Renoprotective Effects of Metabolic Surgery Versus GLP1 Receptor Agonists on Progression of Kidney Impairment in Patients with Established Kidney Disease.

OBJECTIVE: To examine the renoprotective effects of metabolic surgery in patients with established chronic kidney disease (CKD). BACKGROUND: The impact of metabolic surgery compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) in patients with established CKD has not been fully characterized. METHODS: Patients with obesity (BMI ≥30 kg/m2), type 2 diabetes (T2DM), and baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m² who underwent metabolic bariatric surgery at a large U.S. health system (2010-2017) were compared with nonsurgical patients who continuously received GLP-1RA. The primary end point was CKD progression, defined as decline of eGFR by ≥50% or to <15 mL/min/1.73 m2, initiation of dialysis, or kidney transplant. The secondary end point was the incident kidney failure (eGFR <15 mL/min/1.73 m2, dialysis, or kidney transplant) or all-cause mortality. RESULTS: 425 patients, including 183 patients in the metabolic surgery group and 242 patients in the GLP-1RA group, with a median follow-up of 5.8 years (IQR, 4.4-7.6) were analyzed. The cumulative incidence of the primary end point at 8-years was 21.7% (95% CI, 12.2-30.6) in the surgical group and 45.1% (95% CI, 27.7-58.4) in the nonsurgical group, with an adjusted hazard ratio of 0.40 (95% CI, 0.21-0.76), P=0.006. The cumulative incidence of the secondary composite end point at 8-years was 24.0% (95% CI, 14.1-33.2) in the surgical group and 43.8% (95% CI, 28.1-56.1) in the nonsurgical group, with an adjusted HR of 0.56 (95% CI, 0.31-0.99), P=0.048. CONCLUSIONS: Among patients with T2DM, obesity, and established CKD, metabolic surgery, compared with GLP-1RA, was significantly associated with a 60% lower risk of progression of kidney impairment and a 44% lower risk of kidney failure or death. Metabolic surgery should be considered as a therapeutic option for patients with CKD and obesity.

Associations of preoperative patient mental health status and sociodemographic and clinical characteristics with baseline pain, function, and satisfaction in patients undergoing primary shoulder arthroplasty.

HYPOTHESIS AND BACKGROUND: Shoulder pain and dysfunction are common indications for shoulder arthroplasty, yet the factors that are associated with these symptoms are not fully understood. This study aimed to investigate the associations of patient and disease-specific factors with preoperative patient-reported outcome measures (PROMs) in patients undergoing primary shoulder arthroplasty. We hypothesized that worse mental health status assessed by the Veterans RAND 12-Item Health Survey (VR-12) mental component score (MCS), glenoid bone loss, and increasing rotator cuff tear severity would be associated with lower values for the preoperative total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscores. METHODS: We prospectively identified 12 patient factors and 4 disease-specific factors as possible statistical predictors of preoperative PROMs in patients undergoing primary shoulder arthroplasty at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in the preoperative PSS and its subscores. RESULTS: A total of 788 cases performed by 12 surgeons met the inclusion criteria, with a preoperative median total PSS of 31 points (pain, 10 points; function, 18 points; and satisfaction, 1 point). As hypothesized, a lower VR-12 MCS was associated with lower preoperative PSS pain, function, and total scores, but patients with intact status or small to medium rotator cuff tears had modestly lower PSS pain subscores (ie, more pain) than patients with large to massive superior-posterior rotator cuff tears. Glenoid bone loss was not associated with the preoperative PSS. Female sex and fewer years of education (for all 4 outcomes), lower VR-12 MCS and preoperative opioid use (for all outcomes but satisfaction), and rotator cuff tear severity (for pain only) were the factors most prominently associated with preoperative PROMs. CONCLUSION: In addition to mental health status and rotator cuff tear status, patient sex, years of education, and preoperative opioid use were most prominently associated with preoperative PROMs in patients undergoing shoulder arthroplasty. Further studies are needed to investigate whether these factors will also predict postoperative PROMs.

The Potential Effects of Imposing a Body Mass Index Threshold on Patient-Reported Outcomes After Total Knee Arthroplasty.

BACKGROUND: Operative eligibility thresholds based on body mass index (BMI) alone may risk restricting access to improved pain control, function, and quality of life. This study evaluated the use of BMI-cutoffs to offering TKA in avoiding: 1) 90-day readmission, 2) one-year mortality, and 3) failure to achieve clinically important one-year PROMS improvement (MCID). METHODS: A total of 4126 primary elective unilateral TKA patients from 2015 to 2018 were prospectively collected. For specific BMI(kg/m2) cutoffs: 30, 35, 40, 45, and 50, the positive predictive value (PPV) for 90-day readmission, one-year mortality, and failure to achieve one-year MCID were calculated. The number of patients denied complication-free postoperative courses per averted adverse outcome/failed improvement was estimated. RESULTS: Rates of 90-day readmission and one-year mortality were similar across BMI categories (P > .05, each). PPVs for preventing 90-day readmission and one-year mortality were low across all models of BMI cutoffs. The highest PPV for 90-day readmission and one-year mortality was detected at cutoffs of 45 (6.4%) and 40 (0.87%), respectively. BMI cutoff of 40 would deny 18 patients 90-day readmission-free, and 194 patients one-year mortality-free postoperative courses for each averted 90-day readmission/one-year mortality. Such cutoff would also deny 11 patients an MCID per avoided failure. Implementing BMI thresholds alone did not influence the rate of improvements in KOOS-PS, KRQOL, or VR-12. CONCLUSION: Utilizing BMI cutoffs as the sole determinants of TKA ineligibility may deny patients complication-free postoperative courses and clinically important improvements. Shared decision-making supported by predictive tools may aid in balancing the potential benefit TKA offers to obese patients with the potentially increased complication risk and cost of care provision.

