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Atrial nitroso-redox balance and refractoriness following on-pump cardiac surgery: a randomized trial of atorvastatin.
Jayaram, R, Jones, M, Reilly, S, Crabtree, MJ, Pal, N, Goodfellow, N, Nahar, K, Simon, J, Carnicer, R, DeSilva, R, et al
Cardiovascular research. 2022;(1):184-195
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Abstract
AIMS: Systemic inflammation and increased activity of atrial NOX2-containing NADPH oxidases have been associated with the new onset of atrial fibrillation (AF) after cardiac surgery. In addition to lowering LDL-cholesterol, statins exert rapid anti-inflammatory and antioxidant effects, the clinical significance of which remains controversial. METHODS AND RESULTS We first assessed the impact of cardiac surgery and cardiopulmonary bypass (CPB) on atrial nitroso-redox balance by measuring NO synthase (NOS) and GTP cyclohydrolase-1 (GCH-1) activity, biopterin content, and superoxide production in paired samples of the right atrial appendage obtained before (PRE) and after CPB and reperfusion (POST) in 116 patients. The effect of perioperative treatment with atorvastatin (80 mg once daily) on these parameters, blood biomarkers, and the post-operative atrial effective refractory period (AERP) was then evaluated in a randomized, double-blind, placebo-controlled study in 80 patients undergoing cardiac surgery on CPB. CPB and reperfusion led to a significant increase in atrial superoxide production (74% CI 71-76%, n = 46 paired samples, P < 0.0001) and a reduction in atrial tetrahydrobiopterin (BH4) (34% CI 33-35%, n = 36 paired samples, P < 0.01), and in GCH-1 (56% CI 55-58%, n = 26 paired samples, P < 0.001) and NOS activity (58% CI 52-67%, n = 20 paired samples, P < 0.001). Perioperative atorvastatin treatment prevented the effect of CPB and reperfusion on all parameters but had no significant effect on the postoperative right AERP, troponin release, or NT-proBNP after cardiac surgery. CONCLUSION Perioperative statin therapy prevents post-reperfusion atrial nitroso-redox imbalance in patients undergoing on-pump cardiac surgery but has no significant impact on postoperative atrial refractoriness, perioperative myocardial injury, or markers of postoperative LV function. CLINICAL TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT01780740.
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Efficacy of Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in Cardiac Surgical Procedures: A Randomized Controlled | Parallel Group Study.
Ali, I, Hassan, A, Shokri, H, Khorshed, R
The heart surgery forum. 2021;(1):E170-E176
Abstract
BACKGROUND In cardiac surgery, myocardial protection is required during cross-clamping followed by reperfusion. The use of cardioplegic solutions helps preserve myocardial energy stores, hindering electrolyte disturbances and acidosis during periods of myocardial ischaemia. This study aimed to compare the efficacy and safety between the histidine-tryptophan-ketoglutarate (HTK) solution and blood cardioplegia in various cardiac surgeries. METHODS Three-hundred-twenty patients aged 30-70 years old undergoing various cardiac surgeries were randomized into the HTK group and the blood cardioplegia group. The ventilation time, total bypass time, cross-clamp time, length of intensive care unit (ICU) or hospital stay, and postoperative complications were analyzed. RESULTS The total bypass time and cross-clamp time were significantly shorter in the HTK group than in the blood cardioplegia group (P < 0.001). Segmental wall motion abnormalities (SWMA) at postoperative echocardiography were significantly higher in in the blood cardioplegia group (P = 0.008). The number of patients requiring DC Shock was significantly higher in the HTK group (P < 0.001). The number of patients requiring inotropic support was significantly higher in the blood cardioplegia group (P < 0.001). The length of ICU, hospital stay, and ventilation time were significantly longer in the blood cardioplegia group than in the HTK group (P = 0.004, P < 0.001, P < 0.001, respectively). The number of patients requiring prolonged ventilation was significantly higher in the blood cardioplegia group compared with the HTK group (P = 0.022). There was no significant difference between the study groups regarding electrocardiographic changes, 30-day mortality, and 30-day readmission. CONCLUSION The use of HTK cardioplegia was associated with significantly shorter cross-clamp time, bypass time, duration of mechanical ventilation, length of ICU stay, and length of hospital stay. It is associated with less incidence of postoperative segmental wall abnormalities and less need for inotropic support than blood cardioplegia. Custodiol cardioplegia is a safe and feasible option that can be used as an effective substitute for blood cardioplegia to enhance myocardial protection.
