Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU.

BACKGROUND: Randomized, controlled trials have shown both benefit and harm from tight blood-glucose control in patients in the intensive care unit (ICU). Variation in the use of early parenteral nutrition and in insulin-induced severe hypoglycemia might explain this inconsistency. METHODS: We randomly assigned patients, on ICU admission, to liberal glucose control (insulin initiated only when the blood-glucose level was >215 mg per deciliter [>11.9 mmol per liter]) or to tight glucose control (blood-glucose level targeted with the use of the LOGIC-Insulin algorithm at 80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]); parenteral nutrition was withheld in both groups for 1 week. Protocol adherence was determined according to glucose metrics. The primary outcome was the length of time that ICU care was needed, calculated on the basis of time to discharge alive from the ICU, with death accounted for as a competing risk; 90-day mortality was the safety outcome. RESULTS: Of 9230 patients who underwent randomization, 4622 were assigned to liberal glucose control and 4608 to tight glucose control. The median morning blood-glucose level was 140 mg per deciliter (interquartile range, 122 to 161) with liberal glucose control and 107 mg per deciliter (interquartile range, 98 to 117) with tight glucose control. Severe hypoglycemia occurred in 31 patients (0.7%) in the liberal-control group and 47 patients (1.0%) in the tight-control group. The length of time that ICU care was needed was similar in the two groups (hazard ratio for earlier discharge alive with tight glucose control, 1.00; 95% confidence interval, 0.96 to 1.04; P = 0.94). Mortality at 90 days was also similar (10.1% with liberal glucose control and 10.5% with tight glucose control, P = 0.51). Analyses of eight prespecified secondary outcomes suggested that the incidence of new infections, the duration of respiratory and hemodynamic support, the time to discharge alive from the hospital, and mortality in the ICU and hospital were similar in the two groups, whereas severe acute kidney injury and cholestatic liver dysfunction appeared less prevalent with tight glucose control. CONCLUSIONS: In critically ill patients who were not receiving early parenteral nutrition, tight glucose control did not affect the length of time that ICU care was needed or mortality. (Funded by the Research Foundation-Flanders and others; TGC-Fast ClinicalTrials.gov number, NCT03665207.).

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.

Extracorporeal Membrane Oxygenation to Support COVID-19 Patients: A Propensity-Matched Cohort Study.

Background: In patients with severe respiratory failure from COVID-19, extracorporeal membrane oxygenation (ECMO) treatment can facilitate lung-protective ventilation and may improve outcome and survival if conventional therapy fails to assure adequate oxygenation and ventilation. We aimed to perform a confirmatory propensity-matched cohort study comparing the impact of ECMO and maximum invasive mechanical ventilation alone (MVA) on mortality and complications in severe COVID-19 pneumonia. Materials and Methods: All 295 consecutive adult patients with confirmed COVID-19 pneumonia admitted to the intensive care unit (ICU) from March 13th, 2020, to July 31st, 2021 were included. At admission, all patients were classified into 3 categories: (1) full code including the initiation of ECMO therapy (AAA code), (2) full code excluding ECMO (AA code), and (3) do-not-intubate (A code). For the 271 non-ECMO patients, match eligibility was determined for all patients with the AAA code treated with MVA. Propensity score matching was performed using a logistic regression model including the following variables: gender, P/F ratio, SOFA score at admission, and date of ICU admission. The primary endpoint was ICU mortality. Results: A total of 24 ECMO patients were propensity matched to an equal number of MVA patients. ICU mortality was significantly higher in the ECMO arm (45.8%) compared with the MVA cohort (16.67%) (OR 4.23 (1.11, 16.17); p=0.02). Three-month mortality was 50% with ECMO compared to 16.67% after MVA (OR 5.91 (1.55, 22.58); p < 0.01). Applied peak inspiratory pressures (33.42 ± 8.52 vs. 24.74 ± 4.86 mmHg; p < 0.01) and maximal PEEP levels (14.47 ± 3.22 vs. 13.52 ± 3.86 mmHg; p=0.01) were higher with MVA. ICU length of stay (LOS) and hospital LOS were comparable in both groups. Conclusion: ECMO therapy may be associated with an up to a three-fold increase in ICU mortality and 3-month mortality compared to MVA despite the facilitation of lung-protective ventilation settings in mechanically ventilated COVID-19 patients. We cannot confirm the positive results of the first propensity-matched cohort study on this topic. This trial is registered with NCT05158816.

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.

Predictors of poor outcome in critically ill patients with COVID-19 pneumonia treated with extracorporeal membrane oxygenation.

