Key result
Pulmonary valve replacement using the INSPIRIS Resilia bioprosthesis in 21 patients resulted in 1 death, no major complications, and a mean peak gradient of 17 mm Hg at early follow-up.
Why the study?
Bioprosthesis durability in the pulmonary position in congenital heart disease remains suboptimal, prompting evaluation of the new INSPIRIS Resilia valve in children and young patients.
Does the INSPIRIS Resilia bioprosthesis provide good hemodynamic performance and safety when implanted in the pulmonary position in children and young adults with congenital heart disease?
Observational (n=21)
Does the INSPIRIS Resilia bioprosthesis provide good hemodynamic performance and safety when implanted in the pulmonary position in children and young adults with congenital heart disease?
The INSPIRIS Resilia bioprosthesis shows excellent short-term hemodynamic performance and safety when used for pulmonary valve replacement in young patients with congenital heart disease.
Supports feasibility of INSPIRIS Resilia in pulmonary position; hypothesis-generating for durability in congenital patients.
BackgroundThe durability of bioprostheses in the pulmonary position in patients with congenital heart disease remains suboptimal. The new INSPIRIS Resilia aortic valve is characterized by a pericardial tissue that could improve hemodynamic performance and durability. We report initial experience with this valve in the pulmonary position in children and young patients.MethodsA retrospective study was performed. Demographic, clinical, and echocardiographic data were recorded at hospital stay and through follow-up.ResultsBetween June 2017 and October 2019, 21 patients (14 males) underwent implantation of an INSPIRIS Resilia bioprosthesis. The most common diagnosis was repaired tetralogy of Fallot (n = 14). Mean age was 31 ± 16.6 years. Seven patients were children (the youngest 4 years old). One patient with tetralogy of Fallot and preoperative right ventricular failure died after surgery from multiorgan failure. No patient had a permanent pacemaker after surgery or other major complications. Early echocardiograms depicted a mean peak gradient across the valve of 17 ± 7.23 mm Hg, with no paravalvular leaks. At a median follow-up of 20 months (range 1–29 months), all discharged patients were alive without clinical complications. Most recent echocardiograms show good gradients with no paravalvular leaks.ConclusionsIn our experience, the INSPIRIS Resilia aortic valve in the pulmonary position provides excellent in-hospital and short-term results in children and young patients with congenital heart disease. Despite showing here one of the longest follow-ups with this prosthesis, longer investigations are required to assess its durability and the feasibility of valve-in-valve procedures in this challenging population.
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Arribas et al. (2020) conducted an observational in Congenital heart disease (n=21). INSPIRIS Resilia bioprosthesis was evaluated on Clinical and echocardiographic outcomes. Pulmonary valve replacement using the INSPIRIS Resilia bioprosthesis in 21 patients resulted in 1 death, no major complications, and a mean peak gradient of 17 mm Hg at early follow-up.
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