Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.

Background: RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory, and iron-scavenging pathways, as measured by heme oxygenase-1 (HO-1), interleukin-10 (IL-10), and ferritin, respectively. Our primary aim was to determine whether RBT-1 administered before surgery would safely and effectively elicit a preconditioning response in patients undergoing cardiac surgery. Methods: This phase 2, double-blind, randomised, placebo-controlled, parallel-group, adaptive trial, conducted in 19 centres across the USA, Canada, and Australia, enrolled patients scheduled to undergo non-emergent coronary artery bypass graft (CABG) and/or heart valve surgery with cardiopulmonary bypass. Patients were randomised (1:1:1) to receive either a single intravenous infusion of high-dose RBT-1 (90 mg SnPP/240 mg FeS), low-dose RBT-1 (45 mg SnPP/240 mg FeS), or placebo within 24-48 h before surgery. The primary outcome was a preoperative preconditioning response, measured by a composite of plasma HO-1, IL-10, and ferritin. Safety was assessed by adverse events and laboratory parameters. Prespecified adaptive criteria permitted early stopping and enrichment. This trial is registered with ClinicalTrials.gov, NCT04564833. Findings: Between Aug 4, 2021, and Nov 9, 2022, of 135 patients who were enrolled and randomly allocated to a study group (46 high-dose, 45 low-dose, 44 placebo), 132 (98%) were included in the primary analysis (46 high-dose, 42 low-dose, 44 placebo). At interim, the trial proceeded to full enrollment without enrichment. RBT-1 led to a greater preconditioning response than did placebo at high-dose (geometric least squares mean [GLSM] ratio, 3.58; 95% CI, 2.91-4.41; p < 0.0001) and low-dose (GLSM ratio, 2.62; 95% CI, 2.11-3.24; p < 0.0001). RBT-1 was generally well tolerated by patients. The primary drug-related adverse event was dose-dependent photosensitivity, observed in 12 (26%) of 46 patients treated with high-dose RBT-1 and in six (13%) of 45 patients treated with low-dose RBT-1 (safety population). Interpretation: RBT-1 demonstrated a statistically significant cytoprotective preconditioning response and a manageable safety profile. Further research is needed. A phase 3 trial is planned. Funding: Renibus Therapeutics, Inc.

Effect of Buteyko Breathing Technique as an Adjunct to Routine Physiotherapy on Pulmonary Functions in Patients Undergoing Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial.

Background: Coronary artery disease (CAD) poses a substantial and increasing public health concern in India, particularly among individuals aged 20 and above. The postoperative phase following coronary artery bypass graft (CABG) surgery presents potential complications, notably impacting the pulmonary system. Emerging evidence suggests that the Buteyko breathing technique not only improves lung function but also positively influences the psychological well-being of CABG patients. This study seeks to assess the impact of the Buteyko breathing technique on pulmonary functions in individuals who have undergone off-pump CABG. Materials and methods: In this randomized controlled trial, patients undergoing off-pump CABG were allocated to either the Buteyko breathing technique group (n = 35) or the control group (n = 35). The intervention group received supervised Buteyko breathing technique sessions twice daily for 15 minutes, concurrently with cardiac rehabilitation from postoperative day (POD-2 to POD-7). The control group underwent phase I cardiac rehabilitation. Outcome measures, including pulmonary function test (PFT), chest expansion, and breath-holding tests were evaluated at baseline (POD-2) and conclusion (POD-7). Results: Statistical analyses were conducted with a significance level set at p < 0.05. Both the control and intervention groups exhibited statistically significant improvements in pulmonary function, chest expansion at three levels, and breath-holding time (p = 0.0001). However, the Buteyko breathing group demonstrated a more significant improvement compared with the control group. Conclusion: The integration of the Buteyko breathing technique into conventional physiotherapy proves to be a beneficial strategy, leading to improvements in pulmonary function, breath-holding duration, and chest expansion for individuals who underwent off-pump CABG surgery. How to cite this article: Mavkar SS, Shukla MP. Effect of Buteyko Breathing Technique as an Adjunct to Routine Physiotherapy on Pulmonary Functions in Patients Undergoing Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial. Indian J Crit Care Med 2024;28(3):280-285.TRI Number: CTRI/2022/12/048295.

