Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.

BACKGROUND: Surgical occlusion of the left atrial appendage has been hypothesized to prevent ischemic stroke in patients with atrial fibrillation, but this has not been proved. The procedure can be performed during cardiac surgery undertaken for other reasons. METHODS: We conducted a multicenter, randomized trial involving participants with atrial fibrillation and a CHA2DS2-VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating greater risk of stroke) who were scheduled to undergo cardiac surgery for another indication. The participants were randomly assigned to undergo or not undergo occlusion of the left atrial appendage during surgery; all the participants were expected to receive usual care, including oral anticoagulation, during follow-up. The primary outcome was the occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism. The participants, research personnel, and primary care physicians (other than the surgeons) were unaware of the trial-group assignments. RESULTS: The primary analysis population included 2379 participants in the occlusion group and 2391 in the no-occlusion group, with a mean age of 71 years and a mean CHA2DS2-VASc score of 4.2. The participants were followed for a mean of 3.8 years. A total of 92.1% of the participants received the assigned procedure, and at 3 years, 76.8% of the participants continued to receive oral anticoagulation. Stroke or systemic embolism occurred in 114 participants (4.8%) in the occlusion group and in 168 (7.0%) in the no-occlusion group (hazard ratio, 0.67; 95% confidence interval, 0.53 to 0.85; P = 0.001). The incidence of perioperative bleeding, heart failure, or death did not differ significantly between the trial groups. CONCLUSIONS: Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it. (Funded by the Canadian Institutes of Health Research and others; LAAOS III ClinicalTrials.gov number, NCT01561651.).

Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial.

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.

Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. METHODS: The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. FINDINGS: Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs 177 [5%] patients; relative risk [RR] 0·87, 95% CI 0·70-1·07, p=0·19) or the risk of death or major morbidity (909 [24%] vs 885 [24%]; RR 1·03, 95% CI 0·95-1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 [12%] vs 493 [13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295 [8%] vs 289 [8%]). INTERPRETATION: Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. FUNDING: Canadian Institutes of Health Research.

When to anatomically excise a benign lung tumor-correspondence regarding the article: "large mesenchymal cystic and chondroid pulmonary hamartoma mimicking lung cancer: case report".

The decision of whether to perform a large anatomic resection for a lung mass that is not definitely malignant comes often forward in the everyday practice of the thoracic surgeon. The general characteristics of the tumor as well as of the patient and the instinct and experience of the surgeon are the ones that dictate the final choice. Such a decision was made in the case of a large pulmonary hamartoma where a right middle lobectomy was performed with the postoperative course justifying the surgeons' choice.

"Maternal diabetes mellitus and its impact on the risk of delivering a child with congenital heart disease: a systematic review and meta-analysis".

AIM: Maternal pregestational diabetes mellitus (PGDM), type 1 or type 2, has been established as a potential risk factor for congenital heart disease (CHD). At the same time, the correlation between gestational diabetes mellitus (GDM) and increased risk of CHD has not been yet fully elucidated. The objective of this systematic review and meta-analysis (PROSPERO number: CRD42020182390) was to analyze the existing evidence on PGDM and to attempt to fill, to the best of our ability, the remaining knowledge gap in the association of GDM with CHD. MATERIALS AND METHODS: Two authors have independently searched the Pubmed/Medline, Scopus, Cochrane, Web of Science, and Theses Global databases with keywords and Boolean operators. The search yielded 9333 relevant articles, which were later screened for eligibility. Original peer-reviewed (case-control or cohort) studies were included if they were published in English between 1997 and 2020. Thirteen studies on mothers with PGDM and seven studies on mothers with GDM were finally included in our meta-analysis to investigate the association of maternal diabetes with the risk of delivering a child with CHD. The selected studies were all assessed for their methodological quality using the Newcastle-Ottawa scale. Associations with p < .05 were considered statistically significant. RESULTS: Our meta-analysis (I2 > 75%, total population: n = 12,461,586) of 79,476 women with PGDM and 160,893 with GDM produced an odds ratio of 3.48 (2.36-4.61) and 1.55 (1.48-1.61), respectively. Additionally, we did not find any noticeable difference in the risk for CHD among diabetic women living in the USA and Europe. Nevertheless, it still needs to be clarified, whether or not the gestational diabetic population includes undiagnosed women with preexisting diabetes, which might account for the increased risk of delivering a child with CHD in women classified as suffering from GDM. CONCLUSION: While both GDM and PGDM seem to significantly increase the risk of CHD in comparison with the general population, PDGM appears to have a greater association with CHD, being correlated with a 3.5-fold increase in the risk of malformation. Preconceptional and gestational diabetes care are, therefore, essential to mitigate the adverse effect of hyperglycemia on fetal heart formation during pregnancy.

