Wii Sports Games Inspire Seniors to Get Moving

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BALTIMORE — The Wii video game system helped seniors burn calories and become more active in a pilot study of 24 adults aged 66-78 years.

Group members burned 17-176 kcal during 30-minute games of Wii baseball, tennis, or team or individual bowling, Elizabeth Orsega-Smith, Ph.D., reported.

The participants were enrolled at senior centers in Delaware. They were mostly women (87%) with an average age of 72 years. Participants were independent, community dwelling, and healthy but overweight—their mean body mass index was 32.67 kg/m

The participants wore accelerometers on their wrists during the games, and the researchers calculated caloric expenditure from the readings. Caloric expenditure ranged from 22 kcal to 114 kcal for baseball, and from 17 kcal to 72 kcal for tennis. Caloric expenditure for team bowling ranged from 18 kcal to 89 kcal but was 20 kcal to 176 kcal for individual bowling.

Wii games may be an easy option for senior centers and care facilities trying to get older adults to become more active. “For the most part, the seniors were able to pick up the game pretty rapidly. They didn't really have much difficulty in grasping the concept of using the controller and the motions that it takes to bowl, play tennis, or play baseball,” she said. One senior center already had one of the game consoles but did not have a staff member available to help seniors use it; the other center did not have one.

Dr. Orsega-Smith reported that she had no relevant financial conflict of interest.

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BALTIMORE — The Wii video game system helped seniors burn calories and become more active in a pilot study of 24 adults aged 66-78 years.

Group members burned 17-176 kcal during 30-minute games of Wii baseball, tennis, or team or individual bowling, Elizabeth Orsega-Smith, Ph.D., reported.

The participants were enrolled at senior centers in Delaware. They were mostly women (87%) with an average age of 72 years. Participants were independent, community dwelling, and healthy but overweight—their mean body mass index was 32.67 kg/m

The participants wore accelerometers on their wrists during the games, and the researchers calculated caloric expenditure from the readings. Caloric expenditure ranged from 22 kcal to 114 kcal for baseball, and from 17 kcal to 72 kcal for tennis. Caloric expenditure for team bowling ranged from 18 kcal to 89 kcal but was 20 kcal to 176 kcal for individual bowling.

Wii games may be an easy option for senior centers and care facilities trying to get older adults to become more active. “For the most part, the seniors were able to pick up the game pretty rapidly. They didn't really have much difficulty in grasping the concept of using the controller and the motions that it takes to bowl, play tennis, or play baseball,” she said. One senior center already had one of the game consoles but did not have a staff member available to help seniors use it; the other center did not have one.

Dr. Orsega-Smith reported that she had no relevant financial conflict of interest.

BALTIMORE — The Wii video game system helped seniors burn calories and become more active in a pilot study of 24 adults aged 66-78 years.

Group members burned 17-176 kcal during 30-minute games of Wii baseball, tennis, or team or individual bowling, Elizabeth Orsega-Smith, Ph.D., reported.

The participants were enrolled at senior centers in Delaware. They were mostly women (87%) with an average age of 72 years. Participants were independent, community dwelling, and healthy but overweight—their mean body mass index was 32.67 kg/m

The participants wore accelerometers on their wrists during the games, and the researchers calculated caloric expenditure from the readings. Caloric expenditure ranged from 22 kcal to 114 kcal for baseball, and from 17 kcal to 72 kcal for tennis. Caloric expenditure for team bowling ranged from 18 kcal to 89 kcal but was 20 kcal to 176 kcal for individual bowling.

Wii games may be an easy option for senior centers and care facilities trying to get older adults to become more active. “For the most part, the seniors were able to pick up the game pretty rapidly. They didn't really have much difficulty in grasping the concept of using the controller and the motions that it takes to bowl, play tennis, or play baseball,” she said. One senior center already had one of the game consoles but did not have a staff member available to help seniors use it; the other center did not have one.

Dr. Orsega-Smith reported that she had no relevant financial conflict of interest.

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Intra-Arterial Embolization With Fillers Is Rare, But Severe

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Intra-Arterial Embolization With Fillers Is Rare, But Severe

WASHINGTON — Intra-arterial embolization during filler injection is rare, but it can happen to even the most experienced physician, said Dr. Claudio DeLorenzi.

Intra-arterial embolization occurs when a filler needle enters an artery. During injection, the filler flows retrograde in the vessel. Once the pressure from injection is stopped, the product is carried through the vasculature and the results can be disastrous, Dr. DeLorenzi said at the annual meeting of the American Society for Aesthetic Plastic Surgery.

Photos courtesy Dr. Claudio DeLorenzi
    VIDEO - The lesion on the left from filler injection was originally diagnosed as an infection (Click photo to view video on Facebook).

Local and distal necrosis can occur following intra-arterial embolization. Typically the whole angiosome--the vascular territory of skin and underlying muscles, tendons, nerves, and bones--is affected, resulting in full-thickness necrosis.

The first sign of trouble is severe pain, followed typically by a bluish livedo pattern.

This can progress to hemorrhagic blisters, necrotic eschar, and late scarring. "The severity of some of these complications is extreme by any measure," said Dr. DeLorenzi, who is a plastic surgeon in Kitchener, Ont.

"So if you see this reticular bluish pattern, it means that you need to take action," he said. A crash cart for this complication allows for an immediate response. The cart should contain hyaluronidase--which can reverse the effects of hyaluronic acid fillers--aspirin, nitroglycerine paste, and heat compresses.

    Two months after hyaluronidase treatment, the patient had mild scarring.

Dr. DeLorenzi recommended having a low threshold for using hyaluronidase. Recommendations in the literature on the amount to use vary from 25 to 150 units.

Hyaluronidase should be injected diffusely in the affected area, which should then be massaged to distribute the filler. "Even if you've selected a non-hyaluronic acid filler, there may be some role for using hyaluronidase. You may get some improvement in circulation," he said.

Increased risk for intra-arterial embolization appears to be associated with large volumes of filler, small sharp needles, high pressure, deeper injections, and compound type.

"Prevention, of course, is best," said Dr. DeLorenzi. To avoid intra-arterial embolization, he recommends using a small bolus (less than 0.1 cc), a blunt cannula, low pressure, slow injection; knowing the relevant anatomy; being prepared; and using epinephrine prior to the filler procedure (this may reduce the vessel size and the risk of hitting a vessel).

Dr. Delorenzi reported that he is a speaker for Allergan Inc.

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WASHINGTON — Intra-arterial embolization during filler injection is rare, but it can happen to even the most experienced physician, said Dr. Claudio DeLorenzi.

Intra-arterial embolization occurs when a filler needle enters an artery. During injection, the filler flows retrograde in the vessel. Once the pressure from injection is stopped, the product is carried through the vasculature and the results can be disastrous, Dr. DeLorenzi said at the annual meeting of the American Society for Aesthetic Plastic Surgery.

Photos courtesy Dr. Claudio DeLorenzi
    VIDEO - The lesion on the left from filler injection was originally diagnosed as an infection (Click photo to view video on Facebook).

Local and distal necrosis can occur following intra-arterial embolization. Typically the whole angiosome--the vascular territory of skin and underlying muscles, tendons, nerves, and bones--is affected, resulting in full-thickness necrosis.

The first sign of trouble is severe pain, followed typically by a bluish livedo pattern.

This can progress to hemorrhagic blisters, necrotic eschar, and late scarring. "The severity of some of these complications is extreme by any measure," said Dr. DeLorenzi, who is a plastic surgeon in Kitchener, Ont.

"So if you see this reticular bluish pattern, it means that you need to take action," he said. A crash cart for this complication allows for an immediate response. The cart should contain hyaluronidase--which can reverse the effects of hyaluronic acid fillers--aspirin, nitroglycerine paste, and heat compresses.

    Two months after hyaluronidase treatment, the patient had mild scarring.

Dr. DeLorenzi recommended having a low threshold for using hyaluronidase. Recommendations in the literature on the amount to use vary from 25 to 150 units.

Hyaluronidase should be injected diffusely in the affected area, which should then be massaged to distribute the filler. "Even if you've selected a non-hyaluronic acid filler, there may be some role for using hyaluronidase. You may get some improvement in circulation," he said.

Increased risk for intra-arterial embolization appears to be associated with large volumes of filler, small sharp needles, high pressure, deeper injections, and compound type.

"Prevention, of course, is best," said Dr. DeLorenzi. To avoid intra-arterial embolization, he recommends using a small bolus (less than 0.1 cc), a blunt cannula, low pressure, slow injection; knowing the relevant anatomy; being prepared; and using epinephrine prior to the filler procedure (this may reduce the vessel size and the risk of hitting a vessel).

Dr. Delorenzi reported that he is a speaker for Allergan Inc.

WASHINGTON — Intra-arterial embolization during filler injection is rare, but it can happen to even the most experienced physician, said Dr. Claudio DeLorenzi.

Intra-arterial embolization occurs when a filler needle enters an artery. During injection, the filler flows retrograde in the vessel. Once the pressure from injection is stopped, the product is carried through the vasculature and the results can be disastrous, Dr. DeLorenzi said at the annual meeting of the American Society for Aesthetic Plastic Surgery.

Photos courtesy Dr. Claudio DeLorenzi
    VIDEO - The lesion on the left from filler injection was originally diagnosed as an infection (Click photo to view video on Facebook).

Local and distal necrosis can occur following intra-arterial embolization. Typically the whole angiosome--the vascular territory of skin and underlying muscles, tendons, nerves, and bones--is affected, resulting in full-thickness necrosis.

