Congenital Heart Disease

LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.

During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.

"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.

Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA₂D₂-VASc score was 3.1.

During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.

Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA₂D₂-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.

The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.

The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.

Dr. DeSimone had no disclosures.

m.zoler@elsevier.com

LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.

During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.

"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.

Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA₂D₂-VASc score was 3.1.

During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.

Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA₂D₂-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.

The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.

The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.

Dr. DeSimone had no disclosures.

m.zoler@elsevier.com

LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.

During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.

"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.

Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA₂D₂-VASc score was 3.1.

During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.

Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA₂D₂-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.

The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.

The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.

Dr. DeSimone had no disclosures.

m.zoler@elsevier.com

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the AATS annual meeting was any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided an overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a comparison of 549 infants who were randomized to a modified BT or RV-PA shunt; the study revealed a 10% survival advantage for the RV-PA patients at 1 year (N. Engl. J. Med. 2010;362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BT shunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, of the Children’s Hospital of Philadelphia (CHOP). "Most of the benefit of the RV-PA is in the early interstage period." He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points,"it may be time for a new trial."

Dr. Gaynor said he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV-PA may have some advantages for high-risk subgroups, but more data are needed.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "Ultimately, it’s really not about which of these procedures is better, ... but which is better for which subcategory of patient," he added.

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

FT. LAUDERDALE, FLA. – Sex and race appear to play a role in outcomes following congenital heart surgery in children and adolescents, according to a new analysis of data from almost 21,000 patients.

Black patients had significantly greater rates of mortality and complications and a significantly longer length of postoperative stay than other races, while female patients had a significantly shorter length of stay than males, Dr. Daniel J. DiBardino reported at the annual meeting of the Society of Thoracic Surgeons.

"The analysis of demographic and clinical data from nearly 21,000 patients in the congenital heart surgery database revealed important associations between gender, race, and outcome," said Dr. DiBardino, who is a cardiac surgeon at the Blair E. Batson Children’s Hospital in Jackson, Miss.

Dr. DiBardino’s study was chosen as a 2011 Richard E. Clark Paper by the Society of Thoracic Surgeons.

The researchers used data from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). Patients were included in the analysis if they were less than 18 years of age and had undergone cardiac surgery between 2007 and 2009.

Exclusion criteria included centers with more than 15% of data missing for key variables and centers with very small samples (less than five cases).

Data collection included demographics (age, sex, weight, and race) and preoperative data (noncardiac/genetic abnormalities and STS-defined risk factors). Race was classified as white, black, Hispanic, and other.

Operations were classified by STAT Mortality category, which is "a complexity stratification tool based on empiric data from 80,000 cases in STS and EACTS (European Association for Cardio-Thoracic Surgery) databases," said Dr. DiBardino.

The researchers looked at hospital mortality, postoperative length of stay, and complications. Multivariable analyses included dichotomous variables (mortality, complications) and a continuous variable (postoperative length of stay). Models were adjusted for age, weight, noncardiac/genetic abnormalities, any other STS preoperative risk factor, and STAT Mortality category.

In all, 20,399 patients were included from 49 centers. Of these, 54% were male. In terms of race, 55% were white, 17% were black, 16% were Hispanic, and 12% were other.

Based on unadjusted outcomes, there were no differences between the sexes for in-hospital mortality or complications. However, females had significantly shorter postoperative stays. In terms of race, white patients had significantly lower mortality, shorter length of stay, and fewer complications than any of the other racial groups.

In the adjusted multivariate analysis, there was no difference for mortality between the sexes. However, black patients had a significantly greater mortality risk with an odds ratio of 1.67.

Females did have a significantly shorter mean length of stay – 0.8 fewer days. In terms of race, black patients had a significantly longer mean length of stay by 2.4 hospital days, compared with white patients. Hispanic patients also had a significantly longer mean length of stay by almost 1 hospital day.

There was no difference between the sexes in terms of the occurrence of complications. In terms of race, "black patients experienced significantly more complications than other races with an odds ratio of 1.15," according to Dr. DiBardino.

The study is unique with the respect to the use of multivariable models. The researchers measured the association of sex and race with outcomes within each center and then combined the results, in order to mitigate the potential center effects.

"Our results cannot be explained by the possibility that patients of certain races might be disproportionately treated at centers with poorer outcomes in general."

