Continuous versus interrupted abdominal wall closure after emergency midline laparotomy: CONTINT: a randomized controlled trial [NCT00544583].

BACKGROUND: High-level evidence regarding the technique of abdominal wall closure for patients undergoing emergency midline laparotomy is sparse. Therefore, we conducted a randomized controlled trial (RCT) to evaluate the efficacy and safety of two commonly applied abdominal wall closure strategies after primary emergency midline laparotomy. METHODS/DESIGN: CONTINT was a multi-center pragmatic open-label exploratory randomized controlled parallel trial. Two different abdominal wall closure strategies in patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity were compared: the continuous, all-layer suture and the interrupted suture technique. The primary composite endpoint was burst abdomen within 30 days after surgery or incisional hernia within 12 months. As reliable data on this composite primary endpoint were not available for patients undergoing emergency surgery, it was planned to initially recruit 80 patients and conduct an interim analysis after these had completed the 12 months follow-up. RESULTS: From August 31, 2009, to June 28, 2012, 124 patients were randomized of whom 119 underwent surgery and were analyzed according to the intention-to-treat (ITT) principal. The primary composite endpoint did not differ between the continuous suture (C: 27.1%) and the interrupted suture group (I: 30.0%). None of the individual components of the primary endpoint (reoperation due to burst abdomen after 30 days (C: 13.5%, I: 15.1%) and reoperation due to incisional hernia (C: 3.0%, I:11.1%)) differed between groups. Time needed for fascial closure was longer in the interrupted suture group (C: 12.8 ± 4.5 min, I: 17.4 ± 6.1 min). BMI was associated with burst abdomen during the first 30 days with an OR of 1.17 (95% CI 1.04-1.32). CONCLUSION: This RCT showed no difference between continuous suture with slowly absorbable suture versus interrupted rapidly absorbable sutures after primary emergency midline laparotomy in rates of postoperative burst abdomen and incisional hernia after one year. However, the trial was stopped after the interim analysis due to futility as there was no chance to show superiority of one suture technique.

Comparison of Fluid Replacement with Sterofundin ISO® vs. Deltajonin® in Infants Undergoing Craniofacial Surgery-A Retrospective Study.

In recent decades, infusion solutions such as NaCl 0.9% and lactate Ringer's solution have been replaced in clinical practice. Since 2017, the national guidelines for perioperative infusion therapy in children recommend balanced isotonic solutions to maintain fluid balance. The composition of balanced infusion solutions varies with respect to their electrolyte content. Hyperchloremia may be mistaken for hypovolemia and may interfere with volume therapy in pediatric patients. Sterofundin ISO® balanced solution contains 127 mmol/L chloride and may cause hyperchloremic acidosis if administered in large volumes. OBJECTIVES: The purpose of this study was to compare the effects of Sterofundin ISO® (SF) therapy with the balanced isochloremic solution Deltajonin® (DJ) (106 mmol/L chloride) on the acid-base status in infants undergoing craniofacial surgery. METHODS: This retrospective, non-blinded study included 100 infants undergoing craniectomy due to isolated nonsyndromic sagittal craniosynostosis. The first 50 infants received Sterofundin ISO®. Due to changes in national guidelines, the infusion was changed to the isoionic Deltajonin® in an additional 50 infants in 2017. Pre- and postoperative values of chloride, pH, base excess, bicarbonate, and albumin and phosphate were determined, and the strong-ion difference, strong-ion gap, anion gap, and weak acids were calculated. RESULTS: Both groups were comparable in terms of their age, sex, underlying disease, preoperative electrolytes (except K at 3.9 ± 0.3 mmol/L (SF) vs. 4.1 ± 0.3 mmol/L (DJ) and lactate 8.7 ± 2.1 (SF) vs. 9.6 ± 2.6 mmol/L (DJ)). In the Sterofundin ISO® group, hyperchloremic metabolic acidosis was observed in 19 patients, whereas only 2 infants in the Deltajonin® group had hyperchloremic metabolic acidosis. The postoperative chloride level was 111 ± 2.7 mmol/L (SF) vs. 108 ± 2.4 mmol/L (DJ). The difference in anion gap was 12.5 ± 3.0 mmol/L (SF) vs. 14.6 ± 2.8 mmol/L (DJ), and the difference in SIDa (apparent strong-ion difference) was 30.9 mmol/L (SF) vs. 33.8 mmol/L (DJ). CONCLUSIONS: Hyperchloremic acidosis can be induced by the volume replacement with high-chloride-concentration crystalloids such as Sterofundin ISO®. This can be detected using the Stewart model.

