They also queried whether surgeons should avoid direct exposure of paraspinal muscles to INFUSE, and whether prolonged drainage is required where such exposure occurs. Again, the authors questioned whether INFUSE should be utilized in the posterior cervical spine, and at what dose. A 53-year-old patient, following removal of the resultant seroma, exhibited only a partial recovery. One case study reported postoperative neurological deterioration attributed to a massive seroma (severe inflammatory response) attributed to INFUSE utilized to perform a posterior occipital/cervical fusion. The authors recommended that the indications for using INFUSE during anterior cervical surgery be reassessed to determine whether it is safe in this location: at what dose, and with what morbidity. The authors also concluded that high-dose INFUSE, when utilized during anterior cervical spine surgery, contributed to high complication rates attributed to its generalized inflammatory effect (spread to adjacent structures, increased perioperative complications/morbidity). Thirteen additional patients required prolonged hospital stays of greater than 48 h or hospital readmission addressing swallowing/breathing problems, or marked swelling without focal hematomas. Complications included 15 hematomas, 11 of which required surgical removal on postoperative days 4 or 5. In another retrospective anterior cervical study, 35 (23.2%) of 151 patients undergoing anterior diskectomy and fusion (138) or anterior corpectomy and fusion (13) developed complications attributed to INFUSE (2003-2004). The authors concluded, therefore, that INFUSE in anterior cervical surgery posed an unacceptable risk to respiratory function. In particular, acute airway obstruction was attributed to marked soft tissue inflammation/swelling occurring between postoperative days 2 and 7, resulting in a marked increase in unplanned intubations and tracheotomies. Complications associated with INFUSE included a significant increase in the length of stay (LOS), hospital charges, airway-related complications e.g., airway obstruction, reintubation/unplanned postoperatively, tracheotomies, ICU admissions, hoarseness, dyspnea, respiratory failure, dysphagia, readmission, and the need to perform percutaneous gastrostomies (PEG). In another retrospective study (2004-2009), clinical outcomes and fusion rates were compared for 260 patients undergoing anterior cervical surgery with INFUSE versus 515 (control) anterior procedures performed without INFUSE. In the anterior cervical studies in which INFUSE was utilized as an “off-label” device, there was a 5.8% incidence of postoperative soft tissue swelling/dysphagia. One study systemically assessed 240 articles written between 19 on utilizing INFUSE for cervical, thoracic, and lumber surgery only 31 were adequate for inclusion. The increased risks associated with utilizing INFUSE for anterior cervical spine surgeries are well publicized. As Medicare and more insurance companies no longer reimburse or are considering cessation of reimbursement for INFUSE used in an “off-label” capacity (anywhere excluding ALIFs), surgeons may have to turn toward other supplements/alternatives to attain fusion.Ĭons for INFUSE in Cervical Spine Surgery: A Literature Review Presently, INFUSE costs hospitals an average of $5000-6000 for a large package (actual cost without overhead to the hospital). Furthermore, several of the studies look at the major financial implications of utilizing INFUSE. ![]() Surgeons validate its use based upon the “standard of care.” In this review, we examine the cons of utilizing INFUSE, citing its common (e.g., anterior cervical complications) and not-so-commonly known complications, while also taking a cursory look at its pros. Despite its Federal Drug Administration (FDA) approval solely for anterior lumbar interbody fusions (ALIFs) with a lumbar tapered fusion device (LT Cage Medtronic), it has been applied at the discretion of individual surgeons in an “off-label” capacity throughout the spine. The use of bone morphogenetic protein INFUSE (recombinant human bone morphogenetic protein-2 Medtronic, Memphis, TN, USA) in cervical, thoracic, and lumbar spine surgery remains controversial.
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