Mitchel L. Zoler, PhD

Major Finding: After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the heart failure clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic.

Data Source: Randomized study of 1,119 heart failure patients treated at 18 Danish centers.

Disclosures: Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the meeting.

“Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic,” said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. “Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before.”

The stabilization regimen used by the investigators involved uptitrating the drugs patients received so that their medical treatment used drugs such as ACE inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study's other eligibility criteria.

“The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner [GP],” he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, “BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP” repeatedly, he said in an interview (see View on the News, below).

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study's prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker, beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study's primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end-point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

'You need to educate and uptitrate patients, and then they can be followed by a general practitioner.'

Source DR. SCHOU

View on the News

Findings Point to Lower Costs

The results from this study show that properly treated heart failure patients on an evidence-based regimen can be effectively managed by a primary care physician. That's a very powerful and important message. In the United States, heart failure management has become a big business. But every heart failure patient cannot be managed by a cardiologist because the number of patients is increasing too quickly. In the Danish study, general practitioners got the heart failure patients after they were stabilized, and the GPs were trained in how to adjust the patients' diuretic dosages.

These results do not discount a role for heart failure disease management. Disease management works. It is important to have a specific regimen for monitoring and treating heart failure patients. But the results show that it doesn't matter who does the monitoring and treating as long as they received training in how to do it.

The results also showed that we waste time and money if we measure B-type natriuretic peptide repeatedly in heart failure patients. BNP is good for making an initial diagnosis of heart failure, to distinguish heart failure from other disorders with similar symptoms. But once an initial measure is made and the diagnosis confirmed, more BNP measurements don't add anything further. Many U.S. heart failure patients undergo serial measurements despite the lack of good evidence that this helps. Current guidelines from the Heart Failure Society of America call for only measuring BNP initially in heart failure patients, especially when the initial diagnosis is uncertain based on clinical presentation (J. Card. Fail. 2010;16:e1-e194).

PRAKASH C. DEEDWANIA, M.D., is professor of medicine at the University of California, San Francisco, in Fresno. His comments were made in an interview. He reported having no disclosures.

Major Finding: After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the heart failure clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic.

Data Source: Randomized study of 1,119 heart failure patients treated at 18 Danish centers.

Disclosures: Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the meeting.

“Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic,” said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. “Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before.”

The stabilization regimen used by the investigators involved uptitrating the drugs patients received so that their medical treatment used drugs such as ACE inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study's other eligibility criteria.

“The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner [GP],” he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, “BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP” repeatedly, he said in an interview (see View on the News, below).

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study's prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker, beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study's primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end-point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

'You need to educate and uptitrate patients, and then they can be followed by a general practitioner.'

Source DR. SCHOU

View on the News

Findings Point to Lower Costs

The results from this study show that properly treated heart failure patients on an evidence-based regimen can be effectively managed by a primary care physician. That's a very powerful and important message. In the United States, heart failure management has become a big business. But every heart failure patient cannot be managed by a cardiologist because the number of patients is increasing too quickly. In the Danish study, general practitioners got the heart failure patients after they were stabilized, and the GPs were trained in how to adjust the patients' diuretic dosages.

These results do not discount a role for heart failure disease management. Disease management works. It is important to have a specific regimen for monitoring and treating heart failure patients. But the results show that it doesn't matter who does the monitoring and treating as long as they received training in how to do it.

The results also showed that we waste time and money if we measure B-type natriuretic peptide repeatedly in heart failure patients. BNP is good for making an initial diagnosis of heart failure, to distinguish heart failure from other disorders with similar symptoms. But once an initial measure is made and the diagnosis confirmed, more BNP measurements don't add anything further. Many U.S. heart failure patients undergo serial measurements despite the lack of good evidence that this helps. Current guidelines from the Heart Failure Society of America call for only measuring BNP initially in heart failure patients, especially when the initial diagnosis is uncertain based on clinical presentation (J. Card. Fail. 2010;16:e1-e194).

PRAKASH C. DEEDWANIA, M.D., is professor of medicine at the University of California, San Francisco, in Fresno. His comments were made in an interview. He reported having no disclosures.

Major Finding: After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the heart failure clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic.

Data Source: Randomized study of 1,119 heart failure patients treated at 18 Danish centers.

Disclosures: Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the meeting.

“Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic,” said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. “Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before.”

The stabilization regimen used by the investigators involved uptitrating the drugs patients received so that their medical treatment used drugs such as ACE inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study's other eligibility criteria.