What Is the Correlation between Clinical and Radiographic Findings in Patients with Advanced Osteoarthritis of the Knee?

Knee range of motion and patient-reported outcome measures (PROMs) are often used as screening tools to assess the severity of knee osteoarthritis and guide the decision to refer patients to an arthroplasty clinic. However, there is little understanding regarding the correlation between these factors. Thus, the purpose of this study was to determine the correlation between patient-reported clinical function measured with the Oxford Knee Score (OKS), pain assessed using the visual analog scale (VAS), knee range of motion (ROM), and characteristic radiographic features in patients with advanced osteoarthritis of the knee. A prospective analysis of a consecutive series of 138 patients with advanced unilateral osteoarthritis (OA) of the knee was performed. The severity of radiographic OA was classified according to the most commonly used Kellgren and Lawrence classification (K&L). Spearman's rank correlation analysis and multiple linear regression analysis were performed. The OKS was used as a dependent variable and was adjusted for pain, ROM, and nine standardized radiographic parameters on multiple views of the tibiofemoral and patellofemoral joint. OKS and pain correlated weakly with the K&L grade (r = -0.289; p = 0.001; r = 0.258; p = 0.002). K&L grade and the degree of patellofemoral joint space narrowing were identified as independent factors being associated with a poorer OKS (coefficient -4.528, p = 0.021; coefficient -2.211, p = 0.038). Slightly worse results were identified for OKS and pain in patients with K&L grade 4 osteoarthritis compared to patients with K&L grade 3 osteoarthritis (∆OKS 5.5 points, p < 0.001; ∆VAS 1.7 points, p = 0.003). There was no significant difference for passive range of motion between patients with K&L grade 3 or 4. When counseling patients with advanced knee osteoarthritis who may be eligible for knee arthroplasty, it is essential to give primary consideration to pain levels and self-reported limitations experienced during daily activities. Relying solely on knee ROM and PROMs is not an effective screening method for guiding the decision to refer patients to an arthroplasty clinic.

How is hip anatomy reconstruction and inlay wear associated up to 10 years after primary THA using ceramic on highly crosslinked polyethylene bearings?

INTRODUCTION: Conventional polyethylene (PE) wear has been reported to be associated with femoral offset reconstruction and cup orientation after THA. Thus, the present study aimed (1) to determine the polyethylene wear rate of 32 mm ceramic heads with highly cross-linked polyethylene (HXLPE) inlays up to 10 years postoperatively and (2) to identify patient and surgery-related factors affecting the wear rate. METHODS: A prospective cohort study was performed, investigating 101 patients with 101 cementless THAs and ceramic (32 mm) on HXLPE bearings after 6-24 months, 2-5 years and 5-10 years postoperatively. The linear wear rate was determined using a validated software (PolyWare®, Rev 8, Draftware Inc, North Webster, IN, USA) by two reviewers, blinded to each other. A linear regression model was used to identify patient and surgery-related factors on HXLPE -wear. RESULTS: After an initial bedding-in phase of 1 year after surgery, the mean linear wear rate was 0.059 ± 0.031 mm/y at ten years (mean 7.7 years; SD 0.6 years, range 6-10), being below the osteolysis relevant threshold of 0.1 mm/year. The regression analysis demonstrated that age at surgery, BMI, cup inclination or anteversion and the UCLA score were not associated with the linear HXLPE-wear rate. Only increased femoral offset showed a significant correlation with an increased HXLPE-wear rate (correlation coefficient of 0.303; p = 0.003) with a moderate clinical effect size (Cohen's f²=0.11). CONCLUSION: In contrast to conventional PE inlays, hip arthroplasty surgeons may be less concerned about osteolysis-related wear of the HXLPE if the femoral offset is slightly increased. This allows focusing on joint anatomy reconstruction, hip stability and leg length.

Patient- and cycle-specific factors affecting the outcome of frozen-thawed embryo transfers.

