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Hemodynamic Outcomes at 5 Years From a Randomized Controlled Trial Comparing Laser Ablation with Foam Sclerotherapy
Abstracts
Journal of Vascular Surgery: Venous and Lymphatic Disorders
161.e6
Volume 5, Number 1 skin was indurated, and there was hyperpigmentation along a palpable cord. The ultrasound demonstrated a dilated GSV with acute thrombus (Fig 2). Microthrombectomies were performed, which led to a symptomatic relief. The patient 4 weeks later had no hyperpigmentation and was asymptomatic. Conclusions: Superficial thrombophlebitis is a possible immediate complication seen in <5% of patients treated with EVA. Delayed GSV thrombophlebitis after EVA is rare. In our cases, most likely the ablated GSV partially recanalized at some point after the first week and then developed thrombophlebitis. Early microthrombectomy not only provides early symptom relief but may also prevent long-term skin hyperpigmentation.
The Impact of 2013 UK National Institute for Health and Care Excellence Clinical Guideline CG168 on Family Physician (General Practitioner) Management of Varicose Veins Based on the Health improvement Network UK Database Huw Davies, MB, BS, BSc, MRCS, Matthew Popplewell, Ronan Ryan, Tom Marshall, Andrew Bradbury. Background: The UK National Institute for Health and Care Excellence (NICE) Clinical Guideline CG168, published in July 2013, recommends that all people with symptomatic varicose veins (VVs) be referred to a vascular specialist for consideration of interventional treatment. Previously, referral had been mainly limited to those with skin damage and ulcers, with most people being managed conservatively in primary care by family physicians (general practitioners [GPs]), usually with compression. As GPs control access to specialist National Health Service care, their awareness of and compliance with CG168 are critical to successful guideline implementation. The Health Improvement Network (THIN) UK database contains data on around 3.5 million people registered with around 450 GP practices. The aim of this study was to use THIN to assess the impact of CG168 on GP management of people with VVs. Methods: Interrogation of THIN for incident cases of VVs (in people >18 years) during the 18 months before and after publication of CG168 was performed. The two cohorts were compared in terms of demographics, referrals, compression hosiery prescriptions, and interventions. Results: The approximately 2 million eligible patients in each cohort were demographically well matched (40.2% vs 39.5% male; mean age, 62.7 vs 61.8 years; and similar spread of social deprivation and urban/rural residence). Before CG168, 13,014 people were diagnosed with VVs compared with 12,466 afterward. However, there was a significant increase in the number of specialist referrals (3173 to 3457; Cox model hazard ratio [HR], 1.15; P < .0001) and VV interventions (469 to 526; HR, 1.16; P ¼ .023). By contrast, there was a significant reduction in number of prescriptions for compression hosiery (2558 to 2292; HR, 0.93; P ¼ .008). Conclusions: Publication of NICE CG168 has been associated with a statistically significant increase in VV referrals and interventions, and there would appear to be a reduction in the proportion of patients being managed conservatively in primary care with compression only. Although somewhat less than the 25% increase in VV and leg ulcer referrals predicted by NICE, the THIN data are encouraging. However, ongoing professional and patient education is likely to be required to sustain this improvement in evidence-based management of VVs across the United Kingdom.
groups. The aim was to report a snapshot of the ultrasound findings at 5 years of endovenous laser ablation (EVLA) with concurrent phlebectomies as a complete treatment vs a single session of ultrasound-guided foam sclerotherapy (UGFS) into the great saphenous vein (GSV). Methods: All patients were referred from their primary care physician and were randomized at a single National Health Service hospital. Inclusion criteria for both groups (N ¼ 50 patients/legs in each treated group) included a refluxing GSV without significant deep venous, pelvic, or small saphenous vein reflux. Additional treatment with UGFS was the patient’s decision. Assessment included the Venous Clinical Severity Score (VCSS) and the gravitational venous filling index of air plethysmography. Results: The median (interquartile range) follow-up was 68 (64-72) months. Follow-up was complete in EVLA in 44 of 50 and in UGFS in 44 of 50. The VCSS was statistically higher with foam: EVLA, 2 (0-3); UGFS 3 (2-5; P ¼ .001). If GSV occlusion at some point above the knee is defined Table I. Successful outcome variations on the great saphenous vein (GSV) reported with duplex ultrasound Duplex ultrasound outcome (5 years) AK occlusion without reflux
EVLA, % UGFS, %
P valuea
79.5
52.3
.013
4.5
18.2
.089
AK without reflux
79.5
61.4
.101
AK and BK without reflux
50
45.5
.831
No reflux at all including tributaries
27.3
27.3
1.000
AK and BK occlusion without reflux
AK, Above knee; BK, below knee; EVLA, endovenous laser ablation; UGFS, ultrasound-guided foam sclerotherapy. a Fisher exact test.
