Percutaneous Valves Gaining Ground

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Percutaneous Valves Gaining Ground

NEW YORK — Percutaneous placement of aortic valves is rising rapidly, and the two approach techniques each offer advantages.

“Percutaneous aortic valve replacement using the transapical approach and the newer transfemoral artery approach provide an option for patients who have severe aortic valve stenosis and comorbid disease and who would otherwise not be candidates for aortic valve replacement,” Dr. Lars Svensson of the Cleveland Clinic said at the symposium sponsored by the American Association for Thoracic Surgery.

Percutaneous aortic valve replacement evolved because up to 60% of patients with severe aortic valve stenosis were too ill to have an open operation for aortic valve replacement, Dr. Svensson said.

Hence, the new percutaneous valves have largely been used in patients aged older than 85 years, particularly for reoperations. He cited results for patients at the Cleveland Clinic from the Trans-catheter Endovascular Implantation of Valves (REVIVAL) trial. Those who had percutaneous aortic valve replacements fared better than did those who had balloon aortic valvuloplasty alone or no intervention. For the entire series studied at the three primary Cleveland Clinic sites, patients who had percutaneous valve replacement via the transfemoral artery had 7% mortality and 9% incidence of stroke, compared with 17% mortality and 2.5% incidence of immediate stroke in those who had repair via the transapical left ventricular insertion.

The Food and Drug Administration—approved trials, REVIVAL and Placement of Aortic Transcatheter Valve Trial (PARTNER), use transfemoral percutaneous aortic valve replacement as the primary approach if patients have iliac artery access, Dr. Svensson said. “In the United States, a patient only gets a transapical valve if the patient does not have access for valve insertion via the femoral arteries,” he said.

Dr. Svensson also reported results from the first 40 patients in a FDA-approved study of transapical insertion of balloon-expandable stent valves. All valves were successfully placed and 35 valves were successfully seated. A total of 17% of patients died within 30 days, but the stroke rate was very low.

Disclosures: Dr. Svensson stated that he had no conflicts.

My Take

A Potential 'Game Changer'

Catheter-based aortic valve replacement was the “hottest” topic in adult cardiac surgery at this year's meeting. Traditional open-chest aortic valve replacement using cardiopulmonary bypass remains the preferred method for aortic stenosis, but asignificantly large group of patients has not been referred for AVR because of the perceived operative risk related to advanced age and comorbidities. Some of these very-high-risk patients could benefit from a less invasive percutaneous approach. Follow-up on such patients has been relatively short. The percutaneous approach probably will be tried in progressively less complex patients, but it remains to be proved that results will be equivalent to those of standard AVR. Still, technology is rapidly evolving, and the percutaneous approach has the potential to be a “game changer” in the management of aortic valve disease.

FRED A. CRAWFORD JR., M.D., is Distinguished University Professor of Surgery at the Medical University of South Carolina, Charleston.

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NEW YORK — Percutaneous placement of aortic valves is rising rapidly, and the two approach techniques each offer advantages.

“Percutaneous aortic valve replacement using the transapical approach and the newer transfemoral artery approach provide an option for patients who have severe aortic valve stenosis and comorbid disease and who would otherwise not be candidates for aortic valve replacement,” Dr. Lars Svensson of the Cleveland Clinic said at the symposium sponsored by the American Association for Thoracic Surgery.

Percutaneous aortic valve replacement evolved because up to 60% of patients with severe aortic valve stenosis were too ill to have an open operation for aortic valve replacement, Dr. Svensson said.

Hence, the new percutaneous valves have largely been used in patients aged older than 85 years, particularly for reoperations. He cited results for patients at the Cleveland Clinic from the Trans-catheter Endovascular Implantation of Valves (REVIVAL) trial. Those who had percutaneous aortic valve replacements fared better than did those who had balloon aortic valvuloplasty alone or no intervention. For the entire series studied at the three primary Cleveland Clinic sites, patients who had percutaneous valve replacement via the transfemoral artery had 7% mortality and 9% incidence of stroke, compared with 17% mortality and 2.5% incidence of immediate stroke in those who had repair via the transapical left ventricular insertion.

The Food and Drug Administration—approved trials, REVIVAL and Placement of Aortic Transcatheter Valve Trial (PARTNER), use transfemoral percutaneous aortic valve replacement as the primary approach if patients have iliac artery access, Dr. Svensson said. “In the United States, a patient only gets a transapical valve if the patient does not have access for valve insertion via the femoral arteries,” he said.

