Efficacy of Alkaline Phosphatase in Critically Ill Patients with COVID-19: A Multicentre Investigator-Initiated Double-Blind Randomised Placebo-Controlled Trial.

BACKGROUND: Efforts to identify therapies to treat hospitalised patients with COVID-19 are being continued. Alkaline phosphatase (AP) dephosphorylates pro-inflammatory adenosine triphosphate (ATP) into anti-inflammatory adenosine. METHODS: In a randomised controlled trial, we investigated the safety and efficacy of AP in patients with SARS-CoV-2 infection admitted to the ICU. AP or a placebo was administered for four days following admission to the ICU. The primary outcome was the duration of mechanical ventilation. Mortality in 28 days, acute kidney injury, need for reintubation, safety, and inflammatory markers relevant to the described high cytokine release associated with SARS-CoV-2 infection were the secondary outcomes. RESULTS: Between December 2020 and March 2022, 97 patients (of the intended 132) were included, of which 51 were randomised to AP. The trial was terminated prematurely based on meeting the threshold for futility. Compared to the placebo, AP did not affect the duration of mechanical ventilation (9.0 days vs. 9.3 days, p = 1.0). No safety issues were observed. After 28 days, mortality was 9 (18%) in the AP group versus 6 (13%) in the placebo group (p = 0.531). Additionally, no statistically significant differences between the AP and the placebo were observed for the other secondary outcomes. CONCLUSIONS: Alkaline phosphatase (AP) therapy in COVID-19 ICU patients showed no significant benefits in this trial.

Comprehensive antibody and cytokine profiling in hospitalized COVID-19 patients in relation to clinical outcomes in a large Belgian cohort.

The immune response in patients with Coronavirus Disease 2019 (COVID-19) is highly variable and is linked to disease severity and mortality. However, antibody and cytokine responses in the early disease stage and their association with disease course and outcome are still not completely understood. In this large, multi-centre cohort study, blood samples of 434 Belgian COVID-19 hospitalized patients with different disease severities (ranging from asymptomatic/mild to critically ill) from the first wave of the COVID-19 pandemic were obtained. Baseline antibody and cytokine responses were characterized and associations with several clinical outcome parameters were determined. Anti-spike immunoglobulin (Ig)G and IgM levels were elevated in patients with a more severe disease course. This increased baseline antibody response however was associated with decreased odds for hospital mortality. Levels of the pro-inflammatory cytokines IL-6, IP-10 and IL-8, the anti-inflammatory cytokine IL-10 and the antiviral cytokines IFN-α, IFN-ß and IFN-λ1 were increased with disease severity. Remarkably, we found significantly lower levels of IFN-λ2,3 in critically ill patients compared to patients of the moderate and severe disease category. Finally, levels of IL-8, IL-6, IP-10, IL-10, IFN-α, IFN-ß, IFN-γ and IFN-λ1 at baseline were positively associated with mortality, whereas higher IFN-λ2,3 levels were negatively associated with mortality.

Regional anaesthesia for ambulatory surgery.

Regional anaesthesia (RA) has an important and ever-expanding role in ambulatory surgery. Specific practices vary depending on the preferences and resources of the anaesthesia team and hospital setting. It is used for various purposes, including as primary anaesthetic technique for surgery but also as postoperative analgesic modality. The limited duration of action of currently available local anaesthetics limits their application in postoperative pain control and enhanced recovery. The search for the holy grail of regional anaesthetics continues. Current evidence suggests that a peripheral nerve block performed with long-acting local anaesthetics in combination with intravenous or perineural dexamethasone gives the longest and most optimal sensory block. In this review, we outline some possible blocks for ambulatory surgery and additives to perform RA. Moreover, we give an update on local anaesthesia drugs and adjuvants, paediatric RA in ambulatory care and discuss the impact of RA by COVID-19.

Serratus plane block versus standard of care for pain control after totally endoscopic aortic valve replacement: a double-blind, randomized controlled, superiority trial.

