Globaldemographic shifts have substantially affected the prevalence and burden of musculoskeletal diseases.1The incidence of adult spinal deformity (ASD) in populations older than 65 years can reach up to 68%.2Given that the proportion of the global population more than 65 years old will soon exceed the proportion of those younger than 5 years of age, and that by 2050 the rate of the world’s population reaching more than 60 years of age will nearly double, ASD is increasingly being recognized as a disease that could reach epidemic dimensions, becoming a primary concern for healthcare systems.1ASD causes primarily pain and disability, reducing physical function; however, body self-image and mental health are frequently affected as well.3,4Different studies have shown that in patients seeking medical attention, the impact of ASD on health-related quality of life (HRQOL) scores is substantial, and is larger than in other common chronic conditions.3,5
The effectiveness of nonsurgical treatment is very limited6,7而不是广泛研究,而手术treatment in carefully selected patients shows satisfactory results and is associated with sustained improvements in HRQOL scores.8,9The aging of the population, the high prevalence of ASD, and an increasing demand to remain independent without significant disability in older age have together resulted in a marked increase in ASD surgery in recent decades. According to the Nationwide Inpatient Sample, in the US the surgical treatment of ASD increased by more than 50% over the years 2000–2010, compared with an increase of just 20% for other types of spine surgery over the same period of time.10
The primary concern regarding this rapid increase in ASD surgery is its very high rate of perioperative complications.11–16The reported incidence varies between different studies, but can be greater than 70%,12with an 18.8% risk of reoperation12and a 0.3% risk of death.15The cost of ASD surgery is high and varies substantially, due at least in part to the high rates of complications.17The estimated direct cost per surgery in Europe ranges between €30,000 and €60,000. However, a recent US study shows that the catastrophic cost threshold (> US$100,000) is exceeded by 11.9%, 14.8%, and 19.1% of patients at index surgery, 90-day follow-up, and 2-year follow-up, respectively. The current trajectory of healthcare costs in many countries is unsustainable.
The direct cost of spine care is a growing proportion of this expenditure due to a rapid increase in the volume of spine procedures and their associated high costs, coupled with an aging population. During the last decade great efforts have been made on preoperative risk stratification, patient optimization, and personalized surgical planning to mitigate the occurrence of adverse events and improve overall ASD quality metrics.1The goal of our study was to conjointly analyze the largest prospective available ASD data sets to define trends in quality-of-care indicators (complications, reinterventions, and HRQOL outcomes) since 2010, using real-world observational, noninterventional data.
开云体育世界杯赔率
Study Design and Patient Population
Two independent and compatible prospective multicenter ASD databases sharing the same inclusion criteria, one from the US and the other from Europe, were queried and merged. Patients were included in both databases if they were older than 18 years and had at least one of the following: scoliosis ≥ 20°, sagittal vertical axis (SVA) ≥ 5 cm, pelvic tilt ≥ 25°, or thoracic kyphosis (TK) ≥ 60°. Patients were enrolled through an institutional review board–approved protocol at 23 sites (17 in the US, 2 in Spain, 2 in Turkey, 1 in France, and 1 in Switzerland). Prospectively collected data were obtained preoperatively and at 3, 6, 12, and 24 months after surgery. All patients who were treated surgically between January 2010 and December 2016, with 2-year follow-up data available by January 2019, were included in the analysis.