PURPOSE: This study attempted at identifying the main parameters influencing the outcome of frozen embryo transfers. METHODS: This is a single-center retrospective cohort study of 830 frozen-embryo-transfer cycles performed at a German university hospital from January 2012 to December 2016. Main outcome parameters were the clinical pregnancy and live birth rate. Twelve patient- and cycle-dependent factors were analyzed in terms of their influence on the outcome of frozen embryo transfers. Multivariate logistic regression analysis was used for the modelling of the dependency of the different parameters on outcomes. RESULTS: The clinical pregnancy rate in our study was 25.5%, the live birth rate was 16.1% with an average maternal age of 34.2 years at the time of the oocyte retrieval. In the univariate analysis age, number of transferred embryos, blastocyst versus cleavage stage transfer, embryo quality and mode of endometrial preparation affected the birth rate significantly. The birth rate after artificial endometrial preparation was significantly lower than the birth rate after transfers in modified natural cycles (12.8 versus 20.6% with p = 0.031). The multivariate logistic regression analysis showed a significant independent influence of age, number of transferred embryos, culture duration and mode of endometrial preparation on the frozen embryo transfer success rates. Body mass index, nicotine abuse, a history of PCO syndrome or endometriosis and the co-transfer of a second poor-quality embryo to a good-quality embryo appeared to be irrelevant for the outcome in our collective. CONCLUSION: Age, number of transferred embryos, embryo culture duration and the mode of endometrial preparation are independent predictive factors of frozen embryo transfer outcomes.

Complications and revisions in anatomic and reverse short stem shoulder arthroplasty.

INTRODUCTION: One current trend in the field of shoulder arthroplasty is a design shift to shorter and metaphyseal fixed humeral stem components. The aim of this investigation is to analyze complications resulting in revision surgery after anatomic (ASA) and reverse (RSA) short stem arthroplasty. We hypothesize that complications are influenced by the type of prosthesis and indication for arthroplasty. MATERIALS AND METHODS: A total of 279 short stem shoulder prostheses were implanted by the same surgeon (162 ASA; 117 RSA), and 223 of these prostheses were implanted as primary procedures; in 54 cases, arthroplasty was performed secondary to prior open surgery. Main indications were osteoarthritis (OA) (n = 134), cuff tear arthropathy (CTA) (n = 74) and posttraumatic deformities (PTr) (n = 59). Patients were evaluated at 6 weeks (follow-up 1; FU1), 2 years (FU2) and the time span of the last follow-up defined as FU3 with a minimum FU of 2 years. Complications were categorized into early complications (within FU1), intermediate complications (within FU2) and late complications (> 2 years; FU3). RESULTS: In total, 268 prostheses (96.1%) were available for FU1; 267 prostheses (95.7%) were available for FU2 and 218 prostheses (77.8%) were available for FU3. The average time for FU3 was 53.0 months (range 24-95). A complication leading to revision occurred in 21 prostheses (7.8%), 6 (3.7%) in the ASA group and 15 (12.7%) in the RSA group (p < 0.005). The most frequent cause for revision was infection (n = 9; 42.9%). After primary implantation, 3 complications (2.2%) occurred in the ASA and 10 complications (11.0%) in the RSA group (p < 0.005). The complication rate was 2.2% in patients with OA, 13.5% in CTA and 11.9% in PTr. CONCLUSIONS: Primary reverse shoulder arthroplasty had a significantly higher rate of complications and revisions than primary and secondary anatomic shoulder arthroplasty, respectively. Therefore, indications for reverse shoulder arthroplasty should be critically questioned in each individual case.

Perioperative chemotherapy with 5-FU, leucovorin, oxaliplatin, and docetaxel (FLOT) for esophagogastric adenocarcinoma: ten years real-life experience from a surgical perspective.

