Single-center Observational Cohort Study Research Articles

Outcome after resection for invasive intraductal papillary mucinous neoplasia is similar to conventional pancreatic ductal adenocarcinoma

Background/objectivesResections for intraductal papillary mucinous neoplasm (IPMN) have increased last decades. Overall survival (OS) for conventional pancreatic ductal adenocarcinoma (PDAC) is well known but OS for invasive IPMN (inv-IPMN) is not as conclusive. This study aims to elucidate potential differences in clinicopathology and OS between these tumor types and to investigate if the raised number of resections have affected outcome. MethodsConsecutive patients ≥18 years of age resected for inv-IPMN and PDAC at Karolinska University Hospital between 2009 and 2018 were included. Clinicopathological variables were analyzed in multivariable regression models. Outcome was assessed calculating two-year OS, estimating OS using the Kaplan-Meier model and comparing survival functions with log-rank test. Results513 patients were included, 122 with inv-IPMN and 391 with PDAC. During the study period both the proportion resected inv-IPMN and two-year OS, irrespective of tumor type, increased (2.5%–45%; p < 0.001 and 44%–57%; p = 0.005 respectively). In Kaplan-Meier survival analysis inv-IPMN had more favorable median OS (mOS) compared to PDAC (33.6 months vs 19.3 months, p = 0.001). However, in multivariable Cox Regression analysis, tumor type was not a predictor for death, but so were resection period, tumor subtype and N-stage (all p < 0.001). ConclusionIn this large single center observational cohort study, inv-IPMN seemed to have favorable survival outcome compared to PDAC, but after adjusting for predictors for death this benefit vanished. The combination of a pronounced increase in resected inv-IPMN and a concurrent hazard abatement for death within 2 years during the study period proved to be a principal factor.

73. Comparison of 90-day complications in propensity matched robotic-assisted vs nonrobotic-assisted lumbar fusion: robotic assistance does not increase the complication rate

<h3>BACKGROUND CONTEXT</h3> A recent administrative database (PearlDiver) study reported increased 30-day complications with the utilization of robotic-assisted (RA) enabling technology. The authors reported increased fixation-related complications (3%) and infection rates (19%) in RA surgeries. Although there is ample evidence regarding improved pedicle screw accuracy with RA surgery, the complication profile has been called into question. <h3>PURPOSE</h3> The objective of the study is to compare 90-day complication rates between RA and nonrobotic-assisted (NRA) lumbar spinal fusions in propensity-matched cohorts. <h3>STUDY DESIGN/SETTING</h3> Retrospective single center observational propensity-matched observational cohort study. <h3>PATIENT SAMPLE</h3> Patients who underwent 1- to 3-level lumbar fusion surgery for degenerative conditions. <h3>OUTCOME MEASURES</h3> Surgical and medical (major/minor) complications at intraoperative, immediately postoperative, 30- and 90-day postoperative intervals. Additionally, reoperations and readmissions within 90 days. <h3>METHODS</h3> Of 146 RA cases that met inclusion criteria, 114 were successfully propensity matched to 114 patients from 214 cases who had 1-3 level lumbar fusion without robotic assistance based on age, sex, BMI, smoking status, surgical approach (posterior-only or anterior-posterior), ASA grade, revision vs primary, number of surgical levels, and number of interbody levels. We excluded tumor, trauma, infection or deformity cases. Continuous variables were compared using unpaired t-tests and categorical variables were compared using Fisher's exact test with significance set at 0.05. <h3>RESULTS</h3> Consistent with propensity matching, there was no difference in patient demographics and baseline characteristics between groups. Neither group had intraoperative fixation-related complications or required a return to OR for malpositioned screws. All cause intraoperative complication rates were similar between NRA (5.3%) and RA groups (10.5%, p=0.366). Immediate postoperative medical complication rate was also similar between NRA (6.1%) and RA groups (1.8%, p=0.089). Thirty-day complication rates (NRA:15.8% vs RA:12.3%, p=0.446), 90-day complication rates (NRA:15.8% vs RA:14.9%, p=0.854), reoperation rates (NRA:6.1% vs RA:3.5%, p=0.354), and readmission rates (NRA:7.0% vs RA:6.1%, p=0.789) showed no difference between NRA and RA groups. There was no difference between return to OR for infection between the cohorts (NRA:6 [5%] vs RA:1 [0.8%], p=0.119). There was, however, improved length of stay (LOS) in the RA group compared to NRA group (2.5 vs 3.17 days, p=0.018). <h3>CONCLUSIONS</h3> In propensity-matched cohorts, patients undergoing 1- to 3-level level RA posterior lumbar fusion for degenerative conditions did not have increased 90-day complication rate, and had a shorter length of stay compared to NRA patients. There findings differ from a prior administrative database study as the RA group in the current study had 0% return to OR for malpositioned screws and 0.8% return to OR for infection. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

P–791 Comparison of the live birth rate after single embryo transfer in fresh versus frozen cycle: no evidence to support routine freeze-all strategy

