Society of Thoracic Surgeons (STS): Annual Meeting

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.

FT. LAUDERDALE, FLA. – More than a decade ago, the Department of Health and Human Services issued the "Final Rule on Organ Procurement and Transplantation Network Amendments," which was intended to ensure that "organs will be [allocated] based on medical criteria, not accidents of geography." Despite the introduction of this final rule, disparities in waiting list outcomes are known to be significantly influenced by where the transplantation candidate lives, and lower priority candidates are receiving organs at the expense of the more severely ill.

Although all candidates are ranked based on an objective priority score known as the Lung Allocation Score (LAS), lung allocation remains a locally based system. Organs are first allocated based on geography regardless of LAS score. Therefore, organs are initially offered only to the subset of matched lung transplant candidates (based on blood group and size) within the donor’s local Donor Service Area (DSA).

As a result, if an available organ is first accepted for a candidate within the local DSA, it is never offered to potentially more-severely ill candidates at the broader regional or national level – even if the regional or national candidate has a much higher priority score. There is evidence that this is a frequent occurrence, according to research presented by Dr. Mark J. Russo at the annual meeting of the Society of Thoracic Surgeons.

Dr. Russo and his colleagues analyzed data provided by the United Network for Organ Sharing to determine the frequency with which donor lungs were allocated to local candidates when blood group– and size-matched candidates with a higher LAS existed in the same region.

Their study cohort included all locally allocated organs for double lung transplantation in the United States in the year 2009. The researchers then identified all cases in which ABO blood group– and height-matched (within 10 cm) double-lung candidates in the same region had a higher LAS than did the local candidates who actually received the lung. They also calculated the number of these events in which the LAS difference was greater than 10 and greater than 25. The number of these bypassed regional candidates who then died on the waiting list was also determined.

Among the 580 locally allocated double-lung transplants analyzed, there was a mean of 6.0 blood group – and height-matched double-lung events per transplant (3,454 total, impacting 1,193 different candidates) in the same region where candidates had a higher LAS than did the local candidate who received the organ. A total of 24% (828) of the events involved skipping over a regional candidate with an LAS greater than 10 points higher than the local recipient, with 7.2% (250) of events involving a regional candidate with an LAS greater than 25 points higher than the local recipient. Overall, 185 of the bypassed regional candidates died on the waiting list.

Dr. Russo said that although the issue of transportation is important, generally the adverse impact of an additional hour or two of ischemic time due to transportation is not clinically significant, and should not be a major factor in the decision as to local vs. regional candidates. In addition, the regional candidate is often not far from the donor, he added.

"Ideally, a suitable donor organ would be available for every lung transplant candidate who could benefit from transplantation. Unfortunately, there remains a critical scarcity of donor organs available for transplantation. Therefore, efficient allocation of organs is necessary to ensure maximum benefit from the available organs," according to Dr. Russo, a cardiothoracic surgeon at the University of Chicago Medical Center.

"Locally-based allocation results in a high number of events in which a lung is allocated to a lower-priority candidate when an appropriately matched, higher-priority candidate exists in the same region. As a result, low-priority candidates, defined by an LAS less than 50, account for nearly 90% of lung transplant recipients, while candidates with higher LAS scores, defined by an LAS greater than 75, continue to die at extremely high rates while awaiting transplantation," Dr. Russo stated.

Dr. Russo said further that because this study considered only double-lung candidates, did not consider the possibility of national matching, and did not allow for blood groups to be crossed, it likely significantly underestimates the frequency of these events and lives lost.

"These findings suggest that further study of organ sharing over broader geographies should be pursued to determine if it would improve [waiting] list outcomes, including higher rates of organ allocation to higher-priority candidates, improved survival on the waiting list, and greater net benefit from the organs available for transplantation," he concluded.

Dr. Russo reported that he had no financial disclosures.

FT. LAUDERDALE, FLA. – More than a decade ago, the Department of Health and Human Services issued the "Final Rule on Organ Procurement and Transplantation Network Amendments," which was intended to ensure that "organs will be [allocated] based on medical criteria, not accidents of geography." Despite the introduction of this final rule, disparities in waiting list outcomes are known to be significantly influenced by where the transplantation candidate lives, and lower priority candidates are receiving organs at the expense of the more severely ill.

Although all candidates are ranked based on an objective priority score known as the Lung Allocation Score (LAS), lung allocation remains a locally based system. Organs are first allocated based on geography regardless of LAS score. Therefore, organs are initially offered only to the subset of matched lung transplant candidates (based on blood group and size) within the donor’s local Donor Service Area (DSA).