“The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner [GP],” he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, “BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP” repeatedly, he said in an interview (see View on the News, below).

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study's prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker, beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study's primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end-point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

'You need to educate and uptitrate patients, and then they can be followed by a general practitioner.'

Source DR. SCHOU

View on the News

Findings Point to Lower Costs

The results from this study show that properly treated heart failure patients on an evidence-based regimen can be effectively managed by a primary care physician. That's a very powerful and important message. In the United States, heart failure management has become a big business. But every heart failure patient cannot be managed by a cardiologist because the number of patients is increasing too quickly. In the Danish study, general practitioners got the heart failure patients after they were stabilized, and the GPs were trained in how to adjust the patients' diuretic dosages.

These results do not discount a role for heart failure disease management. Disease management works. It is important to have a specific regimen for monitoring and treating heart failure patients. But the results show that it doesn't matter who does the monitoring and treating as long as they received training in how to do it.

The results also showed that we waste time and money if we measure B-type natriuretic peptide repeatedly in heart failure patients. BNP is good for making an initial diagnosis of heart failure, to distinguish heart failure from other disorders with similar symptoms. But once an initial measure is made and the diagnosis confirmed, more BNP measurements don't add anything further. Many U.S. heart failure patients undergo serial measurements despite the lack of good evidence that this helps. Current guidelines from the Heart Failure Society of America call for only measuring BNP initially in heart failure patients, especially when the initial diagnosis is uncertain based on clinical presentation (J. Card. Fail. 2010;16:e1-e194).

PRAKASH C. DEEDWANIA, M.D., is professor of medicine at the University of California, San Francisco, in Fresno. His comments were made in an interview. He reported having no disclosures.

NEW ORLEANS – Women who had early preeclampsia while pregnant faced a threefold increased risk for hypertension 10 years following the affected pregnancy, according to a Dutch study.

But the women showed no significantly increased risk for diabetes, hypercholesterolemia, or metabolic syndrome, Dr. José T. Drost said at the meeting.

This study showed a “very striking, pretty dramatic” difference in the prevalence of hypertension after 10 years, at 44% among women with preeclampsia compared with 17% in women who did not have preeclampsia, said Dr. Glenn A. Hirsch, a cardiologist and director of cardiac rehabilitation at Johns Hopkins Bayview Medical Center, Baltimore.

“Metabolic syndrome may be part of the underlying causal pathway, as waist/hip ratio was increased at baseline in the women with preeclampsia,” Dr. Hirsch said.

The Preeclampsia Risk Evaluation in Females (PREVFEM) study was a 10-year follow-up evaluation of 339 women who developed early preeclampsia while treated at the Isala Clinics during 1991-2005, and 332 matched control women who were pregnant at the same time but did not develop preeclampsia. Dr. Drost and her associates defined early preeclampsia as new-onset hypertension, with a blood pressure of at least 140/90 mm Hg, plus new-onset proteinuria, at a level of at least 0.3 g/24 hr, that first appeared after the 20th gestational week but before the 32nd gestational week.

At the time of the index pregnancy, the age of the women with preeclampsia averaged 30 years, while the controls' average age was 29 years. The index pregnancy was the first pregnancy for 80% of the women with preeclampsia and for 70% of the controls, said Dr. Drost, a researcher in the cardiology department at the Isala Clinics in Zwolle, the Netherlands.

At a screening examination performed a mean of 9-11 years following the index pregnancy, the average blood pressure of the women who had preeclampsia was 127/86 mm Hg, compared with an average of 119/79 in the controls. The prevalence of hypertension was 44% in the women with a history of preeclampsia and 17% in the controls. Women in both groups had a similar average BMI, 29.9 and 26.2 kg/m

In a multivariate analysis that controlled for differences in age, years following pregnancy, and waist circumference, the women with a history of preeclampsia had a significant, 3.3-fold increased risk for hypertension at their follow-up screening examination, compared with the control women, Dr. Drost reported. The prevalence of diabetes and hypercholesterolemia was similar in the two groups at follow-up.

However, the prevalence of metabolic syndrome at follow-up reached 18% in the women who had preeclampsia and 9% in the control women. After adjustment, this represented a 60% increased risk for metabolic syndrome in the women with a history of preeclampsia that fell short of statistical significance.

Dr. Drost had no disclosures.

Hypertension was seen in 44% of women with a history of preeclampsia and 17% of controls 9–11 years later.

Source DR. DROST

NEW ORLEANS – Women who had early preeclampsia while pregnant faced a threefold increased risk for hypertension 10 years following the affected pregnancy, according to a Dutch study.

