Endovascular mechanical thrombectomy of iliofemoral venous stent occlusion with the novel RevCore thrombectomy system: case reports and literature review.

Venous in-stent restenosis is not completely understood, and the currently available treatment is usually unsatisfactory. We describe the cases of two patients treated with the RevCore thrombectomy system (Inari Medical), designed for venous in-stent thrombosis. Case 1 involves a 62-year-old woman with post-thrombotic syndrome from iliac vein stent placement 15 years earlier. Case 2 describes a 30-year-old woman with post-thrombotic syndrome from recurrent iliac vein stent occlusion, despite therapeutic anticoagulation. Both patients had previous recanalization attempts at outside facilities that were unsuccessful. The RevCore system was safe and feasible in these initial cases, and more studies are warranted.

Azygos vein stenting as an alternate route for inferior vena cava obstruction.

Chronic venous insufficiency, caused by inferior vena cava occlusion, can lead to thromboembolic complications and tissue loss. We present two cases of azygos vein stenting (AVS) in which vena cava recanalization techniques were exhausted. In the first case, the left iliac vein and vena cava were recanalized and stented; however, the right iliac vein had been previously resected and required AVS. Conventional recanalization attempts from the right and left iliac systems failed in the second patient with congenital inferior vena cava occlusion; therefore, AVS was chosen to establish in-line drainage.

A systematic review of the treatment of residual below the knee venous reflux after endovenous thermal ablation of the great saphenous vein.

BACKGROUND: Great saphenous vein (GSV) antireflux procedures have evolved during the past few decades to reduce elevated venous pressure. Untreated reflux in the below knee (BK) GSV (BK-GSV) can lead to persistent venous hypertension and deterioration of the venous circulation. The purpose of the present systematic review was to study the influence of BK-GSV intervention on venous disease progression. METHODS: A search was conducted, adhering to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The PubMed and Embase databases were searched and cross-referenced. Studies were included if they had met the inclusion criterion of BK-GSV disease as a primary or secondary outcome. Two of the authors independently determined the eligibility and extracted the relevant data. RevMan, version 5.3 (Cochrane Training, London, UK), and SPSS (IBM Corp, Armonk, NY) were used for statistical computation. RESULTS: Fifteen studies that had assessed BK-GSV reflux recurrence after ablative intervention were included in our analysis. Of the 15 studies, 6 had assessed patients after above knee (AK) high ligation and stripping (HLS), 7 after AK endovenous laser ablation (AK-EVLA), and 2 after AK- and BK-EVLA (AK+BK EVLA). In total, 525 limbs had undergone HLS, 696 AK-EVLA, and 147 AK+BK EVLA. AK+BK EVLA was associated with significantly lower odds of BK-GSV reflux recurrence compared with AK-EVLA only (odds ratio [OR], 0.1857; 95% confidence interval [CI], 0.076-0.4734; P < .0001). Although the odds of recurrent BK-GSV reflux appeared to be greater for patients who had undergone AK-HLS compared with AK+BK HLS, the difference was not statistically significant (OR, 0.62; CI, 0.27-1.43; P = .69). Finally, no statistically significant difference was observed in BK-GSV reflux recurrence between patients receiving AK-EVLA and those receiving AK-HLS (OR, 0.85; 95% CI, 0.52-1.39; P = .31). CONCLUSIONS: Axial hydrostatic reflux from the groin to ankle is best controlled with AK+BK-GSV ablation. However, GSV ablation can result in saphenous nerve injury. For C4 to C6 disease, more aggressive treatment of the AK+BK-GSV is justified if the duplex ultrasound findings demonstrate groin to ankle reflux. Thermal ablation of the BK-GSV has a lower incidence of saphenous nerve injury than does BK saphenous stripping. More randomized controlled trials are needed to answer questions involving disease recurrence and the best techniques to mitigate these recurrences.

An algorithm combining VVSYmQ® and VCSS scores may help to predict disease severity in C2 patients.

