Association of Mechanical Energy and Power with Postoperative Pulmonary Complications in Lung Resection Surgery: A Post Hoc Analysis of Randomized Clinical Trial Data.

BACKGROUND: Mechanical power (MP), the rate of mechanical energy (ME) delivery, is a recently introduced unifying ventilator parameter consisting of tidal volume, airway pressures, and respiratory rates, which predicts pulmonary complications in several clinical contexts. However, ME has not been previously studied in the perioperative context, and neither parameter has been studied in the context of thoracic surgery utilizing one-lung ventilation. METHODS: The relationships between ME variables and postoperative pulmonary complications were evaluated in this post hoc analysis of data from a multicenter randomized clinical trial of lung resection surgery conducted between 2020 and 2021 (n = 1,170). Time-weighted average MP and ME (the area under the MP time curve) were obtained for individual patients. The primary analysis was the association of time-weighted average MP and ME with pulmonary complications within 7 postoperative days. Multivariable logistic regression was performed to examine the relationships between energy variables and the primary outcome. RESULTS: In 1,055 patients analyzed, pulmonary complications occurred in 41% (431 of 1,055). The median (interquartile ranges) ME and time-weighted average MP in patients who developed postoperative pulmonary complications versus those who did not were 1,146 (811 to 1,530) J versus 924 (730 to 1,240) J (P < 0.001), and 6.9 (5.5 to 8.7) J/min versus 6.7 (5.2 to 8.5) J/min (P = 0.091), respectively. ME was independently associated with postoperative pulmonary complications (ORadjusted, 1.44 [95% CI, 1.16 to 1.80]; P = 0.001). However, the association between time-weighted average MP and postoperative pulmonary complications was time-dependent, and time-weighted average MP was significantly associated with postoperative pulmonary complications in cases utilizing longer periods of mechanical ventilation (210 min or greater; ORadjusted, 1.46 [95% CI, 1.11 to 1.93]; P = 0.007). Normalization of ME and time-weighted average MP either to predicted body weight or to respiratory system compliance did not alter these associations. CONCLUSIONS: ME and, in cases requiring longer periods of mechanical ventilation, MP were independently associated with postoperative pulmonary complications in thoracic surgery.

Efficacy of Single-Bolus Administration of Remimazolam During Induction of Anesthesia in Patients Undergoing Cardiac Surgery: A Prospective, Single-Center, Randomized Controlled Study.

BACKGROUND: Remimazolam is a recently marketed ultrashort-acting benzodiazepine. This drug is considered safe and effective during general anesthesia; however, limited information is available about its effects on patients undergoing cardiac surgery. Therefore, the present study was conducted to evaluate the efficacy and hemodynamic stability of a bolus administration of remimazolam during anesthesia induction in patients undergoing cardiac surgery. METHODS: Patients undergoing elective cardiac surgery were randomly assigned to any 1 of the following 3 groups: anesthesia induction with a continuous infusion of remimazolam 6 mg/kg/h (continuous group), a single-bolus injection of remimazolam 0.1 mg/kg (bolus 0.1 group), or a single-bolus injection of remimazolam 0.2 mg/kg (bolus 0.2 group). Time to loss of responsiveness, defined as modified Observer's Assessment of Alertness/Sedation Scale <3, and changes in hemodynamic status during anesthetic induction were measured. RESULTS: Times to loss of responsiveness were 137 ± 20, 71 ± 35, and 48 ± 9 seconds in the continuous, bolus 0.1, and bolus 0.2 groups, respectively. The greatest mean difference was observed between the continuous and bolus 0.2 groups (89.0, 95% confidence interval [CI], 79.1-98.9), followed by the continuous and bolus 0.1 groups (65.8, 95% CI, 46.9-84.7), and lastly between the bolus 0.2 and bolus 0.1 groups (23.2, 95% CI, 6.6-39.8). No significant differences were found in terms of arterial blood pressures and heart rates of the patients. CONCLUSIONS: A single-bolus injection of remimazolam provided efficient anesthetic induction in patients undergoing cardiac surgery. A 0.2 mg/kg bolus injection of remimazolam resulted in the shortest time to loss of responsiveness among the 3 groups, without significantly altering the hemodynamic parameters. Therefore, this dosing can be considered a favorable anesthetic induction method for patients undergoing cardiac surgery.

Effects of Balanced Versus Saline-based Solutions on Acute Kidney Injury in Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial.