Table II. Anatomic sites of reflux in 32 of 44 endovenous laser ablation (EVLA) and 32 of 44 ultrasound-guided foam sclerotherapy (UGFS) legs Site of reflux
EVLA
UGFS
GSV above knee
11
15
Anterior accessory vein
5
4
Thigh perforating vein
2
1
Above-knee tributary
14
16
GSV below knee
18
18
Calf perforating vein
1
1
Below-knee tributary
22
22
Small saphenous vein
4
5
Common femoral vein
1
0
0
2
Popliteal vein
GSV, Great saphenous vein. Several legs had more than one site of reflux.
Hemodynamic Outcomes at 5 Years From a Randomized Controlled Trial Comparing Laser Ablation with Foam Sclerotherapy Evi Kalodiki, MD, MA, PhD, DIC, FRCS, Mustapha Azzam, George Geroulakos, Christopher Lattimer. Background: In venous treatment, hemodynamic outcomes are reported conventionally using duplex ultrasound, in which success is defined as an occlusion of the treated saphenous vein. This is supplemented by a clinical evaluation of whether there are residual or recurrent varicose veins. Confounding variables for use of these outcomes are the presence of reflux despite a successful occlusion and the presence of ultrasound-detectable refluxing tributaries. Furthermore, patients often undergo additional treatments on the same leg, which may adjust the final hemodynamic outcome by ironing out differences between the
Fig. Gravitational venous filling quantified with air plethysmography. Dashed line represents 2.4 mL/s.
161.e7
Abstracts
Journal of Vascular Surgery: Venous and Lymphatic Disorders January 2017
as success, then the results are 93.2% for EVLA and 63.6% for UGFS (P ¼ .001), even though this may be associated with concurrent saphenous reflux and by dismissing competency of an open trunk. Other options for a successful outcome are possible (Table I). The anatomic sites of reflux (failure) appear similar between the two groups (Table II). In the EVLA group, 20 legs had additional foam compared with 56 in the UGFS group. If treatment of the tributaries with one extra foam session was included in the 44 patients in the UGFS group, the “extra” foam figures would be reduced considerably. The venous filling index was significantly greater in the UGFS group and in those patients with reflux somewhere in the leg, irrespective of group (Fig). Conclusions: Laser at 5 years provides a better hemodynamic outcome as measured on air plethysmography, with variable results on ultrasound, depending on the definition of success. In particular, there was no difference in the outcomes when the absence of all reflux was used as the end point. This was associated with a statistical but not clinically relevant difference in the VCSS.
Fig 1. Vein Recanalization.
Correlation Between Pelvic Congestion Syndrome and Body Mass Index Ruhani Nanavati, Demetri Adrahtas, Patrick Jasinski, MD, Nicos Labropoulos, PhD. Stony Brook Medicine. Background: Previous studies of men suggested that patients with varicocele may be leaner than the normal population. No such work exists in women with pelvic congestion syndrome (PCS). This study evaluated the correlation between body mass index (BMI) and PCS. Methods: A case-control study at a single institution was performed in women who had objective diagnosis of PCS. Data were prospectively collected for 100 consecutive patients with PCS. BMI was calculated for every patient and categorized into normal weight (BMI of 30). Diagnosis of PCS was made using ultrasound and venography. Mean BMI was compared with that of the general female population of the United States from 1999 to 2002. Furthermore, analyses included comparison of patients with and without ovarian vein dilation and pelvic varices. Results: There were 100 women with a median age of 44 years (range, 24-73 years). The mean BMI of the study group was 25 6 5.6 kg/m2. The cohort was categorized into 59 women with normal BMI, 23 overweight women, and 18 obese women. The study cohort’s BMI was lower than that of the general U.S. female population (P ¼ .02). The majority of the study group were white women with lower BMI (P < .0001). Leg varicosities were more prevalent in obese patients (100% obese vs 81% normal BMI; P ¼ .01). Patients with ovarian vein dilation had significantly lower BMI (24.1 6 5.6 kg/m2 and 26.7 6 5.4 kg/m2; P ¼ .036). No changes were identified for pelvic varices or reflux. Conclusions: Women with PCS are more likely to have a normal BMI with ovarian vein dilation compared with obese women, who are more frequently affected by leg varicosities.
