Partial In-Stent Thrombosis After Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVE: Iliac vein stenting is a safe and efficacious procedure for the correction of iliac vein stenosis. One of its known major complications is complete iliac vein stent thrombosis. However, we have noticed in our practice that a number of patients developed only early partial in-stent (<60%) thrombosis, within the first 30 days. In order to try to learn more about these lesions, we reviewed the data for possible causes of these lesions. MATERIALS/METHODS: From September 2012 to August 2018, we obtained 3518 iliac vein venograms using intravascular ultrasound (IVUS) for patients with venous insufficiency who failed to respond to conservative therapy. Patients were followed up with transcutaneous duplex ultrasound (DUS) every 3 months for the first year and every 6 - 12 months thereafter. Patients were prescribed clopidogrel for 3 months or were told to continue their pre-existing anticoagulants. RESULTS: There were 2234 women and 1284 men who received an iliac vein stent. The mean age was 65.7 ±14 years. Mean follow-up for this cohort was 17 months. Of 74 patients developed a full thrombosis, 38 developed a partial venous thrombosis and 3406 developed no thrombosis. When comparing those who developed a partial thrombus versus those who developed no thrombus/full thrombus, overall age, laterality, CEAP, gender, and whether the patient received clopidogrel prior to the procedure and after the procedure were not found to be statistically significant factors. However, patients with an ASA score of 2 or 3,were found to be at a higher risk of developing a partial thrombus(P = 0.0223) compared to those who had an ASA score of 1 or 4. CEAP Scores and ASA class breakdown can be seen in Table 1 and Table 2, respectively. Of the 38 partial venous thrombosis that developed,18 completely resolved within the first 3 months after the procedure and 20 remained chronic past 3 months after the procedure. Patients with partial venous thrombosis were asymptomatic upon clinical presentation, and none developed post thrombotic syndrome (PTS) or pulmonary embolism (PE). Male gender was associated with partial thrombus resolution(P = 0.0036) CONCLUSIONS: Patients with ASA scores of 2 or 3, seemed to be at a higher risk of developing a partial thrombus when compared to patients with ASA score of 1 or 4. Male gender was associated with partial thrombus resolution. All other factors appear to not be statistically significant in impacting the development of a partial thrombus. This has been the first attempt to look at this new clinical entity.

Sphygmomanometer-induced hemostasis following iatrogenic guidewire perforation during lower extremity angioplasty.

OBJECTIVES: Iatrogenic guidewire perforation is a well-known complication of lower extremity angioplasty that is often benign or can be easily treated with endovascular techniques. However, perforations that occur in arterial side branches may be more challenging to manage. If bleeding persists, open surgery and fasciotomy may be required to evacuate the resulting hematoma and prevent compartment syndrome. These subsequent procedures increase morbidity and, if the angioplasty was performed in the outpatient setting, necessitate patient transfer to a hospital. To address these challenges, we describe a non-invasive hemostasis technique involving serial sphygmomanometer cuff inflations over the affected site in a series of five patients who experienced this complication at our office. METHODS: We retrospectively reviewed the medical records of consecutive patients undergoing lower extremity angioplasty that were found to have an arterial guidewire perforation on completion angiogram at our outpatient center between February 2012 and February 2017. Patients found to have iatrogenic guidewire perforations were administered intravenous protamine sulfate and were transferred to the surgical recovery room. Patients received ibuprofen or acetaminophen for pain management. A blood pressure cuff was placed around the site of perforation, and patients received serial cuff inflation cycles with repeated examinations of both limbs until patients reported cessation of pain and there were no signs of a developing hematoma. Patients were observed for two hours before they were discharged home. A follow-up duplex ultrasound examination was completed within one week of the intervention. RESULTS: Over the course of five years, 536 angioplasties were performed at our outpatient office. Five of these patients experienced iatrogenic guidewire perforation (0.93%). Perforations occurred in branches of the anterior or posterior tibial artery. All of these patients were successfully managed with the aforementioned hemostasis technique. None of these patients required transfer to a hospital for further management, and no complications were reported at follow-up. CONCLUSIONS: Complications of iatrogenic guidewire perforations in lower extremity arterial side branches can be safely and effectively managed by applying external compression around the affected site with an automatic blood pressure cuff.

