Heart Failure

NEW ORLEANS – Patients with chronic cardiomyopathy can be successfully weaned from ventricular assist devices, and certain parameters can predict long-term cardiac stability after explantation, according to German investigators.

"Unloading-promoted reversal of heart failure allows for long-term transplant-free outcomes after patients are removed from VADs. However, few patients with chronic cardiomyopathy have been weaned from VADs, and the majority only recently," said principal investigator Dr. Michael Dandel of the German Heart Institute Berlin. "The long-term outcomes of patients, therefore, and the reliability of criteria for making weaning decisions, are not well known."

At his clinic, 91 patients with chronic cardiomyopathy (CCM) as the underlying cause of heart failure were weaned from VADs between 1995 and 2010, including 75 weaned from left ventricular assist devices, 13 weaned from biventricular assist devices, and 3 weaned from right ventricular assist devices. Before VAD implantation, the patients had left ventricular ejection fraction (LVEF) values of 10%-20%.

These patients were evaluated as to the feasibility of weaning and to establish criteria that could predict long-term cardiac stability after VAD removal. "With this information, we can improve future weaning decisions and postweaning patient management," Dr. Dandel said at the annual meeting of the American College of Cardiology.

A total of 47 patients were evaluated. Of these 41 (87.2%) had idiopathic cardiomyopathy, 4 (8.5%) had histologic evidence of chronic myocarditis before VAD implantation, and 2 (4.3%) had chronic ischemic cardiomyopathy with severe left ventricular dilation.

Before VAD insertion, all patients had irreversible end-stage heart failure and required continuous positive inotropic support. No attempts were made to use VADs electively with the aim of myocardial recovery only, he said.

Postweaning results. Cardiac stability lasting at least 15 years was achieved by 2 patients, while 10 patients have been stable at least 10 years and 3 at least 5 years, he reported.

"At 5 years, only five patients, 10.6%, had died due to heart failure recurrence or weaning-related complications. Several patients died of other causes," he said.

Postweaning freedom from heart failure recurrence for all evaluated patients was 74% at 3 years and 66% at 5 years, but these results included nine patients at very high risk for poor outcomes. After 2002, when the investigators tightened their criteria for weaning, freedom from heart failure recurrence reached 100% at 3 years, he noted.

Pre-explantation variables predictive of outcomes. "Echo data obtained during ‘off pump’ trials proved to be reliable for detection of recovery during mechanical unloading," Dr. Dandel said. "In particular, off-pump [left ventricle] size, geometry, and ejection fraction were predictive of outcome after weaning, especially when history of heart failure was also considered."

For cardiac stability lasting at least 5 years, pre-explantation "off pump" LVEF of 50% or more was associated with a positive predictive value of 91.7%, while LVEF of 45% or more had a positive predictive value of 79.1%.

The positive predictive value of LVEF of 45% or more was approximately 90% if additional parameters were considered: pre-explantation left ventricle size and geometry, stability of unloading-induced cardiac improvement before VAD removal, and heart failure duration before VAD implantation.

Time to cardiac recovery seemed important, Dr. Dandel said. "Patients who had recurrences needed more time to show an improvement. They needed twice the duration of VAD support as patients who did not have a recurrence," he said.

"Definite cutoff values for certain parameters – including tissue Doppler-derived LV wall motion velocity – allowed us to formulate weaning criteria with high predictability for postweaning stability," he said.

Risk factors for heart failure recurrence. Dr. Dandel and his colleagues also identified several risk factors that predicted heart failure recurrence during the first 3 years after VAD removal. These factors, and their associated probability for recurrence, were:

• Preweaning off-pump LVEF less than 45% plus history of heart failure longer than 5 years (100%).

• Preweaning LVEF less than 45% (88.9%).

• Preweaning off-pump LVEF less than 50% plus left ventricular internal diastolic diameter greater than 55 mm (90%).

• Pre-explantation LVEF less than 50% and preexisting alteration of greater than 10% best value (87.5%).

• LVEF less than 50% plus relative wall thickness decrease of less than 10% during final off-pump trial (83.3%).

Of these, he emphasized the importance of the final off-pump trial values. "An off-pump ejection fraction less than 45% in patients with a history of heart failure for more than 5 years is an absolute contraindication for VAD removal," he noted. "All such patients in our study had a recurrence of heart failure."

Early instability of ejection fraction and unstable geometry also confer a high probability of recurrence. "A wall thickness increase by more than 10% means the reverse in modeling is not stable enough," he added.

"The notion that we can actually wean patients from VADs is still a fairly new concept, and the European experience is larger than that of the United States. This is still a field that is wide open for determining patient selection and predictors of outcome after VAD removal," session moderator Dr. Gregory A. Ewald, medical director of heart transplantation at Barnes-Jewish Hospital, St. Louis, said in an interview.

"Clearly, the echocardiographic appearance of the heart on and off support is a good predictor," Dr. Ewald said, but he noted that nonechocardiographic factors such as exercise tolerance were not studied. He also noted that the field has moved to continuous-flow pumps rather than pulsatile pumps, which constituted much of the German experience. It remains to be determined if the same parameters are completely applicable to the newer-generation devices.

Dr. Dandel and Dr. Ewald reported having no relevant conflicts of interest.

NEW ORLEANS – Patients with chronic cardiomyopathy can be successfully weaned from ventricular assist devices, and certain parameters can predict long-term cardiac stability after explantation, according to German investigators.

"Unloading-promoted reversal of heart failure allows for long-term transplant-free outcomes after patients are removed from VADs. However, few patients with chronic cardiomyopathy have been weaned from VADs, and the majority only recently," said principal investigator Dr. Michael Dandel of the German Heart Institute Berlin. "The long-term outcomes of patients, therefore, and the reliability of criteria for making weaning decisions, are not well known."

At his clinic, 91 patients with chronic cardiomyopathy (CCM) as the underlying cause of heart failure were weaned from VADs between 1995 and 2010, including 75 weaned from left ventricular assist devices, 13 weaned from biventricular assist devices, and 3 weaned from right ventricular assist devices. Before VAD implantation, the patients had left ventricular ejection fraction (LVEF) values of 10%-20%.

These patients were evaluated as to the feasibility of weaning and to establish criteria that could predict long-term cardiac stability after VAD removal. "With this information, we can improve future weaning decisions and postweaning patient management," Dr. Dandel said at the annual meeting of the American College of Cardiology.

A total of 47 patients were evaluated. Of these 41 (87.2%) had idiopathic cardiomyopathy, 4 (8.5%) had histologic evidence of chronic myocarditis before VAD implantation, and 2 (4.3%) had chronic ischemic cardiomyopathy with severe left ventricular dilation.

Before VAD insertion, all patients had irreversible end-stage heart failure and required continuous positive inotropic support. No attempts were made to use VADs electively with the aim of myocardial recovery only, he said.

Postweaning results. Cardiac stability lasting at least 15 years was achieved by 2 patients, while 10 patients have been stable at least 10 years and 3 at least 5 years, he reported.

