Factors Associated with Early Mortality in Acute Type A Aortic Dissection-A Single-Centre Experience.

BACKGROUND: Acute aortic dissection type A (AADA) is a surgical emergency with relevant mortality and morbidity despite improvements in current management protocols. Identifying patients at risk of a fatal outcome and controlling the factors associated with mortality remain of paramount importance. METHODS: In this retrospective observational study, we reviewed the medical records of 117 patients with AADA, who were referred to our centre and operated on between 2005 and 2021. Preoperative, intraoperative, and postoperative variables were analysed and tested for their correlation with in-hospital mortality. RESULTS: The overall survival rate was 83%. Preoperatively, factors associated with mortality were age (p = 0.02), chronic hypertension (p = 0.02), any grade of aortic valve stenosis in the patient's medical history (p = 0.03), atrial fibrillation (p = 0.04), and oral anticoagulation (p = 0.04). Non-survivors had significantly longer operative times (p = 0.002). During the postoperative phase, mortality was strongly associated with acute kidney injury (AKI) (p < 0.001), acute heart failure (p < 0.001), stroke (p = 0.02), focal neurological deficits (p = 0.02), and sepsis (p = 0.001). In the multivariate regression analysis, the onset of postoperative focal neurological deficits was the best predictor of a fatal outcome after adjusting for ARDS (odds ratio: 5.8, 95%-CI: 1.2-41.7, p = 0.04). CONCLUSIONS: In this retrospective analysis, atrial fibrillation, oral anticoagulation, hypertension, and age were significantly correlated with mortality. Postoperatively, acute kidney injury, acute heart failure, sepsis, and focal neurological deficits were correlated with in-hospital mortality, and focal neurological deficit has been identified as a significant predictor of fatal outcomes. Early detection and interdisciplinary management of at-risk patients remain crucial throughout the postoperative phase.

Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial.

Importance: The effect of oral midazolam premedication on patient satisfaction in older patients undergoing surgery is unclear, despite its widespread use. Objective: To determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted in 9 German hospitals between October 2017 and May 2019 (last follow-up, June 24, 2019). Eligible patients aged 65 to 80 years who were scheduled for elective inpatient surgery for at least 30 minutes under general anesthesia and with planned extubation were enrolled. Data were analyzed from November 2019 to December 2020. Interventions: Patients were randomized to receive oral midazolam, 3.75 mg (n = 309), or placebo (n = 307) 30 to 45 minutes prior to anesthesia induction. Main Outcomes and Measures: The primary outcome was global patient satisfaction evaluated using the self-reported Evaluation du Vécu de l'Anesthésie Generale (EVAN-G) questionnaire on the first postoperative day. Key secondary outcomes included sensitivity and subgroup analyses of the primary outcome, perioperative patient vital data, adverse events, serious complications, and cognitive and functional recovery up to 30 days postoperatively. Results: Among 616 randomized patients, 607 were included in the primary analysis. Of these, 377 (62.1%) were male, and the mean (SD) age was 71.9 (4.4) years. The mean (SD) global index of patient satisfaction did not differ between the midazolam and placebo groups (69.5 [10.7] vs 69.6 [10.8], respectively; mean difference, -0.2; 95% CI, -1.9 to 1.6; P = .85). Sensitivity (per-protocol population, multiple imputation) and subgroup analyses (anxiety, frailty, sex, and previous surgical experience) did not alter the primary results. Secondary outcomes did not differ, except for a higher proportion of patients with hypertension (systolic blood pressure ≥160 mm Hg) at anesthesia induction in the placebo group. Conclusion and Relevance: A single low dose of oral midazolam premedication did not alter the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety. These results may be affected by the low dose of oral midazolam. Further trials-including a wider population with commonplace low-dose intravenous midazolam and plasma level measurements-are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03052660.

Poor reporting quality of randomized controlled trials comparing treatments of COVID-19-A retrospective cross-sectional study on the first year of publications.

