Dataset Information

Iliac Venous Stent Embolization to the Right Atrium and Subsequent Extraction With in Vivo Recrimping.

ABSTRACT:

SUBMITTER: Saleem D

PROVIDER: S-EPMC11307573 | biostudies-literature | 2022 Jul-Aug

REPOSITORIES: biostudies-literature

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Iliac Venous Stent Embolization to the Right Atrium and Subsequent Extraction With in Vivo Recrimping.

Saleem Danial D Sethi Sanjum S SS Takeda Koji K Parikh Sahil A SA Finn Matthew T MT

Journal of the Society for Cardiovascular Angiography & Interventions 20220513 4

PMID: 39131945

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Project description:PurposeTo assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.Materials and methodsTwenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months.ResultsFreedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan-Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related.ConclusionThe Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures.Level of evidenceLevel 2-prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. REGISTRATION CLINICALTRIALS.GOV: Unique Identifier NCT02655887.

Project description:PurposeTo determine if compression of the left common iliac vein (LCIV) by the right common iliac artery is associated with left-sided deep venous thrombosis (DVT).Materials and methodsThis institutional review board-approved case-control study was performed in a cohort of 230 consecutive patients (94 men, 136 women; mean age, 57.5 years; range, 10-94 years) at one institution who had undergone contrast material-enhanced computed tomography of the pelvis prior to a diagnosis of unilateral DVT. Demographic data and information on risk factors were collected. Two board-certified radiologists determined iliac vein compression by using quantitative measures of percentage compression {[1 minus (LCIV diameter at point of maximal compression/distal right common iliac vein diameter)] times 100%}, as well as qualitative measures (none, mild, moderate, severe), with estimates of measurement variability. Logistic regression analysis was performed (independent variable, left vs right DVT; dependent variable, iliac vein compression). Cutpoints of relevant compression were evaluated by using splines. Means (with 95% confidence intervals [CIs]) and odds ratios (ORs) (and 95% CIs) of left DVT per 1% increase in percentage compression were calculated.ResultsPatients with right DVT were more likely than those with left DVT to have a history of pulmonary embolism. Overall, in all study patients, mean percentage compression was 36.6%, 66 (29.7%) of 222 had greater than 50% compression, and 16 (7.2%) had greater than 70% compression. At most levels of compression, increasing compression was not associated with left DVT (adjusted ORs, 1.00, 0.99, 1.02) but above 70%, LCIV compression may be associated with left DVT (adjusted ORs, 3.03, 0.91, 10.15).ConclusionIncreasing levels of percentage compression were not associated with left-sided DVT up to 70%; however, greater than 70% compression may be associated with left DVT.Supplemental materialhttp://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12111580/-/DC1.

Dataset Information

Iliac Venous Stent Embolization to the Right Atrium and Subsequent Extraction With in Vivo Recrimping.

Publications

Iliac Venous Stent Embolization to the Right Atrium and Subsequent Extraction With in Vivo Recrimping.

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