OBJECTIVES: To determine whether balanced solutions can reduce the incidence of acute kidney injury after off-pump coronary artery bypass surgery compared with saline. DESIGN: Randomized controlled trial. SETTING: Single tertiary care center. PARTICIPANTS: Patients who underwent off-pump coronary artery bypass surgery between June 2014 and July 2020. INTERVENTIONS: Balanced solution-based chloride-restrictive intravenous fluid strategy. MEASUREMENTS AND MAIN RESULTS: The primary outcome was acute kidney injury within 7 postoperative days, as defined by the 2012 Kidney Disease: Improving Global Outcomes Clinical Practice Guideline. The incidence of acute kidney injury was 4.4% (8/180) in the balanced group and 7.3% (13/178) in the saline group. The difference was not statistically significant (risk difference, -2.86%; 95% confidence interval [CI], -7.72% to 2.01%; risk ratio, 0.61, 95% CI, 0.26 to 1.43; p = 0.35). Compared with the balanced group, the saline group had higher levels of intraoperative serum chloride and lower base excess, which resulted in a lower pH. CONCLUSIONS: In patients undergoing off-pump bypass surgery with a normal estimated glomerular filtration rate, the intraoperative balanced solution-based chloride-restrictive intravenous fluid administration strategy did not decrease the rate of postoperative acute kidney injury compared with the saline-based chloride-liberal intravenous fluid administration strategy.

Impact of Covert Brain Infarction Following Coronary Angiography on Coronary Artery Bypass Surgery Outcomes.

OBJECTIVE: To determine the association between preoperative covert brain infarction following coronary angiography (CAG) and major adverse cardiac and cerebrovascular events (MACCEs) after coronary artery bypass grafting (CABG). DESIGN: A cohort study was conducted between January 2006 and December 2019, with the follow-up period concluding at either 5 years after surgery, the date of death, or April 27, 2023. SETTING: A single tertiary center in Korea. PARTICIPANTS: Patients who underwent preoperative CAG and subsequent brain magnetic resonance imaging (MRI) before elective CABG. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of MACCEs within 30 days of CABG. MACCEs included operative death (all-cause death within 30 days of surgery or before discharge), myocardial infarction, mechanical circulatory support, circulatory arrest, and stroke. Secondary outcomes included each component of MACCEs and all-cause mortality at 5 years after surgery. Of the 2,476 study patients (median [interquartile range] age: 65 [58-71] years; 24.7% were female), 212 (8.6%) had covert cerebral infarction on brain MRI after CAG but before CABG, and 353 (14.3%) patients experienced MACCEs after CABG. After performing 1:4 propensity-score matching, 1,057 patients were included in the final outcome analysis (212 with covert brain infarction and 845 without). The incidence of MACCEs within 30 days was not significantly different between patients with covert brain infarction and those without (15.1% [32/212] v 15.6% [132/845]; risk difference: -0.5, 95% confidence interval: -5.6 to 4.4; risk ratio: 0.97, 95% confidence interval: 0.66 to 1.32, p = 0.85). There were also no significant differences in each component of MACCEs within 30 days. There was no significant difference between the two groups regarding all-cause mortality at 5 years (18.7% v 17.0%, respectively, p for stratified log-rank test = 0.33). CONCLUSIONS: Among patients undergoing elective CABG, there was no significant association between covert brain infarction following CAG and the occurrence of MACCEs within 30 days or long-term mortality after CABG.

Effects of intraoperative inspired oxygen fraction (FiO2 0.3 vs 0.8) on patients undergoing off-pump coronary artery bypass grafting: the CARROT multicenter, cluster-randomized trial.