But the women showed no significantly increased risk for diabetes, hypercholesterolemia, or metabolic syndrome, Dr. José T. Drost said at the meeting.

This study showed a “very striking, pretty dramatic” difference in the prevalence of hypertension after 10 years, at 44% among women with preeclampsia compared with 17% in women who did not have preeclampsia, said Dr. Glenn A. Hirsch, a cardiologist and director of cardiac rehabilitation at Johns Hopkins Bayview Medical Center, Baltimore.

“Metabolic syndrome may be part of the underlying causal pathway, as waist/hip ratio was increased at baseline in the women with preeclampsia,” Dr. Hirsch said.

The Preeclampsia Risk Evaluation in Females (PREVFEM) study was a 10-year follow-up evaluation of 339 women who developed early preeclampsia while treated at the Isala Clinics during 1991-2005, and 332 matched control women who were pregnant at the same time but did not develop preeclampsia. Dr. Drost and her associates defined early preeclampsia as new-onset hypertension, with a blood pressure of at least 140/90 mm Hg, plus new-onset proteinuria, at a level of at least 0.3 g/24 hr, that first appeared after the 20th gestational week but before the 32nd gestational week.

At the time of the index pregnancy, the age of the women with preeclampsia averaged 30 years, while the controls' average age was 29 years. The index pregnancy was the first pregnancy for 80% of the women with preeclampsia and for 70% of the controls, said Dr. Drost, a researcher in the cardiology department at the Isala Clinics in Zwolle, the Netherlands.

At a screening examination performed a mean of 9-11 years following the index pregnancy, the average blood pressure of the women who had preeclampsia was 127/86 mm Hg, compared with an average of 119/79 in the controls. The prevalence of hypertension was 44% in the women with a history of preeclampsia and 17% in the controls. Women in both groups had a similar average BMI, 29.9 and 26.2 kg/m

In a multivariate analysis that controlled for differences in age, years following pregnancy, and waist circumference, the women with a history of preeclampsia had a significant, 3.3-fold increased risk for hypertension at their follow-up screening examination, compared with the control women, Dr. Drost reported. The prevalence of diabetes and hypercholesterolemia was similar in the two groups at follow-up.

However, the prevalence of metabolic syndrome at follow-up reached 18% in the women who had preeclampsia and 9% in the control women. After adjustment, this represented a 60% increased risk for metabolic syndrome in the women with a history of preeclampsia that fell short of statistical significance.

Dr. Drost had no disclosures.

Hypertension was seen in 44% of women with a history of preeclampsia and 17% of controls 9–11 years later.

Source DR. DROST

NEW ORLEANS – Women who had early preeclampsia while pregnant faced a threefold increased risk for hypertension 10 years following the affected pregnancy, according to a Dutch study.

But the women showed no significantly increased risk for diabetes, hypercholesterolemia, or metabolic syndrome, Dr. José T. Drost said at the meeting.

This study showed a “very striking, pretty dramatic” difference in the prevalence of hypertension after 10 years, at 44% among women with preeclampsia compared with 17% in women who did not have preeclampsia, said Dr. Glenn A. Hirsch, a cardiologist and director of cardiac rehabilitation at Johns Hopkins Bayview Medical Center, Baltimore.

“Metabolic syndrome may be part of the underlying causal pathway, as waist/hip ratio was increased at baseline in the women with preeclampsia,” Dr. Hirsch said.

The Preeclampsia Risk Evaluation in Females (PREVFEM) study was a 10-year follow-up evaluation of 339 women who developed early preeclampsia while treated at the Isala Clinics during 1991-2005, and 332 matched control women who were pregnant at the same time but did not develop preeclampsia. Dr. Drost and her associates defined early preeclampsia as new-onset hypertension, with a blood pressure of at least 140/90 mm Hg, plus new-onset proteinuria, at a level of at least 0.3 g/24 hr, that first appeared after the 20th gestational week but before the 32nd gestational week.

At the time of the index pregnancy, the age of the women with preeclampsia averaged 30 years, while the controls' average age was 29 years. The index pregnancy was the first pregnancy for 80% of the women with preeclampsia and for 70% of the controls, said Dr. Drost, a researcher in the cardiology department at the Isala Clinics in Zwolle, the Netherlands.