Dr. Svensson also reported results from the first 40 patients in a FDA-approved study of transapical insertion of balloon-expandable stent valves. All valves were successfully placed and 35 valves were successfully seated. A total of 17% of patients died within 30 days, but the stroke rate was very low.

Disclosures: Dr. Svensson stated that he had no conflicts.

My Take

A Potential 'Game Changer'

Catheter-based aortic valve replacement was the “hottest” topic in adult cardiac surgery at this year's meeting. Traditional open-chest aortic valve replacement using cardiopulmonary bypass remains the preferred method for aortic stenosis, but asignificantly large group of patients has not been referred for AVR because of the perceived operative risk related to advanced age and comorbidities. Some of these very-high-risk patients could benefit from a less invasive percutaneous approach. Follow-up on such patients has been relatively short. The percutaneous approach probably will be tried in progressively less complex patients, but it remains to be proved that results will be equivalent to those of standard AVR. Still, technology is rapidly evolving, and the percutaneous approach has the potential to be a “game changer” in the management of aortic valve disease.

FRED A. CRAWFORD JR., M.D., is Distinguished University Professor of Surgery at the Medical University of South Carolina, Charleston.

NEW YORK — Percutaneous placement of aortic valves is rising rapidly, and the two approach techniques each offer advantages.

“Percutaneous aortic valve replacement using the transapical approach and the newer transfemoral artery approach provide an option for patients who have severe aortic valve stenosis and comorbid disease and who would otherwise not be candidates for aortic valve replacement,” Dr. Lars Svensson of the Cleveland Clinic said at the symposium sponsored by the American Association for Thoracic Surgery.

Percutaneous aortic valve replacement evolved because up to 60% of patients with severe aortic valve stenosis were too ill to have an open operation for aortic valve replacement, Dr. Svensson said.

Hence, the new percutaneous valves have largely been used in patients aged older than 85 years, particularly for reoperations. He cited results for patients at the Cleveland Clinic from the Trans-catheter Endovascular Implantation of Valves (REVIVAL) trial. Those who had percutaneous aortic valve replacements fared better than did those who had balloon aortic valvuloplasty alone or no intervention. For the entire series studied at the three primary Cleveland Clinic sites, patients who had percutaneous valve replacement via the transfemoral artery had 7% mortality and 9% incidence of stroke, compared with 17% mortality and 2.5% incidence of immediate stroke in those who had repair via the transapical left ventricular insertion.

The Food and Drug Administration—approved trials, REVIVAL and Placement of Aortic Transcatheter Valve Trial (PARTNER), use transfemoral percutaneous aortic valve replacement as the primary approach if patients have iliac artery access, Dr. Svensson said. “In the United States, a patient only gets a transapical valve if the patient does not have access for valve insertion via the femoral arteries,” he said.

Dr. Svensson also reported results from the first 40 patients in a FDA-approved study of transapical insertion of balloon-expandable stent valves. All valves were successfully placed and 35 valves were successfully seated. A total of 17% of patients died within 30 days, but the stroke rate was very low.

Disclosures: Dr. Svensson stated that he had no conflicts.

My Take

A Potential 'Game Changer'

Catheter-based aortic valve replacement was the “hottest” topic in adult cardiac surgery at this year's meeting. Traditional open-chest aortic valve replacement using cardiopulmonary bypass remains the preferred method for aortic stenosis, but asignificantly large group of patients has not been referred for AVR because of the perceived operative risk related to advanced age and comorbidities. Some of these very-high-risk patients could benefit from a less invasive percutaneous approach. Follow-up on such patients has been relatively short. The percutaneous approach probably will be tried in progressively less complex patients, but it remains to be proved that results will be equivalent to those of standard AVR. Still, technology is rapidly evolving, and the percutaneous approach has the potential to be a “game changer” in the management of aortic valve disease.

FRED A. CRAWFORD JR., M.D., is Distinguished University Professor of Surgery at the Medical University of South Carolina, Charleston.

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Study Backs Prophylactic Aortic Root Repair

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Study Backs Prophylactic Aortic Root Repair

NEW YORK — Rupture and tear from an aortic root aneurysm is a major cause of death in Marfan syndrome and Loeys-Dietz syndrome, but preventative aortic root repair in these diseases has advanced over the decades to prolong lives and avoid the need for future surgery.

“A prophylactic aortic root replacement in both Marfan syndrome and Loeys-Dietz syndrome has very low operative risks and excellent long -term results,” Dr. Duke Cameron of Johns Hopkins in Baltimore said at the symposium, which was sponsored by the American Association for Thoracic Surgery.

