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The aim of the present study was to report a large, single-center experience using the ClotTriever thrombectomy system (Inari Medical, Irvine, CA) for the management of acute iliofemoral (IF) deep vein thrombosis (DVT). One limitation of all endovascular devices for the treatment of acute IF-DVT has been the inability to completely remove all acute thrombus and the need for adjunctive thrombolysis with its attendant risk of bleeding complications.A single-center retrospective review of consecutive patients with acute IF-DVT treated with the ClotTriever thrombectomy system (Inari Medical) is reported. Procedural efficacy was evaluated by an independent core imaging laboratory (Syntactx, New York, NY). Both procedural and in-hospital safety were assessed during the index hospitalization. The treated vein patency was assessed using duplex ultrasound at 30 days after the procedure.A total of 96 patients were included in the present retrospective review, 40 of whom (40%) had contraindications to thrombolytic therapy. In terms of efficacy, 93 patients (97%) had ≥75% thrombus removal. During the index hospitalization, two patients (2%) had experienced a symptomatic pulmonary embolus. However, no mortality, major bleeding, or device-related complications had occurred in the study population. Of the 96 patients, 64 had undergone duplex ultrasound at 30 days after the procedure. Of the 64 patients, 62 had normal flow (97%), 53 (83%) had normal compressibility, and 11 (17%) had partial compressibility.The ClotTriever thrombectomy catheter was both safe and effective in our cohort of patients with acute IF-DVT outside a randomized clinical trial.

Background Endovenous revascularization is the standard in the management of acute thrombotic, chronic post-thrombotic iliocaval or iliofemoral obstruction, and nonthrombotic iliac vein lesions. The purpose of this study is to describe our single-center experience of postprocedure anticoagulation and antiplatelet regimens used after endovenous revascularization for a variety of venous occlusive conditions. Methods We conducted a retrospective analysis of 100 consecutive patients who underwent endovenous stenting for iliocaval or iliofemoral obstruction from January 1, 2014, to April 30, 2018. Patients treated with direct oral anticoagulants, warfarin, or low-molecular-weight heparin (LMWH) with or without antiplatelet therapy were identified. Demographic, procedural, patency, and follow-up data were collected. Stent patency was evaluated using duplex Doppler ultrasound examination or contrast venography. Results Seventy-one of 100 patients were treated with direct oral anticoagulant therapy (DOAC). Sixteen (23%) were lost to follow-up, leaving 55 (77%) available for analysis. The mean follow-up was 14 months (range, 1-43 months) with 32 patients (58%) followed for 12 months or longer. Primary, primary-assisted, and secondary-assisted patency rates were 87%, 97%, and 98%, respectively, at 12 months. In the non-DOAC group (patients treated with warfarin or LMWH), these rates were 87%, 93%, and 95%, respectively, at 12 months. Antiplatelet therapy, including clopidogrel, aspirin, or both, was used in 53 of 55 patients in the DOAC cohort and 18 of 19 patients in the non-DOAC group. Conclusions Our-single center retrospective analysis demonstrates acceptable primary patency rates when using DOAC therapy compared with those treated with warfarin or LMWH.

Although acute intracranial hemorrhage (ICH) is a rare complication of catheter-directed thrombolysis (CDT), it remains a major concern associated with the use of CDT. The incidence and clinical predictors of developing ICH in the setting of CDT are not known.The National Inpatient Sample database was used to identify all patients with proximal lower extremity or caval deep vein thrombosis (DVT) from January 2005 to December 2013 in the United States. Multivariate logistic regression was performed to identify the clinical predictors of ICH between patients with DVT who had received anticoagulation therapy alone and those who had been treated with CDT plus anticoagulation therapy.Of 138,049 patients with proximal lower extremity or caval DVT, 7119 (5.2%) had received anticoagulation therapy and CDT. Of the patients treated with anticoagulation alone, ICH had occurred in 0.2% compared with 0.7% for those treated with CDT (P .01). The independent predictors of ICH in the CDT cohort were a history of stroke (odds ratio [OR], 19.4; 95% confidence interval [CI], 8.8-42.8; P .01), chronic kidney disease (OR, 2.2; 95% CI, 1.1-4.7; P = .03), age74 years (OR, 2.2; 95% CI, 1.2-4.3; P = .02), male sex (OR, 1.8; 95% CI, 1.01-3.3; P = .048). Of those patients treated with anticoagulation alone, the risk factors for the development of ICH were a history of stroke, hospital teaching status, and age74 years.The results from the present nationwide observational study showed that of patients with DVT treated with CDT, the independent predictors for developing ICH were a history of stroke, chronic kidney disease, male sex, and age 74 years.