INTRODUCTION: Transparent and complete reporting of randomized controlled trials (RCTs) is essential for critical scientific appraisal of the results. It has been argued whether publications during the COVID-19 pandemic have met reporting standards. In this study, we assessed reporting adherence of RCTs on treatment interventions in COVID-19 patients to the CONSORT checklist and discuss which lessons can be learned to improve reporting in the future. METHODS: This was a retrospective, cross-sectional study performed at the University Hospital RWTH Aachen, Germany. We conducted a pragmatic systematic literature search in the PubMed database to identify RCTs on treatment interventions in COVID-19 patients in the first year of publications on the topic (March 2020-February 2021). We investigated the adherence of each publication to the CONSORT checklist and assessed the association between specific predictors and percentage adherence in an exploratory multivariable regression model. RESULTS: We analyzed 127 RCTs and found that the median percentage adherence to the CONSORT checklist was 54.3% [IQR 38.9 to 65.7]. In the exploratory multivariable regression model, the impact factor (highest tertile of impact factor compared to lowest tertile ß = 21.77, 95% CI 13.89 to 29.66, p<0.001; middle tertile compared lowest tertile ß = 11.79, 95% CI 5.74 to 17.84, p<0.001)) and authors' referral to the CONSORT statement (ß = 9.29, 95% CI 2.98 to 15.60, p = 0.004) were associated with a higher percentage adherence to the CONSORT checklist. CONCLUSION: The reporting quality of RCTs on treatment interventions in COVID-19 patients during the first year of publications was poor. Measures to improve reporting quality are urgently needed.

Systematic Review of the Effect of Cerebrospinal Fluid Drainage on Outcomes After Endovascular Descending Thoracic/Thoraco-Abdominal Aortic Aneurysm Repair.

OBJECTIVE: This study aimed to investigate whether prophylactic use of cerebrospinal fluid (CSF) drainage in endovascular descending thoracic aortic aneurysm (DTAA) and thoraco-abdominal aortic aneurysm (TAAA) repair contributes to a lower rate of post-operative spinal cord ischaemia (SCI). DATA SOURCES: MEDLINE, Embase, and CINAHL. REVIEW METHODS: A literature review was conducted in accordance with PRISMA guidelines (PROSPERO registration no. CRD42021245893). Risk of bias was assessed through the Newcastle-Ottawa scale (NOS), and the certainty of evidence was graded using the GRADE approach. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI) of both early and late onset SCI. Pooled outcome estimates were calculated using the odds ratio (OR) and associated 95% CI. The primary outcome was SCI, both early and lateonset. Secondary outcomes were complications of CSF drainage, length of hospital stay, and peri-operative (30 day or in hospital) mortality rates. RESULTS: Twenty-eight observational, retrospective studies were included, reporting 4 814 patients (2 599 patients with and 2 215 without CSF drainage). The NOS showed a moderate risk of bias. The incidence of SCI was similar in patients with CSF drainage (0.05, 95% CI 0.03 ‒ 0.08) and without CSF drainage (0.05, 95% CI 0.00 ‒ 0.14). No significant decrease in SCI was found when using CSF drainage (OR 0.67, 95% CI 0.29 ‒ 1.55, p = .35). The incidence rate of CSF drainage related complication was 0.10 (95% CI 0.04 ‒ 0.19). The 30 day and in hospital mortality rate with CSF drainage was 0.08 (95% CI 0.05 ‒ 0.12). The 30 day and in hospital mortality rate without CSF drainage and comparison with late mortality and length of hospital stay could not be determined due to lack of data. The quality of evidence was considered very low. CONCLUSION: Pre-operative CSF drainage placement was not related to a favourable outcome regarding SCI rate in endovascular TAAA and DTAA repair. Due to the low quality of evidence, no clear recommendation on pre-operative use of CSF drainage placement can be made.

The Effect of Scale Insects on Growth Parameters of cv. Chardonnay and cv. Sauvignon Blanc Grapevines Grown in a Greenhouse.

Plants can respond to insects that feed with stylet mouthparts using various processes that are initiated via the salicylic acid metabolic pathway. In Australia, scale insects of the genus Parthenolecanium can cause economic damage to grapevines as they feed on the vines and produce honeydew as a waste by-product, which supports the growth of black sooty mould on fruit and leaves, potentially affecting the plant growth and yield. Using rootlings of Sauvignon Blanc (SB, resistant) and Chardonnay (Char, susceptible), the growth and production of volatile organic compounds (VOCs) following exposure to scale insect infestations were measured under controlled greenhouse conditions. At harvest, the numbers of scale insects per five leaves were higher on plants infested at the start of the study compared with the control plants. Infested SB had increased dry root and shoot mass compared with the SB control, which was also the case with Char (control and infested). Leaf volatiles differed between cultivars in response to scale infestation. Benzyl alcohol decreased among infested SB plants compared with the other treatments. A change in the salicylic acid pathway as indicated by the change in benzyl alcohol may cause the increased growth in SB associated with the increased scale insect infestation.

Empagliflozin reduces markers of acute kidney injury in patients with acute decompensated heart failure.

