American Society of Transplantation (AST): American Transplant Congress

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.

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.

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.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Eliminating HLA-B matching from the U.S. priority-points formula that was used for allocating deceased-donor kidneys partially eliminated the allocation disparity against black recipients, but a residual disparity remained, based on an analysis of more than 57,000 U.S. kidney transplants during 2000-2009.

Removal of HLA-B matching from the allocation criteria cut the amount of disparity in organs received by black patients, compared with white patients, by a relative 23%, but during 2006-2009 blacks received deceased-donor kidneys at a rate that was 19% below the rate of kidneys that went to white patients, Dr. Erin C. Hall said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons.

In May 2003, the U.S. Organ Procurement and Transplantation Network – the deceased-donor organ distribution network established by the federal government and administered by the United Network for Organ Sharing (UNOS) – eliminated HLA-B matching as an allocation criterion.

Factors that may explain the residual disparity remain unidentified. Future studies could focus on an examination of center-by-center allocation differences by race in an effort to identify other sources for the disparity, said Dr. Hall, a researcher in the transplant surgery division at Johns Hopkins Hospital in Baltimore.

Before May 2003, U.S. kidney allocation procedures gave priority to recipients who matched for more of the six HLA loci, a policy that improved transplantation outcomes but decreased the number of nonwhite recipients who received organs (N. Engl. J. Med. 2004;350:545-51).

To investigate the impact of this change, Dr. Hall and her associated reviewed UNOS records for the 12,956 kidney transplants that were done during 2000–May 2003 using deceased-donor organs, and for the 44,704 transplants done during May 2003–2009. During the two periods, the level of black patients who were registered with UNOS to await kidney transplants held very steady, accounting for 44% all of listed patients before the criterion change, and for 45% after the change.

During 2000-2003, black patients received deceased-donor kidney transplants at 38% below the rate of white patients, according to a multivariate analysis that adjusted for patient differences in age, sex, primary renal disease cause, dialysis modality, use of preemptive transplant, insurance status, education, panel-reactive antibody level over time, and blood type. During 2003-2009, the transplantation rate among black patients was 23% less than it was in white patients. To allow for equilibration in transplant rates following the 2003 criterion change, Dr. Hall also analyzed transplantation rates during 2006-2009. During this period, the rate in black patients lagged 19% behind the rate in white patients, she reported. All three between-group differences were statistically significant. The amount of change between the 38% disparity rate during 2000-2003 and the 23% disparity rate during 2003-2009 constituted a 23% relative decline in the disparity rate.

Dr. Hall said that she had no relevant financial disclosures.

PHILADELPHIA – Selected U.S. organ donors should undergo testing for infection by Trypanosoma cruzi, the etiologic agent of Chagas’ disease, before organs are taken for transplantation, recommended an expert panel initiated by the United Network for Organ Sharing.

U.S. blood donations already undergo routine screening for T. cruzi, Dr. Peter V. Chin-Hong said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. As of early 2011, infectious disease experts estimate that about 300,000 Americans were infected with T. cruzi, and the panel learned of about 30 confirmed cases of T. cruzi transmission from infected donors to U.S. organ recipients, he added.

Dr. Chin-Hong and his fellow panel members also recommended that when an organ donor – either living or deceased – is positive for T. cruzi infection, most organs are still usable for transplant as long as the recipient gives informed consent, is closely monitored for 6 months for signs of infection, and is treated promptly with an appropriate drug regimen if infection starts. The panel’s only exception to this policy was a recommendation that hearts from organ donors that are infected with T. cruzi not be used at all because the pathogen specifically targets the myocardium, and hearts that harbor T. cruzi risk eventually developing cardiomyopathy.

The panel backed an aggressive approach to the use of organs from infected donors because "we were concerned that people were discarding these organs "needlessly," Dr. Chin-Hong said in an interview. He estimated that patients who received a kidney or liver from a donor infected by T cruzi had about a 20%-30% risk of becoming infected by the pathogen, and even if infection occurred, reliable treatment exists with the primary agent, benznidazole, or with the second-line drug, nifurtimox.

"We have not seen any negative outcomes using T. cruzi treatment," he said.