The first sign of trouble is severe pain, followed typically by a bluish livedo pattern.

This can progress to hemorrhagic blisters, necrotic eschar, and late scarring. "The severity of some of these complications is extreme by any measure," said Dr. DeLorenzi, who is a plastic surgeon in Kitchener, Ont.

"So if you see this reticular bluish pattern, it means that you need to take action," he said. A crash cart for this complication allows for an immediate response. The cart should contain hyaluronidase--which can reverse the effects of hyaluronic acid fillers--aspirin, nitroglycerine paste, and heat compresses.

    Two months after hyaluronidase treatment, the patient had mild scarring.

Dr. DeLorenzi recommended having a low threshold for using hyaluronidase. Recommendations in the literature on the amount to use vary from 25 to 150 units.

Hyaluronidase should be injected diffusely in the affected area, which should then be massaged to distribute the filler. "Even if you've selected a non-hyaluronic acid filler, there may be some role for using hyaluronidase. You may get some improvement in circulation," he said.

Increased risk for intra-arterial embolization appears to be associated with large volumes of filler, small sharp needles, high pressure, deeper injections, and compound type.

"Prevention, of course, is best," said Dr. DeLorenzi. To avoid intra-arterial embolization, he recommends using a small bolus (less than 0.1 cc), a blunt cannula, low pressure, slow injection; knowing the relevant anatomy; being prepared; and using epinephrine prior to the filler procedure (this may reduce the vessel size and the risk of hitting a vessel).

Dr. Delorenzi reported that he is a speaker for Allergan Inc.

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BRAF Mutation Predicts Thyroid Ca Recurrence

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BRAF Mutation Predicts Thyroid Ca Recurrence

MINNEAPOLIS — BRAF mutations may offer one answer to the growing need for biomarkers that can accurately predict the risk of thyroid cancer recurrence, said Dr. Stefan K.G. Grebe.

Thyroid cancer, with its rising incidence and low mortality rate, will be the third most common diagnosis in living cancer patients in the next 5–10 years, behind breast and prostate cancers, according to Dr. Grebe. For a newly diagnosed thyroid cancer patient, the lifetime risk of dying from the disease in 10 years—across all ages and stages—is less than 3%.

“We have to bear this in mind when we talk about prognostic markers…. Predictive markers may be more important because hardly anyone ever dies of thyroid cancer,” Dr. Grebe said at the meeting. Depending on the cancer morphotype, 15%–50% of patients will suffer a recurrence in their lifetime. “There really is a need for prolonged—over decades—follow-up of these patients,” which will require sensitive and specific means of detecting recurrences, he stressed.

The BRAF T1799A (V600E) mutation accounts for more than 90% of BRAF mutations in melanoma and papillary thyroid cancer (PTC). Importantly, this mutation is not found in normal tissue. While this mutation occurs in 40%–80% of melanomas and papillary thyroid cancers, it is present in fewer than 10% of other cancers, making it a good candidate biomarker for PTC recurrence, said Dr. Grebe, chair of clinical biochemistry and immunology in the department of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

A good candidate marker also needs a good test. In the case of BRAF V600E this means developing an assay that can detect nucleic acids with this mutation in human blood, plasma, or serum with high sensitivity and specificity. “For residual disease follow-up … you have to have a low sensitivity to detect a low number of mutant copies,” said Dr. Grebe, who has been working on the development of such an assay with his colleagues. They started by evaluating a number of assay techniques to detect BRAF V600E mutations. “Finally we settled on real-time PCR [polymerase chain reaction],” he said.

Once they achieved success with a proof-of-principle study, they prospectively collected blood from all thyroid cancer patients attending a follow-up visit between May 2004 and December 2006 (J. Clin. Endocrinol. Metab. 2009;94:5001–9).

They enrolled 193 patients, of whom 173 had papillary thyroid cancer. Circulating BRAF V600E was detected in 20 of the 173 patients with PTC. It was not detected in the 20 patients with other types of thyroid cancer. Tissue BRAF status correlated with blood BRAF status.

“Overall we found that the BRAF mutation in blood conveyed about a two-and-a-half-fold relative risk of having active or recurrent disease,” said Dr. Grebe. “Potentially this will be an assay of increased value in the future.”

For now, clinicians have to rely on thyroglobulin, which has proved to be a good, but not perfect, tumor marker. Thyroglobulin is highly organ specific but cannot distinguish between benign and cancerous tumor tissue. Its reliability is compromised by residual thyroid tissue.

Perhaps more importantly, thyroglobulin is subject to analytical interferences with uninterpretable results in up to a quarter of patients and measurements. This is largely due to false negatives. “These limitations of thyroglobulin will get worse in the future,” said Dr. Grebe, who predicted that increasing numbers of thyroid cancer patients with even lower mortality will lead to less extensive treatment.

“I don't think in this day and age that you could convince a woman to have a radical mastectomy plus an extensive dissection for a 0.4-cm microcancer of the breast. The same will happen sooner or later with thyroid cancer,” he said. As a result, more patients will have remnant thyroid tissue producing greater background levels of thyroglobulin with greater TSH-related fluctuations.

Disclosures: Dr. Grebe reported that he has no relevant financial relationships.

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MINNEAPOLIS — BRAF mutations may offer one answer to the growing need for biomarkers that can accurately predict the risk of thyroid cancer recurrence, said Dr. Stefan K.G. Grebe.

Thyroid cancer, with its rising incidence and low mortality rate, will be the third most common diagnosis in living cancer patients in the next 5–10 years, behind breast and prostate cancers, according to Dr. Grebe. For a newly diagnosed thyroid cancer patient, the lifetime risk of dying from the disease in 10 years—across all ages and stages—is less than 3%.

“We have to bear this in mind when we talk about prognostic markers…. Predictive markers may be more important because hardly anyone ever dies of thyroid cancer,” Dr. Grebe said at the meeting. Depending on the cancer morphotype, 15%–50% of patients will suffer a recurrence in their lifetime. “There really is a need for prolonged—over decades—follow-up of these patients,” which will require sensitive and specific means of detecting recurrences, he stressed.

The BRAF T1799A (V600E) mutation accounts for more than 90% of BRAF mutations in melanoma and papillary thyroid cancer (PTC). Importantly, this mutation is not found in normal tissue. While this mutation occurs in 40%–80% of melanomas and papillary thyroid cancers, it is present in fewer than 10% of other cancers, making it a good candidate biomarker for PTC recurrence, said Dr. Grebe, chair of clinical biochemistry and immunology in the department of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

A good candidate marker also needs a good test. In the case of BRAF V600E this means developing an assay that can detect nucleic acids with this mutation in human blood, plasma, or serum with high sensitivity and specificity. “For residual disease follow-up … you have to have a low sensitivity to detect a low number of mutant copies,” said Dr. Grebe, who has been working on the development of such an assay with his colleagues. They started by evaluating a number of assay techniques to detect BRAF V600E mutations. “Finally we settled on real-time PCR [polymerase chain reaction],” he said.

Once they achieved success with a proof-of-principle study, they prospectively collected blood from all thyroid cancer patients attending a follow-up visit between May 2004 and December 2006 (J. Clin. Endocrinol. Metab. 2009;94:5001–9).

They enrolled 193 patients, of whom 173 had papillary thyroid cancer. Circulating BRAF V600E was detected in 20 of the 173 patients with PTC. It was not detected in the 20 patients with other types of thyroid cancer. Tissue BRAF status correlated with blood BRAF status.

“Overall we found that the BRAF mutation in blood conveyed about a two-and-a-half-fold relative risk of having active or recurrent disease,” said Dr. Grebe. “Potentially this will be an assay of increased value in the future.”

For now, clinicians have to rely on thyroglobulin, which has proved to be a good, but not perfect, tumor marker. Thyroglobulin is highly organ specific but cannot distinguish between benign and cancerous tumor tissue. Its reliability is compromised by residual thyroid tissue.

Perhaps more importantly, thyroglobulin is subject to analytical interferences with uninterpretable results in up to a quarter of patients and measurements. This is largely due to false negatives. “These limitations of thyroglobulin will get worse in the future,” said Dr. Grebe, who predicted that increasing numbers of thyroid cancer patients with even lower mortality will lead to less extensive treatment.

“I don't think in this day and age that you could convince a woman to have a radical mastectomy plus an extensive dissection for a 0.4-cm microcancer of the breast. The same will happen sooner or later with thyroid cancer,” he said. As a result, more patients will have remnant thyroid tissue producing greater background levels of thyroglobulin with greater TSH-related fluctuations.

Disclosures: Dr. Grebe reported that he has no relevant financial relationships.

MINNEAPOLIS — BRAF mutations may offer one answer to the growing need for biomarkers that can accurately predict the risk of thyroid cancer recurrence, said Dr. Stefan K.G. Grebe.

Thyroid cancer, with its rising incidence and low mortality rate, will be the third most common diagnosis in living cancer patients in the next 5–10 years, behind breast and prostate cancers, according to Dr. Grebe. For a newly diagnosed thyroid cancer patient, the lifetime risk of dying from the disease in 10 years—across all ages and stages—is less than 3%.

“We have to bear this in mind when we talk about prognostic markers…. Predictive markers may be more important because hardly anyone ever dies of thyroid cancer,” Dr. Grebe said at the meeting. Depending on the cancer morphotype, 15%–50% of patients will suffer a recurrence in their lifetime. “There really is a need for prolonged—over decades—follow-up of these patients,” which will require sensitive and specific means of detecting recurrences, he stressed.

