Pachyderm-Shape Guiding Catheters to Simplify BASILICA Leaflet Traversal

摘要

Objectives: To test custom-shape guiding catheter curves intended to simplify aortic valve leaflet laceration. Background: Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is an adjunct to transcatheter aortic valve replacement. It can be technically demanding using popular coronary guiding catheters and catheter-in-guide coaxial systems. New elephant-trunk shaped Pachyderm Left (PAL1,PAL2,PAL3, Launcher, Medtronic) and Right (PJR4) guiding catheters match the geometric requirements to engage aortic cusp hinge points. We evaluate whether these catheters ease BASILICA compared with conventional-shape coronary guiding catheters used in the BASILICA IDE trial. Methods: This is a single-center, consecutive, retrospective observational cohort of patients who underwent BASILICA for risk of TAVR-induced coronary obstruction defined as virtual valve-to-coronary distance <4 mm, immediately upon commercial availability of the new Pachyderm shaped catheters. Clinical, procedural, and angio-graphic details were abstracted from medical records of their index procedure, and were compared to adjudicated findings in the BASILICA IDE trial. Results: Nine leaflets in 6 patients were traversed and lacerated using BASILICA and Pachyderm curve guiding catheters for traversal, including three solo left and three doppio left and right leaflets. Leaflet traversal was universally successful. Leaflet time-to-leaflet traversal was shorter using Pachyderm catheters compared with the BASILICA IDE trial (8.3 min (5.6-15) vs 45 min (20,61 ),p = 0.016). There were no deaths, strokes, or vascular complications. Conclusions: The new Pachyderm shaped guiding catheters significantly hastened the leaflet time-to-traversal during BASILICA TAVR. We recommend they be used instead of conventional coronary-shaped guiding catheters.