Effect of junctional reflux on the venous clinical severity score in patients with insufficiency of the great saphenous vein (JURY study).

OBJECTIVE: Effective treatment options are available for chronic venous insufficiency associated with superficial venous reflux. Although many patients with C2 and C3 disease based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification have combined great saphenous vein (GSV) and saphenofemoral junction (SFJ) reflux, some may not have concomitant SFJ reflux. Several payors have determined that symptom severity in patients without SFJ reflux does not warrant treatment. In patients planned for venous ablation, we tested whether Venous Clinical Severity Scores (VCSS) are equivalent in those with GSV reflux alone compared with those with both GSV and SFJ reflux. METHODS: This cross-sectional study was conducted at 10 centers. Inclusion criteria were: candidate for endovenous ablation as determined by treating physician; 18 to 80 years of age; GSV reflux with or without SFJ reflux on ultrasound; and C2 or C3 disease. Exclusion criteria were prior deep vein thrombosis; prior vein ablation on the index limb; ilio-caval obstruction; and renal, hepatic, or heart failure requiring prior hospitalization. An a priori sample size was calculated. We used multiple linear regression (adjusted for patient characteristics) to compare differences in VCSS scores of the two groups at baseline, and to test whether scores were equivalent using a priori equivalence boundaries of +1 and -1. In secondary analyses, we tested differences in VCSS scores in patients with C2 and C3 disease separately. RESULTS: A total of 352 patients were enrolled; 64.2% (n = 226) had SFJ reflux, and 35.8% (n = 126) did not. The two groups did not differ by major clinical characteristics. The mean age of the cohort was 53.9 ± 14.3 years; women comprised 74.2%; White patients 85.8%; and body mass index was 27.8 ± 6.1 kg/m2. The VCSS scores in patients with and without SFJ reflux were found to be equivalent; SFJ reflux was not a significant predictor of VCSS score; and mean VCSS scores did not differ significantly (6.4 vs 6.6, respectively, P = .40). In secondary subset analyses, VCSS scores were equivalent between C2 patients with and without SFJ reflux, and VCSS scores of C3 patients with SFJ reflux were lower than those without SFJ reflux. CONCLUSIONS: Symptom severity is equivalent in patients with GSV reflux with or without SFJ reflux. The absence of SFJ reflux alone should not determine the treatment paradigm in patients with symptomatic chronic venous insufficiency. Patients with GSV reflux who meet clinical criteria for treatment should have equivalent treatment regardless of whether or not they have SFJ reflux.

Transabdominal ultrasound accurately identifies a significant iliac vein area-reducing lesion in patients with pelvic venous insufficiency.

BACKGROUND: In patients with pelvic venous disorders secondary to pelvic venous insufficiency (PVI), the optimal imaging modality is ill-defined. Transabdominal ultrasound (TAU) is widely used to identify the presence of iliac vein stenosis. The purpose of the present investigation is to determine the accuracy of TAU for determining the presence of an iliac vein area-reducing lesion compared with intravascular ultrasound (IVUS). METHODS: From January to December 2020, a retrospective review of prospectively collected data from 96 patients treated for symptomatic PVI at the Center for Vascular Medicine was performed. All patients had complete history and physical examination findings, demographics, CEAP (clinical, etiologic, anatomic, pathophysiologic), revised venous clinical severity score, and TAU, diagnostic venography, and IVUS measurements recorded in our electronic medical record system. All TAU measurements were performed by the same ultrasound technician with the patient in the supine position. Iliac vein diameters of the common femoral, external iliac, and common iliac veins and the inferior vena cava were obtained. Differences in body habitus were normalized by dividing the minimum diameter measurement of the stenotic vessel with that of the ipsilateral common femoral vein, subtracting this number from 1 and multiplying by 100 (stenosis = [1 - minimal diameter/common femoral diameter] × 100). The normalized stenoses were then compared with the IVUS-derived area reducing measurements. A receiver operating characteristic curve was created, and logistic regression analysis for the probability of predicting an area-reducing lesion of >50% and >60% with TAU was performed. The sensitivity, specificity, and positive and negative predictive values were calculated. RESULTS: The average age of the entire cohort was 49.8 ± 13.5 years, with 69 women and 27 men. The CEAP distribution was as follows: C0, 5%; C1, 5%; C2, 10%; C3, 40%; C4a,b, 30%; C5, 7%; and C6, 3%. The average revised venous clinical severity score was 6.2 ± 2.6. The indications for intervention were leg symptoms alone in 43%, pelvic symptoms alone in 3%, and combined leg and pelvic symptoms in 54%. TAU identified a stenosis of ≥50% in 92 of the 96 patients (96%). For a ≥50% stenosis, a normalized diameter of ≤3 mm demonstrated a sensitivity, specificity, and positive and negative predictive value of 75%, 75%, 98%, and 12%, respectively. Logistic regression analysis indicated that TAU was significant in predicting the presence of a ≥60% area-reducing lesion (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .009). The area under the receiver operating characteristic curve (c-statistic) was 68.6%. The sensitivity, specificity, and positive and negative predictive values were 66.7%, 66.7%, 81.5%, and 47.6%, respectively, for a normalized diameter of ≥4 mm. CONCLUSIONS: The ability of TAU to identify an iliac vein stenosis of ≥50% is 96%. The positive predictive value for TAU to identify a ≥60% iliac vein area-reducing lesion is high, with moderate sensitivity and specificity. For patients with symptoms consistent with pelvic venous disorders secondary to PVI, TAU is a good preintervention screening modality for properly trained vascular imaging specialists with findings that correlate well with IVUS measurements.

Natural history and role of anticoagulation in the management of endovenous glue-induced thrombus.

OBJECTIVE: The natural history of endovenous glue-induced thrombus (EGIT) resolution and the role of anticoagulation (AC) and/or anti-platelet (AP) agents in their management is currently ill-defined. The goal of this investigation is to determine the clinical behavior of EGITs and whether or not AC or AP affects treatment outcomes. METHODS: We performed a retrospective review of all endovenous ablations utilizing cyanoacrylate glue (CAG) from January 2020 to December 2021 at the Center for Vein Restoration. Patients were divided into two groups: (1) patients who developed an EGIT (EGIT/CAG) and (2) patients treated with CAG and no EGIT development (CAG). Demographics, medical/surgical histories, revised Venous Clinical Severity Score (rVCSS), Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ), CEAP, EGIT category, type of anticoagulation, resolution time, location of any deep vein thrombosis (DVT) were analyzed, catheter tip distance, treatment length and proximal thigh diameters were all analyzed. EGITs were categorized as follows: EGIT 1: thrombus extension into the deep vein covering less than 25% of the luminal area; EGIT 2: thrombus between 25% and 49%; EGIT 3: thrombus between 50% and 74%; and EGIT 4: total occlusion. Our protocol is to perform post-procedure duplex scans within 3 to 7 days after endovenous ablations to assess for post-intervention DVTs. RESULTS: During the study period, 2374 patients received 4321 CAG procedures. EGITs were observed in 133 patients (3.1%): EGIT 1 (n = 57); EGIT 2 (n = 35); EGIT 3 (n = 19); and EGIT 4 (n = 22). All EGITs were identified by surveillance scanning. No patient presented with limb or pulmonary symptoms suggestive of VTE. The average age, rVCSS, and CIVIQ 20 of the entire cohort was 65.3 ± 14.2 years, 8.2 ± 2.8, and 48 ± 18.3, respectively with 89 females and 44 males. For EGIT 1, 56 of 57 (98%) resolved at 4.2 ± 5.1 weeks, with one patient lost to follow-up. AC/AP regimen included two aspirin (ASA), one Eliquis, 5 Xarelto, and nothing in 49 patients (86%). For EGIT 2, 27 of 35 (77%) resolved at 4.4 ± 3.4 weeks, one was unresolved, six regressed to EGIT 1, and one remained an EGIT 2 at the last follow-up examination. AC/AP regimens included seven ASA, three Eliquis, three Xarelto, one Coumadin, and nothing in 21 patients (60%). For EGIT 3, 12 were in the common femoral vein (CFV), three in the popliteal vein (POPV), one in the external iliac vein, and three in the gastrocnemius veins. Nine of nineteen (47%) resolved at 6 ± 5.9 weeks, four regressed, one migrated to the proximal CFV, three became chronic, and two were lost to follow-up. AC/AP regimens included three ASA, three Eliquis, seven Xarelto, and nothing in six patients (32%). AC/AP compared with no AC/AP had no effect on clot resolution (P = .3). Of the 22 EGIT 4, one was in the CFV, two were in the POPV, and 18 (82%) were remote calf vein DVTs (15 gastrocnemius, one peroneal [PV], and three posterior tibial veins [PTVs]). The CFV EGIT became chronic, one POPV resolved, and one was lost to follow-up. For the gastrocnemius clots, five became chronic, eight resolved, and two were lost to follow-up. For the PTV clots, one resolved, one became chronic, and one was lost to follow-up. The PV clot became chronic. AC/AP regimen included four ASA, five Eliquis, six Xarelto, and nothing in seven patients. AC/AP compared with no AC/AP had no effect on clot resolution (P = .9). The average proximal thigh diameter (millimeters, mm), vein length treated (mm), and catheter distance (mm) from the junction were the following: EGIT 1 (5.9 ± 2.4, 37.5 ± 17.6, and 5.2 ± 1), EGIT 2 (5.9 ± 1.7, 38 ± 16.9, 4.79 ± 0.71), EGIT 3 (5.1 ± 2.6, 27.9 ± 16.6, and 5.26 ± 1.4), and EGIT 4 (5 ± 1.7, 29.9 ± 15.8, and 5.39 ± 2.18), respectively. Treatment length alone was significantly shorter in EGIT 3 and 4, compared with EGIT 1 and 2 (P ≤ .05). Catheter distance from the junction was longer in EGIT 1, 3, and 4 patients compared with CAG patients (P ≤ .02). CONCLUSIONS: Regardless of EGIT class or severity, the majority of EGITs are not associated with clot extension or migration and tend to resolve or regress. For EGIT class 1 and 2 patients, AC or AP therapy is not necessary, as 86% and 60%, respectively, resolved with observation alone by 4 weeks. For EGIT 3, 68% resolved or regressed regardless of AC or AP use. The majority of EGIT 4 were remote calf vein DVTs. EGIT 3 and 4 associated with the saphenofemoral/popliteal junction are rare. When compared with CAG patients, proximal thigh diameters and treatment lengths were larger and longer in EGIT 1 and 2 patients. Catheter proximity to the junction was not associated with a higher incidence of EGIT formation.

Nitinol stents placed in iliac veins are not associated with prolonged back pain.

INTRODUCTION: Endovascular stenting is the standard of care for the management of symptomatic chronic venous obstruction. The increased radial resistive force and longer lengths of Nitinol stents have led to questions over persistent post-operative back pain. The purpose of this investigation was to assess the incidence and severity of post-operative back pain of Nitinol stents compared to Wallstents. METHODS: A retrospective review of data at the Center for Vascular Medicine was performed. Patient demographics, pre-operative, one week, three-, six,- and 12 month visual analog pain scores (VAS) for back pain, stent type, diameter, length, and vein locations were assessed. RESULTS: From April 2014 to November 2021, 627 (412 women/215 men) patients were assessed for the presence of post-operative back pain after an initial iliac vein stent placement. Stents utilized were Wallstents (n = 114), Venovo (n = 342), and Abre (n = 171). The most common Nitinol stent diameter and lengths were 14 mm, 16 mm, and 120 mm, respectively (p ≤ .03). The incidence of back pain at one week was 66% (411/627). VAS scores at one week and one, three, and six months post-operatively were the following: Wallstents-2.6 ± 3 (n = 66), 1.7 ± 2.6 (n = 43) 0.7 ± 2 (n = 51), and 0 ± 0 (n = 27); Abre-3.5 ± 3 (n = 130), 3.8 ± 3 (n = 19), 1.2 ± 2.5 (n = 12), and 1 ± 2 (n = 5); and Venovo- 2.5 ± 3 (n = 216), 2.4 ± 3 (n = 70), 0.9 ± 2 (n = 68), and 0.6 ± 1.7 (n = 49). There was no difference in the severity of back pain at any time point (p ≥ .99). The development of back pain was unrelated to stent type, diameter, length, or covered vein territory. CONCLUSIONS: Post-operative back pain was observed in 66% of patients at one week. The average pain score at one week for the entire cohort was three, which declined to less than one at one month. No difference in the severity of back pain between groups was observed at any time point, and the development of back pain is unrelated to stent type, diameter, length, or covered vein territory.

A practice audit of short-term outcomes of Wallstents versus Venovo stents for the treatment of nonthrombotic iliac vein outflow stenoses.

