Prospective Registry Data Research Articles

Endometriosis and Negative Perception of the Medical Profession.

This study sought to identify factors independently associated with a negative impression of the medical profession in patients with endometriosis who were presenting to a tertiary referral centre. A cross-sectional analysis was conducted on a prospective data registry between December 2013 and June 2017 at a tertiary referral centre for pelvic pain and endometriosis. The main outcome variable, negative impression about the medical profession, was measured with the four-item subscale of the Endometriosis Health Profile-30 and divided into three groups: no (0), some (1-8), and many (9-16) negative impressions. Patients with a surgical and histological diagnosis of endometriosis were included. Postmenopausal women were excluded. Bivariate analyses determined significant associations (P < 0.05) between variables from the registry and the main outcome. Variables with a significant association were put into ordinal logistic regression with sequential backwards elimination. Negative impression of the medical profession was independently associated with previous surgery that did not help symptoms (adjusted odds ratio [aOR] 1.77; 95% confidence interval [CI] 1.09-2.87; P = 0.021), presentation to an emergency room in the past 3 months (aOR 1.90; 95% CI 1.17-3.07; P = 0.009), and previous visits to a complementary health care provider (aOR 2.16; 95% CI 1.42-3.29; P<0.0005), while controlling for an endometriosis pain-related morbidity composite variable. Negative perception of the medical profession in women with endometriosis was associated with surgical treatment failure, emergency room use, and accessing complementary health care. Each identified factor offers an opportunity for intervention to improve the perception of the medical profession among women with endometriosis.

Development of a Prospective Data Registry System for Non-muscle-Invasive Bladder Cancer Patients Incorporated in the Electronic Patient File System.

Purpose: To develop a prospective non-muscle-invasive bladder cancer (NMIBC) data registry by generating NMIBC-specific electronic case report forms (eCRFs) in our institution's electronic patient file system, and to report on the development and implementation of a prospective multicentric registry.Methods: Templates for data collection, including clinical outcome parameters and quality indicators, were developed in InfoPath™ as an eCRF and were incorporated in our hospital's electronic patient file system. Quality parameters for managing NMIBC patients that were identified by comprehensive literature review were included in the eCRFs. Three separate eCRFs were developed for the management of NMIBC patients: surgery report, bladder instillation form, and multidisciplinary team form.Results: In August 2013, we started a Flemish prospective clinical and pathological data registry for all patients undergoing transurethral resection of bladder tumor (TURBT) for NMIBC in four participating hospitals, three of which continued using this to date. Three more hospitals started enrolling in 2017, 2018, and 2019, respectively. Written reports of the registered clinical actions are automatically generated within the electronic medical file. When urologists complete these eCRFs, an automated ready-to-send letter to the general practitioner is generated. Up till May 2019, 2,756 TURBTs in 2,419 patients are included in the dataset. Currently, we are recruiting over 600 TURBTs every year.Conclusions: Easy-to-use eCRFs were developed and included in the electronic patient file system. This registration tool was implemented in 7 hospitals, 6 of which are still using it today. The register harvests important clinical data, while performing routine clinical practice. The data will be used to analyze real-life data of NMIBC patients, to challenge the existing guidelines, to create novel risk stratification tools, and to develop, monitor and validate quality parameters for NMIBC management.

The Efficacy of Carotid Surgery by Subgroups – The Concept of Stroke Preventing Power (SPP)

Introduction - Carotid endarterectomy (CEA) is performed to prevent strokes. Post hoc analyses of the major randomized controlled trials (RCTs) have emphasized the importance of avoiding delay prior to CEA, but of all subgroups the effect is least present in the largest of groups, male patients with a high grade stenosis (1, 2). However, in the numerous reports on national and international CEA series, patient selection data and complication rates are often reported separately. Our aim was to investigate the effect of the main individual factors on the expected effect on stroke prevention and to develop a reporting standard that could be applied to prospective registry data.

Improved growth of extremely and very preterm babies: Evaluation of a quality-of-care initiative.