At a screening examination performed a mean of 9-11 years following the index pregnancy, the average blood pressure of the women who had preeclampsia was 127/86 mm Hg, compared with an average of 119/79 in the controls. The prevalence of hypertension was 44% in the women with a history of preeclampsia and 17% in the controls. Women in both groups had a similar average BMI, 29.9 and 26.2 kg/m

In a multivariate analysis that controlled for differences in age, years following pregnancy, and waist circumference, the women with a history of preeclampsia had a significant, 3.3-fold increased risk for hypertension at their follow-up screening examination, compared with the control women, Dr. Drost reported. The prevalence of diabetes and hypercholesterolemia was similar in the two groups at follow-up.

However, the prevalence of metabolic syndrome at follow-up reached 18% in the women who had preeclampsia and 9% in the control women. After adjustment, this represented a 60% increased risk for metabolic syndrome in the women with a history of preeclampsia that fell short of statistical significance.

Dr. Drost had no disclosures.

Hypertension was seen in 44% of women with a history of preeclampsia and 17% of controls 9–11 years later.

Source DR. DROST

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety." Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety." Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety." Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

ORLANDO – Patients discharged within a day following laparoscopic Roux-en-Y gastric bypass surgery faced at least a twofold increased risk for 30-day mortality compared with patients discharged 2 days after surgery, in an analysis of more than 50,000 patients who underwent the operation at a U.S. or Canadian hospital during 2007-2010.

The finding raises safety concerns because many medical insurers routinely cover hospitalization for just 1 day following laparoscopic gastric bypass surgery.

"Short-stay laparoscopic gastric bypass should be approached with caution, and merits further investigation," Dr. John M. Morton said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We want to safeguard the [safety] results of bariatric surgery and not backtrack. The big question is whether [1-day discharge] is ready for prime time. I’d approach these patients with a degree of caution. Sending [most gastric bypass] patients home after 2 days is a remarkable achievement. I wouldn’t want that achievement smashed on the rocks of mortality by sending patients home too soon. Right now, I’m not willing to say that the goal length of stay is 1 day," said Dr. Morton, director of bariatric surgery at Stanford (Calif.) University.

Dr. Morton led the study of 51,788 patients who underwent laparoscopic Roux-en-Y gastric bypass surgery at U.S. or Canadian centers that participated in a national bariatric surgery registry during the period from June 2007 to October 2010. The investigators found that during this period, 59% of patients left the hospital after 2 days. However, the second most common discharge period was after 1 day, in 18% of patients, while another 1% were discharged after less than 1 day. The remaining 22% of patients left the hospital 3 or 4 days after surgery.

The 19% discharge rate after 1 day or less surprised Dr. Morton, and reflected the growing pressure from insurers to hasten the discharge of patients following gastric bypass surgery. "I would have expected 1 day discharge in less than 10% of patients," he said in an interview. "It’s been a big shift in our practice patterns to go to 2 days," he added. As recently as the mid-2000s, when laparoscopic gastric bypass began to surpass the number of bypasses performed using open surgery, most patients went home 4 or 5 days following surgery, he said.

The pressure to discharge patients within 1 day following surgery stems largely from a relatively recent policy adopted by Milliman Care Guidelines, a Seattle-based actuarial and consulting company that provides health-cost guidance to many health insurers as well as contractors that administer coverage for the Centers for Medicare and Medicaid Services. Last year, Milliman issued the 14th edition of its Care Guidelines, which began recommending that insurers cover hospitalization following laparoscopic gastric bypass for just 1 day.

Last October, Dr. Morton and other leaders of the American Society for Metabolic and Bariatric Surgery sent a letter to Milliman asking the company to reconsider its position. Dr. Morton, who chairs the society’s Access to Care Committee, launched the new study to collect better information on the medical consequences of faster discharge in this setting. He learned from Milliman that the company’s recommendation for 1-day discharge had been based on one published study reflecting a single center’s experience. That study found 1-day discharge following laparoscopic gastric bypass to be safe (Ann. Surg. 2005;242:494-501).

"I was shocked and dismayed that they advocated a day 1 discharge," said Dr. Morton. "The only motivation can be cost savings. It’s not patient safety. Gastric bypass patients can develop complications that include bleeding, myocardial infarctions, pulmonary embolism, and leaks at anastomoses. "These can be discovered in the first 2 days, and if they occur in the hospital there is an opportunity to rescue the patient."

To better document the impact of discharging patients less than 2 days after gastric bypass, Dr. Morton and his associates used data drawn from the Bariatric Outcomes Longitudinal Database (BOLD), a bariatric surgery database for programs in the United States and Canada begun in 2007 by the Surgical Review Corporation.

