What is the clinical evidence from this study?

Study design: Observational. Population: Tetralogy of Fallot with pulmonary regurgitation (n=10). Intervention: Venus p-valve vs. Baseline. Primary outcome: Right ventricular end-diastolic volume index (ml/m2) at 6 months (p=<0.05).

December 9, 2016Netherlands Heart JournalOpen Access

Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

Q: What are the key findings of this study?

Venus p-valve implantation was successful in all 10 patients, significantly reducing mean right ventricle diastolic volume from 139 to 78 ml/m2 and regurgitation fraction from 42% to 1%.

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Key result

Venus p-valve implantation was successful in all 10 patients, significantly reducing mean right ventricle diastolic volume from 139 to 78 ml/m2 and regurgitation fraction from 42% to 1%.

Authors

FGF. GarayPontificia Universidad Católica de Chile XPXinghua PanMacau University of Science and Technology YZYJ. ZhangShanghai Jiao Tong University

Discussion

Member takes

Implication

Hypothesis-generating for Venus p-valve in patched RVOT; prospective trials needed before clinical adoption.

Study Design

Type

Observational (n=10)

Multicenter

Yes

PICO

Population

10 patients (mean age 32 years, 70% female) with Tetralogy of Fallot and moderate to severe pulmonary regurgitation who underwent Venus p-valve implantation, followed for a mean of 12 months.

Intervention / Comparator

Venus p-valve vs Baseline

Primary Outcome

Right ventricular end-diastolic volume index (ml/m2) at 6 months, p=<0.05

Main Result

Absolute Event Rate: 78% vs 139%

p-value: p=<0.05

Limitations

Small sample size of only 10 patients
Short follow-up period (mean 12 months), requiring further long-term studies to assess durability and stent fractures
Lack of a control group

Cite This Study

Garay et al. (2016) conducted an observational in Tetralogy of Fallot with pulmonary regurgitation (n=10). Venus p-valve vs. Baseline was evaluated on Right ventricular end-diastolic volume index (ml/m2) at 6 months (p=<0.05). Venus p-valve implantation was successful in all 10 patients, significantly reducing mean right ventricle diastolic volume from 139 to 78 ml/m2 and regurgitation fraction from 42% to 1%.

synapsesocial.com/papers/6a6119f1da681fd5a0dd0803 https://doi.org/10.1007/s12471-016-0932-5

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Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

Discussion

Member takes

Implication

Study Design

PICO

Main Result

Limitations

Cite This Study

Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

Discussion

Member takes

Implication

Study Design

PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider