Preliminary Results With a Novel Expanded Polytetrafluoroethylene-based Pulmonary Valved Conduit.

Abstract

A novel polymeric pulmonary valved conduit, resistant to calcification and structural valve deterioration, may provide a more durable therapy option for the pediatric population by preventing loss of right ventricular function and increasing freedom from valve-related reintervention and mortality. This was a prospective, multicenter, single-arm study evaluating safety and performance of an investigational novel expanded polytetrafluoroethylene-based valve. Patients met study inclusion/exclusion criteria, had a signed informed consent, had pre- and postoperative evaluation via transthoracic echocardiography, and 6-month cardiac magnetic resonance imaging. Seventeen patients were enrolled from 3 sites. Median age was 12 years (range, 6-17 years) with 52.9% male. Body surface area ranged from 0.82 to 1.57 m². There has been no mortality and 100% freedom from device related reinterventions. Baseline compared with 6-month cardiac magnetic resonance imaging (in 11 of 16 patients with available data) suggests favorable right ventricular remodeling (right ventricular end-diastolic volume, 123 ± 37 to 94 ± 25 mL/m²) with no significant change in ejection fraction. Through current follow-up, no patient has a right ventricular outflow tract gradient >20 mm Hg (mean, 11.2 ± 4.3 mm Hg). No evidence of worsening valvular insufficiency was observed throughout postoperative serial transthoracic echocardiogram evaluations. No pulmonary regurgitation above baseline (≤ mild) was observed. No patient developed endocarditis. No thrombus or calcification was identified. This preliminary evaluation of a novel expanded polytetrafluoroethylene-based valved conduit suggests promising valve function with no thromboembolic or infectious complications, no valve related reinterventions, no valve-related adverse events or unexpected findings, improved right ventricular volumes, and encouraging hemodynamic performance through current follow-up.