How Much Weight Loss is Required for Cardiovascular Benefits? Insights From a Metabolic Surgery Matched-cohort Study.

OBJECTIVE: The aim of this study was to determine the minimum amount of weight loss required to see a reduction in major adverse cardiovascular events (MACE). BACKGROUND: Although obesity is an established risk factor for morbidity and mortality, the minimum amount of weight loss to have a meaningful impact on cardiovascular health and survival is unknown. METHODS: Patients with obesity (body mass index ≥30 kg/m) and type 2 diabetes who underwent metabolic surgery in an academic center (1998-2017) were propensity-matched 1:5 to nonsurgical patients who received usual care. The adjusted linear and nonlinear effects of weight loss (achieved in the first 18 months after the index date) were studied to identify cut-offs for the minimum weight loss to achieve decreased risk of all-cause mortality and MACE (composite of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation). RESULTS: A total of 7201 patients (1223 surgical and 5978 nonsurgical) with a median follow-up time of 4.9 years (interquartile range, 3.5-7) were included. The positive effect of metabolic surgery was still present after adjusting for weight loss amounts, suggesting that there are weight loss-independent factors contributing to a reduction in risk of MACE and all-cause mortality in the surgical cohort. After considering the weighted estimates from a diverse set of models, the risk of MACE decreases after approximately 10% of weight is lost in the surgical group and approximately 20% in the nonsurgical group. For all-cause mortality, the threshold for benefit appeared to be approximately 5% weight loss after metabolic surgery and 20% in the nonsurgical group. CONCLUSIONS: This large matched-cohort study identified the minimum weight loss thresholds for reduction in risk of MACE and all-cause mortality in patients with obesity and diabetes. Furthermore, in our analysis, the effect of surgery was still present after accounting for weight loss, which may suggest the presence of weight-independent beneficial effects of metabolic surgery on MACE and survival.

Outcomes of resections that spare vs remove an MRI-normal hippocampus.

OBJECTIVE: To characterize seizure and cognitive outcomes of sparing vs removing an magnetic resonance imaging (MRI)-normal hippocampus in patients with temporal lobe epilepsy. METHODS: In this retrospective cohort study, we reviewed clinical, imaging, surgical, and histopathological data on 152 individuals with temporal lobe epilepsy and nonlesional hippocampi categorized into hippocampus-spared (n = 74) or hippocampus-resected (n = 78). Extra-hippocampal lesions were allowed. Pre- and postoperative cognitive data were available on 86 patients. Predictors of seizure and cognitive outcomes were identified using Cox-proportional hazard modeling followed by treatment-specific model reduction according to Akaike information criterion, and built into an online risk calculator. RESULTS: Seizures recurred in 40% within one postoperative year, and in 63% within six postoperative years. Male gender (P = .03), longer epilepsy duration (P < .01), normal MRI (P = .04), invasive evaluation (P = .02), and acute postoperative seizures (P < .01) were associated with a higher risk of recurrence. We found no significant difference in postoperative seizure freedom rates at 5 years between those whose hippocampus was spared and those whose hippocampus was resected (P = .17). Seizure outcome models built with pre- and postoperative data had bootstrap validated concordance indices of 0.65 and 0.72. The dominant hippocampus-spared group had lower rates of decline in verbal memory (39% vs 70%; P = .03) and naming (41% vs 79%; P = .01) compared to the hippocampus-resected group. Partial hippocampus sparing had the same risk of verbal memory decline as for complete removal. SIGNIFICANCE: Sparing or removing an MRI-normal hippocampus yielded similar long-term seizure outcome. A more conservative approach, sparing the hippocampus, only partially shields patients from postoperative cognitive deficits. Risk calculators are provided to facilitate clinical counseling.

Tear characteristics and surgeon influence repair technique and suture anchor use in repair of superior-posterior rotator cuff tendon tears.

BACKGROUND: The factors that associate with surgical decisions about repair technique and the number of suture anchors used in rotator cuff repair have not been previously investigated. This study investigated the extent to which patient, surgeon, and surgical factors associate with performing single-row vs. double-row repair technique and ultimately with the number of suture anchors used. METHODS: Our institution's prospective surgical cohort was queried for patients undergoing suture anchor repair of superior-posterior rotator cuff tendon tears between February 2015 and August 2017. Exclusion criteria were patients with isolated subscapularis tears, tears that were not repaired, repairs without suture anchors, repairs involving graft augmentation, and repairs by surgeons with fewer than 10 cases. Multivariable statistical modeling was used to investigate associations between patient and surgical factors and the choice of repair technique and number of suture anchors used. RESULTS: A total of 925 cases performed by 13 surgeons met inclusion criteria. Tear type (full thickness), tear size (medium, large, and massive), a greater number of torn tendons, repair type (arthroscopic), and surgeon were significantly associated with performing a double-row over a single-row repair. Tear size, a greater number of torn tendons, double-row repair technique, and surgeon were significantly associated with a greater number of anchors used for repair. CONCLUSIONS: Our findings suggest that in the absence of data to conclusively support a clinical benefit of one repair technique over another, surgeons' training, experience, and inherent practice patterns become the primary factors that define their surgical methods.

Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity.

IMPORTANCE: Although metabolic surgery (defined as procedures that influence metabolism by inducing weight loss and altering gastrointestinal physiology) significantly improves cardiometabolic risk factors, the effect on cardiovascular outcomes has been less well characterized. OBJECTIVE: To investigate the relationship between metabolic surgery and incident major adverse cardiovascular events (MACE) in patients with type 2 diabetes and obesity. DESIGN, SETTING, AND PARTICIPANTS: Of 287 438 adult patients with diabetes in the Cleveland Clinic Health System in the United States between 1998 and 2017, 2287 patients underwent metabolic surgery. In this retrospective cohort study, these patients were matched 1:5 to nonsurgical patients with diabetes and obesity (body mass index [BMI] ≥30), resulting in 11 435 control patients, with follow-up through December 2018. EXPOSURES: Metabolic gastrointestinal surgical procedures vs usual care for type 2 diabetes and obesity. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of extended MACE (composite of 6 outcomes), defined as first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation. Secondary end points included 3-component MACE (myocardial infarction, ischemic stroke, and mortality) and the 6 individual components of the primary end point. RESULTS: Among the 13 722 study participants, the distribution of baseline covariates was balanced between the surgical group and the nonsurgical group, including female sex (65.5% vs 64.2%), median age (52.5 vs 54.8 years), BMI (45.1 vs 42.6), and glycated hemoglobin level (7.1% vs 7.1%). The overall median follow-up duration was 3.9 years (interquartile range, 1.9-6.1 years). At the end of the study period, 385 patients in the surgical group and 3243 patients in the nonsurgical group experienced a primary end point (cumulative incidence at 8-years, 30.8% [95% CI, 27.6%-34.0%] in the surgical group and 47.7% [95% CI, 46.1%-49.2%] in the nonsurgical group [P < .001]; absolute 8-year risk difference [ARD], 16.9% [95% CI, 13.1%-20.4%]; adjusted hazard ratio [HR], 0.61 [95% CI, 0.55-0.69]). All 7 prespecified secondary outcomes showed statistically significant differences in favor of metabolic surgery, including mortality. All-cause mortality occurred in 112 patients in the metabolic surgery group and 1111 patients in the nonsurgical group (cumulative incidence at 8 years, 10.0% [95% CI, 7.8%-12.2%] and 17.8% [95% CI, 16.6%-19.0%]; ARD, 7.8% [95% CI, 5.1%-10.2%]; adjusted HR, 0.59 [95% CI, 0.48-0.72]). CONCLUSIONS AND RELEVANCE: Among patients with type 2 diabetes and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE. The findings from this observational study must be confirmed in randomized clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03955952.

Obesity-associated sleep hypoventilation and increased adverse postoperative bariatric surgery outcomes in a large clinical retrospective cohort.

STUDY OBJECTIVES: Although obesity hypoventilation syndrome (OHS) is associated with increased morbidity and mortality, post-bariatric surgery OHS risk remains unclear due to often nonsystematic OHS assessments. METHODS: We leverage a clinical cohort with nocturnal CO2 monitoring during polysomnography to address the hypothesis that patients with obesity-associated sleep hypoventilation (OaSH; ie, stage II OHS) have increased adverse postoperative bariatric surgery outcomes. We retrospectively analyzed data from patients undergoing pre-bariatric surgery polysomnography at the Cleveland Clinic from 2011-2018. OaSH was defined by body mass index ≥ 30 kg/m2 and either polysomnography-based end-tidal CO2 ≥ 45 mmHg or serum bicarbonate ≥ 27 mEq/L. Outcomes considered were as follows: intensive care unit stay, intubation, tracheostomy, discharge disposition other than home or 30-day readmission individually and as a composite, and all-cause mortality. Two-sample t test or Wilcoxon rank-sum test for continuous variables and chi-square or Fisher's exact test for categorical variables were used for OaSH vs non-OaSH comparisons. All-cause mortality was compared using Kaplan-Meier estimation and Cox proportional hazards models. RESULTS: The analytic sample (n = 1,665) was aged 45.2 ± 12 years, 20.4% were male, had a body mass index of 48.7 ± 9 kg/m2, and 63.6% were White. OaSH prevalence was 68.5%. OaSH patients were older and more likely to be male with a higher BMI, apnea-hypopnea index, and glycated hemoglobin. The composite outcome was higher in OaSH vs non-OaSH patients (18.9% vs 14.3%, P = .021). Although some individual outcomes were respectively higher in OaSH vs non-OaSH patients, differences were not statistically significant: intubation (1.5% vs 1.3%, P = .81) and 30-day readmission (13.8% vs 11.3%, P = .16). Long-term mortality (median follow-up: 22.9 months) was not significantly different between groups, likely due to overall low event rate (hazard ratio = 1.39, 95% confidence interval: 0.56, 3.42). CONCLUSIONS: In this largest sample to date of systematically phenotyped OaSH in a bariatric surgery cohort, we identify increased postoperative morbidity in those with sleep-related hypoventilation in stage II OHS when a composite outcome was considered, but individual contributors of intubation, intensive care unit admission, and hospital length of stay were not increased. Further study is needed to identify whether perioperative treatment of OaSH improves post-bariatric surgery outcomes. CITATION: Chindamporn P, Wang L, Bena J, et al. Obesity-associated sleep hypoventilation and increased adverse postoperative bariatric surgery outcomes in a large clinical retrospective cohort. J Clin Sleep Med. 2022;18(12):2793-2801.