"At 5 years, only five patients, 10.6%, had died due to heart failure recurrence or weaning-related complications. Several patients died of other causes," he said.

Postweaning freedom from heart failure recurrence for all evaluated patients was 74% at 3 years and 66% at 5 years, but these results included nine patients at very high risk for poor outcomes. After 2002, when the investigators tightened their criteria for weaning, freedom from heart failure recurrence reached 100% at 3 years, he noted.

Pre-explantation variables predictive of outcomes. "Echo data obtained during ‘off pump’ trials proved to be reliable for detection of recovery during mechanical unloading," Dr. Dandel said. "In particular, off-pump [left ventricle] size, geometry, and ejection fraction were predictive of outcome after weaning, especially when history of heart failure was also considered."

For cardiac stability lasting at least 5 years, pre-explantation "off pump" LVEF of 50% or more was associated with a positive predictive value of 91.7%, while LVEF of 45% or more had a positive predictive value of 79.1%.

The positive predictive value of LVEF of 45% or more was approximately 90% if additional parameters were considered: pre-explantation left ventricle size and geometry, stability of unloading-induced cardiac improvement before VAD removal, and heart failure duration before VAD implantation.

Time to cardiac recovery seemed important, Dr. Dandel said. "Patients who had recurrences needed more time to show an improvement. They needed twice the duration of VAD support as patients who did not have a recurrence," he said.

"Definite cutoff values for certain parameters – including tissue Doppler-derived LV wall motion velocity – allowed us to formulate weaning criteria with high predictability for postweaning stability," he said.

Risk factors for heart failure recurrence. Dr. Dandel and his colleagues also identified several risk factors that predicted heart failure recurrence during the first 3 years after VAD removal. These factors, and their associated probability for recurrence, were:

• Preweaning off-pump LVEF less than 45% plus history of heart failure longer than 5 years (100%).

• Preweaning LVEF less than 45% (88.9%).

• Preweaning off-pump LVEF less than 50% plus left ventricular internal diastolic diameter greater than 55 mm (90%).

• Pre-explantation LVEF less than 50% and preexisting alteration of greater than 10% best value (87.5%).

• LVEF less than 50% plus relative wall thickness decrease of less than 10% during final off-pump trial (83.3%).

Of these, he emphasized the importance of the final off-pump trial values. "An off-pump ejection fraction less than 45% in patients with a history of heart failure for more than 5 years is an absolute contraindication for VAD removal," he noted. "All such patients in our study had a recurrence of heart failure."

Early instability of ejection fraction and unstable geometry also confer a high probability of recurrence. "A wall thickness increase by more than 10% means the reverse in modeling is not stable enough," he added.

"The notion that we can actually wean patients from VADs is still a fairly new concept, and the European experience is larger than that of the United States. This is still a field that is wide open for determining patient selection and predictors of outcome after VAD removal," session moderator Dr. Gregory A. Ewald, medical director of heart transplantation at Barnes-Jewish Hospital, St. Louis, said in an interview.

"Clearly, the echocardiographic appearance of the heart on and off support is a good predictor," Dr. Ewald said, but he noted that nonechocardiographic factors such as exercise tolerance were not studied. He also noted that the field has moved to continuous-flow pumps rather than pulsatile pumps, which constituted much of the German experience. It remains to be determined if the same parameters are completely applicable to the newer-generation devices.

Dr. Dandel and Dr. Ewald reported having no relevant conflicts of interest.

NEW ORLEANS – Patients with chronic cardiomyopathy can be successfully weaned from ventricular assist devices, and certain parameters can predict long-term cardiac stability after explantation, according to German investigators.

"Unloading-promoted reversal of heart failure allows for long-term transplant-free outcomes after patients are removed from VADs. However, few patients with chronic cardiomyopathy have been weaned from VADs, and the majority only recently," said principal investigator Dr. Michael Dandel of the German Heart Institute Berlin. "The long-term outcomes of patients, therefore, and the reliability of criteria for making weaning decisions, are not well known."

At his clinic, 91 patients with chronic cardiomyopathy (CCM) as the underlying cause of heart failure were weaned from VADs between 1995 and 2010, including 75 weaned from left ventricular assist devices, 13 weaned from biventricular assist devices, and 3 weaned from right ventricular assist devices. Before VAD implantation, the patients had left ventricular ejection fraction (LVEF) values of 10%-20%.

These patients were evaluated as to the feasibility of weaning and to establish criteria that could predict long-term cardiac stability after VAD removal. "With this information, we can improve future weaning decisions and postweaning patient management," Dr. Dandel said at the annual meeting of the American College of Cardiology.

A total of 47 patients were evaluated. Of these 41 (87.2%) had idiopathic cardiomyopathy, 4 (8.5%) had histologic evidence of chronic myocarditis before VAD implantation, and 2 (4.3%) had chronic ischemic cardiomyopathy with severe left ventricular dilation.

Before VAD insertion, all patients had irreversible end-stage heart failure and required continuous positive inotropic support. No attempts were made to use VADs electively with the aim of myocardial recovery only, he said.

Postweaning results. Cardiac stability lasting at least 15 years was achieved by 2 patients, while 10 patients have been stable at least 10 years and 3 at least 5 years, he reported.

"At 5 years, only five patients, 10.6%, had died due to heart failure recurrence or weaning-related complications. Several patients died of other causes," he said.

Postweaning freedom from heart failure recurrence for all evaluated patients was 74% at 3 years and 66% at 5 years, but these results included nine patients at very high risk for poor outcomes. After 2002, when the investigators tightened their criteria for weaning, freedom from heart failure recurrence reached 100% at 3 years, he noted.

Pre-explantation variables predictive of outcomes. "Echo data obtained during ‘off pump’ trials proved to be reliable for detection of recovery during mechanical unloading," Dr. Dandel said. "In particular, off-pump [left ventricle] size, geometry, and ejection fraction were predictive of outcome after weaning, especially when history of heart failure was also considered."

For cardiac stability lasting at least 5 years, pre-explantation "off pump" LVEF of 50% or more was associated with a positive predictive value of 91.7%, while LVEF of 45% or more had a positive predictive value of 79.1%.

The positive predictive value of LVEF of 45% or more was approximately 90% if additional parameters were considered: pre-explantation left ventricle size and geometry, stability of unloading-induced cardiac improvement before VAD removal, and heart failure duration before VAD implantation.

Time to cardiac recovery seemed important, Dr. Dandel said. "Patients who had recurrences needed more time to show an improvement. They needed twice the duration of VAD support as patients who did not have a recurrence," he said.

"Definite cutoff values for certain parameters – including tissue Doppler-derived LV wall motion velocity – allowed us to formulate weaning criteria with high predictability for postweaning stability," he said.

Risk factors for heart failure recurrence. Dr. Dandel and his colleagues also identified several risk factors that predicted heart failure recurrence during the first 3 years after VAD removal. These factors, and their associated probability for recurrence, were:

• Preweaning off-pump LVEF less than 45% plus history of heart failure longer than 5 years (100%).