To measure growth outcomes in preterm infants after introduction of a nutritional care bundle. A total of 509 infants of less than 32 weeks' gestation in a level III neonatal intensive care unit in the UK were studied until they were discharged home. Growth and feeding data were extracted from a prospective data registry for 18 months before and after the intervention. The intervention consisted of earlier routine bovine-derived multi-component fortification once the infant has reached 120ml/kg/day of enteral feed from the first day of life and an exclusive human milk diet with routine bovine-derived multi-component fortification of 120 mL/kg/day. After the intervention, growth velocity between birth and 28 days increased from 9.7 ± 4.1 to 12.2 ± 4.6 g/kg/day (mean ± standard deviation), and weight z score change decreased from -1.06 ± 0.56 to -0.76 ± 0.59 (P < 0.00002). For the entire group, growth velocity by the discharge home time point increased by 1 g/kg/day. However, the growth velocity of infants who were discharged on an exclusive human milk diet increased the most, from 10.8 ± 2.2 to 13.0 ± 2.8 g/kg/day (P < 0.00001), eliminating the difference seen between these infants and those discharged on infant formula before the intervention. The introduction of a simple nutritional package improved weight gain, particularly in infants fed exclusive human milk at discharge.

Incidence and Risk Factors for Severity of Postoperative Ileus After Colorectal Surgery: A Prospective Registry Data Analysis.

Defining severe postoperative ileus in terms of consequences could help physicians standardize the management of this condition. The recently described classification based on consequences requires further investigation. The aim of this study was to obtain a snapshot of postoperative ileus in patients undergoing colorectal surgery within enhanced recovery programs and to identify factors associated with non-severe and severe postoperative ileus. This prospective registry data analysis was conducted in 40 centers in five different countries. A total of 786 patients scheduled for colorectal surgery within enhanced recovery programs were included. The primary endpoint was the incidence rate of postoperative ileus as defined by Vather et al. RESULTS: A total of 121 patients experienced postoperative ileus (15.4%). Non-severe POI occurred in 48 patients (6.1%), and severe postoperative ileus occurred in 73 patients (9.3%). In multivariate analysis, the male gender and intra-abdominal complications were associated with severe postoperative ileus: odd ratio (OR) = 2.03 [95% confidence interval (CI) 1.14-3.59], p = 0.01 and OR = 3.60[95% CI 1.75-7.40], p < 0.0001, respectively. Conversely, open laparotomy and urinary retention were associated with non-severe POI: OR = 3.03[95% CI 1.37-6.72], p = 0.006 and OR = 2.70 [95% CI 0.89-8.23], p = 0.08, respectively. Postoperative ileus occurred in 15% of patients after colorectal surgery within enhanced recovery programs. For 60% of patients, this was considered severe. The physiopathology of these two entities could be different, severe POI being linked to intraabdominal complication, while non-severe POI being linked with risk factors for "primary" POI. The physician should pay attention to male patients having POI after colorectal surgery and look for features evocating intraabdominal complications.

Dysphagia After Primary Transoral Robotic Surgery With Neck Dissection vs Nonsurgical Therapy in Patients With Low- to Intermediate-Risk Oropharyngeal Cancer

A major goal of primary transoral robotic surgery (TORS) for oropharyngeal cancer is to optimize swallowing outcomes by personalized treatment based on pathologic staging. However, swallowing outcomes after TORS are uncertain, as are the outcomes compared with nonsurgical options. To estimate rates of acute dysphagia and recovery after TORS and to compare swallowing outcomes by primary treatment modality (TORS or radiotherapy). This case series study was a secondary analysis of prospective registry data from 257 patients enrolled from March 1, 2015, to February 28, 2018, at a single academic institution who, according to the AJCC Staging Manual, 7th edition TNM classification, had low- to intermediate-risk human papillomavirus-related oropharyngeal squamous cell carcinoma possibly resectable by TORS. Patients were stratified by primary treatment (75 underwent TORS and 182 received radiotherapy). Modified barium swallow (MBS) studies graded per Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and the MD Anderson Symptom Inventory-Head and Neck Module (MDASI-HN) questionnaires were administered at standard intervals. Prevalence and severity of dysphagia were estimated per DIGEST before and after TORS and 3 to 6 months after treatment. Moderate-severe dysphagia (DIGEST grade ≥2) was assessed using logistic regression and compared by primary treatment group. The MDASI swallowing symptom severity item scores during and after radiotherapy were compared using generalized estimating equations by treatment status at the start of radiotherapy, after induction, and after TORS. A total of 257 patients (mean [SD] age, 59.54 [9.07] years; 222 [86.4%] male) were included in the study. Dysphagia severity (per DIGEST) was significantly worse after TORS (r = -0.63; 95% CI, -0.78 to -0.44): 17 patients (22.7%; 95% CI, 13.8%-33.8%) had moderate-severe (DIGEST grade ≥2) acute post-TORS dysphagia significantly associated with primary tumor volume (odds ratio, 1.43; 95% CI, 1.11-1.84). DIGEST improved by 3 to 6 months but remained worse than that at baseline; at 3 to 6 months, the number of patients with DIGEST grade 2 or higher dysphagia was 5 (6.7%; 95% CI, 2.2%-14.9%) after primary TORS and 29 (15.9%; 95% CI, 10.9%-22.1%) after radiotherapy. At the start of radiotherapy, MDASI swallowing symptom severity item scores were significantly worse in the post-TORS group compared with postinduction (mean [SD] change, 2.6 [1.1]) and treatment-naive (mean [SD] change, 1.7 [0.3]) patients. This result inverted at radiotherapy end, and all groups converged at 3 to 6 months. Subacute swallowing outcomes were similar regardless of primary treatment modality among patients with low- to intermediate-risk oropharyngeal squamous cell carcinoma.

Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Prospective Patient Data Registry

Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Prospective Patient Data Registry

Downstaging of Hepatocellular Carcinoma Outside Milan Criteria Using SBRT

Orthotopic liver transplantation (OLT) offers the potential for cure in patients (pts) with hepatocellular carcinoma (HCC) who meet Milan criteria. Many pts are outside of Milan at diagnosis or after subsequent progression. Prior studies have shown that downstaging with local therapies can facilitate successful OLT leading to prolonged disease free survival. Stereotactic body radiotherapy (SBRT) is an established local therapy for HCC, though data for this specific indication is limited. From a survey of a large single institution database, the present study therefore reports on outcomes of patients treated with SBRT with the intention of downstaging to facilitate OLT. We surveyed our IRB-approved prospective liver SBRT data registry for pts not meeting Milan criteria and treated with the intention of downstaging. The primary outcome was undergoing OLT. Overall survival (OS) and progression-free survival (PFS) were estimated with Kaplan Meier methods. Time to transplant, as well as local, liver, and extrahepatic failure, were estimated with cumulative incidence functions. 14 pts treated between 2010 and 2018 met criteria for analysis. Median follow up was 27 months and 7 pts were alive at time of analysis. Most were male (n=11), and median age was 60. Median KPS was 80 (range 60-90). 5 pts were Child-Pugh (CP) A, 3 CP B, and 6 CP C. Median size of the largest single lesion was 4.2 cm (1.8 - 6.8 cm). The most common reason for not meeting Milan criteria was multiple lesions larger than 3 cm (n=8). Median AFP at time of SBRT was 40 (3 - 3255). 11 pts (79%) had undergone prior liver directed therapy. Pts were treated a median of 6.5 months after diagnosis. Median dose was 40 Gy, and median number of fractions was 5. There were no local failures. 11 pts (79%) were successfully downstaged to within Milan Criteria after SBRT. 5 pts (36%) had subsequent disease progression within the liver, 2 of whom were successfully salvaged and proceeded to transplant. 2 pts became ineligible for OLT due to extrahepatic failure. In total, 7 pts (50%) underwent OLT at a median 3.6 months after SBRT. Percent necrosis was reported for 5 pts, 4 (80%) of whom had greater than 67%. 2 pts (29%) had recurrence after OLT, one with metastases to lung and the other with solitary recurrence in the transplanted liver. Median OS was 33.0 months for all pts, 14.5 months in pts not undergoing OLT, and not reached for those who did undergo OLT. No pts developed radiation induced liver disease. SBRT provides excellent local control and high rates of radiographic downstaging, however progression within the liver is common. Despite this significant risk, a sizeable number of patients are able to proceed to transplant and achieve prolonged survival. SBRT should be considered for patients requiring downstaging to meet transplant criteria.

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer.

Patients with intestinal cancer (colorectal, appendiceal, and small bowel) with peritoneal metastases (PM) have a poor prognosis. We assessed whether pressurized intraperitoneal aerosol chemotherapy (PIPAC) together with systemic chemotherapy is an effective treatment option for these entities in palliative intent. Between November 2015 and February 2018, prospective data registry was performed (NCT03100708). Thirteen patients with intestinal cancer (median age 61 years [range 49-77]) underwent 26 PIPAC procedures with a median number of 2 interventions per patient (range 1-6). A chemoaerosol consisting of cisplatin/doxorubicin was administered during standard laparoscopy. The median peritoneal carcinomatosis index according to Sugarbaker before the first PIPAC was 14 (range 2-27), and the median ascites volume was 10 mL (range 0-6300 mL). Six patients who received 2 or more PIPAC procedures had decreased and stable ascites volumes, while only 1 patient displayed increased ascites. The median overall survival was 303 days (range 30-490) after the first PIPAC procedure. PIPAC offers a novel treatment option for patients with PM. Our data show that PIPAC is safe and well-tolerated. Ascites production can be controlled by PIPAC in patients with intestinal cancer. Further studies are required to document the significance of PIPAC within palliative therapy concepts. NCT03100708.