AIMS: In this prospective, placebo-controlled, double-blind, exploratory study, we examined early and more delayed effects of empagliflozin treatment on haemodynamic parameters (primary endpoint: cardiac output) and kidney function including parameters of acute kidney injury (AKI) in patients with acute decompensated heart failure (HF). METHODS AND RESULTS: Patients with acute decompensated HF with or without diabetes were randomized to empagliflozin 10 mg or placebo for 30 days. Haemodynamic, laboratory, and urinary parameters were assessed after 6 h, 1 day, 3 days, 7 days, and 30 days of treatment. Median time between hospital admission and randomization was 72 h. Baseline characteristics were not different in the empagliflozin (n = 10) and placebo (n = 9) groups. Empagliflozin led to a significant increase in urinary glucose excretion throughout the study (baseline: 37 ± 15 mg/24 h; Day 1: 14 565 ± 8663 mg/24 h; P = 0.001). Empagliflozin did not affect the primary endpoint of cardiac index or on systemic vascular resistance index at any time point. However, empagliflozin significantly reduced parameters of AKI (urinary TIMP-2 and IGFBP7 by NephroCheck® as indicators of tubular kidney damage), which became significant after 3 days of treatment [placebo: 1.1 ± 1.1 (ng/mL)2 /1000; empagliflozin: 0.3 ± 0.2 (ng/mL)2 /1000; P = 0.02] and remained significant at the 7 day time point [placebo: 2.5 ± 3.8 (ng/mL)2 /1000; empagliflozin: 0.3 ± 0.2 (ng/mL)2 /1000; P = 0.003]. CONCLUSIONS: In this study, empagliflozin treatment did not affect haemodynamic parameters but significantly reduced markers of tubular injury in patients with acute decompensated HF.

Effects of COPD on Left Ventricular and Left Atrial Deformation in Patients with Acute Myocardial Infarction: Strain Analysis Using Speckle-Tracking Echocardiography.

Myocardial strain analysis, which describes myocardial deformation (shortening or lengthening), provides more detailed information about left ventricular (LV) and atrial (LA) functions than conventional echocardiography and delivers prognostic information. To analyze the effects of COPD on left heart function upon acute myocardial infarction (AMI), consecutive AMI patients were retrospectively screened, and patients were included if a post-AMI echocardiography and results of recent pulmonary function tests (PFTs) were available. Strain analysis was performed by a cardiologist who was blinded to clinical information. Overall, 109 AMI patients were included (STEMI: 38%, non-STEMI: 62%). COPD patients (41%) had significantly more impaired LV "global-longitudinal-strain" (LV-GLS) compared to non-COPD patients (−15 ± 4% vs. −18 ± 4%; p < 0.001, respectively), even after adjusting for LV-ejection-fraction (LVEF) and age (mean estimated difference: 1.7%, p = 0.009). Furthermore, COPD patients had more impaired LA strain (LAS) than non-COPD patients in all cardiac cycle phases (estimated mean differences after adjusting for LVEF and age: during reservoir phase: −7.5% (p < 0.001); conduit phase: 5.5% (p < 0.001); contraction phase: 1.9% (p = 0.034)). There were no correlations between PFT variables and strain values. In conclusion, the presence of COPD was associated with more impaired LV and LA functions after AMI, as detected by strain analysis, which was independent of age, LVEF, and PFT variables.

The effect of warm and humidified gas insufflation in gynecological laparoscopy on maintenance of body temperature: a prospective randomized controlled multi-arm trial.

BACKGROUND: Hypothermia is defined as a decrease in body core temperature to below 36 °C. If intraoperative heat-preserving measures are omitted, a patient's temperature will fall by 1 - 2 °C. Even mild forms of intraoperative hypothermia can lead to a marked increase in morbidity and mortality. Using warm and humidified gas insufflation in laparoscopy may help in the maintenance of intraoperative body temperature. METHODS: In this prospective randomized controlled study, we investigated effects of temperature and humidity of the insufflation gas on intra- and postoperative temperature management. 150 patients undergoing gynecologic laparoscopic surgery were randomly assigned to either insufflation with non-warmed, non-humidified CO2 with forced air warming blanket (AIR), humidified warm gas without forced air warming blanket (HUMI) or humidified warm gas combined with forced air warming blanket (HUMI+). We hypothesized that the use of warmed laparoscopic gas would have benefits in the maintenance of body temperature and reduce the occurrence of hypothermia. RESULTS: The use of warm and humidified gas insufflation alone led to more hypothermia episodes with longer duration and longer recovery times as well as significantly lower core body temperature compared to the other two groups. In the comparison of the AIR group and HUMI + group, HUMI + patients had a significantly higher body temperature at arrival at the PACU (Post Anaesthesia Care Unit), had the least occurrence of hypothermia and suffered from less shivering. CONCLUSION: The use of warm and humidified gas insufflation alone does not sufficiently warm the patients. The optimal temperature management is achieved in the combination of external forced air warming and insufflation of warm and humidified laparoscopy gas.