BACKGROUND: To maintain adequate oxygenation is of utmost importance in intraoperative care. However, clinical evidence supporting specific oxygen levels in distinct surgical settings is lacking. This study aimed to compare the effects of 30% and 80% oxygen in off-pump coronary artery bypass grafting (OPCAB). METHODS: This multicenter trial was conducted in three tertiary hospitals from August 2019 to August 2021. Patients undergoing OPCAB were cluster-randomized to receive either 30% or 80% oxygen intraoperatively, based on the month when the surgery was performed. The primary endpoint was the length of hospital stay. Intraoperative hemodynamic data were also compared. RESULTS: A total of 414 patients were cluster-randomized. Length of hospital stay was not different in the 30% oxygen group compared to the 80% oxygen group (median, 7.0 days vs 7.0 days; the sub-distribution hazard ratio, 0.98; 95% confidence interval [CI] 0.83-1.16; P = 0.808). The incidence of postoperative acute kidney injury was significantly higher in the 30% oxygen group than in the 80% oxygen group (30.7% vs 19.4%; odds ratio, 1.94; 95% CI 1.18-3.17; P = 0.036). Intraoperative time-weighted average mixed venous oxygen saturation was significantly higher in the 80% oxygen group (74% vs 64%; P < 0.001). The 80% oxygen group also had a significantly greater intraoperative time-weighted average cerebral regional oxygen saturation than the 30% oxygen group (56% vs 52%; P = 0.002). CONCLUSIONS: In patients undergoing OPCAB, intraoperative administration of 80% oxygen did not decrease the length of hospital stay, compared to 30% oxygen, but may reduce postoperative acute kidney injury. Moreover, compared to 30% oxygen, intraoperative use of 80% oxygen improved oxygen delivery in patients undergoing OPCAB. Trial registration ClinicalTrials.gov (NCT03945565; April 8, 2019).

Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial.

BACKGROUND: Airway driving pressure, easily measured as plateau pressure minus PEEP, is a surrogate for alveolar stress and strain. However, the effect of its targeted reduction remains unclear. METHODS: In this multicentre trial, patients undergoing lung resection surgery were randomised to either a driving pressure group (n=650) receiving an alveolar recruitment/individualised PEEP to deliver the lowest driving pressure or to a conventional protective ventilation group (n=650) with fixed PEEP of 5 cm H2O. The primary outcome was a composite of pulmonary complications within 7 days postoperatively. RESULTS: The modified intention-to-treat analysis included 1170 patients (mean [standard deviation, sd]; age, 63 [10] yr; 47% female). The mean driving pressure was 7.1 cm H2O in the driving pressure group vs 9.2 cm H2O in the protective ventilation group (mean difference [95% confidence interval, CI]; -2.1 [-2.4 to -1.9] cm H2O; P<0.001). The incidence of pulmonary complications was not different between the two groups: driving pressure group (233/576, 40.5%) vs protective ventilation group (254/594, 42.8%) (risk difference -2.3%; 95% CI, -8.0% to 3.3%; P=0.42). Intraoperatively, lung compliance (mean [sd], 42.7 [12.4] vs 33.5 [11.1] ml cm H2O-1; P<0.001) and Pao2 (median [inter-quartile range], 21.5 [14.5 to 30.4] vs 19.5 [13.5 to 29.1] kPa; P=0.03) were higher and the need for rescue ventilation was less frequent (6.8% vs 10.8%; P=0.02) in the driving pressure group. CONCLUSIONS: In lung resection surgery, a driving pressure-guided ventilation improved pulmonary mechanics intraoperatively, but did not reduce the incidence of postoperative pulmonary complications compared with a conventional protective ventilation. CLINICAL TRIAL REGISTRATION: NCT04260451.

Peak systolic myocardial velocity in patients undergoing surgical aortic valve replacement for severe aortic stenosis: prognostic value and natural course.

Myocardial systolic longitudinal function has been known to decrease in patients with severe aortic stenosis (AS). Preoperative peak systolic myocardial velocity at the septal mitral valve annulus (S'), measured using Doppler tissue imaging, was used as an indicator for myocardial systolic longitudinal function. The prognostic value and natural course of S' after surgical aortic valve replacement for severe AS have not been elucidated. This retrospective observational study included patients from January 2006 to December 2018. The patients were divided to 2 groups (pre-S'HIGH vs. pre-S'LOW) with a cut-off 5.4 cm/s of preoperative S' (pre-S') that was identified by restricted cubic spline curve. The primary outcome was postoperative long-term all-cause mortality. Nine hundred and five patients were analyzed. All-cause mortality rate at the median follow-up period of 5.2 years was 12% in pre-S'LOW and 8% in pre-S'HIGH. Multivariate analysis showed that pre-S'LOW was associated with an increased all-cause mortality (hazard ratio, 1.60; 95% confidence interval, 1.04-2.48; P = 0.032). Significantly different trajectories of postoperative S' (post-S') were found between two groups (P < 0.001 for difference): In pre-S'LOW, post-S' increased within 6 months after surgery, and gradually decreased over time, whereas it slowly decreased up to 5 years after surgery and then reached a plateau in pre-S'HIGH. The difference in pre-S' level maintained over time, and remained consistent in the adjusted analysis. Pre-S' < 5.4 cm/s was found to be associated with an increased long-term all-cause mortality. In addition, the trajectories for post-S' were different according to pre-S', which remained after adjustment.

