International Multicenter Database Research Articles

Prevalence of fetal anomalies, stillbirth, neonatal morbidity, or mortality in pregnancies complicated by placenta accreta spectrum disorders.

Placenta accreta spectrum disorders (PAS) lead to major complications in pregnancy. While the maternal morbidity associated with PAS is well known, there is less information regarding neonatal morbidity in this setting. The aim of this study is to describe the neonatal outcomes (fetal malformations, neonatal morbidity, twin births, stillbirth, and neonatal death), using an international multicenter database of PAS cases. This was a prospective, multicenter cohort study based on prospectively collected cases, using the international multicenter database of the International Society for PAS, carried out between January 2020 and June 2022 by 23 centers with experience in PAS care. All PAS cases were included, regardless of whether singleton or multiple pregnancies and were managed in each center according to their own protocols. Data were collected via chart review. Local Ethical Committee approval and Data Use Agreements were obtained according to local policies. There were 315 pregnancies eligible for inclusion, with 12 twin pregnancies, comprising 329 fetuses/newborns; 2 cases were excluded due to inconsistency of data regarding fetal abnormalities. For the calculation of neonatal morbidity and mortality, all elective pregnancy terminations were excluded, hence 311 pregnancies with 323 newborns were analyzed. In our cohort, 3 neonates (0.93%) were stillborn; of the 320 newborns delivered, there were 10 cases (3.13%) of neonatal death. The prevalence of major congenital malformations was 4.64% (15/323 newborns), most commonly, cardiovascular, central nervous system, and gastrointestinal tract malformations. The overall prevalence of major neonatal morbidity in pregnancies complicated by PAS was 47/311 (15.1%). There were no stillbirths, neonatal deaths, or fetal malformations in reported twin gestations. Although some outcomes may be too rare to detect within our cohort and data should be interpreted with caution, our observational data supports reassuring neonatal outcomes for women with PAS.

Proximal foundation anchor variations and their correlation with unplanned return to the operating room (UPROR) in children with EOS treated with magnetically controlled growing rods (MCGR).

The evolution of MCGR technique has led to modifications in the configuration of the proximal construct to decrease the incidence of implant-related complications (IRC) and revision surgeries. However, there is no data characterizing the performance of the most used configurations reducing the risk of complications. 487 patients were identified from an international multicenter EOS database. EOS patients, primary dual MCGR, complete radiographs, and minimum of 2-year follow-up. 76 patients had incomplete X-rays, 5 had apical fusions, and 18 had inconclusive complications, leaving 388 patients for review. A digital spine template was created to document UIV; number of levels; number, type, and location of anchors; as well as implant configuration. First available postoperative and latest follow-up radiographs were reviewed by two senior surgeons and two spine fellows. UPROR due to IRC was defined as any change in proximal anchors between the postoperative and final follow-up radiographs. The most common proximal construct configuration: UIV at T2 (50.0%) with 17.5% UPROR, followed by T3 (34.0%) with 12.1% UPROR; number of levels was three (57.1%) with 16.8% UPROR and two (26.0%) with 17.0% UPROR; number of proximal anchors was six (49.9%) with 14.1% UPROR and four (27.0%) with 18.3% UPROR. The most common anchors were all screws (42.0%) with 9.9% UPROR, and all hooks (26.4%) with 31.4% UPROR (P < 0.001). The construct with the lowest rate of UPROR was a UIV at T2, with six anchors (all screws) across three levels (42 cases), with 0% UPROR. Other construct combinations that yielded 0% UPROR rates were UIV of T3, six anchors (all screws) across three levels (25 cases), and a UIV of T3 with six anchors (screws and hooks) across three3 levels (9 cases). Proximal anchor configuration impacts the incidence of UPROR due to IRC in MCGR. UIV at T2 and T3 compared to T4, and the use of all screws or combination of screws and hooks compared to all hooks were associated with a lower UPROR rate. The most common construct configuration was T2 UIV, three levels, six anchors, and all screws. The use of a combination of six anchors (screws or screws and hooks) across three levels with a UIV at T2 or T3 was associated with a lower UPROR rate.Additional research is needed to further evaluate the variables contributing to configuration selection and their association with IRC.

Stratification of the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state after total shoulder arthroplasty by implant type, preoperative diagnosis, and sex