Ductal Carcinoma in situ after Core Needle Biopsy: In Which Cases Is a Sentinel Node Biopsy Necessary?

Introduction: In some hospitals it is still common practice to carry out a sentinel node biopsy (SNB) if ductal carcinoma in situ (DCIS) is determined in preoperative staging, although this is against international guidelines. The reason for this is because an infiltrative component can be demonstrated frequently in the final pathohistological examination. In this study, we wanted to investigate possible predictors for infiltrative growth, to select patients to do an SNB or to omit it. Material and Methods: All patients with DCIS in the core needle biopsy (CNB), who were treated with surgery including an SNB, were included in a prospective data registry. Patient characteristics were collected through physical examination, mammography and ultrasonography. All characteristics of the DCIS were noted. After surgery, the pathological results were collected. Results: From the 287 patients, 39 (13.6%) had an infiltrative component in the definitive pathological examination despite only DCIS in preoperative CNB. In total, there were only 14 (4.9%) positive SNBs, of which 11 patients had infiltrative growth in the breast tumor and 3 (1.2% of patients with DCIS alone in the final pathology) did not. In addition, characteristics of the CNB, including microcalcifications and comedonecrosis, did not show a statistically significant higher risk for infiltration. Discussion: Considering the low rates of positive SNBs in our population, we think that an SNB should not be performed in advance when DCIS is diagnosed, because if infiltrative growth is found in the final biopsy, an SNB could always be performed afterwards. Only if an SNB cannot be performed afterwards is an SNB indicated.

Persistent symptoms after endovenous thermal ablation may suggest proximal venous outflow obstruction

ObjectiveProximal venous outflow obstruction (PVOO) in the iliac veins and superficial venous disease are inter-related in ways not fully understood. We observed among our patients undergoing vein stent placement for PVOO a significant number having had prior endovenous thermal ablations (EVTA) in their history. This study was undertaken to better characterize these patients and develop an algorithm in their management. MethodsIn a combined retrospective and prospective data registry of 682 patients who underwent vein stent placement for chronic PVOO at a single institution from March 2013 to November 2017, 100 limbs of 99 patients (14.5% of all patients) had a history of EVTA or other superficial venous procedures before their vein stenting. Limbs with dilated truncal veins on ultrasound examination or limbs that underwent poststent EVTA or superficial venous procedures were excluded. The mean age of these 99 patients was 60.2 years (range, 28-88 years; standard deviation, 13.855). Fifty-one percent of the patients were male. The most common presenting symptom of the patient cohort was edema (n = 59), followed by venous-related skin changes (n = 22). ResultsBilateral stents were performed in 58%, with a mean number of 2.06 stents per patient. EVTA was the primary superficial vein procedure in 97%. Bilateral EVTA were performed in 53% and unilateral EVTA in 47%. The mean time between the first EVTA to vein stenting was 1202.7 days. Patients were followed at 30 days, 90 days, 6 months, 1 year, and >1 year. The outcome for each patient at each postoperative visit was compared with preoperative parameters (subject's assessment, physical examination, and provider assessment) and was scored as follows: -1 (worse than preoperative), 0 (no change), +1 (mildly improved), +2 (significantly improved), or +3 (completely recovered). The mean outcome score at 30 days was 1.63 (84 patients), 2.05 at 90 days (62 patients), 2.09 at 6 months (74 patients), 1.93 at 1 year (54 patients), and 1.97 at >1 year (39 patients). ConclusionsApproximately 15% of patients undergoing vein stent placement for chronic PVOO have an antecedent history of superficial venous disease and EVTA. PVOO should be considered and the patient evaluated accordingly if symptoms persisted or recurred after EVTA. Vein stent placement among these patients with PVOO will result in further symptomatic relief, but complete symptomatic relief is not observed in everyone. The algorithm for the management of these patients warrants further investigation.

