June 13, 2014PLoS ONEOpen Access

Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

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Why the study?

Does a novel polymeric transcatheter pulmonary valve provide safe and effective early valvular functionality in a healthy sheep model?

Population

10 healthy male sheep, 5 to 8 months old, weighing an average of 22.5±2.0 kg.

Comparison

Novel polymeric trileaflet transcatheter… vs Glutaraldehyde-treated bovine pericardium valves…

Design

Preclinical

Follow-up

4 weeks

Authors

BZBen ZhangWest China Medical Center of Sichuan University XCXiang ChenJiujiang University TXTongyi XuShenzhen University

Discussion

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Implication

Early feasibility shown in sheep; hypothesis-generating for human trials with durability and safety unproven.

Structured PICO

Does a novel polymeric transcatheter pulmonary valve provide safe and effective early valvular functionality in a healthy sheep model?

Population

10 healthy male sheep, 5 to 8 months old, weighing an average of 22.5±2.0 kg.

Intervention

Novel polymeric trileaflet transcatheter pulmonary valve (PTPV) with a balloon-expandable stent and leaflets made of 0.1-mm expanded polytetrafluoroethylene (ePTFE) coated with phosphorylcholine, implanted via a hybrid transapical approach.

Comparator

Glutaraldehyde-treated bovine pericardium valves implanted via the same hybrid transapical approach.

Outcome

Immediate and early (4-week) valvular functionality and safety assessed by angiography, echocardiography, computed tomography, and cardiac catheterization.surrogate

A novel ePTFE-based polymeric transcatheter pulmonary valve demonstrated safety, feasibility, and good early hemodynamic function at 4 weeks in a sheep model.

Cite This Study

Zhang et al. (2014) studied this question.

synapsesocial.com/papers/6a70d5b45d37378ac1ddfdef https://doi.org/10.1371/journal.pone.0100065

Topics

Transcatheter aortic valve replacement TAVR in low-risk patients

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Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Topics

Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

Discussion

Member takes

Implication

Structured PICO

Cite This Study

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