PURPOSE: According to the results of FLOT4 trial, perioperative FLOT chemotherapy improved overall survival (OS) in locally advanced, resectable esophagogastric adenocarcinoma (EGA) compared to perioperative ECF/ECX. We report real-life data 10 years after introduction of perioperative FLOT at our institution. METHODS: Survival of 356 consecutive EGA patients (cT3/4 and/or cN + and/or cM1) who underwent curative surgical resection was retrospectively analysed from a prospective database. A total of 263 patients received preoperative chemotherapy according to FLOT protocol and 93 patients received an epirubicin/platinum/5FU-based regimen (EPF). Propensity score matching (PSM) according to pretretment characteristics was performed to compensate for heterogeneity between groups. RESULTS: Median OS did not differ between groups (FLOT/EPF 52.1/46.4 months, p = 0.577). After PSM, survival was non-significantly improved after FLOT compared to EPF (median OS not reached/46.4 months, p = 0.156). Perioperative morbidity and mortality did not differ between groups. Histopathologic response rate was 35% after FLOT and 26% after EPF (p = 0.169). R0 resection could be achieved more frequently after FLOT than after EPF (93%/79%, p = 0.023). CONCLUSION: Overall survival after perioperative FLOT followed by surgery is comparable to clinical trials. However, collective real-life application of FLOT failed to provide a significant survival benefit compared to EPF. In clinical reality, patient selection is triggered by age, comorbidity, tumor localization, and clinical tumor stage. Yet matched analyses support FLOT4 trial findings.

RSV-CLASS -Clinical Assessment Severity Score: An easy-to-use clinical disease severity score for respiratory syncytial virus infection in hospitalized children.

Respiratory syncytial virus (RSV) is the most common cause of acute respiratory tract infection in infants and young children often leading to severe disease requiring hospitalization. However, validated tools for systematic assessment of disease severity are lacking. This study aimed at creating and validating a standardized, simple-to-use disease severity score for RSV infection in children-the RSV-CLASS (Clinical Assessment Severity Score). Therefore, data from over 700 RSV-infected children over six winter seasons (2014-2020) was analyzed using univariate and multiple regression analyses for the prediction of lower respiratory tract infection (LRTI) as a proxy for a severe course of the disease. Testing a broad range of respiratory symptoms, they eventually yielded seven items. Performing stepwise selection, these were reduced to the final four items: cough, tachypnea, rales, and wheezing, each receiving one point in the proposed score named RSV-CLASS. The score was calculated for children in two cohorts A and B, one for development and one for validation, with an area under the curve of 0.90 and 0.87, respectively. With a score value of 3 or 4, 97.8% and 100% of the children, respectively, were admitted with LRTI and classified correctly. The RSV-CLASS is a disease severity score based on a neutral, analytical approach using prospective data from a large study cohort. It will contribute to systematically assessing the disease severity of RSV infection and can be used for evidence-based clinical decision-making as well as for research settings.

Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscopy 'Histolog® scanner' for breast margin assessment in comparison with conventional specimen radiography.

PURPOSE: The Histolog® Scanner (SamanTree Medical SA, Lausanne, Switzerland) is a large field-of-view confocal laser scanning microscope designed to allow intraoperative margin assessment by the production of histological images ready for assessment in the operating room. We evaluated the feasibility and the performance of the Histolog® Scanner (HS) to correctly identify infiltrated margins in clinical practice of lumpectomy specimens. It was extrapolated if the utilization of the HS has the potential to reduce infiltrated margins and therefore reduce re-operation rates in patients undergoing breast conserving surgery (BCS) due to a primarily diagnosed breast cancer including ductal carcinoma in situ. METHODS: This is a single-center, prospective, non-interventional, diagnostic pilot study including 50 consecutive patients receiving BCS. The complete surface of the specimen was scanned using the HS intraoperatively. The surgery and the intraoperative margin assessment of the specimen was performed according to the clinical routine consisting of conventional specimen radiography as well as the clinical impression of the surgeon. Three surgeons and an experienced pathologist assessed the scans produced by the HS for cancer cells on the surface. The potential of the HS to correctly identify involved margins was compared to the results of the conventional specimen radiography alone as well as the clinical routine. The histopathological report served as the gold standard. RESULTS: 50 specimens corresponding to 300 surfaces were scanned by the HS. The mean sensitivity of the surgeons to identify involved margins with the HS was 37.5% ± 5.6%, the specificity was 75.2% ± 13.0%. The assessment of resection margins by the pathologist resulted in a sensitivity of 37.5% and a specificity of 81.0%, while the local clinical routine resulted in a sensitivity of 37.5% and a specificity of 78.2%. CONCLUSION: Acquisition of high-resolution histological images using the HS was feasible in clinical practice. Sensitivity and specificity were comparable to clinical routine. With more specific training and experience on image interpretation and acquisition, the HS may have the potential to enable more accuracy in the margin assessment of BCS specimens.

