Abstract 14086: Early Results of a Novel EPTFE-based Pulmonary Valved Conduit in a Pediatric Patient Population

Abstract

Introduction: This prospective, multicenter, single-arm, early feasibility study evaluates the safety and performance of an investigational ePTFE-based valve for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract. 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 increased freedom from valve-related reintervention and mortality. Methods: The primary endpoints at 6 months adjudicated by an independent Clinical Events Committee are valve-related mortality and device-related reintervention. The investigational device is a valved conduit comprised of ePTFE with stretch technology and a flexible tri-leaflet polymeric valve made of an advanced proprietary composite material, which can be tailored to length requirements of the anatomy. All enrolled patients met study inclusion/exclusion criteria and had a signed informed consent form. All patients had pre- and postoperative evaluation via transthoracic echocardiography (TTE). Aspirin was administered for a minimum of three months post procedure and, per institutional protocols, four patients were on temporary Coumadin. Results: Of the 17 patients enrolled from three sites, 52.9% were male. Ages ranged from 6 to 17 years (mean 11.5 ± 3.7). BSA ranged from 0.82 to 1.57 m 2 . At six months follow up, 100% of subjects successfully met the primary endpoint of freedom from valve-related mortality and device-related reintervention. No patient exhibited an RVOT gradient > 20 mmHg. No patients had pulmonary regurgitation above baseline (≤ mild) observed through six months. Throughout postoperative serial TTE evaluation at discharge, 1, 3, and 6 months, no evidence of worsening valvular insufficiency was observed. No patient developed endocarditis and TTE detected no clinically significant thrombus formation. Conclusions: These preliminary data of a novel Pulmonary Valve Conduit suggest improved pulmonic and right ventricular function based on TTE measurements, no unexpected findings, no valve-related adverse events and encouraging hemodynamic performance through 6 months.