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The efficacy of early postoperative enteral immunonutrition on T-lymphocyte count: A randomised control study in low-risk cardiac surgery patients.
Svetikiene, M, Ringaitiene, D, Vezeliene, J, Isajevas, V, Trybe, D, Vicka, V, Malickaite, R, Jurgauskiene, L, Norkuniene, J, Serpytis, M, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(2):372-379
Abstract
BACKGROUND Patients undergoing cardiac surgery have a pronounced immune response that leads to a reduction in cellular immunity. Immune-modulating nutritional supplements are considered to be beneficial for patients undergoing major surgery. However, due to the lack of studies in the cardiac surgery population, the effect of immunonutrition remains unclear in this patient group. OBJECTIVE Our purpose was to research the efficacy of early postoperative enteral immunonutrition on T-lymphocyte count in the cardiac surgery population. METHODS This was a randomised control study of low operative risk adult patients, who underwent elective cardiac surgery. These patients were randomised into immunonutrition and control groups. The immunonutrition group was supplemented with immune nutrients for five postoperative days. The counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations were determined on the day of surgery and on the sixth postoperative day. RESULTS Fifty-five patients were enrolled in the study, the mean age was 69.7 ± 6.3 years, 28 (50.9%) of them were males, the median operative risk was 1.75%. Twenty-seven (49.1%) were randomised into the immunonutrition group. The control and the immunonutrition groups were similar before the intervention. The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56 (∗109/l), p = 0.035 and 1.02 ± 0.36 vs. 0.80 ± 0.43 (∗109/l), p = 0.048, respectively. Regression analysis was performed to determine the efficacy of the immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts were increased to 0.264 (∗109/l), p = 0.039 and 0.232 (∗109/l), p = 0.021, respectively. CONCLUSIONS Early postoperative immunonutrition increases the count of the CD3+ and CD4+ T cells in cardiac surgical patients. Clinical trials identifier number: NCT04047095.
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Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO).
Khoshbin, E, Spencer, S, Solomon, L, Tang, A, Clark, S, Stokes, E, Wordsworth, S, Dabner, L, Edwards, J, Reeves, B, et al
Journal of cardiothoracic surgery. 2021;(1):58
Abstract
BACKGROUND Acute Kidney Injury (AKI) adversely affects outcomes after cardiac surgery. A major mediator of AKI is the activation of leukocytes through exposure to the cardiopulmonary bypass circuit. We evaluate the use of leukodepletion filters throughout bypass to protect against post-operative AKI by removing activated leukocytes during cardiac surgery. METHODS This is a single-centre, double-blind, randomized controlled trial comparing the use of leukodepletion versus a standard arterial filter throughout bypass. Elective adult patients undergoing heart valve surgery with or without concomitant procedures were investigated. The primary clinical outcome measured was the development of AKI according to the KDIGO criteria. Secondary measures included biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires. RESULTS The ROLO trial randomized 64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated). The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI - 2 to 44%). This clinical finding was supported by biomarker levels especially by a tendency toward glomerular insult at 48 h, demonstrated by a raised serum Cystatin C (mean difference 0.11, 95% CI 0.00 to 0.23, p = 0.068) in the leukodepleted group. There was however no clear association between the incidence or severity of AKI and length of hospital stay. On average, health related quality of life returned to pre-operative levels in both groups within 3 months of surgery. CONCLUSIONS Leukocyte depletion during cardiopulmonary bypass does not significantly reduce the incidence of AKI after valvular heart surgery. Other methods to ameliorate renal dysfunction after cardiac surgery need to be investigated. TRIAL REGISTRATION The trial was registered by the International Standard Randomized Controlled Trial Number Registry ISRCTN42121335 . Registered on the 18 February 2014. The trial was run by the Bristol Clinical Trials and Evaluation Unit. This trial was financially supported by the National Institute of Health Research (Research for Patient Benefit), award ID: PB-PG-0711-25,090.