The 51,788 patients who underwent a laparoscopic Roux-en-Y gastric bypass operation during the nearly 3.5-year period reviewed had an average age of 46 years, and almost 80% were women. The researchers limited the study population to patients whose hospitalized length of stay was 4 days or less (94% of all laparoscopic gastric bypasses done during this time). During the 30 days following surgery, the overall mortality rate was 0.1%, the serious complication rate was 0.8%, and 3.8% of patients required readmission.

The analysis divided patients into those discharged the same day as their surgery (a 0-day length of stay), patients discharged the morning after their surgery and within 24 hours of their initial admission (1-day length of stay), and 2-, 3-, or 4-day length of stays.

In a multivariate analysis that controlled for baseline clinical and demographic factors, patients discharged on day 0 had a statistically significant, 13-fold increased risk of 30-day mortality compared with patients discharged on day 2. Patients discharged on day 1 had a twofold increased mortality rate that fell just short of significance (P = .055). Patients discharged on day 3 had a 30-day mortality rate that was virtually the same as that of day 2 patients, while those discharged on day 4 had a greater than fivefold increased mortality rate that was significant. Dr. Morton ascribed this higher mortality rate in patients with a 4-day hospitalization to the increased number of postoperative complications in these patients that likely led to their prolonged hospitalization.

"I think there is an opportunity for faster discharge, but with these data routine ambulatory discharge is not warranted, because 13-fold increased mortality is just not acceptable," commented Dr. Titus Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Dr. Morton said that he has received an educational grant from Ethicon Endo-Surgery, and he has received honoraria from and served on the scientific advisory board of Vibrynt. Dr. Duncan said that he received a teaching grant from Ethicon Endo-Surgery.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

PHILADELPHIA – Obesity shortens long-term survival in patients undergoing orthotopic liver transplant, according to a review of 285 patients.

One year out from their orthotopic liver transplants, obese transplant recipients (those with a body mass index of 30 kg/m² or greater) had a 75% survival rate, significantly less than the 83% survival rate among nonobese liver transplant patients. The procedures were performed at the University of Maryland in Baltimore during 2000-2008, Dr. Sameh A. Fayeh said at the American Transplant Congress.

At 2 years and 5 years after transplantation, survival rates among the obese liver recipients were 67% and 54%, respectively – significantly less than the 79% and 63% survival rates in nonobese patients, said Dr. Fayeh, a transplant surgeon at the University of Maryland.

"I think [obese] patients don’t do well because their continued metabolic derangement, such as diabetes and hypercholesterolemia, affects their survival, but we don’t have proof of this," he said. "It is to be determined whether intensive medical therapy, a rehabilitation program, or bariatric surgery post transplant would improve long-term survival." At the University of Maryland, liver transplants generally are not performed in patients with a body mass index greater than 40 kg/m², Dr. Fayeh added.

Obesity had no impact on short-term survival. At 1 month after transplant, survival rates were 95% among obese recipients and 97% among the nonobese, a difference that was not statistically significant.

During the 9-year period reviewed, 185 nonobese patients and 100 obese patients underwent an orthotopic liver transplant. About a quarter of the patients were at least 60 years old, about a quarter were African American, and slightly more than two-thirds were men. These and other demographic and clinical features were similar in the obese and nonobese subgroups.

Early complications occurred at similar rates in the two subgroups, including the incidence of renal failure, mortality during initial hospitalization, and hospital length of stay. The causes of death throughout the 5-year follow-up were also similar in the two subgroups. The most common causes of death were sepsis, in about 40% of patients, and graft failure, in about a fifth of the patients in both the obese and nonobese subgroups.

In a multivariable analysis, Dr. Fayen and his associates identified five demographic and clinical features that functioned as independent determinants of mortality: a liver that came from a deceased donor, which boosted the risk for death during follow-up by 2.5-fold; donor age older than 50 years, which boosted the mortality risk 2.4-fold; patient age older than 65, which raised mortality 2.2-fold; cold ischemia time for the transplanted organ exceeding 12 hours, which boosted the mortality rate by 80%; and recipient obesity, which raised the mortality risk by 60%.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Fayeh said he had no disclosures.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

LONDON – Use of canakinumab led to greater reductions in pain among patients with acute gouty arthritis flares after 3 days, and superior prevention of new flares during 12 weeks of follow-up, compared with triamcinolone acetonide in a pair of phase III trials that together enrolled 456 patients.

"Canakinumab is a potential new therapeutic option for acute flares in frequently flaring gouty arthritis patients with limited treatment options," Dr. Naomi Schlesinger said at the annual European Congress of Rheumatology.