Effect of preoperative vitamin D on postoperative atrial fibrillation incidence after coronary artery bypass grafting.

BACKGROUND: Post-operative atrial fibrillation (POAF) is associated with adverse long-term cardiovascular events. OBJECTIVES: This study investigated the effects of a high-dose vitamin D administered preoperatively on the postoperative atrial fibrillation (POAF) incidence in patients with vitamin D deficiency following coronary artery bypass grafting (CABG) surgery. METHODS: This randomized controlled clinical trial was conducted on 246 CABG patients with vitamin D deficiency. All patients were randomly divided into intervention and control groups including 123 cases for each group. In the intervention group, from 3 days before surgery, they received a daily dose of 150,000 units of vitamin D orally (50,000 units of Vit D tablet three times a day) and the patients in the control group received placebo tablets before surgery. All patients in the intervention group were assessed continuously for the occurrence of POAF during the recovery period. RESULTS: In terms of gender, age, and BMI there were no significant differences between intervention and control groups. Our findings showed that the use of vitamin D supplements did not cause a significant change in the duration of intubation and hospitalization. The ratio of POAF following CABG surgery in the control and treatment groups was 26% and 11.4%, respectively (odds ratio = 0.36; 95% CI = 0.18-0.72; P = 0.003). CONCLUSIONS: Our findings revealed that high-dose vitamin D supplementation before CABG surgery significantly reduced the incidence of POAF. Further multicenter randomized trials with larger sample sizes are certainly warranted to confirm our results.

The Role of Vitamin D Supplementation Before Coronary Artery Bypass Grafting in Preventing Postoperative Atrial Fibrillation in Patients With Vitamin D Deficiency or Insufficiency: A Systematic Review and Meta-Analysis.

This study aims to evaluate the role of preoperative vitamin D supplementation before coronary artery bypass grafting (CABG) surgery in preventing postoperative atrial fibrillation (POAF) in vitamin D deficient or insufficient patients. Three randomized controlled trials (RCTs) comprising 448 subjects were selected after a detailed search was conducted on PubMed, Cochrane CENTRAL, Scopus, and Embase in December 2022. Analysis was run using RevMan (version 5.4.1; Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). The analysis collected risk ratio (RR) and 95% confidence interval (CI) data from the relevant studies, which were then pooled using a random effects model. A significance level of less than 0.05 (p<0.05) was considered significant. Our analysis showed that compared with the standard of care, preoperative vitamin D supplementation in vitamin D deficient and insufficient patients effectively reduced POAF after CABG surgery (RR=0.6, 95% CI=0.4-0.9, P=0.01). There was no significant difference in the duration of hospitalization between the vitamin D supplementation group compared with the control following CABG (mean difference -0.85, 95% CI -2.13 to 0.43, P = 0.19). This meta-analysis shows that preoperative vitamin D supplementation in vitamin D deficient and insufficient patients undergoing CABG can reduce the rate of POAF. As POAF is associated with many complications, providing vitamin D supplementation to individuals with a vitamin D deficiency undergoing CABG can improve long-term cardiovascular outcomes following surgery.

Early home discharge after robot-assisted coronary artery bypass grafting.