Effect of Baseline Mental Health on 1-Year Outcomes After Hip Arthroscopy: A Prospective Cohort Study.

BACKGROUND: Patient factors, including mental health, sex, and smoking, have been found to be more predictive of preoperative hip pain and function than intra-articular findings during hip arthroscopy for femoroacetabular impingement (FAI); however, little is known about how these factors may influence patients' postoperative outcomes. HYPOTHESIS: We hypothesized that lower patient-reported mental health scores would be significant risk factors for worse patient-reported outcomes (PROs) 1 year after arthroscopic hip surgery for FAI and that baseline intra-articular pathology would fail to demonstrate an association with outcomes 1 year after FAI surgery. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: A prospective cohort of patients undergoing hip arthroscopy for FAI were electronically enrolled. Baseline and 1-year follow-up PROs were collected, including Hip disability and Osteoarthritis Outcome Score for pain (HOOS-Pain), HOOS-Physical Function Short Form (HOOS-PS), and Veterans RAND 12-Item Health Survey-Mental Component Score (VR-12 MCS). Intra-articular operative findings and treatment were documented at the time of surgery. Proportional odds logistic regression models were built for 1-year outcomes (HOOS-Pain, HOOS-PS, and VR-12 MCS). Risk factors included patient characteristics and intraoperative anatomic and pathologic findings. RESULTS: Overall, 494 patients underwent hip arthroscopy for FAI, and 385 (78%) were evaluated at 1 year with at least 1 PRO. The median patient age was 33 years, mean body mass index was 25.5 kg/m2, and 72% were female. Multivariable analysis demonstrated that better baseline HOOS-Pain, HOOS-PS, and VR-12 MCS were significantly associated with improvement in the 1-year scores for each PRO. Higher VR-12 MCS was significantly associated with better 1-year HOOS-Pain and HOOS-PS, while current and former smokers had worse 1-year outcomes than those who never smoked. In ranking each variable's relative importance, baseline HOOS-Pain and HOOS-PS and baseline VR-12 MCS were identified as the strongest predictors of 1-year HOOS-Pain and HOOS-PS in our multivariable model. CONCLUSION: During hip arthroscopy for FAI, patient factors, including baseline hip pain and function, mental health, and smoking, were independently associated with 1-year PROs of hip pain and function, while intra-articular pathology such as the presence of labral tear and its treatment, tear size, tear location, and anchors placed were not independently associated.

Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Gastric Bypass, Sleeve Gastrectomy, and Usual Care.

OBJECTIVE: To determine which one of the two most common metabolic surgical procedures is associated with greater reduction in risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM) and obesity. RESEARCH DESIGN AND METHODS: A total of 13,490 patients including 1,362 Roux-en-Y gastric bypass (RYGB), 693 sleeve gastrectomy (SG), and 11,435 matched nonsurgical patients with T2DM and obesity who received their care at the Cleveland Clinic (1998-2017) were analyzed, with follow-up through December 2018. With multivariable Cox regression analysis we estimated time to incident extended MACE, defined as first occurrence of coronary artery events, cerebrovascular events, heart failure, nephropathy, atrial fibrillation, and all-cause mortality. RESULTS: The cumulative incidence of the primary end point at 5 years was 13.7% (95% CI 11.4-15.9) in the RYGB groups and 24.7% (95% CI 19.0-30.0) in the SG group, with an adjusted hazard ratio (HR) of 0.77 (95% CI 0.60-0.98, P = 0.04). Of the six individual end points, RYGB was associated with a significantly lower cumulative incidence of nephropathy at 5 years compared with SG (2.8% vs. 8.3%, respectively; HR 0.47 [95% CI 0.28-0.79], P = 0.005). Furthermore, RYGB was associated with a greater reduction in body weight, glycated hemoglobin, and use of medications to treat diabetes and cardiovascular diseases. Five years after RYGB, patients required more upper endoscopy (45.8% vs. 35.6%, P < 0.001) and abdominal surgical procedures (10.8% vs. 5.4%, P = 0.001) compared with SG. CONCLUSIONS: In patients with obesity and T2DM, RYGB may be associated with greater weight loss, better diabetes control, and lower risk of MACE and nephropathy compared with SG.

Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success?