Effect of Clomethiazole Vs. Clorazepate on Hepatic Fat and Serum Transaminase Activities in Alcohol-Associated Liver Disease: Results from a Randomized, Controlled Phase II Clinical Trial.

AIMS: Alcohol-associated liver disease (ALD) is a global health problem caused, among other factors, by oxidative stress from the formation of reactive oxygen species (ROS). One important source of ROS is microsomal ethanol metabolism catalyzed by cytochrome P450 2E1 (CYP2E1), which is induced by chronic ethanol consumption. Inhibition of CYP2E1 by clomethiazole (CMZ) decreases oxidative stress in cell cultures and improves ALD in animal studies. Our study aimed to assess the benefits of a CYP2E1 inhibitor (clomethiazole) in detoxification of patients with ALD. METHODS: Open label, randomized controlled clinical trial to study whether CYP2E1 inhibition improves ALD in the patients with alcohol use disorders admitted for alcohol detoxification therapy (ADT). Patients had to have a serum aspartate aminotransferase (AST) activity exceeding twice the upper normal limit at time of admission and be non-cirrhotic defined by fibroscan value <12 kPa. Sixty patients were randomly assigned to ADT with either CMZ or clorazepate (CZP) for 7-10 days in a 1:1 ratio. The chlorzoxazone test of CYP2E1 activity was performed at enrolment and at 2 points during the study. RESULTS: ADT improved hepatic steatosis (controlled attenuation parameter) in both groups significantly. A trend towards a greater improvement in hepatic fat content during ADT (-21.5%) was observed in the CMZ group (252 ± 48 dB/m vs. 321 ± 38 dB/m; P < 0.0001) compared with the CZP group (-13.9%; 273 ± 38 dB/m vs. 317 ± 39 dB/m; P < 0.0001). As already reported, serum AST (P < 0.004) and alanine aminotransferase (ALT) activities (P < 0.0006) significantly decreased in CMZ patients as compared with patients on CZP by the end of hospitalization. A significant correlation was found between AST (P = 0.023), ALT (P = 0.009), GGT (P = 0.039) and CAP. CONCLUSION: This study demonstrates that CMZ improves clinical biomarkers for ALD in humans most likely due to its inhibitory effect on CYP2E1. Because of its addictive potential, CMZ can only be given for a short period of time and therefore other CYP2E1 inhibitors to treat ALD are needed.

Implementation of a spontaneous awakening/spontaneous breathing trial protocol in a surgical intensive care unit: a before and after study.

BACKGROUND: Prolonged invasive mechanical ventilation (IMV) influences patient outcome in multiple ways. In this regard the early weaning from IMV is a major goal to be achieved in the treatment of ICU patients. Adopting a weaning protocol that incorporates a Spontaneous Awakening Trial (SAT) and a Spontaneous Breathing Trial (SBT) seems to be essential to reach this goal. Most studies investigating the effectiveness of SAT/SBT protocols in ICU patients' outcomes have focused mainly on medical or mixed (medical and surgical), but not on exclusively surgical patient populations. Surgical patients usually experience more complications and often undergo revision surgeries, therefore needing longer sedation periods and adequate analgo-sedation therapy. Moreover, the longer IMV times make the weaning process more arduous. METHODS: Our retrospective data analysis therefore investigates the effectiveness of a SAT/SBT protocol implementation in the surgical ICU of Heidelberg University Hospital, focusing exclusively on surgical patients and their outcome related to the weaning process. The SAT/SBT protocol was adopted in Heidelberg ICU starting from 05/2019. We therefore analyzed the time period before and after the implementation between 03/2018 and 08/2020. Adult patients who required invasive ventilation for at least 48 hours were screened for study entry. Demographic data, clinical data and SOFA Score on admission, were collected to define the baseline characteristics of the two groups. Only patients with full adherence to the protocol were included. The primary outcome was defined as the successful extubation, intended as an extubation not followed by successive re-intubations until discharge from the ICU. We performed an univariate analysis to evaluate the rate of successful extubations between the two groups. RESULTS: In total, 199 patients were included in the analysis, 98 of which before the SAT/SBT protocol implementation (control group) and 101 after the SAT/SBT protocol implementation (intervention group). The successful extubation rate in the intervention group resulted in 82% (83/101 patients) compared to 64% (63/98 patients) in the control group (P<0.004). CONCLUSIONS: We conclude that even for an exclusively surgical patient population, the implementation of a SAT/SBT protocol could result in a higher rate of successful extubation.

