New Heart Allocation Algorithm Appears Effective

Article Type
Changed
Wed, 12/14/2016 - 10:29
Display Headline
New Heart Allocation Algorithm Appears Effective

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

Publications
Publications
Topics
Article Type
Display Headline
New Heart Allocation Algorithm Appears Effective
Display Headline
New Heart Allocation Algorithm Appears Effective
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Article Source

FROM THE ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION

PURLs Copyright

Inside the Article

New Heart Allocation Algorithm Appears Effective

Article Type
Changed
Wed, 03/27/2019 - 16:02
Display Headline
New Heart Allocation Algorithm Appears Effective

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

SAN DIEGO – A new allocation algorithm that is designed to improve regional sharing of donor hearts with sicker patients before they are allocated locally to less-sick patients appears to be having the intended effects, according to a national cohort study.

In the study of nearly 12,000 adult patients who were wait-listed for primary heart transplantation in 2004-2009 in the United States, those who were wait-listed after the new algorithm was implemented were 17% less likely to die on the waiting list or to become too sick for transplantation, researchers reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Moreover, this benefit was achieved without any increase in the rate of in-hospital mortality among transplant recipients, even though they were sicker on average.

"The risk of dying on the heart transplant [waiting list] or becoming too sick for transplant has declined [in the United States] since the change in allocation algorithm in 2006," said lead investigator Dr. Tajinder P. Singh, a pediatric cardiologist at Children’s Hospital Boston. And reassuringly, "the shift in hearts to sicker transplant candidates has not resulted in higher early posttransplant mortality."

These findings suggest that the new algorithm has been effective "not only from a utilitarian view, which means most benefit for most people, but even from the fairness or justice perspective," he commented. "By granting the hearts to sicker people, you are taking care of that point of view, too."

An attendee asked whether patterns might differ at the local or regional level vs. the national level, given that some centers in the New York City area, for example, feel they have been hurt by the new algorithm. Dr. Singh replied that because of small patient numbers and regional variations, it was not possible to get a reliable picture at those levels.

"The demand for donor hearts continues to exceed their supply," he said, giving background to the study. "The United Network for Organ Sharing has periodically modified the allocation algorithm in the United States" to improve waiting list outcomes.

The last such modification, implemented in July 2006, expanded the sharing of these scarce organs across a geographic region, making them available first to the sickest patients (those with status 1A or 1B) in a region before allocating them locally to less-sick patients.

"The goal of such a change was to lower national [waiting list] mortality without a concurrent increase in posttransplant mortality, and that consideration is more than theoretical because sicker patients will be at higher risk of dying post transplant," he explained. "The early outcome trends after the allocation change have been supportive, but regional analyses have questioned the merits of the new allocation."

The investigators studied all patients aged 18 years or older who were placed on the waiting list for primary heart transplantation between July 1, 2004, and June 30, 2009, and who were undergoing transplantation of only a heart.

For comparison, the patients were split according to when they were listed into "era 1" (before the date of implementation of the new algorithm) and "era 2" (after that date). Study results were based on 11,864 patients in total; 38% were listed in era 1 and 62% were listed in era 2.

Patients in the two eras were similar with respect to most sociodemographic and medical factors, except that those in era 2 were more likely to be aged 60 years or older (32% vs. 28%), to receive mechanical support (14% vs. 13%), and to be sicker, as indicated by having a transplantation status of 1A (20% vs. 19%) or 1B (38% vs. 32%), for instance.

Overall, 13% of the patients studied either died or had a worsening of their condition that prevented transplantation while they were on the waiting list, the study’s primary end point, Dr. Singh reported.

Before statistical adjustment, patients in era 2 were 14% less likely than their counterparts in era 1 to die or worsen while on the wait list (hazard ratio, 0.86; P = .005). And this benefit was evident among both status 1A patients and status 1B patients individually.