As a result, if an available organ is first accepted for a candidate within the local DSA, it is never offered to potentially more-severely ill candidates at the broader regional or national level – even if the regional or national candidate has a much higher priority score. There is evidence that this is a frequent occurrence, according to research presented by Dr. Mark J. Russo at the annual meeting of the Society of Thoracic Surgeons.

Dr. Russo and his colleagues analyzed data provided by the United Network for Organ Sharing to determine the frequency with which donor lungs were allocated to local candidates when blood group– and size-matched candidates with a higher LAS existed in the same region.

Their study cohort included all locally allocated organs for double lung transplantation in the United States in the year 2009. The researchers then identified all cases in which ABO blood group– and height-matched (within 10 cm) double-lung candidates in the same region had a higher LAS than did the local candidates who actually received the lung. They also calculated the number of these events in which the LAS difference was greater than 10 and greater than 25. The number of these bypassed regional candidates who then died on the waiting list was also determined.

Among the 580 locally allocated double-lung transplants analyzed, there was a mean of 6.0 blood group – and height-matched double-lung events per transplant (3,454 total, impacting 1,193 different candidates) in the same region where candidates had a higher LAS than did the local candidate who received the organ. A total of 24% (828) of the events involved skipping over a regional candidate with an LAS greater than 10 points higher than the local recipient, with 7.2% (250) of events involving a regional candidate with an LAS greater than 25 points higher than the local recipient. Overall, 185 of the bypassed regional candidates died on the waiting list.

Dr. Russo said that although the issue of transportation is important, generally the adverse impact of an additional hour or two of ischemic time due to transportation is not clinically significant, and should not be a major factor in the decision as to local vs. regional candidates. In addition, the regional candidate is often not far from the donor, he added.

"Ideally, a suitable donor organ would be available for every lung transplant candidate who could benefit from transplantation. Unfortunately, there remains a critical scarcity of donor organs available for transplantation. Therefore, efficient allocation of organs is necessary to ensure maximum benefit from the available organs," according to Dr. Russo, a cardiothoracic surgeon at the University of Chicago Medical Center.

"Locally-based allocation results in a high number of events in which a lung is allocated to a lower-priority candidate when an appropriately matched, higher-priority candidate exists in the same region. As a result, low-priority candidates, defined by an LAS less than 50, account for nearly 90% of lung transplant recipients, while candidates with higher LAS scores, defined by an LAS greater than 75, continue to die at extremely high rates while awaiting transplantation," Dr. Russo stated.

Dr. Russo said further that because this study considered only double-lung candidates, did not consider the possibility of national matching, and did not allow for blood groups to be crossed, it likely significantly underestimates the frequency of these events and lives lost.

"These findings suggest that further study of organ sharing over broader geographies should be pursued to determine if it would improve [waiting] list outcomes, including higher rates of organ allocation to higher-priority candidates, improved survival on the waiting list, and greater net benefit from the organs available for transplantation," he concluded.

Dr. Russo reported that he had no financial disclosures.

FT. LAUDERDALE, FLA. – More than a decade ago, the Department of Health and Human Services issued the "Final Rule on Organ Procurement and Transplantation Network Amendments," which was intended to ensure that "organs will be [allocated] based on medical criteria, not accidents of geography." Despite the introduction of this final rule, disparities in waiting list outcomes are known to be significantly influenced by where the transplantation candidate lives, and lower priority candidates are receiving organs at the expense of the more severely ill.

Although all candidates are ranked based on an objective priority score known as the Lung Allocation Score (LAS), lung allocation remains a locally based system. Organs are first allocated based on geography regardless of LAS score. Therefore, organs are initially offered only to the subset of matched lung transplant candidates (based on blood group and size) within the donor’s local Donor Service Area (DSA).

As a result, if an available organ is first accepted for a candidate within the local DSA, it is never offered to potentially more-severely ill candidates at the broader regional or national level – even if the regional or national candidate has a much higher priority score. There is evidence that this is a frequent occurrence, according to research presented by Dr. Mark J. Russo at the annual meeting of the Society of Thoracic Surgeons.

Dr. Russo and his colleagues analyzed data provided by the United Network for Organ Sharing to determine the frequency with which donor lungs were allocated to local candidates when blood group– and size-matched candidates with a higher LAS existed in the same region.

Their study cohort included all locally allocated organs for double lung transplantation in the United States in the year 2009. The researchers then identified all cases in which ABO blood group– and height-matched (within 10 cm) double-lung candidates in the same region had a higher LAS than did the local candidates who actually received the lung. They also calculated the number of these events in which the LAS difference was greater than 10 and greater than 25. The number of these bypassed regional candidates who then died on the waiting list was also determined.

