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No-React® Injectable BioPulmonic™ valves re-evaluated: discouraging follow-up results
Jochen Grohmann1, René Höhn2, Thilo Fleck2
1Department of Congenital Heart Defects and Pediatric Cardiology, Heart Centre, University of Freiburg, Freiburg, Germany jochen.grohmann@universitaets-herzzentrum.de.
Interactive Cardiovascular and Thoracic Surgery
|August 3, 2015
Summary
Mid-term results for the No-React® Injectable BioPulmonic™ valve show disappointing outcomes. Graft failure, primarily due to neointimal formation and malposition, led to reintervention in most patients.
Area of Science:
- Cardiovascular Surgery
- Pediatric Cardiology
- Biomaterials Science
Background:
- The No-React® Injectable BioPulmonic™ valve was developed for minimally invasive pulmonary valve replacement.
- Mid- to long-term follow-up data on this device are limited.
Purpose of the Study:
- To evaluate the mid- to long-term clinical outcomes of the No-React® Injectable BioPulmonic™ valve.
- To identify failure mechanisms and histological findings associated with graft dysfunction.
Main Methods:
- Retrospective analysis of 7 pediatric patients who received the No-React® valve.
- Follow-up included clinical assessment, echocardiography, and cardiac catheterization.
- Histological analysis of explanted valves was performed.
Main Results:
- All 7 patients required recatheterization due to significant systolic gradients across the right ventricular outflow tract.
- Catheterization revealed severe stenosis in 2 patients and moderate stenosis with moderate insufficiency in 4 patients.
- Graft failure was attributed to malposition and neointimal proliferation, necessitating reintervention (redo surgery or valve-in-valve) in 6 patients.
Conclusions:
- Mid-term results of the No-React® Injectable BioPulmonic™ valve implantation are disappointing.
- Neointimal formation and valve malposition are the primary causes of graft failure.
- Further investigation into device design and implantation techniques is warranted.
Keywords:
Congenital heart diseaseMinimally invasive revalvulationNo-react injectable valveStented valveValve-in-valveMore Related Videos
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