OBJECTIVE: The Wallstent (WS; Boston Scientific, Malborough, MA) is currently the standard of care for comparisons of clinical efficacy for new stent devices in the treatment of iliac vein outflow disease. Many vein-specific Nitinol-based stents have been now approved by the Food and Drug Administration for use in the iliofemoral venous system. However, few comparisons of these devices to the current standard have been reported. The purpose of this investigation was to compare the complication and reintervention rates between the WS and Venovo stent (VS; BD, Franklin Lakes, NJ). METHODS: A random sample of 100 WS and 100 VS cases performed from April 2018 through December 2020 were selected for retrospective analysis. The demographics, presenting symptoms, and CEAP (Clinical, Etiology, Anatomy, Pathophysiology) class were assessed. The complication logs and 90-day follow-up data were reviewed for every case to assess the incidence of postoperative deep vein thrombosis, stent thrombosis, in-stent restenosis, bleeding, and transient back pain. RESULTS: WSs had been placed more often in the left common iliac vein segment (52 vs 1), and VSs had been placed more often in the left common iliac vein and external iliac vein segments (36 vs 63; P = .0069). The average diameter and length of the WSs and VSs were 19.7 ± 2.2 mm vs 15 ± 1.4 mm (P = 2.4∗10-44) and 80.8 ± 9 mm vs 117.6 ± 20.4 mm (P = 2.4∗10-38), respectively. The average number of stents per patient was 1.05 for the WSs and 1.03 for the VSs (P = .47). The reintervention rates were similar between the two groups: WS, n = 5; and VS, n = 4 (P = .74). Four of the five WS reinterventions were stent extensions to treat in-stent restenosis and recurrence of symptoms, and one was secondary to occlusion requiring ipsilateral venoplasty and stenting. Two of the four VS reinterventions were venoplasty for in-stent restenosis and two were stent extensions for symptom recurrence. Transient back pain was the most common complication (WS, 37%; VS, 47%; P = 0.28). Insertion site deep vein thrombosis had developed in the three patients in the WS group and four patients in the VS group (P = .71). No patient had experienced bleeding requiring hospitalization, and no stent fractures, stent migration, or deaths had occurred. CONCLUSIONS: The complication and reintervention rates between the WS and VS groups were similar. Both stents demonstrated evidence of in-stent stenosis requiring reintervention. Implanted VSs tended to be smaller in diameter and longer in length and covered the common and external iliac veins more often compared with the WSs. Therefore, one VS can be used to cover two territories compared with the WS for which two stents will be required to cover the same vein territory length.

Pregnancy after iliac vein stenting for pelvic venous insufficiency.

BACKGROUND: The use of iliac vein stenting for the treatment of pelvic pain secondary to pelvic venous insufficiency has significantly increased. In women of childbearing age, the effect of the gravid uterus on stent function and patency is unclear. The purpose of this investigation was to determine the effect of pregnancy on stent patency and reintervention rate in women with iliac vein stents. METHODS: A retrospective chart review and email survey was performed to identify women treated at the Center for Vascular Medicine who were treated with iliac vein stenting and who had subsequent pregnancies. Medical and surgical comorbidities, stent type, location, length, number of stents, reintervention rates, number of pregnancies after stenting, anticoagulation usage during pregnancy, and type of delivery were assessed. RESULTS: From January 2014 to December 2020, 15 women with 16 iliac vein stents and who had 17 subsequent pregnancies were identified. The average age at stenting was 35.3 ± 4.13 years. The average interval between stenting and conception was 350 ± 287 days. Before pregnancy, stent location was in the right common/right external iliac veins in 1 patient and left common/external iliac veins in 14 patients. The average stent diameter and length were 19.6 ± 3 and 79.5 ± 20.3 mm, respectively. Thirteen Boston Scientific Wallstents and three Bard Venovo stents were used before pregnancy. One patient with a Wallstent required a stent extension before pregnancy and one patient had two stents placed at the initial procedure. Two women were pregnant twice after stenting for a total of 17 pregnancies. There were 16 term and 1 premature delivery of single infants. Patients were treated with enoxaparin (Lovenox) for stent-related thrombosis prophylaxis in 11 of 17 pregnancies, 5 had no prophylaxis, and the status of 1 pregnancy is unknown. One asymptomatic patient underwent a stent venoplasty after delivery. CONCLUSIONS: Iliac vein stents tolerate a gravid uterus well. No stents thrombosed during or after pregnancy and none required reintervention secondary to pregnancy-related compression. Anticoagulation with low-molecular-weight heparin should be considered for stent thrombosis prophylaxis. Potential pregnancy should not be considered a contraindication to iliac vein stenting for the treatment of symptomatic pelvic venous insufficiency.

Severity of disease and treatment outcomes of anterior accessory great saphenous veins compared with the great saphenous vein.