Among the 580 locally allocated double-lung transplants analyzed, there was a mean of 6.0 blood group – and height-matched double-lung events per transplant (3,454 total, impacting 1,193 different candidates) in the same region where candidates had a higher LAS than did the local candidate who received the organ. A total of 24% (828) of the events involved skipping over a regional candidate with an LAS greater than 10 points higher than the local recipient, with 7.2% (250) of events involving a regional candidate with an LAS greater than 25 points higher than the local recipient. Overall, 185 of the bypassed regional candidates died on the waiting list.

Dr. Russo said that although the issue of transportation is important, generally the adverse impact of an additional hour or two of ischemic time due to transportation is not clinically significant, and should not be a major factor in the decision as to local vs. regional candidates. In addition, the regional candidate is often not far from the donor, he added.

"Ideally, a suitable donor organ would be available for every lung transplant candidate who could benefit from transplantation. Unfortunately, there remains a critical scarcity of donor organs available for transplantation. Therefore, efficient allocation of organs is necessary to ensure maximum benefit from the available organs," according to Dr. Russo, a cardiothoracic surgeon at the University of Chicago Medical Center.

"Locally-based allocation results in a high number of events in which a lung is allocated to a lower-priority candidate when an appropriately matched, higher-priority candidate exists in the same region. As a result, low-priority candidates, defined by an LAS less than 50, account for nearly 90% of lung transplant recipients, while candidates with higher LAS scores, defined by an LAS greater than 75, continue to die at extremely high rates while awaiting transplantation," Dr. Russo stated.

Dr. Russo said further that because this study considered only double-lung candidates, did not consider the possibility of national matching, and did not allow for blood groups to be crossed, it likely significantly underestimates the frequency of these events and lives lost.

"These findings suggest that further study of organ sharing over broader geographies should be pursued to determine if it would improve [waiting] list outcomes, including higher rates of organ allocation to higher-priority candidates, improved survival on the waiting list, and greater net benefit from the organs available for transplantation," he concluded.

Dr. Russo reported that he had no financial disclosures.

FT. LAUDERDALE, FLA. – Left ventricular assist devices were associated with a significant survival advantage compared with all other support pathways implemented before heart transplant in an analysis of more than 13,000 patients.

There are a variety of support pathways available to eventual heart transplant recipients, but there is little information concerning comparative outcomes of patients bridged with the various treatments. Such information could provide valuable insight for clinical decision making and organ allocation policy, according to Dr. Tara Karamlou.

A large database study was conducted using the United Network Organ Sharing Dataset to track outcomes of status 1 heart transplant recipients from 2000 to 2010. Dr. Karamlou of Seattle Children’s Hospital, and her colleagues, grouped transplant recipients based on the use of support pathways prior to transplant, including patients transitioning from one support pathway to another.

Dr. Karamlou reported her group’s results using Kaplan-Meir plots to compare time-related mortality among the different support-pathway groups. The study sought to uncover multivariable factors for time-related death using hazard regression models, she said at the annual meeting of the Society of Thoracic Surgeons.

There were six initial support pathways used in the 13,250 status 1 heart transplant patients identified in the database. These comprised inotropes (7,607); left ventricular assist devices (LVAD, 4,034); intra-aortic balloon pump (IABP, 729); biventricular assist devices (BIVAD, 521); extracorporeal circulation membrane oxygenation (ECMO, 316); and right ventricular assist devices (RVAD, 43).

"Multivariable analysis showed that LVAD use conferred a significant survival advantage compared with all other support pathways [hazard ratio, 0.71; P greater than .001]," said Dr. Karamlou. All other support treatments showed significantly increased risk of posttransplant death compared with LVAD treatment, including inotropes (HR, 1.1); RVAD (HR, 1.9); and ECMO (HR, 2.2).

There were 2,175 patients in the analysis who transitioned (either escalation or reduction) from one support pathway to another: no support to LVAD; LVAD to BIVAD; inotropes to LVAD; LVAD to inotropes; BIVAD to LVAD; and ECMO to LVAD. Among these patients, those who began with ECMO or BIVAD support followed by LVAD had improved posttransplant survival comparable to that of patients who began on LVAD and continued it throughout their course of pretransplant support.

LVAD support, especially in the setting of bridge to transplant, has clearly undergone several modifications that have made it safer and easier to implant and maintain, she added. Implantation of an LVAD in the current era, based on these findings, has survival superior to all other mechanical circulatory support pathways, and is equivalent to inotropic therapy. Additionally, in patients who are able to be weaned from biventricular support (ECMO and BIVAD therapy), LVAD implantation allows recovery of posttransplant survival to levels equivalent to primary LVAD–only therapy. This finding gives surgeons and cardiologists critical prognostic information regarding triage to pretransplant support pathways.