Impact of Body Mass Index and Sarcopenia on Short- and Long-Term Outcomes After Esophageal Cancer Surgery: An Observational Study.

BACKGROUND: The effects of specific body mass index (BMI) category and sarcopenia within each BMI category on outcomes in patients undergoing esophageal surgery with esophageal squamous cell carcinoma have not been thoroughly examined. METHODS: This study included 1141 patients. Sarcopenia was determined with a total psoas muscle cross-sectional area at the level of the third lumbar vertebra in computed tomography. The outcomes were long-term survival, including overall survival (OS) and recurrence-free survival (RFS), and postoperative complications. RESULTS: The overweight and no sarcopenia group was considered as the reference. After adjusting covariates, the underweight and the normal weight and sarcopenia groups both showed worse OS (underweight group: hazard ratio [HR] 2.04, 95% confidence interval [CI] 1.33-3.13, p = 0.001; normal weight and sarcopenia group: HR 1.93, 95% CI 1.39-2.69, p < 0.001) and worse RFS (underweight group: HR 1.78, 95% CI 1.19-2.67, p = 0.005; normal weight and sarcopenia group: HR 1.70, 95% CI 1.25-2.30, p = 0.001). In addition, the underweight group (odds ratio [OR] 4.74, 95% CI 2.05-10.96, p < 0.001), the normal weight and sarcopenia group (OR 3.26, 95% CI 1.60-6.62, p = 0.001), the overweight and sarcopenia group (OR 2.54, 95% CI 1.14-5.68, p = 0.023), and the obese and no sarcopenia group (OR 2.44, 95% CI 1.14-5.22, p = 0.021) were at significantly higher risk of postoperative 30-day composite complications. CONCLUSIONS: Compared with the overweight and no sarcopenia group, the underweight and the normal weight and sarcopenia groups were associated with worse short- and long-term outcomes.

Incremental Prognostic Value of Left Ventricular Longitudinal Strain Over Ejection Fraction in Coronary Artery Bypass Grafting.

OBJECTIVES: To evaluate the incremental prognostic value of longitudinal strain over left ventricular ejection fraction (LVEF) after coronary artery bypass grafting (CABG). DESIGN: Retrospective cohort study. SETTING: Single tertiary-care center. PARTICIPANTS: Patients underwent isolated CABG between January 2014 and December 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 999 patients (median age, 65 years, 23.5% female) categorized into 3 groups according to their left ventricular (LV) systolic function status: pEF/pS (preserved LVEF and preserved longitudinal strain, n = 490), pEF/iS (preserved LVEF and impaired longitudinal strain, n = 186), and rEF (reduced LVEF, n = 323). During a median follow-up of 2.7 years, 86 (8.6%) patients had died. The 5-year survival significantly differed in patients with preserved LVEF according to the strain status (pEF/pS v pEF/iS, 90.0% v 84.6%; p = 0.002). After adjusting for potential confounders, the pEF/iS group (adjusted hazard ratio [HR], 2.17; 95% CI, 1.10-4.28; p = 0.03) and the rEF group (adjusted HR, 2.96; 95% CI, 1.46-6.00; p = 0.003) had significantly higher risks for all-cause death compared with the pEF/pS group. The addition of longitudinal strain to LVEF in the prediction model significantly improved its performance (global chi-squared, 105.2 v 110.2; p = 0.03). CONCLUSIONS: Left ventricular longitudinal strain could differentiate the prognosis after CABG in patients with preserved LVEF and provide significant incremental prognostic value to LVEF.

Postoperative changes in left ventricular systolic function after combined mitral and aortic valve replacement in patients with rheumatic heart disease.

BACKGROUNDS: We sought to identify short- and long-term changes in postoperative left ventricular systolic function in patients with rheumatic heart disease (RHD) who underwent combined aortic and mitral valve replacement. METHODS: We analyzed 146 patients according to their preoperative left ventricular ejection fraction (LVEF) (113 with preoperative LVEF ≥50% and 33 with preoperative LVEF <50%). A restricted cubic spline model was used to assess the effect of time on the postoperative changes in echocardiographic parameters. RESULTS: There were no significant difference in preoperative and immediately postoperative LVEF before discharge in either group. During median follow-up of 3.2 years (interquartile range: 1.3-4.7 years) after surgery, postoperative LVEF increased slightly and then plateaued in patients with preoperative LVEF ≥50%, whereas it increased over 3-4 years after surgery and then gradually decreased in patients with preoperative LVEF <50% (p < .001). CONCLUSION: Long-term postoperative LVEF showed a downward trend in RHD patients with reduced preoperative LVEF, whereas it reached a plateau in RHD patients with normal preoperative LVEF.

