Device Choice May Influence Embolization Rates in Leg Revascularization

NEW YORK – Choice of procedure for lower-leg revascularization, whether angioplasty, atherectomy, or laser treatment, may influence distal embolization rates and the need for embolic protection devices, according to a study presented at the annual meeting of the Eastern Vascular Society.

The study from Columbia University Medical Center in New York found that distal embolization occurred in fewer than 2% of all revascularization procedures studied, but that newer atherectomy devices may be linked to higher complication rates, Dr. Gauram Shrikhande reported. The study reviewed runoff in 2,137 lesions in approximately 1,000 patients treated from 2004 to 2009.

"On angiography, significant embolization occurs at a lower rate during percutaneous low-extremity interventions, and although rare, it does not affect patency and limb salvage rates if runoff can be reestablished using salvage techniques at the time of the procedure," Dr. Shrikhande said.

However, the analysis showed higher rates of distal embolization with newer atherectomy devices, he said. "Distal embolization during the time of percutaneous lower-extremity intervention is a major concern due to ischemic consequences," Dr. Shrikhande said. "As percutaneous lower-extremity arterial interventions become commonplace and devices are rapidly introduced, it is necessary that we better define rates of distal embolization."

The study compared outcomes among five types of interventions: angioplasty alone; angioplasty with stent; the SilverHawk plaque excision system (FoxHollow Technologies); two newer atherectomy devices – the Diamondback 360 (CSI) and the Jet Stream G2 device (Pathway Medical Technologies Inc.); and an excimer laser (Spectranetics Corp.).

In the study, distal embolization rates ranged from less than 1.0% with both angioplasty procedures and 1.9% for the SilverHawk device to 3.6 % for the excimer laser and 22% for the newer atherectomy devices, he said. "Embolic protection may be considered for certain atherectomy devices, in TASC C and D lesions, and for chronic total occlusions and in-stent restenosis," Dr. Shrikhande said.

The average age of the patients was 71 years; 57% were male, 57% had diabetes mellitus, and 54% had a history of smoking. Indications for intervention were claudication in 44%, tissue loss in 42%, and leg pain at rest in 14%.

The lesions were characterized as stenotic (62.4%), chronic total occlusions (28.8%), and in-stent restenosis (8.8%), according to study results. "Total occlusions and in-stent restenosis lesions had higher rates of embolization than native stenotic lesions," Dr. Shrikhande said. The average length of treated lesions was 10 cm, and 30% were located in the femoral artery.

One of the problems with the study was the relatively low number of patients treated with the newer atherectomy devices, Dr. Shrikhande acknowledged. "This is an ongoing collection of data, and we hope to continue to collect data and update these results," he said.

The results provide cause for rethinking the management of specific lesions, Dr. Shrikhande said. "For in-stent restenosis, I would be more cautions using the newer atherectomy devices, and I would heavily consider using a distal embolic protection device at the outset the procedure," he said.

Dr. Linda Harris of Buffalo, N.Y., raised an issue of cost with atherectomy. "You’ve shown that all the atherectomy devices have a higher rate of peripheral embolization," she said. "They already cost more than the balloons we use for angioplasty and/or stents, now you’re adding potentially embolic protection devices and/or catheters to withdraw the clot that you’ve now embolized." She questioned the utility and cost-benefit of any atherectomy device.

The Columbia study did not include a cost analysis, Dr. Shrikhande said. "I do still feel, however, that the atherectomy devices do have an important role in certain lesions – peripheral lesions, popliteal lesions, and osteal-tibial lesions," he said. "I would continue to use them in selected situations, with the caveats of potential embolization risks."

Dr. Shrikhande had no disclosures relevant to the study.

NEW YORK – Choice of procedure for lower-leg revascularization, whether angioplasty, atherectomy, or laser treatment, may influence distal embolization rates and the need for embolic protection devices, according to a study presented at the annual meeting of the Eastern Vascular Society.

The study from Columbia University Medical Center in New York found that distal embolization occurred in fewer than 2% of all revascularization procedures studied, but that newer atherectomy devices may be linked to higher complication rates, Dr. Gauram Shrikhande reported. The study reviewed runoff in 2,137 lesions in approximately 1,000 patients treated from 2004 to 2009.

"On angiography, significant embolization occurs at a lower rate during percutaneous low-extremity interventions, and although rare, it does not affect patency and limb salvage rates if runoff can be reestablished using salvage techniques at the time of the procedure," Dr. Shrikhande said.

However, the analysis showed higher rates of distal embolization with newer atherectomy devices, he said. "Distal embolization during the time of percutaneous lower-extremity intervention is a major concern due to ischemic consequences," Dr. Shrikhande said. "As percutaneous lower-extremity arterial interventions become commonplace and devices are rapidly introduced, it is necessary that we better define rates of distal embolization."

The study compared outcomes among five types of interventions: angioplasty alone; angioplasty with stent; the SilverHawk plaque excision system (FoxHollow Technologies); two newer atherectomy devices – the Diamondback 360 (CSI) and the Jet Stream G2 device (Pathway Medical Technologies Inc.); and an excimer laser (Spectranetics Corp.).

In the study, distal embolization rates ranged from less than 1.0% with both angioplasty procedures and 1.9% for the SilverHawk device to 3.6 % for the excimer laser and 22% for the newer atherectomy devices, he said. "Embolic protection may be considered for certain atherectomy devices, in TASC C and D lesions, and for chronic total occlusions and in-stent restenosis," Dr. Shrikhande said.