"We do the same thing, except all our donors are screened for T. cruzi," commented Dr. Roberta Lattes, coordinator of transplant infectious diseases at the Institute of Nephrology in Buenos Aires. The only difference is that in Argentina, every organ donors is screened because T. cruzi is endemic in Mexico and in Central and South American. The U.S. panel suggested that U.S. organ donors undergo selection for screening by first asking if the donor was born in any of those regions.

"There is insufficient evidence for universal screening" in the United States, although individual U.S. organ procurement agencies might decide to apply universal screening to donors based on local T. cruzi epidemiology, said Dr. Chin-Hong, director of the transplant and immunocompromised host infectious diseases program at the University of California, San Francisco.

"We don’t use drug prophylaxis" on recipients of organs from infected donors "because the drugs are very toxic, and transmission is not that high," Dr. Lattes said. "But you must monitor, and at the least sign of infection you have to treat." She also agreed that hearts from T. cruzi–infected donors should not be used for transplants.

Organ donors who were born in Mexico or Central or South American should receive screening by a T. cruzi test that is approved by the Food and Drug Administration. Patients who receive an organ from a positive donor should undergo periodic testing with the same tests, weekly for the first 2 months after transplant, followed by every other week for the third month, and then monthly for another 3 months. Blood specimens should also be drawn and monitored microscopically for T. cruzi at the same times, and even more frequent specimens should be drawn, tested, and examined if organ recipients develop fever or signs of rejection. Confirmed infection must be treated promptly.

The panel published their recommendations in April (Am. J. Transplant. 2011;11:672-80).

The United Network for Organ Sharing is a private, nonprofit organization that manages the nation’s organ transplant system under contract with the federal government.

Dr. Chin-Hong said he had no relevant financial disclosures.

PHILADELPHIA – Selected U.S. organ donors should undergo testing for infection by Trypanosoma cruzi, the etiologic agent of Chagas’ disease, before organs are taken for transplantation, recommended an expert panel initiated by the United Network for Organ Sharing.

U.S. blood donations already undergo routine screening for T. cruzi, Dr. Peter V. Chin-Hong said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. As of early 2011, infectious disease experts estimate that about 300,000 Americans were infected with T. cruzi, and the panel learned of about 30 confirmed cases of T. cruzi transmission from infected donors to U.S. organ recipients, he added.

Dr. Chin-Hong and his fellow panel members also recommended that when an organ donor – either living or deceased – is positive for T. cruzi infection, most organs are still usable for transplant as long as the recipient gives informed consent, is closely monitored for 6 months for signs of infection, and is treated promptly with an appropriate drug regimen if infection starts. The panel’s only exception to this policy was a recommendation that hearts from organ donors that are infected with T. cruzi not be used at all because the pathogen specifically targets the myocardium, and hearts that harbor T. cruzi risk eventually developing cardiomyopathy.

The panel backed an aggressive approach to the use of organs from infected donors because "we were concerned that people were discarding these organs "needlessly," Dr. Chin-Hong said in an interview. He estimated that patients who received a kidney or liver from a donor infected by T cruzi had about a 20%-30% risk of becoming infected by the pathogen, and even if infection occurred, reliable treatment exists with the primary agent, benznidazole, or with the second-line drug, nifurtimox.

"We have not seen any negative outcomes using T. cruzi treatment," he said.

"We do the same thing, except all our donors are screened for T. cruzi," commented Dr. Roberta Lattes, coordinator of transplant infectious diseases at the Institute of Nephrology in Buenos Aires. The only difference is that in Argentina, every organ donors is screened because T. cruzi is endemic in Mexico and in Central and South American. The U.S. panel suggested that U.S. organ donors undergo selection for screening by first asking if the donor was born in any of those regions.

"There is insufficient evidence for universal screening" in the United States, although individual U.S. organ procurement agencies might decide to apply universal screening to donors based on local T. cruzi epidemiology, said Dr. Chin-Hong, director of the transplant and immunocompromised host infectious diseases program at the University of California, San Francisco.

"We don’t use drug prophylaxis" on recipients of organs from infected donors "because the drugs are very toxic, and transmission is not that high," Dr. Lattes said. "But you must monitor, and at the least sign of infection you have to treat." She also agreed that hearts from T. cruzi–infected donors should not be used for transplants.