Patient Parameters
Patient characteristics included objective measurements (demographic data and radiographic parameters) and HRQOL scores. Demographic data included patient age, sex, height, weight, and number of previous spine surgeries. Full-length freestanding anteroposterior and lateral spine radiographs were analyzed using validated software for assessment of radiographic parameters. HRQOL scores included the Oswestry Disability Index (ODI),18Scoliosis Research Society-22r (SRS-22r),19and Optum SF-36v2 Health Survey (SF-36).20
Surgical Parameters
Surgical parameters included the following: number of prior spine surgeries, surgical approach, number of fused vertebral levels, use of pelvic fixation, operative time, and estimated blood loss (EBL). In addition, information on the use of interbody fusion was collected as well as whether it was performed as a transforaminal lumbar interbody fusion or anterior/lateral lumbar interbody fusion. Data on osteotomies were collected, including Smith-Petersen osteotomies, pedicle subtraction osteotomies, and vertebral column resections. Complications, from intraoperative incidents through the time of most recent follow-up, were assessed and classified as recommended by McDonnell et al.21
Quality Metrics Indicators
评估我们eval ASD外科治疗的趋势uated 5 dimensions: 1) baseline patient demographics and spinal deformity; 2) surgical invasiveness; 3) deformity correction; 4) postoperative surgical complications; and 5) change in normalized HRQOL scores ([Preoperative − Postoperative] %) at 2-year follow-up. A complication was defined as major if it substantially prolonged hospitalization, involved an invasive intervention, had prolonged or permanent morbidity, or resulted in death during the first 2 years of follow-up. Composite outcomes were used to define complications because the low prevalence of any particular complication made accurate modeling difficult.
Statistical Analysis
Trends and changes in indicators were presented graphically using local regression and were analyzed by adjusted ORs estimated through multivariable logistic regression models. More specifically, results were plotted with generalized additive model (GAM) outcome trends with 95% CIs.
Results
At the time of the analysis 2286 patients (76.8% female) were included in the 2 registries, and 1520 underwent surgery between 2010 and 2016. A total of 1256 (82.6%) had 1-year follow-up data, and 1151 (75.7%) had 2-year follow-up data and were included in the study. Of these, 594 were from the US and 557 were from Europe—surgeries were performed at 23 sites in 5 countries.
Patients who had 2-year follow-up data (included in the study) and those who did not have 2-year follow-up data (not included in the study) had very similar 1-year HRQOL gain: ODI change was −14.15 versus −14.94 (p = 0.67); SRS-22r change was 0.85 versus 0.85 (p = 0.92); SF-36 physical component summary score change was 7.55 versus 7.34 (p = 0.43); and SF-36 mental component summary score change was 5.09 versus 5.11 (p = 0.87), respectively.
The mean age at the time of enrollment of the 1151 patients included in the study was 56.3 years (SD 17.4 years); 40.5% had undergone a previous surgery; 52.1% were American Society of Anesthesiologists (ASA) grade 2; and 28.8% were ASA grade 3. A total of 84.6% were treated using a posterior-only approach and 14.9% had anterior-posterior surgery. The mean surgical time was 366 minutes (SD 187 minutes), the mean total EBL was 1654 ml (SD 1417 ml), 21.5% received a 3-column osteotomy (3CO), and in 54.6% the spine was fused down to the pelvis. The mean number of fused levels was 10.3 (SD 4.45) (Table 1). The baseline mean ODI score was 42.5 (SD 19.2), SRS-22r subtotal was 2.79 (SD 0.67), and the mean baseline SF-36 physical component summary score was 33.5 (SD 10.2).
Surgical characteristics in 1151 patients with ASD
特征 | Value |
---|---|
Invasiveness | |
EBL, ml | 1654.9 (SD 1417.0) |
Surgical time, mins | 365.7 (SD 187.1) |
Approach | |
Posterior only | 974 (84.6%) |
Anterior only | 6 (0.5%) |
Combined anterior-posterior | 171 (14.9%) |
Pts w/ posterior instrumented fusion | 1119 (97.2%) |
Mean no. of posterior levels fused | 10.3 (range 0–19) |
Use of pelvic fixation | 628 (54.6%) |
Use of double rods | 149 (12.9%) |
Pts w/ anterior instrumented fusion | 4 (0.3%) |
Mean no. of anterior levels fused | 0.02 (range 0–11) |
Pts w/ interbody fusions | 577 (50.1%) |
Mean no. of interbody fusions | 1.02 (range 0–9) |
Posterior-only interbody fusions | 400 (69.3%) |
Anterior-only interbody fusions | 156 (27.0%) |
Combined anterior & posterior interbody fusions | 21 (3.7%) |
Pts w/ decompressions | 510 (44.3%) |
Mean no. of levels decompressed | 1.16 (range 0–9) |
Patients w/ decompressions w/o fusion | 9 (0.8%) |
Pts w/ osteotomies | 717 (62.3%) |
Pts w/ 3COs | 247 (21.5%) |
Cervical osteotomies | 2 (0.2%) |
Thoracic osteotomies | 107 (9.3%) |
Thoracolumbar osteotomies | 195 (16.9%) |
Lumbar osteotomies | 413 (35.9%) |
Pts = patients.
