Charlson Comorbidity Index Group Research Articles

Machine learning facilitates the prediction of long-term mortality in patients with tricuspid regurgitation

ObjectiveTricuspid regurgitation (TR) is a prevalent valve disease associated with significant morbidity and mortality. We aimed to apply machine learning (ML) to assess risk stratification in patients with ≥moderate TR.MethodsPatients...

Effectiveness and Safety of Endoscopic Submucosal Dissection for Colorectal Neoplasm in Patients with High Charlson Comorbidity Index Score: A HASID Multicenter Study.

Endoscopic submucosal dissection (ESD) is an effective method for removing early colorectal lesions. However, research on the safety and efficacy of ESD in patients with various underlying conditions remains limited. This study retrospectively examined ESD outcomes in colorectal neoplasm patients from five tertiary medical centers. The Charlson Comorbidity Index (CCI) and age-adjusted CCI (ACCI) were analyzed, and the differences in complete resection and complication rates were analyzed. The CCI, ACCI, and complication rates tended to gradually increase proportionally, and the complication resection rate increased from CCI 2 to ACCI 4 as the starting point, followed by a decreasing trend. Of these, 140 patients (9.7%) had a CCI score of 3 or higher. The high CCI group was older (70.6% vs. 64.7%, p < 0.01) and had a higher proportion of men (70.7% vs. 58.7%, p < 0.01) than the low CCI group. The high CCI group had a higher incidence of cancer than the low CCI group (77.9% vs. 65.2%, p < 0.01). The en bloc resection rate (90.0% vs. 89.3%, p = 0.79) and complete resection rate (75.7% vs. 81.2%, p = 0.12) were not significantly different between the two groups. Colorectal ESD can be safely and effectively performed in patients with various underlying medical conditions.

Association Between Regular Moderate to Vigorous Physical Activity Initiation Following COPD Diagnosis and Mortality: An Emulated Target Trial Using Nationwide Cohort Data

Moderate to vigorous physical activity (MVPA) in patients with COPD affects their overall health outcomes, including symptom relief and improved quality of life. However, the magnitude of the effect of MVPA initiation on real-world clinical outcomes has not been well investigated. How does MVPA initiation affect mortality and severe exacerbation in patients who have not engaged in MVPA prior to COPD diagnosis? This study included patients with COPD aged≥ 40 years who were not performing MVPA prior to COPD diagnosis and who had at least one health screening visit prior to and following their COPD diagnosis between January 1, 2010, and December 31, 2018. The main exposure was MVPA, defined as vigorous aerobic exercise > 20min per day on≥ 3days per week or moderate aerobic exercise > 30min per day on≥ 5days per week. The primary end point was all-cause mortality, and the secondary end point was initial severe exacerbation as the time to event following COPD diagnosis. In total, 110,097 person-trials were included (27,564 MVPA increases and 82,533 control groups). No differences were observed between the covariates following matching. The adjusted hazards ratio of all-cause mortality for the MVPA group compared with the control group was 0.84 (95%CI, 0.79-0.89). In the subgroup analysis, patients aged > 65 years, female patients, those who had never smoked, and patients with a higher Charlson Comorbidity Index score displayed a stronger effect of MVPA on reducing mortality than younger male patients, those who had ever smoked, and patients with a lower Charlson Comorbidity Index score (Pinteraction< .05). The fully adjusted hazards ratio for the risk of severe exacerbation (MVPA group vscontrol) was 0.90 (95%CI, 0.87-0.94). Initiation of MVPA can potentially reduce mortality and severe exacerbations in patients with COPD, although personalized interventions and further clinical trials are necessary.

Impact of comorbidity burden on immune-related adverse events and survival among older adults with cancer on immunotherapy.

12061 Background: Comorbidities are more prevalent among older adults and predict worse outcomes for cytotoxic chemotherapy. Immunotherapies are increasingly used to treat various cancers and have a milder but less predictable toxicity profile. This study aimed to evaluate the association of comorbidity burden with immune-related adverse events (irAEs) and survival among older adults treated with these immunotherapies for any cancer type. Methods: We created a retrospective registry of consecutive patients ≥ 70 years old treated with one or more doses of an immune checkpoint inhibitor for any cancer indication between 2/1/2011- 4/7/2022 at our comprehensive cancer center. Treatment outcomes, including treatment-emergent adverse events, were captured via chart review. The comorbidity burden at the time of immunotherapy initiation was captured by chart abstraction and classified using the Charlson Comorbidity Index (CCI). We compared patients with high CCI scores (≥ 4) to patients with low CCI scores (CCI &lt;4) on the outcome of any irAE yes/no, using chi-square tests. We used the Kaplan-Meier method to compare progression-free survival (PFS) and overall survival (OS) between the two CCI groups. Survival analyses were calculated from the first dose of immunotherapy to death, last follow-up, or disease progression. A two-sided alpha of 0.05 was used for analyses. The study had institutional IRB approval. Results: Our cohort consisted of 1,216 patients (median age 76 years [interquartile range 73 to 80]), of which 217 (18%) had a high CCI score. The most common comorbidities were chronic obstructive lung disease (45%), coronary artery disease (29%), and diabetes (29%). The most common cancer type was lung cancer (46%), followed by melanoma (15%). Patients with a high CCI score had a shorter median overall survival than patients with a low CCI (11.2 vs. 13.8 months, respectively, p = 0.049). However, there was no significant difference in PFS between the high and low CCI groups (median PFS 27.1 vs. 25.0 months, p=0.32). There was no association between the CCI group and the incidence of any-grade irAEs (39% vs. 40%, p = 0.82). There was also no association between CCI group and high-grade (grade ≥3) irAEs (17% vs. 15%, p = 0.35). We did not find any associations between any individual CCI comorbid condition and risk of irAE.1 Conclusions: A high comorbidity burden, as measured by the CCI, was not associated with increased immunotherapy toxicity or shorter PFS among older adults. The presence of comorbidities was associated with shorter OS. These data can support informed decision-making for older adults with comorbidity considering immunotherapy. Reference: 1. Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91(1):8-35. doi: 10.1159/000521288. Epub 2022 Jan 6. PMID: 34991091.

