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HCV infection raises risk of death after kidney transplant
SAN FRANCISCO – Infection with hepatitis C virus is a risk factor for poor outcomes after kidney transplantation, but infection with human immunodeficiency virus is not, finds a cohort study reported at the 2014 World Transplant Congress.
"Centers should be more selective in transplanting HCV-positive kidney transplant candidates. But controlled HIV infection should no longer be perceived as a barrier to kidney transplantation," said first author Dr. Deirdre L. Sawinski of the University of Pennsylvania in Philadelphia.
Further, control of hepatitis C with treatment should be a priority in hopes of improving outcomes, she added.
Researchers studied 111,990 patients from the United Network for Organ Sharing (UNOS) database who had a known serostatus and underwent kidney transplantation in 1996 or later when highly active antiretroviral therapy became widespread. Overall, 4.6% were infected with HCV alone, 0.4% were infected with HIV alone, and 0.1% were coinfected.
Multivariate analyses adjusted for a variety of donor and recipient characteristics, and included a variable for transplant after 2001. This time point "reflects both the year in which more than half of patients were discharged on tacrolimus maintenance therapy as well as the year in which interferon therapy was approved for treatment for hepatitis C," Dr. Sawinski said.
HCV-infected patients and especially HCV and HIV-coinfected patients had significantly higher risks of death (hazard ratio, 1.52 and 3.83, respectively) and of graft loss (HR, 1.48 and 3.40, respectively), compared with uninfected patients. In contrast, patients infected with HIV alone were not at higher risk of death or graft loss.
"The main cause of death for the reference [uninfected] group and the hep C–positive patients was listed as cardiovascular disease, whereas the HIV-positive and coinfected patients most often had infection as their causes of death," Dr. Sawinski said. "However, you have to take that with a grain of salt as 40% of patients across all four groups had missing data [regarding] cause of death."
The risk persisted even after researchers corrected for the impact of antibody-depleting therapy during transplantation on graft survival. However, the UNOS database does not provide information about treatment with interferon before and after direct-acting antiretroviral drugs became available. Additionally, Dr. Sawinski noted, "the UNOS data set does not identify which patients are actually viremic vs. antibody positive." Data are similarly nonspecific for deceased donors but are detailed (antibody positive vs. viremic) for living donors.
A secondary analysis considered a cohort of 180,177 patients with unknown serostatus. In this analysis, the risks of death and graft loss were elevated among patients with dual unknown status relative to those known to be dually uninfected (HR, 1.06 and 1.02), according to data reported at the 2014 World Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. However, these small elevations of risk are "probably not clinically meaningful," commented Dr. Sawinski, who disclosed no relevant conflicts of interest. Risks were not significantly elevated for HCV-positive patients vs. HCV-positive, HIV-unknown patients, or for HIV-positive patients vs. HIV-positive, HCV-unknown patients.
Additionally, main study findings were essentially the same when the cohort with known serostatus and the cohort with an unknown serostatus were combined and the researchers assumed the unknown status patients were uninfected.
This study was selected for a plenary session because it provides information about coinfected patients. Yet, reporting of hepatitis C status was missing in quite a number of patients. Hence, they had to be excluded from this study, which was retrospective in nature. In spite of this, the results do make one think hard about transplanting a coinfected patient. This could all change with the new hepatitis-C therapies, and make outcomes better.
Dr. Roslyn B. Mannon was the session cochair at the meeting and is a professor of medicine and surgery and director of research at the Comprehensive Transplant Institute, University of Alabama, Birmingham. She made her remarks in an interview after the meeting. She has no financial conflicts.
This study was selected for a plenary session because it provides information about coinfected patients. Yet, reporting of hepatitis C status was missing in quite a number of patients. Hence, they had to be excluded from this study, which was retrospective in nature. In spite of this, the results do make one think hard about transplanting a coinfected patient. This could all change with the new hepatitis-C therapies, and make outcomes better.
Dr. Roslyn B. Mannon was the session cochair at the meeting and is a professor of medicine and surgery and director of research at the Comprehensive Transplant Institute, University of Alabama, Birmingham. She made her remarks in an interview after the meeting. She has no financial conflicts.
This study was selected for a plenary session because it provides information about coinfected patients. Yet, reporting of hepatitis C status was missing in quite a number of patients. Hence, they had to be excluded from this study, which was retrospective in nature. In spite of this, the results do make one think hard about transplanting a coinfected patient. This could all change with the new hepatitis-C therapies, and make outcomes better.
Dr. Roslyn B. Mannon was the session cochair at the meeting and is a professor of medicine and surgery and director of research at the Comprehensive Transplant Institute, University of Alabama, Birmingham. She made her remarks in an interview after the meeting. She has no financial conflicts.
SAN FRANCISCO – Infection with hepatitis C virus is a risk factor for poor outcomes after kidney transplantation, but infection with human immunodeficiency virus is not, finds a cohort study reported at the 2014 World Transplant Congress.
"Centers should be more selective in transplanting HCV-positive kidney transplant candidates. But controlled HIV infection should no longer be perceived as a barrier to kidney transplantation," said first author Dr. Deirdre L. Sawinski of the University of Pennsylvania in Philadelphia.
Further, control of hepatitis C with treatment should be a priority in hopes of improving outcomes, she added.
Researchers studied 111,990 patients from the United Network for Organ Sharing (UNOS) database who had a known serostatus and underwent kidney transplantation in 1996 or later when highly active antiretroviral therapy became widespread. Overall, 4.6% were infected with HCV alone, 0.4% were infected with HIV alone, and 0.1% were coinfected.
Multivariate analyses adjusted for a variety of donor and recipient characteristics, and included a variable for transplant after 2001. This time point "reflects both the year in which more than half of patients were discharged on tacrolimus maintenance therapy as well as the year in which interferon therapy was approved for treatment for hepatitis C," Dr. Sawinski said.
HCV-infected patients and especially HCV and HIV-coinfected patients had significantly higher risks of death (hazard ratio, 1.52 and 3.83, respectively) and of graft loss (HR, 1.48 and 3.40, respectively), compared with uninfected patients. In contrast, patients infected with HIV alone were not at higher risk of death or graft loss.
"The main cause of death for the reference [uninfected] group and the hep C–positive patients was listed as cardiovascular disease, whereas the HIV-positive and coinfected patients most often had infection as their causes of death," Dr. Sawinski said. "However, you have to take that with a grain of salt as 40% of patients across all four groups had missing data [regarding] cause of death."
The risk persisted even after researchers corrected for the impact of antibody-depleting therapy during transplantation on graft survival. However, the UNOS database does not provide information about treatment with interferon before and after direct-acting antiretroviral drugs became available. Additionally, Dr. Sawinski noted, "the UNOS data set does not identify which patients are actually viremic vs. antibody positive." Data are similarly nonspecific for deceased donors but are detailed (antibody positive vs. viremic) for living donors.
A secondary analysis considered a cohort of 180,177 patients with unknown serostatus. In this analysis, the risks of death and graft loss were elevated among patients with dual unknown status relative to those known to be dually uninfected (HR, 1.06 and 1.02), according to data reported at the 2014 World Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. However, these small elevations of risk are "probably not clinically meaningful," commented Dr. Sawinski, who disclosed no relevant conflicts of interest. Risks were not significantly elevated for HCV-positive patients vs. HCV-positive, HIV-unknown patients, or for HIV-positive patients vs. HIV-positive, HCV-unknown patients.
Additionally, main study findings were essentially the same when the cohort with known serostatus and the cohort with an unknown serostatus were combined and the researchers assumed the unknown status patients were uninfected.
