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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Lung Function Alone a Poor Marker of Asthma Control in Children
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF ALLERGY, ASTHMA, AND IMMUNOLOGY
Lung Function Alone a Poor Marker of Asthma Control in Children
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
SAN FRANCISCO – Lung function alone is a poor marker of asthma control in children, results from a large retrospective analysis demonstrated.
"Physicians should use all components of the 2007 National Asthma Education and Prevention Program Expert Report 3 guidelines, asking questions to patients not only about daytime and nighttime symptoms, but doing lung function testing as well," Dr. Edward K. Hu advised during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "Even [among] those patients who are enrolled in a disease management program, there is still going to be a large minority who are going to be uncontrolled in one way or another, despite follow-up visits and seeing asthma specialists."
Dr. Hu, a fellow in the division of allergy and immunology at the Los Angeles County/University of Southern California Medical Center, Los Angeles, and his associates studied 453 children aged 5-18 years who were enrolled in an asthma management program in Los Angeles County in 2009 and who made a total of 886 follow-up visits. Initial analysis defined asthma control based solely on lung function. Secondary analysis included all components of asthma control based on the 2007 National Asthma Education and Prevention Program Expert Report 3, which included impairment and risk. Of the 453 children, 61% were male and 83% were Hispanic.
At baseline more than one-quarter of patients (29%) had intermittent disease, 21% had mild persistent disease, 25% had moderate persistent disease, and 25% had severe persistent disease.
Dr. Hu reported that when lung function alone was used, 17% of children exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Inclusion of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
The researchers also found that males, aged 8-11 years, were significantly more likely than their female counterparts to present with normal lung function and uncontrolled disease due to other factors (24% vs. 15%).
Dr. Hu said that he had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF ALLERGY, ASTHMA, AND IMMUNOLOGY
Major Finding: When lung function alone was used as a marker of asthma control in children, 17% of patients exhibited asthma that was not well controlled, and 5% exhibited asthma that was poorly controlled. Consideration of impairment and risk resulted in a downgrade of asthma control in an additional 22% of children.
Data Source: A study of 453 children enrolled in an asthma management program who made a total of 886 follow-up visits.
Disclosures: Dr. Hu said that he had no relevant financial disclosures.
Medical Treatment, Surgery Relieve Venous Disease Symptoms
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN VENOUS FORUM
Major Finding: Patients whose symptom scores improved after conservative treatment for varicose veins were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores.
Data Source: A single-center study of 150 patients with CEAP class 2-4 primary chronic venous disease.
Disclosures: Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
Medical Treatment, Surgery Relieve Venous Disease Symptoms
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
SAN DIEGO - Patients with chronic venous disease who were treated surgically were significantly more likely to experience relief of symptoms than were those who underwent conservative therapy, results from a single-center study showed.
"The interventional treatment of varicose veins is considered to be medically necessary by insurance policies if the patient remains symptomatic after compression stockings or conservative therapy," Dr. Fedor Lurie said at the annual meeting of the American Venous Forum. "This is despite the fact that little is known about symptoms of chronic venous disease. Even less known is how the symptoms of chronic venous disease react to treatment."
Dr. Lurie and his colleague, Dr. Robert L. Kistner, prospectively studied 150 patients (59 men, 91 women; mean age 55 years) with CEAP class 2-4 primary chronic venous disease who were treated at the Kistner Vein Clinic in Honolulu during a 12-month period. (CEAP is a classification system based on the elements of Clinical severity, Etiology or cause, Anatomy, and Pathophysiology.) Initial treatment consisted of compression stockings and other conservative measures, after which patients chose whether to continue conservative treatment or undergo surgery.
Patients completed the Specific Quality of Life and Outcome Response-Venous (SQOR-V) assessment prior to the initial visit, after completion of conservative treatment, and at 1- and 12-month follow-up visits after surgical treatment. The quality of life and symptom score components of this tool were analyzed separately.
Following conservative treatment, symptom scores improved in 85 patients (57%), while quality of life scores improved in 111 patients (74%). Despite this improvement, 121 patients (81%) chose to undergo surgical treatment.
During the 1-month follow-up after surgical treatment, symptom scores improved in 97 patients (80%), while quality of life scores improved in 114 patients (94%).
Dr. Lurie also reported that 51 of 65 patients who did not improve after conservative treatment were treated surgically. Of those 51, only 30 (59%) improved after surgery.