Perioperative rupture risk of unruptured intracranial aneurysms in cardiovascular surgery.

Although unruptured intracranial aneurysms are increasingly being diagnosed incidentally, perioperative rupture risk of unruptured intracranial aneurysm in patients undergoing cardiovascular surgery remains unclear. Therefore, we conducted an observational study to assess the prevalence and perioperative rupture risk of unruptured intracranial aneurysm in patients undergoing cardiovascular surgery. Adult patients (n = 4864) who underwent cardiovascular surgery between January 2010 and December 2016 were included. We assessed the prevalence of unruptured intracranial aneurysms in these patients using preoperative neurovascular imaging. The incidence of postoperative 30-day subarachnoid haemorrhage from aneurysmal rupture was investigated in patients undergoing cardiovascular surgery with unruptured intracranial aneurysm. Postoperative outcomes were compared between patients with unruptured intracranial aneurysm and those without unruptured intracranial aneurysm. Of the 4864 patients (39.6% females; mean ± standard deviation age, 62.3 ± 11.3 years), 353 patients had unruptured intracranial aneurysms (prevalence rate, 7.26%; 95% confidence interval, 6.52-8.06%). Of these, eight patients received surgical or endovascular treatment before surgery and 345 patients underwent cardiovascular surgery with unruptured intracranial aneurysms. Within 30 days postoperatively, subarachnoid haemorrhage occurred only in one patient, and the cumulative postoperative 30-day subarachnoid haemorrhage incidence was 0.29% (95% confidence interval, 0.01% to 1.61%). The Kaplan-Meier estimated subarachnoid haemorrhage probabilities according to the unruptured intracranial aneurysm rupture risk scores were not higher than the previously reported risk in the general population. There were no significant differences in postoperative subarachnoid haemorrhage-free survival, haemorrhagic stroke-free survival, in-hospital mortality, and hospital length of stay between patients with unruptured intracranial aneurysm and those without unruptured intracranial aneurysm. In conclusion, the prevalence of unruptured intracranial aneurysm in patients undergoing cardiovascular surgery is higher than in the general population. However, incidentally detected unruptured intracranial aneurysms are not linked to an increased risk of subarachnoid haemorrhage or adverse postoperative outcomes. These findings may help determine the optimal management of unruptured intracranial aneurysms before cardiovascular surgery.

The relationship of preoperative estimated glomerular filtration rate and outcomes after cardiovascular surgery in patients with normal serum creatinine: a retrospective cohort study.

BACKGROUND: Although serum creatinine concentration has been traditionally used as an index of renal function in clinical practice, it is considered relatively inaccurate, especially in patients with mild renal dysfunction. This study investigated the usefulness of preoperative estimated glomerular filtration rate (eGFR) in predicting complications after cardiovascular surgery in patients with normal serum creatinine concentrations. METHODS: This study included 2208 adults undergoing elective cardiovascular surgery. Preoperative eGFR was calculated using Chronic Kidney Disease Epidemiology Collaboration equations. The relationships between preoperative eGFR and 90 day postoperative composite major complications were analyzed, including 90 day all-cause mortality, major adverse cardiac and cerebrovascular events, severe acute kidney injury, respiratory and gastrointestinal complications, wound infection, sepsis, and multi-organ failure. RESULTS: Of the 2208 included patients, 185 (8.4%) had preoperative eGFR < 60 mL/min/1.73 m2 and 328 (14.9%) experienced postoperative major complications. Multivariable logistic regression analyses showed that preoperatively decreased eGFR was independently associated with an increased risk of composite 90 day major postoperative complications (adjusted odds ratio: 1.232; 95% confidence interval [CI]: 1.148-1.322; P <  0.001). eGFR was a better discriminator of composite 90 day major postoperative complications than serum creatinine, with estimated c-statistics of 0.724 (95% CI: 0.694-0.754) for eGFR and 0.712 (95% CI: 0.680-0.744) for serum creatinine (P = 0.008). CONCLUSIONS: Decreased eGFR was significantly associated with an increased risk of major complications after cardiovascular surgery in patients with preoperatively normal serum creatinine concentrations.

Effect of operative time on the outcome of patients undergoing off-pump coronary artery bypass surgery.