Influence of rivaroxaban compared to vitamin K antagonist treatment upon development of cardiovascular calcification in patients with atrial fibrillation and/or pulmonary embolism.

BACKGROUND: Vitamin K antagonists (VKA) such as warfarin or phenprocoumon have been the mainstay of therapy for long-term oral anticoagulant therapy (OAT) in patients with atrial fibrillation or with pulmonary embolism. Due to interferences with matrix Gla-protein, an important vitamin K-dependent local calcification inhibitor in cardiovascular structures, VKA antagonists stimulate cardiovascular calcification (CVC). In contrast, rivaroxaban, a nonvitamin K-dependent oral anticoagulant (NOAC), should be neutral in terms of CVC. We seek to investigate these potential differences in CVC development between VKA versus NOACs in a randomized controlled trial (RCT). METHODS: The influence of rivaroxaban compared to vitamin K antagonist treatment upon development of cardiovascular calcification in patients with atrial fibrillation and/or pulmonary embolism trial (NCT02066662) is a multicenter, prospective RCT with a two-arm, open-label study design. The primary endpoint is the progression of coronary and aortic valve calcification (quantified as calcification volume score) as assessed by cardiac computed tomography (CT) at 24 months in patients either treated by rivaroxaban or VKA. A total of 192 patients were randomized in a 1:1 fashion. The main inclusion criteria were the presence of atrial fibrillation and/or pulmonary embolism with the indication for OAT and pre-existent coronary calcification. The development of CVC will be assessed by follow-up CT at 12 and 24 months. RESULTS: In total 192 patients (median age 70, 72% male) were enrolled over a period of 5 years and followed up for 2 years.

[Perceptions on handling of opioids: focus COVID-19 : A survey among anesthesiologists via the specialist societies DGAI/BDA]. / Wahrnehmungen zum Umgang mit Opioiden: Fokus COVID-19 : Eine Umfrage unter Anästhesist:innen über die Fachgesellschaften DGAI/BDA.

BACKGROUND: Opioids are part of the daily routine in anesthesiology and palliative care; however, treatment of dyspnea with opioids is presented heterogeneously in guidelines. This may result in an uncertainty concerning opioid indications and ethical concerns, especially when caring for COVID-19 patients. OBJECTIVE: We aimed to examine the perception of anesthesiologists concerning the handling of morphine as the reference opioid (subsequently termed M/O) for symptom control within and outside of a palliative care setting, including care for COVID-19 patients. MATERIAL AND METHODS: Members of the German Society of Anesthesiology and Intensive Care Medicine (DGAI) and the Professional Association of German Anesthesiologists (BDA) received an anonymized online questionnaire (Survey Monkey®; Momentive Inc., San Mateo, CA, USA) in October 2020, containing questions regarding their perception of symptom management with M/O in general, and in particular concerning COVID-19 patients. Participants were asked to rate their perception within and outside a palliative care setting. RESULTS AND DISCUSSION: A total of 1365 anesthesiologists participated; 46% women. Most anesthesiologists were 41-60 years old (58%), worked in a hospital setting (78%), in the operating theatre (63%) and in intensive care units (49%). The majority (57%) reported > 20 years of professional experience (52%) and partial involvement in palliative care (57%). Perception of M/O handling was mostly "certain and confident" (88%) and "clearly regulated" (85%) within a palliative care setting but rated substantially lower for outside palliative care (77%/63%). When caring for COVID-19 patients, handling of M/O was even less often rated "certain and confident" (40%) or "clearly regulated" (29%) outside palliative care. Dyspnea (95%/75%), relief of the dying process (84%/51%), agitation (59%/27%) and anxiety/panic (61%/33%) were more frequently rated as general indications for morphine within versus outside palliative care. The majority of anesthesiologists disputed that M/O is given with the intention to hasten death within (87%) and outside (93%) palliative care. Highest difference in route of administration was reported for the subcutaneous administration of M/O within (76%) versus outside (33%) palliative care, followed by the intravenous route (57%/79%), while oral (66/62%) and transdermal (48%/39%) administration were reported to be used comparatively frequently. Most participants (85%) wanted more frequent involvement of palliative care consultation teams but also more team conferences (75%), supervision (72%), and training on opioid management (69%). CONCLUSION: Anesthesiologists perceived considerable uncertainty in using M/O for nonpalliative care medical settings. Highest uncertainty was seen for the care of patients with COVID-19. The prevalent use of the subcutaneous route for M/O application in palliative care can serve as inspiration for areas outside palliative care as well. Uniform interdisciplinary guidelines for symptom control including dyspnea, education and involvement of a palliative care consultation team should be more considered in the future.