"Several key issues remain unresolved and, based on our results, will require further investigation. For example, the timing and clinical status of the patient surrounding both initial support and transition (either escalation or de-escalation) could not be determined from our data. In my mind, this is a crucial issue because delayed institution of mechanical support can have serious repercussions and, given the significantly increased risk of death with ECMO and BIVAD, a delay in de-escalation of therapy to LVAD could also confer an important survival disadvantage," she said.

"Organ allocation policy development and clinical decision making might benefit by considering these results in order to maximize the societal benefits of heart transplants," Dr. Karamlou concluded.

Dr. Karamlou reported having no financial disclosures.

FT. LAUDERDALE, FLA. – Left ventricular assist devices were associated with a significant survival advantage compared with all other support pathways implemented before heart transplant in an analysis of more than 13,000 patients.

There are a variety of support pathways available to eventual heart transplant recipients, but there is little information concerning comparative outcomes of patients bridged with the various treatments. Such information could provide valuable insight for clinical decision making and organ allocation policy, according to Dr. Tara Karamlou.

A large database study was conducted using the United Network Organ Sharing Dataset to track outcomes of status 1 heart transplant recipients from 2000 to 2010. Dr. Karamlou of Seattle Children’s Hospital, and her colleagues, grouped transplant recipients based on the use of support pathways prior to transplant, including patients transitioning from one support pathway to another.

Dr. Karamlou reported her group’s results using Kaplan-Meir plots to compare time-related mortality among the different support-pathway groups. The study sought to uncover multivariable factors for time-related death using hazard regression models, she said at the annual meeting of the Society of Thoracic Surgeons.

There were six initial support pathways used in the 13,250 status 1 heart transplant patients identified in the database. These comprised inotropes (7,607); left ventricular assist devices (LVAD, 4,034); intra-aortic balloon pump (IABP, 729); biventricular assist devices (BIVAD, 521); extracorporeal circulation membrane oxygenation (ECMO, 316); and right ventricular assist devices (RVAD, 43).

"Multivariable analysis showed that LVAD use conferred a significant survival advantage compared with all other support pathways [hazard ratio, 0.71; P greater than .001]," said Dr. Karamlou. All other support treatments showed significantly increased risk of posttransplant death compared with LVAD treatment, including inotropes (HR, 1.1); RVAD (HR, 1.9); and ECMO (HR, 2.2).

There were 2,175 patients in the analysis who transitioned (either escalation or reduction) from one support pathway to another: no support to LVAD; LVAD to BIVAD; inotropes to LVAD; LVAD to inotropes; BIVAD to LVAD; and ECMO to LVAD. Among these patients, those who began with ECMO or BIVAD support followed by LVAD had improved posttransplant survival comparable to that of patients who began on LVAD and continued it throughout their course of pretransplant support.

LVAD support, especially in the setting of bridge to transplant, has clearly undergone several modifications that have made it safer and easier to implant and maintain, she added. Implantation of an LVAD in the current era, based on these findings, has survival superior to all other mechanical circulatory support pathways, and is equivalent to inotropic therapy. Additionally, in patients who are able to be weaned from biventricular support (ECMO and BIVAD therapy), LVAD implantation allows recovery of posttransplant survival to levels equivalent to primary LVAD–only therapy. This finding gives surgeons and cardiologists critical prognostic information regarding triage to pretransplant support pathways.

"Several key issues remain unresolved and, based on our results, will require further investigation. For example, the timing and clinical status of the patient surrounding both initial support and transition (either escalation or de-escalation) could not be determined from our data. In my mind, this is a crucial issue because delayed institution of mechanical support can have serious repercussions and, given the significantly increased risk of death with ECMO and BIVAD, a delay in de-escalation of therapy to LVAD could also confer an important survival disadvantage," she said.

"Organ allocation policy development and clinical decision making might benefit by considering these results in order to maximize the societal benefits of heart transplants," Dr. Karamlou concluded.

Dr. Karamlou reported having no financial disclosures.

FT. LAUDERDALE, FLA. – Left ventricular assist devices were associated with a significant survival advantage compared with all other support pathways implemented before heart transplant in an analysis of more than 13,000 patients.

There are a variety of support pathways available to eventual heart transplant recipients, but there is little information concerning comparative outcomes of patients bridged with the various treatments. Such information could provide valuable insight for clinical decision making and organ allocation policy, according to Dr. Tara Karamlou.

A large database study was conducted using the United Network Organ Sharing Dataset to track outcomes of status 1 heart transplant recipients from 2000 to 2010. Dr. Karamlou of Seattle Children’s Hospital, and her colleagues, grouped transplant recipients based on the use of support pathways prior to transplant, including patients transitioning from one support pathway to another.

