Key result
3D-guided TPVR with the PT-Valve achieves 100% implantation success and improves RVEF.
Why the study?
Severe pulmonary regurgitation frequently occurs after transannular patch repair of tetralogy of Fallot, causing an enlarged native right ventricular outflow tract with varying shapes.
Does 3D printing-guided transcatheter pulmonary valve replacement improve right ventricular remodeling in patients with severe pulmonary regurgitation and enlarged native right ventricular outflow tracts?
Does 3D printing-guided transcatheter pulmonary valve replacement improve right ventricular remodeling in patients with severe pulmonary regurgitation and enlarged native right ventricular outflow tracts?
3D printing-guided transcatheter pulmonary valve replacement using a self-expanding valve is safe and effectively reverses right ventricular remodeling in patients with severe pulmonary regurgitation and enlarged native outflow tracts.
May enable TPVR in large-RVOT patients; leaves open validation in larger multicenter trials.
Background: Severe pulmonary regurgitation (PR) often occurs following a transannular patch repair of tetralogy of Fallot, resulting in an enlarged native right ventricular outflow tract (nRVOT) with varying shapes. Methods: We conducted a single-center study with eight patients having severe PR and enlarged nRVOT (diameters ≥ 29 mm). Transcatheter pulmonary valve replacement (TPVR) was performed using the self-expanding PT-Valve. Preoperative evaluation included echocardiography, computed tomography, and magnetic resonance imaging. A 3D-printed model of the nRVOT was used for preoperative assessment. Follow-up data were collected in 1-year follow-up. Results: PT-Valve was successfully implanted in all patients, resulting in immediate improvement of severe PR. Pulmonary artery diastolic pressure increased significantly (p < 0.001). No deaths or coronary compression occurred during the procedure. Over a 1-year follow-up, no stent displacement or fracture occurred. Only two patients had trace paravalvular leaks. Magnetic resonance imaging revealed a reversal of right ventricular remodeling, with a significant reduction in right ventricular end-diastolic volume index (p < 0.001) and improved right ventricular ejection fraction (p < 0.001). All patients achieved primary endpoints. Conclusion: 3D printing-guided PT-Valve implantation in enlarged nRVOT for severe PR is safe and effective, expanding TPVR indications and offering potential treatment for a broader patient population.
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Wang et al. (2023) studied Severe pulmonary regurgitation with enlarged native right ventricular outflow tract (n=8). Transcatheter pulmonary valve replacement using the PT-Valve with 3D printing guidance was evaluated on Primary endpoints (not explicitly defined, but included successful implantation and improvement of severe PR). Transcatheter pulmonary valve replacement using the PT-Valve with 3D printing guidance was successfully implanted in all 8 patients, significantly improving right ventricular ejection fraction (p<0.001).
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