Safety of vascular interventions performed in an office-based laboratory in patients with low/moderate procedural risk.

OBJECTIVE: An exponential increase in number of office-based laboratories (OBLs) has occurred in the United States, since the Center for Medicare and Medicaid Services increased reimbursement for outpatient vascular interventions in 2008. This dramatic shift to office-based procedures directed to the objective to assess safety of vascular procedures in OBLs. METHODS: A retrospective analysis was performed to include all procedures performed over a 4-year period at an accredited OBL. The procedures were categorized into groups for analysis; group I, venous procedures; group II, arterial; group III, arteriovenous; and group IV, inferior vena cava filter placement procedures. Local anesthesia, analgesics, and conscious sedation were used in all interventions, individualized to the patient and procedure performed. Arterial closures devices were used in all arterial interventions. Patient selection for procedure at OBL was highly selective to include only patients with low/moderate procedural risk. RESULTS: Nearly 6201 procedures were performed in 2779 patients from 2011 to 2015. The mean age of the study population was 66.5 ± 13.31 years. There were 1852 females (67%) and 928 males (33%). In group I, 5783 venous procedures were performed (3491 vein ablation, 2292 iliac vein stenting); with group II, 238 arterial procedures (125 femoral/popliteal, 71 infrapopliteal, iliac 42); group III, 129 arteriovenous accesses; and group IV, 51 inferior vena cava filter placements. The majority of procedures belonged to American Society of Anesthesiology class II with venous (61%) and arterial (74%) disease. A total of 5% patients were deemed American Society of Anesthesiology class IV (all on hemodialysis). There was no OBL mortality, major bleed, acute limb ischemia, myocardial infarction, stroke, or hospital transfer within 72 hours. Minor complications occurred in 14 patients (0.5%). Thirty-day mortality, unrelated to the procedure, was noted in 9 patients (0.32%). No statistically significant differences were noted in outcomes between the four groups. CONCLUSIONS: Our data suggest that it is safe to use OBL for minimally invasive, noncomplex vascular interventions in patients with a low to moderate cardiovascular procedural risk.

Radiofrequency Ablation Increases the Incidence of Endothermal Heat-Induced Thrombosis.

BACKGROUND: Endovenous thermal ablation has become the procedure of choice in the treatment of superficial venous reflux disease. The current armamentarium of devices and techniques aimed at the elimination of saphenous reflux offers surgeons and interventionalists a variety of treatment options; however, there is a lack of data comparing the safety of these products. The most concerning complication after endovenous thermal ablation is endothermal heat-induced thrombosis (EHIT) due to the risk of progression to deep venous thrombosis. This study aimed to compare the incidence rate of EHIT between radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). METHODS: This was a single-center, office-based, retrospective study over the course of 5 years, in which 3,218 consecutive patients underwent 10,029 endovenous saphenous ablations. The patient cohort was 66.2% female, with an average age of 61.9 years. At the time of each individual intervention, 24, 212, 3,620, 4,806, 200, and 1,167 patients had Clinical-Etiology-Anatomy-Pathophysiology disease 1, 2, 3, 4, 5, and 6, respectively. RESULTS: There was a total of 3,983 EVLT and 6,091 RFA procedures. The most common vessel treated was the great saphenous vein, 63.6% of the time, followed by the small saphenous vein (25.6%), accessory saphenous vein (6.1%), and perforator vein (4.6%). There were 186 cases of EHIT, with 137 (73.6%) identified as type 1 as per the Kabnick classification. Endovenous ablation performed via RFA resulted in significantly more cases of EHIT than of EVLT (109 vs. 77; P = 0.034; odds ratio = 1.52), which was confirmed by a multivariate analysis. CONCLUSIONS: In the largest single-center study of endovenous saphenous ablations to date, RFA was shown to pose a significantly higher risk of EHIT than of EVLT.