Values are presented as mean (SD), number (%), or mean (range).
The mean baseline pelvic incidence–lumbar lordosis mismatch (PI–LL) was 14.1° (SD 23.4°), global tilt was 28.6° (SD 17.0°), and major Cobb angle was 37.0° (SD 23.1°). The mean rate of major complications at 90 days was 17%, at 1 year it was 24%, and at 2 years it was 30%. The mean rate of reoperation at 2 years was 20% (Table 2).
Baseline demographic, HRQOL, and radiological data together with surgical data and rate of postoperative complications and reintervention
Variable | Mean Value (SD) |
---|---|
Age, yrs | 56.3 (17.4) |
BMI | 26.5 (5.55) |
ODI score | 42.5 (19.2) |
SRS-22 function | 2.94 (0.89) |
SRS-22 pain | 2.50 (0.92) |
SRS-22 self-image | 2.40 (0.74) |
SRS-22 mental | 3.28 (0.89) |
SRS-22 subtotal | 2.79 (0.67) |
SF-36 PCS | 33.5 (10.2) |
SF-36 MCS | 44.1 (13.0) |
SVA, mm | 57.6 (69.2) |
Pelvic tilt, ° | 23.2 (11.1) |
Sacral slope, ° | 31.8 (13.7) |
Global tilt, ° | 28.6 (17.0) |
PI-LL, ° | 14.1 (23.4) |
Major Cobb coronal angle, ° | 37 (23.1) |
90-day rate of major complications | 17% |
1-yr rate of major complications | 24% |
2-yr rate of major complications | 30% |
2-yr rate of reop | 20% |
MCS = mental component summary; PCS = physical component summary.
Patient enrollment increased progressively over the study period: 269 patients were operated on between 2010 and 2011 and 329 between 2015 and 2016 (OR 1.64, p < 0.01) (Fig. 1). On the contrary, baseline clinical characteristics such as age (p > 0.32), ASA grade distribution (p > 0.25), and HRQOL scores ODI, SRS-22r, and SF-36 (p > 0.05), as well as sagittal deformity (SVA, pelvic tilt, sacral slope, global tilt, PI–LL) (p > 0.3) and percent of cases with prior surgery, did not change over the study period (Fig. 2).
Since 2010 there has been a sustained reduction in major and minor complications observed at 90 days (major: OR 0.59, 95% CI 0.39–0.90; minor: OR 0.65, 95% CI 0.44–0.95; p < 0.01); at 1 year (major: OR 0.52, 95% CI 0.35–0.75; minor: OR 0.75, 95% CI 0.53–1.07; p < 0.01); and at 2 years of follow-up (major: OR 0.4, 95% CI 0.28–0.57; minor: OR 0.80, 95% CI 0.57–1.13; p < 0.01). There has also been a reduction in the 2-year reintervention rate (OR 0.41, 95% CI 0.27–0.61, p < 0.01) (Table 3andFig. 3). Simultaneously, there is a nonsignificant improvement in the correction of sagittal deformity (PI–LL) (OR 1.11, p = 0.19) associated with a progressive reduction of surgical aggressiveness:22mean number of fused segments 11.2 (SD 4.47) in 2010 versus 9.14 (SD 4.42) in 2016 (OR 0.81, p < 0.01); percent pelvic fixation 60.6% in 2010 versus 46.1% in 2016 (OR 0.66, p < 0.01); and percent 3CO 26.8% in 2010 versus 17.4% in 2016 (OR 0.63, p < 0.01) (Fig. 4). Blood loss 1986 ml (SD 1790 ml) in 2010 versus 1320 ml (SD 1220 ml) in 2016 (p < 0.001) and total surgical time 403 minutes (SD 193 minutes) in 2010 versus 328 minutes (SD 206 minutes) in 2016 (p = 0.001) showed a significant progressive reduction over the study period too. No significant changes were observed regarding surgical approach over the study period. The percentage of cases treated with anterior-posterior surgery, anterior-only surgery, or posterior-only surgery remains stable.