Abstract Study question Is the treatment outcome compromised after superovulation for fresh IVF/ICSI in comparison to frozen cycle with spontaneous ovulation and luteal support with progesterone? Summary answer Live birth rate (LBR) is dependent on embryo quality both in the fresh and frozen cycles with no sign of harmful effect of the superovulation. What is known already Freeze-all strategy has been advocated in recent years based on the assumption that luteal phase after superovulation is not optimal for embryo implantation. The effects of variable hormonal treatments, given in association with ART, on the endometrium, are still largely unknown. Therefore, more data is needed in order to optimize the treatment policies. Study design, size, duration This is an observational retrospective single-center cohort study. Data were collected from Oulu University Hospital’s ART-database including a total of 5647 single embryo transfer cycles from years 1995–2020. Patients stimulated with long agonist protocol for IVF/ICSI and day 2–3 transfer were included. Frozen embryo transfer was performed in a natural cycle with an ovulation test used for timing of transfer. Luteal support with progesterone was given for two weeks in all cycles. Participants/materials, setting, methods There were 3053 IVF/ICSI fresh cycles (2237 top and 816 N-top) and 2594 frozen cycles (806 top and 1788 N-top). The main outcome measure was LBR compared between fresh and frozen cycles when either a top or a N-top embryo was transferred. As a secondary outcome, clinical pregnancy rate was investigated. Data on the age and body mass index (BMI) of the patients was available. Student’s T-test was used to compare continuous variables. Main results and the role of chance The groups did not differ regarding the age and BMI of the patients. After the transfer of a top quality embryo the clinical pregnancy rate (35.4 vs. 30.8%; p &amp;lt; 0.05) and LBR (29.4 vs. 25.5%; p not significant) was slightly higher in the fresh cycle. After the transfer of a N-top quality embryo the clinical pregnancy rate (19.9 vs. 19.4%) and LBR (15.9 vs. 15.4%) were similar both in the fresh and frozen cycles. Limitations, reasons for caution This study only represents cleavage stage embryo transfers, and all FETs were performed in a natural cycle. In a retrospective study there may also be residual confounding that could not be excluded. Wider implications of the findings: This study provides further evidence that treatment outcome regarding LBR is not affected by superovulation therapy. Hence, the use of freeze-all strategy is warranted only in cases with a risk of ovarian hyperstimulation syndrome. Trial registration number Not applicable

Congenital anomalies and genetic disorders in neonates and infants: a single-center observational cohort study

Neonates with genetic disorders or congenital anomalies (CA) contribute considerably to morbidity and mortality in neonatal intensive care units (NICUs). The objective of this study is to study the prevalence of genetic disorders in an academic level IV NICU. We retrospective collected and analyzed both clinical and genetic data of all 1444 infants admitted to the NICU of the Radboudumc (October 2013 to October 2015). Data were collected until infants reached at least 2 years of age. A total of 13% (194/1444) of the patients were genetically tested, and 32% (461/1444) had a CA. A total of 37% (72/194) had a laboratory-confirmed genetic diagnosis. In 53%, the diagnosis was made post-neonatally (median age = 209 days) using assays including exome sequencing. Exactly 63% (291/461) of the patients with CA, however, never received genetic testing, despite being clinically similar those who did.Conclusions: Genetic disorders were suspected in 13% of the cohort, but only confirmed in 5%. Most received their genetic diagnosis in the post-neonatal period. Extrapolation of the diagnostic yield suggests that up to 6% of our cohort may have remained genetically undiagnosed. Our data show the need to improve genetic care in the NICU for more inclusive, earlier, and faster genetic diagnosis to enable tailored management.What is Known:• Genetic disorders are suspected in many neonates but only genetically confirmed in a minority.• The presence of a genetic disorder can be easily missed and will often lead to a diagnostic odyssey requiring extensive evaluations, both clinically and genetically.What is New:• Different aspects of the clinical features and uptake of genetic test in a NICU cohort.• The need to improve genetic care in the NICU for more inclusive, earlier, and faster genetic diagnosis to enable tailored management.

Comparison of renal replacement therapy and renal recovery before and during the COVID-19 pandemic: a single center observational study.

Our objective was to the describe indications, management, complications and outcomes of renal replacement therapy (RRT) in COVID-19 critically ill patients. To contextualize these findings, comparisons were made against 36 non-COVID-19 consecutive patients requiring RRT on ICU. We conducted a retrospective single center observational cohort study of patients requiring acute RRT between 1st March and 30th June 2020. Comparison was made against those receiving RRT in the pre-COVID-19 period from January 2019 to February 2020. Of 154 COVID-19 patients, 47 (30.5%) received continuous venovenous hemofiltration (CVVHF), all of whom required mechanical ventilation and vasopressor support. The requirement for RRT was related to fluid balance rather than azotemia. Compared to 36 non-COVID-19 patients, those with COVID-19 were younger (P=0.016) with a lower serum creatinine on hospital admission (P=0.049), and lesser degrees of metabolic acidosis (P<0.001) and lactatemia (P<0.001) before initiation of RRT. In addition, the duration of RRT requirement was longer (P<0.001). Despite lower CVVHF exchange rates with higher serum creatinine levels following RRT initiation in the COVID-19 patients, metabolic abnormalities were corrected. Hospital mortality was 60% among COVID-19 patients requiring RRT, compared to 67% in non-COVID-19 patients (P=0.508), and renal recovery among survivors without pre-existing CKD was similar (P=0.231). The requirement for RRT in COVID-19 patients was primarily related to fluid balance. Using lower CVVHF exchange rates was effective to correct metabolic abnormalities. Renal recovery occurred in all but one patient by 60 days in the 40% of patients who survived.