The average age of the patients was 71 years; 57% were male, 57% had diabetes mellitus, and 54% had a history of smoking. Indications for intervention were claudication in 44%, tissue loss in 42%, and leg pain at rest in 14%.

The lesions were characterized as stenotic (62.4%), chronic total occlusions (28.8%), and in-stent restenosis (8.8%), according to study results. "Total occlusions and in-stent restenosis lesions had higher rates of embolization than native stenotic lesions," Dr. Shrikhande said. The average length of treated lesions was 10 cm, and 30% were located in the femoral artery.

One of the problems with the study was the relatively low number of patients treated with the newer atherectomy devices, Dr. Shrikhande acknowledged. "This is an ongoing collection of data, and we hope to continue to collect data and update these results," he said.

The results provide cause for rethinking the management of specific lesions, Dr. Shrikhande said. "For in-stent restenosis, I would be more cautions using the newer atherectomy devices, and I would heavily consider using a distal embolic protection device at the outset the procedure," he said.

Dr. Linda Harris of Buffalo, N.Y., raised an issue of cost with atherectomy. "You’ve shown that all the atherectomy devices have a higher rate of peripheral embolization," she said. "They already cost more than the balloons we use for angioplasty and/or stents, now you’re adding potentially embolic protection devices and/or catheters to withdraw the clot that you’ve now embolized." She questioned the utility and cost-benefit of any atherectomy device.

The Columbia study did not include a cost analysis, Dr. Shrikhande said. "I do still feel, however, that the atherectomy devices do have an important role in certain lesions – peripheral lesions, popliteal lesions, and osteal-tibial lesions," he said. "I would continue to use them in selected situations, with the caveats of potential embolization risks."

Dr. Shrikhande had no disclosures relevant to the study.

NEW YORK – Choice of procedure for lower-leg revascularization, whether angioplasty, atherectomy, or laser treatment, may influence distal embolization rates and the need for embolic protection devices, according to a study presented at the annual meeting of the Eastern Vascular Society.

The study from Columbia University Medical Center in New York found that distal embolization occurred in fewer than 2% of all revascularization procedures studied, but that newer atherectomy devices may be linked to higher complication rates, Dr. Gauram Shrikhande reported. The study reviewed runoff in 2,137 lesions in approximately 1,000 patients treated from 2004 to 2009.

"On angiography, significant embolization occurs at a lower rate during percutaneous low-extremity interventions, and although rare, it does not affect patency and limb salvage rates if runoff can be reestablished using salvage techniques at the time of the procedure," Dr. Shrikhande said.

However, the analysis showed higher rates of distal embolization with newer atherectomy devices, he said. "Distal embolization during the time of percutaneous lower-extremity intervention is a major concern due to ischemic consequences," Dr. Shrikhande said. "As percutaneous lower-extremity arterial interventions become commonplace and devices are rapidly introduced, it is necessary that we better define rates of distal embolization."

The study compared outcomes among five types of interventions: angioplasty alone; angioplasty with stent; the SilverHawk plaque excision system (FoxHollow Technologies); two newer atherectomy devices – the Diamondback 360 (CSI) and the Jet Stream G2 device (Pathway Medical Technologies Inc.); and an excimer laser (Spectranetics Corp.).

In the study, distal embolization rates ranged from less than 1.0% with both angioplasty procedures and 1.9% for the SilverHawk device to 3.6 % for the excimer laser and 22% for the newer atherectomy devices, he said. "Embolic protection may be considered for certain atherectomy devices, in TASC C and D lesions, and for chronic total occlusions and in-stent restenosis," Dr. Shrikhande said.

The average age of the patients was 71 years; 57% were male, 57% had diabetes mellitus, and 54% had a history of smoking. Indications for intervention were claudication in 44%, tissue loss in 42%, and leg pain at rest in 14%.

The lesions were characterized as stenotic (62.4%), chronic total occlusions (28.8%), and in-stent restenosis (8.8%), according to study results. "Total occlusions and in-stent restenosis lesions had higher rates of embolization than native stenotic lesions," Dr. Shrikhande said. The average length of treated lesions was 10 cm, and 30% were located in the femoral artery.

One of the problems with the study was the relatively low number of patients treated with the newer atherectomy devices, Dr. Shrikhande acknowledged. "This is an ongoing collection of data, and we hope to continue to collect data and update these results," he said.

The results provide cause for rethinking the management of specific lesions, Dr. Shrikhande said. "For in-stent restenosis, I would be more cautions using the newer atherectomy devices, and I would heavily consider using a distal embolic protection device at the outset the procedure," he said.

Dr. Linda Harris of Buffalo, N.Y., raised an issue of cost with atherectomy. "You’ve shown that all the atherectomy devices have a higher rate of peripheral embolization," she said. "They already cost more than the balloons we use for angioplasty and/or stents, now you’re adding potentially embolic protection devices and/or catheters to withdraw the clot that you’ve now embolized." She questioned the utility and cost-benefit of any atherectomy device.

The Columbia study did not include a cost analysis, Dr. Shrikhande said. "I do still feel, however, that the atherectomy devices do have an important role in certain lesions – peripheral lesions, popliteal lesions, and osteal-tibial lesions," he said. "I would continue to use them in selected situations, with the caveats of potential embolization risks."

Dr. Shrikhande had no disclosures relevant to the study.