OBJECTIVES: Robot-assisted coronary artery bypass grafting (CABG) has been developed as a less invasive alternative for conventional CABG to enhance postoperative recovery, patient satisfaction and early discharge to home. Furthermore, it may provide a basis for hybrid coronary revascularization. To determine the feasibility of this procedure, we compared robot-assisted with conventional off-pump CABG. METHODS: All consecutive patients undergoing a robot-assisted left internal mammary artery-to-left anterior descending coronary artery procedure were compared to consecutive patients undergoing conventional off-pump CABG for single-vessel disease from October 2016 to July 2019. The primary outcome was discharge to home within 5 days after the operation. Secondary outcomes were total hospital stay, reoperations within 48 h, transfusions, atrial fibrillation, 30-day mortality and quality of life 1 month postoperatively. A propensity matched cohort was assembled to correct for possible confounders. RESULTS: A total of 107 patients who had robot-assisted CABG were compared to 194 patients who had conventional off-pump CABG. The primary outcome was reached in 51% of the robot-assisted group versus 19% of the conventional off-pump group (P < 0.01). The median postoperative hospital stay was 5 days for the robot-assisted group versus 7 days in the conventional off-pump group (P < 0.01). Other secondary outcomes did not differ significantly between the groups, and the quality of life 1 month after the operation was equal. The results after propensity matching were similar. CONCLUSIONS: Early discharge to home is more frequent for patients who have robot-assisted CABG than in those who have conventional off-pump CABG, with no difference in health-related quality of life. Therefore, this approach may reduce healthcare resources and provide a solid basis for hybrid coronary revascularization.

The effects of vitamin D supplementation on postoperative atrial fibrillation after coronary artery bypass grafting in patients with vitamin D deficiency.

INTRODUCTION: Postoperative atrial fibrillation (POAF) as a common complication of coronary artery bypass grafting (CABG) surgery is associated with increased mortality and morbidity rates. Vitamin D deficiency increases the prevalence of POAF; however, the effects of vitamin D supplementation on the incidence of POAF have not yet been completely elucidated. METHODS: In this prospective, open-label, randomized clinical trial the level of 25-hydroxy vitamin D (25(OH) D) was measured in patients undergoing CABG surgery. Patients with vitamin D insufficiency (defined as 25(OH) D level < 30 ng/ml) were included and randomly assigned to control group to receive either the general standard of care (Group A) or to study group to receive the general standard of care plus oral vitamin D3 , 600,000 IU 5 days before surgery (Group B). The primary outcome of our study was the occurrence of POAF during the first 5 days after CABG surgery. RESULTS: Totally, 93 patients in group B and 103 patients in group A completed the study. The occurrence of POAF was significantly lower in group B as compared to group A (9.68% vs. 20.39%, p = .038). The length of intensive care unit (ICU) stay and hospital stay were reduced in group B patients (2.21 vs. 3.86 days, p < .001 and 7.40 vs. 9.58 days, p = .022, respectively). CONCLUSION: Our study demonstrated that vitamin D supplementation reduces the incidence of POAF, duration of ICU, and hospital stay following CABG surgery.

Plasma Concentrations of Trace Elements Selenium and Cobalt During and After Coronary Artery Bypass Grafting Surgery.

Trace elements selenium (Se) and cobalt (Co) are essential in the human body, and a correlation between Se and cardiac surgery has been suggested. We investigated the plasma concentrations of Se and Co during and after coronary artery bypass grafting (CABG) surgery under cardiopulmonary bypass (CPB). From December 2019 to January 2020, preoperative plasma samples from isolated first-time CABG patients (n=20; 10 males, 10 females) were prospectively collected post-anesthesia and before CPB (T1), 45 min after CPB started (T2), 90 min after CPB started (T3), and postoperative days 1 (T4), and day 4 (T5). The plasma concentrations of Se and Co were measured. The Se concentration was significantly decreased at T2 (105.24±4.08 vs. 68.56±2.42 µg/L, p<0.001) and T3 (105.24±4.08 vs. 80.41±3.40 µg/L, p<0.001). The Co concentration was significantly decreased at T4 (0.35±0.19 vs. 0.26±0.13 µg/L, p<0.01) and T5 (0.35±0.19 vs. 0.23±0.11 µg/L, p<0.001). Five patients developed atrial fibrillation (AF); there was no other operative mortality or major morbidity. This is the first report of alterations of plasma Se and Co concentrations during and after CABG surgery. Our results may indicate that Se supplementation before or during CABG and Co supplementation after CABG may become necessary for patients undergoing CABG.