The Potential of Shear Wave Elastography to Reduce Unnecessary Biopsies in Breast Cancer Diagnosis: An International, Diagnostic, Multicenter Trial.

PURPOSE: In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis. MATERIALS AND METHODS: We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies. CONCLUSION: A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies).

Persisting Type 2 Endoleaks Following EVAR for AAA Are Associated With AAA Expansion.

PURPOSE: To determine the evolution of abdominal aortic aneurysm (AAA) diameter in the presence of persisting type 2 endoleaks (pEL2) following endovascular abdominal aortic aneurysm repair (EVAR). MATERIALS AND METHODS: This is a retrospective, single-center, case-control study. All patients with pEL2 (pEL2 group, persisting for > 12 months) between 2004 and 2018 were identified and compared with a 1:1 age- and gender-matched control with no endoleak (control group). Primary outcome measures were freedom from AAA expansion and freedom from AAA shrinkage over time. AAA diameter measurements were performed on computed tomography angiography (CTA). Secondary outcome measures were survival, AAA-related mortality, reinterventions for pEL2, incidence of secondary type 1 endoleaks (EL1), and infrarenal aortic branch vessel anatomy. RESULTS: A total of 773 patients were treated with EVAR for AAA between 2004 and 2018. Of them, 286 patients demonstrated type 2 endoleaks (EL2) in postoperative CTA or intraoperative angiography (37%). Forty-five of 286 EL2 (15.7%) were pEL2 (pEL2 group). Freedom from AAA expansion in the pEL2 group was 100%, 96.7%, 85.2%, and 54.3% after 1, 2, 3, and 4 years, respectively, compared with 100% after 1, 2, 3, and 4 years in the control group (p<0.01). Freedom from AAA shrinkage in the pEL2 group after 1, 2, 3, and 4 years was 95.5%, 90.4%, 90.4%, and 79.1%, respectively, compared with 86.7%, 34.8%, 19.3%, and 19.3% in the control group (p<0.01). Overall survival at 1, 2, 3, and 4 years was 100%, 97.6%, 95.0% and 95.0% in the pEL2 group and 100% at 1, 2, 3, and 4 years in the control group (p=0.17). There were no AAA-related deaths in either group. Patients with pEL2 had a significantly increased number of infrarenal aortic branches (p<0.05, respectively). Eighteen patients (40.0%) in the pEL2 group underwent 34 reinterventions for pEL2, with a median follow-up (FU) of 925 days (0-4173). Clinical success was achieved in 9 patients (50.0%). Four patients (8.9%) with pEL2 developed secondary EL1 after a median FU of 1278 days (662-2121). CONCLUSION: pEL2 are associated with AAA expansion during midterm FU. Further studies are warranted to evaluate the association of AAA expansion due to pEL2 with clinical outcomes to allow recommendations with regard to treatment indications.

Mixed reality for the assessment of aortoiliac anatomy in patients with abdominal aortic aneurysm prior to open and endovascular repair: Feasibility and interobserver agreement.

OBJECTIVES: The objective is to evaluate the feasibility and interobserver agreement of a Mixed Reality Viewer (MRV) in the assessment of aortoiliac vascular anatomy of abdominal aortic aneurysm (AAA) patients. METHODS: Fifty preoperative computed tomography angiographies (CTAs) of AAA patients were included. CTAs were assessed in a mixed reality (MR) environment with respect to aortoiliac anatomy according to a standardized protocol by two experienced observers (Mixed Reality Viewer, MRV, Brainlab AG, Germany). Additionally, all CTAs were independently assessed applying the same protocol by the same observers using a conventional DICOM viewer on a two-dimensional screen with multi-planar reconstructions (Conventional viewer, CV, GE Centricity PACS RA1000 Workstation, GE, United States). The protocol included four sets of items: calcification, dilatation, patency, and tortuosity as well as the number of lumbar and renal arteries. Interobserver agreement (IA, Cohen's Kappa, κ) was calculated for every item set. RESULTS: All CTAs could successfully be displayed in the MRV (100%). The MRV demonstrated equal or better IA in the assessment of anterior and posterior calcification (κMRV: 0.68 and 0.61, κCV: 0.33 and 0.45, respectively) as well as tortuosity (κMRV: 0.60, κCV: 0.48) and dilatation (κMRV: 0.68, κCV: 0.67). The CV demonstrated better IA in the assessment of patency (κMRV: 0.74, κCV: 0.93). The CV also identified significantly more lumbar arteries (CV: 379, MRV: 239, p < 0.01). CONCLUSIONS: The MRV is a feasible imaging viewing technology in clinical routine. Future efforts should aim at improving hologram quality and enabling accurate registration of the hologram with the physical patient.