Underexpansion of Wallstents® in the Treatment of Nonthrombotic Iliac Vein Lesions.

BACKGROUND: Iliac vein stenting is increasingly being used in the treatment of chronic venous insufficiency caused by nonthrombotic iliac vein lesions (NIVL). We have noticed that many stents do not deploy to the expected stent area (ESA) as designated by the manufactured stent diameter (MSD). The purpose of this study was to identify factors predictive of Wallstent® underexpansion in the iliocaval venous system. METHODS: Retrospective analysis of all patients with NIVL who were treated with iliac vein stenting using Wallstents® was performed. None of the patients in this study underwent pre-or post-stenting balloon angioplasty. Multiway analysis of variance and multiple linear regression analysis were performed to examine the effects of gender, age, stent laterality, location of stenosis, and CEAP (clinical, etiology, anatomy, and pathophysiology) score at presentation on the proportion of observed stent area (OSA) to ESA. RESULTS: Two-hundred three patients (64 male and 139 female; mean age: 68 ± 13.9 years) underwent 242 treatments between December 2012 and January 2016. Disease severity based on CEAP score were: C1 (0), C2 (0), C3 (n = 59, 24%), C4 (n = 148, 61%), C5 (n = 4, 2%), and C6 (n = 31, 13%). On average, stents deployed to 69.58% of the ESA (range, 23.87­123.35%). Multiple linear regression analysis showed a significant negative correlation between increasing MSD and ESA achieved. Regression coefficients for differences in percent difference between ESA and OSA based on MSD were as follows: 16 mm (−15.0, P = 0.1519), 18 mm (−21.0, P = 0.0077), 20 mm (−23.2, P = 0.0059), and 20­22 mm (−35.3, P < 0.0001). No significant difference in stent underexpansion was detected based on gender, age, stent laterality, location of stenosis, or CEAP score. CONCLUSIONS: Larger MSD is associated with greater magnitude of stent underexpansion. These findings may have implications for future venous stent designing.

Clinical correlation of the area of inferior vena cava, iliac and femoral veins for stent use.

Objective The purpose of the study is to evaluate normal anatomical areas of infrarenal inferior vena cava, common iliac, external iliac and common femoral veins by intravascular ultrasound with the goal of assisting the development of venous-specific stents in the treatment of iliac vein stenosis. Method From February 2012 to December 2013, 656 office-based venograms were performed in our facility. Among them, 576 were stented and 80 were not. The measurements of veins were done intraoperatively using an intravascular ultrasound catheter to record areas of the inferior vena cava, proximal, middle and distal segments of common iliac vein, external iliac vein and common femoral vein. The data were compared between non-diseased segments of patients who were stented and those not stented. The stented diseased segments were excluded. Results The mean patient age was 67.33 years (range 22-96, SD ±13.99). Our data included 218 males, 438 females and 324 right lower extremities and 332 left lower extremities. The presenting symptoms of these patients based on CEAP were C1(0), C2 (185), C3(233), C4(107), C5(89) and C6(42). No correlation was found between area of veins and age, gender, laterality and CEAP score (P > .13). Comparison of the areas of non-diseased iliac vein segments between patients not stented and patients who underwent stenting showed a significant difference, with larger areas in non-stented patients in the distal common iliac vein (P = .039) and inferior vena cava (P = .012). Younger age (P = .03) and male gender (P < .0001) were associated with increased area of iliac vein segments. Conclusion Utilizing the intravascular ultrasound-guided technique, we were able to define normal anatomical areas of non-diseased inferior vena cava, iliac and femoral veins, which could be employed to guide the development of appropriate-sized stents and other tools needed for the treatment of venous insufficiency. There is specific variability in areas of normal vein segments with age and gender with/without stents.