Feasibility and preliminary efficacy of perioperative interventions in patients undergoing coronary artery bypass grafting: the randomized controlled I-COPE trial.

OBJECTIVES: Patients undergoing coronary artery bypass graft (CABG) surgery are exposed to multiple treatment-related stressors, which can impact coping and health-related quality of life (HRQoL). The objective of this trial was to analyse the feasibility and preliminary efficacy of a multi-component intervention that combines psychological support and reduction of hospital-specific stressors on HRQoL, length of hospital and intensive care unit stay, self-efficacy, and plasma interleukin (IL)-6 and -8 levels in CABG patients. METHODS: This three-arm, randomized controlled, single-centre pilot trial assessed the Intervention for CABG to Optimize Patient Experience in 88 patients undergoing elective CABG. Standard medical care (SMC, n = 29) was compared with 2 intervention groups: (i) psychological interventions to optimize treatment expectations (IA group, n = 30) and (ii) multi-component intervention (IB group, n = 29) with psychological interventions plus an additional treatment package (light therapy, noise reduction, music, and if desired, 360° images delivered via virtual reality). RESULTS: The implementation of psychological interventions in routine medical treatment was feasible (91.5% of participants completed all intervention sessions). Both interventions were associated with significantly shorter hospital stay compared to SMC (IA/IB 9.8/9.3 days vs SMC 12.5 days). Self-efficacy expectations at post-surgery were significantly higher compared to SMC both in the IA group (P = 0.011) and marginally in the IB group (P = 0.051). However, there were no treatment effects of the interventions on HRQoL and plasma levels of IL-6 or IL-8 after CABG. CONCLUSIONS: A perioperative multi-component intervention may lead to shorter hospital stay and higher self-efficacy after CABG. Further studies are needed to determine its impact on HRQoL and inflammation. CLINICAL TRIAL REGISTRATION NUMBER: Ethical approval (# 21/2/18) for the study was obtained from the Research Ethics Committee of the University of Göttingen Medical Center, and the trial was registered in the German Clinical Trials Register (DRKS00015309, https://www.drks.de/drks_web/setLocale_EN.do).

Alteration of plasma trace elements magnesium, copper, zinc, iron and calcium during and after coronary artery bypass grafting surgery.

BACKGROUND: Dietary factors including trace elements contribute to the development of disorders including coronary artery diseases. Whether there are differences in concentrations of trace elements between on-pump and off-pump coronary artery bypass grafting (CABG) surgery remains unclear. The aim of this study was to investigate the differences in the plasma level of four trace elements Cu, Fe, Zn, magnesium (Mg), and calcium (Ca) during and after CABG between on-pump and off-pump procedure and the correlation between these trace elements and the development of postoperative AF. METHODS: Fifty-three CABG patients using on-pump or off-pump methods were enrolled. The blood sample was taken before skin incision (T1), 4 h after skin incision (T2), postoperative day1 (T3), and day3 (T4) respectively. Plasma concentrations of Mg, Ca, Fe, Zn, and Cu were determined. RESULTS: The plasma Mg concentration reached the highest level at T3 (0.94 ± 0.03 vs. 1.20 ± 0.03 mmol/L,P < 0.001) and completely recovered at T4 whereas Zn (11.28 ± 0.23 vs. 6.80 ± 0.20 mmol/L, P < 0.001) and Fe (10.97 ± 0.51 vs. 2.22 ± 0.1 µmol/L, P < 0.001) was lowest at T3 and partially recovered at T4. Cu was lowest at T2 (12.10 ± 0.33 vs. 9.62 ± 0.25 µmol/L, P < 0.001) then increased until T4. There were significant differences in Mg and Fe (P < 0.05), as well as Cu (P < 0.01) between on-pump and off-pump groups. No significant differences were detected between postoperative atrial fibrillation and sinus rhythm groups. CONCLUSIONS: In CABG, Cu and Zn are significantly reduced and Cu is recovered at postoperative Day 1 but Zn takes longer to recover. Addition of Mg and Ca during CABG are sufficient to maintain the plasma concentration. However, supplementation of Cu and Zn during and after CABG may be necessary. Further, the correlation between these trace elements and postoperative AF is to be further determined.