OBJECTIVE: Endovenous therapies are currently the standard of care for the treatment of patients with symptomatic great saphenous vein (GSV) reflux. The effectiveness and long-term outcomes of these therapies for anterior accessory great saphenous veins (AAGSVs) are poorly defined. The objective of this investigation is to determine treatment outcomes in patients with symptomatic AAGSV reflux compared with patients with symptomatic GSV reflux. METHODS: Data were prospectively collected in the Center for Vein Restoration's electronic medical record system (NexGen Healthcare Information System, Irvine, Calif) and retrospectively analyzed. Treatment outcomes after a standalone ablation and ablation + phlebectomy were compared in patients with isolated AAGSV and GSV reflux. Treatment outcomes were assessed at 1 month and 6 months postprocedure using the revised Venous Clinical Severity Score (rVCSS) and the 20-item Chronic Venous Insufficiency Quality-of-Life Questionnaire (CIVIQ20) survey for quality of life. Medical and surgical comorbidities, Clinical-Etiological-Anatomical-Pathophysiological classification, body mass index, gender, race, and the average number of procedures performed were all analyzed. RESULTS: From January 2015 to December 2018, 31,186 patients and 49,193 limbs were assessed. Of these, 91 patients/103 limbs had isolated AAGSV reflux, and 7704 patients/10,371 limbs had isolated GSV reflux. There were 95% and 75% women in the isolated AAGSV and GSV groups, respectively (P ≤ .001). For the ablation-only patients, AAGSV (n = 57 patients/61 limbs) and GSV (n = 5349 patients/7191 limbs), there were no differences in preintervention (7.0 ± 2.0 vs 6.8 ± 2.8, P = .99), 1-month (4.0 ± 2.4 vs 3.9 ± 2.8, P = .99), and 6-month (3.9 ± 2.6 vs 3.9 ± 2.9, P = .55) rVCSS scores. Similar results were observed when ablations and phlebectomies were performed (AAGSV [n = 34 patients/42 limbs] and GSV [n = 1848 patients/2491 limbs]). CIVIQ20 scores for patients with isolated AAGSV and GSV were 53.3 ± 19.6 vs 50.6 ± 18.8 (P = .43) preintervention, 37.2 ± 17.6 vs 35.7 ± 15.9 (P = .91) at 1 month, and 41.3 ± 21.7 vs 35.1 ± 15.7 (P = .36) at 6 months, respectively. Postprocedure scores within groups improved at 1 and 6 months (P ≤ .02); however, 6-month AAGSV CIVIQ20 scores after an ablation increased slightly compared with 1-month scores and were not different to preintervention GSV scores (P = .07). When phlebectomies were performed with ablations, 6-month CIVIQ20 scores were similar between groups (P = .72). There was no difference in the average number of ablations in patients with phlebectomies in the AAGSV or GSV group (1.24 ± 0.44 vs 1.35 ± 0.49, P = .15). CONCLUSIONS: Endovenous therapies for the treatment of symptomatic AAGSVs demonstrate similar outcomes to patients with symptomatic GSV reflux. For standalone ablations, the rVCSS scores are similar between the groups; however, CIVIQ20 scores increase to preintervention levels in standalone ablation AAGSV patients at 6 months. This increase disappears when phlebectomies are performed with ablations. Based on these data, patients with symptomatic AAGSV treated with ablation also require treatment of the associated tributaries (varicosities) to achieve similar outcomes to patients with GSV, and this calls into question the effectiveness of ablation for isolated AAGSV reflux.

Immediate postprocedure anticoagulation with factor Xa inhibitors of venous stents for nonthrombotic venous lesions does not increase stent patency.

BACKGROUND: Many clinicians will prescribe anticoagulation therapy for patients after iliac vein stenting to prevent early or late stent thrombosis. At present, it is unknown whether therapeutic anticoagulation has any effect on stent patency. Thus, we assessed the role of short-term anticoagulation on iliac vein stent patency in patients with nonthrombotic iliac vein lesions (NIVLs). METHODS: We performed a retrospective medical record review of all iliac vein stents placed for NIVLs at the Center for Vascular Medicine from January 2018 to December 2019. We compared the stent patency in the two groups. The anticoagulation (AC) group had received rivaroxaban or apixaban postoperatively for a minimum of 90 days and were compared with a group that had received no postoperative anticoagulation (NAC). Stent patency was assessed using transabdominal ultrasound at 3, 6, 12, 18, 24, and 30 months. At the discretion of the treating physician, the patients who demonstrated thrombus layering on surveillance ultrasound scanning continued rivaroxaban or apixaban until thrombus resolution was observed. The demographics and stent location, diameter, and length were assessed. Stent patency was analyzed using life table analyses. Differences in stent patency were analyzed using GraphPad Prism, version 8, statistical software (GraphPad Software Inc, La Jolla, Calif) and the log-rank (Mantel-Cox) test. RESULTS: The number of patients and stents in each group were as follows: AC group, 299 patients and 308 stents; and NAC group, 77 patients and 90 stents. The average age was 52.24 ± 13.44 years and 55.63 ± 14.49 years in the AC and NAC groups, respectively (P ≤ .065). Women constituted 76% of the patients in the AC group and 72% in the NAC group. The average stent diameter and length for the AC group was 20 ± 2 mm and 77 ± 13 mm and for the NAC group was 19 ± 2 mm and 82 ± 9 mm, respectively. The stents had been placed in the right common iliac vein, bilaterally, or left common iliac vein territory in 15%, 3%, and 82% in the AC group and 18%, 2%, and 80% in the NAC group, respectively. The cumulative stent patency at 30 months was 98.7% and 94.6% for the NAC and AC groups, respectively (P ≤ .83). All the stents placed were Wallstents (Boston Scientific, Marlborough, Mass). A total of eight insertion site thromboses occurred that did not affect stent patency: five in the AC group (1.6%) and three in the NAC group (4.5%; P = .15). In addition, 19 patients demonstrated evidence of thrombus layering, with 6 receiving extended anticoagulation. CONCLUSIONS: Our data indicate that perioperative stent thrombosis in patients with NIVLs is uncommon. Thus, anticoagulation for perioperative stent thrombosis prophylaxis is not necessary. Anticoagulation should only be used for patients with insertion site thromboses and should be considered if thrombus layering is observed on surveillance scanning.

Extended Center for Vein Restoration study assessing comparative outcomes for the treatment of chronic venous insufficiency in Medicare- and non-Medicare-eligible patients.

BACKGROUND: We previously reported that chronic venous insufficiency treatment of Medicare-eligible patients achieved outcomes similar to those for non-Medicare-eligible patients. The goal of the present investigation was to assess the long-term treatment outcomes and the effect of race in a larger patient cohort. METHODS: From January 2015 to December 2019, we retrospectively reviewed the data from 131,268 patients who had presented for a lower extremity venous evaluation. We divided the patients into two groups by age: group A was aged ≥65 years and group B, <65 years. The treatments analyzed in each group were axial thermal ablation (TA), axial Varithena ablation (VA), TA plus phlebectomy, VA plus phlebectomy, and TA or VA with phlebectomy and ultrasound-guided foam sclerotherapy (UGFS). The treatment outcomes were assessed using the revised venous clinical severity score (rVCSS) and Chronic Venous Insufficiency Quality of Life 20-item questionnaire (CIVIQ-20) scores at the initial consultation and 1, 6, and 12 months after completion of the treatment plan. RESULTS: Of the 131,268 patients, 40,020 were in group A and 91,248 in group B, with an average age of 74.4 ± 6.6 and 49.9 ± 10.6 years, respectively. Of the 40,020 patients in group A, 15,697 (n = 25,234 limbs) had undergone TA and 1910 (n = 3222 limbs) had undergone VA. Of the 91,248 patients in group B, 35,220 (n = 53,717 limbs) had undergone TA and 2178 (n = 3672 limbs) had undergone VA. For the TA subgroups, all rVCSSs had significantly improved after treatment at each evaluation point (P ≤ .001). For the TA and VA plus phlebectomy with or without UGFS subgroup, the older patients (group A) required 6 months to develop the same degree of improvement as the younger patients (group B) at 1 month. When subdivided by race, all initial and 6-month rVCSSs and CIVIQ-20 scores within a race had improved and were better in group B, except for Asian and Hispanic patients (P ≤ .001). After TA or VA plus phlebectomy, with or without UGFS, the CIVIQ-20 outcomes had improved by 1 month in both groups, although the rVCSS lagged by 6 months in group A. No differences in the rVCSSs or CIVIQ-20 scores were observed between the groups treated with TA or VA. CONCLUSIONS: Medicare-eligible beneficiaries demonstrated improved outcomes similar to those of non-Medicare-eligible beneficiaries after ablation. When TA or VA plus phlebectomy with or without UGFS were examined, group A required 6 months to demonstrate rVCSSs equivalent to those of group B at 1 month. The CIVIQ-20 scores had improved by 1 month in both groups, regardless of the treatment modality. The difference in rVCSSs appeared to be driven by African American and white patients because Hispanic and Asian patients demonstrated equivalent results regardless of age. Patients treated with TA or VA demonstrated equivalent results.