Demographic and clinical features do not affect the outcome of combined endovenous therapy to treat leg swelling.

Background There have been well-documented implications of race/ethnicity on the outcome of various vascular diseases, yet there are limited data on risk factors and outcome of lower limb swelling. While many patients improve with endovenous therapy (thermal ablation or iliac vein stenting), some patients' symptoms persist. The goal of this study was to identify clinical factors including race/ethnicity related to persistent leg swelling after treatment with both iliac vein stenting and thermal ablation. Methods From February 2012 to February 2014, this observational study analyzed data for 173 patients with chronic venous insufficiency who underwent both iliac vein stent placement as well as thermal ablation (radiofrequency ablation or endovenous laser ablation). All procedures of the thermal ablations and the iliac vein stenting were staged. Iliac vein stenosis was identified using intravascular ultrasound of the iliofemoral venous segment showing >50% cross-sectional area or diameter reduction. The patients were queried to the resolution of their leg swelling after both procedures were performed. The resolution of swelling was correlated with age, gender, presenting sign according to CEAP classification, race/ethnicity and degree of iliac vein stenosis. Patients were categorized by Caucasians ( n = 97), African Americans ( n = 27), or Hispanics ( n = 49). Statistical analysis performed using Chi-square and Student's t test. Results Of the total 173 patients who underwent both endovenous closure and iliac vein stent placements, 117 (67.6%) patients were women. The average age was 67 (±13 SD) years. The average pain score was 2.9(±3.1 SD). The average degree of iliac vein stenosis was 66.5(±13.3 SD). About 56.1% were Caucasians, 15.6% were African Americans, and 28.3% were Hispanics. The number of patients with iliac vein stent thrombosis was 2. One hundred fifty-two (87.9%) patients stated that they had improvement in swelling after combined procedures, 100 (65.8%) patients were women. The average age was 67.3 (±13 SD) years. The average pain score was 2.9 (±3.1 SD). The average degree of iliac vein stenosis was 67.3% (±12.8 SD). About 56.6% were Caucasians, 15.1% were African Americans, and 28.3% were Hispanics. The number of patients with iliac vein stent thrombosis was 1. Twenty-one (12.1%) patients stated they had no improvement after both procedures. Correlating these group factors with the group of patients who improved their swelling after the combined procedures we found the following: 17 (81%) of these patients were females ( P=0.16). The average age was 68.4 (±17 SD) years ( P=0.72 SD). The average pain score was 3.2 (±3.7 SD) ( P=0.68). The average degree of iliac vein stenosis was 60.2% (±15.9 SD) ( P=0.02). Around 52.4% were Caucasians, 19% were African Americans, and 28.6% were Hispanics ( P=0.88). The number of patients with iliac vein stent thrombosis was 1 ( P = 0.1). Conclusion These data suggest that the clinical factors including race are not clinically significant factors in the response to swelling after combined iliac stent and endovenous ablation procedures. Interestingly, a higher degree of iliac vein stenosis was associated with improved resolution of swelling.

Clinical correlation with failure of endovenous therapy for leg swelling.