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Vitamin D supplementation protects against reductions in plasma 25-hydroxyvitamin D induced by open-heart surgery: Assess-d trial.
Barker, T, May, HT, Doty, JR, Lappe, DL, Knowlton, KU, Carlquist, J, Konery, K, Inglet, S, Chisum, B, Galenko, O, et al
Physiological reports. 2021;(3):e14747
Abstract
Low vitamin D (serum or plasma 25-hydroxyvitamin D (25(OH)D)) is a global pandemic and associates with a greater prevalence in all-cause and cardiovascular mortality and morbidity. Open-heart surgery is a form of acute stress that decreases circulating 25(OH)D concentrations and exacerbates the preponderance of low vitamin D in a patient population already characterized by low levels. Although supplemental vitamin D increases 25(OH)D, it is unknown if supplemental vitamin D can overcome the decreases in circulating 25(OH)D induced by open-heart surgery. We sought to identify if supplemental vitamin D protects against the acute decrease in plasma 25(OH)D propagated by open-heart surgery during perioperative care. Participants undergoing open-heart surgery were randomly assigned (double-blind) to one of two groups: (a) vitamin D (n = 75; cholecalciferol, 50,000 IU/dose) or (b) placebo (n = 75). Participants received supplements on three separate occasions: orally the evening before surgery and either orally or per nasogastric tube on postoperative days 1 and 2. Plasma 25(OH)D concentrations were measured at baseline (the day before surgery and before the first supplement bolus), after surgery on postoperative days 1, 2, 3, and 4, at hospital discharge (5-8 days after surgery), and at an elective outpatient follow-up visit at 6 months. Supplemental vitamin D abolished the acute decrease in 25(OH)D induced by open-heart surgery during postoperative care. Moreover, plasma 25(OH)D gradually increased from baseline to day 3 and remained significantly increased thereafter but plateaued to discharge with supplemental vitamin D. We conclude that perioperative vitamin D supplementation protects against the immediate decrease in plasma 25(OH)D induced by open-heart surgery. ClinicalTrials.gov Identifier: NCT02460211.
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Prospective Evaluation of Clinico-Pathological Predictors of Postoperative Atrial Fibrillation: An Ancillary Study From the OPERA Trial.
