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Concerns with delayed right ventricle dysfunction have offset the early survival advantages after Norwood procedure with right ventricle to pulmonary artery conduit (NW-RVPA) over the Norwood with Blalock-Taussig shunt (NW-BT) in newborns with left ventricular outflow tract obstruction, but a recent report provides evidence that RV function between the two procedures is comparable for up to six years.
Reporting in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015 Dec;150:1440–52), investigators for the Congenital Heart Surgeons’ Society (CHSS) trial found that NW-RVPA has better overall six-year survival and superior right ventricle function in the short term after surgery than NW-BT. The study involved 454 newborns with critical left ventricular outflow tract obstruction (LVOTO) in the CHSS database who had Norwood stage-1 from 2005 to 2014. Propensity matching paired 169 NW-RVPA patients with the same number of NW-BT patients for comparison. CHSS along with the Hospital for Sick Children in Toronto provided funding for the study.
“For neonates with critical LVOTO and similar baseline characteristics undergoing a Norwood stage-1 operation, the six-year overall survival and transplant-free survival were significantly better after NW-RVPA vs. NW-BT,” said Dr. Travis J. Wilder and his colleagues from the Hospital for Sick Children in Toronto.
Key questions the study sought to answer involved the clinical implications of the small variations in RV function between the two procedures, as well as the association between Norwood procedures and tricuspid valve regurgitation (TR) and overall survival.
Overall six-year survival was 70% for the NW-RVPA group vs. 55% for the NW-BT group. Right ventricle dysfunction rates three months after the procedure were lower for the NW-RVPA group, 6% vs. 16%, but rates of late RV dysfunction were less than 5% for both groups. Likewise, rates of moderate or greater TR at two years were lower in the NW-RVPA group: 11% vs. 16%.
Rates of Fontan operation after six years were higher among the NW-RVPA group (54% vs. 49%), as were transplantation rates (6% vs. 2%). Overall, 2% converted to a biventricular repair, but only after NW-RVPA; and seven patients who had NW-RVPA underwent a tricuspid valve repair, compared with four in the NW-BT group.
“For all survivors not undergoing transplantation or biventricular repair, the prevalence of late moderate or greater RV dysfunction and TR were similar between NW-BT and NW-RVPA at six years, without evidence of increased RV dysfunction for patients who underwent NW-RVPA,” Dr. Wilder and his colleagues said.
Consistent with previous studies, the CHSS study showed an early risk of death after a Norwood stage-1 operation, which may be due to a greater prevalence of significant RV dysfunction as the operation transitions from stage 1 to stage 2, Dr. Wilder and his coauthors said. “Although causation between these two time-related events cannot directly be made, it suggests that poor RV function contributes to early hazard for death,” they said.
The authors acknowledge a number of limitations with their study: the variation in the quality of echocardiogram reports from the multiple institutions involved, the inability of propensity matching to account for unmeasured factors and the influence of center and surgeon volume among participating sites. They also said that the ventriculotomy the NW-RVPA involves can lead to late aneurysm, arrhythmias, and ventricular failure. The adverse effects of ventriculotomy on long-term RV function “may not become apparent for years,” Dr. Wilder and his coauthors said.
Dr. Wilder presented a report of the original results at the 2015 American Association for Thoracic Surgery Annual meeting.
The authors had no relationships to disclose.
“It is time to have the courage to confess that we need a more overarching quality improvement strategy,” Dr. James S. Tweddell of the Children’s Hospital of Wisconsin said of the results of the Congenital Heart Surgeons’ Society (CHSS) study in his invited commentary (J Thorac Cardiovasc Surg. 2015 Dec;150:1453–4).
Dr. Tweddell said the findings of the CHSS study and the earlier Single Ventricle Reconstruction (SVR) trial (N Engl J Med. 2010;362:1980-1992) are similar in terms of transplant-free survival in newborns. And while the dates of the studies’ enrollments overlap – 2005-2008 for SVR and 2005-2014 for CHSS – the more recent findings of the CHSS study would imply an advantage in terms of survival and right ventricle function. Nonetheless, the survival rates are similar, he said. “Only about 60% of patients remain alive.”