Laparoscopic Cholecystectomy under Spinal Anaesthesia – A Single Center Experience

Traditionally, laparoscopic cholecystectomy is performed under general anaesthesia. However, it can be performed under spinal anaesthesia as the dissection is confined to the gall bladder fossa and cystic triangle and bowel handling is usually minimal. The present study was performed to study the feasibility of performing laparoscopic cholecystectomy under spinal anaesthesia. A prospective observational single center cohort study was conducted with a sample size of 60 patients diagnosed with gall stone disease. Laparoscopic cholecystectomy was performed under spinal anaesthesia using low insufflation pressure of 8-10 mm of Hg. The outcomes studied include intra operative events (hypotension, bradycardia, abdominal pain, shoulder pain and requirement for sedation), reasons for conversion (spinal to general anaesthesia and from laparoscopic to open cholecystectomy), post-operative pain and complications. Females were more commonly affected than males and at a younger age. Three cases were converted from spinal to general anaesthesia. Two cases were converted from laparoscopic to open cholecystectomy. Intra operative analgesia and sedation were required in 10% and 13.3% of patients respectively. In the post operative period majority of the patients did not require any analgesia. Complications like headache (3.3%) and low backache (5%) were managed conservatively. About 5% of patients required urinary catheterization for post operative urine retention. Laparoscopic cholecystectomy can be performed safely under spinal anaesthesia with minimum morbidity. Spinal anaesthesia involves less cost and is better in terms of post operative pain control. The incidence of various post operative complications are less and manageable.

Daytime polysomnography to perform titration for upper airway stimulation in patients with obstructive sleep apnea.

PurposeUpper airway stimulation (UAS) is an innovative treatment for patients with obstructive sleep apnea (OSA). UAS titrations are performed 3 months after activation of the device to optimize its effectiveness. In general, these titrations are performed during an in-laboratory overnight polysomnography (PSG). However, overnight titrations are expensive and can be logistically challenging because they are labor-intensive which causes shortage of sleep technicians available for night shifts. In addition, recently, overnight PSGs were postponed and canceled due to the COVID-19 pandemic. We aimed to assess the feasibility of a daytime PSG to perform titration of UAS therapy as an alternative for a conventional overnight PSG.MethodsWe performed a prospective single-center observational cohort study. Patients were included when planned for UAS titration; this was approximately 6 months after UAS activation. Data on sleep architecture, patient experience, and respiratory outcomes were collected to evaluate the feasibility. An overnight follow-up PSG 12 months after implantation was used to compare sleep architecture and therapy response.ResultsOf 23 patients, four were excluded from analysis because of technical issues during PSG. Even though patients slept significantly shorter during the daytime PSG, this was enough time to complete the titration successfully with 30-min sleep in final therapeutic settings in 84% of the patients. Patients (94%) had a positive experience with the daytime titration. Respiratory outcomes were significantly reduced during titration and were maintained at the 12-month follow-up.ConclusionDaytime titrations are a valuable alternative for conventional overnight titrations. Our findings suggest the implementation of daytime titrations as standard of care. This will contribute to easier logistics and better work circumstances for sleep technicians without jeopardizing titration quality.

Impact of vascular liver disease on the menstrual cycle and metabolic status in premenopausal women

BackgroundVascular liver disease (VLD) are rare liver diseases, which affect women at reproductive ages. Main complications are bleeding (portal hypertension, thrombopenia or anticoagulation related) and thromboembolism. Failure of liver function can occur. Thus endocrine abnormalities management and contraception are challenging. Purposeto evaluate the impact on the menstrual cycles and related endocrine abnormalities in women with VLD and respective roles of liver function and portal hypertension. Study designThis was a single-center observational cohort study. Forty-seven premenopausal women with vascular liver disease were included for endocrine and gynecological assessments. Endocrine evaluation was performed at inclusion. Tolerance of contraception was followed up and assessed at 3 and 12 months. Participants, Setting, MethodsForty-seven women (aged 16–50) followed in a Reference Center for Liver Vascular Disease between February 2009 and November 2016 were included and addressed for gynecological and endocrinological management. Twenty-five women had extrahepatic portal vein obstruction, 17 had Budd Chiari Syndrome and five had a porto-sinusoidal vascular disease. We explored gonadotropin at baseline and after GnRH, testosterone, sex hormone binding globulin (SHBG), androstenedione, GH axis and glucose metabolism. All women underwent pelvic ultrasonography. ResultsVascular liver disease was associated with abnormal menstrual cycles in 53% of the women and clinical and/or biological hyperandrogenism and/or a polycystic ovary morphology was identified in 38%. Portal hypertension was correlated to higher testosterone levels (P = 0.04), whereas higher elevated levels SHBG in 28%, correlated with liver failure (P = 0.01). Sixteen had glucose intolerance profile or diabetes. IGF-1 levels were highly correlated with hepatic failure. Abnormal uterine bleeding occurred in 21% of women, 87% of which were due to gynecological pathologies revealed by anticoagulant treatment. Progestin contraception was well tolerated and helped to control bleeding. Conclusion and implicationsendocrine abnormalities, prior described in association with cirrhosis, are also identified in patients with vascular liver disease, and require specific management. Glucose intolerance profile is frequent, further studies are needed to assess significant consequences on cardio-vascular system.