• Preweaning LVEF less than 45% (88.9%).

• Preweaning off-pump LVEF less than 50% plus left ventricular internal diastolic diameter greater than 55 mm (90%).

• Pre-explantation LVEF less than 50% and preexisting alteration of greater than 10% best value (87.5%).

• LVEF less than 50% plus relative wall thickness decrease of less than 10% during final off-pump trial (83.3%).

Of these, he emphasized the importance of the final off-pump trial values. "An off-pump ejection fraction less than 45% in patients with a history of heart failure for more than 5 years is an absolute contraindication for VAD removal," he noted. "All such patients in our study had a recurrence of heart failure."

Early instability of ejection fraction and unstable geometry also confer a high probability of recurrence. "A wall thickness increase by more than 10% means the reverse in modeling is not stable enough," he added.

"The notion that we can actually wean patients from VADs is still a fairly new concept, and the European experience is larger than that of the United States. This is still a field that is wide open for determining patient selection and predictors of outcome after VAD removal," session moderator Dr. Gregory A. Ewald, medical director of heart transplantation at Barnes-Jewish Hospital, St. Louis, said in an interview.

"Clearly, the echocardiographic appearance of the heart on and off support is a good predictor," Dr. Ewald said, but he noted that nonechocardiographic factors such as exercise tolerance were not studied. He also noted that the field has moved to continuous-flow pumps rather than pulsatile pumps, which constituted much of the German experience. It remains to be determined if the same parameters are completely applicable to the newer-generation devices.

Dr. Dandel and Dr. Ewald reported having no relevant conflicts of interest.

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the annual meeting of the International Society for Heart and Lung Transplantation.

"One hypothesis is that there is a concern about adverse outcomes" for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

"The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices," Dr. Nativi said. "So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support."

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). And the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by people with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

"These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors," he said. "But the high-risk donor still remains a matter of controversy."

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. "So we are still struggling to find donors for heart recipients," Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center’s patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR,1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

He acknowledged that factors other than physicians’ decision to avoid the use of hearts from high-risk donors may have contributed to the observed trends. For example, "changes in donor characteristics may have been affected by a potentially changing donor pool," but that possibility is more difficult to study, he said.

Dr. Nativi reported that he had no relevant financial disclosures.

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the annual meeting of the International Society for Heart and Lung Transplantation.

"One hypothesis is that there is a concern about adverse outcomes" for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

"The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices," Dr. Nativi said. "So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support."

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). And the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by people with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

"These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors," he said. "But the high-risk donor still remains a matter of controversy."

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. "So we are still struggling to find donors for heart recipients," Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center’s patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR,1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

He acknowledged that factors other than physicians’ decision to avoid the use of hearts from high-risk donors may have contributed to the observed trends. For example, "changes in donor characteristics may have been affected by a potentially changing donor pool," but that possibility is more difficult to study, he said.

Dr. Nativi reported that he had no relevant financial disclosures.

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the annual meeting of the International Society for Heart and Lung Transplantation.

"One hypothesis is that there is a concern about adverse outcomes" for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

"The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices," Dr. Nativi said. "So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support."

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). And the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by people with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

"These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors," he said. "But the high-risk donor still remains a matter of controversy."

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. "So we are still struggling to find donors for heart recipients," Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center’s patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR,1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

He acknowledged that factors other than physicians’ decision to avoid the use of hearts from high-risk donors may have contributed to the observed trends. For example, "changes in donor characteristics may have been affected by a potentially changing donor pool," but that possibility is more difficult to study, he said.

Dr. Nativi reported that he had no relevant financial disclosures.

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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.

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

Major Finding: For the primary end point of echocardiographic response, defined as a greater than 15% change in left ventricular end systolic volume from baseline to 6-month follow-up, the speckle-tracking echocardiography group had a 70% response and the standard placement group had a 55% response (P = .031).

Data Source: A single-blinded, randomized, controlled trial of 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had NYHA class III/IV heart failure, left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 milliseconds.

Disclosures: Dr. Khan said he had no relevant financial disclosures.

NEW ORLEANS – Using speckle-tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in the TARGET trial.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), said Dr. Fakhar Z. Khan of Cambridge (England) University, who reported the results of the TARGET (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy in Patients with Heart Failure) trial at the meeting.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the investigators found the two groups did not significantly differ.

“This is a well-designed, well-conducted study with impressive differences in clinical outcomes,” said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. “Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences.”

“I am impressed that the modest echocardiographic changes translated to dramatic clinical effects,” commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle-tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, “we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes,” he said.

The single-blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the United Kingdom. Participants were in sinus rhythm, had severe heart failure (New York heart Association class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class, 6-mile walk test results, and quality of life scores.

Patients in the study will continue to have ongoing follow-up.

“STE software can be applied to any existing echocardiographic image at no additional risk to the patient,” Dr. Khan said.

“STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience.”

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Frequent periodic leg movements during sleep were associated with left ventricular hypertrophy in patients with restless legs syndrome, in a study presented at the meeting.

Moreover, patients who had sleep disturbance due to frequent periodic leg movements and severe LVH were at increased risk for heart failure, recurrent hospitalizations, and death.

“We have known for a long time that LVH is a poor prognostic factor that increases the risk of cardiac events. What is new … is that it appears that restless legs syndrome is another risk factor that may predispose patients to, and lead to more complications of, LVH,” Dr. Arshad Jahangir said at the meeting.

Dr. Jahangir, principal investigator in the study and professor of medicine at the Mayo Clinic in Scottsdale, Ariz., said that the findings need to be confirmed in larger studies. Also, it will be important to evaluate whether effective treatments for restless legs syndrome can prevent adverse outcomes associated with LVH.

Approximately 12 million Americans have restless legs syndrome. The condition is increasingly common with age and is implicated in about one-third of all cases of insomnia. Up to 90% of patients also have periodic limb movement disorder. The mechanisms that drive the disorder are not fully understood, Dr. Jahangir said, but the sympathetic nervous system is involved and patients typically have increased heart rate and blood pressure.

The study enrolled 584 restless legs syndrome patients who underwent overnight polysomnography studies. Patients were stratified according to frequency of leg movements during sleep: 45% had frequent leg movements, defined as a Periodic Movement Index [PMI] of more than 35 per hour, and 55% had infrequent leg movements, defined as a PMI of 35 or fewer movements per hour. Despite having a left ventricular ejection fraction of around 60% at baseline, the group with frequent periodic limb movements had a significantly higher left ventricular mass, mass index, and posterior wall thickness, indicating the presence of LVH.

At baseline, the groups with frequent versus infrequent periodic limb movements had similar clinical and echocardiographic parameters, and were comparable for the presence of cardiovascular risk factors, including hypertension, diabetes, heart failure, and renal dysfunction. Patients with frequent periodic limb movements were older (median age 67 vs. 61 years), more often male, had more atrial fibrillation (30% vs. 17%), and more underlying coronary heart disease than those with infrequent periodic limb movements.

