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Midterm Clinical and Echocardiographic Outcomes of Pulmonary Valve Replacement with the Edwards Inspiris Resilia Pericardial Aortic Bioprosthesis
Aditya Sengupta, Peter Pastuszko, Raghav Murthy.
The Mount Sinai Hospital, New York, NY, USA.

OBJECTIVE: Controversy regarding the optimal pulmonary valve substitute remains, with no approved surgical options for pulmonary valve replacement (PVR). We sought to evaluate the feasibility of the Edwards Inspiris pericardial aortic bioprosthesis in the pulmonary position in pediatric and adult subjects requiring PVR.
METHODS: Patients who underwent PVR from 02/2019-03/2021 at our institution were retrospectively reviewed. Progression of valve gradients and degree of pulmonic insufficiency (PI) and stenosis (PS) were assessed at thirty days and one year. Postoperative adverse events analyzed included paravalvular/transvalvular leak, endocarditis, explant, thromboembolism, valve thrombosis, valve-related bleeding, hemolysis, and structural valve degeneration.
RESULTS: Of 21 identified patients with age 26.5 15.0 years (range: 4-60 years), 19 (90.5%) had previously undergone repair of tetralogy of Fallot and 2 (9.5%) had undergone double-outlet right ventricle repair in the neonatal period or infancy. 28.6% underwent subsequent transcatheter procedures. All patients had at least mild RV dilatation (mean RVEDVi 165.6 41.1 mL/m2), and at least moderate pulmonary insufficiency (95.2%) or stenosis (9.5%). Cardiopulmonary bypass and cross-clamp times were 86.8 38.8 and 78.3 20.0 minutes, respectively. At a median follow-up of 21.4 months (range: 2.3-27.3 months), there was no mortality, valve-related reoperations, or adverse events. Valve gradients remained stable from baseline to 30 days and 1 year (Table 1). Progression of PI and PS are shown in Figure 1.
CONCLUSIONS: At midterm follow-up, our data demonstrate excellent safety and effectiveness of the Inspiris pericardial bioprosthesis for PVR. Further studies with longer follow-up are warranted.

Progression of Pulmonic Valve Gradients from Baseline to 30 Days & 1 Year
Pre-Discharge (n = 21)30 Days (n = 21)1 Year (n = 6)P-Value
Mean Gradient (mm Hg)7.4 2.35.8 3.16.3 3.50.37
Peak Gradient (mm Hg)14.6 6.69.1 5.810.0 6.00.14



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