C-reactive Protein for Predicting Early Postoperative Complications in Patients Undergoing Laparoscopic Shaving for Deep Infiltrating Endometriosis

To assess the accuracy of C-reactive protein (CRP) in predicting early postoperative complications in patients undergoing elective laparoscopic shaving for rectosigmoid deep infiltrating endometriosis (DIE). A single-center observational retrospective cohort study. Third-level referral center for endometriosis. A total of 294 patients were included in the study. All of them underwent elective laparoscopic shaving for rectosigmoid DIE. Postoperative CRP levels (assessed from day 3 onward, every 48 hours, until hospital discharge) and early postoperative complications were reviewed to assess CRP as a predictive marker of postoperative complications. The study outcomes were the association between early postoperative complications and CRP levels, the optimal CRP cutoff, and its predictive accuracy. Twenty-five patients (8.5%) experienced early postoperative complications. Five patients with postoperative complications within 2 days of surgery were excluded from the analysis. On postoperative day 3 the difference in the means of CRP levels between patients with and without complications was 2.5 mg/dL (95% CI, 1.0-4.1), whereas on day 5 the difference was 5.3 mg/dL (95% CI, 3.3-7.5), with a significant increase of 2.8 mg/dL (95% CI, 0.2-5.5). On postoperative day 7 the difference was 11.4 mg/dL (95% CI, 8.2-14.6), with an increase of 6.1 mg/dL (95% CI, 2.2-9.9) from day 5. The mean CRP level in the group with complications showed an increase of 1.2 mg/dL (95% CI, -1.3 to 3.8) from day 3 to day 5 and of 6.2 mg/dL (95% CI, 2.6-9.8) from day 5 to day 7. The optimal cutoff for the CRP level in predicting early postoperative complications was 3.1 mg/dL on postoperative day 3 and 5.2 mg/dL on postoperative day 5, with a sensitivity of 87.5% (95% CI, 52.9-97.8) and 80% (95% CI, 37.6-96.4), a specificity of 62.5% (95% CI, 52.1-71.9) and 91.2% (95% CI, 81.1-96.2), a positive predictive value of 17.5% (95% CI, 8.7-31.9) and 44.4% (95% CI, 18.9-73.3), a negative predictive value of 98.2% (95% CI, 90.6-99.7) and 98.1% (95% CI, 90.1-99.7), and an area under the receiver operating characteristic curve of 75.0% (95% CI, 61.9-80.1) and 85.6% (95% CI, 74.1-96.5), respectively. CRP on postoperative day 5 seemed to be a moderately accurate predictive marker of early postoperative complications in the patients who had undergone elective laparoscopic shaving for rectosigmoid DIE.

The Minimally Invasive Treatment of Visceral Artery Pseudoaneurysms: A Retrospective Observational Single Centre Cohort Study on Glue Embolization.

The objective is to report a single centre experience in the embolization of visceral artery pseudoaneurysms with N-butyl-cyanoacrylate-methacryloxy sulfolane (NBCA-MS). A retrospective observational cohort study was conducted on data about all consecutive patients treated for visceral artery pseudoaneurysms in the Interventional Radiology Unit of SS Annunziata Hospital, in Taranto (Italy) between January 2016 and July 2020. Only patients treated with NBCA-MS embolization were included. Clinical and technical outcomes were evaluated during in-hospital stay and at 3-month follow-up by computed angiotomography (CTA). Among 89 patients undergoing treatment for visceral artery pseudoaneurysm, a total of 58 (65.2%) patients (n = 32, 55.2% men; median age 45.8 years, range: 35-81) treated with NBCA-MS only were enrolled. Pseudoaneurysms were located in the renal artery (n = 18 cases, 31%), in the splenic artery (n = 27, 46.6%), in the intra-parenchymal hepatic artery (n = 3, 5.2%), in the common hepatic artery (n = 4, 6.9%) or in the pancreatic artery (n = 6, 10.3%). N-butyl-cyanoacrylate was diluted 1:1 with Lipiodol ultra-fluid, and mean volume injected was 0.6 ± 0.3mL (range: 0.2-2.8mL). Embolization was technically and clinically successful in all patients (n = 58, 100%) with an immediate total thrombosis of the pseudoaneurysm at the completion angiography. No systemic complications were noted in all cases. Five cases (8.6%) of non-target vessel embolization occurred without any clinical complication. No pseudoaneurysm recurrence was detected at the CTA control 1 day postoperatively. In one case (1.7%), a recurrence was detected 4days after the initial treatment and successfully managed by a repeated NBCA-MS embolization. During the hospital stay, 56 patients recovered well but 2 (3.4%) died from multi-organ failure not related to the embolization. No recurrences were detected at the 3-month postoperative CTA in the remaining patients. In properly selected patients affected with visceral artery pseudoaneurysms, NBCA-MS represents a definitive and safe embolization agent.