Background The development and use of minimally invasive procedures provide improved options for the management of symptoms of chronic venous insufficiency. While many patients with iliac venous occlusive disease and superficial venous insufficiency improve with combined iliac venous stenting and correction of superficial venous reflux, some patients have symptoms which persist. The goal of this study was to identify clinical factors related to persistent symptoms in patients with leg swelling after treatment of both iliac vein stenting and thermal ablation. Methods This observational study analyzed data for patients who underwent both iliac vein stent placement as well as endovenous ablation (either RFA or EVLT) as a management for chronic venous insufficiency between February 2012 and February 2014. Follow-up was performed after completion of both procedures and inquiring for improvement of swelling. Statistical analysis performed using Chi-square and student's t-test. Results Of the total 173 patients who underwent both endovenous closure and iliac vein stent placements, 55 (31.8%) patients were men; 29 (16%) patients stated they had no improvement after these procedures. The average age of patients who did not improve was 68.8 (±16.7 SD) years and 66.2 (±13.3 SD) years for patients who improved. Over all, the classification of the presenting symptoms by CEAP classification demonstrated 25.4%, 53.2%, 5.8%, and 15.6%, for C3-C6, respectively. There was no correlation with failure to improve the swelling with: age ( P = .44), gender ( P = .33), presenting symptom ( P = .67), use of calcium channel blockers ( P = .85), nitroglycerin ( P = .86), Plavix ( P = .07), aspirin ( P = .55), Synthyroid ( P = .55), Coumadin ( P = .14), angiotensin receptor blocker ( P = .81), ß Blockers ( P = .61), angiotensin converting enzyme inhibitors ( P = .88), furosemide 40 mg ( P = .74), hydrochlorothiazide 12.5 mg ( P = .07), hydrochlorothiazide 25 mg ( P = .48), and EVLT vs. RFA ( P = .91). The use of furosemide (20 mg) was associated with continued swelling ( P = .01). The use of dual diuretics (furosemide and hydrochlorothiazide) was associated with persistent swelling even after these combined endovenous procedures P = .03). Conclusion These preliminary data suggest that the treatment with diuretics may be associated with failure to relieve lower extremity swelling despite combined endovascular therapy for chronic venous insufficiency.

Effect of Pre-Procedure Clopidogrel With Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVES: Iliac vein stenting is a relatively new procedure in the treatment of chronic venous insufficiency. Research has shown that it is a safe and effective form of treatment, however, one of the well-known risks is in-stent thrombosis. We hypothesize that a single 75 mg dose of Clopidogrel the night prior to the procedures along with a 3-month regimen post-op would decrease the 30-day thrombosis rate. METHODS: A retrospective study was performed on 3,518 patients from September 2012 to August 2018 who received an iliofemoral stent. Patients were broken down into 2 main groups: those given Clopidogrel post-stent and those given Clopidogrel both pre- and post-stent. In our practice, we prescribe a 3-month course of Clopidogrel after iliac vein stenting. Patients were also checked for any anticoagulant medications pre- and/or post-stent. The 30-day thrombosis rates were recorded for each patient. RESULTS: 1,205 patients received Clopidogrel pre-procedurally and post-procedurally, 1,941 patients received Clopidogrel only post-procedurally. 372 patients were excluded from the study because they were on other anti-coagulant medications. Mean follow-up for this cohort was 17 months. 112 total patients developed some degree of 30 day in-stent thrombosis (3.6%). 74 patients developed a complete thrombosis of the stent and 38 developed a partial (≤60% occlusion) thrombosis. Of the 1,205 patients who were on clopidogrel pre-stenting, 28 had a complete thrombosis and 10 had a partial in-stent thrombosis. Of the 1,941 patients on Clopidogrel only post-stenting, 46 had a complete thrombosis and 28 had a partial in-stent thrombosis. Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day any degree of thrombosis rates (complete and partial thrombosis) (p = .33). Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day complete thrombosis rates (p = .93). CONCLUSIONS: There appears to be no statistical difference in 30-day thrombosis rates between those receiving Clopidogrel the night prior vs. those who do not receive Clopidogrel the night prior. Therefore, we conclude that it is not necessary to give this single dose the night prior to iliac vein stenting procedures.

Effect of venous access site on postintervention stent thrombosis for nonthrombotic iliac vein stenting.