The BRAF T1799A (V600E) mutation accounts for more than 90% of BRAF mutations in melanoma and papillary thyroid cancer (PTC). Importantly, this mutation is not found in normal tissue. While this mutation occurs in 40%–80% of melanomas and papillary thyroid cancers, it is present in fewer than 10% of other cancers, making it a good candidate biomarker for PTC recurrence, said Dr. Grebe, chair of clinical biochemistry and immunology in the department of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

A good candidate marker also needs a good test. In the case of BRAF V600E this means developing an assay that can detect nucleic acids with this mutation in human blood, plasma, or serum with high sensitivity and specificity. “For residual disease follow-up … you have to have a low sensitivity to detect a low number of mutant copies,” said Dr. Grebe, who has been working on the development of such an assay with his colleagues. They started by evaluating a number of assay techniques to detect BRAF V600E mutations. “Finally we settled on real-time PCR [polymerase chain reaction],” he said.

Once they achieved success with a proof-of-principle study, they prospectively collected blood from all thyroid cancer patients attending a follow-up visit between May 2004 and December 2006 (J. Clin. Endocrinol. Metab. 2009;94:5001–9).

They enrolled 193 patients, of whom 173 had papillary thyroid cancer. Circulating BRAF V600E was detected in 20 of the 173 patients with PTC. It was not detected in the 20 patients with other types of thyroid cancer. Tissue BRAF status correlated with blood BRAF status.

“Overall we found that the BRAF mutation in blood conveyed about a two-and-a-half-fold relative risk of having active or recurrent disease,” said Dr. Grebe. “Potentially this will be an assay of increased value in the future.”

For now, clinicians have to rely on thyroglobulin, which has proved to be a good, but not perfect, tumor marker. Thyroglobulin is highly organ specific but cannot distinguish between benign and cancerous tumor tissue. Its reliability is compromised by residual thyroid tissue.

Perhaps more importantly, thyroglobulin is subject to analytical interferences with uninterpretable results in up to a quarter of patients and measurements. This is largely due to false negatives. “These limitations of thyroglobulin will get worse in the future,” said Dr. Grebe, who predicted that increasing numbers of thyroid cancer patients with even lower mortality will lead to less extensive treatment.

“I don't think in this day and age that you could convince a woman to have a radical mastectomy plus an extensive dissection for a 0.4-cm microcancer of the breast. The same will happen sooner or later with thyroid cancer,” he said. As a result, more patients will have remnant thyroid tissue producing greater background levels of thyroglobulin with greater TSH-related fluctuations.

Disclosures: Dr. Grebe reported that he has no relevant financial relationships.

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Ultrasound-Assisted Lipoplasty Helps Recontour Jowls

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Ultrasound-Assisted Lipoplasty Helps Recontour Jowls

WASHINGTON — The removal of fat using ultrasound-assisted lipoplasty may be all it takes to recontour the jowls of younger patients and can complement techniques to recontour the jowls of older and more difficult-to-treat patients, said Dr. James C. Grotting.

Photos courtesy Dr. James C. Grotting
    A 34-year-old woman, unsatisfied with the fullness in her cheeks and jowls, is shown before UAL treatment.

Dr. Grotting has been using ultrasound-assisted liposuction (UAL) to recontour the jowls, "especially in the younger round-faced patient - who doesn't require a face lift - and the difficult, older, heavy-jowled patient."

"I think it's important to say that UAL is simply a tool that helps evenly and precisely remove the excess fat that contributes to the formation of the jowls," Dr. Grotting said at the annual meeting of the American Society for Aesthetic Plastic Surgery. "It's my opinion that UAL allows a little more control and may stimulate a modicum of skin retraction." This control helps to minimize the creation of visible lines, furrows, and other irregularities.

Dr. Grotting, a practicing plastic surgeon in Birmingham, Ala., grasps the fat to reposition and observe it to decide if he needs to reduce the amount of fat.

When performing UAL, he doubles the epinephrine injected, and hand-tunnels using the spatulated facial cannula to create the facial plane.  Low power ultrasound helps provide additional control. An incision is then made right in front of the earlobe because "if you get behind the ear lobe, sometimes you get behind the platysma and you could potentially damage the mandibular branch," he said.

    The patient was still pleased with the results at 3-years postsurgery.

The area to be contoured is just the jowl area, extending down into the neck. "It's important to make sure that you're in the subcutaneous plane," he said.

 "I've found this to be a very effective way to treat men - particularly men who are not interested in face lifts." He recommends being more aggressive when contouring the jowls in men because of the thickness of the skin. "I generally will come to the jowl from below."

Dr. Grotting did not have any relevant conflicts to disclose.

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WASHINGTON — The removal of fat using ultrasound-assisted lipoplasty may be all it takes to recontour the jowls of younger patients and can complement techniques to recontour the jowls of older and more difficult-to-treat patients, said Dr. James C. Grotting.

Photos courtesy Dr. James C. Grotting
    A 34-year-old woman, unsatisfied with the fullness in her cheeks and jowls, is shown before UAL treatment.

Dr. Grotting has been using ultrasound-assisted liposuction (UAL) to recontour the jowls, "especially in the younger round-faced patient - who doesn't require a face lift - and the difficult, older, heavy-jowled patient."

"I think it's important to say that UAL is simply a tool that helps evenly and precisely remove the excess fat that contributes to the formation of the jowls," Dr. Grotting said at the annual meeting of the American Society for Aesthetic Plastic Surgery. "It's my opinion that UAL allows a little more control and may stimulate a modicum of skin retraction." This control helps to minimize the creation of visible lines, furrows, and other irregularities.

Dr. Grotting, a practicing plastic surgeon in Birmingham, Ala., grasps the fat to reposition and observe it to decide if he needs to reduce the amount of fat.

When performing UAL, he doubles the epinephrine injected, and hand-tunnels using the spatulated facial cannula to create the facial plane.  Low power ultrasound helps provide additional control. An incision is then made right in front of the earlobe because "if you get behind the ear lobe, sometimes you get behind the platysma and you could potentially damage the mandibular branch," he said.

    The patient was still pleased with the results at 3-years postsurgery.

The area to be contoured is just the jowl area, extending down into the neck. "It's important to make sure that you're in the subcutaneous plane," he said.

 "I've found this to be a very effective way to treat men - particularly men who are not interested in face lifts." He recommends being more aggressive when contouring the jowls in men because of the thickness of the skin. "I generally will come to the jowl from below."

Dr. Grotting did not have any relevant conflicts to disclose.

WASHINGTON — The removal of fat using ultrasound-assisted lipoplasty may be all it takes to recontour the jowls of younger patients and can complement techniques to recontour the jowls of older and more difficult-to-treat patients, said Dr. James C. Grotting.

Photos courtesy Dr. James C. Grotting
    A 34-year-old woman, unsatisfied with the fullness in her cheeks and jowls, is shown before UAL treatment.

Dr. Grotting has been using ultrasound-assisted liposuction (UAL) to recontour the jowls, "especially in the younger round-faced patient - who doesn't require a face lift - and the difficult, older, heavy-jowled patient."

"I think it's important to say that UAL is simply a tool that helps evenly and precisely remove the excess fat that contributes to the formation of the jowls," Dr. Grotting said at the annual meeting of the American Society for Aesthetic Plastic Surgery. "It's my opinion that UAL allows a little more control and may stimulate a modicum of skin retraction." This control helps to minimize the creation of visible lines, furrows, and other irregularities.

Dr. Grotting, a practicing plastic surgeon in Birmingham, Ala., grasps the fat to reposition and observe it to decide if he needs to reduce the amount of fat.

When performing UAL, he doubles the epinephrine injected, and hand-tunnels using the spatulated facial cannula to create the facial plane.  Low power ultrasound helps provide additional control. An incision is then made right in front of the earlobe because "if you get behind the ear lobe, sometimes you get behind the platysma and you could potentially damage the mandibular branch," he said.

    The patient was still pleased with the results at 3-years postsurgery.

The area to be contoured is just the jowl area, extending down into the neck. "It's important to make sure that you're in the subcutaneous plane," he said.

 "I've found this to be a very effective way to treat men - particularly men who are not interested in face lifts." He recommends being more aggressive when contouring the jowls in men because of the thickness of the skin. "I generally will come to the jowl from below."

Dr. Grotting did not have any relevant conflicts to disclose.

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Pregnancy Possible After Fibroid Embolization : Uterine fibroid embolization is not the contraindication to conception it was thought to be.

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Pregnancy Possible After Fibroid Embolization : Uterine fibroid embolization is not the contraindication to conception it was thought to be.

Major Finding: Of the more than half of women who became pregnant after uterine fibroid embolization, 30 women had successful live births and seven pregnancies are ongoing; there were five abortions (one induced and four spontaneous) and one stillbirth.

Data Source: A study of 74 women who underwent UFE.

Disclosures: None was reported.

TAMPA — Pregnancy rates following treatment with uterine fibroid embolization are comparable to those with myomectomy, offering hope for women who choose embolization but still want to conceive, study results showed.

“Uterine fibroid embolization [UFE] is not a contraindication in patients who want to conceive,” Dr. Joao-Martins Pisco said at the meeting.

The fertility rate in a small population of women who underwent UFE was comparable to that reported for myomectomy—58% vs. 57%.