Patients whose symptom scores improved after conservative treatment were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores. They were also 9.4 times more likely to have improved quality of life at 1 month and 4.3 times more likely to have improved quality of life at 1 year.
"The relief of symptoms by conservative therapy is a good predictor of successful surgical treatment," said Dr. Lurie, who is also a clinical professor of vascular surgery at the University of Hawaii. "These findings contradict the present practice of insurance policies that interpret the success of conservative measures as a contraindication to surgical treatment, and provide evidence that those who respond favorably to conservative treatment are the ones who will benefit greatly from surgical elimination of the venous reflux."
He concluded by noting that when the treatment goal is relief of symptoms, "success of conservative therapy should be considered an indication for surgical treatment, and the failure of conservative therapy should be an indication for reconsideration of the true cause of the symptoms."
Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN VENOUS FORUM
Major Finding: Patients whose symptom scores improved after conservative treatment for varicose veins were 15.2 times more likely to have symptom relief at 1 month and 21.3 times more likely to have symptom relief at 1 year than were those who had no improvement in symptom scores.
Data Source: A single-center study of 150 patients with CEAP class 2-4 primary chronic venous disease.
Disclosures: Dr. Lurie and Dr. Kistner said that they had no relevant financial disclosures.
Study Questions Using Biomarker Targets to Improve CKD Outcomes
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
FROM JAMA
Major Finding: Among patients with chronic kidney disease, the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus (relative risk of 1.18), but there were no such associations seen with increasing serum levels of parathyroid hormone or calcium.
Data Source: A meta-analysis of 47 studies involving 327,644 patients with chronic kidney disease.
Disclosures: Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
Study Questions Using Biomarker Targets to Improve CKD Outcomes
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
FROM JAMA
Study Questions Using Biomarker Targets to Improve CKD Outcomes
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
Associations of a biomarker with disease in etiologic research are generally insufficiently strong to provide a basis for clinical decision making in individual patients. Even if serum concentrations of phosphorus, calcium, and parathyroid hormone were consistently associated with clinical outcomes across published studies, the distributions of these markers are likely to overlap substantially among patients who develop disease compared with those who do not, precluding their use as clinical prediction tools. Despite this fact, national and international committees have constructed guidelines that recommend target ranges of serum concentrations of phosphorus, calcium, and parathyroid hormone in clinical chronic kidney disease practice. As Dr. Suetonia C. Palmer and associates point out, such guidelines may promote interventions that do not improve patient outcomes, but increase health care costs and possibly cause harm.
When combined with scientific data to support biological plausibility, biomarker studies can be useful for suggesting novel risk factors for a disease process in humans. They can also underscore the need for clinical trials designed to formally test whether the biomarker plays a causal role in disease development.
However, results from etiologically based studies of phosphorus, calcium, and parathyroid hormone have led to a substantial increase in the use of medications that target these mineral metabolism disorders. There is currently no evidence from placebo-controlled clinical trials that any mineral metabolism treatment can improve clinical outcomes of patients with chronic kidney disease. Furthermore, many drugs currently prescribed to lower concentrations of phosphorus and parathyroid hormone have not been approved for use in patients not receiving dialysis, resulting in substantial off-label drug use and associated costs.
Placebo-controlled clinical trials are the necessary next step to determine the risks and benefits of treatments that target mineral metabolism disturbances in patients with chronic kidney disease as a means to improve their health.
Bryan Kestenbaum, M.D., is with the departments of medicine and epidemiology in the division of nephrology at the University of Washington, Seattle. These remarks are from a published editorial that accompanied the study (JAMA 2011;305:1138-9). He reported having no relevant financial conflicts to disclose.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.
There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.
Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.
The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).
Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.
The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).
The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.
"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.
"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."
The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."
Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
FROM JAMA
Major Finding: Among patients with chronic kidney disease, the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus (relative risk of 1.18), but there were no such associations seen with increasing serum levels of parathyroid hormone or calcium.
Data Source: A meta-analysis of 47 studies involving 327,644 patients with chronic kidney disease.
Disclosures: Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.
Continuing Warfarin During EVLT May Be Safe
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
Major Finding: Lower extremity endovenous laser therapy performed without interruption of warfarin therapy produced no intraoperative bleeding complications, and ablation of the target vessels was successful.