The evaluation of complex relationships between clinical variables and socioeconomic and other factors affecting health care remains a significant challenge.

Since some pertinent socioeconomic data are not collected in the STS-CHSD, an analysis of a linked data set, which capitalizes on the strengths of both the CHSD and those of an administrative claims data set may be the next logical step, said Dr. DiBardino.

Dr. DiBardino and his coinvestigators reported that they have no relevant disclosures.

PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

LOS ANGELES – For the first time, a pediatric stroke severity scale has been validated in a prospective clinical trial.

The study in 15 North American medical centers showed excellent interrater reliability when neurologists used a pediatric version of the National Institutes of Health Stroke Scale for adults to examine children aged 2-18 years with acute arterial ischemic stroke.

The neurologists used the Pediatric NIH Stroke Scale (PedNIHSS) on 113 patients who were examined daily from admission to discharge, or through day 7 of hospitalization.

Interrater reliability was tested in a subset of 25 patients who underwent simultaneous examinations by two pediatric neurologists.

Characteristics of the subgroup were similar to those of the entire cohort, Dr. Rebecca N. Ichord reported at the International Stroke Conference.

The simultaneous raters’ scores were identical in 60% of ratings and were within a 1-point difference in 84% of ratings (Stroke 2011;42:613-7).

Research into potential ways of preventing or treating childhood stroke has been stymied in the past by the lack of a validated and reliable pediatric stroke scale.

The PedNIHSS provides a way to index the severity of a child’s stroke, to make comparisons across treatment groups, and to get a baseline for predicting outcome, said Dr. Ichord, director of the pediatric stroke program at the Children’s Hospital of Philadelphia.

Clinicians, too, have been hungering for such a scale. "I have been asked over and over again [for a pediatric stroke scale] by clinicians who want to have a method of describing the severity of a child’s stroke," she said at the meeting, which was sponsored by the American Heart Association.

"It helps them with clinical decision making. It helps them to prepare parents and counsel parents. It helps to guide them as to how quickly and how urgently the child’s care should move forward. [Such a scale] is absolutely needed and wanted right now by clinicians on the front line," according to Dr. Ichord.

Characteristics of the patients and the strokes in the study were similar to those reported in previous pediatric stroke cohort studies, which suggests the current findings are generalizable and the PedNIHSS should be applicable in other settings.

Because all of the raters in the current study were pediatric neurologists or trainees, a separate study is needed to assess the PedNIHSS in the hands of other specialists, Dr. Ichord said.

The interrater reliability in the study compared favorably with that seen in studies of the adult NIHSS.

The pediatric version also found good interrater reliability for facial weakness, dysarthria, and ataxia, which was not seen with the adult stroke scale. The reasons for this difference are unclear.

The PedNIHSS was drafted by a consensus panel of pediatric and adult stroke experts. They limited the use of the pediatric scale to ages 2-18 years because younger children have limited language abilities, which are needed for use of the PedNIHSS.

Neonates and children younger than 2 years of age with acute ischemic stroke also frequently present without focal deficits, and so may require a scale with less emphasis on focal sensorimotor deficits, the investigators suggested.

A study is underway to compare PedNIHSS scores with infarct volume and with functional outcomes at 3 and 12 months.

Stroke affects 25 in 100,000 newborns and 12 in 100,000 children under 18 years of age. It is the sixth leading cause of death in children, according to the PedNIHSS Web site.

Ischemic stroke, in particular, is one of the top 10 causes of death among children, affecting 1.2-7.9 per 100,000 children aged 1 month to 18 years in North America and Europe, the investigators noted. Some 40%-60% of survivors are left with long-term motor and cognitive deficits that interfere with function.

Dr. Ichord and one of her associates in the study are on the clinical event committee for the Berlin Heart Trial for pediatric ventricular assist devices.

LOS ANGELES – For the first time, a pediatric stroke severity scale has been validated in a prospective clinical trial.

The study in 15 North American medical centers showed excellent interrater reliability when neurologists used a pediatric version of the National Institutes of Health Stroke Scale for adults to examine children aged 2-18 years with acute arterial ischemic stroke.

The neurologists used the Pediatric NIH Stroke Scale (PedNIHSS) on 113 patients who were examined daily from admission to discharge, or through day 7 of hospitalization.

Interrater reliability was tested in a subset of 25 patients who underwent simultaneous examinations by two pediatric neurologists.