Venous Recanalization, Reflux, and Obstruction After Calf Deep Venous Thrombosis Jonah Garry, BA, Alvin Wu, BA, Nicholas Sikalas, MD, Nicos Labropoulos, PhD, RVT. Stony Brook University Hospital. Background: The significance of thrombus lysis and development of venous flow changes are not well understood in patients with calf deep venous thrombosis (C-DVT). This prospective study was designed to determine the patterns of recanalization and reflux development in patients with C-DVT. Methods: Patients presenting with isolated C-DVT were included and prospectively observed with duplex ultrasound. Patients with previous DVT and coexisting proximal DVT were excluded. Follow-up was completed at 4 to 10 days, 3 months, 6 months, and 12 months. Occlusion, venous recanalization (partial or complete), and development of reflux were examined for each patient at follow-up. The axial and muscular veins in the calf were imaged on B-mode and color ultrasound in the supine position for patency and in the standing or sitting position to evaluate reflux with Doppler waveform recordings. The patterns of recanalization were reported as occlusion (no flow or channels were identified), partial recanalization (flow detected within the partially obstructed lumen), and complete recanalization (flow was seen through the entire lumen). Recanalized veins were identified as having reflux or not. A vein was considered to be normal when no reflux and obstruction were found.
Fig 2. Vein Obstruction and Reflux.
Results: In the 104 patients recruited, C-DVT was identified in 117 limbs. Thrombus was found in the peroneal veins in 49 patients (41.8%), the soleal veins in 37 patients (31.6%), the posterior tibial veins in 32 patients (27.4%), the gastrocnemius veins in 26 patients (22.2%), and the anterior tibial veins in 2 patients (1.7%). Initial recanalization in the 4 to 10 days after diagnosis (109 limbs) featured partial recanalization in 16 limbs (14.7%), worsening of the obstruction in 16 limbs (14.7%), and no change in 77 limbs (70.6%). Rates of recanalization, reflux, and obstruction at 3, 6, and 12 months are found in Figs 1 and 2. Conclusions: By 1 year after C-DVT diagnosis, most patients have partial or complete recanalization of the previously thrombosed venous segment. At 1 year, 58% of limbs were normal, whereas 30% of veins demonstrated reflux. Permanent vein occlusion occurs in 16% of the patients.
The Effect of Balloon Angioplasty of Nonthrombotic Iliac Vein Lesions Yuriy Ostrozhynskyy, Hoang Nguyen, Anil Hingorani, Eleanora Iadgarova, Sheila Blumberg, Natalie Marks, Enrico Ascher. Background: Iliac vein stenting of nonthrombotic iliac vein lesions is an evolving treatment option for venous insufficiency. To characterize these lesions, we examined our experience treating these lesions with balloon venoplasty before stenting. Methods: After failed conservative therapy, we performed 1021 venograms with venoplasty and stenting of iliac veins on 713 patients from February 2013 to July 2016. The average age of the patients was 64.88 years (range, 21-99; standard deviation [SD], 614.57), with 451 female and 262 male patients. Intravascular ultrasound was used to measure the area of stenotic iliofemoral veins before and after balloon angioplasty. If >50% cross-sectional area or diameter reduction was found, the stenotic area was treated with balloon angioplasty, sized to the nonstenotic distal vein segment (range, 10 40 mm to 16 60 mm). Results: Before angioplasty, the average cross-sectional stenotic area was 67.97 mm2 (range, 6-318; SD, 634.87). After balloon angioplasty, the average stenotic area was 78.80 mm2 (range, 6-334; SD, 644.50; >10% of baseline before venoplasty), decreased (2; SD, 632.80), and postvenoplasty average of 96.52 mm2 (SD, 649.85). In 294 (28.8%) limbs, the area decreased (average, 28.90%), with prevenoplasty average area of 76.43 mm2 (SD, 638.80) and postvenoplasty average of 53.22 mm2
Journal of Vascular Surgery: Venous and Lymphatic Disorders
161.e6
Volume 5, Number 1 skin was indurated, and there was hyperpigmentation along a palpable cord. The ultrasound demonstrated a dilated GSV with acute thrombus (Fig 2). Microthrombectomies were performed, which led to a symptomatic relief. The patient 4 weeks later had no hyperpigmentation and was asymptomatic. Conclusions: Superficial thrombophlebitis is a possible immediate complication seen in <5% of patients treated with EVA. Delayed GSV thrombophlebitis after EVA is rare. In our cases, most likely the ablated GSV partially recanalized at some point after the first week and then developed thrombophlebitis. Early microthrombectomy not only provides early symptom relief but may also prevent long-term skin hyperpigmentation.