SAN FRANCISCO – Infection with hepatitis C virus is a risk factor for poor outcomes after kidney transplantation, but infection with human immunodeficiency virus is not, finds a cohort study reported at the 2014 World Transplant Congress.
"Centers should be more selective in transplanting HCV-positive kidney transplant candidates. But controlled HIV infection should no longer be perceived as a barrier to kidney transplantation," said first author Dr. Deirdre L. Sawinski of the University of Pennsylvania in Philadelphia.
Further, control of hepatitis C with treatment should be a priority in hopes of improving outcomes, she added.
Researchers studied 111,990 patients from the United Network for Organ Sharing (UNOS) database who had a known serostatus and underwent kidney transplantation in 1996 or later when highly active antiretroviral therapy became widespread. Overall, 4.6% were infected with HCV alone, 0.4% were infected with HIV alone, and 0.1% were coinfected.
Multivariate analyses adjusted for a variety of donor and recipient characteristics, and included a variable for transplant after 2001. This time point "reflects both the year in which more than half of patients were discharged on tacrolimus maintenance therapy as well as the year in which interferon therapy was approved for treatment for hepatitis C," Dr. Sawinski said.
HCV-infected patients and especially HCV and HIV-coinfected patients had significantly higher risks of death (hazard ratio, 1.52 and 3.83, respectively) and of graft loss (HR, 1.48 and 3.40, respectively), compared with uninfected patients. In contrast, patients infected with HIV alone were not at higher risk of death or graft loss.
"The main cause of death for the reference [uninfected] group and the hep C–positive patients was listed as cardiovascular disease, whereas the HIV-positive and coinfected patients most often had infection as their causes of death," Dr. Sawinski said. "However, you have to take that with a grain of salt as 40% of patients across all four groups had missing data [regarding] cause of death."
The risk persisted even after researchers corrected for the impact of antibody-depleting therapy during transplantation on graft survival. However, the UNOS database does not provide information about treatment with interferon before and after direct-acting antiretroviral drugs became available. Additionally, Dr. Sawinski noted, "the UNOS data set does not identify which patients are actually viremic vs. antibody positive." Data are similarly nonspecific for deceased donors but are detailed (antibody positive vs. viremic) for living donors.
A secondary analysis considered a cohort of 180,177 patients with unknown serostatus. In this analysis, the risks of death and graft loss were elevated among patients with dual unknown status relative to those known to be dually uninfected (HR, 1.06 and 1.02), according to data reported at the 2014 World Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. However, these small elevations of risk are "probably not clinically meaningful," commented Dr. Sawinski, who disclosed no relevant conflicts of interest. Risks were not significantly elevated for HCV-positive patients vs. HCV-positive, HIV-unknown patients, or for HIV-positive patients vs. HIV-positive, HCV-unknown patients.
Additionally, main study findings were essentially the same when the cohort with known serostatus and the cohort with an unknown serostatus were combined and the researchers assumed the unknown status patients were uninfected.
2014 WORLD TRANSPLANT CONGRESS
Key clinical point: Centers should be selective when kidney transplant candidates are HCV positive, but controlled HIV infection should no longer be perceived as a barrier.
Major finding: Relative to uninfected peers, HCV-infected patients and HIV/HCV-coinfected patients had higher risks of death (HR, 1.52 and 3.83) and graft loss (HR, 1.48 and 3.40), but HIV-infected patients did not.
Data source: Cohort study of 111,990 patients from the UNOS database who underwent kidney transplant.
Disclosures: Dr. Sawinski disclosed no relevant conflicts of interest.
Many surgical residents consider quitting during training
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
FROM JAMA Surgery
Major finding: More than half of survey respondents (58%) considered quitting their general surgery residency, an issue more persistent with female respondents.
Data source: Analysis of 288 responses to a survey of general surgery residents in 13 residency programs across different regions (West, Southwest, Midwest, and Northeast) and training centers (university programs, independent programs, or hybrid university-affiliated programs without an onsite university or medical school).
Disclosures: The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
FDA approves ex vivo lung perfusion device that preserves donor organs
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
Tests may help before liver transplant, not after
CHICAGO – Two laboratory measurements that are commonly used to assess the cause of symptomatic ascites before liver transplant may be deceptive when used to assess posttransplant ascites, a retrospective study of 15 patients suggested.
Before liver transplant, a serum-ascites albumin gradient (SAAG) greater than 1.1 g/dL differentiates ascites due to portal hypertension rather than other causes 97% of the time. An ascites total protein (aTP) measurement has a lower accuracy for portal hypertension of 57%, but when used in conjunction with SAAG, an aTP of 2.5 g/dL or greater suggests that the cause is cardiac ascites, tuberculous ascites, or peritoneal carcinomatosis, Dr. Jeffrey LaFond explained at the annual Digestive Disease Week.
He and his associates studied the records of 15 patients who developed symptomatic post-transplant ascites that had enough volume to require therapeutic paracentesis. The ascites occurred a mean of 515 days after transplantation (ranging from 14 to 2,744 days). In the work-up for ascites, the sensitivity of SAAG for portal hypertension was 82% and the sensitivity of aTP for portal hypertension was 50%.
Three of 12 patients who had a posttransplant SAAG had a gradient below 1.1 g/dL even though other tests found no evidence of another cause for ascites besides portal hypertension, and two of those three patients had confirmed portal hypertension, he reported. Five of 10 patients with an aTP had a value greater than 2.5 g/dL, even though they had confirmed portal hypertension and normal cardiac function, he reported.
"Assessment of ascites due to portal hypertension and/or vascular stricture in the posttransplant period using SAAG and aTP can be deceiving and cannot be relied upon to make diagnostic interventional decisions," said Dr. LaFond of the University of Virginia, Charlottesville. "A hepatic venogram should be performed early on in patients with posttransplant ascites to evaluate for strictures and portal hypertension.
Records showed that all patients in the study had ascites confirmed by imaging and/or paracenteses and had diagnostic studies to rule out heart failure, opportunistic infection, or malignancy as the source of ascites. Suspected portal hypertension was confirmed by pressure measurements or the presence of vascular strictures on venogram, with portal hypertension defined as a sinusoidal or portosystemic gradient greater than 5 or the presence of a stricture with a gradient of at least 3.
An estimated 3%-7% of patients develop ascites after liver transplant, which has been associated with an increased risk of renal impairment, prolonged hospitalization, and abdominal infections, he said.
Dr. LaFond reported having no financial disclosures.
On Twitter @sherryboschert
*This story was updated 6/3/2014.
CHICAGO – Two laboratory measurements that are commonly used to assess the cause of symptomatic ascites before liver transplant may be deceptive when used to assess posttransplant ascites, a retrospective study of 15 patients suggested.
Before liver transplant, a serum-ascites albumin gradient (SAAG) greater than 1.1 g/dL differentiates ascites due to portal hypertension rather than other causes 97% of the time. An ascites total protein (aTP) measurement has a lower accuracy for portal hypertension of 57%, but when used in conjunction with SAAG, an aTP of 2.5 g/dL or greater suggests that the cause is cardiac ascites, tuberculous ascites, or peritoneal carcinomatosis, Dr. Jeffrey LaFond explained at the annual Digestive Disease Week.
He and his associates studied the records of 15 patients who developed symptomatic post-transplant ascites that had enough volume to require therapeutic paracentesis. The ascites occurred a mean of 515 days after transplantation (ranging from 14 to 2,744 days). In the work-up for ascites, the sensitivity of SAAG for portal hypertension was 82% and the sensitivity of aTP for portal hypertension was 50%.