Clinical significance, as opposed to statistical significance, has increasingly been utilized to evaluate outcomes after total shoulder arthroplasty (TSA). The purpose of this study was to identify thresholds of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for TSA outcome metrics and determine if these thresholds are influenced by prosthesis type (anatomic or reverse TSA), sex, or preoperative diagnosis. A prospectively collected international multicenter database inclusive of 38 surgeons was queried for patients receiving a primary aTSA or rTSA between 2003 and 2021. Prospectively, outcome metrics including ASES, shoulder function score (SFS), SST, UCLA, Constant, VAS Pain, shoulder arthroplasty smart (SAS) score, forward flexion, abduction, external rotation, and internal rotation was recorded preoperatively and at each follow-up. A patient satisfaction question was administered at each follow-up. Anchor-based MCID, SCB, and PASS were calculated as defined previously overall and according to implant type, preoperative diagnosis, and sex. The percentage of patients achieving thresholds was also quantified. A total of 5851 total shoulder arthroplasties (TSAs) including aTSA (n=2236) and rTSA (n=3615) were included in the study cohort. The following were identified as MCID thresholds for the overall (aTSA+rTSA irrespective of diagnosis or sex) cohort: VAS Pain (-1.5), SFS (1.2), SST (2.1), Constant (7.2), ASES (13.9), UCLA (8.2), SPADI (-21.5), and SAS (7.3), Abduction (13°), Forward elevation (16°), External rotation (4°), Internal rotation score (0.2). SCB thresholds for the overall cohort were: VAS Pain (-3.3), SFS (2.9), SST 3.8), Constant (18.9), ASES (33.1), UCLA (12.3), SPADI (-44.7), and SAS (18.2), Abduction (30°), Forward elevation (31°), External rotation (12°), Internal rotation score (0.9). PASS thresholds for the overall cohort were: VAS Pain (0.8), SFS (7.3), SST (9.2), Constant (64.2), ASES (79.5), UCLA (29.5), SPADI (24.7), and SAS (72.5), Abduction (104°), Forward elevation (130°), External rotation (30°), Internal rotation score (3.2). MCID, SCB, and PASS thresholds varied depending on preoperative diagnosis and sex. MCID, SCB, and PASS thresholds vary depending on implant type, preoperative diagnosis, and sex. A comprehensive understanding of these differences as well as identification of clinically relevant thresholds for legacy and novel metrics is essential to assist surgeons in evaluating their patient's outcomes, interpreting the literature, and counseling their patients preoperatively regarding expectations for improvement. Given that PASS thresholds are fragile and vary greatly depending on cohort variability, caution should be exercised in conflating them across different studies.

Impact of accumulating risk factors on the incidence of dislocation after primary reverse total shoulder arthroplasty using a medial glenoid–lateral humerus onlay prosthesis

IntroductionThe aim of this study is to facilitate preoperative identification of patients at-risk for dislocation after reverse total shoulder arthroplasty (rTSA) using the Equinoxe rTSA prosthesis (medialized glenoid, lateralized onlay humerus with a 145° neck angle) and quantify the impact of accumulating risk factors on the occurrence of dislocation. MethodsWe retrospectively analyzed 10,023 primary rTSA patients from an international multi-center database of a single platform shoulder prosthesis and quantified the dislocation rate associated with multiple combinations of previously identified risk factors. To adapt our statistical results for prospective identification of patients most at-risk for dislocation, we stratified our dataset by multiple risk factor combinations and calculated the odds ratio for each cohort to quantify the impact of accumulating risk factors on dislocation. Results136 (52F/83M/1UNK) of 10,023 primary rTSA patients were reported to have a dislocation for a rate of 1.4%. Patients with zero risk factors were rare, where only 12.7% of patients (1,268 of 10,023) had no risk factors, and only 0.5% of these (6 of 1,268) had a report of dislocation. The dislocation rate increased in patient cohorts with an increasing number of risk factors. Specifically, the dislocation rate increased from 0.9% for a patient cohort with 1 risk factor to 1.0% for 2 risk factors, 1.6% for 3 risk factors, 2.7% for 4 risk factors, 5.3% for 5 risk factors, and 7.3% for 6 risk factors. Stratifying dislocation rate by multiple risk factor combinations identified numerous cohorts with either an elevated risk or a diminished risk for dislocation. DiscussionThis 10,023 rTSA multi-center study demonstrated that 1.4% of rTSA patients experienced dislocation with one specific medialized glenoid/lateralized humerus onlay rTSA prosthesis. Stratifying patients by multiple combinations of risk factors demonstrated the impact of accumulating risk factors on incidence of dislocation. rTSA patients with the greatest risk of dislocation were: male gender, age ≤67 years at the time of surgery, patients with BMI ≥31, patients who received cemented humeral stems, patients who received glenospheres having a diameter >40mm, and/or patients who received expanded/laterally offset glenospheres. Patients with these risk factors who are considering rTSA using a medial glenoid/lateral humerus, should be made aware of their elevated dislocation risk profile.

Abstract 082: Angiographic Features and Treatment Results of Dural Arteriovenous Fistulas Cognitive Impairment

Introduction Dural arteriovenous fistulas (dAVFs) have been associated with rapidly progressive dementia in relatively young patients. However, the specific angioarchitecture and characteristics of these dAVFs remain to be fully described. To better understand the specific characteristics of dAVFs associated with cognitive impairment (dAVF‐CI), we utilized the CONDOR multicenter database, which provides a large cohort of dAVF available. By analyzing data from patients with dAVFs‐ CI, we aimed to identify the key features distinguishing these cases and elaborate on the pathophysiology of dAVF‐CI. Methods CONDOR is an international multicenter database comprising 1077 (dAVFs) from 14 international centers. We conducted a retrospective analysis of the CONDOR database, focusing on patients diagnosed with dAVFs‐CI. Propensity score matching analysis was performed to compare Borden type II and type III dAVFs with and without cognitive impairment as control groups. Only dAVFs with cortical venous drainage were included as this aggressive subtype can present with non‐hemorrhagic neurologic deficits. Additionally, logistic regression was then employed to identify significant characteristics associated with dAVF‐CI. Results A total of 60 patients with dAVF‐CI and 60 control dAVFs were included in the analysis. The patients with dAVF‐CI had a mean age of 58 ± 18 years. It was found that all cases of dAVF‐CI exhibited venous hypertension. Additionally, there was a significant association between sinus stenosis and dAVF‐CI (OR: 2.85, 95% CI: 1.16‐7.55, p = 0.027). Moreover, dAVF‐CI cases were characterized by the presence of multiple arteriovenous shunts, with more arterial feeders (OR 1.56, 95% CI 1.22‐2.05, p &lt;0.001) and draining veins (OR 2.05, 95% CI 1.05‐4.46, p = 0.004) compared to the control dAVFs. Venous ectasia was also found to be associated with dAVF‐CI (OR 2.38, 95% CI 1.13‐5.11, p= 0.024). Finally, some patients in which successful dAVF closure was achieved had symptom resolution during follow‐up (OR 2.86, 95% CI 0.85‐9.56, p = 0.09). Conclusion dAVFs‐CI tend to occur in relatively young patients and are characterized by the presence of venous hypertension. The development of sinus stenosis and venous ectasia further hinders proper drainage, contributing to the persistence of venous hypertension. Venous hypertension may impair critical structures such as the thalamus or the cortex leading to rapid cognitive impairment. Successful treatment of dAVFs‐CI can potentially reverse symptoms. Nonetheless, some dAVF‐CI may have persistent symptoms due to chronic hypertension and infarction.