The Impact of 2013 UK National Institute for Health and Care Excellence Clinical Guideline CG168 on Family Physician (General Practitioner) Management of Varicose Veins Based on the Health improvement Network UK Database Huw Davies, MB, BS, BSc, MRCS, Matthew Popplewell, Ronan Ryan, Tom Marshall, Andrew Bradbury. Background: The UK National Institute for Health and Care Excellence (NICE) Clinical Guideline CG168, published in July 2013, recommends that all people with symptomatic varicose veins (VVs) be referred to a vascular specialist for consideration of interventional treatment. Previously, referral had been mainly limited to those with skin damage and ulcers, with most people being managed conservatively in primary care by family physicians (general practitioners [GPs]), usually with compression. As GPs control access to specialist National Health Service care, their awareness of and compliance with CG168 are critical to successful guideline implementation. The Health Improvement Network (THIN) UK database contains data on around 3.5 million people registered with around 450 GP practices. The aim of this study was to use THIN to assess the impact of CG168 on GP management of people with VVs. Methods: Interrogation of THIN for incident cases of VVs (in people >18 years) during the 18 months before and after publication of CG168 was performed. The two cohorts were compared in terms of demographics, referrals, compression hosiery prescriptions, and interventions. Results: The approximately 2 million eligible patients in each cohort were demographically well matched (40.2% vs 39.5% male; mean age, 62.7 vs 61.8 years; and similar spread of social deprivation and urban/rural residence). Before CG168, 13,014 people were diagnosed with VVs compared with 12,466 afterward. However, there was a significant increase in the number of specialist referrals (3173 to 3457; Cox model hazard ratio [HR], 1.15; P < .0001) and VV interventions (469 to 526; HR, 1.16; P ¼ .023). By contrast, there was a significant reduction in number of prescriptions for compression hosiery (2558 to 2292; HR, 0.93; P ¼ .008). Conclusions: Publication of NICE CG168 has been associated with a statistically significant increase in VV referrals and interventions, and there would appear to be a reduction in the proportion of patients being managed conservatively in primary care with compression only. Although somewhat less than the 25% increase in VV and leg ulcer referrals predicted by NICE, the THIN data are encouraging. However, ongoing professional and patient education is likely to be required to sustain this improvement in evidence-based management of VVs across the United Kingdom.
groups. The aim was to report a snapshot of the ultrasound findings at 5 years of endovenous laser ablation (EVLA) with concurrent phlebectomies as a complete treatment vs a single session of ultrasound-guided foam sclerotherapy (UGFS) into the great saphenous vein (GSV). Methods: All patients were referred from their primary care physician and were randomized at a single National Health Service hospital. Inclusion criteria for both groups (N ¼ 50 patients/legs in each treated group) included a refluxing GSV without significant deep venous, pelvic, or small saphenous vein reflux. Additional treatment with UGFS was the patient’s decision. Assessment included the Venous Clinical Severity Score (VCSS) and the gravitational venous filling index of air plethysmography. Results: The median (interquartile range) follow-up was 68 (64-72) months. Follow-up was complete in EVLA in 44 of 50 and in UGFS in 44 of 50. The VCSS was statistically higher with foam: EVLA, 2 (0-3); UGFS 3 (2-5; P ¼ .001). If GSV occlusion at some point above the knee is defined Table I. Successful outcome variations on the great saphenous vein (GSV) reported with duplex ultrasound Duplex ultrasound outcome (5 years) AK occlusion without reflux
EVLA, % UGFS, %
P valuea
79.5
52.3
.013
4.5
18.2
.089
AK without reflux
79.5
61.4
.101
AK and BK without reflux
50
45.5
.831
No reflux at all including tributaries
27.3
27.3
1.000
AK and BK occlusion without reflux
AK, Above knee; BK, below knee; EVLA, endovenous laser ablation; UGFS, ultrasound-guided foam sclerotherapy. a Fisher exact test.