INTRODUCTION: We aimed to identify risk factors associated with ICU mortality in critically ill patients with COVID-19 pneumonia treated with Extracorporeal membrane oxygenation (ECMO). We also aimed to assess protocol violations of the local eligibility criteria of ECMO initiation. METHODS: All 31 consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU and treated with ECMO from March 13th 2020 to 8 December 2021 were enrolled. Eligibility criteria for ECMO initiation were: P/F-ratio<50 mmHg >3 hours, P/F-ratio<80 mmHg >6 hours or pH<7.25 + PaCO2>60 mmHg >6 hours, despite maximal protective invasive ventilation. Primary outcome was ICU mortality. Univariate logistic regression analyses were performed to identify predictors of ICU mortality. RESULTS: 12 out of 31 patients (38.7%) did not survive ECMO treatment in ICU. Half of the non-survivors suffered from acute kidney failure compared to 3 out of 19 survivors (15.79%) (p = .04). Half of the non-survivors required CRRT treatment versus 1 patient in the survivor group (5.3%) (p < .01). Higher age (2.45 (0.97-6.18), p = .05), the development of AKI (5.33 (1.00-28.43), p = .05), need of CRRT during ICU stay (18.00 (1.79-181.31), p = .01) and major bleeding during ECMO therapy (0.51 (0.19-0.89), p < .01) were identified to be predictors of ICU mortality. CONCLUSION: Almost 60% of patients could be treated successfully with ECMO with sustained results at 3 months. Predictors for ICU mortality were development of AKI and need of CRRT during ICU stay, higher age category and major bleeding. Inadvertent ECMO allocation was noted in almost one in five patients.

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.

Predictive value of serial evaluation of the Sequential Organ Failure Assessment (SOFA) score for intensive care unit mortality in critically ill patients with COVID-19: a retrospective cohort study.

BACKGROUND: The Sequential Organ Failure Assessment (SOFA) score has been developed to score the severity of organ dysfunction in critically ill sepsis patients and has been proven to have a high predictive value for intensive care unit (ICU) mortality in severely ill patients. Our goal was to evaluate the prognostic value of the SOFA score as well as trends in SOFA score for ICU mortality in COVID-19 patients. METHODS: All consecutive patients with confirmed COVID-19 pneumonia admitted to the ICU between March 13th, 2020, and October 17th, 2020 were included in this retrospective cohort study. The worst SOFA score was evaluated daily. Multiple logistic regression models were used to evaluate the predictive value of SOFA in ICU mortality. RESULTS: 103 patients were included in this study. 30 patients (29%) died during their ICU stay and 73 (71%) patients were discharged alive. The ICU admission SOFA score was 5.2 ± 3.3 in ICU non-survivors vs. 4.3 ± 2.9 in ICU survivors (P = 0.15). The maximum SOFA score in ICU non-survivors was 11.7 ± 4.7 vs. 7.4 ± 4.3 in ICU survivors. SOFA scores increased the first week in both survivors and non-survivors, but the increase was less pronounced in survivors. In the multiple logistic regression models, neither admission SOFA score nor combination with delta SOFA in the first 48 hours was statistically significantly related to ICU mortality. Only the maximum SOFA score remained significant (OR = 1.23, 95% CI: 1.11-1.37, P < 0.001) in the multiple logistic models with an AUC of 0.91. CONCLUSIONS: Evaluation of SOFA scores in the first 48 hours after ICU admission is not a good prognostic indicator in COVID-19 patients. Only the maximum SOFA score was predictive for ICU mortality.

Validation of the Acute Physiology and Chronic Health Evaluation (APACHE) II and IV Score in COVID-19 Patients.

BACKGROUND: Severity scoring systems are inherent to ICU practice for multiple purposes. Acute Physiology and Chronic Health Evaluation (APACHE) scoring systems are designed for ICU mortality prediction. This study aims to validate APACHE IV in COVID-19 patients admitted to the ICU. METHODS: All COVID-19 patients admitted to the ICU between March 13, 2020, and October 17, 2020, were retrospectively analyzed. APACHE II and APACHE IV scores as well as SOFA scores were calculated within 24 hours after admission. Discrimination for mortality of all three scoring systems was assessed by receiver operating characteristic curves. Youden index was determined for the scoring system with the best discriminative performance. The Hosmer-Lemeshow goodness-of-fit test was used to assess calibration. All analyses were performed for both the overall population as in a subgroup treated with anti-Xa adjusted dosages of LMWHs. RESULTS: 116 patients were admitted to our ICU during the study period. 13 were excluded for various reasons, leaving 103 patients in the statistical analysis of the overall population. 57 patients were treated with anti-Xa adjusted prophylactic dosages of LMWH and were supplementary analyzed in a subgroup analysis. APACHE IV had the best discriminative power of the three scoring systems, both in the overall population (APACHE IV ROC AUC 0.67 vs. APACHE II ROC AUC 0.63) as in the subgroup (APACHE IV ROC AUC 0.82 vs. APACHE II ROC AUC 0.7). This model exhibits good calibration. Hosmer-Lemeshow p values for APACHE IV were 0.9234 for the overall population and 0.8017 for the subgroup. Calibration p values of the APACHE II score were 0.1394 and 0.6475 for the overall versus subgroup, respectively. CONCLUSIONS: APACHE IV provided the best discrimination and calibration of the considered scoring systems in critically ill COVID-19 patients, both in the overall group and in the subgroup with anti-Xa adjusted LMWH doses. Only in the subgroup analysis, discriminative abilities of APACHE IV were very good. This trial is registered with NCT04713852.