The effect of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.

OBJECTIVE: The purpose of this study was to explore the effects of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting. METHODS: A retrospective study of 99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China. According to the different interventions, all the participants were divided into 3 groups: group A: music therapy; group B: rest without music therapy; and group C: conventional treatment. The Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to measure the patient's pain, anxiety and depression before and after 30 min of the intervention. RESULTS: There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention. After 30 min of music therapy, the NRS, SDS and SAS scores of patients in group A were significantly lower than those before music therapy, and the differences were statistically significant. However, before and after the intervention in groups B and C, the NRS, SDS and SAS scores were not statistically significant. By comparison among the three groups after 30 min of intervention, the NRS, SDS and SAS scores in patients in group A were significantly lower than those in groups B and C, and the differences were statistically significant. The scores were not significantly different between groups B and C. CONCLUSION: Music therapy can effectively alleviate the pain, anxiety and depression of patients after coronary artery bypass grafting.

Distressed communities are associated with worse outcomes after coronary artery bypass surgery.

OBJECTIVES: Although low socioeconomic status has been associated with increased risk of complications after cardiac surgery, analyses have typically focused on insurance status, race, or median income. We sought to determine if the Distressed Communities Index, a composite socioeconomic metric, could predict operative mortality after coronary artery bypass grafting. METHODS: All patients who underwent isolated coronary artery bypass grafting (2011-2018) in the National Society of Thoracic Surgeons adult cardiac surgery database were analyzed. Clinical data were paired with the Distressed Communities Index, which accounts for unemployment, education level, poverty rate, median income, business growth, and housing vacancies by ZIP code. Developed by the Economic Innovation Group, Distressed Communities Index scores range from 0 (no distress) to 100 (severe distress). A distressed community was defined as one having a Distressed Communities Index of 75 or greater for univariate analyses. RESULTS: Of the 575,900 patients undergoing coronary artery bypass grafting with a Distressed Communities Index score, the median age was 65 years. The operative mortality rate was 2.0%, and the composite morbidity or mortality rate was 11.5%. Distressed communities were associated with increased Society of Thoracic Surgeons predicted risk of mortality (1.97% vs 1.85%, P < .0001) and risk of composite morbidity or mortality (12.8% vs 11.7%, P < .0001). After adjusting for Society of Thoracic Surgeons risk model, the Distressed Communities Index remained significantly associated with mortality (odds ratio, 1.12; P < .0001) and composite morbidity and mortality (odds ratio, 1.03; P = .002). CONCLUSIONS: Patients from distressed communities are at increased risk for adverse events and death after coronary artery bypass grafting. The Distressed Communities Index is a useful, holistic measure of socioeconomic status that may help identify high-risk patients for quality improvement and should be considered when building risk models or comparing hospitals.

Role of Prophylactic Magnesium Supplementation in Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting: a Systematic Review and Meta-Analysis of 20 Randomized Controlled Trials.

BACKGROUND: Several randomized trials have evaluated the efficacy of prophylactic magnesium (Mg) supplementation in prevention of post-operative atrial fibrillation (POAF) in patients undergoing cardiac artery bypass grafting (CABG). We aimed to determine the role of prophylactic Mg in 3 different settings (intraoperative, postoperative, intraoperative plus postoperative) in prevention of POAF. METHODS: A systemic literature search was performed (until January 19, 2019) using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to identify trials evaluating Mg supplementation post CABG. Primary outcome of our study was reduction in POAF post CABG. RESULTS: We included a total of 2,430 participants (1,196 in the Mg group and 1,234 in the placebo group) enrolled in 20 randomized controlled trials. Pooled analysis demonstrated no reduction in POAF between the two groups (RR 0.90; 95% CI, 0.79-1.03; p=0.13; I2=42.9%). In subgroup analysis, significant reduction in POAF was observed with postoperative Mg supplementation (RR 0.76; 95% CI, 0.58-0.99; p=0.04; I2=17.6%) but not with intraoperative or intraoperative plus postoperative Mg supplementation (RR 0.77; 95% CI, 0.49-1.22; p = 0.27; I2=49% and RR 0.92; 95% CI, 0.68-1.24; p = 0.58; I2=51.8%, respectively). CONCLUSIONS: Magnesium supplementation, especially in the postoperative period, is an effective strategy in reducing POAF following CABG.

Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial.

BACKGROUND: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized "global" biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump coronary artery bypass grafting (CABG). METHODS: This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured. DISCUSSION: The current study is a preliminary monocentric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large-sample clinical trials using relevant patient-centered clinical outcomes as primary endpoints. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.

Population Pharmacokinetic Model-Based Evaluation of Standard Dosing Regimens for Cefuroxime Used in Coronary Artery Bypass Graft Surgery with Cardiopulmonary Bypass.

The purpose of this study was to investigate the population pharmacokinetics (PK) of cefuroxime in patients undergoing coronary artery bypass graft (CABG) surgery. In this observational pharmacokinetic study, multiple blood samples were collected over a 48-h interval of intravenous cefuroxime administration. The samples were analyzed by using a validated high-performance liquid chromatography (HPLC) method. Population pharmacokinetic models were developed using Monolix (version 4.4) software. Pharmacokinetic-pharmacodynamic (PD) simulations were performed to explore the ability of different dosage regimens to achieve the pharmacodynamic targets. A total of 468 blood samples from 78 patients were analyzed. The PK for cefuroxime were best described by a two-compartment model with between-subject variability on clearance, the volume of distribution of the central compartment, and the volume of distribution of the peripheral compartment. The clearance of cefuroxime was related to creatinine clearance (CLCR). Dosing simulations showed that standard dosing regimens of 1.5 g could achieve the PK-PD target of the percentage of the time that the free concentration is maintained above the MIC during a dosing interval (fTMIC) of 65% for an MIC of 8 mg/liter in patients with a CLCR of 30, 60, or 90 ml/min, whereas this dosing regimen failed to achieve the PK-PD target in patients with a CLCR of ≥125 ml/min. In conclusion, administration of standard doses of 1.5 g three times daily provided adequate antibiotic prophylaxis in patients undergoing CABG surgery. Lower doses failed to achieve the PK-PD target. Patients with high CLCR values required either higher doses or shorter intervals of cefuroxime dosing. On the other hand, lower doses (1 g three times daily) produced adequate target attainment for patients with low CLCR values (≤30 ml/min).

Effects of Tongxinluo Capsules combined with routine treatment on Fib and MPV levels in appropriate patients for CABG surgery / 中成药

AIM To investigate the effects of Tongxinluo Capsules (Ginseng Radix et Rhizoma,Hirudo,Scorpio,etc.) combined with routine treatment on fibrinogen (Fib) and mean platelet volume (MPV) levels in appropriate patients for coronary artery bypass graft (CABG) surgery.METHODS One hundred and six patients were randomly assigned into control group (n =50) for routine treatment and observation group (n =56) for combination therapy of Tongxinluo Capsules and routine treatment.Both groups had their Fib and MPV levels evaluated,and safety compared.RESULTS Thirty,ninety days after the treatment,the two groups reported less incidence of composite cardiovascular events (refractory angina pectoris,relapsing myocardial infarction or death) (P ＜ 0.01),and the observation group had an even more obviously reduced plasma Fib level (P ＜0.01).The significantly decreased after-treatment MPV levels in the two groups were observed (P ＜ 0.05),and a most distinct decrease extent was found in the observation group after 90 d (P ＜ 0.05).For the bleeding events,the incidence rates of the observation group and the control group were 5.4％ and 4.0％,respectively.CONCLUSION For appropriate candidates of CABG surgery,Tongxinluo Capsules shows its efficacy in dissolving thrombus and improving clinical symptoms without serious bleeding risk.