Data Source: A single-center study of five patients who underwent 12 separate EVLT procedures without interruption of warfarin therapy.
Disclosures: Dr. Riesenman said that he had no relevant financial conflicts to disclose.
Continuing Warfarin During EVLT May Be Safe
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.
"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."
According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.
"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.
Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.
At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."
No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.
"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."
Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."
Dr. Riesenman said that he had no relevant financial disclosures to make.
Foam Sclerotherapy Appears as Effective as Surgery for Varicose Veins
SAN DIEGO – At 5 years of follow-up, patients who had ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation had equally good clinical results compared with patients who underwent surgical treatment of varicose veins, based on a randomized controlled trial.
"Since surgery may not provide a definitive treatment, foam sclerotherapy could be offered like a dental care treatment model: treating as and when the problem appears," Dr. Evi Kalodiki said at the annual meeting of the American Venous Forum.
Dr. Kalodiki, a vascular surgeon at Ealing Hospital and Imperial College, London, and her associates evaluated 82 legs that were treated in 73 patients. The mean age of the patients was 48 years, and 75% were female. The researchers randomized the cases to two treatments: 39 legs underwent saphenofemoral ligation, stripping, and multiple phlebectomies under general anesthesia (surgery group) and 43 underwent saphenofemoral ligation under local anesthesia with concurrent foam sclerotherapy (foam group).
Assessments included ultrasound, the CEAP (clinical, etiologic, anatomical, pathophysiologic) classification, the Venous Clinical Severity Score, the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Short Form 36 Health Survey (SF-36). Follow-ups were conducted annually until a median of 5.12 years.
Dr. Kalodiki reported that the CEAP classification was similar for the two groups, as was the percentage of legs that required additional foam sessions (40% of legs in the surgery group, with a mean volume of 11 mL for each case, vs. 48% of legs in the foam group, with a mean volume of 9 mL for each case).
Preoperative Venous Clinical Severity Scores (VCSS) were similar for the two groups (median of 5 in the surgery group vs. 4 in the foam group), as were post-treatment VCSS, at a median of 1 in each group. Median changes in VCSS from baseline to 5 years were similar in the two groups: 3 in the surgery group vs. 3.5 in the foam group. Absolute VCSS values at 5 years were a median of 1 in each group.
The AVVQ score also improved in both groups. In the surgery group, the median AVVQ score improved from 16.32 preoperatively to 8.94 at 3 years, while in the foam group the median AVVQ score improved from 12.28 preoperatively to 4.97 at 3 years. These results were maintained at 5 years.
Scores on the mental component of the SF-36 worsened in the surgery group. There was no change in the physical scores of the SF-36 in either group over 3 or 5 years.
There were no significant differences between the groups or within the groups regarding obliteration or reflux above the knee or below the knee at 3 or 5 years. In the majority of cases, the reflux was asymptomatic and was only detected because of the follow-up duplex examination.
The study was funded by STD Pharmaceutical. Dr. Kalodiki said that she had no relevant financial disclosures to make.
SAN DIEGO – At 5 years of follow-up, patients who had ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation had equally good clinical results compared with patients who underwent surgical treatment of varicose veins, based on a randomized controlled trial.
"Since surgery may not provide a definitive treatment, foam sclerotherapy could be offered like a dental care treatment model: treating as and when the problem appears," Dr. Evi Kalodiki said at the annual meeting of the American Venous Forum.
Dr. Kalodiki, a vascular surgeon at Ealing Hospital and Imperial College, London, and her associates evaluated 82 legs that were treated in 73 patients. The mean age of the patients was 48 years, and 75% were female. The researchers randomized the cases to two treatments: 39 legs underwent saphenofemoral ligation, stripping, and multiple phlebectomies under general anesthesia (surgery group) and 43 underwent saphenofemoral ligation under local anesthesia with concurrent foam sclerotherapy (foam group).
Assessments included ultrasound, the CEAP (clinical, etiologic, anatomical, pathophysiologic) classification, the Venous Clinical Severity Score, the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Short Form 36 Health Survey (SF-36). Follow-ups were conducted annually until a median of 5.12 years.
Dr. Kalodiki reported that the CEAP classification was similar for the two groups, as was the percentage of legs that required additional foam sessions (40% of legs in the surgery group, with a mean volume of 11 mL for each case, vs. 48% of legs in the foam group, with a mean volume of 9 mL for each case).