Sensitivity of Biochemical and Imaging Findings for the Diagnosis of Acute Pancreatitis in Children

To determine the diagnostic sensitivity of serum biomarkers and imaging in the diagnosis of acute pancreatitis in children. This was a cross-sectional analysis of prospective registry data for children (age <21years) whose first documented attack of acute pancreatitis occurred between March 2013 and October 2016 at a single-institution, tertiary care center. Main outcome was sensitivity of serum biomarkers and of imaging modalities, measured via descriptive statistics. In total, 112 children met the criteria for acute pancreatitis; 57 (51%) were male with a median age of 13.4years (IQR 9.3-15.8years). Serum amylase and lipase levels were obtained in 85 (76%) and 112 (100%) patients, respectively. Imaging was performed in 98 (88%) patients, with abdominal ultrasound (US) performed in 84 (75%) and computed tomography and/or magnetic resonance imaging performed in 46 (41%) patients. Fifty-three (47%) patients metall 3 diagnostic criteria (clinical, biochemical, and imaging) for acute pancreatitis. Laboratory testing had a 5.4% false-negative rate for acute pancreatitis. Serum lipase alone and amylase alone were 95% (95% CI 89%-98%) and 39% (95% CI 28%-50%) sensitive for acute pancreatitis, respectively. Imaging (any modality) was 61% sensitive (95% CI 51%-71%) for acute pancreatitis with a 34% false-negative rate. US alone was 52% (95% CI 41%-63%) sensitive for acute pancreatitis and computed tomography/magnetic resonance imaging was 78% (95% CI 63%-89%) sensitive. Combinations of diagnostic criteria performed no better than laboratory testing alone. The majority of children coming to medical attention with their first documented occurrence of acute pancreatitis have characteristic symptoms. Serum lipase is highly sensitive for the diagnosis of acute pancreatitis, and serum amylase is moderately sensitive. Imaging, particularly US, is only moderately sensitive, and cross-sectional imaging provides greater sensitivity for diagnosing acute pancreatitis.

Women's health in Northwestern Syria: Findings from Healthy-Syria 2017 study.

ABSTRACTObjectives:Since the uprising in 2011, there have been limited health-care data from inside Syria regarding women’s health. This study aimed to provide an updated account of women’s health, including pregnancy, perinatal care, childbirth, and other conditions to identify obstacles and challenges to health-care delivery in Northwestern Syria.Methods:This is a prospective data registry study, using a medical electronic records system that builds on the International Classification of Diseases, Tenth Revision (ICD-10) codes. We collected data from one medical center in Northwestern Syria during 2017. We conducted a survey to understand patients’ knowledge of and barriers limiting antenatal care (ANC).Results:We studied 7213 patients’ health status and surveyed 134 regarding ANC. Prenatal care, delivery, and miscarriage treatment represented the most common (70%) reasons for women’s health-care visits, followed by menstrual disorders (17%). From 2057 delivery records, 70% delivered vaginally and 30% required cesarean delivery. Our findings showed that 1169 (24%) of the pregnant women (4936) in 2017 were adolescents, of them 22 (0.44%) were 14 years old. Regarding ANC visits, 85% of respondents did not have a single ANC visit in the first trimester, 82% had no visits in the second trimester, and 44% had no visits in the third trimester. Thirty-one percent had no ANC visit throughout the entire pregnancy. Only 13% had postnatal care (PNC) visits. Women who live in the refugee camp are 2.7 times less likely to meet the World Health Organization (WHO) criteria for focused ANC (FANC = 4 visits) compared to those who reside in town (P < 0.001), with only 14% having met the FANC. The major barrier to ANC is related to transportation (34%), followed by factors related to the study center (29%) and knowledge and education (19%). We estimated the number of obstetrics-gynecology doctors per 1000 populations to be 0.02.Conclusions:We found a huge deficiency in ANC and PNC visits, a high adolescent birth rate, and a higher cesarean-to-vaginal delivery ratio than what is recommended by the WHO. We also found a severe shortage in the number of obstetrician-gynecologists serving this population.

Intensity-Modulated Proton and Carbon-Ion Radiation Therapy in the Management of Head and Neck Sarcomas.