Pelvic venous insufficiency secondary to iliac vein stenosis and ovarian vein reflux treated with iliac vein stenting alone.

BACKGROUND: We have previously reported that in women with a pelvic venous disorder secondary to pelvic venous insufficiency, 56% will present with an iliac vein stenosis (IVS) and ovarian vein reflux (OVR). The purpose of the present investigation was to determine whether women with combined disease can be treated using iliac vein stenting alone. METHODS: A retrospective review of prospectively collected data at the Center for Vascular Medicine was performed. We investigated women with pelvic pain or dyspareunia secondary to combined IVS and OVR who had undergone stenting alone. The patient demographics, pre- and 6-month postoperative visual analog scale (VAS) for pain scores, stent type, stent diameter, stent length, and ovarian vein diameters were assessed. All patients had undergone diagnostic venography of their pelvic veins, left ovarian veins, and pelvic reservoirs and intravascular ultrasonography of their iliac veins. RESULTS: From May 2016 to October 2019, 82 patients with a pelvic venous disorder secondary to IVS and OVR were identified. The present data analysis focused on 38 patients with complete pre- and postoperative VAS scores and duplex scan stent patency data at 6 months. The pelvic and dyspareunia VAS scores at the initial and 6-month follow-up visits were as follows: 6.83 ± 3.19 and 4.24 ± 2.65 and 1.72 ± 2.01 and 0.05 ± 2.0, respectively (P ≤ .001). At 6 months, 29 of the 38 women (76%) reported complete resolution of all symptoms, 26 of 28 (93%) reported complete resolution of their dyspareunia, 5 of 38 (13%) reported significant improvement, and 4 of 38 (10%) reported no improvement. The average ovarian vein diameter was 6.7 ± 2.5 mm. The average stent size and length was 18.20 ± 1.6 mm and 92.41 ± 18.5 mm, with 25 placed in the left common iliac, 2 in the right common iliac vein, and 3 bilaterally. Of the 38 patients, 7 required reintervention (18%). An untreated pelvic reservoir was observed in 17 of the 38 patients (44%). One of the two with no response and six of the patients with improvement had OVR and an untreated pelvic reservoir. The remaining 10 patients with a pelvic reservoir had experienced complete resolution of their symptoms with stenting alone. CONCLUSIONS: Of the 38 women with pelvic pain secondary to combined IVS and OVR, 76% achieved complete symptom resolution with iliac vein stenting alone. Most of the women with a pelvic reservoir were asymptomatic and reported full symptom resolution after stenting alone. However, these data suggest that in some women, a relationship might exist between the presence of a pelvic reservoir and the persistence of symptoms. Therefore, for women with combined IVS and OVR, we recommend iliac vein stenting alone and staged ovarian vein embolization only for women with persistent symptoms.

Presentation patterns in women with pelvic venous disorders differ based on age of presentation.

BACKGROUND: The prevalence and presentation patterns in women with pelvic venous disorders (PeVD) secondary to pelvic venous insufficiency (PVI) at various ages are ill-defined. The purpose of this investigation was to determine if the types of symptoms, interventions, and treatment outcomes of women with PeVD varied with age progression. METHODS: From January 2015 to December 2019, we retrospectively reviewed prospectively collected data on 1,280 women with PeVD from our electronic medical record at the Center for Vascular Medicine (CVM). Medical and surgical comorbidities, past medical history, presenting pelvic and lower extremity symptoms, Clinical, Etiology, Anatomy, Pathophysiology (CEAP) class, revised Venous Clinical Severity Score (rVCSS), visual analog pain score (VAS) and types of interventions were assessed. Patients were grouped into five categories based on age of initial presentation: 20-29, 30-39, 40-49, 50-59, and greater than or equal to 60. Patients were also subcategorized according to their course of treatment: Iliac venous stenting alone, ovarian vein embolization (OVE) alone, simultaneous iliac vein stenting and ovarian vein embolization, and staged iliac vein stenting and ovarian vein embolization. Differences in groups were analyzed utilizing chi square, analysis of variance and regression analysis with Graphpad Prism 8 (San Diego, CA) and SAS Studio 3.8 (Cary, NC) statistical software. RESULTS: From January 2015 through December 2019, 1,280 women were treated for PeVD. The average ages in each group were the following: 26.53 ± 2.90 (n = 57), 35.80 ± 2.84 (n = 238), 44.98 ± 2.78 (n = 345), 54.67 ± 2.90 (n = 324) and 68.39 ± 8.44 (n = 316) respectively. The prevalence of PVI by age group was 4.45%,18.59%, 26.95%, 25.31% and 24.70% respectively (p < 0.05). The prevalence of diabetes, hypertension, coronary artery disease (CAD) and hypercholesterolemia differed between age groups (p < 0.05). Significant differences in the prevalence of pelvic pain, dyspareunia, dysmenorrhea, vulvar varices, leg pain, leg edema, leg heaviness, restless legs, varicose veins, and leg ulcers were observed across treatment groups (p < 0.05). CEAP distribution differed by age with CEAP 0-2 decreasing with age, CEAP 3 progressively increasing with age and CEAP 4-6 predominantly observed in patients older than 50. Analysis of variance indicated that with each decile increase in age, the prevalence of leg symptoms increased (p < 0.05) with a reciprocal decrease in pelvic symptoms (p < 0.05). All intervention types were infrequent in twenty year old's. There was a linear increase in stenting with each decile increase in age. The prevalence of OVE was similar across all age groups. There was an overall improvement in VAS scores for all treatment and age groups. For patients in their 20 s, an initial improvement in VAS scores was observed with moderate recurrence of pain observed after three months. CONCLUSION: PeVD presents as a spectrum of signs and symptoms, with pelvic and leg symptoms being inversely related according to age. The prevalence of PeVD is lowest in patients in their twenties with differences in presentation observed with increasing age. Venous stenting progressively increases with each decile of age whereas the prevalence of OVE is similar regardless of age. There is overall improvement in symptoms post intervention, although women in their 20 s do not respond as well to intervention as women in other age groups. Future investigations will focus on determining which pelvic venous lesion is the predominant factor that needs correction to achieve maximal pain reduction.