Corradi, D, Saffitz, JE, Novelli, D, Asimaki, A, Simon, C, Oldoni, E, Masson, S, Meessen, JMTA, Monaco, R, Manuguerra, R, et al
Circulation. Arrhythmia and electrophysiology. 2020;(8):e008382
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Abstract
BACKGROUND Postoperative atrial fibrillation (POAF) occurs in 30% to 50% of patients undergoing cardiac surgery and is associated with increased morbidity and mortality. Prospective identification of structural/molecular changes in atrial myocardium that correlate with myocardial injury and precede and predict risk of POAF may identify new molecular pathways and targets for prevention of this common morbid complication. METHODS Right atrial appendage samples were prospectively collected during cardiac surgery from 239 patients enrolled in the OPERA trial (Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation), fixed in 10% buffered formalin, and embedded in paraffin for histology. We assessed general tissue morphology, cardiomyocyte diameters, myocytolysis (perinuclear myofibril loss), accumulation of perinuclear glycogen, interstitial fibrosis, and myocardial gap junction distribution. We also assayed NT-proBNP (N-terminal pro-B-type natriuretic peptide), hs-cTnT, CRP (C-reactive protein), and circulating oxidative stress biomarkers (F2-isoprostanes, F3-isoprostanes, isofurans) in plasma collected before, during, and 48 hours after surgery. POAF was defined as occurrence of postcardiac surgery atrial fibrillation or flutter of at least 30 seconds duration confirmed by rhythm strip or 12-lead ECG. The follow-up period for all arrhythmias was from surgery until hospital discharge or postoperative day 10. RESULTS Thirty-five percent of patients experienced POAF. Compared with the non-POAF group, they were slightly older and more likely to have chronic obstructive pulmonary disease or heart failure. They also had a higher European System for Cardiac Operative Risk Evaluation and more often underwent valve surgery. No differences in left atrial size were observed between patients with POAF and patients without POAF. The extent of atrial interstitial fibrosis, cardiomyocyte myocytolysis, cardiomyocyte diameter, glycogen score or Cx43 distribution at the time of surgery was not significantly associated with incidence of POAF. None of these histopathologic abnormalities were correlated with levels of NT-proBNP, hs-cTnT, CRP, or oxidative stress biomarkers. CONCLUSIONS In sinus rhythm patients undergoing cardiac surgery, histopathologic changes in the right atrial appendage do not predict POAF. They also do not correlate with biomarkers of cardiac function, inflammation, and oxidative stress. Graphic Abstract: A graphic abstract is available for this article.
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Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial.
Garg, AX, Chan, MTV, Cuerden, MS, Devereaux, PJ, Abbasi, SH, Hildebrand, A, Lamontagne, F, Lamy, A, Noiseux, N, Parikh, CR, et al
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2019;(9):E247-E256
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BACKGROUND Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.
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ZipFix Versus Conventional Sternal Closure: One-Year Follow-Up.
Nezafati, P, Shomali, A, Kahrom, M, Omidvar Tehrani, S, Dianatkhah, M, Nezafati, MH
Heart, lung & circulation. 2019;(3):443-449
Abstract
BACKGROUND The present study aimed to compare postoperative complications commonly revealed after sternotomy closure by new sternal ZipFix™ (Synthes GmbH, Oberdorf, Switzerland) implant and conventional steel wire. METHODS Among the initial 360 subjects, 326 patients enrolled in this randomised control trial who were candidates for cardiac surgery from April 2014 to March 2015. After the surgery, the sternal closure was randomly done with poly-ether-ether-ketone (PEEK) based sternal ZipFix (ZF) on the sternal body (n=168) or with conventional wires (CWs) (n=158). Patients were followed postoperatively as well as 1, 3, 6, and 12 months after discharge regarding postoperative complications such as pain severity, dehiscence, and infection including incisional infections (superficial or deep), and organ/space infection (mediastinitis or osteomyelitis). RESULTS The mean age of the ZF and CW groups were 63.58±10.9 and 62.42±7.1years, respectively (p=0.262). In addition, there was no significant difference between the two groups' baseline characteristics (p>0.05). Our study showed higher mean pain severity score in the conventional closure group compared with ZipFix closure group at all study time points (p<0.001). Infection was seen in 2.76% of the overall participants with no significant difference of incisional and organ infection between the two groups throughout the study. After 1-month follow-up, five patients in the CW group had sternal dehiscence whereas no patients in ZF had dehiscence (p<0.001). CONCLUSIONS Our trial demonstrates greater clinical advantages in terms of pain and sternal dehiscence post surgery by using sternal ZipFix compared to conventional steel wire.
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Temporary autonomic modulation with botulinum toxin type A to reduce atrial fibrillation after cardiac surgery.
