ISET 2013, An International Symposium on Endovascular therapy

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

[email protected]

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

[email protected]

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

[email protected]

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

[email protected]

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.

Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.

He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.

The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.

Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.

The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.

Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.

Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).

These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.

Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

[email protected]

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

[email protected]

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

[email protected]

MIAMI BEACH – Debulking calcified infrapopliteal arteries by performing orbital atherectomy before balloon angioplasty improves outcomes compared with balloon angioplasty alone in patients with critical limb ischemia, according to findings from the randomized, multicenter CALCIUM 360° Trial.

At 12 months’ follow-up, the procedural success rate was 93% in 25 patients with critical limb ischemia and confirmed calcified lesions, who were randomized to receive the combined orbital atherectomy and angioplasty treatment, compared with 82% in 25 similar patients randomized to balloon angioplasty alone, Dr. Jonathan Ellichman reported at ISET 2013, an international symposium on endovascular therapy.

The findings are important given the treatment challenges associated with calcified lesions, the shortcomings of balloon angioplasty alone, and the high costs and mortality associated with amputation in patients with critical limb ischemia, said Dr. Ellichman of the Midwest Cardiovascular Research Foundation, Memphis. In addition, 40% of critical limb ischemia amputees die within 2 years of amputation.

Angiography routinely underestimates the severity of calcification, and its use in patients with calcified lesions is technically challenging and associated with a higher procedural complication rate, leading to increased need for bailout stent placement, he added.

Procedural success for this study was defined as restoration of normal lumen with residual stenosis of 30% or less and with no bailout stenting or dissection types C-F, he said.

The pressures required during balloon angiography were significantly lower for patients in the orbital atherectomy and balloon angioplasty group (maximum average balloon inflation of 5.9 atm, vs. 9.4 atm in the balloon angioplasty–only group). Bailout stenting was required in 7% of 29 lesions treated in the orbital atherectomy and angioplasty patients, and in 14% of 35 lesions in the balloon angioplasty–only patients.

The estimates for freedom from target vessel revascularization and all-cause mortality were 93% and 100%, respectively, at 12 months in the orbital atherectomy and balloon angioplasty group, compared with 80% and 68%, respectively, in the balloon angioplasty–only group.

Patients in this eight-center study included 32 men and 18 women (mean age, 71 years) with 50% or greater stenosis; Rutherford classifications 4-6 in the popliteal, tibial, or peroneal arteries; and more than one patent distal runoff vessel. Those randomized to the orbital atherectomy group were treated with Cardiovascular Systems Inc.’s (CSI’s) Stealth 360° PAD System, which Dr. Ellichman said is his device of choice for treating calcified lesions because of its capabilities with angulated, tortuous tibial vessels.

"Greater than 90% (of patients) in both groups had moderate to severe calcification, which is really the sweet spot for the CSI device," he said.

Based on these findings, it appears that combined orbital atherectomy and balloon angioplasty restores flow in patients with critical limb ischemia, and improves outcomes with respect to patency, limb salvage, and survival. These findings, and their potentially significant economic impact, should be evaluated in larger confirmatory studies, he said.

The CALCIUM 360° Trial was sponsored by CSI, the maker of the Stealth 360° device. Dr. Ellichman reported having no financial disclosures.

MIAMI BEACH – Debulking calcified infrapopliteal arteries by performing orbital atherectomy before balloon angioplasty improves outcomes compared with balloon angioplasty alone in patients with critical limb ischemia, according to findings from the randomized, multicenter CALCIUM 360° Trial.

At 12 months’ follow-up, the procedural success rate was 93% in 25 patients with critical limb ischemia and confirmed calcified lesions, who were randomized to receive the combined orbital atherectomy and angioplasty treatment, compared with 82% in 25 similar patients randomized to balloon angioplasty alone, Dr. Jonathan Ellichman reported at ISET 2013, an international symposium on endovascular therapy.

The findings are important given the treatment challenges associated with calcified lesions, the shortcomings of balloon angioplasty alone, and the high costs and mortality associated with amputation in patients with critical limb ischemia, said Dr. Ellichman of the Midwest Cardiovascular Research Foundation, Memphis. In addition, 40% of critical limb ischemia amputees die within 2 years of amputation.

Angiography routinely underestimates the severity of calcification, and its use in patients with calcified lesions is technically challenging and associated with a higher procedural complication rate, leading to increased need for bailout stent placement, he added.

Procedural success for this study was defined as restoration of normal lumen with residual stenosis of 30% or less and with no bailout stenting or dissection types C-F, he said.

The pressures required during balloon angiography were significantly lower for patients in the orbital atherectomy and balloon angioplasty group (maximum average balloon inflation of 5.9 atm, vs. 9.4 atm in the balloon angioplasty–only group). Bailout stenting was required in 7% of 29 lesions treated in the orbital atherectomy and angioplasty patients, and in 14% of 35 lesions in the balloon angioplasty–only patients.