INTRODUCTION: Serratus anterior plane block has been proposed to reduce opioid requirements after minimally invasive cardiac surgery, but high-quality evidence is lacking. METHODS: This prospective, double-blinded, randomized controlled trial recruited patients undergoing totally endoscopic aortic valve replacement. Patients in the intervention arm received a single-injection serratus anterior plane block on arrival to the intensive care unit added to standard of care. Patients in the control group received routine standard of care, including patient-controlled intravenous analgesia. Primary outcome was piritramide consumption within the first 24 hours after serratus anterior plane block placement. We hypothesized that compared with no block, patients in the intervention arm would consume 25% less opioids. RESULTS: Seventy-five patients were analyzed (n=38 in intervention arm, n=37 in control arm). When comparing the serratus anterior plane group with the control group, median 24-hour cumulative opioid use was 9 (IQR 6-19.5) vs 15 (IQR 11.3-23.3) morphine milligram equivalents, respectively (p<0.01). Also, pain scores at 4, 8 and 24 hours were lower in the intervention arm at 4, 8 and 24 hours, respectively. CONCLUSION: Combined deep and superficial single-injection serratus anterior plane block is superior to standard of care in reducing opioid requirements and postoperative pain intensity up to 24 hours after totally endoscopic aortic valve replacement. TRIAL REGISTRATION NUMBER: NCT04699422.

Patient-Centred Outcomes after Totally Endoscopic Cardiac Surgery: One-Year Follow-Up.

Patient-centred outcomes have grown in popularity over recent years in surgical care research. These patient-centred outcomes can be measured through the health-related quality of life (HRQL) without professional interpretations. In May 2022, a study regarding patient-centred outcomes up to 90 days postoperatively was published. Fourteen days after surgery, the HRQL decreased and returned to baseline levels after 30 days. Next, the HRQL significantly improved 90 days postoperatively. However, this study only focuses on a short-term follow-up of the patients. Hence, this follow-up study aims to assess the HRQL one year after totally endoscopic cardiac surgery. At baseline, 14, 30, and 90 days, and one year after surgery, the HRQL was evaluated using a 36-item short form and 5-dimensional European QoL questionnaires (EQ-5D). Using the 36-item short form questionnaire, a physical and mental component score is calculated. Over the period of one year, this physical and mental component score and the EQ-5D index value significantly improve. According to the visual analogue scale of the EQ-5D, patients score their health significantly higher one year postoperatively. In conclusion, after endoscopic cardiac surgery, the HRQL is significantly improved 90 days postoperatively and remains high one year afterward.

Quality of life in patients undergoing minimally invasive cardiac surgery: a systematic review.

Objective: Minimally invasive procedures have been developed to reduce surgical trauma after cardiac surgery. Clinical recovery is the main focus of most research. Still, patient-centred outcomes, such as the quality of life, can provide a more comprehensive understanding of the impact of the surgery on the patient's life. This systematic review aims to deliver a detailed summary of all available research investigating the quality of recovery, assessed with quality of life instruments, in adults undergoing minimally invasive cardiac surgery. Methods: All randomised trials, cohort studies, and cross-sectional studies assessing the quality of recovery in patients undergoing minimally invasive cardiac surgery compared to conventional cardiac surgery within the last 20 years were included, and a summary was prepared. Results: The randomised trial observed an overall improved quality of life after both minimally invasive and conventional surgery. The quality of life improvement in the minimally invasive group showed a faster course and evolved to a higher level than the conventional surgery group. These findings align with the results of prospective cohort studies. In the cross-sectional studies, no significant difference in the quality of life was seen except for one that observed a significantly higher quality of life in the minimally invasive group. Conclusions: This systematic review indicates that patients may benefit from minimally invasive and conventional cardiac surgery, but patients undergoing minimally invasive cardiac surgery may recover sooner and to a greater extent. However, no firm conclusion could be drawn due to the limited available studies. Therefore, randomised controlled trials are needed.

Incidence, predictors and vascular sequelae of distal limb ischemia in minimally invasive cardiac surgery with femoral artery cannulation: an observational cohort study.