Characteristics of the subgroup were similar to those of the entire cohort, Dr. Rebecca N. Ichord reported at the International Stroke Conference.

The simultaneous raters’ scores were identical in 60% of ratings and were within a 1-point difference in 84% of ratings (Stroke 2011;42:613-7).

Research into potential ways of preventing or treating childhood stroke has been stymied in the past by the lack of a validated and reliable pediatric stroke scale.

The PedNIHSS provides a way to index the severity of a child’s stroke, to make comparisons across treatment groups, and to get a baseline for predicting outcome, said Dr. Ichord, director of the pediatric stroke program at the Children’s Hospital of Philadelphia.

Clinicians, too, have been hungering for such a scale. "I have been asked over and over again [for a pediatric stroke scale] by clinicians who want to have a method of describing the severity of a child’s stroke," she said at the meeting, which was sponsored by the American Heart Association.

"It helps them with clinical decision making. It helps them to prepare parents and counsel parents. It helps to guide them as to how quickly and how urgently the child’s care should move forward. [Such a scale] is absolutely needed and wanted right now by clinicians on the front line," according to Dr. Ichord.

Characteristics of the patients and the strokes in the study were similar to those reported in previous pediatric stroke cohort studies, which suggests the current findings are generalizable and the PedNIHSS should be applicable in other settings.

Because all of the raters in the current study were pediatric neurologists or trainees, a separate study is needed to assess the PedNIHSS in the hands of other specialists, Dr. Ichord said.

The interrater reliability in the study compared favorably with that seen in studies of the adult NIHSS.

The pediatric version also found good interrater reliability for facial weakness, dysarthria, and ataxia, which was not seen with the adult stroke scale. The reasons for this difference are unclear.

The PedNIHSS was drafted by a consensus panel of pediatric and adult stroke experts. They limited the use of the pediatric scale to ages 2-18 years because younger children have limited language abilities, which are needed for use of the PedNIHSS.

Neonates and children younger than 2 years of age with acute ischemic stroke also frequently present without focal deficits, and so may require a scale with less emphasis on focal sensorimotor deficits, the investigators suggested.

A study is underway to compare PedNIHSS scores with infarct volume and with functional outcomes at 3 and 12 months.

Stroke affects 25 in 100,000 newborns and 12 in 100,000 children under 18 years of age. It is the sixth leading cause of death in children, according to the PedNIHSS Web site.

Ischemic stroke, in particular, is one of the top 10 causes of death among children, affecting 1.2-7.9 per 100,000 children aged 1 month to 18 years in North America and Europe, the investigators noted. Some 40%-60% of survivors are left with long-term motor and cognitive deficits that interfere with function.

Dr. Ichord and one of her associates in the study are on the clinical event committee for the Berlin Heart Trial for pediatric ventricular assist devices.

LOS ANGELES – For the first time, a pediatric stroke severity scale has been validated in a prospective clinical trial.

The study in 15 North American medical centers showed excellent interrater reliability when neurologists used a pediatric version of the National Institutes of Health Stroke Scale for adults to examine children aged 2-18 years with acute arterial ischemic stroke.

The neurologists used the Pediatric NIH Stroke Scale (PedNIHSS) on 113 patients who were examined daily from admission to discharge, or through day 7 of hospitalization.

Interrater reliability was tested in a subset of 25 patients who underwent simultaneous examinations by two pediatric neurologists.

Characteristics of the subgroup were similar to those of the entire cohort, Dr. Rebecca N. Ichord reported at the International Stroke Conference.

The simultaneous raters’ scores were identical in 60% of ratings and were within a 1-point difference in 84% of ratings (Stroke 2011;42:613-7).

Research into potential ways of preventing or treating childhood stroke has been stymied in the past by the lack of a validated and reliable pediatric stroke scale.

The PedNIHSS provides a way to index the severity of a child’s stroke, to make comparisons across treatment groups, and to get a baseline for predicting outcome, said Dr. Ichord, director of the pediatric stroke program at the Children’s Hospital of Philadelphia.

Clinicians, too, have been hungering for such a scale. "I have been asked over and over again [for a pediatric stroke scale] by clinicians who want to have a method of describing the severity of a child’s stroke," she said at the meeting, which was sponsored by the American Heart Association.