OBJECTIVE: Prior literature suggests that routine femoral vein (FV) puncture is necessary for interrogation of the iliac veins for stenosis to avoid missing common femoral vein (CFV) lesions. However, this can be technically challenging and poses small but increased risks. The purpose of this study was to compare the incidence of stent thrombosis after iliac vein stenting in the treatment of nonthrombotic iliac vein lesions with use of two discrete venous access sites-the CFV and FV. METHODS: During 4 years, we performed 1605 lower extremity venography studies with intravascular ultrasound (IVUS). There were 372 men and 689 women with an average age of 66 years (range, 21-99 years; standard deviation [SD], ± 14.3 years). After IVUS interrogation, 1513 procedures resulted in venous stenting; 964 patients received stent placement in the common iliac vein, 513 in the external iliac vein, 24 involving the CFV, and 12 involving the FV. The venous puncture site, accessed by ultrasound guidance, varied between the CFV and FV per the surgeon's choice and was documented on the basis of the most distal vein area measured by IVUS during the procedure. Patients were followed up with iliocaval and lower extremity duplex ultrasound within 2 weeks and every 3 months thereafter for the first year. RESULTS: There were 994 patients who received CFV puncture and 611 patients who received FV puncture. In 39 (4.2%) patients receiving CFV punctures with subsequent stent placement, any stent thrombosis developed within 30 days of the intervention; 27 (69.2%) were complete thromboses. In 21 (3.6%) patients who received FV punctures with subsequent stent placement, any stent thrombosis developed within 30 days of intervention; 17 (81.0%) were complete thromboses. There was no significant difference (P = .57) in ≤30-day thromboses between the CFV and FV cohorts. Any in-stent thrombosis developed >30 days after intervention in 18 patients, 11 in limbs that received CFV puncture and 7 with FV puncture (P = .98). Complete stent occlusion occurred in three cases of CFV puncture. No FV punctures led to >30-day complete stent thromboses. The median time to diagnosis of >30-day thrombosis was 11.1 months (range, 2.6-31.9 months; SD, ± 12.86 months). Median follow-up was 20 months (SD, ± 19.18 months). CONCLUSIONS: There was no significant difference between in-stent thrombosis rate and location of initial venous puncture in the setting of outpatient IVUS-guided venography. Both the CFV and FV can be safely used as puncture sites for lower extremity venography.

Early hemodynamic characteristics of eversion and patch carotid endarterectomies.

OBJECTIVE: Carotid endarterectomy (CEA) is currently the gold standard in the operative management of carotid artery stenosis. While eversion and patch CEAs vary greatly in technique, various studies have determined equivalence with regard to clinical outcomes. However, the hemodynamic differences following each procedure are not known. This study aimed to investigate any early hemodynamic differences between eversion and patch CEAs. METHODS: All CEAs performed at our institution from March 2012 to June 2018 were aggregated in a retrospective database by querying the 35301 CPT code from the electronic medical record system. Variables collected included gender, age, laterality of CEA, type of procedure, and pre- and post-operative duplex ultrasound (DUS) date and quantitative findings. Exclusion criteria included any procedure with incomplete data, a post-operative DUS > 90 days following the procedure, CEAs with concomitant bypass(es), isolated external carotid artery (ECA) endarterectomies, and re-do CEAs. RESULTS: One hundred and seventy-one CEAs were performed in 161 unique patients. There were 101 males and 60 females, with an average age of 69.7 (38-96; ± 9.36). 63 CEAs were excluded from analysis: 51 due to incomplete data, eight with a > 90 day post-operative DUS, 2 isolated ECA endarterectomies, 1 CEA with a carotid-subclavian bypass, and 1 re-do CEA secondary to an infected patch. Twenty-seven eversion and 81 patch CEAs were included in analysis. There was no difference in procedure laterality or gender between the two cohorts (p > 0.05); however, patients who received an eversion CEA were older on average (73.3 vs 67.5; p = 0.002). Pre-operative peak systolic velocities (PSV) of the proximal internal carotid artery (ICA), distal ICA, and distal common artery (CCA) were all similar (p > 0.05). Post-operative DUS was performed at 17.0 and 12.9 days in the eversion and patch CEA cohorts, respectively (p = 0.12). Post-operative PSV and change in PSV were similar for all three aforementioned segments (p > 0.05). CONCLUSION: Although eversion and patch CEAs vary greatly in technique and post-procedure anatomy, there was no significant difference in post-operative PSV or change in PSV at or around the carotid bifurcation.