Literature regarding monitoring and consequences of distal limb ischemia due to femoral artery cannulation for Minimally Invasive Cardiac Surgery (MICS) remains limited. The primary objective was to determine its incidence, defined as a ≥ 15% difference in regional Oxygen Saturation (rSO2) lasting ≥ four consecutive minutes between the cannulated and non-cannulated limb. The secondary objectives included: determination of distal limb ischemia, defined as a Tissue Oxygenation Index (TOI) < 50% in the cannulated limb, identification of predictors for distal limb ischemia, determination of a possible association of NIRS-diagnosed ischemia with acute kidney injury, and the need for vascular surgery up to six months after cardiac surgery. A prospective, observational cohort study with blinded rSO2-measurements to prevent intraoperative clinical decision-making. A single-center, community-hospital, clinical study. All consecutive patients ≥ 18 years old, and scheduled for predefined MICS. Patients underwent MICS with bilateral calf muscle rSO2-measurements conducted by Near-Infrared Spectroscopy (NIRS). In total 75/280 patients (26.79%) experienced distal limb ischemia according to the primary objective, while 18/280 patients (6.42%) experienced distal limb ischemia according to the secondary objective. Multivariate logistic regression showed younger age to be an independent predictor for distal limb ischemia (p = 0.003). None of the patients who suffered intraoperative ischemia required vascular surgery within the follow-up period. The incidence of NIRS-diagnosed ischemia varied from 6.4% to 26.8% depending on the used criteria. Short and long-term vascular sequelae, however, are limited and not intraoperative ischemia related. The added value of intraoperative distal limb NIRS monitoring for vascular reasons seems limited. Future research on femoral artery cannulation in MICS should shift focus to other outcome parameters such as acute kidney injury, postoperative pain or paresthesias.

Additive or synergistic analgesic effect of metamizole on standard pain treatment at home after arthroscopic shoulder surgery: A randomised controlled superiority trial.

BACKGROUND: There is growing evidence that the analgesic effect of metamizole is mediated at least partly by central mechanisms, including the endocannabinoid/endovanilloid system. Consequently, metamizole may have additive or even synergistic analgesic effects with paracetamol and nonsteroidal anti-inflammatory drugs (NSAID). OBJECTIVE: This study aimed to assess if triple therapy with metamizole, ibuprofen and paracetamol (MIP) is superior to double therapy with ibuprofen and paracetamol (i.p.) in treating pain at home after ambulatory arthroscopic shoulder surgery. DESIGN/SETTING/PATIENTS/INTERVENTION: In this double-blind, controlled, high-volume single centre, superiority trial, 110 patients undergoing elective ambulatory arthroscopic shoulder surgery were randomised to receive either MIP ( n  = 55) or i.p. ( n  = 55) orally for 4 days between December 2019 and November 2021. Pain intensity at movement and rest, using a numeric rating scale (NRS), perceived pain relief, use of rescue medication and adverse effects of study medication were recorded at the post-anaesthesia care unit (PACU) and on postoperative day (POD) 1 to 4 and 7. Quality of Recovery (QoR) and satisfaction with study medication were measured at POD 7 with telephone follow-up. MAIN OUTCOME MEASURE: The primary outcome measure was postoperative pain intensity on movement measured by an 11-point NRS (where 0 = no pain and 10 = worst pain imaginable) on POD 1. RESULTS: For the primary outcome, superiority of MIP in reducing postoperative pain at movement on POD 1 was not confirmed: mean difference NRS [95% confidence interval (CI), -0.08 (-1.00 to 0.84)]. For pain on movement and at rest, no significant differences were found between groups in the PACU nor on POD 1 to 4 or day 7. Nausea was reported significantly more frequently in the metamizole group (22.6 vs. 58.5; P  < 0.001). Other adverse effects of study medication, rescue opioid consumption, perceived pain relief, QoR at POD 7, and overall patient satisfaction were similar in both groups. CONCLUSION: Clinically, triple oral treatment with metamizole, paracetamol and ibuprofen is not superior to oral paracetamol and ibuprofen in multimodal pain treatment at home after ambulatory arthroscopic shoulder surgery. TRIAL REGISTRATION: European Union Clinical Trials Register 2019-002801-23 and Clinicaltrials.gov NCT04082728.

Observations of nemaline bodies in muscle biopsies of critically ill patients infected with SARS-CoV-2.

Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have been admitted to the intensive care unit (ICU) often face months of physical disability after discharge. To optimize recovery, it is important to understand the role of musculoskeletal alterations in critically ill patients infected with SARS-CoV-2. The main aim of the present study was to describe the presence and morphology of nemaline bodies found in the skeletal muscle tissue from critically ill patients infected with SARS-CoV-2. In n = 7 patients infected with SARS-CoV-2, ultrastructural characteristics of vastus lateralis muscle obtained on days 1-3 and days 5-8 following ICU admission were investigated in more detail with electron microscopy. Those muscle biopsies consistently showed variable degrees of myofiber necrosis and myofibrillar disorganization. In 4/7 (57%) patients on days 5-8, the Z-line material accumulated into nemaline bodies with a typical lattice-like appearance at higher magnification, similar to that found in nemaline myopathy. This study is the first to describe the disintegration of myofibrils and the accumulation of Z-line material into nemaline bodies in the skeletal muscle tissue obtained from critically ill coronavirus disease-19 patients following ICU admission, which should be interpreted primarily as a non-specific pathological response of extreme myofibrillar disintegration associated with myofiber necrosis.

90-Day Patient-Centered Outcomes after Totally Endoscopic Cardiac Surgery: A Prospective Cohort Study.

Over the past years, minimally invasive procedures have been developed to reduce surgical trauma after cardiac surgery. The value of patient-centered outcomes, including the quality of recovery after hospital discharge, is increasingly recognized. Identifying meaningful changes in postoperative function that might have a negative impact on patients without noticeable complications can provide a more comprehensive understanding of the impact on the patient's life. In total, 209 patients were included in this trial. Of these, 193 patients underwent totally endoscopic cardiac surgery, 8 underwent cardiac surgery through a sternotomy, and 8 underwent transcatheter aortic valve implantation. Patients who previously underwent cardiac surgery were excluded. Quality of life was determined through the Short Form 36 and European Quality of Life-5 Dimensions questionnaires before the surgery and 14, 30, and 90 days afterward. In patients who underwent totally endoscopic cardiac surgery, the quality of life improved over the three time periods. The different domains of the questionnaire evolved in a positive manner. However, 14 days postoperatively, a decline in quality of life was noted, followed by a return to baseline at 30 days and an increase at 90 days. In conclusion, totally endoscopic cardiac surgery improves the quality of life 90 days after surgery.

Better COVID-19 Intensive Care Unit survival in females, independent of age, disease severity, comorbidities, and treatment.

Although male Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) patients have higher Intensive Care Unit (ICU) admission rates and a worse disease course, a comprehensive analysis of female and male ICU survival and underlying factors such as comorbidities, risk factors, and/or anti-infection/inflammatory therapy administration is currently lacking. Therefore, we investigated the association between sex and ICU survival, adjusting for these and other variables. In this multicenter observational cohort study, all patients with SARS-CoV-2 pneumonia admitted to seven ICUs in one region across Belgium, The Netherlands, and Germany, and requiring vital organ support during the first pandemic wave were included. With a random intercept for a center, mixed-effects logistic regression was used to investigate the association between sex and ICU survival. Models were adjusted for age, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, comorbidities, and anti-infection/inflammatory therapy. Interaction terms were added to investigate effect modifications by sex with country and sex with obesity. A total of 551 patients (29% were females) were included. Mean age was 65.4 ± 11.2 years. Females were more often obese and smoked less frequently than males (p-value 0.001 and 0.042, respectively). APACHE II scores of females and males were comparable. Overall, ICU mortality was 12% lower in females than males (27% vs 39% respectively, p-value < 0.01) with an odds ratio (OR) of 0.62 (95%CI 0.39-0.96, p-value 0.032) after adjustment for age and APACHE II score, 0.63 (95%CI 0.40-0.99, p-value 0.044) after additional adjustment for comorbidities, and 0.63 (95%CI 0.39-0.99, p-value 0.047) after adjustment for anti-infection/inflammatory therapy. No effect modifications by sex with country and sex with obesity were found (p-values for interaction > 0.23 and 0.84, respectively). ICU survival in female SARS-CoV-2 patients was higher than in male patients, independent of age, disease severity, smoking, obesity, comorbidities, anti-infection/inflammatory therapy, and country. Sex-specific biological mechanisms may play a role, emphasizing the need to address diversity, such as more sex-specific prediction, prognostic, and therapeutic approach strategies.

Worsening COVID-19 Disease Course After Surgical Trauma: A Case Series.