The Charlson comorbidity index and short-term readmission in patients with heart failure: A retrospective cohort study.

The relationship between the Charlson comorbidity index (CCI) and short-term readmission is as yet unknown. Therefore, we aimed to investigate whether the CCI was independently related to short-term readmission in patients with heart failure (HF) after adjusting for other covariates. From December 2016 to June 2019, 2008 patients who underwent HF were enrolled in the study to determine the relationship between CCI and short-term readmission. Patients with HF were divided into 2 categories based on the predefined CCI (low < 3 and high > =3). The relationships between CCI and short-term readmission were analyzed in multivariable logistic regression models and a 2-piece linear regression model. In the high CCI group, the risk of short-term readmission was higher than that in the low CCI group. A curvilinear association was found between CCI and short-term readmission, with a saturation effect predicted at 2.97. In patients with HF who had CCI scores above 2.97, the risk of short-term readmission increased significantly (OR, 2.66; 95% confidence interval, 1.566-4.537). A high CCI was associated with increased short-term readmission in patients with HF, indicating that the CCI could be useful in estimating the readmission rate and has significant predictive value for clinical outcomes in patients with HF.

Dose Intensity and Reasons for Dose Alterations in Patients Excluded from Frontline Diffuse Large B-Cell Lymphoma Clinical Trials Based on Eligibility Criteria: A Mayo Clinic Cohort Study

Background: Frontline clinical trials in DLBCL can exclude up to 24% of the real-world population based on 5 lab-based eligibility criteria (Khurana et al. JCO 2021). Furthermore, these patients have worse clinical outcomes and increased deaths due to lymphoma progression suggesting, that the patients that could benefit the most from novel therapies in clinical trials are left behind. However, the details of chemotherapy dose intensity and its contribution to poor outcomes remain unknown. We sought to evaluate the chemotherapy dose intensity and reasons for dose alterations in these clinical trial ineligible patients and to identify a subset of these patients that can potentially be rescued back into the trials. Methods: Patients with newly diagnosed lymphoma were enrolled from 2002 to 2015 in the Molecular Epidemiology Resource (MER) of the University of Iowa and Mayo Clinic Lymphoma SPORE and prospectively followed. Clinical data, treatment, and outcomes were abstracted from medical records using a standard protocol. Eligible patients had DLBCL, initiated frontline immunochemotherapy (IC), and were ineligible for the ENGINE trial (an ongoing phase III multicenter trial - most restrictive per our prior analysis) based on ENGINE trial's lab criteria. Average relative dose intensity (ADI) was calculated for doxorubicin and cyclophosphamide based on both the actual dose and time to deliver the doses (Bataillard et al. Blood Advances 2021). To identify patients that could be rescued back into trials we divided the patients into 4 categories (Table 1) based on disease risk and Charlson comorbidity index (CCI). High-risk disease was defined as IPI >2 and/or diagnosis to treatment interval (DTI) < 14 days; high-risk comorbidity score was CCI > 2. Baseline patient characteristics and chemotherapy details including reasons for dose alterations were compared between groups. Results: Of the 1265 IC treated DLBCL patients in MER, 305 (24%) patients were deemed ineligible for the ENGINE trial based on 5 lab criteria. Ineligible patients were significantly older (median 68 vs. 61 yrs), with worse performance status (PS >2, 29.8 vs. 12.6%), had elevated LDH (70 vs 52%), high-risk IPI (57 vs. 32%), shorter DTI (median 13 vs. 16 days), and more B-symptoms (43 vs 23%). Of the 305, 144 (47%) patients were treated at Mayo and had complete details on chemo dosing. The baseline characteristics of this cohort and different subgroups are shown in table 1. Over 95% of patients were planned for 6 or more chemo cycles but only 73% completed planned cycles. 56% of patients were admitted to the hospital for cycle 1. The most common reasons for inpatient chemo delivery were symptomatic disease (35%), and lab derangements other than tumor lysis or cytopenia requiring intervention (21%). 19% (28/144) of patients had planned reduction in cycle 1 for both doxorubicin and cyclophosphamide with the most common reasons of older age and comorbidities (57%). Hospitalization/ER visits occurred in 38% (55/144) of the patients after cycle 1, with 22% (32/144) febrile neutropenia. 51% of patients had 1 or more chemo cycles delayed with the most common reason of febrile neutropenia (24%), followed by count recovery (10%). The median age was greater for patients with high CCI compared to low CCI for both high risk (77 vs 57) and low risk (78 vs. 50) disease groups. Patients with high-risk disease more commonly required inpatient admission for cycle 1 and pre-chemo steroids and rituximab optimization. All patients maintained >60% ADI in the low CCI groups (range 60-100%) compared to high CCI (range 20-100%). Clinical outcomes (overall survival) in the high-risk disease and low CCI group were significantly better than high-risk disease and high CCI (Figure 1). Conclusions: Patients who were ineligible for clinical trials based on lab-based criteria had disproportionately more high-risk disease features. Patients with high-risk disease more commonly required pre-chemo steroids and rituximab optimization. While small numbers and unbalanced subgroups limit interpretation, low CCI patients despite high- risk disease were able to maintain ADI and attempts should be made to include these patients in clinical trials. High CCI and high-risk disease subgroup had the worst outcomes and most dose alterations suggesting an unmet need with alternative less toxic treatment strategies and comorbidity management. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Predictors of 30-Day Re-hospitalization After Total Hip and Total Knee Arthroplasty: A Orthopedic Ward Perspective