Dr. Karamlou reported her group’s results using Kaplan-Meir plots to compare time-related mortality among the different support-pathway groups. The study sought to uncover multivariable factors for time-related death using hazard regression models, she said at the annual meeting of the Society of Thoracic Surgeons.

There were six initial support pathways used in the 13,250 status 1 heart transplant patients identified in the database. These comprised inotropes (7,607); left ventricular assist devices (LVAD, 4,034); intra-aortic balloon pump (IABP, 729); biventricular assist devices (BIVAD, 521); extracorporeal circulation membrane oxygenation (ECMO, 316); and right ventricular assist devices (RVAD, 43).

"Multivariable analysis showed that LVAD use conferred a significant survival advantage compared with all other support pathways [hazard ratio, 0.71; P greater than .001]," said Dr. Karamlou. All other support treatments showed significantly increased risk of posttransplant death compared with LVAD treatment, including inotropes (HR, 1.1); RVAD (HR, 1.9); and ECMO (HR, 2.2).

There were 2,175 patients in the analysis who transitioned (either escalation or reduction) from one support pathway to another: no support to LVAD; LVAD to BIVAD; inotropes to LVAD; LVAD to inotropes; BIVAD to LVAD; and ECMO to LVAD. Among these patients, those who began with ECMO or BIVAD support followed by LVAD had improved posttransplant survival comparable to that of patients who began on LVAD and continued it throughout their course of pretransplant support.

LVAD support, especially in the setting of bridge to transplant, has clearly undergone several modifications that have made it safer and easier to implant and maintain, she added. Implantation of an LVAD in the current era, based on these findings, has survival superior to all other mechanical circulatory support pathways, and is equivalent to inotropic therapy. Additionally, in patients who are able to be weaned from biventricular support (ECMO and BIVAD therapy), LVAD implantation allows recovery of posttransplant survival to levels equivalent to primary LVAD–only therapy. This finding gives surgeons and cardiologists critical prognostic information regarding triage to pretransplant support pathways.

"Several key issues remain unresolved and, based on our results, will require further investigation. For example, the timing and clinical status of the patient surrounding both initial support and transition (either escalation or de-escalation) could not be determined from our data. In my mind, this is a crucial issue because delayed institution of mechanical support can have serious repercussions and, given the significantly increased risk of death with ECMO and BIVAD, a delay in de-escalation of therapy to LVAD could also confer an important survival disadvantage," she said.

"Organ allocation policy development and clinical decision making might benefit by considering these results in order to maximize the societal benefits of heart transplants," Dr. Karamlou concluded.

Dr. Karamlou reported having no financial disclosures.

FT. LAUDERDALE, FLA. – The use of full-flow cardiopulmonary bypass, coupled with neurological monitoring, improved cognitive and motor outcomes in a prospective neurologic outcome study of 97 neonates with transposition of the great arteries (both single- and two-ventricle lesions) who underwent an arterial switch operation.

The cohort study, conducted by Dr. Dean B. Andropoulos and his colleagues at the Texas Children’s Hospital in Houston, examined early MRI changes and longer-term neurodevelopmental outcomes after the arterial switch operation (ASO) was performed using a cardiopulmonary bypass (CPB) protocol that avoided deep hypothermic circulatory arrest (DHCA) and low-flow CPB.

The ASO was performed by using CPB with 150-mL/kg per min flows with no low-flow CPB or DHCA; pH stat management; hematocrit 30% or higher; and hypothermia to 24° -28° C. Regional oxygen saturation greater than 50% was maintained by using near infrared spectroscopic monitoring.

Neurologic assessment was performed using brain MRI performed immediately before the operation and 7 days postoperatively. The Bayley Scales of Infant and Toddler Development, Third Edition were used at 12 and 36 months (mean score of 100).

Dextrotransposition of the great arteries was present in 31 of the 97 enrolled patients. Ten of these 31 (32%) had preoperative MRI change, and 19 of 31 (61%) showed new postoperative MRI change, with 75% showing minimal new white matter injury, he said at the annual meeting of the Society of Thoracic Surgeons.

At 2 months, Bayley Scales were performed on 17 of the patients. Their mean cognitive score was 106.5, mean motor score was 90.4, and mean language score was 89.4. Twelve patients had Bayley III testing at 36 months, with a cognitive score of 106.5, motor score of 107.4, and language score of 98.2.

"Our series demonstrates a significant incidence of pre-existing MRI changes, and 61% have new postoperative changes, but all changes in this series were mild," said Dr. Andropoulos.