Gain a Baby Lose a Tooth-Is There an Association between Periodontitis and Preterm Birth?

Preterm birth serves as one of the leading causes of neonatal mortality worldwide. The underlying mechanisms that contribute to preterm birth are not yet fully understood. However, an association between periodontitis and preterm birth has been proposed. The periodontal status and presence of periodontal pathogens in women with different birth outcomes have been previously examined. However, varying definitions of periodontitis and different microbiological methods make their interpretation challenging. The aim of this case-control study on women with and without preterm birth was to investigate their periodontal status using the current classification system for periodontal diseases. Moreover, differences in the periodontal microbiome of the study participants were investigated. Therefore, we collected data on oral and periodontal parameters in 77 puerperal women divided into two groups based on gestational age at delivery: 33 patients with preterm birth (PTB, <37 weeks) and 44 patients with term birth (TB, >37 weeks). These data included pocket probing depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), gingival-bleeding index, DMFT index, and gynecologic and dental history. In addition, their oral microbiome was explored. Median CAL and percentage PPD ≥ 4 mm were significantly higher in the PTB group than in the TB group (p = 0.0128 and p = 0.047, respectively). Birth weight was significantly higher in periodontally healthy women than in those with gingivitis (p = 0.0078) or periodontitis (p = 0.0127). The periodontal microbiome differed significantly between groups. Our results are underlining the possible association between periodontitis and preterm delivery. Women with periodontitis had babies with significantly lower birth weights. The microbiome varied between the groups.

Changes in serum omega fatty acids on a Mediterranean diet intervention in patients with gingivitis: An exploratory study.

BACKGROUND: Omega-6 and omega-3 polyunsaturated fatty acids (PUFAs) are precursors of pro- and anti-inflammatory lipid mediators. Serum PUFA levels could influence the severity of inflammatory oral diseases, such as gingivitis. OBJECTIVE: The study analyzed serum PUFA levels in a six-week randomized controlled trial in individuals on the Mediterranean diet (MedD), associations with the intake of specific foods, and possible correlations with oral inflammatory parameters. METHODS: Data from 37 study participants on either a MedD (MedDG; n = 18) or a "Western diet" in the control group (CG, n = 19) were analyzed. Dental examinations and serum analyses were performed at two time points, T1 (baseline) and T2 (week 6). Serum PUFA status, adherence to the MedD, and data from a Food Frequency Questionnaire were analyzed. RESULTS: Within the MedDG omega-6 fatty acid levels decreased significantly. In the overall sample, the proportional decrease in sites with bleeding on probing correlated weakly to moderately with the decrease in total omega-6 fatty acid level (Spearman's ρ = 0.274) and the decrease in gingival index correlated moderately with the decrease in linoleic acid level (Spearman's ρ = 0.351). Meat and fast-food consumption correlated positively with levels of various omega-6 fatty acids, whereas nut, fish, and dairy product consumption correlated positively with omega-3 levels. CONCLUSION: Adherence to a MedD was associated with a decrease in serum omega-6 levels, which positively affected the omega-6/omega-3 ratio. The MedD associated reduction in serum omega-6 levels may be a mechanism that favorably affects gingival inflammatory parameters.

Concurrent Change in Serum Cholinesterase Activity and Midregional-Proadrennomedullin Level Could Predict Patient Outcome following Liver Transplantation.