Preoperative Venous Clinical Severity Scores (VCSS) were similar for the two groups (median of 5 in the surgery group vs. 4 in the foam group), as were post-treatment VCSS, at a median of 1 in each group. Median changes in VCSS from baseline to 5 years were similar in the two groups: 3 in the surgery group vs. 3.5 in the foam group. Absolute VCSS values at 5 years were a median of 1 in each group.
The AVVQ score also improved in both groups. In the surgery group, the median AVVQ score improved from 16.32 preoperatively to 8.94 at 3 years, while in the foam group the median AVVQ score improved from 12.28 preoperatively to 4.97 at 3 years. These results were maintained at 5 years.
Scores on the mental component of the SF-36 worsened in the surgery group. There was no change in the physical scores of the SF-36 in either group over 3 or 5 years.
There were no significant differences between the groups or within the groups regarding obliteration or reflux above the knee or below the knee at 3 or 5 years. In the majority of cases, the reflux was asymptomatic and was only detected because of the follow-up duplex examination.
The study was funded by STD Pharmaceutical. Dr. Kalodiki said that she had no relevant financial disclosures to make.
SAN DIEGO – At 5 years of follow-up, patients who had ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation had equally good clinical results compared with patients who underwent surgical treatment of varicose veins, based on a randomized controlled trial.
"Since surgery may not provide a definitive treatment, foam sclerotherapy could be offered like a dental care treatment model: treating as and when the problem appears," Dr. Evi Kalodiki said at the annual meeting of the American Venous Forum.
Dr. Kalodiki, a vascular surgeon at Ealing Hospital and Imperial College, London, and her associates evaluated 82 legs that were treated in 73 patients. The mean age of the patients was 48 years, and 75% were female. The researchers randomized the cases to two treatments: 39 legs underwent saphenofemoral ligation, stripping, and multiple phlebectomies under general anesthesia (surgery group) and 43 underwent saphenofemoral ligation under local anesthesia with concurrent foam sclerotherapy (foam group).
Assessments included ultrasound, the CEAP (clinical, etiologic, anatomical, pathophysiologic) classification, the Venous Clinical Severity Score, the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Short Form 36 Health Survey (SF-36). Follow-ups were conducted annually until a median of 5.12 years.
Dr. Kalodiki reported that the CEAP classification was similar for the two groups, as was the percentage of legs that required additional foam sessions (40% of legs in the surgery group, with a mean volume of 11 mL for each case, vs. 48% of legs in the foam group, with a mean volume of 9 mL for each case).
Preoperative Venous Clinical Severity Scores (VCSS) were similar for the two groups (median of 5 in the surgery group vs. 4 in the foam group), as were post-treatment VCSS, at a median of 1 in each group. Median changes in VCSS from baseline to 5 years were similar in the two groups: 3 in the surgery group vs. 3.5 in the foam group. Absolute VCSS values at 5 years were a median of 1 in each group.
The AVVQ score also improved in both groups. In the surgery group, the median AVVQ score improved from 16.32 preoperatively to 8.94 at 3 years, while in the foam group the median AVVQ score improved from 12.28 preoperatively to 4.97 at 3 years. These results were maintained at 5 years.
Scores on the mental component of the SF-36 worsened in the surgery group. There was no change in the physical scores of the SF-36 in either group over 3 or 5 years.
There were no significant differences between the groups or within the groups regarding obliteration or reflux above the knee or below the knee at 3 or 5 years. In the majority of cases, the reflux was asymptomatic and was only detected because of the follow-up duplex examination.
The study was funded by STD Pharmaceutical. Dr. Kalodiki said that she had no relevant financial disclosures to make.
FROM THE ANNUAL MEETING OF THE AMERICAN VENOUS FORUM
Major Finding: Improvements in venous clinical severity scores at 3 and 5 years were similar among patients who underwent saphenofemoral ligation, stripping, and multiple phlebectomies under general anesthesia and those who underwent saphenofemoral ligation under local anesthesia with concurrent foam sclerotherapy.
Data Source: A randomized, controlled trial of 82 legs that were treated in 73 patients with a mean age of 48 years.
Disclosures: The study was funded by STD Pharmaceutical. Dr. Kalodiki said that she had no relevant financial disclosures to make.