OBJECTIVES: The purpose was to assess whether combining patient reported scores (VVSymQ®) and physician reported scores (VCSS) stratifies disease severity in C2 patients. METHODS: Consecutive patients were pooled from the VANISH-1 and VANISH-2 cohorts. VCSS and VVSymQ® were calculated for each patient. The relationship between scoring systems was evaluated using Pearson's correlation and frequency distribution analysis. RESULTS: Two-hundred and ten C2 limbs were included. Scoring systems demonstrated: VVSymQ®: mean = 8.72; VCSS: mean = 6.32; correlation (r = 0.22, p = 0.05). Frequency distribution analysis demonstrated 61.4% of patients had low VVSymQ® and low VCSS; 31.3% had elevated VVSymQ® and increased VCSS; 7.3% were inconsistent with C2 disease. Strict concordance analysis revealed 40.5% had VVSymQ® (< 9)/VCSS (0-6), 18.6% had VVSymQ® (≥ 9)/VCSS (7-9), and 2.9% had VVSymQ® (≥9)/VCSS (≥10). CONCLUSIONS: For combined elevated VVSymQ® and VCSS, moderate/severe disease is corroborated, and intervention may be indicated. For combined lower scores, the disease severity is mild and conservative therapy is more appropriate.

Saphenous vein histopathology 5.5 years after cyanoacrylate closure.

VenaSeal (Medtronic, Minneapolis, Minn) is a cyanoacrylate polymer adhesive for the treatment of patients with chronic venous insufficiency. As an implanted device, questions remain about how long cyanoacrylate persists after closure. In this report, a 65-year-old man was examined 5.5 years after cyanoacrylate closure, and a segment of great saphenous vein was excised for histopathologic analysis. Findings were typical of a foreign body reaction. The vessel was occluded with collagenized mature fibrous tissue and polymer remnants, which were encapsulated by multinucleated giant cells. Focal areas of granulomatous inflammation were present in the vein wall extending to the adventitia.

Clinical response to combination therapy in the treatment of varicose veins.

BACKGROUND: Varicose vein ablation procedures are being performed with increasing frequency; however, there is a lack of consensus on the relative efficacy of combined treatment of saphenous incompetence and symptomatic varicosities vs a staged approach. In this study, we examined the impact on symptom severity when a procedure to eliminate varicosities was added to standard endovenous saphenous ablation. METHODS: The Varicose Vein Module of the American Venous Registry was established by the American Venous Forum in 2010 and collected data from 48 physicians during a 5-year period. We analyzed patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) C2 disease severity and without prior treatment. Combination therapy (CT) was defined as the use of a procedure directly addressing visible varicosities (stab phlebectomy or injection of sclerosant into varicosity) combined with endovenous saphenous vein ablation. Unimodal therapy (UT) was defined as endovenous saphenous vein ablation alone (radiofrequency or laser). Change in symptom severity was assessed by the pretreatment and 1-month follow-up Venous Clinical Severity Score (VCSS). Univariate statistics compared the CT and UT groups, with P values obtained using the Student t-test or Pearson χ2 test as appropriate. A multivariable linear regression model assessed the association of CT with the change in VCSS. RESULTS: There were 526 patients included for analysis (UT, 97; CT, 429). UT patients were more likely to be white (85.6% vs 62.7%; P < .001), had a higher initial VCSS (6.71 vs 5.07; P < .001), and were assessed at an earlier follow-up visit (28.9 days postoperatively vs 33.3 days; P < .001). Compared with UT, CT was associated with an additional half-point reduction in VCSS on univariate analysis (-3.71 points for UT vs -4.20 for CT; P = .13). After treatment, CT was associated with significantly lower scores on the pain and varicose vein components of the VCSS (pain: 0.31 for UT vs 0.07 for CT [P = .0008]; varicose veins: 0.47 for UT vs 0.03 for CT [P < .001]). On the multivariable model, after adjustment for white race, day of follow-up, age group, and initial VCSS, CT was associated with an additional reduction in VCSS of 1.52 points compared with UT (P = .002). CONCLUSIONS: Invasive treatment of C2 chronic venous insufficiency improves symptom severity. Whereas treatment of venous reflux is essential to address venous symptoms, our results suggest that patients further benefit from additional direct treatment of varicosities. For selected patients, CT may present a more effective treatment strategy than saphenous ablation alone.