Introduction: Current guidelines from the American Society of Anesthesiologists recommend postponing elective surgery on COVID-19-positive patients for a minimum of four to twelve weeks. However, literature focusing on the outcomes of COVID-19-positive patients undergoing surgery is scarce. In this case series, the outcome of asymptomatic COVID-19 patients undergoing acute or semi-urgent surgery was evaluated. Case Presentation: A case series of four patients between 32 and 82 years old with a confirmed SARS-CoV-2 infection undergoing acute or semi-urgent surgery was presented here. All four patients were asymptomatic for COVID-19, developing severe respiratory failure following endo CABG, caesarian section, a thyroidectomy, or abdominal surgery. ICU admission, together with invasive ventilation, was necessary for all patients. Two patients required venovenous extracorporeal membrane oxygenation treatment. A mortality of 50% was observed. Conclusions: In conclusion, the present case series suggests that elective surgery in asymptomatic SARS-CoV-2 infected patients might elicit an exacerbated COVID-19 disease course. This study endorses the current international guidelines recommending postponing elective surgery for SARS-CoV-2-positive patients for seven weeks, depending on the severity of the surgery and perioperative morbidities, to minimize postoperative mortality.

The analgesic efficacy of forearm versus upper arm intravenous regional anesthesia (Bier's block): A randomized controlled non-inferiority trial.

STUDY OBJECTIVE: This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery. DESIGN: Observer-blinded, randomized non-inferiority study. SETTING: Operating room. PATIENTS: 280 patients undergoing hand surgery were randomly assigned to UA IVRA (n = 140) or FA IVRA (n = 140). INTERVENTIONS: Forearm IVRA or upper arm IVRA in patients undergoing hand and wrist surgery. MEASUREMENTS: The primary outcome was block success rate of both techniques. Block success was defined as no need of additional analgesics. A second, alternative non-inferiority outcome was defined as no need of conversion to general anesthesia. A difference in success rate of <5% was considered non-inferior. Secondary endpoints were tourniquet pain measured with a Numerical Rating Scale (0-10), satisfaction of patients and surgeons, onset time, surgical time and total OR time. MAIN RESULTS: Non-inferiority of block success rate, defined as no need of additional analgesics or conversion to general anesthesia was inconclusive (5.24%, 95% CI:-4.34%,+14.82%). Non-inferiority of no need of conversion to general anesthesia was confirmed (+0.73%, 95% CI:-0.69%,+2.15%). No differences were observed in onset time (FA: 5 (5, 8) vs UA: 6 (5, 7) min, p = 0.74), surgical time (FA: 8 (5, 12) vs UA: 7 (5, 11) min, p = 0.71), nor total OR stay time (FA: 34 (27, 41) vs UA: 35 (32, 39) min, p = 0.09). Tourniquet pain after 10 min was significantly lower after FA IVRA compared to UA IVRA (FA: 2.00 (0.00, 4.00) vs UA: 3.00 (1.00,5.00) min, p = 0.003). CONCLUSION: We failed to demonstrate non-inferiority of forearm IVRA with a lower dosage of LA in providing a surgical block without rescue opioids and LA. Non-inferiority of no need of conversion to general anesthesia was confirmed.

Evaluation of a comprehensive pre-procedural screening protocol for COVID-19 in times of a high SARS CoV-2 prevalence: a prospective cross-sectional study.

BACKGROUND: To minimise the risk of COVID-19 transmission, an ambulant screening protocol for COVID-19 in patients before admission to the hospital was implemented, combining the SARS CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) on a nasopharyngeal swab, a chest computed tomography (CT) and assessment of clinical symptoms. The aim of this study was to evaluatethe diagnostic yield and the proportionality of this pre-procedural screeningprotocol. METHODS: In this mono-centre, prospective, cross-sectional study, all patients admitted to the hospital between 22nd April 2020 until 14th May 2020 for semi-urgent surgery, haematological or oncological treatment, or electrophysiological investigationunderwent a COVID-19 screening 2 days before their procedure. At a 2-week follow-up, the presence of clinical symptoms was evaluated by telephone as a post-hoc evaluation of the screening approach.Combined positive RT-PCR assay and/or positive chest CT was used as gold standard. Post-procedural outcomes of all patients diagnosed positive for COVID-19 were assessed. RESULTS: In total,528 patients were included of which 20 (3.8%) were diagnosed as COVID-19 positive and 508 (96.2%) as COVID-19 negative. 11 (55.0%) of COVID-19 positive patients had only a positive RT-PCR assay, 3 (15.0%) had only a positive chest CT and 6 (30%) had both a positive RT-PCR assay and chest CT. 10 out of 20 (50.0%) COVID-19 positive patients reported no single clinical symptom at the screening. At 2 week follow-up, 50% of these patients were still asymptomatic. 37.5% of all COVID-19 negative patients were symptomatic at screening. In the COVID-19 negative group without symptoms at screening, 78 (29.3%) patients developed clinical symptoms at a 2-week follow-up. CONCLUSION: This study suggests that routine chest CT and assessment of self-reported symptoms have limited value in the preprocedural COVID-19 screening due to low sensitivity and/or specificity.

