A Novel Bioabsorbable Pulmonary Valved Conduit - Early Feasibility Study (EFS-US) And First In Man (FIM-EU/ASIA): Early Results
David L. S. Morales, MD1, Cindy Herrington, MD2, Emile Bacha, MD3, Victor Morell, MD4, Zsolt Prodan, MD5, Tomasz Mroczek, MD6, Sivakumar Sivalingam, FRCS7, Martijn Cox, PhD8, Luc Verhees8, Ger Bennink, MD9, Federico M. Asch, MD10.
1Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA, 2Children's Hospital Los Angeles, Los Angeles, CA, USA, 3Columbia University Medical Center, New York, NY, USA, 4Children's Hospital of Pittsburgh, Pittsburgh, PA, USA, 5Kids Heart Center, Budapest, Hungary, 6Jagiellonian University, Krakow, Poland, 7National Heart Institute, Kuala Lumpur, Malaysia, 8Xeltis BV, Eindhoven, Netherlands, 9University Medical Center of Cologne, Cologne, Germany, 10MedStar Health Research Institute at Washington Hospital Center, Washington, DC, USA.
The bioabsorbable pulmonary valved conduit(PVC) is electrospun from a supramolecular polymer(Restorex) based on the 2-ureido-4[1H]-pyrimidinone(UPy) motif and designed to be fully functional upon implant, after which functionality & structure are gradually taken over by native cells permeating the material (Endogenous-Tissue-Restoration). We report the Eurasian-FIM:Xplore-1 and US Early Feasibility(EFS):Xplore-2 studies. For the US-EFS study, the first-generation PVC was enhanced by improving the consistency of leaflet thickness during manufacturing in order to improve valve/leaflet durability.
Twelve patients(2-12yo) from July-December/2016 were included at 3-sites(18mm conduit-7 patients &16mm-5 patients). Six patients, (2-9yo) had the second-generation PVC placed at 4 US sites(March-October/2018). All PVCs placed for RVOT reconstruction. All echocardiographic follow-up was assessed by one independent core laboratory.
The 12 FIM patients included did not have any major clinical events (Stroke-re-operation/intervention-death) up to 3-years follow-up. However, echocardiographic assessment showed Moderate/severe regurgitation in 11/12 patients with 6 demonstrating a prolapsing leaflet. The conduit diameters were stable showing no aneurysm or stenosis requiring intervention/operation. One-year follow-up of the six US-patients with the 2ndgeneration PVC demonstrated no moderate/severe regurgitation and/or prolapsing leaflets. One patient was re-operated at 9 months secondary to stenosis.
This potentially bioabsorbable PV conduit demonstrated encouraging conduit performance. Although the first-generation devices did not require clinical reintervention/operation up to 3 years, the PVC devices did not show sufficiently durable valve function. With the enhanced 2ndgeneration device, significantly improved valve durability was demonstrated that has led to the approval of a FDA HDE Pivotal Study to include 55 patients in the US-Europe-Asia.
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