"It helps them with clinical decision making. It helps them to prepare parents and counsel parents. It helps to guide them as to how quickly and how urgently the child’s care should move forward. [Such a scale] is absolutely needed and wanted right now by clinicians on the front line," according to Dr. Ichord.

Characteristics of the patients and the strokes in the study were similar to those reported in previous pediatric stroke cohort studies, which suggests the current findings are generalizable and the PedNIHSS should be applicable in other settings.

Because all of the raters in the current study were pediatric neurologists or trainees, a separate study is needed to assess the PedNIHSS in the hands of other specialists, Dr. Ichord said.

The interrater reliability in the study compared favorably with that seen in studies of the adult NIHSS.

The pediatric version also found good interrater reliability for facial weakness, dysarthria, and ataxia, which was not seen with the adult stroke scale. The reasons for this difference are unclear.

The PedNIHSS was drafted by a consensus panel of pediatric and adult stroke experts. They limited the use of the pediatric scale to ages 2-18 years because younger children have limited language abilities, which are needed for use of the PedNIHSS.

Neonates and children younger than 2 years of age with acute ischemic stroke also frequently present without focal deficits, and so may require a scale with less emphasis on focal sensorimotor deficits, the investigators suggested.

A study is underway to compare PedNIHSS scores with infarct volume and with functional outcomes at 3 and 12 months.

Stroke affects 25 in 100,000 newborns and 12 in 100,000 children under 18 years of age. It is the sixth leading cause of death in children, according to the PedNIHSS Web site.

Ischemic stroke, in particular, is one of the top 10 causes of death among children, affecting 1.2-7.9 per 100,000 children aged 1 month to 18 years in North America and Europe, the investigators noted. Some 40%-60% of survivors are left with long-term motor and cognitive deficits that interfere with function.

Dr. Ichord and one of her associates in the study are on the clinical event committee for the Berlin Heart Trial for pediatric ventricular assist devices.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - More and more patients with congenital heart disease are surviving into adulthood, resulting in a growing number of operations performed to repair adult congenital heart disease (ACHD). Many of these patients also have atherosclerotic coronary artery disease that may need to be addressed at the time of ACHD surgery, but data on the prevalence of coronary artery disease in this population, as well as outcomes after such surgery, are limited.

To address this issue, Dr. John M. Stulak of the Mayo Medical School, Rochester, Minn., and his associates conducted a study of 122 patients (77 male) who underwent concomitant coronary artery bypass grafting (CABG) for atherosclerotic coronary artery disease (CAD) at the time of ACHD repair. Dr. Stulak presented the results at the annual meeting of the Society of Thoracic Surgeons.

Dr. Stulak noted that, based on his findings, "Concomitant CABG may be required at the time of repair of ACHD. Disease of the LAD [left anterior descending coronary artery] is most common, and survival is higher when a LIMA [left internal mammary artery] graft is used. Late functional outcome is good with a low incidence of late angina, MI, or the need for percutaneous coronary intervention."

The patients, mean age 64 years, had surgery between February 1972 and August 2009. A total of 25% had angina, 6% had prior myocardial infarction, and 5% had previous percutaneous intervention.

The most common primary cardiac diagnoses were secundum atrial septal defect (ASD) in 60%, Ebstein anomaly in 11%, partial anomalous pulmonary venous connection (PAPVC) in 7%, and ventricular septal defect (VSD) in 6%. A total of 17% of the patients had a prior cardiac operation.
 
The most common operations included ASD repair in 64%; tricuspid valve surgery (11%), pulmonary valve surgery (8%), VSD repair (8%), and PAPVC repair (7%). A single bypass graft was performed in 69 patients, 2 grafts in 32 patients, 3 grafts in 14 patients, 4 grafts in 5 patients, and 5 grafts in 2 patients. The LIMA was used in 57 of 82 patients (70%) with LAD disease.

The median follow-up was 6 years for 111 available patients. During that time, recurrent CAD was reported in 9 patients (8%); 8 patients (7%) had angina, and 5 (4%) had an MI. Six (5%) patients underwent intervention. All but 11 patients achieved NYHA functional class 1 or 2. The overall survival observed was 76% at 5 years, 56% at 10 years, and 33% at 15 years. In those patients with LAD disease, 10-year survival was significantly higher when LIMA was used (66% vs. 36%).