Table II. Anatomic sites of reflux in 32 of 44 endovenous laser ablation (EVLA) and 32 of 44 ultrasound-guided foam sclerotherapy (UGFS) legs Site of reflux
EVLA
UGFS
GSV above knee
11
15
Anterior accessory vein
5
4
Thigh perforating vein
2
1
Above-knee tributary
14
16
GSV below knee
18
18
Calf perforating vein
1
1
Below-knee tributary
22
22
Small saphenous vein
4
5
Common femoral vein
1
0
0
2
Popliteal vein
GSV, Great saphenous vein. Several legs had more than one site of reflux.
Hemodynamic Outcomes at 5 Years From a Randomized Controlled Trial Comparing Laser Ablation with Foam Sclerotherapy Evi Kalodiki, MD, MA, PhD, DIC, FRCS, Mustapha Azzam, George Geroulakos, Christopher Lattimer. Background: In venous treatment, hemodynamic outcomes are reported conventionally using duplex ultrasound, in which success is defined as an occlusion of the treated saphenous vein. This is supplemented by a clinical evaluation of whether there are residual or recurrent varicose veins. Confounding variables for use of these outcomes are the presence of reflux despite a successful occlusion and the presence of ultrasound-detectable refluxing tributaries. Furthermore, patients often undergo additional treatments on the same leg, which may adjust the final hemodynamic outcome by ironing out differences between the
Fig. Gravitational venous filling quantified with air plethysmography. Dashed line represents 2.4 mL/s.
161.e7
Abstracts
Journal of Vascular Surgery: Venous and Lymphatic Disorders January 2017
as success, then the results are 93.2% for EVLA and 63.6% for UGFS (P ¼ .001), even though this may be associated with concurrent saphenous reflux and by dismissing competency of an open trunk. Other options for a successful outcome are possible (Table I). The anatomic sites of reflux (failure) appear similar between the two groups (Table II). In the EVLA group, 20 legs had additional foam compared with 56 in the UGFS group. If treatment of the tributaries with one extra foam session was included in the 44 patients in the UGFS group, the “extra” foam figures would be reduced considerably. The venous filling index was significantly greater in the UGFS group and in those patients with reflux somewhere in the leg, irrespective of group (Fig). Conclusions: Laser at 5 years provides a better hemodynamic outcome as measured on air plethysmography, with variable results on ultrasound, depending on the definition of success. In particular, there was no difference in the outcomes when the absence of all reflux was used as the end point. This was associated with a statistical but not clinically relevant difference in the VCSS.
Fig 1. Vein Recanalization.
Correlation Between Pelvic Congestion Syndrome and Body Mass Index Ruhani Nanavati, Demetri Adrahtas, Patrick Jasinski, MD, Nicos Labropoulos, PhD. Stony Brook Medicine. Background: Previous studies of men suggested that patients with varicocele may be leaner than the normal population. No such work exists in women with pelvic congestion syndrome (PCS). This study evaluated the correlation between body mass index (BMI) and PCS. Methods: A case-control study at a single institution was performed in women who had objective diagnosis of PCS. Data were prospectively collected for 100 consecutive patients with PCS. BMI was calculated for every patient and categorized into normal weight (BMI of 30). Diagnosis of PCS was made using ultrasound and venography. Mean BMI was compared with that of the general female population of the United States from 1999 to 2002. Furthermore, analyses included comparison of patients with and without ovarian vein dilation and pelvic varices. Results: There were 100 women with a median age of 44 years (range, 24-73 years). The mean BMI of the study group was 25 6 5.6 kg/m2. The cohort was categorized into 59 women with normal BMI, 23 overweight women, and 18 obese women. The study cohort’s BMI was lower than that of the general U.S. female population (P ¼ .02). The majority of the study group were white women with lower BMI (P < .0001). Leg varicosities were more prevalent in obese patients (100% obese vs 81% normal BMI; P ¼ .01). Patients with ovarian vein dilation had significantly lower BMI (24.1 6 5.6 kg/m2 and 26.7 6 5.4 kg/m2; P ¼ .036). No changes were identified for pelvic varices or reflux. Conclusions: Women with PCS are more likely to have a normal BMI with ovarian vein dilation compared with obese women, who are more frequently affected by leg varicosities.