BACKGROUND: When meniscal repair is performed during anterior cruciate ligament (ACL) reconstruction (ACLR), the effect of ACL graft type on meniscal repair outcomes is unclear. HYPOTHESIS: The authors hypothesized that meniscal repairs would fail at the lowest rate when concomitant ACLR was performed with bone--patellar tendon--bone (BTB) autograft. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Patients who underwent meniscal repair at primary ACLR were identified from a longitudinal, prospective cohort. Meniscal repair failures, defined as any subsequent surgical procedure addressing the meniscus, were identified. A logistic regression model was built to assess the association of graft type, patient-specific factors, baseline Marx activity rating score, and meniscal repair location (medial or lateral) with repair failure at 6-year follow-up. RESULTS: A total of 646 patients were included. Grafts used included BTB autograft (55.7%), soft tissue autograft (33.9%), and various allografts (10.4%). We identified 101 patients (15.6%) with a documented meniscal repair failure. Failure occurred in 74 of 420 (17.6%) isolated medial meniscal repairs, 15 of 187 (8%) isolated lateral meniscal repairs, and 12 of 39 (30.7%) of combined medial and lateral meniscal repairs. Meniscal repair failure occurred in 13.9% of patients with BTB autografts, 17.4% of patients with soft tissue autografts, and 19.4% of patients with allografts. The odds of failure within 6 years of index surgery were increased more than 2-fold with allograft versus BTB autograft (odds ratio = 2.34 [95% confidence interval, 1.12-4.92]; P = .02). There was a trend toward increased meniscal repair failures with soft tissue versus BTB autografts (odds ratio = 1.41 [95% confidence interval, 0.87-2.30]; P = .17). The odds of failure were 68% higher with medial versus lateral repairs (P < .001). There was a significant relationship between baseline Marx activity level and the risk of subsequent meniscal repair failure; patients with either very low (0-1 points) or very high (15-16 points) baseline activity levels were at the highest risk (P = .004). CONCLUSION: Meniscal repair location (medial vs lateral) and baseline activity level were the main drivers of meniscal repair outcomes. Graft type was ranked third, demonstrating that meniscal repairs performed with allograft were 2.3 times more likely to fail compared with BTB autograft. There was no significant difference in failure rates between BTB versus soft tissue autografts. REGISTRATION: NCT00463099 (ClinicalTrials.gov identifier).

Developing a personalized outcome prediction tool for knee arthroplasty.

AIMS: The purpose of this study was to develop a personalized outcome prediction tool, to be used with knee arthroplasty patients, that predicts outcomes (lengths of stay (LOS), 90 day readmission, and one-year patient-reported outcome measures (PROMs) on an individual basis and allows for dynamic modifiable risk factors. METHODS: Data were prospectively collected on all patients who underwent total or unicompartmental knee arthroplasty at a between July 2015 and June 2018. Cohort 1 (n = 5,958) was utilized to develop models for LOS and 90 day readmission. Cohort 2 (n = 2,391, surgery date 2015 to 2017) was utilized to develop models for one-year improvements in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score, KOOS function score, and KOOS quality of life (QOL) score. Model accuracies within the imputed data set were assessed through cross-validation with root mean square errors (RMSEs) and mean absolute errors (MAEs) for the LOS and PROMs models, and the index of prediction accuracy (IPA), and area under the curve (AUC) for the readmission models. Model accuracies in new patient data sets were assessed with AUC. RESULTS: Within the imputed datasets, the LOS (RMSE 1.161) and PROMs models (RMSE 15.775, 11.056, 21.680 for KOOS pain, function, and QOL, respectively) demonstrated good accuracy. For all models, the accuracy of predicting outcomes in a new set of patients were consistent with the cross-validation accuracy overall. Upon validation with a new patient dataset, the LOS and readmission models demonstrated high accuracy (71.5% and 65.0%, respectively). Similarly, the one-year PROMs improvement models demonstrated high accuracy in predicting ten-point improvements in KOOS pain (72.1%), function (72.9%), and QOL (70.8%) scores. CONCLUSION: The data-driven models developed in this study offer scalable predictive tools that can accurately estimate the likelihood of improved pain, function, and quality of life one year after knee arthroplasty as well as LOS and 90 day readmission. Cite this article: Bone Joint J 2020;102-B(9):1183-1193.

Predicting 10-Year Risk of End-Organ Complications of Type 2 Diabetes With and Without Metabolic Surgery: A Machine Learning Approach.

