Abstract

Introduction: Transcatheter pulmonary valve replacement (TPVR) is an alternative option to address failing native and bioprosthetic pulmonary valves (BPV). TPVR has expanded to implantation in native right ventricular outflow tracts (nRVOT) and progressively smaller patients. We aim to define the relationship between valve-to-patient size ratio and early development of pulmonary insufficiency (PI). Methods: This single-center retrospective cohort study identified patients who underwent TPVR with a Sapien valve between 2014 and 2021. We collected demographic, anatomic, and pre- and post-TPVR echo data. Echo data were collected at four post-TPVR time points: prior to discharge, short-term (1-9 months), mid-term (9-18 months), and most recent study. The primary outcome was development of moderate or severe PI by mid-term follow-up. Valve size-to-body surface area (BSA) ratio was evaluated for correlation with the development of moderate or severe PI. Results: The cohort consisted of 187 patients; 79 (42.2%) underwent TPVR within the nRVOT (Table). Compared to patients with TPVR in a conduit or BPV, patients with a nRVOT were younger, had lower weight, and lower BSA. Moderate or severe PI post-TPVR was more common in patients in the nRVOT group (P-value < 0.001), occurring in 9 (11.5%) by mid-term follow-up, compared to 2 (1.9%) in a conduit or BPV. In the subset of patients with TPVR within the nRVOT, the development of moderate or severe PI was associated with a larger valve size-BSA ratio (OR=1.13, 95% CI: 1.03, 1.26, P-value=0.012). Conclusions: Development of moderate or severe PI following TPVR with a Sapien valve was rare in this cohort. Patients receiving a Sapien TPVR within the nRVOT with a large valve size-to-BSA ratio were more likely to develop early PI. The increased risk of early valve failure in these patients should inform counseling regarding expected longevity of the valve and may guide valve choice as more transcatheter valve options become available.

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