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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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