BACKGROUND: Several studies have been reporting circadian variation in postoperative morbidity and mortality. We investigated whether the outcomes after off-pump coronary artery bypass (OPCAB) surgery are influenced by the operation start time. METHODS: We retrospectively evaluated 1690 patients who received elective OPCAB surgery from January 2006 to December 2016. The patients were divided into two groups according to the operation start time (morning or afternoon). The primary outcome was the occurrence of a major adverse cardiac event (MACE) within 30 days after surgery and death within 1 year after surgery. Propensity matching analysis and multivariable analyses were performed to evaluate the relationship between the operation start time and postoperative outcomes. RESULTS: There were no significant differences in the overall 1-year mortality rate (2.2% vs 2.9%; P = .568 in the entire cohort and 1.5% vs 2.7%; P = .259 in the propensity-matched cohort) and 30-day MACE rate (8.9% vs 10.4%; P = .378 in the entire cohort and 9.4% vs 10.0%; P = .827 in the propensity-matched cohort) between the morning and afternoon surgery group. Multivariable regression analyses also did not show any significant relationship between the operation start time and postoperative outcomes. CONCLUSIONS: In elective OPCAB surgery, the operative time was not associated with an increased risk of postoperative mortality and complications.

Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study.

BACKGROUND: Minimalist transcatheter aortic valve replacement (TAVR) under monitored anesthesia care (MAC) emphasizes early recovery. Remimazolam is a novel benzodiazepine with a short recovery time. This study hypothesized that remimazolam is non-inferior to dexmedetomidine in terms of recovery after TAVR. METHODS: In this retrospective observational study, remimazolam was compared to dexmedetomidine in patients who underwent TAVR under MAC at a tertiary academic hospital between July 2020 and July 2022. The primary outcome was timely recovery after TAVR, defined as discharge from the intensive care unit within the first day following the procedure. Propensity score matching was used to compare timely recovery between remimazolam and dexmedetomidine, applying a non-inferiority margin of -10%. RESULTS: The study included 464 patients, of whom 218 received remimazolam and 246 received dexmedetomidine. After propensity score matching, 164 patients in each group were included in the analysis. Regarding timely recovery after TAVR, remimazolam was non-inferior to dexmedetomidine (152 of 164 [92.7%] in the remimazolam group versus 153 of 164 [93.3%] in the dexmedetomidine group, risk difference [95% CI]: -0.6% [-6.7%, 5.5%]). The use of remimazolam was associated with fewer postoperative vasopressors/inotropes (21 of 164 [12.8%] vs. 39 of 164 [23.8%]) and temporary pacemakers (TPMs) (76 of 164 [46.3%] vs. 108 of 164 [65.9%]) compared to dexmedetomidine. CONCLUSIONS: In patients undergoing TAVR under MAC, remimazolam was non-inferior to dexmedetomidine in terms of timely recovery. Remimazolam may be associated with better postoperative recovery profiles, including a lesser need for vasopressors/inotropes and TPMs.

A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GDT trial).