Objective: The study was aimed to elucidate risk factors identifiable from ward-derived data of thirty-day re-hospitalization among patients undergoing total hip and total knee arthroplasty.&#x0D; Methods: The study was designed as a cross-sectional and prospective study. The data of the study were collected through the Patient Sociodemographic Form, the Nurse Physical Assessment and Observation Form, the Charlson Comorbidity Index (CCI), and the Katz Activities of Daily Living (ADL) Scale.&#x0D; Results: Patients were scored using this CCI system and grouped as high (high CCI group &gt;2, n = 49) and low CCI (low CCI group ≤2, n = 78) with a cut-off score of 2. The 30-day re-hospitalization rate was 14.2%, and the most common reason for re-hospitalization was a surgical infection.&#x0D; Surgical risk, Activities of daily living dependency, and comorbidities index scores of the patients were not significantly additive effects on rehospitalization (p&gt; 0.05). The results indicate that surgical infection was often the cause of higher rates of re-hospitalization among patients with total knee and total hip arthroplasty.&#x0D; Conclusions: Conclusions: Orthopedic nurses should close observation of surgical site infection and design an effective discharge following-up order to the prevention of re-hospitalization in patients with“high risk”.

Relationship between psoas muscle index and long-term survival in older patients aged ≥ 80years after endoscopic submucosal dissection for gastric cancer.

In Japan, endoscopic submucosal dissection (ESD) has been widely performed for ESD-adapted gastric cancer, but little is known about the prognostic factors after ESD for gastric cancer in older patients. The psoas muscle index (PMI) is an indicator of sarcopenia calculated from computed tomography images and reportedly related to the prognosis of some diseases. This study aimed to explore factors related to long-term survival after ESD for gastric cancer in patients aged ≥ 80years. We retrospectively reviewed 88 patients (63 men, 25 women) with early gastric cancer who underwent ESD at ≥ 80years. Possible factors related to death after gastric ESD were analyzed by univariate and multivariate analyses using a Cox proportional hazards model. The estimated overall survival (OS) was compared between the groups stratified by significant factors. The 5-year OS rate was 73.9% (median follow-up period, 5.4years). In the multivariate analysis, a low PMI (< 6.36 in men, < 3.92 in women) (hazard ratio [HR] 2.89, 95% confidence interval [CI] 1.11-7.54) and high Charlson comorbidity index (CCI) (≥ 3) (HR 1.87, 95% CI 1.14-3.09) were independently related to death after ESD. The 5-year OS rates were significantly higher in the high PMI group (82.3% vs. 70.7%, P = 0.026) and the low CCI group (76.0% vs. 37.9%, P = 0.002). In addition to low CCI, high PMI is a predictor of long-term survival after ESD for gastric cancer in patients aged ≥ 80years.