Outcome of Elective and Emergency Open Thoraco-Abdominal Aortic Aneurysm Repair in 255 Cases: a Retrospective Single Centre Study.

OBJECTIVE: This study reports on open TAAA repair comparing short and long term patient outcome according to the type of repair defined by the Crawford classification and elective vs. emergency repair. Endpoints were death, acute kidney injury (AKI), sepsis, spinal cord ischaemia (SCI), and re-intervention rate. METHODS: This was a retrospective study reporting the outcomes of 255 patients (between 2006 and 2019), designed according to the STROBE criteria. RESULTS: The TAAA distribution was type I 25%, type II 26%, type III 23%, type IV 18%, and type V 7%. Fifty-one (20%) patients had an emergency procedure. Of all the patients, 51% had a history of aortic surgery, 58% suffered from post-dissection TAAA, and 26% had connective tissue disease. The in hospital mortality rate among electively treated patients was 16% (n = 33) vs. 35% (n = 18) in the emergency subgroup; the total mortality rate was 20% (n = 51). The adjusted odds ratio for in hospital death following emergency repair compared with elective repair was 2.52 (95% confidence interval [CI] 1.15 - 5.48). Temporary renal replacement therapy because of AKI was required in 29% (n = 74) of all patients, sepsis from different cause was observed in 37% (n = 94), and SCI in 7% (n = 18, 10 patients suffering from paraplegia and eight from paraparesis). The mean follow up time was 3.0 years (median 1.5, range 0 - 12.8 years). Aortic related re-intervention was required in 2.8%. The total mortality rate during follow up was 22.5% (n = 46); 5.3% (n = 11) of all patients died because of aortic related events. CONCLUSION: Open TAAA repair is associated with an important morbidity and mortality rate, yet the incidence of spinal cord ischaemia may be favourably low if a neuromonitoring protocol is applied. The aortic related re-intervention and aortic related mortality rate during follow up are low.

Intraoperative transfusion practices and perioperative outcome in the European elderly: A secondary analysis of the observational ETPOS study.

The demographic development suggests a dramatic growth in the number of elderly patients undergoing surgery in Europe. Most red blood cell transfusions (RBCT) are administered to older people, but little is known about perioperative transfusion practices in this population. In this secondary analysis of the prospective observational multicentre European Transfusion Practice and Outcome Study (ETPOS), we specifically evaluated intraoperative transfusion practices and the related outcomes of 3149 patients aged 65 years and older. Enrolled patients underwent elective surgery in 123 European hospitals, received at least one RBCT intraoperatively and were followed up for 30 days maximum. The mean haemoglobin value at the beginning of surgery was 108 (21) g/l, 84 (15) g/l before transfusion and 101 (16) g/l at the end of surgery. A median of 2 [1-2] units of RBCT were administered. Mostly, more than one transfusion trigger was present, with physiological triggers being preeminent. We revealed a descriptive association between each intraoperatively administered RBCT and mortality and discharge respectively, within the first 10 postoperative days but not thereafter. In our unadjusted model the hazard ratio (HR) for mortality was 1.11 (95% CI: 1.08-1.15) and the HR for discharge was 0.78 (95% CI: 0.74-0.83). After adjustment for several variables, such as age, preoperative haemoglobin and blood loss, the HR for mortality was 1.10 (95% CI: 1.05-1.15) and HR for discharge was 0.82 (95% CI: 0.78-0.87). Pre-operative anaemia in European elderly surgical patients is undertreated. Various triggers seem to support the decision for RBCT. A closer monitoring of elderly patients receiving intraoperative RBCT for the first 10 postoperative days might be justifiable. Further research on the causal relationship between RBCT and outcomes and on optimal transfusion strategies in the elderly population is warranted. A thorough analysis of different time periods within the first 30 postoperative days is recommended.