Three of 12 patients who had a posttransplant SAAG had a gradient below 1.1 g/dL even though other tests found no evidence of another cause for ascites besides portal hypertension, and two of those three patients had confirmed portal hypertension, he reported. Five of 10 patients with an aTP had a value greater than 2.5 g/dL, even though they had confirmed portal hypertension and normal cardiac function, he reported.
"Assessment of ascites due to portal hypertension and/or vascular stricture in the posttransplant period using SAAG and aTP can be deceiving and cannot be relied upon to make diagnostic interventional decisions," said Dr. LaFond of the University of Virginia, Charlottesville. "A hepatic venogram should be performed early on in patients with posttransplant ascites to evaluate for strictures and portal hypertension.
Records showed that all patients in the study had ascites confirmed by imaging and/or paracenteses and had diagnostic studies to rule out heart failure, opportunistic infection, or malignancy as the source of ascites. Suspected portal hypertension was confirmed by pressure measurements or the presence of vascular strictures on venogram, with portal hypertension defined as a sinusoidal or portosystemic gradient greater than 5 or the presence of a stricture with a gradient of at least 3.
An estimated 3%-7% of patients develop ascites after liver transplant, which has been associated with an increased risk of renal impairment, prolonged hospitalization, and abdominal infections, he said.
Dr. LaFond reported having no financial disclosures.
On Twitter @sherryboschert
*This story was updated 6/3/2014.
CHICAGO – Two laboratory measurements that are commonly used to assess the cause of symptomatic ascites before liver transplant may be deceptive when used to assess posttransplant ascites, a retrospective study of 15 patients suggested.
Before liver transplant, a serum-ascites albumin gradient (SAAG) greater than 1.1 g/dL differentiates ascites due to portal hypertension rather than other causes 97% of the time. An ascites total protein (aTP) measurement has a lower accuracy for portal hypertension of 57%, but when used in conjunction with SAAG, an aTP of 2.5 g/dL or greater suggests that the cause is cardiac ascites, tuberculous ascites, or peritoneal carcinomatosis, Dr. Jeffrey LaFond explained at the annual Digestive Disease Week.
He and his associates studied the records of 15 patients who developed symptomatic post-transplant ascites that had enough volume to require therapeutic paracentesis. The ascites occurred a mean of 515 days after transplantation (ranging from 14 to 2,744 days). In the work-up for ascites, the sensitivity of SAAG for portal hypertension was 82% and the sensitivity of aTP for portal hypertension was 50%.
Three of 12 patients who had a posttransplant SAAG had a gradient below 1.1 g/dL even though other tests found no evidence of another cause for ascites besides portal hypertension, and two of those three patients had confirmed portal hypertension, he reported. Five of 10 patients with an aTP had a value greater than 2.5 g/dL, even though they had confirmed portal hypertension and normal cardiac function, he reported.
"Assessment of ascites due to portal hypertension and/or vascular stricture in the posttransplant period using SAAG and aTP can be deceiving and cannot be relied upon to make diagnostic interventional decisions," said Dr. LaFond of the University of Virginia, Charlottesville. "A hepatic venogram should be performed early on in patients with posttransplant ascites to evaluate for strictures and portal hypertension.
Records showed that all patients in the study had ascites confirmed by imaging and/or paracenteses and had diagnostic studies to rule out heart failure, opportunistic infection, or malignancy as the source of ascites. Suspected portal hypertension was confirmed by pressure measurements or the presence of vascular strictures on venogram, with portal hypertension defined as a sinusoidal or portosystemic gradient greater than 5 or the presence of a stricture with a gradient of at least 3.
An estimated 3%-7% of patients develop ascites after liver transplant, which has been associated with an increased risk of renal impairment, prolonged hospitalization, and abdominal infections, he said.
Dr. LaFond reported having no financial disclosures.
On Twitter @sherryboschert
*This story was updated 6/3/2014.
AT DDW 2014
Key clinical point: Serum-ascites albumin gradient and ascites total protein cannot be relied upon to differentiate the cause of ascites after liver transplant.
Major finding: The sensitivity for portal hypertension as the cause of ascites after liver transplant was 82% for SAAG and 50% for aTP.
Data source: A retrospective study of 15 patients who developed symptomatic ascites after liver transplantation that required intervention.
Disclosures: Dr. LaFond reported having no financial disclosures.
Liver transplant exceptions deserve fresh look
Room air hypoxemia was associated with greater post–liver transplant mortality in hepatopulmonary syndrome patients, according to Dr. David S. Goldberg and his colleagues.
On the other hand, HPS transplant candidates had overall decreased pretransplantation mortality compared with non-HPS patients, suggesting that "current exception policy might overprioritize waitlisted HPS patients," they wrote.
The report appears in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.005).
Dr. Goldberg of the University of Pennsylvania, Philadelphia, looked at all 973 liver transplant candidates from the United Network for Organ Sharing database who had at least one exception application for HPS approved between Feb. 27, 2002, and Dec. 14, 2012.
For comparison, the authors assessed 59,619 non-HPS adult waitlist candidates who registered for their first liver transplantation on or after Feb. 27, 2002.
Overall, there was a 1-year posttransplant survival rate of 91%, a 3-year survival rate of 81%, and a 5-year rate of 76% among the HPS cohort, the authors wrote. Those rates were comparable with the 1-year, 3-year, and 5-year posttransplant rates for non-HPS patients of 89%, 81%, and 74%.
However, looking at pretransplant survival, the authors found that a significantly greater proportion of non-HPS transplant candidates died on the waitlist, compared with HPS patients (20% vs. 9%; P less than .001). That translated to a hazard ratio of 0.82 among HPS patients for dying on the waitlist, compared with non-HPS patients (95% confidence interval, 0.70-0.96).
Next, the authors assessed the relationship between pretransplant room air oxygenation among HPS patients on posttransplant survival rates. They found that patients with pretransplant PaO2 (partial pressure of oxygen in arterial blood) levels of less than 50 mm Hg had a significantly higher posttransplant mortality, compared with patients with PaO2 levels between 50 and 59 mm Hg (HR = 1.56; 95% CI, 1.02-2.38).
Similarly, in a cubic spline model, transplant recipients with a PaO2 of less than 44.0 mm Hg had significantly increased posttransplantation mortality compared with recipients with a PaO2 of 44.1-54.0 mm Hg (HR = 1.58; 95% CI, 1.15-2.18).
"These data must be taken in context, as the 5-year posttransplantation patient survival in HPS patients with the lowest values of PaO2 is still at or above a threshold many would consider acceptable for a transplant recipient," the authors cautioned. "Therefore, the transplant community must decide what degree of hypoxemia makes a patient too high risk," they added.
The authors conceded several limitations. "First, we were unable to employ the strict criteria defining HPS used in prospective multicenter studies," they wrote.
"However, we are confident that most, if not all, of the patients had HPS based on the data documenting hypoxemia and shunting in nearly 90% of patients."
Nevertheless, "excellent posttransplantation outcomes in those with less severe hypoxemia suggest that it might be possible to optimize posttransplantation outcomes for patients with HPS without disadvantaging the broader transplant population," they wrote.
This could be accomplished by a review of current exception algorithms, and "by decreasing the initial number of exception points for HPS patients, while offering additional priority to those whose PaO2 values decline toward higher-risk values," they wrote.
Given the fact that this would increase the overall waitlist time, "an increase rather than decrease in data collected regarding these patients is needed to guide policy," they concluded.