The Charlson Comorbidity Index is associated with risk of 30-day mortality in patients with myocardial injury after non-cardiac surgery

Myocardial injury after non-cardiac surgery (MINS) is a well-known and relevant indicator of early postoperative mortality, but factors related to increased mortality in MINS patients are as yet unknown. The Charlson Comorbidity Index (CCI) is widely used to classify various comorbid conditions and underlying diseases. Our study aimed to determine the prognostic value of CCI with regard to mortality of patients with MINS. This study comprises 5633 patients who had MINS as diagnosed by a rise of postoperative cardiac troponin I above the normal range (≥ 0.04 ng/mL) from January 2010 to June 2019. Patients were divided into two groups according to median weighted CCI score: low CCI (≤ 2) and high CCI (> 2) groups. The primary outcome was 30-day mortality after surgery, and secondary outcomes were 1-year and overall mortalities. Of the 5633 patients, 3428 (60.9%) were in the low CCI group (1.21 ± 0.84) and 2205 (39.1%) were in the high CCI group (4.17 ± 1.82). After propensity score matching, mortality during the first 30 days after surgery was significantly greater in the high CCI group than the low CCI group (9.4% vs. 6.0%, respectively; hazard ratio 1.56, 95% confidence interval 1.23–1.98, p < 0.001). A high CCI score was associated with increased 30-day mortality in patients with MINS, suggesting that the CCI may need to be considered when predicting outcomes of MINS patients.

Charlson Comorbidity Index: An Inaccurate Predictor of Minimally Invasive Lumbar Spinal Fusion Outcomes.

There is a scarcity of research on the Charlson Comorbidity Index (CCI) and its influence on minimum clinically important difference (MCID) achievement after minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF). The objective of this study is to detail the association between the CCI and attaining MCID after MIS TLIF. A prospective surgical registry was retrospectively reviewed for spine surgeries between May 2015 and February 2019. Inclusion criteria were primary or revision, 1- or 2-level MIS TLIF procedures. Patients were stratified based on CCI score: 0 points (no comorbidities), 1-2 points (mild CCI), ≥3 points (moderate CCI). Preoperative, intraoperative, and postoperative variables were assessed by subgroup using appropriate statistical analysis. Subgroups were analyzed with linear regression or χ2 tests for continuous or categorical variables, respectively. Subgroup scores, improvement, and MCID achievement were assessed at postoperative timepoints (eg, 6 weeks, 12 weeks, 6 months, and 1 year) for back and leg pain, Oswestry Disability Index (ODI), SF-12 Physical Composite Score (PCS), and Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF). A total of 171 patients were included (n = 51 [no comorbidities], n = 73 [mild CCI], and n = 47 [moderate CCI]). Higher CCI patients were older and more likely to be smokers, diabetic, arthritic, hypertensive, or have a malignancy history (P < 0.003). Preoperatively, ODI and PROMIS PF were the only patient-reported outcomes with a significant association by CCI group (P = 0.015 and 0.014). Back pain was the only measure that had a significant association with the CCI subgroup at 1 year for score (P = 0.002) or MCID (P = 0.028). By 1 year, regardless of the number of comorbidities, a similar proportion of patients undergoing MIS TLIF were able to achieve MCID for visual analog scale leg, SF-12 PCS, and PROMIS PF. Patients with higher comorbidities are not likely to experience a significant difference in symptom improvement. Regardless of CCI score, MIS TLIF can have a significant benefit for patients. 4. Text.

Small cell carcinoma of the bladder: A population-based analysis of long-term outcomes after radical cystectomy and bladder conservation with chemoradiotherapy.

We aimed to describe the oncological outcomes after radical cystectomy and chemo-radiation for localized small cell bladder cancer (SCBC). This population-based analysis of localized SCBC from 1985-2018 in British Columbia included an analysis (analysis 1) of cancer-specific survival (CSS) and overall survival (OS) of patients treated with curative-intent radical cystectomy (RC) and radiation (RT), and an analysis (analysis 2) of CSS and OS in patients treated with RC and chemoRT consistent with the SCBC Canadian consensus guideline. Seventy-seven patients who were treated with curative intent were identified: 33 patients had RC and 44 had RT. For analysis 1, five-year OS was 29% and 39% for RC and RT, respectively (p=0.51), and five-year CSS was 35% and 52% for RC and RT, respectively (p=0.29). On multivariable analysis, higher Charlson comorbidity index (CCI) and the lack of neoadjuvant chemotherapy (NAC) were associated with worse OS, while higher CCI and Eastern Cooperative Oncology Group (ECOG) were associated with worse CSS. For analysis 2, five-year OS was 56% and 58% for the RC and chemoRT groups, respectively (p=0.90), and five-year CSS was 56% for RC and 71% for chemoRT (p=0.71). Four of 42 (9.5%) chemoRT patients had RC at relapse. SCBC is a rare entity with a poor prognosis. RC and chemoRT offer similar CSS and OS for localized SCBC, even when focusing the analysis on patients treated according to the modern consensus guidelines. NAC should be considered for eligible patients. Both chemoRT and RC treatment options should be discussed with patients with SCBC.