Gestational diabetes mellitus and obesity: effects on offspring

Aim: to identify the risk factors for gestational diabetes mellitus (GDМ) and predictors of perinatal lesions of central nervous system (CNS) combined with GDМ and maternal obesity.Materials and Methods. А retrospective observational case-control non-combined study was conducted to determine GDМ risk factors and their effect on perinatal pathology in 250 women divided into 2 groups. The main group included 150 pregnant women diagnosed with GDМ, the control group – 100 pregnant women without carbohydrate metabolism disorders. An assessment of hereditary, obstetric and gynecological history, as well as somatic health was carried out. Patients from the main group were subdivided into smaller groups: 1А (n = 77) – mothers whose newborns postnatally exerted adverse perinatal outcomes associated with impacting maternal hyperglycemia, and 1В (n = 73) – mothers whose newborns were born healthy. CHAID method (Chi Squared Automatic Interaction Detection) was used to create an algorithm for predicting adverse perinatal outcomes in GDМ. Аt the second stage, a single-center prospective observational non-combined cohort study was conducted to assess an effect of maternal hyperglycemia on formation of perinatal CNS lesions. Pre-labor concentration of neuron-specific enolase (NSE) was measured in the amniotic fluid of full-term fetuses in the group of pregnant women with GDM (n = 33) and in the group of pregnant women lacking carbohydrate metabolism disorders (n = 42).Results. Obesity, late reproductive age, family history of type 2 diabetes mellitus, abortions, early reproductive losses, macrosomic delivery in history are the main risk factors for GDM development. An algorithm was developed that allowed to predict a risk of newborn perinatal pathology in mother with GDM with an overall percentage of correct predictions of 68.7 ± 3.8 %. Pre-labor concentration of NSE in the amniotic fluid of full-term fetuses was elevated by 1.68 times (p = 0.006) in women with combined GDM and obesity (5.56 [3.37–6.24] ng/ml) compared to pregnant women with normal weight lacking carbohydrate metabolism disorders (3.29 [1.49–4.89] ng/ml).Conclusion. Pregnant women with obesity and type 2 diabetes mellitus familial history were featured with most prominent potential of developing perinatal complications. Rise in amniotic fluid NSE level in patients with GDМ corroborates damage of fetal CNS during antenatal period. The maximum NSE level was found in women comorbid with GDM and obesity.

Metabolic derangements are associated with impaired glucose delivery following traumatic brain injury.

Metabolic derangements following traumatic brain injury are poorly characterized. In this single-centre observational cohort study we combined 18F-FDG and multi-tracer oxygen-15 PET to comprehensively characterize the extent and spatial pattern of metabolic derangements.Twenty-six patients requiring sedation and ventilation with intracranial pressure monitoring following head injury within a Neurosciences Critical Care Unit, and 47 healthy volunteers were recruited. Eighteen volunteers were excluded for age over 60 years (n = 11), movement-related artefact (n = 3) or physiological instability during imaging (n = 4). We measured cerebral blood flow, blood volume, oxygen extraction fraction, and 18F-FDG transport into the brain (K1) and its phosphorylation (k3). We calculated oxygen metabolism, 18F-FDG influx rate constant (Ki), glucose metabolism and the oxygen/glucose metabolic ratio. Lesion core, penumbra and peri-penumbra, and normal-appearing brain, ischaemic brain volume and k3 hotspot regions were compared with plasma and microdialysis glucose in patients.Twenty-six head injury patients, median age 40 years (22 male, four female) underwent 34 combined 18F-FDG and oxygen-15 PET at early, intermediate, and late time points (within 24 h, Days 2–5, and Days 6–12 post-injury; n = 12, 8, and 14, respectively), and were compared with 20 volunteers, median age 43 years (15 male, five female) who underwent oxygen-15, and nine volunteers, median age 56 years (three male, six female) who underwent 18F-FDG PET.Higher plasma glucose was associated with higher microdialysate glucose. Blood flow and K1 were decreased in the vicinity of lesions, and closely related when blood flow was <25 ml/100 ml/min. Within normal-appearing brain, K1 was maintained despite lower blood flow than volunteers. Glucose utilization was globally reduced in comparison with volunteers (P < 0.001). k3 was variable; highest within lesions with some patients showing increases with blood flow <25 ml/100 ml/min, but falling steeply with blood flow lower than 12 ml/100 ml/min. k3 hotspots were found distant from lesions, with k3 increases associated with lower plasma glucose (Rho −0.33, P < 0.001) and microdialysis glucose (Rho −0.73, P = 0.02). k3 hotspots showed similar K1 and glucose metabolism to volunteers despite lower blood flow and oxygen metabolism (P < 0.001, both comparisons); oxygen extraction fraction increases consistent with ischaemia were uncommon.We show that glucose delivery was dependent on plasma glucose and cerebral blood flow. Overall glucose utilization was low, but regional increases were associated with reductions in glucose availability, blood flow and oxygen metabolism in the absence of ischaemia. Clinical management should optimize blood flow and glucose delivery and could explore the use of alternative energy substrates.