PurposeWe report our experience of intensity‐modulated proton and carbon‐ion radiotherapy (IMPT/IMCT) for head and neck sarcomas (HNS).Methods and MaterialsAn analysis of the ongoing prospective data registry from the Shanghai Proton and Heavy Ion Center (SPHIC) for patients with HNS was conducted. The 12‐ and 24‐month rates of local recurrence‐free, overall, distant metastasis‐free, progression‐free survival (LRFS, OS, DMFS, and PFS), and acute/late toxicities were calculated. The prognostic factors for the effectiveness of the treatment were also analyzed.ResultsBetween 7/2014 and 5/2018, 51 consecutive patients with HNS received definitive doses of IMCT (41 cases), IMPT (two cases), or their combination (eight cases). One patient had R0 resection and another treated on the Chinese Food and Drug Administration registration trial received IMPT only. Twenty‐seven patients were treated according to various dose escalation trials or institutional protocols using IMCT or IMPT + IMCT boost. Twenty‐two patients with locoregional recurrence (10 and four patients failed surgery or surgery followed by radiotherapy, respectively) or radiation‐induced second primary sarcomas (eight patients) received salvage particle radiotherapy. With a median follow‐up time of 15.7 months, four patients with second primary sarcoma died. The 1‐ and 2‐year OS, PFS, LRFS, and DMFS rates for the entire cohort were 92.9% vs 90%, 73.6% vs 57.4%, 88.4% vs 78.9%, and 84.6% vs 76.5%, respectively. Those rates for patients without prior radiotherapy were 100% vs 100%, 82.1% vs 65.8%, 93.6% vs 85.3%, and 88.4% vs 79.5%, respectively. Multivariate analyses revealed that re‐irradiation was an independent prognostic factor for both LRFS and PFS (P = 0.015 and 0.037, respectively). In addition, gross tumor volume (GTV) was an independent prognostic factor for PFS (P = 0.048). One patient experienced Grade 3 acute toxicity (oral mucositis); another experienced Grade 4 acute event (hemorrhage) which required embolization. He lately died from hemorrhage (Grade 5) at 3.4 months after the completion of treatment. No patient experienced radiation‐induced acute/late toxicity of ≥ Grade 2 otherwise.ConclusionWith few observed acute/late toxicities, IMPT/IMCT provided effective short‐term tumor control in our patients with HNS. Further investigations, preferably in a prospective fashion, will be required to confirm the efficacy and toxicities of IMPT/IMCT in this group of patients.

Preoperative Opioids and 1-year Patient-reported Outcomes After Spine Surgery.

Longitudinal Cohort Study. Determine 1-year patient-reported outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosages in patients undergoing elective spine surgery. Back pain is the most disabling condition worldwide and over half of patients presenting for spine surgery report using opioids. Preoperative dosage has been correlated with poor outcomes, but published studies have not assessed the relationship of both preoperative chronic opioids and opioid dosage with patient-reported outcomes. For patients undergoing elective spine surgery between 2010 and 2017, our prospective institutional spine registry data was linked to opioid prescription data collected from our state's Prescription Drug Monitoring Program to analyze outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosage, while adjusting for confounders through multivariable regression analyses. Outcomes included 1-year meaningful improvements in pain, function, and quality of life. Additional outcomes included 1-year satisfaction, return to work, 90-day complications, and postoperative chronic opioid use. Of 2128 patients included, preoperative chronic opioid therapy was identified in 21% and was associated with significantly higher odds (adjusted odds ratio [95% confidence interval]) of not achieving meaningful improvements at 1-year in extremity pain (aOR:1.5 [1.2-2]), axial pain (aOR:1.7 [1.4-2.2]), function (aOR:1.7 [1.4-2.2]), and quality of life (aOR:1.4 [1.2-1.9]); dissatisfaction (aOR:1.7 [1.3-2.2]); 90-day complications (aOR:2.9 [1.7-4.9]); and postoperative chronic opioid use (aOR:15 [11.4-19.7]). High-preoperative opioid dosage was only associated with postoperative chronic opioid use (aOR:4.9 [3-7.9]). Patients treated with chronic opioids prior to spine surgery are significantly less likely to achieve meaningful improvements at 1-year in pain, function, and quality of life; and less likely to be satisfied at 1-year with higher odds of 90-day complications, regardless of dosage. Both preoperative chronic opioid therapy and high-preoperative dosage are independently associated with postoperative chronic opioid use. 2.

Angioedema in Stroke Patients With Thrombolysis.