Modified Charlson comorbidity index as a pre-operative selection tool for liver transplantation in elderly patients

Liver transplantation is an effective treatment for end-stage liver disease and hepatocellular carcinoma. The number of elderly patients who undergo liver transplantation is increasing. Although it has been known that the overall outcome in elderly patients is no different from the younger ones, there is no tool to predict the prognosis of elderly patients. Therefore, we hypothesized that modified Charlson comorbidity index (CCI), which includes 5 comorbidities, can predict the outcome of elderly patients. We conducted a retrospective study of 155 patients over 65 years old who underwent liver transplantation at Seoul National University Hospital from August 2011 to May 2019. Modified CCI score (MODIFIED CCI) including coronary disease, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, connective tissue disease, and renal insufficiency was calculated. Then, recipients were subcategorized into 2 groups; low MODIFIED CCI group (0-1), and high MODIFIED CCI group (2-5). Proportional hazards analysis was performed to determine the independent effect of each variable on post-transplantation survival using MODIFIED CCI, age at transplantation, gender, Child-Turcotte-Pugh score, Model for End-Stage Liver Disease (MELD) score, and 5-Factor Modified Frailty Index. There were 41 patients in the high MODIFIED CCI group. The high MODIFIED CCI group showed significantly lower 1-, 3- month, and 1, 3, 5-year survival than the low MODIFIED CCI group. In the Cox regression, the MODIFIED CCI (HR = 2.409), gender (HR = 0.447), and MELD score (HR = 1.107) remained. Survival after LT is diminished in patients with preoperative high MELD and MODIFIED CCI score >1. The MODIFIED CCI can be used.

Influences of the Charlson Comorbidity Index and Nutrition Status on Prognosis After Esophageal Cancer Surgery

The Charlson Comorbidity Index (CCI), an indicator that objectively quantifies comorbidities, reduces nutritional status; however, the impact of the CCI on the postoperative nutrition indexes of patients with esophageal cancer remains unclear. In total, 336 patients with esophageal cancer who underwent surgery between January 2011 and April 2017 were included in this study. We investigated the relationship between the CCI and postoperative nutrition indexes. Patients were divided into two groups: CCI ≤1 (low CCI group) and CCI ≥2 (high CCI group). A high CCI was significantly associated with shortened overall survival (OS; 3-year OS rate of 77.9% in the low CCI group versus 59.7% in the high CCI group; p=0.008). Nutritional indexes, such as the Prognostic Nutritional Index (PNI), at 1month after esophagectomy were significantly lower in the high CCI group than in the low CCI group (p=0.031); however, the PNI at 6 months after surgery was similar between the high and low CCI groups. Multivariate analysis identified high CCI as an independent risk factor associated with PNI <45 in esophageal cancer patients at 1 month after esophagectomy (p=0.047). This study showed that CCI ≥2 was significantly associated with poor PNI at 1 month after surgery for esophageal cancer, indicating that it is necessary to administer effective nutritional interventions for patients with postoperative malnutrition, especially those with multiple comorbidities.

Comorbidities Drive the Majority of Overall Mortality in Low-Risk Mucinous Pancreatic Cysts Under Surveillance

Background & AimsThe Charlson Comorbidity Index (CACI) has been suggested as a tool to determine comorbidity burden and guide management for patients with mucinous pancreatic cysts (Intrapapillary Mucinous Neoplasms and Mucinous Cystic Neoplasms), but has not been studied well among “low-risk” mucinous pancreatic cysts i.e. without worrisome features (WF) and high-risk stigmata (HRS). This study sought to determine the comorbidity burden among surveillance population of low-risk pancreatic cysts and provide their follow-up mortality outcomes. MethodsA single center study retrospectively reviewed a prospective pancreatic cyst database and included individuals with low-risk cysts undergoing serial imaging during 2016. Electronic medical records were reviewed to determine their baseline age-adjusted CACI (age-CACI). After 4 years, their progression to WF, disease specific (pancreatic malignancy-related, DSM), extra-pancreatic (EPM), and overall mortalities (OM) were determined using Kaplan-Meir Survival Analysis. Results502 individuals underwent prospective surveillance. The study included 440 individuals with low-risk suspected or presumed mucinous cysts and excluded 50 and 12 individuals with WF and HRS respectively. Over a median follow-up of 56 months, 12 WF progressions, 2 DSMs, 42 EPMs, and 44 OMs were observed. Baseline age-CACI had good predictive capacity for 4-year EPM (Area-Under Curve: 0.87; p< .0001). The median age-CACI of 4 enabled cohort stratification into Low (age-CACI <4) and High CACI (age-CACI ≥4) groups. A significantly higher OM (p< .001) was observed among the High CACI group as compared to the Low CACI group. ConclusionThrough real-time application of CACI to patient outcomes, our analysis supports incorporation of this comorbidity assessment tool in making shared surveillance decisions among low-risk pancreatic cyst population.

