Initial Results With A Novel Expanded Polytetrafluoroethylene (ePTFE) Pulmonary Valved Conduit
Carl L. Backer, MD1, Mark E. Galantowicz, MD2, Christopher W. Baird, MD3, Pedro J. del Nido, MD3.
1UK HealthCare Kentucky Children's Hospital, Lexington, KY, USA, 2Nationwide Children's Hospital, Columbus, OH, USA, 3Boston Children's Hospital, Boston, MA, USA.
Objective(s): A novel ePTFE-based pulmonary valved conduit designed for the reconstruction of the right ventricular outflow tract (RVOT) was evaluated in an early feasibility study.Methods: This was a prospective, multicenter, single-arm study evaluating safety and performance of an investigational novel ePTFE-based valve. The synthetic 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. The conduit can be tailored to length requirements of the anatomy. All patients met the study inclusion/exclusion criteria, had a signed informed consent form and had pre- and postoperative evaluation via transthoracic echocardiography (TTE). Aspirin was administered for a minimum of three months post procedure; per institutional protocols four patients were on temporary Coumadin. Results: Seventeen patients were enrolled from three sites. Ages ranged from 6 to 17 years (mean 11.5 ± 3.7) with 9 (52.9%) males. BSA ranged from 0.82 to 1.57 m2. There has been no mortality. Through six months follow up, no patient has an RVOT gradient > 20 mmHg, (mean 11.2 ± 4.3 mmHg). No evidence of worsening valvular insufficiency was observed throughout postoperative serial TTE evaluation at discharge, 1, 3, 6 months. No pulmonary regurgitation above baseline (≤ mild) was observed through 6 months. No patient developed endocarditis and TTE detected no clinically significant thrombus formation.Conclusions: Six month evaluation of a novel ePTFE-based valved conduit is complete and demonstrates promising valve function with no thromboembolic or infectious complications, and no valve related reinterventions.
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