Double auricles of the right atrium: a unique anatomic deformity.

BACKGROUND: Anatomic deviations, especially those detected during the course of an operation, are medically intriguing, as they raise concerns about their clinical significance and putative complications. CASE PRESENTATION: We present, to our knowledge, for the first time a case of an anatomic deviation in the form of a second right atrial auricle in a 70 year-old, coronary bypass-operated male Caucasian patient of Greek origin. No complications were noted intra-or postoperatively. CONCLUSIONS: A second right atrial auricle was found intraoperatively, without causing any clinical complications, or obstructing the normal course of a surgical procedure.

Visual disorders or "eye stroke"after heart surgery: can we prevent it?

The aim of the study was to elucidate the problem of visual disorders after heart surgery, focusing on aetiology, modes of prevention and treatment. Information from a literature search and the authors' personal experience are provide clues as to the modes of development and the means of avoidance and therapy of this category of postoperative, neurosensory complications. Multiple morbid situations, such as preoperative augmented ocular pressure, perioperative bleeding and hypotension, are shown to be predisposing and precipitating factors. Medical treatment seems to be less important than minimisation of risk factors. Prevention rather than treatment is more helpful for heart-operated patients, as far as postoperative visual disorders are concerned.

The role of apolipoprotein E in cognitive decline and delirium after bypass heart operations.

Cognitive decline and delirium are common complications after heart bypass surgery. Based on the reported role of the APOE-epsilon 4 allele in neurodegenerative diseases, we studied its association with these complications. A neuropsychological test battery consisting of the Mini Mental State Examination, the Wechsler's Memory Scale Revised, the Brief Psychiatric Rating Scale, and the Delirium Rating Scale was applied to 137 APOE-genotyped patients on admission and 1 month after bypass surgery. We correlated the APOE (apolipoprotein E) polymorphism with the postoperative test outcome by taking into account all factors known to influence cognitive capacity after heart surgery. There was a significant decline in all test results 1 month after surgery and a high frequency of postoperative delirium. Neither this decline nor the frequency of delirium was associated with the APOE-epsilon 4 allele. This study confirms the high incidence of cognitive decline and delirium after coronary surgery, but it does not support the role of the APOE-epsilon 4 allele in the occurrence of these complications.

Albumin-glutaraldehyde bioadhesive ("Bioglue") for prevention of postoperative complications after stapled hemorrhoidopexy: A randomized controlled trial.

BACKGROUND: Hemorrhoidopexy using the circumferential stapler is an established method for surgical treatment of patients with prolapsing hemorrhoids. Despite its advantages, complications such as anal canal stenosis, hemorrhage and anastomosis leak with eventual intrapelvic sepsis can cause serious postoperative problems. The aim of this study was to evaluate the utility of a surgical adhesive, the biological albumin-glutaraldehyde glue "Bioglue", in reduction of these postoperative complications. PATIENTS AND METHODS: Between January 2002 and November 2004, 200 patients undergoing stapled hemorrhoidopexy were enrolled in a prospective, randomized clinical trial. One hundred patients were randomly assigned to the control group; the study group consisted of 100 patients who received Bioglue in the mucosa anastomosis area. All patients received standardized postoperative analgesic, laxative and antibiotic treatment. We then evaluated the two groups for postoperative complications (after surgery and 6 months postoperatively). RESULTS: From the control group (no Bioglue application), two patients presented with anal stenosis, two with hemorrhage, three had anastomosis leak and one had thrombosis, whereas none of the patients from the Bioglue group had any of these complications. Both groups had patients with severe postoperative pain (3 each) and fecal incontinence (1 patient each). The overall difference in the number of complications in the two groups was statistically significant (p < 0.05). CONCLUSION: In this first study using Bioglue in patients undergoing circumferential stapled hemorrhoidopexy we have shown that application of the glue is effective in reducing postoperative complications.

Ranolazine enhances the antiarrhythmic activity of amiodarone by accelerating conversion of new-onset atrial fibrillation after cardiac surgery.