[Perceptions on the use of opioids in COVID-19 : A survey of members of the German Association for Palliative Medicine]. / Wahrnehmungen zum Umgang mit Opioiden bei COVID-19 : Eine Umfrage unter Mitgliedern der Deutschen Gesellschaft für Palliativmedizin.

BACKGROUND: Opioids efficiently alleviate pain and dyspnea. However, guidelines on symptom management with opioids differ, which may lead to an uncertainty concerning opioid indication and ethical implication among medical staff, especially when caring for COVID-19 patients. AIMS: We aimed to examine the perception of members of the German Association for Palliative Medicine (DGP) concerning the administration of morphine as the gold standard opioid (subsequently termed M/O) for symptom control within and outside of a palliative care (PC) setting, including care for COVID-19 patients. METHODS: DGP members received an anonymized online questionnaire (Survey Monkey®) containing questions regarding their perception of symptom management with M/O in general and in particular concerning COVID-19 patients. Participants were asked to rate their perception within and outside of a PC setting. RESULTS: Of the 6129 DGP members, N = 506 participated. DGP physicians and nurses perceived handling of M/O as "certain and confident" (98%) and "clearly regulated" within PC (95%) but rated it significantly lower for outside PC (48%/38%). When caring for COVID-19 patients, handling of M/O was even less often rated "certain and confident" (26%) or "clearly regulated" (23%) for outside PC. Dyspnea (99%/52%), relief from the dying process (62%/37%), restlessness (30%/15%) and fear or panic (27%/13%) were more frequently rated as general indications for morphine within versus outside PC. Most participants (89%) wished to involve palliative care consultation teams. CONCLUSIONS: DGP members perceived substantial uncertainty in the handling of M/O for medical fields outside PC. Uniform interdisciplinary guidelines for symptom control, more education, and involvement of a PC consultation team should be increasingly considered in the future.

Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial.

BACKGROUND: Postoperative pain remains a common problem in gynecologic laparoscopy, especially in head zone-related regions, triggered by intra-abdominal pressure during capnoperitoneum. Humidified and prewarmed insufflation gas may ameliorate pain and be beneficial. METHODS: This prospective randomized controlled parallel group multi-arm single-center study investigated the effects of temperature and humidity of insufflation gas on postoperative pain during gynecologic laparoscopy with a duration ≥ 60 min. Female participants (18-70 years) were blinded and randomly assigned-computer generated-to either insufflation with dry cold CO2 with forced air warming blanket ("AIR"), humidified warm gas without forced air warming blanket ("HUMI"), or humidified warm gas with forced air warming blanket ("HUMI +"). We hypothesized that using humidified warm gas resulted in lower pain scores and less analgesic consumption. The primary endpoint postoperative pain was assessed for different pain localizations every 12 h during 7 days after surgery. Secondary endpoints were demand for painkillers and epidural anesthetics, length of stay in recovery room, and hospital stay. (Registration: ClinicalTrials.gov NCT02781194-completed). RESULTS: 150 participants were randomized. Compared to group "AIR" (n = 48), there was significantly less pain in group "HUMI +" (n = 48) in the recovery room (- 1.068; 95% CI - 2.08 to - 0.061), as well as significantly less ibuprofen use at day two (- 0.5871 g ± 0.258; p-value = 0.0471). Other variables did not change significantly. Stratification for presence of endometriosis or non-previous abdominal surgery in patient history revealed significantly less pain in both groups "HUMI" (n = 50) and "HUMI +" versus group "AIR." Related side effects were not noted. CONCLUSION: In the overall population, the use of warm, humidified insufflation gas did not yield clinically relevant effects; however, in predisposed patients with endometriosis and who could otherwise expect high pain levels, warm and humidified gas may be beneficial.