Rate of major complications and reinterventions over the study period
Variable | 2010–2011 | 2012–2013 | 2014 | 2015 | 2016 | p Value |
---|---|---|---|---|---|---|
No. of pts | 269 | 306 | 247 | 214 | 115 | |
Major complication, 90 days | 22% | 15% | 16% | 15% | 12% | 0.126 |
Major complication, 1 yr | 32% | 22% | 23% | 20% | 19% | 0.006 |
Major complication, 2 yrs | 42% | 30% | 26% | 22% | 23% | <0.001 |
Reinterventions, 2 yrs | 30% | 20% | 16% | 15% | 16% | <0.001 |
The change in normalized HRQOL scores at 2 years postoperatively showed a greater gain in ODI score (26% in 2010 vs 40% in 2016, p = 0.02) over the study period, whereas SRS-22r self-image and mental domains (OR 1.16, p = 0.13) showed a nonsignificantly greater gain. SRS-22r function, pain, and satisfaction domains as well as SF-36 normalized change remained stable over the study period. None of the HRQOL measures showed a normalized change reduction from 2010 to 2016 (Fig. 5).
When comparing characteristics between US and EU cohorts, some differences could be identified. At baseline, US patients were slightly older, had a higher BMI, more sagittal deformity, and a worse ODI score. The percentage of patients having pelvic fixation was higher in the US cohort, whereas the percentage of patients receiving 3CO was similar in both continents. SVA and PI–LL correction were slightly higher in US centers, whereas postoperative complications tended to be lower in Europe. Overall, HRQOL normalized change was greater in US patients, but a trend toward greater HRQOL score change over the study period was more evident in Europe.
Discussion
The reported rate of complications and cost of ASD surgery, combined with an increase in the number of surgeries, call for alarm among healthcare payers and providers worldwide.1,23This international (5 countries, 2 continents) longitudinal conjoined effort, based on a minimum 2-year follow-up of prospective multicenter (23 sites), high-quality (follow-up > 75%) data, represents the best available real-world evidence and shows a progressive and robust improvement in quality-of-care indicators associated with ASD surgery. Over the last decade, ASD postoperative complications and reinterventions have been progressively reduced by 50%, patient enrollment has increased, postoperative improvement in disability has augmented, and baseline patient characteristics have remained the same.
The rate of postoperative complications depends fundamentally on 2 factors: patient characteristics and surgical invasiveness.22,24我们的研究表明,努力优化ASDsurgical plans and metrics over the last decade have made the undertaking of cases with similar baseline characteristics more feasible. ASD quality metrics have not improved by operating on healthier and less deformed patients or by decreasing the surgical correction rate. On the contrary, we have been able to achieve the same or better deformity correction, progressively reducing blood loss, surgical time, and use of 3CO or pelvic fixation. Our data and evidence generated over the last decade show that the robust reduction of postoperative complications following ASD surgery is multifactorial and includes surgeons’ learning curve, improved intra- and postoperative patient management, better understanding of the spinal deformity, and refinement of surgical techniques, among others.