Fish oil supplementation for primary prevention of atrial fibrillation after coronary artery bypass graft surgery: A randomized clinical trial.

BACKGROUND: Atrial fibrillation (AF) after cardiac surgery is a common complication that may influence patients' early and long term outcomes and hospital costs. The purpose of this study was to assess the effect of fish oil on occurrence of AF following coronary artery bypass graft surgery (CABG). METHODS: This study was a single-center, randomized, double blinded, placebo-controlled clinical trial. Four-hundred and one patients undergoing coronary artery bypass graft surgery were randomly assigned to receive 2 g/d fish oil or placebo (olive oil) for at least 5 days before surgery. The primary end point was defined as time to AF improvement After AF incidence following isolated CABG or a need for pharmacologic therapy or cardioversion. RESULTS: The time to AF improvement in intervention group was shorter than control group (HR: 2.05; 95% CI = 0.70-6.22, P = 0.20). The incidence of AF in the intervention and control groups was 8.40% vs. 14.07% respectively (p = 0.07). Mean total duration of AF was 20.96 ± 4.71 h in intervention groups and 46.87 ± 7.44 h in control groups (p = 0.04). Mean duration of stay in the ICU and total hospital stay showed a significant reduction in the intervention group (p = 0.003 and p = 0.04, respectively). CONCLUSION: The consumption of PUFA leads to a shorter time to AF improvement, which was not statistically significant. The incidence of AF in patients undergoing CABG surgery was decreased by approximately 5.7%; which was statistically on the borderline. Fish oil reduced median length of stay in the ICU and hospital. Further well-designed studies are needed to overcome the limitations of the existing trials and provide conclusive conclusions.

Levels of vitamin C In the blood plasma patients treated with coronary artery bypass grafting increases significantly after surgery.

One strong risk factor of coronary artery disease (CAD), which affects the levels of vitamin C in the blood is cigarette smoking. The supplementary effects of coronary artery bypass grafting (CABG) is smoking cessation by patients. Therefore, the aim of this study was to examine the level of vitamin C in the blood plasma one day before and one month after CABG. Human blood were collected from 20 patients (men); 1day before and 1 month after CABG. All patients were smoker and after CABG they declared their not smoking. The concentration of vitamin C in the blood plasma was assayed by FIA method with spectrophotometric detection. The mean value of the vitamin C concentration 1day before CABG was 12.36±2.84µmol/L (mean±SD), 1 month after CABG 40.07±10.95µmol/L (mean±SD). The average increase in the concentration of vitamin C was 3.27±0.73 times (mean±SD) and showed significant positive correlations (Pearson r=0.657, p=0.002). It should be consider incorporating the recommendations of preoperative smoking cessation for at least one month prior to CABG and/or additional supplementation. In addition it would be relevant to monitor the level of vitamin C in the patients' blood in the preoperative period.

Heparinase treatment of heparin-contaminated plasma from coronary artery bypass grafting patients enables reliable quantification of microRNAs.

BACKGROUND: microRNAs have recently been identified as powerful biomarkers of human disease. Reliable polymerase chain reaction (PCR)-based quantification of nucleic acids in clinical samples contaminated with polymerase inhibitor heparin requires deheparinization. However, the effects of deheparinization procedure on quantification of nucleic acids remain largely unknown. The aim of this study was to determine whether the deheparinization procedure completely eliminates the inhibition of amplification, while maintaining RNA integrity and technical variability of the measured microRNA levels. METHODS: Heparinized plasma from 9 patients undergoing coronary artery bypass grafting (CABG) and the heparin-free plasma from 58 rats were spiked with a synthetic RNA oligonucleotide and total RNA was extracted. The RNA solutions were then treated with heparinase I to remove contaminating heparin prior to reverse transcription. Levels of synthetic spike-in RNA oligonucleotide, as well as endogenous hsa-miR-1-3p and hsa-miR-208a-3p, were measured using quantitative reverse transcription PCR (RT-qPCR). The amplification efficiency and presence of inhibitors in individual samples were directly determined using calibration curves. RESULTS: In contrast to RNA samples from rat plasma, RNA samples derived from the CABG patient plasma contained inhibitors, which were completely eliminated by treatment with heparinase. The procedure caused a decrease in the amount of detected RNA; however, the technical variability of the measured targets did not change, allowing for the quantification of circulating endogenous hsa-miR-1-3p and hsa-miR-208a-3p in the plasma of CABG patients. CONCLUSIONS: The heparinase treatment procedure enables utilization of RT-qPCR for reliable microRNA quantification in heparinized plasma.

