least it was in Texas, when six federally qualified health organizations implemented a novel, collaborative program to treat depressed patients.

Compared with the clinics with no preexisting mental health services, those that already had something in place had a harder time meeting follow-up, treatment, and symptom improvement targets in the first few months.

"They had difficulty thinking about treating people differently. People fell through the cracks," said the lead investigator in an evaluation of the project, Dr. Amy M. Bauer of the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

In short, "reengineering the airplane in midflight" can be tricky, she said, an important lesson at a time when collaborative care models are gaining traction in the United States.

University of Washington researchers developed the model and helped implement it in Texas. One aspect of the model that makes it novel is that it is population based; instead of focusing on individuals, participants, once they’re enrolled, are entered into a Web-based registry and followed as a group by care managers.

The registry makes it possible to help track patients’ clinical progress, as well as their visit history and prescribed medications. Care managers asked patients about their use of medications and used this information to inform treatment and intensify treatment when indicated. If patients do not follow up, care managers give them a call and address the reasons. However, there was no mechanism to independently verify whether patients were actually using medications as they reported.

"Organizations that already have a very established mental health system are going to have to think carefully about ... how they are going to work on changing it."

The care managers also coordinate patients’ care with primary care doctors who write prescriptions and adjust medications as needed. The whole operation is overseen at each clinic by a psychiatrist who reviews treatment plans, consults on difficult cases, and supervises the care managers, but generally doesn’t see patients directly. "The registry and proactive outreach are elements of the collaborative care model that aim to improve treatment engagement and enhance treatment retention," she said in an interview.

It’s "very different from the traditional model where you have a small group of people and if they stop coming, they’re off your case load," Dr. Bauer said.

The clinics treated 2,821 adult patients from 2006 to 2009; the mean age of patients was around 45, and more than 80% or so were women.

Overall, the clinics did well. After almost a year and a half, 70% or more of enrolled patients had either dropped their Patient Health Questionnaire depression scores (PHQ-9) by 50%, or had scores of 5 or less, indicating remission.

The quickest improvements tended to be at several rural health centers in the Rio Grande Valley. They started with no mental health services at all; "primary care doctors [there] felt really glad to have anything in place," Dr. Bauer said. Six months into the project, 60% or more of patients at the clinics starting from scratch met the improvement targets.

Clinics with at least some preexisting mental health services, however, lagged behind. One had a well-established system that treated depressed patients the old-fashioned way: 1 hour of therapy, no outreach, no clinical coordination, no population-based care.

Improvement rates ranged from about 30% to 60% at the clinics that tried to make existing services fit the new model. The results were significant, and differences between clinic populations were factored into the analysis.

Care got bogged down and remained fragmented in some cases. Patients got lost in a shuffle between primary care, care mangers, and the older mental health program. There were buy-in problems, too; some primary care providers didn’t think it was their role to manage mental health conditions.

The findings suggest "that organizations that already have a very established mental health system are going to have to think carefully about the existing culture of care and how they are going to work on changing it," Dr. Bauer said.

Even with the early problems in some clinics, however, the evaluation revealed that the program "got people into treatment and on medication. No site is so underresourced that it can’t implement a collaborative care model. In the real world, you can do remarkably well when implementing this model," she said.

Dr. Bauer said she had no relevant financial disclosures. The demonstration project was funded by the Hogg Foundation for Mental Health.

SAN FRANCISCO – When it comes to practice transformation, starting from scratch can be better than reinventing the wheel.

At least it was in Texas, when six federally qualified health organizations implemented a novel, collaborative program to treat depressed patients.

Compared with the clinics with no preexisting mental health services, those that already had something in place had a harder time meeting follow-up, treatment, and symptom improvement targets in the first few months.

"They had difficulty thinking about treating people differently. People fell through the cracks," said the lead investigator in an evaluation of the project, Dr. Amy M. Bauer of the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

In short, "reengineering the airplane in midflight" can be tricky, she said, an important lesson at a time when collaborative care models are gaining traction in the United States.

University of Washington researchers developed the model and helped implement it in Texas. One aspect of the model that makes it novel is that it is population based; instead of focusing on individuals, participants, once they’re enrolled, are entered into a Web-based registry and followed as a group by care managers.

The registry makes it possible to help track patients’ clinical progress, as well as their visit history and prescribed medications. Care managers asked patients about their use of medications and used this information to inform treatment and intensify treatment when indicated. If patients do not follow up, care managers give them a call and address the reasons. However, there was no mechanism to independently verify whether patients were actually using medications as they reported.

"Organizations that already have a very established mental health system are going to have to think carefully about ... how they are going to work on changing it."

The care managers also coordinate patients’ care with primary care doctors who write prescriptions and adjust medications as needed. The whole operation is overseen at each clinic by a psychiatrist who reviews treatment plans, consults on difficult cases, and supervises the care managers, but generally doesn’t see patients directly. "The registry and proactive outreach are elements of the collaborative care model that aim to improve treatment engagement and enhance treatment retention," she said in an interview.

It’s "very different from the traditional model where you have a small group of people and if they stop coming, they’re off your case load," Dr. Bauer said.

The clinics treated 2,821 adult patients from 2006 to 2009; the mean age of patients was around 45, and more than 80% or so were women.

Overall, the clinics did well. After almost a year and a half, 70% or more of enrolled patients had either dropped their Patient Health Questionnaire depression scores (PHQ-9) by 50%, or had scores of 5 or less, indicating remission.

The quickest improvements tended to be at several rural health centers in the Rio Grande Valley. They started with no mental health services at all; "primary care doctors [there] felt really glad to have anything in place," Dr. Bauer said. Six months into the project, 60% or more of patients at the clinics starting from scratch met the improvement targets.

Clinics with at least some preexisting mental health services, however, lagged behind. One had a well-established system that treated depressed patients the old-fashioned way: 1 hour of therapy, no outreach, no clinical coordination, no population-based care.

Improvement rates ranged from about 30% to 60% at the clinics that tried to make existing services fit the new model. The results were significant, and differences between clinic populations were factored into the analysis.

Care got bogged down and remained fragmented in some cases. Patients got lost in a shuffle between primary care, care mangers, and the older mental health program. There were buy-in problems, too; some primary care providers didn’t think it was their role to manage mental health conditions.

The findings suggest "that organizations that already have a very established mental health system are going to have to think carefully about the existing culture of care and how they are going to work on changing it," Dr. Bauer said.

Even with the early problems in some clinics, however, the evaluation revealed that the program "got people into treatment and on medication. No site is so underresourced that it can’t implement a collaborative care model. In the real world, you can do remarkably well when implementing this model," she said.

Dr. Bauer said she had no relevant financial disclosures. The demonstration project was funded by the Hogg Foundation for Mental Health.