Novel size-adjustable pulmonary valve US early feasibility study: One-year outcomes.

OBJECTIVE

The Autus Size-Adjustable Valve (ASAV) is a novel surgically implanted fully synthetic expandable pulmonary valve designed for pediatric patients. This first-in-human study evaluated initial device feasibility and safety.

METHODS

This was a Food and Drug Administration-approved prospective, single-arm, multicenter Investigational Device Exemption Early Feasibility Study to evaluate safety and preliminary effectiveness of the ASAV in pediatric patients aged 18 months to 16 years who require pulmonary valve replacement. All potential subjects underwent review by a screening committee to determine eligibility. Subjects had pre- and postoperative evaluation via transthoracic echocardiography. One-year outcomes are reported.

RESULTS

Eleven subjects (9 male) were enrolled at 3 centers. Median age at implant was 8.2 years (range, 2.7-13.9) years and body surface area ranged from 0.6 to 1.3 m2. The ASAV was size-adjusted at implant in all subjects, ranging from 14 mm to 20 mm internal diameter (z score -1 to +1). Median hospital length of stay was 4 (range, 3-5) days. There was no mortality, and 100% of subjects were free from device-related adverse events. No thrombus was observed. No subject developed endocarditis. At 1-year follow-up, 10 (90.9%) subjects had no pulmonary regurgitation (1 subject [8.1%] had trivial pulmonary regurgitation), and the mean right ventricle-pulmonary artery pressure gradient was 16 ± 6 mm Hg.

CONCLUSIONS

One-year results of the novel ASAV Early Feasibility Study demonstrated intact valve function and no device-related adverse events. The ASAV is now under evaluation in an Investigational Device Exemption pivotal study.