Dr. Cameron reported on results of 417 patients with Marfan syndrome who were treated at Johns Hopkins since 1976 and 31 patients with Loeys-Dietz syndrome treated over an 8-year period.

In Marfan syndrome, the threshold aortic root diameter indicated for surgery declined over the years to 5 cm, Dr. Cameron said.

“If there's been a family history of aneurysm or dissection, we've lowered the threshold by about 0.5 cm,” he said, adding that in younger patients, enlargement of the aortic root diameter of more than 1 cm a year is also a reason to operate.

The Hopkins approach for aortic root repair in Marfan syndrome is straightforward, he said: full root replacement with full-thickness, end-to-end anastomosis, mobilization of the three coronary arteries, and root reimplantation. The Hopkins group used a remodeling technique exclusively until 2002, “but became disappointed with annual dilatation and aortic regurgitation seen in some of these patients,” Dr. Cameron said. Now, they perform reimplantation with a Valsalva graft.

The average age of Marfan syndrome patients in the Hopkins' treatment group was 32; ages ranged from 1.5 to 73 years. Three patients died, including 2 of the 45 patients who had urgent or emergency surgery. None of the patients who had elective operations died within 30 days of the operation. At 20 years after surgery, 75% of patients survived.

Aortic root dissection present at the time of the operation reduced a patient's late-term survival time by 50%, Dr. Cameron said, “underscoring again the importance of root replacement before dissection occurs.”

A history of mitral valve surgery, seen mostly in younger patients, was also a predictor of late death. The two most prevalent late-term causes of death were dissection or rupture in the distal aortic or ileac arteries and arrhythmia, he said.

However, freedom from thromboembolism in Bentall procedures with mechanical valves surpassed 90% at 25 years, as did freedom from endocarditis, Dr. Cameron said. “This is better than what one would expect to see with an isolated mechanical aortic valve replacement,” he said. “It makes the point that the Bentall procedure is still one of the very best operations we have in cardiac surgery.”

A previous Hopkins' study showed the Bentall procedure had higher rates of thromboembolism than did valve-sparing aortic root replacement in Marfan syndrome, but valve-sparing surgery had higher rates of reoperation (Ann. Thorac. Surg. 2008;85:2003–10).

Preventative operations in Loeys-Dietz syndrome are similar to those for Marfan syndrome, but the threshold aortic root diameter for intervention is lower: 3 cm in children and 4 cm in adults, Dr. Cameron said.

Overall, the 31 patients with Loeys-Dietz syndrome who had aortic root repair were half the age of Marfan syndrome patients (15 years on average) with an average sinus diameter of 3.9 cm. All had a valve-sparing procedure, and none died during the operation or at follow-up at an average of 3.6 years, Dr. Cameron said.

“When comparing Loeys-Dietz to Marfan syndrome at early to mid-term follow-up, they have very similar operative outcomes,” Dr. Cameron said.

Disclosures: Dr. Cameron had no disclosures relevant to his presentation.

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NEW YORK — Rupture and tear from an aortic root aneurysm is a major cause of death in Marfan syndrome and Loeys-Dietz syndrome, but preventative aortic root repair in these diseases has advanced over the decades to prolong lives and avoid the need for future surgery.

“A prophylactic aortic root replacement in both Marfan syndrome and Loeys-Dietz syndrome has very low operative risks and excellent long -term results,” Dr. Duke Cameron of Johns Hopkins in Baltimore said at the symposium, which was sponsored by the American Association for Thoracic Surgery.

Dr. Cameron reported on results of 417 patients with Marfan syndrome who were treated at Johns Hopkins since 1976 and 31 patients with Loeys-Dietz syndrome treated over an 8-year period.

In Marfan syndrome, the threshold aortic root diameter indicated for surgery declined over the years to 5 cm, Dr. Cameron said.

“If there's been a family history of aneurysm or dissection, we've lowered the threshold by about 0.5 cm,” he said, adding that in younger patients, enlargement of the aortic root diameter of more than 1 cm a year is also a reason to operate.

The Hopkins approach for aortic root repair in Marfan syndrome is straightforward, he said: full root replacement with full-thickness, end-to-end anastomosis, mobilization of the three coronary arteries, and root reimplantation. The Hopkins group used a remodeling technique exclusively until 2002, “but became disappointed with annual dilatation and aortic regurgitation seen in some of these patients,” Dr. Cameron said. Now, they perform reimplantation with a Valsalva graft.

The average age of Marfan syndrome patients in the Hopkins' treatment group was 32; ages ranged from 1.5 to 73 years. Three patients died, including 2 of the 45 patients who had urgent or emergency surgery. None of the patients who had elective operations died within 30 days of the operation. At 20 years after surgery, 75% of patients survived.