The authors disclosed no conflicts of interest. Dr. Goldberg reported receiving funding from the National Institutes of Health, and the study was partially supported by the Health Resources and Services Administration.
This study is an important reminder of the need for ongoing evidence-based revision of the MELD-based liver allocation system. It has been clear since the adoption of MELD for the purpose of organ allocation that there are patients for whom the laboratory components of the MELD score do not accurately portray their disease-associated risk of death. Thus, there is widespread petitioning for MELD exception points for a number of conditions, including hepatopulmonary syndrome (HPS). While criteria for some such conditions are clearly defined, most prominently including hepatocellular carcinoma, for most other conditions practices vary by region and criteria are not always strictly adhered to.
The initial number of points granted for most conditions, including HPS, is arbitrary rather than based on objective analysis. This study suggests that while posttransplant outcomes are similar between patients with HPS exception points and those without points, pretransplant survival is superior in the HPS group, suggesting that perhaps a lower MELD score should be assigned to these patients.
While exceptions are currently a fundamental part of MELD-based liver allocation, greater standardization of MELD exception point criteria is urgently needed. Additional analysis of wait list survival and survival benefit models will be required to ensure that individual groups of patients are not being unjustly overprioritized.
Dr. Elizabeth C. Verna is assistant professor of medicine, Center for Liver Disease and Transplantation, Division of Digestive and Liver Diseases, Columbia University College of Physicians and Surgeons, New York. She disclosed no conflicts of interest.
This study is an important reminder of the need for ongoing evidence-based revision of the MELD-based liver allocation system. It has been clear since the adoption of MELD for the purpose of organ allocation that there are patients for whom the laboratory components of the MELD score do not accurately portray their disease-associated risk of death. Thus, there is widespread petitioning for MELD exception points for a number of conditions, including hepatopulmonary syndrome (HPS). While criteria for some such conditions are clearly defined, most prominently including hepatocellular carcinoma, for most other conditions practices vary by region and criteria are not always strictly adhered to.
The initial number of points granted for most conditions, including HPS, is arbitrary rather than based on objective analysis. This study suggests that while posttransplant outcomes are similar between patients with HPS exception points and those without points, pretransplant survival is superior in the HPS group, suggesting that perhaps a lower MELD score should be assigned to these patients.
While exceptions are currently a fundamental part of MELD-based liver allocation, greater standardization of MELD exception point criteria is urgently needed. Additional analysis of wait list survival and survival benefit models will be required to ensure that individual groups of patients are not being unjustly overprioritized.
Dr. Elizabeth C. Verna is assistant professor of medicine, Center for Liver Disease and Transplantation, Division of Digestive and Liver Diseases, Columbia University College of Physicians and Surgeons, New York. She disclosed no conflicts of interest.
This study is an important reminder of the need for ongoing evidence-based revision of the MELD-based liver allocation system. It has been clear since the adoption of MELD for the purpose of organ allocation that there are patients for whom the laboratory components of the MELD score do not accurately portray their disease-associated risk of death. Thus, there is widespread petitioning for MELD exception points for a number of conditions, including hepatopulmonary syndrome (HPS). While criteria for some such conditions are clearly defined, most prominently including hepatocellular carcinoma, for most other conditions practices vary by region and criteria are not always strictly adhered to.
The initial number of points granted for most conditions, including HPS, is arbitrary rather than based on objective analysis. This study suggests that while posttransplant outcomes are similar between patients with HPS exception points and those without points, pretransplant survival is superior in the HPS group, suggesting that perhaps a lower MELD score should be assigned to these patients.
While exceptions are currently a fundamental part of MELD-based liver allocation, greater standardization of MELD exception point criteria is urgently needed. Additional analysis of wait list survival and survival benefit models will be required to ensure that individual groups of patients are not being unjustly overprioritized.
Dr. Elizabeth C. Verna is assistant professor of medicine, Center for Liver Disease and Transplantation, Division of Digestive and Liver Diseases, Columbia University College of Physicians and Surgeons, New York. She disclosed no conflicts of interest.
Room air hypoxemia was associated with greater post–liver transplant mortality in hepatopulmonary syndrome patients, according to Dr. David S. Goldberg and his colleagues.
On the other hand, HPS transplant candidates had overall decreased pretransplantation mortality compared with non-HPS patients, suggesting that "current exception policy might overprioritize waitlisted HPS patients," they wrote.
The report appears in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.005).
Dr. Goldberg of the University of Pennsylvania, Philadelphia, looked at all 973 liver transplant candidates from the United Network for Organ Sharing database who had at least one exception application for HPS approved between Feb. 27, 2002, and Dec. 14, 2012.
For comparison, the authors assessed 59,619 non-HPS adult waitlist candidates who registered for their first liver transplantation on or after Feb. 27, 2002.
Overall, there was a 1-year posttransplant survival rate of 91%, a 3-year survival rate of 81%, and a 5-year rate of 76% among the HPS cohort, the authors wrote. Those rates were comparable with the 1-year, 3-year, and 5-year posttransplant rates for non-HPS patients of 89%, 81%, and 74%.
However, looking at pretransplant survival, the authors found that a significantly greater proportion of non-HPS transplant candidates died on the waitlist, compared with HPS patients (20% vs. 9%; P less than .001). That translated to a hazard ratio of 0.82 among HPS patients for dying on the waitlist, compared with non-HPS patients (95% confidence interval, 0.70-0.96).
Next, the authors assessed the relationship between pretransplant room air oxygenation among HPS patients on posttransplant survival rates. They found that patients with pretransplant PaO2 (partial pressure of oxygen in arterial blood) levels of less than 50 mm Hg had a significantly higher posttransplant mortality, compared with patients with PaO2 levels between 50 and 59 mm Hg (HR = 1.56; 95% CI, 1.02-2.38).
Similarly, in a cubic spline model, transplant recipients with a PaO2 of less than 44.0 mm Hg had significantly increased posttransplantation mortality compared with recipients with a PaO2 of 44.1-54.0 mm Hg (HR = 1.58; 95% CI, 1.15-2.18).
"These data must be taken in context, as the 5-year posttransplantation patient survival in HPS patients with the lowest values of PaO2 is still at or above a threshold many would consider acceptable for a transplant recipient," the authors cautioned. "Therefore, the transplant community must decide what degree of hypoxemia makes a patient too high risk," they added.
The authors conceded several limitations. "First, we were unable to employ the strict criteria defining HPS used in prospective multicenter studies," they wrote.
"However, we are confident that most, if not all, of the patients had HPS based on the data documenting hypoxemia and shunting in nearly 90% of patients."
Nevertheless, "excellent posttransplantation outcomes in those with less severe hypoxemia suggest that it might be possible to optimize posttransplantation outcomes for patients with HPS without disadvantaging the broader transplant population," they wrote.
This could be accomplished by a review of current exception algorithms, and "by decreasing the initial number of exception points for HPS patients, while offering additional priority to those whose PaO2 values decline toward higher-risk values," they wrote.
Given the fact that this would increase the overall waitlist time, "an increase rather than decrease in data collected regarding these patients is needed to guide policy," they concluded.
The authors disclosed no conflicts of interest. Dr. Goldberg reported receiving funding from the National Institutes of Health, and the study was partially supported by the Health Resources and Services Administration.
Room air hypoxemia was associated with greater post–liver transplant mortality in hepatopulmonary syndrome patients, according to Dr. David S. Goldberg and his colleagues.