P131. The association of comorbidity burden on lumbar decompression postoperative outcomes

BACKGROUND CONTEXT Central stenosis of the spinal canal can be surgically managed through decompression techniques. There is a lack of research on the influence of comorbidity burden on postoperative patient reported outcome (PRO) improvement and on the achievement of minimum clinically important difference (MCID) following lumbar decompression (LD). PURPOSE This study aims to detail the association between comorbidity burden and achievement of MCID following LD. STUDY DESIGN/SETTING Retrospective. PATIENT SAMPLE A total of 314 patients undergoing primary or revision, 1 or 2 level MIS TLIF procedures. OUTCOME MEASURES VAS back, VAS leg, ODI, SF-12 Physical Composite Score (PCS), and PROMIS PF scores, MCID. METHODS A prospectively maintained surgical registry was retrospectively reviewed for eligible spine surgeries between May 2015 and July 2019. Inclusion criteria were primary, single or multilevel lumbar decompressions. Patients were excluded if they did not complete a preoperative Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) survey. Patients were stratified based on Charlson Comorbidity Index (CCI) score: 0 points (no comorbidities), 1–2 points (low CCI), ≥3 points (high CCI). A chi-squared test analyzed the association of CCI subgroups in the following variables: gender, smoking status, comorbid diagnoses, and body mass index (BMI). A t-test was used to evaluate subgroups for mean differences in continuous variables, such as age, operative time (from skin incision to closure), estimated blood loss, length of stay, and discharge day (Table 2). A chi-squared test evaluated the distribution of decompression levels. Postoperative improvement was assessed using linear regression to detect a difference between CCI groups for VAS back, VAS leg, ODI, SF-12 Physical Composite Score (PCS), and PROMIS PF scores pre- and postoperatively (eg, 6 weeks, 12 weeks, 6 months and 1 year). Achievement rate of MCID was compared between CCI groups using chi-squared analysis (Table 4). MCID values utilized were VAS back = 1.2, VAS leg = 1.6, ODI = 12.8, SF-12 PCS = 4.0, and PROMIS PF = 8.0. RESULTS A total of 314 LD patients were included; 123 patients had no comorbidities, 100 had low CCI, and 91 had high CCI. Patients with a high CCI were older, more likely to be smokers, and to have the following comorbid diseases: myocardial infarction, diabetes, arthritis, hypertension, PVD, neurological disease and cancer (all p CONCLUSIONS Patients with increased comorbidity burdens undergoing LD had significantly longer procedure times and hospital stays, but their postoperative evaluations demonstrated no difference in achieving MCID for pain (VAS back and VAS leg) or disability (ODI) metrics up to 1-year. Patients in the high CCI group did, however, have a lower rate of achieving MCID for their physical function surveys. Our results suggest that comorbidity burden influences improvement in physical function following LD. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

The Impact of Comorbidity Burden on Postoperative PROMIS Physical Function Following Minimally Invasive Transforaminal Lumbar Interbody Fusion.

This was a retrospective cohort study. To assess the utility of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF) in assessing postoperative recovery on the basis of the comorbidity burden after minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Few studies have evaluated the effect of comorbidity burden in long-term clinical recovery after MIS TLIF. Patients undergoing primary, 1-level to 2-level MIS TLIF were retrospectively reviewed and stratified on the basis of Charlson Comorbidity Index (CCI) score: 0 points (no comorbidities), 1-2 points (low CCI), ≥3 points (high CCI). CCI was tested for an association with demographic characteristics and perioperative variables using χ analysis and multivariate linear regression. Multivariate linear regression was utilized to determine the association between CCI cohorts and PROMIS PF. A total of 187 1-level and 2-level MIS TLIF patients were included: 53 had no comorbidities, 78 had a low CCI, and 56 a high CCI. One patient in the high CCI group experienced nonunion. Patients reported similar PROMIS PF scores preoperatively and up to 1-year postoperatively. Each cohort experienced a similar improvement in PROMIS PF scores from baseline at each postoperative time point. For patients without comorbidities, the change in the postoperative PROMIS PF score from baseline was significant at every postoperative time point. However, for the patients with ≥1 comorbidities, the change in the postoperative PROMIS PF score from baseline was significant at the 3-month, 6-month, and 1-year time points, however, the change from baseline to 6 weeks was not significant. In this investigation, the authors compared the clinical recovery of patients with varying comorbidities undergoing an MIS TLIF using PROMIS PF. Regardless of comorbidity, patients reported similar preoperative PROMIS PF scores and had similar improvements throughout the 1-year follow-up. This study established that PROMIS PF is an effective tool to evaluate the recovery of patients with differing comorbidities after MIS TLIF.