Aortic root dissection present at the time of the operation reduced a patient's late-term survival time by 50%, Dr. Cameron said, “underscoring again the importance of root replacement before dissection occurs.”

A history of mitral valve surgery, seen mostly in younger patients, was also a predictor of late death. The two most prevalent late-term causes of death were dissection or rupture in the distal aortic or ileac arteries and arrhythmia, he said.

However, freedom from thromboembolism in Bentall procedures with mechanical valves surpassed 90% at 25 years, as did freedom from endocarditis, Dr. Cameron said. “This is better than what one would expect to see with an isolated mechanical aortic valve replacement,” he said. “It makes the point that the Bentall procedure is still one of the very best operations we have in cardiac surgery.”

A previous Hopkins' study showed the Bentall procedure had higher rates of thromboembolism than did valve-sparing aortic root replacement in Marfan syndrome, but valve-sparing surgery had higher rates of reoperation (Ann. Thorac. Surg. 2008;85:2003–10).

Preventative operations in Loeys-Dietz syndrome are similar to those for Marfan syndrome, but the threshold aortic root diameter for intervention is lower: 3 cm in children and 4 cm in adults, Dr. Cameron said.

Overall, the 31 patients with Loeys-Dietz syndrome who had aortic root repair were half the age of Marfan syndrome patients (15 years on average) with an average sinus diameter of 3.9 cm. All had a valve-sparing procedure, and none died during the operation or at follow-up at an average of 3.6 years, Dr. Cameron said.

“When comparing Loeys-Dietz to Marfan syndrome at early to mid-term follow-up, they have very similar operative outcomes,” Dr. Cameron said.

Disclosures: Dr. Cameron had no disclosures relevant to his presentation.

NEW YORK — Rupture and tear from an aortic root aneurysm is a major cause of death in Marfan syndrome and Loeys-Dietz syndrome, but preventative aortic root repair in these diseases has advanced over the decades to prolong lives and avoid the need for future surgery.

“A prophylactic aortic root replacement in both Marfan syndrome and Loeys-Dietz syndrome has very low operative risks and excellent long -term results,” Dr. Duke Cameron of Johns Hopkins in Baltimore said at the symposium, which was sponsored by the American Association for Thoracic Surgery.

Dr. Cameron reported on results of 417 patients with Marfan syndrome who were treated at Johns Hopkins since 1976 and 31 patients with Loeys-Dietz syndrome treated over an 8-year period.

In Marfan syndrome, the threshold aortic root diameter indicated for surgery declined over the years to 5 cm, Dr. Cameron said.

“If there's been a family history of aneurysm or dissection, we've lowered the threshold by about 0.5 cm,” he said, adding that in younger patients, enlargement of the aortic root diameter of more than 1 cm a year is also a reason to operate.

The Hopkins approach for aortic root repair in Marfan syndrome is straightforward, he said: full root replacement with full-thickness, end-to-end anastomosis, mobilization of the three coronary arteries, and root reimplantation. The Hopkins group used a remodeling technique exclusively until 2002, “but became disappointed with annual dilatation and aortic regurgitation seen in some of these patients,” Dr. Cameron said. Now, they perform reimplantation with a Valsalva graft.

The average age of Marfan syndrome patients in the Hopkins' treatment group was 32; ages ranged from 1.5 to 73 years. Three patients died, including 2 of the 45 patients who had urgent or emergency surgery. None of the patients who had elective operations died within 30 days of the operation. At 20 years after surgery, 75% of patients survived.

Aortic root dissection present at the time of the operation reduced a patient's late-term survival time by 50%, Dr. Cameron said, “underscoring again the importance of root replacement before dissection occurs.”

A history of mitral valve surgery, seen mostly in younger patients, was also a predictor of late death. The two most prevalent late-term causes of death were dissection or rupture in the distal aortic or ileac arteries and arrhythmia, he said.

However, freedom from thromboembolism in Bentall procedures with mechanical valves surpassed 90% at 25 years, as did freedom from endocarditis, Dr. Cameron said. “This is better than what one would expect to see with an isolated mechanical aortic valve replacement,” he said. “It makes the point that the Bentall procedure is still one of the very best operations we have in cardiac surgery.”

A previous Hopkins' study showed the Bentall procedure had higher rates of thromboembolism than did valve-sparing aortic root replacement in Marfan syndrome, but valve-sparing surgery had higher rates of reoperation (Ann. Thorac. Surg. 2008;85:2003–10).