On the other hand, HPS transplant candidates had overall decreased pretransplantation mortality compared with non-HPS patients, suggesting that "current exception policy might overprioritize waitlisted HPS patients," they wrote.
The report appears in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.005).
Dr. Goldberg of the University of Pennsylvania, Philadelphia, looked at all 973 liver transplant candidates from the United Network for Organ Sharing database who had at least one exception application for HPS approved between Feb. 27, 2002, and Dec. 14, 2012.
For comparison, the authors assessed 59,619 non-HPS adult waitlist candidates who registered for their first liver transplantation on or after Feb. 27, 2002.
Overall, there was a 1-year posttransplant survival rate of 91%, a 3-year survival rate of 81%, and a 5-year rate of 76% among the HPS cohort, the authors wrote. Those rates were comparable with the 1-year, 3-year, and 5-year posttransplant rates for non-HPS patients of 89%, 81%, and 74%.
However, looking at pretransplant survival, the authors found that a significantly greater proportion of non-HPS transplant candidates died on the waitlist, compared with HPS patients (20% vs. 9%; P less than .001). That translated to a hazard ratio of 0.82 among HPS patients for dying on the waitlist, compared with non-HPS patients (95% confidence interval, 0.70-0.96).
Next, the authors assessed the relationship between pretransplant room air oxygenation among HPS patients on posttransplant survival rates. They found that patients with pretransplant PaO2 (partial pressure of oxygen in arterial blood) levels of less than 50 mm Hg had a significantly higher posttransplant mortality, compared with patients with PaO2 levels between 50 and 59 mm Hg (HR = 1.56; 95% CI, 1.02-2.38).
Similarly, in a cubic spline model, transplant recipients with a PaO2 of less than 44.0 mm Hg had significantly increased posttransplantation mortality compared with recipients with a PaO2 of 44.1-54.0 mm Hg (HR = 1.58; 95% CI, 1.15-2.18).
"These data must be taken in context, as the 5-year posttransplantation patient survival in HPS patients with the lowest values of PaO2 is still at or above a threshold many would consider acceptable for a transplant recipient," the authors cautioned. "Therefore, the transplant community must decide what degree of hypoxemia makes a patient too high risk," they added.
The authors conceded several limitations. "First, we were unable to employ the strict criteria defining HPS used in prospective multicenter studies," they wrote.
"However, we are confident that most, if not all, of the patients had HPS based on the data documenting hypoxemia and shunting in nearly 90% of patients."
Nevertheless, "excellent posttransplantation outcomes in those with less severe hypoxemia suggest that it might be possible to optimize posttransplantation outcomes for patients with HPS without disadvantaging the broader transplant population," they wrote.
This could be accomplished by a review of current exception algorithms, and "by decreasing the initial number of exception points for HPS patients, while offering additional priority to those whose PaO2 values decline toward higher-risk values," they wrote.
Given the fact that this would increase the overall waitlist time, "an increase rather than decrease in data collected regarding these patients is needed to guide policy," they concluded.
The authors disclosed no conflicts of interest. Dr. Goldberg reported receiving funding from the National Institutes of Health, and the study was partially supported by the Health Resources and Services Administration.
FROM GASTROENTEROLOGY
Major finding: Liver transplant recipients with hepatopulmonary syndrome have success similar to that of other transplant candidates, unless severe hypoxemia is present.
Data source: A retrospective cohort study of data submitted to the United Network for Organ Sharing.
Disclosures: The authors disclosed no conflicts of interest. Dr. Goldberg reported receiving funding from the National Institutes of Health, and the study was partially supported by the Health Resources and Services Administration.
Lung transplants in HIV-positive gaining momentum
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
AT CHEST WORLD CONGRESS 2014
Major finding: Mild acute rejection occurred in two HIV-positive patients who were transplanted for idiopathic pulmonary fibrosis; they have remained free of acute rejection and are actively employed 15 months and 41 months after transplant.
Data source: A retrospective analysis of lung transplantation in three HIV-positive patients.
Disclosures: Dr. Seethamraju and his coauthors reported no relevant disclosures.
Outcomes linked to distance from liver transplant center
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
From JAMA
Major finding: Living more than 100 miles from a VA transplant center means that veterans in liver failure are less likely to survive to transplant: A wait-listed veteran living 25 miles from a VATC would have a 62.9% 5-year adjusted probability of survival from first hepatic decompensation event, compared with a 59.8% 5-year adjusted probability of survival for a veteran living 100 miles from a VATC.
Data source: A retrospective analysis of the medical records of 50,637 VA patients eligible for liver transplantation in 2003-2012.
Disclosures: This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Two studies: Preimplant kidney biopsy doesn’t predict organ viability
Preimplant biopsy of donor kidneys doesn’t accurately predict the organs’ viability and leads to many acceptable kidneys being discarded, according to two separate reports published online in the Clinical Journal of the American Society of Nephrology.
Biopsies are obtained routinely from donor kidneys in the United States, and unfavorable biopsy findings are the most frequently cited reason for discarding donor kidneys as unacceptable. Ideally, such samples would be obtained by core needle biopsy, would not be frozen, would be thoroughly examined by a pathologist with special training in reading kidney biopsies, and would be assessed meticulously for chronic tubular atrophy, arteriolar hyalinosis, interstitial inflammation, interstitial fibrosis, and the presence and severity of acute tubular necrosis.
In actual practice, however, these samples are almost always obtained by wedge biopsy, are frozen, and are rushed through a perfunctory examination by whatever pathologist is available so that the organ can be transplanted as quickly as possible if it is found to be acceptable. So many clinicians have questioned whether the results of such biopsies actually assess the organs’ viability and predict graft failure, both groups of researchers noted.
In what they described as the largest cohort study to date on this issue, one team analyzed data regarding 651 consecutive kidney transplants performed during a 2-year period, for which four organ procurement organizations obtained the kidneys from 369 deceased donors. The four organizations performed wedge biopsies immediately after procurement, and different pathology services evaluated frozen sections from these organs and reported their findings to potential transplant centers.
Patient outcomes were tracked using information in the United Network for Organ Sharing (UNOS) database, said Dr. Isaac E. Hall of the section of nephrology and the program of applied translational research, Yale University, New Haven, Conn., and his associates.
They assessed whether a biopsy finding of acute tubular necrosis correlated with the graft’s performance after transplantation. Acute tubular necrosis was reported in 110 biopsies (17%) overall. The four procurement organizations varied widely in their reported rates of the abnormality, from a low of zero cases to a high of 25% of cases. This variation suggests that the process of obtaining and interpreting these biopsies is, at best, not uniform among procurement groups, according to the investigators.
During a median follow-up of 1 year, the primary outcome of interest – delayed graft function – occurred in 45% of kidneys that were reported to have tubular necrosis and in 39% of those reportedly free of such necrosis. This is a nonsignificant difference. There also was no significant difference in the secondary outcome of graft failure between recipients of organs with acute tubular necrosis, compared with recipients of organs without it.
In summary, there was no significant association between biopsy reports of acute tubular necrosis and graft viability. "It is reasonable to question whether acute tubular necrosis, or acute kidney injury in general for that matter, truly causes important allograft outcomes," Dr. Hall and his colleagues wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.08270813]).
In the second study, Dr. Bertram L. Kasiske of the Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, and his associates assessed the records for 83 kidneys that were discarded because of unfavorable biopsy findings (cases) and 83 contralateral kidneys from the same donors that were transplanted (contralateral controls). They compared these findings with those for 151 transplanted kidneys from 83 deceased donors who were matched for the index cases’ donor profiles.