Dr. Stulak added the importance of this study is also to stress that each treatment approach should be individualized whether it is conventional CABG, off-pump CABG, or a staged hybrid technique with percutaneous coronary intervention for CAD.

Dr. Stulak and his colleagues had no disclosures.

SAN DIEGO - Over the past 24 years, the prevalence of indications for pediatric heart transplantation resulting from congenital heart disease has changed. Transplantation for failed SV palliation, including failed Fontan procedure, has now become the predominant indication, according to the observations of a single-center experience reported in the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons.

Heart transplantation is the only viable treatment for children with end-stage heart failure resulting from either congenital heart disease (CHD) or cardiomyopathy. The purpose of this study by Dr. Rochus K. Voeller and his colleagues at Washington University in St. Louis was to review the trends in the indications for transplant and survival following transplant, using a retrospective review of all 307 orthotopic heart transplants performed at St. Louis Children's Hospital from January 1986 to December 2009. Combined heart-lung transplants were excluded from the study.

The indications for transplantation in 1986-2009 were 39% cardiomyopathy, 57% CHD, and 4% retransplant. Of the 174 patients with CHD, 80% had single-ventricle anomalies (SV). In the CHD group, transplantation for failed SV palliation, including the failed Fontan procedure, became the predominant indication in the latest 8-year interval of their program (increasing from 11% in the 1984-1993 period to 60% in the 2002-2009 period). The rate of retransplantation remained low and unchanged across the various time periods, according to Dr. Voeller.

The mean recipient age was 6.1 years, with 41% of the recipients aged younger than 1 year at the time of transplantation. Nearly one-third of all patients had prior surgical procedures or surgery ranging from banding to Fontan operations; 55% of the patients were boys; 8% of patients were bridged with either ECMO (extracorporeal circulation membrane oxygenation) or VAD (ventricular assist devices).

Overall survival of transplant patients was 81%, 76%, 72%, and 65% at 1, 3, 5, and 10 years, respectively. Survival was best in those patients who were transplanted for cardiomyopathy (1-, 3-, 5-, and 10-year survival of 90%, 84%, 81%, and 81%, respectively) and worst in patients with failed palliations for SV anomalies, especially failed Fontan procedures (1-, 3-, 5-, and 10-year survival of 66%, 61%, 61%, and 53%, respectively).

"Our results demonstrate the high-risk nature of transplants in patients with failed palliations for SV anomalies, including Fontan procedures performed during infancy. As the survival with early palliation for SV anomaly patients improves, more centers will be referred with these patients who will require transplantation at some point," said Dr. Voeller in an interview.

"This will not only impact pediatric heart transplant programs, but it will also influence adult transplant programs as well. Patients following SV palliation, including Fontan procedure, are much more difficult patients to transplant because of a variety of factors. Risk factor analysis will be needed to determine which patients might benefit from earlier transplant referral and how to better prepare these patient for transplant in order to reduce the risk of the procedure," he concluded.

Dr. Voeller reported that none of the authors had any financial disclosures.

SAN DIEGO - Over the past 24 years, the prevalence of indications for pediatric heart transplantation resulting from congenital heart disease has changed. Transplantation for failed SV palliation, including failed Fontan procedure, has now become the predominant indication, according to the observations of a single-center experience reported in the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons.

Heart transplantation is the only viable treatment for children with end-stage heart failure resulting from either congenital heart disease (CHD) or cardiomyopathy. The purpose of this study by Dr. Rochus K. Voeller and his colleagues at Washington University in St. Louis was to review the trends in the indications for transplant and survival following transplant, using a retrospective review of all 307 orthotopic heart transplants performed at St. Louis Children's Hospital from January 1986 to December 2009. Combined heart-lung transplants were excluded from the study.

The indications for transplantation in 1986-2009 were 39% cardiomyopathy, 57% CHD, and 4% retransplant. Of the 174 patients with CHD, 80% had single-ventricle anomalies (SV). In the CHD group, transplantation for failed SV palliation, including the failed Fontan procedure, became the predominant indication in the latest 8-year interval of their program (increasing from 11% in the 1984-1993 period to 60% in the 2002-2009 period). The rate of retransplantation remained low and unchanged across the various time periods, according to Dr. Voeller.