The presence of severe LVH [defined as left ventricular mass index >116 g/m

Severe LVH was found in 37% of those with atrial fibrillation and 20% of those without it, suggesting that underlying electrical dysfunction and restless legs syndrome may act together to lead to adverse cardiovascular outcomes.

The study was funded by the National Heart, Lung, and Blood Institute and the Angel and Paul Harvey Cardiovascular Research Endowment to CardioGerontology Research Laboratory at Mayo Clinic Arizona. Dr. Jahangir had no relevant financial disclosures.

To see a video interview with Dr. Jahangir, scan this QR code or visit www.youtube.com/watch?v=qvm1sSQ9LdM&NR=1

NEW ORLEANS – Myocardial viability failed to predict a significant survival benefit from coronary bypass surgery in patients with coronary artery disease and left ventricular dysfunction in the STICH Viability substudy.

The data are surprising and call into question the long-standing practice of assessing myocardial viability as a means to predict clinical benefit from coronary bypass surgery.

The substudy included 610 of the 1,212 patients in the Surgical Treatment for Ischemic Heart Failure (STICH) trial who underwent baseline myocardial viability testing using SPECT or dobutamine echocardiography, or both, and were randomly assigned to aggressive medical therapy with or without coronary artery bypass surgery (CABG).

At a median follow-up of 5 years, 51% of patients without viable myocardium and 37% with viable myocardium died. The presence of viable myocardium significantly reduced the risk of all-cause mortality by 36%, but the survival advantage lost statistical significance in a multivariable analysis that included other prognostic variables, Dr. Robert Bonow reported at the annual meeting of the American College of Cardiology.

The secondary outcome of cardiovascular mortality was also significantly lower in patients with myocardial viability compared with those without myocardial viability, at 29% and 43%, respectively, but once again, the association lost significance in multivariable analysis.

Notably, the secondary composite end point of death plus cardiovascular hospitalization, which is commonly used in heart failure trials, retained significance in multivariable analysis in favor of patients with myocardial viability, occurring in 63% of patients with viable myocardium and 82% of those without.

There was no significant interaction, however, between myocardial viability status and medical versus surgical treatment with respect to mortality, whether assessed according to treatment assigned or to the treatment actually received, said Dr. Bonow, professor of cardiology at Northwestern University in Chicago. Five-year all-cause mortality rates among the 114 patients without myocardial viability were 56% with medical therapy and 42% with CABG. Among the 487 patients with myocardial viability the rates were 35% vs. 31%, respectively.

"The lack of interaction between myocardial viability and benefit from CABG in this study indicates that assessment of myocardial viability, independent of other relevant variables, should not be the deciding factor in selecting the best therapy for patients with ischemic left ventricular function," he said.

Discussant Bernard Gersh, professor of medicine at Mayo Clinic in Rochester, Minn., asked what clinicians should analyze to determine which of their patients with heart failure and coronary disease to send to surgery, particularly in light of the benefits observed with CABG in the primary STICH analysis. Those data showed a 5% reduction in all-cause mortality at 6 years with the addition of CABG to medical therapy.

Dr. Bonow replied, "I think viability may be something you look at in some patients, but the point would be that there are other clinical variables, perhaps coronary anatomy, that one would bring into play."

Dr. Steven Bollings, with the Cardiovascular Center at the University of Michigan in Ann Arbor, said the primary STICH results provide a clear answer that patients with heart failure and left ventricular dysfunction benefit from coronary bypass surgery, but that the viability substudy raises a number of questions. He said that myocardial "may not be the No. 1 criterion by which we send patients to the operating room" and that other variables such as whether the patient has clear distal targets or is robust may be more important.

Dr. Gregg W. Stone of Columbia University, New York, said, "While I admit this is the clearly the best and most important viability study ever done, I don’t know that it definitively answers the question for us that viability doesn’t matter."

He pointed out that the viability data were based on only half of the STICH participants, the subsets were unbalanced with 80% of patients having viable myocardium and that some would say it’s not appropriate to look for interaction testing off of a negative end point.

"What I take away from this is that if there’s viability, I really want to be sure to revascularize," said Dr. Ted E. Feldman of NorthShore University HealthSystem in Evanston, Ill. "But prior to seeing these results, I was inclined to say if there wasn’t viability, not to vascularize. And the results of the trial challenge that historic bias," he added.

STICH Viability was supported by grants from the National Heart, Lung, and Blood Institute and Abbott Laboratories. Dr. Bonow had no relevant disclosures.

NEW ORLEANS – Myocardial viability failed to predict a significant survival benefit from coronary bypass surgery in patients with coronary artery disease and left ventricular dysfunction in the STICH Viability substudy.

The data are surprising and call into question the long-standing practice of assessing myocardial viability as a means to predict clinical benefit from coronary bypass surgery.

The substudy included 610 of the 1,212 patients in the Surgical Treatment for Ischemic Heart Failure (STICH) trial who underwent baseline myocardial viability testing using SPECT or dobutamine echocardiography, or both, and were randomly assigned to aggressive medical therapy with or without coronary artery bypass surgery (CABG).

At a median follow-up of 5 years, 51% of patients without viable myocardium and 37% with viable myocardium died. The presence of viable myocardium significantly reduced the risk of all-cause mortality by 36%, but the survival advantage lost statistical significance in a multivariable analysis that included other prognostic variables, Dr. Robert Bonow reported at the annual meeting of the American College of Cardiology.

The secondary outcome of cardiovascular mortality was also significantly lower in patients with myocardial viability compared with those without myocardial viability, at 29% and 43%, respectively, but once again, the association lost significance in multivariable analysis.

Notably, the secondary composite end point of death plus cardiovascular hospitalization, which is commonly used in heart failure trials, retained significance in multivariable analysis in favor of patients with myocardial viability, occurring in 63% of patients with viable myocardium and 82% of those without.

There was no significant interaction, however, between myocardial viability status and medical versus surgical treatment with respect to mortality, whether assessed according to treatment assigned or to the treatment actually received, said Dr. Bonow, professor of cardiology at Northwestern University in Chicago. Five-year all-cause mortality rates among the 114 patients without myocardial viability were 56% with medical therapy and 42% with CABG. Among the 487 patients with myocardial viability the rates were 35% vs. 31%, respectively.

"The lack of interaction between myocardial viability and benefit from CABG in this study indicates that assessment of myocardial viability, independent of other relevant variables, should not be the deciding factor in selecting the best therapy for patients with ischemic left ventricular function," he said.

Discussant Bernard Gersh, professor of medicine at Mayo Clinic in Rochester, Minn., asked what clinicians should analyze to determine which of their patients with heart failure and coronary disease to send to surgery, particularly in light of the benefits observed with CABG in the primary STICH analysis. Those data showed a 5% reduction in all-cause mortality at 6 years with the addition of CABG to medical therapy.