A two-cohort feasibility study on polyglycolic acid yarn implantation for abolition of saphenous vein reflux.

OBJECTIVE: The objective of this study was to evaluate the feasibility and safety of a polyglycolic acid (PGA) yarn implant for nonthermal ablation of saphenous vein reflux. METHODS: In two consecutive cohort studies (TAHOE I and TAHOE II), the feasibility of abolition of great saphenous vein (GSV) reflux by implantation of a PGA yarn was tested under ultrasound guidance in 51 and 30 patients, respectively. The use of tumescent local anesthesia was not required. Graduated compression stockings and thrombosis prophylaxis with low-molecular-weight heparin were used for 2 weeks after intervention in the first study only. RESULTS: Of 81 enrolled patients, 77 (95%) were available at 6-month follow-up. Complete occlusion of the treated GSV was confirmed by duplex ultrasound in all patients except one patient at day 1. In TAHOE II, closure was preserved in a higher percentage of patients at 6 weeks, with 96.4% vs 82.0% in TAHOE I. The 6-month Kaplan-Meier estimated occlusion rates for TAHOE I and TAHOE II were 68% (95% confidence interval [CI], 54%-79%) and 69% (95% CI, 49%-82%), respectively, with an estimated combined occlusion rate of 69% (95% CI, 57%-76%). Kaplan-Meier analysis yielded a combined reflux-free rate of 85% (95% CI, 75%-91%) at 3 months of follow-up and a rate of 81% (95% CI, 71%-88%) at 6 months of follow-up. Venous Clinical Severity Score (VCSS) improved from a combined mean of 4.6 ± 3.1 at baseline to 2.1 ± 2.2 and 1.6 ± 1.9 at 3 and 6 months, respectively (P < .0001 for 3- and 6-month results). In TAHOE II, four patients with venous ulcers healed at an average of 1.3 months after treatment. CONCLUSIONS: First-in-human use of an endovenous PGA yarn implant for occlusion of refluxing GSVs proved to be feasible, with no serious adverse events. However, recanalization was observed during a period of 6 months in 31% of patients.

Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

OBJECTIVE: The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. METHODS: This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous tumescent anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months. RESULTS: At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 (P < .0001). Pain, edema, and varicosities (VCSS subdomains) improved in 75.9%, 62.1%, and 41.4% of subjects, respectively, at month 36. Overall adverse events were mild or moderate and self-limited. CONCLUSIONS: CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events.

First 10-month results of the Vascular Quality Initiative Varicose Vein Registry.

OBJECTIVE: The Vascular Quality Initiative Varicose Vein Registry (VQI VVR) represents a new Patient Safety Organization database launched in January 2015 as a collaborative effort between the American Venous Forum and the Society for Vascular Surgery. This study was undertaken to identify real-world trends among treatment choices and outcomes of varicose vein patients. METHODS: Registry data prospectively captured anatomic, procedural, and outcome data for patients with C2 or more severe disease undergoing intervention for venous varicosities from January to November 2015. Univariate descriptive statistics of demographic and procedural data was performed. Preprocedural and postprocedural comparisons were performed with t-test or χ2 analysis as appropriate. RESULTS: In total, 2661 veins in 1803 limbs of 1406 patients were treated for varicose vein disease. The majority of patients were female (71.5%) and white (78.3%). Previous varicose vein treatment had been undertaken by 31.2%. The most common site of reflux was the great saphenous vein in 74.4%, with 31% of patients having coexisting deep venous reflux. The right and left extremities were affected equally. Endovenous treatment of axial reflux was the preferred treatment in 89.1%, divided largely between radiofrequency ablation (55.2%) and endovenous laser ablation (33.9%). Clusters were often treated concomitantly with truncal reflux (n = 488 [76%]). The majority of cluster treatments were performed in an office-based setting (78.1%). The majority of clusters were located at the calf (89.7%) and treated with stab phlebectomy (84.8%). For all patients undergoing intervention for varicose veins, Venous Clinical Severity Score (VCSS) improved on average 4.68 ± 3.35 (n = 719; P < .001) postoperatively from a mean preoperative VCSS of 9.39 ± 3.87 to a mean postoperative VCSS of 4.71 ± 3.83. Improvements were seen in patient-reported outcomes (PROs) of heaviness, achiness, throbbing, swelling, itching, appearance, and work impact (total score change, 10.75 ± 6.94; n = 607; P < .001) from a mean preoperative PRO score of 16.48 ± 6.23 to a mean postoperative PRO score of 5.73 ± 5.80. CONCLUSIONS: The VQI VVR provides detailed assessment of varicose vein interventions and is useful for monitoring of changes after treatment. Modern-day varicose vein surgery is characterized by predominantly endovenous treatment of axial vein reflux, phlebectomy of clusters, and substantial improvements in both VCSS and PROs.

