What is the clinical evidence from this study?

Study design: RCT. Population: Deep Venous Valve Insufficiency (n=10). Intervention: Vitamin K antagonists vs. Aspirin (150 mg/d) and clopidogrel (75 mg/d). Primary outcome: Valve patency and competence.

What does this research mean for the field?

Percutaneous implantation of a self-expanding nitinol-framed venous valve bioprosthesis into the porcine venous system is technically feasible, achieving short-term patency and competence. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

April 1, 2003Journal of Endovascular Therapy

A Percutaneous Approach to Deep Venous Valve Insufficiency with a New Self-Expanding Venous Frame Valve

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Key result

Percutaneous venous valve bioprosthesis proves feasible in a porcine model, achieving ~67% patency.

n=10

Why the study?

Is percutaneous implantation of a venous valve bioprosthesis feasible and functional in a porcine model?

Population

10 50-kg pigs

Comparison

Percutaneously delivered venous valve… vs Comparison between two anticoagulation regimens…

Design

Preclinical, Animals were randomly assigned to receive either vitamin K…

Follow-up

Up to 4 weeks

Authors

GBGerrit J. de Borst JTJoep A.W. TeijinkRadboud University Nijmegen MPMarlowe Patterson

Discussion

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Implication

Premature for clinical use; extends preclinical feasibility data while leaving patency and anticoagulation optimization open.

Study Design

Type

RCT (n=10)

Randomization

randomly given

Structured PICO

Is percutaneous implantation of a venous valve bioprosthesis feasible and functional in a porcine model?

Population

10 50-kg pigs undergoing percutaneous venous valve bioprosthesis implantation in the iliac vein, followed for up to 4 weeks.

Intervention

Percutaneously delivered venous valve bioprosthesis (PVVB) implanted in the iliac vein, followed by either vitamin K antagonists (1-2 mg/d) or a combination of aspirin (150 mg/d) and clopidogrel (75 mg/d)

Comparator

Comparison between two anticoagulation regimens: vitamin K antagonists vs. aspirin plus clopidogrel

Outcome

Patency and competence assessed by phlebography at up to 4 weekssurrogate

Percutaneous deployment of a venous valve bioprosthesis is technically feasible in a porcine model, though maintaining patency and managing anticoagulation require further optimization.

Cite This Study

Borst et al. (2003) conducted an RCT in Deep Venous Valve Insufficiency (n=10). Vitamin K antagonists vs. Aspirin (150 mg/d) and clopidogrel (75 mg/d) was evaluated on Valve patency and competence. Percutaneous implantation of a venous valve bioprosthesis in a porcine model was technically feasible, yielding 12 of 18 patent valves at 2 to 4 weeks across two anticoagulation regimens.

synapsesocial.com/papers/6aa7d6bd871ca30df5b1826e https://doi.org/10.1177/152660280301000227

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A Percutaneous Approach to Deep Venous Valve Insufficiency with a New Self-Expanding Venous Frame Valve

Discussion

Member takes

Implication

Study Design

Structured PICO

Cite This Study

A Percutaneous Approach to Deep Venous Valve Insufficiency with a New Self-Expanding Venous Frame Valve

Discussion

Member takes

Implication

Study Design

Structured PICO

Cite This Study

Also Consider

Also Consider