Dr. Bonow replied, "I think viability may be something you look at in some patients, but the point would be that there are other clinical variables, perhaps coronary anatomy, that one would bring into play."

Dr. Steven Bollings, with the Cardiovascular Center at the University of Michigan in Ann Arbor, said the primary STICH results provide a clear answer that patients with heart failure and left ventricular dysfunction benefit from coronary bypass surgery, but that the viability substudy raises a number of questions. He said that myocardial "may not be the No. 1 criterion by which we send patients to the operating room" and that other variables such as whether the patient has clear distal targets or is robust may be more important.

Dr. Gregg W. Stone of Columbia University, New York, said, "While I admit this is the clearly the best and most important viability study ever done, I don’t know that it definitively answers the question for us that viability doesn’t matter."

He pointed out that the viability data were based on only half of the STICH participants, the subsets were unbalanced with 80% of patients having viable myocardium and that some would say it’s not appropriate to look for interaction testing off of a negative end point.

"What I take away from this is that if there’s viability, I really want to be sure to revascularize," said Dr. Ted E. Feldman of NorthShore University HealthSystem in Evanston, Ill. "But prior to seeing these results, I was inclined to say if there wasn’t viability, not to vascularize. And the results of the trial challenge that historic bias," he added.

STICH Viability was supported by grants from the National Heart, Lung, and Blood Institute and Abbott Laboratories. Dr. Bonow had no relevant disclosures.

NEW ORLEANS – Myocardial viability failed to predict a significant survival benefit from coronary bypass surgery in patients with coronary artery disease and left ventricular dysfunction in the STICH Viability substudy.

The data are surprising and call into question the long-standing practice of assessing myocardial viability as a means to predict clinical benefit from coronary bypass surgery.

The substudy included 610 of the 1,212 patients in the Surgical Treatment for Ischemic Heart Failure (STICH) trial who underwent baseline myocardial viability testing using SPECT or dobutamine echocardiography, or both, and were randomly assigned to aggressive medical therapy with or without coronary artery bypass surgery (CABG).

At a median follow-up of 5 years, 51% of patients without viable myocardium and 37% with viable myocardium died. The presence of viable myocardium significantly reduced the risk of all-cause mortality by 36%, but the survival advantage lost statistical significance in a multivariable analysis that included other prognostic variables, Dr. Robert Bonow reported at the annual meeting of the American College of Cardiology.

The secondary outcome of cardiovascular mortality was also significantly lower in patients with myocardial viability compared with those without myocardial viability, at 29% and 43%, respectively, but once again, the association lost significance in multivariable analysis.

Notably, the secondary composite end point of death plus cardiovascular hospitalization, which is commonly used in heart failure trials, retained significance in multivariable analysis in favor of patients with myocardial viability, occurring in 63% of patients with viable myocardium and 82% of those without.

There was no significant interaction, however, between myocardial viability status and medical versus surgical treatment with respect to mortality, whether assessed according to treatment assigned or to the treatment actually received, said Dr. Bonow, professor of cardiology at Northwestern University in Chicago. Five-year all-cause mortality rates among the 114 patients without myocardial viability were 56% with medical therapy and 42% with CABG. Among the 487 patients with myocardial viability the rates were 35% vs. 31%, respectively.

"The lack of interaction between myocardial viability and benefit from CABG in this study indicates that assessment of myocardial viability, independent of other relevant variables, should not be the deciding factor in selecting the best therapy for patients with ischemic left ventricular function," he said.

Discussant Bernard Gersh, professor of medicine at Mayo Clinic in Rochester, Minn., asked what clinicians should analyze to determine which of their patients with heart failure and coronary disease to send to surgery, particularly in light of the benefits observed with CABG in the primary STICH analysis. Those data showed a 5% reduction in all-cause mortality at 6 years with the addition of CABG to medical therapy.

Dr. Bonow replied, "I think viability may be something you look at in some patients, but the point would be that there are other clinical variables, perhaps coronary anatomy, that one would bring into play."

Dr. Steven Bollings, with the Cardiovascular Center at the University of Michigan in Ann Arbor, said the primary STICH results provide a clear answer that patients with heart failure and left ventricular dysfunction benefit from coronary bypass surgery, but that the viability substudy raises a number of questions. He said that myocardial "may not be the No. 1 criterion by which we send patients to the operating room" and that other variables such as whether the patient has clear distal targets or is robust may be more important.

Dr. Gregg W. Stone of Columbia University, New York, said, "While I admit this is the clearly the best and most important viability study ever done, I don’t know that it definitively answers the question for us that viability doesn’t matter."

He pointed out that the viability data were based on only half of the STICH participants, the subsets were unbalanced with 80% of patients having viable myocardium and that some would say it’s not appropriate to look for interaction testing off of a negative end point.

"What I take away from this is that if there’s viability, I really want to be sure to revascularize," said Dr. Ted E. Feldman of NorthShore University HealthSystem in Evanston, Ill. "But prior to seeing these results, I was inclined to say if there wasn’t viability, not to vascularize. And the results of the trial challenge that historic bias," he added.

STICH Viability was supported by grants from the National Heart, Lung, and Blood Institute and Abbott Laboratories. Dr. Bonow had no relevant disclosures.

A program of regular tai chi exercises improved measures of quality of life in patients with chronic heart failure but failed to improve more conventional measures of exercise efficacy, compared with patients who only received education.

"Tai chi exercise, a multicomponent mind-body training modality that is safe and has good rates of adherence, may provide value in improving daily exercise, quality of life, self-efficacy, and mood in frail, deconditioned patients with systolic HF. A more restricted focus on traditional measured exercise capacity may underestimate the potential benefits of integrated interventions such as tai chi," wrote Dr. Gloria Y. Yeh and her coinvestigators in a study released April 25 in the Archives of Internal Medicine.

Photo credit: (c) Willie B. Thomas/iStockphoto.com

Tai chi is a gentle, meditative exercise of flowing circular movements, balance and weight shifting, breathing techniques, visualization, and focused internal awareness. "Tai chi may represent an additional exercise option for patients with HF because it integrates multiple relevant processes, including mild to moderate aerobic activity, upper and lower extremity training, and core strengthening," they said.

The researchers recruited 100 heart failure patients with a left ventricular ejection fraction of 40% or lower in the past 2 years, a stable medical regimen, and New York Heart Association class I-III from Boston medical practices.

They were randomly assigned to receive a 12-week tai chi exercise program or a heart health education program (attention control). All participants continued to receive usual care, noted Dr. Yeh, assistant professor of medicine at Beth Israel Deaconess and in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, both in Boston, and her associates.

All assessments were performed at baseline and at 12 weeks. Patients performed a symptom-limited exercise test using a bicycle ramp protocol to determine peak oxygen uptake, a 6-minute walk test, and a Timed Up and Go functional assessment.

The researchers used the Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess disease-specific quality of life, the Profile of Mood States to assess emotional states expected to respond to clinical intervention, and the Cardiac Exercise Self-Efficacy Instrument to assess patient confidence in performing exercise-related activities.