Efficacy of ultrasound-guided forearm nerve block versus forearm intravenous regional anaesthesia in patients undergoing carpal tunnel release: A randomized controlled trial.

BACKGROUND AND OBJECTIVES: Distal upper extremity surgery is commonly performed under regional anaesthesia, including intravenous regional anaesthesia (IVRA) and ultrasound-guided forearm nerve block. This study aimed to investigate if ultrasound-guided forearm nerve block is superior to forearm IVRA in producing a surgical block in patients undergoing carpal tunnel release. METHODS: In this observer-blinded, randomized controlled superiority trial, 100 patients undergoing carpal tunnel release were randomized to receive ultrasound-guided forearm nerve block (n = 50) or forearm IVRA (n = 50). The primary outcome was anaesthetic efficacy evaluated by classifying the blocks as complete vs incomplete. Complete anaesthesia was defined as total sensory block, incomplete anaesthesia as mild pain requiring more analgesics or need of general anaesthesia. Pain intensity on a numeric rating scale (0-10) was recorded. Surgeon satisfaction with hemostasis, surgical time, and OR stay time were recorded. Patient satisfaction with the quality of the block was assessed at POD 1. RESULTS: In total, 43 (86%) of the forearm nerve blocks were evaluated as complete, compared to 33 (66%) of the forearm IVRA (p = 0.019). After the forearm nerve block, pain intensity was lower at discharge (-1.76 points lower, 95% CI (-2.92, -0.59), p = 0.0006) compared to patients treated with forearm IVRA. No differences in pain experienced at the start of the surgery, during surgery, and at POD1, nor in surgical time or total OR stay were observed between groups. Surgeon (p = 0.0016) and patient satisfaction (p = 0.0023) were slightly higher after forearm nerve block. CONCLUSION: An ultrasound-guided forearm nerve block is superior compared to forearm IVRA in providing a surgical block in patients undergoing carpal tunnel release. TRIAL REGISTRATION: This trial was registered as NCT03411551.

One-month recovery profile and prevalence and predictors of quality of recovery after painful day case surgery: Secondary analysis of a randomized controlled trial.

BACKGROUND/OBJECTIVES: This study aimed to study one-month recovery profile and to identify predictors of Quality of Recovery (QOR) after painful day surgery and investigate the influence of pain therapy on QOR. METHODS/DESIGN: This is a secondary analysis of a single-centre, randomised controlled trial of 200 patients undergoing ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair between January 2016 and March 2017. Primary endpoints were one-month recovery profile and prevalence of poor/good QOR measured by the Functional Recovery Index (FRI), the Global Surgical Recovery index and the EuroQol questionnaire at postoperative day (POD) 1 to 4, 7, 14 and 28. Multiple logistic regression analysis was performed to determine predictors of QOR at POD 7, 14, and 28. Differences in QOR between pain treatment groups were analysed using the Mann-Whitney U test. RESULTS: Four weeks after haemorrhoid surgery, inguinal hernia repair, arthroscopic knee and arthroscopic shoulder surgery, good QOR was present in 71%, 76%, 57% and 24% respectively. Poor QOR was present in 5%, 0%, 7% and 29%, respectively. At POD 7 and POD 28, predictors for poor/intermediate QOR were type of surgery and a high postoperative pain level at POD 4. Male gender was another predictor at POD 7. Female gender and having a paid job were also predictors at POD 28. Type of surgery and long term fear of surgery were predictors at POD 14. No significant differences in total FRI scores were found between the two different pain treatment groups. CONCLUSIONS: The present study shows a procedure-specific variation in recovery profile in the 4-week period after painful day surgery. The best predictors for short-term (POD 7) and long-term (POD 28) poor/intermediate QOR were a high postoperative pain level at POD 4 and type of surgery. Different pain treatment regimens did not result in differences in recovery profile. TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35.