Is it necessary to dilate stents in management of nonthrombotic iliac vein lesions?

OBJECTIVE: Iliac vein stenting is an evolving treatment option for chronic venous insufficiency and management of nonthrombotic iliac vein lesions (NIVLs). Currently described protocols recommend deployed stents to be dilated with balloon venoplasty before completion of the procedure, based on previous literature established from management of arterial lesions. The objective of the study was to investigate the role of balloon venoplasty after stent deployment in the management of NIVLs. METHODS: During the course of 6 months, 71 balloon venoplasties with stenting of iliac veins (34 right and 37 left limbs) were performed. Intraoperatively, we used intravascular ultrasound to measure and to record area of iliofemoral veins. The measurement of stenosis was compared with adjacent nonstenotic iliofemoral veins. If >50% cross-sectional area or diameter reduction was found, it was treated with an appropriate balloon size (range, 10 × 40 mm to 16 × 60 mm) and Wallstent (Boston Scientific, Natick, Mass; 12-24 mm in diameter by 40-90 in mm length). All stents were dilated with a balloon after deployment. Intravascular ultrasound was used to measure the preoperative area of stenotic lesion, area of lesion after stenting, and area after balloon dilation of the stent. RESULTS: The mean age of the patients was 65.34 years (range, 36-99 years; standard deviation [SD], ±13.52 years), with 27 female and 20 male patients. The location of the targeted stenosis was the common iliac vein (31), external iliac vein (36), and common femoral vein (4). The mean area of the stenotic lesion was 99.06 mm2 (range, 28-318 mm2; SD, ±45.87 mm2). The mean area after stenting was 151.51 mm2 (range, 28-303 mm2; SD, ±55.82 mm2). The mean area after dilation of the stent was 162.72 mm2 (range, 86-367 mm2; SD, ±51.94 mm2; P = .22). No statistically significant correlation was found between difference in areas and age of the patient, clinical class (C2-C6), sex, lesion, laterality, and location of targeted lesion. One patient developed an intraluminal partial thrombus within 30 days of intervention. CONCLUSIONS: Our preliminary data show no significant clinical or technical benefit with use of balloon venoplasty to dilate stents after deployment in NIVLs. Postdilation should thus be limited to only those with suboptimal self-expansion of stent after initial deployment on fluoroscopic imaging.

Efficacy of balloon venoplasty alone in the correction of nonthrombotic iliac vein lesions.

OBJECTIVE: Iliac vein stenting of nonthrombotic iliac vein lesions is an evolving treatment course for management of chronic venous insufficiency. To characterize these lesions, we examined our experience treating these lesions with balloon venoplasty before stenting. METHODS: A retrospective analysis was performed to study all patients who underwent venograms with venoplasty and stenting of iliac veins from February 2013 to July 2016. All patients included in the study were treated with a trial conservative management for 3 consecutive months before venogram and, if indicated, venoplasty was performed. If a greater than 50% reduction in cross-sectional area or diameter was observed on intravascular ultrasound examination, the stenotic area was treated with balloon angioplasty, sized to nonstenotic distal vein segment (range, 10 × 40 mm to 16 × 60 mm). Intravascular ultrasound examination was also used to measure the area of stenotic iliofemoral veins before and after balloon angioplasty. RESULTS: A total of 1021 venograms with venoplasty and stenting of iliac veins were performed in 713 patients from February 2013 to July 2016. The mean age of the study population age was 64.88 years (range, 21-99 years; standard deviation [SD], 14.57), with 451 female and 262 male patients. Before angioplasty, the mean cross-sectional stenotic area was 67.97 mm2 (range, 6-318 mm2; SD, 34.87). After balloon angioplasty, the mean stenotic area increased to 78.80 (range, 6-334 mm2; SD, 44.50; P < .001). The targeted stenotic areas were categorized into three categories: group A, increased (>10% of baseline before venoplasty); group B, decreased (<10% of baseline), and group C, no area change (±10% of baseline). In 500 limbs (48.9%), the stenotic areas improved after venoplasty (average 36.99%), with a prevenoplasty average area of 60.81 mm2 (SD, 32.80 mm2) and a postvenoplasty average of 96.52 mm2 (SD, 49.85 mm2). In 294 limbs (28.8%), the area decreased (average 28.90%), with a prevenoplasty average area of 76.43 mm2 (SD, 38.80 mm2) and a postvenoplasty average of 53.22 mm2 (SD, 26.61 mm2). There were 227 patients (22.2%) who had the same area before and after venoplasty. Left-sided lesions had a greater increase in area than right-sided lesions (51.3% vs 46.2%, respectively; P = .048). No significant correlation of stenotic area response with age, presenting symptoms of Clinical, Etiology, Anatomy, and Pathophysiology (C2-C6), gender, or location of targeted lesion was observed. CONCLUSIONS: Our data show there is a highly variable response after venoplasty of stenotic area of nonthrombotic iliac vein lesions. Balloon venoplasty showed greater improvement in improving the area of stenotic left-sided lesions. However, stenting of the lesions should be performed routinely owing to recoil and spasm in lesions.