The effectiveness of lavender essence on strernotomy related pain intensity after coronary artery bypass grafting.

BACKGROUND: Considering the side effects of pharmacological methods, there has been a suggestion to use nonpharmacological methods such Aromatherapy following coronary artery bypass grafting (CABG). This study aims to evaluate the effectiveness of lavender 2% aromatherapy on sternotomy pain intensity after coronary artery bypass graft surgery in patients who have undergone surgery. MATERIALS AND METHODS: During this clinical trial, 50 patients who were candidates for CABG, were randomly divided into two equal groups, that is, the control group (n = 25) and the case group (n = 25). Following CABG, the case group received two drops of 2% lavender oil every 15 minutes with supplemental oxygen and the control group received only supplemental oxygen through a face mask. The data collection tools comprised of the demographic check list and visual analog scale (VAS) for evaluating the pain intensity. The pain intensity were assessed pre- and five, 30, and 60 minutes post aromatherapy. The final data were analyzed by the t-test and chi-squared test. RESULTS: The findings showed that the pain perception intensity in the case group was lower than that in the control group at the 30- and 60-minute phases after intervention (P < 0.0001). CONCLUSION: The result indicated that aromatherapy can be used as a complementary method in postoperative pain reduction, as it reduced pain. The patients require two sedative drugs, and moreover, it avoids expenses of treatment.

Propofol cardioplegia: A single-center, placebo-controlled, randomized controlled trial.

OBJECTIVES: Cardiac surgery with cardiopulmonary bypass and cardioplegic arrest is an effective treatment for coronary artery and aortic valve diseases. However, the myocardium sustains reperfusion injury after ischemic cardioplegic arrest. Our objective was to assess the benefits of supplementing cardioplegia solution with the general anesthetic propofol in patients undergoing either coronary artery bypass grafting (CABG) or aortic valve replacement (AVR). METHODS: A single-center, double-blind randomized controlled trial was carried out to compare cardioplegia solution supplemented with propofol (concentration 6 µg/mL) versus intralipid (placebo). The primary outcome was cardiac troponin T release over the first 48 hours after surgery. RESULTS: We recruited 101 participants (51 in the propofol group, 50 in the intralipid group); 61 underwent CABG and 40 underwent AVR. All participants were followed to 3 months. Cardiac troponin T release was on average 15% lower with propofol supplementation (geometric mean ratio, 0.85; 95% confidence interval [CI], 0.73-1.01; P = .051). There were no differences for CABG participants but propofol-supplemented participants undergoing AVR had poorer postoperative renal function (geometric mean ratio, 1.071; 95% CI, 1.019-1.125; P = .007), with a trend toward longer intensive care stay (median, 89.5 vs 47.0 hours; hazard ratio, 0.58; 95% CI, 0.31-1.09; P = .09) and fewer with perfect health (based on the EQ-5D health utility index) at 3 months (odds ratio, 0.26; 95% CI, 0.06-1.05; P = .058) compared with the intralipid group. Safety profiles were similar. There were no deaths. CONCLUSIONS: Propofol supplementation in cardioplegia appears to be cardioprotective. Its influence on early clinical outcomes may differ between CABG and AVR surgery. A larger, multicenter study is needed to confirm or refute these suggestions.