Prostate Cancer–specific and All-cause Mortality After Robot-assisted Radical Prostatectomy: 20 Years’ Report from the European Association of Urology Robotic Urology Section Scientific Working Group

BackgroundEvidence on long-term oncological efficacy is available only for open radical prostatectomy but remains scarce for robot-assisted radical prostatectomy (RARP). ObjectiveTo validate the long-term survival rates after RARP and provide stratified outcomes based on contemporary prostate cancer (PCa) risk-stratification tools. Design, setting, and participantsA retrospective analysis of the European Association of Urology (EAU) Robotic Urology Section Scientific Working Group international multicenter database for RARP was performed. Patients who underwent RARP at seven pioneer robotic urology programs in Europe and the USA between 2002 and 2012 were included. Outcome measurements and statistical analysisThe primary outcomes were PCa-specific mortality and all-cause mortality. The probability of cancer-specific survival (CSS) was estimated with the competing risks method, and the probability of overall survival (OS) was estimated with the Kaplan-Meier method. Results and limitationsA total of 9876 patients who underwent RARP between 2002 and 2012 were included. Within follow-up, 1071 deaths occurred and 159 were due to PCa. At 15 yr of follow-up, CSS and OS were 97.6% (97.2%, 98.0%) and 85.5% (84.6%, 86.4%), respectively. Stratified analyses based on EAU risk groups at diagnosis and pT stage showed favorable survival rates, with low-risk (n = 4601, 46.6%), intermediate-risk (n = 4056, 41.1%), and high-risk (n = 1219, 12.3%) patients demonstrating CSS rates of 99%, 98%, and 90% at 15 yr, respectively. Notably, patients with pT3a disease had similar survival outcomes to those with pT2 disease, with worse CSS in patients with pT3b PCa (98.9% vs 97.4% vs 86.5%). Multivariable analyses identified age, prostate-specific antigen, biopsy Gleason grade group, clinical T stage, and treatment year as independent predictors of worse oncological outcomes. ConclusionsOur multicenter study with long-term follow-up confirms favorable survival outcomes after RARP for localized PCa. Patients with low- and intermediate-risk disease face a higher risk of mortality from causes other than PCa. On the contrary, high-risk patients have a significantly higher risk of PCa-specific mortality. Patient summaryIn the present study, we reported the outcomes of patients with prostate cancer (PCa) who underwent robot-assisted radical prostatectomy between 10 and 20 yr ago, and we found a very low probability of dying from PCa in patients with low- and intermediate-risk PCa.

Autologous and allogeneic stem‐cell transplantation for transformed Waldenström macroglobulinemia

Introduction: The prognosis of histological transformation (HT) in Waldenström macroglobulinemia (WM) is unfavourable despite the use of diffuse large B-cell lymphoma-directed chemo-immunotherapy. The aim of this study was to evaluate the outcomes after autologous stem-cell transplantation (autoSCT) or allogeneic stem-cell transplantation (alloSCT) in patients with transformed WM. Methods: Patients who received autoSCT or alloSCT between January 1996 and December 2021 were identified in an international multicenter database of 285 patients with transformed WM. The primary end-point was overall survival (OS), calculated from the date of SCT to death from any cause. Secondary end-points were progression-free survival (PFS), incidence of relapse/progression and non-relapse mortality (NRM). Univariate and multivariate analyses were performed using the Cox proportional hazards model for OS and PFS only for the autoSCT cohort, due to the small sample size of the alloSCT cohort. Results: Fifty-six patients were included, 46 had received autoSCT and 10 alloSCT. The median time from HT diagnosis to SCT was 8 months (range, 2–76 months) for autoSCT and 7 months (range, 3–49 months) for alloSCT. The patients received a median of 2 lines of treatment for HT before SCT (range, 1 to 6 for autoSCT and 1 to 3 for alloSCT), and 89% (complete response (CR): 59%) and 80% (CR: 50%) of the patients had chemosensitive disease at the time of autoSCT and alloSCT, respectively. For autoSCT, the conditioning regimen was BEAM in 76% of the patients, and for alloSCT, reduced-intensity conditioning was used in 70% of the cases. The median follow-up time for the surviving patients was 5.5 years (95% CI, 2.8–7.1 years) from autoSCT and 12.6 years (95% CI, 2.7–14.4 years) from alloSCT. The 3-year estimates of OS, PFS and cumulative incidences of relapse and NRM were 57%, 44%, 54%, and 2% for autoSCT and 50%, 50%, 30%, and 20% for alloSCT, respectively. In the autoSCT cohort, CR at SCT was found to be associated with superior OS and PFS (3-year OS, 81% for CR vs. 23% for less than CR, P = 0.001 and 3-year PFS, 62% vs. 21%, P < 0.001) and less than 2 lines of therapy for HT with superior OS (3-year OS, 75% for 1 line vs. 36% for >1 line, P = 0.01). Keywords: Aggressive B-cell non-Hodgkin lymphoma, Stem Cell Transplant No conflicts of interests pertinent to the abstract.