Use of the Clinical, Etiologic, Anatomic, and Pathophysiologic classification and Venous Clinical Severity Score to establish a treatment plan for chronic venous disorders.

To be useful in clinical practice and in the evaluation of clinical therapies for chronic venous disorders, a measurement instrument should be objective, inclusive of all severities of venous disease, and rapidly performed by clinicians. The Clinical, Etiologic, Anatomic, and Pathophysiologic classification helps us identify the etiology, whether it is congenital, nonthrombotic, or post-thrombotic; anatomic segments involved, whether deep, superficial, or perforators; and pathophysiologic data, such as reflux or obstruction. The Venous Clinical Severity Score can be used to observe patients longitudinally, especially after interventions, although the total score is biased with regard to advanced disease, such as C4 through C6. To be able to predict progression of disease, more patient-validated instruments are needed. Physician-reported outcomes (the Venous Clinical Severity Score and the Clinical, Etiologic, Anatomic, and Pathophysiologic classification) in association with a patient-reported outcome may be the solution for the development of an ideal treatment plan.

Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

OBJECTIVES: To evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins. METHODS: Incompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months. RESULT: Of 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836-1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema improved in 89% of legs (n = 34) at 48 hours follow-up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respectively. CONCLUSIONS: The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effective. Clinical efficacy was maintained over a period of 24 months.

First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

OBJECTIVE: The primary objective of this study was to assess the feasibility of an endovenous cyanoacrylate (CA) adhesive implant, delivered with a catheter-based administration system engineered with a nonstick surface, for the treatment of incompetent great saphenous veins (GSVs). The primary safety end point was the rate of serious adverse events related to the procedure. The primary efficacy end point was vein occlusion during follow-up. Secondary end points included the rate of all adverse events and the change in Venous Clinical Severity Scores (VCSSs). METHODS: Thirty-eight incompetent GSVs in 38 symptomatic patients were treated by catheter deployment of CA under ultrasound guidance via a repetitive bolus injection algorithm. By protocol design, perivenous tumescent anesthesia and compression stockings were omitted. Duplex ultrasound imaging and clinical follow-up were performed immediately after the procedure, at 48 hours, and 1, 3, 6, and 12 months. RESULTS: The mean total volume of endovenous CA delivered was 1.3 ± 0.4 mL (range, 0.6-2.3 mL). Immediately after the procedure and at the 48-hour follow-up, the 38 patients (100%) demonstrated complete closure of the GSV. One complete and two partial recanalizations were observed during follow-up at 1, 3, and 6 months, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92% at 12 months of follow-up. Side effects were generally mild and self-limited, most frequently, phlebitis in six patients (15.8%) requiring nonsteroidal anti-inflammatory drugs for an average of 5.7 days. Eight patients (21.1%) showed thread-like thrombus extensions into the common femoral vein of a mean length of 12.6 mm (range, 3.5-35 mm), which resolved spontaneously without anticoagulation. VCSS improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.5 ± 1.4 at 12 months (P < .0001). Edema improved in 34 legs (89%) at the 48-hour follow-up. At the 12-month follow-up, and without additional adjunctive treatment, 18 legs (50%) were free from visible varicosities and an additional eight legs (25%) showed limited varicosities. CONCLUSIONS: The first human use of endovenous CA for closure of insufficient GSVs proved to be feasible, safe, and effective. Endovenous delivery of CA may prove to be an alternative for the correction of saphenous incompetence and may be used without tumescent anesthesia and medical compression stockings.

Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results.

PURPOSE: To conduct a pilot study to demonstrate a novel method of using a proprietary cyanoacrylate (CA) for closure of superficial veins. MATERIALS AND METHODS: Right and left superficial epigastric veins from two swine models were utilized due to the vein's similarities with the human great saphenous vein. Under ultrasound guidance, access was gained and a 5-F delivery catheter was advanced to the junction of the superficial epigastric and abdominus rectus veins. A dispenser gun was then utilized to inject 0.16 mL of CA while compression was applied cephalad to the end of the catheter. Immediately after delivery, the catheter was pulled back 3 cm and manual compression was employed for 30 seconds. After this first injection, the ultrasound probe was repositioned caudad to the injection and cephalad to the catheter tip and another 0.16 mL injection was delivered with immediate 3 cm pullback of the delivery system. Manual compression was applied at the caudad end of the treated vein for 30 seconds. This process was repeated until the entire target segment was treated. RESULTS: At 30 days postimplantation, the treated veins were occluded with no evidence of recanalization or migration. Histological findings revealed that the lumen was dilated by coalescing, arborizing clear spaces with entrapped lytic erythrocytes, demarcated by a thin band of granular eosinophilic material. Spindle cells with dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media. CONCLUSION: Results of this initial study demonstrated that intravascular injection of CA is feasible for closure of superficial veins in animal models. These findings warrant further animal studies of this proprietary CA to assess efficacy, safety and its effects on perivenous structures.

Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results.

BACKGROUND: The introduction of cyanoacrylate (CA) within a blood vessel triggers polymerization, followed by an inflammatory reaction. METHODS: A sheath was positioned 2.0 cm caudad to the junction of the superficial epigastric and abdominus rectus veins in 2 swine, followed by ultrasound-guided injection of 0.16 mL of CA glue. After glue delivery, the catheter was pulled back 3 cm, compression was applied to the treatment site, and the process was repeated for the entire length. At 60 days postimplantation, the veins were harvested surgically and examined histologically. RESULTS: The histologic changes were consistent with a chronic foreign-body-type inflammatory response. Venous closure, segmental wall thickening, and fibrosis were observed. CONCLUSION: Injection of CA is feasible for closure of superficial veins in animal models. Vein closure is achieved via an inflammatory process which ultimately leads to fibrosis.

Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).

PURPOSE: The present study was designed to address the hypothesis that radiofrequency (RF) thermal ablation, as represented by the ClosureFAST system, is associated with improved recovery and quality-of-life (QOL) parameters compared with 980-nm endovenous laser (EVL) thermal ablation of the great saphenous vein (GSV). MATERIALS AND METHODS: Eighty-seven veins in 69 patients were randomized to ClosureFAST or 980-nm EVL treatment of the GSV. The study was prospective, randomized, single-blinded, and carried out at five American sites and one European site. Primary endpoints (postoperative pain, ecchymosis, tenderness, and adverse procedural sequelae) and secondary endpoints (venous clinical severity scores and QOL issues) were measured at 48 hours, 1 week, 2 weeks, and 1 month after treatment. RESULTS: All scores referable to pain, ecchymosis, and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the EVL group (P = .0210); there were no major complications. Venous clinical severity scores and QOL measures were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. CONCLUSIONS: RF thermal ablation was significantly superior to EVL as measured by a comprehensive array of postprocedural recovery and QOL parameters in a randomized prospective comparison between these two thermal ablation modalities for closure of the GSV.

Laser ablation of cutaneous leg veins.

Patients presenting with lower-extremity telangiectasias, commonly known as spider veins, are a frequent presentation for vascular surgeons. The use of lasers in the treatment of lower-extremity spider veins has gained increased popularity during the past 5 years. This technology, driven by consumer demand, has been effective in treating vessels that are refractory to sclerotherapy treatment, vessels that arise from telangiectatic matting, and in patients who experience a phobia to needles. One laser wavelength per machine limits what the practitioner can do. That is, each type of vein responds best to a specific wavelength. Light skin is more forgiving to complications than dark skin. The devices are a complement to good sclerotherapy, not a substitute.