Neurological outcome after minimally invasive coronary artery bypass surgery (NOMICS): An observational prospective cohort study.

BACKGROUND/OBJECTIVES: Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimally invasive CABG procedure with retrograde arterial perfusion. The main objective of this study is to assess neurocognitive outcome after Endo-CABG. METHODS/DESIGN: In this prospective observational cohort study, patients were categorised into: Endo-CABG (n = 60), a comparative Percutaneous Coronary Intervention (PCI) group (n = 60) and a healthy volunteer group (n = 60). A clinical neurological examination was performed both pre- and postoperatively, delirium was assessed postoperatively. A battery of 6 neurocognitive tests, Quality of life (QoL) and the level of depressive feelings were measured at baseline and after 3 months. Patient Satisfaction after Endo-CABG was assessed at 3-month follow-up. Primary endpoints were incidence of postoperative cognitive dysfunction (POCD), stroke and delirium after Endo-CABG. Secondary endpoints were QOL, patient satisfaction and the incidence of depressive feelings after Endo-CABG. RESULTS: In total, 1 patient after Endo-CABG (1.72%) and 1 patient after PCI (1.67%) suffered from stroke during the 3-month follow-up. POCD in a patient is defined as a Reliable Change Index ≤-1.645 or Z-score ≤-1.645 in at least two tests, and was found in respectively 5 and 6 patients 3 months after Endo-CABG and PCI. Total incidence of POCD/stroke was not different (PCI: n= 7 [15.9%]; Endo-CABG: n= 6 [13.0%], p = 0.732). ICU delirium after Endo-CABG was found in 5 (8.6%) patients. QoL increased significantly three months after Endo-CABG and was comparable with QoL level after PCI and in the control group. Patient satisfaction after Endo-CABG and PCI was comparable. At follow-up, the level of depressive feelings was decreased in all groups. CONCLUSIONS: The incidence of poor neurocognitive outcome, including stroke, POCD and postoperative ICU delirium until three months after Endo-CABG is low and comparable with PCI. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT02979782).

Four-Week Pain Profile and Patient Non-Adherence to Pharmacological Pain Therapy After Day Surgery.

BACKGROUND: Nowadays, complicated and painful surgical procedures are encouraged to be carried out in an ambulatory setting. OBJECTIVES: The current study aimed to assess 4-week postoperative pain profiles of 4 painful ambulatory surgical procedures. We analyzed the prevalence of and reasons for non-adherence and partial adherence of patients to a predefined treatment schedule after the ambulant surgery. METHODS: The current study analyzed data from a large randomized trial by evaluating the effect of postoperative pain medication on acute postoperative pain at home during the first 4 postoperative days (POD) in patients scheduled for ambulatory hemorrhoid surgery, shoulder or knee arthroscopy, and inguinal hernia repair. Postoperative pain intensity was assessed at POD 0, 1, 2, 3, 4, 7, 14, and 28 via the Numeric Rating Scale (NRS). Adherence was assessed on POD 1, 2, 3, and 4. RESULTS: Median average pain scores were above an NRS of 3 during the first postoperative week after shoulder arthroscopy and even above 4 during the first postoperative week after hemorrhoid surgery. 26% of patients undergoing shoulder arthroscopy and hemorrhoid surgery still had moderate pain 1 week after surgery. Median average pain scores were below an NRS of 3 during the whole study period after inguinal hernia repair and knee arthroscopy. 24.61% of patients did not use the study medication as prescribed, 5.76% of whom were non-adherent, and 18.85% were partially adherent. CONCLUSIONS: Each type of ambulant surgery has its unique postoperative pain profile. New strategies should be developed for pain therapy at home, particularly after the ambulatory arthroscopic shoulder surgery and hemorrhoid surgery. Non-adherence is uncommon if they are provided with a multimodal analgesic home kit together with clear verbal, written instructions, and intensive follow-up.