Transaortic Approach Works for TAVI With Sapien

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.

FT. LAUDERDALE, FLA. – A transaortic approach may be a useful alternative to the transapical or transfemoral approach when performing transcatheter aortic valve implantation (TAVI), according to a retrospective review of European cases presented at the annual meeting of the Society of Thoracic Surgeons.

Procedural success was achieved in 157 of 158 cases in which surgeons used the transaortic approach to place the Sapien valve with the Ascendra delivery system (both developed by Edwards Lifesciences), Dr. Vinayak Bapat reported.

He provided the results of a retrospective analysis of European multicenter experience with transaortic TAVI. So far, this approach has been encouraging, despite the high-risk population. Perhaps more importantly, no strokes occurred with the transaortic approach, while strokes are a complication associated with the transapical approach.

To date, more than 250 procedures have been performed in Europe. All patients were unsuitable for the transfemoral approach. Dr. Bapat analyzed 158 cases from 10 centers.

More patients were female (61%); mean age was 80 years. Roughly a quarter of patients had diabetes and almost 40% had peripheral vascular disease. The mean valve area was 0.60 cm² and peak gradient was 67 mm Hg.

Thirteen percent of patients had previously undergone coronary artery bypass graft (CABG) surgery and 37% had chronic obstructive pulmonary disease. Twelve percent of patients had an ejection fraction (EF) less than 30%, 23% had an EF of 30%-50%, and almost two-thirds had an EF of more than 50%. Most patients (87%) had a mini-sternotomy performed, 9% had a mini-thoracotomy, and 4% had a sternotomy (these patients also had off-pump CABG and then had a transaortic TAVI).

Dr. Bapat assessed the cases using procedural end points from the Valve Academic Research Consortium (VARC).

Procedural success was achieved in all but one case, in which the left interior mammary artery was damaged. The surgical team proceeded with a femoral/femoral bypass but the patient died on the table.

In terms of device success, the device was placed in the correct position in all other patients (157). In terms of the prosthetic valve performance, a mean postoperative peak gradient of 11 mm Hg was achieved. Lastly, only one valve was deployed in each of these patients. In terms of device size, 47% received a 23-mm device, another 47% received a 26-mm device, and 6% received a 29-mm device.

All-cause mortality at 30 days was 7%. One patient died due to bleeding from a left interior mammary artery tear, six died of renal insufficiency, one died of aortic dissection, and three died of respiratory failure.

Importantly, no major strokes or periprocedural MIs occurred. Two patients had bleeding that required reoperation; eight patients had renal failure that required dialysis, and four patients had perivalvular leaks of at least grade 2.

The transaortic approach mimics the transfemoral approach but goes through the aorta, avoiding the aortic arch. Embolic protection can be used. In addition, aortic purse-string sutures are safer and have no effect on the left ventricle, he said.

This approach can be performed through either a mini-sternotomy or a mini-thoracotomy. The approach depends on the relationship of the sternum and aorta. A mini-sternotomy can go through either the second or third space. "It is used for aortas, which are midline, in obese patients, and in obese patients with poor lung function," said Dr. Bapat. A mini-thoracotomy is performed through the second space. "I think that it’s important not to excise the second costal cartilage because you want to keep this minimally invasive and less painful." This approach is preferred if the aorta is horizontal, on the right side, or if it’s a redo with patent graft.

In contrast, using the transapical approach, acute and chronic left ventricular complications can occur. There is also an effect on respiratory function because the route is through the left chest. A large incision is commonly needed for obese patients.

"I think that transaortic gives you better control, it’s familiar to surgeons, [and] valve crossing is no longer a challenge because you’re working as a heart team...cardiopulmonary bypass – whether on an elective or emergency basis is very easy because the aorta is right in front of you. Finally, conversion – if there is a complication – to full sternotomy is easy," said Dr. Bapat, who is a consultant cardiac surgeon at St. Thomas Hospital in London.

Dr. Bapat reported that he is a consultant for Edwards Lifesciences and Medtronic Inc. All of his coauthors reported significant relationships with Edwards, either as proctors or consultants.