Dr. Pisco reported on 74 women who underwent UFE but still wished to become pregnant. More than half of the women (58%) had spontaneous pregnancies following the procedure. They ranged in age from 29 to 43 years (mean age, 36 years).

UFE is typically offered to women who no longer wish to become pregnant, and myomectomy is usually offered to women who still wish to become pregnant.

However, there are limited data on fertility rates and pregnancy outcomes following UFE to support this practice, said Dr. Pisco, an interventional radiologist at St. Louis Hospital in Lisbon.

None of the women in this series had been able to conceive prior to UFE. Before the procedure, the women were informed of the uncertain effect of UFE on fertility and pregnancy.

Polyvinyl alcohol particles or Embozene microspheres were used to embolize the uterine arteries.

The mean size of the dominant fibroid was 151 cc. The women were cautioned to wait at least 6 months before trying to conceive.

In all, 30 women (84%) had successful live births. Two of these babies (7%)were born prematurely. There were five abortions—one induced and four spontaneous.

One stillbirth occurred in a woman who had previously undergone five myomectomies and who had conceived through in vitro fertilization.

Seven of the remaining pregnancies are ongoing.

Dr. Pisco noted that larger, multicenter, randomized prospective studies are needed comparing UFE and myomectomy.

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Major Finding: Of the more than half of women who became pregnant after uterine fibroid embolization, 30 women had successful live births and seven pregnancies are ongoing; there were five abortions (one induced and four spontaneous) and one stillbirth.

Data Source: A study of 74 women who underwent UFE.

Disclosures: None was reported.

TAMPA — Pregnancy rates following treatment with uterine fibroid embolization are comparable to those with myomectomy, offering hope for women who choose embolization but still want to conceive, study results showed.

“Uterine fibroid embolization [UFE] is not a contraindication in patients who want to conceive,” Dr. Joao-Martins Pisco said at the meeting.

The fertility rate in a small population of women who underwent UFE was comparable to that reported for myomectomy—58% vs. 57%.

Dr. Pisco reported on 74 women who underwent UFE but still wished to become pregnant. More than half of the women (58%) had spontaneous pregnancies following the procedure. They ranged in age from 29 to 43 years (mean age, 36 years).

UFE is typically offered to women who no longer wish to become pregnant, and myomectomy is usually offered to women who still wish to become pregnant.

However, there are limited data on fertility rates and pregnancy outcomes following UFE to support this practice, said Dr. Pisco, an interventional radiologist at St. Louis Hospital in Lisbon.

None of the women in this series had been able to conceive prior to UFE. Before the procedure, the women were informed of the uncertain effect of UFE on fertility and pregnancy.

Polyvinyl alcohol particles or Embozene microspheres were used to embolize the uterine arteries.

The mean size of the dominant fibroid was 151 cc. The women were cautioned to wait at least 6 months before trying to conceive.

In all, 30 women (84%) had successful live births. Two of these babies (7%)were born prematurely. There were five abortions—one induced and four spontaneous.

One stillbirth occurred in a woman who had previously undergone five myomectomies and who had conceived through in vitro fertilization.

Seven of the remaining pregnancies are ongoing.

Dr. Pisco noted that larger, multicenter, randomized prospective studies are needed comparing UFE and myomectomy.

Major Finding: Of the more than half of women who became pregnant after uterine fibroid embolization, 30 women had successful live births and seven pregnancies are ongoing; there were five abortions (one induced and four spontaneous) and one stillbirth.

Data Source: A study of 74 women who underwent UFE.

Disclosures: None was reported.

TAMPA — Pregnancy rates following treatment with uterine fibroid embolization are comparable to those with myomectomy, offering hope for women who choose embolization but still want to conceive, study results showed.

“Uterine fibroid embolization [UFE] is not a contraindication in patients who want to conceive,” Dr. Joao-Martins Pisco said at the meeting.

The fertility rate in a small population of women who underwent UFE was comparable to that reported for myomectomy—58% vs. 57%.

Dr. Pisco reported on 74 women who underwent UFE but still wished to become pregnant. More than half of the women (58%) had spontaneous pregnancies following the procedure. They ranged in age from 29 to 43 years (mean age, 36 years).

UFE is typically offered to women who no longer wish to become pregnant, and myomectomy is usually offered to women who still wish to become pregnant.

However, there are limited data on fertility rates and pregnancy outcomes following UFE to support this practice, said Dr. Pisco, an interventional radiologist at St. Louis Hospital in Lisbon.

None of the women in this series had been able to conceive prior to UFE. Before the procedure, the women were informed of the uncertain effect of UFE on fertility and pregnancy.

Polyvinyl alcohol particles or Embozene microspheres were used to embolize the uterine arteries.

The mean size of the dominant fibroid was 151 cc. The women were cautioned to wait at least 6 months before trying to conceive.

In all, 30 women (84%) had successful live births. Two of these babies (7%)were born prematurely. There were five abortions—one induced and four spontaneous.

One stillbirth occurred in a woman who had previously undergone five myomectomies and who had conceived through in vitro fertilization.

Seven of the remaining pregnancies are ongoing.

Dr. Pisco noted that larger, multicenter, randomized prospective studies are needed comparing UFE and myomectomy.

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RSV Requires Hospitalizing About 3.4 M Yearly

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Major Finding: Mortality related to RSV infection worldwide was estimated to be 66,000-199,000 in children younger than 5 years in 2005, with a total of 99% of these deaths occurring in developing countries.

Data Source: Systematic review of 36 incidence studies, including 10 unpublished studies.

Disclosures: Study funded by the World Health Organization and the Bill & Melinda Gates Foundation.

An estimated 33.8 million new episodes of respiratory syncytial virus—associated acute lower respiratory infection occurred worldwide in children younger than 5 years of age in 2005, based on results of the first study to take a global view of this deadly infection.

The systematic review and meta-analysis used published and unpublished incidence and mortality data for respiratory syncytial virus (RSV)–associated acute lower respiratory infection (ALRI) in both industrialized and developing countries.

The researchers estimated that worldwide 3.4 million young children developed RSV-associated severe ALRI necessitating hospital admission, and an estimated 66,000-199,000 children younger than 5 years of age died of the infection. A total of 99% of these deaths occurred in developing countries, reported Dr. Harish Nair and his coauthors (Lancet 2010;375:1545-55).

The authors pointed out that “substantial uncertainty” surrounds case-fatality ratio estimates from developing countries. To that end, the researchers calculated three estimates of RSV-associated ALRI fatalities to assess the upper and lower bounds, yielding the 66,000-199,000 range.

The incidence of RSV-associated ALRI in developing nations was twice that for industrialized nations. “This estimate represents roughly 22% of all episodes of ALRI in young children,” wrote Dr. Nair, who is a public health sciences doctoral student at the University of Edinburgh, and colleagues.

In an accompanying commentary, Dr. Caroline Breese Hall, professor of pediatrics and infectious diseases at the University of Rochester (N.Y.), highlighted the importance of the study.

The researchers “provide the best current estimates of the global under-5 burden of RSV-associated acute lower respiratory tract infections, and convincingly posit the virus as the foremost cause of all lower respiratory tract infections in young children worldwide,” she said (Lancet 2010;375:1500-2).

The researchers started by performing a systematic literature review using a combination of search terms, manual searching of online journals, and scanning reference lists of identified citations. Studies were limited to those from January 1995 to June 2009. In addition, the researchers “invited the participation of researchers who had done similar studies resulting in unpublished data or supplementary data from published work.”

As inclusion criteria, the researchers chose to use ALRI and severe ALRI, including bronchiolitis and pneumonia. ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall with fast breathing for age. Severe ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall (with or without fast breathing for age) that required hospitalization.

They identified 36 studies with suitable data: 19 published population-based studies, 7 published studies based on hospital discharge records and laboratory diagnosis reports, and 10 unpublished population-based studies. The researchers noted that few studies reported data for the full age range (0-5 years).

The researchers performed a meta-analysis of incidence data and reported pooled estimates using the random effects model. They estimated the incidence for industrial and developing countries for 2005 and summed these estimates to get a global incidence estimate.

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Major Finding: Mortality related to RSV infection worldwide was estimated to be 66,000-199,000 in children younger than 5 years in 2005, with a total of 99% of these deaths occurring in developing countries.

Data Source: Systematic review of 36 incidence studies, including 10 unpublished studies.

Disclosures: Study funded by the World Health Organization and the Bill & Melinda Gates Foundation.

An estimated 33.8 million new episodes of respiratory syncytial virus—associated acute lower respiratory infection occurred worldwide in children younger than 5 years of age in 2005, based on results of the first study to take a global view of this deadly infection.

The systematic review and meta-analysis used published and unpublished incidence and mortality data for respiratory syncytial virus (RSV)–associated acute lower respiratory infection (ALRI) in both industrialized and developing countries.

The researchers estimated that worldwide 3.4 million young children developed RSV-associated severe ALRI necessitating hospital admission, and an estimated 66,000-199,000 children younger than 5 years of age died of the infection. A total of 99% of these deaths occurred in developing countries, reported Dr. Harish Nair and his coauthors (Lancet 2010;375:1545-55).

The authors pointed out that “substantial uncertainty” surrounds case-fatality ratio estimates from developing countries. To that end, the researchers calculated three estimates of RSV-associated ALRI fatalities to assess the upper and lower bounds, yielding the 66,000-199,000 range.

The incidence of RSV-associated ALRI in developing nations was twice that for industrialized nations. “This estimate represents roughly 22% of all episodes of ALRI in young children,” wrote Dr. Nair, who is a public health sciences doctoral student at the University of Edinburgh, and colleagues.