OBJECTIVE: To construct and internally validate prediction models to estimate the risk of long-term end-organ complications and mortality in patients with type 2 diabetes and obesity that can be used to inform treatment decisions for patients and practitioners who are considering metabolic surgery. RESEARCH DESIGN AND METHODS: A total of 2,287 patients with type 2 diabetes who underwent metabolic surgery between 1998 and 2017 in the Cleveland Clinic Health System were propensity-matched 1:5 to 11,435 nonsurgical patients with BMI ≥30 kg/m2 and type 2 diabetes who received usual care with follow-up through December 2018. Multivariable time-to-event regression and random forest machine learning models were built and internally validated using fivefold cross-validation to predict the 10-year risk for four outcomes of interest. The prediction models were programmed to construct user-friendly web-based and smartphone applications of Individualized Diabetes Complications (IDC) Risk Scores for clinical use. RESULTS: The prediction tools demonstrated the following discrimination ability based on the area under the receiver operating characteristic curve (1 = perfect discrimination and 0.5 = chance) at 10 years in the surgical and nonsurgical groups, respectively: all-cause mortality (0.79 and 0.81), coronary artery events (0.66 and 0.67), heart failure (0.73 and 0.75), and nephropathy (0.73 and 0.76). When a patient's data are entered into the IDC application, it estimates the individualized 10-year morbidity and mortality risks with and without undergoing metabolic surgery. CONCLUSIONS: The IDC Risk Scores can provide personalized evidence-based risk information for patients with type 2 diabetes and obesity about future cardiovascular outcomes and mortality with and without metabolic surgery based on their current status of obesity, diabetes, and related cardiometabolic conditions.

Incidence and Predictors of Subsequent Surgery After Anterior Cruciate Ligament Reconstruction: A 6-Year Follow-up Study.

BACKGROUND: The cause of subsequent surgery after anterior cruciate ligament (ACL) reconstruction varies, but if risk factors for specific subsequent surgical procedures can be identified, we can better understand which patients are at greatest risk. PURPOSE: To report the incidence and types of subsequent surgery that occurred in a cohort of patients 6 years after their index ACL reconstruction and to identify which variables were associated with the incidence of patients undergoing subsequent surgery after their index ACL reconstruction. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Patients completed a questionnaire before their index ACL surgery and were followed up at 2 and 6 years. Patients were contacted to determine whether any underwent additional surgery since baseline. Operative reports were obtained, and all surgical procedures were categorized and recorded. Logistic regression models were constructed to predict which patient demographic and surgical variables were associated with the incidence of undergoing subsequent surgery after their index ACL reconstruction. RESULTS: The cohort consisted of 3276 patients (56.3% male) with a median age of 23 years. A 6-year follow-up was obtained on 91.5% (2999/3276) with regard to information on the incidence and frequency of subsequent surgery. Overall, 20.4% (612/2999) of the cohort was documented to have undergone at least 1 subsequent surgery on the ipsilateral knee 6 years after their index ACL reconstruction. The most common subsequent surgical procedures were related to the meniscus (11.9%), revision ACL reconstruction (7.5%), loss of motion (7.8%), and articular cartilage (6.7%). Significant risk factors for incurring subsequent meniscus-related surgery were having a medial meniscal repair at the time of index surgery, reconstruction with a hamstring autograft or allograft, higher baseline Marx activity level, younger age, and cessation of smoking. Significant predictors of undergoing subsequent surgery involving articular cartilage were higher body mass index, higher Marx activity level, reconstruction with a hamstring autograft or allograft, meniscal repair at the time of index surgery, or a grade 3/4 articular cartilage abnormality classified at the time of index ACL reconstruction. Risk factors for incurring subsequent surgery for loss of motion were younger age, female sex, low baseline Knee injury and Osteoarthritis Outcome Score symptom subscore, and reconstruction with a soft tissue allograft. CONCLUSION: These findings can be used to identify patients who are at the greatest risk of incurring subsequent surgery after ACL reconstruction.

Preoperative cut-off values for body mass index deny patients clinically significant improvements in patient-reported outcomes after total hip arthroplasty.

AIMS: Thresholds for operative eligibility based on body mass index (BMI) alone may restrict patient access to the benefits of arthroplasty. The purpose of this study was to evaluate the relationship between BMI and improvements in patient-reported outcome measures (PROMs), and to determine how many patients would have been denied improvements in PROMs if BMI cut-offs were to be implemented. METHODS: A prospective cohort of 3,449 primary total hip arthroplasties (THAs) performed between 2015 and 2018 were analyzed. The following one-year PROMs were evaluated: hip injury and osteoarthritis outcome score (HOOS) pain, HOOS Physical Function Shortform (PS), University of California, Los Angeles (UCLA) activity, Veterans Rand-12 Physical Component Score (VR-12 PCS), and VR-12 Mental Component Score (VR-12 MCS). Positive predictive values for failure to improve and the number of patients denied surgery in order to avoid a failed improvement were calculated for each PROM at different BMI cut-offs. RESULTS: There was a trend to improved outcomes in terms of pain and function improvements with higher BMI. Patients with BMI ≥ 40 kg/m2 had median (Q1, Q3) HOOS pain improvements of 58 points (interquartile range (IQR) 41 to 70) and those with BMI 35 to 40 kg/m2 had median improvements of 55 (IQR 40 to 68). With a BMI cut-off of 30 kg/m2, 21 patients would have been denied a meaningful improvement in HOOS pain score in order to avoid one failed improvement. At a 35 kg/m2 cut-off, 18 patients would be denied improvement, at a 40 kg/m2 cut-off 21 patients would be denied improvement, and at a 45 kg/m2 cut-off 21 patients would be denied improvement. Similar findings were observed for HOOS-PS, UCLA, and VR-12 scores. CONCLUSION: Patients with higher BMIs show greater improvements in PROMs. Using BMI alone to determine eligibility criteria did not improve the rate of clinically meaningful improvements. BMI thresholds prevent patients who may benefit the most from surgery from undergoing THA. Surgeons should consider PROMs improvements in determining eligibility for THA while balancing traditional metrics of preoperative risk stratification. Cite this article: Bone Joint J 2020;102-B(6):683-692.