Ranolazine is a relatively novel antiischemic/antianginal compound with antiarrhythmic properties. We investigated its ability to shorten the time to conversion of postoperative atrial fibrillation (POAF) when added to amiodarone after coronary artery bypass graft (CABG) surgery. In this prospective, randomized, allocation-concealed, single-blind, single-site clinical trial, we enrolled consecutive eligible patients who developed POAF after elective on-pump CABG surgery. Participants were randomized to receive either ranolazine 375 mg twice daily orally plus intravenous amiodarone (active group) or intravenous amiodarone alone (control group). We enrolled 41 patients; 20 in the active and 21 in the control group. There were no significant differences between the groups in terms of age, procedural duration, extracorporeal circulation time, and aortic cross-clamp time. Mean time of conversion was significantly shorter in the active group (19.9 ± 3.2 vs 37.2 ± 3.9 hours, P < .001), suggesting that compared to amiodarone alone, the ranolazine-amiodarone combination had a superior antiarrhythmic effect against POAF.

Effect of ranolazine in preventing postoperative atrial fibrillation in patients undergoing coronary revascularization surgery.

BACKGROUND/OBJECTIVE: Ranolazine is a new anti-ischemic agent approved for chronic angina with additional electrophysiologic properties. The purpose of the present trial was to investigate its effect in preventing postoperative atrial fibrillation (POAF) after on-pump coronary artery bypass graft (CABG) surgery. METHODS: In the current prospective, randomized, (1 active: 2 control), single-blind (outcome assessors), single-centre clinical trial we recruited consecutive eligible patients scheduled for elective on-pump CABG. Participants were assigned to receive either oral ranolazine 375 mg twice daily for 3 days prior to surgery and until discharge, or to receive usual care. Patients were monitored for the development of POAF. RESULTS: We enrolled 102 patients. Significantly lower incidence of POAF was noted in the ranolazine group compared with the control group (3 out of 34 patients, 8.8%, vs 21 out of 68 patients, 30.8%; p< 0.001). Mean values of left atrial diameter and left ventricular ejection fraction between the control and the ranolazine group were not significantly different. CONCLUSION: Our findings suggest a protective role of oral ranolazine when administered in a moderate dose preoperatively in patients undergoing on-pump CABG surgery. Future studies based on a wider sample of patients will eventually support our conclusions.

Classic and non-classic forms of mitral valve prolapse.

OBJECTIVE: To investigate the significance of the established distinction between classic and non-classic forms of mitral valve prolapsed (MVP). METHODS: We included in this prospective study all patients examined in our preventive cardiology outpatient clinics during the biannual period October 2004-October 2006. We examined in total 10.818 patients, 238 of whom (2.2%) were diagnosed for MVP. We noted relevant demographic and clinical data (gender, age of diagnosis, symptoms, need for hospitalization) and performed statistical comparisons between patients with the classic and those with the non-classic form. Follow-up controls were performed three years afterwards. RESULTS: Patients with the classic form had an earlier age of first diagnosis, more prominent symptoms, and more frequently diagnosis for other disorders (atrial septal defect, ventricular septal defect, Marfan syndrome, Ehlers-Danlos syndrome) than the rest of the patients; however, there were no significant differences as far as certain major complications (stroke, death, submission to surgery) were concerned. CONCLUSION: The classic form of mitral valve prolapse is more tightly associated with morbid complications, and a more frequent follow-up control in this group of patients may be useful.

Ondasetron versus haloperidol for the treatment of postcardiotomy delirium: a prospective, randomized, double-blinded study.

BACKGROUND: To investigate the controlling efficacy of ondasetron and haloperidol in regard to the postcardiotomy delirium. METHODS: We included in this prospective, randomized, double-blinded study 80 patients who developed delirium after heart surgery with the application of heart lung-machine. The patients were divided into two, equally-sized groups, which on detection of delirium received ondasetron 8 mg iv or haloperidol 5 mg iv respectively. The statistical analysis compared the baseline and demographic characteristics of the two groups (age, gender, comorbidities, years of education, type of surgery etc.). RESULTS: Both ondasetron and haloperidol had very good delirium controlling effects, without statistically significant differences. DISCUSSION-CONCLUSIONS: Ondasetron and haloperidol are efficient agents as far as the treatment of postcardiotomy delirium is concerned. As, in addition, ondasetron bares milder side-effects, we believe this could be the agent of choice in patients developing postcardiotomy delirium in the future.