In an accompanying commentary, Dr. Caroline Breese Hall, professor of pediatrics and infectious diseases at the University of Rochester (N.Y.), highlighted the importance of the study.

The researchers “provide the best current estimates of the global under-5 burden of RSV-associated acute lower respiratory tract infections, and convincingly posit the virus as the foremost cause of all lower respiratory tract infections in young children worldwide,” she said (Lancet 2010;375:1500-2).

The researchers started by performing a systematic literature review using a combination of search terms, manual searching of online journals, and scanning reference lists of identified citations. Studies were limited to those from January 1995 to June 2009. In addition, the researchers “invited the participation of researchers who had done similar studies resulting in unpublished data or supplementary data from published work.”

As inclusion criteria, the researchers chose to use ALRI and severe ALRI, including bronchiolitis and pneumonia. ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall with fast breathing for age. Severe ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall (with or without fast breathing for age) that required hospitalization.

They identified 36 studies with suitable data: 19 published population-based studies, 7 published studies based on hospital discharge records and laboratory diagnosis reports, and 10 unpublished population-based studies. The researchers noted that few studies reported data for the full age range (0-5 years).

The researchers performed a meta-analysis of incidence data and reported pooled estimates using the random effects model. They estimated the incidence for industrial and developing countries for 2005 and summed these estimates to get a global incidence estimate.

Major Finding: Mortality related to RSV infection worldwide was estimated to be 66,000-199,000 in children younger than 5 years in 2005, with a total of 99% of these deaths occurring in developing countries.

Data Source: Systematic review of 36 incidence studies, including 10 unpublished studies.

Disclosures: Study funded by the World Health Organization and the Bill & Melinda Gates Foundation.

An estimated 33.8 million new episodes of respiratory syncytial virus—associated acute lower respiratory infection occurred worldwide in children younger than 5 years of age in 2005, based on results of the first study to take a global view of this deadly infection.

The systematic review and meta-analysis used published and unpublished incidence and mortality data for respiratory syncytial virus (RSV)–associated acute lower respiratory infection (ALRI) in both industrialized and developing countries.

The researchers estimated that worldwide 3.4 million young children developed RSV-associated severe ALRI necessitating hospital admission, and an estimated 66,000-199,000 children younger than 5 years of age died of the infection. A total of 99% of these deaths occurred in developing countries, reported Dr. Harish Nair and his coauthors (Lancet 2010;375:1545-55).

The authors pointed out that “substantial uncertainty” surrounds case-fatality ratio estimates from developing countries. To that end, the researchers calculated three estimates of RSV-associated ALRI fatalities to assess the upper and lower bounds, yielding the 66,000-199,000 range.

The incidence of RSV-associated ALRI in developing nations was twice that for industrialized nations. “This estimate represents roughly 22% of all episodes of ALRI in young children,” wrote Dr. Nair, who is a public health sciences doctoral student at the University of Edinburgh, and colleagues.

In an accompanying commentary, Dr. Caroline Breese Hall, professor of pediatrics and infectious diseases at the University of Rochester (N.Y.), highlighted the importance of the study.

The researchers “provide the best current estimates of the global under-5 burden of RSV-associated acute lower respiratory tract infections, and convincingly posit the virus as the foremost cause of all lower respiratory tract infections in young children worldwide,” she said (Lancet 2010;375:1500-2).

The researchers started by performing a systematic literature review using a combination of search terms, manual searching of online journals, and scanning reference lists of identified citations. Studies were limited to those from January 1995 to June 2009. In addition, the researchers “invited the participation of researchers who had done similar studies resulting in unpublished data or supplementary data from published work.”

As inclusion criteria, the researchers chose to use ALRI and severe ALRI, including bronchiolitis and pneumonia. ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall with fast breathing for age. Severe ALRI was considered the presence of cough or difficulty breathing with indrawing of the lower chest wall (with or without fast breathing for age) that required hospitalization.

They identified 36 studies with suitable data: 19 published population-based studies, 7 published studies based on hospital discharge records and laboratory diagnosis reports, and 10 unpublished population-based studies. The researchers noted that few studies reported data for the full age range (0-5 years).

The researchers performed a meta-analysis of incidence data and reported pooled estimates using the random effects model. They estimated the incidence for industrial and developing countries for 2005 and summed these estimates to get a global incidence estimate.

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ABI May Predict Coronary Disease in Low-Risk Patients

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ABI May Predict Coronary Disease in Low-Risk Patients

TAMPA — More than 10% of patients with low to intermediate risk for coronary heart disease have an abnormal ankle brachial index, putting them at a higher risk for MI and coronary death than predicted by conventional measures.

In a study of 822 individuals screened for peripheral artery disease (PAD), 11% of those with a low-risk Framingham Risk Score (FRS) for coronary disease and 13% of those with an intermediate-risk score had an abnormal ankle brachial index (ABI).

Abnormal ABI has been associated with increased risk of coronary heart disease (CHD) events and mortality, even in individuals at low to intermediate CHD risk (JAMA 2008;300:197-208), but prevalence estimates of abnormal ABI among older screening populations with low-intermediate FRS have not been reported previously.

“The prevalence of abnormal ABI is high, even in those a without high Framingham Risk Score. … The use of abnormal ABI in screening has the potential to improve risk prediction,” Dr. Raj Dhangana said.

The findings are good news, given that at least 60% of CHD events occur in individuals who were not known to be at high risk (BMJ 2003;327:1267). In fact, almost two-thirds of events occur in individuals who are at low or intermediate risk using the FRS (Am. Heart J. 2002;144:95-100).

The use of ABI for screening could help improve risk prediction for CHD, said Dr. Dhangana, a research fellow at Rhode Island Hospital, Providence.

The researchers analyzed data from the PEDAL Study (Population-Based Examinations to Determine Ankle-Brachial Index)—a multicenter, cross-sectional study conducted at 23 sites of the Legs for Life national free public PAD screening program in 2007-2009.

The FRS was calculated for each participant to determine 10-year risk of CHD. Based on their FRS, patients were stratified into three risk categories: low (less than 6%), intermediate (6%-19%), and high (at least 20%). An abnormal ABI was defined as less than 0.9 and/or greater than 1.4 in either leg.

A low FRS was observed in 256 individuals (31%), and 414 (50%) had an intermediate risk.

Disclosures: Dr. Dhangana has no relevant financial conflicts.

Ankle brachial index may help detect individuals at risk for coronary events.

Source ©Society of Interventional Radiology/www.SIRweb.org

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TAMPA — More than 10% of patients with low to intermediate risk for coronary heart disease have an abnormal ankle brachial index, putting them at a higher risk for MI and coronary death than predicted by conventional measures.

In a study of 822 individuals screened for peripheral artery disease (PAD), 11% of those with a low-risk Framingham Risk Score (FRS) for coronary disease and 13% of those with an intermediate-risk score had an abnormal ankle brachial index (ABI).

Abnormal ABI has been associated with increased risk of coronary heart disease (CHD) events and mortality, even in individuals at low to intermediate CHD risk (JAMA 2008;300:197-208), but prevalence estimates of abnormal ABI among older screening populations with low-intermediate FRS have not been reported previously.

“The prevalence of abnormal ABI is high, even in those a without high Framingham Risk Score. … The use of abnormal ABI in screening has the potential to improve risk prediction,” Dr. Raj Dhangana said.

The findings are good news, given that at least 60% of CHD events occur in individuals who were not known to be at high risk (BMJ 2003;327:1267). In fact, almost two-thirds of events occur in individuals who are at low or intermediate risk using the FRS (Am. Heart J. 2002;144:95-100).

The use of ABI for screening could help improve risk prediction for CHD, said Dr. Dhangana, a research fellow at Rhode Island Hospital, Providence.

The researchers analyzed data from the PEDAL Study (Population-Based Examinations to Determine Ankle-Brachial Index)—a multicenter, cross-sectional study conducted at 23 sites of the Legs for Life national free public PAD screening program in 2007-2009.

The FRS was calculated for each participant to determine 10-year risk of CHD. Based on their FRS, patients were stratified into three risk categories: low (less than 6%), intermediate (6%-19%), and high (at least 20%). An abnormal ABI was defined as less than 0.9 and/or greater than 1.4 in either leg.

A low FRS was observed in 256 individuals (31%), and 414 (50%) had an intermediate risk.

Disclosures: Dr. Dhangana has no relevant financial conflicts.

Ankle brachial index may help detect individuals at risk for coronary events.

Source ©Society of Interventional Radiology/www.SIRweb.org

TAMPA — More than 10% of patients with low to intermediate risk for coronary heart disease have an abnormal ankle brachial index, putting them at a higher risk for MI and coronary death than predicted by conventional measures.

In a study of 822 individuals screened for peripheral artery disease (PAD), 11% of those with a low-risk Framingham Risk Score (FRS) for coronary disease and 13% of those with an intermediate-risk score had an abnormal ankle brachial index (ABI).

Abnormal ABI has been associated with increased risk of coronary heart disease (CHD) events and mortality, even in individuals at low to intermediate CHD risk (JAMA 2008;300:197-208), but prevalence estimates of abnormal ABI among older screening populations with low-intermediate FRS have not been reported previously.

“The prevalence of abnormal ABI is high, even in those a without high Framingham Risk Score. … The use of abnormal ABI in screening has the potential to improve risk prediction,” Dr. Raj Dhangana said.