Anterior Cruciate Ligament Reconstruction in High School and College-Aged Athletes: Does Autograft Choice Influence Anterior Cruciate Ligament Revision Rates?

BACKGROUND: Physicians' and patients' decision-making process between bone-patellar tendon-bone (BTB) and hamstring tendon autografts for anterior cruciate ligament (ACL) reconstruction (ACLR) may be influenced by a variety of factors in the young, active athlete. PURPOSE: To determine the incidence of both ACL graft revisions and contralateral ACL tears resulting in subsequent ACLR in a cohort of high school- and college-aged athletes who initially underwent primary ACLR with either a BTB or a hamstring autograft. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Study inclusion criteria were patients aged 14 to 22 years who were injured in sports, had a contralateral normal knee, and were scheduled to undergo unilateral primary ACLR with either a BTB or a hamstring autograft. All patients were prospectively followed for 6 years to determine whether any subsequent ACLR was performed in either knee after their initial ACLR. Multivariable regression modeling controlled for age, sex, ethnicity/race, body mass index, sport and competition level, baseline activity level, knee laxity, and graft type. The 6-year outcomes were the incidence of subsequent ACLR in either knee. RESULTS: A total of 839 patients were eligible, of which 770 (92%) had 6-year follow-up for the primary outcome measure of the incidence of subsequent ACLR. The median age was 17 years, with 48% female, and the distribution of BTB and hamstring grafts was 492 (64%) and 278 (36%), respectively. The incidence of subsequent ACLR at 6 years was 9.2% in the ipsilateral knee, 11.2% in the contralateral normal knee, and 19.7% for either knee. High-grade preoperative knee laxity (odds ratio [OR], 2.4 [95% confidence interval [CI], 1.4-3.9]; P = .001), autograft type (OR, 2.1 [95% CI, 1.3-3.5]; P = .004), and age (OR, 0.8 [95% CI, 0.7-1.0]; P = .009) were the 3 most influential predictors of ACL graft revision in the ipsilateral knee. The odds of ACL graft revision were 2.1 times higher for patients receiving a hamstring autograft than patients receiving a BTB autograft (95% CI, 1.3-3.5; P = .004). No significant differences were found between autograft choices when looking at the incidence of subsequent ACLR in the contralateral knee. CONCLUSION: There was a high incidence of both ACL graft revisions and contralateral normal ACL tears resulting in subsequent ACLR in this young athletic cohort. The incidence of ACL graft revision at 6 years after index surgery was 2.1 times higher with a hamstring autograft compared with a BTB autograft.

Associations of Preoperative Patient Mental Health and Sociodemographic and Clinical Characteristics With Baseline Pain, Function, and Satisfaction in Patients Undergoing Rotator Cuff Repairs.

BACKGROUND: Shoulder pain and dysfunction are common indications for rotator cuff repair surgery, yet the factors that are associated with these symptoms are not fully understood. PURPOSE/HYPOTHESIS: This study aimed to investigate the associations of patient and disease-specific factors with baseline patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair. We hypothesized that tear size and mental health status, as assessed by the Veterans RAND 12-Item Health Survey mental component score (VR-12 MCS), would be associated with baseline total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscale scores. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: We prospectively identified 12 patient factors and 12 disease-specific factors as possible statistical predictors for baseline PROMs in patients undergoing surgical repair of superior-posterior rotator cuff tears at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in baseline PSS and its subscale scores. RESULTS: A total of 1442 patients who had undergone surgery by 23 surgeons met inclusion criteria, with a baseline median total PSS of 38.5 (pain, 12; function, 24.2; satisfaction, 2). Adjusted R2 in multivariable models demonstrated that the 24 general patient and disease-specific factors accounted for 22% to 24% of the variability in total PSS and its pain and function subscale scores. Large/massive tear size was significantly associated with worse PSS total score and function score but not pain or satisfaction scores. Lower VR-12 MCS was significantly associated with worse total PSS and all 3 subscale scores. Among other factors significantly associated with baseline PROMs were sex, race, preoperative opioid use, years of education, employment status, acromion status, and adhesive capsulitis. Lower VR-12 MCS, preoperative opioid use, female sex, and black race were the factors most strongly associated with baseline PROMs. CONCLUSION: Large/massive tear size, lower VR-12 MCS, and several additional patient and disease-specific factors are associated with baseline PROMs in patients undergoing rotator cuff repair. Further studies are needed to investigate whether these factors will also predict poor postoperative PROMs.

A competing risk nomogram to predict severe late toxicity after modern re-irradiation for squamous carcinoma of the head and neck.

