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Objectives: We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve–XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation.Methods: Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm (n = 5), and 18 mm (n = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared.Results: All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (n = 1), and peripheral stenosis of the branch pulmonary arteries (n = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse.Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.

The Fontan procedure has provided patients with single ventricle physiology extended survival into adulthood and in many cases has improved their quality of life. Atrioventricular valve regurgitation ( AVVR ) is common in single ventricle patients and is associated with increased risk of mortality. AVVR is more common in patients with a systemic tricuspid or common atrioventricular valve but is generally progressive irrespective of underlying valve morphology. AVVR can be attributable to diverse structural and functional abnormalities at multiple levels of the valvar apparatus, as well as ventricular dysfunction and dilation. Multiple imaging modalities including recent advances in 3‐dimensional echocardiography and cross‐sectional imaging have been used to further understand AVVR . Surgery to address AVVR must be tailored to the underlying mechanism and the timing of surgical repair should be chosen carefully. In this review, we discuss the etiologies, treatment options, surgical timing, and outcomes of valve repair or replacement for AVVR in patients with single ventricle congenital heart disease, with a focus on those with a Fontan circulation as AVVR is associated with increased risk for Fontan failure and mortality. In‐depth understanding of the current literature will help guide clinicians in their approach and management of AVVR in this population.

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Introduction: Favorable outcomes with continuous flow devices (CFD) have enticed clinicians to implant CFD in patients smaller than the suggested body surface area (BSA) criteria of >1.5 m 2 . Despite limited data, the VAD community is using CFD in patients down to a BSA of 0.7m 2 . For this reason, we sought to examine the use of CFD in adults with BSA ≤1.5 m 2 and compare outcomes to adult patients with BSA >1.5m 2 . Methods: CFD implants in adults (>18 years) from 04/2008 to 09/2014 were identified using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Patients were divided into two cohorts based on BSA. Patient characteristics and post implant outcomes including mortality, transplant, and adverse events were compared between the two cohorts. Results: Of adults (11142) undergoing CFD implants 2% (239) had BSA of ≤1.5m 2 ; BSA median 1.4m 2 [0.76 – 1.5 m 2 ]. One patient had BSA <1.0m 2 , 6% (15) 1.0-1.2m 2 and 93% (223) >1.2-1.5m 2 . Pre-implant patient characteristics were similar between the two groups except gender and INTERMACS profile [Table]. Overall survival (p=0.8) and favorable outcomes at 1-year were similar between the two groups; however, fewer patients with BSA ≤1.5m 2 were transplanted (p<0.01) [Figure]. There were more bleeding events and infection; however, less renal dysfunction and right heart failure in patients with BSA ≤1.5m 2 [Table]. Conclusion: CFDs can be safely used in smaller adult patients. The outcomes are favorable but clinicians must be mindful that the adverse event profile is different in smaller patients. These results are reassuring for the recent trend in the VAD community for placing CFDs in smaller patients.