Comorbidities Reduce Response to Induction Treatment and Survival in Adults with Philadelphia-Negative Acute Lymphoblastic Leukemia

Background. Comorbidities have a well-established prognostic value in the majority of hematologic neoplasms. However, the impact of comorbidities on adult patients with acute lymphoblastic leukemia (ALL) has been poorly investigated to date. Aims. In this retrospective study of a monocentric cohort of 112 adults with Philadelphia-negative (Ph-neg) ALL consecutively diagnosed between 1990 and 2018 we aimed to assess the association between comorbidities at diagnosis and remission rate, the frequency and severity of adverse events (AE) during frontline treatment, and long-term outcome. Patients and methods. Patients were included, regardless of age, if treated within or according to clinical protocols aimed at curing. Patients initially treated with low-intensity/palliative care were not considered. Ph-positive patients were excluded, as their treatment modalities markedly changed over years due to the availability of tyrosine kinase inhibitors. Patients were defined as high risk if one or more of the following features were present: WBC &gt;30x109/L for B-cell precursor (BCP) or &gt;100x109/L for T-cell precursor (TCP), pro-B, early or mature T ALL phenotype, high risk cytogenetics (according to the ESMO 2016 guidelines), or central nervous system involvement. Comorbidities recorded at diagnosis were classified according to the Charlson Comorbidity Index (CCI). Classification and grading of AE was performed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Responses were defined according to the ESMO 2016 guidelines. Minimal residual disease (MRD) was assessed by 6- or 8-colour flow cytometry with a 10-4 sensitivity. Variables tested for association with complete remission (CR) and MRD-negative status were: age group (stratified into quartiles), gender, phenotype (BCP or TCP), WBC, karyotype, risk class, and CCI score. Event-free survival (EFS) was calculated from the first CR to relapse or death. Overall survival (OS) was calculated from diagnosis until death. EFS and OS were estimated using the Kaplan-Meier method. Results. Median age at diagnosis was 43 years (range 14-75). BCP and TCP were 78% and 22%, respectively. Overall, 51 patients (46%) were considered as standard risk, 46 (41%) as high risk, and 15 (13%) were unclassifiable due to the lack of cytogenetics. CCI score distribution was as follows: 0 (n=66; 59%), 1 (n=18; 16%), 2 (n=9; 8%), and ≥3 (n=19; 17%). CR after induction therapy was obtained by 95/112 patients (85%). CCI was the only variable significantly associated to CR achievement (0-1 vs ≥2: 91% vs 68%; p=0.012). MRD status at the end of induction was evaluable in 64 out of 95 patients in CR and was negative in 28 (44%). No pretreatment variable predicted for the achievement of MRD complete response. Eight patients (7%) died before the first response evaluation; early death rate was significantly higher in patients with CCI ≥2 than in patients with CCI 0-1 (21% vs 2%; p=0.003). Conversely no differences in AE frequency and severity were observed according to CCI (p=0.847) or age group (p=0.881). After a median follow-up of 35 months, 46 patients (41%) were alive. OS was significantly longer in patients with CCI 0-1 as compared to CCI ≥2 (median 87 months, 95%CI: 31 to not reached vs 13 months, 95%CI: 5-36; p&lt;0.001). Notably, pre-treatment risk stratification lost prognostic value in predicting OS and EFS in CCI 0-1 patients, while in CCI ≥2 patients retained its significance (Figure). Overall, 58 patients (52%) were primary refractory or relapsed. Relapse rate was similar according to age groups, phenotype, risk class, and CCI score. CR rate after salvage treatment (CR2) was higher in younger patients (≤43 vs &gt;43 years: 81% vs 44%; p=0.014) and tended to be higher in patients treated with blinatumomab or inotuzumab rather than with standard chemotherapy (82% vs 55%, p=0.17). While there were no differences in CR2 according to CCI group, median survival after first relapse was 12.1 months (95%CI: 7.83-15.24) for CCI 0-1 vs 6.92 months (95%CI: 2.49-12.59) for CCI≥2(p=0.021). Conclusions. Comorbidities have a significant prognostic impact in intensively-treated adults with Ph-neg ALL. Patients with low comorbidities (CCI 0-1) had superior CR rates and less incidence of toxic death after induction, and pre-treatment high risk features did not have a detrimental impact in this group. Figure Disclosures Krampera: Novartis: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees. Bonifacio:Incyte: Honoraria; Pfizer: Honoraria; Novartis: Honoraria, Research Funding; Amgen: Honoraria.

Impact of Comorbidities on Survival of Chronic Myeloid Leukemia Patients Treated with Tyrosine Kinase Inhibitors