Incidence of early diaphragmatic dysfunction after lung transplantation: results of a prospective observational study.

Diaphragmatic dysfunction is common after cardiothoracic surgery, but few studies report its incidence and consequences after lung transplantation. We aimed to estimate the incidence of diaphragmatic dysfunction using ultrasound in lung transplant patients up to 3months postoperatively and evaluated the impact on clinical outcomes. This was a single-center prospective observational cohort study of 27 lung transplant recipients using diaphragmatic ultrasound preoperatively, at 1day, 1week, 1month, and 3months postoperatively. Diaphragmatic dysfunction was defined as excursion<10mm in men and<9mm in women during quiet breathing. Clinical outcomes measured included duration of mechanical ventilation, length of stay (LOS) in Intensive Care (ICU), and hospital LOS. Sixty-two percentage of recipients experienced new, postoperative diaphragmatic dysfunction, but the prevalence fell to 22% at 3months. No differences in clinical outcomes were found between those with diaphragmatic dysfunction compared to those without. Patients who experienced diaphragmatic dysfunction at 1day postoperatively were younger and had a lower BMI than those who did not. Diaphragmatic dysfunction is common after lung transplant, improves significantly within 3months, and did not impact negatively on duration of mechanical ventilation, LOS in ICU or hospital, or discharge destination.

Predictors of mortality, ICU hospitalization, and extrapulmonary complications in COVID-19 patients

ObjectiveA major coronavirus disease 2019 (COVID-19) outbreak occurred in Northeastern France in spring 2020. This single-center retrospective observational cohort study aimed to compare patients with severe COVID-19 and those with non-severe COVID-19 (survivors vs. non-survivors, ICU patients vs. non-ICU patients) and to describe extrapulmonary complications. Patients and methodsWe included all patients with a confirmed diagnosis of COVID-19 admitted to Colmar Hospital in March 2020. ResultsWe examined 600 patients (median age 71.09 years; median body mass index: 26.9 kg/m2); 57.7% were males, 86.3% had at least one comorbidity, 153 (25.5%) required ICU hospitalization, and 115 (19.1%) died. Baseline independent factors associated with death were older age (>75 vs. ≤75 years), male sex, oxygen supply, chronic neurological, renal, and pulmonary diseases, diabetes, cancer, low platelet and hemoglobin counts, and high levels of C-reactive protein (CRP) and serum creatinine. Factors associated with ICU hospitalization were age <75 years, oxygen supply, chronic pulmonary disease, absence of dementia, and high levels of CRP, hemoglobin, and serum creatinine. Among the 600 patients, 80 (13.3%) had an acute renal injury, 33 (5.5%) had a cardiovascular event, 27 (4.5%) had an acute liver injury, 24 (4%) had venous thromboembolism, eight (1.3%) had a neurological event, five (0.8%) had rhabdomyolysis, and one had acute pancreatitis. Most extrapulmonary complications occurred in ICU patients. ConclusionThis study highlighted the main risk factors for ICU hospitalization and death caused by severe COVID-19 and the frequency of numerous extrapulmonary complications in France.

New-onset atrial fibrillation incidence and associated outcomes in the medical intensive care unit.

In patients with critical medical illness, data regarding new-onset atrial fibrillation (NOAF) is relatively sparse. This study examines the incidence, associated risk factors, and associated outcomes of NOAF in patients in the medical intensive care unit (MICU). This single-center retrospective observational cohort study included 2234 patients with MICU stays in 2018. An automated extraction process using ICD-10 codes, validated by a 196-patient manual chart review, was used for data collection. Demographics, medications, and risk factors were collected. Multiple risk scores were calculated for each patient, and AF recurrence was also manually extracted. Length of stay, mortality, and new stroke were primary recorded outcomes. Two hundred and forty one patients of the 2234 patient cohort (11.4%) developed NOAF during their MICU stay. NOAF was associated with greater length of stay in the MICU (5.84vs. 3.52 days, p<.001) and in the hospital (15.7vs. 10.9 days, p<.001). Patients with NOAF had greater odds of hospital mortality (odds ratio (OR)=1.92, 95% confidence interval (CI) 1.34-2.71, p<.001) and 1-year mortality (OR=1.37, 95% CI 1.02-1.82, p=.03). CHARGE-AF scores performed best in predicting NOAF (area under the curve (AUC) 0.691, p<.001). The incidence of NOAF in this MICU cohort was 11.4%, and NOAF was associated with a significant increase in hospital LOS and mortality. Furthermore, the CHARGE-AF score performed best in predicting NOAF.

