Study design: Prospective, observational cohort study.
Objective: To determine the true incidence of adverse events (AEs) in European adults undergoing surgery for degenerative spine diseases. The majority of surgeries performed for degenerative spinal diseases are elective, and the need for adequate estimation of risk-benefit of the intended surgery is imperative. A cumbersome obstacle for adequate estimation of surgery-related risks is that the true incidence of complications or adverse events (AEs) remains unclear.
Methods: All adult patients (≥ 18 years) undergoing spine surgery at a single center from February 1, 2016, to January 31, 2017, were prospectively and consecutively included. Morbidity and mortality were determined using the Spine AdVerse Events Severity (SAVES) system. Additionally, the correlation between the AEs and length of stay (LOS) and mortality was assessed.
Results: A total of 1687 procedures were performed in the study period, and all were included for analysis. Of these, 1399 (83%) were lumbar procedures and 288 (17%) were cervical. The overall incidence of AEs was 47.4%, with a minor AE incidence of 43.2% and a major of 14.5%. Female sex (OR 1.5 [95% CI 1.2-1.9), p < 0.001) and age > 65 years (OR 1.5 [95% CI 1.1-1.7], p = 0.012) were significantly associated with increased odds of having an AE.
Conclusion: Based on prospectively registered AEs in this single-center study, we validated the use of the SAVES system in a European population undergoing spine surgery due to degenerative spine disease. We found a higher incidence of AEs than previously reported in retrospective studies. The major AEs registered occurred significantly more often perioperatively and in patients > 65 years.
Keywords: Adverse events; Complications; Degenerative spine surgery; Prospective.