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LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.
"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.
Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.
Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.
The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.
The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.
Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.
"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.
However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.
Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.
Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.
Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.
Drug-eluting stents have been used in calf vessel by a number of groups for the reasons outlined by the Hackensack University Medical CenterTeam. However, while appealing, there is currently no data to support their use and extra cost. The haemodynamic environment in the coronary arteries is entirely different to that of a lower limb artery and so it is not acceptable to extrapolate results from cardiac interventions to the leg.
The data in this report does little to clarify the situation. While clinical outcomes are the most important factor for the patient, in a small non-randomized observational study they are of little value on their own. It would be helpful to know more about the lesions, in particular why they were selected for drug eluting stents and the immediate hemodynamic effect. The putative reason for using a drug-eluting stent is to reduce restenosis and re-occlusion so without information on these factors the report is of limited value.
With increasing health care costs in a financially challenged world economy, all therapies are likely to come under scrutiny not only for clinical effectiveness but for cost effectiveness as well. The challenge is to produce high quality data in both these areas to support the use of drug -eluting stents before health commissioners refuse to reimburse for the therapy.
Professor Cliff P. Shearman of the University of Southampton, UK, is an associate medical editor for Vascular Specialist.
Drug-eluting stents have been used in calf vessel by a number of groups for the reasons outlined by the Hackensack University Medical CenterTeam. However, while appealing, there is currently no data to support their use and extra cost. The haemodynamic environment in the coronary arteries is entirely different to that of a lower limb artery and so it is not acceptable to extrapolate results from cardiac interventions to the leg.
The data in this report does little to clarify the situation. While clinical outcomes are the most important factor for the patient, in a small non-randomized observational study they are of little value on their own. It would be helpful to know more about the lesions, in particular why they were selected for drug eluting stents and the immediate hemodynamic effect. The putative reason for using a drug-eluting stent is to reduce restenosis and re-occlusion so without information on these factors the report is of limited value.
With increasing health care costs in a financially challenged world economy, all therapies are likely to come under scrutiny not only for clinical effectiveness but for cost effectiveness as well. The challenge is to produce high quality data in both these areas to support the use of drug -eluting stents before health commissioners refuse to reimburse for the therapy.
Professor Cliff P. Shearman of the University of Southampton, UK, is an associate medical editor for Vascular Specialist.
Drug-eluting stents have been used in calf vessel by a number of groups for the reasons outlined by the Hackensack University Medical CenterTeam. However, while appealing, there is currently no data to support their use and extra cost. The haemodynamic environment in the coronary arteries is entirely different to that of a lower limb artery and so it is not acceptable to extrapolate results from cardiac interventions to the leg.
The data in this report does little to clarify the situation. While clinical outcomes are the most important factor for the patient, in a small non-randomized observational study they are of little value on their own. It would be helpful to know more about the lesions, in particular why they were selected for drug eluting stents and the immediate hemodynamic effect. The putative reason for using a drug-eluting stent is to reduce restenosis and re-occlusion so without information on these factors the report is of limited value.
With increasing health care costs in a financially challenged world economy, all therapies are likely to come under scrutiny not only for clinical effectiveness but for cost effectiveness as well. The challenge is to produce high quality data in both these areas to support the use of drug -eluting stents before health commissioners refuse to reimburse for the therapy.
Professor Cliff P. Shearman of the University of Southampton, UK, is an associate medical editor for Vascular Specialist.
LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.
"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.
Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.
Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.
The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.
The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.
Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.
"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.
However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.
Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.
Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.
Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.
LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.
"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.
Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.
Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.
The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.
The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.
Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.
"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.
However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.
Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.
Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.
Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.
Major Finding: In a small series, drug-eluting stents below the knee helped heal foot ulcers and bring pain relief to a majority (16 of 20) of patients with critical limb ischemia.
Data Source: The data were obtained from a retrospectively reviewed case series at Hackensack (N.J.) University Medical Center.
Disclosures: Dr. Wilderman and Dr. Meier said they had no relevant disclosures.