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Dr. James S. Tweddell |
Dr. Tweddell pointed out the CHSS study is not a randomized, controlled trial, “and the shortcomings of the prospective observational study are well known.”
In calling for a “more overarching” quality improvement measure, Dr. Tweddell said that many programs use Norwood performance as a benchmark for outcomes. He proposed collaboration among high and low performing centers, imitating the adult cardiology model. He also suggested consolidation of programs performing the Norwood procedure to eliminate low-volume centers and develop centers of excellence. “The outcome of the Norwood procedure is dependent on both program and surgeon volume,” Dr. Tweddell said.
The CHSS study “is important and identifies a potentially durable benefit to the NW-RVPA,” Dr. Tweddell said, “but perhaps now is the time to focus on strategies between programs rather than solely within programs.”
“It is time to have the courage to confess that we need a more overarching quality improvement strategy,” Dr. James S. Tweddell of the Children’s Hospital of Wisconsin said of the results of the Congenital Heart Surgeons’ Society (CHSS) study in his invited commentary (J Thorac Cardiovasc Surg. 2015 Dec;150:1453–4).
Dr. Tweddell said the findings of the CHSS study and the earlier Single Ventricle Reconstruction (SVR) trial (N Engl J Med. 2010;362:1980-1992) are similar in terms of transplant-free survival in newborns. And while the dates of the studies’ enrollments overlap – 2005-2008 for SVR and 2005-2014 for CHSS – the more recent findings of the CHSS study would imply an advantage in terms of survival and right ventricle function. Nonetheless, the survival rates are similar, he said. “Only about 60% of patients remain alive.”
|
Dr. James S. Tweddell |
Dr. Tweddell pointed out the CHSS study is not a randomized, controlled trial, “and the shortcomings of the prospective observational study are well known.”
In calling for a “more overarching” quality improvement measure, Dr. Tweddell said that many programs use Norwood performance as a benchmark for outcomes. He proposed collaboration among high and low performing centers, imitating the adult cardiology model. He also suggested consolidation of programs performing the Norwood procedure to eliminate low-volume centers and develop centers of excellence. “The outcome of the Norwood procedure is dependent on both program and surgeon volume,” Dr. Tweddell said.
The CHSS study “is important and identifies a potentially durable benefit to the NW-RVPA,” Dr. Tweddell said, “but perhaps now is the time to focus on strategies between programs rather than solely within programs.”
“It is time to have the courage to confess that we need a more overarching quality improvement strategy,” Dr. James S. Tweddell of the Children’s Hospital of Wisconsin said of the results of the Congenital Heart Surgeons’ Society (CHSS) study in his invited commentary (J Thorac Cardiovasc Surg. 2015 Dec;150:1453–4).
Dr. Tweddell said the findings of the CHSS study and the earlier Single Ventricle Reconstruction (SVR) trial (N Engl J Med. 2010;362:1980-1992) are similar in terms of transplant-free survival in newborns. And while the dates of the studies’ enrollments overlap – 2005-2008 for SVR and 2005-2014 for CHSS – the more recent findings of the CHSS study would imply an advantage in terms of survival and right ventricle function. Nonetheless, the survival rates are similar, he said. “Only about 60% of patients remain alive.”
|
Dr. James S. Tweddell |
Dr. Tweddell pointed out the CHSS study is not a randomized, controlled trial, “and the shortcomings of the prospective observational study are well known.”
In calling for a “more overarching” quality improvement measure, Dr. Tweddell said that many programs use Norwood performance as a benchmark for outcomes. He proposed collaboration among high and low performing centers, imitating the adult cardiology model. He also suggested consolidation of programs performing the Norwood procedure to eliminate low-volume centers and develop centers of excellence. “The outcome of the Norwood procedure is dependent on both program and surgeon volume,” Dr. Tweddell said.