The tai chi intervention consisted of 1-hour group classes held twice weekly for 12 weeks by certified instructors. Patients were encouraged to practice at home at least three times a week. Patients in the control group attended nurse practitioner–led education sessions twice weekly and were asked not to start tai chi during the study period.

The mean age of study participants was 67 years, the mean baseline LVEF was 29%, and the median NYHA class was II. Most patients were receiving beta-blockers (86%) and ACE inhibitors (85%).

At 12 weeks, significant improvements were seen in scores on the MLHFQ, Profile of Mood States (total mood disturbance, depression, and vigor subscales), and Cardiac Exercise Self-Efficacy Instrument in the tai chi group, compared with the heart health education group. There were no significant changes in serum biomarkers, which included B-type natriuretic peptide, catecholamines, and C-reactive protein, Dr. Yeh and her associates reported (Arch. Intern. Med. 2011;171:750-7).

Post hoc exploratory analyses pointed to subsets of patients who derived significant benefits from tai chi, compared with education only. Tai chi patients without implanted cardioverter defibrillators devices, those with NYHA class II and III symptoms, and those with a nonischemic etiology of HF improved significantly on the MLHFQ, compared with education-only patients. The researchers also found that participants with a higher baseline resting heart rate had greater improvements in the MLHFQ score in the tai chi group; there was no association in the control group.

"One of the purported mechanisms of mind-body exercises, such as tai chi, is favorable modulation of the autonomic nervous system. In our post hoc analyses, we found that, in participants with higher resting heart rates (and presumably more sympathetic nervous system ‘overdrive’), there was a greater benefit with tai chi," the investigators noted.

At the 6-month follow-up telephone contact, 34 patients in the tai chi group (68.0%) reported continued practice (including daily, weekly, and monthly). There were no adverse events related to the protocol.

Dr. Yeh and her associates reported no significant financial relationships.

A program of regular tai chi exercises improved measures of quality of life in patients with chronic heart failure but failed to improve more conventional measures of exercise efficacy, compared with patients who only received education.

"Tai chi exercise, a multicomponent mind-body training modality that is safe and has good rates of adherence, may provide value in improving daily exercise, quality of life, self-efficacy, and mood in frail, deconditioned patients with systolic HF. A more restricted focus on traditional measured exercise capacity may underestimate the potential benefits of integrated interventions such as tai chi," wrote Dr. Gloria Y. Yeh and her coinvestigators in a study released April 25 in the Archives of Internal Medicine.

Photo credit: (c) Willie B. Thomas/iStockphoto.com

Tai chi is a gentle, meditative exercise of flowing circular movements, balance and weight shifting, breathing techniques, visualization, and focused internal awareness. "Tai chi may represent an additional exercise option for patients with HF because it integrates multiple relevant processes, including mild to moderate aerobic activity, upper and lower extremity training, and core strengthening," they said.

The researchers recruited 100 heart failure patients with a left ventricular ejection fraction of 40% or lower in the past 2 years, a stable medical regimen, and New York Heart Association class I-III from Boston medical practices.

They were randomly assigned to receive a 12-week tai chi exercise program or a heart health education program (attention control). All participants continued to receive usual care, noted Dr. Yeh, assistant professor of medicine at Beth Israel Deaconess and in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, both in Boston, and her associates.

All assessments were performed at baseline and at 12 weeks. Patients performed a symptom-limited exercise test using a bicycle ramp protocol to determine peak oxygen uptake, a 6-minute walk test, and a Timed Up and Go functional assessment.

The researchers used the Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess disease-specific quality of life, the Profile of Mood States to assess emotional states expected to respond to clinical intervention, and the Cardiac Exercise Self-Efficacy Instrument to assess patient confidence in performing exercise-related activities.

The tai chi intervention consisted of 1-hour group classes held twice weekly for 12 weeks by certified instructors. Patients were encouraged to practice at home at least three times a week. Patients in the control group attended nurse practitioner–led education sessions twice weekly and were asked not to start tai chi during the study period.

The mean age of study participants was 67 years, the mean baseline LVEF was 29%, and the median NYHA class was II. Most patients were receiving beta-blockers (86%) and ACE inhibitors (85%).

At 12 weeks, significant improvements were seen in scores on the MLHFQ, Profile of Mood States (total mood disturbance, depression, and vigor subscales), and Cardiac Exercise Self-Efficacy Instrument in the tai chi group, compared with the heart health education group. There were no significant changes in serum biomarkers, which included B-type natriuretic peptide, catecholamines, and C-reactive protein, Dr. Yeh and her associates reported (Arch. Intern. Med. 2011;171:750-7).

Post hoc exploratory analyses pointed to subsets of patients who derived significant benefits from tai chi, compared with education only. Tai chi patients without implanted cardioverter defibrillators devices, those with NYHA class II and III symptoms, and those with a nonischemic etiology of HF improved significantly on the MLHFQ, compared with education-only patients. The researchers also found that participants with a higher baseline resting heart rate had greater improvements in the MLHFQ score in the tai chi group; there was no association in the control group.

"One of the purported mechanisms of mind-body exercises, such as tai chi, is favorable modulation of the autonomic nervous system. In our post hoc analyses, we found that, in participants with higher resting heart rates (and presumably more sympathetic nervous system ‘overdrive’), there was a greater benefit with tai chi," the investigators noted.

At the 6-month follow-up telephone contact, 34 patients in the tai chi group (68.0%) reported continued practice (including daily, weekly, and monthly). There were no adverse events related to the protocol.

Dr. Yeh and her associates reported no significant financial relationships.

A program of regular tai chi exercises improved measures of quality of life in patients with chronic heart failure but failed to improve more conventional measures of exercise efficacy, compared with patients who only received education.

"Tai chi exercise, a multicomponent mind-body training modality that is safe and has good rates of adherence, may provide value in improving daily exercise, quality of life, self-efficacy, and mood in frail, deconditioned patients with systolic HF. A more restricted focus on traditional measured exercise capacity may underestimate the potential benefits of integrated interventions such as tai chi," wrote Dr. Gloria Y. Yeh and her coinvestigators in a study released April 25 in the Archives of Internal Medicine.

Photo credit: (c) Willie B. Thomas/iStockphoto.com

Tai chi is a gentle, meditative exercise of flowing circular movements, balance and weight shifting, breathing techniques, visualization, and focused internal awareness. "Tai chi may represent an additional exercise option for patients with HF because it integrates multiple relevant processes, including mild to moderate aerobic activity, upper and lower extremity training, and core strengthening," they said.

The researchers recruited 100 heart failure patients with a left ventricular ejection fraction of 40% or lower in the past 2 years, a stable medical regimen, and New York Heart Association class I-III from Boston medical practices.

They were randomly assigned to receive a 12-week tai chi exercise program or a heart health education program (attention control). All participants continued to receive usual care, noted Dr. Yeh, assistant professor of medicine at Beth Israel Deaconess and in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, both in Boston, and her associates.