Tyrosine kinase inhibitors treatment changed dramatically the survival of CML patients, approaching to the survival of the normal population. Comorbidities may also impact treatment results. Aim: to investigate the impact of comorbidities in the survival of CML patients treated with TKI Methods: We collected clinical and laboratory data from CML patients treated in a single center from medical records from January 2001 to December 2018. Comorbidities were collected at diagnosis before treatment and Charlson comorbidity index (CCI) was calculated. Because of CML diagnosis, the lowest possible score was 2. Patients were treated with imatinib 400-600 mg and one was treated with dasatinib in first line. Management followed the European Leukemia Net recommendations. OS probabilities were calculated using Kaplan-Meier method. OS was defined as the time between diagnosis and death of any cause, independent of treatment. Cox models were estimated for the multivariate analysis. All calculations were performed with version 24.0 SPSS software. Results: We included 273/310 patients in this analysis; 37 pts were excluded because of previous treated in other centers. Patients characteristics: 57.3% males, median age at diagnosis was 49 (14-86); 263 (96%) chronic phase and 11 (4%) accelerated phase; Sokal low risk 36.8%, intermediate 31.8% high risk 31.4%; EUTOS low risk (81.7%) and high risk (18.3%); median follow-up time was 92 months (1-223). Most frequent comorbidities: hypertension (27.2%); diabetes (7.5%). Smoking at diagnosis (15.3%). CCI group categories were: 2 (n=131), 3 (n=52), 4 (n=46), 5 or more (n=45). Probabilities of OS at 10 years for patients with CCI 2, 3 to 4 and ≥ 5 to were 81%, (95% confidence interval [CI]: 73-89%), 77% (95%CI: 63-100%), 69% (95%CI:53-85%), and 62% (95% CI: 38-86%), respectively. Probabilities of OS according to Sokal score was 86% (low risk) vs. 73% (intermediate) vs. 68% (high risk), P=0.002 and for EUTOS score 79% (low risk) vs. 61% (low risk), P=0.004. OS was lower in patients with hypertension (63% vs. 80%), P=0.018. In a multivariate analysis including CCI Sokal and EUTOS Score, smoking, diabetes, hypertension, the most powerful predictive factors for death were high and intermediate Sokal score and hypertension ((Wald test, P =0.003 and 0.049, respectively). There were 58 deaths, 22 not related to CML and 2 causes unknown. Conclusions: Comorbidities represents an important cause for mortality in CML patients treated in real life, besides known disease risk factors as Sokal and EUTOS scores. CCI high scores and hypertension were related to a lower OS. Figure 1 Disclosures Delamain: Novartis: Honoraria. Pagnano:Abbvie: Consultancy; Sandoz: Consultancy; Pint Pharma: Consultancy.

Increased Charlson Comorbidity Index (CCI) Is Not Associated with Inferior Clinical Outcomes in Patients with Mantle Cell Lymphoma (MCL)

Increased Charlson Comorbidity Index (CCI) Is Not Associated with Inferior Clinical Outcomes in Patients with Mantle Cell Lymphoma (MCL)

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P143. The impact of comorbidity burden on complications, length of stay and direct hospital costs after minimally invasive transforaminal lumbar interbody fusion

BACKGROUND CONTEXT The current health care model emphasizes maximizing patient care through utilization of cost-effective management strategies. Within the field of orthopedic surgery, comorbidity burden has been extensively studied in regards to its association with postoperative outcomes and complication incidence. In the subspecialty spine literature, the presence of comorbidities has been associated with an increased risk for complications, length of inpatient stay and hospital costs. However, few studies have investigated the effect of an elevated comorbidity burden on inpatient complication rate, length of stay or direct hospital costs in minimally-invasive spine surgery populations. PURPOSE To determine if comorbidity burden as determined by Charlson comorbidity Index (CCI) is associated with inpatient complication rate, length of stay or direct hospital costs after minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). STUDY DESIGN/SETTING Retrospective analysis of a prospectively managed surgical database. PATIENT SAMPLE A total of 362 patients who underwent a primary, single-level MIS TLIF between 2012 and 2017. OUTCOME MEASURES Rates of complications, length of stay and direct hospital costs. METHODS A prospectively maintained surgical registry of patients undergoing primary, single-level MIS TLIF for degenerative pathology between 2012 and 2017 was retrospectively reviewed. Patients were stratified by CCI group (0, 1, 2, 3, ≥4). CCI was tested for an association with preoperative demographics and perioperative characteristics using chi-squared analysis or one-way analysis of variance for categorical and continuous variables, respectively. Rates of complications were tabulated spanning the inpatient period and compared between groups using a one-way analysis of variance. Differences in length of stay and direct hospital costs between groups were assessed using a one-way analysis of variance. Statistical significance was set at p RESULTS A total of 362 patients underwent single-level MIS TLIF during the study period and were included in the analysis. Of these, 23.2% (84) had a CCI of 0, 22.4% (81) had a CCI of 1, 18.5% (67) had a CCI of 2, 16.6% (60) had a CCI of 3, and 19.3% (70) had a CCI ≥ 4. Elevated CCI was associated with older age (p .05 for each). One-way analysis of variance indicated that elevated CCI was not associated with total direct hospital costs (p=.469); however, greater CCI was associated with greater costs accrued in the intensive care unit (p=.028). CONCLUSIONS CCI as a reflection of comorbidity burden was not associated with complication rate, length of stay or total direct hospital costs after single-level MIS TLIF. The potential to mitigate the risk of complications in patients with elevated CCI may help prevent extended hospital stays and improve cost-effective patient care. This lack of association may suggest that the limited tissue trauma and operative exposure utilized in the minimally invasive approach may limit the effect of CCI on postoperative outcomes. Further investigation of the effect of comorbidity burden on perioperative and postoperative outcomes in minimally invasive spine surgery is required to better elucidate its value as a predictor of postoperative outcomes.