Video-Assisted Thoracoscopic Transaortic Myectomy for Hypertrophic Obstructive Cardiomyopathy.

Hypertrophic obstructive cardiomyopathy remains one of the more common inherited cardiac disorders with often a major impact on quality of life. Even today, most frequently a sternotomy is performed to conduct the myectomy. Several minimally invasive procedures, under direct vision or through transmitral access, have been demonstrated to operate on these patients. However, we believe our video-assisted transaortic approach could provide a more precise and complete resection than other minimally invasive approaches because of a clearer visualization of the septum and outflow tract. This could further increase the benefits for these patients and potentially make more frail patients eligible for surgical intervention.

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).

Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.

INTRODUCTION: An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome. METHODS: In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups. RESULTS: 46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group. CONCLUSION: Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations. REGISTRATION NUMBER: NCT04394000.

Drug Thrombus Resulting in Superior Vena Cava Syndrome: A Case Report.

INTRODUCTION: Superior vena cava syndrome is one of the more serious complications of central venous catheter insertion. Drug interactions of administered drugs used in association with these catheters can lead to formation of precipitations and consequently thrombus formation. These interactions can be either anion-cation or acid-base based and more commonly present in clinical practice than expected. CASE PRESENTATION: The case of a 31-year old female who was admitted to an intensive care unit with an intracranial haemorrhage, is presented. Occlusion of the superior vena cava was caused by a drug-induced thrombus, formed by the precipitation and clotting of total parenteral nutrition and intravenous drugs. Given the nature of the thrombus and a recent intracranial haemorrhage, the patient was treated with a central thrombectomy supported by a heparin-free extracorporeal membrane oxygenation. CONCLUSION: Knowledge of drug interactions is crucial in order to heighten awareness for the dangers of concomitant drug administration, especially in combination with total parenteral nutrition in critically ill patients.

Neurological outcome after minimal invasive coronary artery surgery (NOMICS): protocol for an observational prospective cohort study.

INTRODUCTION: Adverse neurocognitive outcomes are still an important cause of morbidity and mortality after cardiac surgery. The most common neurocognitive disorders after conventional cardiac surgery are postoperative cognitive dysfunction (POCD), stroke and delirium. Minimal invasive cardiac procedures have recently been introduced into practice. Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimal invasive cardiac procedure based on the conventional CABG procedure. Neurocognitive outcome after minimal invasive cardiac surgery, including Endo-CABG, has never been studied. Therefore, the main objective of this study is to examine neurocognitive outcome after Endo-CABG. METHODS AND ANALYSIS: We will perform a prospective observational cohort study including 150 patients. Patients are categorised into three groups: (1) patients undergoing Endo-CABG, (2) patients undergoing a percutaneous coronary intervention and (3) a healthy volunteer group. All patients in the Endo-CABG group will be treated following a uniform, standardised protocol. To assess neurocognitive outcome after surgery, a battery of six neurocognitive tests will be administered at baseline and at 3-month follow-up. In the Endo-CABG group, a neurological examination will be performed at baseline and postoperatively and delirium will be scored at the intensive care unit. Quality of life (QOL), anxiety and depression will be assessed at baseline and at 3-month follow-up. Satisfaction with Endo-CABG will be assessed at 3-month follow-up. Primary endpoints are the incidence of POCD, stroke and delirium after Endo-CABG. Secondary endpoints are QOL after Endo-CABG, patient satisfaction with Endo-CABG and the incidence of anxiety and depression after Endo-CABG. ETHICS AND DISSEMINATION: The neurological outcome after minimal invasive coronary artery surgery study has received approval of the Jessa Hospital ethics board. It is estimated that the trial will be executed from December 2016 to January 2018, including enrolment and follow-up. Analysis of data, followed by publication of the results, is expected in 2018. TRIAL REGISTRATION NUMBER: NCT02979782.