"Ours is the first controlled study to compare biopsy findings between discarded kidneys and matched transplanted kidneys," Dr. Kasiske and his colleagues noted.
They found that most of the biopsy reports were of low quality, and very few indicated the amounts of tubular atrophy, interstitial inflammation, arteriolar hyalinosis, or acute tubular necrosis. The percentage of glomerulosclerosis was often the only finding upon which to base the decision of whether to use or discard the allograft.
But the percentage of glomerulosclerosis overlapped substantially between cases (discarded kidneys) and controls (transplanted kidneys). This suggests that "information obtained from procurement biopsies is of low quality and may lead to unnecessary discard of transplantable kidneys," Dr. Kasiske and his associates wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.07610713]).
"A reasonable conclusion from this and other studies is that the widespread practice of routinely obtaining procurement biopsies should be abandoned, as has been successfully done in Europe," they noted.
Dr. Hall’s study was supported by the American Heart Association, the Roche Organ Transplantation Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and the U.S. Health Resources and Services Administration. Dr. Kasiske’s study was supported by the Minneapolis Medical Research Foundation, the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients, and the United Network for Organ Sharing. Both research groups reported no potential financial conflicts of interest.
The decision to transplant a particular kidney is extremely complex "and dependent on a multitude of factors, including donor age, clinical history, anatomic abnormalities, terminal creatinine, and biopsy findings," wrote Dr. Sayeed Khan Malek.
"When the biopsy findings are consistent with the clinical evaluation of the donor, they are useful in making the determination about transplanting the kidney. However, biopsy findings considered in isolation are of limited value and should be interpreted with caution when making the decision to turn down a potentially transplantable kidney," he said.
Dr. Sayeed Khan Malek is clinical director of transplant surgery at Brigham and Women’s Hospital, Boston. He reported no potential financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Clin. J. Am. Soc. Nephrol;2014 [doi:10.2215/CJN.00470114]).
The decision to transplant a particular kidney is extremely complex "and dependent on a multitude of factors, including donor age, clinical history, anatomic abnormalities, terminal creatinine, and biopsy findings," wrote Dr. Sayeed Khan Malek.
"When the biopsy findings are consistent with the clinical evaluation of the donor, they are useful in making the determination about transplanting the kidney. However, biopsy findings considered in isolation are of limited value and should be interpreted with caution when making the decision to turn down a potentially transplantable kidney," he said.
Dr. Sayeed Khan Malek is clinical director of transplant surgery at Brigham and Women’s Hospital, Boston. He reported no potential financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Clin. J. Am. Soc. Nephrol;2014 [doi:10.2215/CJN.00470114]).
The decision to transplant a particular kidney is extremely complex "and dependent on a multitude of factors, including donor age, clinical history, anatomic abnormalities, terminal creatinine, and biopsy findings," wrote Dr. Sayeed Khan Malek.
"When the biopsy findings are consistent with the clinical evaluation of the donor, they are useful in making the determination about transplanting the kidney. However, biopsy findings considered in isolation are of limited value and should be interpreted with caution when making the decision to turn down a potentially transplantable kidney," he said.
Dr. Sayeed Khan Malek is clinical director of transplant surgery at Brigham and Women’s Hospital, Boston. He reported no potential financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Clin. J. Am. Soc. Nephrol;2014 [doi:10.2215/CJN.00470114]).
Preimplant biopsy of donor kidneys doesn’t accurately predict the organs’ viability and leads to many acceptable kidneys being discarded, according to two separate reports published online in the Clinical Journal of the American Society of Nephrology.
Biopsies are obtained routinely from donor kidneys in the United States, and unfavorable biopsy findings are the most frequently cited reason for discarding donor kidneys as unacceptable. Ideally, such samples would be obtained by core needle biopsy, would not be frozen, would be thoroughly examined by a pathologist with special training in reading kidney biopsies, and would be assessed meticulously for chronic tubular atrophy, arteriolar hyalinosis, interstitial inflammation, interstitial fibrosis, and the presence and severity of acute tubular necrosis.
In actual practice, however, these samples are almost always obtained by wedge biopsy, are frozen, and are rushed through a perfunctory examination by whatever pathologist is available so that the organ can be transplanted as quickly as possible if it is found to be acceptable. So many clinicians have questioned whether the results of such biopsies actually assess the organs’ viability and predict graft failure, both groups of researchers noted.
In what they described as the largest cohort study to date on this issue, one team analyzed data regarding 651 consecutive kidney transplants performed during a 2-year period, for which four organ procurement organizations obtained the kidneys from 369 deceased donors. The four organizations performed wedge biopsies immediately after procurement, and different pathology services evaluated frozen sections from these organs and reported their findings to potential transplant centers.
Patient outcomes were tracked using information in the United Network for Organ Sharing (UNOS) database, said Dr. Isaac E. Hall of the section of nephrology and the program of applied translational research, Yale University, New Haven, Conn., and his associates.
They assessed whether a biopsy finding of acute tubular necrosis correlated with the graft’s performance after transplantation. Acute tubular necrosis was reported in 110 biopsies (17%) overall. The four procurement organizations varied widely in their reported rates of the abnormality, from a low of zero cases to a high of 25% of cases. This variation suggests that the process of obtaining and interpreting these biopsies is, at best, not uniform among procurement groups, according to the investigators.
During a median follow-up of 1 year, the primary outcome of interest – delayed graft function – occurred in 45% of kidneys that were reported to have tubular necrosis and in 39% of those reportedly free of such necrosis. This is a nonsignificant difference. There also was no significant difference in the secondary outcome of graft failure between recipients of organs with acute tubular necrosis, compared with recipients of organs without it.
In summary, there was no significant association between biopsy reports of acute tubular necrosis and graft viability. "It is reasonable to question whether acute tubular necrosis, or acute kidney injury in general for that matter, truly causes important allograft outcomes," Dr. Hall and his colleagues wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.08270813]).
In the second study, Dr. Bertram L. Kasiske of the Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, and his associates assessed the records for 83 kidneys that were discarded because of unfavorable biopsy findings (cases) and 83 contralateral kidneys from the same donors that were transplanted (contralateral controls). They compared these findings with those for 151 transplanted kidneys from 83 deceased donors who were matched for the index cases’ donor profiles.
"Ours is the first controlled study to compare biopsy findings between discarded kidneys and matched transplanted kidneys," Dr. Kasiske and his colleagues noted.
They found that most of the biopsy reports were of low quality, and very few indicated the amounts of tubular atrophy, interstitial inflammation, arteriolar hyalinosis, or acute tubular necrosis. The percentage of glomerulosclerosis was often the only finding upon which to base the decision of whether to use or discard the allograft.
But the percentage of glomerulosclerosis overlapped substantially between cases (discarded kidneys) and controls (transplanted kidneys). This suggests that "information obtained from procurement biopsies is of low quality and may lead to unnecessary discard of transplantable kidneys," Dr. Kasiske and his associates wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.07610713]).
"A reasonable conclusion from this and other studies is that the widespread practice of routinely obtaining procurement biopsies should be abandoned, as has been successfully done in Europe," they noted.
Dr. Hall’s study was supported by the American Heart Association, the Roche Organ Transplantation Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and the U.S. Health Resources and Services Administration. Dr. Kasiske’s study was supported by the Minneapolis Medical Research Foundation, the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients, and the United Network for Organ Sharing. Both research groups reported no potential financial conflicts of interest.
Preimplant biopsy of donor kidneys doesn’t accurately predict the organs’ viability and leads to many acceptable kidneys being discarded, according to two separate reports published online in the Clinical Journal of the American Society of Nephrology.