ECG Abnormalities in Patients with Acute Exacerbation of Bronchiectasis and Factors Associated with High Probability of Abnormality.

Background Bronchiectasis is an important reason for morbidity and mortality according to the last records that referred to high incidence rate of disease. Cardiovascular problems are common in pulmonary diseases, in general, and it can symptom by ECG abnormalities. The objective of this study was to define the most ECG abnormalities in patients with acute exacerbation of bronchiectasis and to study the correlation between the cardiac disorder and the other risk factors of the exacerbation. Materials and Methods A prospective single-center observational cohort study was done at Aleppo University Hospital for patients with AEB between October 2017 and September 2018. They were divided into 2 groups (normal ECG vs. abnormal). Patients with COPD, cystic fibrosis, new diagnosis of ischemic accident through the last 6 months of the study, and treatment with macrolides or fluoroquinolones through the last 3 months of the study were excluded. We study the percent of abnormalities through the AEB and the percentage of the most common abnormalities. Results 67 patients were included in the study (44 males and 23 females) with a mean age of 52.85 ± 21.456. ECG abnormalities were recorded in 43 patients, and it was more common in men (67.44% of cases). Advanced age and survival state had a statistical significance (p = 0.003, 0.023), respectively, between the 2 groups. Right axis deviation (RAD) is the most common abnormality (23.3%) followed by sinus tachycardia (20.9%), and it is close to T-depression (18.6%). AF was the most common arrhythmia from all recorded arrhythmias (6.98% from all cases). Positive sputum cultures were recorded in 55.8%, and the most common isolated pathogen factor was Pseudomonas aeruginosa. Recurrent pneumonia was seen in 30.2% of all patients with abnormal ECG. We find a high prevalence of ECG abnormalities in patients with Oximetry (90-95%, 39.5%), and the opportunity for abnormalities is equal in the 2 age groups (45–59 and more than 75) that reflexed the possibility of cardiac disorders in any age in patients with AEB. Conclusions ECG abnormalities are common in AEB, and it can happen in any age and any value of Oximetry. It needs more attention because of the prognosis of the cardiac morbidity.

Primary Percutaneous Coronary Intervention in Patients With Type 2 Diabetes With Late/Very Late Stent Thrombosis and de novo Lesions: A Single-Center Observational Cohort Study of Clinical Outcomes and Influencing Factors.

Background: This study compared differences in the risk factors and clinical outcomes of primary percutaneous coronary intervention (PCI) in type 2 diabetes mellitus (DM) and non-DM patients with de novo lesions (DNLs) and late or very late stent thrombosis (LST/VLST).Methods: We used angiography to screen 4,151 patients with acute coronary syndrome for DNL and LST/VLST lesions. Overall, 3,941 patients were included in the analysis and were allocated to the DM (n = 1,286) or non-DM (n = 2,665) group at admission. The primary endpoint was a composite of major adverse cardiovascular events (MACEs), defined as death, myocardial infarction, revascularization, and ischemic stroke, within a median follow-up period of 698 days.Results: In the group with a total white blood cell count >10 × 109/L (P = 0.004), a neutral granular cell count >7 × 109/L (P = 0.030), and neutrophil–lymphocyte ratio >1.5 (P = 0.041), revascularization was better for DNL than for LST/VLST lesions. Among DM patients with DNLs, each unit increase in age was associated with a 53.6% increase in the risk of MACEs [hazard ratio (HR): 1.536, 95% confidence interval (CI), 1.300–1.815, P < 0.0001]. Older age (≥65 years) was associated with a significantly greater risk of MACEs (P < 0.0001). Furthermore, each standard deviation (SD) increase in the level of peak white blood cell counts was associated with a 50.1% increase in the risk of MACEs (HR, 1.501; 95% CI, 1.208–1.864; P = 0.0002). When stratifying the DM population with DNLs according to the D-dimer baseline and peak levels <0.5 vs. ≥0.5 mg/L, the high D-dimer group at baseline had a 2.066-fold higher risk of MACEs (P < 0.0001), and the high peak level D-dimer group had a 1.877-fold higher risk of MACEs (P = 0.001) compared to the low-level groups. Among DM patients with LST/VLST, each unit increase in age was associated with a 75.9% increase in the risk of MACEs (HR: 1.759, 95% CI, 1.052–2.940, P = 0.032). Furthermore, for each SD increase in the peak D-dimer level, the risk of MACEs increased by 59.7% (HR, 1.597; 95% CI, 1.110–2.295; P = 0.041).Conclusion: Following successful primary PCI, the measurement of baseline and peak D-dimer values may help identify individuals at high cardiovascular risk. This suggests a potential benefit of lowering D-dimer levels among T2DM patients with DNL. Furthermore, age and the peak D-dimer values may facilitate the risk stratification of T2DM patients with LST/VLST.

A Study on the Safety of Percutaneous Tracheostomy in Patients with Severe Acute Respiratory Syndrome Novel Corona Virus 2 (SARS-nCoV2) Infection: A Single-Center Observational Cohort Study in a CoVID Intensive Care Unit.