Canakinumab is a fully human monoclonal antibody to interleukin (IL)-1 beta that selectively binds to and inhibits the proinflammatory molecule IL-1 beta, and already has Food and Drug Administration approval for treating CAPS (cryopyrin-associated periodic syndromes).

Based in part on the efficacy and safety data from the two reported phase III trials, Novartis, the company the markets canakinumab (Ilaris), filed an application with the FDA earlier this year for a supplemental indication for treating gouty arthritis flares. The FDA’s Arthritis Advisory Committee plans to discuss this application on June 21.

In the two new gouty arthritis trials, canakinumab’s safety profile during the first 12 weeks of treatment "appeared consistent with longer-term safety data from CAPS patients; there were no safety signals related to specific organ class," said Dr. Schlesinger, chief of the division of rheumatology and connective tissue research at the Robert Wood Johnson Medical School in New Brunswick, N.J. The most notable safety observation she made from the new results centered on "a modest increase in infections, mostly mild to moderate, with no opportunistic infections reported," she said.

Despite this promising safety and efficacy, one expert viewed canakinumab as an agent for a "niche population, patients [with gout] who flare and you can’t do anything about it" using standard drugs, commented Dr. Dinesh Khanna, a rheumatologist specializing in gout at the University of California, Los Angeles.

Goutologists see a lot of patients with diabetes, kidney disease, and hypertension who can’t take NSAIDs or colchicine. "You also can’t give them a steroid monthly, so these patients flare because of their high uric acid level and you’re stuck. These are the patients who can be treated with an anti-IL-1 beta to prevent gout attacks," he said in an interview.

The Beta-RELIEVED (Response in Acute Flare and in Prevention of Episodes of Reflare in Gout) and Beta-RELIEVED II trials enrolled patients within 5 days of an acute flare of gouty arthritis who had at least three flares during the prior year and were contraindicated for, intolerant of, or unresponsive to NSAIDs and colchicine. All patients met the American College of Rheumatology’s diagnostic criteria for gouty arthritis, and had pain intensity of at least 50 mm on a visual analog scale of 0–100 mm.

The researchers randomized patients to receive a subcutaneous injection of 150-mg canakinumab or an intramuscular injection of 40-mg triamcinolone acetonide. Patients who reflared during the subsequent 12 weeks during the first phase of the study qualified to receive an additional dose of their assigned drug with each flare.

The study had two primary end points. One was pain resolution at 72 hours after initial treatment. At that time, patients who were treated with canakinumab in the Beta-RELIEVED study had an average pain score that was 11 mm lower than that of patients in the comparator group, a statistically significant difference, reported Dr. Alexander So, a coinvestigator on the study and professor of rheumatology at the University of Lausanne (Switzerland).

Patients who were treated with canakinumab began to show significantly better pain reduction, compared with those who got triamcinolone within 12 hours after their first dose, and the advantage in pain relief continued each time the investigators measured pain during the first 7 days after treatment, Dr. So said. Neither Dr. So nor Dr. Schlesinger reported the results for this end point from the Beta-RELIEVED II trial.

The second primary end point was the percentage of patients having new flares during the first 12 weeks following their initial therapy. In the Beta-RELIEVED trial, 19% of the 115 patients who were treated with canakinumab and 37% of the 115 patients treated with triamcinolone had a new flare, a 55% relative risk reduction with canakinumab that was statistically significant. In the second trial, canakinumab use led to a 68% relative reduction in new flares, also a statistically significant difference in the study that randomized 226 patients, Dr. Schlesinger reported.

The canakinumab-treated patients also showed other signs of superior response in several secondary efficacy measures. Patients in the canakinumab group had a significant reduction in their mean number of flares, significantly less inflammation and swelling, and better suppression of inflammatory markers after 12 weeks, the researchers said.

In the safety analysis, canakinumab was associated with similar rates of all adverse events, a similar low rate of serious adverse events, and a similar low rate of adverse events leading to discontinuation, compared with patients who received triamcinolone.

The Beta-RELIEVED trials were sponsored by Novartis, which markets canakinumab (Ilaris). Dr. Schlesinger said that she is a on the advisory board of Novartis, Enzyme Rx, Takeda, URL Pharma, and Savient. She is a consultant to and has received research grants from Novartis, and is on the speakers bureau of Takeda and Savient. Dr. So said that he is a consultant to Novartis, Bristol-Myers Squibb, Merck, Pfizer, and UCB Pharma. Dr. Khanna said that he is a consultant to Novartis, Takeda, Savient, and UCB Pharma.

