An In-Vitro Comparison of Steady State Leakage Rates through Introducer Sheaths Used for Fenestrated Endovascular Aortic Aneurysm Repair

Abstract

Background: Fenestrated Endovascular Aneurysm Repair (fEVAR) involves deploying a covered stent into the aorta followed by multiple visceral stents through fenestrations in the main body of graft. The most commonly used large sheaths for cannulation of visceral vessels are the Gore DrySeal Flex, Cook Performer Check-Flo, and Medtronic Sentrant. None of these sheaths were designed for the insertion of multiple sheaths, and so a slow but steady leakage of blood occurs during the procedure. The aim of this paper is to assess in an in vitro setting which large bore sheath has the best valve for use when multiple smaller sheaths are inserted through it.

Methods: Three large bore introducer sheaths (LBISs) were used for this study, The Gore DrySeal Flex LBIS, Medtronic Sentrant LBIS and Cook Performer Check-Flo LBIS. A test rig was constructed, made of an 18-liter fluid reservoir mounted vertically and receiving a constant supply of water from a domestic water supply which flowed into the reservoir and out of an overflow. The reservoir was connected to the LBIS by a vertical plastic pipe with an internal diameter of 40 mm and an isolation valve. The LBIS was connected to the isolation valve by inserting the LBIS up a flexible silicone tube connected to the isolation valve. The LBIS was subject to a constant column/pressure of water and fluid leakage from the LBIS was collected in a plastic pot/tray placed underneath the LBIS. The leakage rates through each LBIS were determined for the following smaller diameter sheath combinations inserted through the valve, one 6 French Sheath, two 6 French Sheaths, two 6 French Sheaths and one 7 French Sheath. This was done to closely mimic a fEVAR procedure in vitro. The procedure was to insert different sheath combinations through the nonreturn valves in the LBIS and measure the volume of fluid that leaked through the valves. The leaked fluid was weighed, and the weight was converted to volume using the density of water (1 g/ml).

Results: The average (mean) leakage rates for each LBIS and each sheath combination showed that leakage rates when only one sheath was inserted were very low. For all 3 LBIS's tested, the leakage rates increased dramatically when multiple sheaths were inserted. The Medtronic LBIS leaked the most, followed by Cook, followed by Gore. For the Cook LBIS, the leakage rates exhibited with 2 × 6 French sheaths were approx. 106 times greater than those for the Gore LBIS and 5 times greater for the 2 × 6 French +1 × 7 French sheath combination. A similar comparison for the Medtronic LBIS versus the Gore LBIS yields factors of 132 and 8.

Conclusions: Leakage rates increase significantly when multiple sheaths are inserted and the Gore LBIS demonstrates significantly lower leakage than both the Cook and Medtronic during procedures that require simultaneous, multiple insertions of smaller sheaths. Although the Gore Dryseal has by far the lowest leakage rate when 3 small diameter sheaths are inserted (just under 1 ml/s), depending on the duration of the procedure this could still result in significant blood loss.