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Foam Sclerotherapy: As Effective as Surgery?
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 to 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.
This industry-funded study appears to have selected a population of relatively typical patients with symptomatic primary varicose veins. It is striking that fully 40% of patients in the surgical group had at least one follow-up foam session and not as surprising that the ligation and foam group required follow-up session(s). It would be interesting to know how many patients in each group required more than one postoperative foam session. The implication that we should approach foam therapy of veins "like a dental treatment model" suggests that treatment of neither group was particularly satisfactory. One also wonders about how variables beyond therapeutic efficacy, such as the fluid relationship between patient expectations and availability of services (syringes at the ready), affect findings of studies like these. Use of standardized outcome metrics and the SF-36 is laudable and can only help us find our way through the weeds and biases intrinsic to all clinical studies.
Magruder C. Donaldson, M.D., is chair of surgery at Metrowest Medical Center in Framingham, Mass. He is also an associate medical editor for Vascular Specialist.
This industry-funded study appears to have selected a population of relatively typical patients with symptomatic primary varicose veins. It is striking that fully 40% of patients in the surgical group had at least one follow-up foam session and not as surprising that the ligation and foam group required follow-up session(s). It would be interesting to know how many patients in each group required more than one postoperative foam session. The implication that we should approach foam therapy of veins "like a dental treatment model" suggests that treatment of neither group was particularly satisfactory. One also wonders about how variables beyond therapeutic efficacy, such as the fluid relationship between patient expectations and availability of services (syringes at the ready), affect findings of studies like these. Use of standardized outcome metrics and the SF-36 is laudable and can only help us find our way through the weeds and biases intrinsic to all clinical studies.
Magruder C. Donaldson, M.D., is chair of surgery at Metrowest Medical Center in Framingham, Mass. He is also an associate medical editor for Vascular Specialist.
This industry-funded study appears to have selected a population of relatively typical patients with symptomatic primary varicose veins. It is striking that fully 40% of patients in the surgical group had at least one follow-up foam session and not as surprising that the ligation and foam group required follow-up session(s). It would be interesting to know how many patients in each group required more than one postoperative foam session. The implication that we should approach foam therapy of veins "like a dental treatment model" suggests that treatment of neither group was particularly satisfactory. One also wonders about how variables beyond therapeutic efficacy, such as the fluid relationship between patient expectations and availability of services (syringes at the ready), affect findings of studies like these. Use of standardized outcome metrics and the SF-36 is laudable and can only help us find our way through the weeds and biases intrinsic to all clinical studies.
Magruder C. Donaldson, M.D., is chair of surgery at Metrowest Medical Center in Framingham, Mass. He is also an associate medical editor for Vascular Specialist.
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 to 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.
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 to 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.
Venous Surgery Compared To 'Conservative' Therapy
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.
This is an interesting study from the point of view of insurance reimbursement for the treatment of varicose veins. It confirms that conservative therapy with stockings will improve symptoms in many patients but they still want to undergo more definitive therapy. The reasons for this are not explained but I would suggest that most patients find wearing stockings inconvenient and also they just do not appreciate the cosmetic issues associated with stocking therapy. Further, I would suggest that although many patients complain about symptoms the predominant issue that drives them to undergo varicose veins removal remains cosmetic. As such, one wonders why insurance carriers should pay for cosmetic vein removal. In this age of skyrocketing health care costs I believe it behooves the vein specialist to truly evaluate their patients to decide whether the patient is using “symptoms” to get insurance to reimburse them for cosmetic vein treatments. If cosmetic issues are predominant then perhaps the patient should bear the cost themselves.
Russell H. Samson, M.D., is a physician in the practice of Samson, Showalter, Lepore, and Nair, and clinical associate professor of surgery, Florida State University.
This is an interesting study from the point of view of insurance reimbursement for the treatment of varicose veins. It confirms that conservative therapy with stockings will improve symptoms in many patients but they still want to undergo more definitive therapy. The reasons for this are not explained but I would suggest that most patients find wearing stockings inconvenient and also they just do not appreciate the cosmetic issues associated with stocking therapy. Further, I would suggest that although many patients complain about symptoms the predominant issue that drives them to undergo varicose veins removal remains cosmetic. As such, one wonders why insurance carriers should pay for cosmetic vein removal. In this age of skyrocketing health care costs I believe it behooves the vein specialist to truly evaluate their patients to decide whether the patient is using “symptoms” to get insurance to reimburse them for cosmetic vein treatments. If cosmetic issues are predominant then perhaps the patient should bear the cost themselves.
Russell H. Samson, M.D., is a physician in the practice of Samson, Showalter, Lepore, and Nair, and clinical associate professor of surgery, Florida State University.
This is an interesting study from the point of view of insurance reimbursement for the treatment of varicose veins. It confirms that conservative therapy with stockings will improve symptoms in many patients but they still want to undergo more definitive therapy. The reasons for this are not explained but I would suggest that most patients find wearing stockings inconvenient and also they just do not appreciate the cosmetic issues associated with stocking therapy. Further, I would suggest that although many patients complain about symptoms the predominant issue that drives them to undergo varicose veins removal remains cosmetic. As such, one wonders why insurance carriers should pay for cosmetic vein removal. In this age of skyrocketing health care costs I believe it behooves the vein specialist to truly evaluate their patients to decide whether the patient is using “symptoms” to get insurance to reimburse them for cosmetic vein treatments. If cosmetic issues are predominant then perhaps the patient should bear the cost themselves.
Russell H. Samson, M.D., is a physician in the practice of Samson, Showalter, Lepore, and Nair, and clinical associate professor of surgery, Florida State University.
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.