Type of anti-thrombotic therapy for venous stenting in patients with non-thrombotic iliac vein lesions does not influence the development of in-stent restenosis.

BACKGROUND: In patients receiving stents for symptomatic non-thrombotic iliac vein lesions, many clinicians prescribe anti-thrombotic medications. Whether or not anti-coagulation post-venous stenting improves stent patency is unknown. The aim of this investigation is to determine whether prophylactic post-operative anti-thrombotic therapy improves stent patency and/or prevents in-stent restenosis. METHODS: The medical records and venous ultrasounds for 389 patients stented for non-thrombotic iliac vein lesions were retrospectively reviewed. Patients were categorized into three anti-thrombotic regimens: Clopidogrel, Aspirin and Clopidogrel, and Apixaban or Rivaroxaban. Patients were routinely assessed for restenosis and stent patency at 6, 26, and 52 weeks and treated with anti-thrombotics for 90 days. RESULTS: Freedom from in-stent restenosis at 6, 26, and 52 weeks were Clopidogrel (91.50, 82.91, 80.95%), Aspirin and Clopidogrel (88.68, 80.03, 80.03%), and Apixaban or Rivaroxaban (91.03, 85.11, 83.18%). Primary patencies were Clopidogrel (98.77, 98.77, 98.10%), Aspirin and Clopidogrel (100, 95.74, 95.74%), and Apixaban or Rivaroxaban (98.70, 98.70, 96.71%). There were no statistically significant differences. CONCLUSIONS: The type of post-operative anti-thrombotic therapy for non-thrombotic iliac vein lesions does not appear to improve stent patency or prevent the development of in-stent restenosis.

Effect of obesity on chronic venous insufficiency treatment outcomes.

BACKGROUND: Obesity is a known risk factor for the development and progression of chronic venous disorders (CVDs). It is currently unknown whether the treatment outcomes, after an intervention for CVDs, are affected by obesity. The purpose of the present investigation was to assess the effectiveness of various CVD treatments in obese patients and determine what level of obesity is associated with poor outcomes. METHODS: Data were prospectively collected in the Center for Vein Restoration electronic medical record system (NexGen Healthcare Information System, Irvine, Calif) and retrospectively analyzed. The patients and limbs were categorized by the following body mass index (BMI) categories: <25, 26 to 30, 31 to 35, 36 to 40, 41 to 45, and >46 kg/m2. The changes in the revised venous clinical severity score and Chronic Venous Insufficiency Quality of Life Questionnaire 20-item (CIVIQ-20) quality of life survey were used to determine the CVD treatment effectiveness for patients who had undergone endovenous thermal ablation (TA), phlebectomy, or ultrasound-guided foam sclerotherapy (USGFS). RESULTS: From January 2015 to December 2017, 65,329 patients (77% female; 23% male) had undergone a venous procedure. Of these patients, 25,592 (39,919 limbs) had undergone ablation alone, ablation with phlebectomy, or ablation with phlebectomy and USGFS. The number of procedures performed was as follows: TA, n = 37,781; USGFS, n = 22,964; and phlebectomy, n = 17,467. The degree of improvement at 6 months after the procedure was progressively less with an increasing BMI for the patients who had undergone TA, and the decrease was more significant for those patients with a BMI >35 kg/m2 (P ≤ .001). The outcomes improved ∼12% with the addition of phlebectomy to TA. The patients who had undergone a combination of TA, phlebectomy, and USGFS demonstrated no additional improvement. Significantly inferior outcomes were noted in patients with a BMI ≥35 kg/m2, with the poorest outcomes observed in patients with a BMI ≥46 kg/m2 (P ≤ .001). The average number of TAs per patient increased with an increasing BMI and was significantly different compared with the number for those with a BMI <30 kg/m2 (P ≤ .001). All pre- and post-CIVIQ-20 quality of life scores, within a BMI category, at 6 months were significantly different (P ≤ .01). No differences in the degree of improvement were observed in patients with a BMI ≥31 kg/m2. Finally, multivariate logistic regression analysis indicated that when controlling for BMI, diabetes, a history of cancer, female gender, and black and Hispanic race were independently associated with poorer outcomes. CONCLUSIONS: Progressive increases in BMI negatively affected CVD-related treatment outcomes as measured using the revised venous clinical severity score and CIVIQ-20. The outcomes progressively worsened with a BMI >35 kg/m2 for patients undergoing CVD treatment. The treatment outcomes for patients with a BMI ≥46 kg/m2 were so poor that weight loss management should be considered before offering CVD treatment.

Racial disparities in the outcomes of superficial vein treatments for chronic venous insufficiency.