Complications with office-based venoplasties and stenting and their clinical correlation.

BACKGROUND: Endovenous therapy by venoplasty and stenting is rapidly gaining momentum and popularity in treatment of chronic venous insufficiency (nonthrombotic iliac vein lesions, in particular). The purpose of this study was to examine the results of office-based venoplasty and stenting procedures that were performed at our office-based facility from July 28, 2012, until April 28, 2013. The study focused on any complications during and after the procedure. METHODS: From July 2012 to April 2013, 245 patients underwent venography for the correction of suspected iliac vein stenosis in the office setting. Data included 74 patients undergoing bilateral iliac procedures and 137 patients undergoing unilateral procedures. The remaining 34 patients underwent venography only, without any intervention. The remaining 285 limbs were classified according to the Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification as follows: C1, n = 0; C2, n = 84; C3, n = 97; C4, n = 34; C5, n = 53, and C6, n = 17. Postprocedure pain was assessed with a Likert scale of 0 to 10, and scores were collected in 108 patients in the latter portion of the study once this was established to be our primary complication. Pain was considered to be significant if ≥ 5 (n = 20) and insignificant if <5 (n = 88). Pearson correlation was used to evaluate any correlation between pain and gender, age, laterality, CEAP scores (2-6), stent size, and balloon size. Fourteen patients had a history of prior deep venous thrombosis (DVT). RESULTS: Out of the series, 90 women and 47 men underwent unilateral intervention, and 23 women and 14 men underwent bilateral intervention. The average age was 69 years (range, 22-96; standard deviation [SD], ± 13). In 20 patients with significant pain, the average pain score was 6 (range, 5-10; SD, ± 1.4). In 88 patients with insignificant pain, the average pain score was 1.15 (range, 0-4; SD, ± 1.5). The overall average pain score for 108 cases was 2 (range, 0-10; SD, ± 2.4). Five patients (2%) who underwent intervention developed thrombosis of the iliac stent either <30 days (n = 4) or >30 days (n = 1); all five patients had history of DVT. No statistically significant correlation of pain to age, gender, laterality, CEAP scores (2-6), or stent and balloon size was found. No correlation was found between stent thrombosis and gender, age, laterality, CEAP scores (2-6), or stent and balloon size. No complications were reported, such as pseudoaneurysm formation, infection, and insertion site DVT, within 5 days. Iliac fossa hematoma developed 30 days after the procedure in one patient, who required hospital admission for evaluation and treatment. CONCLUSIONS: The correction of iliac vein outflow obstruction in office-based settings results in a low incidence of complications, such as thrombosis (2%), and average pain score of 2 of 10 on the Likert scale. The procedure is minimally invasive with minimal complications.