BackgroundWe studied the safety of percutaneous dilatational tracheostomy (PCDT) in severe acute respiratory syndrome novel coronavirus 2 (SARS-nCoV2).Patients and MethodsFrom 01 March 20 to 30 November 2020, 1635 required hospital admission of which 145 (9%) required intensive (ICU) care. The primary outcomes are mortality and secondary outcomes were duration of invasive mechanical ventilation (IMV), length of stay (LOS) in ICU and hospital, and days required for decannulation.ResultsOut of the 145 (9%), 107 (73.7%) were males (mean 61.4 years, median body mass index (BMI) of 28.2 kg/m2), and 38 (26.2%) were females (mean 58.10 years, median BMI of 31.2 kg/m2). In the cohort of 80 (55.17%) requiring IMV, 19 (23.7%) died within 72 hours and were not included in the study, 37 (group “NT”) and 24 (group “T”) had a median duration of ventilation of 9 d (IQR, 6-11) and 12 d (IQR, 11-17.25) respectively. Patients in group “T” underwent PCDT based on clinical criteria (fraction of inspired oxygen (FiO2) of ≤ 50% with positive end-expiratory pressure (PEEP) of ≤ 10 cms of H2O with stable hemodynamics), and 16 (66.7%) had survived. The reverse transcription-polymerase chain reaction (RT-PCR) does not need to be negative, and none of the health care workers (HCW’s) were infected. The Cox-hazard ratio [HR] is 0.19, 95% confidence interval [CI] (0.09, 0.41) with a P-value of <0.001, 83 (57.2%) were discharged with a mortality of 42.8%.ConclusionsPCDT is safe and effective in patients anticipated in need of prolonged mechanical ventilation.

Six-minute walk distance predicts hospitalization in elderly peritoneal dialysis patients: a single-center prospective cohort study

BackgroundThe risk of adverse events associated with peritoneal dialysis (PD) in elderly patients has not been thoroughly investigated. The purpose of this study was to assess the association between physical function and hospitalization in elderly PD patients.MethodsThis is a single-center prospective observational cohort study. Thirty-three aged patients (74.8 ± 5.9 years) participated in a 6-min walk distance, short physical performance battery (SPPB), lower extremity muscle strength, and 10-m walk speed. All subjects were followed until hospitalization to the end of the follow-up period.ResultsThe 6-min walk distance was 332 ± 112.5 m; SPPB was 11 (8.3–12) points; the lower extremity muscle strength was 36.6 ± 9.6%; 10-m walk speed was 1.1± 0.2 m/s. During the follow-up, 19 patients (57.5%) were hospitalized. In the Kaplan-Meier survival analysis and log-rank test, a lower 6-min walk distance and PD vintage were significantly associated with hospitalization (p<0.05). After adjustment for PD vintage in Cox proportional analysis, the 6-min walk distance remained associated with hospitalization (95% confidence interval, 0.98–0.99).ConclusionLower exercise tolerance assessed by the 6-min walk distance was significantly associated with hospitalization in elderly PD patients. Our findings indicate that measurement and intervention of exercise intolerance are essential to predict the clinical outcomes of elderly PD patients.Trial registrationThis study was prospectively registered at inception in the UMIN Clinical Trials Registry under identification number UMIN000038405.

Drug\u2013drug interactions between treatment specific pharmacotherapy and concomitant medication in patients with COVID-19 in the first wave in Spain

Primary aim was to assess prevalence and severity of potential and real drug–drug interactions (DDIs) among therapies for COVID-19 and concomitant medications in hospitalized patients with confirmed SARS-CoV-2 infection. The secondary aim was to analyze factors associated with rDDIs. An observational single center cohort study conducted at a tertiary hospital in Spain from March 1st to April 30th. rDDIs refer to interaction with concomitant drugs prescribed during hospital stay whereas potential DDIs (pDDIs) refer to those with domiciliary medication. DDIs checked with The University of Liverpool resource. Concomitant medications were categorized according to the Anatomical Therapeutic Chemical classification system. Binomial logistic regression was carried out to identify factors associated with rDDIs. A total of 174 patients were analyzed. DDIs were detected in 152 patients (87.4%) with a total of 417 rDDIs between COVID19-related drugs and involved hospital concomitant medication (60 different drugs) while pDDIs were detected in 105 patients (72.9%) with a total of 553 pDDIs. From all 417 rDDIs, 43.2% (n = 180) were associated with lopinavir/ritonavir and 52.9% (n = 221) with hydroxychloroquine, both of them the most prescribed (106 and 165 patients, respectively). The main mechanism of interaction observed was QTc prolongation. Clinically relevant rDDIs were identified among 81.1% (n = 338) (‘potential interactions’) and 14.6% (n = 61) (contraindicated) of the patients. Charlson index (OR 1.34, 95% IC 1.02–1.76) and number of drugs prescribed during admission (OR 1.42, 95% IC 1.12–1.81) were independently associated with rDDIs. Prevalence of patients with real and pDDIs was high, especially those clinically relevant. Both comorbidities and polypharmacy were found as risk factors independently associated with DDIs development.