BACKGROUND: Tranexamic acid (TXA) effectively attenuates hyperfibrinolysis and preemptive administration has been employed to reduce bleeding and blood transfusions in various surgical settings. However, TXA administration could be associated with adverse effects, such as seizures and thromboembolic risks. While patients with fibrinolysis shutdown showed greater thromboembolic complications and mortality, TXA administration may aggravate the degree of shutdown in these patients. Selective TXA administration based on the results of rotational thromboelastometry (ROTEM) would be non-inferior to preemptive TXA administration in reducing postoperative bleeding and beneficial in reducing its risks in patients undergoing cardiovascular surgery. METHODS: This non-inferiority, randomized, double-blind, placebo-controlled, multicenter trial will be performed in 3 tertiary university hospitals from August 2023 to March 2025. Seven hundred sixty-four patients undergoing cardiovascular surgery will be randomly allocated to get TXA as a preemptive (Group-P) or goal-directed strategy (Group-GDT) in each institution (with a 1:1 allocation ratio). After anesthesia induction, TXA (10 mg/kg and 2 mg/kg/h) and a placebo are administered after anesthesia induction in Group-P and Group-GDT, respectively. ROTEM tests are performed immediately before weaning from CPB and at the considerable bleeding post-CPB period. After getting the test results, a placebo is administered in Group-P (regardless of the test results). In Group-GDT, placebo or TXA is administered according to the results: placebo is administered if the amplitude at 10 min (A10-EXTEM) is ≥ 40 mm and lysis within 60 min (LI60-EXTEM) of EXTEM assay is ≥ 85%, or TXA (20 mg/kg) is administered if A10-EXTEM is < 40 mm or LI60-EXTEM is < 85%. The primary outcome is inter-group comparisons of postoperative bleeding (for 24 h). The secondary measures include comparisons of perioperative blood transfusion, coagulation profiles, reoperation, thromboembolic complications, seizures, in-hospital mortality, fibrinolysis phenotypes, and hospital costs. DISCUSSION: The absence of inter-group differences in postoperative bleeding would support the selective strategy's non-inferiority in reducing postoperative bleeding in these patients. The possible reduction in thromboembolic risks, seizures, and fibrinolysis shutdown in Group-GDT would support its superiority in reducing TXA-induced adverse events and the cost of their management. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov with the registration number NCT05806346 on March 28, 2023. TRIAL STATUS: recruiting. Issue date: 2023 March 28 (by Tae-Yop Kim, MD, PhD). The trial was registered in the clinical registration on March 28, 2023 (ClinicalTrials.gov, NCT05806346) and revised to the latest version of its protocol (version no. 8, August 26, 2024) approved by the institutional review boards (IRBs) of all 3 university hospitals (Konkuk University Medical Center, 2023-07-005-001, Asan Medical Center, 2023-0248, and Samsung Medical Center, SMC 2023-06-048-002). Its recruitment was started on August 1, 2023, and will be completed on December 31, 2024. Protocol amendment number: 08 (protocol version 08, August 26, 2024). Revision chronology: 2023 March 28:Original. 2023 April 10:Amendment No 01. The primary reason for the amendment is the modification of Arms (adding one arm for sub-group analyses) and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility, and Study Identification. 2023 May 03:Amendment No 02. The primary reason for the amendment is to modify the Outcome Measures and update the study status. 2023 July 06:Amendment No 03. The primary reason for amendment is to update the chronological study status. 2023 July 07:Amendment No 04. The primary reason for the amendment is the modification of study information (the treatment category was changed to diagnostic, and Phase 4 was changed to not applicable) and a chronological update on the study status. 2023 September 12:Amendment No 06. The primary reason for the amendment is a chronological update in the study status and the inclusion of additional information regarding contacts/locations and oversight. 2023 December 29:Amendment No 07. The primary reason for the amendment is to modify the outcome measures (including detailed information on outcome measures, addition of extra secondary measures, and chronological updates in study status). 2024 August 26:Amendment No 08. The primary reason for the amendment is to add detailed descriptions regarding data handling and the names and roles of the participating institutions and to update the chronological process of the trial.

Impact of Sex on Mortality in Patients Undergoing Surgical Aortic Valve Replacement.

Aortic stenosis (AS) is the second most common valvular heart disease in the United States. Although the prevalence of AS does not significantly differ between the sexes, there is some controversy on whether sex differences affect the long-term mortality of patients with severe AS undergoing surgical aortic valve replacement (SAVR). Therefore, we retrospectively analyzed the medical records of 917 patients (female, n = 424 [46.2%]) with severe AS who had undergone isolated SAVR at a tertiary care center between January 2005 and December 2018. During a median follow-up of 5.2 years, 74 (15.0%) male patients and 41 (9.7%) female patients died. The Kaplan-Meier analysis revealed that the 10-year mortality rate was significantly higher in male than female patients (24.7% vs. 17.9%, log-rank p = 0.005). In the sequential Cox proportional hazard regression model for assessing long-term mortality up to 10 years post-surgery, the adjusted hazard ratio of male sex for mortality was 1.93 (95% confidence interval, 1.28-2.91; p = 0.002). The association between male sex and postoperative long-term mortality was not significantly diminished by any demographic or clinical factor in subgroup analyses. In conclusion, female sex was significantly associated with better long-term survival in patients with severe AS undergoing SAVR.

Prognostic value of left ventricular apical four-chamber longitudinal strain after heart valve surgery in real-world practice.