The CHSS study “is important and identifies a potentially durable benefit to the NW-RVPA,” Dr. Tweddell said, “but perhaps now is the time to focus on strategies between programs rather than solely within programs.”
Concerns with delayed right ventricle dysfunction have offset the early survival advantages after Norwood procedure with right ventricle to pulmonary artery conduit (NW-RVPA) over the Norwood with Blalock-Taussig shunt (NW-BT) in newborns with left ventricular outflow tract obstruction, but a recent report provides evidence that RV function between the two procedures is comparable for up to six years.
Reporting in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015 Dec;150:1440–52), investigators for the Congenital Heart Surgeons’ Society (CHSS) trial found that NW-RVPA has better overall six-year survival and superior right ventricle function in the short term after surgery than NW-BT. The study involved 454 newborns with critical left ventricular outflow tract obstruction (LVOTO) in the CHSS database who had Norwood stage-1 from 2005 to 2014. Propensity matching paired 169 NW-RVPA patients with the same number of NW-BT patients for comparison. CHSS along with the Hospital for Sick Children in Toronto provided funding for the study.
“For neonates with critical LVOTO and similar baseline characteristics undergoing a Norwood stage-1 operation, the six-year overall survival and transplant-free survival were significantly better after NW-RVPA vs. NW-BT,” said Dr. Travis J. Wilder and his colleagues from the Hospital for Sick Children in Toronto.
Key questions the study sought to answer involved the clinical implications of the small variations in RV function between the two procedures, as well as the association between Norwood procedures and tricuspid valve regurgitation (TR) and overall survival.
Overall six-year survival was 70% for the NW-RVPA group vs. 55% for the NW-BT group. Right ventricle dysfunction rates three months after the procedure were lower for the NW-RVPA group, 6% vs. 16%, but rates of late RV dysfunction were less than 5% for both groups. Likewise, rates of moderate or greater TR at two years were lower in the NW-RVPA group: 11% vs. 16%.
Rates of Fontan operation after six years were higher among the NW-RVPA group (54% vs. 49%), as were transplantation rates (6% vs. 2%). Overall, 2% converted to a biventricular repair, but only after NW-RVPA; and seven patients who had NW-RVPA underwent a tricuspid valve repair, compared with four in the NW-BT group.
“For all survivors not undergoing transplantation or biventricular repair, the prevalence of late moderate or greater RV dysfunction and TR were similar between NW-BT and NW-RVPA at six years, without evidence of increased RV dysfunction for patients who underwent NW-RVPA,” Dr. Wilder and his colleagues said.
Consistent with previous studies, the CHSS study showed an early risk of death after a Norwood stage-1 operation, which may be due to a greater prevalence of significant RV dysfunction as the operation transitions from stage 1 to stage 2, Dr. Wilder and his coauthors said. “Although causation between these two time-related events cannot directly be made, it suggests that poor RV function contributes to early hazard for death,” they said.
The authors acknowledge a number of limitations with their study: the variation in the quality of echocardiogram reports from the multiple institutions involved, the inability of propensity matching to account for unmeasured factors and the influence of center and surgeon volume among participating sites. They also said that the ventriculotomy the NW-RVPA involves can lead to late aneurysm, arrhythmias, and ventricular failure. The adverse effects of ventriculotomy on long-term RV function “may not become apparent for years,” Dr. Wilder and his coauthors said.
Dr. Wilder presented a report of the original results at the 2015 American Association for Thoracic Surgery Annual meeting.
The authors had no relationships to disclose.
Concerns with delayed right ventricle dysfunction have offset the early survival advantages after Norwood procedure with right ventricle to pulmonary artery conduit (NW-RVPA) over the Norwood with Blalock-Taussig shunt (NW-BT) in newborns with left ventricular outflow tract obstruction, but a recent report provides evidence that RV function between the two procedures is comparable for up to six years.