Background Chronic venous disease (CVD) is a common vascular disorder with manifestations ranging from asymptomatic spider veins to venous ulcers. Elevated right atrial pressure, otherwise called central venous pressure (CVP), can also result in edema and hyperpigmentation similar to chronic venous insufficiency. Obstructive sleep apnea (OSA) is a known risk factor for elevation of CVP. Prevalence rates of elevated CVP or OSA are unknown in patients presenting with a diagnosis of CVD. Methods This is a single-center, retrospective, descriptive study of patients referred to our tertiary care center with a diagnosis of CVD. Each patient was evaluated by simultaneous venous duplex ultrasound (to assess venous reflux) and limited echocardiography of the right side of the heart (to assess elevated CVP). We assessed the prevalence and predictors of elevated CVP in this cohort using multivariate logistic regression. Results A total of 264 patients with CVD were evaluated, and of these, 22.7% had elevated CVP and 26.9% had OSA. There was no significant difference in the prevalence of OSA or elevated body mass index in the group with elevated CVP compared with patients with normal CVP. The predictors of elevated CVP were age >64.6 years (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.003-1.05; P = .026), diabetes mellitus (OR, 2.19; 95% CI, 1.05-4.5; P = .035), and right lower extremity Venous Clinical Severity Score of ≥8.5 (OR, 1.098; 95% CI, 1.011-1.193; P = .026). Other predictors included prior history of pulmonary embolism and renal insufficiency. Conclusions Compared with the general population, the prevalence of elevated CVP and OSA is significant in this cohort of patients. Age, diabetes, and right lower extremity chronic venous insufficiency symptoms seem to be predictors of elevated CVP. Larger, population-based prevalence studies are needed to confirm these findings.

Objective Several randomized controlled trials (RCTs) have compared different interventions for chronic venous insufficiency (CVI) management, but mixed comparison of these interventions is lacking. The aim of this network meta-analysis was to compare VenaSeal closure system (Medtronic, Minneapolis, Minn) with endovenous laser ablation (EVLA), radiofrequency ablation (RFA), mechanochemical ablation, sclerotherapy, and surgery for management of CVI to achieve anatomic success (complete closure of treated vein within 6 months after intervention) as the primary outcome and health-related quality of life (HRQoL; EuroQol-5 Dimension, Aberdeen Varicose Vein Questionnaire), Venous Clinical Severity Score (VCSS), pain scores, and adverse events as secondary outcomes. Methods A systematic review of journal databases was undertaken, and RCTs between January 1996 and September 2018 comparing different treatment options were included. Risk of bias and quality of publications were assessed using the Cochrane bias tool; Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for study selection and reporting. Twenty RCTs comprising 4570 patients were analyzed. Data for anatomic success, VCSS, HRQoL, pain score, and adverse events were extracted and analyzed using mixed treatment comparison in a network meta-analysis. A Bayesian fixed or random effects model was selected for analysis. Rank probability graphs were generated for various treatments and corresponding ranks obtained to estimate their probability of being best. Relative treatment effects were calculated in terms of log odds ratios for anatomic success and adverse events. Mean difference was calculated for VCSS, HRQoL, and pain score. Results For the primary outcome measure (anatomic success), VenaSeal system had the highest probability of being ranked first (P = .980); RFA was ranked second (P = .365), EVLA third (P = .397), surgery fourth (P = .290), mechanochemical ablation fifth (P = .695), and sclerotherapy sixth (P = .982). For secondary outcome measures, VenaSeal system ranked third for VCSS (P = .332), fifth for EuroQol-5 Dimension (P = .420), and third for Aberdeen Varicose Vein Questionnaire (P = .300). Although, VenaSeal system was slightly inferior to some of the other interventions for HRQoL, the 95% credible interval of log odds ratio indicated insufficient evidence for any concrete conclusion to be drawn. VenaSeal system ranked first in reduction of postoperative pain score from baseline (P = .690) and was lowest in occurrence of adverse events (P = .650). Odds of occurrence of adverse events was 3.3 times in the sclerotherapy arm, 2.7 times in the EVLA arm, 1.6 times with surgery, and 1.1 times with RFA vs VenaSeal system arm. Conclusions VenaSeal system is a promising therapeutic option for anatomic success at 6 months, with fewer occurrences of adverse events (wound and groin infection, pulmonary embolism) in CVI patients compared with other interventions in this study. Additional economic analysis including cost-effectiveness analysis would provide interesting perspectives on real-world insights to patients, payers, and providers.

Objective We previously reported 3-month and 12-month occlusion rates after treatment of clinically symptomatic saphenous vein reflux with either cyanoacrylate closure (CAC) using the VenaSeal Closure System (Medtronic, Dublin, Ireland) or radiofrequency ablation (RFA) in a randomized, multicenter, clinical trial, VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). Herein we report the 24-month follow-up results of the VeClose trial. Methods There were 222 patients with symptomatic great saphenous vein (GSV) incompetence who were randomly assigned to receive either CAC (n = 108) or RFA (n = 114). Patients were not allowed to receive adjunctive treatment of tributary varicosities until after the 3-month visit. Duplex ultrasound of the target vein was performed at day 3 and months 1, 3, 6, 12, and 24 after treatment, and closure was assessed by ultrasound by the treating physician. Overall 24-month success rates were compared; in addition, time to first reopening of the target vein was evaluated using survival analysis. End points such as Venous Clinical Severity Score, EuroQoL-5 Dimension, and Aberdeen Varicose Vein Questionnaire were evaluated. Results Of 222 randomized patients, 171 completed the 24-month follow-up, which included 87 from the CAC group and 84 from the RFA group. The 24-month complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating continued noninferiority of CAC compared with RFA (P = .0034). Symptoms and quality of life improved similarly in both groups. No clinically significant device- or procedure-related late adverse events occurred. Conclusions Both CAC and RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient’s quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years.

Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups.The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events.Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes.The results from the VeClose study roll-in group demonstrate that despite the physician's lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period.