RESUMO
STUDY DESIGN: Prospective, multicenter, partially randomized. OBJECTIVE: Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG). SUMMARY OF BACKGROUND DATA: Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions. METHODS: Primary endpoints were analyzed at 1âyear follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications. RESULTS: Nine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1âyear f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (Pâ=â0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, Pâ=â0.029). Surgical time was similar (skin-to-skin time/no. of screws) at 24.9 minutes RG and 22.9 FG (Pâ=â0.550). Fluoroscopy during surgery/no. of screws was 15.5âseconds RG versus 35.4âseconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6âseconds RG versus 17.8âseconds FG showing an 80% average reduction of fluoro time/screw in RG (Pâ<â0.001). Within 1âyear follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, Pâ<â0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, Pâ<â0.001). CONCLUSION: Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1âmin/case).Level of Evidence: 2.
Assuntos
Parafusos Pediculares , Procedimentos Cirúrgicos Robóticos , Fusão Vertebral , Adulto , Fluoroscopia , Humanos , Vértebras Lombares , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos Prospectivos , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Fusão Vertebral/efeitos adversosRESUMO
We describe cardiovascular responses during the Valsalva maneuver and syncope in the youngest reported patient with stretch syncope, which was induced by neck stretching and back hyperextension. The pattern of cardiovascular responses during stretch syncope was similar to that during a pathologic Valsalva maneuver, indicating adrenergic dysfunction in this patient. These findings indicate that the underlying mechanisms of these two processes are not fundamentally different, and that adrenergic dysfunction observed during the Valsalva maneuver may have resulted in stretch syncope in this patient. However, a simple Valsalva maneuver should not have sufficed to precipitate these episodes, because no syncope or significant hypotension occurred during the Valsalva maneuver. Thus, we suggest that additional factors, such as mechanical compression of vessels or physiologic responses to orthostasis, were aggravated during pathologic Valsalva maneuver responses, which were responsible for the stretch syncope observed.