Use of the GORE�DrySeal Flex Introducer Sheath to Facilitate Implantation of the Transcatheter Venus P-valve

Abstract

Objectives: We report our experience of using the 65 cm large diameter GORE® DrySeal Flex Introducer sheath to facilitate transcatheter implantation of the Venus P-valve in the pulmonary position. Background: Transcatheter implantation of pulmonary valves can be difficult due to rigidity of the valve delivery system or the anatomy of the RVOT and pulmonary artery bifurcation and the risk of iatrogenic damage to the tricuspid valve support apparatus. Using long sheaths to pass and protect the tricuspid valve may facilitate the procedure. Methods: Multi-centre registry of patients who underwent transcatheter pulmonary valve implantation of the Venus P-valve using the GORE® DrySeal Flex introducer sheath to facilitate passage of the valve to the right ventricular outflow tract. Procedural success, time to valve implantation and radiation safety parameters were analyzed. These data were compared to a control group of subjects treated between July 2014 and May 2016 with the same valve but without the use of GORE® DrySeal. Results: Between December 2016 and September 2018, the Venus P-valve was successfully deployed through the GORE® DrySeal in 12 patients. There were no procedure-related complications. As a control group, 10 subjects treated between July 2014 and May 2016 were included. Total procedure time was significantly shorter in the GORE® DrySeal group compared to the control group 96 ± 27 min vs. 164 ± 12 min (p < 0.001). Total screening time was significantly shorter in the GORE® DrySeal group (24 ± 11 min) when compared with the control group (32 ± 14 min, p < 0.001). Conclusions: We describe a modification to the previously described techniques of implanting the Venus P-valve in the pulmonary position after surgical repair of congenital heart disease. In our experience, the GORE® DrySeal sheath has considerably facilitated the procedure and reduced the potential risks.