Prior anticoagulation and bridging thrombolysis improve outcomes in patients with atrial fibrillation undergoing endovascular thrombectomy for anterior circulation stroke

BackgroundWhere stroke occurs with pre-existing atrial fibrillation (AF)studies validating the safety and efficacy of bridging thrombolysis, and the use of endovascular thrombectomy (EVT) in the setting of prior anticoagulation, are...

Abstract P4-07-42: Intervention to Distant Metastatic Lesions in Patients with Breast Cancer

Abstract INTRODUCTION Approximately one-fourth of patients presenting with early-stage breast cancer develop distant metastatic disease, a prominent cause of mortality. The role of metastasis-directed intervention is still uncertain in this cohort. The aim of this study is to evaluate whether intervention to metastatic lesions impacts overall survival (OS) and post-distant recurrence survival (PDRS), defined as survival after first occurrence of metastatic disease. METHODS Our prospectively maintained international multi-center database of patients diagnosed with distant recurrence was retrospectively reviewed. Patients initially presenting with stage I-III breast cancer and diagnosed with metastatic disease to the bone, liver or lung from 2014-2020 were divided into cohorts receiving intervention to their metastases (IM, n=180) versus no interventions to their metastases (NI, n=120). The characteristics of the patients were compared with X2 test. OS curves were calculated by Kaplan-Meier method and multivariable analysis by Cox regression. Statistical significance was set at p&amp;lt; 0.05. RESULTS No significant differences in OS and PDRS were noted between the two groups when comparing age at diagnosis, menopausal status, tumor histopathology, pathological stage, axillary lymph node involvement, and hormone receptor and HER2 status. However, median OS and PDRS were significantly longer for patients who received IM compared to those who did not. The hazard of death was 59% lower with IM than with NI for both OS (HR 0.59: 95% CI 0.42 – 0.83; p=0.002) and for PDRS (HR 0.59: 95% CI 0.42 – 0.84). On multivariable analysis, OS was improved among patients with IM, and among those with lung metastases, compared to liver and bone metastases. CONCLUSIONS Metastatic site intervention had both an OS and PDRS benefit in this cohort. In order to explore the potential for interventions to their metastases, patients who develop limited metastatic disease following initial breast surgery should be discussed at a multidisciplinary tumor board. Post-Distant Recurrence Survival in Patients with Breast Cancer Receiving Intervention to Metastatic Lesions (IM) Versus No Intervention (NI) Citation Format: Hira Abidi, Serdar Ozbas, Beyza Ozcinar, Lutfi Dogan, Arda Isik, Emilia Diego, Priscilla F. McAuliffe, Ronald Johnson, Jennifer Steiman, Efe Sezgin, Atilla Soran. Intervention to Distant Metastatic Lesions in Patients with Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-42.

AUTOMATED LANDMARK DETECTION IN FUNCTIONAL LATERAL RADIOGRAPHS USING DEEP LEARNING

Evaluation of patient specific spinopelvic mobility requires the detection of bony landmarks in lateral functional radiographs. Current manual landmarking methods are inefficient, and subjective. This study proposes a deep learning model to automate landmark detection and derivation of spinopelvic measurements (SPM).A deep learning model was developed using an international multicenter imaging database of 26,109 landmarked preoperative, and postoperative, lateral functional radiographs (HREC: Bellberry: 2020-08-764-A-2). Three functional positions were analysed: 1) standing, 2) contralateral step-up and 3) flexed seated. Landmarks were manually captured and independently verified by qualified engineers during pre-operative planning with additional assistance of 3D computed tomography derived landmarks. Pelvic tilt (PT), sacral slope (SS), and lumbar lordotic angle (LLA) were derived from the predicted landmark coordinates. Interobserver variability was explored in a pilot study, consisting of 9 qualified engineers, annotating three functional images, while blinded to additional 3D information. The dataset was subdivided into 70:20:10 for training, validation, and testing.The model produced a mean absolute error (MAE), for PT, SS, and LLA of 1.7°±3.1°, 3.4°±3.8°, 4.9°±4.5°, respectively. PT MAE values were dependent on functional position: standing 1.2°±1.3°, step 1.7°±4.0°, and seated 2.4°±3.3°, p&lt; 0.001. The mean model prediction time was 0.7 seconds per image. The interobserver 95% confidence interval (CI) for engineer measured PT, SS and LLA (1.9°, 1.9°, 3.1°, respectively) was comparable to the MAE values generated by the model.The model MAE reported comparable performance to the gold standard when blinded to additional 3D information. LLA prediction produced the lowest SPM accuracy potentially due to error propagation from the SS and L1 landmarks. Reduced PT accuracy in step and seated functional positions may be attributed to an increased occlusion of the pubic-symphysis landmark. Our model shows excellent performance when compared against the current gold standard manual annotation process.