Preventative operations in Loeys-Dietz syndrome are similar to those for Marfan syndrome, but the threshold aortic root diameter for intervention is lower: 3 cm in children and 4 cm in adults, Dr. Cameron said.

Overall, the 31 patients with Loeys-Dietz syndrome who had aortic root repair were half the age of Marfan syndrome patients (15 years on average) with an average sinus diameter of 3.9 cm. All had a valve-sparing procedure, and none died during the operation or at follow-up at an average of 3.6 years, Dr. Cameron said.

“When comparing Loeys-Dietz to Marfan syndrome at early to mid-term follow-up, they have very similar operative outcomes,” Dr. Cameron said.

Disclosures: Dr. Cameron had no disclosures relevant to his presentation.

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Observation Only OK After Ascending Aorta Tx

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NEW YORK — Observation is an acceptable alternative to surgical management of ascending aortic dilatation in adult patients with congenital heart disease, judging by a series of 81 patients with long-term follow-up.

The longstanding controversy among thoracic surgeons over the need to repair a dilated ascending aorta during aortic valve repair centers on how large the dilatation should be before starting a repair, and what types of patients should have the preventative operation, Dr. John M. Stulak said at the symposium sponsored by the American Association for Thoracic Surgery.

He and and his colleagues at the Mayo Clinic, Rochester, Minn., analyzed data on 81 patients aged 18–59 with congenital heart failure who were followed over 35 years; 53 had isolated aortic valve repair and 9 had combined valve and ascending root repair. Four patients in the series required reoperation during a median follow-up of 3.8 years.

After the initial operation, 96% of patients remained free from reoperation on the ascending aorta or aortic valve at 5 years and 90% at 8 years. Indications for reoperations were leakage of the prosthetic valve, severe aortic regurgitation after intensive aortic valve repair, and aortic root replacement caused by aneurysm.

“The moderately dilated aorta in the setting of a conotruncal abnormality, especially in patients undergoing isolated aortic valve replacement, may be observed,” said Dr. Stulak.

Disclosures: Dr. Stulak had no relevant conflicts.

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NEW YORK — Observation is an acceptable alternative to surgical management of ascending aortic dilatation in adult patients with congenital heart disease, judging by a series of 81 patients with long-term follow-up.

The longstanding controversy among thoracic surgeons over the need to repair a dilated ascending aorta during aortic valve repair centers on how large the dilatation should be before starting a repair, and what types of patients should have the preventative operation, Dr. John M. Stulak said at the symposium sponsored by the American Association for Thoracic Surgery.

He and and his colleagues at the Mayo Clinic, Rochester, Minn., analyzed data on 81 patients aged 18–59 with congenital heart failure who were followed over 35 years; 53 had isolated aortic valve repair and 9 had combined valve and ascending root repair. Four patients in the series required reoperation during a median follow-up of 3.8 years.

After the initial operation, 96% of patients remained free from reoperation on the ascending aorta or aortic valve at 5 years and 90% at 8 years. Indications for reoperations were leakage of the prosthetic valve, severe aortic regurgitation after intensive aortic valve repair, and aortic root replacement caused by aneurysm.

“The moderately dilated aorta in the setting of a conotruncal abnormality, especially in patients undergoing isolated aortic valve replacement, may be observed,” said Dr. Stulak.

Disclosures: Dr. Stulak had no relevant conflicts.

NEW YORK — Observation is an acceptable alternative to surgical management of ascending aortic dilatation in adult patients with congenital heart disease, judging by a series of 81 patients with long-term follow-up.

The longstanding controversy among thoracic surgeons over the need to repair a dilated ascending aorta during aortic valve repair centers on how large the dilatation should be before starting a repair, and what types of patients should have the preventative operation, Dr. John M. Stulak said at the symposium sponsored by the American Association for Thoracic Surgery.

He and and his colleagues at the Mayo Clinic, Rochester, Minn., analyzed data on 81 patients aged 18–59 with congenital heart failure who were followed over 35 years; 53 had isolated aortic valve repair and 9 had combined valve and ascending root repair. Four patients in the series required reoperation during a median follow-up of 3.8 years.

After the initial operation, 96% of patients remained free from reoperation on the ascending aorta or aortic valve at 5 years and 90% at 8 years. Indications for reoperations were leakage of the prosthetic valve, severe aortic regurgitation after intensive aortic valve repair, and aortic root replacement caused by aneurysm.

“The moderately dilated aorta in the setting of a conotruncal abnormality, especially in patients undergoing isolated aortic valve replacement, may be observed,” said Dr. Stulak.

Disclosures: Dr. Stulak had no relevant conflicts.

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