The findings are good news, given that at least 60% of CHD events occur in individuals who were not known to be at high risk (BMJ 2003;327:1267). In fact, almost two-thirds of events occur in individuals who are at low or intermediate risk using the FRS (Am. Heart J. 2002;144:95-100).

The use of ABI for screening could help improve risk prediction for CHD, said Dr. Dhangana, a research fellow at Rhode Island Hospital, Providence.

The researchers analyzed data from the PEDAL Study (Population-Based Examinations to Determine Ankle-Brachial Index)—a multicenter, cross-sectional study conducted at 23 sites of the Legs for Life national free public PAD screening program in 2007-2009.

The FRS was calculated for each participant to determine 10-year risk of CHD. Based on their FRS, patients were stratified into three risk categories: low (less than 6%), intermediate (6%-19%), and high (at least 20%). An abnormal ABI was defined as less than 0.9 and/or greater than 1.4 in either leg.

A low FRS was observed in 256 individuals (31%), and 414 (50%) had an intermediate risk.

Disclosures: Dr. Dhangana has no relevant financial conflicts.

Ankle brachial index may help detect individuals at risk for coronary events.

Source ©Society of Interventional Radiology/www.SIRweb.org

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Tamoxifen and Raloxifene Hold Up as Breast Cancer Prevention

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WASHINGTON — Tamoxifen and raloxifene offer women at high-risk of developing breast cancer two effective options to prevent the disease, based on 8 years of follow-up data for more than 19,000 women in the STAR trial.

While tamoxifen proved significantly more effective in preventing invasive breast cancer, there was no significant difference between the two drugs in preventing noninvasive breast cancer. And raloxifene (Evista) had significantly less toxicity, including endometrial cancer, thromboembolic complications, and cataracts.

“These data are good news for postmenopausal women who want to reduce their risk of breast cancer,” said Dr. D. Lawrence Wickerham, associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). “The important message is that both [drugs] are options. The decision is a shared one between the patient and her physician.”

Dr. Wickerham presented the latest results for the Study of Tamoxifen and Raloxifene (STAR) trial during a late-breaker session at the annual meeting of the American Association for Cancer Research. The results were also published in the journal Cancer Prevention Research (2010 April 19 [doi:10.1158/1940-6207.CAPR-10-0076

Oncologists at the meeting expressed frustration that more women at high risk are not on the drugs, given the proven efficacy of the two selective estrogen receptor modulators (SERMs) in preventing breast cancer. “I have to ask, why aren't the results of the BCPT [breast cancer prevention trial] and STAR trials more vigorously applied in clinical practice?” said Dr. Gabriel N. Hortobagyi, who was the invited discussant.

Dr. Wickerham echoed this frustration during a press conference. “I see women each week, at a high risk of breast cancer, and I will end up telling one or two of them … all too often … that they have breast cancer. I'd love for that part of my job to go away. These data are a step in that direction,” said Dr. Wickerham, chief of the cancer genetics and prevention section at Allegheny General Hospital in Pittsburgh.

The randomized, double-blind federally funded STAR trial included women at least 35 years of age with a 5-year predicted breast cancer risk of at least 1.66% (based on a modified version of the Gail model). Researchers from the NSABP randomized 19,747 women to receive either tamoxifen or raloxifene (JAMA 2006;295:2742–51).

The update includes 19,490 women—9,736 on tamoxifen and 9,754 on raloxifene. The differences in numbers are due to a combination of loss during follow-up or follow-up data becoming available for women who were lost to follow-up in the original report. Women on tamoxifen received 20 mg/day and those on raloxifene received 60 mg/day.

At an average follow-up of 8 years, the relative risk of invasive breast cancer on raloxifene was 1.24 compared with tamoxifen, which was significant. Both drugs reduced the risk of invasive breast cancer by roughly 50% in the original report (median follow-up 47 months).

In this analysis, “we have estimated, however, that this difference in the raloxifene-treated group represents 76% of tamoxifen's chemopreventative benefit, which translates into at 38% reduction in invasive breast cancers,” Dr. Wickerham reported.

In the 2006 report, raloxifene (81 events) did not appear to be as effective as tamoxifen (57 events) in preventing noninvasive breast cancer. “Now with additional follow-up, those differences have narrowed,” he said. At 8 years, there was no statistical significance between the two groups, with a risk ratio of 1.22. The relative risk of 1.22 favors tamoxifen, but raloxifene preserves 78% of the chemopreventative benefit of tamoxifen. This translates to raloxifene preventing 39% of noninvasive breast cancers.

Raloxifene maintained its toxicity advantage. The relative risk of uterine cancers with raloxifene vs. tamoxifen was 0.55. In addition, there were twice as many hysterectomies for benign disease in the tamoxifen group. This was due in part to an 80% increase in hyperplasia of the endometrium that occurred in women on tamoxifen, Dr. Wickerham said.

Both drugs increase the risk of thromboembolic complications, but there were significantly fewer of these events in women on raloxifene (154), compared with tamoxifen (202).

Dr. Hortobagyi, director of the breast cancer research program at the University of Texas M.D. Anderson Cancer Center in Houston, identified several factors that may be responsible for limited use of tamoxifen and raloxifene for prevention. He cited misinformation about the drugs, fears about toxicities, limited high-risk prediction tools, lack of a marker or measurement to monitor for risk reduction, cost, and insufficient public and professional education about the drugs.

“There is no perfect drug. Certainly in other areas of preventive medicine, there seems to be greater tolerance for adverse effects for effective preventative interventions,” he said, noting a discrepancy between what is considered acceptable risk for other preventative drugs and SERMs. For example, drugs used to prevent hypertension and coronary artery disease have more adverse events and more serious events than do SERMs, he said.

 

 

“The adverse effects of SERMs pale in comparison to the complications of and disability caused by breast cancer,” Dr. Hortobagyi said. “So the challenge today is how to communicate to the public to enhance the utilization of SERMs and reduce further the incidence of breast cancer.”

Disclosures: The study was supported by the National Cancer Institute. Dr. Wickerham reported that he has consulted for Eli Lilly. Dr. Hortobagyi reported no conflicts of interest.

“These data are good news,” Dr. D. Lawrence Wickerham commented.

Source: Kerri Wachter/Elsevier Global Medical News

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WASHINGTON — Tamoxifen and raloxifene offer women at high-risk of developing breast cancer two effective options to prevent the disease, based on 8 years of follow-up data for more than 19,000 women in the STAR trial.

While tamoxifen proved significantly more effective in preventing invasive breast cancer, there was no significant difference between the two drugs in preventing noninvasive breast cancer. And raloxifene (Evista) had significantly less toxicity, including endometrial cancer, thromboembolic complications, and cataracts.

“These data are good news for postmenopausal women who want to reduce their risk of breast cancer,” said Dr. D. Lawrence Wickerham, associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). “The important message is that both [drugs] are options. The decision is a shared one between the patient and her physician.”

Dr. Wickerham presented the latest results for the Study of Tamoxifen and Raloxifene (STAR) trial during a late-breaker session at the annual meeting of the American Association for Cancer Research. The results were also published in the journal Cancer Prevention Research (2010 April 19 [doi:10.1158/1940-6207.CAPR-10-0076

Oncologists at the meeting expressed frustration that more women at high risk are not on the drugs, given the proven efficacy of the two selective estrogen receptor modulators (SERMs) in preventing breast cancer. “I have to ask, why aren't the results of the BCPT [breast cancer prevention trial] and STAR trials more vigorously applied in clinical practice?” said Dr. Gabriel N. Hortobagyi, who was the invited discussant.

Dr. Wickerham echoed this frustration during a press conference. “I see women each week, at a high risk of breast cancer, and I will end up telling one or two of them … all too often … that they have breast cancer. I'd love for that part of my job to go away. These data are a step in that direction,” said Dr. Wickerham, chief of the cancer genetics and prevention section at Allegheny General Hospital in Pittsburgh.

The randomized, double-blind federally funded STAR trial included women at least 35 years of age with a 5-year predicted breast cancer risk of at least 1.66% (based on a modified version of the Gail model). Researchers from the NSABP randomized 19,747 women to receive either tamoxifen or raloxifene (JAMA 2006;295:2742–51).

The update includes 19,490 women—9,736 on tamoxifen and 9,754 on raloxifene. The differences in numbers are due to a combination of loss during follow-up or follow-up data becoming available for women who were lost to follow-up in the original report. Women on tamoxifen received 20 mg/day and those on raloxifene received 60 mg/day.

At an average follow-up of 8 years, the relative risk of invasive breast cancer on raloxifene was 1.24 compared with tamoxifen, which was significant. Both drugs reduced the risk of invasive breast cancer by roughly 50% in the original report (median follow-up 47 months).

In this analysis, “we have estimated, however, that this difference in the raloxifene-treated group represents 76% of tamoxifen's chemopreventative benefit, which translates into at 38% reduction in invasive breast cancers,” Dr. Wickerham reported.

In the 2006 report, raloxifene (81 events) did not appear to be as effective as tamoxifen (57 events) in preventing noninvasive breast cancer. “Now with additional follow-up, those differences have narrowed,” he said. At 8 years, there was no statistical significance between the two groups, with a risk ratio of 1.22. The relative risk of 1.22 favors tamoxifen, but raloxifene preserves 78% of the chemopreventative benefit of tamoxifen. This translates to raloxifene preventing 39% of noninvasive breast cancers.

