Uncertainty remains for long-term outcomes
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STS: Valved conduit shows right ventricular outflow durability

PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.

“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Heidi B. Schubmehl

Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.

The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.

“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”

Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.

Dr. George M. Alfieris

The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.

Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.

The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.

Dr. James Jaggers

One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.

At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.

Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.

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The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.

Dr. James Jaggers

One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.

At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.

Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.

Body

The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.

Dr. James Jaggers

One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.

At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.

Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.

Title
Uncertainty remains for long-term outcomes
Uncertainty remains for long-term outcomes

PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.

“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Heidi B. Schubmehl

Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.

The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.

“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”

Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.

Dr. George M. Alfieris

The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.

Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.

The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.

“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Heidi B. Schubmehl

Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.

The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.

“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”

Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.

Dr. George M. Alfieris

The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.

Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.

The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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Key clinical point: A prosthetic conduit with a porcine valve showed excellent durability for congenital heart defect repairs at intermediate-term follow-up.

Major finding: After an average 7-year follow-up, the replacement valve and conduit had a 92% rate of freedom from valve dysfunction.

Data source: Single-center series of 100 patients.

Disclosures: Dr. Schubmehl and Dr. Alfieris had no disclosures.