The EM tracked robotic catheter allowed better real-time 3D orientation, facilitating navigation, with a reduction in cannulation and fluoroscopy times and improvement of motion consistency and efficiency.
sectional area approximately one-sixth of a normal renal or visceral lumen, providing significant leeway for mal-alignment. In light of this, we routinely use inflated balloons in the target vessels instead of sheaths during FEVAR deployment for the theoretical advantage of improved alignment. We also feel this simple maneuver may protect from atheroembolism during graft opening. The purpose of this study was to compare sheaths to inflated balloons for fenestration-to-target vessel alignment during deployment of a FEVAR bench top model with varying aortic configurations.Methods: A 32 mm diameter Z-Fen proximal body (Cook Medical, Bloomington, Ind) was used for all test deployments. The device was configured with a single scallop (height 10 mm and width 10 mm) placed at the 12:00 position and two small fenestrations (height 8 mm and width 6 mm) placed 15 mm from the edge of the fabric and an arc length of 21.2 mm from the center of scallop on each side. Vinyl tubing with holes drilled to represent the superior mesenteric and renal arteries was used to create models of varying aortic anatomy. The vinyl tubing had an inner diameter of 25.4 mm. The superior mesenteric artery hole was 6.4 mm in diameter, and the renal artery holes were 5.6 mm in diameter. The position of the Z-Fen device in the vinyl tubing was controlled using string threaded through the struts of the proximal free-flow component and the most distal z-stent. A Newton wire was used to simulate the constraining wire and a short piece of plastic cylindrical tubing was used to simulate the top cap during the deployments. Three different aortic models were used. Model A was straight with holes drilled in perfect alignment with the fenestrated graft. Model B was designed to represent tortuous anatomy, the holes were kept aligned, but a 45 angle was placed in the vinyl tubing 4 mm distal to the renal arteries. Model C was designed to represent an ill-measured fenestrated graft and was straight, but the right renal hole was intentionally misplaced 5.6 mm ventral to the appropriate position, and the left renal hole was misplaced 5.6 mm cranial to the appropriate position. For each model, the fenestrated graft was deployed six times using 6F Ansel sheaths (Cook Medical) for alignment and six times using Mustang balloons (Boston Scientific, Marlborough, Mass) inflated to nominal pressure for alignment. A 7mm balloon was used in the superior mesenteric artery hole and 6-mm balloons were used in the renal artery holes. Based on preliminary findings, all deployments were performed with upward traction placed on our deployment model during removal of the constraining wire. Percent area encroachment of graft material on target vessel ostium was calculated using image analysis software and compared with the Student t-test.Results: In model A, average percentage of area encroachment when using sheaths for alignment was 6.4% 6 1.5% compared with 5.8% 6 1.0% for balloons (P ¼ .73). In model B, average percentage area encroachment was 45.9% 6 7.8% for sheaths compared wi...
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