Background and Purpose- Oral angioedema (OA) is a rare but life-threatening complication in patients with ischemic stroke receiving intravenous thrombolysis with r-tPA (recombinant tissue-type plasminogen activator). This study intended to determine associations between thrombolysis-related OA and ischemic stroke lesion sites using a voxel-wise lesion analysis. Methods- Prospective registry data were used to identify ischemic stroke patients with thrombolysis-related OA between 2002 and 2018. For the study registry, ethics approval was obtained by the Ethics Committee of the Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg (clinical registry registration: 377_17Bc). Ischemic stroke patients with thrombolysis treatment but without OA admitted in the years 2011 and 2012 comprised the control group. Ischemic lesions were manually outlined on magnetic resonance imaging (1.5T or 3T) or computed tomographic scans and transformed into stereotaxic space. We determined the lesion overlap and compared the absence or presence of OA voxel-wise between patients with and without lesions in a given voxel using the Liebermeister test. Stroke severity was rated using the National Institutes of Health Stroke Scale score, and blood pressure, heart rate, blood glucose levels, and body temperature were determined on admission. Results- Fifteen ischemic stroke patients with thrombolysis-related OA were identified. The voxel-wise analysis yielded associations between OA and ischemic lesions in the insulo-opercular region with a right hemispheric dominance. Mean blood pressure was significantly lower in patients with OA than in controls. Age, National Institutes of Health Stroke Scale scores, infarct volumes, heart rate, and blood glucose levels did not differ between patients with and without OA. Conclusions- The voxel-wise analysis linked thrombolysis-related OA to right insulo-opercular lesions. The lower blood pressure in patients with thrombolysis-related OA may reflect bradykinin effects causing vasodilatation and increasing vascular permeability.

MON-101 The LD Lync Study: Natural History Study of Lipodystrophy Syndromes: Early Lessons from the Pilot Data

Lipodystrophy syndromes are a heterogeneous cluster of rare diseases characterized by a paucity or abnormal distribution of fat which are also associated with insulin resistance and ectopic lipid deposition. Owing to the rarity of the syndromes, the natural history and exact evolution of clinical, and psychosocial aspects are largely unknown. In March, 2018 we launched a prospective data registry- the LD Lync. The registry will be expanded to multiple centers across the US to ensure maximum number of participants. Anticipated sample size is 500. The goal is to collect data on various aspects of lipodystrophy syndromes (LD) including demographic, morphometric, clinical, genetic, socioeconomic characteristics and novel patient related end points such as quality of life, hunger and pain scales, mood and anxiety, and eating habits. During the past 8 months, we initiated the pilot data collection at our center. As of this month, we collected data on 61 affected individuals (49F/12 M, mean±SD Age: 44±15, with 4 acquired generalized LD (AGL), 3 acquired partial LD (APL), 48 familial partial LD (FPLD), 1 congenital generalized LD (CGL), 5 atypical LD). The median (IQR) difference between symptoms onset and time of diagnosis was 14y (24). The prevalence (95%CI) of diabetes, hypertriglyceridemia, nonalcoholic fatty liver disease were 83% (71-92), 81% (69-90), and 78% (67-89) respectively. In terms of significant organ manifestations, 10% (95%CI:2-18) had myocardial infarction, 3% (0-8) had heart failure, 23% (14-35) had pancreatitis, and 8% (1-16) had malignancy. The (Median: IQR) age of diagnosis of these diseases was heterogeneous: diabetes 31y (26), hypercholesterolemia 27y (20), hypertriglyceridemia 25y (17), fatty liver disease 33y (31), and myocardial infarction 50y (16) . Out of 60 patients, 70% (58-82) are on lipid lowering drugs, 77% (66-87) on glucose lowering drugs, 37% (24-49) on hormones, and 68% (57-80) on anti-hypertensives. Out of the 61 who completed the GAD-7, IPAQ-2002, Modified 13 item binge eating scale, SF-36 scale, PHQ-9, and the perceived financial burden scale, 33% (95% CI, 21-45) had minimal anxiety, 28.3% (17-40) had mild anxiety, 20% (10-30) had moderate anxiety, and 18% (8-28) had severe anxiety. On quality of life, with 100% being the perfect score, our patients had low scores mean(95%CI): 37%(34-40) on emotional wellbeing, 49% (43-55) on social functioning, 55% (48-62) on pain level, and 32% (27-37) on general health. On the financial impact of lipodystrophy: 46% (33-58) reported moderate or higher levels of burden. We conclude that the lipodystrophy syndromes present with a large burden not only in terms of known medical complications but also in socioeconomic and psychosocial aspects of life. Expansion of this registry to include multiple sites in the US and across the globe will improve our understanding of all aspects of these diseases.

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†.

OBJECTIVESDecellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date.METHODSProspective European multicentre trial evaluating DPH for pulmonary valve replacement. Matched comparison of DPH to bovine jugular vein (BJV) conduits and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures.RESULTSIn total, 121 patients (59 female) were prospectively enrolled (August 2014–December 2016), age 21.3 ± 14.4 years, DPH diameter 24.4 ± 2.8 mm. No adverse events occurred with respect to surgical handling; there were 2 early deaths (30 + 59 years) due to myocardial failure after multi-valve procedures and no late mortality (1.7% mortality). After a mean follow-up of 2.2 ± 0.6 years, the primary efficacy end points mean peak gradient (16.1 ± 12.1 mmHg) and regurgitation (mean 0.25 ± 0.48, grade 0–3) were excellent. One reoperation was required for recurrent subvalvular stenosis caused by a pericardial patch and 1 balloon dilatation was performed on a previously stented LPA. 100% follow-up for DPH patients operated before or outside the trial (n = 114) included in the ESPOIR Registry, age 16.6 ± 10.4 years, diameter 24.1 ± 4.2 mm, follow-up 5.1 ± 3.0 years. The combined DPH cohort, n = 235, comprising both Trial and Registry data showed significantly better freedom from explantation (DPH 96.7 ± 2.1%, CH 84.4 ± 3.2%, P = 0.029 and BJV 82.7 ± 3.2%, P = 0.012) and less structural valve degeneration at 10 years when matched to CH, n = 235 and BJV, n = 235 (DPH 61.4 ± 6.6%, CH 39.9 ± 4.4%, n.s., BJV 47.5 ± 4.5%, P = 0.029).CONCLUSIONS: Initial results of the prospective multicentre ESPOIR Trial showed DPH to be safe and efficient. Current DPH results including Registry data were superior to BJV and CH.Trial registration clinicaltrials.gov identifier: NCT 02035540.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases in Solid Organ Graft Recipients: First Experience.

BackgroundTherapy of peritoneal metastases (PM) in solid organ transplant recipients is challenging. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) might constitute a new therapeutic opportunity for these patients.Material/MethodsThis was a single-center, retrospective analysis of prospective registry data (NCT03210298) in a tertiary care center between 1.7.2016 and 31.12.2017. Intraperitoneal administration of oxaliplatin 92 mg/m2 body surface or a combination of cisplatin 7.5 mg/m2 and doxorubicin 1.5 mg/m2, repeated every 6 weeks. Objective tumor response was documented via histology (Peritoneal Regression Grading Score, PRGS), adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.ResultsOut of 71 consecutive patients treated with PIPAC, 2 patients (2.8%) were solid organ transplant recipients. The first patient had metachronous PM of colonic cancer origin after liver transplantation. The second patient had synchronous PM of pancreatic cancer origin after combined kidney-pancreas transplantation. After repeated combined systemic and PIPAC chemotherapy, objective histological response was documented in both patients. No adverse events >CTCAE 2 were recorded. There was no measurable liver or renal toxicity. PIPAC procedures could be repeated (2, resp. 3 cycles) without any interruption of immunosuppressive medication or impairment of respective plasmatic drug levels. The first patient passed away 7 months after the first PIPAC, the second patient was still alive after 8 months.ConclusionsPIPAC can induce objective regression of PM in solid organ transplant recipients without inducing organ toxicity or interfering with immunosuppressive therapy.

Development of a Radiation Oncology-Specific Prospective Data Registry for Research and Quality Improvement: A Clinical Workflow-Based Solution.

The computerized paperless medical recording system has transformed the modern health information system and serves as an idea platform for registry development, particularly in a specialty such as radiation oncology, where technologic advances continue to generate unprecedented amounts of complex data. We present our single-institution experience with the development of a real-time observational registry fully integrated into the process of routine clinical workflow and show how this has the potential to transform research and quality assurance. From May 2011 to May 2016, physicians prospectively inputted data during the process of routine charting on patients seen in clinic. Using a customized interface established between an in-house registry and a commercially available, hospital-based electronic medical record system (Epic Systems, Verona, WI), a departmentally based parser was created for automatic data deposition, which was also linked to the Aria Treatment Planning Station (Varian Medical Systems, Palo Alto, CA). The total number of data fields embedded per disease site ranged from nine to 73 (median, 21 fields). A total of 12,341 patients were logged into the registry, of whom 6,911 completed a course of radiation therapy. Primary disease sites were prostate (n = 2,340), breast (n = 2,159), head or neck (n = 1,426), primary CNS (n = 1,338), lung (n = 749), brain metastasis (n = 739), GI (n = 638), gynecologic (n = 534), and other or benign (n = 3,618). A total of 54 independent, investigator-initiated research studies have been initiated using queries supported by the registry from multiple access points, of which 23 were published in peer-reviewed journals. The development of a radiation oncology-specific registry enhanced research efficiency and facilitated quality assurance by producing clear and quality information to guide clinical practice.