ABSTRACT
PURPOSE: Failed back surgery syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to conventional medical management (CMM) and spinal cord stimulation (SCS) is advised. However, comparative cost-effectiveness research of both clinical approaches still lacks further evidence. This probabilistic cost-effectiveness analysis compares CMM versus SCS plus CMM in FBSS patients for a 5-year period in Spain. PATIENTS AND METHODS: Patient-level data was obtained from a 2-year real-world study (SEFUDOCE) of adults diagnosed with FBSS who were treated with CMM or SCS. Incremental cost-effectiveness ratios (ICER) were estimated in terms of direct clinical cost and quality-adjusted life years (QALYs). Costs ( for 2019) were estimated from the Spanish National Health Service (NHS) perspective. We applied a yearly discount rate of 3% to both costs and outcomes and performed a probabilistic sensitivity analysis using bootstrapping. RESULTS: After 2 years, the health-related quality of life measured by the EQ-5D displayed greater improvements for SCS patients (00.39) than for improved CMM patients (0.01). The proportion of SCS patients using medication fell substantially, particularly for opioids (-49%). In the statistical model projection, compared with the CMM group at year 5, the SCS group showed an incremental cost of 15,406 for an incremental gain of 0.56 0.56 QALYs, for an ICER of 27,330, below the 30,000 willingness-to-pay threshold for Spain. SCS had a 79% of probability of being cost-effective. CONCLUSION: SCS is a cost-effective treatment for FBSS compared to CMM alone based on real-world evidence.
ABSTRACT
Introducción. La dehiscencia esternal es una complicación relativamente frecuente de la esternotomía media y que causa gran morbimortalidad en cirugía cardiotorácica. La obesidad se considera uno de los factores de riesgo más importantes de dehiscencia e infección esternal, y su prevalencia cada vez mayor en la población sometida a cirugía cardíaca. En el presente estudio se evalúa el beneficio clínico del uso profiláctico del refuerzo esternal de tipo Robicsek en los pacientes de alto riesgo que son intervenidos de cirugía cardíaca mayor. Pacientes y método. Se analiza a 290 pacientes consecutivos intervenidos mediante esternotomía media en nuestro centro. La indicación de refuerzo profiláctico esternal se estableció en casos de osteoporosis esternal severa o índice de masa corporal (IMC) >= 30, empleándose la técnica en 105 pacientes, 54 varones y 51 mujeres, cuya edad media era de 67,7 ± 9,1 años y con un IMC medio de 31,8 ± 4,1. Resultados. No hubo dehiscencias no infecciosas en el grupo con refuerzo de tipo Robicsek; sólo se produjo un caso (1,7%) de dehiscencia esternal debida a osteomielitis en el grupo reforzado, con buena respuesta a desbridamiento quirúrgico asociado con antibioterapia por vía intravenosa. Conclusión. El refuerzo de tipo Robicsek reduce la incidencia de dehiscencia esternal en los pacientes de alto riesgo y su indicación profiláctica debe ser considerada en casos de osteroporosis severa o IMC >= 30 (AU)
Introduction. Sternal deshidence is a relatively frequent complication in median sternotomy and causes high morbidity and mortality in cardiothoracic surgery. Obesity is one of the most important risk factors for sternal infection and deshidence and its prevalence is increasingly frequent in patients undergoing cardiac surgery. The aim of the present study was to assess the clinical benefit of the prophylactic use of robicsek sternal reinforcement in high-risk patients undergoing cardiac surgery. Patient and method. Two hundred ninety ninety consecutive patients who underwent median sternotomy in our center were analysed. The indications for prophylactic sternal reinforcement were severe sternal osteoporosis or a body mass indez (BMI) of >= 30. The technique was used in 105 patients, 54 men and 51 women, with a mean age of 67.7 +/- 9.1 years and a mean BMI of 31.8+/-4.1. Results. None of the patients in the reinforcement group developed non-infectious dehiscence; only one patient (1.7%) in this group showed sternal dehiscence due to osteomyelitis with good response to surgical debridement and intravenous antibiotics. Conclusion. Robicsek reinforcement reduces the incidence of sternal dehiscence in high-risk patients and its prophylactic use should be considered in patients with severe osteoporosis or a BMI of >=30 (AU)
Subject(s)
Male , Female , Adult , Aged , Middle Aged , Humans , Surgical Wound Dehiscence/prevention & control , Obesity/complications , Sternum/surgery , Cardiac Surgical Procedures/methods , Osteoporosis/complications , Suture Techniques , Body Mass IndexABSTRACT
INTRODUCTION: Sternal dehiscence is a relatively frequent complication in median sternotomy and causes high morbidity and mortality in cardiothoracic surgery. Obesity is one of the most important risk factors for sternal infection and dehiscence and its prevalence is increasingly frequent in patients undergoing cardiac surgery. The aim of the present study was to assess the clinical benefit of the prophylactic use of Robicsek sternal reinforcement in high-risk patients undergoing cardiac surgery. PATIENTS AND METHOD: Two hundred ninety consecutive patients who underwent median sternotomy in our center were analyzed. The indications for prophylactic sternal reinforcement were severe sternal osteoporosis or a body mass index (BMI) of > or = 30. The technique was used in 105 patients, 54 men and 51 women, with a mean age of 67.7 +/- 9.1 years and a mean BMI of 31.8 +/- 4.1. RESULTS: None of the patients in the reinforcement group developed noninfectious dehiscence; only one patient (1.7%) in this group showed sternal dehiscence due to osteomyelitis with good response to surgical debridement and intravenous antibiotics. CONCLUSION: Robicsek reinforcement reduces the incidence of sternal dehiscence in high-risk patients and its prophylactic use should be considered in patients with severe osteoporosis or a BMI of > or = 30.