Reporting in the January issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015 Dec;150:1440–52), investigators for the Congenital Heart Surgeons’ Society (CHSS) trial found that NW-RVPA has better overall six-year survival and superior right ventricle function in the short term after surgery than NW-BT. The study involved 454 newborns with critical left ventricular outflow tract obstruction (LVOTO) in the CHSS database who had Norwood stage-1 from 2005 to 2014. Propensity matching paired 169 NW-RVPA patients with the same number of NW-BT patients for comparison. CHSS along with the Hospital for Sick Children in Toronto provided funding for the study.
“For neonates with critical LVOTO and similar baseline characteristics undergoing a Norwood stage-1 operation, the six-year overall survival and transplant-free survival were significantly better after NW-RVPA vs. NW-BT,” said Dr. Travis J. Wilder and his colleagues from the Hospital for Sick Children in Toronto.
Key questions the study sought to answer involved the clinical implications of the small variations in RV function between the two procedures, as well as the association between Norwood procedures and tricuspid valve regurgitation (TR) and overall survival.
Overall six-year survival was 70% for the NW-RVPA group vs. 55% for the NW-BT group. Right ventricle dysfunction rates three months after the procedure were lower for the NW-RVPA group, 6% vs. 16%, but rates of late RV dysfunction were less than 5% for both groups. Likewise, rates of moderate or greater TR at two years were lower in the NW-RVPA group: 11% vs. 16%.
Rates of Fontan operation after six years were higher among the NW-RVPA group (54% vs. 49%), as were transplantation rates (6% vs. 2%). Overall, 2% converted to a biventricular repair, but only after NW-RVPA; and seven patients who had NW-RVPA underwent a tricuspid valve repair, compared with four in the NW-BT group.
“For all survivors not undergoing transplantation or biventricular repair, the prevalence of late moderate or greater RV dysfunction and TR were similar between NW-BT and NW-RVPA at six years, without evidence of increased RV dysfunction for patients who underwent NW-RVPA,” Dr. Wilder and his colleagues said.
Consistent with previous studies, the CHSS study showed an early risk of death after a Norwood stage-1 operation, which may be due to a greater prevalence of significant RV dysfunction as the operation transitions from stage 1 to stage 2, Dr. Wilder and his coauthors said. “Although causation between these two time-related events cannot directly be made, it suggests that poor RV function contributes to early hazard for death,” they said.
The authors acknowledge a number of limitations with their study: the variation in the quality of echocardiogram reports from the multiple institutions involved, the inability of propensity matching to account for unmeasured factors and the influence of center and surgeon volume among participating sites. They also said that the ventriculotomy the NW-RVPA involves can lead to late aneurysm, arrhythmias, and ventricular failure. The adverse effects of ventriculotomy on long-term RV function “may not become apparent for years,” Dr. Wilder and his coauthors said.
Dr. Wilder presented a report of the original results at the 2015 American Association for Thoracic Surgery Annual meeting.
The authors had no relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOTHORACIC SURGERY
Key clinical point: For newborns with critical left ventricular outflow tract obstruction (LVOTO) undergoing Norwood stage-1 procedures, Norwood with right ventricle to pulmonary artery conduit (NW-RVPA) resulted in better survival and less short-term right-ventricle dysfunction than matched patients who had the Norwood procedure with Blalock-Taussig shunt (NW-BT).
Major finding: Overall six-year survival was 70% for the NW-RVPA group vs. 55% for the NW-BT group, and RV dysfunction rates three months after the procedure were 6% for NW-RVPA vs. 16% for NW-BT.
Data source: Prospective group of 454 newborns with LVOTO in the Congenital Heart Surgeons’ Society database.
Disclosures: The Congenital Heart Surgeons’ Society and Hospital for Sick Children, Toronto, provided funding for the study. The authors had no relationships to disclose.