The estimated annual incidence in surgically treated ASD cases increased steadily after the year 2000, as shown by Passias et al. in their analysis of US data collected between 2003 and 2010.25Our data show the same trend, with a maintained increment in the number of cases enrolled in the combined US-EU data set from 2010 to 2016. ASD correction requires complex surgical techniques,22which became widely used in the new millennium. Different studies show that for surgeons treating ASD, years of experience is a significant factor in mitigating complications and improving quality measures, including a continuous decrease in operative time as the surgeon’s experience increases.26,27The surgeon’s learning curve has also been associated with a decrease in EBL, although the magnitude of correction may not change with increasing surgeon experience.27Factors other than surgeons’ learning curve may have contributed to the reduction of EBL over the last decade. A recent meta-analysis including articles published through December 2018 shows that the use of tranexamic acid is associated with lower intraoperative blood loss and lower total transfusion volumes in ASD surgery.28Both surgical time and EBL were significantly reduced over our study period, and both have been identified as important predictors of complications following ASD surgery.22
Simultaneously, multiple efforts have been made worldwide to better understand sagittal alignment and ASD surgical correction. The improved definition of individualized postoperative alignment goals has been repeatedly associated with fewer postoperative mechanical complications.29–32Refinement of anterior and posterior surgical techniques restoring segmental lordosis has reduced the use of 3CO, a procedure that is technically challenging and that carries high morbidity rates.33,34Although still needed in a substantial proportion of patients with ASD (pelvic fixation 50%; 3CO 20%), our data may suggest some overuse of pelvic fixation and 3CO in earlier times. The more strict and adjusted use of these techniques has probably contributed to improvements in ASD surgical outcomes in the later cohorts. The use of multirod constructs, effective to provide increased stability to potentially prevent or at least delay implant failure and symptomatic pseudarthrosis, is nowadays common practice in ASD surgeries.35The larger postoperative improvement in disability observed over the study period can be explained by the very relevant reduction in the complication and reoperation rate. Núñez-Pereira et al. showed that even when properly managed and resolved, surgical complications still have a relevant impact on surgical outcomes, being associated with worse HRQOL scores at mid- and long-term follow-up.36
Our study has the limitations of observational longitudinal studies, not allowing us to establish causal relationships. However, the combined International Spine Study Group (ISSG) and European Spine Study Group (ESSG) data set represents the largest and most comprehensive ASD-specific, prospective, longitudinal source of information. With a 2-year follow-up rate of > 75%, the data included in this study, coming from 17 centers, 2 continents, and 5 countries, represent the best available evidence of real-world ASD surgical practice and provide the medical community with an outstanding source of information on trends associated with treatment. The large number of centers and surgeons involved advocate for the generalizability of the reported results to a wide range of patients. The latest developments are centered on personalized risk stratification,37ASD cluster analysis,38and personalized prediction of midterm surgical outcomes.39,40Together with a sophisticated refinement of the surgical technique and preoperative patient optimization, these advancements forecast a maintained improvement in ASD quality metrics allowing patients, providers, and payers to face the ASD epidemic more efficiently.
Conclusions
Our analysis shows a robust global improvement in ASD surgery quality metrics over the last decade within our large combined database. Surgical complications and reoperations have been reduced by half, improvement in disability has been increased, and correction rates have been maintained in patients with similar baseline characteristics.