BACKGROUND: Chronic venous disease (CVD) affects >20 million people in the United States. Despite this huge prevalence, there are few data on whether the effectiveness of current CVD therapies for symptomatic superficial vein reflux is affected by race. The goal of this investigation was to evaluate CVD treatment outcomes in various races in the United States. METHODS: From January 2015 to December 2017, we retrospectively reviewed and prospectively collected data from 66,621 patients who presented for CVD evaluation. We divided patients into five racial groups: African American, Asian, Hispanic, other (race not recorded), and white. Presenting signs and symptoms, treatment modalities, number of procedures per patient, and preintervention and postintervention revised Venous Clinical Severity Scores (rVCSSs) were evaluated. All racial groups were stratified by Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class for subgroup analysis. RESULTS: The average age of the entire cohort was 56.8 ± 14.7 years, with 51,393 women (77%) and 15,228 men (23%). Prevalence by race was 17% African American, 3% Asian, 18% Hispanic, 8% others, and 55% white. There was a higher incidence of C0 disease in whites (44%) and African Americans (31%); C1 and C2 disease in whites (46% and 55%) and Hispanics (28% and 25%); and C3, C4, C5, and C6 disease in whites (60%, 57%, 58%, and 61%) and African Americans (19%, 17%, 19%, and 21%). Pain as an initial presenting symptom was more common in African Americans, Asians, and Hispanics (29%, 29%, and 31%). Swelling was highest in African Americans (18%) and cramping in Hispanics (14%). Skin changes and venous ulcers were most common in African Americans (16% and 21%) and whites (63% and 61%). With regard to the average number of procedures performed, Hispanics (1.98 ± 1.24) and others (2.07 ± 1.25) required fewer stand-alone ablations compared with whites (2.31 ± 1.56), Asians (2.36 ± 1.58), and African Americans (2.27 ± 1.56; P ≤ .0001. With the addition of phlebectomies to ablations, Hispanics (3.78 ± 2.08) continued to require fewer procedures, and Asians required the greatest number of phlebectomies compared with all groups (P ≤ .001). When ultrasound-guided foam sclerotherapy was added to ablation and phlebectomy, African Americans required more procedures compared with all races (4.38 ± 2.59; P ≤ .01). For stand-alone ablations, Hispanics (2.18 ± 2.34) and Asians (1.91 ± 2.35) demonstrated lower postprocedure rVCSSs compared with African Americans (2.79 ± 2.88) and whites (2.8 ± 2.85; P ≤ .0001). For ablations with phlebectomies, all races demonstrated similar results except for Hispanics (2.19 ± 2.14), who did better than whites (2.85 ± 2.75; P ≤ .002). For ablations with phlebectomies and ultrasound-guided foam sclerotherapy, all races had similar results (P ≤ .0001). CONCLUSIONS: In the United States, CVD is primarily observed in white women. There are differences in the incidence and prevalence of disease severity and symptom presentation based on race. The incidence of CVD decreases with age in all racial groups except whites. Hispanics required the fewest procedures and African Americans required the most for optimal results. Postintervention rVCSSs equalized in all races when ablations were combined with phlebectomies and ultrasound-guided foam sclerotherapy.

Infrapopliteal Arterial Pseudoaneurysm Development Secondary to Blunt Trauma: Case Series and Literature Review.

OBJECTIVES: Infrapopliteal arterial pseudoaneurysms (IAP) following blunt trauma with associated orthopedic injuries are uncommon, often present in a delayed fashion, and encompass a diagnostic and therapeutic dilemma. Herein, we present a series of IAPs that were diagnosed following blunt trauma and their management. METHODS: Case series consisting of 3 patients and a review of the international literature. RESULTS: Our case series included 3 patients presenting with IAPs following blunt trauma with associated orthopedic injuries. They were all identified in a delayed manner (>3 weeks) after the orthopedic injuries were treated. All patients presented with pain and a pulsatile mass while one concurrently had neurologic deficits. The pseudoaneurysms were diagnosed by duplex ultrasound and confirmed by angiography to be originating from the tibioperoneal trunk, anterior tibial, and posterior tibial arteries respectively. Two patients were treated with surgical excision. Of these, one required an arterial bypass procedure while the other underwent direct ligation only. The third patient was treated by endovascular coiling. A literature review from 1950 to the present found 51 reported cases of IAP resulting from blunt trauma. Ninety percent of trauma-related infrapopliteal injuries occurred in men with a mean delay in diagnosis of 5.6 months (median 1.8 months) after injury. Since 1950, management has shifted from primarily ligation to incorporating minimally invasive endovascular techniques when appropriate. CONCLUSIONS: Infrapopliteal artery pseudoaneurysms are rare following blunt skeletal trauma. A delay in diagnosis often occurs and can result in major morbidity and extensive surgical intervention. We recommend a high index of suspicion and a thorough vascular examination in patients with lower extremity skeletal trauma to help identify and treat these injuries early and effectively.

Spine stabilization is a risk factor for the development of pelvic iliac vein lesions.

BACKGROUND: Open lumbar spine stabilization surgery often requires mobilization of the left and right common iliac veins (CIVs) and the placement of plates and screws that can impinge on them. We reviewed our venography experience of the past 3 years to determine whether there is an association between spine stabilization surgery and the development of symptomatic iliac vein outflow lesions. METHODS: A retrospective chart review of prospectively collected data from our electronic medical record system was performed to identify patients who underwent venography with or without venous stenting and had a history of previous lumbar spine stabilization. Patients' demographics, medical comorbidities, venograms, and intravascular ultrasound (IVUS) data were collected and analyzed. The senior author reviewed all venograms and IVUS images of patients with previous spine stabilization procedures. RESULTS: From January 2014 to April 2018, venography was performed in 1713 limbs in 1245 patients at the Center for Vascular Medicine. Of the 1245 patients, 18 patients had a history of lumbar spine stabilization procedures: five anterior-posterior and 13 posterior. Nine had single-level and eight had two- or three-level fusions. All 18 patients demonstrated pelvic lesions. These included 1 left CIV aneurysm, 5 left CIV stenoses, 3 bilateral CIV stenoses, 2 left CIV and inferior vena cava occlusions, and 2 external iliac vein stenoses. The aneurysm patient was treated with anticoagulation, 8 patients underwent stenting, 1 patient refused stenting because of relocation to another country, 1 inferior vena cava-CIV occlusion could not be crossed, fear of dislodging a thrombus and the proximity to a protruding posteriorly placed screw prevented stenting in 2 patients, and 4 patients had a venoplasty alone because of undersizing of a stenosis or missed lesions with IVUS after review by a blinded reviewer. Lesions in anterior lumbar interbody fusion patients were extremely stenotic, required predilation, and resulted in a residual stenosis requiring venoplasty at a second setting in one patient. CONCLUSIONS: Lumbar spine stabilization surgery may be a risk factor for development of symptomatic venous outflow obstruction lesions. During venography and stenting in patients with anterior lumbar interbody fusion approaches, significant scarring may be encountered, resulting in a residual stenosis after stent placement. Predilation venoplasty, before stent deployment, is recommended to prevent stent migration. Furthermore, a history of spine stabilization surgery in patients presenting with pelvic symptoms, lower extremity pain or swelling, or post-thrombotic symptoms should prompt consideration of a pelvic venous duplex ultrasound examination to determine whether an iliac venous outflow lesion is present.