PURPOSE: Severe late toxicity is common after re-irradiation for recurrent or second primary (RSP) squamous carcinoma of the head and neck. However, many patients experience complications from tumor progression before manifesting late effects. We constructed a nomogram to examine this relationship between late toxicity and competing risks. METHODS AND MATERIALS: Patients with RSP squamous carcinoma originating in a field previously irradiated to ≥40 Gy and treated with IMRT-based re-irradiation to ≥40 Gy were collected. Grade ≥3 late toxicity developing ≥90 days after re-irradiation was collected. A multivariable competing-risk model was fit to the actuarial risk of late toxicity with progression or death as the competing risk. The final bootstrap optimized model was converted into a nomogram. RESULTS: From 9 institutions, 505 patients were included. The 2-year incidence of grade ≥3 late toxicity was 16.7% (95% CI 13.2-20.2%) whereas progression or death was 64.2% (95% CI 59.7-68.8%). The median freedom from late toxicity, progression or death was 10.7, 5.5 and 3.2 months for RPA class I-III patients respectively, whereas the median OS was 44.9, 15.9 and 7.9 months, respectively. The final model included six clinical factors. Notably, dose, volume and fractionation did not significantly impact toxicity. CONCLUSIONS: After re-irradiation, the risk of progression or death is approximately four times the risk of radiation-related severe late toxicity. The risk of late toxicity may be more dependent on patient and disease factors than modifiable treatment factors. This model is useful for patient selection, pre-treatment consent and post-treatment survivorship following re-irradiation.

Neighborhood Socioeconomic Status Affects Patient-Reported Outcome 2 Years After ACL Reconstruction.

BACKGROUND: Lower socioeconomic status (SES) is associated with worse patient-reported outcome (PRO) after orthopaedic procedures. In patients with anterior cruciate ligament (ACL) reconstruction, evaluating SES by use of traditional measures such as years of education or occupation is problematic because this group has a large proportion of younger patients. We hypothesized that lower education level and lower values for SES would predict worse PRO at 2 years after ACL reconstruction and that the effect of education level would vary with patient age. PURPOSE: To compare the performance of multivariable models that use traditional measures of SES with models that use an index of neighborhood SES derived from United States (US) Census data. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A cohort of 675 patients (45% female; median age, 20 years), were prospectively enrolled and evaluated 2 years after ACL reconstruction with questionnaires including the International Knee Documentation Committee (IKDC) questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), and the Marx activity rating scale (Marx). In addition, a new variable was generated for this study, the SES index, which used geocoding performed retrospectively to identify the census tract of residence for each participant at the time of enrollment and extract neighborhood SES measures from the 2000 US Census Descriptive Statistics. Multivariable models were constructed that included traditional measures of SES as well as the SES index, and the quality of models was compared through use of the likelihood ratio test. RESULTS: Lower SES index was associated with worse PRO for all measures. Models that included the SES index explained more variability than models with traditional SES. In addition, a statistically significant variation was found regarding the impact of education on PRO based on patient age for the IKDC score, the Marx scale, and 4 of the 5 KOOS subscales. CONCLUSION: This study demonstrates that lower neighborhood SES is associated with worse PRO after ACL reconstruction and that age and education have a significant interaction in this patient population. Future studies in patients who have undergone ACL reconstruction should attempt to account for neighborhood SES when adjusting for confounding factors; further, targeting patients from areas with lower neighborhood SES with special interventions may offer an opportunity to improve their outcomes.

Predictors of Radiographic Osteoarthritis 2 to 3 Years After Anterior Cruciate Ligament Reconstruction: Data From the MOON On-site Nested Cohort.

BACKGROUND: Multiple studies have shown that patients are susceptible to posttraumatic osteoarthritis (PTOA) after an anterior cruciate ligament (ACL) injury, even with ACL reconstruction (ACLR). Prospective studies using multivariable analysis to identify risk factors for PTOA are lacking. PURPOSE/HYPOTHESIS: This study aimed to identify baseline predictors of radiographic PTOA after ACLR at an early time point. We hypothesized that meniscal injuries and cartilage lesions would be associated with worse radiographic PTOA using the Osteoarthritis Research Society International (OARSI) atlas criteria. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A total of 421 patients who underwent ACLR returned on-site for standardized posteroanterior semiflexed knee radiography at a minimum of 2 years after surgery. The mean age was 19.8 years, with 51.3% female patients. At baseline, data on demographics, graft type, meniscal status/treatment, and cartilage status were collected. OARSI atlas criteria were used to grade all knee radiographs. Multivariable ordinal regression models identified baseline predictors of radiographic OARSI grades at follow-up. RESULTS: Older age (odds ratio [OR], 1.06) and higher body mass index (OR, 1.05) were statistically significantly associated with a higher OARSI grade in the medial compartment. Patients who underwent meniscal repair and partial meniscectomy had statistically significantly higher OARSI grades in the medial compartment (meniscal repair OR, 1.92; meniscectomy OR, 2.11) and in the lateral compartment (meniscal repair OR, 1.96; meniscectomy OR, 2.97). Graft type, cartilage lesions, sex, and Marx activity rating scale score had no significant association with the OARSI grade. CONCLUSION: Older patients with a higher body mass index who have an ACL tear with a concurrent meniscal tear requiring partial meniscectomy or meniscal repair should be advised of their increased risk of developing radiographic PTOA. Alternatively, patients with an ACL tear with an articular cartilage lesion can be reassured that they are not at an increased risk of developing early radiographic knee PTOA at 2 to 3 years after ACLR.