Development and validation of safety and efficacy-associated risk calculator for hepatocellular carcinoma in the elderly after resection (SEARCHER): A multi-institutional observational study

BackgroundIncreased life expectancy and improved perioperative management have resulted in increased utilization of hepatectomy for hepatocellular carcinoma (HCC) among elderly patients. However, individualized model for predicting the surgical safety and efficacy is lacking. The present study aimed to develop a safety and efficacy-associated risk calculator for HCC in the elderly after resection (SEARCHER). MethodsFrom an international multicenter database, elderly patients who underwent curative-intent hepatectomy for HCC were stratified by patient age: 65–69 years, 70–74 years, 75–79 years, and ≥80 years. Short- and long-term outcomes among the 4 groups were compared. Univariate and multivariate analyses of risk factors of postoperative major morbidity, cancer-specific survival (CSS) and overall survival (OS) were performed in the training cohort. A nomogram-based online calculator was then constructed and validated in the validation cohort. ResultsWith increasing age, the risk of postoperative major morbidity and worse OS increased (P = 0.001 and 0.020), but not postoperative mortality and CSS (P = 0.577 and 0.890) among patients across the 4 groups. Based on three nomograms to predict major morbidity, CSS and OS, the SEARCHER model was constructed and made available at https://elderlyhcc.shinyapps.io/SEARCHER. The model demonstrated excellent calibration and optimal performance in both the training and validation cohorts, and performed better than the several commonly-used conventional scoring and staging systems of HCC. ConclusionsWith higher potential postoperative major morbidity and worse OS as patients age, the decision of whether to perform a hepatectomy for HCC needs to be comprehensively considered in the elderly. The proposed SEARCHER model demonstrated good performance to individually predict safety and efficacy of hepatectomy in elderly patients with HCC.

Adjustable Gastric Banding Conversion to One Anastomosis Gastric Bypass: Data Analysis of a Multicenter Database

IntroductionOne anastomosis gastric bypass (OAGB) has been proposed as a rescue technique for laparoscopic adjustable gastric banding (LAGB) poor responders. AimWe sought to analyze, complications, mortality, and medium-term weight loss results after LAGB conversion to OAGB. MethodsData analysis of an international multicenter database. ResultsOne hundred eighty-nine LAGB-to-OAGB operations were retrospectively analyzed. Eighty-seven (46.0%) were converted in one stage. Patients operated on in two stages had a higher preoperative body mass index (BMI) (37.9 vs. 41.3 kg/m2, p = 0.0007) and were more likely to have encountered technical complications, such as slippage or erosions (36% vs. 78%, p < 0.0001). Postoperative complications occurred in 4.8% of the patients (4.6% and 4.9% in the one-stage and the two-stage group, respectively). Leak rate, bleeding episodes, and mortality were 2.6%, 0.5%, and 0.5%, respectively. The final BMI was 30.2 at a mean follow-up of 31.4 months. Follow-up at 1, 3, and 5 years was 100%, 88%, and 70%, respectively. ConclusionConversion from LAGB to OAGB is safe and effective. The one-stage approach appears to be the preferred option in non-complicate cases, while the two-step approach is mostly done for more complicated cases.

Pelvic thickness, sex, ethnicity, and age affect pelvic incidence in healthy volunteers of Multi-Ethnic Alignment Normative Study (MEANS) database.

The purpose of this study was to investigate the affecting factors on pelvic incidence (PI) and to test the hypothesis that PI changes even after skeletal maturity probably due to hypermobility of the sacroiliac joint using a large international multi-center database. A prospective and cross-sectional healthy adult volunteers, ages 18-80years, across 5 countries were used. Radiographic measurements included standard whole body alignment parameters. Bivariate regression analyses between PI versus demographics and spino-pelvic anatomical parameters were performed. An effect of sex on pelvic anatomical parameters was also investigated. Multivariate logistic regression with a forward stepwise procedure was performed to identify the contributing factors to PI, and an appropriate model was obtained. PI showed a significant positive correlation with age in pooled data. Divided by sex, however, there was no correlation in men, but women showed a significant higher correlation coefficient. Pelvic thickness (PTh) had a significant negative correlation with age in pooled data. Divided by sex, no correlation was found in men, but there was a significant correlation in women with higher correlation coefficient. The stepwise multivariate analysis for the factors on PI identified four significant factors: age, sex, ethnicity, and PTh. PTh, sex, ethnicity, and age affected PI. There was a positive correlation between PI and age. The tendency was more significant in woman than in man. The results support the hypothesis that PI increases with aging, but the change seems to be small and needs to be verified in a longitudinal evaluation.

Use of Vancomycin Powder in Spinal Deformity Surgery in Cerebral Palsy Patients is Associated With Proteus Surgical Site Infections.

Surgical site infection (SSI) rates in pediatric spinal deformity surgery for cerebral palsy (CP) patients are higher than that in idiopathic scoliosis. The use of vancomycin powder is associated with decreased risk of SSI in neuromuscular patients. Prior studies in adult and pediatric early-onset scoliosis patients have shown that vancomycin powder alters microbacterial profile in patients that develop SSI. However, the effects of topical vancomycin powder on microbiology in spinal deformity surgery for CP patients has not been studied. An international multicenter database of CP neuromuscular scoliosis patients was used in this retrospective cohort study. All patients that underwent posterior spinal instrumented fusion for CP neuromuscular scoliosis from 2008 to 2019 were queried, and 50 cases complicated by postoperative SSI were identified. Intraoperative antibiotic details were documented in 49 cases (98.0%). Microbiology details were documented in 45 cases (91.8%). Microbiology for patients that received topical vancomycin powder were compared with patients that did not. A multivariate regression model was used to control for potential confounders. There were 45 patients included in this study. There were 27 males (60.0%) and 18 females (40.0%). Mean age at surgery was 14.8±2.4 years. There were 24 patients that received topical vancomycin powder (53.3%). The mean time from index surgery to SSI was 4.3±11.3 months.On univariate analysis of microbiology cultures by vancomycin powder cohort, there were no significant differences in culture types. Proteus spp. trended on significance with association with vancomycin powder use (P=0.078). When controlling for potential confounders on multivariate analysis, intraoperative topical vancomycin powder was associated with increased risk for proteus infection (adjusted odds ratio: 262.900, 95% confidence interval: 1.806-38,267.121, P=0.028). In CP patients undergoing pediatric spinal deformity surgery, the use of vancomycin powder was independently associated with increased risk for proteus infections. Further study into antibiotic regimens for spinal deformity surgery in the CP population should be performed. Level III-retrospective cohort study.