PHILADELPHIA – Women who become pregnant after receiving a transplanted liver face an elevated risk of graft rejection, especially during or immediately following the pregnancy, based on a review of 161 U.S. cases.

"The data suggest poorer outcomes for both mothers and their newborns in female liver recipients with risk factors for graft loss within 5 years post pregnancy," Dr. Carlo B. Ramirez said at the American Transplant Congress. "The findings highlight the high-risk nature of this group, warranting closer follow-up of both mother and child," said Dr. Ramirez, a transplant surgeon at Thomas Jefferson University, Philadelphia.

Of the 161 women who became pregnant following a liver transplant and were enrolled in the National Transplantation Pregnancy Registry (in place since 1991), 16 (10%) lost their graft within 5 years following their first posttransplant pregnancy. The pregnancy and the 3 months following pregnancy posed a particular risk, with half of the women who eventually lost their graft experiencing rejection during that time. In a multivariate model that took into account baseline risk factors, women with a liver transplant faced a 14-fold increased risk for graft loss during the pregnancy, Dr. Ramirez said.

"A lot of patients who have a stable equilibrium with their graft may destabilize under stress. It is possible that there is low-grade, clinically insignificant rejection in some of these patients prior to pregnancy" that then becomes exacerbated by the stress of pregnancy, commented Dr. Jean C. Emond, professor of surgery and director of transplantation at Columbia University in New York. Dr. Emond suggested that a liver biopsy prior to pregnancy might be warranted to assess the stability of the transplant.

Other risk factors for graft loss included younger age of the mother and low gestational age at the time of delivery. In the multivariate analysis, the risk for graft loss fell by a statistically significant 26% for each additional year of age for the mother. Graft loss fell by a statistically significant 5% for each additional week of gestational age when delivery occurred.

Among the 16 women who lost their graft during pregnancy or the following 5 years, their average age when they conceived was 22 years old, compared with an average age of 28 years old among the 145 women who did not lose their graft. Average gestational age at delivery was 33 weeks among the women who lost their graft, and 37 weeks among the women who did not lose their graft.

The average age of the women at the time they received their liver transplant was 18 years among those who later lost their grafts, and 23 years among those who retained their grafts. However, the average time between transplantation and conception was an identical 4.3 years in both groups.

The only other risk factor for graft loss that approached statistical significance in the multivariate model was viral hepatitis as the etiologic agent for the liver failure that led to the transplants. Viral hepatitis was the cause of liver failure for six (38%) of the women who lost their grafts following pregnancy, and for 23 (16%) of the women who did not lose their grafts. In the multivariate model, viral hepatitis as the cause of liver failure was linked with a nearly fourfold increased risk for women losing their graft during or after pregnancy, but this relationship failed to meet the standard criterion for statistical significance, Dr. Ramirez said.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Ramirez said he had no disclosures. The National Transplantation Pregnancy Registry has been supported by grants from Novartis, Astellas, Genentech, Pfizer, Teva, and Sandoz.

PHILADELPHIA – Women who become pregnant after receiving a transplanted liver face an elevated risk of graft rejection, especially during or immediately following the pregnancy, based on a review of 161 U.S. cases.

"The data suggest poorer outcomes for both mothers and their newborns in female liver recipients with risk factors for graft loss within 5 years post pregnancy," Dr. Carlo B. Ramirez said at the American Transplant Congress. "The findings highlight the high-risk nature of this group, warranting closer follow-up of both mother and child," said Dr. Ramirez, a transplant surgeon at Thomas Jefferson University, Philadelphia.

Of the 161 women who became pregnant following a liver transplant and were enrolled in the National Transplantation Pregnancy Registry (in place since 1991), 16 (10%) lost their graft within 5 years following their first posttransplant pregnancy. The pregnancy and the 3 months following pregnancy posed a particular risk, with half of the women who eventually lost their graft experiencing rejection during that time. In a multivariate model that took into account baseline risk factors, women with a liver transplant faced a 14-fold increased risk for graft loss during the pregnancy, Dr. Ramirez said.

"A lot of patients who have a stable equilibrium with their graft may destabilize under stress. It is possible that there is low-grade, clinically insignificant rejection in some of these patients prior to pregnancy" that then becomes exacerbated by the stress of pregnancy, commented Dr. Jean C. Emond, professor of surgery and director of transplantation at Columbia University in New York. Dr. Emond suggested that a liver biopsy prior to pregnancy might be warranted to assess the stability of the transplant.

