Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience

BACKGROUND: Open and minimally invasive lumbar fusion procedures have inherent procedural risks, with posterior and transforaminal approaches resulting in significant soft-tissue injury and the anterior approach endangering organs and major blood vessels. An alternative lumbar fusion technique uses a small paracoccygeal incision and a presacral approach to the L5-S1 intervertebral space, which avoids critical structures and may result in a favorable safety profile versus open and other minimally invasive fusion techniques. The purpose of this study was to evaluate complications associated with axial interbody lumbar fusion procedures using the Axial Lumbar Interbody Fusion (AxiaLIF) System (TranS1, Wilmington, North Carolina) in the postmarketing period. METHODS: Between March 2005 and March 2010, 9,152 patients underwent interbody fusion with the AxiaLIF System through an axial presacral approach. A single-level L5-S1 fusion was performed in 8,034 patients (88%), and a 2-level (L4-S1) fusion was used in 1,118 (12%). A predefined database was designed to record device- or procedure-related complaints via spontaneous reporting. The complications that were recorded included bowel injury, superficial wound and systemic infections, transient intraoperative hypotension, migration, subsidence, presacral hematoma, sacral fracture, vascular injury, nerve injury, and ureter injury. RESULTS: Complications were reported in 120 of 9,152 patients (1.3%). The most commonly reported complications were bowel injury (n = 59, 0.6%) and transient intraoperative hypotension (n = 20, 0.2%). The overall complication rate was similar between single-level (n = 102, 1.3%) and 2-level (n = 18, 1.6%) fusion procedures, with no significant differences noted for any single complication. CONCLUSIONS: The 5-year postmarketing surveillance experience with the AxiaLIF System suggests that axial interbody lumbar fusion through the presacral approach is associated with a low incidence of complications. The overall complication rates observed in our evaluation compare favorably with those reported in trials of open and minimally invasive lumbar fusion surgery.