Baclofen Pump Use: Complications After Growth-friendly Instrumentation for Early-onset Scoliosis.

Patients with early-onset scoliosis (EOS) and spasticity may receive treatment with an intrathecal baclofen pump. We assessed how baclofen pumps are associated with the odds of complications and secondary interventions after growth-friendly (GF) spine surgery for EOS and analyzed infectious complications within the pump cohort. Using a prospectively maintained, international multicenter database, we studied patients with neuromuscular EOS with baclofen pumps who underwent GF spine surgery from 2002 through 2019 (n=25). Baclofen pumps were implanted before GF instrumentation in 18 patients, during in 2 patients, and after in 5 patients. Patients with existing pumps at initial GF spine surgery were matched 1:3 with 54 patients (control group) without pumps according to treatment center, year of surgery, diagnosis, surgery type, and preoperative curve magnitude. Univariate analysis and multivariate logistic regression were performed to compare complications and secondary interventions between the 2 cohorts. Patients with baclofen pumps had 4.8 times the odds [95% confidence interval (CI): 1.5-16] of experiencing any complication within 1 year after initial GF spine surgery compared with controls. During mean follow-up of 6.9±4.3 years, they had 4.7 times the odds (95% CI: 1.3-16) of deep surgical site infection and 5.6 times the odds (95% CI: 1.2-26) of spinal rod removal after any complication. Differences in rates of mechanical complication, such as rod migration and breakage, were nonsignificant between the 2 groups. For the 9 patients (50%) with pumps who experienced infections, the most common microorganisms were Staphylococcus aureus (4 patients) and Pseudomonas aeruginosa (2). The pump/catheter was revised or removed, in addition to antibiotic therapy or surgical irrigation and debridement, in 2 patients. Among patients with neuromuscular EOS, those with baclofen pumps are much more likely to experience complications within 1 year after GF spine surgery. They are also more likely to have deep surgical site infections, with S. aureus and P. aeruginosa being the most common causative organisms, and to require spinal rod removal. Level III-retrospective comparative study.

Efficacy and Long-Term Outcomes of Autologous Stem Cell Transplant (ASCT) for Patients with POEMS Syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin Changes): A CIBMTR Analysis

IntroductionPOEMS syndrome is a rare disease associated with a plasma cell dyscrasia with limited information regarding the role of ASCT. Small single institution series have demonstrated deep and durable responses after ASCT along with neurological improvement. Despite these benefits, ASCT is thought to have higher treatment related morbidity and mortality, limiting its use. We describe the outcomes from an international multicenter database of patients with POEMS syndrome undergoing ASCT.MethodsWe performed a retrospective analysis using the Center for International Blood and Marrow Transplant Research (CIBMTR) database to evaluate the outcomes of patients undergoing ASCT for POEMS syndrome. Standard descriptive methods were used to report patient characteristics. Univariate and multivariate analysis were performed to identify predicators for non-relapse mortality (NRM), relapse, progression-free and overall survival (PFS, OS). NRM was compared between POEMS and multiple myeloma (MM) patients who underwent ASCT during the same time period.ResultsBetween 2008-2018, 331 pts with POEMS syndrome who underwent ASCT were identified. The median age was 51 years, with 66% males. Racial distribution was 65% Caucasians, 19% African American, 5% other, and 10% missing. Pre-transplant characteristics included 70% patients had Karnofsky score <90, and 50% had HCT-CI ≥ 3, reflecting underlying disease severity and symptoms. The most common comorbidity was pulmonary (52%). Only 14% of patients were in very good partial response or better at the time of ASCT and 72 (22%) patients underwent ASCT without prior treatment. The median time from diagnosis to ASCT was 7 months and 74% underwent ASCT within 12 months of diagnosis. The most common mobilization strategy was GCSF +/- plerixafor in 50% of pts and 87% of pts received conditioning with 200mg/m2 of Melphalan. The median follow up was 48 (range 3-137) months. At day 100, NRM was 0.9 % (95% CI: 0.2-2.2%). At 4 years, NRM was 4.9% (95% CI: 2.6-7.9%), relapse 15.4% (95% CI 11.3-20.1%), PFS 79.7% (95% CI 74.5-84.3%) and OS 92% (95% CI 89.2-95.6%). Subsequent neoplasms were seen in 16 (5%) with 4 myeloid malignancy and 12 solid tumors. On multivariate analysis, age ≥ 60 years was associated with greater hazards of mortality, HR 2.6 (95% CI 1.2-5.6), p 0.01. The figure shows the comparable NRM between POEMS and MM (p 0.31).Conclusions:We report outcomes of the largest ASCT series of POEMS patients. Despite a high HCT-CI and low functional status among patients with POEMS syndrome, no difference in NRM was seen when compared to MM. Post-transplant outcomes were excellent and support single center data on the role of ASCT in this rare disease. [Display omitted] DisclosuresKansagra: Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Alynylam: Membership on an entity's Board of Directors or advisory committees; Cota Health: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees. Dispenzieri: Alnylam: Research Funding; Pfizer: Research Funding; Sorrento Therapeutics: Consultancy; Takeda: Research Funding; Oncopeptides: Consultancy; Janssen: Consultancy, Research Funding. Kumar: Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; BMS: Consultancy, Research Funding; Oncopeptides: Consultancy; Beigene: Consultancy; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche-Genentech: Consultancy, Research Funding; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Antengene: Consultancy, Honoraria; Novartis: Research Funding; Bluebird Bio: Consultancy; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Research Funding; Carsgen: Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Tenebio: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Research Funding. Qazilbash: Bristol-Myers Squibb: Other: Advisory Board; NexImmune: Research Funding; Janssen: Research Funding; Biolline: Research Funding; Oncopeptides: Other: Advisory Board; Angiocrine: Research Funding; Amgen: Research Funding. Shah: GSK: Consultancy; Karyopharm: Consultancy; Oncopeptides: Consultancy; Indapta Therapeutics: Consultancy; Janssen: Research Funding; Nektar: Research Funding; Bluebird Bio: Research Funding; Teneobio: Research Funding; CareDx: Consultancy; BMS/Celgene: Research Funding; Sanofi: Consultancy; Sutro Biopharma: Research Funding; CSL Behring: Consultancy; Poseida: Research Funding; Precision Biosciences: Research Funding; Amgen: Consultancy; Kite: Consultancy. D'Souza: Sanofi, Takeda, Teneobio, CAELUM, Prothena: Research Funding; Imbrium, Pfizer, BMS: Membership on an entity's Board of Directors or advisory committees; Janssen, Prothena: Consultancy.