All assessments were performed at baseline and at 12 weeks. Patients performed a symptom-limited exercise test using a bicycle ramp protocol to determine peak oxygen uptake, a 6-minute walk test, and a Timed Up and Go functional assessment.

The researchers used the Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess disease-specific quality of life, the Profile of Mood States to assess emotional states expected to respond to clinical intervention, and the Cardiac Exercise Self-Efficacy Instrument to assess patient confidence in performing exercise-related activities.

The tai chi intervention consisted of 1-hour group classes held twice weekly for 12 weeks by certified instructors. Patients were encouraged to practice at home at least three times a week. Patients in the control group attended nurse practitioner–led education sessions twice weekly and were asked not to start tai chi during the study period.

The mean age of study participants was 67 years, the mean baseline LVEF was 29%, and the median NYHA class was II. Most patients were receiving beta-blockers (86%) and ACE inhibitors (85%).

At 12 weeks, significant improvements were seen in scores on the MLHFQ, Profile of Mood States (total mood disturbance, depression, and vigor subscales), and Cardiac Exercise Self-Efficacy Instrument in the tai chi group, compared with the heart health education group. There were no significant changes in serum biomarkers, which included B-type natriuretic peptide, catecholamines, and C-reactive protein, Dr. Yeh and her associates reported (Arch. Intern. Med. 2011;171:750-7).

Post hoc exploratory analyses pointed to subsets of patients who derived significant benefits from tai chi, compared with education only. Tai chi patients without implanted cardioverter defibrillators devices, those with NYHA class II and III symptoms, and those with a nonischemic etiology of HF improved significantly on the MLHFQ, compared with education-only patients. The researchers also found that participants with a higher baseline resting heart rate had greater improvements in the MLHFQ score in the tai chi group; there was no association in the control group.

"One of the purported mechanisms of mind-body exercises, such as tai chi, is favorable modulation of the autonomic nervous system. In our post hoc analyses, we found that, in participants with higher resting heart rates (and presumably more sympathetic nervous system ‘overdrive’), there was a greater benefit with tai chi," the investigators noted.

At the 6-month follow-up telephone contact, 34 patients in the tai chi group (68.0%) reported continued practice (including daily, weekly, and monthly). There were no adverse events related to the protocol.

Dr. Yeh and her associates reported no significant financial relationships.

Nearly one-quarter of Medicare patients hospitalized for heart failure are subsequently discharged to a skilled nursing facility, and those patients are significantly more likely to be rehospitalized or die within 1 year than are similar patients discharged to home, according to the findings of a large observational study of more than 15,400 patients from 149 hospitals.

Absolute rehospitalization rates in those discharged to a skilled nursing facility vs. home were 27% vs. 23.5%, respectively, at 30 days, and 76.1% vs. 72.2%, respectively, at 1 year. All-cause mortality rates were 14.4% vs. 4.1% at 30 days and 53.5% vs. 29.1% at 1 year, Dr. Larry A. Allen and his colleagues reported online March 29 in Circulation: Heart Failure.

After adjustment for numerous demographic and health-related factors, discharge to a skilled nursing facility in these patients remained significantly associated with an increased risk of death (hazard ratio 1.76), said Dr. Allen of the Colorado Cardiovascular Outcomes Research Consortium, University of Colorado Denver, Aurora, Colo. (Circulation: Heart Failure 2011 March 29 [doi:10.1161/CIRCHEARTFAILURE.110.959171]).

Patients included in the analysis were 15,459 adults aged 65 years or older (median age 80 years) who were discharged to a skilled nursing facility (24.1%), to home with home health service (22.3%), or to home with self-care (53.6%). The patients had been hospitalized for heart failure for at least 3 days (median 5 days) during 2005-2006.

The patients were part of the Get With The Guidelines – Heart Failure Program registry, an ongoing, voluntary quality-improvement initiative of the American Heart Association, the investigators said.

Factors found to be significantly associated with discharge to a skilled nursing facility included longer hospital stay (odds ratio 1.12 per day); advanced age (OR 1.98 per 10-year increase); female sex (OR 1.53); systolic blood pressure (OR 0.94 per 10 mm Hg increase); left ventricular ejection fraction less than 40% (OR 0.91); sodium level (OR 1.05 per 10 mEq/L increase); and history of hyperlipidemia (OR 0.74), anemia (OR 1.31), diabetes (OR 1.19), valvular heart disease (OR 0.72), myocardial infarction (OR 0.86), bypass surgery or percutaneous coronary intervention (OR 0.80), implantable defibrillator (OR 0.76), depression (OR 2.11), stroke (OR 1.55), peripheral vascular disease (OR 1.13), or chronic obstructive pulmonary disease or asthma (OR 1.11).

Across the country, the rate of discharges to skilled nursing facilities was highest in the Northeast (30%) and lowest in the West (23.6%). Hospitals that treated more racial minorities and younger patients were among those with the lowest rates of discharge to skilled nursing facilities.

In this study, hospitalized heart failure patients who were discharged to a skilled nursing facility were 79% more likely to die than those discharged to home – even after adjusting for a wide range of patient factors known to be associated with adverse outcomes, the investigators said.

"However, discharge to [a skilled nursing facility] is by its very nature determined by criteria such as poor mobility, cognitive impairment, frailty, and poor in-home support, which are also important determinants of outcome," they wrote, noting that those determinants of outcome were not captured in this analysis. Therefore, the researchers said, conclusions about whether discharge to a skilled nursing facility directly impacts patient outcomes cannot be drawn.

Still, the findings have potential implications for communicating prognoses to patients and families, medical decision-making, and assessing care provided at skilled nursing facilities, they said.

The high absolute rates of death following discharge to skilled nursing facilities, in particular, have potential implications for communication, discharge planning, and goals of care, they said.

"Additionally, we must consider whether a different set of quality measures [is] needed for this unique group of patients," the investigators concluded.

This study was funded by the American Heart Association, GlaxoSmithKline, and Medtronic through their support of the Get With The Guidelines – Heart Failure Program, and the Agency for Healthcare Research and Quality. Dr. Allen had no conflicts of interest to disclose. Other authors on the study reported numerous relationships with various pharmaceutical companies and other organizations.

Nearly one-quarter of Medicare patients hospitalized for heart failure are subsequently discharged to a skilled nursing facility, and those patients are significantly more likely to be rehospitalized or die within 1 year than are similar patients discharged to home, according to the findings of a large observational study of more than 15,400 patients from 149 hospitals.

Absolute rehospitalization rates in those discharged to a skilled nursing facility vs. home were 27% vs. 23.5%, respectively, at 30 days, and 76.1% vs. 72.2%, respectively, at 1 year. All-cause mortality rates were 14.4% vs. 4.1% at 30 days and 53.5% vs. 29.1% at 1 year, Dr. Larry A. Allen and his colleagues reported online March 29 in Circulation: Heart Failure.