"At 12 months, the cognitive score of these children was above the population mean, but their motor and language performance was lower. By 36 months, language and motor scores had improved significantly. Thus, full-flow CPB coupled to cerebral monitoring may improve neurological outcomes."

Because of these results, "future studies of ASO patients should include short- and long-term neurodevelopmental studies," he said.

With greatly improved 30-day neonatal arterial switch operation mortality rates (for example, at the Texas Children’s Hospital in Houston there were no 30-day hospital mortalities for 175 ASOs since 2000), there are increasing expectations for better neurologic outcomes, according to Dr. Andropoulos, and such considerations are increasingly important.

Dr. Andropoulos reported having no financial conflicts.

FT. LAUDERDALE, FLA. – The use of full-flow cardiopulmonary bypass, coupled with neurological monitoring, improved cognitive and motor outcomes in a prospective neurologic outcome study of 97 neonates with transposition of the great arteries (both single- and two-ventricle lesions) who underwent an arterial switch operation.

The cohort study, conducted by Dr. Dean B. Andropoulos and his colleagues at the Texas Children’s Hospital in Houston, examined early MRI changes and longer-term neurodevelopmental outcomes after the arterial switch operation (ASO) was performed using a cardiopulmonary bypass (CPB) protocol that avoided deep hypothermic circulatory arrest (DHCA) and low-flow CPB.

The ASO was performed by using CPB with 150-mL/kg per min flows with no low-flow CPB or DHCA; pH stat management; hematocrit 30% or higher; and hypothermia to 24° -28° C. Regional oxygen saturation greater than 50% was maintained by using near infrared spectroscopic monitoring.

Neurologic assessment was performed using brain MRI performed immediately before the operation and 7 days postoperatively. The Bayley Scales of Infant and Toddler Development, Third Edition were used at 12 and 36 months (mean score of 100).

Dextrotransposition of the great arteries was present in 31 of the 97 enrolled patients. Ten of these 31 (32%) had preoperative MRI change, and 19 of 31 (61%) showed new postoperative MRI change, with 75% showing minimal new white matter injury, he said at the annual meeting of the Society of Thoracic Surgeons.

At 2 months, Bayley Scales were performed on 17 of the patients. Their mean cognitive score was 106.5, mean motor score was 90.4, and mean language score was 89.4. Twelve patients had Bayley III testing at 36 months, with a cognitive score of 106.5, motor score of 107.4, and language score of 98.2.

"Our series demonstrates a significant incidence of pre-existing MRI changes, and 61% have new postoperative changes, but all changes in this series were mild," said Dr. Andropoulos.

"At 12 months, the cognitive score of these children was above the population mean, but their motor and language performance was lower. By 36 months, language and motor scores had improved significantly. Thus, full-flow CPB coupled to cerebral monitoring may improve neurological outcomes."

Because of these results, "future studies of ASO patients should include short- and long-term neurodevelopmental studies," he said.

With greatly improved 30-day neonatal arterial switch operation mortality rates (for example, at the Texas Children’s Hospital in Houston there were no 30-day hospital mortalities for 175 ASOs since 2000), there are increasing expectations for better neurologic outcomes, according to Dr. Andropoulos, and such considerations are increasingly important.

Dr. Andropoulos reported having no financial conflicts.

FT. LAUDERDALE, FLA. – The use of full-flow cardiopulmonary bypass, coupled with neurological monitoring, improved cognitive and motor outcomes in a prospective neurologic outcome study of 97 neonates with transposition of the great arteries (both single- and two-ventricle lesions) who underwent an arterial switch operation.

The cohort study, conducted by Dr. Dean B. Andropoulos and his colleagues at the Texas Children’s Hospital in Houston, examined early MRI changes and longer-term neurodevelopmental outcomes after the arterial switch operation (ASO) was performed using a cardiopulmonary bypass (CPB) protocol that avoided deep hypothermic circulatory arrest (DHCA) and low-flow CPB.

The ASO was performed by using CPB with 150-mL/kg per min flows with no low-flow CPB or DHCA; pH stat management; hematocrit 30% or higher; and hypothermia to 24° -28° C. Regional oxygen saturation greater than 50% was maintained by using near infrared spectroscopic monitoring.

Neurologic assessment was performed using brain MRI performed immediately before the operation and 7 days postoperatively. The Bayley Scales of Infant and Toddler Development, Third Edition were used at 12 and 36 months (mean score of 100).

Dextrotransposition of the great arteries was present in 31 of the 97 enrolled patients. Ten of these 31 (32%) had preoperative MRI change, and 19 of 31 (61%) showed new postoperative MRI change, with 75% showing minimal new white matter injury, he said at the annual meeting of the Society of Thoracic Surgeons.