Raloxifene maintained its toxicity advantage. The relative risk of uterine cancers with raloxifene vs. tamoxifen was 0.55. In addition, there were twice as many hysterectomies for benign disease in the tamoxifen group. This was due in part to an 80% increase in hyperplasia of the endometrium that occurred in women on tamoxifen, Dr. Wickerham said.

Both drugs increase the risk of thromboembolic complications, but there were significantly fewer of these events in women on raloxifene (154), compared with tamoxifen (202).

Dr. Hortobagyi, director of the breast cancer research program at the University of Texas M.D. Anderson Cancer Center in Houston, identified several factors that may be responsible for limited use of tamoxifen and raloxifene for prevention. He cited misinformation about the drugs, fears about toxicities, limited high-risk prediction tools, lack of a marker or measurement to monitor for risk reduction, cost, and insufficient public and professional education about the drugs.

“There is no perfect drug. Certainly in other areas of preventive medicine, there seems to be greater tolerance for adverse effects for effective preventative interventions,” he said, noting a discrepancy between what is considered acceptable risk for other preventative drugs and SERMs. For example, drugs used to prevent hypertension and coronary artery disease have more adverse events and more serious events than do SERMs, he said.

 

 

“The adverse effects of SERMs pale in comparison to the complications of and disability caused by breast cancer,” Dr. Hortobagyi said. “So the challenge today is how to communicate to the public to enhance the utilization of SERMs and reduce further the incidence of breast cancer.”

Disclosures: The study was supported by the National Cancer Institute. Dr. Wickerham reported that he has consulted for Eli Lilly. Dr. Hortobagyi reported no conflicts of interest.

“These data are good news,” Dr. D. Lawrence Wickerham commented.

Source: Kerri Wachter/Elsevier Global Medical News

WASHINGTON — Tamoxifen and raloxifene offer women at high-risk of developing breast cancer two effective options to prevent the disease, based on 8 years of follow-up data for more than 19,000 women in the STAR trial.

While tamoxifen proved significantly more effective in preventing invasive breast cancer, there was no significant difference between the two drugs in preventing noninvasive breast cancer. And raloxifene (Evista) had significantly less toxicity, including endometrial cancer, thromboembolic complications, and cataracts.

“These data are good news for postmenopausal women who want to reduce their risk of breast cancer,” said Dr. D. Lawrence Wickerham, associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). “The important message is that both [drugs] are options. The decision is a shared one between the patient and her physician.”

Dr. Wickerham presented the latest results for the Study of Tamoxifen and Raloxifene (STAR) trial during a late-breaker session at the annual meeting of the American Association for Cancer Research. The results were also published in the journal Cancer Prevention Research (2010 April 19 [doi:10.1158/1940-6207.CAPR-10-0076

Oncologists at the meeting expressed frustration that more women at high risk are not on the drugs, given the proven efficacy of the two selective estrogen receptor modulators (SERMs) in preventing breast cancer. “I have to ask, why aren't the results of the BCPT [breast cancer prevention trial] and STAR trials more vigorously applied in clinical practice?” said Dr. Gabriel N. Hortobagyi, who was the invited discussant.

Dr. Wickerham echoed this frustration during a press conference. “I see women each week, at a high risk of breast cancer, and I will end up telling one or two of them … all too often … that they have breast cancer. I'd love for that part of my job to go away. These data are a step in that direction,” said Dr. Wickerham, chief of the cancer genetics and prevention section at Allegheny General Hospital in Pittsburgh.

The randomized, double-blind federally funded STAR trial included women at least 35 years of age with a 5-year predicted breast cancer risk of at least 1.66% (based on a modified version of the Gail model). Researchers from the NSABP randomized 19,747 women to receive either tamoxifen or raloxifene (JAMA 2006;295:2742–51).

The update includes 19,490 women—9,736 on tamoxifen and 9,754 on raloxifene. The differences in numbers are due to a combination of loss during follow-up or follow-up data becoming available for women who were lost to follow-up in the original report. Women on tamoxifen received 20 mg/day and those on raloxifene received 60 mg/day.

At an average follow-up of 8 years, the relative risk of invasive breast cancer on raloxifene was 1.24 compared with tamoxifen, which was significant. Both drugs reduced the risk of invasive breast cancer by roughly 50% in the original report (median follow-up 47 months).

In this analysis, “we have estimated, however, that this difference in the raloxifene-treated group represents 76% of tamoxifen's chemopreventative benefit, which translates into at 38% reduction in invasive breast cancers,” Dr. Wickerham reported.

In the 2006 report, raloxifene (81 events) did not appear to be as effective as tamoxifen (57 events) in preventing noninvasive breast cancer. “Now with additional follow-up, those differences have narrowed,” he said. At 8 years, there was no statistical significance between the two groups, with a risk ratio of 1.22. The relative risk of 1.22 favors tamoxifen, but raloxifene preserves 78% of the chemopreventative benefit of tamoxifen. This translates to raloxifene preventing 39% of noninvasive breast cancers.

Raloxifene maintained its toxicity advantage. The relative risk of uterine cancers with raloxifene vs. tamoxifen was 0.55. In addition, there were twice as many hysterectomies for benign disease in the tamoxifen group. This was due in part to an 80% increase in hyperplasia of the endometrium that occurred in women on tamoxifen, Dr. Wickerham said.

Both drugs increase the risk of thromboembolic complications, but there were significantly fewer of these events in women on raloxifene (154), compared with tamoxifen (202).

Dr. Hortobagyi, director of the breast cancer research program at the University of Texas M.D. Anderson Cancer Center in Houston, identified several factors that may be responsible for limited use of tamoxifen and raloxifene for prevention. He cited misinformation about the drugs, fears about toxicities, limited high-risk prediction tools, lack of a marker or measurement to monitor for risk reduction, cost, and insufficient public and professional education about the drugs.

“There is no perfect drug. Certainly in other areas of preventive medicine, there seems to be greater tolerance for adverse effects for effective preventative interventions,” he said, noting a discrepancy between what is considered acceptable risk for other preventative drugs and SERMs. For example, drugs used to prevent hypertension and coronary artery disease have more adverse events and more serious events than do SERMs, he said.

 

 

“The adverse effects of SERMs pale in comparison to the complications of and disability caused by breast cancer,” Dr. Hortobagyi said. “So the challenge today is how to communicate to the public to enhance the utilization of SERMs and reduce further the incidence of breast cancer.”

Disclosures: The study was supported by the National Cancer Institute. Dr. Wickerham reported that he has consulted for Eli Lilly. Dr. Hortobagyi reported no conflicts of interest.

“These data are good news,” Dr. D. Lawrence Wickerham commented.

Source: Kerri Wachter/Elsevier Global Medical News

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MRgFUS Improved Fibroid Symptoms

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MRgFUS Improved Fibroid Symptoms

Major Finding: In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

Data Source: A study of 69 women with fibroids who underwent MRgFUS and rated their percent improvement.

Disclosures: Dr. Hesley reported that she has received research grant support for other studies from InSightec, which makes the ExAblate system. However, this study was not funded by outside sources

TAMPA — Ninety percent of women who underwent magnetic resonance–guided focused ultrasound ablation for uterine fibroids reported their symptom improvement as excellent or considerable at 12 months' follow-up, in a small study of the noninvasive treatment.

“This is an effective noninvasive treatment option for patients, with an alternative treatment rate and reported symptom improvement in patients that is very comparable to the literature for myomectomy and uterine artery embolization,” Dr. Gina K. Hesley said at the annual meeting of the Society of Interventional Radiology.

In MR-guided focused ultrasound ablation (MRgFUS), high-intensity focused ultrasound is used during an MR scan to thermally destroy pathogenic tissue—in this case fibroids. The main advantage of MRgFUS is that the procedure is noninvasive. The concomitant use of MRI allows precise targeting of the fibroid and monitoring of the temperature increase in the fibroid tissue.

A total of 125 patients were scheduled for MRgFUS at the Mayo Clinic between March 2005 and September 2008. The researchers followed 119 patients who completed MRgFUS treatment for 12 months using phone interviews to assess symptomatic relief and any additional procedures for fibroid-related symptoms. Additional treatments included uterine embolization, myomectomy, hysterectomy, and gonadotropin-releasing hormone agonist treatment.

The women in the study were premenopausal and had no desire to have children in the future, noted Dr. Hesley, a radiologist at the Mayo Clinic in Rochester, Minn. They had to have at least one uterine fibroid of at least 3 cm in diameter.

Women with many uterine fibroids were counseled to have uterine embolization instead of MRgFUS.

Symptomatic improvement was self-reported based on percent improvement. The researchers considered 0%-10% improvement as insignificant, 11%-40% improvement as moderate, 41%-70% improvement as considerable, and 71%-100% as excellent.

Following treatment, 15 patients were lost to follow-up and 4 patients had their fibroids removed during surgeries performed for reasons unrelated to fibroid symptoms. Of the remaining 100 patients, 8 underwent alternative treatments: 6 patients had hysterectomies, and 2 had myomectomies.

A total of 11 patients did not provide any information about symptomatic improvement, leaving 89 patients available for a phone interview at 12-months' follow-up.

Of these, 97% reported overall symptom improvement. A total of 69 patients rated their percent improvement. In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

The researchers have received initial approval for National Institutes of Health funding of a randomized controlled trial comparing MRgFUS and uterine embolization.

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Major Finding: In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

Data Source: A study of 69 women with fibroids who underwent MRgFUS and rated their percent improvement.