Waldron, NH, Cooter, M, Haney, JC, Schroder, JN, Gaca, JG, Lin, SS, Sigurdsson, MI, Fudim, M, Podgoreanu, MV, Stafford-Smith, M, et al
Heart rhythm. 2019;(2):178-184
Abstract
BACKGROUND Postoperative atrial fibrillation (POAF) frequently complicates cardiac surgery and is associated with worse outcomes. The cardiac autonomic nervous system is implicated in the pathogenesis of POAF. OBJECTIVE The purpose of this study was to determine the efficacy and safety of selective cardiac autonomic modulation in preventing POAF. METHODS In this randomized, double-blind, placebo-controlled trial, adults undergoing cardiac surgery were randomized 1:1 to intraoperative injection of 250 units onabotulinumtoxinA (botulinum toxin type A [BoNTA]) or placebo into epicardial fat pads. The study was powered to detect a 40% reduction in relative risk of POAF. Time to first episode of in-hospital POAF was the primary outcome, evaluated in patients receiving injection. Additionally, incidence of POAF, length of stay (LOS), and adverse events were examined. RESULTS The trial assigned 145 patients to injection, 15 of whom were dropped before treatment, leaving 130 patients for analysis. Overall, 36.5% (23/63) of BoNTA-treated patients developed POAF compared with 47.8% (32/67) of placebo-treated patients. The time-to-event analysis revealed a hazard ratio of 0.69 (95% confidence interval 0.41-1.19; P = .18) for the BoNTA vs placebo arm. There were no significant differences in postoperative hospital LOS (median [interquartile range] 6.0 [3.4] vs 6.2 [3.7] days; P = .51) or adverse events prolonging LOS (27/63 [42.9%] vs 30/67 [44.8%]; P = .83) in patients receiving BoNTA vs placebo. CONCLUSION Epicardial injection of onabotulinumtoxinA was without discernible adverse effects, but we failed to detect a significant difference in risk of POAF. Future large-scale studies of epicardial onabotulinumtoxinA injection as a potential POAF prevention strategy should be designed to study smaller, but clinically meaningful, treatment effects.
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20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients After Cardiac Surgery (the HAS FLAIR Study).
Wigmore, GJ, Anstey, JR, St John, A, Greaney, J, Morales-Codina, M, Presneill, JJ, Deane, AM, MacIsaac, CM, Bailey, M, Tatoulis, J, et al
Journal of cardiothoracic and vascular anesthesia. 2019;(11):2920-2927
Abstract
OBJECTIVE To compare the effects of fluid bolus therapy using 20% albumin versus crystalloid on fluid balance, hemodynamic parameters, and intensive care unit (ICU) treatment effects in post-cardiac surgery patients. DESIGN Sequential period open-label pilot study. SETTING University teaching hospital. PARTICIPANTS One hundred adult cardiac surgery patients who were prescribed fluid bolus therapy to correct hypotension or perceived hypovolemia or to optimize cardiac index during the first 24 hours in the ICU. INTERVENTIONS The first 50 patients were treated with crystalloid fluid bolus therapy in the first period (control), and 50 patients with up to 2 treatments of 100 mL of 20% albumin fluid bolus therapy in the second period (intervention), followed by crystalloid therapy if needed. MEASUREMENTS AND MAIN RESULTS Demographic characteristics were similar at baseline. The intervention was associated with a less positive median fluid balance in the first 24 hours (albumin: 1,100 [650-1,960] v crystalloid: 1,970 [1,430-2,550] p = 0.001), fewer episodes of fluid bolus therapy (3 [2-5] v 5 [4-7]; p < 0.0001) and a lesser volume of fluid bolus therapy (700 [200-1,450] v 1,500 mL/24 h [1,100-2,250]; p < 0.0001). The intervention also was associated with a decreased median overall dose of norepinephrine in the first 24 hours of ICU stay (19 [0-52] v 47 µg/kg/24 hours [0-134]; p = 0.025) and shorter median time to cessation of norepinephrine (17 [5-28] v 28 hours [20-48]; p = 0.002). CONCLUSION Post-cardiac surgery fluid bolus therapy with 20% albumin when compared with crystalloid fluid resulted in less positive fluid balance as well as several hemodynamic and potential ICU treatment advantages.