Biopsies are obtained routinely from donor kidneys in the United States, and unfavorable biopsy findings are the most frequently cited reason for discarding donor kidneys as unacceptable. Ideally, such samples would be obtained by core needle biopsy, would not be frozen, would be thoroughly examined by a pathologist with special training in reading kidney biopsies, and would be assessed meticulously for chronic tubular atrophy, arteriolar hyalinosis, interstitial inflammation, interstitial fibrosis, and the presence and severity of acute tubular necrosis.
In actual practice, however, these samples are almost always obtained by wedge biopsy, are frozen, and are rushed through a perfunctory examination by whatever pathologist is available so that the organ can be transplanted as quickly as possible if it is found to be acceptable. So many clinicians have questioned whether the results of such biopsies actually assess the organs’ viability and predict graft failure, both groups of researchers noted.
In what they described as the largest cohort study to date on this issue, one team analyzed data regarding 651 consecutive kidney transplants performed during a 2-year period, for which four organ procurement organizations obtained the kidneys from 369 deceased donors. The four organizations performed wedge biopsies immediately after procurement, and different pathology services evaluated frozen sections from these organs and reported their findings to potential transplant centers.
Patient outcomes were tracked using information in the United Network for Organ Sharing (UNOS) database, said Dr. Isaac E. Hall of the section of nephrology and the program of applied translational research, Yale University, New Haven, Conn., and his associates.
They assessed whether a biopsy finding of acute tubular necrosis correlated with the graft’s performance after transplantation. Acute tubular necrosis was reported in 110 biopsies (17%) overall. The four procurement organizations varied widely in their reported rates of the abnormality, from a low of zero cases to a high of 25% of cases. This variation suggests that the process of obtaining and interpreting these biopsies is, at best, not uniform among procurement groups, according to the investigators.
During a median follow-up of 1 year, the primary outcome of interest – delayed graft function – occurred in 45% of kidneys that were reported to have tubular necrosis and in 39% of those reportedly free of such necrosis. This is a nonsignificant difference. There also was no significant difference in the secondary outcome of graft failure between recipients of organs with acute tubular necrosis, compared with recipients of organs without it.
In summary, there was no significant association between biopsy reports of acute tubular necrosis and graft viability. "It is reasonable to question whether acute tubular necrosis, or acute kidney injury in general for that matter, truly causes important allograft outcomes," Dr. Hall and his colleagues wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.08270813]).
In the second study, Dr. Bertram L. Kasiske of the Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, and his associates assessed the records for 83 kidneys that were discarded because of unfavorable biopsy findings (cases) and 83 contralateral kidneys from the same donors that were transplanted (contralateral controls). They compared these findings with those for 151 transplanted kidneys from 83 deceased donors who were matched for the index cases’ donor profiles.
"Ours is the first controlled study to compare biopsy findings between discarded kidneys and matched transplanted kidneys," Dr. Kasiske and his colleagues noted.
They found that most of the biopsy reports were of low quality, and very few indicated the amounts of tubular atrophy, interstitial inflammation, arteriolar hyalinosis, or acute tubular necrosis. The percentage of glomerulosclerosis was often the only finding upon which to base the decision of whether to use or discard the allograft.
But the percentage of glomerulosclerosis overlapped substantially between cases (discarded kidneys) and controls (transplanted kidneys). This suggests that "information obtained from procurement biopsies is of low quality and may lead to unnecessary discard of transplantable kidneys," Dr. Kasiske and his associates wrote (Clin. J. Am. Soc. Nephrol. 2014 [doi:10.2215/CJN.07610713]).
"A reasonable conclusion from this and other studies is that the widespread practice of routinely obtaining procurement biopsies should be abandoned, as has been successfully done in Europe," they noted.
Dr. Hall’s study was supported by the American Heart Association, the Roche Organ Transplantation Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and the U.S. Health Resources and Services Administration. Dr. Kasiske’s study was supported by the Minneapolis Medical Research Foundation, the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients, and the United Network for Organ Sharing. Both research groups reported no potential financial conflicts of interest.
FROM THE CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
Major finding: In one study, biopsy findings from donor kidneys did not correlate with performance of the allografts after transplantation, and in another study, the biopsy findings for kidneys that were discarded as unacceptable were basically the same as those for contralateral kidneys that were successfully transplanted.
Data source: A multicenter cohort study involving 651 kidney transplantations during a 2-year period, and a case-control study involving 83 donor kidneys that were discarded because of unfavorable biopsy findings plus 83 contralateral kidneys from the same donors that were successfully transplanted.
Disclosures: Dr. Hall’s study was supported by the American Heart Association, the Roche Organ Transplantation Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and the U.S. Health Resources and Services Administration. Dr. Kasiske’s study was supported by the Minneapolis Medical Research Foundation, the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients, and UNOS. Both research groups reported no potential financial conflicts of interest.
NASH liver transplant mortality differs from non-NASH
Cardiovascular complications and sepsis are two major concerns after liver transplant for nonalcoholic steatohepatitis, more so than after liver transplant for other indications.
The finding comes from what the authors called the first systematic review and meta-analysis to investigate the cumulative clinical experience of liver transplant for NASH, wrote Dr. Xiaofei Wang and colleagues in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2013.09.023).
In their analysis, Dr. Wang, of the Affiliated Hospital of North Sichuan Medical College, Nanchong, China, and colleagues performed a search of PubMed, Embase, the Cochrane Library, and the Web of Science for studies published through Sept. 1, 2012, that looked at liver transplant for nonalcoholic fatty liver disease (NAFLD) or NASH. Reviews were excluded, as were studies in which NASH patients could not be separated out from non-NASH liver transplant recipients.
Overall, nine studies were analyzed, all of which measured outcomes after liver transplant for NASH. Other indications for transplant included primary biliary cirrhosis/primary sclerosing cholangitis, alcoholic liver disease, hepatitis C, hepatitis B, and cryptogenic cirrhosis.
The researchers found that, on the whole, survival rates at post-transplant years 1, 3, and 5 did not significantly differ between NASH patients and their non-NASH counterparts (1-year odds ratio, 0.77; 95% confidence interval, 0.59-1.00; P = .05; 3-year OR, 0.97; 95% CI, 0.67-1.40; P = .86; 5-year OR, 1.09; 95% CI, 0.77-1.56; P = .63).
Nevertheless, NASH patients registered more deaths due to "cardiovascular events" compared with non-NASH liver transplant recipients, the authors wrote (OR, 1.65; 95% CI, 1.01-2.70; P = .05).
The authors also found that NASH patients were significantly more likely to die of sepsis post transplant than were non-NASH patients (OR, 1.71; 95% CI, 1.17-2.50; P = .006).
On the other hand, NASH patients had fewer deaths caused by graft failure than did patients undergoing liver transplant for other indications (OR, 0.21; 95% CI, 0.05-0.89; P = .03).
In an attempt to explain their findings, the authors pointed out that while cardiovascular events are the top cause of non–graft-related mortality in all liver transplants, NASH patients might be especially susceptible, given that their diagnosis is "frequently associated" with cardiovascular risk factors such as obesity, diabetes, and hypertension. Indeed, these same characteristics might also predispose these patients to postoperative infection and sepsis, they added.
And regarding the finding that graft-related mortality is actually lower among NASH patients, Dr. Wang and colleagues postulated that this may be due to the "lower likelihood of disease recurrence, and this may mean lower rates of graft failure compared with other liver diseases, such as hepatitis C virus and hepatitis B virus infection."