Reliability and accuracy of duplex ultrasound vein mapping for dialysis access.

BACKGROUND: Duplex ultrasound vein mapping (DUVM) may increase autogenous dialysis access procedures but has not been universally adopted by surgeons. METHODS: We determined reliability and accuracy of arm vein measurements on physical examination (PE) and DUVM, compared to direct measurements in the operating room (OR, gold standard). Operative plans were developed from each set of measurements and we evaluated which approach identified more options for autogenous procedures. RESULTS: Vein diameters measured on DUVM correlated well with OR measurements but those made on PE did not. Autogenous access options were identified in 34.8% of patients based on PE and in 96.6% based on their DUVM. The 6-month primary-patency was 86.4%; assisted primary-patency was 89.8%. CONCLUSIONS: Duplex ultrasound vein mapping is more reliable and accurate for assessing arm vein anatomy than physical examination. It identifies more autogenous options than physical-examination alone. It is essential for the preoperative evaluation for dialysis access.

Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency.

BACKGROUND: Reflux in the ovarian veins, with or without an obstructive venous outflow component, is reported to be the primary cause of pelvic venous insufficiency (PVI). The degree to which venous outflow obstruction plays a role in PVI is currently ill-defined. METHODS: We retrospectively reviewed the charts of 227 women with PVI who presented to the Center for Vascular Medicine from January 2012 to September 2015. Assessments and interventions consisted of an evaluation for other causes of chronic pelvic pain by a gynecologist; preintervention and postintervention visual analog scale (VAS) pain score; complete venous duplex ultrasound examination; and Clinical, Etiology, Anatomy, and Pathophysiology classification. All patients underwent diagnostic venography of their pelvic and left ovarian veins as well as intravascular ultrasound of their iliac veins. Patients were treated in one of six ways: ovarian vein embolization (OVE) alone (chemical ± coils), OVE with staged iliac vein stenting, OVE with simultaneous iliac vein stenting, iliac vein stenting alone, OVE with venoplasty, and venoplasty alone. RESULTS: Of the 227 women treated, the average age and number of pregnancies was 46.4 ± 10.4 years and 3.36 ± 1.99, respectively. Treatment distribution was the following: OVE, n = 39; OVE with staged stenting, n = 94; OVE with simultaneous stenting, n = 33; stenting alone, n = 50; OVE with venoplasty, n = 8; and venoplasty alone, n = 3. Seven patients in the OVE and stenting groups (staged) and one patient in the OVE + venoplasty group required a second embolization of the left ovarian vein. Eighty percent (181/227) of patients demonstrated an iliac stenosis >50% by intravascular ultrasound. Average VAS scores for the entire cohort before and after intervention were 8.45 ± 1.11 and 1.86 ± 1.61 (P ≤ .001). In the staged group, only 9 of 94 patients reported a decrease in the VAS score with OVE alone. VAS score decreased from 8.6 ± 0.89 before OVE to 7.97 ± 2.10 after OVE. After the planned staged stenting, VAS score decreased to 1.33 ± 2.33 (P ≤ .001). Similarly, in the simultaneous group, preintervention scores were 8.63 ± 1.07 and decreased to 2.36 ± 2.67 after OVE + stenting (P ≤ .001). CONCLUSIONS: The majority of patients in our series (80%) demonstrated a significant iliac vein stenosis. These observations indicate that the incidence of iliac vein outflow obstruction in PVI is greater than previously reported. In patients with combined ovarian vein reflux and iliac vein outflow obstruction, our data suggest that pelvic venous outflow lesions should be treated first and that ovarian vein reflux should be treated only if symptoms persist. In women with an outflow lesion, ovarian vein reflux, and a large pelvic reservoir, we recommend simultaneous treatment.

The Center for Vein Restoration Study on presenting symptoms, treatment modalities, and outcomes in Medicare-eligible patients with chronic venous disorders.

BACKGROUND: Chronic venous disorders (CVDs) have been estimated to affect up to 20 million Americans. Despite this huge prevalence, the signs, symptoms, and treatment outcomes in patients 65 years of age and older are not well defined. Our goal was to determine the presentation and treatment outcomes in elderly patients compared with a cohort of patients younger than 65 years. METHODS: From January 2015 to December 2016, we retrospectively reviewed prospectively collected data from 38,750 patients with CVD from the Center for Vein Restoration's electronic medical record (NextGen Healthcare Information Systems, Irvine, Calif). We divided patients into two groups; group A patients were younger than 65 years, and group B patients were 65 years of age or older. Medical and surgical history, presenting symptoms, treatment modalities, and revised Venous Clinical Severity Score before and after intervention were evaluated. A multivariate logistic regression analysis was performed to determine the predictive value of presenting and associated symptoms. Groups A and B were subdivided by Clinical, Etiology, Anatomy, and Pathophysiology class for subgroup analysis. Data were analyzed with GraphPad Prism (GraphPad Software Inc, La Jolla, Calif) or SAS version 9.4 statistical software package (SAS Institute, Cary, NC). RESULTS: There were 27,536 patients in group A and 11,214 in group B. Women constituted 78% of all patients. Group B demonstrated a higher incidence of chronic diseases compared with group A (P ≤ .003). As initial presenting symptoms, pain, heaviness, fatigue, and aching were more common in group A than in group B (61% vs 55%, 30% vs 27%, 27% vs 24%, and 17% vs 12%, respectively; P ≤ .001). Swelling, skin discoloration, and venous ulceration were more common in group B than in group A (29% vs 23%, 12% vs 6%, and 5% vs 2%; P ≤ .001). Ablations were more commonly performed in group B patients with C4 to C6 disease (P ≤ .004). The revised Venous Clinical Severity Scores before and 1 month after intervention were similar between groups. Treatment improvement was statistically significant in both groups (P ≤ .001). Multivariate logistic regression analysis indicated that varices, bleeding, swelling, skin changes, venous ulceration, aching, heaviness, pain, fatigue, cramping, and restless legs were associated with the presence of CVD (P ≤ .001). CONCLUSIONS: Medicare beneficiaries presented with more chronic diseases and more severe disease. Initial and associated symptoms were highly associated with the presence of CVD. Despite requiring more interventions than patients younger than 65 years, Medicare beneficiaries demonstrated the same degree of clinical improvement. Medicare should not develop coverage policy decisions that prevent access to therapies that alleviate CVD-induced symptoms.