Venous Recanalization, Reflux, and Obstruction After Calf Deep Venous Thrombosis Jonah Garry, BA, Alvin Wu, BA, Nicholas Sikalas, MD, Nicos Labropoulos, PhD, RVT. Stony Brook University Hospital. Background: The significance of thrombus lysis and development of venous flow changes are not well understood in patients with calf deep venous thrombosis (C-DVT). This prospective study was designed to determine the patterns of recanalization and reflux development in patients with C-DVT. Methods: Patients presenting with isolated C-DVT were included and prospectively observed with duplex ultrasound. Patients with previous DVT and coexisting proximal DVT were excluded. Follow-up was completed at 4 to 10 days, 3 months, 6 months, and 12 months. Occlusion, venous recanalization (partial or complete), and development of reflux were examined for each patient at follow-up. The axial and muscular veins in the calf were imaged on B-mode and color ultrasound in the supine position for patency and in the standing or sitting position to evaluate reflux with Doppler waveform recordings. The patterns of recanalization were reported as occlusion (no flow or channels were identified), partial recanalization (flow detected within the partially obstructed lumen), and complete recanalization (flow was seen through the entire lumen). Recanalized veins were identified as having reflux or not. A vein was considered to be normal when no reflux and obstruction were found.
Fig 2. Vein Obstruction and Reflux.
Results: In the 104 patients recruited, C-DVT was identified in 117 limbs. Thrombus was found in the peroneal veins in 49 patients (41.8%), the soleal veins in 37 patients (31.6%), the posterior tibial veins in 32 patients (27.4%), the gastrocnemius veins in 26 patients (22.2%), and the anterior tibial veins in 2 patients (1.7%). Initial recanalization in the 4 to 10 days after diagnosis (109 limbs) featured partial recanalization in 16 limbs (14.7%), worsening of the obstruction in 16 limbs (14.7%), and no change in 77 limbs (70.6%). Rates of recanalization, reflux, and obstruction at 3, 6, and 12 months are found in Figs 1 and 2. Conclusions: By 1 year after C-DVT diagnosis, most patients have partial or complete recanalization of the previously thrombosed venous segment. At 1 year, 58% of limbs were normal, whereas 30% of veins demonstrated reflux. Permanent vein occlusion occurs in 16% of the patients.
The Effect of Balloon Angioplasty of Nonthrombotic Iliac Vein Lesions Yuriy Ostrozhynskyy, Hoang Nguyen, Anil Hingorani, Eleanora Iadgarova, Sheila Blumberg, Natalie Marks, Enrico Ascher. Background: Iliac vein stenting of nonthrombotic iliac vein lesions is an evolving treatment option for venous insufficiency. To characterize these lesions, we examined our experience treating these lesions with balloon venoplasty before stenting. Methods: After failed conservative therapy, we performed 1021 venograms with venoplasty and stenting of iliac veins on 713 patients from February 2013 to July 2016. The average age of the patients was 64.88 years (range, 21-99; standard deviation [SD], 614.57), with 451 female and 262 male patients. Intravascular ultrasound was used to measure the area of stenotic iliofemoral veins before and after balloon angioplasty. If >50% cross-sectional area or diameter reduction was found, the stenotic area was treated with balloon angioplasty, sized to the nonstenotic distal vein segment (range, 10 40 mm to 16 60 mm). Results: Before angioplasty, the average cross-sectional stenotic area was 67.97 mm2 (range, 6-318; SD, 634.87). After balloon angioplasty, the average stenotic area was 78.80 mm2 (range, 6-334; SD, 644.50; >10% of baseline before venoplasty), decreased (2; SD, 632.80), and postvenoplasty average of 96.52 mm2 (SD, 649.85). In 294 (28.8%) limbs, the area decreased (average, 28.90%), with prevenoplasty average area of 76.43 mm2 (SD, 638.80) and postvenoplasty average of 53.22 mm2