BACKGROUND: Left ventricular longitudinal strain is an emerging marker of ventricular systolic function. However, the prognostic value of apical four-chamber longitudinal strain after heart valve surgery in real-world clinical practice is uncertain. The authors investigated whether left ventricular apical four-chamber longitudinal strain measured in real-world practice is helpful for predicting postoperative outcomes in patients undergoing heart valve surgery. METHODS: This observational cohort study was conducted in patients who underwent heart valve surgery between January 2014 and December 2018 at a tertiary hospital in South Korea. The exposure of interest was preoperative left ventricular apical four-chamber longitudinal strain. The primary outcome was postoperative all-cause mortality. RESULTS: Among 1,773 study patients (median age, 63 years; female, 45.9%), 132 (7.4%) died during a median follow-up of 27.2 months. Preoperative left ventricular apical four-chamber longitudinal strain was significantly associated with all-cause mortality (adjusted hazard ratio, 0.94 per 1% increment in absolute value; 95% CI [0.90, 0.99], P = 0.022), whereas left ventricular ejection fraction (LVEF) was not significantly associated with all-cause mortality (adjusted hazard ratio: 1.01, 95% CI [0.99, 1.03], P = 0.222). Moreover, combining left ventricular apical four-chamber longitudinal strain to the LVEF and conventional prognostic factors enhance the prognostic model for all-cause mortality (P = 0.022). CONCLUSIONS: In patients undergoing heart valve surgery without coronary artery disease, left ventricular apical four-chamber longitudinal strain measured in real-world clinical practice was independently associated with postoperative survival. Left ventricular longitudinal strain measurement may be helpful for outcome prediction after valve surgery.

Forward Left Ventricular Ejection Fraction as a Predictor of Postoperative Left Ventricular Dysfunction in Patients with Degenerative Mitral Regurgitation.

BACKGROUND: Left ventricular dysfunction (LVD) can occur immediately after mitral valve repair (MVr) for degenerative mitral regurgitation (DMR) in some patients with normal preoperative left ventricular ejection fraction (LVEF). This study investigated whether forward LVEF, calculated as left ventricular outflow tract stroke volume divided by left ventricular end-diastolic volume, could predict LVD immediately after MVr in patients with DMR and normal LVEF. METHODS: Echocardiographic and clinical data were retrospectively evaluated in 234 patients with DMR ≥ moderate and preoperative LVEF ≥ 60%. LVD and non-LVD were defined as LVEF < 50% and ≥50%, respectively, as measured by echocardiography after MVr and before discharge. RESULTS: Of the 234 patients, 52 (22.2%) developed LVD at median three days (interquartile range: 3-4 days). Preoperative forward LVEF in the LVD and non-LVD groups were 24.0% (18.9-29.5%) and 33.2% (26.4-39.4%), respectively (p < 0.001). Receiver operating characteristic (ROC) analyses showed that forward LVEF was predictive of LVD, with an area under the ROC curve of 0.79 (95% confidence interval: 0.73-0.86), and an optimal cut-off was 31.8% (sensitivity: 88.5%, specificity: 58.2%, positive predictive value: 37.7%, and negative predictive value: 94.6%). Preoperative forward LVEF significantly correlated with preoperative mitral regurgitant volume (correlation coefficient [CC] = -0.86, p < 0.001) and regurgitant fraction (CC = -0.98, p < 0.001), but not with preoperative LVEF (CC = 0.112, p = 0.088). CONCLUSION: Preoperative forward LVEF could be useful in predicting postoperative LVD immediately after MVr in patients with DMR and normal LVEF, with an optimal cut-off of 31.8%.

Changes in Left Ventricular Ejection Fraction after Mitral Valve Repair for Primary Mitral Regurgitation.

This study sought to identify the short- and long-term changes in left ventricular ejection fraction (LVEF) after mitral valve repair (MVr) in patients with chronic primary mitral regurgitation according to preoperative LVEF (pre-LVEF) and preoperative left ventricular end-systolic diameter (pre-LVESD). This study evaluated 461 patients. Restricted cubic spline regression models were constructed to demonstrate the long-term changes in postoperative LVEF (post-LVEF). The patients were divided into four groups according to pre-LVEF (<50%, 50-60%, 60-70%, and ≥70%). The higher the pre-LVEF was, the greater was the decrease in LVEF immediately after MVr. In the same pre-LVEF range, immediate post-LVEF was lower in patients with pre-LVESD ≥ 40 mm than in those with pre-LVESD < 40 mm. The patterns of long-term changes in post-LVEF differed according to pre-LVEF (p for interaction < 0.001). The long-term post-LVEF reached a plateau of approximately 60% when the pre-LVEF was ≥50%, but it seemed to show a downward trend after reaching a peak at approximately 3-4 years after MVr when the pre-LVEF was ≥70%. The patterns of short- and long-term changes in post-LVEF differed according to pre-LVEF and pre-LVESD values in patients with chronic primary mitral regurgitation after MVr.