Continued versus Interrupted Targeted Therapy during Metastasis-Directed Stereotactic Radiotherapy: A Retrospective Multi-Center Safety and Efficacy Analysis.

Simple SummaryThe increasing use of targeted therapy (TT) has resulted in prolonged disease control and survival in many metastatic cancers. In parallel, stereotactic radiotherapy (SRT) is increasingly performed in patients receiving TT to obtain a durable control of resistant metastases, and thereby to prolong the time to disseminated disease progression and switch of systemic therapy. The aim of this study was to analyze the safety and efficacy of SRT combined with TT in metastatic cancer patients and to assess the influence of continuous vs. interrupted TT during metastasis-directed SRT. The data of 454 SRTs in 158 patients from the international multicenter database (TOaSTT) on metastatic cancer patients treated with SRT and concurrent TT (within 30 days) were analyzed. We found that there was no significant difference in survival, progression, or severe toxicity, whether TT was interrupted during SRT or not. Although any-grade acute and late SRT-related toxicity occurred in 63 (40%) and 52 (33%) patients, severe SRT-related toxicity rates were low (3% and 4%, respectively). The highest toxicity rates were observed for the combination of SRT and EGFRi or BRAF/MEKi, and any grade of toxicity was significantly increased when EGFRi or BRAF/MEKi were continued during SRT. However, this did not account for severe toxicity.The increasing use of targeted therapy (TT) has resulted in prolonged disease control and survival in many metastatic cancers. In parallel, stereotactic radiotherapy (SRT) is increasingly performed in patients receiving TT to obtain a durable control of resistant metastases, and thereby to prolong the time to disseminated disease progression and switch of systemic therapy. The aims of this study were to analyze the safety and efficacy of SRT combined with TT in metastatic cancer patients and to assess the influence of continuous vs. interrupted TT during metastasis-directed SRT. The data of 454 SRTs in 158 patients from the international multicenter database (TOaSTT) on metastatic cancer patients treated with SRT and concurrent TT (within 30 days) were analyzed using Kaplan–Meier and log rank testing. Toxicity was defined by the CTCAE v4.03 criteria. The median FU was 19.9 mo (range 1–102 mo); 1y OS, PFS and LC were 59%, 24% and 84%, respectively. Median TTS was 25.5 mo (95% CI 11–40). TT was started before SRT in 77% of patients. TT was interrupted during SRT in 44% of patients, with a median interruption of 7 (range 1–42) days. There was no significant difference in OS or PFS whether TT was temporarily interrupted during SRT or not. Any-grade acute and late SRT-related toxicity occurred in 63 (40%) and 52 (33%) patients, respectively. The highest toxicity rates were observed for the combination of SRT and EGFRi or BRAF/MEKi, and any-grade toxicity was significantly increased when EGFRi (p = 0.016) or BRAF/MEKi (p = 0.009) were continued during SRT. Severe (≥grade 3) acute and late SRT-related toxicity were observed in 5 (3%) and 7 (4%) patients, respectively, most frequently in patients treated with EGFRi or BRAF/MEKi and in the intracranial cohort. There was no significant difference in severe toxicity whether TT was interrupted before and after SRT or not. In conclusion, SRT and continuous vs. interrupted TT in metastatic cancer patients did not influence OS or PFS. Overall, severe toxicity of combined treatment was rare; a potentially increased toxicity after SRT and continuous treatment with EGFR inhibitors or BRAF(±MEK) inhibitors requires further evaluation.

Robot-assisted partial nephrectomy: 7-year outcomes.

