Early clinical experience with the straight design of Venus P-valve™ in dysfunctional right ventricular outflow tracts

Catheter Cardiovasc Interv. 2020 Nov;96(6):E653-E659. doi: 10.1002/ccd.28819. Epub 2020 Feb 25.

Abstract

Objectives: To assess the initial procedural and short to medium-term experience with the straight design of the Venus P-valve™ (Venus MedTech, Hangzhou, China) in dysfunctional right ventricular outflow tracts (RVOT).

Background: The Melody™ valve (Medtronic, Minneapolis, Minnesota) has been the only percutaneous valve option for smaller RVOT conduits. The straight Venus P-valve™ may provide an alternative to the Melody™ valve.

Methods: Retrospective data collection of patient characteristics, procedural data, clinical and imaging follow-up of the straight Venus P-valve™.

Results: Nine patients (four female) with a mean age of 23.1 ± 7.5 years and a mean weight of 72.7 ± 29.4 kg underwent straight Venus P-valve™ implantation between 03/2014 and 06/2016. All patients had right ventricle-to-pulmonary artery conduits which were pre-stented before the valve implantation. All valves were deployed successfully without any significant procedural complications. During the mean follow-up of 24 ± 9.1 months, there were no valve related re-interventions or deterioration in valve performance. There was one case of insignificant, single wire frame fracture and no cases of endocarditis. The cohort demonstrated a reduction in pulmonary regurgitation and tricuspid regurgitation, which was sustained throughout the follow-up. Similarly the gradient across the RVOT tract did not significantly increase.

Conclusions: Implantation of the straight Venus P-valve™ has provided satisfactory short to mid-term results with high success rates and no complications and may be considered as an alternative option in patients with RVOT dysfunction.

Keywords: congenital heart disease; percutaneous intervention; transcatheter pulmonary valve.

Publication types

  • Multicenter Study
  • Video-Audio Media

MeSH terms

  • Adolescent
  • Adult
  • Bioprosthesis*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Surgical Procedures / adverse effects*
  • Compassionate Use Trials
  • Female
  • Heart Defects, Congenital / surgery*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Prosthesis Design
  • Pulmonary Valve / diagnostic imaging
  • Pulmonary Valve / physiopathology
  • Pulmonary Valve / surgery*
  • Pulmonary Valve Insufficiency / diagnostic imaging
  • Pulmonary Valve Insufficiency / physiopathology
  • Pulmonary Valve Insufficiency / surgery*
  • Pulmonary Valve Stenosis / diagnostic imaging
  • Pulmonary Valve Stenosis / physiopathology
  • Pulmonary Valve Stenosis / surgery*
  • Retrospective Studies
  • Treatment Outcome
  • Ventricular Outflow Obstruction / diagnostic imaging
  • Ventricular Outflow Obstruction / etiology
  • Ventricular Outflow Obstruction / physiopathology
  • Ventricular Outflow Obstruction / surgery*
  • Young Adult