Other risk factors for graft loss included younger age of the mother and low gestational age at the time of delivery. In the multivariate analysis, the risk for graft loss fell by a statistically significant 26% for each additional year of age for the mother. Graft loss fell by a statistically significant 5% for each additional week of gestational age when delivery occurred.

Among the 16 women who lost their graft during pregnancy or the following 5 years, their average age when they conceived was 22 years old, compared with an average age of 28 years old among the 145 women who did not lose their graft. Average gestational age at delivery was 33 weeks among the women who lost their graft, and 37 weeks among the women who did not lose their graft.

The average age of the women at the time they received their liver transplant was 18 years among those who later lost their grafts, and 23 years among those who retained their grafts. However, the average time between transplantation and conception was an identical 4.3 years in both groups.

The only other risk factor for graft loss that approached statistical significance in the multivariate model was viral hepatitis as the etiologic agent for the liver failure that led to the transplants. Viral hepatitis was the cause of liver failure for six (38%) of the women who lost their grafts following pregnancy, and for 23 (16%) of the women who did not lose their grafts. In the multivariate model, viral hepatitis as the cause of liver failure was linked with a nearly fourfold increased risk for women losing their graft during or after pregnancy, but this relationship failed to meet the standard criterion for statistical significance, Dr. Ramirez said.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Ramirez said he had no disclosures. The National Transplantation Pregnancy Registry has been supported by grants from Novartis, Astellas, Genentech, Pfizer, Teva, and Sandoz.

PHILADELPHIA – Women who become pregnant after receiving a transplanted liver face an elevated risk of graft rejection, especially during or immediately following the pregnancy, based on a review of 161 U.S. cases.

"The data suggest poorer outcomes for both mothers and their newborns in female liver recipients with risk factors for graft loss within 5 years post pregnancy," Dr. Carlo B. Ramirez said at the American Transplant Congress. "The findings highlight the high-risk nature of this group, warranting closer follow-up of both mother and child," said Dr. Ramirez, a transplant surgeon at Thomas Jefferson University, Philadelphia.

Of the 161 women who became pregnant following a liver transplant and were enrolled in the National Transplantation Pregnancy Registry (in place since 1991), 16 (10%) lost their graft within 5 years following their first posttransplant pregnancy. The pregnancy and the 3 months following pregnancy posed a particular risk, with half of the women who eventually lost their graft experiencing rejection during that time. In a multivariate model that took into account baseline risk factors, women with a liver transplant faced a 14-fold increased risk for graft loss during the pregnancy, Dr. Ramirez said.

"A lot of patients who have a stable equilibrium with their graft may destabilize under stress. It is possible that there is low-grade, clinically insignificant rejection in some of these patients prior to pregnancy" that then becomes exacerbated by the stress of pregnancy, commented Dr. Jean C. Emond, professor of surgery and director of transplantation at Columbia University in New York. Dr. Emond suggested that a liver biopsy prior to pregnancy might be warranted to assess the stability of the transplant.

Other risk factors for graft loss included younger age of the mother and low gestational age at the time of delivery. In the multivariate analysis, the risk for graft loss fell by a statistically significant 26% for each additional year of age for the mother. Graft loss fell by a statistically significant 5% for each additional week of gestational age when delivery occurred.

Among the 16 women who lost their graft during pregnancy or the following 5 years, their average age when they conceived was 22 years old, compared with an average age of 28 years old among the 145 women who did not lose their graft. Average gestational age at delivery was 33 weeks among the women who lost their graft, and 37 weeks among the women who did not lose their graft.

The average age of the women at the time they received their liver transplant was 18 years among those who later lost their grafts, and 23 years among those who retained their grafts. However, the average time between transplantation and conception was an identical 4.3 years in both groups.

The only other risk factor for graft loss that approached statistical significance in the multivariate model was viral hepatitis as the etiologic agent for the liver failure that led to the transplants. Viral hepatitis was the cause of liver failure for six (38%) of the women who lost their grafts following pregnancy, and for 23 (16%) of the women who did not lose their grafts. In the multivariate model, viral hepatitis as the cause of liver failure was linked with a nearly fourfold increased risk for women losing their graft during or after pregnancy, but this relationship failed to meet the standard criterion for statistical significance, Dr. Ramirez said.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Ramirez said he had no disclosures. The National Transplantation Pregnancy Registry has been supported by grants from Novartis, Astellas, Genentech, Pfizer, Teva, and Sandoz.