The role of robot-assisted partial nephrectomy (RAPN) in the management of renal masses has exponentially grown over the past 10 years. Nevertheless, data on long term outcomes of the procedure remains limited. Herein we report oncological and functional outcomes of patients who underwent RAPN for a malignant mass with a median follow-up of 7 years, the longest follow-up to date. A retrospective analysis of an international multicenter database was performed. All consecutive patients undergoing surgery between 2009 and 2013 with a minimum of 3-year follow-up and complete data on renal function were included. Demographics, surgical and perioperative outcomes were analyzed. Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were evaluated using Kaplan-Meier analysis. Overall, our study cohort was composed of eighty-five patients with a median follow-up of 88 months. Median clinical tumor size was 3 cm, with mostly (74.1%) clinical stage T1a, and median RENAL score 6. Final histopathologic analysis revealed clear cell RCC in 76.5% of cases. PSM was present in seven patients (8.2%). Eleven overall deaths (12.9%) occurred in the cohort during the follow-up period. Two of these (2.33%) were attributed to metastatic RCC. The OS, CSS, and DFS rates were 91.7%, 97.7%, and 91.7% at 84 months, respectively. Regarding the renal functional outcomes, seventeen patients (20.1%) presented a CKD upstaging in our cohort. Our findings show excellent 7-year oncologic and functional outcomes of the procedure, which duplicate those achieved in historical series of open and laparoscopic surgery.

Development and validation of an individualized prediction calculator of postoperative mortality within 6 months after surgical resection for hepatocellular carcinoma: An international multicenter study

Evidence-based decision-making is critical to optimize the benefits and mitigate futility associated with surgery for patients with malignancies. Untreated hepatocellular carcinoma (HCC) has a median survival of only 6 months. The objective was to develop and validate an individualized patient-specific tool to predict preoperatively the benefit of surgery to provide a survival benefit of at least 6 months following resection. Using an international multicenter database, patients who underwent curative-intent liver resection for HCC from 2008 to 2017 were identified. Using random assignment, two-thirds of patients were assigned to a training cohort with the remaining one-third assigned to the validation cohort. Independent predictors of postoperative death within 6 months after surgery for HCC were identified and used to construct a nomogram model with a corresponding online calculator. The predictive accuracy of the calculator was assessed using C-index and calibration curves. Independent factors associated with death within 6 months of surgery included age, Child-Pugh grading, portal hypertension, alpha-fetoprotein level, tumor rupture, tumor size, tumor number and gross vascular invasion. A nomogram that incorporated these factors demonstrated excellent calibration and good performance in both the training and validation cohorts (C-indexes: 0.802 and 0.798). The nomogram also performed better than four other commonly-used HCC staging systems (C-indexes: 0.800 vs. 0.542-0.748). An easy-to-use online prediction calculator was able to identify patients at highest risk of death within 6 months of surgery for HCC. The proposed online calculator may help guide surgical decision-making to avoid futile surgery for patients with HCC.

Assessment of Textbook Outcome in Laparoscopic and Open Liver Surgery

Textbook outcome (TO) is a composite measure that captures the most desirable surgical outcomes as a single indicator, yet to date TO has not been defined and assessed in the field of laparoscopic liver resection (LLR) and open liver resection (OLR). To obtain international agreement on the definition of TO in liver surgery (TOLS) and to assess the incidence of TO in LLR and OLR in a large international multicenter database using a propensity-score matched analysis. Patients undergoing LLR or OLR for all liver diseases between January 2011 and October 2019 were analyzed using a large international multicenter liver surgical database. An international survey was conducted among all members of the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) and International Hepato-Pancreato-Biliary Association (IHPBA) to reach agreement on the definition of TOLS. The rate of TOLS was assessed for LLR and OLR before and after propensity-score matching. Factors associated with achieving TOLS were investigated. Textbook outcome, with TOLS defined as the absence of intraoperative incidents of grade 2 or higher, postoperative bile leak grade B or C, severe postoperative complications, readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin. A total of 8188 patients (4559 LLR; median age, 65 years [interquartile range, 55-73 years]; 2529 were male [55.8%] and 3629 OLR; median age, 64 years [interquartile range, 56-71 years]; 2204 were male [60.7%]) were included in the analysis of whom 69.1% achieved TOLS; 74.8% for LLR and 61.9% for OLR (P < .001). On multivariable analysis, American Society of Anesthesiologists grade III, previous abdominal surgery, histological diagnosis of colorectal liver metastases (odds ratio [OR], 0.656 [95% CI, 0.457-0.940]; P = .02), cholangiocarcinoma, non-CRLM, a tumor size of 30 mm or more, minor resection of posterior/superior segments (OR, 0.716 [95% CI, 0.577-0.887]; P = .002), anatomically major resection (OR, 0.579 [95% CI, 0.418-0.803]; P = .001), and nonanatomical resection (OR, 0.612 [95% CI, 0.476-0.788]; P < .001) were associated with a worse TOLS rate after LLR. For OLR, only histological diagnosis of cholangiocarcinoma (OR, 0.360 [95% CI, 0.214-0.607]; P < .001) and a tumor size of 30 mm or more (30-50 mm = OR, 0.718 [95% CI, 0.565-0.911]; P = .01; 50.1-100 mm = OR, 0.729 [95% CI, 0.554-0.960]; P = .02; >10 cm = OR, 0.550 [95% CI, 0.366-0.826]; P = .004) were associated with a worse TOLS rate. In this multicenter study, TOLS was found to be a useful tool for assessing patient-level hospital performance and may have utility in optimizing patient outcomes after LLR and OLR.