BACKGROUND: After liver transplantation (LTX), patients are susceptible to opportunistic infections resulting in reduced outcomes within the early post-transplantation period. The postoperative monitoring of LTX patients has gained much importance in recent years. However, reliable plasmatic markers predicting 90-day outcomes are still lacking. METHODS: In the post hoc analysis of a prospective, observational study, butyrylcholinesterase (BChE), mid-regional proadrenomedullin (MR-proADM), as well as conventional inflammatory markers (procalcitonin, C-reactive protein) were evaluated in 93 patients at seven consecutive timepoints within the first 28 days following LTX. RESULTS: Persistently reduced activity of BChE and elevated MR-proADM levels indicated reduced 90-day survival following LTX. Furthermore, reduced BChE and increased MR-proADM activity could indicate early post-transplantation bacterial infections, whereas conventional inflammatory biomarkers showed no diagnostic efficacy within the observation period. CONCLUSION: Concurrent assessment of BChE and MR-proADM activity might serve as a bedside diagnostic tool for early bacterial infections following liver transplantation. Thus, a combined utilization of the two biomarkers may be a useful tool in the risk evaluation of patients following liver transplantation.

Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

Non-Invasive Ventilation as a Therapy Option for Acute Exacerbations of Chronic Obstructive Pulmonary Disease and Acute Cardiopulmonary Oedema in Emergency Medical Services.

In this observational prospective multicenter study conducted between October 2016 and October 2018, we tested the hypothesis that the use of prehospital non-invasive ventilation (phNIV) to treat patients with acute respiratory insufficiency (ARI) caused by severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and acute cardiopulmonary oedema (ACPE) is effective, time-efficient and safe. The data were collected at four different physician response units and three admitting hospitals in a German EMS system. Patients with respiratory failure due to acute exacerbation of chronic obstructive pulmonary disease and acute cardiopulmonary oedema were enrolled. A total of 545 patients were eligible for the final analysis. Patients were treated with oxygen supplementation, non-invasive ventilation or invasive mechanical ventilation. The primary outcomes were defined as changes in the clinical parameters and the in-hospital course. The secondary outcomes included time efficiency, peri-interventional complications, treatment failure rate, and side-effects. Oxygenation under phNIV improved equally to endotracheal intubation (ETI), and more effectively in comparison to standard oxygen therapy (SOT) (paO2 SOT vs. non-invasive ventilation (NIV) vs. ETI: 82 mmHg vs. 125 mmHg vs. 135 mmHg, p-value SOT vs. NIV < 0.0001). In a matched subgroup analysis phNIV was accompanied by a reduced time of mechanical ventilation (phNIV: 1.8 d vs. ETI: 4.2 d) and a shortened length of stay at the intensive care unit (3.4 d vs. 5.8 d). The data support the hypothesis that the treatment of severe AECOPD/ACPE-induced ARI using prehospital NIV is effective, time efficient and safe. Compared to ETI, a matched comparison supports the hypothesis that prehospital implementation of NIV may provide benefits for an in-hospital course.

Dental imaging using an ultra-high resolution photon-counting CT system.

Clinical photon-counting CT (PCCT) offers a spatial resolution of about 200 µm and might allow for acquisitions close to conventional dental CBCTs. In this study, the capabilities of this new system in comparison to dental CBCTs shall be evaluated. All 8 apical osteolysis identified in CBCT were identified by both readers in all three PCCT scan protocols. Mean visibility scores showed statistical significant differences for root canals(p = 0.0001), periodontal space(p = 0.0090), cortical(p = 0.0003) and spongious bone(p = 0.0293) in favor of high and medium dose PCCT acquisitions. Overall, both devices showed excellent image quality of all structures assessed. Interrater-agreement showed high values for all protocols in all structures. Bland-Altman plots revealed a high concordance of both modalities with the reference measurements. In vitro, ultra-high resolution PCCT can reliably identify different diagnostic entities and structures relevant for dental diagnostics similar to conventional dental CBCT with similar radiation dose. Acquisitions of five cadaveric heads were performed in an experimental CT-system containing an ultra-high resolution PC detector (0.25 mm pixel size in isocenter) as well as in a dental CBCT scanner. Acquisitions were performed using dose levels of 8.5 mGy, 38.0 mGy and 66.5 mGy (CTDI16cm) in case of PCCT and of 8.94 mGy (CTDI16cm) in case of CBCT. The quality of delineation of hard tissues, root-canals, periodontal-space as well as apical osteolysis was assessed by two readers. Mean visibility scores and interrater-agreement (overall agreement (%)) were calculated. Vertical bone loss (bl) and thickness (bt) of the buccal bone lamina of 15 lower incisors were measured and compared to reference measurements by ore microscopy and clinical probing.