Utility of BeBack crossing catheter in fistula creation during percutaneous deep vein arterialization
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ABSTRACT:
SUBMITTER: Ong D
PROVIDER: S-EPMC10547733 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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Project description:We present the case of a young man with severe comorbidities who presented with gangrene and rest pain of his right foot. He had already undergone a contralateral below knee amputation for a nonsalvageable left foot due to chronic limb threatening ischemia. We performed percutaneous deep vein arterialization using off-the-shelf devices to attempt limb salvage of his right foot.
| S-EPMC10300387 | biostudies-literature
Project description:BackgroundPercutaneous deep vein arterialization (pDVA) is considered a treatment modality in patients with no-option critical limb ischemia. However, there is still a paucity of evidence regarding its safety and efficacy.Data sourcesMEDLINE (via PubMed), Embase and Web of Science databases as well as the CENTRAL registry up to the end of June 2023.MethodsThis review adhered to the PRISMA guidelines (PROSPERO registration no. CRD42023445171). The risk of bias was assessed using the methodological index for non-randomized studies (MINORS). Primary endpoints included technical success, overall survival and limb salvage during the follow-up. Amputation-free survival at 30 days, 6 months and 1 year as well as complete wound healing, major adverse limb events and reintervention were investigated as secondary outcomes.ResultsFive observational studies, comprising 208 patients (142 Rutherford class 5/77 Rutherford class 6), were included. MINORS revealed a low risk of bias. The meta-analysis reached a pooled technical success rate of 96.2% (95% CI: 91.5-98.4), an overall survival of 82.8% (95% CI: 70.5-95.2) and a limb salvage rate of 77.2% (95% CI: 65.2-89.1) during the follow-up. The amputation-free survival at 30 days, 6 months and 1 year was 87.8%, 68.7% and 65.6%, respectively. Furthermore, pDVA resulted in a complete wound healing rate of 53.4% (95% CI: 30.3-76.5). The pooled reintervention rate was as high as 46.7% (37.1-56.3%).ConclusionsPDVA seems a feasible bail-out strategy for patients with no option for routine treatment of CLTI. However, due to the small number of studies, the strength of the evidence is low.
| S-EPMC10886738 | biostudies-literature
Project description:The global expression profile of the arterialized rat jugular vein was established to identify candidate genes and cellular pathways underlying the remodeling process. The arterialized jugular vein was analyzed on days 3 and 28 post-surgery and compared with the normal jugular vein and carotid artery. A gene array platform detected 9846 genes in all samples. A heatmap analysis uncovered patterns of gene expression showing that the arterialized vein underwent a partial transition from vein to artery from day 3 to 28 post-surgery. The same pattern was verified for 1845 key differentially expressed genes by performing a pairwise comparison of the jugular vein with the other groups. Interestingly, hierarchical clustering of 60 genes with altered expression on day 3 and day 28 displayed an expression pattern similar to that of the carotid artery. Enrichment analysis results and the network relationship among genes modulated during vein arterialization showed that collagen might play a role in the early remodeling process. Indeed, the total collagen content was increased, with the augmented expression of collagen I, collagen IV, and collagen V in arterialized veins. Additionally, there was an increase in the expression of versican and Thy-1 and a decrease in the expression of biglycan and β1-integrin. Overall, we provide evidence that vein arterialization remodeling is accompanied by consistent patterns of gene expression and that collagen may be an essential element underlying extracellular matrix changes that support the increased vascular wall stress of the new hemodynamic environment.
| S-EPMC6463024 | biostudies-literature
Project description:BACKGROUND:Critical limb ischemia (CLI) is the clinical end stage of peripheral artery disease and is associated with high amputation, mortality rates and poor quality of life. For CLI patients with no revascularization options, venous arterialization could be an alternative technique for limb salvage. A systematic review and meta-analysis published in 2017 concluded that venous arterialization may be considered a viable alternative. A recent development, is the Percutaneous Deep Vein Arterialization (pDVA), that is CE-marked and currently under investigation of the FDA. This procedure, called LimFlow, is a novel, minimally invasive, endovascular approach to perform a venous arterialization procedure. The limited evidence for its use necessitates a scientific judgement of the pDVA. Therefore, we initiated a prospective clinical post market trial to investigate the outcome of the pDVA in no-option critical limb ischemia. METHODS/DESIGN:The objective of this prospective study is to collect "real-life" clinical data among a population of patients treated with the pDVA in order to evaluate the clinical effectiveness and safety of the LimFlow System in patients with no-option critical limb ischemia. This study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on up to fifty (50) eligible patients with a twelve-month follow-up period. The Primary endpoint is measured by amputation free survival. Secondary endpoints are complete wound healing, primary and secondary patency, limb salvage, renal function and technical and procedural success. Patients will be assessed at regular intervals during one year after the initial percutaneous deep vein arterialization procedure through clinical evaluation and self-completed questionnaires. DISCUSSION:The last decade several studies have been published with promising results and the number of treated patients has considerably grown. Venous arterialization could be a valuable treatment option in patients with often no other options than amputation of the affected limb. The first results in men are promising although more research and long term follow up is needed to establish the efficacy of this new treatment modality. With this prospective study, we evaluate the clinical effectiveness and safety in patients with no-option CLI treated with the pDVA (LimFlow System). TRIAL REGISTRATION:NCT03321552 .
| S-EPMC6966404 | biostudies-literature
Project description:BackgroundThe post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome.MethodsWe randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up.ResultsBetween 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups.ConclusionsAmong patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).
| S-EPMC5763501 | biostudies-literature
Project description: Not available
| S-EPMC7683226 | biostudies-literature
Project description:Preoperative assessment prior to surgical arteriovenous fistulas (AVFs) including ultrasound-guided mapping has been shown to have beneficial effects on their immediate success as well as early outcomes. This has led to their wide acceptance and adoption however clinical practice criteria is variable and is reflected in variabilities in practice. When transposing this to percutaneously created endovascular AVFs (endoAVFs), variable preoperative assessment criteria could equally result in variable practice and potentially subsequent and expectant outcomes. We aimed to review literature on reported validated methodologies and workflows of preoperative assessment for surgical AVF creation as reported in highest levels of available evidence, specifically randomized controlled trials. Published practice recommendations and guidelines on best clinical practice as well as systematic reviews and meta-analyses of published studies were also reviewed. Data on practice methodology from identified trial publications and protocols was collated and a summative narrative synthesis was carried out which compared these methodologies to additional assessments that may be required when targeting assessment for percutaneous endoAVF formation, based on our units experience as part of an international multicentre trial. In this review we present a brief overview of published literature and guidelines and propose a unified and uniform workflow for preoperative assessment for surgical AVFs and endoAVFs to aide clinical and imaging practice.
| S-EPMC7857810 | biostudies-literature
Project description:The beating of a pulmonary vein during cardiac catheterization is a rare phenomenon caused by the heart beating through the pericardial effusion when a cardiac tamponade occurs. This "beating pulmonary vein" sign is useful for early detection of a tamponade before circulatory collapse occurs.
| S-EPMC8815090 | biostudies-literature
Project description: Not available
| S-EPMC8353338 | biostudies-literature
Project description:Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS).To estimate the cost effectiveness of additional CDT compared with standard treatment alone.Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY).In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64,709 for additional CDT and $51,866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20,429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55,000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50,000/QALY gained.Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding.
| S-EPMC4027959 | biostudies-literature