Organ donors who were born in Mexico or Central or South American should receive screening by a T. cruzi test that is approved by the Food and Drug Administration. Patients who receive an organ from a positive donor should undergo periodic testing with the same tests, weekly for the first 2 months after transplant, followed by every other week for the third month, and then monthly for another 3 months. Blood specimens should also be drawn and monitored microscopically for T. cruzi at the same times, and even more frequent specimens should be drawn, tested, and examined if organ recipients develop fever or signs of rejection. Confirmed infection must be treated promptly.

The panel published their recommendations in April (Am. J. Transplant. 2011;11:672-80).

The United Network for Organ Sharing is a private, nonprofit organization that manages the nation’s organ transplant system under contract with the federal government.

Dr. Chin-Hong said he had no relevant financial disclosures.

PHILADELPHIA – Selected U.S. organ donors should undergo testing for infection by Trypanosoma cruzi, the etiologic agent of Chagas’ disease, before organs are taken for transplantation, recommended an expert panel initiated by the United Network for Organ Sharing.

U.S. blood donations already undergo routine screening for T. cruzi, Dr. Peter V. Chin-Hong said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. As of early 2011, infectious disease experts estimate that about 300,000 Americans were infected with T. cruzi, and the panel learned of about 30 confirmed cases of T. cruzi transmission from infected donors to U.S. organ recipients, he added.

Dr. Chin-Hong and his fellow panel members also recommended that when an organ donor – either living or deceased – is positive for T. cruzi infection, most organs are still usable for transplant as long as the recipient gives informed consent, is closely monitored for 6 months for signs of infection, and is treated promptly with an appropriate drug regimen if infection starts. The panel’s only exception to this policy was a recommendation that hearts from organ donors that are infected with T. cruzi not be used at all because the pathogen specifically targets the myocardium, and hearts that harbor T. cruzi risk eventually developing cardiomyopathy.

The panel backed an aggressive approach to the use of organs from infected donors because "we were concerned that people were discarding these organs "needlessly," Dr. Chin-Hong said in an interview. He estimated that patients who received a kidney or liver from a donor infected by T cruzi had about a 20%-30% risk of becoming infected by the pathogen, and even if infection occurred, reliable treatment exists with the primary agent, benznidazole, or with the second-line drug, nifurtimox.

"We have not seen any negative outcomes using T. cruzi treatment," he said.

"We do the same thing, except all our donors are screened for T. cruzi," commented Dr. Roberta Lattes, coordinator of transplant infectious diseases at the Institute of Nephrology in Buenos Aires. The only difference is that in Argentina, every organ donors is screened because T. cruzi is endemic in Mexico and in Central and South American. The U.S. panel suggested that U.S. organ donors undergo selection for screening by first asking if the donor was born in any of those regions.

"There is insufficient evidence for universal screening" in the United States, although individual U.S. organ procurement agencies might decide to apply universal screening to donors based on local T. cruzi epidemiology, said Dr. Chin-Hong, director of the transplant and immunocompromised host infectious diseases program at the University of California, San Francisco.

"We don’t use drug prophylaxis" on recipients of organs from infected donors "because the drugs are very toxic, and transmission is not that high," Dr. Lattes said. "But you must monitor, and at the least sign of infection you have to treat." She also agreed that hearts from T. cruzi–infected donors should not be used for transplants.

Organ donors who were born in Mexico or Central or South American should receive screening by a T. cruzi test that is approved by the Food and Drug Administration. Patients who receive an organ from a positive donor should undergo periodic testing with the same tests, weekly for the first 2 months after transplant, followed by every other week for the third month, and then monthly for another 3 months. Blood specimens should also be drawn and monitored microscopically for T. cruzi at the same times, and even more frequent specimens should be drawn, tested, and examined if organ recipients develop fever or signs of rejection. Confirmed infection must be treated promptly.

The panel published their recommendations in April (Am. J. Transplant. 2011;11:672-80).

The United Network for Organ Sharing is a private, nonprofit organization that manages the nation’s organ transplant system under contract with the federal government.

Dr. Chin-Hong said he had no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.