At 2 months, Bayley Scales were performed on 17 of the patients. Their mean cognitive score was 106.5, mean motor score was 90.4, and mean language score was 89.4. Twelve patients had Bayley III testing at 36 months, with a cognitive score of 106.5, motor score of 107.4, and language score of 98.2.

"Our series demonstrates a significant incidence of pre-existing MRI changes, and 61% have new postoperative changes, but all changes in this series were mild," said Dr. Andropoulos.

"At 12 months, the cognitive score of these children was above the population mean, but their motor and language performance was lower. By 36 months, language and motor scores had improved significantly. Thus, full-flow CPB coupled to cerebral monitoring may improve neurological outcomes."

Because of these results, "future studies of ASO patients should include short- and long-term neurodevelopmental studies," he said.

With greatly improved 30-day neonatal arterial switch operation mortality rates (for example, at the Texas Children’s Hospital in Houston there were no 30-day hospital mortalities for 175 ASOs since 2000), there are increasing expectations for better neurologic outcomes, according to Dr. Andropoulos, and such considerations are increasingly important.

Dr. Andropoulos reported having no financial conflicts.

FT. LAUDERDALE, FLA – Early repair – within one week – of acquired ventral septal defect in patients with myocardial infarction was associated with a significantly higher mortality rate than was later repair in a retrospective review.

Acquired ventral septal defect (VSD), a relatively rare but devastating complication of myocardial infarction, frequently leads to cardiogenic shock and death. Surgical repair is generally required, although there is a high mortality.

To identify risk factors for poor patient outcomes, a study of the Society for Thoracic Surgeons National Database was performed to characterize patients undergoing post-MI VSD surgical repair, Dr. George J. Arnaoutakis said at the annual meeting of the Society of Thoracic Surgeons.

This retrospective review identified all adults (patients greater than 18 years of age) who underwent post-MI VSD repair between 1999 and 2010. The primary outcome measure was operative mortality and patients with congenital VSD were excluded.

"This largest to date study examining post-MI VSD repair was done in part to provide a surgical benchmark for future comparisons as percutaneous closure devices emerge to treat this condition," noted Dr. Arnaoutakis of the division of cardiac surgery at Johns Hopkins University, Baltimore.

The demographics of the 2,876 patients included in the study were a mean age of 68 years; 56.5% of the patients were men; and 7.5% of patients had prior coronary artery bypass grafting (CABG) surgery. Operative characteristics included preoperative support with an intraaortic balloon pump (65%); urgent status (35%); emergent status (49.7%); and concomitant CABG (63.9%).

Timing of surgery was found to be an important predictor of risk, with 54% mortality occurring in patients who had repair less than 7 days after MI, and 18% mortality in those patients who had their surgery greater than 7 days after MI. Multivariate analysis also showed that the timing of MI with relation to VSD repair was independently associated with operative mortality.

Overall, major morbidity and mortality was high, at nearly 77%. Other surgical characteristics significantly associated with higher mortality included longer cardiopulmonary bypass time, preoperative dialysis, emergent surgery, and shock.

"Ventricular septal rupture remains a devastating complication after myocardial infarction," he said, with a shorter time interval between MI and surgical repair of the VSD, being highly associated with operative mortality, Dr Arnaoutakis summarized.

He did point out that one flaw in this study based on the STS Database was that it could not account for patients who died while waiting for VSD repair, which might influence the results. In addition the overall incidence of acquired VSD was too low to determine the effect of individual surgeon or center volume on mortality rates.

Dr. Arnaoutakis agreed with audience suggestions that given the high overall mortality rate of surgical VSD closure, perhaps consideration of the new percutaneous closure devices and the possibility of ventricular assist device support might be reasonable options.

Dr. Arnaoutakis reported having no financial conflicts. Another researcher on the project reported research support from HeartWare International Inc. and Thoratec Corp.

FT. LAUDERDALE, FLA – Early repair – within one week – of acquired ventral septal defect in patients with myocardial infarction was associated with a significantly higher mortality rate than was later repair in a retrospective review.

Acquired ventral septal defect (VSD), a relatively rare but devastating complication of myocardial infarction, frequently leads to cardiogenic shock and death. Surgical repair is generally required, although there is a high mortality.

To identify risk factors for poor patient outcomes, a study of the Society for Thoracic Surgeons National Database was performed to characterize patients undergoing post-MI VSD surgical repair, Dr. George J. Arnaoutakis said at the annual meeting of the Society of Thoracic Surgeons.

This retrospective review identified all adults (patients greater than 18 years of age) who underwent post-MI VSD repair between 1999 and 2010. The primary outcome measure was operative mortality and patients with congenital VSD were excluded.