After adjustment for numerous potential confounders, patients in era 2 were 17% less likely to die or worsen while on the wait list (HR, 0.83; P = .001). The benefit was similar in most subgroups, except that by race, it was mainly limited to white patients.

Other risk-reducing factors included having an implantable cardioverter defibrillator (HR, 0.87) and having a continuous-flow left ventricular assist device (HR, 0.56).

Overall, 65% of the patients ultimately underwent transplantation. Compared with their counterparts in era 1, era 2 transplant recipients had a shorter median wait time before receiving a heart (55 vs. 63 days; P less than .001) and were more likely to be status 1A at transplantation (48% vs. 37%; P less than .001).

 

 

The donor ischemic time was longer for recipients in era 2 (3.3 vs. 3.2 hours; P = .02), but the small difference was probably not clinically important, according to Dr. Singh.

The lack of a greater difference in ischemic time – despite the sharing of organs over larger geographic areas in the latter era – was not surprising, he said. "The way it occurred, it went from local to within 500 miles, say. It may be broader regional sharing, but it’s not long distance to get to [the heart] and bring the heart in to the surgery."

There was no rise in the rate of in-hospital mortality post transplantation with implementation of the new algorithm. In fact, "interestingly, in-hospital mortality was lower rather than higher [in era 2], even though sicker patients were getting transplanted," Dr. Singh commented, with a rate of 5.3% in era 2, compared with 6.3% in era 1.

Dr. Singh reported having no conflicts of interest related to the research.

Publications
Publications
Topics
Article Type
Display Headline
New Heart Allocation Algorithm Appears Effective
Display Headline
New Heart Allocation Algorithm Appears Effective
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Legacy Keywords
heart allocation algorithm, donor hearts, waiting list, heart transplantation, International Society for Heart and Lung Transplantation, transplant recipients, Dr. Tajinder P. Singh,
Article Source

FROM THE ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION

PURLs Copyright

Inside the Article

Vitals

Major Finding: With implementation of the new heart allocation algorithm, the adjusted risk of dying on the waiting list or becoming too sick for transplantation fell by 17%, with no increase in in-hospital mortality after transplantation.

Data Source: A cohort study of 11,864 adults who were wait-listed for primary heart transplantation between 2004 and 2009.

Disclosures: Dr. Singh reported that he did not have any relevant conflicts of interest.

VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

Article Type
Changed
Fri, 12/07/2018 - 13:55
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Publications
Publications
Topics
Article Type
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Article Source

FROM THE ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION

PURLs Copyright

Inside the Article

Vitals

Major Finding: Among patients retransplanted at least a year after an initial transplantation, median survival was 7 years and did not differ between those bridged with a VAD and those who did not receive any mechanical circulatory support.

Data Source: A retrospective review of 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Disclosures: Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

Article Type
Changed
Wed, 12/14/2016 - 10:29
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Publications
Publications
Topics
Article Type
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Article Source

FROM THE ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION

PURLs Copyright

Inside the Article

VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

Article Type
Changed
Fri, 01/18/2019 - 10:54
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

SAN DIEGO – Ventricular assist devices appear to be a "reasonable strategy" for supporting certain patients who have failing cardiac grafts and are waiting for a new heart, concludes a retrospective review of more than 1,500 patients who had a second transplant.

In the group who had retransplantation at least 1 year after their first transplantation, median survival was about 7 years. There was no difference between patients bridged with a ventricular assist device (VAD) and those who did not have bridging with any type of mechanical circulatory support (MCS), according to results reported at the annual meeting of the International Society for Heart and Lung Transplantation.

Dr. David L.S. Morales    

But survival was poor for those who were bridged after any interval with extracorporeal membrane oxygenation (ECMO) and for those who underwent retransplantation because they had primary graft failure or a hyperacute rejection, regardless of whether they were mechanically supported.