Disclosures: Dr. Hesley reported that she has received research grant support for other studies from InSightec, which makes the ExAblate system. However, this study was not funded by outside sources

TAMPA — Ninety percent of women who underwent magnetic resonance–guided focused ultrasound ablation for uterine fibroids reported their symptom improvement as excellent or considerable at 12 months' follow-up, in a small study of the noninvasive treatment.

“This is an effective noninvasive treatment option for patients, with an alternative treatment rate and reported symptom improvement in patients that is very comparable to the literature for myomectomy and uterine artery embolization,” Dr. Gina K. Hesley said at the annual meeting of the Society of Interventional Radiology.

In MR-guided focused ultrasound ablation (MRgFUS), high-intensity focused ultrasound is used during an MR scan to thermally destroy pathogenic tissue—in this case fibroids. The main advantage of MRgFUS is that the procedure is noninvasive. The concomitant use of MRI allows precise targeting of the fibroid and monitoring of the temperature increase in the fibroid tissue.

A total of 125 patients were scheduled for MRgFUS at the Mayo Clinic between March 2005 and September 2008. The researchers followed 119 patients who completed MRgFUS treatment for 12 months using phone interviews to assess symptomatic relief and any additional procedures for fibroid-related symptoms. Additional treatments included uterine embolization, myomectomy, hysterectomy, and gonadotropin-releasing hormone agonist treatment.

The women in the study were premenopausal and had no desire to have children in the future, noted Dr. Hesley, a radiologist at the Mayo Clinic in Rochester, Minn. They had to have at least one uterine fibroid of at least 3 cm in diameter.

Women with many uterine fibroids were counseled to have uterine embolization instead of MRgFUS.

Symptomatic improvement was self-reported based on percent improvement. The researchers considered 0%-10% improvement as insignificant, 11%-40% improvement as moderate, 41%-70% improvement as considerable, and 71%-100% as excellent.

Following treatment, 15 patients were lost to follow-up and 4 patients had their fibroids removed during surgeries performed for reasons unrelated to fibroid symptoms. Of the remaining 100 patients, 8 underwent alternative treatments: 6 patients had hysterectomies, and 2 had myomectomies.

A total of 11 patients did not provide any information about symptomatic improvement, leaving 89 patients available for a phone interview at 12-months' follow-up.

Of these, 97% reported overall symptom improvement. A total of 69 patients rated their percent improvement. In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

The researchers have received initial approval for National Institutes of Health funding of a randomized controlled trial comparing MRgFUS and uterine embolization.

Major Finding: In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

Data Source: A study of 69 women with fibroids who underwent MRgFUS and rated their percent improvement.

Disclosures: Dr. Hesley reported that she has received research grant support for other studies from InSightec, which makes the ExAblate system. However, this study was not funded by outside sources

TAMPA — Ninety percent of women who underwent magnetic resonance–guided focused ultrasound ablation for uterine fibroids reported their symptom improvement as excellent or considerable at 12 months' follow-up, in a small study of the noninvasive treatment.

“This is an effective noninvasive treatment option for patients, with an alternative treatment rate and reported symptom improvement in patients that is very comparable to the literature for myomectomy and uterine artery embolization,” Dr. Gina K. Hesley said at the annual meeting of the Society of Interventional Radiology.

In MR-guided focused ultrasound ablation (MRgFUS), high-intensity focused ultrasound is used during an MR scan to thermally destroy pathogenic tissue—in this case fibroids. The main advantage of MRgFUS is that the procedure is noninvasive. The concomitant use of MRI allows precise targeting of the fibroid and monitoring of the temperature increase in the fibroid tissue.

A total of 125 patients were scheduled for MRgFUS at the Mayo Clinic between March 2005 and September 2008. The researchers followed 119 patients who completed MRgFUS treatment for 12 months using phone interviews to assess symptomatic relief and any additional procedures for fibroid-related symptoms. Additional treatments included uterine embolization, myomectomy, hysterectomy, and gonadotropin-releasing hormone agonist treatment.

The women in the study were premenopausal and had no desire to have children in the future, noted Dr. Hesley, a radiologist at the Mayo Clinic in Rochester, Minn. They had to have at least one uterine fibroid of at least 3 cm in diameter.

Women with many uterine fibroids were counseled to have uterine embolization instead of MRgFUS.

Symptomatic improvement was self-reported based on percent improvement. The researchers considered 0%-10% improvement as insignificant, 11%-40% improvement as moderate, 41%-70% improvement as considerable, and 71%-100% as excellent.

Following treatment, 15 patients were lost to follow-up and 4 patients had their fibroids removed during surgeries performed for reasons unrelated to fibroid symptoms. Of the remaining 100 patients, 8 underwent alternative treatments: 6 patients had hysterectomies, and 2 had myomectomies.

A total of 11 patients did not provide any information about symptomatic improvement, leaving 89 patients available for a phone interview at 12-months' follow-up.

Of these, 97% reported overall symptom improvement. A total of 69 patients rated their percent improvement. In all, 74% rated their symptom improvement as excellent, 16% as considerable, 9% as moderate, and 1% as insignificant.

The researchers have received initial approval for National Institutes of Health funding of a randomized controlled trial comparing MRgFUS and uterine embolization.

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Wingspan Stent Effective in Intracranial Lesions

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SAN ANTONIO — The Gateway balloon-Wingspan stent system was an effective and safe treatment option for patients with intracranial lesions with more than 50% stenosis, Dr. R. Charles Callison, Jr., said at the annual International Stroke Conference.

Dr. Callision, of the division of interventional neuroradiology at the University of Iowa, Iowa City, used a comprehensive database of all patients undergoing endovascular treatment of symptomatic intracranial atheromatous disease (sICAD) with the Wingspan stent system during December 2005–July 2009. In all, 110 patients with 138 lesions were treated. Greater than 50% stenosis occurred in 50 lesions, followed by 70%–80% stenosis for 48 lesions, and 50%–69% for 37 lesions.

Technical success was achieved in 99% of lesions. There were two failures to cross a balloon or stent. Acute in-stent thrombosis was noted periprocedurally in 11% of cases, all of which were successfully treated with intravenous tirofiban.

The combined major stroke and death rate in the first 30 days—a coprimary end point—was 5.5% (mortality 1.8%). The rate of ipsilateral stroke and death after 30 days—a coprimary end point—was 1.8% (no mortality). Eight minor ischemic events occurred; all were transient ischemic attacks.

On angiography, the initial mean stenosis rate was 77%. The postprocedure stenosis rate was 18% and 19% of lesions required post dilation.

Dr. Callison reported that he has no relevant financial relationships. One of his coinvestigators is a consultant for Boston Scientific, maker of the Wingspan stent.

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SAN ANTONIO — The Gateway balloon-Wingspan stent system was an effective and safe treatment option for patients with intracranial lesions with more than 50% stenosis, Dr. R. Charles Callison, Jr., said at the annual International Stroke Conference.

Dr. Callision, of the division of interventional neuroradiology at the University of Iowa, Iowa City, used a comprehensive database of all patients undergoing endovascular treatment of symptomatic intracranial atheromatous disease (sICAD) with the Wingspan stent system during December 2005–July 2009. In all, 110 patients with 138 lesions were treated. Greater than 50% stenosis occurred in 50 lesions, followed by 70%–80% stenosis for 48 lesions, and 50%–69% for 37 lesions.

Technical success was achieved in 99% of lesions. There were two failures to cross a balloon or stent. Acute in-stent thrombosis was noted periprocedurally in 11% of cases, all of which were successfully treated with intravenous tirofiban.

The combined major stroke and death rate in the first 30 days—a coprimary end point—was 5.5% (mortality 1.8%). The rate of ipsilateral stroke and death after 30 days—a coprimary end point—was 1.8% (no mortality). Eight minor ischemic events occurred; all were transient ischemic attacks.

On angiography, the initial mean stenosis rate was 77%. The postprocedure stenosis rate was 18% and 19% of lesions required post dilation.

Dr. Callison reported that he has no relevant financial relationships. One of his coinvestigators is a consultant for Boston Scientific, maker of the Wingspan stent.

SAN ANTONIO — The Gateway balloon-Wingspan stent system was an effective and safe treatment option for patients with intracranial lesions with more than 50% stenosis, Dr. R. Charles Callison, Jr., said at the annual International Stroke Conference.

Dr. Callision, of the division of interventional neuroradiology at the University of Iowa, Iowa City, used a comprehensive database of all patients undergoing endovascular treatment of symptomatic intracranial atheromatous disease (sICAD) with the Wingspan stent system during December 2005–July 2009. In all, 110 patients with 138 lesions were treated. Greater than 50% stenosis occurred in 50 lesions, followed by 70%–80% stenosis for 48 lesions, and 50%–69% for 37 lesions.

Technical success was achieved in 99% of lesions. There were two failures to cross a balloon or stent. Acute in-stent thrombosis was noted periprocedurally in 11% of cases, all of which were successfully treated with intravenous tirofiban.

The combined major stroke and death rate in the first 30 days—a coprimary end point—was 5.5% (mortality 1.8%). The rate of ipsilateral stroke and death after 30 days—a coprimary end point—was 1.8% (no mortality). Eight minor ischemic events occurred; all were transient ischemic attacks.

On angiography, the initial mean stenosis rate was 77%. The postprocedure stenosis rate was 18% and 19% of lesions required post dilation.

Dr. Callison reported that he has no relevant financial relationships. One of his coinvestigators is a consultant for Boston Scientific, maker of the Wingspan stent.

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