Disclosures
ISSG基金会收到资金的支持DePuy Synthes, K2M, NuVasive, Orthofix, and Zimmer Biomet. The ESSG receives funding support from DePuy Synthes and Medtronic. Dr. Pellisé是美敦力公司的顾问和DePuy脊柱,he also received clinical or research support for the study described (includes equipment or material) from those companies. He is a board member of the Scoliosis Research Society and an associate board member of the AO Spine Deformity Knowledge Forum. Dr. Gum is an employee of Norton Healthcare and a consultant for Medtronic, Acuity, K2M/Stryker, NuVasive, and Mazor. He is in the speaker’s bureau for DePuy, and receives royalties from Acuity and NuVasive. He has received honoraria from Picira Pharmaceuticals, Baxter, Broadwater, and NASS. He has received clinical or research support for the study described (includes equipment or material) from Integra, Intellirod Spine Inc., Pfizer, ISSG, NuVasive, Norton Healthcare, Texas Scottish Rite Hospital, Alan L. and Jacqueline B. Stuart Research, Cerepedics Inc., SRS, and Medtronic. He reports direct stock ownership in Cingulate Therapeutics, and holds a patent with Medtronic. He is on the advisory/editorial boards of K2M/Stryker, Medtronic, and National Spine Health. Dr. Obeid is a consultant for DePuy Synthes and Medtronic. He has received clinical or research support for the study described (includes equipment or material) from DePuy Synthes. He receives royalties from Alphatec, Spineart, and Clariance. Dr. Smith is a consultant for Zimmer Biomet, NuVasive, Stryker, DePuy, Cerapedics, and Carlsmed. He reports direct stock ownership in NuVasive and Alphatec, and he receives royalties from Zimmer Biomet, NuVasive, and Thieme. He receives support of a non–study-related clinical or research effort that he oversees from DePuy Synthes, NuVasive, and AO Spine. He receives clinical or research support for the study described (includes equipment or material) from DePuy Synthes. AO Spine has provided him with fellowship support. Dr. Kleinstück is in the speaker’s bureau for DePuy Synthes. Dr. Bess is a consultant for K2M Stryker, and is a patent holder with K2M Stryker and NuVasive. He receives clinical or research support for the study described (includes equipment or material) from DePuy Synthes, ISSGF, K2M Stryker, and NuVasive. He receives support of a non–study-related clinical or research effort that he oversees from Medtronic, Globus, and SI Bone. He receives royalties from K2M Stryker. Dr. Pizones is a consultant for Medtronic. Dr. Lafage is a consultant for Globus Medical. She receives royalties from NuVasive and honoraria from DePuy Synthes and J&J. Dr. Schwab is a consultant for Zimmer Biomet, MSD, and Globus Medical. He receives royalties from MDS and Zimmer Biomet. He is on the executive committee of the ISSG. Dr. Burton is a patent holder with DePuy, and has direct stock ownership in Progenerative Medica. He receives clinical or research support for the study described (includes equipment or material) from the ISSG Foundation. Dr. Klineberg is a consultant for DePuy Synthes, Stryker, and Medicrea/Medtronic. He receives honoraria and a fellowship grant from AO Spine. Dr. Shaffrey is a consultant for Medtronic, NuVasive, and SI Bone. He has direct stock ownership in NuVasive, and is a patent holder with Medtronic, NuVasive, and Zimmer Biomet. He receives royalties from Medtronic, NuVasive, and SI Bone. Dr. Ames is an employee of UCSF. He receives royalties from Stryker, DePuy Synthes, Biomet Zimmer Spine, NuVasive, Next Orthosurgical, K2M, and Medicrea. He is a consultant for DePuy Synthes, Medtronic, Medicrea, and K2M. He conducts research for Titan Spine, DePuy Synthes, and ISSG; is on the editorial board ofOperative Neurosurgery; receives grant funding from SRS; is on the executive committee for ISSG; and is a director for Global Spinal Analytics.
Author Contributions
Conception and design: Pellisé, Serra-Burriel. Acquisition of data: Pellisé, Gum, Obeid, Smith, Kleinstück, Bess, Pizones, Pérez-Grueso, Schwab, Burton, Klineberg, Shaffrey, Alanay, Ames. Analysis and interpretation of data: Pellisé, Serra-Burriel, Vila-Casademunt. Drafting the article: Pellisé, Serra-Burriel. Critically revising the article: Vila-Casademunt, Gum, Obeid, Smith, Kleinstück, Bess, Pizones, Lafage, Pérez-Grueso, Schwab, Burton, Klineberg, Shaffrey, Alanay, Ames. Reviewed submitted version of manuscript: Pellisé, Serra-Burriel. Approved the final version of the manuscript on behalf of all authors: Pellisé. Statistical analysis: Serra-Burriel. Administrative/technical/material support: Vila-Casademunt. Study supervision: Pellisé, Ames.
Supplemental Information
Previous Presentations
This work was presented online at the 55th Scoliosis Research Society (SRS) Annual Meeting (September 9–13, 2020); at the 2020 Eurospine Annual Meeting (October 6–9, 2020); and at the 34th Spanish Spine Society (GEER) Annual Meeting (December 10–12, 2020).
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