"The use of ECMO to bridge any patient to retransplantation does not appear judicious, nor does the use of MCS to bridge patients with primary graft failure or hyperacute rejection to retransplantation," said coinvestigator Dr. David L.S. Morales of the departments of surgery and pediatrics at the Texas Children’s Hospital in Houston. "However, the use of VADs to bridge patients to transplant after a year could be a reasonable strategy."

Although MCS is widely accepted for bridging patients to initial heart transplantation, its use for bridging to retransplantation has not been well studied. The investigators therefore took a closer look at this issue, analyzing data from the United Network for Organ Sharing (UNOS) database for 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Results showed that just 8% of the patients were bridged to retransplantation, with a VAD in about two-thirds of cases and ECMO in the other third. The mean age was 41 years in the former and 35 years in the latter, with children (younger than age 18) comprising 15% and 35%, respectively.

The patients bridged to retransplantation were significantly more likely than were their nonbridged counterparts to have primary graft failure or hyperacute rejection (54% vs. 11%) and significantly less likely to have chronic rejection (16% vs. 63%).

And the bridged patients by and large underwent retransplantation early, with 64% in the VAD group and 76% in the ECMO group retransplanted within 3 months of their primary transplantation, compared with just 12% of their nonbridged peers.

"Regardless of MCS, patients retransplanted for primary graft failure or hyperacute rejection do not do well," Dr. Morales commented. Specifically, in patients with these indications for retransplantation, the 1-year mortality rate was 83%, with essentially no difference according to whether they received bridging or the type.

In the entire study population, median overall survival after retransplantation was 6.1 years in nonbridged patients, significantly longer than the 1.5 years in VAD-bridged patients and the 30 days in ECMO-bridged patients.

But when analyses were restricted to patients who underwent retransplantation at least 1 year after primary transplantation, median survival was similar in nonbridged and VAD-bridged patients, at 7.0 and 6.9 years. Compared with those groups, however, survival was significantly shorter – just 6 months – in the ECMO group.

"Patients bridged to retransplant with ECMO have poor outcomes regardless of timing or indication," Dr. Morales concluded of the findings. "And all patients retransplanted for hyperacute rejection or primary graft failure do poorly, regardless of MCS," he said. "However, patients who are bridged with a VAD to retransplant that is done a year post–primary transplant do have similar outcomes as compared to retransplant patients without MCS."

As for study limitations, "it is very important to note that we do not know the number of patients placed on MCS as a bridge to transplant who died while on support," he pointed out.

Despite the more favorable findings for VAD bridging, his pediatric patients needing retransplantation in adolescence often have chronic vasculopathy in their graft, Dr. Morales said. "They are a very, very difficult group to support with mechanical support with LVADs because we have to continue the immunosuppression," and the patients often die from infections as a result.

"It’s one of the reasons I’m interested in the total artificial heart, because the ability to take the heart out completely and stop immunosuppression I think will help bridge those patients," he commented. "The total artificial heart has lasted in patients for quite a long period of time, and I think eventually will start to be used maybe as a bridge to destination, as it was originally intended."

 

 

Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.

Publications
Publications
Topics
Article Type
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Display Headline
VADs Reasonable for Bridging to Cardiac Retransplantation Sometimes
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Legacy Keywords
Ventricular assist devices, failing cardiac grafts, heart transplant, retransplantation, VAD, mechanical circulatory support, MCS, International Society for Heart and Lung Transplantation, extracorporeal membrane oxygenation, ECMO, primary graft failure, hyperacute rejection, Dr. David L.S. Morales,
Article Source

FROM THE ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION

PURLs Copyright

Inside the Article

Vitals

Major Finding: Among patients retransplanted at least a year after an initial transplantation, median survival was 7 years and did not differ between those bridged with a VAD and those who did not receive any mechanical circulatory support.

Data Source: A retrospective review of 1,535 patients who underwent cardiac retransplantation during 1982-2009.

Disclosures: Dr. Morales disclosed having relationships with Berlin Heart Inc., Syncardia Systems Inc., and CircuLite Inc. as an investigator and/or consultant.