Effects of empagliflozin on erythropoiesis in patients with type 2 diabetes: Data from a randomized, placebo-controlled study.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been shown to significantly reduce hospitalization for heart failure (HHF) and cardiovascular (CV) mortality in various CV outcome trials in patients with and without type 2 diabetes mellitus (T2D). SGLT2 inhibition further increased haemoglobin and haematocrit levels by an as yet unknown mechanism, and this increase has been shown to be an independent predictor of the CV benefit of these agents, for example, in the EMPA-REG OUTCOME trial. The present analysis of the EMPA haemodynamic study examined the early and delayed effects of empagliflozin treatment on haemoglobin and haematocrit levels, in addition to measures of erythropoiesis and iron metabolism, to better understand the underlying mechanisms. In this prospective, placebo-controlled, double-blind, randomized, two-arm parallel, interventional and exploratory study, 44 patients with T2D were randomized into two groups and received empagliflozin 10 mg or placebo for a period of 3 months in addition to their concomitant medication. Blood and urine was collected at baseline, on Day 1, on Day 3 and after 3 months of treatment to investigate effects on haematological variables, erythropoietin concentrations and indices of iron stores. Baseline characteristics were comparable in the empagliflozin (n = 20) and placebo (n = 22) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.3 ± 22.7 g/24 h; Day 1: 48.4 ± 34.7 g/24 h; P < 0.001) as well as urinary volume (baseline: 1740 ± 601 mL/24 h; Day 1: 2112 ± 837 mL/24 h; P = 0.011) already after 1 day and throughout the 3-month study period, while haematocrit and haemoglobin were only increased after 3 months of treatment (haematocrit: baseline: 40.6% ± 4.6%; Month 3: 42.2% ± 4.8%, P < 0.001; haemoglobin: baseline: 136 ± 19 g/L; Month 3: 142 ± 25 g/L; P = 0.008). In addition, after 3 months, empagliflozin further increased red blood cell count (P < 0.001) and transferrin concentrations (P = 0.063) and there was a trend toward increased erythropoietin levels (P = 0.117), while ferritin (P = 0.017), total iron (P = 0.053) and transferrin saturation levels (P = 0.030) decreased. Interestingly, the increase in urinary glucose excretion significantly correlated with the induction of erythropoietin in empagliflozin-treated patients at the 3-month timepoint (Spearman rho 0.64; P = 0.008). Empagliflozin increased haemoglobin concentrations and haematocrit with a delayed time kinetic, which was most likely attributable to increased erythropoiesis with augmented iron utilization and not haemoconcentration. This might be attributable to reduced tubular glucose reabsorption in response to SGLT2 inhibition, possibly resulting in diminished cellular stress as a mechanism for increased renal erythropoietin secretion.

Effects of Transcatheter Mitral Valve Repair Using MitraClip® Device on Sleep Disordered Breathing in Patients with Mitral Valve Regurgitation.

Sleep disordered breathing (SDB) is common among patients with valvular heart disease, and successful valve surgery could reduce SDB severity. However, data about the effects of transcatheter mitral valve repair on SDB are scarce. Therefore, mitral regurgitation (MR) patients undergoing MitraClip-placement were prospectively enrolled. Before MitraClip-placement, daytime sleepiness and sleep quality were assessed using the Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), respectively; and all patients underwent SDB screening using five-channel respiratory polygraphy. After 3-6 months, patients had a similar reassessment including: ESS, PSQI, and respiratory polygraphy. 67 patients were included (77 ± 8years). Despite normal sleepiness scores, 41 patients (61%) had SDB with apnea-hypopnea-index (AHI) ≥ 15 h before MitraClip-placement, of whom only three patients had known SDB previously. Compared to patients without SDB, patients with SDB had similar sleepiness scores but higher NT-proBNP values at baseline (4325 vs. 1520 pg/mL, p < 0.001). At follow-up, there were significant AHI improvements among patients with SDB (p = 0.013). However, there were no significant sleepiness score changes. In conclusion, the prevalence of SDB among MitraClip candidates is very high even in those without daytime sleepiness. MR patients with SDB have higher NT-proBNP values, which may reflect a worse prognosis. MitraClip-placement may improve the underlying SDB, which could be an additional benefit of the procedure.

Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study.

BACKGROUND: In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The early separation of the HHF event curves within the first 3 months of the trial suggest that immediate hemodynamic effects may play a role. However, hitherto no data exist on early effects of SGLT2 inhibitors on hemodynamic parameters and cardiac function. Thus, this study examined early and delayed effects of empagliflozin treatment on hemodynamic parameters including systemic vascular resistance index, cardiac index, and stroke volume index, as well as echocardiographic measures of cardiac function. METHODS: In this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Hemodynamic and echocardiographic parameters were assessed after 1 day, 3 days and 3 months of treatment. RESULTS: Baseline characteristics were not different in the empagliflozin (n = 22) and placebo (n = 20) group. Empagliflozin led to a significant increase in urinary glucose excretion (baseline: 7.3 ± 22.7 g/24 h; day 1: 48.4 ± 34.7 g/24 h; p < 0.001) as well as urinary volume (1740 ± 601 mL/24 h to 2112 ± 837 mL/24 h; p = 0.011) already after one day compared to placebo. Treatment with empagliflozin had no effect on the primary endpoint of systemic vascular resistance index, nor on cardiac index, stroke volume index or pulse rate at any time point. In addition, echocardiography showed no difference in left ventricular systolic function as assessed by left ventricular ejections fraction and strain analysis. However, empagliflozin significantly improved left ventricular filling pressure as assessed by a reduction of early mitral inflow velocity relative to early diastolic left ventricular relaxation (E/e') which became significant at day 1 of treatment (baseline: 9.2 ± 2.6; day 1: 8.5 ± 2.2; p = 0.005) and remained apparent throughout the study. This was primarily attributable to reduced early mitral inflow velocity E (baseline: 0.8 ± 0.2 m/s; day 1: 0.73 ± 0.2 m/sec; p = 0.003). CONCLUSIONS: Empagliflozin treatment of patients with T2D has no significant effect on hemodynamic parameters after 1 or 3 days, nor after 3 months, but leads to rapid and sustained significant improvement of diastolic function. Trial registration EudraCT Number: 2016-000172-19; date of registration: 2017-02-20 (clinicaltrialregister.eu).