After adjustment for numerous demographic and health-related factors, discharge to a skilled nursing facility in these patients remained significantly associated with an increased risk of death (hazard ratio 1.76), said Dr. Allen of the Colorado Cardiovascular Outcomes Research Consortium, University of Colorado Denver, Aurora, Colo. (Circulation: Heart Failure 2011 March 29 [doi:10.1161/CIRCHEARTFAILURE.110.959171]).

Patients included in the analysis were 15,459 adults aged 65 years or older (median age 80 years) who were discharged to a skilled nursing facility (24.1%), to home with home health service (22.3%), or to home with self-care (53.6%). The patients had been hospitalized for heart failure for at least 3 days (median 5 days) during 2005-2006.

The patients were part of the Get With The Guidelines – Heart Failure Program registry, an ongoing, voluntary quality-improvement initiative of the American Heart Association, the investigators said.

Factors found to be significantly associated with discharge to a skilled nursing facility included longer hospital stay (odds ratio 1.12 per day); advanced age (OR 1.98 per 10-year increase); female sex (OR 1.53); systolic blood pressure (OR 0.94 per 10 mm Hg increase); left ventricular ejection fraction less than 40% (OR 0.91); sodium level (OR 1.05 per 10 mEq/L increase); and history of hyperlipidemia (OR 0.74), anemia (OR 1.31), diabetes (OR 1.19), valvular heart disease (OR 0.72), myocardial infarction (OR 0.86), bypass surgery or percutaneous coronary intervention (OR 0.80), implantable defibrillator (OR 0.76), depression (OR 2.11), stroke (OR 1.55), peripheral vascular disease (OR 1.13), or chronic obstructive pulmonary disease or asthma (OR 1.11).

Across the country, the rate of discharges to skilled nursing facilities was highest in the Northeast (30%) and lowest in the West (23.6%). Hospitals that treated more racial minorities and younger patients were among those with the lowest rates of discharge to skilled nursing facilities.

In this study, hospitalized heart failure patients who were discharged to a skilled nursing facility were 79% more likely to die than those discharged to home – even after adjusting for a wide range of patient factors known to be associated with adverse outcomes, the investigators said.

"However, discharge to [a skilled nursing facility] is by its very nature determined by criteria such as poor mobility, cognitive impairment, frailty, and poor in-home support, which are also important determinants of outcome," they wrote, noting that those determinants of outcome were not captured in this analysis. Therefore, the researchers said, conclusions about whether discharge to a skilled nursing facility directly impacts patient outcomes cannot be drawn.

Still, the findings have potential implications for communicating prognoses to patients and families, medical decision-making, and assessing care provided at skilled nursing facilities, they said.

The high absolute rates of death following discharge to skilled nursing facilities, in particular, have potential implications for communication, discharge planning, and goals of care, they said.

"Additionally, we must consider whether a different set of quality measures [is] needed for this unique group of patients," the investigators concluded.

This study was funded by the American Heart Association, GlaxoSmithKline, and Medtronic through their support of the Get With The Guidelines – Heart Failure Program, and the Agency for Healthcare Research and Quality. Dr. Allen had no conflicts of interest to disclose. Other authors on the study reported numerous relationships with various pharmaceutical companies and other organizations.

Nearly one-quarter of Medicare patients hospitalized for heart failure are subsequently discharged to a skilled nursing facility, and those patients are significantly more likely to be rehospitalized or die within 1 year than are similar patients discharged to home, according to the findings of a large observational study of more than 15,400 patients from 149 hospitals.

Absolute rehospitalization rates in those discharged to a skilled nursing facility vs. home were 27% vs. 23.5%, respectively, at 30 days, and 76.1% vs. 72.2%, respectively, at 1 year. All-cause mortality rates were 14.4% vs. 4.1% at 30 days and 53.5% vs. 29.1% at 1 year, Dr. Larry A. Allen and his colleagues reported online March 29 in Circulation: Heart Failure.

After adjustment for numerous demographic and health-related factors, discharge to a skilled nursing facility in these patients remained significantly associated with an increased risk of death (hazard ratio 1.76), said Dr. Allen of the Colorado Cardiovascular Outcomes Research Consortium, University of Colorado Denver, Aurora, Colo. (Circulation: Heart Failure 2011 March 29 [doi:10.1161/CIRCHEARTFAILURE.110.959171]).

Patients included in the analysis were 15,459 adults aged 65 years or older (median age 80 years) who were discharged to a skilled nursing facility (24.1%), to home with home health service (22.3%), or to home with self-care (53.6%). The patients had been hospitalized for heart failure for at least 3 days (median 5 days) during 2005-2006.

The patients were part of the Get With The Guidelines – Heart Failure Program registry, an ongoing, voluntary quality-improvement initiative of the American Heart Association, the investigators said.

Factors found to be significantly associated with discharge to a skilled nursing facility included longer hospital stay (odds ratio 1.12 per day); advanced age (OR 1.98 per 10-year increase); female sex (OR 1.53); systolic blood pressure (OR 0.94 per 10 mm Hg increase); left ventricular ejection fraction less than 40% (OR 0.91); sodium level (OR 1.05 per 10 mEq/L increase); and history of hyperlipidemia (OR 0.74), anemia (OR 1.31), diabetes (OR 1.19), valvular heart disease (OR 0.72), myocardial infarction (OR 0.86), bypass surgery or percutaneous coronary intervention (OR 0.80), implantable defibrillator (OR 0.76), depression (OR 2.11), stroke (OR 1.55), peripheral vascular disease (OR 1.13), or chronic obstructive pulmonary disease or asthma (OR 1.11).

Across the country, the rate of discharges to skilled nursing facilities was highest in the Northeast (30%) and lowest in the West (23.6%). Hospitals that treated more racial minorities and younger patients were among those with the lowest rates of discharge to skilled nursing facilities.

In this study, hospitalized heart failure patients who were discharged to a skilled nursing facility were 79% more likely to die than those discharged to home – even after adjusting for a wide range of patient factors known to be associated with adverse outcomes, the investigators said.

"However, discharge to [a skilled nursing facility] is by its very nature determined by criteria such as poor mobility, cognitive impairment, frailty, and poor in-home support, which are also important determinants of outcome," they wrote, noting that those determinants of outcome were not captured in this analysis. Therefore, the researchers said, conclusions about whether discharge to a skilled nursing facility directly impacts patient outcomes cannot be drawn.

Still, the findings have potential implications for communicating prognoses to patients and families, medical decision-making, and assessing care provided at skilled nursing facilities, they said.

The high absolute rates of death following discharge to skilled nursing facilities, in particular, have potential implications for communication, discharge planning, and goals of care, they said.

"Additionally, we must consider whether a different set of quality measures [is] needed for this unique group of patients," the investigators concluded.

This study was funded by the American Heart Association, GlaxoSmithKline, and Medtronic through their support of the Get With The Guidelines – Heart Failure Program, and the Agency for Healthcare Research and Quality. Dr. Allen had no conflicts of interest to disclose. Other authors on the study reported numerous relationships with various pharmaceutical companies and other organizations.