"This largest to date study examining post-MI VSD repair was done in part to provide a surgical benchmark for future comparisons as percutaneous closure devices emerge to treat this condition," noted Dr. Arnaoutakis of the division of cardiac surgery at Johns Hopkins University, Baltimore.

The demographics of the 2,876 patients included in the study were a mean age of 68 years; 56.5% of the patients were men; and 7.5% of patients had prior coronary artery bypass grafting (CABG) surgery. Operative characteristics included preoperative support with an intraaortic balloon pump (65%); urgent status (35%); emergent status (49.7%); and concomitant CABG (63.9%).

Timing of surgery was found to be an important predictor of risk, with 54% mortality occurring in patients who had repair less than 7 days after MI, and 18% mortality in those patients who had their surgery greater than 7 days after MI. Multivariate analysis also showed that the timing of MI with relation to VSD repair was independently associated with operative mortality.

Overall, major morbidity and mortality was high, at nearly 77%. Other surgical characteristics significantly associated with higher mortality included longer cardiopulmonary bypass time, preoperative dialysis, emergent surgery, and shock.

"Ventricular septal rupture remains a devastating complication after myocardial infarction," he said, with a shorter time interval between MI and surgical repair of the VSD, being highly associated with operative mortality, Dr Arnaoutakis summarized.

He did point out that one flaw in this study based on the STS Database was that it could not account for patients who died while waiting for VSD repair, which might influence the results. In addition the overall incidence of acquired VSD was too low to determine the effect of individual surgeon or center volume on mortality rates.

Dr. Arnaoutakis agreed with audience suggestions that given the high overall mortality rate of surgical VSD closure, perhaps consideration of the new percutaneous closure devices and the possibility of ventricular assist device support might be reasonable options.

Dr. Arnaoutakis reported having no financial conflicts. Another researcher on the project reported research support from HeartWare International Inc. and Thoratec Corp.

FT. LAUDERDALE, FLA – Early repair – within one week – of acquired ventral septal defect in patients with myocardial infarction was associated with a significantly higher mortality rate than was later repair in a retrospective review.

Acquired ventral septal defect (VSD), a relatively rare but devastating complication of myocardial infarction, frequently leads to cardiogenic shock and death. Surgical repair is generally required, although there is a high mortality.

To identify risk factors for poor patient outcomes, a study of the Society for Thoracic Surgeons National Database was performed to characterize patients undergoing post-MI VSD surgical repair, Dr. George J. Arnaoutakis said at the annual meeting of the Society of Thoracic Surgeons.

This retrospective review identified all adults (patients greater than 18 years of age) who underwent post-MI VSD repair between 1999 and 2010. The primary outcome measure was operative mortality and patients with congenital VSD were excluded.

"This largest to date study examining post-MI VSD repair was done in part to provide a surgical benchmark for future comparisons as percutaneous closure devices emerge to treat this condition," noted Dr. Arnaoutakis of the division of cardiac surgery at Johns Hopkins University, Baltimore.

The demographics of the 2,876 patients included in the study were a mean age of 68 years; 56.5% of the patients were men; and 7.5% of patients had prior coronary artery bypass grafting (CABG) surgery. Operative characteristics included preoperative support with an intraaortic balloon pump (65%); urgent status (35%); emergent status (49.7%); and concomitant CABG (63.9%).

Timing of surgery was found to be an important predictor of risk, with 54% mortality occurring in patients who had repair less than 7 days after MI, and 18% mortality in those patients who had their surgery greater than 7 days after MI. Multivariate analysis also showed that the timing of MI with relation to VSD repair was independently associated with operative mortality.

Overall, major morbidity and mortality was high, at nearly 77%. Other surgical characteristics significantly associated with higher mortality included longer cardiopulmonary bypass time, preoperative dialysis, emergent surgery, and shock.

"Ventricular septal rupture remains a devastating complication after myocardial infarction," he said, with a shorter time interval between MI and surgical repair of the VSD, being highly associated with operative mortality, Dr Arnaoutakis summarized.

He did point out that one flaw in this study based on the STS Database was that it could not account for patients who died while waiting for VSD repair, which might influence the results. In addition the overall incidence of acquired VSD was too low to determine the effect of individual surgeon or center volume on mortality rates.

Dr. Arnaoutakis agreed with audience suggestions that given the high overall mortality rate of surgical VSD closure, perhaps consideration of the new percutaneous closure devices and the possibility of ventricular assist device support might be reasonable options.

Dr. Arnaoutakis reported having no financial conflicts. Another researcher on the project reported research support from HeartWare International Inc. and Thoratec Corp.