The estimates for freedom from target vessel revascularization and all-cause mortality were 93% and 100%, respectively, at 12 months in the orbital atherectomy and balloon angioplasty group, compared with 80% and 68%, respectively, in the balloon angioplasty–only group.

Patients in this eight-center study included 32 men and 18 women (mean age, 71 years) with 50% or greater stenosis; Rutherford classifications 4-6 in the popliteal, tibial, or peroneal arteries; and more than one patent distal runoff vessel. Those randomized to the orbital atherectomy group were treated with Cardiovascular Systems Inc.’s (CSI’s) Stealth 360° PAD System, which Dr. Ellichman said is his device of choice for treating calcified lesions because of its capabilities with angulated, tortuous tibial vessels.

"Greater than 90% (of patients) in both groups had moderate to severe calcification, which is really the sweet spot for the CSI device," he said.

Based on these findings, it appears that combined orbital atherectomy and balloon angioplasty restores flow in patients with critical limb ischemia, and improves outcomes with respect to patency, limb salvage, and survival. These findings, and their potentially significant economic impact, should be evaluated in larger confirmatory studies, he said.

The CALCIUM 360° Trial was sponsored by CSI, the maker of the Stealth 360° device. Dr. Ellichman reported having no financial disclosures.

MIAMI BEACH – Debulking calcified infrapopliteal arteries by performing orbital atherectomy before balloon angioplasty improves outcomes compared with balloon angioplasty alone in patients with critical limb ischemia, according to findings from the randomized, multicenter CALCIUM 360° Trial.

At 12 months’ follow-up, the procedural success rate was 93% in 25 patients with critical limb ischemia and confirmed calcified lesions, who were randomized to receive the combined orbital atherectomy and angioplasty treatment, compared with 82% in 25 similar patients randomized to balloon angioplasty alone, Dr. Jonathan Ellichman reported at ISET 2013, an international symposium on endovascular therapy.

The findings are important given the treatment challenges associated with calcified lesions, the shortcomings of balloon angioplasty alone, and the high costs and mortality associated with amputation in patients with critical limb ischemia, said Dr. Ellichman of the Midwest Cardiovascular Research Foundation, Memphis. In addition, 40% of critical limb ischemia amputees die within 2 years of amputation.

Angiography routinely underestimates the severity of calcification, and its use in patients with calcified lesions is technically challenging and associated with a higher procedural complication rate, leading to increased need for bailout stent placement, he added.

Procedural success for this study was defined as restoration of normal lumen with residual stenosis of 30% or less and with no bailout stenting or dissection types C-F, he said.

The pressures required during balloon angiography were significantly lower for patients in the orbital atherectomy and balloon angioplasty group (maximum average balloon inflation of 5.9 atm, vs. 9.4 atm in the balloon angioplasty–only group). Bailout stenting was required in 7% of 29 lesions treated in the orbital atherectomy and angioplasty patients, and in 14% of 35 lesions in the balloon angioplasty–only patients.

The estimates for freedom from target vessel revascularization and all-cause mortality were 93% and 100%, respectively, at 12 months in the orbital atherectomy and balloon angioplasty group, compared with 80% and 68%, respectively, in the balloon angioplasty–only group.

Patients in this eight-center study included 32 men and 18 women (mean age, 71 years) with 50% or greater stenosis; Rutherford classifications 4-6 in the popliteal, tibial, or peroneal arteries; and more than one patent distal runoff vessel. Those randomized to the orbital atherectomy group were treated with Cardiovascular Systems Inc.’s (CSI’s) Stealth 360° PAD System, which Dr. Ellichman said is his device of choice for treating calcified lesions because of its capabilities with angulated, tortuous tibial vessels.

"Greater than 90% (of patients) in both groups had moderate to severe calcification, which is really the sweet spot for the CSI device," he said.

Based on these findings, it appears that combined orbital atherectomy and balloon angioplasty restores flow in patients with critical limb ischemia, and improves outcomes with respect to patency, limb salvage, and survival. These findings, and their potentially significant economic impact, should be evaluated in larger confirmatory studies, he said.

The CALCIUM 360° Trial was sponsored by CSI, the maker of the Stealth 360° device. Dr. Ellichman reported having no financial disclosures.

Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.

The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.

Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.

The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.

Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.

The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.

No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.

In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.

The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.

This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.

Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.

Dr. McLucas reported having no financial disclosures.

Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.

The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.

Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.

The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.

Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.

The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.

No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.

In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.

The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.

This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.

Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.

Dr. McLucas reported having no financial disclosures.

Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.

The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.

Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.

The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.

Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.

The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.

No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.

In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.

The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.

This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.

Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.

Dr. McLucas reported having no financial disclosures.