The mean recipient age was 6.1 years, with 41% of the recipients aged younger than 1 year at the time of transplantation. Nearly one-third of all patients had prior surgical procedures or surgery ranging from banding to Fontan operations; 55% of the patients were boys; 8% of patients were bridged with either ECMO (extracorporeal circulation membrane oxygenation) or VAD (ventricular assist devices).

Overall survival of transplant patients was 81%, 76%, 72%, and 65% at 1, 3, 5, and 10 years, respectively. Survival was best in those patients who were transplanted for cardiomyopathy (1-, 3-, 5-, and 10-year survival of 90%, 84%, 81%, and 81%, respectively) and worst in patients with failed palliations for SV anomalies, especially failed Fontan procedures (1-, 3-, 5-, and 10-year survival of 66%, 61%, 61%, and 53%, respectively).

"Our results demonstrate the high-risk nature of transplants in patients with failed palliations for SV anomalies, including Fontan procedures performed during infancy. As the survival with early palliation for SV anomaly patients improves, more centers will be referred with these patients who will require transplantation at some point," said Dr. Voeller in an interview.

"This will not only impact pediatric heart transplant programs, but it will also influence adult transplant programs as well. Patients following SV palliation, including Fontan procedure, are much more difficult patients to transplant because of a variety of factors. Risk factor analysis will be needed to determine which patients might benefit from earlier transplant referral and how to better prepare these patient for transplant in order to reduce the risk of the procedure," he concluded.

Dr. Voeller reported that none of the authors had any financial disclosures.

SAN DIEGO - Over the past 24 years, the prevalence of indications for pediatric heart transplantation resulting from congenital heart disease has changed. Transplantation for failed SV palliation, including failed Fontan procedure, has now become the predominant indication, according to the observations of a single-center experience reported in the J. Maxwell Chamberlain Memorial Paper for Congenital Heart Surgery at the annual meeting of the Society of Thoracic Surgeons.

Heart transplantation is the only viable treatment for children with end-stage heart failure resulting from either congenital heart disease (CHD) or cardiomyopathy. The purpose of this study by Dr. Rochus K. Voeller and his colleagues at Washington University in St. Louis was to review the trends in the indications for transplant and survival following transplant, using a retrospective review of all 307 orthotopic heart transplants performed at St. Louis Children's Hospital from January 1986 to December 2009. Combined heart-lung transplants were excluded from the study.

The indications for transplantation in 1986-2009 were 39% cardiomyopathy, 57% CHD, and 4% retransplant. Of the 174 patients with CHD, 80% had single-ventricle anomalies (SV). In the CHD group, transplantation for failed SV palliation, including the failed Fontan procedure, became the predominant indication in the latest 8-year interval of their program (increasing from 11% in the 1984-1993 period to 60% in the 2002-2009 period). The rate of retransplantation remained low and unchanged across the various time periods, according to Dr. Voeller.

The mean recipient age was 6.1 years, with 41% of the recipients aged younger than 1 year at the time of transplantation. Nearly one-third of all patients had prior surgical procedures or surgery ranging from banding to Fontan operations; 55% of the patients were boys; 8% of patients were bridged with either ECMO (extracorporeal circulation membrane oxygenation) or VAD (ventricular assist devices).

Overall survival of transplant patients was 81%, 76%, 72%, and 65% at 1, 3, 5, and 10 years, respectively. Survival was best in those patients who were transplanted for cardiomyopathy (1-, 3-, 5-, and 10-year survival of 90%, 84%, 81%, and 81%, respectively) and worst in patients with failed palliations for SV anomalies, especially failed Fontan procedures (1-, 3-, 5-, and 10-year survival of 66%, 61%, 61%, and 53%, respectively).

"Our results demonstrate the high-risk nature of transplants in patients with failed palliations for SV anomalies, including Fontan procedures performed during infancy. As the survival with early palliation for SV anomaly patients improves, more centers will be referred with these patients who will require transplantation at some point," said Dr. Voeller in an interview.

"This will not only impact pediatric heart transplant programs, but it will also influence adult transplant programs as well. Patients following SV palliation, including Fontan procedure, are much more difficult patients to transplant because of a variety of factors. Risk factor analysis will be needed to determine which patients might benefit from earlier transplant referral and how to better prepare these patient for transplant in order to reduce the risk of the procedure," he concluded.

Dr. Voeller reported that none of the authors had any financial disclosures.