Screen-detected atrial fibrillation predicts mortality in elderly subjects.

AIMS: Current guidelines recommend opportunistic screening for atrial fibrillation (AF) but the prognosis of individuals is unclear. The aim of this investigation is to determine prevalence and 1-year outcome of individuals with screen-detected AF. METHODS AND RESULTS: We performed a prospective, pharmacy-based single time point AF screening study in 7107 elderly citizens (≥65 years) using a hand-held, single-lead electrocardiogram (ECG) device. Prevalence of AF was assessed, and data on all-cause death and hospitalization for cardiovascular (CV) causes were collected over a median follow-up of 401 (372; 435) days. Mean age of participants was 74 ± 5.9 years, with 58% (N = 4130) of female sex. Automated heart rhythm analyses identified AF in 432 (6.1%) participants, with newly diagnosed AF in 3.6% of all subjects. During follow-up, 62 participants (0.9%) died and 390 (6.0%) were hospitalized for CV causes. Total mortality was 2.3% in participants with a screen-detected AF and 0.8% in subjects with a normal ECG [hazard ratio (HR) 2.94; 95% confidence interval (CI) 1.49-5.78; P = 0.002]; hospitalization for CV causes occurred in 10.6% and 5.5%, respectively (HR 2.08; 95% CI 1.52-2.84; P < 0.001). Compared with subjects without a history of AF at baseline and a normal ECG, participants with newly diagnosed or known AF had a significantly higher mortality risk with HRs of 2.64 (95% CI 1.05-6.66; P = 0.04) and 2.68 (95% CI 1.44-4.97; P = 0.002), respectively. After multivariable adjustment, screen-detected AF remained a significant predictor of death or hospitalization for CV causes. CONCLUSION: Pharmacy-based, automated AF screening in elderly citizens identified subjects with unknown AF and an excess mortality risk over the next year.

EULAR/eumusc.net standards of care for rheumatoid arthritis: cross-sectional analyses of importance, level of implementation and care gaps experienced by patients and rheumatologists across 35 European countries.

OBJECTIVE: As part of European League against Rheumatism (EULAR)/European Musculoskeletal Conditions Surveillance and Information Network, 20 user-focused standards of care (SoCs) for rheumatoid arthritis (RA) addressing 16 domains of care were developed. This study aimed to explore gaps in implementation of these SoCs across Europe. METHODS: Two cross-sectional surveys on the importance, level of and barriers (patients only) to implementation of each SoC (0-10, 10 highest) were designed to be conducted among patients and rheumatologists in 50 European countries. Care gaps were calculated as the difference between the actual and maximum possible score for implementation (ie, 10) multiplied by the care importance score, resulting in care gaps (0-100, maximal gap). Factors associated with the problematic care gaps (ie, gap≥30 and importance≥6 and implementation<6) and strong barriers (≥6) were further analysed in multilevel logistic regression models. RESULTS: Overall, 26 and 31 countries provided data from 1873 patients and 1131 rheumatologists, respectively. 19 out of 20 SoCs were problematic from the perspectives of more than 20% of patients, while this was true for only 10 SoCs for rheumatologists. Rheumatologists in countries with lower gross domestic product and non-European Union countries were more likely to report problematic gaps in 15 of 20 SoCs, while virtually no differences were observed among patients. Lack of relevance of some SoCs (71%) and limited time of professionals (66%) were the most frequent implementation barriers identified by patients. CONCLUSIONS: Many problematic gaps were reported across several essential aspects of RA care. More efforts need to be devoted to implementation of EULAR SoCs.