The authors conceded that there were several limitations to their analysis, not the least being heterogeneity between included studies. Moreover, two large population-based studies using national databases were ultimately excluded due to patient duplication and poor accuracy with regard to the cause of death.
In any case, the current analysis shows that "more attention and careful consideration are required in selecting patients with NASH for liver transplant, along with aggressive management of cardiovascular complications and sepsis after transplantation."
The authors disclosed no conflicts of interest related to this study. They wrote that funding was provided by the scientific research development project of North Sichuan Medical College.
Cardiovascular complications and sepsis are two major concerns after liver transplant for nonalcoholic steatohepatitis, more so than after liver transplant for other indications.
The finding comes from what the authors called the first systematic review and meta-analysis to investigate the cumulative clinical experience of liver transplant for NASH, wrote Dr. Xiaofei Wang and colleagues in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2013.09.023).
In their analysis, Dr. Wang, of the Affiliated Hospital of North Sichuan Medical College, Nanchong, China, and colleagues performed a search of PubMed, Embase, the Cochrane Library, and the Web of Science for studies published through Sept. 1, 2012, that looked at liver transplant for nonalcoholic fatty liver disease (NAFLD) or NASH. Reviews were excluded, as were studies in which NASH patients could not be separated out from non-NASH liver transplant recipients.
Overall, nine studies were analyzed, all of which measured outcomes after liver transplant for NASH. Other indications for transplant included primary biliary cirrhosis/primary sclerosing cholangitis, alcoholic liver disease, hepatitis C, hepatitis B, and cryptogenic cirrhosis.
The researchers found that, on the whole, survival rates at post-transplant years 1, 3, and 5 did not significantly differ between NASH patients and their non-NASH counterparts (1-year odds ratio, 0.77; 95% confidence interval, 0.59-1.00; P = .05; 3-year OR, 0.97; 95% CI, 0.67-1.40; P = .86; 5-year OR, 1.09; 95% CI, 0.77-1.56; P = .63).
Nevertheless, NASH patients registered more deaths due to "cardiovascular events" compared with non-NASH liver transplant recipients, the authors wrote (OR, 1.65; 95% CI, 1.01-2.70; P = .05).
The authors also found that NASH patients were significantly more likely to die of sepsis post transplant than were non-NASH patients (OR, 1.71; 95% CI, 1.17-2.50; P = .006).
On the other hand, NASH patients had fewer deaths caused by graft failure than did patients undergoing liver transplant for other indications (OR, 0.21; 95% CI, 0.05-0.89; P = .03).
In an attempt to explain their findings, the authors pointed out that while cardiovascular events are the top cause of non–graft-related mortality in all liver transplants, NASH patients might be especially susceptible, given that their diagnosis is "frequently associated" with cardiovascular risk factors such as obesity, diabetes, and hypertension. Indeed, these same characteristics might also predispose these patients to postoperative infection and sepsis, they added.
And regarding the finding that graft-related mortality is actually lower among NASH patients, Dr. Wang and colleagues postulated that this may be due to the "lower likelihood of disease recurrence, and this may mean lower rates of graft failure compared with other liver diseases, such as hepatitis C virus and hepatitis B virus infection."
The authors conceded that there were several limitations to their analysis, not the least being heterogeneity between included studies. Moreover, two large population-based studies using national databases were ultimately excluded due to patient duplication and poor accuracy with regard to the cause of death.
In any case, the current analysis shows that "more attention and careful consideration are required in selecting patients with NASH for liver transplant, along with aggressive management of cardiovascular complications and sepsis after transplantation."
The authors disclosed no conflicts of interest related to this study. They wrote that funding was provided by the scientific research development project of North Sichuan Medical College.
Cardiovascular complications and sepsis are two major concerns after liver transplant for nonalcoholic steatohepatitis, more so than after liver transplant for other indications.
The finding comes from what the authors called the first systematic review and meta-analysis to investigate the cumulative clinical experience of liver transplant for NASH, wrote Dr. Xiaofei Wang and colleagues in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2013.09.023).
In their analysis, Dr. Wang, of the Affiliated Hospital of North Sichuan Medical College, Nanchong, China, and colleagues performed a search of PubMed, Embase, the Cochrane Library, and the Web of Science for studies published through Sept. 1, 2012, that looked at liver transplant for nonalcoholic fatty liver disease (NAFLD) or NASH. Reviews were excluded, as were studies in which NASH patients could not be separated out from non-NASH liver transplant recipients.
Overall, nine studies were analyzed, all of which measured outcomes after liver transplant for NASH. Other indications for transplant included primary biliary cirrhosis/primary sclerosing cholangitis, alcoholic liver disease, hepatitis C, hepatitis B, and cryptogenic cirrhosis.
The researchers found that, on the whole, survival rates at post-transplant years 1, 3, and 5 did not significantly differ between NASH patients and their non-NASH counterparts (1-year odds ratio, 0.77; 95% confidence interval, 0.59-1.00; P = .05; 3-year OR, 0.97; 95% CI, 0.67-1.40; P = .86; 5-year OR, 1.09; 95% CI, 0.77-1.56; P = .63).
Nevertheless, NASH patients registered more deaths due to "cardiovascular events" compared with non-NASH liver transplant recipients, the authors wrote (OR, 1.65; 95% CI, 1.01-2.70; P = .05).
The authors also found that NASH patients were significantly more likely to die of sepsis post transplant than were non-NASH patients (OR, 1.71; 95% CI, 1.17-2.50; P = .006).
On the other hand, NASH patients had fewer deaths caused by graft failure than did patients undergoing liver transplant for other indications (OR, 0.21; 95% CI, 0.05-0.89; P = .03).
In an attempt to explain their findings, the authors pointed out that while cardiovascular events are the top cause of non–graft-related mortality in all liver transplants, NASH patients might be especially susceptible, given that their diagnosis is "frequently associated" with cardiovascular risk factors such as obesity, diabetes, and hypertension. Indeed, these same characteristics might also predispose these patients to postoperative infection and sepsis, they added.
And regarding the finding that graft-related mortality is actually lower among NASH patients, Dr. Wang and colleagues postulated that this may be due to the "lower likelihood of disease recurrence, and this may mean lower rates of graft failure compared with other liver diseases, such as hepatitis C virus and hepatitis B virus infection."
The authors conceded that there were several limitations to their analysis, not the least being heterogeneity between included studies. Moreover, two large population-based studies using national databases were ultimately excluded due to patient duplication and poor accuracy with regard to the cause of death.
In any case, the current analysis shows that "more attention and careful consideration are required in selecting patients with NASH for liver transplant, along with aggressive management of cardiovascular complications and sepsis after transplantation."
The authors disclosed no conflicts of interest related to this study. They wrote that funding was provided by the scientific research development project of North Sichuan Medical College.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Major finding: Patients undergoing liver transplant for nonalcoholic steatohepatitis are at a greater risk for death due to sepsis and cardiovascular complications.
Data source: A meta-analysis of nine studies published through September 2012.
Disclosures: The authors disclosed no conflicts of interest related to this study. They wrote that funding was provided by the scientific research development project of North Sichuan Medical College.
Later lung retransplant may boost survival
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
AT THE STS ANNUAL MEETING
Major finding: Survival was significantly reduced for early (within 90 days) retransplant, compared with primary transplant (HR, 1.38).
Data source: A retrospective cohort study including 9,270 primary lung transplant patients and 456 retransplant patients.
Disclosures: Mr. Osho reported having no disclosures.